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Efficacy of YOga in people with chronic non-specific low BACK pain and poor PROgnosis (YOBACK-PRO): protocol for a randomised clinical trial

Por: Nunes · S. M. · Rizzo · R. R. · Franco · M. R. · Ferreira · F. R. · Barros · L. J. G. · Maciel · I. T. · Santos · R. L. · Nascimento · R. R. · Couto · A. J. · Quaresma · L. S. · Fontes · R. M. · Ferreira · E. M. R. · Maher · C. G. · McAuley · J. H. · Pinto · R. Z.
Introduction

Yoga has been shown to improve pain and function compared with no exercise in people with chronic low back pain (LBP), but treatment effects are small. Given that yoga is a mind–body intervention that addresses physical as well as psychological factors, it may be more effective for patients with chronic LBP who are at high risk of poor prognosis. The study aims to investigate the efficacy of a 12-week yoga programme combined with education in reducing pain and disability for individuals with chronic LBP at high risk of poor prognosis at short (12 weeks) and intermediate (24 weeks) terms, compared with a control group receiving education only.

Methods and analysis

A randomised controlled trial will include 110 adults with chronic non-specific LBP reporting an average pain intensity of 3 points or more on a 0–10 scale over the past week and classified as high risk of poor prognosis (ie, scoring 50 points or above) on the Orebro Musculoskeletal Pain Questionnaire short-form. Participants in the control group will receive an educational booklet and attend three face-to-face lectures over a 3-month period. In the intervention group, in addition to the booklet and lectures, participants will attend group yoga sessions twice a week for 12 weeks, totalling 24 yoga sessions. The primary outcome is disability assessed at 12 weeks, measured using the Roland-Morris Disability Questionnaire.

Ethics and dissemination

The study was approved by the Human Research Ethics Committee of Universidade Federal de Minas Gerais (Protocol number CAAE: 57028022.0.0000.5149). Findings will be disseminated to trial participants, clinicians and the broader public and scientific community.

Trial registration number

NCT05953155.

Decisional needs among patients and physicians in the treatment of chronic myeloid leukaemia: a qualitative analysis in the Netherlands

Por: Mingels · S. · Cloots · M. J. J. · Smit · Y. · Blijlevens · N. M. A. · Posthuma · E. F. M. · Dekker · A. L. A. J. · Fijten · R. R. R. · Wener · E. · Kromkamp · C. C. G.
Objective

Treatment advancements in chronic myeloid leukaemia (CML) have made the disease manageable but carry significant risk of side effects. Bridging information gaps between patients and physicians through shared decision-making (SDM) is increasingly favoured, yet understanding treatment complexities remains a challenge. This study sought to identify decisional and informational needs of both patients and physicians in CML care.

Design

A qualitative study using semi-structured interviews was conducted to investigate the opinions, attitudes and preferences of both patients with chronic myeloid leukaemia and physicians.

Setting

Patients and physicians were recruited through the Dutch CMyLife platform, an initiative of haematologists, patients and patient organisations. They were provided with the participant information and invited to participate if interested.

Participants

A total of 15 interviews (n=10 patients, n=5 physicians) were conducted between April and October 2023.

Primary and secondary outcome measures

A pre-defined interview guide was developed based on the Decisional Needs Assessment questionnaire. Interview transcripts were thematically analysed.

Results

Eight themes and 28 sub-themes were observed, highlighting patient needs, treatment choices and informational preferences. Patients emphasised the importance of understanding medication options and side effects, while physicians stressed the necessity of delivering up-to-date and comprehensible information. Almost all participants had experienced professionals making the treatment decision, without patient involvement, especially when initiating treatment. Some patients expressed too little information and missed partnership with professionals at treatment onset. Peer support, decision-making dynamics and the role of caregivers were also significant considerations.

