Running head: GUIDELINE ASSESSMENT Guideline Assessment Paper Vaginal Birth after Cesarean: New Insights Pediatric/Maternal/Women’s Group: Joan Berkey, Emily Gast, Mary Groves, Mary Holstad, Jody Hosch, Jay Jackson, Julie Johnson, Jennifer Lewis, Susan Rasmusson, DeAnne Savick The University of Iowa December 2011 1 GUIDELINE ASSESSMENT 2 Introduction The guideline selected for group review is National Institutes of Health Consensus Development Conference (NIH) statement: Vaginal birth after cesarean: New insights (NIH, 2010). The guideline addresses six clinical questions: 1. What are the rates and patterns of utilization of trial of labor (TOL) after prior cesarean delivery, vaginal birth after cesarean delivery (VBAC), and repeat cesarean delivery in the United States? 2. Among women who attempt a TOL after prior cesarean delivery, what are the vaginal delivery rates and the factors that influence it? 3. What are the short- and long-term benefits and harms to the mother of attempting a TOL after prior cesarean versus elective repeat cesarean delivery (ERCD), and what factors influence benefits and harms? 4. What are the short- and long-term benefits and harms to the baby of maternal attempt at TOL after prior cesarean versus ERCD, and what factors influence benefits and harms? 5. What are the nonmedical factors that influence the patterns and utilization of TOL after prior cesarean delivery? 6. What are the critical gaps in the evidence for decision-making, and what is the priority investigations needed to address these gaps (NIH, 2010)? Childbirth in the U.S. has become a highly medicalized process. Practitioners have learned to manage labor by mitigating crisis. The woman is still a passive patient who looks to others to direct her actions (Gibson, 2011). This guideline was chosen for review because it provides a meta-analysis of literature that pertains to the issue of whether confidence can be placed in the recommendation for the patient population to undergo VBAC. Once familiar with the NIH Consensus findings, the nurse is in a better position to translate the research findings into practice. Childbirth practices in the U.S. create both a problem focused trigger and a knowledge focused trigger as defined by the Iowa Model of Evidence-Based Practice (EBP) to Promote GUIDELINE ASSESSMENT 3 Quality Care (Titler, et.al, 2001). The problem focus trigger or key element associated with this clinical nursing problem is disparity in health care delivery as evidenced by whether a facility offers the VBAC option (Agency for Healthcare and Research Quality, AHRQ, 2010). The knowledge focused trigger that is a key element to this clinical nursing problem is that the NIH recommends VBAC as safe for most women who meet criteria, and many medical institutions have not acted in ways to follow the guideline (AHRQ, 2010). The clinical problems associated with VBAC that nurses can influence are alluded to in the above paragraph. In addition to medical and organizational issues, VBAC also involves emotional and financial considerations. Decision-making about mode of birth after a cesarean delivery presents challenges to women and to caregivers, and requires a balance of risks and benefits according to individual circumstances (Shorten, et. al, 2005). A randomized controlled trial (RCT) conducted by Shorten et. al in 2005 found that the use of a decision-aid tool was effective to improve knowledge and reduce decisional conflict regarding mode of delivery. Costs and resources directly affect the delivery of health care. Cost of health care affects access and quality. Current indicators for cost will continue to create disparities in health care delivery, and debates on these issues will drive improvements that will lead nurses to new roles, tasks, and challenges in the decades ahead (Jerome-D’Emilia, 2008). TOL after previous cesarean is unlikely to be associated with a significant cost savings for the institution as TOL is associated with increased incidence of neonatal neurological damage. Factors other than cost must govern decisions about TOL versus ERCD (Clark, et. al, 2000). However, risks associated with ERCD may pose increased cost and poorer outcomes than that associated with VBAC (Scott, 2010). GUIDELINE ASSESSMENT 4 The NIH Consensus panel, after weighing the risks and benefits continue to recommend that a TOL is a reasonable and safe option for women with one prior low transverse uterine incision. The panel recommends that practitioners use the six identified clinical questions to guide them when counseling women in