Plain Language Home Plain Language Toolkit Home Plain Language Home Why Plain Language is Important Using Plain Language When Writing For Medications When Talking to Patients Tools Patient-Friendly Word List PDF Tools to Help Patients For a printable (PDF) version of this toolkit contact patienthealth@ghc. org. What is plain language? Plain language is communication that an audience can understand the first time they read or hear it. The concept of using plain language is closely related to the concept of health literacy. In short, clear communication is critical to successful health care. Providing high-quality care is at the heart of Group Health, and clear communication is both a key component of quality and an expression of our core values. Group Health’s key strategies focus on patients, people, and purchasers. By using plain language, we: ● ● Want to Learn More? Frequently Asked Questions Resources and References Contact Us Show patients that we're invested in them and respect their needs. Optimize performance and effectively engage people on staff by ensuring that information is readily understandable, and less likely to result in medical errors or compromise patient safety. ● Demonstrate to purchasers that we are a trusted partner with this attention to clear and comprehensible products and services. Plain language makes sense See some health-care related "before" and "after" plain language examples. Group Health Plain Language partners: ● ● ● ● ● ● ● Center for Health Studies Communications and Community Relations Group Health Permanente Practice and Leadership Development Interpretive Services Patient Health Education Resources (PHER) Patient Safety Quality and Informatics Division of S2Q Comments or questions? Contact us: patienthealth@ghc.org. 1 of 56 Copyright© 2007–2008 Group Health Cooperative. All rights reserved. Why Plain Language is Important Plain Language Toolkit Why Plain Language is Important Plain Language Home Improves Communication Why Plain Language is Important In health care, plain language is critically important, but often overlooked. Clinicians are accustomed to using complex medical terms, and often need to give their patients a large amount of information in a short span of time, without much opportunity to clarify difficult terms or complicated instructions. Using Plain Language When Writing For Medications When Talking to Patients Tools Patient-Friendly Word List PDF Tools to Help Patients Want to Learn More? Frequently Asked Questions Resources and References Contact Us The benefit of using plain language is like a two-way street. Clear communication: • Helps people understand information more rapidly, and • Makes it easier for the person giving the information. Improves Patient Safety If we can reduce the need for extra information, follow-up questions, or repeated explanations, both providers and patients will feel more satisfied and better informed in an encounter— whether the encounter is online, by phone, or in-person. In addition, plain language has the potential to improve patient safety. Consider that: • A 2006 study examined patients’ abilities to understand five common instructions on prescription medications. Both patients with adequate and low literacy had difficulty 3 understanding at least one of the five instructions . • Treatment adherence may also be affected by patients’ literacy levels. This has been 6 10 shown in studies of HIV therapy and asthma inhalers . To address this growing concern, the recent Joint Commission report on health literacy and patient safety recommends making plain language a “universal precaution” in all patient encounters, especially given the safety implications of a misunderstood drug interaction or other 8 patient instruction . View the full report. PDF Many Benefits for All Everyone, regardless of age, education, or cultural background, needs information he or she can understand quickly and easily. We may all find ourselves in situations where we need fast and easy access to information that can help guide our actions or decisions. Plain Language Home | Q&I Home | InContext Home Revised: 3/5/2008 For content questions, contact, Content Owner. For technical questions, contact, Web Developer. 2 of 56 Using Plain Language in Materials Plain Language Toolkit Using Plain Language When Writing Plain Language Home Here are some tips on using plain language if you're creating materials on your own. Why Plain Language is Important Choose common, everyday words. Using Plain Language When Writing For Medications When Talking to Patients Tools Patient-Friendly Word List PDF Tools to Help Patients Want to Learn More? Frequently Asked Questions Resources and References • Use the patient-friendly word list to help you replace medical jargon and other difficult terms. • Use examples and/or analogies whenever possible. For instance, you can describe arthritis by saying it’s like “a creaky hinge on a door.” Give information in understandable chunks. • Be concise. Sentences should be no more than 15 words long, on average. Paragraphs should contain only one main idea. • Get rid of unnecessary information. Focus only on what the patient needs to know. Write in a conversational style (as if you were speaking). • Use active voice, where the subject of the sentence is performing the action. • Address the reader directly, using “you” and other pronouns Organize the information with the reader in mind. Contact Us • Be clear about what the patient needs to do and when they need to do it. • Put the most important information first. Emphasize other important information by bulleting, indenting, using bold or larger font, or placing the message in a box. Make it look easy to read. • Use ample white space. Margins should be no less than 1 inch. Include white space or use bullets to break up chunks of solid text. • Give readers “road signs” to help them identify the different topics that are covered. Use clear, descriptive headings that the audience will find meaningful. This will help readers skim the document to find key points. Plain Language Home | Q&I Home | InContext Home 3 of 56 Plain language tips for labeling medications Plain Language Toolkit Using Plain Language For Medications Plain Language Home How do you know you're giving clear medication instructions? • Use simple language that the general public can understand. Why Plain Language is Important • Avoid acronyms or abbreviations. Group Health maintains a list of prohibited abbreviations. • Directions for use should be in complete sentences. Using Plain Language When Writing For Medications When Talking to Patients • Use numeric symbols instead of spelling out numbers. (For example: use “3” instead of “three”.) • The route of administration (e.g., take by mouth, apply on skin) should be typed on the prescription label where possible. • Do not use “Take as directed” as a direction on a prescription. Tools Patient-Friendly Word List PDF Tools to Help Patients Want to Learn More? Frequently Asked Questions Resources and References Contact Us • If there is a maximum dose per day, convert that into the number of tablets and make sure it's on the label. • When using auxiliary labels on prescription bottles, counsel the patient about their meaning. These labels are often mis-understood. You can also use the visual cue (pictograph) instructions for taking medications PDF Encourage the patient to: • Maintain a current medication list. • Talk to their physician regularly about their medications, especially when they get a new prescription, or start to feel any side effects. • Ask questions about anything they don’t fully understand—this is their body and their health. Try giving them the Know Your Medicines (PDF) hand-out to prompt more questions. How can you tell if the patient understands what you're saying? Before leaving, a patient should be able to answer the following questions about their medications: • What is the purpose of this medication? Alternatives: What is this medication for? Why am I taking this medication? • How should I use this medication? What are the exact directions for taking this medication? • What should I expect from this medication? How will this medication make me feel? What will it do to my body? 4 of 56 Plain language tips for labeling medications • What should I do if I have a problem with this medication? Plain Language Home | Q&I Home | InContext Home Revised: 11/9/2007 For content questions, contact, Content Owner. For technical questions, contact, Web Developer. Copyright© 2007–2008 Group Health Cooperative. All rights reserved. 5 of 56 Using Plain Language When Talking to Patients Plain Language Toolkit Using Plain Language When Talking to Patients Plain Language Home Plain language enhances communication between patients and their health care teams. Why Plain Language is Important Studies show effective communication with patients has a positive effect on health outcomes, including: • Lower rates of anxiety, pain, and psychological distress Using Plain Language When Writing For Medications When Talking to Patients • Higher rates of compliance and symptom resolution. 9 When communication isn't clear, patients : • Don't understand explanations of diagnosis or treatment • Feel their concerns have been ignored. Tools Patient-Friendly Word List PDF Tools to Help Patients Want to Learn More? Frequently Asked Questions Resources and References Contact Us How do you know when you're using clear communication? 9 Try using these tips to improve interpersonal communication with patients : • Skip fancy words—they don't enhance communication. Use plain, non-medical language like what you see in our patient-friendly word list. If you need to use complicated or unusual words, be sure to define them as you go. Try to explain things to patients using common, everday language. For example; use the word “pain-killer” instead of “analgesic” or use analogies like “arthritis is like a creaky hinge on a door.” • Slow down. Communication can be improved by speaking slowly and spending just a bit more time with each patient. This will help foster a patient-centered approach to the clinician-patient interaction. • Be mindful of cultural issues when communicating, including different languages, accents, and dialects—both yours and the patient's. • Show or draw pictures. Visual images can improve the patient’s recall of ideas. • Limit the amount of information provided and then repeat it. Information is best remembered when it is given in small pieces that are pertinent to the tasks at hand. Repetition further enhances recall. 6 of 56 Using Plain Language When Talking to Patients • Use the teach-back or show-me technique. - Don’t simply ask a patient, “Do you understand?” or “Do you have any questions?” - Ask your patients to tell you or show you what they’ll do and how they’ll do it. - If the patient doesn’t seem to understand, assume you didn’t explain it well enough. Reteach the information using a different approach. • Create a shame-free environment. Make patients feel comfortable asking questions. Enlist the aid of others (patient’s family, friends) to promote understanding. How can you tell if the patient understands what you're saying? 9 At the end of each office visit, a patient should be able to answer the following questions : • What health problems do I have and what should I do about them? • Where do I go for tests, medicines, and appointments? • How should I take my medicine? - When do I take it? - What will it do? - How do I know if it’s working? - Who do I call if I have questions? • What other instructions did my doctor give me? - What do I need to do? - How do I do it? - When do I do it? • What are the next steps? - When do I need to see my doctor again? - Do I have another appointment? If so, what’s the date and time? - Are there phone numbers to call? Want more on communicating with patients? You will find more information about communicating with patients, including using the Four Habits Model, on the GHP Clinician Patient Communication page. Also, try these sample encounters for more ideas on how to improve the patient/provider relationship. http://xnet.kp.org/permanentejournal/fall99pj/habitstab6.html http://xnet.kp.org/permanentejournal/fall99pj/habitstab4.html Plain Language Home | Q&I Home | InContext Home 7 of 56 Copyright© 2007–2008 Group Health Cooperative. All rights reserved. 3ODLQ/DQJXDJH7RRONLW:RUG/LVW 8SGDWHG)HEUXDU\ 7KHIROORZLQJOLVWFRQWDLQVFRPPRQPHGLFDOWHUPVDQGKHDOWKFDUHMDUJRQ²ZLWKVXJJHVWHGDOWHUQDWLYHV 7U\WRXVHSODLQQRQPHGLFDOODQJXDJHZKHQHYHUSRVVLEOHLQERWKVSHDNLQJDQGZULWLQJ:KHQZRUNLQJ ZLWKSDWLHQWVRQHRQRQHSOHDVHXVHSURIHVVLRQDOGLVFUHWLRQ,I\RXGRQHHGWRXVHFRPSOLFDWHGRU XQXVXDOZRUGVEHVXUHWRGHILQHWKHPDV\RXJR :HXSGDWHWKLVZRUGOLVWSHULRGLFDOO\EDVHGRQIHHGEDFNIURPRXUXVHUV/HWXVKHDUIURP\RX<RXPD\ HPDLO\RXUVXJJHVWLRQVRUFRPPHQWVWRSDWLHQWKHDOWK#JKFRUJ ,QVWHDGRI 7U\WKLV« DEGRPHQ VWRPDFKWXPP\EHOO\ DEUDVLRQ VFUDSHVFUDWFK DEVRUE WDNHLQIOXLGVVRDNXS DEVWDLQIURP GRQ WGRQ¶WXVHGRQ¶WKDYHJRZLWKRXW DFFRPSDQ\ JRDORQJZLWKFRPHZLWK DFFRPSOLVK FDUU\RXWGR DFFRUGLQJO\ VRIRUWKDWUHDVRQDVDUHVXOW DFFUXH DGGJDLQEXLOGXS DFFXPXODWH DGGEXLOGXSFROOHFWJDWKHU DFFXUDWH FRUUHFWH[DFWULJKW DFTXLUH JHW DFWLYDWH EHJLQVWDUW DFXWH VXGGHQQHZUHFHQWLQWHQVHIODUHXSVHULRXVSDLQVKRUWWHUP DGGLFWLYH KDELWIRUPLQJ DGGLWLRQDO DGGHGH[WUDPRUHRWKHU DGGUHVV WDONDERXWGLVFXVV DGHTXDWH HQRXJK DGMDFHQW QH[WWRE\ DGPLQLVWHU JLYH DGYDQWDJHRXV KHOSIXOXVHIXO DGYHUVH KDUPIXOEDG DGYHUVHO\LPSDFW KXUWVHWEDFN DIILUPDWLYH \HVSRVLWLYH 3/$,1/$1*8$*(722/.,7:25'/,67 &23<5,*+7±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¶WKDYHDVWHDG\EHDW DUWHULRVFOHURVLVRU DWKHURVFOHURVLV KDUGHQLQJRIWKHDUWHULHV DUWLFXODWH VD\VWDWHWHOO DVFHUWDLQ ILQGRXWOHDUQ DVFRUELFDFLG YLWDPLQ& DVSK\[LDWHDVSK\[LDWLRQ FKRNHLQJVXIIRFDWHWLRQ DVSLUDWHDVSLUDWLRQ IOXLGLQWKHOXQJV DVVD\ ODEWHVW 3/$,1/$1*8$*(722/.,7:25'/,67 &23<5,*+7±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¶UHRYHUZHLJKW EUDG\FDUGLD VORZKHDUWEHDW EXWWRFNV EXWWEDFNVLGHUHDUUHDUHQG FDOFXODWH DGGXSILJXUHRXW FDSDEOHFDSDELOLW\ DEOHDELOLW\ FDUFLQRJHQ VRPHWKLQJWKDWFDQFDXVHFDQFHU FDUFLQRPD FDQFHU FDUGLDF RILQUHODWHGWRWKHKHDUW FDUGLRORJLVW KHDUWGRFWRU FDUGLRYDVFXODU KHDUWDQGRUEORRGYHVVHO FDUSDO ZULVW FDWHJRU\ NLQGFODVVJURXS FDWKHWHU DWXEHIRUSXWWLQJIOXLGVLQWRWDNLQJIOXLGVRXWRIWKHERG\ FDWKHWHUL]H SXWDWXEHLQWRSDUWRIWKHERG\ FDYHDW ZDUQLQJGHWDLOWRWKLQNDERXW FHDVH VWRS FHOOFXOWXUH WLVVXHVDPSOHRUDVWXG\RIWKHWLVVXH FHOOXOLWLV VNLQLQIHFWLRQ &HQWUDO1HUYRXV6\VWHP &16 EUDLQDQGVSLQDOFRUG 3/$,1/$1*8$*(722/.,7:25'/,67 &23<5,*+7±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±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±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¶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±*5283+($/7+&223(5$7,9($//5,*+765(6(59(' 3DJHRI HPEROLVWHPEROXV FORWWKDWEORFNVDEORRGYHVVHORUDUWHU\ HPHVLV WKURZLQJXSYRPLWLQJ HPSLULFDOHYLGHQFH SURRI HPSOR\ XVH HPSOR\PHQW ZRUN HQDEOH DOORZOHW HQFRXQWHU PHHWPHHWLQJ HQFRXUDJH XUJH HQGHDYRU WU\ HQGRPHWULXP OLQLQJRIWKHXWHUXV HQODUJH JHWELJJHU HQUROO EHLQMRLQ HQVXH IROORZLQJRFFXUDIWHUKDSSHQQH[W HQVXUH PDNHVXUH HQXPHUDWH FRXQW HQXUHVLV SUREOHPVFRQWUROOLQJXULQHEODGGHUFRQWUROSUREOHPV HSLGHPLRORJLVW VFLHQWLVWZKRVWXGLHVGLVHDVHV HSLVRGH ERXWRUDWWDFN HTXLOLEULXP EDODQFH HTXLYDOHQW HTXDOWKHVDPHDV HTXLWDEOH IDLU HUDGLFDWH JHWULGRI HUXSWLRQVNLQ UDVKRUEUHDNRXW HVSHFLDOO\ PDLQO\PRVWO\ HVWDEOLVK VHWXSDOVRVKRZSURYH HWLRORJ\ FDXVH HYDOXDWH ORRNDWVWXG\PHDVXUHUDWH HYLGHQFHRI SURRIRIVLJQVRI HYLGHQW FOHDU H[DFHUEDWH PDNHZRUVH H[DPLQDWLRQ H[DP H[DPLQH ORRNDWVWXG\ H[FLVH UHPRYHE\FXWWLQJFXWRXW H[KDOH EUHDWKHRXW H[KLELW VKRZ H[SHGLWHH[SHGLWLRXV VSHHGXSPDNHVRPHWKLQJJRIDVWHUPDNHVRPHWKLQJHDVLHU IDVWTXLFN H[SHQG VSHQG H[SHULHQFLQJ IHHOLQJJRLQJWKURXJKKDYLQJ H[SLUHH[SLUDWLRQ HQGGDWHUXQRXW 3/$,1/$1*8$*(722/.,7:25'/,67 &23<5,*+7±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¶VKHDOWK KD]DUGRXV GDQJHURXVQRWVDIH KHDULQJLPSDLUPHQW KHDULQJORVVRUGHDIQHVV KHDUWIDLOXUH KHDUWLVQ WSXPSLQJKDUGHQRXJK KHPDWRFULW DPRXQWRIUHGEORRGFHOOVLQWKHEORRG KHPDWRPD EUXLVH KHPRUUKDJH KHDY\EOHHGLQJ KHQFH VR KHSDWLF RILQUHODWHGWRWKHOLYHU 3/$,1/$1*8$*(722/.,7:25'/,67 &23<5,*+7±*5283+($/7+&223(5$7,9($//5,*+765(6(59(' 3DJHRI KHULWDEOHKHUHGLWDU\ JHQHWLFWUDLWVWKDWDUHSDVVHGGRZQLQIDPLOLHV KHUSHVVLPSOH[W\SH FROGVRUH KHUSHVVLPSOH[W\SH KHUSHV KHUSHV]RVWHU VKLQJOHV KHWHURJHQHRXV GLIIHUHQWPL[HG KLUVXWLVP XQZDQWHGKDLUJURZWK KRPRJHQHRXV VDPHRUVLPLODU KRZHYHU EXW K\SHURSLD IDUVLJKWHGQHVV K\SHUVHQVLWLYLW\ YHU\VHQVLWLYHWR K\SHUWHQVLRQK\SRWHQVLRQ EORRGSUHVVXUHWKDW¶VWRRKLJKEORRGSUHVVXUHWKDW VWRRORZ K\SHUWK\URLGLVP K\SRWK\URLGLVP RYHUDFWLYHWK\URLGWRRPXFKWK\URLGKRUPRQHXQGHUDFWLYHWK\URLG QRWHQRXJKWK\URLGKRUPRQH K\SRWKHVLV LGHDEHLQJWHVWHG K\SR[LD QRWHQRXJKR[\JHQLQWKHEORRG LGHQWLFDO VDPHH[DFWO\DOLNH LGHQWLILHG IRXQG LGHQWLI\ ILQGRXWSLQSRLQWQDPHVKRZ LGLRSDWKLF ZHGRQ¶WNQRZZKDWFDXVHVLW LPPHGLDWHO\ ULJKWDZD\QRZDWRQFH LPPHUVH FRYHULQGLSLQ LPPXQRWKHUDS\ WUHDWPHQWWRPDNHWKHLPPXQHV\VWHPZRUNEHWWHUERRVWLPPXQH V\VWHP LPSDFW FKDQJHDIIHFW LPSHGH VORZPDNHLWKDUGHUWR LPSODQW SXWLQWRWKHERG\ LPSOHPHQW FDUU\RXWSXWLQSODFHVWDUW LPSRWHQWLPSRWHQFH ZKHQDPDQHLWKHUFDQ¶WJHWRUFDQ¶WNHHSDQHUHFWLRQ LQDGGLWLRQ DOVRWRRDQG LQOLHXRI LQVWHDGRI LQWKHHYHQWRI LI LQYLWUR LQDWHVWWXEHRUODE LQFDSDFLWDWH PDNHLWKDUGRULPSRVVLEOHWRGR LQFHSWLRQ VWDUWEHJLQQLQJ LQFLGHQFH QXPEHURIQHZFDVHVKRZPDQ\WLPHVLWRFFXUV LQFLVLRQ FXWVOLW LQFOXGLQJ DORQJZLWKOLNHVXFKDV LQFRUUHFW ZURQJQRWULJKW LQFUHDVHLQFUHDVHG UDLVHKLJKHU LQGLFDWH PHDQVKRZVXJJHVWWHOOXVILOOLQZULWHGRZQ 3/$,1/$1*8$*(722/.,7:25'/,67 &23<5,*+7±*5283+($/7+&223(5$7,9($//5,*+765(6(59(' 3DJHRI LQGLFDWLRQ VLJQV\PSWRP LQHIIHFWXDO GRHVQ¶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±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¶WJHWDQ\PRUHPHQVWUXDOSHULRGV PHQVHVPHQVWUXDWLRQ PHQVWUXDOSHULRG PHWDEROLVPPHWDEROL]H KRZWKHERG\EUHDNVGRZQIRRGLQWRHQHUJ\ PHWDVWDVL]H VSUHDG PHWDVWDWLF FDQFHUWKDWKDVVSUHDG PLOLDULD SULFNO\KHDW PLQLPDOPLQLPXP OHDVWVPDOOHVWVOLJKWDWOHDVW PLQLPL]H GHFUHDVHORZHUUHGXFH 3/$,1/$1*8$*(722/.,7:25'/,67 &23<5,*+7±*5283+($/7+&223(5$7,9($//5,*+765(6(59(' 3DJHRI PRELOHPRELOLW\ DEOHDELOLW\WRPRYHDURXQG PRGHUDWHYHUE OLPLWFRQWURO PRGLI\PRGLILFDWLRQ FKDQJH PRQLWRU FKHFNRQNHHSWUDFNRIZDWFK PRUELGLW\ GLVHDVHUDWHLOOQHVVUDWH PRUWDOLW\ GHDWKUDWHGHDWKG\LQJ PRWLOLW\ PRYHPHQWDELOLW\WRPRYH PXVFXORVNHOHWDO PXVFOHVDQGERQHV PXWDWLRQ JHQHWLFGHIHFW P\RFDUGLDOLQIDUFWLRQ0, KHDUWDWWDFN P\RSLD QHDUVLJKWHGQHVVZKHQLW¶VKDUGWRVHHWKLQJVWKDWDUHIDUDZD\ QDXVHDQDXVHRXV XSVHWVWRPDFKIHHOLQJOLNHWKURZLQJXSIHHOOLNHYRPLWLQJ QHEXORXV YDJXHQRWFOHDU QHFHVVDU\ QHHGHGQHHGWR QHJOLJLEOH VPDOO QHSKURSDWK\ NLGQH\GLVHDVH QHXUDOJLD QHUYHSDLQ QHXURQ QHUYHFHOO QRGXOH OXPS QRQFRPSOLDQW QRWIROORZLQJDWUHDWPHQWSODQ QRQLQYDVLYH ZLWKRXWXVLQJVXUJHU\QHHGOHVRUFXWWLQJWKHVNLQ QRWLILFDWLRQQRWLI\ WRWHOOOHWNQRZ QXPHUDWH FRXQW QXPHURXV PDQ\ QXWULHQW IRRG REMHFWLYH DLPJRDO REOLJDWHREOLJDWLRQ UHTXLUHELQGPHDQVWKDW\RXKDYHWRGXW\ REVHUYH VHH REVWUXFW EORFNRUFORVH REWDLQ JHWWDNH RFFDVLRQDOO\ VRPHWLPHV RFFOXGHRFFOXVLRQ EORFNEORFNDJH RFFXSDWLRQDO MREZRUN RQFRORJLVW GRFWRUZKRWUHDWVFDQFHU RQFRORJ\ VWXG\RUWUHDWPHQWRIFDQFHU RQVHW VWDUW RSSRUWXQLW\ FKDQFH RSWLPXPRSWLPDO EHVWJUHDWHVWPRVW RSWLRQ FKRLFHZD\ RUDORUDODGPLQLVWUDWLRQ JLYHQE\PRXWK 3/$,1/$1*8$*(722/.,7:25'/,67 &23<5,*+7±*5283+($/7+&223(5$7,9($//5,*+765(6(59(' 3DJHRI RUWKRSHGLF RIDERXWUHODWHGWRWKHERQHV RVWHRSRURVLV EULWWOHERQHGLVHDVHKDYLQJERQHVWKDWFDQEUHDNHDVLO\ RWKHUZLVH LIQRW RWRODU\QJRORJLVW HDUQRVHDQGWKURDWGRFWRU RXWFRPHV UHVXOWVORQJWHUPFKDQJHV SDOOLDWLYH PDNHIHHOEHWWHUEXWQRWFXUHHDVHV\PSWRPV SDOORU SDOHQHVV SDOSDWH IHHO SDOSLWDWLRQ IDVWKHDUWEHDW SDUDPHWHU OLPLWERXQGDU\ SDUHVWKHVLD WLQJOLQJSULFNOLQJRUEXUQLQJIHHOLQJRQWKHVNLQWKDWFDQ¶WEH H[SODLQHGRUGRHVQ¶WVHHPWRKDYHDQ\FDXVH SDUWLFLSDQW SHUVRQZKRWDNHVSDUW SDUWLFLSDWHLQJLRQ EHGRMRLQRSWLQWDNHSDUW LQJ SDUWXULWLRQ ODERUDQGGHOLYHU\FKLOGELUWK SDWKRJHQHVLV FDXVHRIDGLVHDVH SHUIRUDWLRQ KROH SHUIRUP GR SHULRGLFDOO\ IURPWLPHWRWLPH SHULRUDO DURXQGWKHPRXWK SHULSKHUDO RQWKHHGJHQRWFHQWUDO SHUPLWWHG DOORZHGOHW SHUVLVW ODVWNHHSJRLQJGRHVQ¶WVWRS SHUVLVWHQW ODVWLQJ SHUVRQQHO VWDIISHRSOH SHUWDLQLQJWR DERXWRIRQ SHUXVH UHDGVWXG\H[DPLQHZLWKFDUH SHUYDVLYH ZLGHVSUHDG SKDUPDFHXWLFDO GUXJ SKDUPDFRWKHUDS\ XVHGUXJVWRWUHDWDGLVHDVHRUFRQGLWLRQ SKDU\QJLWLV VRUHWKURDW SK\VLFLDQ GRFWRU SK\VLRORJLFDO KDYLQJWRGRZLWKWKHERG\ SLJPHQWDWLRQ FRORU SODFHER DSLOOWKDWGRHVQ¶WKDYHDQ\GUXJVRUPHGLFLQHD³VXJDU´SLOO SODFHQWD SDUWRIWKHPRWKHU¶VZRPEWKDWVXSSOLHVR[\JHQDQGQXWULWLRQWRKHU XQERUQEDE\ SODTXHDUWHU\ IDWW\GHSRVLW SODVPD WKHIOXLGSDUWRIEORRG SODVPDJOXFRVH EORRGVXJDU 3/$,1/$1*8$*(722/.,7:25'/,67 &23<5,*+7±*5283+($/7+&223(5$7,9($//5,*+765(6(59(' 3DJHRI SRUWLRQ SDUW SRVLWURQHPLVVLRQ WRPRJUDSK\ 3(7VFDQRULPDJLQJWHVWWHVWGRQHWRORRNDWRUJDQVLQWKHERG\ SRVVHVV KDYHRZQ SRVWHULRU EDFN SRVWRSHUDWLYHSRVWRS DIWHUVXUJHU\ SUHDGROHVFHQW SUHWHHQ SUHFOLQLFDO LVQ¶WFDXVLQJV\PSWRPV\HWQRVLJQV\HW SUHFOXGH SUHYHQWUXOHRXW SUHGLVSRVHGSUHGLVSRVLWLRQ OLNHO\WRLQFOLQHGWR SUHQDWDO EHIRUHELUWK SUHVHQWO\ ULJKWQRZ SUHVHQWZLWK KDYH SUHVHUYH NHHS SUHYDOHQFHSUHYDOHQW KRZRIWHQLWKDSSHQVFRPPRQKDSSHQVRIWHQ SUHYHQW VWRSSXWDVWRSWRWRNHHSIURPKDSSHQLQJ SUHYLRXVSUHYLRXVO\ EHIRUHHDUOLHU SULQFLSDOLQYHVWLJDWRU KHDGUHVHDUFKHUVFLHQWLVWLQFKDUJHRIDVWXG\ SULRUWR HDUOLHUEHIRUH SULRULWL]H UDQNRUGHUSXWLQRUGHURILPSRUWDQFH SURDFWLYH WDNLQJDFWLRQRQ\RXURZQ SURFHGXUH VRPHWKLQJWKDWLVGRQHDSURFHVV SURFHHG GRJRDKHDGVWDUWWU\ SURFXUHSURFXUHPHQW EX\JHW SURILFLHQF\SURILFLHQW VNLOOVNLOOHG SURJQRVLV RXWORRN SURJUHVVYHUE SURJUHVVLYH ZRUVHQJHWVZRUVH SURKLELWSURKLELWLYH SURKLELWHGIURP SUHYHQWUHVWULFWLYHVWULFWPD\QRWGRQ¶WDOORZ SURPXOJDWH PDNHLVVXHSXEOLVK SURQH O\LQJIDFHGRZQO\LQJRQ\RXUVWRPDFK SURSK\OD[LV VRPHWKLQJWKDWSUHYHQWVGLVHDVHRULQIHFWLRQ SURVWKHVLV UHSODFHPHQWIRUDERG\SDUWVXFKDVDPDQPDGHDUP SURWRFRO SODQRIVWXG\UXOHSURFHVV SURYLGH JLYHXVRIIHUVD\ SURYLGHGWKDW LI SURYLGHU GRFWRUFOLQLFLDQSHUVRQZKRJLYHVKHDOWKFDUH SUR[LPDO FORVHFORVHUWRWKHFHQWHURIWKHERG\ SV\FKRSDWKRORJ\ PHQWDOLOOQHVV SV\FKRVRFLDO PHQWDODQGVRFLDO 3/$,1/$1*8$*(722/.,7:25'/,67 &23<5,*+7±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±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¶UHEUHDWKLQJLQDQGRXW VWDWHRIWKHDUW ODWHVW VWHQRVLV JHWWLQJPRUHQDUURZ VWLPXODWH H[FLWHWULJJHU VWUDWHJ\VWUDWHJL]H PDNHDSODQ VWUHSWRFRFFDO VWUHS VXEFXWDQHRXV XQGHUWKHVNLQ 3/$,1/$1*8$*(722/.,7:25'/,67 &23<5,*+7±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±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±*5283+($/7+&223(5$7,9($//5,*+765(6(59(' 3DJHRI Plain Language Tools to Help Patients Plain Language Toolkit Tools to Help Patients Plain Language Home These hand-outs can help patients be active partners in communicating. Why Plain Language is Important Getting the Most from Your Doctor's Visit PDF Tips on Commmunicating with Your Health Care Team. Using Plain Language When Writing For Medications When Talking to Patients Preparing for My Doctor Visit PDF Self-care diary and checklist of questions. Tools Patient-Friendly Word List PDF Tools to Help Patients Know Your Medicines PDF Questions a patient should ask and tips for keeping track of medications. Supporting Good Health Communication PDF Internet resources for patients. Want to Learn More? Frequently Asked Questions Resources and References Contact Us Plain Language Home | Q&I Home | InContext Home Revised: 11/9/2007 For content questions, contact, Content Owner. For technical questions, contact, Web Developer. Copyright© 2007–2008 Group Health Cooperative. All rights reserved. 