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AnteayerBMJ Open

Effect and safety of electroacupuncture on weight loss in obese patients with pre-diabetes: study protocol of a randomised controlled trial

Por: Li · X. · Lin · J. · Hu · C. · Liu · B. · Li · F. · Li · J. · Zeng · X. · Li · S. · Mi · Y. · Yin · X. · Xu · S.
Introduction

Obesity has been identified as a significant risk factor for several chronic conditions, including diabetes, tumours and cardiovascular disease, and has been associated with increased mortality rates. Despite the well-established clinical practice of electroacupuncture (EA) as a potential treatment option for obesity, its efficacy remains questionable, primarily due to the paucity of empirical evidence supporting its therapeutic benefits.

Methods and analysis

The present study aims to investigate the efficacy and safety of EA for weight loss in obese individuals with pre-diabetes, using a randomised, placebo-controlled clinical trial design. A total of 256 eligible patients will be randomly assigned to one of two groups: EA (comprising EA treatment with health education) or superficial acupuncture (SA) (comprising SA treatment with health education). The intervention will be administered three times per week for the initial 12 weeks, two times per week for the subsequent 8 weeks and one time per week for the final 4 weeks, with a 24-week follow-up period. The primary outcome measure will be the percentage of patients who achieve a reduction of 10% or more in their body weight at week 24. Secondary outcome measures will include changes in body weight and body mass index, blood test results, data collected by the body composition analyser, size of adipose tissue scanned by MRI of the abdomen and the Impact of Weight on Quality of Life, the 21-item Three-Factor Eating Questionnaire-Revised and the Food Craving Questionnaire-Trait. The Treatment Emergent Symptom Scale will be employed to monitor every adverse reaction from baseline to follow-up.

Ethics and dissemination

This trial has received ethical clearance from the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine under the registration number 2021SHL-KY-74. All participants will provide their written informed consent prior to their enrolment. The findings of this investigation will be disseminated through peer-reviewed publications and scholarly conferences.

Trial registration number

NCT05237089.

National cross-sectional cluster survey of tuberculosis prevalence in Timor-Leste: a study protocol

Por: Lopes · C. · Joao · J. C. · Lowbridge · C. · Martins · N. · dos Santos · R. I. G. · da Silva · E. · Dias · J. · Ramalingam · S. · Amaral · S. · Oakley · T. · Ico · L. d. C. · Sarmento · N. · Yan · J. · Francis · J. R.
Introduction

Timor-Leste has one of the world’s highest estimated tuberculosis (TB) incidences, yet the data which informs this estimate is limited and the true burden of TB disease is not known. TB prevalence surveys offer the best means of determining robust estimates of disease burden. This study aims to provide an estimate of the prevalence of bacteriologically confirmed pulmonary TB in Timor-Leste and provide additional insights into diagnostic coverage and health-seeking behaviour of persons with symptoms suggestive of TB.

Methods and analysis

A national population-based cross-sectional cluster survey will be conducted in which participants aged 15 years and older will be screened for pulmonary TB using an algorithm consisting of symptom screening and digital X-ray of the chest with computer-aided detection software for X-ray interpretation. Xpert Ultra and liquid culture methods will be used to confirm survey TB cases. Additional data will be collected from persons reporting symptoms suggestive of TB to assess health-seeking behaviour and access to TB diagnosis and care. The survey aims to screen a target sample population of 20 068 people, living within 50 clusters, representing every municipality of Timor-Leste. Bacteriologically confirmed pulmonary TB prevalence will be estimated using WHO-recommended methods.

Ethics and dissemination

Research ethics approval has been granted by the human research ethics committee of the Northern Territory, Australia, and the Instituto Nacional da Saúde, Timor-Leste. The results will be published in a peer-reviewed scientific journal and disseminated with relevant stakeholders.

Trial registration number

ACTRN12623000718640.

Home-based mobile-guided exercise-based cardiac rehabilitation among patients undergoing transcatheter aortic valve replacement (REHAB-TAVR): protocol for a randomised clinical trial

Por: Shen · Z. · Mi · S. · Huang · C. · Zhou · D. · Pan · W. · Xu · X. · Lin · Y. · Zhang · Y.
Introduction

Transcatheter aortic valve replacement (TAVR) is a standard treatment for aortic stenosis, particularly in older adults. Reduced exercise capacity and frailty significantly impact outcomes in TAVR patients, yet current management lacks strategies to address these issues. This study aims to assess the effectiveness of home-based mobile-guided exercise-based cardiac rehabilitation in TAVR patients, led by a multidisciplinary team with clear progression milestones.

