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This study analyzes pilot randomized clinical trials (RCTs) in hospitalized patients to understand feasibility assessment methods. Improving pilot RCT design and reporting can reduce research waste and enhance future trial value.

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Area of Science:

  • Clinical Trials Methodology
  • Health Services Research
  • Medical Research Design

Background:

  • Randomized clinical trials (RCTs) are resource-intensive, with failures in recruitment, group separation, and follow-up leading to research waste.
  • Pilot RCTs are crucial for assessing the viability of definitive trials, including recruitment, protocol adherence, and data collection.
  • Enhanced attention to the design, conduct, and reporting of pilot RCTs is necessary to maximize their value.

Purpose of the Study:

  • To describe and characterize the feasibility assessment methodology used in contemporary pilot RCTs involving hospitalized patients.
  • To identify common practices and variations in how feasibility is assessed in pilot trials across different medical and surgical specialties.

Main Methods:

  • A methodological study involving a systematic search for pilot/feasibility RCTs published within a recent timeframe (initially 6 months, expandable to 5 years).
  • Data extraction on key trial characteristics, feasibility assessment areas, methodology (e.g., pre-defined outcomes, progression criteria), and plans for definitive trials.
  • Descriptive statistical analysis of extracted data, stratified by intervention type, area of care, and comparator type.

Main Results:

  • The study will provide data on the key features of current pilot RCTs in hospitalized patients.
  • It will detail the specific feasibility assessment methodologies employed in these trials.
  • Findings will be summarized using descriptive statistics, offering insights into the landscape of pilot trial conduct.

Conclusions:

  • The findings will illuminate the methodologies used for feasibility assessment in contemporary pilot RCTs.
  • This knowledge can inform improvements in the design, conduct, and reporting of future pilot RCTs.
  • Ultimately, enhancing pilot RCTs will increase their value and contribute to reducing overall research waste.