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49 emner vises.
Jaensson, M., Stenberg, E., Liang, Y., Nilsson, U., Dahlberg, K.
BMJ Open, 30.11.2021
Tilføjet 30.11.2021
Objectives
The aim was to psychometrically test and evaluate the Swedish functional health literacy scale and the Swedish communicative and critical health literacy scale in patients undergoing bariatric surgery.
Design
A prospective cross-sectional psychometric study.
Setting
Patients from three bariatric centres in Sweden were consecutively included in this study.
Participants
A total of 704 patients undergoing bariatric surgery filled in the questionnaires preoperatively. Inclusion criteria were scheduled for primary bariatric surgery (Roux-en-Y gastric bypass or sleeve gastrectomy) and greater than 17 years, proficiency in Swedish.
Primary and secondary measures
Psychometric outcomes of the Swedish Functional Health Literacy scale and the Swedish Communicative and Critical Health Literacy scale.
Results
There was a higher proportion of females (74.4%, n=523) to males (25.6%, n=180). The mean age was 42 years (SD 11.5). Limited functional health literacy and limited communicative and critical health literacy (including both inadequate and problematic health literacy) was reported in 55% (n=390) and 40% (n=285), respectively. Cronbach alpha for the Swedish Functional Health Literacy scale was α=0.86 and for the Swedish Communicative and Critical Health Literacy scale, α=0.87. Construct validity showed weak to negative correlations between the Swedish Functional Health Literacy scale and income, education and SF-36/RAND36 summary scores. Confirmatory factor analysis showed a one-factor solution for the Swedish Functional Health Literacy scale and a two-factor solution for the Swedish Communicative and Critical Health Literacy scale.
Conclusions
The Swedish Functional Health Literacy scale and the Swedish Communicative and Critical Health Literacy scale are valid and reliable to use for patients undergoing bariatric surgery in a Swedish context. Measuring dimensions of health literacy can be used as a guide for the development of health literacy friendly patient information in patients undergoing bariatric surgery.
Læs mere Tjek på PubMedBretherton, C. P., Claireaux, H. A., Gower, J., Martin, S., Thornhill, A., Johnson, L., Silvester, L., Kearney, R. S., Baxter, M., Dixon, P., Giblin, V., Griffin, X. L., Eardley, W.
BMJ Open, 30.11.2021
Tilføjet 30.11.2021
Objective
To determine research priorities for the management of complex fractures, which represent the shared priorities of patients, their families, carers and healthcare professionals.
Design/setting
A national (UK) research priority setting partnership.
Participants
People who have experienced a complex fracture, their carers and relatives, and relevant healthcare professionals and clinical academics involved in treating patients with complex fractures. The scope includes open fractures, fractures to joints broken into multiple pieces, multiple concomitant fractures and fractures involving the pelvis and acetabulum.
Methods
A multiphase priority setting exercise was conducted in partnership with the James Lind Alliance over 21 months (October 2019 to June 2021). A national survey asked respondents to submit their research uncertainties which were then combined into several indicative questions. The existing evidence was searched to ensure that the questions had not already been sufficiently answered. A second national survey asked respondents to prioritise the research questions. A final shortlist of 18 questions was taken to a stakeholder workshop, where a consensus was reached on the top 10 priorities.
Results
A total of 532 uncertainties, submitted by 158 respondents (including 33 patients/carers) were received during the initial survey. These were refined into 58 unique indicative questions, of which all 58 were judged to be true uncertainties after review of the existing evidence. 136 people (including 56 patients/carers) responded to the interim prioritisation survey and 18 questions were taken to a final consensus workshop between patients, carers and healthcare professionals. At the final workshop, a consensus was reached for the ranking of the top 10 questions.
Conclusions
The top 10 research priorities for complex fracture include questions regarding rehabilitation, complications, psychological support and return to life-roles. These shared priorities will now be used to guide funders and teams wishing to research complex fractures over the coming decade.
Læs mere Tjek på PubMedZhang, S., Shi, Y., Liu, B., Wang, H., Zhao, X., Wang, X., Sun, T.
BMJ Open, 29.11.2021
Tilføjet 30.11.2021
Objectives
The current study aimed to evaluate the status quo of perceived job demands and resources respectively among Chinese doctors, to examine the mediating role of work–family conflicts in the relationship between perceived job demands and various indicators of well-being, and to test the mediating role of psychological attachment in the relationship between perceived job resources and thriving at work among Chinese doctors.
Design
A cross-sectional online survey study.
Setting
Online questionnaires were administered across 30 provinces.
Participants
A total of 2617 doctors provided sufficiently complete responses to be used in the study.
Results
Perceived job demands (M=3.843, SD=0.791) of participants were positively associated with work–family conflicts (B=0.454, p<0.001) and negatively associated with job satisfaction (B=–0.065, p<0.001) and life satisfaction (B=–0.261, p<0.001). Work–family conflicts partially mediated the relationship between job demands and life satisfaction and fully mediated the relationship between job demands and job satisfaction. Perceived job resources (M=2.474, SD=0.740) among Chinese doctors were positively associated with psychological attachment (B=0.988, p<0.001) and thriving at work (B=0.582, p<0.001). Furthermore, psychological attachment partially mediated the relationship between perceived job resources and thriving at work.
Conclusion
Doctors in China with high-level job demands tended to exhibit increased work–family conflicts, which in turn threatened their job and life satisfaction. On the contrary, doctors with greater job resources were more likely to thrive at work by increasing their degree of psychological attachment. The current study suggested that Chinese health policymakers and hospital administrators should provide a work environment with a dynamic equilibrium between doctors’ job demands and resources.
Læs mere Tjek på PubMedAmigo, F., Dalmau-Bueno, A., Garcia-Altes, A.
BMJ Open, 29.11.2021
Tilføjet 30.11.2021
Background
‘Weekend effect’ is a term used to describe the increased mortality associated with weekend emergency admissions to hospital, in contrast with admission on weekdays. The objective of the present study is to determine whether the weekend effect is present in hospitals in Catalonia.
Methods
We analysed all urgent admissions in Catalonia in 2018, for a group of pathologies. Two groups were defined (those admitted on a weekday and those admitted on a weekend). We obtained mortality at 3, 7, 15 and 30 days, and applied a proportions test to both groups. Additionally, we used Cox’s regression for mortality at 30 days, using the admission on a weekend as the exposition, adjusting by socioeconomic and clinical variables. We used the hospital discharge database and the Central Registry of the Insured Population.
Results
72 427 admissions for the selected pathologies during 2018 were found. No statistically significant differences in mortality at 30 days (p=0.524) or at 15 days (p=0.119) according to the day of admission were observed. However, significant differences were found in mortality at 7 days (p=0.025) and at 3 days (p=0.002). The hazard rate associated with the weekend was 1.13 (95% CI: 1.04 to 1.23). By contrast, the adjusted HR of the weekend interaction with time was 0.99 (95% CI: 0.99 to 1.00).
Conclusions
There is a weekend effect, but it is not constant in time. This could suggest the existence of dysfunctions in the quality of care during the weekend.
Læs mere Tjek på PubMedLu, S., Zhang, A. Y., Liu, T., Choy, J. C. P., Ma, M. S. L., Wong, G., Lum, T.
BMJ Open, 29.11.2021
Tilføjet 30.11.2021
Objectives
To understand and assess the degree of personalisation of tailored activities for people with dementia (PWD); and to estimate the magnitude of the effects of levels of personalisation on reducing behavioural and psychological symptoms of dementia (BPSD), improving quality of life (QoL) and level of engagement.
Design
Systematic review with meta-analysis.
Data sources
ProQuest, PubMed, Ovid, Cochrane Library, Web of Science and CINAHL were searched from the start of indexing to May 2020.
Eligibility criteria
We included randomised controlled trials and quasi-experimental studies assessing the effects of tailored activities for people aged 60 years or older with dementia or cognitive impairment on the outcomes of BPSD, QoL, depression and level of engagement with control groups.
Data extraction and synthesis
Two researchers screened studies, extracted data and assessed risks of bias. A rating scheme to assess the degree of personalisation of tailored activities was developed to classify tailored activities into high/medium/low groups. Effect sizes were expressed using standardised mean differences at 95% Confidence Interval (CI). Subgroup analyses were conducted to assess whether the degree of personalisation of tailored activities affected outcomes of interest.
Results
Thirty-five studies covering 2390 participants from 16 countries/regions were identified. Studies with a high-level of personalisation interventions (n=8) had a significant and moderate effect on reducing BPSD (standardised mean differences, SMD=–0.52, p<0.05), followed by medium (n=6; SMD=–0.38, p=0.071) and low-level personalisation interventions (n=6; SMD=–0.15, p=0.076). Tailored activities with a high-level of personalisation had a moderate effect size on improving QoL (n=5; SMD=0.52, p<0.05), followed by a medium level (n=3; SMD=0.41, p<0.05) of personalisation.
Conclusions
To develop high-level tailored activities to reduce BPSD and improve QoL among PWD, we recommend applying comprehensive assessments to identify and address two or more PWD characteristics in designed tailored activities and allow modification of interventions to respond to changing PWD needs/circumstances.
PROSPERO registration number
CRD42020168556.
Læs mere Tjek på PubMedRasmussen, B., Hakonsen, S. J., Toft, B.
BMJ Open, 29.11.2021
Tilføjet 30.11.2021
Introduction
Cardiac rehabilitation has become an integral part of secondary treatment of cardiovascular heart disease. Despite evidence demonstrating that cardiac rehabilitation improves prognoses, reduces disease progression and helps patients to find a new foothold in life, many patients do not enrol. Face-to-face interventions can encourage patients to enrol; however, it is unclear which strategies have been developed, how they are structured in a hospital context and whether they target the life-world of the patients. The objective of this scoping review is to map and evaluate the nature and characteristics of studies that have reported on face-to-face interventions to encourage patients to enrol in cardiac rehabilitation.
Methods and analysis
This review will be guided by the Joanna Briggs Institute Methodology for Scoping Reviews. A search strategy developed in cooperation with a research secretary will be applied in six databases including studies published from 2000 in English, Danish, Norwegian, Swedish and German with no restriction on publication type or study design. Studies involving adult patients with ischaemic heart disease or heart failure will be included. Studies providing the intervention after enrolment in cardiac rehabilitation will be excluded. Study selection will be performed independently by two reviewers. Data will be extracted by two reviewers using predefined data charting forms. The presentation of data will be a narrative summary of the characteristics and key findings to facilitate the integration of diverse evidence, and as we deem appropriate will be supported by a diagrammatic or tabular presentation.
Ethics and dissemination
This scoping review will use data from existing publications and does not require ethical approval. Results will be reported through publication in a scientific journal and presented on relevant conferences and disseminated as part of future workshops with professionals involved in communication with patients about enrolment in cardiac rehabilitation.
Læs mere Tjek på PubMedChen, T., Bachani, A. M., Li, Q.
BMJ Open, 29.11.2021
Tilføjet 30.11.2021
Objectives
While appropriate child restraint use in motor vehicles can reduce the risk of injuries or deaths, few previous studies have assessed child restraint practice in China. We aim to describe the prevalence of child restraint use and investigate risk factors affecting child restraint practice in Shanghai, China.
Design and setting
A cross-sectional observational study was conducted near children’s hospitals, kindergartens, entertainment places and shopping malls in Shanghai, China.
Participants
Eight rounds of data were collected between October 2015 and April 2019 with a total sample size of 12 061 children.
Primary outcome measures
At each site, trained field workers observed and recorded child restraint use in all passing motor vehicles with at least one child passenger.
