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.
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.
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.
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.
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 (NStudy1=2,288 and NStudy2=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.
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.
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/XPMU3 Results: 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.
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