Article type
Year
Abstract
Background: randomized clinical trials (RCT) are a specific type of study design that evaluates the effect (benefits and harms) of an intervention. When appropriately conducted, their rigorous methodology ensures that the only difference between study groups is the intervention under evaluation. The heterogeneity of the participants included is reduced by applying eligibility criteria (inclusion and exclusion criteria), which also improves the internal validity of the study. However, poorly justified reasons for exclusion criteria may also lead to a reduction of generalizability of findings, which deprives specific patient populations from having evidence available to inform their healthcare decision.
Objectives: to assess the appropriateness of exclusion criteria of RCTs published in the field of dentistry within the last two years.
Methods: we searched MEDLINE, Embase, CENTRAL and LILACs from March 2017 to March 2019 to identify potential records matching our inclusion criteria. Four reviewers (CU, AV, MM & AC) screened 25% of the records by title and abstract. Two pairs of reviewers (CU & AC, AV & MM) performed full-text eligibility assessment on 10% of those records. The four reviewers extracted descriptive data from the studies finally included with which to pilot the data extraction and assessment of exclusion criteria. We developed explicit criteria to assess the extent to which exclusion criteria were appropriately justified, as opposed to poorly justified. Identifying poorly justified exclusion criteria will allow us to explore further which subgroups of patients may have been unnecessarily prevented from participating in the trials. We will perform data extraction from all the included RCTs and assess the appropriateness of every exclusion criterion in those studies following an standardized process.
Results: we identified a total of 2132 records. After title and abstract screening, 639 records were included for full-text assessment. We randomly selected 64 studies (10%) from these studies, and assessed their final eligibility. From this pilot sample, we included 50 studies. These included RCTs were conducted in the areas of periodontology (n = 10), maxillofacial surgery (n = 8), sedation/anesthesia (n = 6), dental implants (n = 6), rehabilitation (n = 5), caries prevention/treatment (n = 5), oral pathology (n = 4), and six covered other conditions.
During the assessment of exclusion criteria, five studies failed to report information about the exclusion criteria they used. In addition, we classified 33 studies having poor justification for individual exclusions, and only 12 studies fulfilled our 'appropriately justified' classification. Definitive results will be presented at the Colloquium.
Conclusions: several RCTs failed to justify the reasons for their exclusion criteria. This issue could lead to unnecessary and undesirable exclusion of large segments of the population, and seriously threaten generalizability.
Patient or healthcare consumer involvement: not applicable
Objectives: to assess the appropriateness of exclusion criteria of RCTs published in the field of dentistry within the last two years.
Methods: we searched MEDLINE, Embase, CENTRAL and LILACs from March 2017 to March 2019 to identify potential records matching our inclusion criteria. Four reviewers (CU, AV, MM & AC) screened 25% of the records by title and abstract. Two pairs of reviewers (CU & AC, AV & MM) performed full-text eligibility assessment on 10% of those records. The four reviewers extracted descriptive data from the studies finally included with which to pilot the data extraction and assessment of exclusion criteria. We developed explicit criteria to assess the extent to which exclusion criteria were appropriately justified, as opposed to poorly justified. Identifying poorly justified exclusion criteria will allow us to explore further which subgroups of patients may have been unnecessarily prevented from participating in the trials. We will perform data extraction from all the included RCTs and assess the appropriateness of every exclusion criterion in those studies following an standardized process.
Results: we identified a total of 2132 records. After title and abstract screening, 639 records were included for full-text assessment. We randomly selected 64 studies (10%) from these studies, and assessed their final eligibility. From this pilot sample, we included 50 studies. These included RCTs were conducted in the areas of periodontology (n = 10), maxillofacial surgery (n = 8), sedation/anesthesia (n = 6), dental implants (n = 6), rehabilitation (n = 5), caries prevention/treatment (n = 5), oral pathology (n = 4), and six covered other conditions.
During the assessment of exclusion criteria, five studies failed to report information about the exclusion criteria they used. In addition, we classified 33 studies having poor justification for individual exclusions, and only 12 studies fulfilled our 'appropriately justified' classification. Definitive results will be presented at the Colloquium.
Conclusions: several RCTs failed to justify the reasons for their exclusion criteria. This issue could lead to unnecessary and undesirable exclusion of large segments of the population, and seriously threaten generalizability.
Patient or healthcare consumer involvement: not applicable
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