Las practicas de tratamiento de los pacientes se basan a menudo en la investigacion clinica. Las revisiones sistematicas son un tipo de investigacion clinica fundamental. Cuando se han realizado varios estudios similares (es decir, estudios que investigan las mismas cuestiones de investigacion utilizando metodos similares), estos pueden identificarse y analizarse en una revision sistematica. Asi, las revisiones sistematicas resumen los estudios existentes y proporcionan una vision general de un campo de investigacion especifico. Por lo tanto, pueden tener una gran influencia en las decisiones sobre la atencion al paciente y es esencial que sean fiables. A veces, las revisiones sistematicas estan financiadas por empresas con un interes economico en los resultados y las conclusiones de la revision. Por ejemplo, porque producen un medicamento o dispositivo investigado en la revision. En otras ocasiones, las revisiones sistematicas son llevadas a cabo por investigadores con un interes financiero personal en un resultado especifico. Por ejemplo, cuando el investigador actua como consultor de la empresa que produce una intervencion que es evaluada en la revision. Estos conflictos de intereses financieros pueden repercutir en la forma en que se realizan las revisiones sistematicas y se informa de ellas. La Revision Metodologica Cochrane se centra en los conflictos de intereses financieros relacionados con las empresas de medicamentos o dispositivos en las revisiones sistematicas. El objetivo principal fue investigar el grado en que las revisiones sistematicas con conflictos de intereses financieros presentan los resultados de la revision y sacan conclusiones mas favorables que las revisiones sistematicas sin dichos conflictos de intereses financieros. El objetivo secundario fue investigar el grado en que las revisiones sistematicas con conflictos de intereses financieros difieren en calidad metodologica de las revisiones sistematicas sin dichos conflictos de intereses financieros. Se encontraron 10 estudios que comparaban revisiones sistematicas con y sin conflictos de intereses financieros. Sobre la base de 2 de estos estudios, no se encontraron pruebas de una diferencia en los resultados de la revision entre ambas revisiones sistematicas. Sobre la base de 7 estudios, se encontro que las revisiones sistematicas con conflictos de intereses financieros tenian con mas frecuencia conclusiones favorables a la intervencion experimental [razon de riesgo (risk ratio, RR): 1,98; intervalo de confianza (IC) del 95%: 1,26 a 3,11]. Ademas, sobre la base de 4 estudios, las revisiones sistematicas con conflictos de intereses financieros tendieron a tener menor calidad metodologica (la RR para 11 dimensiones de calidad metodologica oscilo entre 1,00 y 1,83). Los analisis sugieren que, cuando las revisiones sistematicas tienen conflictos de intereses financieros relacionados con empresas de medicamentos o dispositivos, estas son de menor calidad metodologica y tienen conclusiones mas favorables. Sin embargo, no esta claro si esto se deriva de diferencias reales en los resultados de la revision o de la sobreinterpretacion de estos. Basandonos en estos hallazgos, se sugiere que las personas que utilizan las revisiones sistematicas, incluidos pacientes, medicos, desarrolladores de guias clinicas y planificadores de futura investigacion, utilicen principalmente revisiones sistematicas sin conflictos de intereses financieros. Si tales revisiones no se encuentran disponibles, se sugiere que los usuarios sean especialmente cautelosos cuando lean e interpreten revisiones sistematicas con conflictos de intereses financieros.

BACKGROUND: Selective reporting of trial results is common. OBJECTIVE: To study selective reporting in clinical study reports, company trial registers and publications of quality of life in placebo-controlled trials of antidepressants. METHODS: We compared clinical study reports of four antidepressants (fluoxetine, duloxetine, paroxetine and sertraline) obtained from two European drug regulators, data from online company registers, and publications received or retrieved from Eli Lilly and GlaxoSmithKline. Pfizer was also contacted but did not provide any publications. RESULTS: We included 15 trials (19,015 pages) and 4717 patients. Six trials had used SF-36, seven EQ-5D and two both instruments. Nine of the 15 CSRs (60%) displayed selective reporting. In the companies' online registers, there was selective reporting for all 15 trials (100%). We received 20 publications from Eli Lilly and retrieved six from the GlaxoSmithKline register. There was selective reporting in 24 of the 26 publications (92%). Despite extensive selective reporting, we found only small differences between placebo and active drugs. CONCLUSIONS: Access to the full raw data from clinical trials and to case report forms for all patients are needed to evaluate the effect of antidepressants on quality of life. Regulatory agencies should refuse to approve drugs or new indications based on incomplete reporting.