Results
The overall child safety restraint use rate was 6.42%. Child restraint use rate rose over time, from 5.12% in round 1% to 8.55% in round 8 (p<0.001). Results from the adjusted logistic regression model showed that children occupants with the following risk factors had a higher likelihood of child restraint use: children younger than 5 years compared with those aged 5–12 years (OR 2.12; 95% CI 1.78 to 2.53; p<0.001), sitting in rear seat compared with those in front seat (OR 31.80; 95% CI 4.45 to 227.14; p=0.001), children occupants observed near entertainment places (OR 2.34; 95% CI 1.67 to 3.28; p<0.001) or near shopping malls (OR 1.86; 95% CI 1.36 to 2.55; p<0.001) compared with those near children’s hospitals and transportation in the morning compared with afternoon (OR 1.30; 95% CI 1.04 to 1.62; p=0.021).
Conclusions
The overall child safety restraint use rate was low in Shanghai. Our findings may shed light on monitoring child restraint practice and have implications for intervention programmes for children occupants with the identified risk factors, which may help to promote child restraint use in motor vehicles and prevent road traffic injuries or deaths.
Læs mere Tjek på PubMedEvenson, K. R., Bellettiere, J., Cuthbertson, C. C., Di, C., Dushkes, R., Howard, A. G., Parada Jr., H., Schumacher, B. T., Shiroma, E. J., Wang, G., Lee, I.-M., LaCroix, A. Z.
BMJ Open, 29.11.2021
Tilføjet 30.11.2021
Purpose
This paper describes the Women’s Health Accelerometry Collaboration, a consortium of two prospective cohort studies of women age 62 years or older, harmonised to explore the association of accelerometer-assessed physical activity and sedentary behaviour with cancer incidence and mortality.
Participants
A total of 23 443 women (age mean 73.4, SD 6.8) living in the USA and participating in an observational study were included; 17 061 from the Women’s Health Study (WHS) and 6382 from the Women’s Health Initiative Objective Physical Activity and Cardiovascular Health (WHI/OPACH) Study.
Findings to date
Accelerometry, cancer outcomes and covariate harmonisation was conducted to align the two cohort studies. Physical activity and sedentary behaviour were measured using similar procedures with an ActiGraph GT3X+ accelerometer, worn at the hip for 1 week, during 2011–2014 for WHS and 2012–2014 for WHI/OPACH. Cancer outcomes were ascertained via ongoing surveillance using physician adjudicated cancer diagnosis. Relevant covariates were measured using questionnaire or physical assessments. Among 23 443 women who wore the accelerometer for at least 10 hours on a single day, 22 868 women wore the accelerometer at least 10 hours/day on ≥4 of 7 days. The analytical sample (n=22 852) averaged 4976 (SD 2669) steps/day and engaged in an average of 80.8 (SD 46.5) min/day of moderate-to-vigorous, 105.5 (SD 33.3) min/day of light high and 182.1 (SD 46.1) min/day of light low physical activity. A mean of 8.7 (SD 1.7) hours/day were spent in sedentary behaviour. Overall, 11.8% of the cohort had a cancer diagnosis (other than non-melanoma skin cancer) at the time of accelerometry measurement. During an average of 5.9 (SD 1.6) years of follow-up, 1378 cancer events among which 414 were fatal have occurred.
Future plans
Using the harmonised cohort, we will access ongoing cancer surveillance to quantify the associations of physical activity and sedentary behaviour with cancer incidence and mortality.
Læs mere Tjek på PubMedLugani, F., Angeletti, A., Ravani, P., Vivarelli, M., Colucci, M., Caridi, G., Verrina, E., Emma, F., Ghiggeri, G. M.
BMJ Open, 29.11.2021
Tilføjet 30.11.2021
Introduction
Glucocorticoids induce remission in 90% of children with idiopathic nephrotic syndrome (INS). Some become steroid-dependent (SD) and require the addition of steroid sparing drugs such as calcineurin-inhibitors (CNI) or cyclophosphamide, to maintain remission. Considering the toxicity of these drugs, alternative interventions are needed for long-term treatment. The anti-CD20 antibody rituximab has shown promising steroid-sparing properties, with conflicting results in complicated forms of SD-INS. Mycophenolate mofetil (MMF) resulted effective in maintaining free-steroid remission, however, studies are limited to few uncontrolled trials with reported different dose of MMF.
Methods and analysis
This open-label, two-parallel-arm, superiority controlled randomised clinical trial will enrol children with SD-INS maintained in remission with oral glucocorticoids or CNI. Children and young adults will be randomised to either MMF (1.200 mg/m2) or rituximab (375 mg/m2) infusion. After enrolment, glucocorticoids will be tapered until complete withdrawal. We will enrol 160 children and young adults to detect as significant at the two-sided p value of 0.01 with a power >0.8 a reduction in the risk of 1-year relapse (primary end-point). As secondary endpoints, we will compare the amount of glucocorticoids required to maintain complete remission at 6 and 24 months.
Ethics and dissemination
The trial was approved by the local ethics boards (Comitato Etico Regione Liguria CER Liguria https://www.portalericerca-liguria.it/). We will publish the study results at international scientific meetings.
Trial registration numbers
NCT004585152.
Læs mere Tjek på PubMedLiu, Y., Li, J., Dou, Y., Ma, H.
BMJ Open, 29.11.2021
Tilføjet 30.11.2021
Objective
The prevalence of type 2 diabetes mellitus (T2DM) and hypertension (HTN) has notably increased in recent years. However, there is little evidence from large-scale studies assessing the joint effect of T2DM and HTN on the risk of cardiovascular events in China. This study was performed to investigate the association of T2DM and HTN with the incidence of combined vascular events (VEs) and stroke in China.
Design
A retrospective cohort study.
Setting
Data were collected from the SuValue database which includes the electronic medical records of >90 million patients from 161 hospitals across 18 provinces in China.
Participants
Patients aged ≥18 with a diagnosis of T2DM and/or HTN were included. Non-T2DM and non-HTN patients were included in this study as controls.
Outcomes
Incidence of combined VEs and stroke during the study.
Results
In the current study, 8012 patients with T2DM, 9653 patients with HTN, 3592 patients with both T2DM and HTN and 10 561 patients without T2DM or HTN were included. T2DM was significantly associated with combined VE and stroke risk (HR 1.332, 95% CI 1.134 to 1.565 and HR 1.584, 95% CI 1.246 to 2.014, respectively). HTN was significantly associated with combined VE and stroke risk (HR 3.244, 95% CI 2.946 to 3.572 and HR 4.543, 95% CI 3.918 to 5.268, respectively). T2DM combined with HTN was significantly associated with combined VE and stroke risk (HR 3.002, 95% CI 2.577 to 3.497 and HR 4.151, 95% CI 3.346 to 5.149, respectively). HTN was associated with a higher combined VE and stroke risk than T2DM (HR 2.435, 95% CI 2.113 to 2.805 and HR 2.868, 95% CI 2.341 to 3.513, respectively).
Conclusion
T2DM and HTN were strongly associated with combined VE and stroke risk; however, the HTN-only group had a higher combined VE and stroke risk than the T2DM-only group.
Læs mere Tjek på PubMedNoyes, J., Roberts, G., Williams, G., Chess, J., Mc Laughlin, L.
BMJ Open, 29.11.2021
Tilføjet 30.11.2021
Objectives
To explore how people with chronic kidney disease who are pre-dialysis, family members and healthcare professionals together navigate common shared decision-making processes and to assess how this impacts future treatment choice.
Design
Coproductive qualitative study, underpinned by the Making Good Decisions in Collaboration shared decision-model. Semistructured interviews with a purposive sample from February 2019 - January 2020. Interview data were analysed using framework analysis. Coproduction of logic models/roadmaps and recommendations.
Setting
Five Welsh kidney services.
Participants
95 participants (37 patients, 19 family members and 39 professionals); 44 people supported coproduction (18 patients, 8 family members and 18 professionals).
Findings
Shared decision-making was too generic and clinically focused and had little impact on people getting onto home dialysis. Preferences of where, when and how to implement shared decision-making varied widely. Apathy experienced by patients, caused by lack of symptoms, denial, social circumstances and health systems issues made future treatment discussions difficult. Families had unmet and unrecognised needs, which significantly influenced patient decisions. Protocols containing treatment hierarchies and standards were understood by professionals but not translated for patients and families. Variation in dialysis treatment was discussed to match individual lifestyles. Patients and professionals were, however, defaulting to the perceived simplest option. It was easy for patients to opt for hospital-based treatments by listing important but easily modifiable factors.
Conclusions
Shared decision-making processes need to be individually tailored with more attention on patients who could choose a home therapy but select a different option. There are critical points in the decision-making process where changes could benefit patients. Patients need to be better educated and their preconceived ideas and misconceptions gently challenged. Healthcare professionals need to update their knowledge in order to provide the best advice and guidance. There needs to be more awareness of the costs and benefits of the various treatment options when making decisions.
Læs mere Tjek på PubMedZhan, W., Zhu, J., Hua, X., Ye, J., Chen, Q., Zhang, J.
BMJ Open, 29.11.2021
Tilføjet 30.11.2021
Objectives
To describe the epidemiology of uterine rupture in China from 2015 to 2016 and to build a prediction model for uterine rupture in women with a scarred uterus.
Setting
A multicentre cross-sectional survey conducted in 96 hospitals across China in 2015–2016.
Participants
Our survey initially included 77 789 birth records from hospitals with 1000 or more deliveries per year. We excluded 2567 births less than 24 gestational weeks or unknown and 1042 births with unknown status of uterine rupture, leaving 74 180 births for the final analysis.
Primary and secondary outcome measures
Complete and incomplete uterine rupture and the risk factors, and a prediction model for uterine rupture in women with scarred uterus (assigned each birth a weight based on the sampling frame).
Results
The weighted incidence of uterine rupture was 0.18% (95% CI 0.05% to 0.23%) in our study population during 2015 and 2016. The weighted incidence of uterine rupture in women with scarred and intact uterus was 0.79% (95% CI 0.63% to 0.91%) and 0.05% (95% CI 0.02% to 0.13%), respectively. Younger or older maternal age, prepregnancy diabetes, overweight or obesity, complications during pregnancy (hypertensive disorders in pregnancy and gestational diabetes), low education, repeat caesarean section (≥2), multiple abortions (≥2), assisted reproductive technology, placenta previa, induce labour, fetal malpresentation, multiple pregnancy, anaemia, high parity and antepartum stillbirth were associated with an increased risk of uterine rupture. The prediction model including eight variables (OR >1.5) yielded an area under the curve (AUC) of 0.812 (95% CI 0.793 to 0.836) in predicting uterine rupture in women with scarred uterus with sensitivity and specificity of 77.2% and 69.8%, respectively.
Conclusions
The incidence of uterine rupture was 0.18% in this population in 2015–2016. The predictive model based on eight easily available variables had a moderate predictive value in predicting uterine rupture in women with scarred uterus. Strategies based on predictions may be considered to further reduce the burden of uterine rupture in China.
Læs mere Tjek på PubMedDe Neubourg, D., Janssens, L., Verhaegen, I., Smits, E., Mol, B. W., Roelant, E.
BMJ Open, 29.11.2021
Tilføjet 30.11.2021
Introduction
Tubal patency testing is an essential part in the fertility workup of many subfertile women. Hysterosalpingography (HSG) has long been the test of choice in many clinics. There is evidence from a large randomised multicentre trial and from a recent meta-analysis that women who had HSG using oil soluble contrast medium (OSCM) had higher rates of ongoing pregnancy compared with women who underwent this procedure using water contrast. However, the field is moving away from HSG and nowadays hysterosalpingo-foam sonography (Hyfosy) using ultrasound guidance is considered as the first line office tubal patency test. Therefore, a large multicentre randomised clinical trial (RCT) will be initiated to evaluate if flushing the fallopian tubes with OSCM after a normal Hyfosy showing at least one patent fallopian tube will increase the live birth rate as compared with no flushing.
