Journal of clinical epidemiology
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Multicenter Study
The trials within cohorts design facilitated efficient patient enrollment and generalizability in oncology setting.
The trials within cohorts (TwiCs) design aims to improve recruitment efficiency. We conducted the first TwiCs in radiation oncology and described efficiency of the design and generalizability of the results. ⋯ The TwiCs design is feasible, allows enrollment of a high proportion of randomizable patients, with positive impact on trial efficiency and generalizability of results in a clinical oncology setting.
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Multicenter Study
Evidence to Decision framework provides a structured "roadmap" for making GRADE guidelines recommendations.
It is unclear how guidelines panelists discuss and consider factors (criteria) that are formally and not formally included in the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. To describe the use of decision criteria, we explored how panelists adhered to GRADE criteria and sought to identify any emerging non-GRADE criteria when the panelists used the Evidence to Decision (EtD) framework as part of GRADE application. ⋯ The GRADE EtD framework provides structure to guidelines panel meetings, and ensures that the panelists consider all established formal GRADE criteria as they decide on the recommendation text, strength, and direction (for or against an intervention). This is the first study assessing the use of GRADE's EtD framework during real-time guidelines development using panel discussions. Given the widespread use of GRADE, this study provides important information for practice recommendations generated when guidelines panels explicitly follow, in a transparent and systematic manner, the structured GRADE EtD framework. By recognizing the extent to which panels discuss and consider GRADE and other (non-GRADE) criteria for producing guideline recommendations, we are one step closer to understanding the decision-making process in panels that use a structured framework such as the GRADE EtD framework.
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Multicenter Study
Do clinicians want recommendations? A multicenter study comparing evidence summaries with and without GRADE recommendations.
Evidence-based clinical practice guidelines provide recommendations to assist clinicians in decision-making and to reduce the gap between best current research evidence and clinical practice. However, some argue that providing preappraised evidence summaries alone, rather than recommendations, is more appropriate. The objective of the study is to evaluate clinicians' preferences, and understanding of the evidence and intended course of action in response to evidence summaries with and without recommendations. ⋯ Evidence summaries alone are not enough to impact clinicians' course of action. Clinicians clearly prefer having recommendations accompanying evidence summaries in the context of low or very low certainty of evidence (Trial registration NCT02006017).
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Randomized Controlled Trial Multicenter Study Pragmatic Clinical Trial
A prospective cohort and extended comprehensive-cohort design provided insights about the generalizability of a pragmatic trial: the ProtecT prostate cancer trial.
Randomized controlled trials (RCTs) deliver robust internally valid evidence but generalizability is often neglected. Design features built into the Prostate testing for cancer and Treatment (ProtecT) RCT of treatments for localized prostate cancer (PCa) provided insights into its generalizability. ⋯ The design features of the ProtecT RCT provided data to assess the representativeness of the prospective cohort and generalizability of the findings of the RCT. Greater attention to collecting data at the design stage of pragmatic trials would better support later judgments by clinicians/policy-makers about the generalizability of RCT findings in clinical practice.
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Multicenter Study
Five comorbidities reflected the health status in patients with chronic obstructive pulmonary disease: the newly developed COMCOLD index.
This study aimed to identify those comorbidities with greatest impact on patient-reported health status in patients with chronic obstructive pulmonary disease (COPD) and to develop a comorbidity index that reflects their combined impact. ⋯ The COMCOLD index reflects the combined impact of five important comorbidities from patients' perspective and complements existing comorbidity indices that predict death. It may help clinicians focus on comorbidities affecting patients' health status the most.