Objectives The objective of this study was to identify and summarize 1) appraisal tools and other guides which address conflicts of interest in medical research studies; and 2) top journals with policies on managing conflicts of interest in journal papers. Study Design and Setting We searched bibliographic databases, other sources, and websites of 30 top medical journals. Two authors selected documents and extracted data. Results We included 27 appraisal tools. None were designed specifically for addressing conflicts of interest and they included only 1-2 short items on conflicts of interest. We also included eight other types of guides. Of 27 appraisal tools, 23 addressed study funding, and 19 authors' conflicts of interest. Nine tools addressed availability of conflicts of interest information, 13 reported conflicts of interest, and five influence from conflicts of interest. Twelve of 30 top journals had conflicts of interest managing policies (beyond disclosure). One journal restricted nonresearch papers (e.g., editorials) to authors without financial conflicts of interest and ten only restricted under certain circumstances. Conclusion Appraisal tools that address conflicts of interest typically do so superficially and rarely address how conflicts of interest may influence studies. Less than half of top medical journals have explicit policies on managing conflicts of interest.

BACKGROUND:Financial conflicts of interest in systematic reviews (e.g. funding by drug or device companies or authors' collaboration with such companies) may impact on how the reviews are conducted and reported. OBJECTIVES:To investigate the degree to which financial conflicts of interest related to drug and device companies are associated with results, conclusions, and methodological quality of systematic reviews. SEARCH METHODS:We searched PubMed, Embase, and the Cochrane Methodology Register for studies published up to November 2016. We also read reference lists of included studies, searched grey literature sources, and Web of Science for studies citing the included studies. SELECTION CRITERIA:Eligible studies were studies that compared systematic reviews with and without financial conflicts of interest in order to investigate differences in results (estimated treatment effect and frequency of statistically favourable results), frequency of favourable conclusions, or measures of methodological quality of the review (e.g. as evaluated on the Oxman and Guyatt index). DATA COLLECTION AND ANALYSIS:Two review authors independently determined the eligibility of studies, extracted data, and assessed risk of bias. We synthesised the results of each study relevant to each of our outcomes. For meta-analyses, we used Mantel-Haenszel random-effects models to estimate risk ratios (RR) with 95% confidence intervals (CIs), with RR > 1 indicating that systematic reviews with financial conflicts of interest more frequently had statistically favourable results or favourable conclusions, and had lower methodological quality. When a quantitative synthesis was considered not meaningful, results from individual studies were summarised qualitatively. MAIN RESULTS:Ten studies with a total of 995 systematic reviews of drug studies and 15 systematic reviews of device studies were included. We assessed two studies as low risk of bias and eight as high risk, primarily because of risk of confounding. The estimated treatment effect was not statistically significantly different for systematic reviews with and without financial conflicts of interest (Z-score: 0.46, P value: 0.64; based on one study of 14 systematic reviews which had a matched design, comparing otherwise similar systematic reviews). We found no statistically significant difference in frequency of statistically favourable results for systematic reviews with and without financial conflicts of interest (RR: 0.84, 95% CI: 0.62 to 1.14; based on one study of 124 systematic reviews). An analysis adjusting for confounding due to methodological quality (i.e. score on the Oxman and Guyatt index) provided a similar result. Systematic reviews with financial conflicts of interest more often had favourable conclusions compared with systematic reviews without (RR: 1.98, 95% CI: 1.26 to 3.11; based on seven studies of 411 systematic reviews). Similar results were found in two studies with a matched design, which therefore had a reduced risk of confounding. Systematic reviews with financial conflicts of interest tended to have lower methodological quality compared with systematic reviews without financial conflicts of interest (RR for 11 dimensions of methodological quality spanned from 1.00 to 1.83). Similar results were found in analyses based on two studies with matched designs. AUTHORS' CONCLUSIONS:Systematic reviews with financial conflicts of interest more often have favourable conclusions and tend to have lower methodological quality than systematic reviews without financial conflicts of interest. However, it is uncertain whether financial conflicts of interest are associated with the results of systematic reviews. We suggest that patients, clinicians, developers of clinical guidelines, and planners of further research could primarily use systematic reviews without financial conflicts of interest. If only systematic reviews with financial conflicts of interest are available, we suggest that users read the review conclusions with skepticism, critically appraise the methods applied, and interpret the review results with caution.