Conclusions

Both shared and distinct perspectives on CML treatment decision-making between patients and physicians were revealed, underscoring the complexity of decisional needs in CML management. The findings emphasise the importance of patient-centred care, SDM and tailored communication strategies to optimise patient outcomes and satisfaction. Improved communication and evidence-based decision-making tools can significantly impact patient well-being. Further research and interventions are necessary to address the challenges in decision-making processes in CML care.

Postgraduate digital health training programmes for primary care physicians: a scoping review protocol

Por: Leon-Herrera · S. · Anjos De Almeida · V. · Yokus · S. E. · Li · E. · Batista · S. R. R. · Teixeira · J. · Neves · A. L. · Gomez Bravo · R.
Introduction

The digital transformation of healthcare has created an urgent need for primary care physicians (PCPs) to acquire competencies in digital health. However, the structure and scope of postgraduate training programmes remain poorly defined and unevenly implemented worldwide, and no scoping review has yet synthesised the evidence. This review aims to map existing postgraduate digital health training programmes for PCPs, including their content, structure and delivery approaches.

Methods and analysis

This scoping review will follow the Joanna Briggs Institute methodology and adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. A systematic search will be conducted across five databases (PubMed, Scopus, Cochrane Library, ScienceDirect and Web of Science) and relevant grey literature, covering publications from January 2019 to June 2025. Studies describing postgraduate digital health training programmes for PCPs will be eligible for inclusion. Data will be extracted and synthesised descriptively and thematically using an inductive approach.

Ethics and dissemination

As this study is based on a review of publicly available literature, ethical approval is not required. The findings will be disseminated through a peer-reviewed publication and conference presentations and will inform future curriculum development and policy in digital health education for PCPs. The results may also inform national curriculum reforms and accreditation standards, supporting more consistent and competency-based digital health education globally.

PROSPERO registration details

This scoping review protocol has been registered with the Open Science Framework.

Public health assistance for people with haemophilia in Brazil (PATCH study): a cross-sectional study protocol

Por: Roberti · M. d. R. F. · Gea · Y. R. e. A. · Marinho · I. A. · Inacio · P. P. · Camelo · R. M. · de Castro · T. F. · Batista · S. R. R.
Introduction

Haemophilia is a rare inherited bleeding disorder with complex support and costly treatment. Comprehensive care for people with haemophilia (PwH) must take place in structured and continuously evaluated treatment centres. The aim of the Public Assistance for People with Haemophilia in Brazil Project (PATCH Project) is to assess the infrastructure, human resources and healthcare delivery processes of Brazilian Blood Centres (BC) involved in the provision of haemophilia care.

Methods and analysis

This is a nationwide cross-sectional study involving 98 BC across Brazil’s 26 states and the Federal District, focusing on the care provided to PwH. A self-administered structured questionnaire was prepared, based on national and international recommendations for management, treatment and outcomes assessment in PwH. The criteria of the World Federation of Haemophilia and the European Association for Haemophilia and Allied Disorders will be used to define standards of quality.

Ethics and dissemination

Ethical approval for this study was granted by the Human Research Ethics Committee of the Federal University of Goiás, the coordinating centre (protocol CAAE 53863221.8.0000.5078), and subsequently by all participating institutions. Written informed consent is obtained from all participants prior to enrolment. Study findings will be disseminated through publication in peer-reviewed journals and presentation at international scientific conferences. Research data will be managed in accordance with ethical and legal standards and will be made available on reasonable request to support future investigations.

Protocol registration

Not applicable

Prevention of postamputation pain with targeted muscle reinnervation (PreventPAP trial): protocol for a national, multicentre, randomised, sham-controlled trial

Por: Tendijck · G. A. H. · van Schaik · J. · Dijkman · R. R. · Niesters · M. · van Zwet · E. W. · van den Hout · W. B. · Ploeg · A. J. · van Rijt · W. G. · de Ruiter · G. C. W. · Coert · J. H. · Duraku · L. S. · Zuidam · J. M. · van de Water · W. · Pondaag · W. · van der Krogt · H. · Groe
Introduction

In the Netherlands, approximately 2200 major amputations of the lower extremities are performed each year, the majority in vascular patients. Around 61% of these patients will develop postamputation pain (PAP). PAP is a severe, lifelong, disabling condition profoundly affecting quality of life. During amputations, the common practice is to cut the nerves without employing nerve-surgical techniques to prevent chronic pain due to neuroma formation. In recent years, targeted muscle reinnervation (TMR) has been the most frequently studied technique for treating PAP, inhibiting neuroma formation by rerouting the cut mixed nerve to a functional motor nerve. We hypothesise that a primary TMR procedure during major lower limb amputations will result in a lower prevalence of PAP.

