Differences in interaction and subgroup-specific effects were observed between randomized and nonrandomized studies in three empirical examples

Contains fulltext : 118275.pdf (publisher's version ) (Open Access)OBJECTIVE: To determine the comparability of subgroup-specific and interaction effects (differences between subgroups) between different study designs. STUDY DESIGN AND SETTING: We compared effects of interventions based on observational studies, randomized clinical trials (RCTs), and individual patient data meta-analyses (IPDMAs) of RCTs (reference) on three clinical topics: (1) mammography screening and breast cancer mortality, (2) coronary artery bypass surgery (CABG) and all-cause mortality, and (3) statins and incidence of major coronary events. Main, subgroup-specific, and interaction effects were compared. RESULTS: Main and subgroup-specific effects were comparable with respect to the direction of the effects. Differences in the magnitude of subgroup-specific effects in observational studies yielded different interactions compared with those in IPDMA. In the mammography example, the ratio of risk ratios (RRR) (i.e., interaction effect) among observational studies was 1.46 [95% confidence interval (CI): 1.09, 1.96] compared with an IPDMA effect of 1.10 (95% CI: 0.89, 1.37). For the CABG studies, the observational RRR was 1.03 (95% CI: 0.84, 1.26), whereas in the IPDMA, this was 1.40 (95% CI: 1.08, 1.1.81). Finally, in the statin example, the RRR was 1.35 (95% CI: 1.13, 1.61) and 0.90 (95% CI: 0.84, 0.97) for observational studies and IPDMA, respectively. CONCLUSION: Main and subgroup-specific effects based on observational data were similar to main and subgroup-specific effects in IPDMAs based on RCTs, yet interactions differed

Resilience in Lower Grade Glioma Patients

Current data show that resilience is an important factor in cancer patients’ well-being. We aim to explore the resilience of patients with lower grade glioma (LGG) and the potentially influencing factors. We performed a cross-sectional assessment of adult patients with LGG who were enrolled in the LoG-Glio registry. By phone interview, we administered the following measures: Resilience Scale (RS-13), distress thermometer, Montreal Cognitive Assessment Test for visually impaired patients (MoCA-Blind), internalized stigmatization by brain tumor (ISBI), Eastern Cooperative Oncological Group performance status (ECOG), patients’ perspective questionnaire (PPQ) and typical clinical parameters. We calculated correlations and multivariate regression models. Of 74 patients who were assessed, 38% of those showed a low level of resilience. Our results revealed significant correlations of resilience with distress (p < 0.001, −0.49), MOCA (p = 0.003, 0.342), ECOG (p < 0.001, −0.602), stigmatization (p < 0.001, −0.558), pain (p < 0.001, −0.524), and occupation (p = 0.007, 0.329). In multivariate analyses, resilience was negatively associated with elevated ECOG (p = 0.020, β = −0.383) and stigmatization levels (p = 0.008, β = −0.350). Occupation showed a tendency towards a significant association with resilience (p = 0.088, β = −0.254). Overall, low resilience affected more than one third of our cohort. Low functional status is a specific risk factor for low resilience. The relevant influence of stigmatization on resilience is a novel finding for patients suffering from a glioma and should be routinely identified and targeted in clinical routine