Do Editorial policies support ethical research? A thematic text analysis of author instructions in psychiatry journals

Introduction: According to the Declaration of Helsinki and other guidelines, clinical studies should be approved by a research ethics committee and seek valid informed consent from the participants. Editors of medical journals are encouraged by the ICMJE and COPE to include requirements for these principles in the journal's instructions for authors. This study assessed the editorial policies of psychiatry journals regarding ethics review and informed consent. Methods and Findings: The information given on ethics review and informed consent and the mentioning of the ICMJE and COPE recommendations were assessed within author's instructions and online submission procedures of all 123 eligible psychiatry journals. While 54% and 58% of editorial policies required ethics review and informed consent, only 14% and 19% demanded the reporting of these issues in the manuscript. The TOP-10 psychiatry journals (ranked by impact factor) performed similarly in this regard. Conclusions: Only every second psychiatry journal adheres to the ICMJE's recommendation to inform authors about requirements for informed consent and ethics review. Furthermore, we argue that even the ICMJE's recommendations in this regard are insufficient, at least for ethically challenging clinical trials. At the same time, ideal scientific design sometimes even needs to be compromised for ethical reasons. We suggest that features of clinical studies that make them morally controversial, but not necessarily unethical, are analogous to methodological limitations and should thus be reported explicitly. Editorial policies as well as reporting guidelines such as CONSORT should be extended to support a meaningful reporting of ethical research

Do German university medical centres promote robust and transparent research? A cross-sectional study of institutional policies

Background: In light of replication and translational failures, biomedical research practices have recently come under scrutiny. Experts have pointed out that the current incentive structures at research institutions do not sufficiently incentivise researchers to invest in robustness and transparency and instead incentivise them to optimize their fitness in the struggle for publications and grants. This cross-sectional study aimed to describe whether and how relevant policies of university medical centres in Germany support the robust and transparent conduct of research and how prevalent traditional metrics are. Methods: For 38 German university medical centres, we searched for institutional policies for academic degrees and academic appointments as well as websites for their core facilities and research in general between December 2020 and February 2021. We screened the documents for mentions of indicators of robust and transparent research (study registration; reporting of results; sharing of research data, code and protocols; open access; and measures to increase robustness) and for mentions of more traditional metrics of career progression (number of publications; number and value of awarded grants; impact factors; and authorship order). Results: While open access was mentioned in 16% of PhD regulations, other indicators of robust and transparent research were mentioned in less than 10% of institutional policies for academic degrees and academic appointments. These indicators were more frequently mentioned on the core facility and general research websites. Institutional policies for academic degrees and academic appointments had frequent mentions of traditional metrics. Conclusions: References to robust and transparent research practices are, with a few exceptions, generally uncommon in institutional policies at German university medical centres, while traditional criteria for academic promotion and tenure still prevail

Developments in the Frequency of Ratings and Evaluation Tendencies: A Review of German Physician Rating Websites