26 of 56 Plain Language Frequently Asked Questions Plain Language Toolkit Frequently Asked Questions Plain Language Home Why Plain Language is Important Using Plain Language When Writing For Medications When Talking to Patients About Plain Language Using plain language takes too much time and effort. Is it really that important? Why do I need to communicate in plain language with patients who don't have limited literacy skills? How does using plain language relate to health literacy? Why do I still see materials that don't look like they use plain language principles? Who is behind Group Health’s plain language efforts? Where can I get more information? Tools Patient-Friendly Word List PDF Tools to Help Patients Want to Learn More? Frequently Asked Questions Resources and References Contact Us How to Use Plain Language How can I tell if my patients are having trouble understanding? My patients don’t ask questions, so doesn’t that mean they understand what I said? Who can help me make sure that the materials I am writing are easy to read? If I use plain language, won’t patients think I’m talking down to them? About Plain Language Using plain language takes too much time and effort. Is it really that important? Investing the time and effort to communicate clearly has been proven to be cost saving and more efficient in the long run. Quality health care depends on effective communication. Poor communication can cause medication and treatment errors, is linked to poor outcomes and lower patient satisfaction, and costs the health care industry tens of billions of per year. When we use plain language, we are more likely to achieve effective communication, helping to ensure that our patients will be safe, healthy, and satisfied with their care. Why do I need to communicate in plain language with patients who don't have limited literacy skills? Even highly-educated patients prefer health information that is easy to understand. No matter how literate a person may be, stresses related to health can affect anyone's ability to understand information. Even a routine 27 of 56 Plain Language Frequently Asked Questions office visit or well-adult check-up can be stressful, especially if the provider is using unfamiliar language. Using plain language levels the playing field and puts the patient at ease, increasing the chances that they will walk away feeling confident that they know what they need to do and when they need to do it. How does using plain language relate to health literacy? Group Health cares for people with a range of needs. Some of our patients might have health literacy concerns because they read at lower grade levels, they might not speak English as a first language, or they might have sight or hearing problems that get in the way of understanding the information we give them. Others might be too busy juggling careers and families to spend time reading complex health information. By using plain language principles we’re ensuring that all our communication can be easily understood by everyone, including those with limited health literacy. Why do I still see materials that don't look like they use plain language principles? Different departments are revising their materials at different rates based on resources and commitments. Our hope is to always produce and use the best possible materials we can. If you'd like to help your department make changes to your materials, start by reviewing Using Plain Language When Writing. You can also visit the Patient Health Education Resources site for more on developing materials on your own. Who is behind Group Health’s plain language efforts? The 2007 Plain Language Toolkit contributors worked in collaboration to help create resources for verbal and written communication here at Group Health. Our objective is to make the use of plain language an easy and accessible communication “habit” for all staff. Where can I get more information? There are many resources out there for people who want to communicate more clearly. Take a look at our Resources and References page for external web sites and published materials on Plain Language and Health Literacy. Training on how to write medical information in plain language is offered by the National Institutes of Health. Or, contact us at patienthealth@ghc.org. How to use plain language How can I tell if my patients understand what I’ve told them? 28 of 56 Plain Language Frequently Asked Questions The best way to make sure your patients understood is to use teach-back or show-me techniques. Ask you patients to tell you what they will do, how they’ll do it, and what could happen if they don’t. If your patient isn’t able to explain it to you correctly, then re-teach the information using a different method. My patients don’t ask questions, so doesn’t that mean they understand what I said? Not necessarily! Anxiety, embarrassment, language barriers, and/or the desire not to burden the provider may inhibit patients from asking questions or expressing confusion. It’s best not to assume that patients accurately heard and understand their medical instructions, but rather make it a habit to confirm comprehension. For very complex care instructions, such as mastering a new device (metereddose inhalers for asthma, insulin pump, etc.), using “teach-back” or “teach-togoal” is a recommended, evidence-based strategy. If patients have family members or friends with them, it can also be beneficial to ensure that they understand the patient’s instructions as well. Who can help me make sure that the materials I am writing are easy to read? For general tips and guidelines on plain language, take a look at Using Plain Language When Writing. If you are developing your own materials and would like help with writing, editing, and formatting, e-mail Patient Health Education Resources (PHER). PHER staff can help you create materials that are easy to read and follow Group Health's branding and image standards. If I use plain language, won’t patients think I’m talking down to them? Actually, studies have shown that use of clear communication is overwhelmingly appreciated and desired by patients. Using clear communication means avoiding medical jargon and other technical language. Related elements include using a respectful tone and creating an environment where patients feel safe asking questions. Even under the best of circumstances, a trip to the doctor’s office can be stressful. If a provider uses language that is very technical and unclear to the patient, that stress level is bound to increase, along with the potential for making mistakes related to medical instructions. Plain Language Home | Q&I Home | InContext Home Revised: 11/9/2007 For content questions, contact, Content Owner. For technical questions, contact, Web Developer. 29 of 56 Plain Language Additional Resources Plain Language Toolkit Resources and References Plain Language Home Why Plain Language is Important Using Plain Language When Writing For Medications When Talking to Patients On InContext External Web sites Publications and works cited On InContext Many areas of Group Health have recommendations on how to write or communicate better. Here are just a few: • Patient Health Education Resources (PHER): patienthealth@ghc.org • Communications & Community Relations Tools Patient-Friendly Word List PDF Tools to Help Patients Want to Learn More? Frequently Asked Questions Resources and References Contact Us • GHP Leadership & Development • Interpretive Services External Web sites Plain language and health literacy initiatives • American Medical Association Foundation Health Literacy Initative Working to raise awareness among health care providers about the link between health and literacy. Find out more about their toolkit Health Literacy: A Manual for Clinicians, and train-the-trainers seminar. • National Institutes of Health Clear Communication: Health Literacy Initiative Defines health literacy and discusses why it’s an issue and how to improve communication strategies for health professionals. Links to current research in health literacy supported by the NIH. • Pfizer Clear Health Communication Initiative Pfizer supports research in clinical settings to begin to develop solutions that center around clear communication • Plain Language Action and Information Network Gives history of Plain Language Movement, provides examples of documents before and after being rewritten using plain language principles, and links to key articles supporting the use of plain language in organizational settings. • Plain Language Association International Members of the network include editors, writers, attorneys, and educators from around the world. Provides links to advice and information on writing and designing clear communication materials using plain language. 30 of 56 Plain Language Additional Resources • U.S. Department of Health and Human Services One of the primary objectives of Healthy People 2010 is the improvement of health literacy. Read the full text of the objective: Health Literacy Action Plan—Communicating Health: Priorities and Strategies for Progress (2003): More about health literacy • Agency for Healthcare Research and Quality Health Literacy and Cultural and Linguistic Competency resource page provides links to research studies, implantation strategies, evidence reports and tools for testing the quality of your materials. Assessment tool Is Our Pharmacy Meeting Patients’ Needs? A Pharmacy Health Literacy Assessment Tool PDF The Agency for Healthcare Research and Quality (AHRQ) sponsored the development of this health literacy tool to help organizations capture three critical perspectives—that of objective auditors, pharmacy staff, and patients. Although the various components specifically address the needs of a large outpatient pharmacy, the toolkit can be used as a template and modified and adapted to fill the needs of any organization or department within the organization. It can be used in its entirety to conduct a comprehensive assessment; however, each component is designed to stand alone. • Harvard School of Public Health, Health Literacy Studies Information for researchers and practitioners in the public health, medical, and adult education fields. Links to Easy-To-Read health information sites, grouped by health topic. • Health and Literacy Special Collection A clearinghouse of information related to teaching and learning health literacy skills, including links to health education resources, easy-to-read and multilingual health information, and health literacy research. • Health Literacy Consulting Resources and articles to help individuals and organizations communicate about health information in ways patients, families, and employees can more easily understand. • Plain Language: A Promising Strategy for Clearly Communicating Health Information and Improving Health Literacy PDF From the U.S. Department of Health and Human Services: An overview of plain language and health literacy terms, tips on writing and speaking plainly, and a summary of reasons why plain language has the potential to improve health literacy. 31 of 56 Plain Language Additional Resources • Quick Guide to Health Literacy PDF From the U.S. Department of Health and Human Services: A summary of issues related to health literacy, suggestions for improving health literacy in your organization, and examples of health literacy best practices. • Teaching Patients with Low Literacy Skills. Second Edition (1996). Doak, Doak, & Root Considered a classic text in health literacy, the authors, Ceci and Len Doak, are often introduced at health literacy conferences as 'the grandparents' of health literacy. Writing tips • Centers for Disease Control Simply Put (PDF), tips for creating easy-to-read print materials. • Group Health Center for Health Studies Readability Toolkit (PDF) Strategies and resources to help clinical researchers create easyto-read consent forms and other print materials for study participants. • Medline Plus How to Write Easy to Read Health Materials • Southern Institute on Children and Families Health Literacy Style Manual PDF • State of Washington Department of Health Guidelines for Developing Easy-to-Read Health Education Materials • University of Utah, Health Sciences Center Patient Education Materials: An Author's Guide Alternative word lists • University of California at Davis • University of Michigan Medical School • University of Utah Health Sciences Center Enhancing provider/patient communication • Group Health Permanente Practice and Leadership Development Team Four Habits Model PDF, Kaiser Permanente 32 of 56 Plain Language Additional Resources • AskMe3 Sponsored by the Partnership for Clear Health Communication (PCHC). The PCHC serves as an information source regarding the scope and impact of health literacy in the U. S., as well as what providers and patients can do to improve health communication in every provider-patient interaction. • Familydoctor.org Patient-friendly site has an extensive index of conditions, health tools, including a dictionary of common medical terms, and a section on healthy living. All material is written and reviewed by physicians and patient education professionals. • FDA Easy-to-Read Publications This site has a collection of easy-to-read brochures in English and Spanish on a variety of health topics. You can print them or order free copies. • FDA Information for Seniors Easy-to-read articles on a variety of health issues that affect older adults. Topics include arthritis, cancer, nutrition, food safety, and women's health. Also links to other organizations with information for older adults. • KidsHealth Sections for parents, kids, and teens, including interactive games. The kids’ articles are easy to read and written for children. Also appropriate for adult learners with low-literacy skills. • Medline Plus Interactive tutorials teach about health topics with animated graphics and simple text. • United States Department of Health and Human Services Quick Guide to Health Literacy and Older Adults The U.S. Department of Health and Human Services released this new health literacy tool in October 2007, in recognition of Health Literacy Month. The guide is designed especially for people who serve older adults. It provides useful strategies and suggestions to help bridge the communication gap between professionals and older adults. Publications and works cited 1 Ratzan SC, Parker RM, 2000. Introduction. In National Library of Medicine Current Bibliographies in Medicine: Health Literacy. 2 AHRQ Report—Literacy and Health Outcomes. 2004 http://www.ahrq.gov/clinic/ epcsums/litsum.htm 3 Davis TC, et al Literacy and misunderstanding prescription drug labels. Annals of Internal Medicine 2006. View ProQuest article 4 Frankel RM, Stein, T. Getting the Most out of the Clinical Encounter: The Four Habits Model. The Permanente Journal, Vol 3, No. 3. Kaiser Permanente 1999 http://xnet.kp.org/permanentejournal/fall99pj/habits.html 33 of 56 Plain Language Additional Resources 5 Institutes of Medicine Report—Health Literacy: A Prescription To End Confusion (2004): http://www.iom.edu/report.asp?id=19723 6 Kalichman SC, et al. Adherence to combination antiretroviral therapies in HIV patients of low literacy. Journal of General Internal Medicine, 1999. 7 National Library of Medicine Bibliography—Understanding Health Literacy and Its Barriers (2004): http://www.nlm.nih.gov/pubs/cbm/healthliteracybarriers.html 8 The Joint Commission on Accreditation of Healthcare Organizations. “What Did the Doctor Say?:” Improving Health Literacy to Protect Patient Safety. 2007. View PDF 9 Weiss, BD. Health Literacy: A Manual for Clinicians. American Medical Association and American Medical Association Foundation, 2003 View PDF 10 Williams MV, et al. Inadequate literacy is a barrier to asthma knowledge and self-care. Chest. 1998. Plain Language Home | InContext Home Revised: 1/30/2008 For content questions, contact the Content Owner. For technical questions, contact the Web Developer. Copyright© 2007–2008 Group Health Cooperative. All rights reserved. 34 of 56 Plain Language Task Force Plain Language Toolkit Contact Us Plain Language Home Comments or questions? Contact us: patienthealth@ghc.org. Why Plain Language is Important Using Plain Language When Writing For Medications When Talking to Patients Tools Patient-Friendly Word List PDF Tools to Help Patients Want to Learn More? Frequently Asked Questions Resources and References 2007 Plain Language Toolkit contributors Britt Anderson, Interpretive Services Pat Bailey, Communications Sara Faulkner, GHP Practice and Leadership Development Sarah Greene, Center for Health Studies Erin Gunn, Cancer Screening Programs Judy Hucka, Web Services and Usability Testing Lola Leblanc, Communications Kathryn Ramos, Patient Health Education Resources Pamela Richardson, Clinical Improvement & Prevention Jessica Ridpath, Center for Health Studies Diane Schultz, Pharmacy/Medication Safety Robyn Shean, Patient Health Education Resources Kim Wicklund, Health Information & Promotion Sheila Yates, Patient Safety Contact Us Plain Language Home | InContext Home Revised: 1/15/2008 For content questions, contact, Content Owner. For technical questions, contact, Web Developer. Copyright© 2007–2008 Group Health Cooperative. All rights reserved. 35 of 56 Plain Language Examples Plain Language Toolkit Text Examples Plain Language Home Example 1 PDF before Why Plain Language is Important Treatment Information for Patients GOALS AND PURPOSE OF RADIATION THERAPY Radiation uses high-energy beams and particles to disrupt the ability for cancer cells to reproduce and grow. It is used to kill cells and shrink a tumor. The goal of treatment is to destroy the tumor and ease uncomfortable symptoms caused by the tumor. Using Plain Language When Writing For Medications When Talking to Patients Tools Patient-Friendly Word List PDF Tools to Help Patients Want to Learn More? Frequently Asked Questions Resources and References Contact Us Another goal of treatment is to minimize injury to healthy tissues. This is accomplished by careful treatment planning and treatment delivery by the Radiation Team. Radiation is also used to treat overgrowth of non-cancerous cells. Example 1 PDF after Radiation Therapy: Treatment Information for Patients What is radiation therapy? Radiation therapy uses high doses of radiation to destroy cancer cells and tumors. Radiation can shrink tumors and prevent symptoms caused by tumors. Radiation may also be used to treat non-cancerous health conditions. Example 2 before Your initial evaluation may take up to one hour. During the evaluation, your therapist will provide appropriate testing and discuss various treatment strategies designed to help you reach your optimal state of health and function. It is advised that you wear comfortable and loose clothing for this initial evaluation. If your legs or feet are being examined, gym shorts are recommended. Example 2 after Your first appointment may take up to one hour. Your therapist will do some tests and talk to you about your treatment options. Please wear comfortable clothes that fit loosely. If we are looking at your legs or feet, please wear shorts. Q&I Home | InContext Home Revised: 11/26/2007 For content questions, contact, Content Owner. For technical questions, contact, Web Developer. 36 of 56 Copyright© 2007–2008 Group Health Cooperative. All rights reserved. About the Center for Health Studies Center for Health Studies CHS Home About the Center for Health Studies CHS Bibliography Notes from Eric (Internal Newsletter) News Releases CHS Mission History Areas of Research CHS Services and Specialty Areas Events Participate in a Study External Newsletter Center Staff GHC's Dept. Prev. Care MacColl Institute GHC Research Procedures CHS External Site Contact Info The Group Health Center for Health Studies (CHS) conducts research that supports Group Health in its mission to "transform healthcare." Founded in 1983, CHS conducts approximately 150 studies at any given time. It receives about 90 percent of its funding from outside sources such as the National Institutes of Health, the Centers for Disease Control and Prevention, and the Robert Wood Johnson Foundation. CHS conducts much of its research in collaboration with other institutions, including the University of Washington, Fred Hutchinson Cancer Research Center, and Harvard University. To date, CHS investigators have published more than 1,000 articles in peer-reviewed journals. CHS has more than 200 employees, including staff from the MacColl Institute for Healthcare Innovation and the Department of Preventive Care. The Center's researchers have a broad range of professional backgrounds, including medicine, epidemiology, economics, biostatistics, and health psychology. The Mission of the Center for Health Studies The Center for Health Studies was founded by Group Health Cooperative to promote the prevention and effective treatment of major health problems—benefiting Group Health members and the general public. To that end, scientists at the Center for Health Studies conduct epidemiologic, health services, behavioral, and clinical research addressing a wide and evolving range of clinical and public health questions. Research training and dissemination of research findings are essential to the Center’s mission. Collaborations with other academic institutions are key to the 37 of 56 About the Center for Health Studies Center’s success. Research activities central to the Center’s mission include: ● ● ● ● developing and testing innovative approaches for both preventing and effectively treating major health problems organizing health care delivery to improve the health of entire populations translating scientific knowledge into effective and efficient clinical practice informing policy decisions regarding the structure, organization, and financing of health care The Center accomplishes these goals through diverse programs of research conducted within and beyond the enrolled population of Group Health Cooperative. Top of page The History of the Center for Health Studies Research has been a part of Group Health's mission since it was founded in 1946. The Cooperative's commitment to research became truly evident in 1983, when the Board of Trustees established the Center for Health Studies (CHS). Under the leadership of its first director, Ed Wagner, MD, MPH, the Center grew significantly, raising nearly $12 million in grants by 1998. The Center now has an annual budget of $22 million and receives about 90 percent of its funds from research grants and contracts. The Center's success can be attributed in large part to its alignment with Group Health's mission and clinical performance goals. The Group Health delivery and data systems have provided fertile ground for CHS research. At the same time, CHS research has helped the Cooperative find new and better ways to provide care and coverage. For example, Center investigators have participated in the development of Group Health's "clinical roadmaps." These are the guidelines providers use to identify, design, and deliver the most effective treatments for specific patient populations. Center staff have contributed to the development of road maps for senior care, diabetes, tobacco addiction, depression, breast cancer treatment and screening, colon cancer screening, HIV/AIDS, and more. The Center's researchers have also influenced health care 38 of 56 About the Center for Health Studies nationally through the publication of their research and through their service on many prominent national health policy and research advisory groups. Top of page Areas of Research The Center for Health Studies conducts research in: ● ● ● ● ● ● ● ● ● ● ● ● ● ● Aging and Geriatrics Behavior Change Cancer Control Cardiovascular Health Child & Adolescent Health Chronic Illness Management Complementary and Alternative Medicine Department of Preventive Care Health Services & Economics Immunization & Infectious Diseases MacColl Institute Mental Health Pharmacoepidemiology and Patient Safety Women's Health Top of page CHS Services and Speciality Areas Research and Administrative Operations These departments are responsible for the oversight of Center for Health Studies (CHS) finances and administration of grants. Staff are skilled in research financing, budgeting and contracting and have expertise in grantee requirements and regulatory compliance. Services include: ● ● Project Developmentis the first point of contact for project results. Project development staff provide expertise in research project administration. Staff assists internal and external investigators in developing grants for funding consideration including all pre-award activities, budget preparation and scopes of work. Research Review provides oversight of the study approval process including Research and Human Subjects Review 39 of 56 About the Center for Health Studies ● Committee and contracting. Business and Grant Operations provides financial and contract management and post-award grant administration. Information Technologies Every encounter a Group Health enrollee has with the medical care system generates data. These data and processes for their uses are organized into SAS data sets for research purposes. Management of these data, their summarizations and analysis are functions of the Center's Information Technology Division. Other responsibilities include on-going maintenance and updating of Center-wide computer equipment and technologies as well as staff training. Survey Program A distinct operational unit within the Center since 1988, the Survey Research Program (SRP) specializes in conducting telephone and mail surveys for projects within the Center and the community. The program performs data collection for projects of varying size, complexity and duration. Survey program staff consult on survey design and administration; field telephone or mailed surveys; track respondents; and enter, edit code and clean data. The program uses computer assisted telephone interviewing (CATI) software for telephone surveys. SRP has 14 CATI stations, and can expand capacity, as needed. Research Clinics The Center has clinical research sites in Seattle and Redmond, WA. Its Seattle location has a laboratory, exam/interview room and specialized equipment which can measure bone mineral density, pulmonary function, body fat, and cardiac strength. Its Redmond site includes a room for bone mineral density measurements and a combination exam room/laboratory. Both are staffed by nurse practitioners, registered nurses, medical assistants, and clinical research assistants. Top of page | InContext Home Revised: 05/26/2004 For more information, contact us. Copyright © 2001 All rights reserved. XXXXXXXXXXX 40 of 56 Patient Health Education Resources Patient Health Education Resources (PHER) Home PHER Home How PHER Can Help Patient Education Guidelines Samples of Our Work More About Us Contact Us Patient Health Education Resources (PHER) develops health education material for our members that supports informed decision-making, promotes self-care, and reinforces Group Health's guidelines and best practices. We follow plain language standards when writing health content for patients. These guidelines allow us to provide our members with clear and concise messages. (See also Plain Language Toolkit.) The following are Group Health's primary resources for patient health education: ● ● ● Patient Health Education Resources (PHER) MyGroupHealth Healthwise® Knowledgebase* *If the information in the Healthwise Knowledgebase isn't exactly what you're looking for, please let us know. Our partnership with Healthwise, Inc., allows us to provide feedback. Still have questions? Contact us at patienthealth@ghc.org for further assistance. Q&I Home | InContext Home Revised: 11/9/2007 For content information, e-mail patienthealth@ghc.org. For technical information, contact Web developer. Copyright© 2007 Group Health Cooperative. All rights reserved. 