Martha A Hellems, Matthew J Gurka, Gregory F Hayden
Statistical literacy for readers of Pediatrics: a moving target
Pediatrics
extra benefit programme physiotherapy addition advice alone following firsttime traumatic shoulder dislocation uncertain compared clinical costeffectiveness single session advice single session advice programme physiotherapy primary objective quantify draw inferences observed differences oxford shoulder instability score trial treatment groups 6 months post randomisation adults firsttime traumatic shoulder dislocation pragmatic multicentre superiority randomised controlled trial embedded qualitative study fortyone hospitals uk nhs adults radiologically confirmed firsttime traumatic anterior shoulder dislocation managed nonoperatively people neurovascular complications bilateral dislocations unable adhere trial procedures unable attend physiotherapy within 6 weeks injury previously randomised excluded participants received initial shoulder examination followed advice aid selfmanagement lasting 1 hour administered physiotherapist control participants randomised receive additional programme physiotherapy offered sessions lasting 30 minutes maximum duration 4 months date randomisation intervention primary outcome measure oxford shoulder instability score selfcompleted outcome measure containing 12 questions 04 points possible scores 0 worst function 48 best function measurements collected 6 weeks 3 months 6 months 12 months postal questionnaire 6 months primary outcome time point primary health outcome economic evaluation qualityadjusted lifeyear accordance national institute health care excellence guidelines 14 november 2018 14 march 2022 482 participants randomised advice n 240 advice programme physiotherapy n 242 participants 34 female mean age 45 years treatment arms balanced baseline statistically significant difference primary outcome advice advice plus programme physiotherapy 6 months primary intentiontotreat adjusted analysis favours physiotherapy 15 95 confidence interval 03 35 earlier 3month 6week time points oxford shoulder instability score 048 higher scores indicate better function probability physiotherapy costeffective willingnesstopay threshold 30000 095 found little difference primary outcome secondary outcomes advice additional physiotherapy sessions found likely costeffective however small imprecise incremental costs qualityadjusted lifeyears raise questions whether best use scarce physiotherapy resources given current service demands loss followup 27 however observed standard deviation much smaller anticipated changes parameters reduced number participants required observe planned target difference four points post hoc sensitivity analysis accounting missing data gives similar results research directed towards optimising selfmanagement strategies study registered isrctn63184243 award funded national institute health care research nihr health technology assessment programme nihr award ref 1616756 published full health technology assessment vol 28 22 see nihr funding awards website award information