regard to VBAC versus ERCD. In addition, the guideline encourages hospitals, maternity care providers, health care and professional liability insurers, consumers, and policymakers collaborate on the development of integrated services that could mitigate or eliminate barriers to TOL (NIH, 2010). The pediatric/maternal/women’s health group selected this guideline based upon discussion among its members. One of the members shared that she personally has experienced three VBACs, and expressed concern about the declining VBAC rate. It has been recognized through lecture information from Nursing Research 96:143 (Taylor, 2011) that the National Guideline Clearinghouse (NGC) website provides high quality guidelines. Using vaginal birth after cesarean as our search terms allowed identification of new information in the literature regarding VBAC. The pediatric/maternal/women’s health group used the following criteria as recommended by M. Titler and S. Adams for developing an evidence-base practice, (LoBiondoWood & Haber, 2010) to decide to use VBAC: New insights: 1. The guideline is recent, published in 2010, 2. The guideline is authored by practiced professionals with high levels of expertise in synthesizing research, and 3. it is endorsed by the highly reputable National Institutes of Health. Other guidelines of consideration concerned use of doulas, music therapy, kangaroo care, breastfeeding counselors, and hormone replacement therapy after a hysterectomy. Databases utilized to search for evidence-based guidelines included CINAHL, Cochrane, National GUIDELINE ASSESSMENT 5 Guideline Clearinghouse, and PsychInfo. The group’s decision was unanimous to evaluate VBAC: New insights (NIH, 2010) to determine whether this guideline can be utilized as a helpful reference in the process of refining individual institution specific evidence-based policies, procedures, or standards in efforts to apply in practice (Titler & Adams, 2010). Scope and Purpose The Consensus Development Conference panel’s major goal in this initiative is “to support pregnant women with one prior transverse uterine incision to make informed decisions about TOL compared with ERCD” (NIH, 2010, p 13). The NIH in a 1980 Consensus Conference found VBAC as a mechanism to safely reduce the cesarean rate. The conference, at that time was concerned with clinical issues surrounding the increasing rate of cesarean deliveries. Today, one out of every three births is a cesarean delivery (AHRQ, 2010). The authors of the guideline believe the guideline will benefit the patient, the community, health care delivery systems, and health and liability insurers. The guideline is specifically written for healthy women of reproductive age, with a singleton gestation, in the U.S. who had prior cesarean delivery. To be eligible for TOL the American College of Obstetrics and Gynecology (ACOG) states that the uterus must not have more than two low, transverse uterine scars, no other forms of uterine scar/s or anomalies, or previous ruptures. The health care team must be prepared to monitor labor, refer to cesarean, and have personnel available on weekends and evenings (International Cesarean Awareness Network, ICAN, 2006). In forty-three U.S. studies, 74% of those who attempted TOL delivered vaginally (AHRQ, 2010). Stakeholder Involvement GUIDELINE ASSESSMENT 6 The guideline development panel was established by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the Office of Medical Applications of Research (OMAR) of the NIH to do a thorough evaluation of relevant research to guide practice, education, and planning. The Agency of Health Research and Quality (AHRQ), a department of the NIH, has established Evidence-Based Practice Centers (EPC) geographically throughout the U.S. The AHRQ sponsors the development of evidence reports and technology to assist the private and public sectors in efforts to improve the quality of health care (NIH, 2010). The panel members consisted of MD’s, and advanced degree nurses working in educational institutions. The target users were clearly defined. The women who fall in the scope of this guideline, as well as their caregivers were meant to gain from the recommendations in the guideline. There was no apparent piloting of the guideline on its attended target. It was a reflection of the panel’s assessment of medical knowledge available at the time the statement was written. The Consensus Development panel addresses the limitations within the guideline for not piloting the recommendations. The panel cites ethical reasons and that further data analysis