Methods and analysis

We propose a national, multicentre, randomised, sham-controlled trial comparing TMR with traction neurectomy in major amputations of the lower extremities in patients with vascular disease. 203 patients will be recruited with an indication for a transfemoral to transtibial amputation as a primary or secondary sequela of vascular disease. The subjects are randomly assigned to the TMR group or the traction neurectomy group. PAP will be evaluated 1 year postoperatively as the primary endpoint. Secondary outcomes include quality of life, mobility, neuropathic pain, hospital anxiety and depression, cost-effectiveness and complications.

Ethics and dissemination

This study has been reviewed and approved by the local ethical review body, ‘The Medical Ethics Committee Leiden The Hague Delft’, under the reference: P24.073 on 28 November 2024. Results will be published in peer-reviewed journals.

Trial registration number

NCT06719245. Dutch trial registry: NL87196.058.24

Clinician experiences in a DBT-informed consultation group embedded within a US academic primary care clinic: a qualitative study

Por: Gier · N. M. · Maurer · R. R. · Tang · J. W.
Objective

Traditional wellness programming focuses on bringing together individual clinicians during personal time for resources and skill building, without a focus on skill building in the contexts and teams they are embedded in daily. We developed a dialectical behaviour therapy (DBT)-informed consultation group, ‘Complex Care Rounds’ (CCR), implemented within the usual workflow of a primary care clinic. The goal of CCR was to facilitate interprofessional team communication and enhance clinician motivation and efficacy, while simultaneously addressing medical and social needs of patients. During the twice-weekly group, team members provided validation and shared feedback while acknowledging the needs of the clinician and patient. The aim of this study was to explore clinician perspectives on participation in CCR and to create a conceptual model to understand CCR’s influence on individual team members as well as team dynamics.

Setting

The research was completed at the Comprehensive Care Programme, a primary care programme for patients with Medicare insurance at high risk of hospitalisation at an academic institution in Chicago, Illinois, USA.

Study design

This was a qualitative research study examining reflective essays written by participants on how participating in CCR has impacted them. Template analysis, a form of thematic analysis, was applied to code and organise themes.

Study participants

Participants included 12 clinical team members (physicians, nurses, social service team members) and 7 trainees (AmeriCorps members, medical students) from the Comprehensive Care Programme.

Results

We found that CCR’s shared team frameworks (theme 1) grounded in DBT promoted a practice of self-compassion (theme 2) as well as a validating team environment (theme 3) within our interprofessional team. Improvements to patient care (theme 4) extended from increased personal capacity, support from team members and a structured approach to team interactions.

Conclusions

DBT-informed consultation groups embedded within a clinical practice have the potential to promote a practice and culture of interprofessional team members tending to self and others, while also building one’s own skills and capacity to care for complex patients.

Trial registration number

Clinical trial: NCT04489693; Pre-results"

Prehabilitation of frail elderly PAtients undergoing majoR surgEry at HOME (PREPARE-HOME): a superiority parallel-group randomised controlled trial protocol evaluating smart wearable enhanced prehabilitation versus usual care

Por: Leong · Y. H. · Tay · V. Y. J. · Yang · X. · Tan · C. J. · Au-Yong · P.-S. · Sim · J. L. X. · Ng · R. R. G. · Ong · M. E. H. · Tan · B. P. Y. · Abdullah · H. R. · Ke · Y.
Introduction

Frailty is a key predictor of adverse surgical outcomes in older adults, contributing to increased postoperative complications, prolonged hospitalisation and delayed recovery. Prehabilitation—targeting improvements in physical function before surgery—can mitigate these risks. However, traditional programmes often face low adherence due to logistical barriers. Integrating smart wearable devices into tele-supervised, home-based prehabilitation may enhance adherence, engagement and clinical outcomes.

