Technical essentials for collecting patient experience data in patient-focused drug development_Chinese Journal of Evidence-Based Medicine

Authors：

SHI Menglong ¹ , ZHANG Chenyao ¹ , WU Xiaolei ¹ , MA Yucong ¹ , DU Liang ² , LIU Binglin ³ ,  CAO Lujia ¹ ,  ZHANG Junhua ¹

1. Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, P. R. China;
2. Chinese Evidence-based Medicine Center, West China Hospital of Sichuan University, Chengdu 610041, P. R. China;
3. Center for Drug Evaluation, China Food and Drug Administration, Beijing 100022, P. R. China;

Corresponding author：

CAO Lujia, Email: caolujia0825@163.com; ZHANG Junhua, Email: zjhtcm@foxmail.com

Keywords：

Patient-focused drug development; Patient experience data; Qualitative research methods; Quantitative research methods; Mixed research methods

DOI：

10.7507/1672-2531.202307069

Video：

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Abstract Full text Figures/Tables Video References Cited by

As subjects in drug clinical trials and participants in medical practice, patients can best understand their own conditions and needs. With this in mind, the FDA proposed "patient-centered drug discovery" and issued a set of guidelines to incorporate patient experiences, perspectives, needs, and preferences into the drug development and evaluation process. Guideline (2), methods for identifying important patient information, mainly describes methods and precautions for collecting and extracting patient experience data. This paper will focus on the characteristics, common methods and precautions of qualitative, quantitative and mixed research methods in the collection of patient experience data, in order to provide help for the comprehensive collection of patient experience data.

Citation： SHI Menglong, ZHANG Chenyao, WU Xiaolei, MA Yucong, DU Liang, LIU Binglin, CAO Lujia, ZHANG Junhua. Technical essentials for collecting patient experience data in patient-focused drug development. Chinese Journal of Evidence-Based Medicine, 2024, 24(4): 478-483. doi: 10.7507/1672-2531.202307069 Copy

1.	Ameer B. Patient-reported outcomes: listening for what is most important in clinical care and patient-focused drug development. J Clin Pharmacol, 2021, 61(7): 845-847.
2.	Mühlbacher AC, Juhnke C, Beyer AR, et al. Patient-focused benefit-risk analysis to inform regulatory decisions: the European Union perspective. Value Health, 2016, 19(6): 734-740.
3.	Ho MP, Gonzalez JM, Lerner HP, et al. Incorporating patient-preference evidence into regulatory decision making. Surg Endosc, 2015, 29(10): 2984-2993.
4.	Sharma NS. Patient centric approach for clinical trials: current trend and new opportunities. Perspect Clin Res, 2015, 6(3): 134-138.
5.	FDA. CDER patient-focused drug development.
6.	宋彩梅. 美国食品药品监督管理局以患者为中心的药物开发系列指导原则1-《综合和有代表性的信息收集指导原则》介绍. 中国临床药理学杂志, 2021, 37(17): 2381-2384.
7.	FDA. Patient-focused drug development: methods to identify what is important to patients.
8.	FDA. Patient-focused drug development: collecting comprehensive and representative input.
9.	FDA. Patient-focused drug development: incorporating clinical outcome assessments into endpoints for regulatory decision-making.
10.	Elsawi R, Dainty K, Smith Begolka W, et al. The multidimensional burden of atopic dermatitis among adults: results from a large national survey. JAMA Dermatol, 2022, 158(8): 887-892.
11.	Maurer M, Mangrum R, Hilliard-Boone T, et al. Understanding the influence and impact of stakeholder engagement in patient-centered outcomes research: a qualitative study. J Gen Intern Med, 2022, 37(Suppl 1): 6-13.
12.	Parikh K, Hinds PS, Teach SJ. Using stakeholder engagement to develop a hospital-initiated, patient-centered intervention to improve hospital-to-home transitions for children with asthma. Hosp Pediatr, 2019, 9(6): 460-463.
13.	Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care, 2007, 19(6): 349-357.
14.	Shapka JD, Domene JF, Khan S, et al. Online versus in-person interviews with adolescents: an exploration of data equivalence. Comput Human Behav, 2016, 58: 361-367.
15.	Morel T, Cano SJ. Measuring what matters to rare disease patients - reflections on the work by the IRDiRC taskforce on patient-centered outcome measures. Orphanet J Rare Dis, 2017, 12(1): 171.
16.	Gaglio B, Henton M, Barbeau A, et al. Methodological standards for qualitative and mixed methods patient centered outcomes research. BMJ, 371: m4435.
17.	Pozzar RA, Xiong N, Hong F, et al. How does patient-centered communication in ovarian cancer care enhance patient well-being. A mixed methods study. Gynecol Oncol, 2022, 167(2): 261-268.
18.	Haider AH, Schneider EB, Kodadek LM, et al. Emergency department query for patient-centered approaches to sexual orientation and gender identity: the EQUALITY study. JAMA Intern Med, 2017, 177(6): 819-828.
19.	FDA. Patient-focused drug development glossary.
20.	Gleibs IH. Turning virtual public spaces into laboratories: thoughts on conducting online field studies using social network sites. Anal Soc Issues Public Policy, 2014, 14: 352-370.