methods will need to be created to better inform outcomes (NIH, 2010). Once the guideline was drafted, it was sent to federal agencies, maternity and pediatric clinicians, advocacy groups, payers, policymakers, content experts, and researchers. These stakeholders cover a vast range of professional and public service realms. Rigor of Development An extensive literature search was done in collection of data to be used for the guideline. The databases used were MEDLINE, DARE, and Cochrane. The search terms were not given, however studies chosen addressed the questions given in the introduction, which addressed the GUIDELINE ASSESSMENT 7 benefits and harms of the clinical intervention (Oregon Health & Science University EPC, 2007). Data was also obtained from systematic reviews, hand searches, web sites, and expert consultation. Dates included in the search were 1996 through September 2009. Of the 3,134 citations retrieved in the literature search, two hundred and three were selected for review and synthesis after applying the inclusion and exclusion criteria. Inclusion and exclusion criteria were described as well as the rationale. For example: Studies done in the United States or developed countries were included, and studies from developing countries were excluded in order to ascertain that “maternal and infant outcomes were applicable” (NIH, 2010, p 2). The target population was “women with previous cesarean delivery who are eligible for a trial of labor (TOL) or elective repeat cesarean delivery” (NIH, 2010, p 2). Once the scope of the guideline was written, a search guided by the identified clinical questions was accomplished by two investigators who reviewed a random set of titles and abstracts for full text review until an appropriate level of reliability was reached (NIH, 2010). The data used was retrieved from meta-analysis, review of published meta-analysis, and systematic review with evidence tables. Website searches of specialty organizations such as ACOG and AWHONN resulted in similar recommendations for practice when planning mode of delivery. The EPC further divided the studies depending on the type and level of evidence obtained. They were primarily concerned with TOL that resulted in VBAC, induction of labor (IOL), finding predictors of VBAC success, what models are being used to predict VBAC, maternal outcomes, neonatal outcomes, uterine rupture, abnormal placentation, obesity, multiple cesarean sections, and direction of uterine scar (NIH, 2010). Only high and moderate strength of evidence was used and rating of the studies was individualized based upon the type of study GUIDELINE ASSESSMENT 8 design. The criteria to rate study designs was developed by the U.S. Preventative Services Task Force (USPSTF). Rating methods from the National Health Service Center for Reviews and Dissemination, based at the University of York in England was also used to rate the studies (NIH, 2010). Disagreements about quality of research were solved through consensus based upon the ratings that the reviewers assigned to the studies. Measures to reduce bias were explained in the guideline under the heading: Strength of available evidence (NIH, 2010). Before publication of the guideline, a review of the Oregon Health & Science EPC’s findings was done by the NIH and the AHRQ. To address all stakeholders, the guideline was introduced for review by the public prior to publication. This was accomplished via a question and answer session at the NIH Consensus Development Conference in June of 2010. The guideline was formed using current evidence. It clearly recognizes the need for continued research and revision as gaps in the literature are being identified and strategies to address the gaps are being developed. Health benefits for the mother who achieve VBAC include shorter hospitalization, less incidence of deep vein thrombosis, and a decreased risk for maternal mortality. Mortality for the mother increases when subjected to ERCD due to RCD’s association with abnormal placentation. Health benefits for the infant who is born vaginally include less respiratory distress, earlier contact with mother and earlier opportunities for feeding/breastfeeding (NIH, 2010). Uterine rupture is identified as the primary risk associated with TOL. The guideline acknowledges limitations that include the absence of the ability to predict uterine rupture. Studies of moderate quality were available on the incidence of uterine rupture. The occurrence of uterine rupture is increased with TOL and IOL versus spontaneous labor, but many other factors