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Background: Involving patients and consumers in research design helps ensure relevance for those affected by the problem being investigated and can optimize recruitment to clinical trials. This is particularly important when conducting research involving pregnant women. Aims: We investigated women's motivations to participate in a hypothetical randomized control trial (RCT) of a third-trimester screening test for intrapartum fetal compromise (IFC) and adverse perinatal outcomes. Materials and methods: Women attending for routine antenatal care at a tertiary center were invited to complete a short, anonymized patient acceptability survey. The survey was developed with the assistance of the Perinatal Society of Australia and New Zealand's Consumer Advisory Panel and consisted of Likert scales and open-ended questions. It was designed to ascertain women's responses to research issues, particularly the acceptability of being randomized to a non-revealed arm of a screening test RCT. Results: 100 pregnant women took part; 40% indicated that they would agree/strongly agree to participate in a hypothetical RCT regardless of whether they were given the result of a screening test and 31% were unsure. Randomization to either an intervention or control group was acceptable to 47%, 30% were unsure and 23% were not willing to be randomized. Reasons to participate included the desire to contribute to research and to improve pregnancy care. Conclusions: Participation in an RCT of a screening test for IFC involving non-disclosure of the test result was acceptable to a large minority of pregnant women. This finding supports the feasibility of conducting a large-scale study of this design. [ABSTRACT FROM AUTHOR]

Background: Evidence for the use of splints to reduce pain and improve function and quality of life in thumb carpometacarpal osteoarthritis (CMC OA) is sparse and poor despite recommendations by international guidelines. Objective: To outline the protocol for a study designed to determine the feasibility of conducting a fully powered pragmatic randomized controlled trial (RCT) comparing soft splint vs no splint for thumb CMC OA. Methods: The proposed pragmatic, assessor-blinded, and partial participant blinded parallel-group feasibility RCT will recruit 30 adults with thumb CMC OA and randomise to: splint intervention or usual care control. Randomization will be stratified by hand dominance. Primary feasibility outcomes are recruitment rate over a 4-month period, retention rate at 6 months, intervention acceptability, and rate of adverse events. Study costs, intervention fidelity, and clinical outcomes will also be evaluated. Measurements will be collected at baseline, 4 weeks, and 6 months post-initiation of treatment. This trial has been registered with the Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12618001639213. Major Findings: N/A. Conclusions: If shown to be effective, soft off-the shelf splints would be a good first-line non-pharmacological, non-surgical option for thumb CMC OA as prescribed by health professionals or accessed directly by patients. This feasibility study will inform a future, fully powered RCT as evaluated by success of the recruitment strategy; assessment time and acceptability; implementation and evaluation of 'usual care'; and intervention procedures and adherence. [ABSTRACT FROM AUTHOR]