Minds Handbook for Clinical Practice Guideline Development 2014

Transcription

1 Minds Handbook for Clinical Practice Guideline Development 2014 Editorial Supervisors: Tsuguya Fukui, Naohito Yamaguchi Editors: Toshio Morizane, Masahiro Yoshida, Noriko Kojimahara VERSION 1.0 February 1, 2015 Minds Guideline Center Japan Council for Quality Health Care This document is translated from Minds 診療ガイドライン作成の手引 2014 (Japanese) issued by IGAKU-SHOIN Ltd. with permission.

2 Minds Handbook for Clinical Practice Guideline Development 2014 Editorial Supervisors: Tsuguya Fukui, Naohito Yamaguchi Editors: Toshio Morizane, Masahiro Yoshida, Noriko Kojimahara VERSION 1.0 February 1, 2015 Minds Guideline Center Japan Council for Quality Health Care This document is translated from Minds 2014 (Japanese) issued by IGAKU-SHOIN Ltd. with permission.

3 Minds Handbook for Clinical Practice Guideline Development 2014 Publication: February 1, Version 1.0 Editorial Supervisors: Tsuguya Fukui, Naohito Yamaguchi Editors: Publisher: Toshio Morizane, Masahiro Yoshida, Noriko Kojimahara Minds Guideline Center, Japan Council for Quality Health Care Reproduction of this work (copying, scanning, digitizing, etc.) without permission is prohibited with limited exceptions permitted under the Copyright Act, such as reproduction for private use. Recommended citation form Minds Guideline Center, Japan Council for Quality Health Care (2014). Minds Handbook for Clinical Practice Guideline Development 2014.

4 Editorial Supervisors Tsuguya Chairman, Guideline Evaluation and Approval Committee, Minds Guideline Center, Fukui Japan Council for Quality Health Care Chairman of the Board of Trustees, St. Luke s International University President, St. Luke s International Hospital Naohito Yamaguchi Director, Minds Guideline Center, Executive Board Member, Japan Council for Quality Health Care Professor, Department of Public Health, School of Medicine, Tokyo Women s Medical University Editors Toshio Morizane Masahiro Yoshida Noriko Kojimahara Chairman, EBM and Guideline Development Support Committee, Minds Guideline Center, Senior Visiting Researcher, Japan Council for Quality Health Care Part-time Lecturer, Department of Internal Medicine, School of Medicine, Keio University Visiting Professor, Faculty of Medicine, Toho University Part-time Physician, Center for Digestive and Liver Diseases, Ofuna Chuo Hospital General Manager, Department of EBM and Guidelines, Minds Guideline Center, Japan Council for Quality Health Care Professor, Clinical Research Centers for Medicine, International University of Health and Welfare Director, Department of Hemodialysis and Surgery, Chemotherapy Research Institute, KAKEN Hospital Member, EBM and Guideline Development Support Committee, Minds Guideline Center, Visiting Researcher, Japan Council for Quality Health Care Associate Professor, Department of Public Health, School of Medicine, Tokyo Women s Medical University Grateful acknowledgment is made to the individuals who contributed to the production of this handbook. iii

5 Authors (in the order of the Japanese hiragana) Akiko Leader, Department of EBM and Guidelines, Minds Guideline Center, Okumura Japan Council for Quality Health Care Fujimi Kawai Kosuke Kiyohara Noriko Kojimahara Yasuto Sato Yosuke Hatakeyama Toshio Morizane Naohito Yamaguchi Masahiro Yoshida Member, EBM and Guideline Development Support Committee, Minds Guideline Center, Japan Council for Quality Health Care Manager, St. Luke s International University Library Visiting Researcher, Japan Council for Quality Health Care Assistant Professor, Department of Public Health, School of Medicine, Tokyo Women s Medical University Member, EBM and Guideline Development Support Committee, Minds Guideline Center, Visiting Researcher, Japan Council for Quality Health Care Associate Professor, Department of Public Health, School of Medicine, Tokyo Women s Medical University Member, EBM and Guideline Development Support Committee, Minds Guideline Center, Visiting Researcher, Japan Council for Quality Health Care Lecturer, Department of Public Health, School of Medicine, Tokyo Women s Medical University Department of EBM and Guidelines, Minds Guideline Center, Japan Council for Quality Health Care Chairman, EBM and Guideline Development Support Committee, Minds Guideline Center, Senior Visiting Researcher, Japan Council for Quality Health Care Part-time Lecturer, Department of Internal Medicine, School of Medicine, Keio University Visiting Professor, Faculty of Medicine, Toho University Part-time Physician, Center for Digestive and Liver Diseases, Ofuna Chuo Hospital Director, Minds Guideline Center, Executive Board Member, Japan Council for Quality Health Care Professor, Department of Public Health, School of Medicine, Tokyo Women s Medical University General Manager, Department of EBM and Guidelines, Minds Guideline Center, Japan Council for Quality Health Care Professor, Clinical Research Centers for Medicine, International University of Health and Welfare Director, Department of Hemodialysis and Surgery, Chemotherapy Research Institute, KAKEN Hospital External Review Committee Members (in the order of the Japanese alphabet) Takahiro Professor, Department of Endocrine Surgery, Tokyo Women s Medical University Okamoto Hiromichi Kuwabara Kiichiro Tsutani Takeo Nakayama Toshio Fukuoka Director, Jinho Law Office Visiting Professor, Faculty of Medicine, Toho University Project Professor, Department of Drug Policy and Management, Graduate School of Pharmaceutical Sciences, University of Tokyo Professor, Department of Health Informatics, School of Public Health, Graduate School of Medicine, Kyoto University Chief Director, Department of General Medicine, Ohara Memorial Healthcare Foundation Kurashiki Central Hospital iv