1. Ameer B. Patient-reported outcomes: listening for what is most important in clinical care and patient-focused drug development. J Clin Pharmacol, 2021, 61(7): 845-847.
2. Mühlbacher AC, Juhnke C, Beyer AR, et al. Patient-focused benefit-risk analysis to inform regulatory decisions: the European Union perspective. Value Health, 2016, 19(6): 734-740.
3. Ho MP, Gonzalez JM, Lerner HP, et al. Incorporating patient-preference evidence into regulatory decision making. Surg Endosc, 2015, 29(10): 2984-2993.
4. Sharma NS. Patient centric approach for clinical trials: current trend and new opportunities. Perspect Clin Res, 2015, 6(3): 134-138.
5. FDA. CDER patient-focused drug development.
6. 宋彩梅. 美国食品药品监督管理局以患者为中心的药物开发系列指导原则1-《综合和有代表性的信息收集指导原则》介绍. 中国临床药理学杂志, 2021, 37(17): 2381-2384.
7. FDA. Patient-focused drug development: methods to identify what is important to patients.
8. FDA. Patient-focused drug development: collecting comprehensive and representative input.
9. FDA. Patient-focused drug development: incorporating clinical outcome assessments into endpoints for regulatory decision-making.
10. Elsawi R, Dainty K, Smith Begolka W, et al. The multidimensional burden of atopic dermatitis among adults: results from a large national survey. JAMA Dermatol, 2022, 158(8): 887-892.
11. Maurer M, Mangrum R, Hilliard-Boone T, et al. Understanding the influence and impact of stakeholder engagement in patient-centered outcomes research: a qualitative study. J Gen Intern Med, 2022, 37(Suppl 1): 6-13.
12. Parikh K, Hinds PS, Teach SJ. Using stakeholder engagement to develop a hospital-initiated, patient-centered intervention to improve hospital-to-home transitions for children with asthma. Hosp Pediatr, 2019, 9(6): 460-463.
13. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care, 2007, 19(6): 349-357.
14. Shapka JD, Domene JF, Khan S, et al. Online versus in-person interviews with adolescents: an exploration of data equivalence. Comput Human Behav, 2016, 58: 361-367.
15. Morel T, Cano SJ. Measuring what matters to rare disease patients - reflections on the work by the IRDiRC taskforce on patient-centered outcome measures. Orphanet J Rare Dis, 2017, 12(1): 171.
16. Gaglio B, Henton M, Barbeau A, et al. Methodological standards for qualitative and mixed methods patient centered outcomes research. BMJ, 371: m4435.
17. Pozzar RA, Xiong N, Hong F, et al. How does patient-centered communication in ovarian cancer care enhance patient well-being. A mixed methods study. Gynecol Oncol, 2022, 167(2): 261-268.
18. Haider AH, Schneider EB, Kodadek LM, et al. Emergency department query for patient-centered approaches to sexual orientation and gender identity: the EQUALITY study. JAMA Intern Med, 2017, 177(6): 819-828.
19. FDA. Patient-focused drug development glossary.
20. Gleibs IH. Turning virtual public spaces into laboratories: thoughts on conducting online field studies using social network sites. Anal Soc Issues Public Policy, 2014, 14: 352-370.

Chinese Journal of Evidence-Based Medicine

Technical essentials for collecting patient experience data in patient-focused drug development

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