Content of reports on clinical trials: A critical review

Meinert, Curtis L.; Tonascia, Susan; Higgins, Karen

doi:10.1016/s0197-2456(84)80013-6

Cited by 55 publications

(22 citation statements)

References 128 publications

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“…Improper handling of exclusions after randomisation introduces bias 10 11 12 13 14 15 16 17 18 19. Unfortunately, many trials in our study provided inadequate information on exclusions, which corroborates previous research 20 21 24. Authors must provide complete information on exclusions after randomisation and whether the primary analysis used the intention to treat principle 3.…”

Section: Discussionsupporting

confidence: 72%

Blinding and exclusions after allocation in randomised controlled trials: survey of published parallel group trials in obstetrics and gynaecology

Schulz

Grimes

Altman³

et al. 1996

BMJ

146

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Investigators could have double blinded more often. When they did double blind, they reported poorly and rarely evaluated it. Paradoxically, trials that reported exclusions seemed generally of a higher methodological standard than those that had no apparent exclusions. Exclusions from analysis may have been made in some of the trials in which no exclusions were reported. Editors and readers of reports of randomised trials should understand that flawed reporting of exclusions may often provide a misleading impression of the quality of the trial.

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Section: Discussionsupporting

confidence: 72%

Blinding and exclusions after allocation in randomised controlled trials: survey of published parallel group trials in obstetrics and gynaecology

Schulz

Grimes

Altman³

et al. 1996

BMJ

146

View full text Add to dashboard Cite

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“…27 After these early studies there was a steady trickle of similar studies, examining the reporting of clinical trials in journal articles. [28][29][30][31][32][33] Recent years have seen a vast number of such studies. Dechartres and colleagues identified 177 literature reviews published from 1987 to 2007, 58% of which were published Box 2.…”

Section: Assessing Published Reports Of Clinical Trialsmentioning

confidence: 99%

A history of the evolution of guidelines for reporting medical research: the long road to the EQUATOR Network

2016

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“…There has been an increase in reporting of sample size calculation from 4% of clinical trials in 1980 to 83% in 2002. 11,12 An investigation of all RCTs indexed in PubMed in the years 2000 and 2006 show that while sample size parameters were only reported in 27% of trials in 2000, this increased to 45% of trials in 2006. 13 Reporting of sample size calculations in prosthodontic RCTs is similarly inadequate.…”

Section: Discussionmentioning

confidence: 99%

Reporting of Sample Size Parameters in Randomized Controlled Trials Published in Prosthodontic Journals

Dumbrigue¹,

Dumbrigue

et al. 2019

Journal of Prosthodontics

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Purpose An important consideration in the proper planning of randomized controlled trials (RCTs) is the determination of sample size. A study may fail to answer its research question if the sample size is inadequate, while a large enough sample size may be impractical to implement. The purpose of this study is to describe the reporting of sample size methodology and parameters used in RCTs published in prosthodontic journals. Materials and Methods A MEDLINE search for publications categorized as RCTs was conducted for articles in The Journal of Prosthodontics and The Journal of Prosthetic Dentistry published from 2008 to 2017. The Abstract and Methodology sections of RCTs identified were reviewed, and the following data recorded: reporting of method used to calculate sample size and reporting of parameters used for sample size calculation ‐ type I error (α), type II error (β) or power, minimal clinically relevant difference (MCRD), and variability. Results The search strategy retrieved 96 articles; 42 met inclusion criteria for RCTs and were reviewed. Fifty percent (21) of RCTs reported how sample size was determined, but only 17% (7) of RCTs reported all 4 parameters. Type I error (α) was reported in 90% (38) of RCTs, 38% (16) reported power, while only 26% (11) and 12% (5) reported MCRD and variability, respectively. Conclusion Methodology and parameters used for sample size determination are inadequately reported in RCTs published in prosthodontic journals.

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Content of reports on clinical trials: A critical review

Cited by 55 publications

References 128 publications

Blinding and exclusions after allocation in randomised controlled trials: survey of published parallel group trials in obstetrics and gynaecology

Blinding and exclusions after allocation in randomised controlled trials: survey of published parallel group trials in obstetrics and gynaecology

A history of the evolution of guidelines for reporting medical research: the long road to the EQUATOR Network

Reporting of Sample Size Parameters in Randomized Controlled Trials Published in Prosthodontic Journals

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