Methods of Randomized Controlled Clinical Trials in Health Services Research

Balas, E. Andrew; Austin, Suzanne; Ewigman, Bernard; Brown, Gordon D.; Mitchell, Joyce A.

doi:10.1097/00005650-199507000-00005

Cited by 52 publications

(38 citation statements)

References 33 publications

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“…RCTs were evaluated using a 100-point evaluation tool that has been cited in the literature and used previously for similar reviews. [4][5][6] Non-randomised, controlled or observational studies were assessed using a 10-point rating scale that has also been cited in similar reviews of CDSS in the literature and is designed to accommodate evaluation of nonrandomised trials. 3,7,8 Minimum scoring requirements for inclusion in the final review were set at 50 for RCT's and five for non-randomised or observational trials.…”

Section: Study Evaluationmentioning

confidence: 99%

The use and effectiveness of electronic clinical decision support tools in the ambulatory/primary care setting: a systematic review of the literature

Bryan¹,

Boren²

2008

Journal of Innovation in Health Informatics

114

105

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Section: Study Evaluationmentioning

confidence: 99%

The use and effectiveness of electronic clinical decision support tools in the ambulatory/primary care setting: a systematic review of the literature

Bryan¹,

Boren²

2008

Journal of Innovation in Health Informatics

114

105

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“…Global Health (1) scale$; (2) critical appraisal tool; (3) critical appraisal; (4) critical appraisal review; (5) appraisal of research methodology; (6) research design review; (7) quality assessment; (8) 1 or 2 or 3 or 4 or 5 or 6 or 7; (9) randomized controlled trial; (10) 8 and 9 80 HealthSTAR (1) scale$; (2) critical appraisal tool; (3) critical appraisal; (4) critical appraisal review; (5) appraisal of research methodology; (6) research design review; (7) quality assessment; (8) 1 or 2 or 3 or 4 or 5 or 6 or 7; (9) randomized controlled trial; (10) The included studies accounted for 21 scales and their modifications including: Jadad, 15,17,19,25,27,[60][61][62]64,[67][68][69]71,72,78,80,118,120,121,144 Maastricht, 3,62,126 Delphi List, 23,28,79,[81][82][83]90,92,99,[107][108][109][110] 13, 74,77,130,131,140,141 Maastricht-Amsterdam List (MAL), 29,85-90,93-97,99 -102,104 -106,112, 113,143 Van Tulder, 81, 82, 84, 91,92,98,103,107,108,110,111,114,142 Bizzini,26 Chalmers, 14,16,22,63,65,70,117,124,125,[127][128][129]138,139 Reisch,122,123 Andrew,115,116 Imperiale, 135 Detsky, 16,59 Cho and Bero, 119 Balas, 133 Sindhu, 20 Downs and Black,134 Nguyen, 137 Oxford Pain Validity Scale (OPVS), 21 Arrivé, 76 18,66,73,…”

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confidence: 99%

Scales to Assess the Quality of Randomized Controlled Trials: A Systematic Review

et al. 2008

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Background and PurposeThe methodological quality of randomized controlled trials (RCTs) is commonly evaluated in order to assess the risk of biased estimates of treatment effects. The purpose of this systematic review was to identify scales used to evaluate the methodological quality of RCTs in health care research and summarize the content, construction, development, and psychometric properties of these scales. MethodsExtensive electronic database searches, along with a manual search, were performed. ResultsOne hundred five relevant studies were identified. They accounted for 21 scales and their modifications. The majority of scales had not been rigorously developed or tested for validity and reliability. The Jadad Scale presented the best validity and reliability evidence; however, its validity for physical therapy trials has not been supported. Discussion and ConclusionMany scales are used to evaluate the methodological quality of RCTs, but most of these scales have not been adequately developed and have not been adequately tested for validity and reliability. A valid and reliable scale for the assessment of the methodological quality of physical therapy trials needs to be developed. T he medical literature is an important resource to guide clinical decision making and research. The evaluation of the methodological quality of studies is an essential step in the process of selecting the best clinical literature. According to Verhagen et al, 1 assessment of methodological quality involves evaluation of internal validity (the degree to which a study's design, conduct, and analysis have minimized biases) and external validity (the extent to which the results of a study can be generalized outside the experimental situation) as well as statistical analysis of primary research. Taken together, these validity constructs are important in determining the methodological quality of primary research. Khan et al 2 pointed out that some reasons for performing quality assessment include: to determine a minimum quality threshold for the selection of the primary studies for a systematic review; to explore differences in quality as an explanation for heterogeneity in study results; to weigh the results in proportion to the quality in metaanalysis; and, more importantly, to guide interpretation of findings, help determine the strength of inferences, and guide recommendations for future research and clinical practice.The assessment of the quality of controlled trials is essential because variations in the quality of trials can affect the conclusions about the existing evidence. 3 In a review of trials evaluating primarily medical treatments, Moher and colleagues 4,5 demonstrated that trials that did not include features such as blinding and allocation concealment tended to report an exaggerated treatment effect compared with trials that did include these features. These facts emphasize the importance of methodological quality assessment in order to provide accurate information on therapeutic effects.Trial quality can be divided ...