Methods and analysis

The study involves 90 patients aged 60–89 in a single centre who will be randomised to a 3-month novel multidomain exercise intervention or routine care. Outcome assessors will be blinded towards group allocation. The primary outcome is the 6-min walk distance at month 3. The secondary outcomes include the 6-min walk distance at month 6, physical function measured by total Short Physical Performance Battery score and exercise adherence measured by the Exercise Adherence Rating Scale at months 3 and 6. Additional outcome measures, including rehospitalisations, death, handgrip strength, frailty (Fried Criteria and Essential Toolset), cognitive function (Mini-Mental State Examination), quality of life (EuroQol 5-Dimension 5-Level), nutritional status (Mini-Nutritional Assessment), anxiety (General Anxiety Disorder-7), depression (Geriatric Depression Scale), sleep (Pittsburgh Sleep Quality Index), functional capacity (Duke Activity Status Index), clinical indices (body mass index, symptoms, signs, left ventricular ejection fraction (LVEF), N-Terminal Pro-Brain Natriuretic Peptide, etc) and social support (Lubben Social Network Scale-6), along with comprehensive cost analysis, enhance the study’s significance. The study’s findings hold crucial implications for crafting an effective exercise-focused cardiac rehabilitation strategy for TAVR patients. Community implementation not only deepens understanding but also fosters the potential integration of exercise-based cardiac rehabilitation into self-care, promising enhanced patient adherence and overall cardiovascular health management.

Ethics and dissemination

Ethical approval was obtained from the Zhongshan Hospital, Fudan University Ethics Committee (B2022-062R). Results will be disseminated to local stakeholders and the research community through publications and conferences.

Trial registration number

NCT05989594

Attrition from longitudinal ageing studies and performance across domains of cognitive functioning: an individual participant data meta-analysis

Por: Hernandez · R. · Jin · H. · Lee · P.-J. · Schneider · S. · Junghaenel · D. U. · Stone · A. A. · Meijer · E. · Gao · H. · Maupin · D. · Zelinski · E. M.
Objectives

This paper examined the magnitude of differences in performance across domains of cognitive functioning between participants who attrited from studies and those who did not, using data from longitudinal ageing studies where multiple cognitive tests were administered.

Design

Individual participant data meta-analysis.

Participants

Data are from 10 epidemiological longitudinal studies on ageing (total n=209 518) from several Western countries (UK, USA, Mexico, etc). Each study had multiple waves of data (range of 2–17 waves), with multiple cognitive tests administered at each wave (range of 4–17 tests). Only waves with cognitive tests and information on participant dropout at the immediate next wave for adults aged 50 years or older were used in the meta-analysis.

Measures

For each pair of consecutive study waves, we compared the difference in cognitive scores (Cohen’s d) between participants who dropped out at the next study wave and those who remained. Note that our operationalisation of dropout was inclusive of all causes (eg, mortality). The proportion of participant dropout at each wave was also computed.

Results

The average proportion of dropouts between consecutive study waves was 0.26 (0.18 to 0.34). People who attrited were found to have significantly lower levels of cognitive functioning in all domains (at the wave 2–3 years before attrition) compared with those who did not attrit, with small-to-medium effect sizes (overall d=0.37 (0.30 to 0.43)).

Conclusions

Older adults who attrited from longitudinal ageing studies had lower cognitive functioning (assessed at the timepoint before attrition) across all domains as compared with individuals who remained. Cognitive functioning differences may contribute to selection bias in longitudinal ageing studies, impeding accurate conclusions in developmental research. In addition, examining the functional capabilities of attriters may be valuable for determining whether attriters experience functional limitations requiring healthcare attention.

Evaluations of virtual exercise programmes for adults with mobility limitations: a scoping review protocol incorporating an equity lens to inform the development of strategies to optimise participation of under-represented groups

Por: dos Santos · R. B. · Lin · J. · Badwal · A. · Singh · H. · Jaglal · S. B. · Sperling · C. · Salbach · N. M.
Introduction

For individuals with mobility limitations, virtual exercise programmes can address the challenges of in-person participation in community exercise programmes. A synthesis of studies of virtual exercise programmes targeting mobility limitations provided outside of conventional rehabilitation services and strategies used to optimise equitable access and inclusivity in these programmes is lacking. We aim to characterise evaluations of virtual exercise programmes for adults with mobility limitations, and the nature of and extent to which equity, diversity and inclusion considerations are integrated in the research process.

Methods and analysis

A scoping review following a six-stage methodological framework, including a consultation exercise, is proposed. A comprehensive strategy will be used to search Medline, Embase, PEDro, CINAHL and Scopus to identify peer-reviewed studies evaluating virtual exercise programmes for adults with mobility limitations living in the community. Three trained reviewers will select studies independently. Data (eg, study methodology, programme structure and content, participant characteristics) will be extracted using a standardised form, and collated and summarised using quantitative and qualitative methods. The PROGRESS-Plus and International Classification of Functioning, Disability and Health frameworks will be used to classify participant characteristics and study outcomes, respectively. During the consultation exercise, key knowledge users, including exercise participants, programme providers and coordinators, and members of community organisations for persons living with disabilities and under-represented groups, will be asked to provide insights regarding the applicability of review findings. A directed content analysis of data from the consultation exercise will be performed.