This trial protocol describes the PREhabilitation of frail elderly PAtients undergoing majoR surgEry at HOME study with the objective to evaluate the effectiveness of a wearable-enhanced, tele-supervised prehabilitation programme (swSEP) versus standard care (unsupervised prehabilitation, uSEP) on improving preoperative functional capacity and postoperative outcomes in frail older adults undergoing major elective surgery.

Methods and analysis

This single-centre, prospective, randomised controlled trial will enrol 190 patients aged ≥65 years scheduled for major elective, non-cardiac surgery at Singapore General Hospital. Participants with frailty (Edmonton Frail Scale ≥6) will be randomised 1:1 to either the swSEP group (tele-supervised exercise with Fitbit Inspire 3 monitoring) or the uSEP group (standard physiotherapy education, exercise booklet and inspiratory muscle training if maximal inspiratory pressure 2O). The primary outcome is change in 6 min walk test distance from baseline to 1–3 days presurgery. Secondary outcomes include 30 s sit-to-stand test, handgrip strength, postoperative complications (per American College of Surgeons National Surgical Quality Improvement Program), hospital length of stay, readmissions, five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L) and adherence. Data will be analysed using t-tests, analysis of covariance, logistic regression and Cox models, with stratification by baseline nutritional status.

Ethics and dissemination

Approved by the SingHealth Institutional Review Board (CIRB Ref: 2024/2242). Trial registered on ClinicalTrials.gov (NCT06633614). Results will be disseminated via peer-reviewed publications and academic conferences. Contact: irb@singhealth.com.sg

Trial registration number

ClinicalTrials.gov Identifier: NCT06633614

Trends of diabetes and pre-diabetes in Indonesia 2013-2023: a serial analysis of national health surveys

Por: Muharram · F. R. · Swannjo · J. B. · Melbiarta · R. R. · Martini · S.
Objectives

To examine trends in the prevalence of diabetes and pre-diabetes in Indonesia from 2013 to 2023 and to explore demographic and socioeconomic factors associated with these changes.

Design

Secondary data analysis on multiseries cross-sectional study.

Setting

Three waves of the Indonesian National Health Survey (2013, 2018 and 2023), each employing nationally representative, stratified multistage sampling.

Participants

Nationally representative respondents aged 15 years and older who completed fasting plasma glucose (FPG) and oral glucose tolerance tests (OGTT).

Primary and secondary outcome measures

Diabetes and pre-diabetes were defined based on FPG and OGTT tests and self-reported diagnosis. Multivariable and ordinal logistic regression models assessed associations between glycaemic status and demographic, socioeconomic and health-related factors.

Results

From 2013 to 2023, the prevalence of diabetes rose from 10.7% (95% CI: 10.2% to 11.2%) in 2013 to 11.8% (11.3% to 12.3%) in 2018, before declining to 11.3% (10.7% to 11.9%) in 2023. Meanwhile, pre-diabetes prevalence decreased from 44.5% (43.6% to 45.3%) in 2013 to 39.2% (38.0% to 40.3%) in 2023. Age-standardised and synthetic cohort analysis revealed that younger birth cohorts had lower diabetes prevalence at the same age compared with older generations. In contrast, diabetes prevalence remained high and stable among older adults, suggesting that an increase in diabetes prevalence was due to the increase in older population size rather than increased risk. Multivariable regression confirms that higher age and BMI were strong predictors for diabetes, pre-diabetes and abnormal glycaemic states. Wealth quintiles showed different associations: higher wealth was linked to lower pre-diabetes odds, but not consistently to diabetes.

