PMID- 37259102
OWN - NLM
STAT- MEDLINE
DCOM- 20230602
LR  - 20240306
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 24
IP  - 1
DP  - 2023 May 31
TI  - Reporting of PPI and the MCID in phase III/IV randomised controlled trials-a 
      systematic review.
PG  - 370
LID - 10.1186/s13063-023-07367-0 [doi]
LID - 370
AB  - 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.
CI  - (c) 2023. The Author(s).
FAU - Brennan, Joseph
AU  - Brennan J
AD  - Royal Infirmary of Edinburgh, Edinburgh, EH16 4SA, UK.
FAU - Poon, Michael T C
AU  - Poon MTC
AUID- ORCID: 0000-0002-0053-2184
AD  - Tumour Centre of Excellence, Cancer Research UK Edinburgh Centre, Brain, 
      University of Edinburgh, Edinburgh, EH4 2XR, UK. michael.poon@ed.ac.uk.
AD  - Centre for Medical Informatics, Usher Institute, University of Edinburgh, Nine 
      BioQuarter, 9 Little France Road, Edinburgh, EH16 4UX, UK. michael.poon@ed.ac.uk.
FAU - Christopher, Edward
AU  - Christopher E
AD  - Royal Infirmary of Edinburgh, Edinburgh, EH16 4SA, UK.
FAU - Fulton, Olivia
AU  - Fulton O
AD  - Patient Advisory Group, Wellcome Trust Clinical Research Facility, Western 
      General Hospital, Edinburgh, EH4 2XU, UK.
FAU - Porteous, Carol
AU  - Porteous C
AD  - Patient and Public Involvement, Wellcome Trust Clinical Research Facility, 
      Western General Hospital, Edinburgh, EH4 2XU, UK.
FAU - Brennan, Paul M
AU  - Brennan PM
AD  - Tumour Centre of Excellence, Cancer Research UK Edinburgh Centre, Brain, 
      University of Edinburgh, Edinburgh, EH4 2XR, UK.
AD  - Translational Neurosurgery, Centre for Clinical Brain Sciences, University of 
      Edinburgh, Edinburgh, UK.
LA  - eng
GR  - 27589/CRUK_/Cancer Research UK/United Kingdom
GR  - C157/A27589/CRUK_/Cancer Research UK/United Kingdom
PT  - Journal Article
PT  - Review
PT  - Systematic Review
DEP - 20230531
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
SB  - IM
MH  - Humans
MH  - *Minimal Clinically Important Difference
MH  - *Outcome Assessment, Health Care
MH  - Randomized Controlled Trials as Topic
PMC - PMC10233858
OTO - NOTNLM
OT  - Minimal clinically important difference
OT  - Public and patient involvement
OT  - Randomised controlled trials
COIS- MTCP is supported by Cancer Research UK Brain Tumour Centre of Excellence Award 
      (C157/A27589). All other authors declare that they have no competing interests.
EDAT- 2023/06/01 01:08
MHDA- 2023/06/02 06:42
PMCR- 2023/05/31
CRDT- 2023/05/31 23:40
PHST- 2022/07/19 00:00 [received]
PHST- 2023/05/09 00:00 [accepted]
PHST- 2023/06/02 06:42 [medline]
PHST- 2023/06/01 01:08 [pubmed]
PHST- 2023/05/31 23:40 [entrez]
PHST- 2023/05/31 00:00 [pmc-release]
AID - 10.1186/s13063-023-07367-0 [pii]
AID - 7367 [pii]
AID - 10.1186/s13063-023-07367-0 [doi]
PST - epublish
SO  - Trials. 2023 May 31;24(1):370. doi: 10.1186/s13063-023-07367-0.