Ethics and dissemination

The research ethics board at the University of Toronto approved the consultation exercise. Findings will be disseminated through peer-reviewed publications and conference presentations. Findings will enhance understanding of current research evaluating virtual exercise programmes and inform future research and strategies for promoting equitable access and outcomes for individuals with mobility limitations.

Registration details

https://doi.org/10.17605/OSF.IO/X5JMA.

Sarcopenia in systemic sclerosis: prevalence and impact--a systematic review and meta-analysis

Por: Tu · X. · Lin · T. · Ju · Y. · Shu · X. · Jiang · T. · Ge · N. · Yue · J.
Objective

This review aims to provide an estimate of sarcopenia prevalence and its impact on clinical characteristics in patients with systemic sclerosis (SSc).

Design

Systematic review and meta-analysis.

Data sources

Embase, Medline, Web of Science and the Cochrane Central Register of Controlled Trials were systemically searched from inception to 24 May 2023.

Eligibility criteria for selecting studies

We included observational studies that reported the prevalence of sarcopenia in patients with SSc.

Data extraction and synthesis

Two reviewers independently performed study selection and data extraction using standardised methods. Risk of bias was assessed using the Agency for Healthcare Research and Quality Scale and the Newcastle–Ottawa Scale. Meta-analysis was conducted using random effects models.

Results

A total of 4583 articles were screened and 9 studies with data from 815 patients were included in the analysis (8 cross-sectional studies and 1 retrospective cohort study). The overall prevalence of sarcopenia in patients with SSc was 22% (95% CI 17% to 28%). Patients with SSc with sarcopenia had a poorer quality of life (mean difference –12.02; 95% CI –19.11 to –4.93) and higher C reactive protein (CRP) levels (standardised mean difference 0.67; 95% CI 0.35 to 1.00).

Conclusions

Sarcopenia is common in patients with SSc. Patients with SSc with sarcopenia had a worse quality of life and higher CRP levels, based on our findings. Given the detrimental impact of sarcopenia on quality of life, future efforts aimed at early identification of sarcopenia in the clinical assessment of patients with SSc may have significance.

PROSPERO registration number

CRD42022368326.

Toxoplasma gondii seropositivity and cognitive functioning in older adults: an analysis of cross-sectional data of the National Health and Nutrition Examination Survey 2011-2014

Por: Song · G. · Zhao · Q. · Chen · H. · Li · M. · Zhang · Z. · Qu · Z. · Yang · C. · Lin · X. · Ma · W. · Standlee · C. R.
Objectives

This study sought to examine the relationship between Toxoplasma gondii seropositivity and cognitive function in older adults.

Design

An observational cross-sectional study.

Setting

The National Health and Nutrition Examination Survey (NHANES) study took place at participants’ homes and mobile examination centres.

Participants

A total of 2956 older adults aged 60 and above from the NHANES from 2011 to 2014 were included in the study. Exposure of interest: participants had serum Toxoplasma gondii antibody analysed in the laboratory. A value>33 IU/mL was categorised as seropositive for Toxoplasma gondii infection; Toxoplasma gondii infection.

Primary and secondary outcome measures

Cognitive tests included the Consortium to Establish a Registry for Alzheimer’s Disease Word Learning subtest (CERAD-WL) for immediate and delayed memory, the Animal Fluency Test (AFT), and the Digit Symbol Substitution Test (DSST).

Results

About half of the 2956 participants (mean age 70.0) were female (51.0%), non-Hispanic White (48.3%), and completed some college or above (48.3%). A total of 703 participants were positive for Toxoplasma gondii infection (23.8%). Adjusted linear regression showed that compared with participants with negative Toxoplasma gondii infection, those with positive Toxoplasma gondii infection had lower CERAD-WL immediate memory (beta (β) –0.16, 95% CI –0.25 to –0.07), CERAD-WL delayed memory (β –0.15, 95% CI –0.24 to –0.06), AFT (β –0.15, 95% CI –0.24 to –0.06), DSST (β –0.34, 95% CI –0.43 to –0.26), and global cognition (β –0.24, 95% CI –0.32 to –0.16) z-scores after controlling for the covariates.

Conclusions

Toxoplasma gondii seropositivity is associated with worse immediate and delayed verbal learning, language proficiency, executive functioning, processing speed, sustained attention, working memory, as well as global cognition in older adults. Public health measures aiming at preventing Toxoplasma gondii infection may help preserve cognitive functioning in older adults.