Background: Physician rating websites (PRWs) have been developed to allow all patients to rate, comment, and discuss physicians’ quality online as a source of information for others searching for a physician. At the beginning of 2010, a sample of 298 randomly selected physicians from the physician associations in Hamburg and Thuringia were searched for on 6 German PRWs to examine the frequency of ratings and evaluation tendencies. Objective: The objective of this study was to examine (1) the number of identifiable physicians on German PRWs; (2) the number of rated physicians on German PRWs; (3) the average and maximum number of ratings per physician on German PRWs; (4) the average rating on German PRWs; (5) the website visitor ranking positions of German PRWs; and (6) how these data compare with 2010 results. Methods: A random stratified sample of 298 selected physicians from the physician associations in Hamburg and Thuringia was generated. Every selected physician was searched for on the 6 PRWs (Jameda, Imedo, Docinsider, Esando, Topmedic, and Medführer) used in the 2010 study and a PRW, Arztnavigator, launched by Allgemeine Ortskrankenkasse (AOK). Results: The results were as follows: (1) Between 65.1% (194/298) on Imedo to 94.6% (282/298) on AOK-Arztnavigator of the physicians were identified on the selected PRWs. (2) Between 16.4% (49/298) on Esando to 83.2% (248/298) on Jameda of the sample had been rated at least once. (3) The average number of ratings per physician ranged from 1.2 (Esando) to 7.5 (AOK-Arztnavigator). The maximum number of ratings per physician ranged from 3 (Esando) to 115 (Docinsider), indicating an increase compared with the ratings of 2 to 27 in the 2010 study sample. (4) The average converted standardized rating (1=positive, 2=neutral, and 3=negative) ranged from 1.0 (Medführer) to 1.2 (Jameda and Topmedic). (5) Only Jameda (position 317) and Medführer (position 9796) were placed among the top 10,000 visited websites in Germany. Conclusions: Whereas there has been an overall increase in the number of ratings when summing up ratings from all 7 analyzed German PRWs, this represents an average addition of only 4 new ratings per physician in a year. The increase has also not been even across the PRWs, and it would be advisable for the users of PRWs to utilize a number of PRWs to ascertain the rating of any given physician. Further research is needed to identify barriers for patients to rate their physicians and to assist efforts to increase the number of ratings on PRWs to consequently improve the fairness and practical importance of PRWs

Public awareness and use of German physician ratings sites: Cross-sectional survey of four north German cities

Background: Physician rating websites (PRWs) allow patients to rate, comment, and discuss physicians’ quality. The ability of PRWs to influence patient decision making and health care quality is dependent, in part, on sufficient awareness and usage of PRWs. However, previous studies have found relatively low levels of awareness and usage of PRWs, which has raised concerns about the representativeness and validity of information on PRWs. Objective: The objectives of this study were to examine (1) participants’ awareness, use, and contribution of ratings on PRWs and how this compares with other rating websites; (2) factors that predict awareness, use, and contribution of ratings on PRWs; and (3) participants’ attitudes toward PRWs in relation to selecting a physician. Methods: A mailed cross-sectional survey was sent to a random sample (N=1542) from four North German cities (Nordhorn, Hildesheim, Bremen, and Hambur g) between April and July 2016. Survey questions explored respondents’ awareness, use, and contribution of ratings on rating websites for service (physicians, hospitals, and hotels and restaurants) and products (media and technical) in general and the role of PRWs when searching for a new physician. Results: A total of 280 completed surveys were returned (280/1542, 18.16% response rate), with the following findings: (1) Overall, 72.5% (200/276) of respondents were aware of PRWs. Of the respondents who were aware of PRWs, 43.6% (86/197) had used PRWs. Of the respondents who had used PRWs, 23% (19/83) had rated physicians at least once. Awareness, use, and contribution of ratings on PRWs were significantly lower in comparison with all other rating websites, except for hospital rating websites. (2) Except for the impact of responders’ gender and marital status on the awareness of PRWs and responders’ age on the use of PRWs, no other predictors had a relevant impact. (3) Whereas 31.8% (85/267) of the respondents reported that PRWs were a very important or somewhat important information source when searching for a new physician, respondents significantly more often reported that family , friends and colleagues (259/277, 93.5%), other physicians (219/274, 79.9%), and practice websites (108/266, 40.6%) were important information sources. Conclusions: Whereas awareness of German PRWs appears to have substantially increased, the use of PRWs and contribution of ratings remains relatively low. Further research is needed to examine the reasons why only a few patients are rating physicians. However, given the information inequality between provider and consumer will always be higher for consumers using the services of physicians, it is possible that people will always rely more on interpersonal recommendations than impersonal public information before selecting a physician

How Psychiatry Journals Support the Unbiased Translation of Clinical Research. A Cross-Sectional Study of Editorial Policies

