Inclusion and exclusion criteria and the problem of describing homogeneity of study populations in clinical trials

Porzsolt, Franz; Wiedemann, Felicitas; Becker, Susanne Isabel; Rhoads, CJ

doi:10.1136/bmjebm-2018-111115

Cited by 15 publications

(19 citation statements)

References 9 publications

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“…A total of 67% of the articles report exclusion criteria. This is consistent with previous reviews that demonstrated exclusion criteria defined in 69 out of 101 selected articles (Porzsolt et al, 2019). The importance of correctly defining exclusion criteria in clinical trials lies in integrating characteristics of subjects prone to lose during intervention or follow-up for various reasons, which, if not applied correctly, could increase the risk of both adverse events and biased results (Patino & Ferreira, 2018).…”

Section: What Was Already Known and Contrasted With The Findings Of This Review?supporting

confidence: 88%

Adherence characteristics and reasons for abandonment of physical exercise-based interventions in older adults in Latin America: A scoping review (Características de la adherencia y motivos del abandono de las intervenciones basadas en el ejercicio físic

Cigarroa¹,

Zapata-Lamana²,

Leiva-Gajardo³

et al. 2021

Retos

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This review describes the adherence characteristics and reasons for abandonment physical exercise-based interventions in older adults in Latin America. This scoping review was conducted in accordance with the PRISMA statement. Articles were searched in MEDLINE by PubMed, ELSEVIER by SCOPUS and SciELO. The MeSH terms "Exercise", Exercise Therapy" and "Aged" were used between 2015 and 2020. We searched for articles in Spanish, English, and Portuguese carried out in people aged 65 years and over.101 out of 4,642 randomized controlled trials (RCT) were included. A total sample of 5,013 older adults (79% women), with an average age of 68.2 years started their studies and 4,312 finished it, presenting an adherence to the interventions of 86%. Most of the studies were carried out in healthy older adults, in places enabled for the practice of physical activity, in charge of a physical activity professional, and the interventions were performed carried out through group therapeutic exercise. No article reported information on the minimum time of participation to the session to be considered as carried out. Only 30% of the articles reported the minimum participation of older adults in the intervention to include them in the study analysis, and 21% reported the average number of sessions attended to the intervention. The main reasons for abandonment were personal causes unrelated to the intervention. Only 5% of the articles reported injury of one of the participants (in two of them the injury was related to the intervention applied). This review characterized the physical exercise programs in older adults in Latin America, as well the adherence characteristics and the main reasons for abandonment to physical exercise-based interventions, by summarizing available evidence derived from RCTs. Resumen. Esta revisión describe las características de adherencia y motivos de abandono de las intervenciones basadas en ejercicio físico en adultos mayores en América Latina. Esta revisión de alcance se realizó de acuerdo con la declaración PRISMA. Los artículos fueron buscados en MEDLINE por PubMed, ELSEVIER por SCOPUS y SciELO. Los términos MeSH "Ejercicio", Terapia de ejercicio "y" Anciano "se utilizaron entre 2015 y 2020. Se buscaron artículos en español, inglés y portugués realizados en personas de 65 años o más. Se incluyeron 101 de 4.642 ensayos aleatorizados controlados (ECA), en una muestra total de 5.013 adultos mayores (79% mujeres), con una edad promedio de 68,2 años, que iniciaron sus estudios finalizando 4.312, presentando una adherencia a las intervenciones del 86%. La mayoría de los estudios fueron realizado en adultos mayores sanos, en lugares habilitados para la práctica de actividad física, a cargo de un profesional de actividad física, y las intervenciones se realizaron a través de ejercicio terapéutico grupal. Ningún artículo reportó información sobre el tiempo mínimo de participación a la sesión Sólo el 30% de los artículos informaron la participación mínima de los adultos mayores en la intervención para incluirlos en el análisis del estudio, y el 21% informó el número medio de sesiones. atendidos a la intervención. Los principales motivos de abandono fueron causas personales ajenas a la intervención. Solo el 5% de los artículos reportaron lesión de uno de los participantes (en dos de ellos la lesión estuvo relacionada con la intervención aplicada). Esta revisión caracterizó los programas de ejercicio físico en adultos mayores en América Latina, así como las características de adherencia y los principales motivos de abandono a las intervenciones basadas en ejercicio físico, al resumir la evidencia disponible derivada de ECA.