Importance of kidney function, number of chronic conditions and medications for hospitalisation in elderly in Blekinge County, Sweden: a case-control study

Por: Norstedt · I. · Thorell · K. · Halling · A.
Objectives

To study the association between risk for hospitalisation in an elderly population related to renal function, number of chronic diseases and number of prescribed drugs.

Design

A case–control study. Persons hospitalised were included and their controls were obtained from electronic hospital medical records. If data were lacking on creatinine levels, multiple imputation was used.

Setting

Blekinge County in southwestern Sweden.

Participants

Study of individuals aged 75 years or older in 2013. We identified a total of 2,941 patients with a first hospitalisation. Of these, 81 were excluded, 78 due to incomplete data and 3 because of lack of control persons. Controls were matched to the same sex and birth year, which resulted in 5720 persons.

Primary and secondary outcome measures

To analyse the OR for hospitalisation conditional logistic regression was used.

Results

A total of 695 persons lacked creatinine value. Using imputation values comparing persons with estimated glomerular filtration rate (eGFR) 2 with ≥30 univariate analyses showed an increased OR 2.35 (95% CI 1.83 to 3.03). Adjusted analyses demonstrated an OR of 1.90 (95% CI 1.46 to 2.47). Comparing eGFR2 against ≥45 univariate analyses showed OR 1.38 (95% CI 1.22 to 1.57). Adjusted analyses OR for the same group were 1.17 (95% CI 1.03 to 1.33). In both models, the OR for five or more chronic conditions and five or more medications showed a statistically increased risk for hospitalisation.

Conclusions

There is a need for systems using data collected in routine care to follow elderly patients to minimise avoidable hospitalisations that can cause adverse effects. Renal function, number of chronic conditions and medications are factors that are of significant importance. This study demonstrates the complexity of this patient group.

Modifiable prognostic factors of high societal costs among people on sick leave due to musculoskeletal disorders: findings from an occupational cohort study

Por: Killingmo · R. M. · Tveter · A. T. · Pripp · A. H. · Tingulstad · A. · Maas · E. · Rysstad · T. · Grotle · M.
Objectives

The objective was to identify modifiable prognostic factors of high societal costs among people on sick leave due to musculoskeletal disorders, and to identify modifiable prognostic factors of high costs related to separately healthcare utilisation and productivity loss.

Design

A prospective cohort study with a 1-year follow-up.

Participants and setting

A total of 549 participants (aged 18–67 years) on sick leave (≥ 4 weeks) due to musculoskeletal disorders in Norway were included.

Outcome measures and method

The primary outcome was societal costs aggregated for 1 year of follow-up and dichotomised as high or low, defined by the top 25th percentile. Secondary outcomes were high costs related to separately healthcare utilisation and productivity loss aggregated for 1 year of follow-up. Healthcare utilisation was collected from public records and included primary, secondary and tertiary healthcare use. Productivity loss was collected from public records and included absenteeism, work assessment allowance and disability pension. Nine modifiable prognostic factors were selected based on previous literature. Univariable and multivariable binary logistic regression analyses were performed to identify associations (crude and adjusted for selected covariates) between each modifiable prognostic factor and having high costs.

Results

Adjusted for selected covariates, six modifiable prognostic factors associated with high societal costs were identified: pain severity, disability, self-perceived health, sleep quality, return to work expectation and long-lasting disorder expectation. Depressive symptoms, work satisfaction and health literacy showed no prognostic value. More or less similar results were observed when high costs were related to separately healthcare utilisation and productivity loss.

Conclusion

Factors identified in this study are potential target areas for interventions which could reduce high societal costs among people on sick leave due to musculoskeletal disorders. However, future research aimed at replicating these findings is warranted.

Trial registration number

NCT04196634, 12 December 2019.

NeuroMotion smartphone application for remote General Movements Assessment: a feasibility study in Nepal

Por: Kukka · A. J. · Sundelin · H. E. K. · Basnet · O. · Paudel · P. · Upadhyay Subedi · K. · Svensson · K. · Brown · N. · Litorp · H. · Gurung · R. · Bhattarai · P. · Wrammert · J. · KC · A.
Objectives

To evaluate the feasibility of using the NeuroMotion smartphone application for remote General Movements Assessment for screening infants for cerebral palsy in Kathmandu, Nepal.

Method

Thirty-one term-born infants at risk of cerebral palsy due to birth asphyxia or neonatal seizures were recruited for the follow-up at Paropakar Maternity and Women’s Hospital, 1 October 2021 to 7 January 2022. Parents filmed their children at home using the application at 3 months’ age and the videos were assessed for technical quality using a standardised form and for fidgety movements by Prechtl’s General Movements Assessment. The usability of the application was evaluated through a parental survey.

