Why are medical and health-related studies not being published? A systematic review of reasons given by investigators

Objective: About half of medical and health related studies are not published. We conducted a systematic review of reports on reasons given by investigators for not publishing their studies in peer-reviewed journals. Methods: MEDLINE, EMBASE, PsycINFO, and SCOPUS (until 13/09/2013), and references of identified articles were searched to identify reports of surveys that provided data on reasons given by investigators for not publishing studies. The proportion of non-submission and reasons for non-publication was calculated using the number of unpublished studies as the denominator. Because of heterogeneity across studies, quantitative pooling was not conducted. Exploratory subgroup analyses were conducted. Results: We included 54 survey reports. Data from 38 included reports were available to estimate proportions of at least one reason given for not publishing studies. The proportion of non-submission among unpublished studies ranged from 55% to 100%, with a median of 85%. The reasons given by investigators for not publishing their studies included: lack of time or low priority (median 33%), studies being incomplete (median 15%), study not for publication (median 14%), manuscript in preparation or under review (median 12%), unimportant or negative result (median 12%), poor study quality or design (median 11%), fear of rejection (median 12%), rejection by journals (median 6%), author or co-author problems (median 10%), and sponsor or funder problems (median 9%). In general, the frequency of reasons given for non-publication was not associated with the source of unpublished studies, study design, or time when a survey was conducted. Conclusions: Non-submission of studies for publication remains the main cause of non-publication of studies. Measures to reduce non-publication of studies and alternative models of research dissemination need to be developed to address the main reasons given by investigators for not publishing their studies, such as lack of time or low priority and fear of being rejected by journals

The use of meta-analysis in economic evaluation

Meta-analysis provides a family of statistical techniques for combining the results of similar studies. This paper examines the meta-analysis of clinical data in economic studies, and points to the issues and considerations that must be addressed when designing and conducting a meta-analysis of clinical data for use in an economic evaluation. We investigate whether the standard approaches employed in the meta-analysis of clinical data are satisfactory to meet the demands of economic evaluation, and assess the meta-analyses contained in a sample of economic evaluations identified from the NHS conomic Evaluation Database. Finally, we provide guidance on the appropriate use of meta-analysis for economic evaluations.economic evaluation, meta-analysis

A survey of orthopaedic journal editors determining the criteria of manuscript selection for publication

Background: To investigate the characteristics of editors and criteria used by orthopaedic journal editors in assessing submitted manuscripts. Methods: Between 2008 to 2009 all 70 editors of Medline listed orthopaedic journals were approached prospectively with a questionnaire to determine the criteria used in assessing manuscripts for publication. Results: There was a 42% response rate. There was 1 female editor and the rest were male with 57% greater than 60 years of age. 67% of the editors worked in university teaching hospitals and 90% of publications were in English.The review process differed between journals with 59% using a review proforma, 52% reviewing an anonymised manuscript, 76% using a routine statistical review and 59% of journals used 2 reviewers routinely. In 89% of the editors surveyed, the editor was able to overrule the final decision of the reviewers.Important design factors considered for manuscript acceptance were that the study conclusions were justified (80%), that the statistical analysis was appropriate (76%), that the findings could change practice (72%). The level of evidence (70%) and type of study (62%) were deemed less important. When asked what factors were important in the manuscript influencing acceptance, 73% cited an understandable manuscript, 53% cited a well written manuscript and 50% a thorough literature review as very important factors. Conclusions: The editorial and review process in orthopaedic journals uses different approaches. There may be a risk of language bias among editors of orthopaedic journals with under-representation of non-English publications in the orthopaedic literature

Impact of the NHS Stop Smoking Services on smoking prevalence in England:A simulation modelling evaluation

