To examine changes in the screening, diagnosis, treatment and management of drug-resistant tuberculosis (DRTB) patients, and investigate the impacts of DRTB-related policies on patients of different demographic and socioeconomic characteristics.
A retrospective cohort study using registry data, plus a survey on DRTB-related policies.
All prefecture-level Centres for Disease Control in Zhejiang Province, China.
Alongside the care cascade, we examined: (1) reported number of presumptive DRTB patients; (2) percentage of presumptive patients with drug susceptibility testing (DST) records; (3) percentage of DRTB/rifampicin-resistant (RR) patients registered; (4) percentage of RR/multidrug-resistant TB (MDRTB) patients that received anti-DRTB treatment; and (5) percentage of RR/MDRTB patients cured/completed treatment among those treated. Multivariate logistic regressions were conducted to explore the impacts of DRTB policies after adjusting for other factors.
The number of reported presumptive DRTB patients and the percentage with DST records largely increased during 2015–2018, and the percentage of registered patients who received anti-DRTB treatment also increased from 59.0% to 86.5%. Patients under the policies of equipping GeneXpert plus expanded criteria for DST had a higher likelihood of being registered compared with no GeneXpert (adjusted OR (aOR)=2.57, 95% CI: 1.20 to 5.51), while for treatment initiation the association was only significant when further expanding the registration criteria (aOR=2.38, 95% CI: 1.19 to 4.79). Patients with registered residence inside Zhejiang were more likely to be registered (aOR=1.96, 95% CI: 1.52 to 2.52), treated (aOR=3.83, 95% CI: 2.78 to 5.28) and complete treatment (aOR=1.92, 95% CI: 1.03 to 3.59) compared with those outside.
The policy changes on DST and registration have effectively improved DRTB case finding and care. Nevertheless, challenges remain in servicing vulnerable groups such as migrants and improving equity in the access to TB care. Future policies should provide comprehensive support for migrants to complete treatment at their current place of residence.
Evaluate the accuracy of the Breast Cancer Risk Assessment Tool (BCRAT), International Breast Cancer Intervention Study risk evaluation tool (IBIS), Polygenic Risk Scores (PRS) and combined scores (BCRAT+PRS and IBIS +PRS) to predict the occurrence of invasive breast cancers at 5 years in a French-Canadian population.
Population-based cohort study.
We used the population-based cohort CARTaGENE, composed of 43 037 Quebec residents aged between 40 and 69 years and broadly representative of the population recorded on the Quebec administrative health insurance registries.
10 200 women recruited in 2009–2010 were included for validating BCRAT and IBIS and 4555 with genetic information for validating the PRS and combined scores.
We computed the absolute risks of breast cancer at 5 years using BCRAT, IBIS, four published PRS and combined models. We reported the overall calibration performance, goodness-of-fit test and discriminatory accuracy.
131 (1.28%) women developed a breast cancer at 5 years for validating BCRAT and IBIS and 58 (1.27%) for validating PRS and combined scores. Median follow-up was 5 years. BCRAT and IBIS had an overall expected-to-observed ratio of 1.01 (0.85–1.19) and 1.02 (0.86–1.21) but with significant differences when partitioning by risk groups (p
In this French-Canadian population-based cohort, BCRAT and IBIS have good mean calibration that could be improved for risk subgroups, and modest discriminatory accuracy. Despite this modest discriminatory power, these tools can be of interest for primary care physicians for delivering a personalised message to their high-risk patients, regarding screening and lifestyle counselling.
This study aims to define appropriate domains and items for the development of a self-administered questionnaire to assess the risk of developing work-related musculoskeletal disorder (WMSD) and the risk of its progression to chronicity.
Literature review and survey study.
A literature review and a two-round interview with 15 experts in musculoskeletal pain were performed to identify the available domains for WMSD assessment.
To ensure quality, only validated questionnaires were included for the Delphi process. A three-round Delphi method, with three round steps, was used to select the most pertinent and relevant domains and items.