Introduction: Reporting guidelines (e. g. CONSORT) have been developed as tools to improve quality and reduce bias in reporting research findings. Trial registration has been recommended for countering selective publication. The International Committee of Medical Journal Editors (ICMJE) encourages the implementation of reporting guidelines and trial registration as uniform requirements (URM). For the last two decades, however, biased reporting and insufficient registration of clinical trials has been identified in several literature reviews and other investigations. No study has so far investigated the extent to which author instructions in psychiatry journals encourage following reporting guidelines and trial registration. Method: Psychiatry Journals were identified from the 2011 Journal Citation Report. Information given in the author instructions and during the submission procedure of all journals was assessed on whether major reporting guidelines, trial registration and the ICMJE's URM in general were mentioned and adherence recommended. Results: We included 123 psychiatry journals (English and German language) in our analysis. A minority recommend or require 1) following the URM (21%), 2) adherence to reporting guidelines such as CONSORT, PRISMA, STROBE (23%, 7%, 4%), or 3) registration of clinical trials (34%). The subsample of the top-10 psychiatry journals (ranked by impact factor) provided much better but still improvable rates. For example, 70% of the top-10 psychiatry journals do not ask for the specific trial registration number. Discussion: Under the assumption that better reported and better registered clinical research that does not lack substantial information will improve the understanding, credibility, and unbiased translation of clinical research findings, several stakeholders including readers (physicians, patients), authors, reviewers, and editors might benefit from improved author instructions in psychiatry journals. A first step of improvement would consist in requiring adherence to the broadly accepted reporting guidelines and to trial registration

Preclinical efficacy in investigator's brochures:Stakeholders' views on measures to improve completeness and robustness

Aims:Research ethics committees and regulatory agencies assess whether the benefits of a proposed early-stage clinical trial outweigh the risks based on preclinical studies reported in investigator's brochures (IBs). Recent studies have indicated that the reporting of preclinical evidence presented in IBs does not enable proper risk-benefit assessment. We interviewed different stakeholders (regulators, research ethics committee members, preclinical and clinical researchers, ethicists, and metaresearchers) about their views on measures to increase the completeness and robustness of preclinical evidence reporting in IBs. Methods: This study was preregistered (https://osf.io/nvzwy/). We used purposive sampling and invited stakeholders to participate in an online semistructured interview between March and June 2021. Themes were derived using inductive content analysis. We used a strengths, weaknesses, opportunities and threats matrix to categorize our findings. Results: Twenty-seven international stakeholders participated. The interviewees pointed to several strengths and opportunities to improve completeness and robustness, mainly more transparent and systematic justifications for the included studies. However, weaknesses and threats were mentioned that could undermine efforts to enable a more thorough assessment: The interviewees stressed that current review practices are sufficient to ensure the safe conduct of first-in-human trials. They feared that changes to the IB structure or review process could overburden stakeholders and slow drug development. Conclusion: In principle, more robust decision-making processes align with the interests of all stakeholders and with many current initiatives to increase the translatability of preclinical research and limit uninformative or ill-justified trials early in the development process. Further research should investigate measures that could be implemented to benefit all stakeholders.</p

Challenges and proposed solutions in making clinical research on COVID-19 ethical: a status quo analysis across German research ethics committees