GUIDELINE ASSESSMENT 9 such as direction of uterine scar, gestational age, demographics, current and past obstetrical history, and hospital type can influence the risk (NIH, 2010). The panel provides strategies for how to address gaps in the literature, and possibly improve mode of delivery decision making. The strategies include initiation of a National Childbirth Study in which participants are recruited into the study early in their pregnancies, the development of prediction tools, improve consistency of identifying concepts and variables that are to be studied and translate these concepts into operational definitions, (LoBiondo-Wood & Haber, 2010), and creating a model reimbursement scheme to enhance financial incentives for institutions to provide VBAC (Oregon Health & Science University EPC, 2007). Clarity and Presentation The Consensus Development Conference addressed emerging issues in the literature regarding VBAC, and provided recommendations with level of evidence. The evidence summarized contains data with high-moderate grade and also low-absent data. “We intentionally identify outcomes without supporting data to stimulate further research and highlight the variety of important issues that may not be well studied” (NIH, 2010, p 7). Specific recommendations for practice concerning this guideline are based on best available evidence and will always be based upon consultation with the physician in regard to current pregnancy factors, previous births (vaginal or C-section), medical history (obesity), hospital capability, and physician preference. “Liability risks associated with maternal and perinatal mortality and morbidity have a major impact on the willingness of physicians and healthcare institutions to offer trial of labor” (NIH, 2010, p 27). A significant contribution realized by this guideline is the identification of predictors of who will be likely to successfully VBAC, and the development of prediction tools. The evidence GUIDELINE ASSESSMENT 10 finds that African and Hispanic women achieve VBAC less than Caucasian women, although African and Hispanic women attempt TOL at greater rates than Caucasian women. In addition, women whose infants are greater than 4Kg, and women who give birth in rural or private hospitals also VBAC less. Conversely, predictors indicate that women who had previously delivered vaginally and/or who began TOL with a higher Bishop score had increased success with VBAC (Oregon Health & Science University EPC, 2007). Screening tools for predicting VBAC have been developed by three scientists. They are the scored model by Flamm, the scored model by Grobman, and the Troyer model. A decision analysis of any scored model would need to achieve a sensitivity and specificity of 85%, which none of these tools achieved. The details of the models can be located in the evidence report Appendix N of the Oregon Health & Science University EPC meta-analysis on VBAC: New insights, 2007. Overall, scoring models provide reasonable ability to identify women who are good candidates for VBAC, but none have discriminating ability to consistently identify women who are at risk for RCD (Oregon Health & Science University EPC, 2007). Due to lack of high level evidence and physician/ hospital liability threats, this topic continues to need large amounts of research. Application The NIH and guideline development panel recognizes that in order to implement the VBAC trials, they will have to take into consideration each hospital’s policies, level of care they are able to provide, and ensure that patient safety is priority, “the American College of Obstetricians and Gynecologists recommends that TOL only be performed in institutions equipped to respond to obstetric emergencies” (NIH, 2010, p 26). GUIDELINE ASSESSMENT 11 Several screening tools and decision aids have been proposed to help women understand the risks, benefits, and implications of TOL compared with ERCD. A list of implementation strategies was collected to assist in implementation of the guideline. “Screening questions; such as maternal age, body mass index, prior cesarean indication, cervical dilation and effacement at admission, have the ability to predict the likelihood of successful TOL” (NIH, 2010, p 12) is an example. These screening tools will aid the woman and her physician in the shared decision making process throughout her pregnancy to make the final decisions related to birthing methods. Key recommendations that ACOG and the American Society of Anesthesiologists should provide to all patients are information about the risks and