Clinical trials during pandemic in primary care: Low number and low validity after one-year experience

Tatsioni, Athina; Siountri, Iliana; Tsamoulis, Donatos; Vafeidou, Kyriaki

doi:10.1080/13814788.2021.1986279

Cited by 4 publications

(4 citation statements)

References 37 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Several clinical fields, including primary health care (PHC), have suggested the pragmatic design in randomized controlled trials (RCTs) as one of the approaches that inform whether an intervention should be adopted in practice 1,13 . PHC research has prioritized identifying effective care for populations with multiple morbidity or social determinants that jeopardize health equity, especially in periods of global crisis 18,19 . It also has aimed to evaluate how complex interventions, including behavioural approaches, and interventions on processes of care, can be implemented often under time and resource constraints 1 .…”

Section: Introductionmentioning

confidence: 99%

“…1,13 PHC research has prioritized identifying effective care for populations with multiple morbidity or social determinants that jeopardize health equity, especially in periods of global crisis. 18,19 It also has aimed to evaluate how complex interventions, including behavioural approaches, and interventions on processes of care, can be implemented often under time and resource constraints. 1 Pragmatic RCTs may help identify which interventions in PHC should be recommended or prioritized, thus providing all stakeholders with adequate information to understand the applicability and generalizability of the findings.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Generalizability of randomized controlled trials in primary health care: Applying the PRECIS‐2 tool on published protocols

Papagiannopoulou

Laiou

Tatsi³

et al. 2022

Evaluation Clinical Practice

Self Cite

View full text Add to dashboard Cite

Rationale: Pragmatic design may facilitate the generalizability of effectiveness of randomized controlled trials (RCTs) in primary health care (PHC). Aims and Objectives:The aim of this study was to investigate whether published protocols in PHC were designed pragmatically and to explore whether specific trial characteristics may be related to a pragmatic design.Methods: Using the Pragmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2), we assessed pragmatism for 123 published RCT protocols. For each domain, we calculated the mean score with the 95% confidence interval (95% CI).Interrater reliability was assessed by weighted κ-coefficient with 95% CI. We examined potential associations of published protocol characteristics with overall pragmatism by performing univariate and multivariate analyses. Results:We observed the highest score for primary analysis (4.66, 95% CI: 4.51, 4.82). The eligibility score was intermediate (3.16, 95% CI: 3.01, 3.32). Domains with scores towards the explanatory side included organization (2.50, 95% CI: 2.36, 2.63), flexibility of delivery (2.74, 95% CI: 2.60, 2.88) and flexibility of adherence (3.00, 95% CI: 2.83, 3.17). Interrater agreement was good (κ = 0.61; 95% CI: 0.34, 0.80; p < 0.001). Higher sample sizes were correlated to a pragmatic design (odds ratio: 6.86, 95% CI: 1.64, 28.75; p = 0.04). Conclusion:Most RCT protocols were rated as intermediate in the pragmaticexplanatory continuum. Future research may guide all stakeholders on how best to incorporate the level of pragmatism in the interpretation of the results so that the trials are more likely to be applicable in real-world settings.

show abstract

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Generalizability of randomized controlled trials in primary health care: Applying the PRECIS‐2 tool on published protocols

Papagiannopoulou

Laiou

Tatsi³

et al. 2022

Evaluation Clinical Practice

Self Cite

View full text Add to dashboard Cite

show abstract

“… 20 Recent articles on the COVID-19 pandemic also supported a scarcity of RCTs in PC. 21 PC clinical practice guidelines are often supported from evidence extrapolated by other specialty fields, often of uncertain relevance to PC patients. 22 Unlike other clinical fields, PC is based on a long-term relationship with the patients, and PC professionals have to factor in the family and other contextual factors including increasing social isolation, immigration, unemployment, and changes in the environment, on illness and health.…”

Section: Discussionmentioning

confidence: 99%

Health outcomes in primary care: a 20-year evidence map of randomized controlled trials

et al. 2022

Self Cite

View full text Add to dashboard Cite

Objective To quantify the different types of health outcomes assessed as primary outcomes in randomized controlled trials (RCTs) in the primary care (PC) setting during the last 20 years and identify whether potential gaps exist in specific types of health care and types of intervention. Methods We systematically searched PubMed, Scopus, and Cochrane Central Register of Controlled Trials, from January 2000 to September 2020 for published RCTs in PC. We recorded characteristics of eligible studies and mapped evidence by health outcome category (patient health outcomes, health services outcomes); and for each outcome category, by types of health care (preventive, acute, chronic, palliative), and by types of intervention (drug, behavioural, on structure, and on process). For RCTs assessing patient health outcomes as primary outcomes, we further mapped using the quality-of-care dimensions, that is, effectiveness, safety, and patient-centredness. Results Of the 518 eligible RCTs in PC, 357 (68.9%) evaluated a patient health outcome as the primary outcome, and 161 (31.1%) evaluated only health services outcomes as primary outcomes. Many focused on population with chronic illness (224 trials; 43.2%) and evaluated interventions on processes of health care (239 trials; 46.1%). Research gaps identified include preventive and palliative care, behavioural interventions, and safety and patient-centredness outcomes as primary outcomes. Conclusion Our evidence map showed research gaps in certain types of health care and interventions. It also showed research gaps in assessing safety and measures to place patient at the centre of health care delivery as primary outcomes.

show abstract

“…6 Researchers in primary care should consider that physical, behavioral, and social health are all intertwined, and thus achieving desirable outcomes may require complex interventions DOI: 10.32385/rpmgf.v38i5.13609 care, virtual monitoring, and self-care training for consideration in future research planning. [14][15][16][17] Complex interventions may incorporate main primary care characteristics, including the patient's first contact with the health care system, continuity, integration, and coordination of services. [18][19] Specific RCT designs including pragmatic, cluster or stepped-wedged trials may also be necessary to appropriately evaluate these interventions and ensure generalizability.…”

Section: Athina Tatsionimentioning

confidence: 99%

Clinical trials in primary care: bridging the gap between evidence-based recommendations and clinical practice

Tatsioni

2022

RPMGF

View full text Add to dashboard Cite

show abstract

Clinical trials during pandemic in primary care: Low number and low validity after one-year experience

Cited by 4 publications

References 37 publications

Generalizability of randomized controlled trials in primary health care: Applying the PRECIS‐2 tool on published protocols

Generalizability of randomized controlled trials in primary health care: Applying the PRECIS‐2 tool on published protocols

Health outcomes in primary care: a 20-year evidence map of randomized controlled trials

Clinical trials in primary care: bridging the gap between evidence-based recommendations and clinical practice

Contact Info

Product

Resources

About