Background: In the course of the COVID-19 pandemic, the biomedical research community's attempt to focus the attention on fighting COVID-19, led to several challenges within the field of research ethics. However, we know little about the practical relevance of these challenges for Research Ethics Committees (RECs). Methods: We conducted a qualitative survey across all 52 German RECs on the challenges and potential solutions with reviewing proposals for COVID-19 studies. We de-identified the answers and applied thematic text analysis for the extraction and synthesis of challenges and potential solutions that we grouped under established principles for clinical research ethics. Results: We received an overall response rate of 42%. The 22 responding RECs reported that they had assessed a total of 441 study proposals on COVID-19 until 21 April 2020. For the review of these proposals the RECs indicated a broad spectrum of challenges regarding (1) social value (e.g. lack of coordination), (2) scientific validity (e.g. provisional study planning), (3) favourable risk-benefit ratio (e.g. difficult benefit assessment), (4) informed consent (e.g. strict isolation measures), (5) independent review (e.g. lack of time), (6) fair selection of trial participants (e.g. inclusion of vulnerable groups), and (7) respect for study participants (e.g. data security). Mentioned solutions ranged from improved local/national coordination, over guidance on modified consent procedures, to priority setting across clinical studies. Conclusions: RECs are facing a broad spectrum of pressing challenges in reviewing COVID-19 studies. Some challenges for consent procedures are well known from research in intensive care settings but are further aggravated by infection measures. Other challenges such as reviewing several clinical studies at the same time that potentially compete for the recruitment of in-house COVID-19 patients are unique to the current situation. For some of the challenges the proposed solutions in our survey could relatively easy be translated into practice. Others need further conceptual and empirical research. Our findings together with the increasing body of literature on COVID-19 research ethics, and further stakeholder engagement should inform the development of hands-on guidance for researchers, funders, RECs, and further oversight bodies

Publication rates in animal research. Extent and characteristics of published and nonpublished animal studies followed up at two German university medical centres

Non-publication and publication bias in animal research is a core topic in current debates on the “reproducibility crisis” and “failure rates in clinical research”. To date, however, we lack reliable evidence on the extent of non-publication in animal research. We collected a random and stratified sample (n = 210) from all archived animal study protocols of two major German UMCs (university medical centres) and tracked their results publication. The overall publication rate was 67%. Excluding doctoral theses as results publications, the publication rate decreased to 58%. We did not find substantial differences in publication rates with regard to i) the year of animal study approval, ii) the two UMCs, iii) the animal type (rodents vs. non-rodents), iv) the scope of research (basic vs. preclinical), or v) the discipline of the applicant. Via the most reliable assessment strategy currently available, our study confirms that the non-publication of results from animal studies conducted at UMCs is relatively common. The non-publication of 33% of all animal studies is problematic for the following reasons: A) the primary legitimation of animal research, which is the intended knowledge gain for the wider scientific community, B) the waste of public resources, C) the unnecessary repetition of animal studies, and D) incomplete and potentially biased preclinical evidence for decision making on launching early human trials. Results dissemination should become a professional standard for animal research. Academic institutions and research funders should develop effective policies in this regard

Attitudes towards animal study registries and their characteristics: An online survey of three cohorts of animal researchers

OBJECTIVES: Prospective registration of animal studies has been suggested as a new measure to increase value and reduce waste in biomedical research. We sought to further explore and quantify animal researchers' attitudes and preferences regarding animal study registries (ASRs). DESIGN: Cross-sectional online survey. SETTING AND PARTICIPANTS: We conducted a survey with three different samples representing animal researchers: i) corresponding authors from journals with high Eigenfactor, ii) a random Pubmed sample and iii) members of the CAMARADES network. MAIN OUTCOME MEASURES: Perceived level of importance of different aspects of publication bias, the effect of ASRs on different aspects of research as well as the importance of different research types for being registered. RESULTS: The survey yielded responses from 413 animal researchers (response rate 7%). The respondents indicated, that some aspects of ASRs can increase administrative burden but could be outweighed by other aspects decreasing this burden. Animal researchers found it more important to register studies that involved animal species with higher levels of cognitive capabilities. The time frame for making registry entries publicly available revealed a strong heterogeneity among respondents, with the largest proportion voting for "access only after consent by the principal investigator" and the second largest proportion voting for "access immediately after registration". CONCLUSIONS: The fact that the more senior and experienced animal researchers participating in this survey clearly indicated the practical importance of publication bias and the importance of ASRs underscores the problem awareness across animal researchers and the willingness to actively engage in study registration if effective safeguards for the potential weaknesses of ASRs are put into place. To overcome the first-mover dilemma international consensus statements on how to deal with prospective registration of animal studies might be necessary for all relevant stakeholder groups including animal researchers, academic institutions, private companies, funders, regulatory agencies, and journals