Nine questionnaires were identified through the expert discussion and literature review, comprising 38 candidate domains and 504 items. In the first round of the Delphi group, 17 domains reached more than 70% agreement and were selected. In the second round, 10 domains were rejected, while 11 were selected to complete the pool of domains. In the third and final round, 89 items belonging to 28 domains were defined as significant to develop a WMSDs risk assessment questionnaire.
No specific risk assessment questionnaires for WMSDs were identified from the literature. WMSD risk of presence and chronicity can be defined by an assessment tool based on the biopsychosocial model and the fear-avoidance components of chronic pain. The present study provides the formulation and operationalisation of the constructs in domains and items needed for developing and validating the questionnaire.
In oncology and palliative care, patient question prompt lists (QPLs) with sample questions for patient and family increased patients’ involvement in decision-making and improved outcomes if physicians actively endorsed asking questions. Therefore, we aim to evaluate practitioners’ perceptions of acceptability and possible use of a QPL about palliative and end-of-life care in dementia.
Mixed-methods evaluation study of a QPL developed with family caregivers and experts comprising a survey and interviews with practitioners.
Two academic medical training centres for primary and long-term care in the Netherlands.
Practitioners (n=66; 73% woman; mean of 21 (SD 11) years of experience) who were mostly general practitioners and elderly care physicians.
The main survey outcome was acceptability measured with a 15–75 acceptability scale with ≥45 meaning ‘acceptable’.
The survey response rate was 21% (66 of 320 participated). The QPL was regarded as acceptable (mean 51, SD 10) but 64% felt it was too long. Thirty-five per cent would want training to be able to answer the questions. Those who felt unable to answer (31%) found the QPL less acceptable (mean 46 vs 54 for others; p=0.015). We identified three themes from nine interviews: (1) enhancing conversations through discussing difficult topics, (2) proactively engaging in end-of-life conversations and (3) possible implementation.
Acceptability of the QPL was adequate, but physicians feeling confident to be able to address questions about end-of-life care is crucial when implementing it in practice, and may require training. To facilitate discussions of advance care planning and palliative care, families and persons with dementia should also be empowered to access the QPL themselves.
To translate and adapt the Chelsea Critical Care Physical Assessment Tool (CPAx) into Chinese version (‘CPAx-Chi’), test the reliability and validity of CPAx-Chi, and verify the cut-off point for the diagnosis of intensive care unit-acquired weakness (ICU-AW).
Cross-sectional observational study.
Forward and back translation, cross-cultural adaptation and pretesting of CPAx into CPAx-Chi were based on the Brislin model. Participants were recruited from the general ICU of five third-grade class-A hospitals in western China. Two hundred critically ill adult patients (median age: 53 years; 64% men) with duration of ICU stay ≥48 hours and Glasgow Coma Scale ≥11 were included in this study. Two researchers simultaneously and independently assessed eligible patients using the Medical Research Council Muscle Score (MRC-Score) and CPAx-Chi.
The content validity index of items was 0.889. The content validity index of scale was 0.955. Taking the MRC-Score scale as standard, the criterion validity of CPAx-Chi was r=0.758 (p
CPAx-Chi demonstrated content validity, criterion-related validity and reliability. CPAx-Chi showed the best accuracy in assessment of patients at risk of ICU-AW with good sensitivity and specificity at a recommended cut-off of 31.
To develop a model of in-hospital mortality using medical record front page (MRFP) data and assess its validity in case-mix standardisation by comparison with a model developed using the complete medical record data.
A nationally representative retrospective study.
Representative hospitals in China, covering 161 hospitals in modelling cohort and 156 hospitals in validation cohort.
Representative patients admitted for acute myocardial infarction. 8370 patients in modelling cohort and 9704 patients in validation cohort.
In-hospital mortality, which was defined explicitly as death that occurred during hospitalisation, and the hospital-level risk standardised mortality rate (RSMR).