41 of 56 Patient Safety Home Page Patient Safety Patient Safety Home Report an Unusual Occurrence Information Culture Survey About Patient Safety Hospital Patient Safety Frequently Asked Questions Toolkits Disclosure Leadership Safety Rounds External Resources/Tools Contact Us Report an Unusual Occurrence About patient safety Welcome to the Patient Safety homepage. Patient Safety is a fundamental component of Group Health's mission to deliver high quality health care: It is every patient's right and every employee's and practitioner's responsibility. This site provides staff with some high-level patient safety information and tools, as well as some guidance regarding where to go for additional information, training, and support. In order to support all staff in providing the safest care possible, it is important to identify issues and build safer systems to prevent accidental injuries. Recognizing that system breakdowns–and not "human failure"–are most often the cause of problems and errors, we must all recognize and accept that "to err is human." Group Health leaders and managers encourage reporting any/all unusual clinical occurrences - be it an error, a potential error, or a "near miss" (or, "good save") from everyone without fear of retaliation for reporting. We will use this system of unusual occurrence reporting to learn from unusual occurrences and to identify system weaknesses and breakdowns so that future errors can be avoided and ensure the care we give our patients is safe and effective. Q&I Home | InContext Home Revised: 11/12/2007 For content questions contact Patient Safety Manager. For technical questions contact the Web Developer. Copyright© 2005–2007 Group Health Cooperative. All rights reserved. 42 of 56 Prohibited Abbreviations The Group Health Hospital System created a list of Prohibited Abbreviations that are known to interfere with clear and explicit communication among caregivers. As of April 15, 2005, the Hospital Pharmacy will no longer dispense medications until the abbreviation has been verified. If any prohibited item is used in an order, it may not be executed until the practitioner has been contacted to verify the order. One hundred percent compliance is mandatory. An RN or Pharmacist will contact the practitioner each and every time a prohibited abbreviation is used. To be spared that extra phone call, please DO NOT USE any of the items on the following list. The practitioner is asked to respond as soon as possible so as to not cause undue delays in the provision of medications to the patient. PROHIBITED ABBREVIATIONS (as approved by the Hospital Medical Executive Committee): Do not use Misinterpretation Use U Read as a zero (0) or a four (4), causing a 10-fold overdose or greater (4U seen as “40” or 4u seen as 44”). Write: unit IU Leading decimal (.1 mg) Misread as IV (intravenous) or 10 (ten). Misread as 1 mg if the decimal point is not seen. Misread as 10 mg if the decimal point is not seen. Write: unit or international unit Use a zero before a decimal point 0.1 mg 1 mg Do not write a zero by itself after a decimal point mcg or write micrograms Write : days or doses Write: daily or qam or qhs Trailing zero (1.0 mg) g d (as in “X3d” or “3d”) qd, q.d., QD, Q.D. qod, q.o.d., Q.O.D. MgSO4 MS MS04 < and > Mistaken for mg Mistaken for days or doses Mistaken as q.i.d., especially if the period after the “q” or the tail of the “q” is misunderstood as an “i.” Misinterpreted as “q.d.” (daily) or “q.i.d. (four times daily) if the “o” is poorly written. Mistaken for Morphine Write: every other day Mistaken for Magnesium Sulfate Write: Magnesium Sulfate or MagSO4 or Mag Write: Morphine Mistakenly used opposite of intended Write: less than and greater than Source: Institute for Safe Medication Practice, JCAHO For more information about tools to help prevent medication errors, please contact the Pharmacy Manager: Central: Misalee Gori at 206-326-3421; or Eastside: Dana McKenna at 425-883-5590. 4/05 43 of 56 Medication Dosing Instructions for: Place patient sticker here Medication: __________________________ 1 2 am am 3 am 4 am 5 am 6 am 7 am 8 am 9 am 10 am 11 am 12 noon 1 pm 2 pm 3 pm 4 pm 5 pm 6 pm 7 pm 8 pm 9 pm 10 pm 11 pm 12 pm Dose 1 Dose 2 Dose 3 Dose 4 Time: _______________________ Time: _______________________ Time: _______________________ Time: ______________________ ____________________ ___________________ ___________________ ___________________ ___________________ ____________________ _____________________ _______________ ____________________ _______________ _______________ _______________ ____________________ _______________ _______________ ____________________ _______________ _____________________ ____________________ _______________ Pharmacy Instructions: Sunday Monday Tuesday Wednesday Thursday Friday Saturday (Clip here) Special Instructions: Stay out of the sun. May cause drowsiness. Do not take with alcohol. Take with food. Take with water. Other: _________________________ 44 of 56 +DELW ,QYHVWLQWKH %HJLQQLQJ (OLFLWWKH 3DWLHQW¶V 3HUVSHFWLYH 'HPRQVWUDWH (PSDWK\ ,QYHVWLQ WKH(QG 7+()285+$%,7602'(/ 6NLOOV &UHDWHUDSSRUW TXLFNO\ • • • • • • 7HFKQLTXHVDQG([DPSOHV ,QWURGXFH\RXUVHOIWRHYHU\RQHLQWKHURRP $FNQRZOHGJHZDLW &RQYH\NQRZOHGJHRISDWLHQW¶VKLVWRU\E\FRPPHQWLQJRQSULRUYLVLWRUSUREOHP $WWHQGWRWKHSDWLHQW¶VFRPIRUW 0DNHDVRFLDOFRPPHQWRUDVNDQRQPHGLFDOTXHVWLRQWRSXWSDWLHQWDWHDVH $GDSW\RXUODQJXDJHSDFHDQGSRVWXUHLQUHVSRQVHWRWKHSDWLHQW 'UDZRXWWKH SDWLHQW¶VFRQFHUQV • 6WDUWZLWKRSHQHQGHGTXHVWLRQV 3ODQWKHYLVLWZLWK WKHSDWLHQW • 5HSHDWFRQFHUQVEDFNWRFKHFNXQGHUVWDQGLQJ • /HWWKHSDWLHQWNQRZZKDWWRH[SHFW³+RZDERXWLIZHVWDUWZLWKWDONLQJ $VNIRUWKH SDWLHQW¶VLGHDV ³:KDWZRXOG\RXOLNHKHOSZLWKWRGD\"´2U³,XQGHUVWDQGWKDW\RX¶UHKHUH IRU«&RXOG\RXWHOOPHPRUHDERXWWKDW"´ ³:KDWHOVH"´ • 6SHDNGLUHFWO\ZLWKWKHSDWLHQWZKHQXVLQJDQLQWHUSUHWHU PRUHDERXW«WKHQ,¶OOGRDQH[DPDQGWKHQZH¶OOJRRYHUSRVVLEOHWHVWVZD\V WRWUHDWWKLV"6RXQG2."´ • 3ULRULWL]HZKHQQHFHVVDU\³/HW¶VPDNHVXUHZHWDONDERXW;DQG< ,WVRXQGV OLNH\RXDOVRZDQWWRPDNHVXUHZHFRYHU=,IZHFDQ¶WJHWWRWKHRWKHU FRQFHUQVOHW¶V«´ • $VVHVVWKHSDWLHQW¶VSRLQWRIYLHZ − ³:KDWGR\RXWKLQNLVFDXVLQJ\RXUV\PSWRPV"´ − ³:KDWZRUULHV\RXPRVWDERXWWKLVSUREOHP"´ • $VNDERXWLGHDVIURPVLJQLILFDQWRWKHUV (OLFLWVSHFLILF UHTXHVWV • 'HWHUPLQHWKHSDWLHQW¶VJRDOLQVHHNLQJFDUH³ZKHQ\RX¶YHEHHQWKLQNLQJ ([SORUHWKHLPSDFW RQWKHSDWLHQW¶VOLIH • &KHFNFRQWH[W³+RZKDVWKHLOOQHVVDIIHFWHG\RXUGDLO\DFWLYLWLHVZRUN IDPLO\"´ %HRSHQWRWKH SDWLHQW¶VHPRWLRQV • $VVHVVFKDQJHVLQERG\ODQJXDJHDQGYRLFHWRQH • /RRNIRURSSRUWXQLWLHVWRXVHEULHIHPSDWKLFFRPPHQWVRUJHVWXUHV DERXWWKLVYLVLWKRZZHUH\RXKRSLQJ,FRXOGKHOS"´ • 1DPHDOLNHO\HPRWLRQ³7KDWVRXQGVUHDOO\XSVHWWLQJ´ 0DNHDWOHDVWRQH HPSDWKLFVWDWHPHQW • &RPSOLPHQWWKHSDWLHQWRQHIIRUWVWRDGGUHVVRZQSUREOHP &RQYH\HPSDWK\ QRQYHUEDOO\ • 8VHDSDXVHWRXFKRUDIDFLDOH[SUHVVLRQ %HDZDUHRI\RXU RZQUHDFWLRQV 'HOLYHUGLDJQRVWLF LQIRUPDWLRQ • • • • 8VH\RXUHPRWLRQDOUHVSRQVHDVDFOXHWRZKDWWKHSDWLHQWPLJKWEHIHHOLQJ 7DNHDEULHIWLPHRXWLIQHFHVVDU\ )UDPHGLDJQRVLVLQWHUPVRISDWLHQW¶VRULJLQDOFRQFHUQV 7HVWIRUSDWLHQWFRPSUHKHQVLRQ 3URYLGHHGXFDWLRQ • • • • ([SODLQUDWLRQDOHIRUWHVWVDQGWUHDWPHQWV 5HYLHZSRVVLEOHVLGHHIIHFWVDQGH[SHFWHGFRXUVHRIUHFRYHU\ 5HFRPPHQGOLIHVW\OHFKDQJHV 3URYLGHZULWWHQPDWHULDOVDQGUHIHUWRRWKHUUHVRXUFHV+HDOWKZLVH+DQGERRN ,QYROYHWKHSDWLHQW LQPDNLQJ GHFLVLRQV • 'LVFXVVWUHDWPHQWJRDOV • ([SORUHRSWLRQVOLVWHQLQJIRUWKHSDWLHQW¶VSUHIHUHQFHV • 6HWOLPLWVUHVSHFWIXOO\³,FDQXQGHUVWDQGKRZJHWWLQJWKDWWHVWPDNHVVHQVHWR &RPSOHWHWKHYLVLW • $VNIRUDGGLWLRQDOTXHVWLRQV³$Q\WKLQJHOVH\RXZDQWHGWRWDONDERXW"´ • $VVHVVVDWLVIDFWLRQ³'LG\RXJHWZKDW\RXQHHGHG"´ • 5HDVVXUHWKHSDWLHQWRIRQJRLQJ FDUH 3D\RII • (VWDEOLVKHVD ZHOFRPLQJDWPRVSKHUH • $OORZVIDVWHUDFFHVVWR UHDOUHDVRQIRUYLVLW • ,QFUHDVHVGLDJQRVWLF DFFXUDF\ • 5HTXLUHVOHVV ZRUN • 3UHYHQWV³2KE\ WKHZD\«´DWWKHHQG RIWKHYLVLW • )DFLOLWDWHVQHJRWLDWLQJ DQDJHQGD • 'HFUHDVHVSRWHQWLDO IRUFRQIOLFW • 5HVSHFWVGLYHUVLW\ • $OORZVWKHSDWLHQWWR SURYLGHLPSRUWDQW GLDJQRVWLFFOXHV • 6XUIDFHVKLGGHQ FRQFHUQV • 5HYHDOVXVHRI DOWHUQDWLYHWUHDWPHQWV RUUHTXHVWVIRUWHVWV • ,PSURYHVGLDJQRVLVRI GHSUHVVLRQDQGDQ[LHW\ • $GGVGHSWKDQG PHDQLQJWRWKHYLVLW • %XLOGVWUXVWOHDGLQJ WREHWWHUGLDJQRVWLF LQIRUPDWLRQ DGKHUHQFHDQG RXWFRPHV • 0DNHVOLPLWVHWWLQJRU VD\LQJ³QR´HDVLHU • ,QFUHDVHVSRWHQWLDOIRU FROODERUDWLRQ • ,PSDFWVKHDOWK RXWFRPHV • ,PSURYHVDGKHUHQFH • 5HGXFHVUHWXUQFDOOV DQGYLVLWV • (QFRXUDJHVVHOIFDUH \RX)URPP\SRLQWRIYLHZVLQFHWKHUHVXOWVZRQ¶WKHOSXVGLDJQRVHRUWUHDW \RXUV\PSWRPV, VXJJHVWZHFRQVLGHUWKLVLQVWHDG´ • $VVHVVWKHSDWLHQW¶VDELOLW\DQGPRWLYDWLRQWRFDUU\RXWSODQ 3K\VLFLDQ(GXFDWLRQ'HYHORSPHQW730*,QF 55 of 56 1RUHODWLRQWR6WHSKHQ&RYH\¶VERRN7KH6HYHQ+DELWVRI+LJKO\(IIHFWLYH3HRSOH 45 of 56 KWWSNSQHWNSRUJFSF 3DWLHQW(GXFDWLRQ *HWWLQJWKHPRVWRXWRI\RXUGRFWRUYLVLWV &RPPXQLFDWLQJZLWK\RXUKHDOWKFDUHWHDP *RRGKHDOWKFDUHLVDSDUWQHUVKLSEHWZHHQSDWLHQWVDQGWKHLUKHDOWKFDUHSURYLGHUV 2QHRIWKHNH\VLQWKLVSDUWQHUVKLSLVFOHDUFRPPXQLFDWLRQEHWZHHQSDWLHQWVDQGWKHLU KHDOWKFDUHWHDPV7KDW·VZK\LW·VVRLPSRUWDQWWR SODQDKHDGIRURXUYLVLWVDQGWRXVH SODLQODQJXDJHZKHQZHWDONDERXWKHDOWKFRQFHUQV 3ODLQODQJXDJHLVFRPPXQLFDWLRQWKDWJHWVWKHPHVVDJHDFURVVWKHILUVWWLPH\RXKHDU RUUHDGLW,W·VLQIRUPDWLRQWKDW·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·UHWDNLQJFDQ KHOS\RXDQG\RXUGRFWRUPDNHGHFLVLRQVDERXW\RXUWUHDWPHQW 8VHWKH$VN0HTXHVWLRQV :KHQ\RXJRWRVHH\RXUGRFWRUQXUVHRUSKDUPDFLVWDVN :KDWLVP\PDLQKHDOWKSUREOHP" :KDWGR,QHHGWRGR" :K\LVLWLPSRUWDQWIRUPHWRGRWKLV" 3+(5 5HY'DWH *URXS+HDOWK&RRSHUDWLYH 46 of 56 7DNHQRWHV :ULWHGRZQWKHWKLQJV\RXWDONDERXWDQGWKHGHFLVLRQV\RXPDNHZLWK\RXUKHDOWK FDUHWHDP7KLVZLOOKHOS\RXUHPHPEHUZKDW \RXGHFLGHGDQGZKDW\RXQHHGWRGR 7DNHVRPHRQHZLWK\RX %ULQJDWUXVWHGIULHQGRUDPHPEHURI\RXUIDPLO\WRKHOS\RXDW\RXUYLVLWV+HRUVKH FDQKHOSWDNHQRWHVDQGDVNTXHVWLRQV $VNIRUGHILQLWLRQV ,W·VRND\WRVD\\RXGRQ·WXQGHUVWDQG+HDOWKLQIRUPDWLRQWKDW·VQHZFDQEH FRQIXVLQJ,IVRPHRQHRQ\RXUKHDOWKFDUHWHDPXVHVWHUPV\RXGRQ·WXQGHUVWDQGDVN KLPRUKHUWRH[SODLQDJDLQLQSODLQODQJXDJH$VNLQJTXHVWLRQVKHOSV\RXXQGHUVWDQG ZKDWWRGRWRVWD\ZHOORUWRJHWEHWWHU 5HFDS $WWKHHQGRI\RXUDSSRLQWPHQWWHOO\RXUGRFWRURUQXUVHZKDW\RXSODQWRGRDQG ZKHQDQGKRZ\RX·OOGRLW )ROORZXS ,I\RXJHWKRPHDQGVWLOOKDYHTXHVWLRQVFDOORUVHQGDVHFXUHHPDLOPHVVDJHWR\RXU KHDOWKFDUHWHDP6HFXUHHPDLOZRUNVZHOOEHFDXVHLWJLYHV\RXFRPSOHWHSULYDF\DQG \RX·OOKDYHDZULWWHQUHFRUGRI\RXUGRFWRU·VUHSO\,I\RXGRQ·WKDYHDFFHVVDOUHDG\ \RXFDQVLJQXSIRUVHFXUHPHVVDJLQJZLWK\RXUKHDOWKFDUHWHDPRQWKH*URXS+HDOWK :HEVLWHDWZZZJKFRUJ $VN0HLVDSURJUDPRIWKH3DUWQHUVKLSIRU&OHDU+HDOWK&RPPXQLFDWLRQDFRDOLWLRQRIQDWLRQDO RUJDQL]DWLRQVZRUNLQJWRJHWKHUWRSURPRWHKHDOWKOLWHUDF\DQGEHWWHUKHDOWKRXWFRPHV 7KLVKDQGRXWZDVGHYHORSHGLQSDUWIURPLQIRUPDWLRQIURPWKH-RXUQDORI3DWLHQW6DIHW\/LSSLQFRWW :LOOLDPV:LONLQVWKH3DUWQHUVKLSIRU&OHDU+HDOWK&RPPXQLFDWLRQDQGWKH$0$)RXQGDWLRQ 47 of 56 What the test results mean What I need to watch for What to do if this happens When to call my doctor My main health concern Other health concerns I want to talk about What my doctor said to do What tests I need XX-1234 Notes PHER Rev. Date 2007149 © 2007 Group Health Cooperative Checklist of questions Self-care diary Preparing for my doctor visit Patient Education Symptoms How long/how often Action I took Result Comments Doctor’s phone number___________________________________ Doctor’s name_______________________________________________________ Date Patient number__________________________________________ Name_______________________________________________________________ Self-care Diary Patient Education Know Your Medicines When you get a prescription for a new medicine, ask your doctor or pharmacist these questions: What is the name of the medicine? Why do I need it? What time should I take? How long should I take it? Are there any side effects? Could this medicine interact with other medicine that I’m taking, including non-prescription medicine or supplements? Here are some tips that can help you keep track of your medicines. Keep a record of all your medicine, including non-prescription medicine and supplements. Write down the medicine’s name, the dose you take, how often you take it, and the reason you’re taking it. Take your medication record with you when you go to see your doctor or pharmacist and ask about possible drug interactions. Go through your medicines often. Check for prescriptions that are out of date. Talk to a member of your health care team before you change anything about the way you take your medicines. Use a pillbox to help you organize your medicines. Ask your pharmacist to put easy-to-open caps or large-print labels on medicine bottles. Call the Group Health Resource Line for a free medication record card. 1-800-9922279 PHER Rev. Date 2007255 © 2007 Group Health Cooperative 50 of 56 Patient Education Supporting Good Health Communication: Internet Resources for Patients AskMe3 – www.askme3.org This website gives tips on how doctors and patients can improve health communication. It recommends that patients ask 3 questions any time they talk with a doctor, nurse, or pharmacist: What is my main problem? What do I need to do? Why is it important for me to do this? There is also a checklist to help you prepare for doctor visits. The site is sponsored by the Partnership for Clear Health Communication. FDA Easy-to-Read Publications – www.fda.gov/opacom/lowlit/7lowlit.html This website has a collection of easy-to-read brochures in English and Spanish on a variety of health topics. You can print them or order free copies. FDA Information for Seniors - www.fda.gov/oc/olderpersons/ This website has easy-to-read articles on a variety of health issues that affect older adults. Topics include arthritis, cancer, nutrition, food safety, and women's health. There are also links to more information for older adults. Medline Plus - www.nlm.nih.gov/medlineplus/tutorial.html This website includes interactive features that teach about health topics with animated graphics and simple text. Also available in Spanish. Continued on back page » » » 51 of 56 KidsHealth - www.kidshealth.org There are sections for parents, kids, and teens, including interactive games. The kids’ articles are easy to read and written for children. These articles may also be appropriate for adult learners with low-literacy skills. FamilyDoctor – www.familydoctor.org This patient-friendly site has several helpful health tools, including a dictionary of common medical terms and a section on healthy living. All material is written and reviewed by doctors and patient educators. The site is sponsored by the American Academy of Family Physicians. 2 52 of 56 Radiation Therapy Treatment Information for Patients Contains unnecessary information GOALS AND PURPOSE OF RADIATION THERAPY Radiation uses high-energy beams and particles to disrupt the ability for cancer cells to reproduce and grow. It is used to kill cells and shrink a tumor. The goal of treatment is to destroy the tumor and ease uncomfortable symptoms caused by the tumor. RISKS OF RADIATION TREATMENT As with any other type of treatment for a disease, there are risks associated with receiving radiation therapy. • The brief, high doses of radiation that damage or destroy cancer cells can also affect normal tissues. When this occurs, some patients may experience side effects. • There can also be long-term complications, some of which may be permanent. Serious or permanent complications are less likely with modern radiation therapy equipment and techniques. accelerator. Overall duration of treatment The duration of the treatment will vary, depending on the goal and other specifics of your treatment. On average, radiation therapy is given five days a week, for a period of four to seven weeks. It is important to remember that there are numerous treatment regimes, and they may require more or less time, may be more than once a day or less than five days a week. Your treatment program will be outlined for you by your radiation oncologist/nurse practitioner before you begin and discussed again during the course of the treatment. Physical activity during treatment The limits you may experience will depend on your overall condition and on any side effects you experience. Many patients are able to continue work and perform household tasks, as well as enjoy most of their leisure Medical activities while they are being treated. Others find that they require more jargon rest than usual. We find that regular exercise (for example a 15-20 minute walk several times a week) will help minimize fatigue caused by treatment. Your radiation oncologist/nurse practitioner may suggest that you limit activities that irritate the area being treated. 53 of 56 SIDE EFFECTS DURING TREATMENT Written in There may be some short-term or permanent side effects. Short-term side the passive effects occur during or very shortly after the treatment and may persist for voice a few weeks after the treatment is completed. Your radiation Sentence is oncologist/nurse practitioner will observe you carefully for side effects too long during your treatment, and will discuss any necessary corrective measures with you. Please do not hesitate to ask about anything that worries you. Doesn’t • Your radiation oncologist/nurse practitioner can give you ideas on how to directly address the alleviate some of the discomfort without jeopardizing the quality of the reader treatments. During radiation treatment, we may recommend that you apply aloe vera gel for comfort and to help prevent a more severe skin reaction. We do not recommend the application of any powders, creams, lotions, medications, perfumes, deodorants, body oils, ointments, or home Most important remedies in the treated area, as many have ingredients that could increase information skin reactions on the area being treated. isn’t in first • For other specifics regarding skin care, see guidelines for self care, sentence above. Paragraph needs more Hair loss Hair loss can be caused by radiation, but only if that area is being treated. white space For instance, if your chest is being treated, you will not lose the hair from your head from the radiation. Also, many patients find that hair does not grow back within several months after treatments are completed; it may take longer. Ask your radiation oncologist/nurse practitioner what you can expect. If your scalp is being treated, and irritation or hair loss occurs, there are many types of hats, turbans, toupees, and wigs to accommodate Doesn’t clearly state what theeveryone. To get a hairpiece that looks good and fits well, it’s best to be before your hair loss. If the scalp is in the treatment field, the patient needsevaluated to do hair will usually thin out painlessly about two weeks into treatment. and when they need to do it SIDE EFFECTS ASSOCIATED WITH TREATMENT OF SPECIFIC AREAS Breast Irradiation If you are receiving radiation after a lumpectomy or mastectomy, we recommend wearing your bra as little as possible. The material rubbing against your skin can be irritating. The most common areas of skin reactions are under your arm, on the nipple, and under the breast. Apply cornstarch under the bra band to decrease friction rubbing when you must wear one. Throughout the course of treatment, your radiation team will be checking the area of treatment for skin reactions (see guidelines for selfcare during treatment above). 54 of 56 Patient Education Removed unnecessary information Radiation Therapy: Treatment Information for Patients What is radiation therapy? Radiation therapy uses high doses of radiation to destroy cancer cells and tumors. Radiation can shrink tumors and prevent symptoms caused by tumors. Radiation may also be used to treat noncancerous health conditions. Good use of “road signs” to help reader see what topics are covered What are the risks of radiation therapy? As with any kind of treatment, radiation therapy has some risks. Risks from radiation therapy depend on the part of your body that is treated. They can range from short-term side-effects, which are common, to long-term complications, which are rare. Your doctor, nurse practitioner, or another member of your therapy team will talk to you about the risks and side effects from your specific treatment. How long will my appointment take? Usually, your appointment will take about 15 to 20 minutes. This includes the time it takes to set up the machine and make sure you’re in the right position for receiving treatment. The amount of time you’ll actually be getting radiation treatment is only a few minutes. Replaced Good use of an example medical jargon Can I still be physically active? Many people are able to go to work and continue with their normal daily activities while going through radiation treatment. Some people need more rest than usual. Getting regular exercise, such as a 15 to 20 minute walk on most days, can help you feel less tired. Your doctor or nurse practitioner may suggest avoiding activities that irritate the treatment area. Written in the active voice Does radiation therapy have any side effects? You may have short-term or long-term side effects. Short-term side effects happen during or right after treatment, and may last for a few weeks after treatment is completed. Your health care team will watch for side effects and give you tips to manage them. Ask your health care team any questions about side effects. Skin changes The skin in the treatment area may get red, irritated, or look tanned or sunburned. Your skin may also feel very dry and itchy. While you are going through treatment, your health care team will check your skin and look for skin problems. 1 PHER Rev. Date 2007200 © 2007 Group Health Cooperative 55 of 56 While you are going through treatment, try using aloe gel to soothe your skin. Don’t put anything on your skin for 3 hours before treatment. Don’t use any powders, creams, lotions, medications, Shortened perfumes, deodorants, body oils, ointments, or home remedies on the treatment area. These Addressed the products can irritate your skin. Ask your health care team for tips to prevent and treat skin the sentence reader directly problems. Hair loss Radiation therapy can cause some people to lose their hair. This only happens in the area that is Added more treated with radiation. For example, if your chest is treated, you won’t lose the hair from your head. white space If your head is treated, you might lose hair from your scalp. Put the most People usually lose their hair about two weeks after starting treatment. For most people, hair grows important back within several months after completing treatment, but sometimes it takes longer. If you lose information hair from your scalp, there are many options for covering your head, including hats, turbans, first toupees, and wigs. Ask your doctor or nurse practitioner if you have questions about hair loss. Side effects associated with treatment of specific areas Clearly states what the patient needs to do and when they need to do it Treatment to the breast or breasts: If you have radiation treatment after breast surgery, go without a bra as often as possible. The fabric can irritate your skin. At times when you have to wear a bra, you can help prevent irritation by putting a little cornstarch where the bra touches your skin. 2 56 of 56 Center for Health Studies PRISM PRISM [ Project to Review and Improve Study Materials] Readability Toolkit Notes for users • This Toolkit is a copyrighted, public domain resource that you may feel free to use and share as you see fit. • Navigation links and links to dozens of outside resources are indicated in standard hyperlink format (blue underlined text). The external links in this edition were last accessed on November 19, 2007. • We welcome your feedback about the Toolkit’s usefulness, as well as suggestions for improvements or updates. Please send your comments by email to the PRISM team at PRISM@ghc.org. • We plan to update the Toolkit periodically. To receive updated versions, please register your email address via our online tracking system available at http://www.surveymonkey.com/s.aspx?sm=4_2b6cCfUKcjVtUKiwmKE87w_3d_3d. Suggested citation: Ridpath JR, Greene SM, Wiese CJ; PRISM Readability Toolkit. 3rd ed. Seattle: Group Health Center for Health Studies; 2007. © 2006 Group Health Center for Health Studies, Second edition Third edition, Version 1, updated November 2007 Lead author contact info: Jessica Ridpath Research Communications Coordinator Group Health Center for Health Studies 1730 Minor Ave, Suite 1600 Seattle, WA 98101 206-287-2032 ridpath.j@ghc.org Acknowledgements: Michelle Kindall designed the cover and provided critical feedback on the design of the third edition. The following project managers were instrumental in developing the first edition: Julia Anderson, Barbara Carste, Kelly Ehrlich, Dawn Fitzgibbons, Christine Mahoney, Paula Sandler, Dottie Oliver, and Emily Westbrook. This work was supported primarily by the core budget of the Group Health Center for Health Studies. Additional support was provided by the National Institutes of Health, under Contract No. HHSN268200425212C, "ReEngineering the Clinical Research Enterprise.” Synopsis of PRISM Resources Project to Review and Improve Study Materials (PRISM) is a Group Health Center for Health Studies initiative to improve the quality of print materials used in communication with research participants. Our primary goal is to create written study materials that are readable and participant-centered. PRISM consists of three resources that have been tailored for research, but that may be helpful in any health care environment: • This Readability Toolkit • A plain language editing service • A readability training workshop The PRISM Readability Toolkit is a compendium of strategies, real-world examples, and related resources to aid researchers and others in the health care setting create print materials that an audience (such as a potential study participant or patient) can easily understand. The PRISM plain language editing service is available on a fee-for-service basis. Our editors will make sure your materials are clear, readable, and well-organized. We do this by: • Converting research jargon, medical terminology, and other complex terms into plain language. • Using reader-friendly sentence structure and formatting. • Identifying any concepts or procedures that are confusing and suggesting ways to improve overall organization and clarity. • Correcting errors and ensuring consistency between materials. • Checking the final reading level of your materials. In many cases, we can get your materials to an 8th grade reading level or below. The PRISM readability training workshop promotes health literacy awareness and describes concrete strategies for writing in plain language. It is based on the principles and techniques employed in this Toolkit. We offer a menu of training options and can customize the workshop to meet your needs. Tailored workshops include hands-on editing exercises based on the kinds of print materials you typically develop. For more information about the PRISM editing service or training workshop, including price and timeline estimates, please contact Jessica Ridpath at 206-287-2032 or PRISM@ghc.org. 1 Contents How this Toolkit Can Help You............................................................................... 3 What You Should Know Before Using this Toolkit................................................. 