Self-reported disability trajectories and their predictors among patients receiving care by physical therapists for musculoskeletal conditions: a retrospective analysis of registry data

Objectives
To identify clustered trajectories of self-reported disability following the initiation of care by a physical therapist in outpatient orthopaedic settings and to determine baseline factors that distinguish between different trajectories.

Design
Retrospective cohort study using electronic health record and patient-reported outcome data.

Setting
Data were extracted from the ATI Patient Outcomes Registry, encompassing patient encounters from over 900 ATI outpatient physical therapy clinics in 26 states across the USA.

Participants
Patients receiving physical therapy after surgery were excluded. The final analytical sample included 597 245 unique patients initiating care between 1 January 2016 and 31 December 2021 for management of a spine, upper extremity or lower extremity musculoskeletal condition.

Interventions
Patients received treatments which could include strengthening and range of motion exercises, manual therapy, education, functional training and pain-relieving modalities.

Primary and secondary outcome measures
The primary outcome was trajectory of self-reported, joint-specific disability measure scores up to 6 months following initial evaluation.

Results
Three distinct disability trajectory clusters were identified (proportion of sample; beta coefficient (95% CI)): significant immediate worsening (3.4%; –1.31 (–1.33, –1.28)), significant gradual improvement (61.4%; (0.36 (0.35, 0.36)) and minimal change (35.2%; –0.20 (–0.21, –0.19)). Results were similar when stratified by primary diagnosis of upper extremity, lower extremity or spine conditions, with small differences in the relative proportion of trajectory class membership by body region. Predictive factors for less favourable disability trajectories included older age, lower physical and mental health scores, body region, higher social deprivation index, insurance type and certain comorbidities.

Conclusions
Most patients showed improvement in disability after exposure to treatment by a physical therapist, but a notable proportion experienced minimal change or worsening. Multiple demographic, physical, mental and social health factors differentiated trajectory class membership, highlighting opportunities to improve how and to whom this type of guideline-supported non-pharmacological care is delivered.

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Economic evaluation of a lifestyle intervention for individuals with overweight or obesity suffering from chronic low back pain (the BO2WL trial): a protocol for a health economic analysis

Introduction
Low back pain (LBP) is highly prevalent across the Western world, including Switzerland (CH) and Belgium (BE), with women experiencing higher disability rates than men. Chronic LBP (CLBP), persisting beyond 3 months, leads to diminished health-related quality of life and increased healthcare and societal costs. Evidence indicates a direct relationship between body mass index (BMI) and CLBP severity, with high BMI significantly driving LBP-related healthcare expenses. Current evidence supports combining pain neuroscience education (PNE) with cognition-targeted exercise therapy (CTET) to effectively manage CLBP.
An economic evaluation alongside a randomised controlled trial, entitled ‘Lifestyle Intervention in Overweight/Obese CLBP Patients: an International Multi-centre RCT’ (BO2WL), will be conducted in CH and BE. It aims to evaluate the addition of a lifestyle intervention to PNE and CTET compared with PNE and CTET alone for treating individuals with CLBP and overweight or obesity. This protocol outlines the details of the economic evaluation of this trial.

Methods and analysis
The trial consists of a 14-week intervention followed by a 52-week post-intervention follow-up. Primary outcomes include direct and indirect costs, as well as quality-adjusted life years and pain intensity. Cost data will be converted into 2026 Belgium (BE) and 2026 Swiss Francs (CHF) for CH, with a discount rate of 3.5%. Incremental cost-utility and cost-effectiveness ratios will be calculated from a societal perspective for each country.

Ethics and dissemination
Ethics approval was obtained by the local ethics committees (Bern, CH: project ID 2022–02210; Brussels and Geel, BE: BUN 1432022000296). Results of the main trial and economic evaluation will be submitted for publication in a peer-reviewed journal.

Trial registration number
NCT05811624.

