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Supervised exercise training is among the first-line therapies for patients with peripheral artery disease (PAD). Current recommendations for exercise include guidance focusing on claudication pain, programme and session duration, and frequency. However, no guidance is offered regarding exercise training intensity. This study aims to compare the effects of 12-week-long supervised walking exercise training (high-intensity interval training (HIIT) vs moderate-intensity exercise (MOD)) in patients with chronic symptomatic PAD.
This study is a monocentric, interventional, non-blinded randomised controlled trial. 60 patients (30 in each group) will be randomly allocated (by using the random permuted blocks) to 12 weeks (three times a week) of HIIT or MOD. For HIIT, exercise sessions will consist of alternating brief high-intensity (≥85% of the peak heart rate (HRpeak)) periods (≤60 s) of work with periods of passive rest. Patients will be asked to complete 1 and then 2 sets of 5–7 (progressing to 10–15x60 s) walking intervals. For the MOD group, exercise training sessions will consist of an alternation of periods of work performed at moderate intensity (≤76% HRpeak) and periods of passive rest. Interventions will be matched by training load. The primary outcome will be the maximal walking distance. Secondary outcomes will include functional performance, functional capacity, heath-related quality of life, self-perceived walking abilities, physical activity and haemodynamic parameters.
The Angiof-HIIT Study was approved by the Human Research Ethics Committee of the Canton de Vaud (study number: 2022-01752). Written consent is mandatory prior to enrolment and randomisation. The results will be disseminated via national and international scientific meetings, scientific peer-reviewed journals and social media.
In over 50 years since the genetic counseling (GC) profession began, a systematic study of GC communication skills and patient-reported outcomes in actual sessions across multiple clinical specialties has never been conducted. To optimize GC quality and improve efficiency of care, the field must first be able to comprehensively measure GC skills and determine which skills are most critical to achieving positive patient experiences and outcomes. This study aims to characterise GC communication skills using a novel and pragmatic measure and link variations in communication skills to patient-reported outcomes, across clinical specialties and with patients from diverse backgrounds in the USA. Our community-engagement and provider-engagement approach is crucial to develop recommendations for quality, culturally informed GC care, which are greatly needed to improve GC practice.
A mixed methods, sequential explanatory design will be used to collect and analyze: audio-recorded GC sessions in cancer, cardiac, and prenatal/reproductive genetic indications; pre-visit and post-visit quantitative surveys capturing patient experiences and outcomes and post-visit qualitative interview data. A novel, practical checklist will measure GC communication skills. Coincidence analysis will identify patterns of GC skills that are consistent with high scores on patient-reported measures. Two-level, multilevel models will be used to evaluate how GC communication skills and other session/patient characteristics predict patient-reported outcomes. Four community advisory boards (CABs) and a genetic counselor advisory board will inform the study design and analysis.
This study has been approved by the single Institutional Review Board of the University of Minnesota. This research poses no greater than minimal risk to participants. Results from this study will be shared through national and international conferences and through community-based dissemination as guided by the study’s CABs. A lay summary will also be disseminated to all participants.
This study aims to reduce potentially inappropriate prescribing (PIP) of statins and foster healthy lifestyle promotion in cardiovascular disease (CVD) primary prevention in low-risk patients. To this end, we will compare the effectiveness and feasibility of several de-implementation strategies developed following the structured design process of the Behaviour Change Wheel targeting key determinants of the clinical decision-making process in CVD prevention.
A cluster randomised implementation trial, with an additional control group, will be launched, involving family physicians (FPs) from 13 Integrated Healthcare Organisations (IHOs) of Osakidetza-Basque Health Service with non-zero incidence rates of PIP of statins in 2021. All FPs will be exposed to a non-reflective decision assistance strategy based on reminders and decision support tools. Additionally, FPs from two of the IHOs will be randomly assigned to one of two increasingly intensive de-implementation strategies: adding a decision information strategy based on knowledge dissemination and a reflective decision structure strategy through audit/feedback. The target population comprises women aged 45–74 years and men aged 40–74 years with moderately elevated cholesterol levels but no diagnosed CVD and low cardiovascular risk (REGICOR
The study was approved by the Basque Country Clinical Research Ethics Committee and was registered in ClinicalTrials.gov (NCT04022850). Results will be disseminated in scientific peer-reviewed journals.