5 The Principles of Plain Language............................................................................. 7 How to Determine Reading Level............................................................................ 11 Quick Reference Guide for Improving Readability.................................................. 13 Editing Checklist for Participant Materials...............................................................15 Resources for Informed Consent Documents........................................................... 18 Resources for HIPAA Authorization Documents..................................................... 34 Appendices Appendix A: Instructions for Checking Readability in Microsoft Word™……….. 36 Appendix B: Alternative Wording Suggestions…………………………………... 37 Appendix C: Examples of Improved Readability…………………………………. 56 Appendix D: Examples of Improved Formatting…………………………………. 64 Appendix E: Repository of Readability References and Resources...…………….. 71 2 How this Toolkit Can Help You We created this Toolkit to help health care researchers develop print materials that study participants can easily read and understand. Nearly half of American adults read at or below an 8th grade reading level. 1 However, most informed consent templates are written at a 10th grade reading level or higher. 2 Written materials for research study participants must often explain complex ideas and information, including the purpose of the study, detailed study procedures, and confusing privacy laws. This can make the development of easy-to-read study materials challenging. Using this Toolkit will help research teams more easily develop consent forms and other participant materials using “plain language.” Plain language is communication (either written or spoken) that an audience can understand the first time they read or hear it. It is clear, concise, and straight-forward and is formatted for easy reading. The underlying principle is that the communication is developed with the reader’s needs in mind. In other words, the process and results are participant-centered. Although it is primarily geared toward research, many of the guidelines and strategies in this Toolkit can be applied to print materials used in any health care setting. They can also be adapted to work within guidelines or templates you may currently be using. The Toolkit is made up of multiple modules that you can use separately or together. It provides a detailed description of plain language principles, as well as concrete guidelines, tools, examples, and resources to help you adhere to those principles. The modules are: What You Should Know Before Using this Toolkit – Background information on health literacy, plain language, and why both are important in the research context The Principles of Plain Language – An explanation of the components of plain language, as well as concrete strategies that support plain language writing How to Determine Reading Level – Information and advice about using readability formulas to rate the approximate reading level of your materials; see also Appendix A: Instructions for Checking Readability in Microsoft Word™ Quick Reference Guide for Improving Readability – An at-a-glance summary of plain language principles and strategies, plus other formatting, editing, and proofreading tips Editing Checklist for Participant Materials – A companion to the Quick Reference Guide that guides users through a systematic process to improve readability, identify unclear concepts, and eliminate proofreading errors Resources for Informed Consent Documents – Readability advice and resources specifically for consent forms, including a list of common pitfalls, links to helpful consent templates and guidelines, and a selection of easy-to-read template language for common consent topics, such as randomization and voluntary participation 1 2003 National Assessment of Adult Literacy Survey (NAAL), National Center for Education Statistics, www.nces.ed.gov/naal 2 Paasche-Orlow M, et al. Readability standards for informed consent forms as compare with actual readability. NEJM. 2003 Feb 20;348(8). 3 Resources for HIPAA Authorization Documents – Links to helpful HIPAA templates and guidelines, along with a brief selection of easy-to-read HIPAA language Alternative wording suggestions – A list of plain language alternatives for hundreds of words typically used in medical and research settings and links to online resources that define medical and research jargon Examples of improved readability – Before and after “snapshots” of plain language revisions to original text taken from actual participant materials Examples of improved formatting – Techniques for improving readability through formatting changes are illustrated with three before and after examples: an advance letter, a consent form, and a study information sheet. While the focus is on improved formatting, all three examples also illustrate other plain language techniques. Repository of readability resources and references – A clearinghouse of web-based resources focused on health literacy, readability, plain language, and informed consent, plus a short bibliography of articles related to literacy and readability in health research << Back to contents page 4 What You Should Know Before Using this Toolkit Background on health literacy and plain language Recent high-profile reports from the Institute of Medicine (IOM) and the Joint Commission on the Accreditation of Hospitals (JCAHO) have highlighted the problem of limited health literacy in the United States. 3,4 The health care environment is typically so complex that most Americans—even those with average or above average literacy skills—may not be able to understand or act on information that is critical to their health and well-being. One way we can begin to close this gap is to improve the readability of print materials used in all health care contexts, including health care research. To this end, the U.S. Department of Health and Human Services (DHHS), JCAHO, and the IOM have all recommended that health information be written in plain language. For a comprehensive summary of why plain language is one promising solution to our nation’s health literacy crisis, see Stableford and Mettger’s 2007 article, Plain Language: A Strategic Response to the Health Literacy Challenge. Why plain language is especially important in research Many words and concepts that are commonly used in medical and research settings are complicated and unfamiliar to the average adult. However, federal regulations require that informed consent documents be written in language that is understandable to the subject. 5 Because nearly half of American adults read at or below an 8th grade reading level, 6 most IRBs recommend or require that participant materials meet a reading level target of 6th-8th grade. In order to conduct compliant and ethical research, research teams should strive to ensure that all print materials used in communication with study participants are as easy as possible to read. Of special concern to researchers is that people with chronic mental and/or physical health conditions are among several vulnerable populations whose reading level is below the national average. 7 Considering how often chronic medical conditions are the focus of research, it is imperative that the research community be mindful of how difficult it might be for certain populations to read and understand consent forms and other print materials used in health care research. Regardless of the population under study, research suggests that even people with average and above-average reading skills prefer easy-to-read information. 8,9 3 IOM 2004, “Health Literacy: A Prescription to End Confusion” JCAHO 2007, “What Did the Doctor Say?: Improving Heath Literacy to Protect Patient Safety” 5 45 CFR 46 6 2003 National Assessment of Adult Literacy Survey (NAAL), National Center for Education Statistics, www.nces.ed.gov/naal 7 2003 NAAL 8 Davis TC, et al. Parent comprehension of polio vaccine information pamphlets. Pediatrics. 1996;97:804810. 9 Kleinmann S, Enlow B. Is plain language appropriate for well-educated and politically important people? Results of research with congressional correspondence. Clarity. 2003;50:4-11. 4 5 One strategy that can aid the development of study materials is to use a participant-centered approach. Ask yourself what it would be like to participate in a given study. What thoughts, feelings, and questions would be on the participant’s mind? For instance, participants who are invited into a study because they have diabetes will likely want to know how the research team came to know about their condition. Other common questions might include: Will my doctor find out I am in the study? Should I talk to my doctor first? What’s in it for me? Do I have a choice about what happens to me? Will there be bad side effects? If so, what are they and what can I do about them? How do I find out more information? Try to anticipate a participant’s concerns and questions and address them thoughtfully. This will help you develop materials that are inviting and meaningful and may increase the chance that your readers will understand what you’ve written. << Back to contents page 6 The Principles of Plain Language This section explains four major principles of plain language, describes several strategies that support those principles, and provides links to additional plain language resources. Plain language: more than just simple words Stated simply, using plain language means communicating clearly. No one technique describes plain language, rather it consists of a range of strategies that lead to a common end: clear, readable information. While it may be obvious that plain language is based on using understandable language and avoiding jargon or other unfamiliar terms, there is much more to it than that. Plain language is written in a conversational style, with ideas organized into short, succinct sentences and paragraphs. Using plain language also involves using reader-friendly formatting so that the document looks easy to read. Finally, using plain language means keeping your readers’ needs in the forefront of your mind as you organize and filter your content. Doing so helps you organize the content in a way that will make sense to the reader and omit unnecessary details. The most important thing to bear in mind when using plain language is that it is a continual process of improvement. Achieving clear communication is more of an art than a science, and your skills will improve dramatically with practice. The clearest communication—and the best examples of plain language—usually result after multiple rounds of editing, so be prepared for an iterative process. Strategies to support plain language principles The principles and strategies described below are summarized in the Quick Reference Guide on page 13. Use language your audience can easily understand. In most cases, this means using common, everyday words, which may mean adjusting your writing style significantly if you’re used to writing in an academic or scientific environment. The key is to edit rigorously and search for multi-syllable words that you can replace with simpler alternatives. It’s also important to look out for short words with complex or multiple meanings. Use plain language word lists to help you replace or define jargon or other complex words. See the Alternative Wording Suggestions on page 37, which is a compilation of selections from several plain language words lists available on the intranet. You cannot always avoid using complex words and concepts, especially in medical and research materials, but you can use examples, analogies, and visual aids to help explain them. 7 To gauge the complexity of the language you’re using, it can be helpful to check the reading level using a readability formula. Most readability formulas are based on the US high school grading system and will give you an approximation of the education level required to understand what you’ve written. However, all readability formulas have limitations that must be considered. For more about using readability formulas, see How to Determine Reading Level on page 11. Write in a conversational style, as if you were speaking Use active voice, where the subject acts instead of being acted upon. It is more readable and more powerful than passive voice. “We will ask you questions about your health” is active, while “You will be asked questions about your health” is passive. Write in the first person using pronouns, such as “I,” “we,” and “you.” It is more engaging and more personal. People will often read comfortably at a higher grade level than normal if they are interested in and can relate to the subject matter. The more words about people and the more sentences addressed to an audience, the more interesting a document is to read. Although it may seem awkward, reading your document aloud is probably the best way to ensure that you’re using a conversational style. Also, taking a break if you get stuck can be helpful. Try stepping away from the keyboard (or the paper and pen) and just speaking your thoughts. Organize and filter content with your readers’ needs in mind When developing content, try to follow the thought process of your reader. What information is most important to them? How should you order the information items to help it make the most sense? Are there concepts that may not be clear to someone who doesn’t know what you know? At times, our writing may be based on assumptions or lack context that will limit how meaningful the message will be to the intended audience. Ironically, we also tend to include significantly more information than the reader really needs in order to understand the key points. One great way to answer these questions is to ask someone who is unfamiliar with your project to read your document, such as a neighbor, friend, or relative who is fairly representative of your audience. You may be surprised at the different impressions or confusing information that an unfamiliar reader identifies. Provide information in understandable chunks by using short sentences and limiting paragraphs to one main idea. Break up sentences joined with semicolons or conjunctions, and aim for an average sentence length of 15 words or less. Varying the length of your sentences will improve flow. Paragraphs should start with a clear topic sentence and should not include unrelated details. Avoid information overload by limiting the content in your document to what the reader truly needs to know. Look carefully for information that does not add value to your document and omit it. 8 Organize your document in a way that will make sense to your readers. Put the most important information first. When relevant, ensure that stepwise information is in chronological order. Be clear about what your participants need to do and when they need to do it. Take time to consider what you know about your audience—their literacy level, age, culture, ethnicity, or potential chronic health conditions. Does your writing include information or assumptions that may not be meaningful (or that may be mis-interpreted or off-putting) within your readers’ cultural or social environment? Do your readers have special needs related to language or other abilities? Use large font for the elderly or for other populations who may have poor eyesight, like people with diabetes or glaucoma. Use the simplest language possible when writing assent forms for minors, and consider using cartoons, pictures, or other graphical methods to describe the study. Use reader-friendly formatting Readers are often discouraged by dense-looking pages. Therefore, do not assume that one page is always better than two. One page crammed with information is often more intimidating than multiple pages. Adequate white space and margins provide visual breaks that encourage the reader to keep going. Avoid decreasing margins to force text to fit on one page. Top and bottom margins should be at least 1 inch, and side margins should be at least 1.25 inches. Always consider how best to make use of any white space that may be left over. You may be able to add space between paragraphs or increase the font size of text or headers. Break up chunks of dense copy since this can cause readers to miss important information. Convert long lists embedded in sentences into bulleted lists with one point per line. It is especially important to put lists of critical information, like eligibility criteria, in bullet format. Use a numbered list if the order of items is important. Give your readers “road signs” that help them navigate your document and process information more quickly and effectively. A document is easier to read when there are descriptive headers for each section. Headers should be specific and should be graphically emphasized to stand out. In many cases, questions like, “What will happen if I take part in this study?” make suitable headers in the research context. Emphasize important information using bold or larger font, borders, or other graphical elements. This will draw the reader’s attention to critical information, even when they are only skimming your document. Avoid using justified margins or putting sentences in italics or all capital letters, as both increase the strain on the reader. It is okay to put 1 or 2 words in italics or all caps. 9 Helpful plain language resources There are many other excellent resources that describe techniques for improving readability and include information about plain language principles and strategies. Among the most comprehensive are: • The Health Literacy Style Manual – A detailed guide that includes tips on project planning, writing, formatting, field testing, and translating into languages other than English. Unlike many plain language resources, it addresses the readability of applications and other forms and is based on a variety of real-world examples. Developed by The MAXIMUS Center for Health Literacy as part of a national program funded by the Robert Wood Johnson Foundation. • Teaching Patients with Low Literacy Skills, 2nd Edition – A classic health literacy textbook for educators that includes information on reader comprehension, tips for using effective visuals, and an incredibly useful tool for assessing the suitability of materials that goes beyond the limitations of readability formulas. The book is now out of print, but is included among a wide range of resources available on the Health Literacy Website at the Harvard School of Public Health and can be downloaded for free. • Pfizer’s Principles for Clear Health Communication Handbook – A thorough compilation of strategies and information specifically developed for the health care setting. Many more helpful resources and websites are listed in Appendix E: Repository of Readability References and Resources on page 71. << Back to contents page 10 How to Determine Reading Level There are many formulas available to help determine the approximate reading level of a document, and you can find a wealth of information about each of them on the Internet. Most readability formulas provide a grade level score and are based on the average number of syllables per word and words per sentence. In general, the more syllables there are in a word and the more words there are in a sentences, the harder it is to read and understand the text. Among the most commonly used methods to determine readability are the Fry formula and the Flesch-Kincaid formula. Most health literacy experts recommend using the Fry formula, however, the analysis can take 20 minutes or more since computations are traditionally done by hand. The Flesch-Kincaid formula has been criticized for being less accurate than the Fry, however, results can be obtained quickly and automatically using the readability analysis tool in Microsoft Word™. Assessing the reading level via multiple formulas is probably the best way to get a reasonably accurate estimate of reading level. Many software packages provide multiple readability scores, and this may be the best option for those who can afford the investment. Despite the fact that the Flesch-Kincaid method may be less accurate than the Fry, it still has considerable value as a rough estimate and is especially useful when time or resources are limited. The readability tool in Microsoft Word™ also provides the Flesch Reading Ease score and the percent of passive sentences (see table below). For instructions on how to use the readability analysis tool in Microsoft Word™, please see Appendix A on page 36. Pfizer’s Principles for Health Communication provides a detailed description of how to use the Fry formula (see http://pfizerhealthliteracy.com/pdf/PfizerPrinciples.pdf). For other resources and information related to readability, see Appendix E: Repository of Readability References and Resources on page 71. Readability statistics available in Microsoft Word™ Formula Description PRISM Goal Flesch-Kincaid Reading Level provides a grade level score based on the US high school grade level system 8th grade or below Flesch Reading Ease 90-100 = Very easy 80-89 = Easy 70-79 = Fairly easy 60-69 = Standard 50-59 = Fairly difficult 30-49 = Difficult 0-29 = Very confusing 70 or greater Percent passive sentences gives the proportion of sentences written in passive voice 0-10% 11 Things to consider when using readability formulas • Formulas do not take overall organization, formatting, or page density into account, all of which significantly impact readability. • Sometimes we cannot avoid using multi-syllable words like “mammography” or “immunization.” If possible, substitute them with “x-ray of the breast” and “shot.” But if this is not possible, be sure to adequately define them in the materials and acknowledge that this will slightly increase your target grade level. • The number of syllables does not always correspond to how easy a word is to read and understand. For instance, “comprise” is a two-syllable word that is often misunderstood. Similarly, the number of words does not always correspond to how easy a sentence is to read. • Readability formulas will provide an approximate grade level score, however, it is still important to be conscious of the overall quality of the text. It is possible to write using short words and sentences that are still difficult for the average reader to comprehend. Goldfarb and DuBay suggest that it is important to avoid mechanically “writing to the formula,” and provide excellent examples of conscious revisions that make text easier to read, even though they score slightly higher on the FleschKincaid scale. 