Results

Twenty families sent in altogether 46 videos out of which 35 had approved technical quality. Sixteen children had at least one video with approved technical quality. Three infants lacked fidgety movements. The level of agreement between assessors was acceptable (Krippendorf alpha 0.781). Parental answers to the usability survey were in general positive.

Interpretation

Engaging parents in screening of cerebral palsy with the help of a smartphone-aided remote General Movements Assessment is possible in the urban area of a South Asian lower middle-income country.

Kentucky Outreach Service Kiosk (KyOSK) Study protocol: a community-level, controlled quasi-experimental, type 1 hybrid effectiveness study to assess implementation, effectiveness and cost-effectiveness of a community-tailored harm reduction kiosk on HIV,

Por: Young · A. M. · Havens · J. R. · Cooper · H. L. F. · Fallin-Bennett · A. · Fanucchi · L. · Freeman · P. R. · Knudsen · H. · Livingston · M. D. · McCollister · K. E. · Stone · J. · Vickerman · P. · Freeman · E. · Jahangir · T. · Larimore · E. · White · C. R. · Cheatom · C. · Community S
Introduction

Many rural communities bear a disproportionate share of drug-related harms. Innovative harm reduction service models, such as vending machines or kiosks, can expand access to services that reduce drug-related harms. However, few kiosks operate in the USA, and their implementation, impact and cost-effectiveness have not been adequately evaluated in rural settings. This paper describes the Kentucky Outreach Service Kiosk (KyOSK) Study protocol to test the effectiveness, implementation outcomes and cost-effectiveness of a community-tailored, harm reduction kiosk in reducing HIV, hepatitis C and overdose risk in rural Appalachia.

Methods and analysis

KyOSK is a community-level, controlled quasi-experimental, non-randomised trial. KyOSK involves two cohorts of people who use drugs, one in an intervention county (n=425) and one in a control county (n=325). People who are 18 years or older, are community-dwelling residents in the target counties and have used drugs to get high in the past 6 months are eligible. The trial compares the effectiveness of a fixed-site, staffed syringe service programme (standard of care) with the standard of care supplemented with a kiosk. The kiosk will contain various harm reduction supplies accessible to participants upon valid code entry, allowing dispensing data to be linked to participant survey data. The kiosk will include a call-back feature that allows participants to select needed services and receive linkage-to-care services from a peer recovery coach. The cohorts complete follow-up surveys every 6 months for 36 months (three preceding kiosk implementation and four post-implementation). The study will test the effectiveness of the kiosk on reducing risk behaviours associated with overdose, HIV and hepatitis C, as well as implementation outcomes and cost-effectiveness.

Ethics and dissemination

The University of Kentucky Institutional Review Board approved the protocol. Results will be disseminated in academic conferences and peer-reviewed journals, online and print media, and community meetings.

Trial registration number

NCT05657106.

Interventional embolisation for patients with cirrhosis and recurrent or persistent hepatic encephalopathy related to spontaneous portosystemic shunts: protocol for a prospective, non-randomised controlled study

Por: Ke · Q. · Lin · T. · Lei · X. · Weng · X. · He · J. · Huang · X. · Li · L. · Guo · W.-H.
Introduction

The presence of spontaneous portosystemic shunts (SPSS) has been identified to be associated with hepatic encephalopathy (HE) in patients with cirrhosis. Nevertheless, the role of interventional embolisation in managing such patients remains poorly defined. Consequently, this prospective controlled study aims to assess the efficacy and safety of interventional embolisation as a therapeutic approach for patients with cirrhosis and recurrent or persistent HE related to SPSS.

Methods and analysis

Cirrhotic patients diagnosed with recurrent or persistent HE associated with SPSS will be recruited for this study, and assigned to either the interventional embolisation group or the standard medical treatment group. The efficacy endpoints encompass the evaluation of postoperative alleviation of HE symptoms and the incidence of overt HE recurrence during the follow-up period, as well as the duration and frequency of hospitalisations for HE, alterations in liver function and volume, and overall survival. The safety endpoints encompass both immediate and long-term postoperative complications.

Ethics and dissemination

This study will be conducted in strict adherence to the principles of good clinical practice and the guidelines outlined in the Declaration of Helsinki. Ethical approval for the trial has been obtained from the Ethics Committee of Mengchao Hepatobiliary Hospital of Fujian Medical University (2023_013_02). Written informed consent will be obtained from all the participants by the treating physician for each patient prior to their enrolment. The documented informed consent forms will be retained as part of the clinical trial records for future reference. The study findings will be disseminated through publication in peer-reviewed journals and will be presented at international conferences.

Trial registration number

ChiCTR2300072189.

