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Nevin Manimala Statistics

Protocol for a 2-year longitudinal study of eating disturbances, mental health problems and overuse injuries in rock climbers (CLIMB)

BMJ Open. 2023 Sep 13;13(9):e074631. doi: 10.1136/bmjopen-2023-074631.

ABSTRACT

INTRODUCTION: Rock climbing is a rapidly growing sport in which performance may be affected by participant’s weight and leanness, and there may be pressure on athletes with respect to their eating behaviour and body weight. However, there is sparse research performed on climbers, constituting a knowledge gap which the present study aims to fill. The primary outcomes of the study are to examine disordered eating and overuse injuries in rock climbers. Secondary variables are body image, indicators of relative energy deficiency, mental health problems, compulsive training, perfectionism, sleep quality and bone density.

METHOD AND ANALYSIS: This prospective longitudinal study aims to recruit Swedish competitive rock climbers (>13 years) via the Swedish Climbing Federation. A non-athlete control group will be recruited via social media (n=equal of the climbing group). Data will be collected using streamlined validated web-based questionnaires with three follow-ups over 2 years. Inclusion criteria for rock climbers will be a minimum advanced level according to International Rock-Climbing Research Association. The non-athlete control group is matched for age and gender. Exclusion criteria are having competed at an elite level in any sport as well as training more often than twice per week. Statistical analyses will include multinominal logistic regression, multivariate analysis of variance (MANOVA) and structural equation modelling (SEM). We will assess effect measure modification when relevant and conduct sensitivity analyses to assess the impact of lost to follow-up.

ETHICS AND DISSEMINATION: The Rock-Climbers’ Longitudinal attitudes towards Injuries, Mental health and Body image study, CLIMB, was approved by the Swedish ethics authority (2021-05557-01). Results will be disseminated through peer-reviewed research papers, reports, research conferences, student theses and stakeholder communications.

TRIAL REGISTRATION NUMBER: NCT05587270.

PMID:37709336 | DOI:10.1136/bmjopen-2023-074631

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Novel use of structural equation modelling to examine diet and metabolic traits associated with microvascular endothelial dysfunction in middle-aged Chinese males: a cross-sectional study

BMJ Open. 2023 Sep 13;13(9):e073357. doi: 10.1136/bmjopen-2023-073357.

ABSTRACT

BACKGROUND: The present study aims to use structural equation modelling (SEM) with multiple regression pathways to examine direct and indirect links from diet and metabolic traits to microvascular endothelial dysfunction (ED) among middle-aged Chinese males.

METHODS: The study was conducted in middle-aged Chinese males, who underwent a health check-up between 2018 and 2019. Data on lifestyle behaviour factors (physical activity, diet pattern, sleep quality and diet data underwent factor analysis in advance) and metabolic risk factors referring to metabolic traits were introduced into the SEM to examine inter-relationship among these factors and their association with ED, as evaluated by the reactive hyperaemia index (RHI).

RESULTS: Both exploratory factor analysis and confirmatory factor analysis identified two major dietary patterns: ‘prudent pattern’ and ‘western pattern’. The univariate test suggested that only triglycerides (TGs) and prudent dietary pattern were directly associated with RHI. Furthermore, prudent dietary pattern had an indirect association with RHI via TG (prudent diet→TG: β=-0.15, p<0.05; TG→RHI: β=-0.17, p<0.001). As to confirming the hypothesised association between variables apart, physical activity frequency was correlated to the decrease in TG (β=-0.29, p<0.001), but had no direct correlation to RHI.

CONCLUSION: The network of direct and indirect associations among diet pattern and cardiometabolic risk factors with RHI measured ED among middle-aged males. The most significant modifiable factors identified were TG and prudent diet pattern, which needs to be targeted as preventive strategies for early microvascular impairment.

PMID:37709331 | DOI:10.1136/bmjopen-2023-073357

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Study environment and the incidence of mental health problems and activity-limiting musculoskeletal problems among university students: the SUN cohort study

BMJ Open. 2023 Sep 14;13(9):e072178. doi: 10.1136/bmjopen-2023-072178.

ABSTRACT

OBJECTIVE: To determine the association between different aspects of study environment and the incidence of mental health problems and activity-limiting musculoskeletal problems.

DESIGN, SETTING AND PARTICIPANTS: We recruited a cohort of 4262 Swedish university students of whom 2503 (59%) were without moderate or worse mental health problems and 2871 (67%) without activity-limiting musculoskeletal problems at baseline. The participants were followed at five time points over 1 year using web surveys.