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Relationship between resilience and social trust in nursing homes in Guangzhou, China: a cross-sectional study

Objectives
To identify latent resilience profiles among older adults residing in nursing homes and to examine the mediating role of perceived social support in the relationship between resilience and social trust.

Design
A cross-sectional survey conducted between January and May 2023.

Setting
Three nursing homes in urban Guangzhou, China.

Participants
A total of 233 older adults aged 60 years or above living in nursing homes.

Primary and secondary outcome measures
Identification of latent profiles of resilience and the mediating effect of perceived social support on the relationship between resilience and social trust.

Results
Of the 254 participants, 233 (91.7%) completed the survey. The sample comprised 60% females, with 55% aged 80 or older. Three distinct latent profiles of resilience were identified: low resilience (55.8%), moderate resilience (12.0%) and high resilience (32.2%). Moreover, perceived social support significantly mediated the relationship between resilience and social trust (B=0.72, SE=0.23, 95% CI (0.3, 1.21)).

Conclusion
Perceived social support mediates the link between resilience and social trust in institutionalised older adults. Tailored care strategies based on individual resilience profiles may enhance social support and foster trust, contributing to active ageing in nursing home residents.

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Effect of perioperative haemodynamic management based on cerebral autoregulation monitored by Cerebral Oximetry Index during carotid endarterectomy: protocol of a randomised trial

Introduction
Impaired cerebral autoregulation is associated with postoperative ischaemic brain injury and often occurs in patients with carotid artery stenosis. Adequate cerebral perfusion should therefore be maintained during carotid endarterectomies. Whether guiding intraoperative blood pressure to the Cerebral Oximetry Index (a measure of cerebral perfusion adequacy) reduces postoperative cerebral ischaemia remains unclear.

Methods and analysis
We plan a dual-centre randomised blinded trial. A total of 560 patients having elective carotid endarterectomy will be randomly assigned to guided versus routine haemodynamic management. In patients randomised to guided management, mean arterial pressure will be titrated to maintain a normal cerebral oximetry index. In the routine care group, mean arterial pressure will be targeted to within 20% of individual preoperative baseline values. The primary outcome will be the incidence of new ischaemic brain injury within 3 days after surgery assessed by brain imaging, with or without clinical symptoms. Secondary outcomes include the incidence of postoperative delirium, cognitive function and pain severity.

Ethics approval and dissemination
The study protocol (V.1.2, 1 January 2025) has been approved by the Medical Ethics Committee of Beijing Tiantan Hospital, Capital Medicine University (KY2024-049-03) and Xuanwu Hospital, Capital Medical University (LYS2025-023-001). The findings of the study will be disseminated in a peer-reviewed journal and at a scientific conference.

Trial registration number
NCT06406842.

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Supplementary effects of low-frequency transcutaneous electrical nerve stimulation on individuals with obesity combined with metabolic syndromes: study protocol for a randomised controlled trial

Introduction
Obesity combined with metabolic syndrome is a major global public health problem. This trial aims to investigate the therapeutic effects of low-frequency transcutaneous electrical nerve stimulation (Lo-TENS) in individuals with obesity and coexisting metabolic syndrome. The study will also delve into the underlying mechanisms through which Lo-TENS may mitigate the symptoms of metabolic syndrome, providing insights into its potential as a novel treatment approach.

Methods and analysis
This randomised controlled trial will enrol 63 individuals with obesity and metabolic syndrome, and randomly assign them to one of the three groups: (1) peripheral stimulation group, (2) central stimulation group and (3) sham stimulation group. Each participant will receive a 30 min daily session of their assigned stimulation, conducted 5 days a week for a duration of 12 weeks. The primary outcomes of interest are body mass index and fasting blood glucose, with secondary outcomes encompassing blood pressure, triglyceride levels and various metabolic biomarkers. Comprehensive assessments will be performed at baseline, immediately post intervention, and followed by a 12-week follow-up evaluation to monitor long-term effects and sustainability of potential benefits.

