CASE STUDY REPORT MODEL BY FREYA MAGNUSSON, CMT, NASM CPT Freya Magnusson, CMT, NASM-CPT This case report model is designed to be used by any type of health care provider in the licensed and/or certified health professions. The word “client” will be used in substitution of the word “patient” and “therapy” or “therapies” in substitution of the word “treatment” or “treatments” to keep within my scopes of practice as both a Certified Massage Therapist and a Certified Personal Trainer in the State of California as of the date of this printing. August 10th, 2014. In my search to find the ideal case report model to use for my research, I closely examined three leading templates. Since none of them quite fit my needs as designed, I decided to take the best aspects from each to create my own ideal case report template. Thus, this case report model in no way represents my own original ideas, but is a blend of the best aspects of the three I reviewed. The author whose work provided the most guidance is Dr. Brian Budgell, DC, PhD, a Canadian chiropractor and a member of the Journal of Canadian Chiropractic Association’s Editorial Board. Budgell’s case report template impressed me the most because of the extreme detail and specificity he devotes to each aspect of his template. Most templates I reviewed including my three favorites were less than three pages in length, gave cryptic guidance and appeared to represent an outline of a case report rather than provide true instruction on the actual writing of a case report. Hence, I quote and cite Budgell more than the other two publications in my infusion process. What also impressed me were the specific examples he gives on pages 203 and 204 of each aspect of his case presentation outline. It was extremely helpful to see that applicable client scenario modeled. Budgell was the only author that I came across in my reviews that attempted this. The Journal of Medical Case Reports (JMCR) was my second favorite model largely due to its details and emphasis on the legal aspects of obtaining informed consent with any given situation. Legal protocol was given for each possible scenario. The JMCR advised what to do when the client was deceased, when no consent was possible or available to consent, or when the client was a minor child. No other model I reviewed contained such practical legal counsel. This earned high marks with me since being ethical on all aspects of the scientific process is a crucial part of procuring high-quality science to the public. My third favorite model, “Case Reports: The Care Guidelines” provided helpful filler criterion in the Diagnostic Focus Assessment section, the Follow Up Outcomes section, the Clinical Findings section and the Ethics Approval section. No other case report model I reviewed detailed out a statement of whether the case was reviewed by an ethics committee or an Institutional Review Board (IRB). This model serves useful in filling in the gaps of the other three and providing the essential ethics issues. As aforementioned this case report template has creatively combined the best aspects from the three models highlighted above. I am making it available for use by anyone who may find it useful to further their own research as I have with my own. 1 Case studies provide crucial direction to inspire, develop and steer higher-tiered scientific research such as randomized controlled trials (RCTs) and systematic reviews. According to Budgell (2008), “They also serve to provide valuable teaching material and unique individual investigational opportunities for demonstrating both classical and unusual client presentations which may present to the health professional at any time.” (p. 199). While even the highest quality case study research is still admittedly the lowest tier on the scientific research hierarchy, in the interest of protecting the public, it’s important to understand the reasons for the different tiers of research and why they exist. Even the most compelling case study would not provide enough evidence to warrant the passing of a new drug or medical procedure. RCTs and systematic reviews are the highest tiers of scientific evidence and the pathway in which new drugs or medical procedures are researched and approved. For example, if you read a case study from a prestigious research hospital that attributed the success of a patient’s recovery from cancer to a natural supplement the patient self-administered, it would not be sufficient evidence to warrant that supplement’s effectiveness. One could not refer to the case study as “scientific proof.” Scientific proof would instead come from high-quality, numerous and rigorously designed RCTs and systematic reviews proving the supplement’s consistent effectiveness to be considered strong scientific evidence. This example demonstrates how the public can sometimes be misled by what they understand to qualify as hard, scientific evidence. It’s my hope that this case report template provides a balanced structure of both scientifically recognized, standard criteria with a creative, detailed instructional guidance. Case studies conducted using this template are meant to further higher-tiered scientific investigation through RCT’s and systematic reviews. With that said, I shall now proceed with the introduction and instructional guidance section of the case report template. A high-quality case report should be between 500 to 1,500 words in length which is the equivalent of one to three pages in 12 point font, or 500 words equaling one page. (Budgell, 2008). Using an efficient, clear and direct writing style with clinically recognized language is expected and appreciated by reviewers, many of whom will be clinicians or professional researchers with limited time to search through ubiquitous, cloudy-written case reports. Concisely and precisely well-written case reports will both serve to furnish the reviewers with quality, detailed information while simultaneously recognizing the author or authors amongst scientific circles. The following model on page 3 can be adapted or expanded as appropriate to fit your individual needs or preferences and should be viewed as a guide rather than an authority on case report models. I hope it serves as an aid to help further the quantity and quality of case reports by both novice and experienced scientific writers. 