EXPOSURES: Self-rated discrimination, high study pace, low social cohesion and poor physical environment measured at baseline.

OUTCOMES: Self-rated mental health problems defined as scoring above cut-off on any of the subscales of the Depression, Anxiety and Stress Scale. Self-rated activity-limiting musculoskeletal problems in any body location assessed by the Nordic Musculoskeletal Questionnaire.

STATISTICAL ANALYSIS: Discrete survival-time analysis was used to estimate the hazard rate ratio (HR) of each exposure-outcome combination while adjusting for gender, age, living situation, education type, year of studies, place of birth and parental education as potential confounders.

RESULTS: For discrimination, adjusted HRs were 1.75 (95% CI 1.40 to 2.19) for mental health problems and 1.39 (95% CI 1.12 to 1.72) for activity-limiting musculoskeletal problems. For high study pace, adjusted HRs were 1.70 (95% CI 1.48 to 1.94) for mental health problems and 1.25 (95% CI 1.09 to 1.43) for activity-limiting musculoskeletal problems. For low social cohesion, adjusted HRs were 1.51 (95% CI 1.29 to 1.77) for mental health problems and 1.08 (95% CI 0.93 to 1.25) for activity-limiting musculoskeletal problems. For perceived poor physical study environment, adjusted HRs were 1.20 (95% CI 0.99 to 1.45) for mental health problems and 1.20 (95% CI 1.01 to 1.43) for activity-limiting musculoskeletal problems.

CONCLUSIONS: Several aspects of the study environment were associated with the incidence of mental health problems and activity-limiting musculoskeletal problems in this sample of Swedish university students.

PMID:37709330 | DOI:10.1136/bmjopen-2023-072178

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Using telemedicine to improve early medical abortion at home (UTAH): a randomised controlled trial to compare telemedicine with in-person consultation for early medical abortion

BMJ Open. 2023 Sep 13;13(9):e073630. doi: 10.1136/bmjopen-2023-073630.

ABSTRACT

OBJECTIVES: To compare telephone consultations with in-person consultations for the provision of medical abortion (using mifepristone 200 mg and misoprostol 800 µg). We hypothesised that telemedicine consultations would be non-inferior to in-person consultations with a non-inferiority limit of 3%.

DESIGN: Randomised controlled trial with 1:1 allocation.

SETTING: Community abortion service housed within an integrated sexual and reproductive health service in Edinburgh, UK.

PARTICIPANTS: The trial began on 13 January 2020, but was stopped early due to COVID-19; recruitment was suspended on 31 March 2020, and was formally closed on 31 August 2021. A total of 125 participants were randomised, approximately 10% of the total planned, with 63 assigned to telemedicine and 62 to in-person consultation.

PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome: efficacy of medical abortion, defined as complete abortion without surgical intervention.

SECONDARY OUTCOMES: satisfaction with consultation type, preparedness, unscheduled contact with care, complication rate, time spent in clinical contact and uptake of long-acting contraception.

RESULTS: Primary outcome was available for 115 participants (lost-to-follow-up telemedicine=2, in-person=8), secondary outcomes were available for 110 participants (n=5 and n=10 in telemedicine and in-person groups did not complete questionnaires). There were no significant differences between groups in treatment efficacy (telemedicine 57/63 (90.5%), in-person 48/62 (77.4%)). However, non-inferiority was not demonstrated (+3.3% in favour of telemedicine, CI -6.6% to +13.3%, lower than non-inferiority margin). There were no significant differences in most secondary outcomes, however, there was more unscheduled contact with care in the telemedicine group (12 (19%) vs 3 (5%), p=0.01). The overall time spent in clinical contact was statistically significantly lower in the telemedicine group (mean 94 (SD 24) vs 111 (24) min, p=0.0005).

CONCLUSIONS: Telemedicine for medical abortion appeared to be effective, safe and acceptable to women, with less time spent in the clinic. However, due to the small sample size resulting from early cessation, the study was underpowered to confirm this conclusion. These findings warrant further investigation in larger scale studies.

TRIAL REGISTRATION NUMBER: NCT04139382.

PMID:37709327 | DOI:10.1136/bmjopen-2023-073630

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Risk factors for neonatal mortality: an observational cohort study in Sarlahi district of rural southern Nepal

BMJ Open. 2023 Sep 14;13(9):e066931. doi: 10.1136/bmjopen-2022-066931.

