Journal of clinical epidemiology
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The aim of the study was to quantify the risk of major congenital malformations (MCM) associated with first-trimester exposure to antiemetics. ⋯ First-trimester doxylamine-pyridoxine and metoclopramide exposure was associated with a significantly increased risk of overall and specific MCM.
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Randomized Controlled Trial Comparative Study
PROMIS 4-item measures and numeric rating scales efficiently assess SPADE symptoms compared with legacy measures.
The 5 SPADE (sleep, pain, anxiety, depression, and low energy/fatigue) symptoms are among the most prevalent and disabling symptoms in clinical practice. This study evaluates the minimally important difference (MID) of Patient-Reported Outcomes Measurement Information System (PROMIS) measures and their correspondence with other brief measures to assess SPADE symptoms. ⋯ A 2-step screening process for SPADE symptoms might use single-item NRS scores, proceeding to PROMIS scales for NRS scores ≥5. A PROMIS T-score change of three points represents a reasonable MID estimate, with two to four points approximating lower and upper bounds.
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The Trials within Cohorts (TwiCs) design is an alternative for pragmatic randomized controlled trials (RCTs) and might overcome disadvantages such as difficult recruitment, dropout after randomization to control, and contamination. We investigated the applicability of the TwiCs design in an exercise oncology study regarding the recruitment process, representativeness of the study sample, contamination, participation, and dropout. ⋯ The TwiCs design improved logistics in recruitment and prevented contamination, but noncompliance due to refusal of the intervention was higher compared with conventional pragmatic exercise oncology RCTs, which may dilute the estimated intervention effect.
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Recruitment to pragmatic trials is often difficult, and little is known about factors associated with key participation and treatment decisions. These were explored in the Prostate cancer testing and Treatment (ProtecT) study. ⋯ The comprehensive cohort design provided new insights into trial recruitment and participation decisions. Opportunities to improve recruitment by supporting recruiters with equipoise and patient preferences were identified.
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The Core Outcome Set-STAndards for Development (COS-STAD) contains 11 standards (12 criteria) that are deemed to be the minimum design recommendations for all core outcome set (COS) development projects. Cancer is currently the disease area with the highest number of published COSs and is a major cause of worldwide morbidity and mortality. The aim of this study was to provide a baseline of cancer COS standards. ⋯ With the exception of "scope" specification, there is much need for improvement. Poor reporting often made it challenging to assess whether minimum standards were met. The consensus process criteria were most difficult to assess, particularly those that required an assessment of being a priori. This is the first application of COS-STAD criteria to studies that have developed COSs and provides a baseline of cancer COS standards of development.