FreshRSS

🔒
☐ ☆ ✇ PLOS ONE Medicine&Health

Prevalence and impact of sarcopenia in individuals with heart failure with reduced ejection fraction (the SARC-HF study): A prospective observational study protocol

by Pablo Marino Corrêa Nascimento, Luiz Fernando Rodrigues Junior, Mauro Felippe Felix Mediano, Valéria Gonçalves da Silva, Bernardo Rangel Tura, Fabio César Sousa Nogueira, Gilberto Domont, Adriana Bastos Carvalho, Antônio Carlos Campos de Carvalho, Taís Hanae Kasai-Brunswick, Claudio Tinoco Mesquita, Humberto Villacorta Junior, Helena Cramer Veiga Rey

Sarcopenia, a clinical syndrome primarily associated with reduced muscle mass in the elderly, has a negative impact on quality of life and survival. It can occur secondarily to other diseases such as heart failure (HF), a complex clinical syndrome with high morbidity and mortality. The simultaneous occurrence of these two conditions can worsen the prognosis of their carriers, especially in the most severe cases of HF, as in patients with reduced left ventricular ejection fraction (LVEF). However, due to the heterogeneous diagnostic criteria for sarcopenia, estimates of its prevalence present a wide variation, leading to new criteria having been recently proposed for its diagnosis, emphasizing muscle strength and function rather than skeletal muscle mass. The primary objective of this study is to evaluate the prevalence of sarcopenia and/or dynapenia in individuals with HF with reduced LVEF according to the most recent criteria, and compare the gene and protein expression of those patients with and without sarcopenia. The secondary objectives are to evaluate the association of sarcopenia and/or dynapenia with the risk of clinical events and death, quality of life, cardiorespiratory capacity, ventilatory efficiency, and respiratory muscle strength. The participants will answer questionnaires to evaluate sarcopenia and quality of life, and will undergo the following tests: handgrip strength, gait speed, dual-energy X-ray absorptiometry, respiratory muscle strength, cardiopulmonary exercise, as well as genomic and proteomic analysis, and dosage of N-terminal pro-B-type natriuretic peptide and growth differentiation factor-15. An association between sarcopenia and/or dynapenia with unfavorable clinical evolution is expected to be found, in addition to reduced quality of life, cardiorespiratory capacity, ventilatory efficiency, and respiratory muscle strength.
☐ ☆ ✇ PLOS ONE Medicine&Health

Retinoid orphan receptor gamma t (rorγt) promotes inflammatory eosinophilia but is dispensable for innate immune-mediated colitis

by Alvaro Torres-Huerta, Katelyn Ruley-Haase, Theodore Reed, Antonia Boger-May, Derek Rubadeux, Lauren Mayer, Arpitha Mysore Rajashekara, Morgan Hiller, Madeleine Frech, Connor Roncagli, Cameron Pedersen, Mary Catherine Camacho, Lauren Hollmer, Lauren English, Grace Kane, David L. Boone

Inflammatory bowel diseases (IBD) result from uncontrolled inflammation in the intestinal mucosa leading to damage and loss of function. Both innate and adaptive immunity contribute to the inflammation of IBD and innate and adaptive immune cells reciprocally activate each other in a forward feedback loop. In order to better understand innate immune contributions to IBD, we developed a model of spontaneous 100% penetrant, early onset colitis that occurs in the absence of adaptive immunity by crossing villin-TNFAIP3 mice to RAG1-/- mice (TRAG mice). This model is driven by microbes and features increased levels of innate lymphoid cells in the intestinal mucosa. To investigate the role of type 3 innate lymphoid cells (ILC3) in the innate colitis of TRAG mice, we crossed them to retinoid orphan receptor gamma t deficient (Rorγt-/-) mice. Rorγt-/- x TRAG mice exhibited markedly reduced eosinophilia in the colonic mucosa, but colitis persisted in these mice. Colitis in Rorγt-/- x TRAG mice was characterized by increased infiltration of the intestinal mucosa by neutrophils, inflammatory monocytes, macrophages and other innate cells. RNA and cellular profiles of Rorγt-/- x TRAG mice were consistent with a lack of ILC3 and ILC3 derived cytokines, reduced antimicrobial factors, increased activation oof epithelial repair processes and reduced activation of epithelial cell STAT3. The colitis in Rorγt-/- x TRAG mice was ameliorated by antibiotic treatment indicating that microbes contribute to the ILC3-independent colitis of these mice. Together, these gene expression and cell signaling signatures reflect the double-edged sword of ILC3 in the intestine, inducing both proinflammatory and antimicrobial protective responses. Thus, Rorγt promotes eosinophilia but Rorγt and Rorγt-dependent ILC3 are dispensable for the innate colitis in TRAG mice.
☐ ☆ ✇ BMJ Open

Health-related quality of life after 12 months post discharge in patients hospitalised with COVID-19-related severe acute respiratory infection (SARI): a prospective analysis of SF-36 data and correlation with retrospective admission data on age, disease

Por: Wright · G. · Senthil · K. · Zadeh-Kochek · A. · Au · J. H.-s. · Zhang · J. · Huang · J. · Saripalli · R. · Khan · M. · Ghauri · O. · Kim · S. · Mohammed · Z. · Alves · C. · Koduri · G. — Marzo 20th 2024 at 16:56

Long-term outcome and ‘health-related quality of life’ (HRQoL) following hospitalisation for COVID-19-related severe acute respiratory infection (SARI) is limited.