A total of 14 variables were included in the model predicting in-hospital mortality based on MRFP data, with the area under receiver operating characteristic curve of 0.78 among modelling cohort and 0.79 among validation cohort. The median of absolute difference between the hospital RSMR predicted by hierarchical generalised linear models established based on MRFP data and complete medical record data, which was built as ‘reference model’, was 0.08% (10th and 90th percentiles: –1.8% and 1.6%). In the regression model comparing the RSMR between two models, the slope and intercept of the regression equation is 0.90 and 0.007 in modelling cohort, while 0.85 and 0.010 in validation cohort, which indicated that the evaluation capability from two models were very similar.
The models based on MRFP data showed good discrimination and calibration capability, as well as similar risk prediction effect in comparison with the model based on complete medical record data, which proved that MRFP data could be suitable for risk adjustment in hospital performance measurement.
The severity of cerebral small vessel disease (SVD) is assessed through neuroimaging findings, including hypertensive arteriopathy (HA)-SVD and cerebral amyloid angiopathy (CAA)-SVD. HA-SVD and CAA-SVD have been collectively estimated as total scores: the HA-SVD and CAA-SVD scores, respectively. Previous reports suggest that HA-SVD scores are associated with cognitive function; however, the relationship between CAA-SVD scores and cognitive function remains unclear. Therefore, we examined the association between CAA-SVD scores and cognitive function. Furthermore, we developed a modified CAA-SVD score considering cortical microinfarcts and posterior dominant white matter hyperintensities, which are imaging findings of CAA, and examined the association between these scores and cognitive function in the same patient group.
Single centre study from a memory clinic.
Subjects were diagnosed with mild cognitive impairment (MCI) or mild dementia in our memory clinic between February 2017 and July 2019 and underwent clinical dementia rating scale and brain MRI assessment. A total of 42 patients (aged 75.3±9.12 years) were registered prospectively.
We evaluated intellectual function, memory, frontal lobe function and constructional ability. Furthermore, the relationship between each score and cognitive function was examined.
The CAA-SVD score showed significant associations with cognitive function (R2=0.63, p=0.016), but the HA-SVD score did not (R2=0.41, p=0.35). The modified CAA-SVD score was also significantly associated with cognitive function (R2=0.65, p=0.008).
Cognitive function is associated with the CAA-SVD score, and more efficiently with the modified CAA-SVD score, in memory clinic patients. Although we have not validated the weighting of the modified CAA-SVD score, these scores can be a predictor of cognitive deterioration in patients with MCI and mild dementia.
To summarise current evidence on the use of pentoxifylline (PTX) to prevent contrast-induced nephropathy (CIN).
The PubMed, Embase and CENTRAL databases were searched for randomised controlled trials including patients with and without PTX undergoing contrast media exposure. We analysed the incidence of CIN and serum creatinine changes before and after contrast media exposure. All statistical analyses were conducted with Review Manager V.5.3.
We finally enrolled in seven randomised controlled trials with a total of 1484 patients in this analysis. All of seven included studies were performed in patients undergoing angioplasty or stenting. The overall rates of CIN were 8.8% and 10.4% in the PTX groups and control groups, respectively. However, no significant reduction in the CIN rate was observed in the patients treated with PTX compared with the control groups (OR 0.81, 95% CI 0.57 to 1.13, I2=0, p=0.21). All studies reported no hospital mortality and the new requirement for dialysis during the trials.
Perioperative administration of PTX to patients undergoing angioplasty did not significantly reduce the development of CIN but showed some weak tendency of lower serum creatinine increase. Based on the available trials, the evidence does not support the administration of PTX for the prevention of CIN. More trials with larger sample sizes are needed to evaluate the role of PTX in CIN prevention.