6 Editorial Management Kyoko Tamura, Madoka Utagawa Minds Guideline Center, Japan Council for Quality Health Care For general comments or inquiries about the contents Minds Guideline Center, Japan Council for Quality Health Care Toyo Bldg Misaki-cho, Chiyoda-ku, Tokyo TEL: /FAX: v

7 vi

8 2014 Edition Preface Approximately seven years have passed since the publication of the Minds Handbook for Clinical Practice Guideline Development In the meantime, Japan followed the United States and several advanced nations in Europe and saw a large number of high-quality clinical practice guidelines (CPGs) founded on the principle of evidence-based medicine (EBM) developed by specialized medical societies and such. Many of these CPGs can be viewed on the Minds website and a growing number of them are becoming available in both Japanese and English. As one of the advocates who have long urged the development of evidence-based CPGs as the most effective method to disseminate EBM since the time when no such guidelines existed in Japan, I now reflect with amazement on how much progress has been made over these years. At the same time, I would like to pay my respects to many individuals who have dedicated their efforts to the development of CPGs. Structurally, there is a limit to how many CPGs Minds can publish in a certain period of time. Therefore, a process is required for selecting the ones to be published from the numerous CPGs that have been developed. For this purpose, the Guideline Evaluation and Approval Committee was established within Minds and I have been taking part in its bimonthly selection process with the secretariat staff and other committee members. In the selection process, we refer to the Appraisal of Guidelines for Research and Evaluation II (AGREE II), which is the 2009 revised edition of AGREE, a global evaluation instrument released in 2003, and place particular emphasis on the points relating to the stringency of the development process. Although there has been an increase in the number of evidence-based CPGs that are close to ideal, we have also been able to identify the areas for improvement shared by the majority of CPGs. For example, many of them fail to provide sufficient descriptions about intentions or views of the groups targeted by the CPGs (patients, the public, etc.), as well as about the criteria for monitoring or supervising the degree of conformity with the CPGs at clinical sites. Particularly with regard to the latter, such criteria can help promote the use of CPGs in clinical settings, and are essential in the measurement of Quality Indicators, which are becoming increasingly prevalent in Japan, and in the adoption of the Plan Do Check Act (PDCA) cycle. Since the time when evidence-based CPGs first became a topic of discussion in the medical community of our nation, one issue that had worried many was the legal aspect of CPGs. Analysis of the data on recent medical lawsuits revealed that CPGs may constitute at least a part of the medical standards but are not considered normative, as clinicians had originally feared. Nevertheless, if the treatment actually provided was found inconsistent with CPGs, the doctor might not be questioned for the violation of duty of care, but would still be held responsible for an infringement of the duty to explain. Therefore, it is necessary for doctors to stay abreast of the latest CPGs and be ready to provide adequate explanations for patients whenever needed. In addition, when providing treatment not in line with the recommendations in CPGs, it is strongly suggested that the doctor state the reason in the patient s medical record. This book (Handbook 2014) describes the procedure of developing CPGs in great detail and provides many templates that can be used in the process. Compared to the previous edition (Handbook 2007), the vii

9 contents are far more advanced, but there is no change to the basic concept of EBM. To improve the validity on both scientific and ethical grounds, the methods of developing evidence-based CPGs themselves are evolving worldwide. At the initiative of the editors, Dr. Toshio Morizane, Dr. Masahiro Yoshida, and Dr. Noriko Kojimahara, doctors who are well versed in the latest information on the methods of developing CPGs had made substantial changes to the previous edition within the range considered feasible in Japan. The book was then subjected to external reviews by experts in the field before being completed. We hope that this book will be widely used to further enhance the quality of evidence-based CPGs, which serve as an essential tool in improving the quality of the medical care of our nation. March 2014 On behalf of the editorial supervisors Tsuguya Fukui viii