OBJECTIVES To determine the role of academic authors, funders, and contract research organisations in industry funded trials of vaccines, drugs, and devices and to determine lead academic authors' experiences with industry funder collaborations. DESIGN Cross sectional analysis of trial publications and survey of lead academic authors. ELIGIBILITY CRITERIA FOR SELECTING STUDIES The most recent 200 phase III and IV trials of vaccines, drugs, and devices with full industry funding, at least one academic author, published in one of the top seven high impact general medical journals (New England Journal of Medicine, Lancet, JAMA, BMJ, Annals of Internal Medicine, JAMA Internal Medicine, and PLoS Medicine). RESULTS Employees of industry funders co-authored 173 (87%) of publications; 183 (92%) trials reported involvement of funders in design, and 167 (84%) reported involvement of academic authors. Data analysis involved the funder in 146 (73%) trials and the academic authors in 79 (40%). Trial reporting involved the funder in 173 (87%) trials and academic authors in 197 (99%). Contract research organisations were involved in the reporting of 123 (62%) trials. Eighty (40%) of 200 lead academic authors responded to the survey. Twenty nine (33%) of the 80 responders reported that academics had final say on the design. Ten responders described involvement of an unnamed funder and/or contract research organisation employee in the data analysis and/or reporting. Most academic authors found the collaboration with industry funder beneficial, but 3 (4%) experienced delay in publication due to the industry funder and 9 (11%) reported disagreements with the industry funder, mostly concerning trial design and reporting. CONCLUSIONS Industry employees and academic authors are involved in the design, conduct, and reporting of most industry funded trials in high impact journals. However, data analysis is often conducted without academic involvement. Academics view the collaboration as beneficial, but some report loss of academic freedom.

This is a protocol for a Cochrane Review (Methodology). The objectives are as follows: The primary objectives are to investigate to what degree: funding of systematic reviews by drug, device, and imaging companies and authors' other financial conflicts of interest are associated with effect size estimate; and funding of systematic reviews by drug, device, and imaging companies and authors' other financial conflicts of interest are associated with conclusions that are favourable to the sponsor. The secondary objective is to investigate to what degree: funding of systematic reviews by drug, device, and imaging companies and authors' other financial conflicts of interest are associated with the methodological quality of systematic reviews as presented by the reviews