Objective

To assess the impact of HRQoL in patients hospitalised with COVID-19-related SARI at 1 year post discharge, focusing on the potential impact of age, frailty, and disease severity.

Method

Routinely collected outcome data on 1207 patients admitted with confirmed COVID-19 related SARI across all three secondary care sites in our NHS trust over 3 months were assessed in this retrospective cohort study. Of those surviving 1 year, we prospectively collected 36-item short form (SF-36) HRQoL questionnaires, comparing three age groups (

Results

Overall mortality was 46.5% in admitted patients. In our SF-36 cohort (n=169), there was a significant reduction in all HRQoL domains versus normative data; the most significant reductions were in the physical component (pemotional component (physical well-being versus CFS (the correlation coefficient=–0.37, p

Conclusion

There was a significant reduction in all SF-36 domains at 1 year. Poor CFS at admission was associated with a significant and prolonged impact on physical parameters at 1 year. Age had little impact on the severity of HRQoL, except in the domains of physical functioning and the overall physical component.

☐ ☆ ✇ BMJ Open

Temporal trends of ambulance time intervals for suspected stroke/transient ischaemic attack (TIA) before and during the COVID-19 pandemic in Ireland: a quasi-experimental study

Por: Burton · E. · Quinn · R. · Crosbie-Staunton · K. · Deasy · C. · Masterson · S. · O'Donnell · C. · Merwick · A. · Willis · D. · Kearney · P. M. · Mc Carthy · V. J. C. · Buckley · C. M. — Marzo 20th 2024 at 16:56
Objectives

Time is a fundamental component of acute stroke and transient ischaemic attack (TIA) care, thus minimising prehospital delays is a crucial part of the stroke chain of survival. COVID-19 restrictions were introduced in Ireland in response to the pandemic, which resulted in major societal changes. However, current research on the effects of the COVID-19 pandemic on prehospital care for stroke/TIA is limited to early COVID-19 waves. Thus, we aimed to investigate the effect of the COVID-19 pandemic on ambulance time intervals and suspected stroke/TIA call volume for adults with suspected stroke and TIA in Ireland, from 2018 to 2021.

Design

We conducted a secondary data analysis with a quasi-experimental design.

Setting

We used data from the National Ambulance Service in Ireland. We defined the COVID-19 period as ‘1 March 2020–31 December 2021’ and the pre-COVID-19 period ‘1 January 2018–29 February 2020’.

Primary and secondary outcome measures

We compared five ambulance time intervals: ‘allocation performance’, ‘mobilisation performance’, ‘response time’, ‘on scene time’ and ‘conveyance time’ between the two periods using descriptive and regression analyses. We also compared call volume for suspected stroke/TIA between the pre-COVID-19 and COVID-19 periods using interrupted time series analysis.

Participants

We included all suspected stroke/TIA cases ≥18 years who called the National Ambulance Service from 2018 to 2021.

Results

40 004 cases were included: 19 826 in the pre-COVID-19 period and 19 731 in the COVID-19 period. All ambulance time intervals increased during the pandemic period compared with pre-COVID-19 (p

Conclusions

A ’shock' like a pandemic has a negative impact on the prehospital phase of care for time-sensitive conditions like stroke/TIA. System evaluation and public awareness campaigns are required to ensure maintenance of prehospital stroke pathways amidst future healthcare crises. Thus, this research is relevant to routine and extraordinary prehospital service planning.

☐ ☆ ✇ BMJ Open

Role of physical activity in the relationship between recovery from work and insomnia among early childhood education and care professionals: a cross-sectional study

Por: Karihtala · T. · Puttonen · S. · Valtonen · A. M. · Kautiainen · H. · Hopsu · L. · Heinonen · A. — Marzo 20th 2024 at 05:26
Objectives

This study aimed to investigate the association between recovery from work and insomnia and the role of objectively measured leisure-time physical activity and occupational physical activity in this association.

Design

Cross-sectional.

Setting and participants

Study with female early childhood education and care professionals (N=224) in Finland was conducted between April 2017 and September 2018.

Methods

Recovery from work was measured with the Need for Recovery scale and insomnia with the Jenkins Sleep Scale. Physical activity was measured with an accelerometer for 7 days and analysed to represent leisure-time physical activity and occupational physical activity (min/day).

Results

Both Jenkins Sleep Scale and occupational physical activity significantly predicted Need for Recovery (β=0.29; 95% CI 0.17 to 0.42 and β=0.14; 95% CI 0.01 to 0.27, respectively). A low relationship was observed between the Need for Recovery and Jenkins Sleep Scale (r=0.32, 95% Cl 0.19 to 0.44). After categorising participants into four groups based on median splits of occupational and leisure-time physical activity, relationships between the Need for Recovery and Jenkins Sleep Scale were low to moderate in the high occupational physical activity and leisure time physical activity group (r=0.38, 95% Cl 0.14 to 0.61), and in the high occupational physical activity and low leisure-time physical activity group (r=0.40, 95% Cl 0.18 to 0.63).

Conclusion

Both insomnia and physical activity at work seem to be relevant in recovery from work. To enhance recovery, especially those involved in high physical activity at work, should seek methods to improve recovery, by incorporating activities that promote recuperation both during their workday and in their leisure time. Further research on the relevance of physical activity in recovery with longitudinal setting is warranted.

