Current landscape and reflections on methodological frameworks for patient and public involvement in clinical research_Chinese Journal of Evidence-Based Medicine

Authors：

ZHANG Luyao ¹ , ZHUANG Rong ² ,  YAN Shiyan ^3,4

1. School of Management, Beijing University of Chinese Medicine, Beijing 102400, P. R. China;
2. School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing 100029, P. R. China;
3. First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, P. R. China;
4. National Clinical Research Center for Chinese Medicine, Tianjin 300381, P. R. China;

Corresponding?author：

YAN Shiyan, Email: yanshiyan0927@sina.com

Keywords：

Patient and public involvement; Frameworks; Clinical research

DOI：

10.7507/1672-2531.202512184

Video：

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With the rise of the "patient-centered" concept, the roles of patients and the public in research have gradually shifted from passive recipients to active participants. Patient and public involvement (PPI) research has become a key path to addressing the shortcomings of traditional research. This paper provides a systematic review of the evolution and key components of patient and public involvement. It conducts an in-depth analysis of various PPI frameworks, with a focus on representative models from the United Kingdom and the United States. The study offers a detailed introduction to the five categories of PPI frameworks summarized by Greenhalgh et al., namely: power-focused frameworks, priority-setting frameworks, study-focused frameworks, report-focused frameworks, and partnership-focused frameworks. It highlights the prevailing practical challenges, such as limited generalizability and difficulties in quantitative evaluation. By correlating these findings with the preliminary explorations of PPI in China, this review offers valuable insights to support the standardization and quality enhancement of PPI research in the country.

Citation： ZHANG Luyao, ZHUANG Rong, YAN Shiyan. Current landscape and reflections on methodological frameworks for patient and public involvement in clinical research. Chinese Journal of Evidence-Based Medicine, 2026, 26(5): 606-614. doi: 10.7507/1672-2531.202512184 Copy