Understanding human mobility’s role in malaria transmission is critical to successful control and elimination. However, common approaches to measuring mobility are ill-equipped for remote regions such as the Amazon. This study develops a network survey to quantify the effect of community connectivity and mobility on malaria transmission.
We measure community connectivity across the study area using a respondent driven sampling design among key informants who are at least 18 years of age. 45 initial communities will be selected: 10 in Brazil, 10 in Ecuador and 25 in Peru. Participants will be recruited in each initial node and administered a survey to obtain data on each community’s mobility patterns. Survey responses will be ranked and the 2–3 most connected communities will then be selected and surveyed. This process will be repeated for a third round of data collection. Community network matrices will be linked with each country’s malaria surveillance system to test the effects of mobility on disease risk.
This study protocol has been approved by the institutional review boards of Duke University (USA), Universidad San Francisco de Quito (Ecuador), Universidad Peruana Cayetano Heredia (Peru) and Universidade Federal Minas Gerais (Brazil). Results will be disseminated in communities by the end of the study.
To identify the reasons and/or risk factors for hospital admission and/or emergency department attendance for older (≥60 years) residents of long-term care facilities.
Older adults' use of acute services is associated with significant financial and social costs. A global understanding of the reasons for the use of acute services may allow for early identification and intervention, avoid clinical deterioration, reduce the demand for health services and improve quality of life.
Systematic review registered in PROSPERO (CRD42022326964) and reported following PRISMA guidelines.
The search strategy was developed in consultation with an academic librarian. The strategy used MeSH terms and relevant keywords. Articles published since 2017 in English were eligible for inclusion. CINAHL, MEDLINE, Scopus and Web of Science Core Collection were searched (11/08/22). Title, abstract, and full texts were screened against the inclusion/exclusion criteria; data extraction was performed two blinded reviewers. Quality of evidence was assessed using the NewCastle Ottawa Scale (NOS).
Thirty-nine articles were eligible and included in this review; included research was assessed as high-quality with a low risk of bias. Hospital admission was reported as most likely to occur during the first year of residence in long-term care. Respiratory and cardiovascular diagnoses were frequently associated with acute services use. Frailty, hypotensive medications, falls and inadequate nutrition were associated with unplanned service use.
Modifiable risks have been identified that may act as a trigger for assessment and be amenable to early intervention. Coordinated intervention may have significant individual, social and economic benefits.
This review has identified several modifiable reasons for acute service use by older adults. Early and coordinated intervention may reduce the risk of hospital admission and/or emergency department.
This systematic review was conducted and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) methodology.
No patient or public contribution.
To examine family planning through the community’s perception, belief system and cultural impact; in addition to identifying the determining factors for family planning uptake.
A descriptive exploratory study.
Three communities were selected from three local government areas, each in the three senatorial districts in Ekiti State.
The study was conducted among young unmarried women in the reproductive age group who were sexually active as well as married men and women in the reproductive age group who are currently living with their partners and were sexually active.
Eight focus group discussions were conducted in the community in 2019 with 28 male and 50 female participants. The audio recordings were transcribed, triangulated with notes and analysed using QSR NVivo V.8 software. Community perception, beliefs and perceptions of the utility of family planning, as well as cultural, religious and other factors determining family planning uptake were analysed.
The majority of the participants had the perception that family planning helps married couple only. There were diverse beliefs about family planning and mixed reactions with respect to the impact of culture and religion on family planning uptake. Furthermore, a number of factors were identified in determining family planning uptake—intrapersonal, interpersonal and health system factors.
The study concluded that there are varied reactions to family planning uptake due to varied perception, cultural and religious beliefs and determining factors. It was recommended that more targeted male partner engagement in campaign would boost family planning uptake.
To synthesize the literature on the experiences of patients, families and healthcare professionals with video calls during hospital admission. Second, to investigate facilitators and barriers of implementation of video calls in hospital wards.
Scoping review.