Trial registration number

NCT03854877.

☐ ☆ ✇ BMJ Open

Protocol for the process evaluation of an intervention to improve antenatal smoking cessation support (MOHMQuit) in maternity services in New South Wales, Australia

Por: Longman · J. · Paul · C. · Cashmore · A. · Twyman · L. · Barnes · L. A. J. · Adams · C. · Bonevski · B. · Milat · A. · Passey · M. E. — Marzo 20th 2024 at 03:21
Introduction

Smoking cessation in pregnancy remains a public health priority. Our team used the Behaviour Change Wheel to develop the Midwives and Obstetricians Helping Mothers to Quit smoking (MOHMQuit) intervention with health system, leader (including managers and educators) and clinician components. MOHMQuit addresses a critical evidence to practice gap in the provision of smoking cessation support in antenatal care. It involves nine maternity services in New South Wales in a cluster randomised stepped-wedge controlled trial of effectiveness. This paper describes the design and rationale for the process evaluation of MOHMQuit. The process evaluation aims to assess to what extent and how MOHMQuit is being implemented (acceptability; adoption/uptake; appropriateness; feasibility; fidelity; penetration and sustainability), and the context in which it is implemented, in order to support further refinement of MOHMQuit throughout the trial, and aid understanding and interpretation of the results of the trial.

Methods and analysis

The process evaluation is an integral part of the stepped-wedge trial. Its design is underpinned by implementation science frameworks and adopts a mixed methods approach. Quantitative evidence from participating leaders and clinicians in our study will be used to produce individual and site-level descriptive statistics. Qualitative evidence of leaders’ perceptions about the implementation will be collected using semistructured interviews and will be analysed descriptively within-site and thematically across the dataset. The process evaluation will also use publicly available data and observations from the research team implementing MOHMQuit, for example, training logs. These data will be synthesised to provide site-level as well as individual-level implementation outcomes.

Ethics and dissemination

The study received ethical approval from the Population Health Services Research Ethics Committee for NSW, Australia (Reference 2021/ETH00887). Results will be communicated via the study’s steering committee and will also be published in peer-reviewed journals and presented at conferences.

Trial registration number

Australian New Zealand Trials Registry ACTRN12622000167763. https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12622000167763.

☐ ☆ ✇ BMJ Open

Socioeconomic inequalities in skilled attendance at birth and caesarean section rates in Myanmar 2015-2016: a cross-sectional study

Por: Show · K. L. · Maung · T. M. · Disney · G. · Bohren · M. A. · Lumbiganon · P. · Ngamjarus · C. — Marzo 19th 2024 at 04:02
Objectives

This study aims to assess inequalities in skilled birth attendance and utilisation of caesarean section (CS) in Myanmar.

Study design

Cross-sectional study design.

Setting and population

We used secondary data from the Myanmar Demographic and Health Survey (2015–2016). Our outcome measures of skilled birth attendance and utilisation of CS were taken from the most recent birth of interviewed women. Absolute and relative inequalities across several sociodemographic characteristics were assessed and evaluated by calculating rate differences, rate ratio and concentration indexes.

Results

More than one-third (36%, 95% CI 32.5% to 39.4%) of women gave birth without a skilled birth attendant present at their most recent birth. 40.7% (95% CI 37.8% to 43.7%) gave birth in healthcare facilities, and the CS rate was 19.7% (95% CI 17.9% to 21.8%) for their most recent birth. The highest proportion of birth without a skilled provider was found in the hilly regions and rural residents, poorest and less educated women, and those with less than four antenatal care visits. Inequalities in birth without a skilled provider were observed across regions, place of residence, wealth quintile, education level and number of antenatal care taken. The highest rate of CS was found among plain regions and urban residents, richest women, more than secondary education, those with more than four antenatal care visits and in private health facilities. Inequalities in CS utilisation were observed across place of residence, wealth quintiles, education level, number of antenatal care taken and type of health facilities.

Conclusion

This study provides evidence regarding inequalities in maternal health service utilisation in Myanmar. Increasing maternal health service availability and accessibility, promoting quality of care and health education campaigns to increase maternal health services utilisation are recommended.

☐ ☆ ✇ BMJ Open

Roles of health system leadership under emergency in drought-affected districts in northeast Uganda: a mixed-method study

Por: Njuguna · C. · Tola · H. · Maina · B. N. · Magambo · K. N. · Namukose · S. · Kamau · S. · Tegegn · Y. W. — Marzo 19th 2024 at 04:02
Objective

Health system leadership plays a critical role in sustaining healthcare delivery during emergencies. Thus, we aimed to assess the contribution of health system leadership in sustaining healthcare delivery under emergency conditions based on adaptive leadership theoretical framework.

Design

We employed a concurrent mixed-methods study approach to assess health system leadership roles during emergency. This involved a quantitative survey administered to 150 health facilities managers/service focal persons selected via multistage sampling method from 15 districts, and qualitative interviews with 48 key informants who purposively selected.

Participants

We interviewed health facility managers, services focal persons, district health officers and residential district commissioners. We also reviewed weekly emergency situation reports and other relevant documents related to the emergency response. We used structured questionnaire, observation checklist and semistructured questionnaire to collect data. We employed descriptive statistics to analyse quantitative data and thematic analysis for qualitative data.

Main outcome

Health system leadership contributions in sustaining healthcare delivery during emergencies.