ABSTRACT

OBJECTIVES: To assess the association between maternal characteristics, adverse birth outcomes (small-for-gestational-age (SGA) and/or preterm) and neonatal mortality in rural Nepal.

DESIGN: This is a secondary observational analysis to identify risk factors for neonatal mortality, using data from a randomised trial to assess the impact of newborn massage with different oils on neonatal mortality in Sarlahi district, Nepal.

SETTING: Rural Sarlahi district, Nepal.

PARTICIPANTS: 40 119 pregnant women enrolled from 9 September 2010 to 16 January 2017.

MAIN OUTCOME: The outcome variable is neonatal death. Cox regression was used to estimate adjusted Hazard Ratios (aHRs) to assess the association between adverse birth outcomes and neonatal mortality.

RESULTS: There were 32 004 live births and 998 neonatal deaths. SGA and/or preterm birth was strongly associated with increased neonatal mortality: SGA and preterm (aHR: 7.09, 95% CI: (4.44 to 11.31)), SGA and term/post-term (aHR: 2.12, 95% CI: (1.58 to 2.86)), appropriate-for-gestational-age/large-for-gestational-age and preterm (aHR: 3.23, 95% CI: (2.30 to 4.54)). Neonatal mortality was increased with a history of prior child deaths (aHR: 1.53, 95% CI: (1.24 to 1.87)), being a twin or triplet (aHR: 5.64, 95% CI: (4.25 to 7.48)), births at health posts/clinics or in hospital (aHR: 1.34, 95% CI: (1.13 to 1.58)) and on the way to facilities or outdoors (aHR: 2.26, 95% CI: (1.57 to 3.26)). Risk was lower with increasing maternal height from <145 cm to 145-150 cm (aHR: 0.78, 95% CI: (0.65 to 0.94)) to ≥150 cm (aHR: 0.57, 95% CI: (0.47 to 0.68)), four or more antenatal care (ANC) visits (aHR: 0.67, 95% CI: (0.53 to 0.86)) and education >5 years (aHR: 0.75, 95% CI: (0.62 to 0.92)).

CONCLUSION: SGA and/or preterm birth are strongly associated with increased neonatal mortality. To reduce neonatal mortality, interventions that prevent SGA and preterm births by promoting ANC and facility delivery, and care of high-risk infants after birth should be tested.

TRIAL REGISTRATION NUMBER: NCT01177111.

PMID:37709319 | DOI:10.1136/bmjopen-2022-066931

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Time to recovery and its predictors among under five children in outpatient therapeutic feeding programme in Borena zone, Southern Ethiopia: a retrospective cohort study

BMJ Open. 2023 Sep 14;13(9):e077062. doi: 10.1136/bmjopen-2023-077062.

ABSTRACT

OBJECTIVES: This study aimed to assess the time to recovery and its predictors among 6-59 months aged children treated at an outpatient therapeutic feeding programme in Borena zone.

DESIGN: A retrospective cohort study.

SETTING: Facility based; 23 treatment sites included in this study.

PARTICIPANTS: Among the cohorts of 601 children aged 6-59 months enrolled from July 2019 to June 2021, records of 590 children were selected using systematic random sampling. Transfers and incomplete records were excluded.

PRIMARY AND SECONDARY OUTCOME MEASURES: Time to recovery was a main outcome while its predictors were secondary outcomes.

RESULTS: The median recovery time was 49 days (95% CI=49 to 52) with a recovery rate of 79.8% (95% CI=76.4 to 83.0). Absence of comorbidity (adjusted HR, AHR=1.72, 95% CI=1.08 to 2.73), referral way by trained mothers on screening (AHR=1.91, 95% CI=1.25 to 2.91), new admission (AHR=1.59, 95% CI=1.05 to 2.41) and adequate Plumpy’Nut provision (AHR=2.10, 95% CI=1.72 to 2.56) were significantly associated with time to recovery. It is also found that being from a distance ≥30 min to treatment site lowers a chance of recovery by 27% (AHR=0.73, 95% CI=0.60 to 0.89).