The primary purpose was to measure the birth weight of infants of mothers with gestational diabetes (IMGDs) at different gestational ages to develop new reference charts and curves for them. A further purpose was to compare them with those of 159 334 infants in China to provide more accurate reference charts for the diagnosis of suspected abnormal birth weight of IMGDs. The final purpose was to evaluate the key periods for such mothers to control their weight in line with the difference of fetal weight of each two neighbouring gestational ages.
A specialised hospital in South China
IMGDs born here from January 2014 to December 2018.
Birth weight, gestational ages of IMGDs, gender and year of birth.
Data of 14 311 singleton live births at the gestational weeks 25–42 here were collected. The proportions of low birth weight, normal birth weight and macrosomia were 7.26%, 87.04%, and 5.70%, respectively. The proportions of small for gestational age, appropriate for gestational age and large for gestational age were 5.69%, 84.42% and 9.89%, respectively. In the macrosomia group, the mean of all birth weight in 2017 decreased for the first time since 2014. Both the means of birth weight of male infants at gestational weeks 36–41 and of female at weeks 38–40 were greater than that of the 159 334 infants. The increase of each weekly mean of IMGDs at gestational weeks 27–31 and 33–35 was >10% compared with the former. Based on this, new reference charts of birth weight for IMGDs in terms of different gestational age and gender were formulated.
These charts may be applied as reference for more accurate diagnosis and quick treatment of abnormal birth weight. This study showed that the identification of key periods for fetal weight gain was helpful for the management of the weight of women with gestational diabetes.
A neonatal nutritional risk screening tool (NNRST) was developed by using Delphi and analytic hierarchy processes in China. We verified the accuracy of this tool and analysed whether it effectively screened neonates with nutritional risk.
Prospective validation study.
In total, 338 neonates who were admitted to the neonatal unit of Children’s Hospital of Chongqing Medical University from May–July 2016 completed the study. Nutritional risk screening and length and head circumference measurements were performed weekly. Weight was measured every morning, and other relevant clinical data were recorded during hospitalisation.
We evaluated the sensitivity, specificity, validity, reliability, and positive and negative predictive value of the screening tool. Various characteristics of neonates in different risk groups were analysed to determine the rationality of the nutritional risk classification.
The sensitivity, specificity, and positive and negative predictive values were 85.11%, 91.07%, 60.61% and 97.43%, respectively. The criterion validity was texted by the Spearman correlation analysis (r=0.530) and independent samples non-parametric tests (p=0.000). The content validity (Spearman correlation coefficient) was 0.321–0.735. The inter-rater reliability (kappa value) was 0.890. Among the neonatal clinical indicators, gestational age, birth weight, length, admission head circumference, admission albumin, admission total proteins, discharge weight, discharge length and head circumference decreased with increasing nutrition risk level; the length of stay and the rate of parenteral nutrition support increased with increasing nutrition risk level. In the comparison of complications during hospitalisation, the incidence of necrotising enterocolitis and congenital gastrointestinal malformation increased with increasing nutrition risk level.
The validation results for the NNRST are reliable. The tool can be used to preliminarily determine the degree of neonatal nutritional risk, but its predictive value needs to be determined in future large-sample studies.
This study investigated the knowledge, attitudes and psychological status of hepatitis C virus (HCV)-positive patients through a cross-sectional survey to provide scientific strategies for improving their treatment compliance and quality of life.
The research was conducted in nine hospitals in five provincial administrative regions in China, namely Inner Mongolia, Jilin, Beijing, Hebei and Sichuan.
A total of 457 patients were recruited for this study and 409 patients were included in the final analysis. The participants were 215 men and 194 women, with an average age of 59 years.
The primary outcomes were scores on scales assessing knowledge, attitudes and psychological status. The secondary outcomes were transmission of HCV, preference regarding the mode in which information about HCV was provided and factors affecting treatment.
Blood transfusion was the most common route of HCV transmission (42.7%), followed by surgery (15.9%) and blood donation/sale (8.7%). The misunderstanding of HCV and negative attitudes towards other HCV-positive patients were relatively common among HCV-positive patients and were more pronounced among rural and ethnic minority populations. HCV-positive patients were generally categorised as possibly having symptoms of depression. Patients with negative attitudes were more likely to have symptoms of depression (OR=0.6, 95% CI 0.4 to 0.8).