2 -Beginning of Case Report Template Cover Page: The first sentence should title the case study, case report, or case series topic; e.g. A client presenting with _____ in ______: a case report (or if the case report details more than one client: a case series (JMCR, 2014). According to Budgell (2008), “Two examples of titles are singular or compound.” (p. 200) Budgell (2008) examples this by stating, “A case study of hypertension which responded to spinal manipulation,” or “Response of hypertension to spinal manipulation: a case study.” (p. 200). Article titles in leading journals average between 8 and 9 words in length (Budgell, 2008). According to Case Reports: The Care Guidelines (2013), “Describe the phenomenon of greatest interest (symptom, diagnosis, diagnostic test, intervention, outcome in the title.” (p.1) Author’s Full Name 1 1, academic degrees/credentials, Author’s Full Name 2 2, (the second numbers are superscript), The qualification for authorship pertains to the author(s) ability to both explain and defend the article (Budgell, 2008). According to Budgell (2008), “Contact information—either home or institutional—should be provided for each author along with the authors’ academic qualifications.” (p. 200) Address: 1 Full postal address (institutional address) of author 1; and so on. Email: Email addresses for the authors; email@address.com; Telephone: ________ Disclaimers: Sources of Financial Support, if any: 3 Abstract: A structured abstract as opposed to a narrative abstract uses subheadings and is becoming the preferred format for scientific and clinical studies. This is because they standardize the abstract to ensure certain criteria are included (Budgell, 2008). Another advantage of the structured abstract is that it gives the reader enough information to decide whether or not to proceed on to the full article (Budgell, 2008). Two questions to keep in mind are: Is the case report of interest to a particular clinical specialty of medicine? Will it have a broader, clinical impact across medicine as a whole (JMCR, 2014)? Mention briefly how it might advance knowledge of a disease, etiology, or drug/supplement/herbal medication therapy or mechanism (JMCR, 2014). The abstract should start on page 2 of the case report, be between 150 to 350 words or onethird to three-fourths of a page and abbreviations or references in the abstract should be avoided (JMCR, 2014). The Journal of Medical Case Reports (JMCR, 2014) advises the following: Structure it into 3 sections: an introduction, a case presentation and a conclusion 1) Introduction: An introduction about why this case is significant and needs to be reported Include whether this is the first report of this kind in the literature or part of a collection of existing literature 2) Case Presentation: Brief details of what the client presented with, including the client’s age, sex and ethnic background 3) Conclusion: A brief conclusion of what the clinical impact could be. Finally, summarize the following information if relevant: 1) Rationale for this case report, 2) Presenting concerns (chief complaints or symptoms, diagnoses), 3) Interventions (diagnostic, preventative, prognostic, therapeutic exchange), 4) Outcomes, and 5) Main lessons from this case report. (p. 2) Key Words: Provide 3-8 key words that will help potential readers search for and find this case report (around 5 is average) (Budgell, 2008). Budgell (2008) advises to “Choose key words from a standard list of keywords, such as MeSH (Medical subject headings) which is available in most libraries or visit this address: http://www.ncbi.nlm.nih.gov:80/entrez/meshbrowser.cgi “(p. 200). Introduction/Background Information: This section should: create reader interest, establish a problem that was the catalyst for the study, place it within a larger context of the academic literature and target a specific audience. Budgell (2008) states, “We need to have a clear idea of 4 what is particularly interesting about the case we want to describe” (p. 201). This can be accomplished by doing the following: In a few sentences, describe the context of the case, place it in a historical research or social context, research similar cases if any, describing briefly the possible challenges with the existing diagnosis, co-occurring conditions or management of the diagnosis or conditions and list the background information of the research topic (Budgell, 2008). The introduction should be a few paragraphs in length including the disorder, usual presentation, progression and an explanation of the presentation if it is a new disease (Budgell, 2008). If it is a case discussing an adverse drug/supplement/herbal medication interaction, the introduction should detail the agent’s common use and any prior reported side effects, as well as a brief literature review (JMCR, 2014). Before listing Budgell’s specific seven-step example of a case presentation, here are some general notes on developing one. Begin the case presentation with several sentences