Methods and analysis
We plan a multicentre two arm, 1:1 randomised, open-label pragmatic comparative trial in 12 Belgian centres. After informed consent, we will randomise infertile women between 18 and 40 years of age, undergoing Hyfosy as part of the fertility workup to Hyfosy with additional tubal flushing with OSCM versus Hyfosy without additional flushing. Infertility is defined as lack of conception despite 12 months of unprotected intercourse, or three cycles of donor insemination without pregnancy or three ovulatory ovulation induction cycles without pregnancy, all three in combination with at least one patent tube on Hyfosy. Primary endpoint will be live birth with conception within 6 months after randomisation.
Ethics and dissemination
Approval on 11 May 2021 by the Ethics Committee from ZNA Hospital Antwerp who was the central Ethics Committee for the Clinical Trial Regulation Pilot (Pilot 412) in the 12 centres. The findings from this RCT will be disseminated in peer-reviewed publications and presentations at scientific international meetings.
Trial registration numbers
EudraCT number: 2020-002135-30 and NCT04379973.
Læs mere Tjek på PubMedRenz, B. W., Adrion, C., Klinger, C., Ilmer, M., DHaese, J. G., Buhr, H.-J., Mansmann, U., Werner, J., PyloResPres Study Group
BMJ Open, 29.11.2021
Tilføjet 30.11.2021
Introduction
Partial pancreatoduodenectomy (PD) is the treatment of choice for various benign and malignant tumours of the pancreatic head or the periampullary region. For reconstruction of the gastrointestinal passage, two stomach-preserving PD variants exist: pylorus preservation PD (ppPD) or pylorus resection PD (prPD) with preservation of the stomach. In pancreatic surgery, delayed gastric emptying (DGE) remains a serious complication after PD with an incidence varying between 4.5% and 45%, potentially delaying hospital discharge or further treatment, for example, adjuvant chemotherapy. Evidence is lacking to assess, which variant of PD entails fewer postoperative DGE.
Methods and analysis
The protocol of a large-scale, multicentre, pragmatic, two-arm parallel-group, registry-based randomised controlled trial (rRCT) using a two-stage group-sequential design is presented. This patient-blind rRCT aims to demonstrate the superiority of prPD over ppPD with respect to the overall incidence of DGE within 30 days after index surgery in a German real-world setting. A total of 984 adults undergoing elective PD for any indication will be randomised in a 1:1 ratio. Patients will be recruited at about 30 hospitals being members of the StuDoQ|Pancreas registry established by the German Society of General and Visceral Surgery. The postoperative follow-up for each patient will be 30 days. The primary analysis will follow an intention-to-treat approach and applies a binary logistic random intercepts model. Secondary perioperative outcomes include overall severe morbidity (Clavien-Dindo classification), blood loss, 30-day all-cause mortality, postoperative hospital stay and operation time. Complication rates and adverse events will be closely monitored.
Ethics and dissemination
This protocol was approved by the leading ethics committee of the Medical Faculty of the Ludwig-Maximilians-Universität, Munich (reference number 19-221). The results will be published in a peer-reviewed journal and presented at international conferences. Study findings will also be disseminated via the website (http://www.dgav.de/studoq/pylorespres/).
Trial registration number
DRKS-ID: DRKS00018842.
Læs mere Tjek på PubMedLiu, X., Robbins, S., Wang, X., Virk, S., Schuck, K., Deveza, L. A., Oo, W. M., Carmichael, K., Antony, B., Eckstein, F., Wirth, W., Little, C., Linklater, J., Harris, A., Humphries, D., O'Connell, R., Heller, G., Buttel, T., Lohmander, S., Ding, C., Hunter, D. J.
BMJ Open, 29.11.2021
Tilføjet 30.11.2021
Introduction
Knee osteoarthritis (KOA) is a highly prevalent disabling joint disease. Intra-articular stem cell therapy is increasingly being used for treating KOA with little high-quality evidence to support its use. The aim of this study is to investigate the efficacy, safety and cost-effectiveness of allogeneic mesenchymal stem cells (Cymerus MSCs) for treating symptomatic tibiofemoral KOA and improving knee structure over 24 months.
Methods and analysis
The Stem Cell injections for symptomatic relief and strUctural improvement in people with Tibiofemoral knee OsteoaRthritis study is a phase III, multi-centre, parallel, superiority, randomised, double-blind, placebo-controlled trial, which will be conducted in Sydney and Hobart, Australia. 440 participants (220 per arm) aged over 40 years with painful KOA and mild to moderate structural change on X-ray (Kellgren and Lawrence grade 2 or 3) with medial minimum joint space width between 1 and 4 mm in the study knee will be recruited from the community and randomly allocated to receive either intra-articular MSCs or saline at baseline, week 3 and week 52. The coprimary outcomes will be the proportion of participants achieving patient-acceptable symptom state for knee pain at 24 months and quantitative central medial femorotibial compartment cartilage thickness change from baseline to 24 months. Main secondary outcomes include change in knee pain, Patient Global Assessment, physical function, quality of life and other structural changes. Additional data for cost-effectiveness analysis will also be recorded. Adverse events will be monitored throughout the study. The primary analysis will be conducted using modified intention-to-treat.
Ethics and dissemination
This protocol has been approved by The University of Sydney (USYD) Human Research Ethics Committee (HREC) #: 2020/119 and The University of Tasmania (UTAS) HREC #: H0021868. All participants will be required to provide informed consent. Dissemination will occur through conferences, social media, and scientific publications.
Trial registration numbers
Australian New Zealand Clinical Trials Registry (ACTRN12620000870954); U1111-1234-4897.
Læs mere Tjek på PubMedBelavy, D. L., Diwan, A. D., Ford, J., Miller, C. T., Hahne, A. J., Mundell, N., Tagliaferri, S., Bowe, S., Pedder, H., Saueressig, T., Zhao, X., Chen, X., Balasundaram, A. P., Arora, N. K., Owen, P. J.
BMJ Open, 29.11.2021
Tilføjet 30.11.2021
Introduction
Chronic low back pain disorders (CLBDs) present a substantial societal burden; however, optimal treatment remains debated. To date, pairwise and network meta-analyses have evaluated individual treatment modes, yet a comparison of a wide range of common treatments is required to evaluate their relative effectiveness. Using network meta-analysis, we aim to evaluate the effectiveness of treatments (acupuncture, education or advice, electrophysical agents, exercise, manual therapies/manipulation, massage, the McKenzie method, pharmacotherapy, psychological therapies, surgery, epidural injections, percutaneous treatments, traction, physical therapy, multidisciplinary pain management, placebo, ‘usual care’ and/or no treatment) on pain intensity, disability and/or mental health in patients with CLBDs.
Methods and analysis
Six electronic databases and reference lists of 285 prior systematic reviews were searched. Eligible studies will be randomised controlled/clinical trials (including cross-over and cluster designs) that examine individual treatments or treatment combinations in adult patients with CLBDs. Studies must be published in English, German or Chinese as a full-journal publication in a peer-reviewed journal. A narrative approach will be used to synthesise and report qualitative and quantitative data, and, where feasible, network meta-analyses will be performed. Reporting of the review will be informed by Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidance, including the network meta-analysis extension (PRISMA-NMA). The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach for network meta-analysis will be implemented for assessing the quality of the findings.
Ethics and dissemination
Ethical approval is not required for this systematic review of the published data. Findings will be disseminated via peer-reviewed publication.
PROSPERO registration number
PROSPERO registration number CRD42020182039.
Læs mere Tjek på PubMedEeles, A. L., Burnett, A. C., Cheong, J. L., Aldis, A., Pallot, L., Polonidis, T., Rust, K., Hunt, R. W., Delany, C., Spittle, A. J., The Centre of Research Excellence in Newborn Medicine, Allen, McIntyre, Cheong, Doyle, Davis, Anderson, Spittle, Hunt, Thompson, Lee, Manley, Owen, Goldfeld, Roberts, Jacobs, Burnett, Dawson, Boland, Dalziel, Treyvaud, Thio, Aldis
BMJ Open, 26.11.2021
Tilføjet 30.11.2021
Objective
Neonatal conditions can have lifelong implications for the health and well-being of children and families. Traditionally, parents and patients have not been included in shaping the agenda for research and yet they are profoundly affected by the neonatal experience and its consequences. This study aimed to identify consensus research priorities among parents/patients of newborn medicine in Australia and New Zealand.
Design
Parents/patients with experience of neonatal care in Australia and New Zealand completed an online Delphi study to identify research priorities across four epochs (neonatal admission, early childhood, childhood/adolescence and adulthood). Parents/patients first generated key challenges in each of these epochs. Through inductive thematic analysis, recurring topics were identified and research questions generated. Parents/patients rated these questions in terms of priorities and a list of questions consistently rated as high priority was identified.
Participants
393 individuals participated, 388 parents whose children had received neonatal care and 5 adults who had received neonatal care themselves.
Results
Many research questions were identified as high-priority across the lifespan. These included how to best support parental mental health, relationships between parents and neonatal clinical staff (including involvement in care and communication), bonding and the parent–child relationship, improving neonatal medical care and addressing long-term impacts on child health and neurodevelopment.
Conclusions
Parents with experience of newborn medicine have strong, clear and recurring research priorities spanning neonatal care practices, psychological and other impacts on families, and impacts on child development. These findings should guide neonatal research efforts. In addition to generating new knowledge, improved translation of existing evidence to parents is also needed.
Læs mere Tjek på PubMedCai, Z., Xian, J., Araujo, C., Zhang, Z., Zhou, H., Peng, H., Sharma, M., Zhao, Y.
BMJ Open, 26.11.2021
Tilføjet 30.11.2021
Objectives
This study aims to assess the independent and combined associations between multiple lifestyle behaviours and academic grades of inner urban high school students (IUHSSs) and peri-urban high school students (PUHSSs).
Design
A cross-sectional study was conducted.
Participants
There are 1481 high school students (49.9% boys) in this study, who were enrolled from one inner urban and two peri-urban schools in Chongqing, China.
Outcome measures
Academic grades were assessed based on the students’ self-reported grade ranking in the last cumulative examination.
Results
In IUHSSs and PUHSSs, high frequency of sugar-sweetened beverage consumption was unlikely to obtain high academic grades (OR 0.56, 95% CI 0.32 to 0.99 and 0.63, 95% CI 0.42 to 0.96), respectively). Among IUHSSs, meeting the recommendations for weekday screen time and egg consumption (OR 1.57, 95% CI 1.06 to 2.34 and 1.60, 95% CI 1.04 to 2.47, respectively) and high frequency of fruit consumption (1.67, 95% CI 1.11 to 2.50) were significantly associated with high academic grades; meeting the recommendation for weekday sleep duration was unlikely to obtain high academic grades (0.46, 95% CI 0.21 to 0.98). Among PUHSSs, meeting the recommendations for weekend sleep duration (1.40, 95% CI 1.02 to 1.93) and eating dinner regularly (1.55, 95% CI 1.01 to 2.37) had significant associations with high academic grades. No significant associations were found between physical activity and academic grades in both IUHSSs and PUHSSs (p>0.05). Moreover, IUHSSs with 9–13 healthy lifestyle behaviours were 3.25 times more likely to achieve high academic grades than IUHSSs with 1–6 healthy lifestyle behaviours (3.25, 95% CI 1.96 to 5.40). No significant associations were found in the combined associations between multiple lifestyle behaviours and academic grades among PUHSSs (p>0.05).