Non-communicable disease care in Sierra Leone: a mixed-methods study of the drivers and barriers to retention in care for hypertension

Por: Dibba · Y. · Kachimanga · C. · Gassimu · J. · Kulinkina · A. V. · Bukhman · G. · Gilbert · H. N. · Adler · A. J. · Mukherjee · J. S.
Objective

To retrospectively analyse routinely collected data on the drivers and barriers to retention in chronic care for patients with hypertension in the Kono District of Sierra Leone.

Design

Convergent mixed-methods study.

Setting

Koidu Government Hospital, a secondary-level hospital in Kono District.

Participants

We conducted a descriptive analysis of key variables for 1628 patients with hypertension attending the non-communicable disease (NCD) clinic between February 2018 and August 2019 and qualitative interviews with 21 patients and 7 staff to assess factors shaping patients’ retention in care at the clinic.

Outcomes

Three mutually exclusive outcomes were defined for the study period: adherence to the treatment protocol (attending >80% of scheduled visits); loss-to-follow-up (LTFU) (consecutive 6 months of missed appointments) and engaged in (but not fully adherent) with treatment (

Results

57% of patients were adherent, 20% were engaged in treatment and 22% were LTFU. At enrolment, in the unadjusted variables, patients with higher systolic and diastolic blood pressures had better adherence than those with lower blood pressures (OR 1.005, 95% CI 1.002 to 1.009, p=0.004 and OR 1.008, 95% CI 1.004 to 1.012, p

Conclusion

Free medications, high-quality services and health education may be effective ways of helping NCD patients stay engaged in care. Facility and socioeconomic factors can pose challenges to retention in care.

Enhanced active case finding of drug-resistant tuberculosis in Namibia: a protocol for the hotspots, hospitals, and households (H3TB) study

Por: Shavuka · O. · Iipumbu · E. · Boois · L. · Günther · G. · Hoddinott · G. · Lin · H.-H. · Nepolo · E. · Niemann · S. · Ruswa · N. · Seddon · J. · Claassens · M. M.
Introduction

Namibia is a high tuberculosis (TB)-burden country with an estimated incidence of 460/100 000 (around 12 000 cases) per year. Approximately 4.5% of new cases and 7.9% of previously treated TB cases are multidrug resistant (MDR) and 47% of patients with MDR-TB are HIV coinfected. Published data suggest a clustering of MDR-TB transmission in specific areas. Identifying transmission clusters is key to implementing high-yield and cost-effective interventions. This includes knowing the yield of finding TB cases in high-transmission zones (eg, community hotspots, hospitals or households) to deliver community-based interventions. We aim to identify such transmission zones for enhanced case finding and evaluate the effectiveness of this approach.

Methods and analysis

H3TB is an observational cross-sectional study evaluating MDR-TB active case finding strategies. Sputum samples from MDR-TB cases in three regions of Namibia will be evaluated by whole genome sequencing (WGS) in addition to routine sputum investigations (Xpert MTB/RIF, culture and drug susceptibility testing). We will collect information on household contacts, use of community spaces and geographical map intersections between participants, synthesising these data to identify transmission hotspots. We will look at the feasibility, acceptability, yield and cost of case finding strategies in these hotspots, and in households of patients with MDR-TB and visitors of hospitalised patients with MDR-TB. A compartmental transmission dynamic model will be constructed to evaluate the impact and cost-effectiveness of the strategies if scaled.

Ethics and dissemination

Ethics approval was obtained. Participants will give informed consent. H3TB will capitalise on a partnership with the Ministry of Health and Social Services to follow up individuals diagnosed with MDR-TB and integrate WGS data with innovative contact network mapping, to allow enhanced case finding. Study data will contribute towards a systems approach to TB control. Equally important, it will serve as a role model for similar studies in other high-incidence settings.

Trends of mean systolic and diastolic blood pressure among adults in Shenzhen, China, 1997-2018: findings from three rounds of the population-based survey

Por: Peng · K. · Cai · W. · Liu · X. · Liu · Y. · Ouyang · M. · Gong · J. · Wang · Z. · Wang · Y. · Hao · J. · Wang · W. · Zhao · H. · Lin · K. · Han · G. · Shi · Y. · Xie · Y. · Xie · Y. · Lei · L. · Si · L.
Objective

To quantify the trends in systolic and diastolic blood pressure (BP) among adults in Shenzhen from 1997 to 2018.

Design

Cross-sectional study.

Settings

The data were collected from all districts in Shenzhen, China in the years of 1997, 2009 and 2018 by multistage cluster sampling procedure.

Participants

Participants were residents aged 18–69 years in Shenzhen, China. A total of 26 621 people were included: 8266 people in 1997, 8599 people in 2009 and 9756 people in 2018.

