PMID- 34613468
OWN - NLM
STAT- MEDLINE
DCOM- 20221026
LR  - 20221026
IS  - 1432-1068 (Electronic)
IS  - 1633-8065 (Print)
IS  - 1633-8065 (Linking)
VI  - 32
IP  - 8
DP  - 2022 Dec
TI  - A review of trauma and orthopaedic randomised clinical trials published in 
      high-impact general medical journals.
PG  - 1469-1479
LID - 10.1007/s00590-021-03137-3 [doi]
AB  - INTRODUCTION: The recent past has seen a significant increase in the number of 
      trauma and orthopaedic randomised clinical trials published in "the big five" 
      general medical journals. The quality of this research has, however, not yet been 
      established. METHODS: We therefore set out to critically appraise the quality of 
      available literature over a 10-year period (April 2010-April 2020) through a 
      systematic search of these 5 high-impact general medical journals (JAMA, NEJM, 
      BMJ, Lancet and Annals). A standardised data extraction proforma was utilised to 
      gather information regarding: trial design, sample size calculation, results, 
      study quality and pragmatism. Quality assessment was performed using the Cochrane 
      Risk of Bias 2 tool and the modified Delphi list. Study pragmatism was assessed 
      using the PRECIS-2 tool. RESULTS: A total of 25 studies were eligible for 
      inclusion. Over half of the included trials did not meet their sample size 
      calculation for the primary outcome, with a similar proportion of these studies 
      at risk of type II error for their non-significant results. There was a high 
      degree of pragmatism according to PRECIS-2. Non-significant studies had greater 
      pragmatism that those with statistically significant results (p < 0.001). Only 
      56% studies provided adequate justification for the minimum clinically important 
      difference (MCID) in the population assessed. Overall, very few studies were 
      deemed high quality/low risk of bias. CONCLUSIONS: These findings highlight that 
      there are some important methodological concerns present within the current 
      evidence base of RCTs published in high-impact medical journals. Potential 
      strategies that may improve future trial design are highlighted. LEVEL OF 
      EVIDENCE: Level 1.
CI  - (c) 2021. The Author(s).
FAU - Farrow, Luke
AU  - Farrow L
AUID- ORCID: 0000-0002-1443-5908
AD  - Institute of Applied Health Sciences, University of Aberdeen, Foresterhill, 
      Aberdeen, AB25 2ZD, Scotland, UK. luke.farrow@abdn.ac.uk.
AD  - Aberdeen Royal Infirmary, Aberdeen, UK. luke.farrow@abdn.ac.uk.
FAU - Gardner, William T
AU  - Gardner WT
AD  - Aberdeen Royal Infirmary, Aberdeen, UK.
FAU - Ablett, Andrew D
AU  - Ablett AD
AD  - Edinburgh Royal Infirmary, Edinburgh, UK.
FAU - Kutuzov, Vladislav
AU  - Kutuzov V
AD  - Charing Cross Hospital, London, UK.
FAU - Johnstone, Alan
AU  - Johnstone A
AD  - Aberdeen Royal Infirmary, Aberdeen, UK.
LA  - eng
PT  - Journal Article
PT  - Review
PT  - Systematic Review
DEP - 20211006
PL  - France
TA  - Eur J Orthop Surg Traumatol
JT  - European journal of orthopaedic surgery & traumatology : orthopedie traumatologie
JID - 9518037
SB  - IM
MH  - Humans
MH  - Bias
MH  - *Orthopedics
MH  - *Periodicals as Topic
MH  - Randomized Controlled Trials as Topic
PMC - PMC9587938
OTO - NOTNLM
OT  - Orthopaedics
OT  - Quality
OT  - RCT
OT  - Review
OT  - Trauma
OT  - Trial
COIS- The authors have no relevant financial or non-financial interests to disclose.
EDAT- 2021/10/07 06:00
MHDA- 2022/10/26 06:00
PMCR- 2021/10/06
CRDT- 2021/10/06 12:32
PHST- 2021/07/11 00:00 [received]
PHST- 2021/09/26 00:00 [accepted]
PHST- 2021/10/07 06:00 [pubmed]
PHST- 2022/10/26 06:00 [medline]
PHST- 2021/10/06 12:32 [entrez]
PHST- 2021/10/06 00:00 [pmc-release]
AID - 10.1007/s00590-021-03137-3 [pii]
AID - 3137 [pii]
AID - 10.1007/s00590-021-03137-3 [doi]
PST - ppublish
SO  - Eur J Orthop Surg Traumatol. 2022 Dec;32(8):1469-1479. doi: 
      10.1007/s00590-021-03137-3. Epub 2021 Oct 6.