Conclusions
Correlations were observed between lifestyle behaviours and academic grades among high school students, and cumulative associations between multiple healthy lifestyle behaviours and academic outcomes appear to be stronger than the independent associations. These findings are particularly applicable to IUHSSs.
Læs mere Tjek på PubMedKlein, A., Wolters, N. E., Bol, E. J. M., Koelen, J., de Koning, L., Roetink, S. S. M., van Blom, J. J., Pronk, T., van der Heijde, C., Salemink, E., Bolinski, F., Riper, H., Karyotaki, E., Cuijpers, P., Schneider, S., Rapee, R. M., Vonk, P., Wiers, R. W.
BMJ Open, 26.11.2021
Tilføjet 30.11.2021
Introduction
Emerging adulthood is a phase in life that is associated with an increased risk to develop a variety of mental health disorders including anxiety and depression. However, less than 25% of university students receive professional help for their mental health reports. Internet-based cognitive behavioural therapy (iCBT) may entail useful interventions in a format that is attractive for university students. The aim of this study protocol is to test the effectiveness of a therapist-guided versus a computer-guided transdiagnostic iCBT programme with a main focus on anxiety and depression.
Methods and analysis
University students with anxiety and/or depressive symptoms will be randomised to a (1) 7-week iCBT programme (excluding booster session) with therapist feedback, (2) the identical iCBT programme with computer feedback only or (3) care as usual. Participants in the care as usual condition are informed and referred to conventional care services and encouraged to seek the help they need. Primary outcome variables are self-reported levels of anxiety as measured with the General Anxiety Disorder-7 and self-reported levels of depression as measured with the Patient Health Questionnaire-9. Secondary outcomes include treatment adherence, client satisfaction, medical service use, substance use, quality of life and academic achievement. Assessments will take place at baseline (t1), midtreatment (t2), post-treatment (t3), at 6 months (t4) and 12 months (t5) postbaseline. Social anxiety and perfectionism are included as potentially important predictors of treatment outcome. Power calculations are based on a 3 (group) x 3 (measurement: pretreatment, midtreatment and post-treatment) interaction, resulting in an aimed sample of 276 participants. Data will be analysed based on intention-to-treat and per protocol samples using mixed linear models.
Ethics and dissemination
The current study was approved by the Medical Ethics Review Committee (METC) of the Academic Medical Centre, Amsterdam, The Netherlands (number: NL64929.018.18). Results of this trial will be published in peer-reviewed journals.
Trial registration number
NL7328.
Læs mere Tjek på PubMedBhusal, U. P., Sapkota, V. P.
BMJ Open, 26.11.2021
Tilføjet 30.11.2021
Objectives
We analysed predictors of health insurance enrolment in Nepal, measured wealth-related inequality and decomposed inequality into its contributing factors.
Design
Cross-sectional study.
Setting
We used nationally representative data based on Nepal Multiple Indicator Cluster Survey 2019. Out of 10 958 households included in this study, 6.95% households were enroled in at least one health insurance scheme.
Primary outcome
measures health insurance (of any type) enrolment.
Results
Households were more likely to have health insurance membership when household head have higher secondary education or above compared with households without formal education (adjusted OR 1.87; 95% CI: 1.32 to 2.64)). Households with mass media exposure were nearly three times more likely to get enroled into the schemes compared with their counterparts (adjusted OR 2.96; 95% CI 2.03 to 4.31). Hindus had greater odds of being enroled (adjusted OR 1.82; 95% CI 1.20 to 2.77) compared with non-Hindus. Dalits were less likely to get enroled compared with Brahmin, Chhetri and Madhesi (adjusted OR 0.66; 95% CI 0.47 to 0.94). Households from province 2, Bagmati and Sudurpaschim were less likely to have membership compared with households from province 1. Households from Richer and Richest wealth quintiles were more than two times more likely to have health insurance membership compared with households from the poorest wealth quintile. A positive concentration index 0.25 (95% CI 0.21 to 0.30; p<0.001) indicated disproportionately higher health insurance enrolment among wealthy households.
Conclusions
Education of household head, exposure to mass media, religious and ethnic background, geographical location (province) and wealth status were key predictors of health insurance enrolment in Nepal. There was a significant wealth-related inequality in health insurance affiliation. The study recommends regular monitoring of inequality in health insurance enrolment across demographic and socioeconomic groups to ensure progress towards Universal Health Coverage.
Læs mere Tjek på PubMedLi, W., Song, Y., Chen, K., Ying, J., Zheng, Z., Qiao, S., Yang, M., Zhang, M., Zhang, Y.
BMJ Open, 26.11.2021
Tilføjet 30.11.2021
Objective
Aiming to investigate diabetic retinopathy (DR) risk factors and predictive models by machine learning using a large sample dataset.
Design
Retrospective study based on a large sample and a high dimensional database.
Setting
A Chinese central tertiary hospital in Beijing.
Participants
Information on 32 452 inpatients with type-2 diabetes mellitus (T2DM) were retrieved from the electronic medical record system from 1 January 2013 to 31 December 2017.
Methods
Sixty variables (including demography information, physical and laboratory measurements, system diseases and insulin treatments) were retained for baseline analysis. The optimal 17 variables were selected by recursive feature elimination. The prediction model was built based on XGBoost algorithm, and it was compared with three other popular machine learning techniques: logistic regression, random forest and support vector machine. In order to explain the results of XGBoost model more visually, the Shapley Additive exPlanation (SHAP) method was used.
Results
DR occurred in 2038 (6.28%) T2DM patients. The XGBoost model was identified as the best prediction model with the highest AUC (area under the curve value, 0.90) and showed that an HbA1c value greater than 8%, nephropathy, a serum creatinine value greater than 100 µmol/L, insulin treatment and diabetic lower extremity arterial disease were associated with an increased risk of DR. A patient’s age over 65 was associated with a decreased risk of DR.
Conclusions
With better comprehensive performance, XGBoost model had high reliability to assess risk indicators of DR. The most critical risk factors of DR and the cut-off of risk factors can be found by SHAP method to render the output of the XGBoost model clinically interpretable.
Læs mere Tjek på PubMedJensen, H. A. R., Ekholm, O.
BMJ Open, 26.11.2021
Tilføjet 30.11.2021
Objective
Information on the use of complementary and alternative medicine (CAM) in the general population is often collected by means of surveys, causing the reliability of data to rely on the memory accuracy of the respondent. The objective of this study was to examine the consistency in self-reported CAM use using data from two survey waves 4 years apart.
Design
Longitudinal study.
Setting/participants
Data were obtained from the Danish Health and Morbidity Surveys. A nationally representative subsample of the individuals invited in 2013 was reinvited in 2017. In all, 2297 individuals (≥16 years) completed the self-administered questionnaire in both waves, including questions on for example, CAM use.
Main outcome measures
The use of six different CAM therapies (acupuncture; craniosacral therapy; faith healing and/or clairvoyance; nutritional counselling; massage; osteopathy or other manipulative therapies; reflexology) was assessed by the response categories ‘Yes, within the past 12 months’, ‘Yes, but previously than within the past 12 months’ and ‘No’. For each CAM therapy, an inconsistent response was defined as either the response combination (1) ‘Yes, within the past 12 months’ in 2013 and ‘No’ in 2017, or (2) ‘Yes, within the past 12 months’ or ‘Yes, but previously than within the past 12 months’ in 2013 and ‘No’ in 2017.
Results
The inconsistency percentages varied across CAM therapies. The highest levels of inconsistency for CAM use within the past 12 months were observed for nutritional counselling (64.9 %) and faith healing and/or clairvoyance (36.4 %). The lowest proportion of inconsistent responses was observed for acupuncture (18.3%). Overall, the same pattern was observed for lifetime CAM use.
Conclusions
The results highlight the difficulty in obtaining reliable prevalence estimates on the use of CAM in the general population. Future studies should take these findings into account when interpreting similar analyses.
Læs mere Tjek på PubMedHagelskjaer, V., Nielsen, K. T., von Bulow, C., Oestergaard, L. G., Graff, M., Waehrens, E. E.
BMJ Open, 26.11.2021
Tilføjet 30.11.2021
Introduction
The need to develop and evaluate interventions, addressing problems performing activities of daily living (ADL) among persons with chronic conditions, is evident. Guided by the British Medical Research Council’s guidance on how to develop and evaluate complex interventions, the occupational therapy programme (A Better everyday LifE (ABLE)) was developed and feasibility tested. The aim of this protocol is to report the planned design and methods for evaluating effectiveness, process and cost-effectiveness of the programme.
Methods and analysis
The evaluation is designed as a randomised controlled trial with blinded assessors and investigators. Eighty participants with chronic conditions and ADL problems are randomly allocated to ABLE or usual occupational therapy. Data for effectiveness and cost-effectiveness evaluations are collected at baseline (week 0), post intervention (week 10) and follow-up (week 26). Coprimary outcomes are self-reported ADL ability (ADL-Interview (ADL-I) performance) and observed ADL motor ability (Assessment of Motor and Process Skills (AMPS)). Secondary outcomes are perceived satisfaction with ADL ability (ADL-I satisfaction); and observed ADL process ability (AMPS). Explorative outcomes are occupational balance (Occupational Balance Questionnaire); perceived change (Client-Weighted Problems Questionnaire) and general health (first question of the MOS 36-item Short Form Survey Instrument). The process evaluation is based on quantitative data from registration forms and qualitative interview data, collected during and after the intervention period. A realist evaluation approach is applied. A programme theory expresses how context (C) and mechanisms (M) in the programme may lead to certain outcomes (O), in so-called CMO configurations. Outcomes in the cost-effectiveness evaluation are quality-adjusted life years (EuroQool 5-dimension) and changes in ADL ability (AMPS, ADL-I). Costs are estimated from microcosting and national registers.
Ethics and dissemination
Danish Data Protection Service Agency approval: Journal-nr.: P-2020-203. The Ethical Committee confirmed no approval needed: Journal-nr.: 19 045 758. Dissemination for study participants, in peer-reviewed journals and conferences.
Trial registration number
NCT04295837
Læs mere Tjek på PubMedHesketh, K., Low, J., Andrews, R., Jones, C. A., Jones, H., Jung, M. E., Little, J., Mateus, C., Pulsford, R., Singer, J., Sprung, V. S., McManus, A. M., Cocks, M.
BMJ Open, 26.11.2021
Tilføjet 30.11.2021
Introduction
Exercise and physical activity (PA) are fundamental to the treatment of type 2 diabetes. Current exercise and PA strategies for newly diagnosed individuals with type 2 diabetes are either clinically effective but unsuitable in routine practice (supervised exercise) or suitable in routine practice but clinically ineffective (PA advice). Mobile health (mHealth) technologies, offering biometric data to patients and healthcare professionals, may bridge the gap between supervised exercise and PA advice, enabling patients to engage in regular long-term physically active lifestyles. This feasibility randomised controlled trial (RCT) will evaluate the use of mHealth technology when incorporated into a structured home-based exercise and PA intervention, in those recently diagnosed with type 2 diabetes.
Methods and analysis
This feasibility multicentre, parallel group RCT will recruit 120 individuals with type 2 diabetes (diagnosis within 5–24 months, aged 40–75 years) in the UK (n=60) and Canada (n=60). Participants will undertake a 6-month structured exercise and PA intervention and be supported by an exercise specialist (active control). The intervention group will receive additional support from a smartwatch and phone app, providing real-time feedback and enabling improved communication between the exercise specialist and participant. Primary outcomes are recruitment rate, adherence to exercise and loss to follow-up. Secondary outcomes include a qualitative process evaluation and piloting of potential clinical outcome measures for a future RCT.