Primary and secondary outcome measures

All participants were surveyed about their sociodemographic and lifestyle information. BP was measured by trained physicians using a mercury sphygmomanometer. Hypertension was defined as systolic BP of at least 140 mm Hg and diastolic BP of at least 90 mm Hg, self-reported use of antihypertensive medications or both. Hypertension control was defined as systolic BP values of less than 140 mm Hg and diastolic BP values of less than 90 mm Hg.

Result

Age-adjusted mean systolic BP increased from 117±16 mm Hg to 123±15 mm Hg (p

Conclusions

The mean systolic BP and diastolic BP among adults in Shenzhen increased from 1997 to 2018, and no improvements in hypertension awareness, treatment and control rates were found.

Comparative effectiveness of biologics in patients with rheumatoid arthritis stratified by body mass index: a cohort study in a Swiss registry

Objectives

Obesity is associated with lower treatment response in patients with rheumatoid arthritis (RA). In patients with obesity, abatacept was suggested as a preferable option to tumour necrosis factor-alpha inhibitors. We aimed to assess the comparative effectiveness of etanercept, infliximab and abatacept, compared with adalimumab, in patients with RA with obesity. Secondarily, we also investigated this in patients with overweight and normal weight for completeness.

Design

Observational cohort study.

Setting

Swiss Clinical Quality Management in Rheumatic Diseases (SCQM) registry (1997–2019).

Participants

Adult patients with RA from the SCQM registry who received etanercept, infliximab, abatacept or adalimumab as their first biological or targeted synthetic disease-modifying antirheumatic drug were classified based on their body mass index (BMI) at the start of that treatment in three cohorts: obese, overweight, normal weight. They were followed for a maximum of 1 year.

Exposure

The study exposure of interest was the patients’ first biological, particularly: etanercept, infliximab and abatacept, compared with adalimumab.

Primary and secondary outcome measures

The primary study outcome was remission within 12 months, defined as 28-joint Disease Activity Score (DAS28)

Results

The study included 443 obese, 829 overweight and 1243 normal weight patients with RA. There were no statistically significant differences in the odds of DAS28-remission at ≤12 months for etanercept, infliximab and abatacept, compared with adalimumab, in any of the BMI cohorts.

Conclusions

No differences in DAS28-remission were found between the study drugs and adalimumab as first biologic in patients with RA, independently of the BMI cohort. We did not find evidence that treatment with abatacept increased the likelihood of remission compared with adalimumab among obese patients with RA.

Research on the barriers to accessing sexual healthcare for sexually diverse Muslim men: protocol for a scoping review

Por: Noor · M. N. · Shaw · S. Y. · Linton · J. · Lorway · R.
Introduction

Sexually diverse Muslim men are seen to be at a higher risk for HIV and other sexually transmitted infections due to their limited access to sexual healthcare services. We outline a protocol to conduct a scoping review of research on the barriers that may impede these men’s access to sexual healthcare.

Methods and analysis

To conduct this scoping review, we will follow the methodological framework developed by Arksey and O’Malley and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses’ extension for scoping reviews. To classify the barriers to sexual healthcare, we will employ Bronfenbrenner’s socioecological model as a conceptual framework. We will conduct a literature search via Medline, Embase and Global Health (OVID); Scopus; CINAHL on EBSCOhost along with several other EBSCOhost databases (Academic Search Complete, Canadian Reference Centre, Alternative Press Index, Family & Society Studies Worldwide, Social Work Abstracts) and Google Scholar, published until November 2023. Journal articles, published in the English language, describing quantitative and qualitative research on sexual healthcare access barriers for sexually diverse Muslim men will be included in the review. Commentaries and correspondences, along with grey literature including research reports and conference abstracts, as well as studies that do not include men with the Muslim faith, will be considered ineligible. Following screening of titles and abstracts, we will conduct a full-text screening to determine the final number of studies to be included in the review. A Microsoft Excel spreadsheet will be used to extract study characteristics, and information on sexual healthcare access barriers will be classified according to the socioecological model’s core concepts.

Ethics and dissemination

Our review does not require ethics approval. We will disseminate the review findings through peer-reviewed academic journals, seminars and conference presentations.

Association between tuberculosis and pregnancy outcomes: a retrospective cohort study of women in Cape Town, South Africa

Por: Meehan · S.-A. · Hesseling · A. C. · von Delft · A. · Marx · F. M. · Hughes · J. A. · Bock · P. · Banke-Thomas · A. · Dunbar · R. · Phelanyane · F. · Smith · M. · Osman · M.
Background

Tuberculosis (TB) remains a leading cause of mortality among women of childbearing age and a significant contributor to maternal mortality. Pregnant women with TB are at high risk of adverse pregnancy outcomes. This study aimed to determine risk factors for an adverse pregnancy outcome among pregnant women diagnosed with TB.

