Requirements of patient participation in the development manual of clinical practice guidelines: a systematic review_Chinese Journal of Evidence-Based Medicine

Authors：

GAO Yicheng , XIA Ruyu , LUO Minjing , FENG Yuting , CHAI Qianyun , LIANG Changhao , WANG Yaqi ,  FEI Yutong

Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, P. R. China;

Corresponding author：

FEI Yutong, Email: yutong_fei@163.com

Keywords：

Patient participation; Guideline manual; Values and preferences; Clinical practice guidelines; Methodology

DOI：

10.7507/1672-2531.202204142

Video：

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Objective To systematically review the requirements of patient participation in clinical practice guidelines (CPGs) in Chinese and foreign guideline development manuals. Methods Thirty-six authoritative society websites and guideline databases and 5 commonly used databases were searched online. Relevant information on patients’ participation in the guideline manuals was collected, summarized, and analyzed. Results A total of 37 manuals (33 foreign and 4 Chinese) were included. The requirements for the number of patients, the right to speak, status equality, and the right to vote in the guideline development manual accounted for 35.1%, 13.5%, 8.1%, and 5.4%, respectively. The requirements for participants’ mode of participation were not mentioned in the guideline development manuals from 2000 to 2010. There were 6 (16.2%) in 2011–2015 and 12 (32.4%) in 2016–2022. The comprehensive guidelines for multiple disease types accounted for 35.7%, 28.6%, and 57.1%, respectively, in terms of requirements for participants’ knowledge or experience, management of specialized personnel, and training support. The specific guidelines for a certain type of disease or drug accounted for 21.7%, 4.3%, and 17.4%, respectively; fifteen (40.5%) guideline development manuals mentioned the specific collection forms of patients’ values and preferences in guideline development. Conclusion Given changes to medical models and the emphasis on patients’ rights and interests, an increasing number of manuals have proposed requirements that consider the expression of patients’ values and preferences in manual development, and the dimensions of manual development are constantly enriched. However, manuals outlining the requirements of patient participation are still not comprehensive and can continue to improve.

Citation： GAO Yicheng, XIA Ruyu, LUO Minjing, FENG Yuting, CHAI Qianyun, LIANG Changhao, WANG Yaqi, FEI Yutong. Requirements of patient participation in the development manual of clinical practice guidelines: a systematic review. Chinese Journal of Evidence-Based Medicine, 2022, 22(10): 1182-1188. doi: 10.7507/1672-2531.202204142 Copy