benefits of VBAC, possible emergency situations, and to make public their TOL policies. The panel is concerned that medical-legal considerations add to and in many instances exacerbates barriers to TOL due to fear of a medical lawsuit. The panel recommends supporting the women and their informed decision about TOL and having the clinicians incorporate an evidence-based approach into the decision-making process. Organizational changes may be necessary to support implementation of the guideline and would include establishment of a steering committee within the organization, and the provision of training sessions (Titler & Adams, 2010). Cost containment along with consumer demand may drive these changes (Clark, 2000). Editorial Independence “The panel was made up of fifteen members representing the fields of obstetrics and gynecology, urogynecology, maternal and fetal medicine, pediatrics, midwifery, clinical pharmacology, medical ethics, internal medicine, family medicine, perinatal and reproductive psychiatry, anesthesiology, nursing, biostatistics, epidemiology, healthcare regulation, risk management, and a public representative” (NIH, 2010). The panelists who participated in this GUIDELINE ASSESSMENT 12 conference signed forms attesting that they had no financial or scientific conflict of interest (NIH, 2010). Twenty experts from pertinent fields were also present to provide data to the panel and conference audience (NIH, 2010). The NIH Consensus and State-of-the-Science Statements are prepared by independent panels of health professionals and public representatives on the basis of results of systematic literature, presentations by investigators working in relevant areas, questions and statements from conference attendees during open discussion periods, and closed deliberations by the panel (NIH, 2010). The panel did their best to assess the medical information available at the time and provide a statement of the knowledge to healthcare providers, patients, and the general public with a reasonable assessment of currently available data on VBAC. Level of Evidence The panel writing the guideline went to great lengths to ensure strength of evidence and bias reduction. Individual studies’ strength of evidence were graded by the USPSTF and National Health Service Center that included RCTs, cohort, case-control, and case series studies (NIH, 2010, p 4). Only studies of high and moderate strength were used except in cases where there was no other research available. Therefore, when analyzing the evidence, the panelists were able to determine in which categories higher levels of evidence is required. Data from the studies were entered into tables and summarized. “Benefits and adverse effects of mode of delivery were considered equally important and both types of outcomes were abstracted” (NIH, 2010, p 3). Meta-analyses were done to synthesize data and qualitative data is used when meta-analysis was not appropriate. Given the existing research in which evidence ranged from Level I to Level VII, the panelists assessed the overall strength of the evidence for each key question. The purpose to grade the body of evidence overall is to provide information beyond study design hierarchy and internal validity assessment. Parameters thought important to GUIDELINE ASSESSMENT 13 policymakers included quantity of evidence, assessment of risk of bias, precision, directness, and consistency (NIH, 2010). Conclusion The purpose of this guideline is to evaluate if women can safely undergo a VBAC. As noted on the AGREE Overall Guideline Assessment table on p. 23 of this paper, our group overall recommends this guideline with modifications. Areas that seemed adequately investigated were the scope and purpose, clarity of presentation, and editorial independence of this guideline. Areas that the group felt needed improvement or modifications were stakeholder involvement, rigor of development, and applicability. This guideline has a clearly stated purpose, and the panel proposing this guideline feels that using the specific questions listed will help patients and caregivers make informed decisions regarding the decision to have a VBAC delivery, or an ERCD. The clarity and presentation scores from the groups AGREE table were overall good, but it is also noted that this topic still needs research due to the lack of high level evidence which is most likely due to the physicians and hospitals risk of liability. Editorial independence was also clearly stated and the panelists signed forms attesting that they had no scientific or financial conflict