Ethics and dissemination
The trial has been granted ethical approval by the ethics committee of the Second People’s Hospital of Kunming (approval number: 202305001). The study’s findings will be disseminated through peer-reviewed journal publications and international conference presentations.

Trial registration number
Chinese Clinical Trial Registry Platform: www.chictr.org.cn (No. ChiCTR2400089104).

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Uptake of the IMMPACT-recommended core outcome set in randomised controlled trials on chronic neck or shoulder pain: a cross-sectional study

Objective
To analyse the uptake rate of Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT)-recommended core outcome set (COS) in randomised controlled trials (RCTs) on chronic neck or shoulder pain and its potential influencing factors.

Design
A cross-sectional study.

Setting
WHO International Clinical Trials Registry Platform, involving 15 registries.

Participants
RCT registrations on chronic neck or shoulder pain.

Primary outcome measures
The uptake rate of IMMPACT-recommended COS in RCTs focusing on chronic neck or shoulder pain.

Results
A total of 1057 RCT registrations were included between 2 February 2004 and 8 February 2023. The most used domains were pain (n=1003, 94.9%) and physical functioning (n=971, 91.9%), while the remaining four core domains and supplementary domains received less attention (

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Identification of core outcomes for quality in routine care provided to people living with dementia in Australia: a multilevel modified Delphi consensus study

Objective
To co-design a core outcome set with people living with dementia and other stakeholders that can be used to measure the quality of dementia care in home care and residential settings.

Design
Multilevel modified Delphi consensus study. A priori consensus threshold of 70% was used to include or exclude outcomes.

Setting
Routine dementia care provided through home care and residential aged care facilities in Australia.

Participants
A stakeholder panel comprising people living with dementia, formal and family/informal carers of people living with dementia, advocates, policy experts, allied-health professionals, nurses and professionals working in the aged care industry. Round 1 included 10 panellists; subsequent rounds extended the number of participants to 24.

Results
Seven outcome domains (Death, Physiological and clinical, Functional, Life impact, Resources, Adverse events and Education), encompassing 105 individual outcomes were considered by the panel over four rounds.
The 105 outcomes were distilled to 16 outcomes identified as important in home care and 15 in residential aged care. In both settings, nine outcomes (Dignity, Advanced care planning, Meaningful activities, Feeling safe and secure, Emotional wellbeing, Quality of Life, Resource utilisation, Safety incidents and Dementia-specific qualifications for care staff) were considered important.
Additionally, seven outcomes in the home care setting (Behavioural symptoms of dementia, Diagnosis of dementia, Hygiene, Importance of Relationships, Quality of carer and family lives, Dementia care navigation and Opportunities for unpaid carers) and six outcomes in the residential aged care setting (Neuropsychiatric symptoms of dementia, Pain, Hygiene and comfort, Medication safety, Staff carer morale and Adverse effects) were classified as important.

Conclusions
The outcomes identified during this modified Delphi consensus study provide a promising basis for the development of a meaningful, practical and measurable core outcome set that could be used in dementia care settings to improve the quality of routine care provided to people living with dementia.

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Changes in cardiovascular disease risk, lung function and other clinical health outcomes when people who smoke use e-cigarettes to reduce cigarette smoking: an exploratory analysis from a randomised placebo-controlled trial

Objectives
To examine changes in cardiovascular disease (CVD) risk factors, lung function and clinical laboratory markers among people who smoke who used e-cigarettes to reduce their cigarette smoking.

Design
Four-arm, parallel-group, double-blind, randomised placebo-controlled trial.

Setting
Two sites—Virginia Commonwealth University (Richmond, Virginia, USA) and Penn State University, College of Medicine (Hershey, Pennsylvania, USA).

Participants
Adults (n=520) aged 21–65 years who smoked at least 10 cigarettes per day, had an expired-air carbon monoxide reading of >9 parts per million at baseline and were interested in reducing their cigarette consumption.