HCV-positive patients had a poor understanding of HCV and a negative attitude towards other HCV-positive patients. It is very important to develop effective health education strategies to improve the knowledge, attitudes and mental health of HCV-positive patients and enhance treatment compliance.
Kidney transplantation remains the best treatment for end-stage kidney disease, however the requirement for indefinite immunosuppression increases the risk of cardiovascular disease, cancer and infection, leading to a reduction in long-term patient and graft survival. The gut microbiome is a critical determinant of health and modulates host immunity and metabolism through a number of recognised pathways, including through the production of immunomodulatory short-chain fatty acids (SCFA). Dietary supplementation with non-digestible fibre can augment the microbial production of SCFA and lead to favourable immune and metabolic outcomes, although this has yet to be shown in human kidney transplant recipients.
Dietary inulin for gut health in solid-organ transplantation (DIGEST) is a single-centre, unblinded, pilot parallel-arm randomised controlled trial designed to assess the feasibility and adherence of dietary inulin, a naturally occurring dietary fibre, in the early post-transplant period in kidney transplant recipients. Participants will be randomised at day 28 post-transplant to a 4-week period of dietary inulin (10–20 g/day) in addition to standard care, or standard care alone, and followed-up until week 12 post-transplant.
The primary outcomes of the study are: (i) the feasibility of participant recruitment, randomisation and retention; (ii) adherence to the intervention (inulin) and (iii) the tolerability of inulin determined by changes in gastrointestinal symptoms as scored on the Gastrointestinal Symptom Rating Scale.
Secondary outcomes include: (1) glycaemic variability determined by continuous glucose monitoring; (2) abundance of SCFA-producing microbiota, as determined by 16s rRNA sequencing of the faecal metagenome; (3) serum SCFA concentrations; (4) peripheral blood immune cell populations; (5) recipient inflammatory and metabolic profiles and (6) the incidence of biopsy-proven acute rejection and kidney function determined by estimated glomerular filtration rate.
All study visits, clinical and laboratory assessments will be integrated into usual post-transplant care, creating no additional healthcare encounters or procedures. The risks associated with this study are minor. Inulin has been shown to be well tolerated across a variety of cohorts, with the occurrence of short-term adverse gastrointestinal symptoms self-limiting. However, with gastrointestinal adverse events common following kidney transplantation, the tolerability of inulin in this cohort remains unknown. The results of DIGEST will be published in peer-reviewed journals and presented at academic conferences. This study has been approved by the Sydney Local Health District’s Ethics Committee (Royal Prince Alfred Hospital Zone).
To evaluate the prescription and discontinuation of psychotropic drugs (PD) and drugs with anticholinergic properties (DAP) in residents with dementia admitted to Roken, a major type of long-term care facility in Japan.
A nationwide questionnaire survey across 3598 Roken in Japan in 2015 (up to five randomly selected residents per facility).
This study included 1201 residents from 343 Roken (response rate: 10%). We determined the presence and severity of dementia using a nationally standardised measure.
Prescriptions of PD and DAP at admission and 2 months after admission were evaluated. Multivariable logistic regression was used to evaluate the associations of residents’ baseline characteristics with prescriptions or discontinuation.