of interest (NIH, 2010). Areas of this guideline the group felt needed improvement included stakeholder involvement, as there was no apparent piloting of this guideline to the target users. The guideline was drafted with panel members consisting of MD’s and advanced degree nurses that used their assessment of medical knowledge available at that time. Only high and moderate strength of evidence was used to develop this policy except when no other studies were available which speaks of the rigor of development, however, there was disagreement about the quality of research which was not explained in detail. The NIH and guideline panel recognizes limitations to the use of this guideline which refers to the applicability of using this guideline. The main GUIDELINE ASSESSMENT 14 limitation to a VBAC delivery that needs to be considered is the individual hospital’s policy and their ability to respond to an obstetric emergency (NIH, 2010, p. 26). As noted in the introduction to this paper, childbirth practices in the U.S. create a problem focused trigger as well as a knowledge focused trigger as defined by the Iowa Model of EBP to Promote Quality Care (Titler, et.al., 2001), and the knowledge focused trigger is a key element to the development of this guideline: The NIH recommends VBAC as safe for most women who meet specific criteria, and many hospitals have not acted in ways that follow this guideline (AHRQ, 2010). Even with a few drawbacks, this guideline has many good attributes that can help women take an active role in deciding how they want to delivery their babies and this group recommends utilizing this guideline—even with its limitations. GUIDELINE ASSESSMENT 15 References Clark, S. L., Scott, J. R., Porter, T. F., Schlappy, D. A., McClellan, V., & Burton, D.A. (2000). Is vaginal birth after cesarean less expensive than repeat cesarean delivery? American Journal of Obstetrics & Gynecology, 182, 599-602. Gibson, F. (2011). Traveling through time to normal birth. Issues in perinatal care, 38, pp. 266268. doi: 10.1111/j.1523-536X.2011.00493.x Guise, J.M., Eden, K., Emeis, C., Denman, M.A., Marshall, N., Fu, R., Janik, R., &et.al. (2007). Vaginal Birth after Cesarean: New Insights. Evidence Report/Technology Assessment No.191. Oregon Health & Science University Evidence-based Practice Center under Contract No. 290-2007-10057-I. AHRQ Publication No. 10-E003. Rockville, MD: Agency for Healthcare Research and Quality. International Cesarean Awareness Network, (2006) VBAC: Vaginal birth after cesarean. Retrieved from www.americanpregnancy.org/labornbirth/vbac.html on 12-4-2011. Jerome-D’Emilia, B. (2008). Public health and primary health care systems and health care transformation. In M. Stanhope & J. Lancaster (Eds.), Public health nursing: Populationcentered health care in the community, 7th ed. (pp. 46-66). St. Louis, MO: Mosby. National Institutes of Health. (2010). National Institutes of Health Conference statement: Vaginal birth after cesarean: New insights. Retrieved from www.guideline.gov/index.aspx on 11-202011. Scott, J. (2010). Solving the vaginal birth after cesarean dilemma. Obstetrics and Gynecology, 115(6), 1112-1113. doi: 10.1097/AOG.0b013e3181e0d1b6 Shorten A., Shorten, B., Keogh, J., West, S., & Morris, J. (2005). Making choices for childbirth: A randomized controlled trial of a decision-aid for informed birth after cesarean. Issues in Perinatal Care, 32, pp. 252-261. doi: 10.1111/j.0730-7659.2005.00383.x GUIDELINE ASSESSMENT 16 Sullivan-Bolyai, S., & Bova, C. (2010). Data-collection methods. In G. LoBiondo-Wood & J. Haber (Eds.), Nursing research: Methods and critical appraisal for evidence-based practice, 7th ed. (pp. 268-284). St. Louis, MO: Mosby. Taylor, J. (2011). Application of research and evidence-based guidelines. 96:143 Research for nursing practice. The University of Iowa. Iowa City, Iowa. Titler, M., & Adams, S. (2010). Developing an evidence-based practice. In G. LoBiondo-Wood, & J. Haber (Eds.). Nursing research: Methods and critical appraisal for evidence-based practice, 7th ed. (pp. 385-437). St. Louis, MO: Mosby. Titler, M., Kleiber, C., Steelman, V., Rakel, B., Budreau, G., Everett, L., Buckwaiter, K., & et.al. (2001). The Iowa model of evidence-based practice to promote quality care. Critical Care Clinics of North America, 13, 497-509. GUIDELINE ASSESSMENT 17 Appraisal Instrument Summary for Vaginal birth after cesarean: New insights (NIH, 2010). AGREE Table 1 DOMAIN 1SCOPE & PURPOSE Appraiser 1 Appraiser 2 Appraiser 3 Appraiser 4 Appraiser 5 Emily/Julie Jay/Mary G Jennifer/ Jody/Susan