Ethics and dissemination
The trial was approved in the UK by the South East Scotland Research Ethics Committee 01 (20/SS/0101) and in Canada by the Clinical Research Ethics Board of the University of British Columbia (H20-01936), and is being conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Results will be published in peer-reviewed journals and presented at national and international scientific meetings.
Trial registration numbers
ISRCTN14335124; ClinicalTrials.gov: NCT04653532.
Læs mere Tjek på PubMedBrown, T. T., Hurley, V. B., Rodriguez, H. P.
BMJ Open, 26.11.2021
Tilføjet 30.11.2021
Objective
Musculoskeletal problems like hip and knee osteoarthritis and low-back pain are preference sensitive conditions. Patient engagement strategies (PES), such as shared decision-making and motivational interviewing, can help align patients’ preferences with treatment options and potentially reduce spending. We assess the association of physician practice-level adoption of PES with utilisation and spending.
Design
Cross-sectional study in which patients were matched across low, moderate and high levels of PES via coarsened exact matching.
Setting
Primary and secondary care in 2190 physician practices.
Participants
39 336 hip, 48 362 knee and 67 940 low-back patients who were Medicare beneficiaries were matched to the 2017–2018 National Survey of Healthcare Organizations and Systems.
Primary and secondary outcome measures
Total hip replacement (THR), total knee replacement (TKR), 1–2 level posterior lumbar fusion (LF), total annual spending, components of total annual spending.
Results
Total annual spending for patients with musculoskeletal problems did not differ for practices with low versus moderate PES, low versus high PES or moderate versus high PES, but spending was significantly lower in some categories for practices with relatively higher PES adoption. For hospital-owned and health system-owned practices, the ORs of receiving LF were 0.632 (95% CI 0.396 to 1.009) for patients attributed to practices with high PES compared with patients attributed to practices with moderate PES. For independent practices, the odds of receiving THR were 1.403 (95% CI 1.035 to 1.902) for patients attributed to practices with moderate PES compared with patients attributed to practices with low PES.
Conclusions
Practice-level adoption of PES for patients with musculoskeletal problems was generally not associated with total spending. PES, however, may steer patients toward evidence-based treatments. Opportunities for overall spending reduction exist as indicated by the variation in the subcomponents of total spending by PES adoption.
Læs mere Tjek på PubMedLiu, H., Chen, G., Li, J., Hao, C., Zhang, B., Bai, Y., Song, L., Chen, C., Xie, H., Liu, T., Caine, E. D., Hou, F.
BMJ Open, 26.11.2021
Tilføjet 30.11.2021
Introduction
The postdischarge suicide risk among psychiatric patients is significantly higher than it is among patients with other diseases and general population. The brief contact interventions (BCIs) are recommended to decrease suicide risk in areas with limited mental health service resources like China. This study aims to develop a postdischarge suicide intervention strategy based on BCIs and evaluate its implementability under the implementation outcome framework.
Methods and analysis
This study will invite psychiatric patients and family members, clinical and community mental health service providers as the community team to develop a postdischarge suicide intervention strategy. The study will recruit 312 patients with psychotic symptoms and 312 patients with major depressive disorder discharged from Shenzhen Kangning Hospital (SKH) in a Sequential Multiple Assignment Randomised Trial. Participants will be initially randomised into two intervention groups to receive BCIs monthly and weekly, and they will be rerandomised into three intervention groups to receive BCIs monthly, biweekly and weekly at 3 months after discharge according to the change of their suicide risk. Follow-ups are scheduled at 1, 3, 6 and 12 months after discharge. With the intention-to-treat approach, generalised estimating equation and survival analysis will be applied. This study will also collect qualitative and quantitative information on implementation and service outcomes from the community team.
Ethics/dissemination
This study has received ethical approval from the Ethics Committee Review Board of SKH. All participants will provide written informed consent prior to enrolment. The findings of the study will be disseminated through peer-reviewed scientific journals, conference presentations. A project report will be submitted to the National Natural Science Foundation of China as the concluding report of this funded project, and to the mental health authorities in the Shenzhen to refine and apply evidence-based and pragmatic interventions into health systems for postdischarge suicide prevention.
Trial registration number
NCT04907669.
Læs mere Tjek på PubMedHuang, Y.-C., Lee, J.-D., Weng, H.-H., Lin, L.-C., Tsai, Y.-H., Yang, J.-T.
BMJ Open, 26.11.2021
Tilføjet 30.11.2021
Introduction
Branch atheromatous disease (BAD) contributes to small-vessel occlusion in cases of occlusion or stenosis of large calibre penetrating arteries, and it is associated with a higher possibility of early neurological deterioration (END) and recurrent stroke in acute ischaemic stroke. As the pathology of BAD is due to atherosclerosis, we postulate that early intensive medical treatment with dual antiplatelet therapy (DAPT) and high-intensity statins may prevent END and recurrent stroke in acute small subcortical infarction caused by BAD.
Methods and analysis
In this prospective, single-centre, open-label, non-randomised, single-arm study using a historical control, we will compare early DAPT and high-intensity statin treatment with a historical control group of patients with BAD who were treated with single antiplatelet therapy without high-intensity statin treatment. Patients will be eligible for enrolment if they are admitted for acute ischaemic stroke within 24 hours, have a National Institutes of Health Stroke Scale (NIHSS) score of 1–8 and are diagnosed with BAD by MRI. Patients will take aspirin, clopidogrel and high-intensity statins (atorvastatin or rosuvastatin) within 24 hours of stroke onset, followed by aspirin or clopidogrel alone from day 22. The primary endpoint is the percentage of patients who develop END within 7 days of stroke onset (defined as an increase in the NIHSS score ≥2 points) and recurrent stroke within 30 days. The total sample sizes will be 138 for the intervention group and 277 for the control group. A historical control group will be drawn from previous prospective observation studies.
Ethics and dissemination
The protocol of this study has been approved by the Institutional Review Board of Chang Gung Memorial Hospital (202001386A3). All participants will have to sign and date an informed consent form. The findings arising from this study will be disseminated in peer-reviewed journals and academic conferences.
Trial registration number
NCT04824911.
Læs mere Tjek på PubMedOkada, I., Iwamoto, K., Miyata, S., Fujimoto, A., Tanaka, M., Amano, M., Matsuyama, N., Taoka, T., Naganawa, S., Ozaki, N.
BMJ Open, 26.11.2021
Tilføjet 30.11.2021
Introduction
Bidirectional associations have been reported between sleep disturbance and both cognitive impairment, including Alzheimer’s disease and amyloid beta-peptide (Aβ) accumulation. These relationships can be explained by the glymphatic system, which acts as a garbage drainage system in the brain. As interstitial fluid dynamics are suggested to increase during sleep, clearance of Aβ can be influenced by sleep disturbance or deprivation. We hypothesised that using lemborexant, an orexin receptor antagonist, to improve sleep quality would also improve the function of the glymphatic system. We plan to examine the effect of lemborexant on sleep quality and the glymphatic system among patients with insomnia disorder.
Methods and analysis
This pilot study is designed as an open-label, single-arm, single-centre trial. Thirty patients aged 50 years and over with insomnia will be recruited. The participants will take lemborexant (5 mg) at bedtime for 12 weeks and undergo a home-based sleep study at baseline and weeks 4 and 12, as well as MRI examinations to evaluate the glymphatic system at baseline and week 12. The primary outcome will be changes in objective sleep parameters as evaluated using a sleep monitoring system. The secondary outcomes will be changes in subjective sleep parameters. The relationships between changes in sleep parameters and the glymphatic system will be evaluated using diffusion tensor image analysis along the perivascular space, which is called the ALPS-index. Sleep parameters and the ALPS-index will be analysed using a paired t-test or Pearson’s correlation coefficient.
Ethics and dissemination
The study protocol was approved by Nagoya University Certified Review Board. The findings from this research will be published in peer-reviewed journals and be presented at local, national and international conferences.
Trial registration number
jRCTs041210024.
Læs mere Tjek på PubMedDobson, R., Craner, M., Waddingham, E., Miller, A., Cavey, A., Webb, S., Hemingway, C., Hobart, J., Evangelou, N., Scolding, N., Rog, D., Nicholas, R., Marta, M., Blain, C., Young, C. A., Ford, H. L., Matthews, P. M.
BMJ Open, 25.11.2021
Tilføjet 30.11.2021
Introduction
The power of ‘real world’ data to improve our understanding of the clinical aspects of multiple sclerosis (MS) is starting to be realised. Disease modifying therapy (DMT) use across the UK is driven by national prescribing guidelines. As such, the UK provides an ideal country in which to gather MS outcomes data. A rigorously conducted observational study with a focus on pharmacovigilance has the potential to provide important data to inform clinicians and patients while testing the reliability of estimates from pivotal trials when applied to patients in the UK.
Methods and analysis
The primary aim of this study is to characterise the incidence and compare the risk of serious adverse events in people with MS treated with DMTs. The OPTIMISE:MS database enables electronic data capture and secure data transfer. Selected clinical data, clinical histories and patient-reported outcomes are collected in a harmonised fashion across sites at the time of routine clinical visits. The first patient was recruited to the study on 24 May 2019. As of January 2021, 1615 individuals have baseline data recorded; follow-up data are being captured and will be reported in due course.
Ethics and dissemination
This study has ethical permission (London City and East; Ref 19/LO/0064). Potential concerns around data storage and sharing are mitigated by the separation of identifiable data from all other clinical data, and limiting access to any identifiable data. The results of this study will be disseminated via publication. Participants provide consent for anonymised data to be shared for further research use, further enhancing the value of the study.
Læs mere Tjek på PubMedHuang, Q., Hao, S., You, J., Yao, X., Li, Z., Schilling, J., Thyparambil, S., Liao, W.-L., Zhou, X., Mo, L., Ladella, S., Davies-Balch, S. R., Zhao, H., Fan, D., Whitin, J. C., Cohen, H. J., McElhinney, D. B., Wong, R. J., Shaw, G. M., Stevenson, D. K., Sylvester, K. G., Ling, X. B.
BMJ Open, 25.11.2021
Tilføjet 30.11.2021
Objective
This study aimed to develop a blood test for the prediction of pre-eclampsia (PE) early in gestation. We hypothesised that the longitudinal measurements of circulating adipokines and sphingolipids in maternal serum over the course of pregnancy could identify novel prognostic biomarkers that are predictive of impending event of PE early in gestation.
Study design
Retrospective discovery and longitudinal confirmation.
Setting
Maternity units from two US hospitals.
Participants
Six previously published studies of placental tissue (78 PE and 95 non-PE) were compiled for genomic discovery, maternal sera from 15 women (7 non-PE and 8 PE) enrolled at ProMedDx were used for sphingolipidomic discovery, and maternal sera from 40 women (20 non-PE and 20 PE) enrolled at Stanford University were used for longitudinal observation.
Outcome measures
Biomarker candidates from discovery were longitudinally confirmed and compared in parallel to the ratio of placental growth factor (PlGF) and soluble fms-like tyrosine kinase (sFlt-1) using the same cohort. The datasets were generated by enzyme-linked immunosorbent and liquid chromatography-tandem mass spectrometric assays.
Results
Our discovery integrating genomic and sphingolipidomic analysis identified leptin (Lep) and ceramide (Cer) (d18:1/25:0) as novel biomarkers for early gestational assessment of PE. Our longitudinal observation revealed a marked elevation of Lep/Cer (d18:1/25:0) ratio in maternal serum at a median of 23 weeks’ gestation among women with impending PE as compared with women with uncomplicated pregnancy. The Lep/Cer (d18:1/25:0) ratio significantly outperformed the established sFlt-1/PlGF ratio in predicting impending event of PE with superior sensitivity (85% vs 20%) and area under curve (0.92 vs 0.52) from 5 to 25 weeks of gestation.
