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 The proportion of non-submission and reasons for non-publication was calculated using the number of unpublished studies as the denominator.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 The proportion of non-submission among unpublished studies ranged from 55% to 100%, with a median of 85%.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their studies included: lack of time or low priority (median 33%), studies being incomplete (median 15%), study not for publication (median 14%), manuscript in preparation or under review (median 12%), unimportant or negative result (median 12%), poor study quality or design (median 11%),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 In general, the frequency of reasons given for non-publication was not associated with the source of unpublished studies, study design, or time when a survey was conducted.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

Strengths and limitations of healthcare databases in the evaluation of hypoglycaemia

In this issue of DOM, Zaccardi et al. present an analysis of hypoglycaemia-related hospitalizations in the Hospital Episodes Statistics (HES) administrative database of the English National Health Service. [1] Notable strengths of the work include a large sample size involving more than 100 000 cases of hypoglycaemia, and nationwide capture spanning a duration of ten years. Key conclusions include the possibility of a U-shaped relationship between risk of hypoglycaemia and age, as well as possible associations between social deprivation and ethnicity with greater risk of hypoglycaemia

Safety of short-term dual antiplatelet therapy after drug-eluting stents:An updated meta-analysis with direct and adjusted indirect comparison of randomized control trials

Background: Duration of dual antiplatelet therapy (DAPT) following drug-eluting stents (DES) remains controversial and is a topic of ongoing research. Methods: Direct and adjusted indirect comparisons of all the recent randomized control trials (RCTs) were performed to evaluate the safety of short-term versus long-term DAPT following DES. Results: 8 RCTs were identified and 7 (16,318 subjects) were included. 4 groups of 3 vs 12 months, 6 vs 12 months, 6 vs 24 months and 12 vs 24 months of DAPT were used for direct comparison. There was no significant difference in stent thrombosis, myocardial infarction (MI), stroke and revascularization, cardiovascular and all-cause mortality between the different durations in all 4 groups. Pooling trials of 3–6 months of DAPT against 12 months, we found a significant reduction in the risk of total bleeding (RR 0.61, 95% CI 0.43–0.87). Adjusted indirect comparison between 3 vs 6 months, 3 vs 24 months and 6 vs 24 month duration of DAPT showed no significant differences in risk of death or MI, or revascularization between 3 or 6 months and 24 months. However, 24 months of DAPT was associated with significantly more bleeding than 3 or 6 months. Conclusions: 3 to 6 months of DAPT following second generation DES and above is safe with no increased risk of thrombotic complications and mortality, and lower bleeding risk. However a tailored approach may be more appropriate for high-risk patients. Keywords: Percutaneous coronary intervention; Drug-eluting stent; Acute coronary syndrome; Dual antiplatelet treatment; Duration of therap

An overview of the benefits and drawbacks of inhaled corticosteroids in chronic obstructive pulmonary disease

Sonal Singh1, Yoon K Loke21Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; 2School of Medicine, Health Policy and Practice, University of East Anglia, Norwich, EnglandBackground: The benefit harm profile of inhaled corticosteroids, and their effect on patient oriented outcomes and comorbid pneumonia, osteoporosis and cardiovascular disease in patients with chronic obstructive pulmonary disease remain uncertain.Methods: An overview of the evidence on the risks and benefits of inhaled corticosteroids (fluticasone and budesonide) in chronic obstructive pulmonary disease from recent randomized controlled trials and systematic reviews. Observational studies on adverse effects were also evaluated.Results: Evidence from recent meta-analysis suggests a modest benefit from inhaled corticosteroid long-acting beta-agonist combination inhalers on the frequency of exacerbations, (rate ratio [RR], 0.82; 95% confidence interval [CI]: 0.78 to 0.88), in improvements in quality of life measures, and forced expiratory volume in one second when compared to long-acting beta-agonists alone. On the outcome of pneumonia, our updated meta-analysis of trials (n = 24 trials; RR, 1.56; 95% CI: 1.40–1.74, P < 0.0001) and observational studies (n = 4 studies; RR, 1.44; 95% CI: 1.20–1.75, P = 0.0001) shows a significant increase in the risk of pneumonia with the inhaled corticosteroids currently available (fluticasone and budesonide). Evidence for any intraclass differences in the risk of pneumonia between currently available formulations is inconclusive due to the absence of head to head trials. Inhaled corticosteroids have no cardiovascular effects.Conclusions: Among patients with chronic obstructive pulmonary disease, clinicians should carefully balance these long-term risks of inhaled corticosteroid against their symptomatic benefits.Keywords: inhaled corticosteroids, chronic obstructive pulmonary disease, pneumonia, cardiovascular event

