P2-16-06: A Systematic Review of Standardised Clinical Outcomes and Patient Reported Outcome Measures (PROMS) in Breast Reconstruction.

Abstract

Abstract Introduction: Failure to prospectively define and report surgical complications across a range of study designs is a confounding factor that fundamentally compromises the interpretation of data on health-related quality of life (HRQL) and PROMS. The UK National Mastectomy and Breast Reconstruction audit on 5000 breast reconstruction patients found higher than expected levels of complications (including rates of reoperation and levels of infection). We aimed to analyze the reporting of complications in a systematic review of all studies evaluating PROMS in breast reconstruction since 19781. Methods: Efficace criteria for HRQL methodology were used to assess the inclusion eligibility for each study1. Two out of 34 eligible studies were excluded due to overlapping patient datasets and small numbers (n<5) of breast reconstruction cases. Two reviewers examined the reporting of complications. The study designs comprised: 2 randomised controlled trials (RCT); 10 prospective longitudinal studies (PLS) and 20 retrospective studies (RS). RCTs and PLS were evaluated for predefined complications, their grading according to Clavien-Dindo2 and their integration into the evaluation of PROMS results. RS were evaluated for the reporting of complications and their statistical methodology. Results: A total of 3213 patients were included in the 32 studies. The type of reconstruction was only recorded in 71% of patients. The majority of patients in these studies underwent abdominal flap reconstruction, compared to implant only techniques (32%), and less than 10% comprising Latissimus dorsi flaps. Only 19% of studies recorded complications with the majority (81%) failing to report any complications. Only 3 studies provided details of the numbers and level of complications amongst a total of 44 patients (1.4% of the total number of patients). Reported complications were graded and classified either as major (requiring surgical intervention) or minor comprising 55% and 45%, respectively. None of the RCT or PLS studies defined either the type or level of complications a priori, nor stratified complications based on risk factors such as age, body mass index, smoking and diabetes. Conclusion: There is a significant under estimation of the contribution of complications to HRQL and PROMS reporting. This fact diminishes the current evidence on the effects of breast reconstruction on PROMS. There should be collective efforts to improve the standards of documentation for clinical outcomes in breast reconstruction. This together with standardized reporting of PROMS will consolidate clinical evidence upon which decision-making and provision of patient information can be confidently based. 1. Winters ZE, Benson JR, Pusic AL. Annals of Surgery 2010;252(6):929–42 2. Dindo D et al. Annals of Surgery 2004;240(2):205–213 Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P2-16-06.