Mario Malički

Is there a solution to publication bias? Researchers call for changes in dissemination of clinical research results

OBJECTIVES To explore opinions of authors of published reports of clinical trials and Cochrane systematic reviews on the causes and methods of preventing publication bias. STUDY DESIGN AND SETTING An online questionnaire was developed and sent to researchers publishing in high-impact or national general medical journals, authors of Cochrane systematic reviews, and a general population of researchers. Open-ended questions about publication bias were qualitatively analyzed. We also held a focus group with experienced researchers and/or Cochrane reviewers. RESULTS Publication bias was common: 48 (36%) respondents had own unpublished trials and 40 (30%) admitted selective outcome reporting; but researchers felt strongly that blame rested also with the system that promotes and augments publication bias practices. Qualitative analysis of both survey responses and focus group discussion identified possible ways of reducing publication bias through increased transparency, improvements to trial registries, search engines and databases, enhancement of the role of institutional review boards, positive encouragement of scientists, and policy changes. CONCLUSION Although well aware of the problem, clinical researchers knowingly contribute to problems of selective reporting and nonpublication of trials. They call for changes in current practices of journal-based communication of trial reporting and for systematic evaluation of measures to decrease publication bias.

No health research without education for research--experience from an integrated course in undergraduate medical curriculum.

13 (Honey and Mumford Learning Styles and Myers–Briggs Type Indicator – MBTI). The reflector learning style was the most preferred and pragmatist, the least preferred learning style in both groups and the personality-type SFEJ was the commonest MBTI bestfit type amongst both groups. The poor performers were similar to the satisfactory performers in Learning Styles and Personality profiles (p4 0.05). Contrary to our hypothesis, the findings showed that learning style preference and personality profile were not related to clinical under-performance. There are limitations to our study with a single-point estimate of clinical performance in one centre. However, our study did not show any differences in Learning Style preferences and Personality profiles in poorly and satisfactorily performing medical students in an early clinical assessment. It might be that poorly performing clinical students are best identified using a composite measure of clinical performance, either cross-sectional or longitudinal, which would allow further investigation of the underlying causes and evidencebased targeted remediation.

Study Design, Publication Outcome, and Funding of Research Presented at International Congresses on Peer Review and Biomedical Publication

The first International Congress on Peer Review and Biomedical Publication (PRC) was organized in 1989 to “subject the editorial review process to some of the rigorous scrutiny that editors and reviewers demand of the scientists whose work they are assessing.”1 Since then, peer review research was introduced as a Medical Subject Heading (MeSH),2 and the number of indexed articles has been continuously increasing. To evaluate the development of peer review research in biomedicine, we analyzed research presented at all PRCs since 1989.

Why do you think you should be the author on this manuscript? Analysis of open-ended responses of authors in a general medical journal

BackgroundTo assess how authors would describe their contribution to the submitted manuscript without reference to or requirement to satisfy authorship criteria of the International Committee of Medical Journal Editors (ICMJE), we analyzed responses of authors to an open-ended question “Why do you think you should be the author on this manuscript?”.MethodsResponses of authors (n=1425) who submitted their manuscripts (n=345) to the Croatian Medical Journal, an international general medical journal, from March 2009 until July 2010 were transcribed and matched to ICMJE criteria. Statements that could not be matched were separately categorized. Responses according to the number of authors or their byline position on the manuscript were analyzed using Mann–Whitney U test and Moses test of extreme reactions.ResultsThe number of authors per manuscript ranged from 1 to 26 (median=4, IQR=3-6), with the median of 2 contributions per author (IQR=2-3). Authors’ responses could be matched to the ICMJE criteria in 1116 (87.0%) cases. Among these, only 15.6% clearly declared contributions from all 3 ICMJE criteria; however, if signing of the authorship form was taken as the fulfillment of the third ICMJE criterion, overall fraction of deserving authorship was 54.2%. Non-ICMJE contributions were declared by 98 (7.6%) authors whose other contributions could be matched to ICMJE criteria, and by 116 (13.0%) authors whose contributions could not be matched to ICMJE criteria. The most frequently reported non-ICMJE contribution was literature review. Authors on manuscripts with more than 8 authors declared more contributions than those on manuscript with 8 or fewer authors: median 2, IQR 1–4, vs. median 2, IQR 1–3, respectively (Mann Whitney U test, p=0.001; Moses Test of Extreme Reactions, p<0.001). Almost a third of single authors (n=9; 31.0%) reported contributions that could not be matched to any ICMJE criterion.ConclusionsIn cases of multi-author collaborative efforts but not in manuscripts with fewer authors open-ended authorship declaration without instructions on ICMJE criteria elicited responses from authors that were similar to responses when ICMJE criteria were explicitly required. Current authorship criteria and the practice of contribution declaration should be revised in order to capture deserving authorship in biomedical research.