CONCLUSIONS: The findings showed that a time to recovery was within an acceptable range. Incidence of recovery is enhanced with early case detection, proper management, nearby service, new admissions, provision of adequate Plumpy’Nut and enabling mothers to screen their own children for acute malnutrition. However, we did not observe a statistically significant association among breastfeeding status, type of health facility, wasting type, vaccination and routine medications. Service providers should improve adherence to treatment protocols, defaulter tracing, community outreach and timely case identification.

PMID:37709317 | DOI:10.1136/bmjopen-2023-077062

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Effectiveness of music-based interventions to address well-being in people with a vision impairment: a scoping review

BMJ Open. 2023 Sep 14;13(9):e067502. doi: 10.1136/bmjopen-2022-067502.

ABSTRACT

OBJECTIVES: The objectives of this review were to identify the types of music-based interventions and associated accessibility challenges for people who have visual impairment (VI) and their reported effects on psychological, physiological and social well-being.

DESIGN: A scoping review was developed according to the Joanna Briggs Institute methodology and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist and guidelines. A narrative synthesis was conducted to map out the types of music-based interventions undertaken and to compare the therapeutic outcomes. The studies were evaluated according to the music reporting checklist.

RESULTS: In total 5082 records were identified, 69 full-text articles were screened and 13 studies were included. Eleven studies included younger children and teenagers, two focused on adults with acquired VI. Ten studies involved active music therapy strategies and three used passive music listening. Eleven of the studies focused on social outcomes and two reported mental health. Although the studies reported that music-based intervention strategies improved psychosocial well-being in people with a VI, conclusions could not be drawn as robust outcome measures were not generally used and only four of the studies included any statistical analysis.

CONCLUSIONS: Although potential was evident, details of intervention protocols and training requirements were not sufficiently reported and further, high-quality evidence-based studies are required.

PMID:37709316 | DOI:10.1136/bmjopen-2022-067502

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Retrospective cohort study investigating synergism of air pollution and corticosteroid exposure in promoting cardiovascular and thromboembolic events in older adults

BMJ Open. 2023 Sep 13;13(9):e072810. doi: 10.1136/bmjopen-2023-072810.

ABSTRACT

OBJECTIVE: To evaluate the synergistic effects created by fine particulate matter (PM2.5) and corticosteroid use on hospitalisation and mortality in older adults at high risk for cardiovascular thromboembolic events (CTEs).

DESIGN AND SETTING: A retrospective cohort study using a US nationwide administrative healthcare claims database.

PARTICIPANTS: A 50% random sample of participants with high-risk conditions for CTE from the 2008-2016 Medicare Fee-for-Service population.

EXPOSURES: Corticosteroid therapy and seasonal-average PM2.5.

MAIN OUTCOME MEASURES: Incidences of myocardial infarction or acute coronary syndrome (MI/ACS), ischaemic stroke or transient ischaemic attack, heart failure (HF), venous thromboembolism, atrial fibrillation and all-cause mortality. We assessed additive interactions between PM2.5 and corticosteroids using estimates of the relative excess risk due to interaction (RERI) obtained using marginal structural models for causal inference.

RESULTS: Among the 1 936 786 individuals in the high CTE risk cohort (mean age 76.8, 40.0% male, 87.4% white), the mean PM2.5 exposure level was 8.3±2.4 µg/m3 and 37.7% had at least one prescription for a systemic corticosteroid during follow-up. For all outcomes, we observed increases in risk associated with corticosteroid use and with increasing PM2.5 exposure. PM2.5 demonstrated a non-linear relationship with some outcomes. We also observed evidence of an interaction existing between corticosteroid use and PM2.5 for some CTEs. For an increase in PM2.5 from 8 μg/m3 to 12 μg/m3 (a policy-relevant change), the RERI of corticosteroid use and PM2.5 was significant for HF (15.6%, 95% CI 4.0%, 27.3%). Increasing PM2.5 from 5 μg/m3 to 10 μg/m3 yielded significant RERIs for incidences of HF (32.4; 95% CI 14.9%, 49.9%) and MI/ACSs (29.8%; 95% CI 5.5%, 54.0%).

CONCLUSION: PM2.5 and systemic corticosteroid use were independently associated with increases in CTE hospitalisations. We also found evidence of significant additive interactions between the two exposures for HF and MI/ACSs suggesting synergy between these two exposures.

PMID:37709308 | DOI:10.1136/bmjopen-2023-072810

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Identification and characterisation of diabetes in Uganda: protocol for the nested, population-based ‘Diabetes in low-resource Populations’ (DOP) Study

BMJ Open. 2023 Sep 13;13(9):e071747. doi: 10.1136/bmjopen-2023-071747.