1.	Wicks P, Richards T, Denegri S, et al. Patients' roles and rights in research. BMJ, 2018, 362: k3193.
2.	European Medicines Agency. Regulatory science strategy.
3.	Price A, Albarqouni L, Kirkpatrick J, et al. Patient and public involvement in the design of clinical trials: an overview of systematic reviews. J Eval Clin Pract, 2018, 24(1): 240-253.
4.	Gamble C, Dudley L, Allam A, et al. Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation. BMJ Open, 2014, 4(7): e005234.
5.	National Institute for Health Research. About INVOLVE.
6.	Frank L, Forsythe L, Ellis L, et al. Conceptual and practical foundations of patient engagement in research at the patient-centered outcomes research institute. Qual Life Res, 2015, 24(5): 1033-1041.
7.	Staniszewska S, Brett J, Mockford C, et al. The GRIPP checklist: strengthening the quality of patient and public involvement reporting in research. Int J Technol Assess Health Care, 2011, 27(4): 391-399.
8.	Staniszewska S, Brett J, Simera I, et al. GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research. Res Involv Engagem, 2017, 3: 13.
9.	National Institute for Health Research. UK standards for public involvement: better public involvement for better health and social care research.
10.	Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ, 2025, 389: e081123.
11.	Chan AW, Boutron I, Hopewell S, et al. SPIRIT 2025 statement: updated guideline for protocols of randomised trials. BMJ, 2025, 389: e081477.
12.	National Institute for Health Research. Briefing notes for researchers: public involvement in NHS, public health and social care research.
13.	Ashcroft J, Wykes T, Taylor J, et al. Impact on the individual: what do patients and carers gain, lose and expect from being involved in research. J Ment Health, 2016, 25(1): 28-35.
14.	Aguayo GA, Goetzinger C, Scibilia R, et al. Methods to generate innovative research ideas and improve patient and public involvement in modern epidemiological research: review, patient viewpoint, and guidelines for implementation of a digital cohort study. J Med Internet Res, 2021, 23(12): e25743.
15.	Wright D, Foster C, Amir Z, et al. Critical appraisal guidelines for assessing the quality and impact of user involvement in research. Health Expect, 2010, 13(4): 359-368.
16.	National Institute for Health Research. Public involvement in research: values and principles framework INVOLVE.
17.	National Institute for Health Research (NIHR). Involving children and young people as advisors in research.
18.	Patient-Centered Outcomes Research Institute. Dissemination and implementation framework and toolkit.
19.	Shippee ND, Domecq Garces JP, Prutsky Lopez GJ, et al. Patient and service user engagement in research: a systematic review and synthesized framework. Health Expect, 2015, 18(5): 1151-1166.
20.	Government of Canada. Guidelines on public engagement 2023: public engagement process guide.
21.	Gibson A, Welsman J, Britten N. Evaluating patient and public involvement in health research: from theoretical model to practical workshop. Health Expect, 2017, 20(5): 826-835.
22.	National Institute for Health Research. Briefing notes for researchers: public involvement in NHS, health and social care research.
23.	Dillon EC, Tuzzio L, Madrid S, et al. Measuring the impact of patient-engaged research: how a methods workshop identified critical outcomes of research engagement. J Patient Cent Res Rev, 2017, 4(4): 237-246.
24.	Patient-Centered Outcomes Research Institute. Guidance on the design and conduct of trials in real-world settings: factors to consider in pragmatic patient-centered outcomes research.
25.	European Patients’ Academy on Therapeutic Innovation (EUPATI). The EUPATI patient involvement in medicines R&D roadmap.
26.	Greenhalgh T, Hinton L, Finlay T, et al. Frameworks for supporting patient and public involvement in research: systematic review and co-design pilot. Health Expect, 2019, 22(4): 785-801.
27.	Oliver S, Clarke-Jones L, Rees R, et al. Involving consumers in research and development agenda setting for the NHS: developing an evidence-based approach. Health Technol Assess, 2004, 8(15): 1-148.
28.	Gibson A, Britten N, Lynch J. Theoretical directions for an emancipatory concept of patient and public involvement. Health (London), 2012, 16(5): 531-547.
29.	Viergever RF, Olifson S, Ghaffar A, et al. A checklist for health research priority setting: nine common themes of good practice. Health Res Policy Syst, 2010, 8: 36.
30.	Pollock A, St George B, Fenton M, et al. Development of a new model to engage patients and clinicians in setting research priorities. J Health Serv Res Policy, 2014, 19(1): 12-18.
31.	Pollock A, Campbell P, Struthers C, et al. Development of the ACTIVE framework to describe stakeholder involvement in systematic reviews. J Health Serv Res Policy, 2019, 24(4): 245-255.
32.	Baines RL, Regan de Bere S. Optimizing patient and public involvement (PPI): Identifying its "essential" and "desirable" principles using a systematic review and modified Delphi methodology. Health Expect, 2018, 21(1): 327-335.
33.	de Wit MP, Elberse JE, Broerse JE, et al. Do not forget the professional--the value of the FIRST model for guiding the structural involvement of patients in rheumatology research. Health Expect, 2015, 18(4): 489-503.
34.	Arnstein SR. A ladder of citizen participation. J Am Inst Plann, 1969, 35: 216-224.
35.	Mullen P, Murray-Sykes K, Kearns WE. Community health council representation on planning teams: a question of politics. Public Health, 1984, 98(3): 143-151.
36.	Forsythe LP, Ellis LE, Edmundson L, et al. Patient and Stakeholder Engagement in the PCORI Pilot Projects: Description and Lessons Learned. J Gen Intern Med, 2016, 31(1): 13-21.
37.	Ocloo J, Matthews R. From tokenism to empowerment: progressing patient and public involvement in healthcare improvement. BMJ Qual Saf, 2016, 25(8): 626-632.
38.	Brett J, Staniszewska S, Mockford C, et al. Mapping the impact of patient and public involvement on health and social care research: a systematic review. Health Expect, 2014, 17(5): 637-650.
39.	林瀅, 屠建鋒, 王麗瓊, 等. “患者及公眾參與”(PPI)在針灸臨床研究中的應用思考. 中國針灸, 2022, 42(10): 1179-1183.
40.	周芬. 患者及公眾參與臨床實踐指南構建及其方法的研究進展. 護理學報, 2020, 27(5): 14-17.
41.	楊輝, Shane Thomas, Colette Browning. 公眾參與醫療服務質量改進: 國際經驗和中國展望. 中國衛生質量管理, 2010, 17(2): 108-112.
42.	國家藥品監督管理局藥品審評中心. 關于發布《以患者為中心的藥物臨床試驗設計技術指導原則(試行)》《以患者為中心的藥物臨床試驗實施技術指導原則(試行)》《以患者為中心的藥物獲益-風險評估技術指導原則(試行)》的通告(2023年第44號).