Results

Health system leadership was effective in leading emergency response and ensuring the continuity of health service during emergencies. Community engagement, partners coordination and intersectoral collaboration were effectively used in the emergency response and ensuring continuity of healthcare delivery. Deployment of experienced personnel and essential medical and non-medical supplies played a critical role in the continuity of health service. Availability of incidence management teams across health system significantly contributed to health system leadership. Participation of village health teams in community engagement and information communication helped in the success of health system leadership under emergency.

Conclusion

Adaptive health system leadership played a crucial role in managing health services delivery under emergency conditions. Effective partnership coordination and collaboration across sectors, frequent information communication, building local actor capacity and implementing scheduled supportive supervisions emerged as key strategies for sustaining health services during emergencies.

☐ ☆ ✇ BMJ Open

Multicentre, randomised, double-blind, placebo-controlled, proof of concept study of LSALT peptide as prevention of acute respiratory distress syndrome and acute kidney injury in patients infected with SARS-CoV-2 (COVID-19)

Por: Somayaji · R. · Luke · D. R. · Lau · A. · Guner · R. · Tabak · O. F. · Hepokoski · M. · Gardetto · N. · Conrad · S. A. · Kumar · S. D. · Ghosh · K. · Robbins · S. M. · Senger · D. L. · Sun · D. · Lim · R. K. S. · Liu · J. · Eser · F. · Karaali · R. · Tremblay · A. · Muruve · D. — Marzo 15th 2024 at 14:25
Objective

Dipeptidase-1 (DPEP-1) is a recently discovered leucocyte adhesion receptor for neutrophils and monocytes in the lungs and kidneys and serves as a potential therapeutic target to attenuate inflammation in moderate-to-severe COVID-19. We aimed to evaluate the safety and efficacy of the DPEP-1 inhibitor, LSALT peptide, to prevent specific organ dysfunction in patients hospitalised with COVID-19.

Design

Phase 2a randomised, placebo-controlled, double-blinded, trial.

Setting

Hospitals in Canada, Turkey and the USA.

Participants

A total of 61 subjects with moderate-to-severe COVID-19.

Interventions

Randomisation to LSALT peptide 5 mg intravenously daily or placebo for up to 14 days.

Primary and secondary outcome measures

The primary endpoint was the proportion of subjects alive and free of respiratory failure and/or the need for renal replacement therapy (RRT). Numerous secondary and exploratory endpoints were assessed including ventilation-free days, and changes in kidney function or serum biomarkers.

Results

At 28 days, 27 (90.3%) and 28 (93.3%) of subjects in the placebo and LSALT groups were free of respiratory failure and the need for RRT (p=0.86). On days 14 and 28, the number of patients still requiring more intensive respiratory support (O2 ≥6 L/minute, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation) was 6 (19.4%) and 3 (9.7%) in the placebo group versus 2 (6.7%) and 2 (6.7%) in the LSALT group, respectively (p=0.14; p=0.67). Unadjusted analysis of ventilation-free days demonstrated 22.8 days for the LSALT group compared with 20.9 in the placebo group (p=0.4). LSALT-treated subjects had a significant reduction in the fold expression from baseline to end of treatment of serum CXCL10 compared with placebo (p=0.02). Treatment-emergent adverse events were similar between groups.

Conclusion

In a Phase 2 study, LSALT peptide was demonstrated to be safe and tolerated in patients hospitalised with moderate-to-severe COVID-19.

Trial registration number

NCT04402957.

☐ ☆ ✇ BMJ Open

IMPROVE study protocol, investigating post-stroke local muscle vibrations to promote cerebral plasticity and functional recovery: a single-blind randomised controlled trial

Por: Julliand · S. · Papaxanthis · C. · Delphin · C. · Mock · A. · Raumel · M.-A. · Gueugnon · M. · Ornetti · P. · Laroche · D. — Marzo 15th 2024 at 14:25
Introduction

Spasticity is a frequent disabling consequence following a stroke. Local muscle vibrations (LMVs) have been proposed as a treatment to address this problem. However, little is known about their clinical and neurophysiological impacts when used repeatedly during the subacute phase post-stroke. This project aims to evaluate the effects of a 6-week LMV protocol on the paretic limb on spasticity development in a post-stroke subacute population.

Methods and analysis

This is an interventional, controlled, randomised, single-blind (patient) trial. 100 participants over 18 years old will be recruited, within 6 weeks following a first stroke with hemiparesis or hemiplegia. All participants will receive a conventional rehabilitation programme, plus 18 sessions of LMV (ie, continuously for 30 min) on relaxed wrist and elbow flexors: either (1) at 80 Hz for the interventional group or (2) at 40 Hz plus a foam band between the skin and the device for the control group.

Participants will be evaluated at baseline, at 3 weeks and 6 weeks, and at 6 months after the end of the intervention. Spasticity will be measured by the modified Ashworth scale and with an isokinetic dynamometer. Sensorimotor function will be assessed with the Fugl-Meyer assessment of the upper extremity. Corticospinal and spinal excitabilities will be measured each time.

Ethics and dissemination

This study was recorded in a clinical trial and obtained approval from the institutional review board (Comité de protection des personnes Ile de France IV, 2021-A03219-32). All participants will be required to provide informed consent. The results of this trial will be published in peer-reviewed journals to disseminate information to clinicians and impact their practice for an improved patient’s care.