Conclusions
Our study demonstrated the longitudinal measurement of maternal Lep/Cer (d18:1/25:0) ratio allows the non-invasive assessment of PE to identify pregnancy at high risk in early gestation, outperforming the established sFlt-1/PlGF ratio test.
Læs mere Tjek på PubMedMoustafa, M., Mali, M. E., Lopez-Verdugo, F., Sanyang, O., Nellermoe, J., Price, R. R., Manortey, S., Biritwum-Nyarko, A., Ofei, I., Sorensen, J., Goldsmith, A., Brownson, K. E., Kumah, A., Sutherland, E.
BMJ Open, 25.11.2021
Tilføjet 30.11.2021
Objectives
Define the services available for the care of breast cancer at hospitals in the Eastern Region of Ghana, identify areas of the region with limited access to care through geospatial mapping, and test a novel survey instrument in anticipation of a nationwide scale up of the study.
Design
A cross-sectional, facility-based survey study.
Setting
This study was conducted at 33 of the 34 hospitals in the Eastern Region of Ghana from March 2020 to May 2020.
Participants
The 33 hospitals surveyed represented 97% of all hospitals in the region. This included private, government, quasi-government and faith-based organisation owned hospitals.
Results
Sixteen hospitals (82%) surveyed provided basic screening services, 11 (33%) provided pathological diagnosis and 3 (9%) provided those services in addition to basic surgical care.53%, 64% and 78% of the population lived within 10 km, 25 km and 45 km of screening, diagnostic and treatment services respectively. Limited chemotherapy was available at two hospitals (6%), endocrine therapy at one hospital (3%) and radiotherapy was not available. Twenty-nine hospitals (88%) employed a general practitioner and 13 (39%) employed a surgeon. Oncology specialists, pathology personnel and a plastic surgeon were only available in one hospital (3%) in the Eastern Region.
Conclusions
Although 16 hospitals (82%) provided screening, only half the population lived within reasonable distance of these services. Few hospitals offered diagnosis and surgical services, but 64% and 78% of the population lived within a reasonable distance of these hospitals. Geospatial analysis suggested two priorities to cost-effectively expand breast cancer services: (1) increase the number of health facilities providing screening services and (2) centralise basic imaging, pathological and surgical services at targeted hospitals.
Læs mere Tjek på PubMedSertsewold, S. G., Debie, A., Geberu, D. M.
BMJ Open, 25.11.2021
Tilføjet 30.11.2021
Objective
This study aimed to analyse the prevalence and factors associated with continuum of maternal healthcare services among women who gave birth in Siyadebirena Wayu district, Central Ethiopia.
Design
Community-based cross-sectional study.
Setting
At eight Kebeles in Central Ethiopia.
Participants
The study was done on 614 women aged 15–49 years using interviewer-administered structured questionnaire. Following proportional allocation of the sample, we used simple random sampling technique to select study participants.
Methods
Binary logistic regression model was fitted to identify the factors associated with the outcome. Variables with p<0.2 in the bivariable analysis were the candidates for multivariable analysis. A p<0.05 and adjusted OR (AOR) with 95% CI were taken to declare the factors and the strengths of association with continuum of maternal healthcare utilisation.
Outcome
Continuum of maternal healthcare utilisation.
Results
Only 16.1% (95% CI 13.3% to 19.0%) of the women had used a complete continuum of maternal health services. Variables, such as contraceptive use (AOR 4.95; 95% CI 1.61 to 15.20), autonomy (AOR 4.45; 95% CI 1.69 to 11.60), urban residence (AOR 3.91; 95% CI 1.06 to 14.39), educated women (AOR 5.36; 95% CI 1.15 to 25.06), took less than 30 min to reach a health facility (AOR 3.17; 95% CI 1.38 to 7.25), use public transportation (AOR 2.48; 95% CI 1.12 to 5.52) and good knowledge (AOR 9.88; 95% CI 3.89 to 25.0) were positively associated with continuum of maternal healthcare. In the contrary, women who had third child birth order (AOR 0.22; 95% CI 0.06 to 0.8) was negatively associated.
Conclusions
Overall, the level of the continuum of maternal healthcare services utilisation was low compared with the national and global targets. Therefore, programme planners and implementer had better conduct health education to enhance the awareness of women about continuum of maternal healthcare services. Healthcare sector policy-makers and managers shall also scale up healthcare facilities to improve access to maternal healthcare services.
Læs mere Tjek på PubMedBhandari, B., Schutte, A. E., Jayasuriya, R., Vaidya, A., Subedi, M., Narasimhan, P.
BMJ Open, 25.11.2021
Tilføjet 30.11.2021
Background
Understanding contextual needs and preferences is important for a successful design and effective outcome of a mHealth strategy.
Objectives
This formative study aimed to explore the perspectives of patients and providers on the acceptability of a mHealth (text message) strategy and elicit preferred features of a mHealth strategy for hypertension management.
Design
A qualitative study was conducted using in-depth interviews and focus group discussions guided by the technology acceptance model.
Setting
The study was conducted at primary healthcare facilities and at a tertiary level referral hospital in Kathmandu, Nepal.
Participants
A total of 61 participants, patients with hypertension (n=41), their family members (n=5), healthcare workers (n=11) and key informants (n=4) were included. We purposively recruited patients with hypertension aged 30–70 who attended the selected healthcare facilities to obtain maximum variation based on their age, sex and literacy.
Results
The respondents perceived the mHealth strategy to be useful as it would reinforce medication compliance and behaviour change. Participants valued the trustworthiness of information from health authorities that could be delivered privately. Some implementation challenges were identified including a lack of technical manpower, resources for software development, gaps in recording a patient’s essential information and digital illiteracy. Solutions proposed were having system-level preparedness for recording the patient’s details, establishing a separate technical department in the hospital and involving a family member to assist illiterate/elderly patients. In addition, participants preferred text messages in the local language, containing comprehensive contextual content (disease, treatment, cultural foods and misconceptions) delivered at regular intervals (2–3 times/week) preferably in the morning or evening.
Conclusions
We found that a simple text messaging strategy was acceptable for hypertension management in this low/middle-income country setting. However, meticulous planning must address the needs of a diverse range of participants to ensure the mHealth strategy is acceptable to wider groups.
Læs mere Tjek på PubMedShepard, K., Buivydaite, R., Vincent, C.
BMJ Open, 25.11.2021
Tilføjet 30.11.2021
Objectives
To describe the current work of the Patient Advice and Liaison Service (PALS) and assess the service’s potential to resolve concerns and contribute to organisational learning.
Design
A qualitative study using semistructured interviews.
Setting
Four mental health trusts and four acute trusts in the English National Health Service, a total of eight PALS across different trusts.
Participants
Twenty-four participants comprising of PALS staff and clinicians working with PALS teams.
Methods
Semistructured interviews were undertaken with participants using video conferencing software. The framework method was used for the analysis of the large qualitative dataset, which is a conventional method of analysis, similar to thematic or qualitative content analysis.
Results
PALS teams fulfil their core responsibilities by acting as point of contact for patients, providing information and resolving a variety of recurrent problems, including PALS staff communication, staff attitudes and waiting times. The remit and responsibilities of each PALS has often broadened over time. Barriers to resolving concerns included a lack of awareness of PALS, limited to no policies informing how staff resolve concerns, an emphasis on complaints and the attitude of clinical staff. Senior management had widely differing views on how the PALS should operate and the management of complaints is a much higher priority. Few PALS teams carried out any analysis of the data or shared data within their organisations.
Conclusions
PALS teams fulfil their core responsibilities by acting as point of contact for patients, providing information and resolving concerns. PALS staff also act as navigators of services, mediators between families and staff and, occasionally, patient advocates in supporting them to raise concerns. PALS has the potential to reduce complaints, increase patient satisfaction and provide rapid organisational feedback. Achieving this potential will require more awareness and support within organisations together with updated national policy guidance.
Læs mere Tjek på PubMedMillgate, E., Kravariti, E., Egerton, A., Howes, O. D., Murray, R. M., Kassoumeri, L., Donocik, J., Lewis, S., Drake, R., Lawrie, S., Murphy, A., Collier, T., Lees, J., Stockton-Powdrell, C., Walters, J., Deakin, B., MacCabe, J.
BMJ Open, 25.11.2021
Tilføjet 30.11.2021
Background
70%–84% of individuals with antipsychotic treatment resistance show non-response from the first episode. Emerging cross-sectional evidence comparing cognitive profiles in treatment resistant schizophrenia to treatment-responsive schizophrenia has indicated that verbal memory and language functions may be more impaired in treatment resistance. We sought to confirm this finding by comparing cognitive performance between antipsychotic non-responders (NR) and responders (R) using a brief cognitive battery for schizophrenia, with a primary focus on verbal tasks compared against other measures of cognition.
Design
Cross-sectional.
Setting
This cross-sectional study recruited antipsychotic treatment R and antipsychotic NR across four UK sites. Cognitive performance was assessed using the Brief Assessment of Cognition in Schizophrenia (BACS).
Participants
One hundred and six participants aged 18–65 years with a diagnosis of schizophrenia or schizophreniform disorder were recruited according to their treatment response, with 52 NR and 54 R cases.
Outcomes
Composite and subscale scores of cognitive performance on the BACS. Group (R vs NR) differences in cognitive scores were investigated using univariable and multivariable linear regressions adjusted for age, gender and illness duration.
Results
Univariable regression models observed no significant differences between R and NR groups on any measure of the BACS, including verbal memory (ß=–1.99, 95% CI –6.63 to 2.66, p=0.398) and verbal fluency (ß=1.23, 95% CI –2.46 to 4.91, p=0.510). This pattern of findings was consistent in multivariable models.
Conclusions
The lack of group difference in cognition in our sample is likely due to a lack of clinical distinction between our groups. Future investigations should aim to use machine learning methods using longitudinal first episode samples to identify responder subtypes within schizophrenia, and how cognitive factors may interact within this.
Trail registration number
REC: 15/LO/0038.
Læs mere Tjek på PubMedRasti, R., Brännström, J., Martensson, A., Zenk, I., Gantelius, J., Gaudenzi, G., Alvesson, H. M., Alfven, T.
BMJ Open, 25.11.2021
Tilføjet 30.11.2021
Objectives
In many resource-limited health systems, point-of-care tests (POCTs) are the only means for clinical patient sample analyses. However, the speed and simplicity of POCTs also makes their use appealing to clinicians in high-income countries (HICs), despite greater laboratory accessibility. Although also part of the clinical routine in HICs, clinician perceptions of the utility of POCTs are relatively unknown in such settings as compared with others. In a Swedish paediatric emergency department (PED) where POCT use is routine, we aimed to characterise healthcare providers’ perspectives on the clinical utility of POCTs and explore their implementation in the local setting; to discuss and compare such perspectives, to those reported in other settings; and finally, to gather requests for ideal novel POCTs.
Design
Qualitative focus group discussions study. A data-driven content analysis approach was used for analysis.
Setting
The PED of a secondary paediatric hospital in Stockholm, Sweden.
Participants
Twenty-four healthcare providers clinically active at the PED were enrolled in six focus groups.
Results
A range of POCTs was routinely used. The emerging theme Utility of our POCT use is double-edged illustrated the perceived utility of POCTs. While POCT services were considered to have clinical and social value, the local routine for their use was named to distract clinicians from the care for patients. Requests were made for ideal POCTs and their implementation.
