In studies of surgical interventions, an outcome is defined as an observation used to capture and assess the effect of treatment such as effectiveness (benefits) and assessment of side effects (risk). Given the inherent challenges to conducting randomized controlled trials in the surgical context, we are likely to rely on reports of non-randomized retrospective or prospective cohorts and case series to guide our decision-making about the risks and benefits of different surgical procedures for a given patient with velopharyngeal dysfunction (VPD). To date, studies of surgery for VPD have reported widely varying outcomes, particularly in relation to speech assessment. There has been a dearth of patient-reported outcomes included and sleep-disordered breathing has been inconsistently reported. Here we make the case for a core outcome set for reporting outcomes of surgery for VPD, which would facilitate the comparison of results between centers and inform clinical decision-making for patients who require surgery.

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Measuring and Reporting Outcomes in VPD Surgery

  • David J. A. Orr,
  • Catherine de Blacam

摘要

In studies of surgical interventions, an outcome is defined as an observation used to capture and assess the effect of treatment such as effectiveness (benefits) and assessment of side effects (risk). Given the inherent challenges to conducting randomized controlled trials in the surgical context, we are likely to rely on reports of non-randomized retrospective or prospective cohorts and case series to guide our decision-making about the risks and benefits of different surgical procedures for a given patient with velopharyngeal dysfunction (VPD). To date, studies of surgery for VPD have reported widely varying outcomes, particularly in relation to speech assessment. There has been a dearth of patient-reported outcomes included and sleep-disordered breathing has been inconsistently reported. Here we make the case for a core outcome set for reporting outcomes of surgery for VPD, which would facilitate the comparison of results between centers and inform clinical decision-making for patients who require surgery.