10 Preface to the First Edition A broad range of medical knowledge and understanding of each patient s individuality play an essential role in treating diseases and resolving problems in medical care. However, with medical knowledge alone, there is a diverse range of fields to cover and scientific information and techniques in each field continue to expand and advance. It is virtually impossible for a single medical practitioner to adequately resolve all diseases and problems. By preparing guidelines that describe the clinical practice actually performed by the most skilled experts in each field, many other medical practitioners can refer to the guidelines in their practice, which should allow more patients to receive high-quality medical care equivalent to expert levels. Such ideas must have emerged when it first became the norm for medical care to be provided by specialists. In fact, since the time of Hippocrates in ancient Greece, a myriad of clinical practice guidelines have been created. These guidelines were conventionally developed at individual levels using various methods. However, around 1990, when efficacy, safety, and economic efficiency became important in medical care, attempts were initiated to develop clinical practice guidelines through reasonable (scientific) methods among Western nations, which were eventually developed into national projects to promote the dissemination of such guidelines, while objectively evaluating their clinical efficacy. The Institute of Medicine, a subsidiary organization of the U.S. National Academy of Sciences, defined clinical practice guidelines (CPGs) in its 1990 report as systematically developed statements to assist practitioners and patients make decisions about appropriate health care for specific clinical circumstances. 1) It said that the greatest characteristic of CPGs is that they are developed through a procedure founded on the principle of evidence-based medicine (EBM). In the United States, due to the widespread use of CPGs developed by an external Federal agency known as the Agency for Health Care Policy and Research (AHCPR), currently the Agency for Healthcare Research and Quality (AHRQ), as well as those developed through allocated research grants, it seems impossible to talk about the nation s medical care without referring to evidence-based CPGs. On the other hand, Japan s Ministry of Health, Labour and Welfare has also played a significant role in the dissemination of evidence-based CPGs in our nation. In the Study Group on Health Technology Assessment (HTA) for , the status of the overseas dissemination of the concept of EBM and EBM-based procedure was shared for the first time, and the subsequently established Study Group on the Promotion of HTA ( ) decided on implementing educational workshops and research promotion for CPG developers as measures to disseminate EBM in Japan. At the same time, the group collected expert opinions from the aspects of morbidity rates and individual/social burdens and set the priority order for diseases and conditions to develop CPGs for. After 1990, specialized medical societies and research groups approved for research grants were required to attend a briefing session on the EBM-based procedure before ix

11 developing CPGs. Finally, the 2001 Study Group on the Dissemination of Health Technology Information decided that completed CPGs were to be disseminated via the Internet and other media by the Japan Council for Quality Health Care. As of August 2007, a total of 38 CPGs are being published on the Minds website by the Medical Information Network Distribution Service within the Japan Council for Quality Health Care, which are accessible to not just doctors but the general public as well. As a member, I participate in all of the three study groups relating to EBM and CPGs mentioned above, and since 1999, have explained the concept of EBM and the procedure to develop CPGs to specialized medical societies and research groups in briefing sessions before they undertake CPG development. In November 2001, the Procedure to Develop Clinical Practice Guidelines, ver ) was published in print and on the Internet, which has served as a reference guide for the development of many CPGs. Now, we once again worked out the procedure to develop CPGs that is considered the most valid at this time based on our accumulated experience of developing CPGs and evaluating the quality of CPGs to select the ones to be published on the Minds website. It is our sincere hope that this handbook will be widely used for the development of CPGs of higher quality to help improve patient outcomes, which is its ultimate objective. August 2007 On behalf of the editors Tsuguya Fukui [Literature] 1) Field MJ, Lohr KN, (eds.). Clinical Practice Guidelines: Directions for a new program. Washington, DC, National Academy Press, ) Fukui T, Tango T. Shinryo Gaidorain no Sakusei no Tejun (The Procedure to Develop Clinical Practice Guidelines) ver. 4.3, 7 Nov x

12 Introduction The Japan Council for Quality Health Care launched the Medical Information Network Distribution Service (Minds) in 2002 under the Project for EBM Guideline Promotion. Clinical practice guidelines (CPGs), which were selected as highly credible from the viewpoint of development method, are shared online on the Minds website ( Furthermore, Minds assigns the highest priority to proposing the method of developing CPGs based on the principle of EBM to relevant medical societies and research groups the primary developers of CPGs and providing support for their guideline development. In 2007, Minds published the Minds Handbook for Clinical Practice Guideline Development 2007 (Handbook 2007) to propose the procedure to develop CPGs that was considered appropriate at that time. Now, as seven years have passed, the method has evolved substantially across the world, and newly improved methods are being established. Accordingly, Minds decided to compile a revised edition of the Handbook 2007 and publish the Minds Handbook for Clinical Practice Guideline Development 2014 (Handbook 2014) to introduce the newly established methods. The Handbook 2014 covers much of the same contents as the Handbook 2007, but provides better descriptions of certain contents that were not sufficiently described in the Handbook The Handbook 2014 emphasizes the importance of the idea of body of evidence. To develop a CPG, the established method called systematic review should be adopted, in which the evidence is searched for systematically in published research articles or other sources and is evaluated and integrated as the body of evidence. The Handbook 2014 also emphasizes the importance of the idea of balance between benefit and harm. When a CPG proposes a recommendation of an intervention method that can be considered the most appropriate among alternative intervention options in certain clinical circumstances of diagnosis, treatment, prevention, or nursing care, the harm of interventions should be given as high an emphasis as the benefit in comparing alternative intervention methods. Potential users of this handbook are all of those involved in the development of CPGs; those such as directors of medical societies or research groups who make decisions about which guidelines should be developed; those who determine the scope of a CPG and formulate the recommendations of CPGs; and those who conduct the systematic reviews of evidence. This handbook proceeds in the same order as the process of CPG development, and therefore, the entire picture of the development process can be grasped by reading from beginning to end. We also ensured that the contents can easily be understood without having special knowledge about medicine, epidemiology, or biology. The evidence on which a CPG is based is universal, but a CPG itself can vary from country to country, because different countries adopt different healthcare policies and systems. Thus, we take account of circumstances specific to Japan, when we propose our method. We explored the CPG development method that is considered appropriate for our healthcare system, while studying various CPG development methods developed overseas. To develop this handbook, a series of finalization process was adopted: the authors first drafted the preliminary version; the preliminary version was reviewed and modified by a series of editorial xi

