Equivalent user experience and improved community augmented meta-analyses knowledge for a new version of a Plain Language Summary guideline.

Plain Language Summaries (PLS) offer a promising solution to make meta-analytic psychological research more accessible for non-experts and laypeople. However, existing writing guidelines for this type of publication are seldom grounded in empirical studies. To address this and to test two versions of a new PLS guideline, we investigated the impact of PLSs of psychological meta-analyses on laypeoples' PLS-related knowledge and their user experience (accessibility, understanding, empowerment). In a preregistered online-study, N = 2,041 German-speaking participants read two PLSs. We varied the inclusion of a disclaimer on PLS authorship, a statement on the causality of effects, additional information on community augmented meta-analyses (CAMA) and the PLS guideline version. Results partially confirmed our preregistered hypotheses: Participants answered knowledge items on CAMA more correctly when a PLS contained additional information on CAMA, and there were no user experience differences between the old and the new guideline versions. Unexpectedly, a priori hypotheses regarding improved knowledge via the use of a disclaimer and a causality statement were not confirmed. Reasons for this, as well as general aspects related to science communication via PLSs aimed at educating laypeople, are discussed.

Completeness and consistency of primary outcome reporting in COVID-19 publications in the early pandemic phase: a descriptive study.

BACKGROUND: The COVID-19 pandemic saw a steep increase in the number of rapidly published scientific studies, especially early in the pandemic. Some have suggested COVID-19 trial reporting is of lower quality than typical reports, but there is limited evidence for this in terms of primary outcome reporting. The objective of this study was to assess the prevalence of completely defined primary outcomes reported in registry entries, preprints, and journal articles, and to assess consistent primary outcome reporting between these sources. METHODS: This is a descriptive study of a cohort of registered interventional clinical trials for the treatment and prevention of COVID-19, drawn from the DIssemination of REgistered COVID-19 Clinical Trials (DIRECCT) study dataset. The main outcomes are: 1) Prevalence of complete primary outcome reporting; 2) Prevalence of consistent primary outcome reporting between registry entry and preprint as well as registry entry and journal article pairs. RESULTS: We analyzed 87 trials with 116 corresponding publications (87 registry entries, 53 preprints and 63 journal articles). All primary outcomes were completely defined in 47/87 (54%) registry entries, 31/53 (58%) preprints and 44/63 (70%) journal articles. All primary outcomes were consistently reported in 13/53 (25%) registry-preprint pairs and 27/63 (43%) registry-journal article pairs. No primary outcome was specified in 13/53 (25%) preprints and 8/63 (13%) journal articles. In this sample, complete primary outcome reporting occurred more frequently in trials with vs. without involvement of pharmaceutical companies (76% vs. 45%), and in RCTs vs. other study designs (68% vs. 49%). The same pattern was observed for consistent primary outcome reporting (with vs. without pharma: 56% vs. 12%, RCT vs. other: 43% vs. 22%). CONCLUSIONS: In COVID-19 trials in the early phase of the pandemic, all primary outcomes were completely defined in 54%, 58%, and 70% of registry entries, preprints and journal articles, respectively. Only 25% of preprints and 43% of journal articles reported primary outcomes consistent with registry entries.

Transdiagnostic psychosocial interventions to promote mental health in forcibly displaced persons: a systematic review and meta-analysis.

Background: People forced to leave their homes, such as refugees and internally displaced persons, are exposed to various stressors during their forced displacement, putting them at risk for mental disorders.Objective: To summarize evidence on the efficacy of psychosocial interventions aiming to promote mental health and/or to prevent mental symptoms by fostering transdiagnostic skills in forcibly displaced persons of all ages.Method: Four databases and reference lists were searched for randomized controlled trials on interventions in this population on 11 March 2022. Thirty-six studies were eligible, 32 studies (comprising 5299 participants) were included in random-effects multilevel meta-analyses examining the effects of interventions on mental symptoms and positive mental health (e.g. wellbeing) as well as moderators to account for heterogeneity. OSF Preregistration-ID: 10.17605/OSF.IO/XPMU3Results: Our search resulted in 32 eligible studies, with 10 reporting on children/adolescents and 27 on adult populations. There was no evidence for favourable intervention effects in children/adolescents, with 44.4% of the effect sizes pointing to potentially negative effects yet remaining non-significant. For adult populations, our meta-analyses showed a close-to-significant favourable effect for mental symptoms, M(SMD) = 0.33, 95% CI [-0.03, 0.69], which was significant when analyses were limited to high-quality studies and larger for clinical compared to non-clinical populations. No effects emerged for positive mental health. Heterogeneity was considerable and could not be explained by various moderators (e.g. type of control, duration, setting, theoretical basis). Certainty of evidence was very low across all outcomes limiting the generalizability of our findings.Conclusion: The present review provides at most weak evidence for an effect favouring transdiagnostic psychosocial interventions over control conditions for adult populations but not for children and adolescents. Future research should combine the imperative of humanitarian aid in face of major crises with studying the diverse needs of forcibly displaced persons to improve and tailor future interventions.