Trial registration number

Clinical Trial: NCT05315726

Dataset

EUDRAct

☐ ☆ ✇ BMJ Open

Cost-effectiveness of the top 100 drugs by public spending in Canada, 2015-2021: a repeated cross-sectional study

Por: Gaudette · E. · Rizzardo · S. · Zhang · Y. · Pothier · K. R. · Tadrous · M. — Marzo 14th 2024 at 06:01
Objectives

To assess the distribution and spending by cost-effectiveness category among those drugs with the highest public spending levels in Canada.

Design

Repeated cross-sectional study.

Setting

The Canadian provinces of Manitoba, Ontario, New Brunswick, Nova Scotia, Prince Edward Island and Newfoundland.

Main outcomes and measures

Cost-effectiveness assessments by the Canadian Agency for Drugs and Technologies in Health (CADTH) for top-100 brand-name outpatient drugs by gross public plan spending in any year between 2015 and 2021 in Canada Institute for Health Information’s National Prescription Drug Utilization Information System data. Gross public plan spending by cost-effectiveness category.

Results

From 2015 to 2021, 152 brand-name drugs occupied a top-100 rank and were included in the analysis. Of those, 117 had been assessed by CADTH. During the 7-year period, there was an increase in both top-100 drugs with cost-effective (from 18 to 24) and cost-ineffective (from 29 to 41) assessments, while drugs not assessed or with an unclear assessment declined (from 31 to 19 and from 22 to 16, respectively). As a share of spending on top-100 drugs with an assessment, spending on cost-effective drugs was mostly stable at 40%–46% from 2015 to 2021, while spending on cost-ineffective drugs increased from 30% to 45%.

Conclusion

A large and growing share of public drug spending has been allocated to cost-ineffective drugs in Canada. Dedicating large budgets to such treatments prevents spending with greater health impact elsewhere in the healthcare system and could restrain the capacity to pay for groundbreaking pharmaceutical innovation in the future.

☐ ☆ ✇ BMJ Open

Investigating patient engagement associations between a postdischarge texting programme and patient experience, readmission and revisit rates outcomes

Por: Bruce · C. · Pinn-Kirkland · T. · Meyers · A. · Javaluyas · E. · Osborn · J. · Kelkar · S. · Bruchhaus · L. · McLaury · K. · Sauceda · K. · Carr · K. · Garcia · C. · Arabie · L. A. · Williams · T. · Vozzella · G. · Nisar · T. · Schwartz · R. L. · Sasangohar · F. — Marzo 14th 2024 at 06:01
Objectives

This study aimed (1) to examine the association between patient engagement with a bidirectional, semiautomated postdischarge texting programme and Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey outcomes, readmissions and revisit rates in a large health system and (2) to describe operational and clinical flow considerations for implementing a postdischarge texting programme.

Setting

The study involved 1 main academic hospital (beds: 2500+) and 6 community hospitals (beds: 190–400, averaging 300 beds per hospital) in Houston, Texas.

Methods

Retrospective, observational cohort study between non-engaged patients (responded with 0–2 incoming text messages) and engaged patients (responded with 3+ incoming, patient-initiated text messages) between December 2022 and May 2023. We used the two-tailed t-test for continuous variables and 2 test for categorical variables to compare the baseline characteristics between the two cohorts. For the binary outcomes, such as the revisit (1=yes, vs 0=no) and readmissions (1=yes vs 0=no), we constructed mixed effect logistic regression models with the random effects to account for repeated measurements from the hospitals. For the continuous outcome, such as the case mix index (CMI), a generalised linear quantile mixed effect model was built. All tests for significance were two tailed, using an alpha level of 0.05, and 95% CIs were provided. Significance tests were performed to evaluate the CMI and readmissions and revisit rates.

Results

From 78 883 patients who were contacted over the course of this pilot implementation, 49 222 (62.4%) responded, with 39 442 (50%) responded with 3+ incoming text messages. The engaged cohort had higher HCAHPS scores in all domains compared with the non-engaged cohort. The engaged cohort used significantly fewer 30-day acute care resources, experiencing 29% fewer overall readmissions and 20% fewer revisit rates (23% less likely to revisit) and were 27% less likely to be readmitted. The results were statistically significant for all but two hospitals.

Conclusions

This study builds on the few postdischarge texting studies, and also builds on the patient engagement literature, finding that patient engagement with postdischarge texting can be associated with fewer acute care resources. To our knowledge, this is the only study that documented an association between a text-based postdischarge programme and HCAHPS scores, perhaps owing to the bidirectionality and ease with which patients could interact with nurses. Future research should explore the texting paradigms to evaluate their associated outcomes in a variety of postdischarge applications.

☐ ☆ ✇ BMJ Open

Exploring the feasibility and acceptance of an optimised physiotherapy approach for lateral elbow tendinopathy: a qualitative investigation within the OPTimisE trial

Por: Bateman · M. · Saunders · B. · Cooper · K. · Littlewood · C. · Hill · J. C. — Marzo 14th 2024 at 06:01
Objectives

To explore the acceptability of an optimised physiotherapy (OPTimisE) intervention for people with lateral elbow tendinopathy (LET) and feasibility of comparing it to usual care in a randomised controlled trial.

Design

Semistructured interviews, analysed using thematic analysis and mapped onto the COM-B model of behaviour change.