13 meetings; and then the final version was edited by reflecting comments in external evaluations by external panel members and public comments. Finally, I would like to comment on how the method we propose here should be situated among different methods proposed elsewhere; our method is one of various methods recognized as appropriate worldwide and it is not our intention to insist that our method should be adopted for all CPGs in Japan. We hope that this handbook can help further improve the quality of CPGs, and thereby can contribute to improving the quality of healthcare in Japan. March 2014 Naohito Yamaguchi Director, Minds Guideline Center, Executive Board Member, Japan Council for Quality Health Care xii

14 Contents 2014 Edition Preface... vii Preface to the First Edition... ix Introduction... xi Chapter 1 Overview About This Handbook... 2 About the Method Proposed in This Handbook... 2 About Clinical Practice Guidelines... 3 The overall picture of the CPG development process... 3 Chapter 2 Preparation Procedures for Developing Clinical Practice Guidelines and Schedule... 8 Determination of Development Body of Clinical Practice Guidelines... 8 Establishment of Task Forces to Develop Clinical Practice Guidelines... 9 Funds to Develop Clinical Practice Guidelines Conflict of Interest (COI) Participation of Patients and Citizens in Developing Clinical Practice Guidelines Chapter 3 Scope What is Scope? Structure of Scope Process of Scope Development Formulation of Clinical Question Specification of Systematic Review Procedures from Formulating Recommendations to Finalization and Publication of the CPG.. 25 Chapter 4 Systematic Review Overview of Systematic Review Identifying the Evidence Evaluation of the Body of Evidence Integration of the Body of Evidence Determination of the Strength of Evidence of the Body of Evidence Preparation of Systematic Review Report xiii

15 Chapter 5 Recommendations Outline of the Recommendation Development Process Method for Unbiased Determination A Draft of Recommendation and the Strength of Recommendation Consensus Methods Comment Writing Summary for the Public Chapter 6 Finalization Additional Documents to Be Created for Finalization Drafting Clinical Practice Guidelines External Review AGREE II (The Appraisal of Guidelines for Research & Evaluation II) Publication Chapter 7 Dissemination, Implementation, and Assessment of Clinical Practice Guidelines Outline Organizational issues after publication Implementation Effectiveness assessment Revision A collection of templates Literature References INDEX xiv

16 Chapter 1 Overview About this handbook... 2 About the method proposed in this handbook... 2 About clinical practice guidelines... 3 The overall picture of the CPG development process... 3

17 Chapter 1 Overview 1 About this handbook Seven years have passed since the publication of the Minds Handbook for Clinical Practice Guideline Development Meanwhile, the method of developing clinical practice guidelines (CPGs) made substantial progress on a global scale. Accordingly, we decided to create the Minds Manual for Clinical Practice Guideline Development (Manual). The Manual is available on the Minds website, but for the convenience of users, we decided to publish the summarized version of the Manual as a book titled the Minds Handbook for Clinical Practice Guideline Development 2014 (Handbook 2014). Those who wish to know the details of CPG development method should refer to the Manual, because some explanations were omitted due to space limitations. The Handbook 2014 focuses on the method of conducting de novo systematic reviews for evaluation of the body of evidence; the methods of applying existing systematic review articles and adaptation of existing CPGs are beyond the scope of this handbook. The Handbook 2014 also focuses on the formulation of recommendations regarding treatment interventions; formulation of recommendations on other interventions such as diagnosis will be covered by the Manual. The method of incorporating health economics analysis into CPG development will also be covered by the Manual in the future. This handbook provides step-by-step explanations according to the process of developing CPGs we propose, and a series of templates are provided so that, by filling relevant information and documents into the templates, the draft of CPG can easily be compiled. The Handbook 2014 follows the steps of CPG development so that it can guide the members of the guideline development group. This handbook is also hopefully useful for CPG users to understand the key points of using CPGs. 2 About the method proposed in this handbook The CPG development method we propose in this handbook was adopted as an appropriate one for CPG development in Japan, after an extensive review of existing methods proposed by world recognized organizations, such as the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group, the Cochrane Collaboration, the Agency for Healthcare Research and Quality (AHRQ), and the Oxford EBM Centre. Those who wish to use any of the original methods proposed by these organizations should refer to their original literature. (See the bibliography at the end of the book [p.107].) The method we propose in this handbook is not the only one of choice. The method can be modified in accordance with the actual situation that the guideline development group faces. 2

