OBJECTIVE: To compare the estimated cost-effectiveness of childhood (adeno)tonsillectomy vs medical therapy for recurrent sore throats from the intention-to-treat (ITT) analysis of a randomized controlled trial (RCT) with that modeled on the recorded timing of surgical interventions as observed in all participants irrespective of their original group allocation. STUDY DESIGN: A pragmatic RCT (trial) with a parallel nonrandomized patient preference group (cohort) of (adeno)tonsillectomy vs medical therapy. SETTING: Five secondary care UK otolaryngology departments. SUBJECTS AND METHODS: Eligible children, aged 4 to 15 years, were enrolled to the trial (268) or cohort (461) groups. Outcomes included sore throat diaries, quality of life, and general practice consultations. The RCT protocol ITT analysis was compared with an as-treated analysis incorporating the cohort group, modeled to reflect the timing of tonsillectomy and the differential switch rates among the original groups. RESULTS: In the RCT ITT analysis, tonsillectomy saved 3.5 sore throats, whereas the as-treated model suggested an average reduction of more than 8 sore throats in 2 years for surgery within 10 weeks of consultation, falling to only 3.5 twelve months later due to the spontaneous improvement in the medical therapy group. CONCLUSION: In eligible UK school-age children, tonsillectomy can save up to 8 sore throats at a reasonable cost, if performed promptly. Further prospective data collection, accounting for baseline and per-trial preferences and choice, is urgently needed.
RCT Entities:
OBJECTIVE: To compare the estimated cost-effectiveness of childhood (adeno)tonsillectomy vs medical therapy for recurrent sore throats from the intention-to-treat (ITT) analysis of a randomized controlled trial (RCT) with that modeled on the recorded timing of surgical interventions as observed in all participants irrespective of their original group allocation. STUDY DESIGN: A pragmatic RCT (trial) with a parallel nonrandomized patient preference group (cohort) of (adeno)tonsillectomy vs medical therapy. SETTING: Five secondary care UK otolaryngology departments. SUBJECTS AND METHODS: Eligible children, aged 4 to 15 years, were enrolled to the trial (268) or cohort (461) groups. Outcomes included sore throat diaries, quality of life, and general practice consultations. The RCT protocol ITT analysis was compared with an as-treated analysis incorporating the cohort group, modeled to reflect the timing of tonsillectomy and the differential switch rates among the original groups. RESULTS: In the RCT ITT analysis, tonsillectomy saved 3.5 sore throats, whereas the as-treated model suggested an average reduction of more than 8 sore throats in 2 years for surgery within 10 weeks of consultation, falling to only 3.5 twelve months later due to the spontaneous improvement in the medical therapy group. CONCLUSION: In eligible UK school-age children, tonsillectomy can save up to 8 sore throats at a reasonable cost, if performed promptly. Further prospective data collection, accounting for baseline and per-trial preferences and choice, is urgently needed.
Authors: Anna Morad; Nila A Sathe; David O Francis; Melissa L McPheeters; Sivakumar Chinnadurai Journal: Pediatrics Date: 2017-01-17 Impact factor: 7.124
Authors: Rishi Mandavia; Alec Knight; Alexander W Carter; Connor Toal; Elias Mossialos; Peter Littlejohns; Anne Gm Schilder Journal: BMJ Open Date: 2018-09-12 Impact factor: 2.692