1. Wicks P, Richards T, Denegri S, et al. Patients' roles and rights in research. BMJ, 2018, 362: k3193.
2. European Medicines Agency. Regulatory science strategy.
3. Price A, Albarqouni L, Kirkpatrick J, et al. Patient and public involvement in the design of clinical trials: an overview of systematic reviews. J Eval Clin Pract, 2018, 24(1): 240-253.
4. Gamble C, Dudley L, Allam A, et al. Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation. BMJ Open, 2014, 4(7): e005234.
5. National Institute for Health Research. About INVOLVE.
6. Frank L, Forsythe L, Ellis L, et al. Conceptual and practical foundations of patient engagement in research at the patient-centered outcomes research institute. Qual Life Res, 2015, 24(5): 1033-1041.
7. Staniszewska S, Brett J, Mockford C, et al. The GRIPP checklist: strengthening the quality of patient and public involvement reporting in research. Int J Technol Assess Health Care, 2011, 27(4): 391-399.
8. Staniszewska S, Brett J, Simera I, et al. GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research. Res Involv Engagem, 2017, 3: 13.
9. National Institute for Health Research. UK standards for public involvement: better public involvement for better health and social care research.
10. Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ, 2025, 389: e081123.
11. Chan AW, Boutron I, Hopewell S, et al. SPIRIT 2025 statement: updated guideline for protocols of randomised trials. BMJ, 2025, 389: e081477.
12. National Institute for Health Research. Briefing notes for researchers: public involvement in NHS, public health and social care research.
13. Ashcroft J, Wykes T, Taylor J, et al. Impact on the individual: what do patients and carers gain, lose and expect from being involved in research. J Ment Health, 2016, 25(1): 28-35.
14. Aguayo GA, Goetzinger C, Scibilia R, et al. Methods to generate innovative research ideas and improve patient and public involvement in modern epidemiological research: review, patient viewpoint, and guidelines for implementation of a digital cohort study. J Med Internet Res, 2021, 23(12): e25743.
15. Wright D, Foster C, Amir Z, et al. Critical appraisal guidelines for assessing the quality and impact of user involvement in research. Health Expect, 2010, 13(4): 359-368.
16. National Institute for Health Research. Public involvement in research: values and principles framework INVOLVE.
17. National Institute for Health Research (NIHR). Involving children and young people as advisors in research.
18. Patient-Centered Outcomes Research Institute. Dissemination and implementation framework and toolkit.
19. Shippee ND, Domecq Garces JP, Prutsky Lopez GJ, et al. Patient and service user engagement in research: a systematic review and synthesized framework. Health Expect, 2015, 18(5): 1151-1166.
20. Government of Canada. Guidelines on public engagement 2023: public engagement process guide.
21. Gibson A, Welsman J, Britten N. Evaluating patient and public involvement in health research: from theoretical model to practical workshop. Health Expect, 2017, 20(5): 826-835.
22. National Institute for Health Research. Briefing notes for researchers: public involvement in NHS, health and social care research.
23. Dillon EC, Tuzzio L, Madrid S, et al. Measuring the impact of patient-engaged research: how a methods workshop identified critical outcomes of research engagement. J Patient Cent Res Rev, 2017, 4(4): 237-246.