in narrative form using the client’s own words describing the original complaint, the history and results of any examinations performed, the existing diagnosis/management of the case and introduction of the raw data (Budgell, 2008). Introduce the important information that we obtained from our history-taking which usually leads to a differential diagnosis by a qualified provider authorized and licensed to diagnose, i.e. a short list of the most likely diseases or disorders underlying the client’s symptoms (Budgell, 2008). Describe the client characteristics (relevant demographics (without adding any details that could lead to the identification of the client)—list age, gender, ethnicity, occupation) and his/her or their (if a case series, in which details must be included for all clients) presenting concern(s) with relevant details of related past medical history of the client; the client’s symptoms and signs; any tests that were carried out and a description of any therapies or interventions (JMCR, 2014). Case Presentation: Budgell (2008) has designed a seven-step method outlining a quality case presentation format. I collectively cite and credit him here for the example listed below simply for format’s sake. The individual examples below have been changed to chronicle my own experience with an episode of chronic nerve pain lasting three months in which I required round-the-clock medication which proved ineffective in managing my pain. I finally sought treatment from a holistic chiropractor in San Francisco, CA, Karen Montalbano, D.C. who performed a gentle adjustment and in less than thirty minutes; I walked out of her office painfree with the pain never again recurring. 1) Introductory sentence: e.g. This 31 year old female office worker presented for the therapeutic resolution of chronic low-back and leg pain. 2) Describe the essential nature of the complaint, including location, intensity and associated symptoms: e.g. her low-back pain presented in the lumbar spine region, bilaterally but worse on the right. There is referring pain down her right, posterior leg, ending at the dorsal side of her right foot. She describes the pain as having an intensity of up to six out of ten, accompanied by a feeling of burning, tingling pain. The pain is constant without variation in intensity. 3) Further development of history including details of time and circumstances of onset, and the evolution of the complaint: e.g. this problem began to develop eight years ago when she commenced work as an Administrative Assistant. One day at work before going home for the day, she attempted to empty an office paper recycle bin. It was a routine task she did each day after work. She anticipated the load to be far less 5 than it actually was and as she lifted the bin and pivoted to the right, she realized the actual weight of the bin was far greater and had to drop the bin to the floor and empty it by smaller handfuls instead. When she arrived home, she noticed she was in a lot of pain. Over the next few weeks, her pain had sustained the same level of intensity. 4) Describe relieving and aggravating factors, including responses to past therapies: e.g. she made an appointment with her medical doctor who prescribed some pain medication (Naproxen Sodium) which did not provide any significant relief to the pain. She received several massage therapy sessions and while they did provide relief to her lumbar muscles and surrounding musculature, the nerve pain remained constant. Finally after three months of suffering, she made an appointment with a local chiropractor close to work in case she would need to seek recurrent treatments. The chiropractor did a gentle adjustment and within thirty minutes, she was pain-free. There has been no recurrence of the nerve pain or low-back pain since that appointment eight years ago. 5) Include other health history, if relevant: e.g. she reports that she is in good health except for being overweight and unconditioned athletically. 6) Include family history, if relevant: e.g. there is no family history of chronic low-back pain or neuralgia. 7) Summarize the results of the examination, which might include general observation and postural analysis, orthopedic exam, neurological exam and chiropractic examination (static and motion palpation): use anatomical terminology, e.g. the client was diagnosed with low-back pain due to a postural strain of the quadrus lumborem muscles. No exams or tests other than a general physical with her primary care physician were ordered. The client self-referred to Karen Montalbano, a local chiropractor for treatment and received lasting relief after one adjustment. Discussion: Additional comments that provide any additional relevant information that explain specific therapy decisions (JMCR, 2014). Explain both correlations and apparent inconsistencies of the case presentation. Within one or two sentences describe the lessons to be learned (Budgell, 2008). If there is a well-established item of physiology or pathology which illuminates the case, we certainly include it (Budgell, 2008). Clinical Findings: Describe the results of the clinical examination; the client’s medical, family and psychosocial history (Case Reports, 2013). Lifestyle and genetic history should be noted as well as listing any relevant co-occurring conditions or existing dual diagnoses here (Case Reports, 2013). A notation of past therapeutic interventions that were tried should be mentioned. Budgell (2008) advises the following: If we are using a named orthopedic or neurological test, it is best to both name and describe the test (since some people may know the test by a different name). Also, we