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Reporting of PPI and the MCID in phase III/IV randomised controlled trials-a systematic review
Joseph Brennan1, Michael T C Poon2,3, Edward Christopher1
1Royal Infirmary of Edinburgh, Edinburgh, EH16 4SA, UK.
Background:
Patient and public involvement (PPI) in clinical trial design contributes to ensuring the research objectives and outcome measures are relevant to patients. The minimal clinically important difference (MCID) in the primary outcome influences trial design and feasibility and should be predicated on PPI. We aimed to determine current practice of reporting PPI and the MCID in phase III/IV randomised controlled trials (RCTs).
Methods:
Following a search of Medline, Embase, and the Cochrane Central Register of Controlled Trials, we included primary publications of phase III/IV RCTs, in English, inclusive of any medical specialty or type of intervention, that reported a health-related outcome. We excluded protocols and secondary publications of RCTs. We extracted RCT characteristics, the use of PPI, and use of the MCID.
Results:
Between 1 July 2019 and 13 January 2020, 123 phase III/IV RCTs matched our eligibility criteria. Ninety percent evaluated a medical rather than surgical intervention. Oncology accounted for 21% of all included RCTs. Only 2.4% (n = 3) and 1.6% (n = 2) RCTs described PPI and the MCID respectively.
Conclusions:
PPI and the MCID are poorly reported, so it is uncertain how these contributed to trial design. Improvement in the reporting of these items would increase confidence that results are relevant and clinically significant to patients, contributing to improving the overall trial design.
Trial Registration:
Not registered.
Insights
Patient and public involvement (PPI) and minimal clinically important difference (MCID) are rarely reported in phase III/IV clinical trials. Improved reporting is crucial for ensuring trial relevance and clinical significance to patients.
Area of Science:
- Clinical Trial Design
- Patient-Centered Research
- Health Outcomes Research
Background:
- Patient and Public Involvement (PPI) is vital for aligning clinical trial objectives and outcomes with patient needs.
- The Minimal Clinically Important Difference (MCID) is essential for trial design and feasibility, and should incorporate PPI.
- Current practices in reporting PPI and MCID in Phase III/IV Randomized Controlled Trials (RCTs) require investigation.
Approach:
- A systematic literature search was conducted across Medline, Embase, and the Cochrane Central Register of Controlled Trials.
- Included were primary publications of Phase III/IV RCTs reporting health-related outcomes, excluding protocols and secondary publications.
- Data extracted included RCT characteristics, PPI utilization, and MCID reporting.
Key Points:
- Out of 123 eligible Phase III/IV RCTs published between July 2019 and January 2020, 90% focused on medical interventions, with 21% in oncology.
- Only 2.4% of RCTs reported PPI, and a mere 1.6% reported MCID.
- This indicates a significant gap in reporting these critical elements in clinical trial design.
Conclusions:
- Patient and Public Involvement (PPI) and Minimal Clinically Important Difference (MCID) are inadequately reported in current clinical trials.
- The lack of reporting makes it difficult to ascertain their contribution to trial design and relevance.
- Enhancing the reporting of PPI and MCID will increase confidence in the clinical significance and patient relevance of trial outcomes, ultimately improving trial design.
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