Article ; Online: Patient and public involvement is suboptimal in randomized controlled trials addressing a chronic condition.
Journal of clinical epidemiology
2023 Volume 160, Page(s) 71–82
Abstract: Objectives: To describe patient and public involvement (PPI) in randomized controlled trials (RCTs) addressing a chronic condition and to analyze whether PPI is associated with trial characteristics.: Study design and setting: We used PubMed search ... ...
| Abstract | Objectives: To describe patient and public involvement (PPI) in randomized controlled trials (RCTs) addressing a chronic condition and to analyze whether PPI is associated with trial characteristics. Study design and setting: We used PubMed search to identify RCTs addressing a chronic condition and published in journals with a mandatory PPI statement. Results: Across 101 RCTs; 40 (40%) reported PPI at any stage of the research process. PPI contribution occurred mostly at the design stage of RCTs (n = 36), especially for assessing the burden of the intervention (n = 24), and at the conduct stage (n = 21), with the elaboration of communication materials (n = 14). Less than one-third (13/40) of RCTs included PPI in the development or choice of outcome measures. As compared with non-PPI RCTs, PPI RCTs more frequently were published in The BMJ, had a corresponding author from the United Kingdom, reported a public funding source, had a higher inclusion rate, used usual care as a control and evaluated a digital intervention. PPI RCTs were associated with less frequent use of placebo as a control group. Conclusion: Our results underline that PPI is not uncommon in RCTs of chronic conditions but infrequently occurred at a key stage. Yet, the engagement of patients as a real partner in RCTs of chronic conditions should be enhanced. |
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| MeSH term(s) | Humans ; Randomized Controlled Trials as Topic ; Chronic Disease ; Patient Participation ; Outcome Assessment, Health Care ; United Kingdom | |||||
| Language | English | |||||
| Publishing date | 2023-06-24 | |||||
| Publishing country | United States | |||||
| Document type | Journal Article | |||||
| ZDB-ID | 639306-8 | |||||
| ISSN | 1878-5921 ; 0895-4356 | |||||
| ISSN (online) | 1878-5921 | |||||
| ISSN | 0895-4356 | |||||
| DOI | 10.1016/j.jclinepi.2023.06.012 | |||||
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| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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