Setting

Conducted as part of the OPTimisE Pilot & Feasibility randomised controlled trial within physiotherapy departments in the United Kingdom National Health Service.

Participants

17 patients with LET (purposively sampled to provide representativeness based on age, sex, ethnicity, deprivation index and treatment allocation) and all 8 physiotherapists involved as treating clinicians or site principal investigators.

Results

Four themes were identified. First, participants reported the OPTimisE intervention as acceptable. Second, differences between the OPTimisE intervention and usual care were identified, including the use of an orthosis, holistic advice/education including modifiable risk factors, forearm stretches, general upper body strengthening and a more prescriptive exercise-dosing regimen. Third, participants provided feedback related to the trial resources, which were viewed positively, but identified language translation as a need. Fourth, feedback related to trial processes identified the need for changes to outcome collection and reduction of administrative burden. From the perspective of adopting the OPTimisE intervention, we found evidence that participants were able to change their behaviour. Considering the findings through the lens of the COM-B model, the intervention is likely to be deliverable in practice and the trial can be delivered at scale with some additional support for physiotherapists.

Conclusions

Overall, the OPTimisE intervention was found to be different to usual care and acceptable to patients and physiotherapists. The study highlighted the need to refine trial processes and resources prior to a full-scale trial, to reduce administrative burden, increase support for physiotherapists, improve return rate of outcome questionnaires and provide language translation.

Trial registration number

ISRCTN database 19 July 2021. https://www.isrctn.com/ISRCTN64444585.

☐ ☆ ✇ BMJ Open

Comparative effectiveness of baricitinib and alternative biological DMARDs in a Swiss cohort study of patients with RA

Por: Gilbert · B. T. P. · Mongin · D. · Aymon · R. · Lauper · K. · Laedermann · C. · Perrier · C. · Mueller · R. · Courvoisier · D. S. · Finckh · A. — Marzo 13th 2024 at 05:20
Objectives

This observational study compares the effectiveness of baricitinib (BARI), a targeted synthetic disease-modifying antirheumatic drug (tsDMARD), with alternative biological DMARDs (bDMARDs) in patients with rheumatoid arthritis (RA), from a prospective, longitudinal cohort.

Methods

We compared patients initiating a treatment course (TC) of BARI, tumour necrosis factor inhibitors (TNFi) or bDMARDs with other modes of action (OMA), during a period when all these DMARDs were available in Switzerland. The primary outcome was drug maintenance; secondary outcomes included discontinuation rates related specifically to ineffectiveness and adverse events. We further analysed rates of low disease activity (LDA) and remission (REM) at 12 months and drug maintenance in bDMARD-naïve and tsDMARD-naïve population.

Results

A total of 1053 TCs were included: 273 on BARI, 473 on TNFi and 307 on OMA. BARI was prescribed to older patients with longer disease duration and more previous treatment failures than TNFi. Compared with BARI, the adjusted drug maintenance was significantly shorter for TNFi (HR for discontinuation: 1.76; 95% CI, 1.32 to 2.35) but not compared with OMA (HR 1.27; 95% CI, 0.93 to 1.72). These results were similar in the b/tsDMARD-naïve population. The higher discontinuation of TNFi was mostly due to increased discontinuation for ineffectiveness (HR 1.49; 95% CI, 1.03 to 2.15), with no significant differences in drug discontinuation for adverse events (HR 1.46; 95% CI, 0.83 to 2.57). The LDA and REM rates at 12 months did not differ significantly between the three groups.

Conclusions

BARI demonstrated a significantly higher drug maintenance compared with TNFi, mainly due to lower drug discontinuations for ineffectiveness. We found no difference in drug maintenance between BARI and OMA. Clinical outcomes did not differ between the three groups. Our results suggest that BARI is an appropriate therapeutic alternative to bDMARDs in the management of RA.

☐ ☆ ✇ BMJ Open

Tuberculosis infection and hypertension: prevalence estimates from the US National Health and Nutrition Examination Survey

Por: Salindri · A. D. · Auld · S. C. · Gujral · U. P. · Urbina · E. M. · Andrews · J. R. · Huaman · M. A. · Magee · M. J. — Marzo 13th 2024 at 05:20
Objectives

Tuberculosis infection (TBI) is marked by dynamic host–pathogen interactions with persistent low-grade inflammation and is associated with increased risk of cardiovascular diseases (CVD) including acute coronary syndrome, myocardial infarction and stroke. However, few studies assess the relationship between TBI and hypertension, an intermediate of CVD. We sought to determine the association between TBI and hypertension using data representative of the adult US population.

Methods

We performed cross-sectional analyses using data from the 2011–2012 US National Health and Nutrition Examination Survey (NHANES). Eligible participants included adults with valid QuantiFERON-TB Gold In-Tube (QFT-GIT) test results who also had blood pressure measures and no history of TB disease. TBI was defined by a positive QFT-GIT. We defined hypertension by either elevated measured blood pressure levels (ie, systolic ≥130 mm Hg or diastolic ≥80 mm Hg) or known hypertension indications (ie, self-reported previous diagnosis or use of antihypertensive medications). Analyses were performed using robust quasi-Poisson regressions and accounted for the stratified probability sampling design of NHANES.

