Checklist for the qualitative evaluation of clinical studies with particular focus on external validity and model validity

Bornhöft, Gudrun; Matthiessen, Peter F.; Maxion-Bergemann, S; Wolf, Ursula; Kienle, GS; Michalsen, Andreas; Vollmar, HC; Gilbertson, Simon

doi:10.1111/j.2042-7166.2006.tb04808.x

Cited by 19 publications

(27 citation statements)

References 25 publications

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“…Frameworks for the evaluation of external validity have been proposed, including qualitative studies, such as in integral ''process evaluations'' [270] and checklists [271]. Measures that incorporate baseline risk when calculating therapeutic effects, such as the number needed to treat to obtain one additional favourable outcome and the number needed to treat to produce one adverse effect, are helpful in assessing the benefit-to-risk balance in an individual patient or group with characteristics that differ from the typical trial participant [268,272,273].…”

Section: Item 21 Generalisability (External Validity Applicability)mentioning

confidence: 99%

CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials

Moher

Hopewell

Schulz

et al. 2010

Journal of Clinical Epidemiology

1,802

1,374

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Overwhelming evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Recent methodological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias. A group of scientists and editors developed the CONSORT (Consolidated Standards of Reporting Trials) statement to improve the quality of reporting of RCTs. It was first published in 1996 and updated in 2001. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major international editorial groups have endorsed the CONSORT statement. The statement facilitates critical appraisal and interpretation of RCTs. During the 2001 CONSORT revision, it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports. A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement. After an expert meeting in January 2007, the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement. This update improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition, such as selective outcome reporting bias. This explanatory and elaboration document-intended to enhance the use, understanding, and dissemination of the CONSORT statement-has also been extensively revised. It presents the meaning and rationale for each new and updated checklist item providing examples of good reporting and, where possible, references to relevant empirical studies. Several examples of flow diagrams are included. The CONSORT 2010 Statement, this revised explanatory and elaboration document, and the associated website (www.consort-statement.org) should be helpful resources to improve reporting of randomised trials.

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Section: Item 21 Generalisability (External Validity Applicability)mentioning

confidence: 99%

CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials

Moher

Hopewell

Schulz

et al. 2010

Journal of Clinical Epidemiology

1,802

1,374

View full text Add to dashboard Cite

show abstract

“…Concurrently, Egger et al (2003), analyzing 159 systematic reviews, found a bias toward more beneficial intervention effects in inadequately concealed and unblinded trials. Although numerous quality assessment scales (Chalmers et al 1981;Jadad et al 1996;Slim et al 2003;Westwood et al 2005) and checklists (e.g., Bornhoeft et al 2006;Higgins and Green 2006) have been suggested there is still little agreement neither about the definition of study quality nor about the method and structure of instruments. According to Deeks et al (2003) who identified 194 quality appraisal tools used in previous reviews and provided a comparison between the sixty most sophisticated instruments, we decided to employ the Downs and Black (1998) scale for the following reasons: (i) it allows for assessment of both randomized and non-randomized trials; (ii) it was shown to exhibit satisfactory reliability and inter-rater agreement and is easy to use; (iii) it is rather comprehensive pertaining to potential biases addressed (although Deeks et al 2003, still recommended inclusion of additional items like one addressing baseline comparability of groups, which we appreciated by way of including pre-test differences as a predictor variable).…”

Section: Inclusion/exclusion Criteriamentioning

confidence: 99%

A Comprehensive Meta-Analysis of Triple P-Positive Parenting Program Using Hierarchical Linear Modeling: Effectiveness and Moderating Variables

Nowak¹,

Heinrichs

2008

Clin Child Fam Psychol Rev

550

340

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A meta-analysis encompassing all studies evaluating the impact of the Triple P-Positive Parenting Program on parent and child outcome measures was conducted in an effort to identify variables that moderate the program's effectiveness. Hierarchical linear models (HLM) with three levels of data were employed to analyze effect sizes. The results (N=55 studies) indicate that Triple P causes positive changes in parenting skills, child problem behavior and parental well-being in the small to moderate range, varying as a function of the intensity of the intervention. The most salient findings of variables moderating the interventions' impact were larger effects found on parent report as compared to observational measures and more improvement associated with more intensive formats and initially more distressed families. Sample characteristics (e.g., child's age, being a boy) and methodological features (e.g., study quality) exhibited different degrees of predictive power. The analysis clearly identified several strengths of the Triple P system, most importantly its ability to effect meaningful improvement in parents and children. Some limitations pertain to the small evidence-base of certain formats of Triple P and the lack of follow-up data beyond 3 years after the intervention. Many of the present findings may be relevant to other evidence-based parenting programs.

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“…Global scoring using scales was composed of reporting quality, internal validity, and applicability of the results [26,27,32,41,45,46,48,50e67]. A small proportion of the scales distinguished evaluation of external and internal validity but did not provide separate scores for validity [30,31,44,68,69]. Checklists provided a more transparent evaluation of quality components.…”

Section: Quality Assessment With Scales or Checklistsmentioning

confidence: 99%

A systematic review of tools used to assess the quality of observational studies that examine incidence or prevalence and risk factors for diseases

Shamliyan

Kane

Dickinson

2010

Journal of Clinical Epidemiology

182

137

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Checklist for the qualitative evaluation of clinical studies with particular focus on external validity and model validity

Cited by 19 publications

References 25 publications

CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials

CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials

A Comprehensive Meta-Analysis of Triple P-Positive Parenting Program Using Hierarchical Linear Modeling: Effectiveness and Moderating Variables

A systematic review of tools used to assess the quality of observational studies that examine incidence or prevalence and risk factors for diseases

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