ABSTRACT

INTRODUCTION: Sub-Saharan Africa is experiencing an increasing burden of diabetes, but there are little reliable data, particularly at the community level, on the true prevalence or why this condition affects young and relatively lean individuals. Moreover, the detection of diabetes in Africa remains poor, not only due to a lack of resources but because the performance of available diagnostic tests is unclear.

METHODS: This research aims to (1) determine the prevalence and risk factors of diabetes in a rural Ugandan population, (2) use clinical and biochemical markers to define different diabetes phenotypes and (3) study the progression of diabetes in this population. We will also assess the utility of the widely used tests (glycated haemoglobin (HbA1c), oral glucose tolerance test (OGTT) and fasting glucose) in diagnosing diabetes.

DESIGN: This is a population-based study nested within the longstanding general population cohort in southwestern Uganda. We will undertake a population survey to identify individuals with diabetes based on fasting glucose, HbA1c, OGTT results or history of pre-existing diabetes.

PARTICIPANTS: The study intends to enrol up to 11 700 individuals aged 18 years and above, residing within the study area and not pregnant or within 6 months post-delivery date. All participants will have detailed biophysical and biochemical/metabolic measurements. Individuals identified to have diabetes and a random selection of controls will have repeat tests to test reproducibility before referral and enrolment into a diabetic clinic. Participants will then be followed up for 1 year to assess the course of the disease, including response to therapy and diabetes-related complications.

CONCLUSIONS: These data will improve our understanding of the burden of diabetes in Uganda, the risk factors that drive it and underlying pathophysiological mechanisms, as well as better ways to detect this condition. This will inform new approaches to improve the prevention and management of diabetes.

ETHICS AND DISSEMINATION: This study protocol was approved by the Uganda Virus Research Institute Research Ethics Committee (REC) (number: G.C./127/21/09/858), the London School of Hygiene and Tropical Medicine REC (number: 26638) and the Uganda National Council for Science and Technology (protocol number: HS1791ES). Written informed consent will be obtained from all participants before being enrolled on to the study and conducting study-related procedures. Research findings will be disseminated in policy briefs, seminars, local and international conferences and publications in peer-reviewed open-access journals. As part of the dissemination plans, findings will also be disseminated to patient care groups and to clinicians.

TRIAL REGISTRATION NUMBER: NCT05487079.

PMID:37709304 | DOI:10.1136/bmjopen-2023-071747

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Cardiovascular events more than 6 months after pregnancy in patients with congenital heart disease

Open Heart. 2023 Sep;10(2):e002430. doi: 10.1136/openhrt-2023-002430.

ABSTRACT

OBJECTIVES: Patients with congenital heart disease (CHD) are increasingly pursuing pregnancy, highlighting the need for data on late cardiovascular events (more than 6 months after delivery). We aimed to determine the incidence of late cardiovascular events in postpartum patients with CHD and evaluate the accuracy of the existing risk scores in predicting these events.

STUDY DESIGN: We identified patients with CHD who delivered between 2008 and 2020 at a tertiary centre and had follow-up data for greater than 6 months post partum. Late cardiovascular events were defined as heart failure, arrhythmia, thromboembolic events, endocarditis, urgent cardiovascular interventions or death. Survival analysis and Cox proportional model were used to estimate the incidence of late cardiovascular events and determine the hazard ratio of factors associated with these events.

RESULTS: Of 117 patients, 19% had 36 late cardiovascular events over a median follow-up of 3.8 years. Annual incidence of any late cardiovascular event was 5.7%. Hazards of late cardiovascular events were significantly higher among those with higher Cardiac Disease in Pregnancy Study (CARPREG) II and Zwangerschap bij Aangeboren HARtAfwijking-Pregnancy in Women With Congenital Heart Disease (ZAHARA) risk scores and among patients with prepregnancy New York Heart Association class≥II. C-statistic to predict the late cardiovascular events was highest for ZAHARA (0.7823), followed by CARPREG II (0.6902) and prepregnancy New York Heart Association class≥ II (0.6677).

CONCLUSIONS: Currently available risk tools designed for prognostication during the peripartum period can also be used to determine risks of late maternal cardiovascular events among those with CHD. These findings provide important new information for counselling and risk modification.

PMID:37709299 | DOI:10.1136/openhrt-2023-002430