Study protocol of a sequential, multiple assignment, randomised trial using an adaptive intervention to reduce loneliness among Chinese older adults in Hong Kong

Background
Loneliness is a prevalent and alarming issue among older adults that requires effective interventions. While randomised controlled trials have been commonly undertaken to explore reduction in loneliness, there is a growing recognition that a comprehensive treatment strategy involving multiple interventions may yield better outcomes. Therefore, this study aims to develop and identify a two-stage adaptive intervention that combines telephone-delivered behavioural activation (Tele-BA) and mindfulness techniques (Tele-MF) to reduce loneliness in older adults in Hong Kong.

Methods
A Sequential, Multiple Assignment, Randomised Trial (SMART) design will be adopted. 244 lonely older adults will be recruited from the community and randomly assigned to either one of the 4-week two-stage, embedded adaptive interventions involving different sequences and dosages of Tele-BA and Tele-MF (eg, 4 weeks of Tele-BA followed by booster sessions for responders or 4 weeks of Tele-BA followed by 4 weeks of Tele-BA with motivational component or 4 weeks of Tele-MF for non-responders) based on a set of decision rules. The primary outcome will be loneliness measured by the Revised University of California Los Angeles (UCLA) Loneliness Scale. Secondary outcomes, such as De Jong Gierveld Loneliness Scale, perceived stress, sleep quality and depressive and anxiety symptoms, will be assessed. Adhering to the intention-to-treat principles, the data will be analysed using linear mixed models. The findings may have implications for the development of psychosocial adaptive interventions involving BA and MF to reduce loneliness and improve well-being among older adults in Hong Kong using the SMART design.

Ethics and dissemination
Ethical approval was obtained by the Human Research Ethics Committee at The Education University of Hong Kong (reference: 2022-2023-0117). The findings from this study will be presented in academic conferences and submitted for publication.

Trial registration number
ChiCTR2300077472.

Leggi
Agosto 2024

Pharmacist-led primary care interventions to promote medicines optimisation and reduce overprescribing: a systematic review of UK studies and initiatives

Objectives
To systematically review and synthesise evidence on the effectiveness and implementation barriers/facilitators of pharmacist-led interventions to promote medicines optimisation and reduce overprescribing in UK primary care.

Design
Systematic review.

Setting
UK primary care.

Methods
We searched MEDLINE, Embase, CINAHL PsycINFO and The Cochrane Library for UK-based studies published between January 2013 and February 2023. Targeted searches for grey literature were conducted in May 2023. Quantitative and qualitative studies (including conference abstracts and grey literature) that addressed a relevant intervention and reported a primary outcome related to changes in prescribing were eligible for inclusion. Quality of included studies was assessed using the Multiple Methods Appraisal Tool. We performed a narrative synthesis, grouping studies by publication status, setting and type of data reported (effectiveness or implementation).

Results
We included 14 peer-reviewed journal articles and 11 conference abstracts, together with 4 case study reports. The journal articles reported 10 different interventions, 5 delivered in general practice, 4 in care homes and 1 in community pharmacy. The quality of evidence was higher in general practice than in care home settings. It was consistently reported that the intervention improved outcomes related to prescribing, although the limited number of studies and wide range of outcomes reported made it difficult to estimate the size of any effect. Implementation was strongly influenced by relationships between pharmacists and other health and care professionals, especially general practitioners. Implementation in care homes appeared to be more complex than in general practice because of differences in systems and ‘culture’ between health and social care.

Conclusions
Pharmacist-led interventions have been reported to reduce overprescribing in primary care settings in the UK but a shortage of high-quality evidence means that more rigorous studies using high-quality designs are needed. More research is also needed in community pharmacy settings; to assess intervention effects on patient outcomes other than prescribing and to investigate how reducing overprescribing can impact health inequalities.

PROSPERO registration number
CRD42023396366.

Leggi
Agosto 2024

Omega-3 Fatty Acids and Arrhythmias

Circulation, Volume 150, Issue 6, Page 488-503, August 6, 2024. The pro- and antiarrhythmic effects of omega-3 polyunsaturated fatty acids (n-3 PUFAs) have been extensively studied in preclinical and human trials. Despite early evidence of an antiarrhythmic role of n-3 PUFA in the prevention of sudden cardiac death and postoperative and persistent atrial fibrillation (AF), subsequent well-designed randomized trials have largely not shown an antiarrhythmic benefit. Two trials that tested moderate and high-dose n-3 PUFA demonstrated a reduction in sudden cardiac death, but these findings have not been widely replicated, and the potential of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) to reduce arrhythmic death in combination, or as monotherapy, remains uncertain. The accumulated clinical evidence does not support supplementation of n-3 PUFA for postoperative AF or secondary prevention of AF. Several large, contemporary, randomized controlled trials of high-dose n-3 PUFA for primary or secondary cardiovascular prevention have demonstrated a small, significant, dose-dependent increased risk of incident AF compared with mineral oil or corn oil comparator. These findings were reproduced with both icosapent ethyl monotherapy and a mixed EPA+DHA formulation. The proarrhythmic mechanism of increased AF in contemporary cohorts exposed to high-dose n-3 PUFA is unknown. EPA and DHA and their metabolites have pleiotropic cardiometabolic and pro- and antiarrhythmic effects, including modification of the lipid raft microenvironment; alteration of cell membrane structure and fluidity; modulation of sodium, potassium, and calcium currents; and regulation of gene transcription, cell proliferation, and inflammation. Further characterization of the complex association between EPA, EPA+DHA, and DHA and AF is needed. Which formulations, dose ranges, and patient subgroups are at highest risk, remain unclear.