Upper gastrointestinal bleed associated with cholinesterase inhibitor use

An 86-year-old man was admitted with a 3-day history of melaena and syncope. He was haemodynamically compromised and anaemic on presentation. His only medical history was mild Alzheimer's disease diagnosed 6 months prior. For this, he was on donepezil, a cholinesterase inhibitor (ChEI), with a recent dose increase 3 months earlier. After fluid resuscitation with packed red cells, an endoscopy was performed, which showed an acute duodenal ulcer. This was treated with a high-dose proton pump inhibitor. The patient recovered well and was discharged on donepezil with the addition of a gastro-protective proton pump inhibitor. In view of other absent risk factors of upper gastrointestinal haemorrhage, donepezil was the likely causative agent. ChEIs are associated with frequent side effects and increased hospitalisation due to central and peripheral increase in acetylcholine. With this case report, we review the literature of side effects related to ChEIs, where the mechanisms of action, complications and appropriate management are discussed

What is the evidence of the impact of microfinance on the well-being of poor people?

The concept of microcredit was first introduced in Bangladesh by Nobel Peace Prize winner Muhammad Yunus. Professor Yunus started Grameen Bank (GB) more than 30 years ago with the aim of reducing poverty by providing small loans to the country’s rural poor (Yunus 1999). Microcredit has evolved over the years and does not only provide credit to the poor, but also now spans a myriad of other services including savings, insurance, remittances and non-financial services such as financial literacy training and skills development programmes; microcredit is now referred to as microfinance (Armendáriz de Aghion and Morduch 2005, 2010). A key feature of microfinance has been the targeting of women on the grounds that, compared to men, they perform better as clients of microfinance institutions and that their participation has more desirable development outcomes (Pitt and Khandker 1998). Despite the apparent success and popularity of microfinance, no clear evidence yet exists that microfinance programmes have positive impacts (Armendáriz de Aghion and Morduch 2005, 2010; and many others). There have been four major reviews examining impacts of microfinance (Sebstad and Chen, 1996; Gaile and Foster 1996, Goldberg 2005, Odell 2010, see also Orso 2011). These reviews concluded that, while anecdotes and other inspiring stories (such as Todd 1996) purported to show that microfinance can make a real difference in the lives of those served, rigorous quantitative evidence on the nature, magnitude and balance of microfinance impact is still scarce and inconclusive (Armendáriz de Aghion and Morduch 2005, 2010). Overall, it is widely acknowledged that no well-known study robustly shows any strong impacts of microfinance (Armendáriz de Aghion and Morduch 2005, p199-230). Because of the growth of the microfinance industry and the attention the sector has received from policy makers, donors and private investors in recent years, existing microfinance impact evaluations need to be re-investigated; the robustness of claims that microfinance successfully alleviates poverty and empowers women must be scrutinised more carefully. Hence, this review revisits the evidence of microfinance evaluations focusing on the technical challenges of conducting rigorous microfinance impact evaluations

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

Student Selected Components - a modern curriculum to complement a systems-based medical degree

The 2009 version of the GMC’s Tomorrows Doctors describes student selected components as “an integral part of the curriculum, enabling students to demonstrate mandatory competences while allowing choice in studying an area of particular interest to them”. The definition of SSCs and guidance for their delivery and assessment have been interpreted in a variety of ways by individual medical schools and by regional consortia of medical schools. To complement our systems-based MBBS modules we have developed a longitudinal Student Selected Studies (SSS) curriculum which has been reviewed and modified since 2011. Throughout the SSS curriculum, students develop academic skills and competences such as literature review or developing a clinical or research question. In years 1 to 3 these competences are acquired whilst focusing on topics from a given theme of study, for example physiology, pharmacology or ethics. In year 4 the students apply the skills acquired in the earlier years to the evaluation of a case described in their own clinical-placement log-book. In the first three years when students learn how to deliver formal presentations, using PowerPoint, conference-style posters, or anatomy demonstrations, they are given specialist tutor support, and feedback is given in formative assessments; allowing the students to make corrections and refine their skills before summative assessments take place. Our curriculum development has been shaped by the use of a competency-based teaching and assessment strategy with a focus on the student’s longitudinal development through the use of a feedforward strategy (Hattie, 2007) during and after formative assessments