10 • The Flesch-Kincaid formula looks for periods to identify the end of a sentence. If your text includes a bulleted or numbered list, adding periods at the end of each item will yield a better score. To get the most accurate score, remove periods that don’t end a sentence, as in “Dr.” or “Mr.” • In older versions of Microsoft Word™, the Flesch-Kincaid Reading Level formula maxes out at a score of 12th grade. This means that different versions of the software will give different grade-level scores, and text rated at 12th grade may actually be college level or higher. Recent versions (2003 and newer) do not have this limitation and will provide exact college-level scores. If you are using an older version of Microsoft Word™, you may be able to fix the error by downloading the applicable Service Pack. • You can use the tool in Microsoft Word™ to check the readability of a sentence, a paragraph, or the entire document, however, shorter passages will yield less accurate results. (In fact, some formulas will not work at all unless you use a passage of 100 words or more.) If it is difficult to meet your target, try checking each paragraph individually to identify problematic text. << Back to contents page 10 Goldfarb N and Dubay WH. Writing good at a seventh-grade reading level. Journal of Clinical Best Practices. Vol.2, No.1, Jan 2006 12 Quick Reference Guide for Improving Readability Guiding principles of plain language include: • Use language your audience can easily understand. • Write in a conversational style, as if you were speaking. • Organize and filter content with your readers’ needs in mind. • Use reader-friendly formatting so that your document looks easy to read. The following specific strategies will help you adhere to these principles: Check the reading level. • Choose a readability formula, but be aware that they all have limitations—getting a “good score” is not a guarantee that your document is easy to read. Choose common, everyday words. • Replace multi-syllable (or short but complex) words with simpler vocabulary. Avoid research and medical jargon whenever possible. If you must use a complicated term, define it in plain language and provide an example, an analogy, or a visual aid. • Refer to the list of Alternative Wording Suggestions and other online resources, as necessary (see page 37). Use active voice. • The subject of your sentence should act, instead of being acted upon. “We will ask you questions about your health” is active, while “You will be asked questions about your health” is passive Write in the first-person. • Use pronouns, such as “I,” “we,” and “you.” This encourages the use of active voice and will be clearer and more engaging to the reader. Keep sentences short and to the point. • Break up sentences joined with conjunctions or semicolons. It’s okay to begin a complete sentence with “And” or “But.” • Try to vary sentence length. Sentences should average 15 words or less. Limit paragraphs to one main idea. • Start with a clear and concise topic sentence. Remove or relocate details that do not relate to the central topic. A paragraph of 1 or 2 sentences is okay. Use clear and descriptive headings. • Meaningful headings that describe the content of different sections will give your readers “road signs” and help them navigate your document more easily. • Use large font, bold, or other emphasis to ensure the headings stand out. 13 Consider the needs of your audience. • Include only the information that your audience really needs to know. • Use large font and/or age-appropriate or culturally-sensitive language to meet the needs of special populations like the elderly, children, minorities, or people with chronic health conditions, etc. Organize and format your document so that key information is clear and easy to find. • Lead with the most important information, and sequence the information in a logical fashion that the audience can easily follow. • Use bold, larger font, bullets, or graphics to emphasize critical information. Do not use justified margins or put entire sentences in all caps or italics. • Put long lists of items into bulleted lists whenever practical. Use numerical lists whenever if the items need to be understood or completed in order Use adequate white space and margins. • Break up dense copy by using ample white space between paragraphs and headings. Consider using all white space that may be leftover by adding space between paragraphs or increasing the font size of headers or text. • Avoid decreasing margins to force text to fit on one page. Top and bottom margins should be at least 1”, and side margins should be at least 1.25.” Read your document aloud. • This is one of the best ways to find errors and test for overall flow and clarity when you proofread. It can also help you troubleshoot—when you get stuck, try just speaking your thoughts. Ask others to read and edit the document. • Someone unfamiliar to the project is more likely to notice text that is unclear. • The person who will use the document most—such as the person who will administer informed consent—should always have a chance to review it. Use fresh eyes when you edit or proofread. • Whenever possible, set the material aside for a day or two and proofread it again after taking a break. This step, along with reading your document out loud, is a good way to find errors that may have been overlooked before. Double-check names and contact information. • Call all phone numbers and check all links and email addresses. Confirm that all names have been spelled correctly and that all titles are correct. << Back to contents page 14 Editing Checklist for Participant Materials Use the editing checklist that follows to improve the readability of participant materials. It was designed for project managers, research assistants, and others who may be coordinating the development of study documents. The checklist is meant as an interactive tool to both guide and track the revision process. The Quick Reference Guide for Improving Readability on the previous page gives more detail about how to check the various items on the list. Each row on the checklist corresponds sequentially to a point in the guide. If you have any questions, feel free to contact Jessica Ridpath at 206-287-2032 or PRISM@ghc.org. Notes for using the editing checklist The checklist is divided into three columns. The first column is for checking off the items listed in the second column. The third column is for tracking important notes and exceptions: • You will probably want to check some items more than once. • It’s a good idea to save completed checklists to keep track of changes and decisions. • Track things like multi-syllable words that impact readability but sometimes cannot be avoided. Two examples are “mammography” and “immunization.” • Make note of important dates and the names of people who helped edit the document. The dates and details of decisions or any other information that the user finds helpful can also be tracked in the third column. The checklist consists of three phases. The phases should be completed in order. The items within each phase may be checked in any order. • In Phase 1, the primary reviewer (usually the project manager) checks the reading level and makes revisions to improve readability. • In Phase 2, the primary reviewer checks the reading level again and asks other people to edit the document. • In Phase 3, the primary reviewer confirms contact information and other details. The last steps are to get signoff from the project team and log the final reading level. << Back to contents page 15 Editing Checklist for Participant Materials Study: _______________________________________ Initials of primary reviewer: __________ Document: ____________________________________ Document date or version: __________ Date final version due: __________ Date due to IRB: __________ Refer to the Quick Reference Guide for Improving Readability as needed. PHASE 1 – Primary Review √ Item to be checked Exceptions, Comments, and Notes Reading level Common, everyday words • jargon replaced or defined • examples, analogies, visual aids Active voice First-person Sentences are short and to the point • average 15 words or less Paragraphs have one main idea • lead with clear topic sentences Clear and descriptive headings 16 Context, style, and amount of information are appropriate for the audience Clear organization and format • lead with key information • use bold, bullets, or other emphasis as needed Adequate white space and margins Read aloud to ensure overall clarity and logical flow Date: _________ PHASE 2 – Secondary Review Reading level Reviewed by others: • PI • Staff member Name: __________________________ Date: _________ • User Name: __________________________ Date: _________ • Someone unfamiliar to the project Name: __________________________ Date: _________ Proofread for typos and grammatical errors Date: _________ PHASE 3 – Final Review Names and contact information are correct Date: _________ Signoff from PI and/or project team Date: _________ Final reading level 17 Resources for Informed Consent Documents Writing an informed consent document in plain language is typically not an easy task. This is especially true in biomedical studies that often include descriptions of complex study procedures and complicated risks. Furthermore, the study sponsor, the reviewing IRB, or the research institution will sometimes mandate language that is inaccessible to the typical study participant. Given that informed consent requirements vary by sponsoring agency, research institution, and level of risk (to name a few), it is important that plain language strategies for consent forms be flexible and adaptable. In essence, there is no “one size fits all” plain language template for informed consent. The informed consent resources in this Toolkit were selected with these variables in mind and might be useful when applied to the process of developing new consent documents or applying existing consent form templates: Avoiding common pitfalls Helpful consent templates Helpful consent guidelines Easy-to-read template language for consent forms Avoiding common pitfalls There is an obvious tension between meeting federal, institutional, and other requirements and creating a short, readable consent form, and no amount of word-smithing can take the place of a rigorous and participant-centered informed consent process. However, there are many pitfalls related to informed consent documents that can be avoided. The following insights are derived from our experience editing consent forms and may help researchers overcome some of the unique challenges of creating readable informed consent forms. • Watch closely for dense formatting. Many consent forms that contain readable language are formatted so densely that comprehending them is still problematic. • Consent forms often contain significantly more information than may be absolutely necessary, going far beyond the required elements of informed consent. Edit rigorously and consider providing supplemental information in separate handouts. • Risks and benefits are often the most difficult informed consent concepts to describe and to understand because they often involve complex numerical concepts. The International Cancer Screening Network 11 suggest the following strategies to help make this information understandable: o Use visual aids, such as systematic ovals. o Use the smallest possible denominator, for instance, report rates per 100 instead of 100,000. o Use the same denominator when comparing different probabilities. 11 National Cancer Institute (NCI). Designing print materials: A communication guide for breast cancer screening: NIH, 2007. NIH Publication No. 07-6100. http://appliedresearch.cancer.gov/icsn/manual.pdf 18 • Look out for topic sentences that are buried in the middle or end of a paragraph, especially in relation to the purpose of the study. • Be cautious if you cut and paste content from consent forms from previous studies. Sometimes an unnecessary component or some false information will inadvertently be inserted. Helpful consent templates As noted elsewhere in this Toolkit, writing in plain language is a continual process of improvement. There may not be any one perfect example of plain language at its best. No matter how readable something is, it seems there are always ways to improve it, especially when the content is as complicated as consent forms tend to be. We have reviewed dozens of informed consent templates and have edited dozens of consent forms, and have found the following to be among the more readable consent form templates: • University of South Florida – Templates for biomedical studies, social-behavioral studies, and varying levels of risk, as well as assent forms and parental consent forms. The templates include HIPAA authorization language when required. • Johns Hopkins University – Combined informed consent and HIPAA authorization template, assent form template, and short form templates for non-English speakers. Helpful consent guidelines • University of Illinois at Chicago – Policy on informed consent, including specific guidelines about formatting and readability and links to other helpful resources (see pages 9-12 of the policy). • Association of American Medical Colleges – “Universal Use of Short and Readable Informed Consent Documents: How Do We Get There,” a summary from a May 2007 strategic planning meeting that includes a review of informed consent literature, potential approaches for improving informed consent, and success stories from the field. Easy-to-read template language for consent forms The following is a compilation of easy-to-read language for common topics in consent forms. These examples were gathered from actual language in consent forms at the Center for Health Studies (CHS), as well as consent form templates made available on the public websites of other research institutions. 19 Notes for users • The Flesch-Kincaid formula was used to rate the approximate grade level of each selection. • Feel free to combine passages from different selections or use excerpts from a specific selection in combination with other language. • Phrases that will need to be revised to reflect individual research settings are highlighted in grey, with instructions for inserting specific information in brackets. Topics Table 1: Introduction/Researchers’ Statement……………………………..............21 Table 2: Request for Permission to Review Medical Records……………............. 23 Table 3: Randomization……………………………………………………............ 24 Table 4: Blood Draw Procedures………………………………………….............. 25 Table 5: Risks of Drawing Blood…………………………………………............. 26 Table 6: Risks of Survey Questions………………………………………............. 27 Table 7: No Guarantee of Direct Benefit to Participants………………….............. 28 Table 8: Voluntary Participation and Withdrawal…………………………............ 29 Table 9: Confidentiality……………………………………………………............ 31 Table 10: Participant’s Statement/Signature………………………………............ 32 Table 11: Study Staff Statement/Signature………………………………….......... 33 << Back to contents page 20 Table 1 Introduction/Researchers’ Statement Grade level We are inviting you to take part in a research study. The purpose of this consent form is to give you information to help you decide if you want to be in the study. Please read this form carefully and ask study staff to explain anything you do not understand. You will have a chance to ask questions before you make your decision. This process is called ‘informed consent.’ 6.2 We are asking you to be in a research study. Being in this study is voluntary. To make an informed judgment on whether or not you want to be part of this study, you should understand the risks and benefits of participating. This process is known as informed consent. 6.2 This consent form gives you detailed information about the research study. Please ask any questions you may have about the study or this form before signing it. We will give you a copy of the consent form to keep. Please read this form carefully. Take time to ask study staff as many questions about the study as you would like. If there are any words or information that you do not understand, study staff will explain them to you. Reading this form and talking to study staff may help you decide whether to participate or not. If you decide to take part in the research study, you must sign the end of this form. 6.3 from Chesapeake IRB Informed Consent Template 4.8 What you should know about this study: • You are being asked to join a research study. • This consent form explains the research study and your part in the study. • Please read it carefully. Take as much time as you need. • Please ask the study staff questions about anything you do not understand. • You can ask questions now or anytime during the study. • If you join the study, you can change your mind later. • You can quit the study at any time. • If you decide to quit the study, it will not affect your care at Group Health [insert name of facility or institution]. from Johns Hopkins University 21 Introduction/Researchers’ Statement Grade level You are invited to think about taking part in a research study. This form will tell you about the purpose of the research, its possible risks and benefits, other options that you have, and your rights as a participant in the study. Please take your time to make your decision. Everyone who takes part in research at Group Health [insert name of facility or institution] should know that: • Being in any study is voluntary. • You may or may not benefit from being in the study. Knowledge we gain from this study may benefit others in the future. • You may leave the study at any time and none of the benefits you normally receive will be taken away. • Please ask any questions you have about this study. Please also take whatever time you need to talk about the study with your doctor, study staff, and your family and friends. The decision to be in the study or not is yours. If you decide to take part, please sign and date the end of this form. < Back to template language topics 22 6.3 Table 2 Request for Permission to Review Medical Records We are asking that you allow us to collect some information from your medical records for this study. We will not look at your entire medical record. Instead, we will use a computer to collect information about your use of health care services, including: Grade level 6.2 • number and types of medications. • clinic visits. • lab test results. • trips to the hospital. • [insert others]. We will collect this information for a period of about two years [insert time frame], starting one year before your first phone survey [insert event] and ending one year after. Checking the medical records of people in the study is an important part of this research. For this reason, we are asking that you allow us to look at your computerized records at Group Health [insert name of facility or institution]. We are interested in seeing what kinds of medicines you take and what kinds of visits you make in the next year and a half [insert time frame].* * can also give a range: “...between 2000 and 2006.” < Back to template language topics 23 8.5 Table 3 Randomization Grade level We will use a computer to randomly assign you to one of the study groups. This means that you will be put into a group by chance. It is like flipping a coin or drawing names out of a hat*. You will have an equal chance of being in placed in any group. 3.8 adapted from an example at Georgetown University There will be about 1500 [insert number] people in this study. They will be assigned randomly to one of three [insert number] study groups: 4.8 [list groups] Which group you will be in is decided by chance, like the flip of a coin*. You will be randomly assigned to receive one of the four [insert number] study treatments. This means that whichever study treatment you receive will be decided purely by chance, like drawing names out of hat*. You will have a 1in 4 [insert odds] chance of receiving any one of the study treatments. 6.7 We will not tell you which group you are assigned to. Study staff at your visits will not know your group assignment either. But we can quickly find out which group you are in if we ever need to know in order to protect your safety. * “flipping a coin” works best to describe a two-arm study; “drawing names out of a hat” works best to describe a study with multiple treatment arms. < Back to template language topics 24 Table 4 Blood Draw Procedures Note: Include volume of blood only in teaspoons or tablespoons, rather than ml, cc, or oz. Use the following equivalents: • 5cc = 1 teaspoon • 15cc = 1 Tablespoon • 1 oz = 2 Tablespoons < Back to template language topics 25 Table 5 Risks of Drawing Blood Grade level You may feel a slight needle prick when we draw your blood. Some people may have a slight bruise that will go away in a day or two. Sometimes, people feel light headed or faint. 3.1 There are no major risks of having blood drawn. It can be uncomfortable and can sometimes cause a bruise. In rare cases, it can cause fainting. Only trained people will draw your blood. 3.7 You may feel bothered by the needle stick, and a bruise may form. In rare cases, some people faint or the site becomes infected. 4.3 < Back to template language topics 26 Table 6 Risks of Survey Questions Grade level You may feel uncomfortable answering some questions on the survey*. You may skip any question that you do not want to answer. 6.4 The interview includes some questions that may seem sensitive or personal*. You are free to skip any question or item for any reason. 7.3 *IRBs may require that the risks section explicitly mention questions pertaining to sexual history, drug use, alcohol consumption, or other potentially sensitive topics. < Back to template language topics 27 Table 7 No Guarantee of Direct Benefit to Participants You may or may not receive any benefit from being in the study. It is possible that you may get better, stay the same, or get worse. If you take part in this study, other people with diabetes [insert condition] may be helped. Grade level 5.2 from Chesapeake IRB Informed Consent Template We do not expect you to benefit from being in this study. Others may benefit in the future from the information we get from this study. 6.7 We don’t know if you will benefit from being in this study. However, we hope results of this study will help improve treatment at Group Health [insert facility or institution] and in other health systems around the country. 7.4 We can’t guarantee that you will benefit from being in this study. However, we hope to use the information from this study to develop new programs for treating back pain [insert condition]. 7.9 < Back to template language topics 28 Table 8 Voluntary Participation and Withdrawal Grade level Can you leave the study early? 4.2 • You can agree to be in the study now and change your mind later. • If you wish to stop, please tell us right away. • Leaving this study early will not affect your regular medical care. from Johns Hopkins University Being in this study is voluntary. You can decide not to be in the study. If you decide not to be in the study, you will not lose any benefits that you have. 4.4 Taking part in this study is up to you. You may choose not to take part or to leave the study at any time. If you choose not to take part or to leave the study, your regular medical care will not be affected. 4.8 from Georgetown University Taking part in research is voluntary. You may decide not to be in the study. If you decide to take part, you may leave the study at any time. Your decision will not affect your medical care at Group Health [insert facility or institution]. There are no penalties or loss of benefits if you choose not to take part or to leave the study early. 5.0 from Children’s Hospital Taking part in this study is voluntary. If you choose not to b in this study, your care at Group Health [insert facility or institution] will not be affected. 5.8 You may choose not to participate at any time during the study. Leaving the study will not affect your care at Group Health [insert facility or institution]. from University of Chicago Entering a research study is voluntary. Anyone who is asked to be in a research study may say no. If you start a research study, you may stop at any time. You do not need to give a reason. No doctor will treat you differently if you choose not to be in a research study or later decide to stop participating. If you stop, it is important to tell study staff and follow any instructions that they may give you. 6.2 from Chesapeake IRB Informed Consent Template Your participation in this study is voluntary. You are free to leave this study at any time. Your care at Group Health [insert facility or institution] will not be affected by whether you decide to participate. 29 6.6 Voluntary Participation and Withdrawal Grade level Your Rights 7.1 It is important for you to know that: • Your participation is voluntary. • You may decide not to take part or to leave the study at any time. This will not change the quality of the health care you receive. • We will tell you about any new information or changes in the study that might affect your willingness to participate. from University of Massachusetts Medical School < Back to template language topics 30 Table 9 Confidentiality Grade level Your confidentiality is one of our main concerns. We will store all of your research records in locked cabinets and secure computer files. We will not place your name on any research data. Instead, we will assign a code number to your information. We will keep the master list that links your name to your code number in a locked cabinet. 6.3 We will keep all the information you give us confidential as provided by law. The only exception is any risk of possible harm to others or to your self. We will not share your study results with anyone unless you ask us to. Your name will not appear in any reports about this study. We will keep information about you confidential as provided by law. We will label your audiotapes and survey answers [insert applicable study data] with a study number only. Your study number is not related to your name or Group Health medical record number [insert applicable patient identifier]. 8.0 We will keep the audiotapes in a locked cabinet. Information from the interviews will be stored in protected computer files. We will destroy the audiotapes and the link between your name and study number by March 2010 [insert date]. We will never use your name in reports about this study. We will not share your answers with your doctor or anyone else without your permission. However, if we think you are in danger of harming yourself, we are obligated to get help for you. [use this clause only if necessary] We will keep information about you confidential in accordance with the law. We will use a study number instead of your name to identify your blood sample and survey answers [insert applicable study data]. We will keep the link between your name and your ID number in a separate computer file. Only staff with proper security clearances can access those files. You will not be named in published reports. 8.2 Your privacy is important to us. We will do everything we can to protect the confidentiality of your personal information*. You will be given a study number. We will use this number on your surveys and other research papers instead of your name or Group Health consumer number [insert applicable patient identifier]. We will not include personal information about you in any reports or papers about this study. 8.9 from the US Department of Justice *Note: Some IRBs may require “as provided by law” or a similar clause. < Back to template language topics 31 Table 10 Participant’s Statement/Signature Grade level • I have read this form and the research study has been explained to me. • I have been given the chance to ask questions, and my questions have been answered. If I have more questions, I have been told who to call. • I agree to be in the research study described above. • I will receive a copy of this consent form after I sign it. 4.5 from Northwestern University I have read this form or have had it read to me. I have been told what will happen if I take part in this study, including the risks and benefits. I have had a chance to ask questions, and they have been answered to my satisfaction. I have been told that the people listed in this form will answer any questions I have in the future. Study staff will give me a copy of this consent form for my records. By signing below, I am voluntarily deciding to be in this research study. 