Joan/Mary H DeAnne TOTAL The overall objective is the guideline is specifically described 7/7 7/6 7/7 7/7 7/7 69 The clinical question covered by the guideline is specifically described 6/6 6/6 6/7 7/6 6/6 62 The population to whom the guideline is meant to apply is specifically described 7/7 7/7 7/7 7/7 7/7 70 TOTAL 40 39 41 41 40 201 GUIDELINE ASSESSMENT 18 AGREE Table 2 DOMAIN 2 STAKEHOLDER INVOLVEMENT Appraiser 1 Appraiser 2 Appraiser 3 Appraiser 4 Appraiser 5 Emily/Julie Jay/Mary G Jennifer/ Jody/Susan Joan/Mary H DeAnne TOTAL 4. Guideline development group involves individuals from all relevant professional groups 6/6 6/6 6/5 6/6 5/6 58 5. The views and preferences of the target population have been sought 2/1 4/1 1/1 1/1 2/1 15 6. The target users of the guideline are clearly defined 6/7 7/7 6/7 7/6 7/7 67 TOTAL 28 31 26 27 28 140 GUIDELINE ASSESSMENT 19 AGREE Table 3 DOMAIN 3 RIGOUR OF DEVELOPMENT Appraiser 1 Appraiser 2 Appraiser 3 Appraiser 4 Emily/Julie Jay/Mary G Jennifer/ Jody/Susan Joan/Mary H Appraiser5 TOTAL De Anne 7. Systematic methods were used to search for evidence 8. The criteria for selecting the evidence are clearly described 9. The strength and limitations of the body of evidence are clearly described 10. The methods for formulating the recommendations are clearly described 11. The health benefits, side effects, and risks have been considered in formulating the recommendations 12. There is an explicit link between the recommendations and the supporting evidence 13. The guideline has been externally reviewed by experts prior to 7/6 7/6 6/7 5/5 7/7 63 7/7 7/7 7/7 7/7 7/7 70 6/5 6/6 6/3 6/6 6/5 55 6/6 7/4 6/6 5/3 6/6 55 6/6 7/5 5/4 5/7 7/6 58 5/3 7/3 5/2 4/3 7/1 40 5/3 7/1 3/1 2/2 1/2 27 GUIDELINE ASSESSMENT its publication 14. A procedure for updating the guideline is provided TOTAL 20 3/1 3/1 1/6 1/1 2/1 20 82 84 75 69 78 388 AGREE Table 4 DOMAIN 4CLARITY OF PRESENTATION Appraiser 1 Appraiser 2 Appraiser 3 Appraiser 4 Emily/Julie Jay/Mary G Jennifer/ Jody/Susan TOTAL Joan/Mary H DeAnne 15. The recommendations are specific and unambiguous 16. The different options for management of the health issue are clearly defined 17. Key recommendations are easily identifiable TOTAL Appraiser 5 7/6 7/6 6/7 7/6 7/7 66 6/5 6/5 5/5 6/5 7/4 54 7/5 6/5 6/5 7/5 6/6 58 36 35 34 36 37 178 GUIDELINE ASSESSMENT 21 AGREE Table 5 DOMAIN 5APPLICABILITY Appraiser 1 Appraiser 2 Appraiser 3 Appraiser 4 Appraiser 5 Emily/Julie Jay/Mary G Jennifer/ Jody/Susan Joan/Mary H DeAnne 18. The guideline describes facilitators and barriers to its application 19. The guideline provides advice and/or tools on how the recommendations can be put into practice 20. The potential resource implications of applying the recommendations have been considered 21. The guideline presents monitoring and/or auditing criteria TOTAL TOTAL 6/5 6/5 5/3 6/6 6/5 53 4/3 2/3 2/3 4/3 1/4 29 4/4 3/4 4/5 4/4 1/6 39 2/4 2/5 2/7 2/2 1/4 31 32 30 31 31 28 152 GUIDELINE ASSESSMENT 22 AGREE Table 6 DOMAIN 6EDITORIAL INDEPENDENCE 22. The views of the funding body have not influenced the content of the guidelines 23. Competing interests of guideline development group members have been recorded and addressed TOTAL Appraiser 1 Appraiser 2 Appraiser 3 Appraiser 4 Appraiser 5 TOTAL Emily Jay Jennifer Jody Joan Julie Mary G. DeAnne Susan Mary H. 7/7 7/7 7/7 7/7 7/7 70 7/7 7/7 7/7 7/7 7/5 68 28 28 28 28 26 138 AGREE TOTAL SCORES DOMAIN Scope and Purpose Stakeholder Involvement Rigour of Development Clarity of Presentation Applicability Editorial Independence SCORE OBTAINED (TOTAL) 201 140 388 178 152 138 PERCENTAGE (TOTAL) 95% 61% 64% 82% 47% 98% GUIDELINE ASSESSMENT Overall guideline assessment 23 AGREE Overall Guideline Assessment Appraiser Appraiser Appraiser Appraiser 1 2 3 4 Jennifer/ Jody/Sue Emily/Julie Jay/Mary DeAnne G. 5/4 NA/5 5/5 5/4 Rate the overall quality of this guideline. I would recommend this guideline Julie/Emily for use. Yes X/X Yes, with modifications No Jay/Mary G. NA/X Jennifer/ DeAnne X/X Appraiser 5 Joan/Mary H. 6/4 TOTAL 43 Jody/Sue Joan/Mary H. XX X X GUIDELINE ASSESSMENT Individual Contributions to this Paper Joan Berkey Rigor of Development, Level of Evidence Emily Gast Clarity & Presentation Mary Groves AGREE Tables and calculations Mary Holstad AGREE Tables and calculations, Title page Jody Hosch Application Jay Jackson Scope & Purpose, Stakeholder Involvement Julie Johnson AGREE Tables and calculations Jennifer Lewis Editorial Independence Susan Rasmusson Conclusion DeAnne Savick Guideline topic paper, Introduction, Reference page 24