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ObjectiveThe purpose of this paper is to perform a systematic review and meta-analysis in order to summarise the prevalence of diabetes and pre-diabetes and their associated risk factors in Bangladesh.DesignSystematic review and meta-analysis.ParticipantsGeneral population of Bangladesh.Data sourcesPubMed, Medline, Embase, Bangladesh Journals Online, Science Direct, Scopus, Cochrane Library and Web of Science were used to search for studies, published between 1st of January 1995 and 31st of August 2019, on the prevalence of diabetes and pre-diabetes and their associated risk factors in Bangladesh. Only articles published in the English language articles were considered. Two authors independently selected studies. The quality of the articles was also assessed.ResultsOut of 996 potentially relevant studies, 26 population-based studies, which together involved a total of 80 775 individuals, were included in the meta-analysis. The pooled prevalence of diabetes in the general population was 7.8% (95% CI: 6.4–9.3). In a sample of 56 452 individuals, the pooled prevalence of pre-diabetes was 10.1% (95% CI: 6.7–14.0; 17 studies). The univariable meta-regression analyses showed that the prevalence of diabetes is associated with the factors: the year of study, age of patients and presence of hypertension. The prevalence of diabetes was significantly higher in urban areas compared with rural areas, while there was no significant gender difference.ConclusionsThis meta-analysis suggests a relatively high prevalence of pre-diabetes and diabetes in Bangladesh, with a significant difference between rural and urban areas. The main factors of diabetes include urbanisation, increasing age, hypertension and time period. Further research is needed to identify strategies for early detecting, prevention and treatment of people with diabetes in the population.PROSPERO registration numberCRD42019148205.

ObjectivesWithin cost-effectiveness models, prevalence figures can inform transition probabilities. The methodological quality of studies can inform the choice of prevalence figures but no single obvious candidate tool exists for assessing quality of the observational epidemiological studies for selecting prevalence estimates. We aimed to compare different tools to assess the risk of bias of studies reporting prevalence, and develop and compare possible numerical scoring systems using these tools to set a threshold for inclusion of reports of prevalence in an economic analysis of neonatal hypoglycaemia.DesignAssessments of bias using two tools (Joanna Briggs Institute (JBI) Checklist for Prevalence Studies and a modified version of Risk Of Bias In Non-randomised Studies-of Interventions (ROBINS-I)) were compared for 18 studies relevant to a single setting (neonatal hypoglycaemia). Inclusions of studies for use in a decision analysis model were considered based on summary scores derived from these tools.ResultsBoth tools were considered easy to use and produced dispersed scores for each of the 40 study–outcome combinations. The modified ROBINS-I scores were more skewed than the JBI scores, particularly at higher thresholds. The studies selected for inclusion are generally the same using either tool; if 50% was used as the cut-off threshold using the Applicable Score both tools would yield the same results. However, the JBI tool is shorter and may be easier to interpret and apply to studies that do not involve a control group, while the modified ROBINS-I tool assesses more methodological detail in studies that include a control group.ConclusionBoth tools performed well for systematically assessing studies that report on outcome prevalence and provided similar discrimination between studies for risk of bias. This convergent validity supports use of both tools for the purpose of assessing risk of bias and selecting studies that report prevalence for inclusion in economic analyses.

ObjectivesTo evaluate the extent and quality of patient involvement reporting in examples of current practice in health research.DesignMixed-methods study. We used a targeted search strategy across three cohorts to identify health research publications that reported patient involvement: original research articles published in 2019 in the British Medical Journal (BMJ), articles listed in the Patient-Centered Outcomes Research Institute (PCORI) database (2019), and articles citing the GRIPP2 (Guidance for Reporting Involvement of Patients and Public) reporting checklist for patient involvement or a critical appraisal guideline for user involvement. Publications were coded according to three coding schemes: ‘phase of involvement’, the GRIPP2-Short Form (GRIPP2-SF) reporting checklist and the critical appraisal guideline.Outcome measuresThe phase of the study in which patients were actively involved. For the BMJ sample, the proportion of publications that reported patient involvement. The quality of reporting based on the GRIPP2-SF reporting guideline. The quality of patient involvement based on the critical appraisal guideline. Quantitative and qualitative results are reported.ResultsWe included 86 publications that reported patient involvement. Patients were most frequently involved in study design (90% of publications, n=77), followed by study conduct (71%, n=61) and dissemination (42%, n=36). Reporting of patient involvement was often incomplete, for example, only 40% of publications (n=34) reported the aim of patient involvement. While the methods (57%, n=49) and results (59%, n=51) of involvement were reported more frequently, reporting was often unspecific and the influence of patients’ input remained vague. Therefore, a systematic assessment of the quality and impact of patient involvement according to the critical appraisal guideline was not feasible across samples.ConclusionsAs patient involvement is increasingly seen as an integral part of the research process and requested by funding bodies, it is essential that researchers receive specific guidance on how to report patient involvement activities. Complete reporting builds the foundation for assessing the quality of patient involvement and its impact on research.