Prescription rates decreased for antidementia drugs (19.4% to 13.0%), hypnotics (25.1% to 22.6%) and anxiolytics (12.3% to 10.7%), whereas those for other PD, such as antipsychotics (13.2% to 13.6%), antidepressants (7.4% to 6.7%), antiepileptic drugs (7.1% to 7.8%) and DAP (35.2% to 36.6%) did not statistically significantly decrease. Some factors were associated with the prescriptions, for example, for antipsychotics, older age (≥85 years) (adjusted OR (aOR), 0.60; 95% CI 0.43 to 0.85) and being bedridden (aOR 0.67; 95% CI 0.47 to 0.97) were associated with a lower use of antipsychotics, whereas severe dementia was associated with a higher use of antipsychotics (aOR 3.26; 95% CI 2.26 to 4.70). At an individual level, a quarter of residents prescribed PD or DAP at admission had discontinued at least one PD or DAP, respectively, 2 months after admission. Antidementia drug use in severe dementia (aOR 1.86; 95% CI 1.04 to 3.31) and PD use in older age (aOR 1.61; 95% CI 1.00 to 2.60; in residents with disabling dementia) were associated with discontinuation.
There is possible scope for deprescribing PD and DAP in Roken residents with dementia to mitigate the risks of adverse events.
Evidence suggests that homeless patients experience worse quality of care and poorer health outcomes across a range of medical conditions. It remains unclear, however, whether differences in care delivery at safety-net versus non-safety-net hospitals explain these disparities. We aimed to investigate whether homeless versus non-homeless adults hospitalised for cardiovascular conditions (acute myocardial infarction (AMI) and stroke) experience differences in care delivery and health outcomes at safety-net versus non-safety-net hospitals.
Data including all hospital admissions in four states (Florida, Massachusetts, Maryland, and New York) in 2014.
We analysed 167 105 adults aged 18 years or older hospitalised for cardiovascular conditions (age mean=64.5 years; 75 361 (45.1%) women; 2123 (1.3%) homeless hospitalisations) discharged from 348 hospitals.
Risk-adjusted diagnostic and therapeutic procedure and in-hospital mortality, after adjusting for patient characteristics and state and quarter fixed effects.
At safety-net hospitals, homeless adults hospitalised for AMI were less likely to receive coronary angiogram (adjusted OR (aOR), 0.42; 95% CI, 0.36 to 0.50; p
Disparities in receipt of diagnostic and therapeutic procedures for homeless patients with cardiovascular conditions were observed only at safety-net hospitals. However, we found no evidence that these differences influenced in-hospital mortality markedly.
Stroke is a frequent disease in the older population of Western Europe with aphasia as a common consequence. Aphasia is known to impede targeting treatment to individual patients’ needs and therefore may reduce treatment success. In Germany, the postacute care of patients who had stroke is provided by different healthcare institutions of different sectors (rehabilitation, nursing and primary care) with substantial difficulties to coordinate services. We will conduct two qualitative evidence syntheses (QESs) aiming at exploring distinct healthcare needs and desires of older people living with poststroke aphasia. We thereby hope to support the development of integrated care models based on needs of patients who are very restricted to communicate them. Since various methods of QESs exist, the aim of the study embedding the two QESs was to determine if findings differ according to the approach used.
We will conduct two QESs by using metaethnography (ME) and thematic synthesis (ThS) independently to synthesise the findings of primary qualitative studies. The main differences between these two methods are the underlying epistemologies (idealism (ME) vs realism (ThS)) and the type of research question (emerging (ME) vs fixed (ThS)).
We will search seven bibliographical databases. Inclusion criteria comprise: patients with poststroke aphasia, aged 65 years and older, studies in German/English, all types of qualitative studies concerning needs and desires related to healthcare or the healthcare system. The protocol was registered in the International Prospective Register of Systematic Reviews, follows Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines and includes three items from the Enhancing Transparency in Reporting the synthesis of Qualitative Research checklist.
Ethical approval is not required. Findings will be published in a peer-reviewed journal and presented on national conferences.
The craniofacial abnormalities found in infants with cleft palate (CP) decrease their airway patency and increase their risk of obstructive sleep apnoea (OSA). We hypothesise that optimising sleep position in infants with CP may improve airway patency and offer a ‘low-cost, high-impact’ intervention to prevent the negative impacts of OSA. Because cleft centres give inconsistent advice about sleep position: some recommend back-lying and others side-lying, we will compare these in a randomised controlled trial.