Interventions
E-cigarettes with 0, 8 or 36 mg/mL nicotine liquid concentration or a cigarette substitute.

Primary outcome measures
CVD risk factors (blood lipids, C-reactive protein, blood pressure, heart rate, waist-to-hip ratio, body mass index and INTERHEART risk score), lung function (spirometry indices, and pulmonary symptoms and functional state using the Clinical Chronic Obstructive Pulmonary Disorder Questionnaire), and other clinical laboratory markers (complete blood count and complete metabolic panel).

Results
At 6 months, the use of nicotine e-cigarettes caused no significant between-group differences for most measures. However, participants randomised to the 36 mg/mL e-cigarette condition had significantly higher levels of high-density lipoprotein (HDL) (p=0.003 unadjusted, p=0.002 adjusted) and lower levels of low-density lipoprotein (LDL) (p=0.044 adjusted) and cholesterol/HDL ratio (p=0.034 unadjusted, p=0.026 adjusted) compared with the cigarette substitute condition. Also, those in the 36 mg/mL e-cigarette condition had higher HDL levels than those in the 0 mg/mL condition (p=0.016 unadjusted, p=0.019 adjusted).

Conclusions
Participants randomised to the highest nicotine e-cigarette condition showed modest improvements in some measures of blood lipids (eg, increased HDL, and reduced LDL and cholesterol/HDL ratio) as compared with a non-aerosol cigarette substitute among individuals attempting to reduce their cigarette smoking. Future studies of e-cigarettes for smoking cessation would benefit from including these measures to further explore the results found in this study.

Trial registration number
NCT02342795.

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Trends in high remnant cholesterol level and its risk factors among US adults using NHANES data from 1999 to 2020: a serial cross-sectional study

Objectives
To describe the trends in high remnant cholesterol (HRC) prevalence and identify its risk factors.

Design
A serial cross-sectional study.

Setting
Data from the National Health and Nutrition Examination Survey (NHANES) 1999–2020 were analysed.

Participants
A total of 24 658 adults aged ≥18 years with fasting total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C) and triglycerides (TG) measured were included.

Outcome measure
Serum TC was measured using an enzymatic method. HDL-C and TG were quantified using photometry. Low-density lipoprotein cholesterol (LDL-C) was estimated by using the Sampson formula. Remnant cholesterol (RC) was defined as TC–HDL-C–LDL-C. HRC was defined as RC≥0.78 mmol/L.

Results
The multivariable-adjusted survey-weighted HRC prevalence decreased from 26.6% (1999–2002) to 13.7% (2015–2020) with a 5.4% reduction per year (plinear-trend

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Association between Charlson Comorbidity Index and in-hospital outcomes among aortic stenosis patients undergoing aortic valve replacement: an observational study at the National Clinical Research Center for Cardiovascular Diseases

Objectives
This study aimed to evaluate the impact of the Charlson Comorbidity Index (CCI) on in-hospital outcomes in patients with aortic stenosis (AS) undergoing aortic valve replacement (AVR) and to compare the efficacy of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in patients with different comorbidity burdens.

Setting
The National Clinical Research Center for Cardiovascular Diseases.

Participants
A retrospective analysis was conducted on 3380 AS patients who underwent AVR in Beijing Anzhen Hospital from January 2015 to October 2021.

Interventions
Patients were stratified into low (0–1) and high (≥2) CCI groups.

Primary and secondary outcome measures
The primary outcome was Valve Academic Research Consortium-2 (VARC-2) composite early safety endpoints.

Results
Patients with high CCI scores exhibited significantly higher rates of VARC-2 composite adverse outcomes compared with those with low scores (50.3% vs 44.2%, p=0.001). After adjusting for confounding factors, high CCI scores were independently associated with the VARC-2 composite adverse outcomes (OR=1.36, 95% CI 1.17 to 1.58, p

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Carbon footprint of a sample of clinical trials for people with neurological disorders: cross-sectional analysis

Objective
To quantify the carbon footprint of a sample of clinical trials for neurological disorders.