24. Patient-Centered Outcomes Research Institute. Guidance on the design and conduct of trials in real-world settings: factors to consider in pragmatic patient-centered outcomes research.
25. European Patients’ Academy on Therapeutic Innovation (EUPATI). The EUPATI patient involvement in medicines R&D roadmap.
26. Greenhalgh T, Hinton L, Finlay T, et al. Frameworks for supporting patient and public involvement in research: systematic review and co-design pilot. Health Expect, 2019, 22(4): 785-801.
27. Oliver S, Clarke-Jones L, Rees R, et al. Involving consumers in research and development agenda setting for the NHS: developing an evidence-based approach. Health Technol Assess, 2004, 8(15): 1-148.
28. Gibson A, Britten N, Lynch J. Theoretical directions for an emancipatory concept of patient and public involvement. Health (London), 2012, 16(5): 531-547.
29. Viergever RF, Olifson S, Ghaffar A, et al. A checklist for health research priority setting: nine common themes of good practice. Health Res Policy Syst, 2010, 8: 36.
30. Pollock A, St George B, Fenton M, et al. Development of a new model to engage patients and clinicians in setting research priorities. J Health Serv Res Policy, 2014, 19(1): 12-18.
31. Pollock A, Campbell P, Struthers C, et al. Development of the ACTIVE framework to describe stakeholder involvement in systematic reviews. J Health Serv Res Policy, 2019, 24(4): 245-255.
32. Baines RL, Regan de Bere S. Optimizing patient and public involvement (PPI): Identifying its "essential" and "desirable" principles using a systematic review and modified Delphi methodology. Health Expect, 2018, 21(1): 327-335.
33. de Wit MP, Elberse JE, Broerse JE, et al. Do not forget the professional--the value of the FIRST model for guiding the structural involvement of patients in rheumatology research. Health Expect, 2015, 18(4): 489-503.
34. Arnstein SR. A ladder of citizen participation. J Am Inst Plann, 1969, 35: 216-224.
35. Mullen P, Murray-Sykes K, Kearns WE. Community health council representation on planning teams: a question of politics. Public Health, 1984, 98(3): 143-151.
36. Forsythe LP, Ellis LE, Edmundson L, et al. Patient and Stakeholder Engagement in the PCORI Pilot Projects: Description and Lessons Learned. J Gen Intern Med, 2016, 31(1): 13-21.
37. Ocloo J, Matthews R. From tokenism to empowerment: progressing patient and public involvement in healthcare improvement. BMJ Qual Saf, 2016, 25(8): 626-632.
38. Brett J, Staniszewska S, Mockford C, et al. Mapping the impact of patient and public involvement on health and social care research: a systematic review. Health Expect, 2014, 17(5): 637-650.
39. 林瀅, 屠建鋒, 王麗瓊, 等. “患者及公眾參與”(PPI)在針灸臨床研究中的應用思考. 中國針灸, 2022, 42(10): 1179-1183.
40. 周芬. 患者及公眾參與臨床實踐指南構建及其方法的研究進展. 護理學報, 2020, 27(5): 14-17.
41. 楊輝, Shane Thomas, Colette Browning. 公眾參與醫療服務質量改進: 國際經驗和中國展望. 中國衛生質量管理, 2010, 17(2): 108-112.
42. 國家藥品監督管理局藥品審評中心. 關于發布《以患者為中心的藥物臨床試驗設計技術指導原則(試行)》《以患者為中心的藥物臨床試驗實施技術指導原則(試行)》《以患者為中心的藥物獲益-風險評估技術指導原則(試行)》的通告(2023年第44號).

Chinese Journal of Evidence-Based Medicine

Current landscape and reflections on methodological frameworks for patient and public involvement in clinical research

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