Participant recruitment and attrition in surgical randomised trials with placebo controls versus non-operative controls: a meta-epidemiological study and meta-analysis.

OBJECTIVE: To compare differences in recruitment and attrition between placebo control randomised trials of surgery, and trials of the same surgical interventions and conditions that used non-operative (non-placebo) controls. DESIGN: Meta-epidemiological study. DATA SOURCES: Randomised controlled trials were identified from an electronic search of MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials from their inception date to 21 November 2018. STUDY SELECTION: Placebo control trials evaluating efficacy of any surgical intervention and non-operative control trials of the same surgical intervention were included in this study. 25 730 records were retrieved from our systemic search, identifying 61 placebo control and 38 non-operative control trials for inclusion in analysis. OUTCOME MEASURES: Primary outcome measures were recruitment and attrition. These were assessed in terms of recruitment rate (number of participants enrolled, as a proportion of those eligible) and overall attrition rate (composite of dropout, loss to follow-up and cross-overs, expressed as proportion of total sample size). Secondary outcome measures included participant cross-over rate, dropout and loss to follow-up. RESULTS: Unadjusted pooled recruitment and attrition rates were similar between placebo and non-operative control trials. Study characteristics were not significantly different apart from time to primary timepoint which was shorter in studies with placebo controls (365 vs 274 days, p=0.006). After adjusting for covariates (follow-up duration and number of timepoints), the attrition rate of placebo control trials was almost twice as high compared with non-operative controlled-trials (incident rate ratio (IRR) (95% CI) 1.8 (1.1 to 3.0), p=0.032). The incorporation of one additional follow-up timepoint (regardless of follow-up duration) was associated with reduced attrition in placebo control surgical trials (IRR (95% CI) 0.64 (0.52 to 0.79), p<0.001). CONCLUSIONS: Placebo control trials of surgery have similar recruitment issues but higher attrition compared with non-operative (non-placebo) control trials. Study design should incorporate strategies such as increased timepoints for given follow-up duration to mitigate losses to follow-up and dropout. PROSPERO REGISTRATION NUMBER: CRD42019117364.

Adherence by orthopaedic surgeons to AHPRA and Australian Orthopaedic Association advertising guidelines.

OBJECTIVES: To examine adherence to Australian Health Practitioner Regulation Agency (AHPRA) and Australian Orthopaedic Association (AOA) advertising guidelines by AOA members. DESIGN, SETTING: Cross-sectional survey, Australia. PARTICIPANTS: Two samples of AOA member orthopaedic surgeons: 81 randomly selected from a list of AOA members with publicly available contact details (AOA random sample); and a sample obtained by searching with Google for "orthopaedic surgeon" and the name of the major city in each of the eight Australian states and territories in turn; the top eight results for each search were considered for inclusion (AOA Google sample). MAIN OUTCOME MEASURES: Non-compliance of advertising material, by surgeon sample, with the AHPRA and AOA guidelines; associations between non-compliance and sample, state, location (metropolitan, regional), and subspecialty. RESULTS: Of the 81 surgeons in the AOA random sample, 52 (64%) were non-compliant with at least one aspect of the AHPRA guidelines, and 53 (65%) were non-compliant with at least one aspect of the AOA guidelines. Of the 59 surgeons in the AOA Google sample, 48 were non-compliant with the AHPRA guidelines (81%) and 46 with the AOA guidelines (78%). Incidence of non-compliance with the AHPRA guidelines was influenced by sample source (AOA Google v AOA random: incidence rate ratio [IRR], 1.37; 95% CI, 1.01-1.87), but not non-compliance with the AOA guidelines (IRR, 1.09; 95% CI, 0.77-1.55). CONCLUSION: A large proportion of AOA members who advertise online do not comply with AHPRA and AOA advertising guidelines.