18 3 About clinical practice guidelines In this handbook, a CPG is defined as follows: Minds Definition of Clinical Practice Guidelines A clinical practice guideline is a document that presents appropriate recommendations to assist patients and practitioners in making decisions regarding clinical practice of high importance, based on the body of evidence evaluated and integrated by systematic reviews and the balance between benefits and harms. Chapter 1 Overview 4 The overall picture of the CPG development process As proposed in the Minds Handbook for Clinical Practice Guideline Development 2007 (Handbook 2007), a CPG is developed according to the principle of evidence-based medicine (EBM), which is considered a global standard. The Handbook 2014 proposes a process involving three separate task forces to ensure unbiased development procedures, and emphasizes the importance of evaluating the body of evidence that takes into consideration the balance between benefits and harms. 1) The structure of the three task forces The Guideline Executive Committee is assumed to make decisions on what CPGs should be developed, to arrange budgetary issues, and to organize the Guideline Development Group. The Guideline Executive Committee is often organized in the governing board of medical society or research group or as a standing committee within the governing board. The Guideline Development Group confirms the scope by deciding on topics and clinical questions (CQ *1 ) to be covered in the CPG. The Systematic Review Team (SR Team) conducts systematic reviews for CQs defined by the Guideline Development Group according to the method described in the scope. The Guideline Development Group formulates recommendations, based on the systematic review report compiled by the SR Team, and finalizes the CPG. Members of the Guideline Executive Committee, the Guideline Development Group, and the SR Team may undertake more than one task or may discuss with other groups, but, as a general rule, these three groups function independently to ensure transparency *1: Other than the term clinical questions, expressions such as health questions, healthcare questions, or review questions are used. 3

19 Chapter 1 Overview throughout the development process. The completed CPG is approved by the Guideline Executive Committee, before being published. While the Guideline Executive Committee is the group representing the primary development body, such as a medical society, the Guideline Development Group should be made up of not just members of the medical society but also of individuals representing patients, citizens, and other stakeholders with various backgrounds, and thus is assumed to have different constituents from the Guideline Executive Committee. Since the SR Team is required to have expertise to conduct systematic reviews, it is likely to be a separate task force. Guideline Executive Committee Guideline Development Group Systematic Review Team (SR Team) Clarification of the development purpose and determination of the framework Understanding of the current situation of the theme targeted by the scope <Scope> Defining CQs based on key clinical issues Identifying the evidence Evaluation/integration of evidence Formulation of recommendations <SR report> Revision Development of a draft of the CPG Dissemination/ Implementation/Assessment External evaluation Publication Finalization of the CPG Fig. 1-1 Process of Developing CPGs by the Three Task Forces 2) Unbiasedness of Development Process In the process of CPG development, developers are frequently required to make important decisions, in situations, for example, when evaluating the body of evidence, and when formulating recommendations. Those involved in the development process take every precaution not to let prejudice cloud their judgment, but there is a limit to how careful one can be and it is not easy to avoid making a biased judgment. Therefore, 4

20 it is necessary to adopt a framework to avoid biases in judgment throughout the development process. One factor that can cause biased decisions is a conflict of interest (COI). In addition to such problems as shareholdings of companies related to drugs or medical equipment mentioned in the CPG, or monetary contributions from these companies, research grants can also lead to financial COI. One may have more positive opinions about treatment methods that he/she specializes in, and if recommendations by the CPG can affect one s professional position, it is possible for the person to make a biased judgment due to academic COI. Besides personal COI, it is also necessary to consider organizational COI, which affects the organizations involved in CPG development, as a whole. A biased judgment can occur at an unconscious level and there is a limit to one s desire to remain unbiased. One effective measure against academic COI is to include those with various intellectual interests as members of the Guideline Development Group, thus making it possible to balance intellectual interests through discussion among such members. As a measure against financial COI, rules should be set in advance to restrict the appointment of concerned individuals to the Guideline Development Group, or restrict participation in certain decision-making processes. Furthermore, in all phases of the development process, grounds or reasons for judgments and decisions are required to be disclosed in writing. Chapter 1 Overview 3) Evaluation of body of evidence All selected research reports with the same study design are evaluated for each outcome of CQ, and the set of summaries of evidence arranged by outcome and study design is called the body of evidence. Clinical studies, even when they are conducted on the same theme, do not necessarily produce the same results, due to differences in the study design, study population, intervention method, method of measuring patient outcomes, or statistical uncertainty. A systematic review, consisting of searching relevant clinical studies and evaluating and integrating the identified findings into the body of evidence, is considered to be the best method to avoid biases. 4) Balance between benefits and harms Patient outcomes resulting from interventions include not only expected effects (benefits) but also adverse events (harms) as well. All critical and important patient outcomes of benefits and harms should be listed when formulating a CQ; the body of evidence should be evaluated by systematic review of all listed critical and important outcomes; and thus the balance of benefits and harms should be taken into account in formulating recommendations for the CQ. In addition to harmful outcomes, increased expenses and physical or psychological burdens should also be considered as a disadvantage for patients. 5

21

22 Chapter 2 Preparation Procedures for Developing Clinical Practice Guidelines and Schedule... 8 Determination of Development Body of Clinical Practice Guidelines... 8 Establishment of Task Forces to Develop Clinical Practice Guidelines... 9 Funds to Develop Clinical Practice Guidelines Conflict of Interest (COI) Participation of Patients and Citizens in Developing Clinical Practice Guidelines... 12

