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A Historical Analysis of Randomized Controlled Trials in Anterior Cruciate Ligament Surgery.

Abstract The purpose of this systematic review was to comprehensively assess the quality of reporting of randomized controlled trials (RCTs) relating to anterior cruciate ligament (ACL) reconstruction. Specifically, this review explored factors related to the quality of the RCTs and trends in the quality of reporting over time.
PMID
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Authors

Mayor MeshTerms

Outcome Assessment (Health Care)

Keywords
Journal Title the journal of bone and joint surgery. american volume
Publication Year Start




PMID- 29257011
OWN - NLM
STAT- MEDLINE
DCOM- 20171227
LR  - 20171227
IS  - 1535-1386 (Electronic)
IS  - 0021-9355 (Linking)
VI  - 99
IP  - 24
DP  - 2017 Dec 20
TI  - A Historical Analysis of Randomized Controlled Trials in Anterior Cruciate
      Ligament Surgery.
PG  - 2062-2068
LID - 10.2106/JBJS.16.01408 [doi]
AB  - BACKGROUND: The purpose of this systematic review was to comprehensively assess
      the quality of reporting of randomized controlled trials (RCTs) relating to
      anterior cruciate ligament (ACL) reconstruction. Specifically, this review
      explored factors related to the quality of the RCTs and trends in the quality of 
      reporting over time. METHODS: The online databases PubMed, Ovid (MEDLINE), and
      Embase were used to search for all RCTs on the topic of ACL reconstruction from
      database inception until April 14, 2016. The quality of reporting was evaluated
      using the Detsky quality index and the Consolidated Standards of Reporting Trials
      (CONSORT) checklist for reporting trials of nonpharmacologic treatments. A
      multivariate regression analysis was used to assess predictors of quality
      reporting. RESULTS: The online search yielded 2,933 articles, 412 of which met
      the inclusion criteria and were assessed for quality of reporting. There was a
      significant (p < 0.0001) increase in the number of RCTs published over time. The 
      mean Detsky score (and standard deviation) across all included RCTs was 68.9% +/-
      13.2%. The strongest predictors of quality reporting were the inclusion of a
      CONSORT flow diagram (beta-coefficient, 10.0; 95% confidence interval [CI]: 8.45 
      to 11.61; p < 0.0001) and being published in the year 2009 or later
      (beta-coefficient, 5.2; 95% CI: 3.87 to 6.45; p < 0.0001). The factors
      demonstrating the greatest improvement over time were the inclusion of a full
      description of the randomization procedure (p = 0.001) and prospective
      calculation of the sample size (p = 0.002). CONCLUSIONS: There has been a
      significant increase in both the quantity and quality of RCTs relating to ACL
      reconstruction over time. Specifically, the reporting of a methodologically sound
      randomization process and prospective calculation of sample size have
      significantly improved in recent years. However, since the year 2009, the number 
      of trials and reporting in these trials has remained relatively consistent. The
      use of a CONSORT flow diagram is a strong predictor of high-quality reporting.
FAU - Kay, Jeffrey
AU  - Kay J
AD  - Division of Orthopaedic Surgery, Department of Surgery (J.K., M.M., D.d.S., and
      O.R.A.), and Department of Clinical Epidemiology and Biostatistics (N.S.),
      McMaster University, Hamilton, Ontario, Canada.
FAU - Memon, Muzammil
AU  - Memon M
AD  - Division of Orthopaedic Surgery, Department of Surgery (J.K., M.M., D.d.S., and
      O.R.A.), and Department of Clinical Epidemiology and Biostatistics (N.S.),
      McMaster University, Hamilton, Ontario, Canada.
FAU - Sa, Darren de
AU  - Sa D
AD  - Division of Orthopaedic Surgery, Department of Surgery (J.K., M.M., D.d.S., and
      O.R.A.), and Department of Clinical Epidemiology and Biostatistics (N.S.),
      McMaster University, Hamilton, Ontario, Canada.
FAU - Simunovic, Nicole
AU  - Simunovic N
AD  - Division of Orthopaedic Surgery, Department of Surgery (J.K., M.M., D.d.S., and
      O.R.A.), and Department of Clinical Epidemiology and Biostatistics (N.S.),
      McMaster University, Hamilton, Ontario, Canada.
FAU - Musahl, Volker
AU  - Musahl V
AD  - Department of Orthopaedic Surgery, University of Pittsburgh, Pittsburgh,
      Pennsylvania.
FAU - Fu, Freddie H
AU  - Fu FH
AD  - Department of Orthopaedic Surgery, University of Pittsburgh, Pittsburgh,
      Pennsylvania.
FAU - Karlsson, Jon
AU  - Karlsson J
AD  - Department of Orthopaedics, Institute of Clinical Sciences, The Sahlgrenska
      Academy, University of Gothenburg, Gothenburg, Sweden.
FAU - Ayeni, Olufemi R
AU  - Ayeni OR
AD  - Division of Orthopaedic Surgery, Department of Surgery (J.K., M.M., D.d.S., and
      O.R.A.), and Department of Clinical Epidemiology and Biostatistics (N.S.),
      McMaster University, Hamilton, Ontario, Canada.
AD  - Department of Orthopaedics, Institute of Clinical Sciences, The Sahlgrenska
      Academy, University of Gothenburg, Gothenburg, Sweden.
LA  - eng
PT  - Journal Article
PT  - Review
PL  - United States
TA  - J Bone Joint Surg Am
JT  - The Journal of bone and joint surgery. American volume
JID - 0014030
SB  - AIM
SB  - IM
MH  - Anterior Cruciate Ligament Injuries/*surgery
MH  - Anterior Cruciate Ligament Reconstruction/*methods
MH  - Canada
MH  - Checklist/*standards
MH  - Female
MH  - Humans
MH  - Male
MH  - *Outcome Assessment (Health Care)
MH  - Publications
MH  - Randomized Controlled Trials as Topic/*standards
EDAT- 2017/12/20 06:00
MHDA- 2017/12/28 06:00
CRDT- 2017/12/20 06:00
PHST- 2017/12/20 06:00 [entrez]
PHST- 2017/12/20 06:00 [pubmed]
PHST- 2017/12/28 06:00 [medline]
AID - 10.2106/JBJS.16.01408 [doi]
AID - 00004623-201712200-00002 [pii]
PST - ppublish
SO  - J Bone Joint Surg Am. 2017 Dec 20;99(24):2062-2068. doi: 10.2106/JBJS.16.01408.