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2.	Institute of Medicine. Clinical practice guidelines we can trust. Washington, DC: National Academies Press, 2011.
3.	陈耀龙, 杨克虎, 王小钦, 等. 中国制订/修订临床诊疗指南的指导原则(2022版). 中华医学杂志, 2022, 102(10): 697-703.
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8.	National Institute for Health and Care Excellence (NICE). Developing nice guidelines: the manual, 2020. Available at: https://www.nice.org.uk/process/pmg20/chapter/glossary.
9.	British HIV Association. BHIVS guideline development manual, 2020. Available at: http://www.bhiva.org/.
10.	The National Society of Genetic Counselors. Evidence-based clinical practice guideline development manual, 2020. Available at: https://www.nsgc.org/.
11.	冯佳佳, 董子洵, 史楠楠, 等. 制订/修订《中成药临床应用循证指南》的方法与程序. 中国研究型医院, 2020, 7(3): 93-97.
12.	Scottish Intercollegiate Guidelines Network (SIGN). A guideline developer’s handbook, 2019. Available at: http://www.sign.ac.uk/.
13.	European Society of Human Reproduction and Embryology. Manual for ESHRE guideline development, 2019. Available at: https://www.eshre.eu/.
14.	American Academy of Neurology. Clinical practice guideline process manual, 2017. Avaliabel at: https://www.aan.com/.
15.	The American College of Occupational and Environmental Medicine. Practice Guidelines Methodology, 2017. Available at: http://www.acoem.org/.
16.	The European Society of Cardiology. Governing policies and procedures for the writing of ESC clinical practice guidelines, 2017. Available at: https://www.escardio.org/.
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18.	Mohd Mustapa MF, Exton LS, Bell HK, et al. Updated guidance for writing a British Association of Dermatologists clinical guideline: the adoption of the GRADE methodology 2016. Br J Dermatol, 2017, 176(1): 44-51.
19.	Garritty CM, Norris SL, Moher D. Developing WHO rapid advice guidelines in the setting of a public health emergency. J Clin Epidemiol, 2017, 82: 47-60.
20.	Rosenfeld RM, Nnacheta LC, Corrigan MD. Clinical consensus statement development manual. Otolaryngol Head Neck Surg, 2015, 153(Suppl 2): S1-S14.
21.	Sousa-Uva M, Head SJ, Thielmann M, et al. Methodology manual for European Association for Cardio-Thoracic Surgery (EACTS) clinical guidelines. Eur J Cardiothorac Surg, 2015, 48(6): 809-816.
22.	Ntaios G, Bornstein NM, Caso V, et al. The European stroke organisation guidelines: a standard operating procedure. Int J Stroke, 2015, 10(Suppl A100): 128-135.
23.	Bischoff SC, Singer P, Koller M, et al. Standard operating procedures for ESPEN guidelines and consensus papers. Clin Nutr, 2015, 34(6): 1043-1051.
24.	The Kidney Health Australia - Caring for Australasians with Renal Impairment (KHA-CARI). KHA-CARI guideline development manual, 2015. Available at: https://www.cariguidelines.org/.
25.	Ministry of Health Malaysia. Manual on development and implementation of evidence-based clinical practice guidelines. Putrajaya: MoH, 2015.
26.	中华医学会肝病学分会, 中华医学会感染病学分会. 关于临床实践指南制订的规范. 中华肝脏病杂志, 2015, 23(12): 881-887.
27.	Lewis SZ, Diekemper R, Ornelas J, et al. Methodologies for the development of CHEST guidelines and expert panel reports. Chest, 2014, 146(1): 182-192.
28.	Nagler EV, Webster AC, Bolignano D, et al. European renal best practice (ERBP) Guideline development methodology: towards the best possible guidelines. Nephrol Dial Transplant, 2014, 29(4): 731-738.
29.	World Health Organization. Handbook for Guideline Development, 2014. Avaliable at: http://www.who.int/.
30.	Rosenfeld RM, Shiffman RN, Robertson P, et al. Clinical practice guideline development manual, third edition: a quality-driven approach for translating evidence into action. Otolaryngol Head Neck Surg, 2013, 148(Suppl 1): S1-S55.
31.	National Clinical Effectiveness Committee. Guideline developers manual, 2013. Available at: http://www.lenus.ie/.
32.	Qaseem A, Forland F, Macbeth F, et al. Guidelines international network: toward international standards for clinical practice guidelines. Ann Intern Med, 2012, 156(7): 525-531.
33.	National Health and Medical Research Council (NHMRC). Procedures and requirements for meeting the 2011 NHMRC standard for practice guidelines-summary for developers. Melbourne: National Health and Medical Research Council, 2011.
34.	Murad MH, Montori VM, Sidawy AN, et al. Guideline methodology of the Society for Vascular Surgery including the experience with the GRADE framework. J Vasc Surg, 2011, 53(5): 1375-1380.
35.	American College of Cardiology Foundation and American Heart Association (ACCF/AHA). Methodology manual and policies from the ACCF/AHA task force on practice guidelines, 2010. Available at: http://professional.heart.org/.
36.	World Stroke Organization (WSO). Clinical practice guideline development handbook of stroke care, 2009. Available at: http://www.world-stroke.org/.
37.	Palda VA, Davis D, Goldman J. A guide to the Canadian Medical Association handbook on clinical practice guidelines. CMAJ, 2007, 177(10): 1221-1226.
38.	International Diabetes Federation (IDF). Guide for Guidelines, 2003. Available at: https://www.idf.org/.
39.	The New Zealand Guidelines Group (NZGG). Handbook for the preparation of explicit evidenced-based clinical practice guidelines, 2001. Available at: http://www.health.govt.nz/.

