Evidence-based construction of transparency evaluation tool 2.0 of clinical practice guidelines_Chinese Journal of Evidence-Based Medicine

Authors：

ZHANG Na ^1,2,3 , LONG Youlin ^1,2,3 , WANG Xinyi ^1,2,3 , WANG Xinyao ^1,2,3 , GUO Qiong ^1,2 , CHEN Yaolong ^4,5,6 ,  WANG Qiang ⁷ , LI Zhengchi ⁸ , DU Liang ^1,2,3

1. General Practice Medical Center, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;
2. Medical Device Regulatory Research and Evaluation Center, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;
3. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;
4. Research Unit of Evidence-Based Evaluation and Guidelines, Chinese Academy of Medical Sciences, Lanzhou 730000, P. R. China;
5. World Health Organization Collaborating Centre for Guideline Implementation and Knowledge Translation, Lanzhou 730000, P. R. China;
6. School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, P. R. China;
7. Medical Management Service Guidance Center, National Health Commission of the People's Republic of China, Beijing 100000, P. R. China;
8. CPC Committee Office, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;

Corresponding?author：

WANG Qiang, Email: duliang0606@vip.sina.com

Keywords：

Clinical practice guideline; Transparency; Public trust; Conflict of interest; Formulation process

DOI：

10.7507/1672-2531.202306103

Video：

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Objective To develop a transparency evaluation tool 2.0 of clinical practice guidelines (CPGs) oriented by public trust. Methods The Delphi method was employed to score and select the importance and operability of evaluation indicators. The analytic hierarchy process was used to determine the weights of the indicators. And the final evaluation indicator system was determined through expert consensus meeting. Results It constructed two first-level indicators including conflict of interest and formulation process, and six second-level indicators, including guideline developers, reviewers, protocol and registration, evidence production, recommendation formation, and external review. Based on the second-level indicators, a total of 21 third-level indicators were constructed from the perspectives of disclosure and management. The logical structure of the tool is rigorous and harmonious. Conclusion The CPGs transparency assessment tool 2.0 developed in this study provides measurement standards and an evaluation framework for assessing transparency in CPGs.

Citation： ZHANG Na, LONG Youlin, WANG Xinyi, WANG Xinyao, GUO Qiong, CHEN Yaolong, WANG Qiang, LI Zhengchi, DU Liang. Evidence-based construction of transparency evaluation tool 2.0 of clinical practice guidelines. Chinese Journal of Evidence-Based Medicine, 2023, 23(9): 1066-1071. doi: 10.7507/1672-2531.202306103 Copy