should describe the actual results, since not all readers will have the same understanding of what constitutes a “positive” or “negative” result. X-rays or other graphics and images are only helpful if they are clear enough to be easily reproduced and if they are accompanied by a legend. (p. 201) 6 Therapeutic Focus and Assessment: Be as specific as possible in describing the therapy used; instead of saying that the client received “therapeutic bodywork,” explain the type of therapeutic intervention used and whether it was a surgical, pharmacological, preventive, herbal, lifestyle, or a specific type of manual therapy intervention (Budgell, 2008). If we used a manual therapy, it is best to name the technique and to describe the technique (Budgell, 2008). Our case study may be read by people who are not familiar with the specific technique and, even within the related circles of practitioners of that technique, the nomenclature for it may not be standardized (Budgell, 2008). What was the intervention’s (duration, frequency, dosage, or any specific quality pertaining to administration) and how was it administered? (Case Reports, 2013). Management, Follow-Up and Outcome: Describe the course of the client’s complaint. 1) Be as specific as possible when describing the therapy provided, how and why the therapy finished, the nature of the therapy, the frequency and duration of care: (Budgell, 2008) e.g. The client undertook a session of therapy consisting of a upper thoracic and lumbar spinal manipulation one time. Manipulation was accompanied by a gentle rocking motion administered to the paraspinal muscles and the stretching of the upper trapezius. If care was terminated by the researcher or the client, list the reasons why and if they were referred to another provider. 2) If possible, refer to objective measures of the client’s progress: (Budgell, 2008) e.g. the client maintained a low-back pain and nerve pain diary indicating that she had lessened pain immediately after treatment and no recurrence of the pain ever again. List the adherence to the intervention either in percentages or statistical numbers and how this was measured or calculated (Case Reports, 2013). 3) Describe the resolution of care: (Budgell, 2008) e.g. based on the client’s reported progress immediately after care, the client found she needed no further treatment and the issue has permanently corrected. 4) List adverse effects or unplanned events (Case Reports, 2013). Where possible, make reference to any client-reported or clinicianassessed reported outcome measures which you used to objectively demonstrate how the client’s condition evolved through the course of management (Budgell, 2008). Finally, list any relevant test results (Case Reports, 2013). Summary: This section consolidates the principle points of the paper. Be detailed, concise, and significant, i.e. a comprehensive restatement of the study’s purpose, scope, methods, results, conclusions, findings, and recommendations. It should be proportional to the length of the study 500 words is a good average = 1 page in length = 7 aspects = 1 ½ to 2 paragraphs per aspect. Stick to the facts and stay focused on what is interesting or remarkable about this case (Budgell, 2008). A case study should be a relatively modest description of what actually happened, unless you have extensive knowledge to discuss physiology and pathology, avoid speculating about possible underlying mechanisms (Budgell, 2008). According to Budgell (2008), “The thing of greatest value that you can provide to your colleagues is an honest record of clinical events” (p. 200). The client outcome will speak for itself (Budgell, 2008). Client Perspective: Include the client’s own reports of improvements or worsening, use a wellaccepted method of measuring their improvement (Budgell, 2008). According to Budgell (2008), “Use data from visual analogue scales (VAS) for pain, or a journal of medication usage” (p 202). The client should state what originally motivated him or she to seek medical advice, a description of his or her symptoms, whether the symptoms were improved or worsened at 7 times, how any tests or test results, positive or negative therapies affected them, how the problem is currently and if it is still a problem at all (JMCR, 2014). Informed Consent: This section is required and should provide a statement to confirm that the client has given his or her informed consent to be a participant in the study, consent for the study to be published using the participant’s information and consent to be photographed and those photographs to be published (JMCR, 2014). According to the JMCR (2013), “A copy of the written consent is available for review by the author or Editor-in-Chief of this journal.” (p. 3). The JMCR (2013) further states: In the absence of consent, a case report about a living person must be anonymised so that neither the individual, nor anyone who knows them, can identify themselves from the published article. If the person described in the case report has died, then consent for publication must be sought from their next of kin. If the individual described in the case report is a minor, or unable to provide consent, then consent must be sought from their parents or legal guardians. In each case, the statement in the ‘Consent’ section of the manuscript should be amended accordingly. (p. 3) Competing Interests: List any competing interests. According to the JMCR, (2013) “A competing interest exists when your interpretation of data or presentation of information could possibly be influenced by your personal or financial relationship with other people or organizations/institutions” (p. 4) If