The aim is to determine the clinical effectiveness of side-lying as compared with back-lying sleep positioning in terms of reducing oxygen desaturation resulting from OSA in 244 infants aged 3–5 weeks of age, diagnosed with an isolated CP in/by UK cleft centres. Primary outcome is the 4% Oxygen Desaturation Index measured using pulse oximetry during sleep.
1. Multicentre randomised controlled trial of side-lying compared with back-lying sleep positioning in reducing oxygen desaturation resulting from OSA in infants with CP at one month of age. 2. Internal pilot questionnaire-based study to support parents and clinicians regarding study participation, seeking to identify and address any barriers to recruitment. Monitoring data from the internal pilot will be used in the final analysis. 3. Co-development of new UK recommendations with Cleft Lip and Palate Association (CLAPA) regarding sleep position for infants with CP.
The study protocol has received the favourable opinion of the West Midlands-South Birmingham Research Ethics Committee. Study results will be published on affiliated webpages and in peer-reviewed publications and conference contributions.
Shoulder conditions are a major cause of morbidity in the general population. Many clinical practice guidelines (CPGs) for shoulder conditions have been developed. Their purpose is to provide evidence-based recommendations to assist clinicians in providing optimal care to maximise patient outcomes. The aim of this systematic review is to identify, appraise, and compare the content and quality of CPGs for atraumatic shoulder conditions.
CPGs for atraumatic shoulder conditions will be included provided they make recommendations about diagnosis and/or management, are identified by their authors as a guideline and are consistent with the Appraisal of Guidelines for Research and Evaluation (AGREE) II definition of a guideline. A systematic search of electronic databases, online guideline repositories and the websites of relevant professional societies will be conducted to identify eligible CPGs. Search terms relating to shoulder conditions (eg, ‘adhesive capsulitis’, ‘rotator cuff’ and ‘bursitis’) will be combined with a validated search filter for CPGs. Pairs of independent reviewers will determine eligibility of CPGs identified by the search. Quality appraisal of included CPGs will be performed using the AGREE II instrument. Recommendations from each CPG and how they were determined will be extracted and compared across similar CPGs. Results from this systematic review will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement.
Ethical approval is not required for this systematic review. The results from this study will be published in a peer-reviewed journal and disseminated to professional societies that publish shoulder CPGs, clinical policy groups, clinicians, researchers and consumers.
To describe the prevalence of modifiable risk factors for upper digestive tract cancer (UDTC) and its coprevalence, and investigate relevant influencing factors of modifiable UDTC risk factors coprevalence among residents aged 40–69 years in Yangzhong city, China.
A total of 21 175 participants aged 40–69 years were enrolled in the study. 1962 subjects were excluded due to missing age, marital status or some other selected information. Eventually, 19 213 participants were available for the present analysis.
Prevalence and coprevalence of eight modifiable UDTC risk factors (overweight or obesity, current smoking, excessive alcohol consumption, insufficient vegetables intake, insufficient fruit intake and the consumption of pickled, fried and hot food) were analysed.
The prevalence of overweight/obesity, current smoking, excessive alcohol consumption, insufficient vegetables intake, insufficient fruit intake and the consumption of pickled, fried and hot food in this study was 45.3%, 24.1%, 16.2%, 66.1%, 94.5%, 68.1%, 36.0% and 88.4%, respectively. Nearly all (99.9%) participants showed one or more UDTC risk factors, 98.6% of the participants showed at least two risk factors, 92.2% of the participants had at least three risk factors and 69.7% of the participants had four or more risk factors. Multivariate logistic regression analysis revealed that men, younger age, single, higher education, higher annual family income and smaller household size were more likely to present modifiable UDTC risk factors coprevalence.
The prevalence and coprevalence of modifiable UDTC risk factors are high among participants in Yangzhong city. Extra attention must be paid to these groups who are susceptible to risk factors coprevalence during screening progress. Relative departments also need to make significant public health programmes that aim to decrease modifiable UDTC risk factors coprevalence among residents aged 40–69 years from high-risk areas of UDTC.