Background The English National Health Service NHS Stop Smoking Services (SSS), established in 2001, were the first such services in the world. An appropriate evaluation of the SSS has national and international significance. This modelling study sought to evaluate the impact of the SSS on changes in smoking prevalence in England. Methods A discrete time state-transition model was developed to simulate changes in smoking status among the adult population in England during 2001-2016. Input parameters were based on data from national statistics, population representative surveys and published literature. The main outcome was the percentage point reduction in smoking prevalence attributable to the SSS. Results Smoking prevalence was reduced by 10.8 % in absolute terms during 2001-2016 in England, and 15.3 % of the reduction could be attributable to the SSS. The percentage point reduction in smoking prevalence each year was on average 0.72%, and 0.11 % could be attributable to the SSS. The proportion of SSS supported quit attempts increased from 5.5 % in 2001, to as high as 18.9 % in 2011, and then reduced to 8.2 % in 2016. Quit attempts with SSS support had a higher success rate than those without SSS support (15.1% vs 11.3%). Smoking prevalence in England continued to decline after the SSS was much reduced from 2013 onwards. Conclusions Approximately 15% of the percentage point reduction in smoking prevalence during 2001-2016 in England may be attributable to the NHS SSS, although uncertainty remains regarding the actual impact of the formal smoking cessation services

Antibiotics for eradicating meningococcal carriages: Network meta-analysis and investigation of evidence inconsistency

AIM: To compare different antibiotics for eradicating the carriage of Neisseria meningitidis, and to investigate heterogeneity and evidence inconsistency.  METHODS: From a search of PubMed and published systematic reviews, we identified 23 trials evaluating 15 antibiotics that could be connected in a trial network. The outcome of interest is the eradication of N. meningitidis. We used WinBUGS to conduct random-effects, mixed treatment comparisons. Heterogeneity and evidence inconsistency was investigated by meta-regression modelling and examining characteristics of trial participants and interventions evaluated.  RESULTS: Rifampin, ciprofloxacin, minocycline, ceftriaxone, and azythromycin were statistically significantly (P<0.05) more effective than placebo. The probability of being the best was 67.0% for a combination of rifampin and minocycline, 25.0% for ceftriaxone, 1.7% for azythromycin, and below 1% for the remaining regimens. Significant inconsistency between the direct and indirect estimates was observed for the comparison of rifampin and ciprofloxacin (P<0.01), which may be caused by different types of carriers and different doses of ciprofloxacin.  CONCLUSION: A range of prophylactic antibiotic regimens are effective for eradicating meningococcal carriages, and treatment choice will depend on the individual priorities of the patients and physicians. In clinical situations where complete eradication is considered to be of the utmost importance, a combination of rifampin and minocycline seems to offer the highest likelihood of success. Ceftriaxone as a single intramuscular injection is also likely to be more effective as compared with the other two antibiotics (ciprofloxacin or rifampin) recommended by the current guidelines

Justification and reporting of subgroup analyses were lacking or inadequate in randomized controlled trials

Objectives: The aim of the article was to assess the appropriateness and rationales of subgroup analyses planned in protocols of randomized controlled trials and reported in subsequent corresponding trial publications. Study Design and Setting: We searched PubMed to identify trial protocols published in journals during 2006–2017. From a total of 3,774 initially identified records, we included a random sample of 479 protocols and identified 280 trial publications corresponding to the included protocols. Results: Subgroup analyses were specified in 19% of the protocols and reported in 21% of the trial publications. Of the 94 protocols with planned subgroup analyses, 32% mentioned testing for interaction, and only three considered statistical power. Subgroup analyses were not prespecified in 56% of the 59 trial publications with subgroup analyses. Subgroup analyses were stated as prespecified in nine trial publications, without support evidence from the corresponding protocols. Subgroup analyses were often reported insufficiently for assessing the consistency of subgroup effects across studies. Justifications for subgroup analyses were provided in only four trial protocols and seven trial publications. Conclusion: Inappropriate specification and reporting of subgroup analyses remain problematic in protocols and reports of randomized controlled trials. Justifications or rationales for subgroup analyses were only rarely provided in trial protocols and reports

Off-hour admission and mortality risk for 28 specific diseases: A systematic review and meta-analysis of 251 cohorts