1.	Chen Y, Wang C, Shang H, et al. Clinical practice guidelines in China. BMJ, 2018, 360: j5158.
2.	McMillan Boyles C, Spoel P, Montgomery P, et al. Representations of clinical practice guidelines and health equity in healthcare literature: an integrative review. J Nurs Scholarsh, 2023, 55(2): 506-520.
3.	Cabana MD, Rand CS, Powe NR, et al. Why don't physicians follow clinical practice guidelines? A framework for improvement. JAMA, 1999, 282(15): 1458-1465.
4.	Moulds RF. Clinical practice guidelines: the need for greater transparency in formulating recommendations. Med J Aust, 2011, 195(6): 324-325.
5.	Scott IA, Guyatt GH. Clinical practice guidelines: the need for greater transparency in formulating recommendations. Med J Aust, 2011, 195(1): 29-33.
6.	Dewidar O, Kawala BA, Antequera A, et al. Methodological guidance for incorporating equity when informing rapid-policy and guideline development. J Clin Epidemiol, 2022, 150: 142-153.
7.	Chen Y, Yang K, Maru?ic A, et al. A reporting tool for practice guidelines in health care: the RIGHT statement. Ann Intern Med, 2017, 166(2): 128-132.
8.	O'Shaughnessy SM, Lee JY, Rong LQ, et al. Quality of recent clinical practice guidelines in anaesthesia publications using the appraisal of guidelines for research and evaluation Ⅱ instrument. Br J Anaesth, 2022, 128(4): 655-663.
9.	Morgano GP, Mbuagbaw L, Santesso N, et al. Defining decision thresholds for judgments on health benefits and harms using the grading of recommendations assessment, development and evaluation (GRADE) evidence to decision (EtD) frameworks: a protocol for a randomised methodological study (GRADE-THRESHOLD). BMJ Open, 2022, 12(3): e053246.
10.	Wayant C, Cooper C, Turner D, et al. Evaluation of the NCCN guidelines using the RIGHT statement and AGREE-Ⅱ instrument: a cross-sectional review. BMJ Evid Based Med, 2019, 24(6): 219-226.
11.	楊柳, 龍囿霖, 程祎凡, 等. 臨床實踐指南透明度評價工具的循證構建. 中國循證醫學雜志, 2021, 21(8): 869-875.
12.	Niederberger M, K?berich S, . Coming to consensus: the Delphi technique. Eur J Cardiovasc Nurs, 2021, 20(7): 692-695.
13.	Improta G, Perrone A, Russo MA, et al. Health technology assessment (HTA) of optoelectronic biosensors for oncology by analytic hierarchy process (AHP) and Likert scale. BMC Med Res Methodol, 2019, 19(1): 140.
14.	王春枝, 斯琴. 德爾菲法中的數據統計處理方法及其應用研究. 內蒙古財經學院學報(綜合版), 2011, 9(4): 92-96.
15.	王桾蔓, 文進. 應用德爾菲法構建地震災區健康融入所有政策評價指標體系. 中國循證醫學雜志, 2021, 21(7): 754-759.
16.	Kursa MB. Kendall transformation brings a robust categorical representation of ordinal data. Sci Rep, 2022, 12(1): 8341.
17.	張帥, 張守琳, 鄒迪, 等. 基于德爾菲法及層次分析法構建IgA腎病氣陰兩虛證條目權重. 世界科學技術-中醫藥現代化, 2023, (7): 1-9.
18.	Costa DS, Mamede HS, da Silva MM. A method for selecting processes for automation with AHP and TOPSIS. Heliyon, 2023, 9(3): e13683.
19.	Liang J, Zou G, Gu C, et al. Study on skin infection model of Staphylococcus aureus based on analytic hierarchy process and Delphi method. Heliyon, 2023, 9(6): e16327.
20.	Saaty TL. Decision making with the analytic hierarchy process. Int J Serv Sci, 2008, 1(1): 83-98.
21.	Peng G, Han L, Liu Z, et al. An application of fuzzy analytic hierarchy process in risk evaluation model. Front Psychol, 2021, 12: 715003.
22.	Bassand JP, Hamm C. Guidelines for anticoagulant use in acute coronary syndromes. Lancet, 2008, 372(9638): 532-533.
23.	Norris SL, Holmer HK, Ogden LA, et al. Conflict of interest in clinical practice guideline development: a systematic review. PLoS One, 2011, 6(10): e25153.
24.	Tabatabavakili S, Khan R, Scaffidi MA, et al. Financial conflicts of interest in clinical practice guidelines: a systematic review. Mayo Clin Proc Innov Qual Outcomes, 2021, 5(2): 466-475.
25.	陳耀龍, 王健健, 詹思延, 等. 如何應對指南制訂中的利益沖突. 協和醫學雜志, 2019, 10(6): 685-691.
26.	Burgers JS, Grol R, Klazinga NS, et al. Towards evidence-based clinical practice: an international survey of 18 clinical guideline programs. Int J Qual Health Care, 2003, 15(1): 31-45.
27.	van den Bergh RCN, Ost P, Surcel C, et al. Are clinical guidelines designed according to guidelines? Cross-sectional assessment of quality and transparency of clinical guidelines in urology. World J Urol, 2018, 36(9): 1489-1494.
28.	Don-Wauchope AC, Sievenpiper JL, Hill SA, et al. Applicability of the AGREE Ⅱ instrument in evaluating the development process and quality of current national academy of clinical biochemistry guidelines. Clin Chem, 2012, 58(10): 1426-1437.
29.	Saito H, Ozaki A, Sawano T, et al. Evaluation of pharmaceutical company payments and conflict of interest disclosures among oncology clinical practice guideline authors in Japan. JAMA Netw Open, 2019, 2(4): e192834.
30.	Cosgrove L, Bursztajn HJ, Erlich DR, et al. Conflicts of interest and the quality of recommendations in clinical guidelines. J Eval Clin Pract, 2013, 19(4): 674-681.
31.	葉志康, Guyatt G. 臨床實踐指南制定標準: 由表及里, 臨床專家如何讀懂臨床指南的內在. 中國全科醫學, 2023, (7): 1-7.
32.	李緒輝, 黃橋, 王永博, 等. 臨床實踐指南實施性促進研究之一: 實施性現狀與促進策略. 醫學新知, 2021, 31(6): 410-418.