PubMed, CINAHL and Google Scholar were searched for relevant publications in the period between 2011 and 2023. Publications were selected if they focused on experiences of patients, families or healthcare professionals with video calls between patients and their families; or between families of hospitalized patients and healthcare professionals. Quantitative and qualitative data were summarized in data charting forms.
Forty-three studies were included. Patients and families were satisfied with video calls as it facilitated daily communication. Family members felt more engaged and felt they could provide support to their loved ones during admission. Healthcare professionals experienced video calls as an effective way to communicate when in-person visits were not allowed. However, they felt that video calls were emotionally difficult as it was hard to provide support at distance and to use communication skills effectively. Assigning local champions and training of healthcare professionals were identified as facilitators for implementation. Technical issues and increased workload were mentioned as main barriers.
Patients, families and healthcare professionals consider video calls as a good alternative when in-person visits are not allowed. Healthcare professionals experience more hesitation towards video calls during admission, as it increases perceived workload. In addition, they are uncertain whether video calls are as effective as in-person conservations.
When implementing video calls in hospital wards, policymakers and healthcare professionals should select strategies that address the positive aspects of family involvement at distance and the use of digital communication skills.
No patient or public contribution.
Clinical pharmacy services often involve multifaceted pharmacist-led interventions. However, current pharmacy practice models vary across different countries. Despite the documented benefits of clinical pharmacy services, the characteristics of pharmacist-led interventions in different countries have not yet been adequately explored and described. Therefore, this protocol outlines the methodology for a proposed scoping review aiming to investigate various types of multifaceted pharmacist-led interventions and the outcomes used to evaluate their effectiveness within secondary care settings. Additionally, the scoping review will map the current evidence surrounding the characteristics of interventions and outcomes reported across various countries of socioeconomic status.
The scoping review will be conducted according to the JBI Methodology for Scoping Reviews and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) Extension for Scoping Reviews. We will systematically search the following electronic databases: MEDLINE (Ovid), CINAHL (EbscoHost), Embase (embase.com), Scopus (scopus.com), Cochrane Library (cochranelibrary.com) and APA PsycInfo (Ovid). Additionally, the reference lists of identified reviews and included full texts will be searched for relevant papers. Grey literature sources, such as International Pharmaceutical Abstracts and the International Pharmaceutical Federation (FIP) website, will be searched. We will include primary studies published in the English language from January 2013 to December 2023, involving secondary care multifaceted pharmacist-led interventions. Two independent reviewers will screen studies against eligibility criteria and use a piloted data extraction form to extract relevant information. We will extract relevant data, complete a tabular summary from each included publication and analyse it.
Ethical approval is not required as we will be using data from publicly available literature sources. Findings will be disseminated in publications and presentations with relevant stakeholders. We aim to map available evidence across the breadth of studies that have reported multifaceted pharmacist-led interventions and their outcomes.
Skin Cutaneous Melanoma (SKCM) is a form of cancer that originates in the pigment-producing cells, known as melanocytes, of the skin. Delay wound healing is often correlated with the occurrence of and progression of SKCM. In this comprehensive study, we investigated the intricate roles of two important wound healing genes in SKCM, including Matrix Metalloproteinase-2 (MMP2) and Matrix Metalloproteinase-9 (MMP9). Through a multi-faceted approach, we collected clinical samples, conducted molecular experiments, including RT-qPCR, bisulphite sequencing, cell culture, cell Counting Kit-8, colony formation, and wound healing assays. Beside this, we also used various other databases/tools/approaches for additional analysis including, UALCAN, GEPIA, HPA, MEXPRESS, cBioPortal, KM plotter, DrugBank, and molecular docking. Our results revealed a significant up-regulation of MMP2 and MMP9 in SKCM tissues compared to normal counterparts. Moreover, promoter methylation analysis suggested an epigenetic regulatory mechanism. Validations using TCGA datasets and immunohistochemistry emphasized the clinical relevance of MMP2 and MMP9 dysregulation. Functional assays demonstrated their synergistic impact on proliferation and migration in SKCM cells. Furthermore, we identified potential therapeutic candidates, Estradiol and Calcitriol, through drug prediction and molecular docking analyses. These compounds exhibited binding affinities, suggesting their potential as MMP2/MMP9 inhibitors. Overall, our study elucidates the diagnostic, prognostic, and therapeutic implications of MMP2 and MMP9 in SKCM, shedding light on their complex interplay in SKCM occurrence and progression.