Conclusion
Despite their clinical integration, deficient implementation routines limit the benefits of POCT services to this well-resourced paediatric clinic. As such deficiencies are shared with other settings, it is suggested that some characteristics of POCTs and of their utility are less related to resource level and more to policy deficiency. To address this, we propose the appointment of skilled laboratory personnel as ambassadors to hospital clinics offering POCT services, to ensure higher utility of such services.
Læs mere Tjek på PubMedJi, Y., Zhao, X., Feng, Y., Qu, Y., Liu, Y., Wu, S., Wu, Y., Xue, F., Liu, Y.
BMJ Open, 25.11.2021
Tilføjet 30.11.2021
Objectives
The prevalence of childhood hypertension is rising in parallel with the increasing prevalence of overweight and obesity in children. How growth trajectories from childhood to puberty relate to high blood pressure (HBP) is not well defined. We aimed to characterise potential body mass index (BMI) dynamic changing trajectories from childhood to puberty and investigate their association with HBP.
Design
A dynamic prospective cohort.
Setting
China Health and Nutrition Survey 1991–2015.
Participants
There were 1907 participants (1027 men and 880 women) in this study.
Outcomes
The primary outcome was HBP defined as systolic blood pressure (SBP)/diastolic blood pressure (DBP) exceeding the standards or diagnosis by medical records or taking antihypertensive medication.
Results
A model of cubic parameters with three groups was chosen, labelled as normal increasing group (85.16%, n=1624), high increasing group (9.81%, n=187) and resolving group (5.03%, n=96). Compared with the normal increasing group, the unadjusted HRs (95% CIs) for the resolving and high increasing groups were 0.91 (0.45 to 1.86) and 1.88 (1.26 to 2.81), respectively. After adjusting for baseline age, region, sex, baseline BMI z-score, baseline SBP and baseline DBP in model 3, the HRs (95% CIs) for the resolving and high increasing groups were 0.66 (0.30 to 1.45) and 1.56 (1.02 to 2.38).
Conclusions
These results indicate that the BMI trajectories from childhood to puberty have significant impact on HBP risk. Puberty is a crucial period for the development of HBP.
Læs mere Tjek på PubMedChen, Q., Chen, J., Zhou, Y., Huang, L., Tang, Y., Li, J., Zhang, J.
BMJ Open, 25.11.2021
Tilføjet 30.11.2021
Objective
Asthma is a common chronic disease that imposes a substantial burden on individuals and society. However, the natural history of childhood asthma in a large population remained to be studied. This study aimed to describe the natural course of childhood asthma and examine the association between early life factors and childhood asthma.
Design
A population-based cohort study.
Setting
This study was based on the national registry data in Denmark.
Participants
All liveborn singletons in Denmark during 1995–1997 were identified and followed them till the end of 2009. Finally, 193 673 children were eligible for our study.
Exposures
The following characteristics were examined as potential early life factors associated with childhood asthma, including parity, maternal asthma history, maternal smoking during pregnancy, maternal social status, delivery method and gender.
Main outcomes and measures
Asthma cases were identified on the basis of hospitalisation for asthma and prescriptions for antiasthmatic medications. Asthma remission was defined as no hospitalisation or prescription recorded for 2 years. Cox proportional hazards’ regression and logistic regression were used to evaluate the association between early life factors and the occurrence and remission of childhood asthma.
Results
The cumulative occurrence rate of asthma in children aged 3–14 years was 13.3% and the remission rate was 44.1%. The occurrence rate decreased with age. Being female had a lower risk of asthma (HR: 0.72, 95% CI 0.70 to 0.74) and higher remission rate of asthma (HR: 1.18, 1.13 to 1.22), while maternal asthma was associated with a higher risk of asthma (HR: 2.15, 2.04 to 2.26) and decreased remission rate of asthma (HR: 0.79, 0.73 to 0.85). These patterns remained the same for early onset asthma.
Conclusions
Female gender had a lower risk of asthma and a better chance of remission, while maternal asthma history had an opposite effect. The early life factors may influence the natural course of childhood asthma.
Læs mere Tjek på PubMedAye, W. T., Lien, L., Stigum, H., Bjertness, E.
BMJ Open, 25.11.2021
Tilføjet 30.11.2021
Objectives
To estimate the prevalence of emotional, physical and sexual childhood abuse, and symptoms of post-traumatic stress disorder (PTSD) and to examine the association between childhood abuse and adult mental health problems, including mental distress and PTSD symptoms.
Design
A community-based cross-sectional study was conducted. Childhood abuse was assessed with the NorVold Abuse Questionnaire, and mental distress and symptoms of PTSD were measured using the Hopkins Symptom Checklist 10 and the Impact of Event Scale—Revised, respectively. The Wald test and multiple linear regression analysis were applied for testing differences between proportions and the association between childhood abuse and adult mental health outcomes, respectively.
Setting
Urban and rural areas of the Yangon Region, Myanmar.
Participants
A total of 2377 men and women aged 18–49 years were included. Institutionalised people, monks, nuns and individuals deemed too ill physically and/or mentally to participate were excluded.
Results
Overall, 21.1% (95% CI 18.8 to 23.6) reported any form of childhood abuse, 10.4% (95% CI 8.9 to 12.4) physical abuse, 10.4% (95% CI 8.8 to 12.2) emotional abuse and 7.3% (95% CI 5.7 to 9.3) sexual abuse. Childhood abuse was more common in women (29.8%) than in men (12.4%). The prevalence of PTSD symptoms in the total sample was 6.6%. After adjusting for confounding variables, positive associations were found between childhood abuse with adult mental distress and PTSD symptoms among women and older men.
Conclusions
Childhood abuse is prevalent among both men and women in the Yangon Region of Myanmar and associated with adult mental health problems. Approximately 7% of people report PTSD symptoms. It should prompt local health professionals and policy makers to establish prevention programmes to eliminate violence against children and to organise services for victims of childhood abuse. Care should be taken in generalising findings for less populated areas.
Læs mere Tjek på PubMedLaberge, M., Rekik, M., Djiffa, K. M.
BMJ Open, 25.11.2021
Tilføjet 30.11.2021
Objectives
Examine variations in parent’s preferences for their child’s type 1 diabetes (T1D) follow-up care and the determinants of the preferred intensity of care. Clinical guidelines recommend multidisciplinary management of T1D, with follow-up visits with an endocrinologist at least every 3 months in the paediatric population. However, there could be heterogeneity in parents’ needs, and preferences in terms of care management may deviate from clinical guidelines.
Setting
Not applicable.
Participants
Parents who have a child living with T1D and who reside in Quebec, Canada.
Intervention
In collaboration with a patient-partner (a parent of a child with T1D), we developed a survey to collect data from parents of children living with T1D. Our primary outcome of interest was the preferred time in months between two appointments. We ran a probit model to analyse longer time (over 3 months between appointments), compared with the standard of care (3 months or less).
Results
Results suggest that about one-third (33%) of parents want to deviate from the guideline. Parents who want to increase the time between appointments are more experienced in the management of the disease and have higher costs than those who wish to follow the 3-month guideline. The number of years since the diagnosis is positively associated with a preference for a longer time between appointments, while the perceived useful of information provided during the consultation, and a parent having made a change in their professional life were negatively associated with a desire to space out appointments. The child’s gender is not a significant factor in parents’ preferences.
Conclusions
Adapting visit protocols could make the health system more efficient to respond to T1D patients and their parent’s needs.
Læs mere Tjek på PubMedZhang, X., Li, Y., Gao, L., Yu, Q., Zhou, C., Zou, W.
BMJ Open, 25.11.2021
Tilføjet 30.11.2021
Introduction
A surrogate marker to evaluate artery endothelial response when stimulated by reactive hyperaemia, known as brachial flow-mediated dilation (FMD), has prognostic value in predicting hypertensive organ damage and cardiovascular disease events. However, the degree of correlation between brachial FMD and masked hypertension (MH) outcomes is still unclear. Therefore, the purpose of this study is to pool data regarding FMD with respect to MH.
Methods and analysis
Electronic databases MEDLINE, EMBASE, China National Knowledge Infrastructure and Cochrane Library will be searched for the following keywords: endothelial dysfunction, flow-mediated dilation, and masked hypertension, masked uncontrolled hypertension (MUCH) and prehypertension. The following are the eligibility criteria: population—adults (18 years old or older) without hypertension at baseline, with suspected endothelial dysfunction, or from MH/MUCH populations (office blood pressure <140/90 mm Hg and home blood pressure ≥135 mm Hg and/or 85 mm Hg) and from controlled clinical trials, cohort studies, or randomised and controlled trials; exposures—any metrics for FMD; comparisons—participants without MH or MUCH; and outcome—change in FMD between the case group and the control group. Two authors will be engaged in screening and collecting data independently; disagreements will be resolved through discussion. Data extraction will include primary data designated as HR, OR, correlations and regression coefficients. Comprehensive Meta-Analysis V.2.0 will be used to conduct related subgroup and sensitivity analyses and publication bias.
Ethics and dissemination
This study does not require ethics approval. It will be submitted to a peer-reviewed journal.
PROSPERO registration number
CRD42020208362.
Læs mere Tjek på PubMedNetere, A. K., Muhammad, E. A., Asres, M. S., Teklie, M. T.
BMJ Open, 25.11.2021
Tilføjet 30.11.2021
Objective
The study determined the comparative renal functions on patients with diabetes treated with ACE inhibitors (ACEIs) plus either thiazide diuretics or calcium channel blockers (CCBs) in Northwestern Ethiopia.
Design
Retrospective cohort study design was employed to collect the data from medical records of patients with diabetes followed for 1–5 years (N=404).
Setting
The medical records of patients in chronic diabetic follow-up clinics of the hospital.
Participants
All the patients with diabetes medical records in Northwestern Ethiopian specialised hospital.
Main outcome measures
Exposures were ACEIs plus thiazide diuretics or CCBs collected from March to June 2020. Outcomes were defined as declining in estimated glomerular filtration rate (eGFR) values by ≥30% from the baseline recorded from 2015 to 2019. Descriptive and analytical statistics were illustrated to compare the study groups. Kaplan-Meier with log- rank test was used to plot the survival analyses curve. Potential factors substantially associated to renal events were examined using cox proportional hazards model.
Result
About 20% of patients developed renal events and significant numbers were from hydrochlorothiazide (HCT) users. The mean eGFR levels were significantly higher in patients on CCBs users over the follow-up years compared with HCT-based users. The CCBs users had an 18.8 mL/min/1.73 m2 higher in eGFR levels at the end of the follow-up period than HCT users (p<0.001). HCT users had shorter survival probability overtime to develop the outcomes compared with CCBs users (p=0.003). The CCBs-based regimen prevented risks of declining in renal function by 56.4% than HCT (p=0.001). Hazards of declining in eGFR levels were 93% higher for the patients with initial systolic blood pressure (SBP) levels were more than 150 mm Hg (p=0.006).
Conclusion
Compared with HCT, patients on CCBs had significantly prevented risks of renal events. However, both groups appeared with the same cardiovascular events. HCT-based regimen and higher initial SBP levels were significantly associated with eGFR reductions.
Læs mere Tjek på PubMedVesela, R., Elenjord, R., Lehnbom, E. C., Ofstad, E. H., Johnsgard, T., Zahl-Holmstad, B., Risor, T., Wisloff, T., Roslie, L., Filseth, O. M., Valle, P.-C., Svendsen, K., Froyshov, H. M., Garcia, B. H.