Results

The overall prevalence of TBI was 5.7% (95% CI 4.7% to 6.7%) and hypertension was present among 48.9% (95% CI 45.2% to 52.7%) of participants. The prevalence of hypertension was higher among those with TBI (58.5%, 95% CI 52.4% to 64.5%) than those without TBI (48.3%, 95% CI 44.5% to 52.1%) (prevalence ratio (PR) 1.2, 95% CI 1.1 to 1.3). However, after adjusting for confounders, the prevalence of hypertension was similar for those with and without TBI (adjusted PR 1.0, 95% CI 1.0 to 1.1). The unadjusted prevalence of hypertension was higher among those with TBI versus no TBI, especially among individuals without CVD risk factors including those with normal body mass index (PR 1.6, 95% CI 1.2 to 2.0), euglycaemia (PR 1.3, 95% CI 1.1 to 1.5) or non-smokers (PR 1.2, 95% CI 1.1 to 1.4).

Conclusions

More than half of adults with TBI in the USA had hypertension. Importantly, we observed a relationship between TBI and hypertension among those without established CVD risk factors.

Summary

The prevalence of hypertension was high (59%) among adults with TBI in the USA. In addition, we found that the prevalence of hypertension was significantly higher among adults with positive QFT without established hypertension risk factors.

☐ ☆ ✇ BMJ Open

Assessing the acceptability of, adherence to and preference for a dual prevention pill (DPP) for HIV and pregnancy prevention compared to oral pre-exposure prophylaxis (PrEP) and oral contraception taken separately: protocols for two randomised, controlle

Por: Friedland · B. A. · Mgodi · N. M. · Palanee-Phillips · T. · Mathur · S. · Plagianos · M. G. · Bruce · I. V. · Lansiaux · M. · Murombedzi · C. · Musara · P. · Dandadzi · A. · Reddy · K. · Ndlovu · N. · Zulu · S. K. · Shale · L. R. · Zieman · B. · Haddad · L. B. — Marzo 13th 2024 at 05:20
Introduction

Oral pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention method; however, uptake and persistence have been low among southern African women. A dual prevention pill (DPP) that combines PrEP with oral contraception (OC) may increase PrEP use and better meet women’s sexual and reproductive health needs. We will gauge the DPP’s acceptability in two cross-over clinical trials.

Methods and analysis

PC952 (Zimbabwe) and PC953 (South Africa) will compare acceptability, adherence and preference for an over-encapsulated DPP versus PrEP and OCs taken separately. HIV-negative, non-pregnant cisgender females in Johannesburg, South Africa (n=96, 16–40 years) and Harare, Zimbabwe (n=30, 16–24 years) will be randomised 1:1 to the order of regimens—DPP or two separate tablets—each used for three 28-day cycles, followed by a 6-month choice period in South Africa. Monthly clinic visits include HIV and pregnancy testing; safety assessments and risk reduction and adherence counselling. We will assess adherence (monthly) based on tenofovir diphosphate drug levels in dried blood spots and by self-report. We will evaluate acceptability (monthly) and preference (end of cross-over) via computer-assisted self-interviewing and in-depth interviews with a subset of participants. Data collection started in September 2022 and ended in January 2024.

Ethics and dissemination

PC952 was approved by the Ministry of Health and Child Care, Medical Research Council, Research Council and Medicines Control Authority of Zimbabwe; the Chitungwiza City Health Ethics Committee; and the Joint Research Ethics Committee for the University of Zimbabwe Faculty of Medicine and Health Sciences and Parirenyatwa Group of Hospitals. PC953 was approved by the South African Health Products Regulatory Authority and the University of the Witwatersrand’s Human Research Ethics Committee. The Population Council IRB approved both studies. We will disseminate results in open-access journals, clinical trials registries, and at local and international meetings and conferences.

Trial registration numbers

NCT04778514, NCT04778527.

☐ ☆ ✇ BMJ Open

What do spouse primary caregivers of patients with glioblastoma want medical providers to know? A qualitative thematic reflexive analysis of letters written by primary caregivers from a secret Facebook support group

Por: Coman · D. L. · Chard · M. P. · Desautels · L. · Lutz · B. J. · Minns · L. A. — Marzo 13th 2024 at 05:20
Objectives

To analyse the content of letters written by female spouse primary caregivers of patients with glioblastoma multiforme (GBM), a devastating and terminal primary brain cancer, and give voice to their experiences for medical providers of patients with GBM.

Design

A qualitative study using reflexive thematic analysis of letters written by female spouses/life partners and primary caregivers of patients with GBM.

Participants

101 current or former female spouse primary caregivers of patients with GBM wrote letters to share with the medical community between July 2019 and August 2019. Inclusion criteria: (1) the primary caregiver who is a spouse of a patient with glioblastoma, (2) be a member of the secret Facebook group, ‘We are the wives of GBM and this is our story’, and (3) completed informed consent for the contents of their letter to be included for primary and secondary data analysis. Participants who wrote letters but did not complete the informed consent were excluded from the study.

Results

Themes from the letters included the patient experiences: (1) medical details of the disease trajectory, (2) interactions of the patient/caregiver dyads with healthcare and (3) the changing patient condition over time. Themes focused on the caregiver experiences: (1) caregiver challenges, (2) caregiver responses and (3) caregiver coping strategies, and description of tangible needs that would help other caregivers in the future. Caregiver needs were highest during the living with disease progression phase. Caregivers wanted more education and to be valued as members of the care team.

Conclusion

Shared decision-making through family-centred care would be beneficial for primary caregivers of patients with GBM. These findings provide opportunities to guide more timely and tailored interventions to provide support and improve care for patient/caregiver dyads to help mitigate the burden of this progressive disease and improve quality of life for caregivers.