1. Chen Y, Wang C, Shang H, et al. Clinical practice guidelines in China. BMJ, 2018, 360: j5158.
2. McMillan Boyles C, Spoel P, Montgomery P, et al. Representations of clinical practice guidelines and health equity in healthcare literature: an integrative review. J Nurs Scholarsh, 2023, 55(2): 506-520.
3. Cabana MD, Rand CS, Powe NR, et al. Why don't physicians follow clinical practice guidelines? A framework for improvement. JAMA, 1999, 282(15): 1458-1465.
4. Moulds RF. Clinical practice guidelines: the need for greater transparency in formulating recommendations. Med J Aust, 2011, 195(6): 324-325.
5. Scott IA, Guyatt GH. Clinical practice guidelines: the need for greater transparency in formulating recommendations. Med J Aust, 2011, 195(1): 29-33.
6. Dewidar O, Kawala BA, Antequera A, et al. Methodological guidance for incorporating equity when informing rapid-policy and guideline development. J Clin Epidemiol, 2022, 150: 142-153.
7. Chen Y, Yang K, Maru?ic A, et al. A reporting tool for practice guidelines in health care: the RIGHT statement. Ann Intern Med, 2017, 166(2): 128-132.
8. O'Shaughnessy SM, Lee JY, Rong LQ, et al. Quality of recent clinical practice guidelines in anaesthesia publications using the appraisal of guidelines for research and evaluation Ⅱ instrument. Br J Anaesth, 2022, 128(4): 655-663.
9. Morgano GP, Mbuagbaw L, Santesso N, et al. Defining decision thresholds for judgments on health benefits and harms using the grading of recommendations assessment, development and evaluation (GRADE) evidence to decision (EtD) frameworks: a protocol for a randomised methodological study (GRADE-THRESHOLD). BMJ Open, 2022, 12(3): e053246.
10. Wayant C, Cooper C, Turner D, et al. Evaluation of the NCCN guidelines using the RIGHT statement and AGREE-Ⅱ instrument: a cross-sectional review. BMJ Evid Based Med, 2019, 24(6): 219-226.
11. 楊柳, 龍囿霖, 程祎凡, 等. 臨床實踐指南透明度評價工具的循證構建. 中國循證醫學雜志, 2021, 21(8): 869-875.
12. Niederberger M, K?berich S, . Coming to consensus: the Delphi technique. Eur J Cardiovasc Nurs, 2021, 20(7): 692-695.
13. Improta G, Perrone A, Russo MA, et al. Health technology assessment (HTA) of optoelectronic biosensors for oncology by analytic hierarchy process (AHP) and Likert scale. BMC Med Res Methodol, 2019, 19(1): 140.
14. 王春枝, 斯琴. 德爾菲法中的數據統計處理方法及其應用研究. 內蒙古財經學院學報(綜合版), 2011, 9(4): 92-96.
15. 王桾蔓, 文進. 應用德爾菲法構建地震災區健康融入所有政策評價指標體系. 中國循證醫學雜志, 2021, 21(7): 754-759.
16. Kursa MB. Kendall transformation brings a robust categorical representation of ordinal data. Sci Rep, 2022, 12(1): 8341.
17. 張帥, 張守琳, 鄒迪, 等. 基于德爾菲法及層次分析法構建IgA腎病氣陰兩虛證條目權重. 世界科學技術-中醫藥現代化, 2023, (7): 1-9.
18. Costa DS, Mamede HS, da Silva MM. A method for selecting processes for automation with AHP and TOPSIS. Heliyon, 2023, 9(3): e13683.
19. Liang J, Zou G, Gu C, et al. Study on skin infection model of Staphylococcus aureus based on analytic hierarchy process and Delphi method. Heliyon, 2023, 9(6): e16327.
20. Saaty TL. Decision making with the analytic hierarchy process. Int J Serv Sci, 2008, 1(1): 83-98.
21. Peng G, Han L, Liu Z, et al. An application of fuzzy analytic hierarchy process in risk evaluation model. Front Psychol, 2021, 12: 715003.
22. Bassand JP, Hamm C. Guidelines for anticoagulant use in acute coronary syndromes. Lancet, 2008, 372(9638): 532-533.
23. Norris SL, Holmer HK, Ogden LA, et al. Conflict of interest in clinical practice guideline development: a systematic review. PLoS One, 2011, 6(10): e25153.
24. Tabatabavakili S, Khan R, Scaffidi MA, et al. Financial conflicts of interest in clinical practice guidelines: a systematic review. Mayo Clin Proc Innov Qual Outcomes, 2021, 5(2): 466-475.
25. 陳耀龍, 王健健, 詹思延, 等. 如何應對指南制訂中的利益沖突. 協和醫學雜志, 2019, 10(6): 685-691.
26. Burgers JS, Grol R, Klazinga NS, et al. Towards evidence-based clinical practice: an international survey of 18 clinical guideline programs. Int J Qual Health Care, 2003, 15(1): 31-45.
27. van den Bergh RCN, Ost P, Surcel C, et al. Are clinical guidelines designed according to guidelines? Cross-sectional assessment of quality and transparency of clinical guidelines in urology. World J Urol, 2018, 36(9): 1489-1494.
28. Don-Wauchope AC, Sievenpiper JL, Hill SA, et al. Applicability of the AGREE Ⅱ instrument in evaluating the development process and quality of current national academy of clinical biochemistry guidelines. Clin Chem, 2012, 58(10): 1426-1437.
29. Saito H, Ozaki A, Sawano T, et al. Evaluation of pharmaceutical company payments and conflict of interest disclosures among oncology clinical practice guideline authors in Japan. JAMA Netw Open, 2019, 2(4): e192834.
30. Cosgrove L, Bursztajn HJ, Erlich DR, et al. Conflicts of interest and the quality of recommendations in clinical guidelines. J Eval Clin Pract, 2013, 19(4): 674-681.
31. 葉志康, Guyatt G. 臨床實踐指南制定標準: 由表及里, 臨床專家如何讀懂臨床指南的內在. 中國全科醫學, 2023, (7): 1-7.
32. 李緒輝, 黃橋, 王永博, 等. 臨床實踐指南實施性促進研究之一: 實施性現狀與促進策略. 醫學新知, 2021, 31(6): 410-418.

Chinese Journal of Evidence-Based Medicine

Evidence-based construction of transparency evaluation tool 2.0 of clinical practice guidelines

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