Extent, Awareness and Perception of Dissemination Bias in Qualitative Research: An Explorative Survey

Background Qualitative research findings are increasingly used to inform decision-making. Research has indicated that not all quantitative research on the effects of interventions is disseminated or published. The extent to which qualitative researchers also systematically underreport or fail to publish certain types of research findings, and the impact this may have, has received little attention. Methods A survey was delivered online to gather data regarding non-dissemination and dissemination bias in qualitative research. We invited relevant stakeholders through our professional networks, authors of qualitative research identified through a systematic literature search, and further via snowball sampling. Results 1032 people took part in the survey of whom 859 participants identified as researchers, 133 as editors and 682 as peer reviewers. 68.1% of the researchers said that they had conducted at least one qualitative study that they had not published in a peer-reviewed journal. The main reasons for non-dissemination were that a publication was still intended (35.7%), resource constraints (35.4%), and that the authors gave up after the paper was rejected by one or more journals (32.5%). A majority of the editors and peer reviewers “(strongly) agreed” that the main reasons for rejecting a manuscript of a qualitative study were inadequate study quality (59.5%; 68.5%) and inadequate reporting quality (59.1%; 57.5%). Of 800 respondents, 83.1% “(strongly) agreed” that non-dissemination and possible resulting dissemination bias might undermine the willingness of funders to support qualitative research. 72.6% and 71.2%, respectively, “(strongly) agreed” that non-dissemination might lead to inappropriate health policy and health care. Conclusions The proportion of non-dissemination in qualitative research is substantial. Researchers, editors and peer reviewers play an important role in this. Non-dissemination and resulting dissemination bias may impact on health care research, practice and policy. More detailed investigations on patterns and causes of the non-dissemination of qualitative research are needed.

Students' and parents' attitudes toward basic life support training in primary schools.

Aim To assess attitudes of students and their parents toward basic life support (BLS) training in primary schools, along with their perceptions of students’ fears toward applying and training BLS. Methods In October 2011, a specifically designed, voluntary and anonymous questionnaire was distributed to 7th and 8th grade students and to their parents in two primary schools in Split, Croatia. Completed questionnaires were analyzed to determine the validity of the scale, and to determine sex and group differences in individual items and the whole scale. Results The questionnaires were completed by 301 school children and 361 parents. Cronbach’s alpha of the whole scale was 0.83, indicating good internal consistency. The students’ score for the whole attitude scale was 73.7 ± 11.1 out of maximum 95, while the parents’ score was 68.0 ± 11.9. Students’ attitude was significantly more positive than that of the parents (U = 29.7, P < 0.001). The greatest perceived students’ fear toward applying BLS was that they would harm the person in need of BLS. Conclusion Our study showed that in Croatia both students in their last two years of primary school and their parents had a positive attitude toward BLS training in primary schools. Implementing compulsory BLS training in Croatia’s primary schools could help increase students’ confidence, quell their fears toward applying BLS, and possibly even increase the survival of bystander-witnessed cardiac arrests.

Editorial research and the publication process in biomedicine and health: Report from the Esteve Foundation Discussion Group, December 2012

Despite the fact that there are more than twenty thousand biomedical journals in the world, research into the work of editors and publication process in biomedical and health care journals is rare. In December 2012, the Esteve Foundation, a non-profit scientific institution that fosters progress in pharmacotherapy by means of scientific communication and discussion organized a discussion group of 7 editors and/or experts in peer review biomedical publishing. They presented findings of past editorial research, discussed the lack of competitive funding schemes and specialized journals for dissemination of editorial research, and reported on the great diversity of misconduct and conflict of interest policies, as well as adherence to reporting guidelines. Furthermore, they reported on the reluctance of editors to investigate allegations of misconduct or increase the level of data sharing in health research. In the end, they concluded that if editors are to remain gatekeepers of scientific knowledge they should reaffirm their focus on the integrity of the scientific record and completeness of the data they publish. Additionally, more research should be undertaken to understand why many journals are not adhering to editorial standards, and what obstacles editors face when engaging in editorial research.