Design
Cross-sectional study.

Method
Two clinical trial registries were searched on 29 December 2022 for phase 2–4 randomised controlled trials led from and recruiting in the UK, enrolling people with any of the 15 neurological disorders with the highest global burden, that had started recruitment or been registered in the preceding 5 years. Eligible trials were invited to share data to estimate emissions in each of the 10 modules of the Low Carbon Clinical Trials footprinting guidance. The primary outcome measure was kg of carbon dioxide equivalent (CO2e).

Results
318 randomised controlled trials were found, nine were eligible and six shared data (three completed and three ongoing). The module with the highest estimated CO2e for each trial was the Clinical Trial Unit staff emissions (median 24 126 kg CO2e, IQR 10 395–78,867; range 45–79% of overall emissions of each trial); commuting accounted for >50% of CO2e in this module. The second and third highest modules were trial-specific participant assessments (median 11 497 kg CO2e, IQR 825–15,682) and trial supplies and equipment (median 1161 kg CO2e, IQR 226–6632). The total carbon footprint of these six trials involving 2248 participants at 239 sites was 2 63 215 kg CO2e.

Conclusions
Emissions by Clinical Trials Unit staff were the top modifiable carbon hotspot in six randomised controlled trials for people with neurological disorders, which had a total carbon footprint equivalent to 1364 passengers’ return aeroplane journeys between London and Edinburgh.

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Incidence of, and factors associated with, oral mucous membrane medical device-related pressure injury in critically ill patients with orotracheal intubation: a prospective cohort study

Objectives
This study aimed to investigate the incidence of oral mucous membrane medical device-related pressure injury (MDR-MM PI) and identify its risk factors in critically ill patients undergoing orotracheal intubation, guided by the conceptual framework of pressure injury development. The findings aim to inform effective preventive strategies in intensive care settings.

Design
Prospective cohort study.

Setting
General intensive care unit (ICU) of a tertiary care hospital in China.

Participants
Patients aged ≥18 years who underwent oral endotracheal intubation were included between July 2023 and July 2024. Exclusion criteria were (1) existing oral mucosal injuries before intubation, (2) radiotherapy-induced oral mucositis, (3) patients undergoing oral surgery and (4) intubation duration of less than 24 hours. A total of 420 patients met the criteria and were included in the final analysis.

Outcomes
The outcomes included the incidence of oral MDR-MM PI, the time to oral MDR-MM PI occurrence and the identification of risk factors using multivariate Cox regression analysis.

Results
Among the 420 patients, 43.10% (n=181) developed oral MDR-MM PI, with Stage I accounting for 38.67% and Stage II for 61.33%. The lower lip (38.67%) and upper lip (38.12%) were the most common injury sites. The median time to oral MDR-MM PI occurrence was 8 days (95% CI: 7.134 to 8.866). Significant risk factors identified through multivariate Cox regression included sepsis (HR=2.090, 95% CI: 1.273 to 3.431), lower platelet (PLT) counts (HR=0.997, 95% CI: 0.995 to 0.999) and use of hard bite blocks (HR=1.553, 95% CI: 1.082 to 2.230). Probiotics showed a protective effect (HR=0.632, 95% CI: 0.468 to 0.854, p

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Treatment Tolerability

when transfusions are gifted with sleepless hours voices grow dazed with tragic powers as if we’ve transcended the phase of gathering flowers & magically ascended countless towers with no stars outside of the night to climb into bed with us & no mornings giving water from a faucet of rust & what begins as a dog becomes a different dog with so little control over its bark-like instinct we examine our bruises blindfolded in a fog of pain covering everything with a god-like fabric because no mercy is bright enough to pass this fatigue onto another— treatment tolerability is a sister that failed our mother & grand sentimentality is its little brother

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