6.2 Please initial each statement you consent to: 6.8 __ To take part in this study. __ To allow the researchers to look at my Group Health [insert facility or institution] computerized medical records related to the health care I receive. __ To be contacted about this research in the future. • This study has been explained to me. • I volunteer to take part in this research. • I have had a chance to ask questions, and my questions have been answered. • If I have questions later on about the research, I can ask one of the researchers listed in this form. • If I have questions about my rights as a research subject, I can call the Group Health Human Subjects Division at (206) 287-2919 [insert applicable info]. • I agree to allow the researchers to use my medical records as described in this consent form [remove if not applicable]. • I understand that if I am not able to answer questions for this study in the future, study staff will contact a family member or close friend to do this for me [remove if not applicable]. • I will receive a copy of this consent form. 7.8 < Back to template language topics 32 Table 11 Study Staff Statement/Signature Grade level • I have carefully explained to the subject the nature and purpose of this study. • The subject has been given enough time and an adequate place to read and review this form. • The subject has had a chance to ask questions and receive answers about this study. 7.3 from Chesapeake IRB I have explained the above research study over the telephone [remove if not applicable]. The participant was given time to discuss the study and ask questions. I can be reached at the phone number listed on this form to answer any other questions that the participant may have. I will mail [or “give,” if applicable] a signed copy of the consent form to the participant. < Back to template language topics << Back to contents page 33 7.5 Resources for HIPAA Authorization Documents Despite federal requirements that HIPAA privacy notices and authorizations for research be written in plain language, few HIPAA forms can be considered readable. In fact, a recent study of HIPAA authorizations from over 100 research institutions found that the mean reading level score was between 11th grade and college-level, depending on the readability formula used 12 . As with informed consent, we have reviewed and edited dozens of HIPAA authorizations, but have yet to identify or create a HIPAA form written entirely in plain language. Nonetheless, the HIPAA resources listed here may help researchers make strides toward this goal. Helpful HIPAA authorization templates Among the more readable HIPAA templates we have found are: • University of California (system wide) – stand-alone HIPAA template • Seattle Children’s Hospital Research Institute – stand-alone HIPAA template • University of South Florida – stand-alone HIPAA template, as well as HIPAA language within the consent templates • Johns Hopkins University – HIPAA language within the consent template Helpful HIPAA guidelines • Phoenix Health Systems HIPAA Advisory – “Plain Language Principles and Thesaurus for Making HIPAA Privacy Notices More Readable,” a summary of plain language strategies tailored for HIPAA privacy notices, but still quite helpful when applied to HIPAA authorizations for research. Easy-to-read template language for HIPAA Institutionally-mandated HIPAA language varies dramatically. As with informed consent, there is no “one size fits all” plain language explanation of HIPAA for research. The following excerpts can be included together or separately within the main study consent form, but you may need to add other language required by your sponsor or your institution. 12 Breese P, et al. The Health Insurance Portability and Accountability Act and the informed consent process. Ann Intern Med. 2004;141:897-898. 34 Flesch-Kincaid grade level score when all excerpts are used together = 7.7 How will you protect my privacy? Your health information is protected by a federal privacy law called HIPAA (the Health Insurance Portability and Accountability Act). This law applies to health care organizations and their employees. This law may not apply to researchers who do not work for health care organizations. Even if this law does not apply [insert if used with above or similar paragraph], [All or all] researchers working on this study will take the following steps to protect your privacy: • We will store all study information in locked cabinets or secure computer files. • We will keep your name, address, and all other information that could identify you separate from the information we collect for the study. • We will not use your name in any reports about this study. Grade level 10.0* Grade level 8.6 This study has also been reviewed and approved by an institutional review board (IRB). An IRB is a committee that protects the rights of research subjects. The researchers listed on the first page of this form and their staff will use your health information only for this study. Staff from Group Health [insert facility or institution] and/or the funding agency may look at study records to make sure we follow the rules. We will not share the information we collect for this study with anyone else except as permitted by law. Grade level 8.6 What if I change my mind later? Grade level 5.4 You can change your mind any time about letting us use your information for this study. If you change your mind, you may take back your consent by writing to: Dr. Jane Researcher [insert appropriate info] Group Health Center for Health Studies 1730 Minor Avenue, Suite 1600 Seattle, WA 98101 If you take back your consent: • It will not affect your health care at Group Health [insert facility or institution]. • Your health plan benefits will not change. • We may still use the study information we collected before we received the letter taking back your consent. But, we will not collect any new information after that point. * Deleting “(the Health Insurance Portability and Accountability Act)” brings the grade level score of the first selection down to 7.7 << Back to contents page 35 Appendix A: Instructions for Checking Readability in Microsoft Word™ Microsoft Word™ provides a readability analysis tool in the Spellchecker. To activate this tool: • Go to the “Tools” menu and select “Options.” • Click on the “Spelling & Grammar” tab. • Check “Show readability statistics” under the “Grammar” heading. Each time you check spelling and grammar, you will be given several readability statistics, including: • The Flesch-Kincaid grade level score (based on the US high school grade level system). • The Flesch Reading Ease score (based on a 100-point scale; the higher the score, the more readable the text). • Counts, averages, and percent of passive sentences. 36 Appendix B: Alternative Wording Suggestions This list includes a selection of commonly-used medical terms, research jargon, and other complex words paired with suggestions for plain language alternatives. It is a compilation of original entries * and entries selected from a variety of plain language word lists publicly available on the intranet: • Simple Words and Phrases (plainlanguage.gov) • Glossary of Human Subjects Terminology (University of California at Davis, Office of Research) • Plain Language Principles and Thesaurus for Making HIPAA Privacy Notices More Readable (HIPAAdvisory, Phoenix Health Systems) • Writing Style Guide and Dictionary of Plain English (Duncan Kent & Associates Ltd.) This list is by no means exhaustive, and we encourage you to refer to other resources as needed. For definitions of more specialized medical terminology, try the University of Michigan Medical School Simplification Guide to Medical Terms; for definitions of research jargon, try the glossary of research terms developed by The Cochrane Collaboration. << Back to contents page Navigation links: A B C D E F G H I J K L M N O P N P Q R S T U V W X Y Z Instead of … Try this … (You may need to use different forms or combinations depending on how the term is used) A TOP abdomen stomach, tummy, belly abrasion scrape, scratch absorb take in fluids, soak up abstain from don't, don’t use, don’t have, go without accompany go (along) with, come with accomplish carry out, do accordingly so, for that reason, as a result accrue add, gain, build up accumulate add, build up, collect, gather accurate correct, exact, right acquire get * Developed in collaboration with the Group Health Plain Language Task Force activate begin, start acute sudden, new, recent; intense flare-up, serious pain addictive habit-forming additional added, extra, more, other, address talk about, discuss adequate enough adjacent next to, by administer give advantageous helpful, useful adverse harmful, bad adversely impact hurt, set back affirmative yes, positive aggravate make worse aggregate all together, added together, combined agitation anxiety, restlessness, nervousness ailment sickness, illness, health problem, complaint allergen something that causes allergies allergic rhinitis hay fever alleviate ease, decrease, lessen allocate divide, give based on a plan allow let alopecia hair loss alternative choice, option ameliorate improve, get better, make better ambulate walk ambulatory able to walk amend change ameliorate improve analgesic pain killer analyze look at, study, examine anaphylaxis shock or serious allergic reaction anesthetic (general) a drug that puts you to sleep anesthetic (local) a drug that numbs an area of your body angina (or angina pectoris) chest pain anterior front anticipate expect anticoagulant blood thinner anti-inflammatory helps swelling go down apparent clear, plain, show up 38 appreciate, appreciation thankful, thanks apprise inform, tell appropriate(ly) correct(ly), proper(ly), right approximate(ly) about, around, roughly arrhythmia irregular heartbeat, (condition in which or when) the heart does not have a steady beat arteriosclerosis (or atherosclerosis) hardening of the arteries articulate say, state, tell ascertain find out, learn ascorbic acid vitamin C asphyxiate, asphyxiation choke (ing), suffocate (tion) aspirate, aspiration fluid in the lungs assay lab test assess learn about, study assessment interview, quiz, rating, report, test assist, assistance help, aid associated with linked to, related to asymptomatic without symptoms atopic dermatitis itchy red rash attain meet attempt try audit review, inspect, look at aural hearing B TOP bacteria germs beneficial helpful, good benefit (noun) good effect, advantage benefit (verb) help, be useful to benign isn't harmful, not cancer bilateral on both sides biopsy sample of tissue from part of the body blood glucose blood sugar blood profile series of blood tests bradycardia slow heart beat C TOP calculate add up, figure out capable, capability able, ability carcinogen something that can cause cancer 39 carcinoma cancer cardiac heart-related, related to the heart, (of or in) the heart cardiologist heart doctor cardiovascular heart and/or blood vessel carpal wrist category kind, class, group catheter a tube for taking fluids into or out of the body catheterize put a tube into (part of the body) caveat warning cease stop cell culture tissue sample or a study of the tissue cellulitis skin infection Central Nervous System (CNS) brain and spinal cord cerebral hemorrhage (or cerebral accident or cerebrovascular accident or CVA) stroke, blood clot in the brain cessation stop, pause chemotherapy drugs to treat cancer chest film chest X-ray chronic lasting a long time, life-long clavicle collarbone clinical (related to) medical care clinical trial a research study that tests new treatments on patients coagulate clot, stop flowing cognitive learning, thinking cognizant aware (of) coitus sexual intercourse collaborate with work with colon the large intestine colonoscopy exam of the inside of the rectum and colon (or large intestine) using a flexible tube with a lens at the end colorectal (of or in) the colon or rectum commence begin, start commitment promise commonly most often communicate write, tell, talk, let you know compensate, compensation pay, give money complete finish, do, fill out, take part in comply with follow 40 component part, section, phase comprise form, include, make up computed tomography CT scan or imaging test, 3-D X-ray conceal(ed) hide (hidden) concerning about, on condition how you feel, health problem conduct(ing) do(ing) congenital present at birth, born with congenital anomaly birth defect congestive heart failure condition where the heart isn't pumping hard enough conjunctivitis pink eye consequence result consequently so, because of this consider think about consolidate combine, join, put together contains has constitutes is, forms, makes up construct build, make contingent upon if continue go on, keep (on) contraceptive birth control contract(ing) [a disease] get(ing) [a disease] contraindicated not recommended, can cause a bad reaction, not permitted contrast medium dye contribute give, help controlled trial a research study that compares a one treatment to another treatment contusion bruise convene meet convenient handy, works well conversion change convulsion seizure coronary (related to) the blood vessels that bring blood to the heart, (of or in) the blood vessels that bring blood to the heart coronary thrombosis heart attack correlation link correspond similar to, be in agreement with crucial important currently now cutaneous (in, of, or about) the skin, (related to) the skin D TOP 41 debilitating weakening decision choice decrease lower, reduce deem think, believe, consider deep vein thrombosis a blood clot deep in the vein deficiency not enough deficit shortage degeneration getting or gets worse delete remove, take out, cut, drop demonstrate prove, show depart leave describing tell about designate choose, name, select, appoint detect find (out) determine decide, find (out), learn (if) detrimental harmful, bad develop occur, start to get, happen diabetic person who has diabetes diagnose, diagnosis (find the) problem or condition diagnostic procedure a test to look for a problem diaphoresis sweating difficulties problems, trouble diffuse widespread, scattered digit finger or toe dilute add liquid, make less strong diminish(ed) go down, decrease, less (of), lower disclose give, share, tell, show discoloration change in color disconnect undo discontinue drop, stop discover find (out), learn if discrepancy conflict, difference, error, split disseminate(d) give, share, send, pass on, (spread out) diuretic drug that makes you urinate (or pee) more diverticulitis condition in which the colon becomes inflamed or infected donate give double blind a study in which neither the researchers nor the subjects know what drug the subject is getting dressing bandage due to the fact because 42 dysfunction not working dysmenorrhea painful period cramps dyspepsia heartburn dysphagia trouble swallowing dyspnea trouble breathing E TOP echocardiography, echocardiogram pictures of the heart edema swelling efficacy how well (a treatment) works elect choose, pick electrolytes salts in the blood that control the balance of fluids in the body elevate high, higher, raise eliminate get rid of, remove, cut, end, go to the bathroom elucidate explain embolism lump of blood, clot emesis throwing up, vomiting empirical evidence proof employ use employment work enable allow, let encounter meet, meeting encourage urge endeavor try endometrium lining of the uterus enlarge get bigger enroll be in, join ensue follow(ing), occur after, happen next ensure make sure enumerate count enuresis problems controlling urine, bladder control problems epidemiologist scientist who studies diseases episode bout or attack equilibrium balance equivalent equal equitable fair eradicate get rid of eruption (skin) rash or breakout especially mainly, mostly establish set up; also, show, prove 43 etiology cause evaluate look at, study, measure, rate evidence of proof of, signs of evident clear exacerbate make worse examination exam examine look at, study excise remove by cutting, cut out exhale breathe out exhibit show expedite, expeditious speed up, make (something) go faster, make (something) easier, (fast, quick) expend spend experiencing feeling, going through, having expire, expiration end (date), run out explicit plain, clear external outside (the body) exude ooze F TOP facilitate help, ease, make (something) easier failed to did not feasible can be done, possible, workable febrile fever femur thigh bone, bone that connects the hip and knee finalize complete, finish forfeit give up, lose formulate work out, form forward send fracture(d) break, (broken) frequently often, a lot fructose fruit sugar function act, role, work fundamental basic furnish give, send G TOP gastric stomach-related, (related to) the stomach, (of or in) the stomach gastroenterologist doctor who treats problems with digestion gastroesophageal reflux (GERD=gastroesophageal heartburn reflux disease) 44 generalized wide-spread gerontological age-related, (related to) aging, about aging gestation pregnancy GI specialist doctor who treats problems with digestion glucose sugar gradually slowly, over time gynecologist doctor trained in women’s health H TOP hazardous dangerous, not safe hearing impairment hearing loss or deafness heart failure heart isn't pumping hard enough hematocrit amount of red blood cells in the blood hematoma bruise hemorrhage heavy bleeding hence so hepatic liver heritable, hereditary genetic, traits that are passed down in families herpes simplex type 1 cold sore herpes simplex type 2 herpes herpes zoster shingles heterogeneous different, mixed hirsutism unwanted hair growth homogeneous same or similar however but hyperopia farsighted(ness) hypersensitivity very sensitive to hypertension (hypotension) blood pressure that’s too high (blood pressure that's too low) hyperthyroidism (hypothyroidism) overactive thyroid, too much thyroid hormone (underactive thyroid, not enough thyroid hormone) hypothesis idea being tested hypoxia not enough oxygen in the blood I TOP identical same, exactly alike identified found identify find (out), pinpoint, name, show idiopathic we don’t know what causes it immediately right away, now, at once immerse cover in 45 immunotherapy treatment to make the immune system work better (boost immune system) impact change, affect impede slow, make it harder to implant put into the body implement carry out, put in place, start in addition also, too, and in vitro in a test tube or lab incapacitate make unable to do inception start incidence number of new cases, how many times it occurs incision cut, slit including along with, like, such as incorrect wrong, not right increase, increased raise, higher indicate mean, show, suggest, tell us, fill in, write down indication sign, symptom ineffectual not effective, useless, of no use infectious (disease) passed from one person to the next infertile not able to get pregnant inflammation swelling, painful swelling influence affect inform tell informed consent deciding to get a certain treatment or be in a research study after thinking about the risks and benefits infusion putting a substance into the body through the blood ingest eat or drink inhale breathe in inhibit stop inhibitor drug that slows down or stops something from happening initial first initiate begin, start injection shot in lieu of instead (of) innovation new idea, new way inquire ask institute start, set up instrument tool insufficient not enough, too little intake what you eat or drink; what goes into your body 46 intent, intention aim, goal, purpose interface (web or computer interface) meet, work with, (program) intermittent off and on internal inside the body interior inside internist doctor interrupt stop intervention treatment intramuscular in a muscle intravenous in a vein intubate put a tube down your throat into your airway so you can breathe invasive procedure to go into the body through a cut or puncture investigation study investigator(s) researcher(s), people doing the study issue give J TOP jaundice yellow-looking skin juvenile (condition) childhood (condition) K TOP L TOP laceration cut, tear lactation breast-feeding lactose sugar found in milk larynx voice box lateral side, on the side lethargic sluggish; very sleepy limb arm or leg lingual tongue lipids fats in the blood lipid profile (or lipid panel) amount of fats in the blood locality place locally, localized in one area locate find location place lymphoma cancer of the lymph nodes (or tissues) M TOP magnetic resonance pictures of the body taken with magnetic energy 47 imaging (MRI) magnitude size maintain keep, support malaise general feeling of being sick, feeling bad malignant, malignancy cancer that may spread to other parts of the body malingering pretending to be sick majority (of) most manifestation sign manner way materialize appear maximum greatest, largest, most mean (statistical) average (statistical) medication drug, medicine menarche first menstrual period menopause when periods stop menses, menstruation period metabolism, metabolize how the body breaks down food into energy metastasize spread metastatic cancer that has spread miliaria prickly heat minimal (minimum) least, smallest, slight (at least) minimize decrease, lower, reduce mobile (mobility) able (ability) to move around moderate (verb) limit, control modify, modification change monitor check (on), keep track (of), watch morbidity disease rate, illness rate mortality death rate, death, dying motility movement, ability to move musculoskeletal muscles and bones mutation genetic defect myocardial infarction (MI) heart attack N TOP nausea upset stomach, feeling like throwing up nebulous vague, not clear necessary needed, need to negligible small neuralgia nerve pain neuron nerve cell 48 nodule lump noncompliant not following a treatment plan noninvasive without using surgery, needles, or cutting the skin notification, notify to tell, let know numerate count numerous many nutrient food O TOP objective aim, goal obligate, obligation require, bind, mean that (you) have to, duty observe see obstruct block or close obtain get, take occasionally sometimes occlude (occlusion) block (blockage) occupation(al) job, work oncologist doctor who treats cancer oncology study or treatment of cancer onset start opportunity chance optimum, optimal best, greatest, most option choice, way oral (oral administration) (given) by mouth orthopedic (related to) the bones, (of or about) the bones osteoporosis brittle bone disease, having bones that can break easily otherwise if not otolaryngologist ear, nose, and throat specialist outcomes results, (long-term) changes P TOP palliative make feel better but not cure, ease symptoms pallor paleness palpate feel palpitation fast heartbeat parameter limit, boundary participate (ing, ion) be, do, join, opt in, take part (ing) parturition labor and delivery, childbirth pathogen(esis) cause of a disease perforation hole perform do 49 periodically from time to time perioral around the mouth peripheral on the edge, not central permit(ted) allow(ed), let persist last, keep going persistent lasting personnel staff, people pertaining to about, of, on, related to peruse read pervasive wide-spread pharmaceutical, pharmacotherapy drug, drug therapy pharyngitis sore throat physician doctor physiological having to do with the body pigmentation color placebo an inactive substance, sugar pill, a pill that contains no drug or medicine placenta the organ that joins the mother and the fetus (or unborn baby) inside the womb plaque (artery) fatty deposit plasma the fluid part of blood plasma glucose blood sugar portion part positron emission tomography PET scan or imaging test possess have, own posterior back postoperative (post-op) after surgery preadolescent preteen preclinical isn’t causing symptoms yet, no signs yet preclude prevent predisposed, predisposition likely to, inclined to prenatal before birth presently soon present with have preserve keep prevalence, prevalent rate of occurrence, common, large amount in a population previous, previously before, earlier principal investigator head researcher, scientist in charge of a study 50 prior (to) earlier, before prioritize rank, order, put in order of importance proactive taking action on your own procedure something that is done, a process proceed do, go ahead, start, try procure, procurement buy(ing), get(ing) proficiency, proficient skill, skilled prognosis outlook progress (verb), progressive worsen, get(s) worse prohibit, prohibitive, prohibited from prevent, restrict(ive), strict, may not promulgate make, issue, publish prone lying on the stomach prophylaxis something that prevents disease or infection prospective study study following people forward in time prosthesis replacement for a body part, such as a man-made arm protocol plan of study, rule provide give (us), offer, say provided that if provider doctor, clinician, person who gives health care proximal close, closer to the center of the body psychopathology mental illness psychosocial mental and social psychotropic mind-altering pulmonary (in, of or about) the lungs, (related to) the lungs pulmonary embolism blood clot in the lung purchase buy pursuant to by, following, under Q TOP questionnaire R survey, series of questions TOP radiologist doctor who specializes in reading X-rays radiology X-ray department ramifications outcomes, problems, results randomization assignment to a (study or treatment) group by chance, like flipping a coin [if there are 2 groups]...like drawing names out of a hat [if there are