☐ ☆ ✇ BMJ Open

Exploring community behaviours and stakeholder challenges in engaging communities with dengue prevention behaviour in Malaysia: implementation research for a qualitative study with a community-based participatory research design

Por: Samsudin · N. A. · Karim · N. · Othman · H. · Naserrudin · N. A. · Sahani · M. · Hod · R. · Siau · C. S. · Harif · M. N. · Abd. Samad · B. H. · Zaini · Z.-I. I. — Marzo 13th 2024 at 05:20
Objectives

To use a community-based participatory research (CBPR) design to explore local community behaviours and stakeholders’ challenges in engaging communities in dengue prevention behaviours in Hulu Langat, Selangor, Malaysia.

Design

This CBPR design in implementation comprised in-depth interviews (IDIs) and focus group discussions (FGDs). Themes were identified from the data with inductive and deductive thematic analysis.

Setting

FGDs were conducted in local community areas and IDIs were conducted in the local authority (LA) office and the Hulu Langat district health office.

Participants

All FGD and IDI participants consented to the study, and included health authorities (n=4), LAs (n=7), community leader (n=1), faith leader (n=1), patients diagnosed with dengue (IDIs, n=2) and permanent residents of Hulu Langat who had been exposed to dengue infectious disease (FGDs, n=27).

Results

The main themes were categorised into community behaviour and stakeholder challenges. The community behaviour-related themes were awareness of dengue disease and Aedes mosquitoes, perception of risk and severity, and involvement of authorities. The themes related to stakeholder challenges were resource constraints and capacity issues, jurisdictional constraints and coordination, and educational dissemination and vandalism.

Conclusions

The actions of the authorities shape community and stakeholder behaviours. Effective communication, including clear and aesthetically pleasing messages, motivates individuals to take appropriate actions. It is crucial for the authorities to engage in inclusive communication and consider diverse perspectives, such as those of residents and individuals exposed to dengue infection. Authorities that provide accurate and unbiased information foster transparency and enable informed decision-making by all stakeholders.

☐ ☆ ✇ BMJ Open

Association between expedited review designations and the US or global burden of disease for drugs approved by the US Food and Drug Administration, 2010-2019: a cross-sectional analysis

Por: Jackson · M. J. · Vaughan · G. · Ledley · F. D. — Marzo 12th 2024 at 13:46
Objectives

Pharmaceutical innovation can contribute to reducing the burden of disease in human populations. This research asks whether products approved by the US Food and Drug Administration (FDA) from 2010 to 2019 and expedited review programmes incentivising development of products for serious disease were aligned with the US or global burden of disease.

Design

Cross-sectional study.

Outcome measures

Association of FDA product approvals (2010–2019), first approved indications, designations for expedited review with the burden of disease (disability-adjusted life years (DALYs)), years of life lost (YLL) and years of life lived with disability (YLD) for 122 WHO Global Health Estimates (GHE) conditions in US and global (ex-US) populations.

Results

The FDA approved 387 drugs in 2010–2019 with lead indications associated with 59/122 GHE conditions. Conditions with at least one new drug had greater US DALYs (p=0.001), US YLL (p1) with US and global YLL.

Conclusions

FDA drug approvals from 2010 to 2019 were more strongly aligned with US than global disease burden. Designations for expedited review were not aligned with either the US or global burdens of disease and may inadvertently disincentivise development of products addressing global disease burdens. These results may inform policies to better align pharmaceutical innovation with the burdens of disease.

☐ ☆ ✇ BMJ Open

Changes in medical student attendance and its impact on student educational outcomes: a systematic review protocol

Por: Nagappan · P. G. · Brown · S. · McManus · A. · Sayers · S. · Absar · S. · Tan · S. R. X. · Kuhn · I. · Lau · E. · Tulinius · C. — Marzo 12th 2024 at 06:06
Introduction

The COVID-19 pandemic has had a significant impact on medical education, with many institutions shifting to online learning to ensure the safety of students and staff. However, there has been a decline in in-person attendance at medical schools across the UK and worldwide following the relaxation of social distancing rules and the reinstation of in-person teaching. Importantly, this trend has been observed prior to the pandemic. While reflected within the literature, there is currently no systematic review describing these changes. We aim to find out how medical students’ attendance is changing as documented within the literature and its impact on their educational outcomes.

Methods and analysis

This systematic review will follow the guidelines of the Centre of Research and Dissemination, Meta-analyses of Observational Studies in Epidemiology and Preferred Reporting Items for Systematic Reviews and Meta-Analyses. We will search the major databases of Medline via Ovid, Embase via Ovid, Scopus, Web of Science, British Education Index via EBSCOhost and ERIC via EBSCOhost.

Two reviewers will independently screen each paper and extract data, with a third reviewer for dispute resolution. All studies reporting on medical students from various universities, both graduate and undergraduate and describing changes in attendance and/or students‘ educational outcomes will be included. Risk of bias in individual studies will be assessed using the Newcastle-Ottawa Scale and confidence in cumulative evidence will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative Research approach. A narrative synthesis of the findings from all included studies will be reported.

Ethics and dissemination

Ethical approval is not required for this systematic review of existing publicly available literature. We will subsequently aim to publish the results of this systematic review in a peer-reviewed journal.

❌