Conclusions

The ageing population drives the rise of diabetes prevalence in Indonesia. Generational improvements were shown among younger adults, while persistent high diabetes prevalence in older adults underscores ongoing challenges. These findings highlight the importance of age-targeted and cohort-targeted screening and prevention strategies.

Quantitative retinal morphology and mortality in individuals with proliferative diabetic retinopathy: a retrospective cohort study in a large real-world population

Por: Khan · A. Z. · Ribeiro Reis · A. P. · Olvera-Barrios · A. · Zhou · Y. · Williamson · D. J. · Struyyen · R. R. · Khalid · H. · Egan · C. · Denniston · A. K. · Keane · P. A. · Wagner · S. K.
Objectives

To investigate whether quantitative retinal markers, derived from multimodal retinal imaging, are associated with increased risk of mortality among individuals with proliferative diabetic retinopathy (PDR), the most severe form of diabetic retinopathy.

Design

Longitudinal retrospective cohort analysis.

Setting

This study was nested within the AlzEye cohort, which links longitudinal multimodal retinal imaging data routinely collected from a large tertiary ophthalmic institution in London, UK, with nationally held hospital admissions data across England.

Participants

A total of 675 individuals (1129 eyes) with PDR were included from the AlzEye cohort. Participants were aged ≥40 years (mean age 57.3 years, SD 10.3), and 410 (60.7%) were male.

Outcome measures

The primary outcome was all-cause mortality. Quantitative retinal markers were derived from fundus photographs and optical coherence tomography using AutoMorph and Topcon Advanced Boundary Segmentation, respectively. We used unadjusted and adjusted Cox-proportional hazards models to estimate hazard ratios (HR) for the association between retinal features and time to death.

Results

After adjusting for sociodemographic factors, each 1-SD decrease in arterial fractal dimension (HR: 1.54, 95% CI: 1.18 to 2.04), arterial vessel density (HR: 1.59, 95% CI: 1.15 to 2.17), arterial average width (HR: 1.35, 95% CI: 1.02 to 1.79), central retinal arteriolar equivalent (HR: 1.39, 95% CI: 1.05 to 1.82) and ganglion cell-inner plexiform layer (GC-IPL) thickness (HR: 1.61, 95% CI: 1.03 to 2.50) was associated with increased mortality risk. When also adjusting for hypertension, arterial fractal dimension (HR: 1.45, 95% CI: 1.08 to 1.92), arterial vessel density (HR: 1.47, 95% CI: 1.05 to 2.08) and GC-IPL thickness (HR: 1.56, 95% CI: 1.03 to 2.38) remained significantly associated with mortality.

Conclusions

Several quantitative retinal markers, relating to both microvascular morphology and retinal neural thickness, are associated with increased mortality among individuals with PDR. The role of retinal imaging in identifying those individuals with PDR most at risk of imminent life-threatening sequelae warrants further investigation.

Economic evaluation of integrating nutritional support intervention in Indias National Tuberculosis Elimination Programme: implications for low-income and middle-income countries

Por: Jyani · G. · Prinja · S. · Nadipally · S. · Shankar · M. · Rao · N. · Rao · V. · Singh · R. R. · Shah · A. · Chugh · Y. · Monga · D. · Sharma · A. · Aggarwal · A.
Objectives

This study aimed to evaluate the cost-effectiveness of integrating nutritional support into India’s National Tuberculosis Elimination Programme (NTEP) using the MUKTI initiative.

Design

Economic evaluation.

Setting

Primary data on the cost of delivering healthcare services, out-of-pocket expenditure and health-related quality of life among patients with tuberculosis (TB) were collected from Dhar district of Madhya Pradesh, India.

Intervention

Integration of nutritional support (MUKTI initiative) into the NTEP of India.

Control

Routine standard of care in the NTEP of India.

Primary outcome measure

Incremental cost per quality-adjusted life year (QALY) gained.

