ObjectivesThis review addresses the common problem of missing patient-reported outcome (PRO) data in clinical trials by assessing the current practice of their statistical handling as reported in... Show moreObjectivesThis review addresses the common problem of missing patient-reported outcome (PRO) data in clinical trials by assessing the current practice of their statistical handling as reported in publications of randomized controlled trials (RCTs) in patients with breast cancer.Study Design and SettingWe searched PubMed to identify RCTs evaluating biomedical treatments in breast cancer patients with at least one PRO endpoint published between January 2019 and February 2022. Two reviewers independently assessed the eligibility of the publications for this scoping review and extracted prespecified information on missing PRO data and related statistical practices.ResultsOf 1,598 publications identified, 118 trials met the inclusion criteria. Eighty-eight (74.6%) trials reported the extent of missing data, with 11 (9.3%) not containing any missing PRO data. Twenty-one (19.6%) trials explicitly stated the statistical approach for handling missing data, with a preference for single imputation over multiple imputation approaches (57.2%/19.0%). Only six (5.6%) trials reported a sensitivity analysis to examine the extent to the results being affected by changes in assumptions made about missing PRO data.ConclusionInternational efforts to raise awareness of the importance of accurately reporting state-of-the-art handling of missing PRO data are not yet fully reflected in the current literature of breast cancer RCTs. Show less
Over a century ago, the systematic evaluation of medical treatment outcomes was first described by Ernest Codman. At that time a too progressive thought, while the value of measuring the quality of... Show moreOver a century ago, the systematic evaluation of medical treatment outcomes was first described by Ernest Codman. At that time a too progressive thought, while the value of measuring the quality of care is seen nowadays.The NABON Breast Cancer Audit (NBCA) provides insight into the various care processes that are part of the complex multidisciplinary treatment of patients diagnosed with breast cancer. Results of the NBCA show a good and still improving quality of care for patients diagnosed with breast cancer. In addition, this thesis provides insight into a sub-area where variation between hospitals is found; the performance of an immediate breast reconstruction in patients undergoing mastectomy. Many factors influence this hospital variation, such as patient and tumour factors, hospital factors and differences in indications for immediate breast reconstruction between surgeons and plastic surgeons. Physicians should inform patients about the various breast cancer treatment options. Informing a patient about immediate breast reconstruction results in a 14 times higher chance of actually undergoing a breast reconstruction after mastectomy.These factors should to be evaluated and improved as quality of life is higher for patients with immediate breast reconstruction than with mastectomy alone. By continuously measuring, providing feedback and acting on the data found at both a national level and in the consultation room, Ernest Codman's heritage will certainly be realized. Show less