ObjectivesNon-conveyed patients represent a significant proportion of all patients cared for by ambulance services in the western world. However, scientific knowledge on non-conveyance is sparse. Therefore, the aim of this study was to describe the prevalence of non-conveyance, investigate associations and compare patients’ characteristics, drug administration, initial problems and vital signs between non-conveyed and conveyed patients.DesignA population-based retrospective cohort study.SettingThe study setting area, Stockholm, Sweden, has a population of 2.3 million inhabitants, with seven emergency hospitals. Annually, approximately 210 000 assignments are performed by 73 ambulances. All ambulance assignments performed from 1 January to 31 December 2015 were included.ResultsIn total, 23 603 ambulance assignments ended in non-conveyance—13.8% of all ambulance assignments performed in 2015. Compared with conveyed patients, non-conveyed patients were younger and more often female (median age 50.1 years for non-conveyed vs 61.7 years for conveyed; female=52 %, both p values <0.001). Approximately half of all ambulance assignments ending in non-conveyance were initially prioritised and dispatched as the highest priority. Non-conveyed patients were more often assessed by ambulance clinicians as presenting non-specific symptoms or symptoms related to psychiatric problems. Low blood glucose levels were highly associated with non-conveyance (adjusted OR (AOR): 15; 95 % CI 11.18 to 20.13), although non-conveyed patients presented abnormal vital signs across all categories of vital signs. Moreover, drugs were more often administered to younger non-conveyed patients. Older patients were more often conveyed and administered drugs once conveyed (AOR: 1.29; 95 % CI 1.07 to 1.56).ConclusionsThis study shows that non-conveyed patients represent a non-negligible proportion of all patients in contact with ambulance services. In general, most cases of non-conveyance occur at the highest dispatch level, to a large extent involve younger patients, and features problems assessed by ambulance clinicians as non-specific or related to psychiatric symptoms.

IntroductionIn Germany, there has been no population-level pharmacoepidemiological study on the safety of the COVID-19 vaccines. One factor preventing such a study so far relates to challenges combining the different relevant data bodies on vaccination with suitable outcome data, specifically statutory health insurance claims data. Individual identifiers used across these data bodies are of unknown quality and reliability for data linkage.Methods and analysisAs part of a larger pharmacovigilance study on the COVID-19 vaccines, called RiCO (German ‘Risikoevaluation der COVID-19-Impfstoffe’, Englisch ‘Risk assessment of COVID-19 vaccines’), a feasibility study is being conducted to determine the overall confidence level with which existing data can be analysed in relation to the safety of the COVID-19 vaccine. This RiCO feasibility study will establish a data flow combining claims data and vaccination data for a subsample of the total German population, describe data quality for each dataset from the various sources, estimate the proportion of the different linkage errors and will develop various approaches for linking the data in addition to the simple form of linkage using a common identifier in order to reduce possible linkage errors. These last three points are the core objective of the feasibility study. A secondary objective is to test the viability of the required data flow involving multiple stakeholders from different parts of the healthcare system.Ethics and disseminationResults will be published and used to plan the actual pharmacovigilance study on the COVID-19 vaccines for Germany, as well as future research on the role of COVID-19 vaccines as risk or protective factors for long-term COVID-19 effects. In accordance with national legal requirements, permission to use of the statutory health insurance claims data was requested and granted by the national regulatory authority for statutory health insurances. The vaccination data will be used in accordance with the requirements of the national regulation on COVID-19 vaccinations. Ethical approval was not required for this secondary data study and was therefore not sought. The results of the feasibility study will be published in a suitable, peer-reviewed scientific journal. Results will also be presented to stakeholders from German statutory health insurances and government organisations.

ObjectivesTo trial a simplified, time and cost-saving method for remote evaluation of fellowship applications and compare this with existing panel review processes by analysing concordance between funding decisions, and the use of a lottery-based decision method for proposals of similar quality.DesignThe study involved 134 junior fellowship proposals for postdoctoral research (‘Postdoc.Mobility’). The official method used two panel reviewers who independently scored the application, followed by triage and discussion of selected applications in a panel. Very competitive/uncompetitive proposals were directly funded/rejected without discussion. The simplified procedure used the scores of the two panel members, with or without the score of an additional, third expert. Both methods could further use a lottery to decide on applications of similar quality close to the funding threshold. The same funding rate was applied, and the agreement between the two methods analysed.SettingSwiss National Science Foundation (SNSF).ParticipantsPostdoc.Mobility panel reviewers and additional expert reviewers.Primary outcome measurePer cent agreement between the simplified and official evaluation method with 95% CIs.ResultsThe simplified procedure based on three reviews agreed in 80.6% (95% CI: 73.9% to 87.3%) of applicants with the official funding outcome. The agreement was 86.6% (95% CI: 80.6% to 91.8%) when using the two reviews of the panel members. The agreement between the two methods was lower for the group of applications discussed in the panel (64.2% and 73.1%, respectively), and higher for directly funded/rejected applications (range: 96.7%–100%). The lottery was used in 8 (6.0%) of 134 applications (official method), 19 (14.2%) applications (simplified, three reviewers) and 23 (17.2%) applications (simplified, two reviewers). With the simplified procedure, evaluation costs could have been halved and 31 hours of meeting time saved for the two 2019 calls.ConclusionAgreement between the two methods was high. The simplified procedure could represent a viable evaluation method for the Postdoc.Mobility early career instrument at the SNSF.