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“…4 Furthermore, estimates of intervention efficacy are exaggerated by 30% to 37% in RCTs with unclear or inadequate allocation concealment 3,4 and by 17% in RCTs without double-blinding. 3 The quality of RCTs has been shown to improve with time 9,10 and to differ between intervention areas in primary health care. 11 An increasing number of RCTs are multicentered and sponsored by the industry.…”

mentioning

confidence: 99%

Randomized clinical trials inHepatology: Predictors of quality

1999

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Evidence shows that the quality of randomized clinical trials (RCTs) affects estimates of intervention efficacy, which is significantly exaggerated in low-quality trials. The present study examines the quality of all 235 RCTs published in HEPATOLOGY from the initiation in 1981 through August 1998. Quality was assessed by means of a validated 5-point scale and separate quality components associated with empirical evidence of bias. Only 26% of all RCTs reported sample size calculations, 52% adequate generation of the allocation sequence, 34% adequate allocation concealment and 34% double-blinding. The median quality score of all trials was 3 points (range, 1-5 points). Multiple logistic regression analysis explored the association between quality and therapeutic areas, number of centers, external funding, year of publication, and country of origin. Highquality trials were most likely to investigate portal hypertension (odds ratio Randomized clinical trials (RCTs) and systematic reviews of RCTs are the most reliable tools in estimating intervention efficacy. 1 However, deficiencies in the quality of the design, conduct, and report of RCTs may bias the estimates of intervention efficacy. [2][3][4][5] To quantify the quality of RCTs, a number of scales have been developed. 6 A main limitation of quality assessments is that there is no comparative gold standard. However, one quality scale 7 has been validated against the quantitative results of RCTs. 4,8 A low-quality score was associated with 34% exaggeration of the estimated intervention efficacy. 4 Furthermore, estimates of intervention efficacy are exaggerated by 30% to 37% in RCTs with unclear or inadequate allocation concealment 3,4 and by 17% in RCTs without double-blinding. 3 The quality of RCTs has been shown to improve with time 9,10 and to differ between intervention areas in primary health care. 11 An increasing number of RCTs are multicentered and sponsored by the industry. 12 The quality of RCTs in relation to the number of participating centers has not previously been examined, but the quality of trials sponsored by drug companies was not significantly different when compared with trials with other sponsors. 13 One study found the peer reviewing in Gastroenterology biased against nonAmerican authors. 14 It is not known whether this nationality bias is reflected in the quality of published RCTs.[Insufficient registration of RCTs 9,15-18 and publication bias 19 limit the precision in estimates of intervention efficacy. 20 The specialist literature is being handsearched by the Cochrane Hepato-Biliary Group* 21-23 to identify RCTs 9,16,18 and expand the basis on which systematic reviews are performed. 16 The main objective of the present study was to describe the quality of all RCTs published as original articles in HEPATOL-OGY. † The quality assessment describes the confidence that the design, conduct, and report of a RCT will restrict bias. Quality was assessed by means of a validated scale 7 and separate components, which have been associated with empiri...

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Methods of Randomized Controlled Clinical Trials in Health Services Research

Cited by 52 publications

References 33 publications

The use and effectiveness of electronic clinical decision support tools in the ambulatory/primary care setting: a systematic review of the literature

The use and effectiveness of electronic clinical decision support tools in the ambulatory/primary care setting: a systematic review of the literature

Scales to Assess the Quality of Randomized Controlled Trials: A Systematic Review

Randomized clinical trials inHepatology: Predictors of quality

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