more than 2 groups] random(ly) by chance random sample group of (people) chosen by chance; selected by chanced, like 51 drawing names out of a hat range area, between (x) and (y), from low(est) to high(est) receive get recur return, come back, happen again referral send to see another doctor reflect say, show reflux heartburn refractory hard to treat, hard to manage regarding about, of, on regardless no matter regimen treatment plan regulate affect, control regulations rules relapse slip, backslide, return of a disease relevant (to) about, tied in with, related to relocate move remain stay, wait remainder rest, what is leftover remaining other, (second, last, final), left, left over remission cancer that has gone away renal (in, of, or about) the kidneys, (related to) the kidneys render make, give replicable can be done again represents is request ask require(d), requirement must do or have, need(ed) researchers people doing the study resect cut out, take out through surgery reside, residence live, house, home respiration breathing restrictions limits retain keep retinol vitamin A retrospective study a study looking at things that have already happened revise(d), revision change(d), new reveal give us, show, tell routinely often, commonly rupture break open, burst 52 S TOP sarcoma type of cancer satisfactory okay, fine, good sclerosis hardening, getting (or growing) hard sedative a drug to calm or make less anxious sedentary inactive, not active seldom rarely, not very often selection choice sensation feeling sepsis a very serious infection sequentially in a row, in order, by number several a few, a number of, some severe serious, bad severity how bad shall will similar (to) like, alike similarity likeness sinusitis sinus infection solely only solicit ask for, request somnolence sleepiness specify name specimen sample spirometer a device that measures how much air (you) are breathing in and out state-of-the-art latest stenosis getting more narrow stimulate excite, trigger strategy, strategize (make a) plan streptococcal strep subcutaneous under the skin sublingual medication taken by dissolving under the tongue submit give, send subsequent(ly) after, later, next, then substantial big, large, much sucrose sugar sufficient enough, plenty suggest(s) supine show(s) there might be lying on your back 53 sustain keep going sustenance support, food sutures stitches symptomatic having symptoms systemic whole body T TOP tachycardia very fast heart beat tap use a needle to take out fluid tear a ligament (torn ligament) sprain telephone phone terminal not curable, causes death, going to die terminate, termination put an end to, stop, end therapeutic modality treatment therapy treatment therefore so, as a result thoracic chest thrombosis blood clots in the blood vessels topical (application) surface, on the skin, (put on, rubbed on the skin) toxic, toxin poisonous, poison toxicity bad side effects trachea windpipe transdermal through the skin transmit(ted), transmission send (sent), spread to, pass on transpire happen trauma injury, wound tremor shaking U TOP ultimate final uncommon rare undergo have understand learn, see unequivocal clear unnecessary not needed utilize, utilization use 54 V TOP validate approve, confirm variable factor, changes over time varicella chickenpox variety many different kinds vector an insect or other animal that carries disease vertigo dizziness viable practical, workable, possible visualize picture, see, imagine W TOP warrant call for, permit whereas because, since withdraw (from) drop, leave, take back X TOP Y TOP Z TOP 55 Appendix C: Examples of Improved Readability The following examples came from original and revised text in actual study materials fielded at the Group Health Center for Health Studies. Some examples are based on materials that were fielded prior to the PRISM initiative. (In these cases, study topics and names have been changed or omitted.) Other examples are based on materials that underwent PRISM editing prior to fielding. The revised versions demonstrate the use of active voice, simpler vocabulary, shorter sentences, shorter paragraphs, bulleting important information, and other plain language strategies. Changes are emphasized using bold font. We used the readability analysis tool in Microsoft Word™ to report the Flesch-Kincaid grade level score, the Flesch Reading Ease, and the percent of passive sentences. Examples 1 through 4 are excerpted from participant invitation materials, i.e. advance letters and study brochures; Examples 5 through 8 are excerpted from informed consent documents. << Back to contents page Example 1 Original Revised • • • • • • Grade level = 13.0 Reading Ease = 39.9 20% passive sentences If you agree to participate, we will arrange a screening interview with you at our research clinic. During this interview, you will be asked to do some tasks that measure your thinking and problem-solving abilities and answer questions about your medical history and occupational history. If you are willing, a trained technician will obtain a blood sample of approximately two tablespoons. This visit should take approximately two hours. If you are eligible to participate in the study, every two years we will repeat the initial assessment procedures at the Center for Health Studies, and we will periodically review your medical record to see if there is a change. 56 Grade level = 7.2 Reading Ease = 71.2 0% passive sentences If you agree to be in the study, we will invite you to an interview at our research clinic. During this interview, we will ask you to do some tasks that measure your thinking and problem-solving abilities. We will also ask you questions about your medical and work histories. If you are willing, we will take a blood sample of about two tablespoons. This visit should take about two hours. If you are eligible for the study, we will ask you to come in for a similar interview and blood draw every two years. We will also check your medical record from time to time to see if there is a change. Example 2 Original Revised • • • • • • Grade level = 11.2 Reading Ease = 51.0 71% passive sentences If you meet the eligibility requirements and are interested in participating, you will have a 1 in 4 chance of being assigned to each of four groups. Three in 4 participants will be assigned to study treatment, and 1 in 4 will be assigned to usual medical care. Participants assigned to the study treatment group will make 10 visits over a 7-week period. These visits will be paid for by the study. All participants will receive a stateof-the-art book describing many techniques for caring for athlete’s foot. Regardless of group assignment, all participants will be contacted at 2, 6, and 12 months after the start of the study for about a 20-minute telephone interview. Although we cannot guarantee that you will benefit from the treatment you are assigned, knowledge gained from this study will help improve care for athlete’s foot at Group Health. 57 Grade level = 6.3 Reading Ease = 75.1 9% passive sentences If you are interested in and eligible for this study, you will be assigned by chance to one of the four study groups. Three groups will receive study treatment. The fourth group will receive usual medical care. You will have a 1 in 4 chance of being in any group. If you are in a study treatment group, you will make 10 visits over a 7-week period. The study will pay for these visits. Everyone in the study will receive a state-ofthe-art book about different ways to care for athlete’s foot. No matter which group you are in, we will call you for three phone surveys that will last about 20 minutes each. These surveys will take place 2, 6, and 12 months after you join the study. We cannot guarantee that you will benefit from the treatment you get. However, the knowledge we gain from this study will help improve care for athlete’s foot at Group Health. Example 3 (There are revisions throughout, so changed text has not been emphasized in this example.) Original Revised • • • • • • Grade level = 13.7 Reading Ease = 44.0 0% passive sentences Group Health Cooperative recognizes the importance of positive health behaviors and their role in building a healthy and rewarding lifestyle. So we want to invite you to participate in a new research study for Group Health members called the SCALP Study. Group Health Cooperative, Kaiser Permanente, and HealthMedia, Inc., a leading multimedia group, are sponsoring this research to test the effectiveness of online programs for helping people prevent and treat dandruff. Before finalizing the programs, we need to pilot test them in a small group of persons who have dandruff. If you are one of the thousands of people who say they want to do something about their dandruff, we would like to ask you to participate in this study. To be eligible to enter the study, you must have dandruff, be a member of Group Health, have an email address and the ability to access the internet at least once or twice per week, and meet certain other eligibility requirements. 58 Grade level = 7.0 Reading Ease = 68.8 0% passive sentences Group Health Cooperative knows that positive health behaviors help build a healthy and rewarding lifestyle. If you are one of the thousands of people who say they want to do something about their dandruff, we’d like to invite you to take part in SCALP, a new research study for Group Health members. Group Health Cooperative, Kaiser Permanente, and HealthMedia, Inc., a leading multimedia group, are sponsoring this research. The goal of this project is to create online programs to help people prevent and treat dandruff. To make sure that these programs are as helpful as possible, we first need to test them in a small group of people. To be eligible for the study, you must: • Have dandruff. • Be a member of Group Health. • Have an email address. • Be able to access the Internet at least once or twice per week. • Meet certain other requirements. Example 4 Original Revised • • • • • • Grade level = 13.2 Reading Ease = 52.8 0% passive sentences Grade level = 7.4 Reading Ease = 70.9 0% passive sentences Can you take five minutes for a study about helping people with arthritis get a good night’s sleep? Can you take five minutes to provide information that will help plan an important study to aid people with arthritis pain and problems getting a good night’s sleep? I am an investigator at Group Health Center for Health Studies who is planning a major study to test new ways of helping people with arthritis pain and sleep problems. If you have arthritis, you may know what it’s like to have trouble sleeping. I am a researcher at Group Health Center for Health Studies. We are planning a major study about arthritis and sleep problems. Before we can do the study, we need to know how many members of Group Health have arthritis pain and trouble sleeping. We also need to know if our members might be interested in a group program to help people with arthritis pain and sleep problems. We want to test this program in research funded by the National Institutes of Health. In order to plan the research, I need to know how many people have arthritis pain and sleep problems. I also need to know to what extent people with these problems might be interested in participating in a group program for arthritis pain and sleep problems that we want to test in research funded by the National Institutes of Health. 59 Example 5 Original Revised • • • • • • Grade level = 12.6 Reading Ease = 47.8 0% passive sentences Grade level = 6.9 Reading Ease = 69.6 0% passive sentences Purpose Why are you doing this study? We are interested in understanding how older adult members of Group Health Cooperative feel about physical activity. We are also interested in hearing what their thoughts are about the physical activity programs that Group Health offers to its members. The results of this study will help us better understand the needs of older adult members regarding physical activity programs. We are doing this study to learn more about how older adult members of Group Health Cooperative feel about physical activity. We also want to hear their thoughts on the physical activity programs that Group Health offers to its members. Doing this study will help us find out what kinds of physical activity programs our older adult members need. What does this study involve? Procedures If you agree to be in this study, you will take part in a telephone interview. The interview will last about 30 minutes. The study investigator will ask questions about your physical activity, your use of the Silver Sneakers or EnhanceFitness programs, and general questions about yourself and your health. Here are examples of several questions, “What kinds of physical activities have you done in the past that you are not doing now?”, “What would help to keep you physically active?”, “When was it most difficult for you to continue with your exercise?” 60 If you agree to be in this study, we will ask you to do one phone survey. The call will last about 30 minutes. We will ask questions about your physical activity and your use of the Silver Sneakers or EnhanceFitness programs at Group Health. We will also ask general questions about yourself and your health. Here are some examples: • What kinds of physical activities have you done in the past that you are NOT doing now? • What would help to keep you physically active? • When was it most difficult for you to keep up with your exercise? Example 6 Original Revised • • • • • • Grade level = 9.5 Reading Ease = 57.5 20% passive sentences Procedures If you agree to participate in this study we will schedule a telephone interview at a time that is best for you. The telephone call will last about 30 to 60 minutes and will ask about your experiences with headaches and mood. The interview will be audiotaped and then transcribed so that we may record your responses. No one other than the research team and the transcriptionists will hear the audiotapes. We will reimburse you $30 for your time if you participate in the telephone interview. 61 Grade level = 4.9 Reading Ease = 84.9 0% passive sentences What will happen if I take part in this study? If you agree to be in this study, we will set up a phone survey at a time that is best for you. The call will last about 30 to 60 minutes. We will ask about your experiences with headaches and mood. We will record the interview on an audiotape and then write down your answers. No one other than the research team and the person who writes down the answers will hear the tapes. We will give you $30 for your time if you take part in the phone survey. Example 7 Original Revised • • • • • • Grade level = 11.2 Reading Ease = 45.9 40% passive sentences All of your research records will be maintained indefinitely in our research offices, in locked files and passwordprotected computer files. We will not place your name on any research data. We will assign a code number to your information, and a master list identifying you by your code number will be maintained by the Principal Investigator in a locked file. Only investigators listed on this consent form and personnel directly related to this study will have access to your study records. Selected people working for the study sponsors may see the information about you (both personal, including your name, and other information) held by the study doctor. Your information will be examined to confirm that it is correct and that it is related to you. These persons are required to maintain the confidentiality of your information. We will not reveal the results of your participation to anyone unless requested by you. Your name will not appear in any publications or reports produced from this study. All information and results generated from this study will be kept indefinitely 62 Grade level = 6.9 Reading Ease = 68.5 0% passive sentences We will keep your research records in locked cabinets and secure computer files. We will not place your name on any research data. Instead, we will assign a code number to your information. We will keep the master list that links your name to your code number in a locked cabinet. Only the researchers listed on this consent form and staff who work on this study will have access to your study records. Certain people working for the study sponsors may see your name or other personal information about you. They will look at this information to make sure that it is correct. They must keep your information confidential. We will not share your study results with anyone unless you ask us to. Your name will not appear in any reports about this study. We will keep the information and results from this study indefinitely. Example 8 Original Revised • • • • • • Grade level = 14.8 Reading Ease = 38.7 0% passive sentences By signing this form, you consent to (authorize) the use of health information from your Group Health medical records needed for this study, which would include your use of health care services such as number and types of medications, clinic visits, laboratory test results and hospitalizations. Some of the information collected will be about mental health medications and visits. We will collect this information for a period of one year before your first telephone survey date and one year after your first telephone survey date. Grade level = 6.5 Reading Ease = 66.4 0% passive sentences If you sign this form, you are authorizing us to use health information from your Group Health medical records for this study. This means you are giving consent for us to collect some information from your medical records. We will not look at your entire medical record. Instead, we will use a computer to collect information about your use of health care services, including: • number and types of medications. • clinic visits. • lab test results. • trips to the hospital. • mental health medications and visits. We will collect this information for a period of about two years, starting one year before your first phone survey and ending one year after. << Back to contents page 63 Appendix D: Examples of Improved Formatting The following snapshots of common types of participant materials demonstrate how formatting changes can dramatically affect the overall look and feel of a document. Each example also contains a variety of other plain language revisions, which may also be helpful to consider. However, the primary purpose of this section is to illustrate the effect of formatting on readability. As with other examples in this Toolkit, we report the Flesch-Kincaid grade level scores and the percent of passive sentences for the original and revised documents. To provide a better at-aglance comparison of the two versions, we converted two-page documents to one page (by adjusting page orientation and reducing font size). Examples Advance letter, original……………………………………………........... 65 Advance letter, revised……………………………………………............ 66 Consent form, original……………………………………………............. 67 Consent form, revised……………………………………………….......... 68 Study Information Sheet, original…………………………………............69 Study Information Sheet, revised…………………………………............ 70 << Back to contents page 64 ORIGINAL Grade level = 6.9, 5% passive sentences Example #1 DATE Dear Parent or Guardian of [CHILD'S FNAME LNAME]: We know teens aren’t the same as adults, yet we often treat them as if they are. Assessing their health needs can be a challenge. It is important to have health information just about teens. Group Health and the University of Washington are doing a study to find out more about teen health. We believe that this study tell us the best way to identify the needs of our adolescent patients. A random sample of Group Health enrollees between the ages of 13 and 17 years are being invited to take part in the study. [CHILD FNAME] is among that group. Enclosed is a consent form for you, the parent or guardian. If you are willing to have [CHILD FNAME] participate in the study, please follow these steps: 1) Read and sign the consent form. 2) Fold the consent form and put it in the return envelope. 3) Give the survey, and the return envelope with the consent for to your child, so s/he can read the survey, and answer the questions in a private place. 4) Remind your child that when s/he is done, to put the completed survey in the envelope with the consent form, and mail it back to us. (no postage needed) The $2 is for your child to keep, whether or not s/he does the survey. Participation is voluntary. Whether or not you choose to take part in this study will not affect the care you or your child receives at Group Health. If you have any questions about the study, please call the Project Manager, Susie Manager, at 206-555-5555. If you do not want wish to participate, call our toll-free line, 1(877) 555-5555, and leave that message. Please leave your name, phone number, and your child’s full name. Please say that you are calling about the ASC Study. Sincerely, Jane Researcher, MD, MPH Group Health Center for Health Studies 65 REVISED Grade level = 6.6, 4% passive sentences DATE Dear Parent or Guardian of [CHILD'S FNAME LNAME]: Deciding what is best for your teenager’s health can be a challenge. Teens aren’t children anymore, but they aren’t adults yet either. That’s why it’s important that we do research on teen health. Group Health and the University of Washington are doing a study that we hope will tell us the best way to figure out the needs of our teen patients. Why are you asking us to be in this study? We are inviting Group Health teenagers between 13 and 17 years old to take part in this study. [CHILD NAME] was one of [n] teens chosen at random to receive this invitation. What do we do if we’d like to take part? First, read over the enclosed consent form and study brochure. Then, talk to [CHILD NAME] and decide together about being in the study. If you choose to take part, please follow these steps: 1) Sign the consent form and put it in the return envelope. 2) Give the survey and the envelope (with the consent form inside) to your teen, so he or she can answer the questions in a private place. 