Elderly people (≥65 years) with type 2 diabetes mellitus (T2DM) are becoming increasingly prevalent, notably in Japan. As cardiovascular (CV) risk increases with age and sodium–glucose cotransporter-2 (SGLT2) inhibitors reduce CV risk, elderly patients with T2DM are increasingly likely to be prescribed these glucose-lowering drugs. There is controversy surrounding the effects of SGLT2 inhibitors on muscle mass, particularly in elderly patients for whom loss of muscle is especially undesirable; however, robust evidence on this important issue is lacking. Consequently, we have designed a clinical trial of the SGLT2 inhibitor empagliflozin in elderly Japanese patients with T2DM (Empagliflozin in Elderly T2DM Patients (EMPA-ELDERLY)) to assess its effects on body composition as well as glycaemic control. EMPA-ELDERLY will be the first randomised clinical trial of an SGLT2 inhibitor in elderly patients with T2DM to evaluate effects on skeletal muscle mass, muscle strength and physical performance concurrently.
EMPA-ELDERLY is a randomised, double-blind, placebo-controlled, parallel-group clinical trial to be conducted in Japan. Patients with T2DM aged ≥65 years are eligible if they are Japanese with a body mass index of ≥22 kg/m2 and glycated haemoglobin (HbA1c) levels from ≥7.0% to ≤10.0% from either diet and exercise alone or treatment with oral glucose-lowering drugs. Approximately 128 participants will be randomised 1:1 to once per day, oral, double-blind treatment with empagliflozin 10 mg or matching placebo for 52 weeks. The primary endpoint is the change in HbA1c level from baseline at week 52. Secondary endpoints include changes from baseline to 52 weeks in body composition, including muscle mass and body fat, measured by bioelectrical impedance analysis, as well as skeletal muscle index, grip strength and time in the five-time chair stand test. Other endpoints include changes in patient-reported outcomes (including quality of life), cognitive function and safety.
We will submit the trial results to conferences and peer-reviewed journals.
Childhood overweight and obesity (OWO) is a primary global health challenge. Childhood OWO prevention is now a public health priority in China. The Sino-Canadian Healthy Life Trajectories Initiative (SCHeLTI), one of four trials being undertaken by the international HeLTI consortium, aims to evaluate the effectiveness of a multifaceted, community-family-mother-child intervention on childhood OWO and non-communicable diseases risk.
This is a multicentre, cluster-randomised, controlled trial conducted in Shanghai, China. The unit of randomisation is the service area of Maternal Child Health Units (N=36). We will recruit 4500 women/partners/families in maternity and district level hospitals. Participants in the intervention group will receive a multifaceted, integrated package of health promotion interventions beginning in preconception or in the first trimester of pregnancy, continuing into infancy and early childhood. The intervention, which is centred on a modified motivational interviewing approach, will target early-life maternal and child risk factors for adiposity. Through the development of a biological specimen bank, we will study potential mechanisms underlying the effects of the intervention. The primary outcome for the trial is childhood OWO (body mass index for age ≥85th percentile) at 5 years of age, based on WHO sex-specific standards. The study has a power of 0.8 (α=0.05) to detect a 30% risk reduction in the proportion of children with OWO at 5 years of age, from 24.4% in the control group to 17% in the intervention group. Recruitment was launched on 30 August 2018 for the pilot study and 10 January 2019 for the formal study.
The study has been approved by the Medical Research Ethics Committee of the International Peace Maternity and Child Health Hospital in Shanghai, China, and the Research Ethics Board of the Centre Intégré Universitaire de Santé et Services Sociaux de l’Estrie–CHUS in Sherbrooke, Canada. Data sharing policies are consistent with the governance policy of the HeLTI consortium and government legislation.
November 11, 2020 (Version #5).