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Section: What Was Already Known and Contrasted With The Findings Of This Review?supporting

confidence: 88%

Adherence characteristics and reasons for abandonment of physical exercise-based interventions in older adults in Latin America: A scoping review (Características de la adherencia y motivos del abandono de las intervenciones basadas en el ejercicio físic

Cigarroa¹,

Zapata-Lamana²,

Leiva-Gajardo³

et al. 2021

Retos

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“…These data indicate: 1) although it is not possible (or maybe even desirable) to establish a list of de nitive categories for selection criteria, they seem to be limited across study subjects, their identi cation could be interesting to promote a better comparison between studies and some efforts of this sort can be found in the literature (9). 2) there are only a few categories that could serve as a guide for inclusion or exclusion, since most of the categories (10 out of 18 or about 56%) were found either listed as inclusion or exclusion criteria or even as both in some cases; 3) in at least one third of the situations in which the same category was mentioned as inclusion and exclusion this could be avoided and in most cases indicate a certain confusion about the role of the criteria for the study; 4) excluding particularities of cervical cancer studies only two categories remained as inclusion only and one as exclusion only.…”

Section: Discussionmentioning

confidence: 99%

“…The reported number was in 15% of studies lower than the IQR and in 21% of studies higher. Inclusion (exclusion) criteria were not reported in 25% (31%) of studies (9). However, there is no clear differentiation between these criteria or even these differential functions in many clinical trials, even though a precise description of them is important not only to identify the homogeneity/heterogeneity of the population studied, but also to assess the very internal and external validity of the study and to identify which studies are actually comparable.…”

Section: Introductionmentioning

confidence: 99%

Critical Appraisal on the Selection Criteria for Evidence-based Healthcare

Mayer

Gonçalves

Porzsolt³

2021

Preprint

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Background: Evidence-Based healthcare deals basically with published clinical trials to guide the decision making on what treatment to use for any specific conditions.Aims: The present paper assessed the inclusion and exclusion criteria used in clinical trials of cervical cancer aiming at establishing a clear distinction between each criterion.Methods: We performed a bibliographical search in pubmed with the terms cervical cancer and treatment or therapy filtered for clinical trials with human subjects for the last ten years. A total of 30 papers were used extracting and classifying the inclusion and exclusion category according to the characteristic they described. Results: We found no clear parameter to establish which criteria could exclusively serve as inclusion or exclusion across the papers, about 56% of the categories identified were found either listed as inclusion or exclusion criteria or even as both in some cases.Conclusions: The key issue of selection criteria is not in its form but in its function, the first point to consider is if the trial is experimental (focused on efficacy and proof of principle) or observational (pragmatic trials, focused on effectiveness and real world conditions). We suggest, inclusion criteria should be broad, focused on the investigated condition; exclusion criteria should apply only to the subset of this “included” population, and do not take part in observational studies. These conclusions do not serve only for researchers but should affect practitioners and policy makers to correctly compare the results of investigated treatment.

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“…No difference was found among the groups of studies for exclusion criteria. In real-world practice, patients are not excluded from treatment 13 15 16 48…”

Section: Discussionmentioning

confidence: 99%

Efficacy and effectiveness studies of depression are not well-differentiated in the literature: a systematic review

Schmaling

Kaplan

Porzsolt³

2020

BMJ EBM

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BackgroundIn the literature on the treatment of depression, efficacy and effectiveness research have different purposes and should apply different research methodologies.ObjectiveThe purpose of the study was to review characteristics of depression treatment studies identified using efficacy or effectiveness search terms. We considered subject inclusion and exclusion criteria; numbers of subjects enrolled and the proportion in the primary analyses; inclusion of a Consolidated Standards of Reporting Trials (CONSORT) flow diagram; use of random assignment; use of placebo control conditions; lengths of treatment and follow-up; primary outcome variable; trial registration; journal impact factor.Study selectionStudies indexed as efficacy AND ‘real-world’ AND depression or effectiveness AND ‘real-world’ AND depression in PubMed up to 18 May 2019.Findings27 studies met the inclusion criteria: 13 effectiveness studies, 6 efficacy studies and 8 studies indexed as both effectiveness and efficacy. Studies identified as effectiveness, efficacy, or both differed on three outcome measures: the inclusion criteria were lengthier for efficacy than for effectiveness studies; efficacy studies were more likely to have a placebo control condition than effectiveness studies; and the journal impact factor was lower for effectiveness studies than for studies from the efficacy search or studies identified by both searches.ConclusionsEfficacy and effectiveness research hypothetically use different methodologies, but the efficacy and effectiveness literatures in the treatment of depression were comparable for most of the coded characteristics. The lack of distinguishable characteristics suggests that variably applied terminology may hinder efforts to narrow the gap between research and practice.PROSPERO registration number#CRD42019136840.

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Inclusion and exclusion criteria and the problem of describing homogeneity of study populations in clinical trials

Cited by 15 publications

References 9 publications

Adherence characteristics and reasons for abandonment of physical exercise-based interventions in older adults in Latin America: A scoping review (Características de la adherencia y motivos del abandono de las intervenciones basadas en el ejercicio físic

Adherence characteristics and reasons for abandonment of physical exercise-based interventions in older adults in Latin America: A scoping review (Características de la adherencia y motivos del abandono de las intervenciones basadas en el ejercicio físic

Critical Appraisal on the Selection Criteria for Evidence-based Healthcare

Efficacy and effectiveness studies of depression are not well-differentiated in the literature: a systematic review

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