This review is the first to examine the efficacy of transdiagnostic interventions for mental health promotion and prevention of mental disorders in forcibly displaced persons of all ages.Overall, we found no favourable effect of transdiagnostic interventions in both children/adolescents and adults. Excluding studies at high risk of bias, there was weak evidence for a small favourable effect in adults, but not in children and adolescents. Thus, so far, there is weak evidence for transdiagnostic interventions in forcibly displaced persons.Research efforts need to match care needs: While most people live and need care in low-income countries, the majority of research has been conducted in high-income countries.

Plain language summaries: A systematic review of theory, guidelines and empirical research.

Plain language summaries (PLSs) have been introduced to communicate research in an understandable way to a nonexpert audience. Guidelines for writing PLSs have been developed and empirical research on PLSs has been conducted, but terminology and research approaches in this comparatively young field vary considerably. This prompted us to review the current state of the art of the theoretical and empirical literature on PLSs. The two main objectives of this review were to develop a conceptual framework for PLS theory, and to synthesize empirical evidence on PLS criteria. We began by searching Web of Science, PubMed, PsycInfo and PSYNDEX (last search 07/2021). In our review, we included empirical investigations of PLSs, reports on PLS development, PLS guidelines, and theoretical articles referring to PLSs. A conceptual framework was developed through content analysis. Empirical studies investigating effects of PLS criteria on defined outcomes were narratively synthesized. We identified 7,714 records, of which 90 articles met the inclusion criteria. All articles were used to develop a conceptual framework for PLSs which comprises 12 categories: six of PLS aims and six of PLS characteristics. Thirty-three articles empirically investigated effects of PLSs on several outcomes, but study designs were too heterogeneous to identify definite criteria for high-quality PLSs. Few studies identified effects of various criteria on accessibility, understanding, knowledge, communication of research, and empowerment. We did not find empirical evidence to support most of the criteria we identified in the PLS writing guidelines. We conclude that although considerable work on establishing and investigating PLSs is available, empirical evidence on criteria for high-quality PLSs remains scarce. The conceptual framework developed in this review may provide a valuable starting point for future guideline developers and PLS researchers.

Physicians' attitudes towards disclosure of payments from pharmaceutical companies in a nationwide voluntary transparency database: a cross-sectional survey.

OBJECTIVES: To 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. DESIGN: A national cross-sectional survey conducted in 2018 among physicians who voluntarily disclosed at least one payment in the German transparency regulation. SETTING: Retrospective 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. PARTICIPANTS: German 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. RESULTS: Data 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. CONCLUSIONS: While 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.

Mental health and psychosocial support strategies in highly contagious emerging disease outbreaks of substantial public concern: A systematic scoping review.

BACKGROUND: Acute disease outbreaks such as the COVID-19 pandemic cause a high burden of psychological distress in people worldwide. Interventions to enable people to better cope with such distress should be based on the best available evidence. We therefore performed a scoping review to systematically identify and summarize the available literature of interventions that target the distress of people in the face of highly contagious disease outbreaks. METHODS: MEDLINE, Cochrane CENTRAL, Web of Science (January 2000 to May 7, 2020), and reference lists were systematically searched and screened by two independent reviewers. Quantitative and qualitative studies investigating the effects of psychological interventions before, during, and after outbreaks of highly contagious emerging infectious diseases, such as SARS, MERS, Ebola, or COVID-19 were included. Study effects were grouped (e.g. for healthcare professionals, community members, people at risk) and intervention contents at the individual and organizational level summarized. We assessed the level of evidence using a modified scheme from the Oxford Centre for Evidence-based Medicine and the Australian National Health and Medical Research Council. RESULTS: Of 4030 records found, 19 studies were included (two RCTs). Most interventions were delivered during-exposure and face-to-face, focused on healthcare workers and crisis personnel, and combined psychoeducation with training of coping strategies. Based on two high-quality studies, beneficial effects were reported for resilience factors (e.g. positive cognitive appraisal) and professional attitudes of healthcare workers, with mixed findings for mental health (e.g. depression). Across all studies, there was positive qualitative feedback from participants and facilitators. We identified seven ongoing studies mostly using online- and mobile-based deliveries. CONCLUSIONS: There is preliminary evidence for beneficial effects of interventions to enable people to better cope with the distress of highly contagious emerging disease outbreaks. Besides the need for more high-quality studies, the summarized evidence may inform decision makers to plan interventions during the current pandemic and to develop pandemic preparedness plans.

How to Put It Plainly? Findings From Two Randomized Controlled Studies on Writing Plain Language Summaries for Psychological Meta-Analyses.