23 Chapter 2 Preparation 1 Procedures for Developing Clinical Practice Guidelines and Schedule A clinical practice guideline (CPG) shall be developed in accordance with the following procedures. It is necessary to make definite plans in consideration of the time needed to develop the CPG as a whole, and the time and money needed for each procedure. (1) Clarification of development objectives (2) Determination of development body (3) Establishment of secretariat and task forces (4) Scope development (5) Systematic review (6) Formulation of recommendations (7) Development of CPG draft (8) External review and invitation of public comments (9) Publication (10) Dissemination/Implementation/Assessment (11) Revision [Template ID: 2-1 Procedures and Schedule for Guideline Development O *1 ] 2 Determination of Development Body of Clinical Practice Guideline The development body is the organization, such as a medical society or research group, responsible for CPG development. The development body may consist of a single medical society or research group, or may consist of multiple related medical societies or research groups to jointly take the responsibility to develop a CPG from the preparatory stage, depending on selected themes and topics. For example, with various views of experts from societies of internists and surgeons, societies of physicians and dentists, societies of physicians and nurses, and so forth, it will be possible to develop less biased CPGs through the entire CPG development process. [Template ID: 2-2 Preparation for CPG Development_(1)G *2 ] *1: Templates shall be given the following symbols at the end of their names in response to relevant documents. G: Clinical Practice Guideline, O: For operation *2: Numbers shown in parentheses, such as (1) and (2), indicate the fields in Template

24 3 Establishment of Task Forces to Develop Clinical Practice Guidelines One of the most important points in developing CPGs is to establish task forces with unbiased member structure. In particular, representatives of task forces, including the chairperson of the Guideline Executive Committee, should be carefully selected in consideration of financial and academic conflict of interests (COI). [For further information, see Chapter 2 5 Conflict of Interest (COI), p. 11]. 1) Guideline Executive Committee The Guideline Executive Committee established under the development body is the committee responsible for making decisions on which health topic is covered by the CPG, budgets for CPG development, and appointing members of other task forces. In the case of a single medical society or research group, its board meeting or standing committee often takes a role as the Guideline Executive Committee. In cases where multiple medical societies and research groups work together to develop CPGs, a council -like organization may be the Guideline Executive Committee consisting of persons representing societies and research groups. As for roles of the Guideline Executive Committee, see Fig. 1-1 (p. 4). [Template ID: 2-2 Preparation for CPG Development_(2)G] Chapter 2 Preparation 2) Secretariat of Guideline Development The Secretariat should be established to manage the progress of CPG development, communications between members of the Guideline Development Group, adjustment of schedule for development meetings, reservation of conference room, clerical work such as literature collection, management of funds, and so forth. [Template ID: 2-2 Preparation for CPG Development_(3)G] 3) Guideline Development Group The Guideline Development Group is responsible for establishing the scope, which is a written planning document for CPG development, determining clinical questions (CQs), formulating recommendations in response to systematic review reports, and developing a draft CPG (Fig. 1-1). The Guideline Executive Committee appoints the members of the Guideline Development Group. The Guideline Development Group will consist of approximately a dozen members, depending on the characteristics of the health topic and the type of the CPG. It should include experts from various fields related to contents of the CPG. It is desirable that the members include experts who are selected from medical societies related to the topics covered by the CPG, in a balanced manner, with careful consideration of interests. The members should also include diverse members in consideration of sex and economic and academic interests: practitioners, such as primary care physicians, nurses, and pharmacists, experts specialized in CPG development (experts on medical literature search, such as librarians, epidemiologists, and statisticians), healthcare economists, lawyers, patients, the public, and policymakers. Also, it is necessary to consider COI to be mentioned in Chapter 2 5. [Template ID: 2-2 Preparation for CPG Development_(4)G] 9

25 Chapter 2 Preparation 4) Systematic Review Team (SR Team) The Systematic Review Team (SR Team) is a group responsible for conducting systematic reviews, and the Team should be independent from the Guideline Development Group and members should be appointed by the Guideline Executive Committee. It is desirable that the SR Team members have training and experience in conducting systematic reviews. For each CQ, the SR Team should judge the possibility of adopting existing systematic review articles or of adapting the systematic reviews in overseas CPGs, and should conduct a de novo systematic review if no existing systematic review is found. In Japan, healthcare practitioners, such as physicians, often perform systematic reviews, but it is desirable that experts on medical literature search, such as librarians, epidemiologists, and statisticians, who are familiar with systematic review methodology, are invited to the Team in order to gain the technical support necessary for systematic review. Also, it is necessary to consider COI to be mentioned in Chapter 2 5. [Template ID: 2-2 Preparation for CPG Development_(5)G] 5) External Review Committee The External Review Committee evaluates the draft CPG from a neutral standpoint, and it advises on the improvement of a CPG draft. The members of the External Review Committee are appointed by the Guideline Executive Committee. It is necessary to consider COI to be mentioned in Chapter 2 5. It is necessary to consider the method of receiving review results from disease specialists and primary care physicians of multiple interested medical societies, other healthcare practitioners, epidemiologists, economists, legal experts, patients, and the public. It might be necessary, depending on the topics, to broadly seek public comments by disclosing the CPG draft on websites of medical societies for a certain period. [Template ID: 2-2 Preparation for CPG Development_(6)G] 4 Funds to Develop Clinical Practice Guidelines The Guideline Executive Committee estimates the budget necessary for CPG development, and records the source of funds. Major costs necessary for CPG development include cost of transportation fares, cost of conference venues, cost of literature search and collection, and cost of publishing. Not only public funds and company funds but also funds from medical societies should be recorded. [Template ID: 2-3 Funds for Guideline Development O] 10