Background: A considerable amount of studies have examined the relationship between off-hours (weekends and nights) admission and mortality risk for various diseases, but the results remain equivocal. Methods and Results: Through a search of EMBASE, PUBMED, Web of Science, and Cochrane Database of Systematic Reviews, we identified cohort studies that evaluated the association between off-hour admission and mortality risk for disease. In a random effects meta-analysis of 140 identified articles (251 cohorts), off-hour admission was strongly associated with increased mortality for aortic aneurysm (odds ratio [OR], 1.52; 95% confidence interval, 1.30-1.77), breast cancer (1.50, 1.21-1.86), leukemia (1.45, 1.17-1.79), respiratory neoplasm (1.32, 1.20-1.26), pancreatic cancer (1.32, 1.12-1.56), malignant neoplasm of genitourinary organs (1.27, 1.08-1.49), colorectal cancer (1.26, 1.07-1.49), pulmonary embolism (1.20, 1.13-1.28), arrhythmia and cardiac arrest (1.19, 1.09-1.29), and lymphoma (1.19, 1.06-1.34). Weaker (OR<1.19) but statistically significant association was noted for renal failure, traumatic brain injury, heart failure, intracerebral hemorrhage, subarachnoid hemorrhage, stroke, gastrointestinal bleeding, myocardial infarction, chronic obstructive pulmonary disease, and bloodstream infections. No association was found for hip fracture, pneumonia, intestinal obstruction, aspiration pneumonia, peptic ulcer, trauma, diverticulitis, and neonatal mortality. Overall, Off-hour admission was associated with increased mortality for 28 diseases combined (OR, 1.11; 95% confidence interval, 1.10-1.13).Conclusions: Off-hour admission is associated with increased mortality risk, and the associations varied substantially for different diseases. Specialists, nurses, as well as hospital administrators and health policy makers can take these findings into consideration to improve the quality and continuity of medical services

Differences and Similarities in Diabetes Research between China and the USA

Diabetes mellitus is one of the major non-communicable diseases (NCD) with increasing prevalence in China. There is a lack of high-quality research focusing on prevention and management of diabetes in low and middle income countries (LMICs) compared to developed countries. This comparative study aims to describe the characteristics of diabetes research conducted in China and the USA. The study included 800 studies on diabetes mellitus from both countries. Compared with studies in the USA, studies in China were more likely to be laboratory-based primary research (50.5% versus 30.8%), more likely to use animal subjects (47% versus 27.5%), more likely to focused on risk factors (22.7% versus. 14.7%), more likely to be case-controlled studies (17.7% versus 10.0%), and more likely to evaluate pharmacological treatments (36.5% versus 20.7%). Further, compared with studies in the USA, studies in China were less likely to involve patients (42.7% versus 60.7%), less likely to be clinical trials (6.2% versus 14.5%), less likely to be cohort studies (8.8% versus. 26.0%), and less likely to evaluate disease management interventions (3.3% versus 13.3%). Clinical studies in China should be more patient-based to facilitate more effective control and management of diabetes

Stakeholder views on publication bias in health services research

Objectives: While the presence of publication bias in clinical research is well documented, little is known about its role in the reporting of health services research. This paper explores stakeholder perceptions and experiences with regard to the role of publication and related biases in quantitative research relating to the quality, accessibility and organization of health services. Methods: We present findings from semi-structured interviews with those responsible for the funding, publishing and/or conduct of quantitative health services research, primarily in the UK. Additional data collection includes interviews with health care decision makers as ‘end users’ of health services research, and a focus group with patient and service user representatives. The final sample comprised 24 interviews and eight focus group participants. Results: Many study participants felt unable to say with any degree of certainty whether publication bias represents a significant problem in quantitative health services research. Participants drew broad contrasts between externally funded and peer reviewed research on the one hand, and end user funded quality improvement projects on the other, with the latter perceived as more vulnerable to selective publication and author over-claiming. Multiple study objectives, and a general acceptance of ‘mess and noise’ in the data and its interpretation was seen to reduce the importance attached to replicable estimates of effect sizes in health services research. The relative absence of external scrutiny, either from manufacturers of interventions or health system decision makers, added to this general sense of ‘low stakes’ of health services research. As a result, while many participants advocated study pre-registration and using protocols to pre-identify outcomes, others saw this as an unwarranted imposition. Conclusions: This study finds that incentives towards publication and related bias are likely to be present, but not to the same degree as in clinical research. In health services research, these were seen as being offset by other forms of ‘novelty’ bias in the reporting and publishing of research findings