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Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM): protocol for a randomised feasibility trial

Por: Simpson · S. A. · Evans · R. A. · Gilbert · H. R. · Branson · A. · Barber · S. · McIntosh · E. · Ahmed · Z. · Dean · S. G. · Doherty · P. J. · Gardiner · N. · Greaves · C. · Daw · P. · Ibbotson · T. · Jani · B. · Jolly · K. · Mair · F. · Ormandy · P. · Smith · S. · Singh · S. J. · Taylor · R.
Introduction

Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM) is a research programme that seeks to develop and evaluate a comprehensive exercise-based rehabilitation intervention designed for people with multimorbidity, the presence of multiple long-term conditions (MLTCs). This paper describes the protocol for a randomised trial to assess the feasibility and acceptability of the PERFORM intervention, study design and processes.

Methods and analysis

A multicentre, parallel two-group randomised trial with individual 2:1 allocation to the PERFORM exercise-based intervention plus usual care (intervention) or usual care alone (control). The primary outcome of this feasibility trial will be to assess whether prespecified progression criteria (recruitment, retention, intervention adherence) are met to progress to the full randomised trial. The trial will be conducted across three UK sites and 60 people with MLTCs, defined as two or more LTCs, with at least one having evidence of the beneficial effect of exercise. The PERFORM intervention comprises an 8-week (twice a week for 6 weeks and once a week for 2 weeks) supervised rehabilitation programme of personalised exercise training and self-management education delivered by trained healthcare professionals followed by two maintenance sessions. Trial participants will be recruited over a 4.5-month period, and outcomes assessed at baseline (prerandomisation) and 3 months postrandomisation and include health-related quality of life, psychological well-being, symptom burden, frailty, exercise capacity, physical activity, sleep, cognition and serious adverse events. A mixed-methods process evaluation will assess acceptability, feasibility and fidelity of intervention delivery and feasibility of trial processes. An economic evaluation will assess the feasibility of data collection and estimate the costs of the PERFORM intervention.

Ethics and dissemination

The trial has been given favourable opinion by the West Midlands, Edgbaston Research Ethics Service (Ref: 23/WM/0057). Participants will be asked to give full, written consent to take part by trained researchers. Findings will be disseminated via journals, presentations and targeted communications to clinicians, commissioners, service users and patients and the public.

Trial registration number

ISRCTN68786622.

Protocol version

2.0 (16 May 2023).

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.

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.
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.

Silhouette showcards confirm altered obesity-associated body image perception in international cohort study of African-origin populations

Por: Choo-Kang · C. · Reese · T. O. · Micklesfield · L. K. · Bovet · P. · Bedu-Addo · K. · Forrester · T. · Gilbert · J. A. · Goedecke · J. H. · Plange-Rhule · J. · Lambert · E. V. · Layden · B. T. · Rae · D. E. · Viswanathan · B. · Luke · A. · Dugas · L.
Objectives

Given the increasing prevalence of obesity and need for effective interventions, there is a growing interest in understanding how an individual’s body image can inform obesity prevention and management. This study’s objective was to examine the use of silhouette showcards to measure body size perception compared with measured body mass index, and assess body size dissatisfaction, in three different African-origin populations spanning the epidemiological transition. An ancillary objective was to investigate associations between body size perception and dissatisfaction with diabetes and hypertension.

Setting

Research visits were completed in local research clinics in respective countries.

Participants

Seven hundred and fifty-one African-origin participants from the USA and the Republic of Seychelles (both high-income countries), and Ghana (low/middle-income country).

Primary and secondary outcome measures

Silhouette showcards were used to measure perceived body size and body size dissatisfaction. Objectively measured body size was measured using a scale and stadiometer. Diabetes was defined as fasting blood glucose ≥126 mg/dL and hypertension was defined as ≥130 mm Hg/80 mm Hg.

Results

Most women and men from the USA and Seychelles had ‘Perceived minus Actual weight status Discrepancy’ scores less than 0, meaning they underestimated their actual body size. Similarly, most overweight or obese men and women also underestimated their body size, while normal weight men and women were accurately able to estimate their body size. Finally, participants with diabetes were able to accurately estimate their body size and similarly desired a smaller body size.

Conclusions

This study highlights that overweight and obese women and men from countries spanning the epidemiological transition were unable to accurately perceive their actual body size. Understanding people’s perception of their body size is critical to implementing successful obesity prevention programmes across the epidemiological transition.

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

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

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

Design

Convergent mixed-methods study.

Setting

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

Participants

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

Outcomes

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

Results

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

Conclusion

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

Comparing undergraduate research experiences before, during, and after the COVID-19 quarantine: The successful adaptation of the BUILD PODER Summer JumpStart program

by Patricia Escobedo, Daniel Garcia, Liam Cascelli, Gabriela Chavira, Gilberto E. Flores, Jodi L. Constantine Brown, David Boyns, Andrew T. Ainsworth

In March 2020, the COVID-19 pandemic forced many in person undergraduate research experiences (UREs) to pivot to remote online training. To investigate how the COVID-19 quarantine disrupted student URE outcomes over time, the current study examines Building Infrastructure Leading to Diversity (BUILD) Promoting Opportunities for Diversity in Education and Research (PODER) URE outcomes across different platforms (in-person, remote, and hybrid models) by comparing student survey data from 2019 to 2021. Participants consisted of three cohorts: 2019 (n = 26 students), 2020 (n = 33), 2021 (n = 34). The BUILD PODER Summer JumpStart program (SJS), which aims to increase diversity in Science, Technology, Engineering, and Mathematics (STEM) by recruiting mostly underrepresented students, was conducted in person in 2019, remotely in 2020 and using a hybrid model in 2021. All students completed an online survey on the first and last day of the four-week SJS program. We used one-way and mixed ANOVA models to analyze Cohort, Time (pre-test vs. post-test scores), and interaction of Cohort and Time for Research Self-Efficacy, Sense of Belonging, Mentor Relationship, Mentee Knowledge, Health, Stress, and Student Program Satisfaction measures. Despite the platform changes, student scores increased significantly over time for all measures. There was a significant main effect of Time for Research Self-Efficacy, Sense of Belonging, Mentor Relationship, Mentee Knowledge, Health Assessment, and Stress Management. Findings indicate that URE programs that are implemented remotely and using a hybrid format can provide students with experiences similar to in-person URE programs. In addition, remote UREs may provide added benefits compared to in-person programs. For instance, remote UREs could engage more historically minoritized students, who may experience barriers to access, such as work/family commitments, financial constraints, and geographic limitations.
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