Methods

Using TB programmatic data, this retrospective cohort analysis included all women who were routinely diagnosed with TB in the public sector between October 2018 and March 2020 in two health subdistricts of Cape Town, and who were documented to be pregnant during their TB episode. Adverse pregnancy outcome was defined as either a live birth of an infant weighing

Results

Of 248 pregnant women, half (52%) were living with HIV; all were on antiretroviral therapy at the time of their TB diagnosis. Pregnancy outcomes were documented in 215 (87%) women, of whom 74 (34%) had an adverse pregnancy outcome. Being older (35–44 years vs 25–34 years (adjusted OR (aOR): 3.99; 95% CI: 1.37 to 11.57), living with HIV (aOR: 2.72; 95% CI: 0.99 to 4.63), having an unfavourable TB outcome (aOR: 2.29; 95% CI: 1.03 to 5.08) and having presented to antenatal services ≤1 month prior to delivery (aOR: 10.57; 95% CI: 4.01 to 27.89) were associated with higher odds of an adverse pregnancy outcome.

Conclusions

Pregnancy outcomes among women with TB were poor, irrespective of HIV status. Pregnant women with TB are a complex population who need additional support prior to, during and after TB treatment to improve TB treatment and pregnancy outcomes. Pregnancy status should be considered for inclusion in TB registries.

Assessing the heterogeneity of the impact of COVID-19 incidence on all-cause excess mortality among healthcare districts in Lombardy, Italy, to evaluate the local response to the pandemic: an ecological study

Por: Paganuzzi · M. · Nattino · G. · Ghilardi · G. I. · Costantino · G. · Rossi · C. · Cortellaro · F. · Cosentini · R. · Paglia · S. · Migliori · M. · Mira · A. · Bertolini · G. · On behalf of the Fenice network
Objectives

The fragmentation of the response to the COVID-19 pandemic at national, regional and local levels is a possible source of variability in the impact of the pandemic on society. This study aims to assess how much of this variability affected the burden of COVID-19, measured in terms of all-cause 2020 excess mortality.

Design

Ecological retrospective study.

Setting

Lombardy region of Italy, 2015–2020.

Outcome measures

We evaluated the relationship between the intensity of the epidemics and excess mortality, assessing the heterogeneity of this relationship across the 91 districts after adjusting for relevant confounders.

Results

The epidemic intensity was quantified as the COVID-19 hospitalisations per 1000 inhabitants. Five confounders were identified through a directed acyclic graph: age distribution, population density, pro-capita gross domestic product, restriction policy and population mobility.

Analyses were based on a negative binomial regression model with district-specific random effects. We found a strong, positive association between COVID-19 hospitalisations and 2020 excess mortality (p

Conclusions

The homogeneous effect of the COVID-19 spread on the excess mortality in the Lombardy districts suggests that, despite the unprecedented conditions, the pandemic reactions did not result in health disparities in the region.

Is reduced heart rate variability associated with functional somatic disorders? A cross-sectional population-based study; DanFunD

Por: Jorgensen · T. · Dantoft · T. M. · Petersen · M. W. · Gormsen · L. · Winter-Jensen · M. · Fink · P. · Linneberg · A. · Benros · M. E. · Eplov · L. F. · Bjerregaard · A. A. · Schovsbo · S. U. · Brinth · L. S.
Objectives

It has been hypothesised that functional somatic disorders (FSD) could be initiated by sympathetic predominance in the autonomic nervous system as measured by low heart rate variability (HRV). Earlier studies on the association between HRV and FSD are small case–control studies hampered by selection bias and do not consider the great overlap between the various FSDs. The aim of the present study is to assess any associations between HRV and various FSDs and whether chronic stress confounds such an association.

Design

A cross-sectional general population-based study.

Setting

The Danish Study of Functional Somatic Disorders conducted 2013–2015 in 10 municipalities in the western part of Greater Copenhagen, Denmark.

Participants

A total of 6891 men and women aged 18–72 years were included in the analyses after exclusion of 602 persons with missing HRV data. Various delimitations of FSD (chronic fatigue, chronic widespread pain, irritable bowel and bodily distress syndrome) were identified by validated questionnaires and diagnostic interviews. HRV parameters in time and frequency domains were calculated from successive beat-to-beat heart rate (HR) data using the ‘E-motion’ HR monitor device during 7 min of supine rest. Chronic stress was assessed by Cohen’s self-perceived stress scale.

Outcome measures

Logistic regression analyses were used to calculate possible associations between the various delimitations of FSD and HRV adjusting for chronic stress.

Results

Persons with FSD had a slightly higher mean HR and lower HRV as measured by time domain parameters, whereas associations with frequency domain parameters were not consistent. Adjusting for chronic stress attenuated associations slightly.

Conclusion

The study supports a sympathetic predominance in persons with FSD, which could not be entirely explained by chronic stress. However, it is not possible to conclude whether the association is a causal factor to or a consequence of FSD.

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