there are no competing interests, the author must state, “The author(s) declare that they have no competing interests” (JMCR, 2014) Ethics Approval: List if an ethics committee or Institutional Review Board (IRB) gave approval (Case Reports, 2013). If yes, please provide. If not, state that there was no ethics committee or IRB involvement (Case Reports, 2013). De-Identification: All client-related data must be anonymised (Case Reports, 2013). Authors’ and Non-Authors’ Contributions: Use initials to refer to each author’s contribution (JM CR, 2014). For example, “FM analyzed and interpreted the client data regarding the oncology disease and the course of treatment administered (JMCR, 2014). RH performed the histological examination of the liver and was a major contributor in writing the paper (JMCR, 2014). All authors read and approved the final manuscript” (JMCR, 2014). All contributors who are not authors should be listed in an acknowledgements section (JMCR, 2014). Examples of those who might be acknowledged include a person who contributed strictly technical help, a 8 person who contributed writing assistance or a department chair or advisor that provided general support (JMCR, 2014). Acknowledgements: This section thanks those who provided help, critical feedback, peerreview, assistance and editing or revisions to include important intellectual content in the preparation of the case study (JMCR, 2014). It’s inappropriate to thank others, including the participant(s) in the study who did not directly participate in the actual study design, concept, acquisition of data, data analysis or interpretation of the data (Budgell, 2008). References and Appendices: The popular search engine for English-language references is Medline: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi List all references and appendices in APA format (Budgell, 2008). All references must be numbered consecutively, in square brackets [ ], in the order in which they are cited in the text, followed by any in tables or legends (JMCR, 2014). According to JMCR (2014), “No more than 15 references should be listed” (p. 5) Budgell advises not to refer to personal, undocumented communication that a reader would not be able to search and verify (Budgell, 2008). Graphs and Legends: If you are uncertain about whether or not to include a graph in your case study report, Budgell (2008) advises, “A good rule for graphs is that they should contain sufficient information to be generally decipherable without reference to a legend” (p. 202). Ensure that your colored graphs and legends can be read clearly in black and gray print as they may end up photocopied in these colors and clarity, integrity and data may become lost over time rendering them useless. Tables, figures and photographs: According to the Journal of Medical Case Reports (2014), “For each figure, the following information should be provided: Figure number (in sequence, using Arabic numerals—i.e. Figure 1, 2, 3, etc.); short title of figure (maximum 15 words); detailed legend, up to 300 words or slightly more than ½ a page” (p. 5). Budgell (2008) advises that, “Tables, figures and photographs should be included at the end of the manuscript in a timeline format” (p. 202). Additional Files: There may be times where an author wishes to provide additional information such as data sets, tables, or other information (JMCR, 2014). If you have additional data files, you should reference them clearly by file name within the article such as ‘See additional file 2: Movie2 for data performing this analysis’ (JMCR, 2014). According to the Journal of Medical Case Reports (2014), “List the following information in a separate section of the manuscript text, immediately following the tables (if any): File Name File Format (including a name and a URL of an appropriate viewer if format is unusual) Title of data Description of data” (p. 5) Permissions: Budgell (2008) advises, “If any tables, figures, or photographs, or substantial quotations, have been borrowed from other publications, we must include a letter of permission from the publisher” (p. 202). 9 -End of Case Report TemplateReferences: Budgell, B. (2008). Guidelines to the Writing of Case Studies, The Journal of the Canadian Chiropractic Association, 52(4), 199-204. Riley, D. (2013). Case Report Writing Template for Authors. Case Reports: The Care Guidelines. Retrieved from http://www.CARETemplate-English.docx. From the website: www.CAREstatement.org (2014). The Journal of Medical Case Reports. Biomed Central Ltd. Retrieved from http://www.jmedicalcasereports.com/authors/instructions/casereport Acknowledgements: I would like to thank the following people for their contribution in the peer review process of the formation of this case report template: A. Kechedijan, C.N.A.; S. Martin, R.N.; The author of this case study report model, Freya Magnusson, CMT, NASM CPT, gives full permission and consent for any private or public use, publication or reproduction of this document in any format, electronic or otherwise to any person, organization, or institution interested in it without requiring prior permission in writing. I only ask that when referencing or using this case report model, the words “courtesy of Freya Magnusson, CMT, NASM-CPT” be included. FM 8/10/14. The author has obtained written, verbal and/or electronic permission from all people and organizations listed in this paper to publish their contributions and if applicable, have consented to be listed by actual name. Copies of these permissions are available from the author upon written request to the address listed on the author’s website: http://optimalhealth.abmp.com FM 8/10/14. 10