BACKGROUND:The world is short of 7.2 million health-care workers and this figure is growing. The shortage of teachers is even greater, which limits traditional education modes. eLearning may help overcome this training need. Offline eLearning is useful in remote and resource-limited settings with poor internet access. To inform investments in offline eLearning, we need to establish its effectiveness in terms of gaining knowledge and skills, students' satisfaction and attitudes towards eLearning. METHODS:We conducted a systematic review of offline eLearning for students enrolled in undergraduate, health-related university degrees. We included randomised controlled trials that compared offline eLearning to traditional learning or an alternative eLearning method. We searched the major bibliographic databases in August 2013 to identify articles that focused primarily on students' knowledge, skills, satisfaction and attitudes toward eLearning, and health economic information and adverse effects as secondary outcomes. We also searched reference lists of relevant studies. Two reviewers independently extracted data from the included studies. We synthesized the findings using a thematic summary approach. FINDINGS:Forty-nine studies, including 4955 students enrolled in undergraduate medical, dentistry, nursing, psychology, or physical therapy studies, met the inclusion criteria. Eleven of the 33 studies testing knowledge gains found significantly higher gains in the eLearning intervention groups compared to traditional learning, whereas 21 did not detect significant differences or found mixed results. One study did not test for differences. Eight studies detected significantly higher skill gains in the eLearning intervention groups, whilst the other 5 testing skill gains did not detect differences between groups. No study found offline eLearning as inferior. Generally no differences in attitudes or preference of eLearning over traditional learning were observed. No clear trends were found in the comparison of different modes of eLearning. Most of the studies were small and subject to several biases. CONCLUSIONS:Our results suggest that offline eLearning is equivalent and possibly superior to traditional learning regarding knowledge, skills, attitudes and satisfaction. Although a robust conclusion cannot be drawn due to variable quality of the evidence, these results justify further investment into offline eLearning to address the global health care workforce shortage.

Objectives: To determine the prevalence of conflicts of interest (COIs) among Danish physicians who are authors of clinical drug trial reports and determine the extent of undisclosed COIs in trial publications.Design: Cross-sectional study.Setting: The 100 most recent drug trial reports with at least one Danish non-industry employed physician author published in a journal adhering to the International Committee of Medical Journal Editors' (ICMJE) manuscript guidelines. For each article, two observers independently extracted trial characteristics and the authors' COIs. Disclosed COIs were compared to what was registered on the Danish Health and Medicines Authority's public disclosure list.Participants: Trial authors who are Danish physicians.Main outcome measures: Number of disclosed and undisclosed COIs.Results: One observer screened 928 articles and two observers assessed 120 articles for eligibility. The 100 included trials were published from February 2011 to May 2013 and included 318 Danish non-industry employed authors. Eighty-six of the 318 authors (27%) reported one or more COIs in the journal article. We found undisclosed COIs for 40 of 318 authors (13%) related to the trial sponsor or manufacturer of trial drugs. Seventy-nine of 318 authors (25%) had undisclosed COIs related to competing companies manufacturing drugs for the same indication and 136 (43%) had undisclosed COIs with any drug manufacturer.Conclusions: Almost half of all authors had undisclosed COIs in clinical trials reported in journals adhering to the International Committee of Medical Journal Editors' manuscript guidelines. Self-declared COIs cannot be trusted, but public registries may assist editors in ensuring that more COIs are being reported.

INTRODUCTION:In 2001, a Cochrane review of mammography screening questioned whether screening reduces breast cancer mortality, and a more comprehensive review in Lancet, also in 2001, reported considerable overdiagnosis and overtreatment. This led to a heated debate and a recent review of the evidence by UK experts intended to be independent.OBJECTIVE:To explore if general medical and specialty journals differed in accepting the results and methods of three Cochrane reviews on mammography screening.METHODS:We identified articles citing the Lancet review from 2001 or updated versions of the Cochrane review (last search 20 April 2012). We explored which results were quoted, whether the methods and results were accepted (explicit agreement or quoted without caveats), differences between general and specialty journals, and change over time.RESULTS:We included 171 articles. The results for overdiagnosis were not quoted in 87% (148/171) of included articles and the results for breast cancer mortality were not quoted in 53% (91/171) of articles. 11% (7/63) of articles in general medical journals accepted the results for overdiagnosis compared with 3% (3/108) in specialty journals (p=0.05). 14% (9/63) of articles in general medical journals accepted the methods of the review compared with 1% (1/108) in specialty journals (p=0.001). Specialty journals were more likely to explicitly reject the estimated effect on breast cancer mortality 26% (28/108), compared with 8% (5/63) in general medical journals, p=0.02.CONCLUSIONS:Articles in specialty journals were more likely to explicitly reject results from the Cochrane reviews, and less likely to accept the results and methods, than articles in general medical journals. Several specialty journals are published by interest groups and some authors have vested interests in mammography screening.