BMJ Open, 25.11.2021
Tilføjet 30.11.2021
Introduction
The ‘emergency department (ED) pharmacist’ is an integrated part of the ED interdisciplinary team in many countries, which have shown to improve medication safety and reduce costs related to hospitalisations. In Norway, few EDs are equipped with ED pharmacists, and research describing effects on patients has not been conducted. The aim of this study is to investigate the impact of introducing clinical pharmacists to the interdisciplinary ED team. In this multicentre study, the intervention will be pragmatically implemented in the regular operation of three EDs in Northern Norway; Tromsø, Bodø and Harstad. Clinical pharmacists will work as an integrated part of the ED team, providing pharmaceutical care services such as medication reconciliation, review and/or counselling. The primary endpoint is ‘time in hospital during 30 days after admission to the ED’, combining (1) time in ED, (2) time in hospital (if hospitalised) and (3) time in ED and/or hospital if re-hospitalised during 30 days after admission. Secondary endpoints include time to rehospitalisation, length of stay in ED and hospital and rehospitalisation and mortality rates.
Methods and analysis
We will apply a non-randomised stepped-wedge study design, where we in a staggered way implement the ED pharmacists in all three EDs after a 3, 6 and 9 months control period, respectively. We will include all patients going through the three EDs during the 12-month study period. Patient data will be collected retrospectively from national data registries, the hospital system and from patient records.
Ethics and dissemination
The Regional Committee for Medical and Health Research Ethics and Local Patient Protection Officers in all hospitals have approved the study. Patients will be informed about the ongoing study on a general basis with ads on posters and flyers.
Trial registration number
NCT04722588.
Læs mere Tjek på PubMedWu, B., Lu, Y., Yu, Y., Yue, H., Wang, J., Chong, Y., Cui, W.
BMJ Open, 25.11.2021
Tilføjet 30.11.2021
Introduction
Abnormal coagulation function aggravates the prognosis of patients with traumatic brain injury (TBI). It was reported that the antifibrinolytic drug tranexamic acid (TXA) could reduce intracranial haemorrhage and mortality in non-operative patients with TBI. However, there is a lack of evaluation of TXA in patients with TBI undergoing craniotomy.
Methods and analysis
This is a single-centre randomised controlled, double-blind, parallel study aiming to investigate the effectiveness and safety of TXA in patients with TBI during the perioperative period. Blood loss and transfusion, neurological function, adverse events, mortality and serum immune-inflammatory cytokines will be collected and analysed.
Ethics and dissemination
Ethical approval has been granted by the Medical Ethics Committee of Beijing Tian Tan Hospital, Capital Medical University (reference number KY 2020-136-03). The results of this study will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals.
Trial registration number
ChiCTR2100041911.
Læs mere Tjek på PubMedvan Niekerk, S.-M., Kamalakannan, S., Inglis-Jassiem, G., Charumbira, M. Y., Fernandes, S., Webster, J., English, R., Louw, Q. A., Smythe, T.
BMJ Open, 25.11.2021
Tilføjet 30.11.2021
Objectives
To explore the opportunities and challenges within the health system to facilitate the achievement of universal health coverage (UHC) for people with stroke (PWS) in South Africa (SA).
Setting
SA.
Design
Scoping review.
Search methods
We conducted a scoping review of opportunities and challenges to achieve UHC for PWS in SA. Global and Africa-specific databases and grey literature were searched in July 2020. We included studies of all designs that described the healthcare system for PWS. Two frameworks, the Health Systems Dynamics Framework and WHO Framework, were used to map data on governance and regulation, resources, service delivery, context, reorientation of care and community engagement. A narrative approach was used to synthesise results.
Results
Fifty-nine articles were included in the review. Over half (n=31, 52.5%) were conducted in Western Cape province and most (n=41, 69.4%) were conducted in urban areas. Studies evaluated a diverse range of health system categories and various outcomes. The most common reported component was service delivery (n=46, 77.9%), and only four studies (6.7%) evaluated governance and regulation. Service delivery factors for stroke care were frequently reported as poor and compounded by context-related limiting factors. Governance and regulations for stroke care in terms of government support, investment in policy, treatment guidelines, resource distribution and commitment to evidence-based solutions were limited. Promising supporting factors included adequately equipped and staffed urban tertiary facilities, the emergence of Stroke units, prompt assessment by health professionals, positive staff attitudes and care, two clinical care guidelines and educational and information resources being available.
Conclusion
This review fills a gap in the literature by providing the range of opportunities and challenges to achieve health for all PWS in SA. It highlights some health system areas that show encouraging trends to improve service delivery including comprehensiveness, quality and perceptions of care.
Læs mere Tjek på PubMedShrestha, R., Upadhyay, S. K., Khatri, B., Bhattarai, J. R., Kayastha, M., Upadhyay, M. P.
BMJ Open, 25.11.2021
Tilføjet 30.11.2021
Objective
This non-inferiority study aimed to determine the burden of obesity in a hospital outpatient setting of a developing country, using three commonly employed metrics as predictors of hypertension (HTN).
Design
A cross-sectional study design was adopted.
Setting
This study was conducted in Health Promotion and Risk Factor Screening Services of a tertiary hospital for eye and ear, nose, throat in a semiurban area of Nepal.
Participants
2256 randomly selected outpatients between 40 and 69 years old.
Outcome measures
The three obesity metrics and HTN were analysed for association using correlation, the area under the receiver operating characteristic (ROC) curve and ORs.
Results
The prevalence of obesity or overweight by body mass index (BMI) was 58.29%; by waist-to-height ratio (WHtR) was 85.95%, high waist circumference (WC) was observed among 66.76% of participants. Female participants had a greater prevalence of high WC (77.46%) than males (53.73%) (p<0.001). Prevalence of HTN and pre-HTN were 40.67% and 36.77%, respectively. The areas under the ROC curve were significantly higher than 0.5 for BMI (0.593), WHtR (0.602) and WC (0.610).
Conclusion
This study showed that WHtR and WC measured were not inferior to BMI as a metric for obesity detection and HTN prediction. Because of its low cost, simplicity of measurement and better ability to predict HTN, it may become a more usable metric in health facilities of low-income and middle-income countries.
Læs mere Tjek på PubMedShakya, P., Shrestha, A., Karmacharya, B. M., Shrestha, A., Kulseng, B. E., Skovlund, E., Sen, A.
BMJ Open, 24.11.2021
Tilføjet 30.11.2021
Introduction
Evidence suggests that diabetes burden can be reduced by implementing early lifestyle intervention programmes in population with pre-diabetes in high-income countries. However, little is known in developing nations like Nepal. This study aims to assess effectiveness of community-based Diabetes Prevention Education Program (DiPEP) on haemoglobin A1c (HbA1c) level, proportion of pre-diabetes reverting to normoglycaemia, diet, physical activity, weight reduction, diabetes knowledge and health literacy after 6 months of follow-up. Furthermore, we will also conduct qualitative studies to explore experiences of participants of intervention sessions and perception of healthcare workers/volunteers about DiPEP.
Methods and analyses
This is a community-based two-arm, open-label, cluster randomised controlled trial. We will randomise 14 clusters into intervention arm and control arm. Estimated total sample size is 448. We will screen individuals without diabetes, aged 18–64 years, and permanent residents of study sites. HbA1c test will be only performed if both Indian Diabetes Risk Score and random blood sugar value are ≥60 and 140–250 mg/dL, respectively. At baseline, participants in intervention arm will receive DiPEP package (including intensive intervention classes, diabetes prevention brochure, exercise calendar and food record booklet), and participants in control arm will be provided only with diabetes prevention brochure. The change in outcome measures will be compared between intervention to control arm after 6 months of follow-up by linear mixed models. Also, we will conduct individual interviews among participants and healthcare workers as part of a qualitative study. We will use thematic analysis to analyse qualitative data.
Ethics and dissemination
Regional Committee for Medical and Health Research Ethics, Norway; Nepal Health Research Council, Nepal and Institutional Review Committee, Kathmandu University School of Medical Sciences have approved the study. The DiPEP package can be implemented in other communities of Nepal if it is effective in preventing diabetes.
Trial registration number
NCT04074148, 2019/783.
Læs mere Tjek på PubMedSoley-Bori, M., Lingam, R., Satherley, R.-M., Forman, J., Cecil, L., Fox-Rushby, J., Wolfe, I.
BMJ Open, 24.11.2021
Tilføjet 30.11.2021
Introduction
The Children and Young People’s Health Partnership (CYPHP) Evelina London Model of Care is a new approach to integrated care delivery for children and young people (CYP) with common health complaints and chronic conditions. CYPHP includes population health management (services shaped by data-driven understanding of population and individual needs, applied in this case to enable proactive case finding and tailored biopsychosocial care), specialist clinics with multidisciplinary health teams and training resources for professionals working with CYP. This complex health system strengthening programme has been implemented in South London since April 2018 and will be evaluated using a cluster randomised controlled trial with an embedded process evaluation. This protocol describes the within-trial and beyond-trial economic evaluation of CYPHP.
Methods and analysis
The economic evaluation will identify, measure and value resources and health outcome impacts of CYPHP compared with enhanced usual care from a National Health Service/Personal Social Service and a broader societal perspective. The study population includes 90 000 CYP under 16 years of age in 23 clusters (groups of general practitioner (GP) practices) to assess health service use and costs, with more detailed cost-effectiveness analysis of a targeted sample of 2138 CYP with asthma, eczema or constipation (tracer conditions). For the cost-effectiveness analysis, health outcomes will be measured using the Paediatric Quality of Life Inventory and quality-adjusted life years (QALYs) using the Child Health Utility 9 Dimensions (CHU-9D) measure. To account for changes in parental well-being, the Warwick-Edinburg Mental Well-being Scale will be integrated with QALYs in a cost–benefit analysis. The within-trial economic evaluation will be complemented by a novel long-term model that expands the analytical horizon to 10 years. Analyses will adhere to good practice guidelines and National Institute for Health and Care Excellence public health reference case.
Ethics and dissemination
The study has received ethical approval from South West-Cornwall and Plymouth Research Ethics Committee (REC Reference: 17/SW/0275). Results will be submitted for publication in peer-reviewed journals, made available in briefing papers for local decision-makers, and provided to the local community through website and public events. Findings will be generalisable to community-based models of care, especially in urban settings.
Trial registration number
NCT03461848.
Læs mere Tjek på PubMedHanlon, H. R., Prihodova, L., Russell, T., Donegan, D., O'Shaughnessy, A., Hoey, H.
BMJ Open, 24.11.2021
Tilføjet 30.11.2021
Objectives
To examine experiences of participation in a mandatory system of continuing professional development (CPD) among doctors in Ireland, in order to identify areas for improvement.
Design
A qualitative cross-sectional design was used.
Participants
1408 participants (701 male, 707 female) were recruited via email from a population of 4350 doctors enrolled on a Royal College of Physicians of Ireland Professional Competence Scheme (PCS) for the 2017/2018 year, and completed an online survey as part of a larger study examining experiences and attitudes towards participation in PCS. A subset of the sample (434 participants) responded to an optional open-ended question about PCS participation. Responses to the open-ended question were analysed using thematic analysis.
Results
Thematic analysis resulted in five main themes relating to perceived barriers to PCS participation across a wide range of areas: ‘Evidence of participation’, ‘The structure of PCS’, ‘Questioning the benefits of formal CPD’, ‘Workplace challenges’ and ‘Access issues’.
Conclusions
Taken together, the five themes outlined in this study give a wide-ranging, in-depth picture of the challenges faced by Irish doctors, which expand on well-documented factors such as time constraints, to illustrate a series of complex, interacting factors. Some barriers, such as difficulty obtaining evidence of participation, may be relatively easily addressed. Others, such as issues with the way the PCS is structured, are more intractable, and require further research to understand more fully and develop appropriate solutions.
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