Statistical analysis of patient-reported outcome data in randomised controlled trials of locally advanced and metastatic breast cancer: a systematic review

Although patient-reported outcomes (PROs), such as health-related quality of life, are important endpoints in randomised controlled trials (RCTs), there is little consensus about the analysis, interpretation, and reporting of these data. We did a systematic review to assess the variability, quality, and standards of PRO data analyses in advanced breast cancer RCTs. We searched PubMed for English language articles published in peer-reviewed journals between Jan 1, 2001, and Oct 30, 2017. Eligible articles were those that reported PRO results from RCTs of adult patients with advanced breast cancer receiving anti-cancer treatments with reported sample sizes of at least 50 patients—66 RCTs met the selection criteria. Only eight (12%) RCTs reported a specific PRO research hypothesis. Heterogeneity in the statistical methods used to assess PRO data was observed, with a mixture of longitudinal and cross-sectional techniques. Not all articles addressed the problem of multiple testing. Fewer than half of RCTs (28 [42%]) reported the clinical significance of their findings. 48 (73%) did not report how missing data were handled. Our systematic review shows a need to improve standards in the analysis, interpretation, and reporting of PRO data in cancer RCTs. Lack of standardisation makes it difficult to draw robust conclusions and compare findings across trials. The Setting International Standards in the Analyzing Patient-Reported Outcomes and Quality of Life Data Consortium was set up to address this need and develop recommendations on the analysis of PRO data in RCTs

Novel applications of response time-based memory detection

Even professionals cannot accurately distinguish truth from lie without technological aids. The Concealed Information Test, a questioning protocol designed to reveal memory, has been shown to validly detect feigned ignorance. This dissertation addresses restrictions limiting the applied viability of the response time-based Concealed Information Test (RT-CIT) by investigating possible remedies. First, previous research has shown that the RT-CIT’s validity is reduced when only one testable piece of information is available. The findings suggest this is a result from examinees approaching the task differently when there is only one testable piece of information, but also that the presentation in different modalities increases the validity. Second, the RT-CIT does not detect the source of the tested knowledge. Therefore, critical information available to uninvolved people leads to false positive classifications. Contrary to the inventor’s initial publication, the modified Inducer RT-CIT protocol was not immune to this information contamination, but an alternative RT-based test, the autobiographical Implicit Association Test, was. Third, until now, the evaluation of RT-CIT data requires knowledge of critical information on the examiner’s side. I investigated two novel analytic methods that allow the RT-CIT to be used as an information gathering tool. Fourth, a technological innovation to test RT-CIT theory and to explore new RT-CIT measures, an analog keyboard that is sensitive to minimal finger movements, was introduced. Concealed information was marked by more partial errors – though they were quite rare. Taken together, the current dissertation demonstrates new applications of response time-based memory detection and thereby increases their appeal for practice

Novel applications of response time-based memory detection

Even professionals cannot accurately distinguish truth from lie without technological aids. The Concealed Information Test, a questioning protocol designed to reveal memory, has been shown to validly detect feigned ignorance. This dissertation addresses restrictions limiting the applied viability of the response time-based Concealed Information Test (RT-CIT) by investigating possible remedies. First, previous research has shown that the RT-CIT’s validity is reduced when only one testable piece of information is available. The findings suggest this is a result from examinees approaching the task differently when there is only one testable piece of information, but also that the presentation in different modalities increases the validity. Second, the RT-CIT does not detect the source of the tested knowledge. Therefore, critical information available to uninvolved people leads to false positive classifications. Contrary to the inventor’s initial publication, the modified Inducer RT-CIT protocol was not immune to this information contamination, but an alternative RT-based test, the autobiographical Implicit Association Test, was. Third, until now, the evaluation of RT-CIT data requires knowledge of critical information on the examiner’s side. I investigated two novel analytic methods that allow the RT-CIT to be used as an information gathering tool. Fourth, a technological innovation to test RT-CIT theory and to explore new RT-CIT measures, an analog keyboard that is sensitive to minimal finger movements, was introduced. Concealed information was marked by more partial errors – though they were quite rare. Taken together, the current dissertation demonstrates new applications of response time-based memory detection and thereby increases their appeal for practice