Methods

A mathematical model, combining a Markov model and a compartmental susceptible–infected–recovered model, was used to simulate outcomes for patients with pulmonary TB under NTEP and MUKTI protocols. Primary data collected from 2615 patients with TB, supplemented with estimates from published literature, were used to model progression of disease, treatment outcomes and community transmission dynamics over a 2-year time horizon. Health-related quality of life was assessed using the EuroQol 5-Dimension 5-Level scale. Costs to the health system and out-of-pocket expenditures were included. A multivariable probabilistic sensitivity analysis was undertaken to estimate the effect of joint parameter uncertainty. A scenario analysis explored outcomes without considering community transmission. Results are presented based on health-system and abridged societal perspectives.

Results

Over 2 years, patients in the NTEP plus MUKTI programme had higher life years (1.693 vs 1.622) and QALYs (1.357 vs 1.294) than those in NTEP alone, with increased health system costs (11 538 vs 6807 (US$139 vs US$82)). Incremental cost per life year gained and QALY gained were 67 164 (US$809) and 76 306 (US$919), respectively. At the per capita gross domestic product threshold of 161 500 (US$1946) for India, the MUKTI programme had a 99.9% probability of being cost-effective but exceeded the threshold when excluding community transmission.

Conclusion

The findings highlight the potential benefits of a cost-effective, holistic approach that addresses socio-economic determinants such as nutrition. Reduction in community transmission is the driver of cost-effectiveness of nutritional interventions in patients with TB.

Correlation between fatigue and pulmonary involvement in the post-COVID-19 condition: a cross-sectional study 6-12 months after hospital discharge

Por: Kajiwara · M. S. · Lamas · C. A. · Luna · L. A. V. d. · Yokoyama · T. S. · de Oliveira · P. R. · Chate · R. C. · Sawamura · M. V. Y. · Imamura · M. · Carvalho · C. R. R. d. · Salge · J. M. · HCFMUSP COVID-19 task force · Araujo · Segurado · Montal · Miethke-Morais · Levin · Peron
Introduction

Post-COVID-19 conditions (PCC) may include pulmonary sequelae, fatigue and other symptoms, but its mechanisms are not fully elucidated.

Objective

This study investigated the correlation between fatigue and the presence of pulmonary abnormalities in PCC patients with respiratory involvement 6–12 months after hospitalisation.

Design

Cross-sectional study.

Setting

A tertiary hospital in Brazil.

Participants

315 patients, aged ≥18 years, were considered eligible based on SARS-CoV-2 infection confirmed by reverse transcription-PCR.

Methods

Pulmonary function tests (PFT), cardiopulmonary exercise tests (CPET), chest CT and hand grip were performed. The following scales were applied: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale, Euroqol 5 Dimensions quality of life (EQ-5D) and Hospital Anxiety and Depression Scale (HADS). Participants were divided between the fatigue group (FACIT-F≤30) and the non-fatigue group (FACIT-F>30). For the statistical analysis, the primary outcome was the difference in the diffusing capacity of the lungs for carbon monoxide (DLCO) between groups. Considered secondary outcomes were differences in PFT, CPET, chest CT, hand grip, EQ-5D and HADS.

Results

The fatigue group had 81 patients (25.7%) against 234 (74.3%). PFT and CPET showed no significant difference in DLCO and oxygen consumption peak values between groups. The fatigue group had a lower workload (mean 55.3±21.3 watts vs 66.5±23.2 watts, p=0.003), higher breathing reserve (median 41.9% (33.8–52.5) vs 37.7% (28.9–47.1), p=0.028) and lower prevalence of ground glass opacity (60.8% vs 77.7%, p=0.003) and reticulation (36.7% vs 54.9%, p=0.005) in chest CT. The fatigue group had higher anxiety (57% vs 24%, p

Conclusion

Fatigue in patients with PCC 6–12 months after hospitalisation is relatively common and had weak correlation with pulmonary disorders. Our results suggested fatigue could be strongly related with peripheral disorders such as reduced musculoskeletal strength or psychosocial limitations.

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