Leggi
Agosto 2024

Boosting enjoyment and social inclusion to increase physical activity and reduce sedentary behaviour among older adults: protocol for a feasibility study to test the JOIN4JOY approach in five European countries

Introduction
Programmes for older people aimed at increasing physical activity (PA) and reducing sedentary behaviour (SB) traditionally focus on achieving functional and health improvements. Focusing on enjoyment and social inclusion could strengthen adherence and help reach older people with social disadvantages. The aim of this study is to assess the feasibility and acceptability of the Join4Joy approach in PA programmes and its assessment tools.

Methods and analysis
A multicentric, pragmatic, pre-post feasibility study using mixed methods will be conducted. The intervention will consist of a PA programme boosting enjoyment and social inclusion, grounded on a co-creation process. Trainers will offer twelve, 1-hour weekly sessions of structured, supervised, group-based PA. Participants will be encouraged to increase activity in daily living. 144 older people will be recruited from the community and nursing homes in Spain, Denmark, Italy, Germany, and France. Additionally, participants and trainers will be invited to join virtual communities of practice to share their experiences across settings and countries. Qualitative procedures will be used to explore the acceptability of the design via interviews and focus groups with participants and trainers. Quantitative methods will be used to assess uptake, adherence, retention, reach, satisfaction, enjoyment (PACES questionnaire), physical function (e.g., Short Physical Performance Battery), quality of life (EQ-5D-5L scale), perceived improvement (Patient Global Impression of Improvement scale-I), activities of daily living (Barthel index) and SB and PA patterns (IPAQ and accelerometry). The degree and type of participation in virtual communities of practice will also be assessed. SPSS software will be used for the analysis of quantitative variables. Qualitative data will be analysed using reflective thematic analysis following Braun and Clarke (2006).

Ethics and dissemination
A favourable report by the Research Ethics Committee of UVic-UCC (282/2023) was obtained on 26 June 26th, 2023. Participation and withdrawal will be voluntary. Participants’ (or their legal guardians’, when necessary) written permission will be required. Results of the study will be disseminated through publication of scientific articles, presentations at sport and health-related professional conferences and congresses, as well as through social media and via the Join4Joy website.

Study registration
ClinicalTrials.gov, NCT06100835.

Leggi
Luglio 2024

Core socioDemographic data variables in ICU Trials (CoDe-IT): a protocol for generating core data variables using a Delphi consensus process

Introduction
Sociodemographic variables influence health outcomes, either directly (ie, gender identity) or indirectly (eg, structural/systemic racism based on ethnoracial group). Identification of how sociodemographic variables can impact the health of critically ill adults is important to guide care and research design for this population. However, despite the growing recognition of the importance of collecting sociodemographic measures that influence health outcomes, insufficient and inconsistent data collection of sociodemographic variables persists in critical care studies. We aim to develop a set of core data variables (CoDaV) for social determinants of health specific to studies involving critically ill adults.

Methods and analysis
We will conduct a scoping review to generate a list of possible sociodemographic measures to be used for round 1 of the modified Delphi processes. We will engage relevant knowledge users (previous intensive care unit patients and family members, critical care researchers, critical care clinicians and research co-ordinators) to participate in the modified Delphi consensus survey to identify the CoDaV. A final consensus meeting will be held with knowledge user representatives to discuss the final CoDaV, how each sociodemographic variable will be collected (eg, level of granularity) and how to disseminate the CoDaV for use in critical care studies.

Ethics and dissemination
The University of Calgary conjoint health research ethics board has approved this study protocol (REB22-1648).

Leggi
Luglio 2024

Service Dogs May Reduce Veterans’ PTSD Symptoms

Military members and veterans with posttraumatic stress disorder (PTSD) who partnered with a psychiatric service dog in addition to receiving usual care for the condition had less severe symptoms after 3 months than those who received typical care only, according to results from a nonrandomized clinical trial involving 156 participants in the US.

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Luglio 2024

Pouchitis: Is It Time to Think Beyond the Inflammation in the Pouch?

After pan-proctocolectomy with ileal pouch–anal anastomosis (IPAA) for intractable ulcerative colitis (UC), about 50% of patients experience pouchitis.1 The prevalence of pouchitis is 5-fold higher in UC than in patients who undergo the same surgery for familial adenomatous polyposis (FAP), based on a systematic review and meta-analysis (SRMA) of 59 publications involving more than 18,000 patients with UC and 860 patients with FAP.1 This difference in the prevalence of pouchitis does not appear to be related to mechanical factors or complications from the pouch surgery.

Leggi
Luglio 2024