Plain language summaries (PLS) aim to communicate research findings to laypersons in an easily understandable manner. Despite the societal relevance of making psychological research findings available to the public, our empirical knowledge on how to write PLS of psychology studies is still scarce. In this article, we present two experimental studies investigating six characteristics of PLS for psychological meta-analyses. We specifically focused on approaches for (1) handling technical terms, (2) communicating the quality of evidence by explaining the methodological approach of meta-analyses, (3) explaining how synthesized studies operationalized their research questions, (4) handling statistical terms, (5) structuring PLS, and (6) explaining complex meta-analytic designs. To develop empirically validated guidelines on writing PLS, two randomized controlled studies including large samples stratified for education status, age, and gender (N Study1=2,288 and N Study2=2,211) were conducted. Eight PLS of meta-analyses from different areas of psychology were investigated as study materials. Main outcome variables were user experience (i.e., perceived accessibility, perceived understanding, and perceived empowerment) and knowledge acquisition, as well as understanding and knowledge of the quality of evidence. Overall, our hypotheses were partially confirmed, with our results underlining, among other things, the importance of explaining or replacing content-related technical terms (i.e., theoretical concepts) and indicating the detrimental effects of providing too many details on statistical concepts on user experience. Drawing on these and further findings, we derive five empirically well-founded rules on the lay-friendly communication of meta-analytic research findings in psychology. Implications for PLS authors and future research on PLS are discussed.

Voluntary disclosures of payments from pharmaceutical companies to healthcare professionals in Germany: a descriptive study of disclosures in 2015 and 2016.

OBJECTIVE: To 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 PARTICIPANTS: Cohort 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 MEASURES: Number 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. RESULTS: 28 230 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. CONCLUSIONS: If 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.

Discrepancies from registered protocols and spin occurred frequently in randomized psychotherapy trials-A meta-epidemiologic study.

OBJECTIVES: This study aimed to investigate the relationship between trial registration, trial discrepancy from registered protocol, and spin in nonpharmacological trials. STUDY DESIGN AND SETTING: 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). RESULTS: 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). CONCLUSION: 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.

Teaching Conflicts of Interest and Shared Decision-Making to Improve Risk Communication: a Randomized Controlled Trial.

BACKGROUND: Risk communication is a core aspect of a physician's work and a fundamental prerequisite for successful shared decision-making. However, many physicians are not able to adequately communicate risks to patients due to a lack of understanding of statistics as well as inadequate management of conflicts of interest (COI). OBJECTIVE: To evaluate the effects of an integrated curriculum encompassing COI and shared decision-making on the participants' risk communication competence, that is, their competence to advise patients on the benefits and harms of diagnostic or therapeutic interventions. DESIGN: A rater-blind randomized controlled trial with a 30 (± 1)-week follow-up conducted from October 2016 to June 2017 at two German academic medical centers. PARTICIPANTS: Sixty-three medical students in their fourth or fifth year. INTERVENTIONS: Participants received either a newly developed 15-h curriculum or a course manual adapted from teaching as usual. MAIN MEASURES: Primary outcome: change in risk communication performance in a video-observed structured clinical examination (VOSCE). KEY RESULTS: Participants were 25.7 years old on average (SD 3.6); 73% (46/63) were female. Increase in risk communication performance was significantly higher in the intervention group with post-intervention Cohen's d of 2.35 (95% confidence interval (CI) 1.62 to 3.01, p < 0.01) and of 1.83 (CI 1.13 to 2.47, p < 0.01) 30 (± 1) weeks later. Secondary outcomes with the exception of frequency of interactions with the pharmaceutical industry also showed relevant improvements in the intervention as compared with the control group (d between 0.91 and 2.04 (p < 0.001)). CONCLUSIONS: Our results show that an integrated curriculum encompassing COI and risk communication leads to a large and sustainable increase in risk communication performance. We interpret the large effect sizes to be a result of the integration of topics that are usually taught separately, leading to a more effective organization of knowledge. TRIAL REGISTRATION: The trial is registered in the International Clinical Trials Registry with the trial number DRKS00010890.

Development of a checklist for evaluating psychiatric reports.

BACKGROUND: Performing a psychiatric interview and documenting the recorded findings in the form of a brief psychiatric report is one of the main learning goals in the psychiatric curriculum for medical students. However, observing and assessing students' reports is time consuming and there are no objective assessment tools at hand. Thus, we applied an integrative approach for designing a checklist that evaluates clinical performance, as a tool for the assessment of a psychiatric report. METHODS: A systematic review of the literature yielded no objective instrument for assessing the quality of written reports of psychiatric interviews. We used a 4-step mixed-methods approach to design a checklist as an assessment tool for psychiatric reports: 1. Development of a draft checklist, using literature research and focus group interviews; 2. Pilot testing and subsequent group discussion about modifications resulting from the pilot testing; 3. Creating a scoring system; 4. Testing for interrater-reliability, internal consistency and validity. RESULTS: The final checklist consisted of 36 items with a Cronbach's alpha of 0.833. Selectivity of items ranged between 0.080 and 0.796. After rater-training, an interrater-reliability of 0.96 (ICC) was achieved. CONCLUSIONS: Our approach, which integrated published evidence and the knowledge of domain experts, resulted in a reliable and valid checklist. It offers an objective instrument to measure the ability to document psychiatric interviews. It facilitates a transparent assessment of students' learning goals with the goal of structural alignment of learning goals and assessment. We discuss ways it may additionally be used to measure the ability to perform a psychiatric interview and supplement other assessment formats.