Multiple myeloma (MM) is a plasma cell tumour with over 5800 new cases each year in the UK. The introduction of biological therapies has improved outcomes for the majority of patients with MM, but in approximately 20% of patients the tumour is characterised by genetic changes which confer a significantly poorer prognosis, generally termed high-risk (HR) MM. It is important to diagnose these genetic changes early and identify more effective first-line treatment options for these patients. The Myeloma UK OPTIMUM trial (MUK ) evaluates novel treatment strategies for patients with HRMM. Patients with suspected or newly diagnosed MM, fit for intensive therapy, are offered participation in a tumour genetic screening protocol (MUK ), with primary endpoint proportion of patients with molecular screening performed within 8 weeks. Patients identified as molecularly HR are invited into the phase II, single-arm, multicentre trial (MUK ) investigating an intensive treatment schedule comprising bortezomib, lenalidomide, daratumumab, low-dose cyclophosphamide and dexamethasone, with single high-dose melphalan and autologous stem cell transplantation (ASCT) followed by combination consolidation and maintenance therapy. MUK primary endpoints are minimal residual disease (MRD) at day 100 post-ASCT and progression-free survival. Secondary endpoints include response, safety and quality of life. The trial uses a Bayesian decision rule to determine if this treatment strategy is sufficiently active for further study. Patients identified as not having HR disease receive standard treatment and are followed up in a cohort study. Exploratory studies include longitudinal whole-body diffusion-weighted MRI for imaging MRD testing. Ethics approval London South East Research Ethics Committee (Ref: 17/LO/0022, 17/LO/0023). Results of studies will be submitted for publication in a peer-reviewed journal. ISRCTN16847817, May 2017; Pre-results.

ObjectivesWe examined whether providing educational events for participants in a birth cohort study would increase the response rates of study questionnaires.DesignBirth cohort study.SettingQuestionnaires were distributed and returned by post twice in 1 year. We developed and implemented two educational sessions; a Baby Food lecture for mothers with children around 8 months old (analysis 1) and a Eurythmic session for mothers with children around 1 year and 8 months old (analysis 2). Mothers with children over the target ages were not invited (not-invited group). The invited participants were divided into three groups: those who did not apply to attend (not-applied group), those who applied but did not attend (applied group), and those who applied and attended (attended group).ParticipantsThe participants were 5379 mother–child pairs registered with the Toyama Regional Center of the Japan Environment and Children’s Study (JECS).Outcome measureThe outcome measure was return of the JECS questionnaire for 1 year old sent out after the Baby Food lecture and the JECS questionnaire for 2 years old sent out after the Eurythmic session. The questionnaires were returned to us by post.ResultsThe response rate for the attended group of the Baby Food lecture was 99.7%, and the odds ratio (OR) was significantly higher for this group than for the not-invited group (crude OR 24.54; 95% confidence interval (CI) 3.42 to 176.13; analysis 1). After the exclusion of participants who had previously attended the Baby Food lecture, the response rate for the attended group of the Eurythmic session was 97.8%, and the OR was significantly higher for this group than for the not-invited group (adjusted OR 5.66; 95% CI 1.93 to 16.54; analysis 2).ConclusionProviding educational events that are appropriate to the age and needs of the participants may increase questionnaire response rates in birth cohort studies.Trial registration numberUMIN 000030786.

ObjectiveMany studies have demonstrated that elevated serum uric acid (SUA) level is linked with metabolic syndrome (MetS). However, whether there is a sex difference in the association between SUA and MetS has not been determined. This study aimed to accurately explore the impact of SUA longitudinal changes on MetS by sex.DesignA prospective cohort study.SettingThe Health Check-up Centre of the Second Hospital affiliated with Dalian Medical University from 2010 to 2016.ParticipantsA health check-up cohort of 577 men and 1698 women aged 20–60 years who did not exhibit MetS or hyperuricaemia at baseline and underwent at least two physical examinations from 2010 to 2016.Primary and secondary outcome measuresWeight, height, blood pressure and blood biochemistry parameters, including SUA, were measured. MetS was defined according to the Joint Interim Statement criteria.MethodsBased on longitudinal data, a linear mixed-effects model was constructed to explore the characteristics of SUA dynamic changes in males and females, and joint modelling of longitudinal and survival data was done to analyse the association between SUA dynamic changes and MetS occurrence.ResultsThe natural logarithm of SUA (LNSUA) in females exhibited a gradually increasing trend, and its annual growth rate in females who developed MetS was greater than that of the non-MetS females. The longitudinal growth of SUA in females was a risk factor for the onset of MetS, and the estimated HR was 13.2580 (95% CI 1.9106 to 91.9957) for each 1-unit rise in LNSUA longitudinally. An association between the longitudinal growth of LNSUA and MetS was not found in males.ConclusionsThe longitudinal increase in SUA in females could increase the risk of MetS, even if the SUA changes within the normal range. The longitudinal increase in SUA in males was not a predictor for MetS.