1. Staniszewska S, Brett J, Simera I, et al. GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research. BMJ, 2017, 358: j3453.
2. Institute of Medicine. Clinical practice guidelines we can trust. Washington, DC: National Academies Press, 2011.
3. 陈耀龙, 杨克虎, 王小钦, 等. 中国制订/修订临床诊疗指南的指导原则(2022版). 中华医学杂志, 2022, 102(10): 697-703.
4. American Society of Clinical Oncology (ASCO). Methodology manual, 2021. Available at: https://www.asco.org/practice-patients/guidelines.
5. Infectious Diseases Society of America. Handbook on clinical practice guideline development, 2021. Avaliable at: http://www.idsociety.org/.
6. Minds Guideline Center, Japan Council for Quality Health Care. Minds handbook for clinical practice guideline development 2021. Available at: http://www.en.jcqhc.or.jp/.
7. U. S. Preventive Services Task Force. Procedure manual, 2021. Available at: https://www.uspreventiveservicestaskforce.org/uspstf/.
8. National Institute for Health and Care Excellence (NICE). Developing nice guidelines: the manual, 2020. Available at: https://www.nice.org.uk/process/pmg20/chapter/glossary.
9. British HIV Association. BHIVS guideline development manual, 2020. Available at: http://www.bhiva.org/.
10. The National Society of Genetic Counselors. Evidence-based clinical practice guideline development manual, 2020. Available at: https://www.nsgc.org/.
11. 冯佳佳, 董子洵, 史楠楠, 等. 制订/修订《中成药临床应用循证指南》的方法与程序. 中国研究型医院, 2020, 7(3): 93-97.
12. Scottish Intercollegiate Guidelines Network (SIGN). A guideline developer’s handbook, 2019. Available at: http://www.sign.ac.uk/.
13. European Society of Human Reproduction and Embryology. Manual for ESHRE guideline development, 2019. Available at: https://www.eshre.eu/.
14. American Academy of Neurology. Clinical practice guideline process manual, 2017. Avaliabel at: https://www.aan.com/.
15. The American College of Occupational and Environmental Medicine. Practice Guidelines Methodology, 2017. Available at: http://www.acoem.org/.
16. The European Society of Cardiology. Governing policies and procedures for the writing of ESC clinical practice guidelines, 2017. Available at: https://www.escardio.org/.
17. 胡琳莉, 黄国宁, 孙海翔, 等. CSRM指南共识的制订规范(2016). 生殖医学杂志, 2017, 26(4): 289-301.
18. Mohd Mustapa MF, Exton LS, Bell HK, et al. Updated guidance for writing a British Association of Dermatologists clinical guideline: the adoption of the GRADE methodology 2016. Br J Dermatol, 2017, 176(1): 44-51.
19. Garritty CM, Norris SL, Moher D. Developing WHO rapid advice guidelines in the setting of a public health emergency. J Clin Epidemiol, 2017, 82: 47-60.
20. Rosenfeld RM, Nnacheta LC, Corrigan MD. Clinical consensus statement development manual. Otolaryngol Head Neck Surg, 2015, 153(Suppl 2): S1-S14.
21. Sousa-Uva M, Head SJ, Thielmann M, et al. Methodology manual for European Association for Cardio-Thoracic Surgery (EACTS) clinical guidelines. Eur J Cardiothorac Surg, 2015, 48(6): 809-816.
22. Ntaios G, Bornstein NM, Caso V, et al. The European stroke organisation guidelines: a standard operating procedure. Int J Stroke, 2015, 10(Suppl A100): 128-135.
23. Bischoff SC, Singer P, Koller M, et al. Standard operating procedures for ESPEN guidelines and consensus papers. Clin Nutr, 2015, 34(6): 1043-1051.
24. The Kidney Health Australia - Caring for Australasians with Renal Impairment (KHA-CARI). KHA-CARI guideline development manual, 2015. Available at: https://www.cariguidelines.org/.
25. Ministry of Health Malaysia. Manual on development and implementation of evidence-based clinical practice guidelines. Putrajaya: MoH, 2015.
26. 中华医学会肝病学分会, 中华医学会感染病学分会. 关于临床实践指南制订的规范. 中华肝脏病杂志, 2015, 23(12): 881-887.
27. Lewis SZ, Diekemper R, Ornelas J, et al. Methodologies for the development of CHEST guidelines and expert panel reports. Chest, 2014, 146(1): 182-192.
28. Nagler EV, Webster AC, Bolignano D, et al. European renal best practice (ERBP) Guideline development methodology: towards the best possible guidelines. Nephrol Dial Transplant, 2014, 29(4): 731-738.
29. World Health Organization. Handbook for Guideline Development, 2014. Avaliable at: http://www.who.int/.
30. Rosenfeld RM, Shiffman RN, Robertson P, et al. Clinical practice guideline development manual, third edition: a quality-driven approach for translating evidence into action. Otolaryngol Head Neck Surg, 2013, 148(Suppl 1): S1-S55.
31. National Clinical Effectiveness Committee. Guideline developers manual, 2013. Available at: http://www.lenus.ie/.
32. Qaseem A, Forland F, Macbeth F, et al. Guidelines international network: toward international standards for clinical practice guidelines. Ann Intern Med, 2012, 156(7): 525-531.
33. National Health and Medical Research Council (NHMRC). Procedures and requirements for meeting the 2011 NHMRC standard for practice guidelines-summary for developers. Melbourne: National Health and Medical Research Council, 2011.
34. Murad MH, Montori VM, Sidawy AN, et al. Guideline methodology of the Society for Vascular Surgery including the experience with the GRADE framework. J Vasc Surg, 2011, 53(5): 1375-1380.
35. American College of Cardiology Foundation and American Heart Association (ACCF/AHA). Methodology manual and policies from the ACCF/AHA task force on practice guidelines, 2010. Available at: http://professional.heart.org/.
36. World Stroke Organization (WSO). Clinical practice guideline development handbook of stroke care, 2009. Available at: http://www.world-stroke.org/.
37. Palda VA, Davis D, Goldman J. A guide to the Canadian Medical Association handbook on clinical practice guidelines. CMAJ, 2007, 177(10): 1221-1226.
38. International Diabetes Federation (IDF). Guide for Guidelines, 2003. Available at: https://www.idf.org/.
39. The New Zealand Guidelines Group (NZGG). Handbook for the preparation of explicit evidenced-based clinical practice guidelines, 2001. Available at: http://www.health.govt.nz/.

Chinese Journal of Evidence-Based Medicine

Requirements of patient participation in the development manual of clinical practice guidelines: a systematic review

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