ArticleBMC medical research methodology2006
Checklist for the qualitative evaluation of clinical studies with particular focus on external validity and model validity.
Article in BMC medical research methodology, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 9 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
28 citing papers in PubMed, 9 syntheses or guidelines pooled it.
- Identification of tools used to assess the external validity of randomized controlled trials in reviews: a systematic review of measurement properties.BMC medical research methodology · 2022Pooled it
- Pooled it
- Withdrawal reasons of randomized controlled trials on type 2 diabetes: a systematic review.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2021Pooled it
- Components of the transitional care model (TCM) to reduce readmission in geriatric patients: a systematic review.BMC geriatrics · 2020Pooled it
- Systematic mapping of checklists for assessing transferability.Systematic reviews · 2019Pooled it
- The external validity of randomized controlled trials of hypertension within China: from the perspective of sample representation.PloS one · 2013Pooled it
- Effects of Ginkgo biloba in dementia: systematic review and meta-analysis.BMC geriatrics · 2010Pooled it
- A comprehensive meta-analysis of Triple P-Positive Parenting Program using hierarchical linear modeling: effectiveness and moderating variables.Clinical child and family psychology review · 2008Pooled it
- [External validity of clinical trials for treatment of dementia with ginkgo biloba extracts].Zeitschrift fur Gerontologie und Geriatrie · 2008Pooled it
- A Randomized Three-Arm Double-Blind Placebo-Controlled Study of Homeopathic Treatment of Children and Youth with Attention-Deficit/Hyperactivity Disorder.Journal of integrative and complementary medicine · 2024Trial
- Representativeness of participants in a lifestyle intervention study in obese pregnant women - the difference between study participants and non-participants.Obesity facts · 2014Trial
- The current state of the quality of homeopathic clinical research.Complementary therapies in medicine · 2025Review
- Appraising clinical applicability of studies: mapping and synthesis of current frameworks, and proposal of the FrACAS framework and VICORT checklist.BMC medical research methodology · 2021Article
- A path analysis on the direct and indirect effects of the unit environment on eating dependence among cognitively impaired nursing home residents.BMC health services research · 2019Observational
- Whole Systems Research Methods in Health Care: A Scoping Review.Journal of alternative and complementary medicine (New York, N.Y.) · 2019Article
- Article
- "Just because you're pregnant, doesn't mean you're sick!" A qualitative study of beliefs regarding physical activity in black South African women.BMC pregnancy and childbirth · 2016Article
- Healthy ageing in Europe: prioritizing interventions to improve health literacy.BMC research notes · 2016Article
- The relationship between external and internal validity of randomized controlled trials: A sample of hypertension trials from China.Contemporary clinical trials communications · 2015Article
- How to assess the external validity and model validity of therapeutic trials: a conceptual approach to systematic review methodology.Evidence-based complementary and alternative medicine : eCAM · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIt is often stated that external validity is not sufficiently considered in the assessment of clinical studies. Although tools for its evaluation have been established, there is a lack of awareness of their significance and application. In this article, a comprehensive checklist is presented addressing these relevant criteria.
methodsThe checklist was developed by listing the most commonly used assessment criteria for clinical studies. Additionally, specific lists for individual applications were included. The categories of biases of internal validity (selection, performance, attrition and detection bias) correspond to structural, treatment-related and observational differences between the test and control groups. Analogously, we have extended these categories to address external validity and model validity, regarding similarity between the study population/conditions and the general population/conditions related to structure, treatment and observation.
resultsA checklist is presented, in which the evaluation criteria concerning external validity and model validity are systemized and transformed into a questionnaire format.
conclusionThe checklist presented in this article can be applied to both planning and evaluating of clinical studies. We encourage the prospective user to modify the checklists according to the respective application and research question. The higher expenditure needed for the evaluation of clinical studies in systematic reviews is justified, particularly in the light of the influential nature of their conclusions on therapeutic decisions and the creation of clinical guidelines.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.