3) Remind your teen to put the finished survey in the envelope with the consent form and mail it back to us. (no postage needed) What if we don’t want to be in the study? If you don’t want to be in the study, please call our toll-free line, 1-877-555-5555. Leave a message with your name, phone number, and your child’s full name. Please say that you are calling about the ASC Study. The $2 is for your teen to keep, whether or not [he/she] does the survey. Being in this study is voluntary. Your decision will not affect the care your family receives at Group Health. If you have any questions about the study, please call the Project Manager, Susie Manager, at 206-555-5555. Sincerely, Jane Researcher, MD, MPH Group Health Center for Health Studies 66 ORIGINAL Grade level = 9.4, 32% passive sentences Example #2 may protect the information from improper use. Information that identifies you/your teen, collected for this study, will not be shared with anyone else except as permitted by law. Introduction We are inviting your teenage son or daughter to be in a research study. Group Health members between the ages of 13-17 years are being invited to participate. This consent form will give you information about the study, so you can understand enough about the risks and benefits to make an informed decision. This process is called informed consent. Please read it carefully. It will explain the purpose of the study, what we are asking you to do, the possible risks and benefits, and your rights as a volunteer in the study. If you have any questions, please call Susie Manager at 206-555-5555. Any benefits you are entitled to will not be affected by whether or not you participate in this study. Unless you take back your permission, this authorization for use of your health information will expire on 7/1/2010, which is 1 year after the end of the study. At any time, you may take back (revoke) your permission for the use of your health information for this study. To do this, you may write to Susie Manager at 1730 Minor Ave, Suite 1600, Seattle, WA 98101-1448. If you take back your permission, the researchers may keep the health information that they have already collected. What is the purpose of the study? The purpose of this research study is to test how well brief screening questionnaires can identify physical and emotional concerns that might put a teen’s health at risk. We plan to use what we learn in this study to help design better ways to identify the health care needs of teens. Will my teen or I get any benefit from being in the study? There is no direct benefit for you or for your teen. Information that your teen provides might help physicians take better care of other teens in the future. The results of this survey will not be reported back to you or to your teen’s doctor at Group Health. If I agree to have my teen be in the study, what will he/she have to do? Teens who choose to participate in this study will be asked to fill out the 8-item survey that is attached to this consent form and to return it by mail. Based on their responses to the questionnaire, some teens and one of their parents will also be invited to participate in a second study. Are there any risks to the study? One risk of this study is that your teen might feel uncomfortable answering the survey questions. We have attached the survey to this consent form so that you can look at the questions before giving the survey to your teen. Your teen can choose not to answer any questions that make him or her uncomfortable. Another risk is that, although we have a security plan to keep survey responses confidential, it is possible that someone else may see them. Confidentiality The information that your teen provides will be kept confidential as provided by law. Your teen’s responses will be identified by study number only and only researchers and staff (listed above) will have access to it. The responses to the survey will not be reported back to your doctors at Group Health or to you. Privacy Your/your teen’s health information is protected by a federal privacy law (called HIPAA) that applies to health care organizations and their employees. For this study, Group Health Cooperative will give your/your teen’s health information to the researchers listed on this form and their staff to be used only for research purposes. In addition, authorized staff from Group Health and/or the funding agency may review study records to watch over the honesty and/or safety of the research. Any information shared with others outside of Group Health may no longer be protected under this federal law. However, other laws, regulations and agreements Your Teen’s Participation is Voluntary Your teen’s participation in this study is completely voluntary. You or your teen may refuse to participate in any part of the study at any time. It will not change the health care your teen receives from Group Health. Your teen may skip any questions he or she does not want to answer. Whether or not you and your teen choose to participate, a $2-dollar bill is enclosed as a thank-you for your teen. Parent/Guardian’s Statement: I have read this form. I give my consent for my child to take part in this research study. I have been told that if I have any questions, I can ask them at any time by calling the ASC Project Manager, Susie Manager, at 206-555-5555. I have been told that my child or I can withdraw permission at any time. If I have any questions about my child’s rights as a research subject, I can call the Group Health Cooperative Human Subjects Review Office at (206) 555-5555. _____________________ PLEASE PRINT Parent/guardian name _____________________ _________________ _________ Parent/Guardian Signature Relationship To Teen Date REVISED Grade level = 7.4, 3% passive sentences Introduction Privacy We are inviting your teenager to be in a research study. This consent form will give you information to help you and your teen decide if you want to take part. Please read it carefully. It will explain the purpose of the study, what we are asking you to do, the possible risks and benefits, and your rights as a volunteer in the study. If you have any questions, please call Susie Manager at 206-555-5555. Your family’s health information is protected by a federal privacy law (called HIPAA) that applies to health care organizations and their employees. Only the researchers listed on this form and their staff will look at your teen’s survey answers. We will use the health information we collect from the surveys for research only. Staff from Group Health and/or the funding agency may look at study records to make sure that we follow the rules. Any information shared with others outside of Group Health may no longer be protected under this federal law. However, other laws, regulations and agreements may protect the information from improper use. We will not share your name or other information that would identify you or your teen with anyone else except as permitted by law. What is this study about? We want to find better ways to identify the health care needs of teens. This study will test how well a brief survey can point to the physical and emotional concerns that might put a teen’s health at risk. If we agree to be in the study, what will we do? You can change your mind about being in this study at any time. You may also change your mind at any time about letting us use your teen’s survey answers for this study. To do this, please write to Susie Manager at 1730 Minor Ave, Suite 1600, Seattle, WA 98101-1448. Your decision will not affect your family’s benefits or care at Group Health. If you and your teen decide to be in this study, you will sign this consent form and your teen will fill out the enclosed survey. Unless you change your mind, we will use your teen’s survey answers until July 1, 2010, which is one year after the study ends. • After you sign this form, please put it in the return envelope. Give the envelope (with this signed form inside) and the survey to your teen. Being in this study is voluntary • The survey includes eight questions about your teen’s health. Please make sure your teen has a private place to fill out the survey. It is up to you and your teen whether to take part in this study. You or your teen may decide not to be in the study at any time. This decision will not change the health care your family receives from Group Health. • After your teen has finished the survey, he or she should mail it and the consent form to us in the return envelope (no postage needed). • We have enclosed a second copy of the consent form for your records. Your teen may skip any survey questions he or she does not want to answer. We have enclosed a $2-dollar bill as a thank-you for your teen, whether or not s/he chooses to do the survey. Parent/Guardian’s Statement Are there any risks involved? • I have read this consent form. One risk of this study is that your teen might feel uncomfortable answering some of the survey questions. You can look at the questions before giving the survey to your teen. Your teen can skip any question that s/he does not want to answer. • I give consent for my teen to be in this study. • I can ask questions about the study anytime by calling the Project Manager, Susie Manager, at 206-555-5555. Another risk is that someone other than study staff may see your teen’s survey answers. We think this risk is very small. We have a security plan to keep survey answers confidential. Will we get any benefit from being in the study? • My teen or I can choose to leave the study at any time. • I have received a copy of this consent form for my records. • If I have any questions about my child’s rights as a research subject, I can call the Group Health Cooperative Human Subjects Review Office at 206-555-5555. There is no direct benefit to you or your teen. Results from this study might help doctors take better care of teens in the future. Confidentiality _________________________________ Please PRINT Name of Parent/Guardian _____________________ Relationship to teen We will keep the information in your teen’s survey confidential as provided by law. We will keep track of your teen’s answers using a study number instead of his or her name. Only the researchers listed on this form and their staff will have access to survey answers. We will not share your teen’s answers with you or your doctors at Group Health. _________________________________ Parent/Guardian Signature _____________________ Date 68 ORIGINAL Grade level = 10.6, 17% passive sentences choose to withdraw from the study at any time without affecting your enrollment or treatment at Group Health Cooperative. Example #3 INFORMATION STATEMENT Your answers to questions will remain confidential as provided by law and will not be included in your medical record. You will not be asked to take any medications or supplements for this study. Purpose: The purpose of this study is to identify better ways to help Group Health members deal with certain symptoms of stress and worry. The study is funded by the National Institutes of Health. What is Involved: This study consists of several steps. Agreeing to participate in Step 1 does not obligate you to participate in Steps 2 or 3. If you have any questions about the study, feel free to call the project manager, Sally Manager at (206) 555-5555. If you have questions about your rights as a research subject, please call Group Health’s Office for Human Subject Research at (206) 555-5555. Step 1 is completing and returning the enclosed brief questionnaire about stress and worry in your life. The purpose of this questionnaire is to find out if you are eligible to participate in the second step of this study. If your answers on the questionnaire make you eligible for the next step, we will contact you about Step 2. We expect that only a small number of those who complete the questionnaire will be eligible for step 2, and we will only contact those persons. If you do not hear back from us, you may call Sally Manager at 206-555-5555 to find out if you meet our criteria for Step 2. You can find more information about resources on stress management in My Group Health http://www.ghc.org/, or by contacting your personal physician. Investigators: Jane Researcher, PhD, Group Health Center for Health Studies, (206) 555-5555 Joe Scientist, PhD, Group Health Center for Health Studies, (206) 555-5555 Jennifer Doctor, PhD, Group Health Center for Health Studies, (206) 555-5555 If you are found eligible for Step 2, a study staff member will telephone you within 2 weeks of receiving your questionnaire. If you are willing, they will do a 10 – 15 minute telephone interview which will ask about your general physical and mental health and health behaviors (such as uncontrollable worry). If this interview suggests that our project is right for you, we will invite you to take part in Step 3. If you remain eligible and interested, you will proceed to Step 3, which consists of visiting our clinic for an initial interview lasting 45 – 60 minutes. You would be paid $20 for your time if you complete this interview. If the interview confirms your eligibility and you are interested in participating, you would be assigned by chance to receive one of 3 treatment groups. The three treatments are: Therapeutic Massage: a gentle massage of the muscles and other soft tissues Thermotherapy: a gentle heat treatment using heating pads and warm towels Tranquility Treatment: relaxation therapy involving music and deep breathing You would then receive a series of 10 one hour relaxation treatments over 3 months. At the end of the 3 months and again 3 months later, we would ask you to visit our clinic for followup interviews. You would receive $20 for each of these interviews. All treatment sessions will take place at our downtown Seattle clinic located at 1730 Minor Ave. Parking will be paid by the study. Other Information About Participating: Participation in this study is voluntary and whether or not you participate will not affect the care you receive at Group Health. If you agree to participate, you may choose not to answer any questions you would rather not answer. Also, you may 69 REVISED Grade level = 7.2, 4% passive sentences The three treatments are: Study Information Sheet What is the goal of this study? The goal of this study is to find better ways to help people deal with symptoms of stress and worry. ¾ Therapeutic Massage - gentle massage of the muscles and other soft tissues ¾ Thermotherapy - gentle heat treatment using heating pads and warm towels ¾ Tranquility Treatment - relaxation therapy with music and deep breathing Over the following 3 months, you will come to 10 one-hour treatment sessions. All treatment sessions will take place at our research clinic in downtown Seattle. The address is 1730 Minor Avenue. The study will pay for your parking. Why are you asking me to be in this study? We will also ask you to come to our clinic for two follow-up interviews. One will happen after you finish your series of treatment sessions, and the other will happen 3 months later. We will give you $20 for doing each interview. We are inviting you and other Group Health members who have visited a Group Health provider in the last 6 months to take part in this study. How do I find out if I am eligible for the study? What else should I know about this study? Finding out if this study is right for you happens in three steps: ¾ ¾ ¾ Being in this study is voluntary. Whether or not you take part will not affect the care you receive at Group Health. If you decide to take part, you may leave the study at any time. You may also skip any survey or interview questions that you don’t want to answer. Step 1 is to complete and return the enclosed brief survey about stress and worry in your life. Your answers to the survey will tell us if you are eligible for Step 2. If we find that you are eligible for Step 2, we will call you within 2 weeks of getting your survey. We will keep all the information you give us confidential as provided by law. We will not share your answers to the surveys and interviews with your doctor or put them in your medical record. We won’t ask you to take any medications or supplements for this study. Step 2 is a 10-15 minute phone survey about your general physical and mental health. There are also some questions about certain health behaviors, such as uncontrollable worry. If your answers to the phone survey show that you are eligible for the study, we will invite you to take part in Step 3. Who do I call if I have questions? Step 3 is a visit to our research clinic for an interview that will last about 45-60 minutes. If we confirm that you are eligible for the study, we will invite you to take part in one of three treatment groups (described below). We will also give you $20 to thank you for doing in the interview. Agreeing to take part in Step 1 does not mean you have to do Steps 2 or 3. You can say no to any part of the study at any time. ¾ If you have any questions about the study, feel free to call the project manager, Sally Manager at (206) 555-5555. ¾ If you have questions about your rights as a research subject, please call Group Health’s Office for Human Subject Research at (206) 555-5555. Who is leading this study? A team of researchers from Group Health Center for Health Studies are leading this study: We expect that only a small number of those who do Step 1 will be eligible for step 2. If you do not hear back from us after Step 1, you may call Sally Manager at 206-555-5555 to find out if you meet our criteria for Step 2. What happens in the treatment groups? ¾ Jane Researcher, PhD, (206) 555-5555 ¾ Joe Scientist, PhD, (206) 555-5555 ¾ Jennifer Doctor, PhD, (206) 555-5555 The study is paid for by the National Institutes of health. If you decide to take part in the treatment phase of the study, we will use a computer to randomly assign you to one of three treatment groups. This means you will be put into a group by chance. It is like flipping a coin or drawing names out of a hat. Where can I get more information about managing stress? To find more information and resources on stress management, visit MyGroupHealth online at www.ghc.org, or talk to your doctor. 70 Appendix E: Repository of Readability References and Resources I. Large-scale Health Literacy and Plain Language Initiatives American Medical Association Foundation Health Literacy Initiative Working to raise awareness among health care providers about the link between health and literacy. Find out more about their toolkit Health Literacy: A Manual for Clinicians, and train-thetrainers seminar. National Institutes of Health - Clear Communication: Health Literacy Initiative Defines health literacy and discusses why it’s an issue and how to improve communication strategies for health professionals. Links to current research in health literacy supported by the NIH. Pfizer Clear Health Communication Initiative Pfizer supports research in clinical settings to begin to develop solutions that center around clear communication. Tools are provided for clinicians, researchers, the media, and public health professionals. Plain Language Action and Information Network Federal government’s contribution to the plain language movement. This site provides a history of this movement, examples of documents before and after being rewritten using plain language principles, and links to key articles supporting the use of plain language in organizational settings. Plain Language Association International An international group called The Plain Language Network. Members of the network include editors, writers, attorneys, and educators from around the world. Provides links to advice and information on writing and designing clear communication materials using plain language. U.S. Department of Health and Human Services One of the primary objectives of Healthy People 2010 is the improvement of health literacy. Read the full text of the objective: Health Literacy Action Plan—Communicating Health: Priorities and Strategies for Progress (2003): II. Key background reports on general literacy and health literacy Results of the 2003 National Assessment of Adult Literacy (NAAL) Health Literacy Report from the 2003 National Assessment of Adult Literacy Health Literacy: A Prescription to End Confusion 71 More health literacy Web resources Agency for Healthcare Research and Quality Health Literacy and Cultural and Linguistic Competency resource page provides links to research studies, implantation strategies, evidence reports and tools for testing the quality of your materials. Harvard School of Public Health, Health Literacy Studies Information for researchers and practitioners in the public health, medical, and adult education fields. Links to Easy-To-Read health information sites, grouped by health topic. Health and Literacy Special Collection A clearinghouse of information related to teaching and learning health literacy skills, including links to health education resources, easy-to-read and multilingual health information, and health literacy research. Health Literacy Consulting Resources and articles to help individuals and organizations communicate about health information in ways patients, families, and employees can more easily understand. Plain Language: A Promising Strategy for Clearly Communicating Health Information and Improving Health Literacy PDF From the U.S. Department of Health and Human Services: An overview of plain language and health literacy terms, tips on writing and speaking plainly, and a summary of reasons why plain language has the potential to improve health literacy. Quick Guide to Health Literacy From the U.S. Department of Health and Human Services: A summary of issues related to health literacy, suggestions for improving health literacy in your organization, and examples of health literacy best practices. Teaching Patients with Low Literacy Skills. Second Edition (1996). Doak, Doak, & Root. Considered a classic text in health literacy, the authors are often introduced at health literacy conferences as 'the grandparents' of health literacy. Low Health Literacy: Implications for National Health Policy. This recent report from the University of Connecticut School of Business “dollarizes” the financial burden on the U.S. economy, and advocates that low health literacy be addressed as part of national health care reform. Medical Library Association Contains many hyperlinked resources listed that currently are developing health literacy standards National Library of Medicine/National Institutes of Health – definitions, research findings, economic impact of low health literacy, bibliographies, a compendium of web sites, and health literacy listservs. “What Did the Doctor Say?:” Improving Health Literacy to Protect Patient Safety. The Joint Commission on Accreditation of Healthcare Organizations developed this comprehensive 2007 report on the real and potential impact of health literacy. 72 Writing tips and how-to guides Simply Put PDF Tips for creating easy-to-read print materials from the Centers for Disease Control and Prevention (CDC). How to Write Easy to Read Health Materials Tips from the smart folks at Medline Plus, who develop lay-oriented health information. Health Literacy Style Manual PDF Southern Institute on Children and Families Guidelines for Developing Easy-to-Read Health Education Materials State of Washington Department of Health Patient Education Materials: An Author's Guide University of Utah, Health Sciences Center Web pages with lists of alternative wording suggestions for medical and research terminology University of California at Davis University of Michigan Medical School University of Utah Health Sciences Center Enhancing provider/patient communication AskMe3 Sponsored by the Partnership for Clear Health Communication (PCHC). The PCHC serves as an information source regarding the scope and impact of health literacy in the U.S., as well as what providers and patients can do to improve health communication in every provider-patient interaction. Familydoctor.org Patient-friendly site has an extensive index of conditions, health tools, including a dictionary of common medical terms, and a section on healthy living. All material is written and reviewed by physicians and patient education professionals. FDA Easy-to-Read Publications This site has a collection of easy-to-read brochures in English and Spanish on a variety of health topics. You can print them or order free copies. FDA Information for Seniors Easy-to-read articles on a variety of health issues that affect older adults. Topics include arthritis, cancer, nutrition, food safety, and women's health. Also links to other organizations with information for older adults. 73 KidsHealth Sections for parents, kids, and teens, including interactive games. The kids’ articles are easy to read and written for children. Also appropriate for adult learners with low-literacy skills. Medline Plus Interactive tutorials teach about health topics with animated graphics and simple text. Health in Plain Terms. A call to action from the Puget Sound Health Alliance. This is a resource for both consumers (helping them get the care they need), and providers (tools to help them talk to their patients in language that is easily understood. Health Literacy: A Manual for Clinicians. American Medical Association and American Medical Association Foundation, 2003 An abbreviated list of published articles on literacy and readability in health research (this is an ever-growing bibliography) Berkman ND, et al. Literacy and health outcomes. Summary, Evidence Report/Technology Assessment No. 87. AHRQ Publication No. 04-E0007-1. Rockville, MD: Agency for Healthcare Research and Quality. Jan 2004. Bjorn E, Rossel P, Holm S. Can the written information to research subjects be improved – an empirical study. J of Med Ethics. 1999;25:263-267 Cox K. Informed consent and decision-making: patients' experiences of the process of recruitment to phases I and II anti-cancer drug trials. Patient Educ Couns. 2002 Jan;46(1):318. Coyne CA, et al. Randomized, controlled trial of an easy-to-read informed consent statement for clinical trial participation: A study of the Eastern Cooperative Oncology Group. J of Clinical Oncol. Mar 1, 2003;21(5):836-842. Davis TC, et al. Literacy and misunderstanding prescription drug labels. Annals Int Med. Dec 2006;145(12):887-894. Davis TC, et al. Informed consent for clinical trials: a comparative study of standard versus simplified forms. J of Natl Cancer Inst. May 6, 1998;90(9):668-674. Davis TC, et al. Parent comprehension of polio vaccine information pamphlets. Pediatrics. 1996;97:804-810. Goldfarb NH and DuBay WH. Writing good at a seventh-grade reading level. J of Clinical Research Best Practices. Vol.2, No.1, Jan 2006 Hochhauser M. Is it ethical to give out unreadable information? Managed Care Quarterly. Spring 2003. Hopper KD, Tenhave TR, Hartzel J. Informed consent forms for clinical and research imaging procedures: how much do patients understand? Am J Roentgenol. 1995 Feb;164(2):493-6. Kalichman SC, et al. Adherence to combination antiretroviral therapies in HIV patients of low literacy. Journal of General Internal Medicine, 1999. 74 Meade CD. Improving understanding of the informed consent process and document. Seminars in Onc Nursing. May 1999;15(2):124-137. Miller C, et al. Comprehension and recall of the informational content of the informed consent document: an evaluation of 168 patients in a controlled clinical trial. J of Clin Res and Drug Development. 1994;8:237-248. Paasche-Orlow MK, Taylor HA, Brancati FL. Readability standards for informed-consent forms as compared with actual readability. N Engl J Med. 2003 Feb 20;348(8):721-6. Philipson S, et al. Effectiveness of a writing improvement intervention program on the readability of the research informed consent document. J of Investigative Med. Nov 1999;47(9):437-445. Raich P, Plomer K, Coyne C. Literacy, comprehension, and informed consent in clinical research. Cancer Investigation. 2001;19(4):437-445 Ratzan SC, Parker RM, 2000. Introduction. In National Library of Medicine Current Bibliographies in Medicine: Health Literacy. Sugarman J, Lavori PW, Boeger M, Cain C, Edson R, Morrison V, Yeh SS. Evaluating the quality of informed consent. Clinical Trials, Feb 2005; 2: 34 - 41. Titus S and Keane M. Do you understand?: an ethical assessment of researchers’ description of the consenting process. J of Clin Ethics. Spring 1996; 7(1):60-68. White L, et al. Informed consent for medical research: common discrepancies and readability. Academic Emerg Med. August 1996;3(8):745-750. Wolf MS, et al. Health literacy and health risk behaviors among older adults. Am J Prev Med 2007;32(1):19-24. Williams MV, et al. Inadequate literacy is a barrier to asthma knowledge and self-care. Chest. 1998. Two sites especially worthwhile for researchers and IRBs Simplification of Informed Consent Documents Plain language recommendations from the National Cancer Institute and a consent form template for cancer-related clinical trials. Universal Use of Short And Readable Informed Consent Documents: How Do We Get There? Summary of Strategic Planning Meeting May 30, 2007 held by the American Association of Medical Colleges to review potential approaches and available resources to move the research community toward common usage of informed consent documents that are both short and written in simple and comprehensible language. << Back to contents page 75 We’re happy to update this list with other references or resources you may come across. Contact Jessica Ridpath at PRISM@ghc.org or 206-287-2032 with suggested additions. 76