Association of trait and specific hopes: cross sectional study on students and workers of health professions in Split, Croatia

Introduction. Hope (hoping) is most commonly assessed as a dispositional trait and associated with quality of life, self-care agency and non-attempts of suicide. However, little research has been conducted on hoping for specific events. Materials and Methods. We distributed a survey consisting of Integrative Hope Scale (IHS) and visual analogue scales on which respondents could declare their levels (intensity) of hope for specific events, to all first year health students enrolled at the University Department of Health Studies, Split, Croatia in 2011/2012, as well as to working health professionals attending a nursing conference in April 2012. Results. A total of 161 (89.4%) students and 88 (89.8%) working health professionals returned the completed questionnaires. We found high trait hope scores of students and working health professionals (Md = 111, 95% CI [109–113] vs. Md = 115, 95% CI [112–119]; U = 5,353, P = 0.065), and weak to moderate correlations of trait and specific hopes (r = 0.18–0.48, Spearman’s rank correlation coefficient). Students and workers reported 31 different things they hoped for most in life, of which the most prevalent were being healthy and happy. There was very little agreement between participants’ reported influence of the four factors compromising the trait hope (self-confidence, ambition, optimism, and social support) on their specific hopes. Conclusions. Our findings, while strengthening the validity of hope as a trait, indicate that specific hopes of individuals are moderated by factors not captured by the IHS trait scale. Further research should explore specific hoping in detail, as well as the effectiveness of interventions aimed at increasing specific or generalized hoping.

Decisional conflict and vaccine uptake: cross-sectional study of 2012/2013 influenza season in Croatia

Introduction As scientific, media and individual opinions on the need for seasonal influenza vaccination differ, we explored patients’ decisional conflict and perceived physician and social support when making a vaccination choice. Material and methods We conducted a survey of patients with previous vaccination experience in a single family medicine office in Split, Croatia. The questionnaire included the Decisional Conflict Scale (DCS), perceived social support, and attitudes and knowledge concerning vaccination. Results Out of 203 (86%) adult patients with previous vaccination experience, 182 (40.4%) opted to vaccinate in the current season, 98 (48.3%) refused, and 22 (11.3%) were undecided. The median decisional conflict score was highest among those undecided (43.8 out of the maximum 100, interquartile range (IQR) 33.2–52.3), lowest among those opting to vaccinate (17.2, IQR 9.4–26.6), and intermediate among those who refused vaccination (25.0, IQR 17.2–39.1) (p < 0.001, Kruskal-Wallis test and post-hoc Mann-Whitney U tests). The most common self-reported reasons for vaccination were previous vaccination experience (n = 85, 42%) and media information (n = 62, 30%). Those who refused vaccination felt less satisfied with the support they received from their family physician than those who decided to vaccinate (median 6.5 (IQR 0–9) vs. 9 (IQR 5–10) on a scale from 0 to 10), respectively; p = 0.001, Mann-Whitney U test). Conclusions Higher decisional conflict of patients who refuse influenza vaccination and those undecided, alongside their perceived low support of the family physician in making that choice, emphasize the importance family doctors play in advising and helping patients make informed decisions about seasonal influenza vaccination.

Diagnostic Interview for Genetic Studies: validity and reliability of the Croatian version.

Objective To test the validity and reliability of the Diagnostic Interview for Genetic Studies (DIGS) in patients with mental illness in Croatia. Materials and methods Following translation, back-translation, and pilot testing, the Croatian version of DIGS (CRO-DIGS) was administered to a total of 150 inpatients and outpatients diagnosed at the Clinical Hospital in Split with bipolar and major depressive disorder (n=56), schizophrenia and schizoaffective disorder (n=62), and alcohol dependence or use disorders (n=32). Initial testing was performed independently by one interviewer and one observer blinded to the diagnosis, and a retest was performed after 8 weeks by a third examiner. Results The validity of CRO-DIGS was high (&kgr;=0.916), with an excellent inter-rater (&kgr;=0.824) reliability, especially for bipolar disorder (&kgr;=0.956). Following an 8 week test–retest interval, the reliability for all diagnoses was found to be excellent (&kgr;=0.843). Conclusion Our study has shown excellent validity and reliability of the Croatian version of DIGS, making it a promising instrument to assess mental illness of patients. The development of a valid and reliable diagnostic tool such as the CRO-DIGS will considerably advance the scientific communities’ ability to carry out genetic studies of psychiatric illness in the region.