26 5 Conflict of Interest (COI) 1) COI in Development of Clinical Practice Guidelines It is essential to manage and disclose in advance the COI of all candidates potentially engaged in CPG development in order to ensure rigor and transparency in the process of CPG development. COI is classified broadly into academic COI and financial COI: Academic COI is related to intellectual interests, such as specialties and personal preferences, and professional interests, such as promotion and career formation, whereas Financial COI is related to economic relations with specific companies or groups and acquisition of research funds (Table 2-1). In addition to personal COI, organizational COI, both academic and economic, may influence the CPG development. Organizational COI is related to organizations, such as the medical society to which members of the Guideline Development Group belong. Especially pertaining to academic COI, specialties of members of Guideline Development Group may influence important processes of CPG development, such as CQ selection and formulation of recommendations. Chapter 2 Preparation Table 2-1 Types of COI Personal COI Organizational COI Academic COI Specialties and preferences Promotion Career formation Specialties promoted by scientific/medical societies and research groups Academic advancement of scientific/medical societies and research groups Competition with other interested organizations Financial COI Provision of economic benefits from specific companies/organizations to the member or his/her family Benefits from acquisition of research fund Provision of equipment, human resources, and research environment Academic support from specific companies/organizations to scientific /medical societies and research groups Economic advancement of scientific/medical societies and research groups 2) Management of and Response to COI Personal COI Judgment about the appropriateness of participation in task forces Prior to establishing task forces mentioned in Chapter 2 3, financial COI should be self-reported by candidates to the Guideline Executive Committee, and the Committee shall discuss the appropriateness of participation in task forces. Candidates receiving funds from companies or organizations related to the content of CPG might have limited roles in CPG development. It is necessary to give careful consideration especially to the 11

27 Chapter 2 Preparation Chairpersons of the Guideline Executive Committee and the Guideline Development Group. The executive board of medical societies or research groups should select an appropriate person after fully discussing whether he/she would be subject to suspicion from outside. Concerning the management of academic COI, it is necessary to ensure that the Guideline Development Group is not biased toward specific specialties. (Chapter 2 3) Guideline Development Group, p. 9.). [Template ID: 2-4 COI Report (1) Declaration Form of Financial COI O] Management of COI in the process of CPG development All members should be requested to self-report to the Chairperson of the Guideline Development Group if any change occurs in financial COI in the process of CPG development. Management of financial COI in the process of CPG development should be decided through discussion in the Guideline Development Group. Specifically, restriction of participation, such as (1) withdrawal from the Guideline Development Group or SR Team, and (2) restriction of voting right for each specific role, can be considered. Organizational COI Funds to develop CPGs are especially important in organizational COI. The Guideline Executive Committee should fully discuss whether donations from specific organizations might influence the CPG development. As a response to academic organizational COI, it is very important that medical societies and research groups that may be involved in the content of CPGs widely and jointly participate in the CPG development [Chapter 2 3 1)]. Management and Disclosure of Information Concerning COI Measures taken for management of COI should be described in CPGs. However, since individually collected COI declarations may contain confidential personal information, the Guideline Executive Committee should strictly manage them, and store them for a certain period until the time of next revision. [Template ID: 2-5 COI Report (2) Summary of Financial COI Declaration and Response Policy O] 3 6 Participation of Patients and Citizens in Developing Clinical Practice Guidelines A CPG is intended to support decision making by patients and practitioners in clinical practice, and it is extremely important to reflect values of patients and citizens in CPG development. If CPGs are developed only by healthcare practitioners, the values, preferences, and needs of the target population may be overlooked or misunderstood even if careful consideration is apparently given. It is essential to have patients and citizens participate in the CPG development in order to evaluate appropriately the patient outcomes, based on the actual situation of the target population. 12

28 The ways to have patients and citizens participate in CPG development include making decisions on topics through discussion with target population in the early stage of scope development, having patient representatives participate as members of the Guideline Development Group in formulating recommendations, and receiving feedback from the target population about the CPG draft prior to publication. The opinions of the target population on the value and preferences can be obtained by literature review, interview survey, or questionnaire survey. Chapter 2 Preparation 13

29 Chapter 2 Preparation 2-1 Procedures and Schedule for Guideline Development O: Entry Method Time Schedule Clarification of development objectives Determination of development body Establishment of Secretariat and task forces Enter date of target completion of each process and review as needed. Scope development Systematic review Date: Formulation of recommendations Date: Development of draft CPG Date: External Review and collection of public comments To seek public comments broadly, disclose draft clinical practice guidelines and seek opinions. Publication Date: Dissemination, implementation, and assessment Date: Revision Date: 14

