ObjectiveTo analyse voluntary payment reports of pharmaceutical companies to German healthcare professionals (HCPs) in 2015 and 2016 based on an industry-self-regulating transparency codex.Design and ...participantsCohort study of all German HCPs who voluntarily agreed that at least one payment they received in 2015 and 2016 from pharmaceutical companies is disclosed.Main outcome measuresNumber of HCPs who disclosed at least one payment in the database; separated by year of disclosure and whether they disclosed once or repeatedly. Amount of disclosed payments and distribution parameters of disclosed annual payment sums per person; separated by year of disclosure und whether they disclosed once or repeatedly.Results28 230 HCPs agreed to the disclosure of at least one payment in the database. In 2015, 19 905 HCPs agreed to the disclosure, decreasing to 15 782 HCPs in 2016. Whereas 7457 disclosed payments in both years, 12 448 disclosed only in 2015 and 8325 only in 2016. Payments of €32 426 721 in 2015 and €23 289 343 in 2016 were disclosed, that is, 27% and 23% of the total amounts spent on HCPs, respectively. Distribution of annual payments was skewed: the top 1% of HCPs disclosed annual payment sums between €17 049 and €200 194, while the median disclosed annual payment sum per person was €536 (IQR €1092). Disclosed payments were higher in male physicians and in physicians with higher academic degree.ConclusionsIf voluntary, disclosure rates of payments are low and therefore only provide a fragmented picture of interactions between HCPs and pharmaceutical companies. Efforts must be intensified to ensure obligatory disclosure of all payments worldwide.
ObjectivesTo investigate German physicians’ attitudes towards and experiences with voluntary disclosure of payments by pharmaceutical companies in a public database and their impact on future ...decisions for or against disclosure.DesignA national cross-sectional survey conducted in 2018 among physicians who voluntarily disclosed at least one payment in the German transparency regulation.SettingRetrospective paper-pencil questionnaire about attitudes towards and experiences with voluntary payment disclosures in the first (2015) and second (2016) years of the German transparency regulation.ParticipantsGerman physicians who disclosed either in the first year only, the second year only, or in both years of the transparency regulation.Primary outcomes(1) The probability to disclose in 2016, predicted by physicians’ experience of reactions from others in 2015, descriptive norms and attitudes towards transparency; (2) Frequency and (3) Content of reactions from others in 2015 compared with 2016.ResultsData of 234 respondents were analysed (n=42, 45 and 147 physicians who disclosed in 2015, 2016 or both years, respectively). The probability to disclose in 2016 was not predicted by perceived reactions, norms or attitudes towards transparency (p>0.01). Most participants reported not to have received any reactions by patients (190/234, 81%), colleagues (128/234, 55%) or the private environment (153/234, 65%). Neither frequency nor content of reactions differed between the first and second years (scale 1–5; frequency: Mdn2015,2016 = 1.33 vs 1.00, rb=−0.17, p>0.01; content: Mdn2015,2016 = 3.00 vs 3.00, rb=0.19, p>0.01). However, media reporting, fear of reputational damage and a feeling of being defamed were mentioned as reasons for non-disclosure.ConclusionsWhile confirmatory analyses did not provide significant results, descriptive analyses showed that participants who voluntarily disclose payments mainly do not experience any reactions towards their disclosures but report fears about losing their reputation due to disclosures.
The independence of research is a key strategic issue of modern societies. Dealing with it appropriately poses legal, economic, political, social and cultural problems for society, which have been ...studied by the corresponding disciplines and are increasingly the subject of reflexive discourses of scientific communities. Unfortunately, problems of independence are usually framed in disciplinary contexts without due consideration of other perspectives’ relevance or possible contributions. To overcome these limitations, we review disciplinary perspectives and findings on the independence of research and identify interdisciplinary prospects that could inform a research programme.
The SARS-CoV-2 pandemic turned out to be a serious threat to mental and physical health. However, the relative contribution of corona-specific (DH
) and general stressors (DH
) on mental burden, and ...specific protective and risk factors for mental health are still not well understood. In a representative sample (
= 3,055) of the German adult population, mental health, potential risk, and protective factors as well as DH
and DH
exposure were assessed online during the SARS-CoV-2 pandemic (June and July 2020). The impact of these factors on mental health was analyzed using descriptive statistics, data visualizations, multiple regressions, and moderation analyses. The most burdensome DH
were financial and sleeping problems, respectively, and DH
corona-media reports and exclusion from recreational activities/important social events. 31 and 24% of total mental health was explained by DH
and DH
, respectively. Both predictors combined explained 36%, resulting in an increase in variance due to DH
of only 5% (R
adjusted). Being female, older and a lower educational level were identified as general risk factors, somatic diseases as a corona-specific risk factor, and self-efficacy and locus of control (LOC) proved to be corona-specific protective factors. Further analyses showed that older age and being diagnosed with a somatic illness attenuated the positive influence of LOC, self-efficacy, and social support on resilience. Although the data showed that after the first easing restrictions, the stressor load was comparable to pre-pandemic data (with DH
not making a significant contribution), different risk and protective factors could be identified for general and corona-specific stressors. In line with observations from network analysis from other groups, the positive impact of resilience factors was especially diminished in the most vulnerable groups (elderly and somatically ill). This highlights the need to especially target these vulnerable groups to foster their resilience in upcoming waves of the corona pandemic.
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•Protocol discrepancies and spin in psychotherapy research are investigated in detail.•Discrepancies are less frequent in prospectively vs retrospectively registered ...trials.•Psychotherapy trial registration is not associated with less spin in the publications.
This study aimed to investigate the relationship between trial registration, trial discrepancy from registered protocol, and spin in nonpharmacological trials.
Recent psychotherapy trials on depression (2015–2018) were analyzed regarding their registration status and its relationship to discrepancies between registered and published primary outcomes and to spin (discrepancy between the nonsignificant finding in a study and an overly beneficial interpretation of the effect of the treatment).
A total of 196 trials were identified, of which 78 (40%) had been registered prospectively and 56 (29%) had been registered retrospectively. In 102 (76%) of 134 registered trials, discrepancies between trial and protocol were present. Of 72 trials with a nonsignificant difference between treatments for the primary outcome, 68 trials (94%) showed spin. Discrepancies from protocol were less frequent in prospectively than in retrospectively registered trials (odds ratio= 0.19; 95% confidence interval CI: 0.07–0.52), but regarding the amount of spin, there was no difference between prospectively and retrospectively registered trials (rb = −0.12; 95% CI: −0.41 to 0.19) or between registered and unregistered trials (rb = −0.22, 95% CI −0.49 to 0.08).
Protocol discrepancies and spin have a high prevalence in psychotherapy outcome research. The results show no relation between registration and spin, but prospective registration may prevent discrepancies from protocol.
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