30 2-2 Preparation for CPG Development G: Entry Guide (1) Development Body (2) Guideline Executive Committee Organization for Developing Clinical Practice Guidelines (CPG) Principal medical society /research group Collaborative medical society /research group Collaborative medical society /research group Collaborative medical society /research group Chairperson (indicate by Name Affiliated organization/specialty Affiliated medical society Role in CPG development Place a check mark on chairperson. A CPG is often developed by collaboration of two or more medical societies or research groups related to the theme and topic. Clearly enter the specialized field. Enter the role and responsibility in CPG development. Chapter 2 Preparation (3) Secretariat Representative (indicate by Name Affiliated organization/specialty Affiliated medical society Role in CPG development Chairperson (indicate by Name Affiliated organization/specialty Affiliated medical society Role in CPG development (4) Guideline Development Group Name Affiliated organization/specialty Affiliated scientific/medical society (5) Systematic Review Team Name Affiliated organization/specialty Affiliated scientific/medical society (6) External Review Committee 15

31 Chapter 2 Preparation 2-3 Funds for Guideline Development O: Entry Guide Cost items Budget Funder Remarks List the cost items necessary for CPG development, and enter the budget and funders for each cost item. 16

32 2-4 COI Report (1) - Declaration Form of Financial COI O: Entry Guide Clinical Practice Guideline Name Affiliation I hereby declare the economic relationship with the companies, organizations, or parties during the period between (date: / / ) and (date: / / ) to the above clinical practice guidelines as follows. Related items Declaration criteria* For the first declaration, enter data of the latest 3 years. Presence of COI Declarer/family Period Name of the company, organization, or party Remarks Chapter 2 Preparation Board member, Consultant Stocks More than million-yen /year More than million-yen /year Present/ Absent Present/ Absent Declarer/family Declarer/family If there is any COI, enter the timing when the relationship started. Patent royalty More than million-yen /year Present/ Absent Declarer/family Lecture fee Manuscript fee More than million-yen /year More than million-yen /year Present/ Absent Present/ Absent Declarer/family Describe who is actually related, the declarer himself or his family member. Criteria are usually set as to who should be included in family members, such as within Declarer/family the second degree of relationship. Research fee (contract or joint research fee) Scholarship (incentive) donation More than million-yen /year More than million-yen /year Present/ Absent Present/ Absent The said person Declarer Specify the declaration criteria for each related item, such as more than million yen annually. Endowed chair More than million-yen /year Present/ Absent Declarer Others ( ) More than million-yen /year Present/ Absent Declarer/family Date of declaration : Signature : If the sign is an autograph, stamp can be omitted. This form is compiled according to The Guideline for Management of Conflict of Interest in Medical Research (February 2011) issued by the Conflict of Interest Committee, Section of Clinical Medicine, the Japanese Association of Medical Sciences. *) Declaration criteria shall be determined by the Guideline Executive Committee. 17

33 Chapter 2 Preparation 2-5 COI Report (2) - Summary of Financial COI Declaration and Response Policy O: Entry Guide COI report Summary of financial COI declaration Policy for response to the above It is acceptable to disclose several COIs related to the subject topics at a time. Disclosure standards shall be specified, but how to disclose shall be decided by organizations developing the guidelines. 18

34 Chapter 3 Scope What is Scope? Structure of Scope Process of Scope Development Formulation of Clinical Question Specification of Systematic Review Procedures from Formulating Recommendations to Finalization and Publication of the CPG... 25

35 Chapter 3 Scope 1 What is Scope? The scope is defined as a document to be prepared at the beginning of CPG development, to clarify the basic characteristics of the health topic and contents to be covered in the CPG, and to specify the methods of systematic review, formulation of recommendations, finalization, and publishing of the CPG. Thus, the scope can be considered as a planning document of CPG development. A CPG is developed by the Guideline Development Group and the Systematic Review Team (SR Team), and the scope is prepared through discussions by the members of the Guideline Development Group at the beginning of CPG development. Public comments for the drafted scope may be sought to hear the opinions of all stakeholders, including healthcare professionals and patients who may use the CPG, and governments and groups that may be influenced by the CPG, before finalizing the scope. The scope should be prepared at the beginning of the CPG development process, but it can be revised, if necessary, during the course of CPG development. In this case, the reason and approval process of revision should be described clearly in the scope with the date and version of the revised edition. 2 Structure of Scope The items to be described in the standard scope are those included in the following template [Template ID: 3-3 Scope S], but in this handbook, we recommend using the structure in the following box, in which Basic characteristics of the health topic are included. Basic characteristics of the health topic Clinical characteristics of the health topic Epidemiological characteristics of the health topic Overall flow of clinical practice of the health topic (The above shall be summarized in the following templates) [Template ID: 3-1 Basic Characteristics of Health Topic S *1 ] [Template ID: 3-2 Clinical Practice Flowchart (Fig.) S] Scope [Template ID: 3-3 Scope S] *1: Templates shall be given the following symbols at the end of their names in response to relevant documents. S: Template included in scope, O: For operation 20