Gain insight into the process of shared decision-making (SDM) in daily hospital care for patients with dementia from nurses' perspectives.
Explorative qualitative design.
In-depth digital interviews were conducted with 14 registered nurses between June and November 2022. A phenomenological approach was applied using Colaizzi's seven-step method.
Five themes were identified in the data: (1) SDM in daily care: How shared decision-making is applied; (2) Nurses' perceptions and competence: How nurses perceive and manage SDM; (3) Nurses' roles and advocacy: The evolving roles of nurses and their advocacy efforts, (4) Recognition of dementia and its impact: How nurses recognize and manage dementia; and (5) Interventions to support SDM: Strategies and interventions to facilitate SDM.
This study highlights the complexity of SDM in patients with dementia. It demonstrates the importance of the involvement of relatives, omission of patient goals in discussions and perceived deficiencies of nurses. The early identification of dementia, evaluation of nuanced capacity and targeted communication are essential. Further research and enhanced training are required to improve care in this context.
Potential areas for further research on SDM in nurses involving patients with dementia include investigating the effects of integrating goal discussions into SDM training for nurses, overcoming barriers to SDM competence, and challenging the idea that SDM is solely the responsibility of physicians. These findings highlight the need for policies that encourage interdisciplinary collaboration, address misconceptions and recommend training programmes that focus on applying SDM to the daily care of patients with dementia, thereby improving the overall quality of patient care.
The Consolidated Criteria for Reporting Qualitative Research (COREQ) checklist was used for reporting.
No patient or public contribution.
Dementia is a complex medical condition that poses significant challenges to healthcare systems and support services. People living with dementia (PLWD) and their carers experience complex needs often exacerbated by social isolation and challenges in accessing support. Social prescribing (SP) seeks to enable PLWD and their carers to access community and voluntary sector resources to support them address such needs. Existing research, however, does not describe what SP interventions are currently in place in dementia care. Little is known about the needs these interventions are designed to address, the reasons that lead PLWD and their carers to participate in them, their effectiveness and the extent to which they could increase positive health outcomes if adopted and how.
A complex intervention systematic review of SP for PLWD and/or their carers will be conducted using an iterative logic model approach. Six electronic (MEDLINE, EMBASE, PsycINFO, CINAHL, Scopus and Cochrane/CENTRAL) and two grey literature databases (EThOS and CORE) were searched for publications between 1 January 2003 and June 2023, supplemented by handsearching of reference lists of included studies. Study selection, data extraction and risk of bias assessment, using Gough’s Weight of Evidence Framework, will be independently performed by two reviewers. A narrative approach will be employed to synthesise and report quantitative and qualitative data. Reporting will be informed by the Preferred Reporting Items for Systematic Review and Meta-Analysis Complex Interventions extension statement and checklist.
No ethical approval is required due to this systematic review operating only with secondary sources. Findings will be disseminated through peer-reviewed publications, conference presentations and meetings with key stakeholders including healthcare professionals, patient and carer groups, community organisations (eg, the Social Prescribing Network and the Evidence Collaborative at the National Academy for Social Prescribing), policymakers and funding bodies.
CRD42023428625.
Childhood obesity is an escalating crisis in the United States. Health policy may impact this epidemic which disproportionally affects underserved populations.
The aim was to use the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework to assess health policy impact on preventing or treating school-aged children (5 > 18 years) with obesity in underserved populations.
A scoping review of 842 articles was conducted. Twenty-four articles met the inclusion criteria and underwent data extraction.
Twelve studies included subgroup analysis, with four suggesting an impact of policy on at-risk groups. None of the 24 studies fully applied the RE-AIM framework. Policies positively impacted childhood obesity in 12 studies across the sample.
Our review revealed inconsistent evidence for the effectiveness of policy on childhood obesity, perhaps due to the lack of focus on the social determinants of health. In addition, many studies did not evaluate the outcomes for underserved populations. Therefore, we propose more attention to social determinants in future legislation and evaluation of policy effectiveness on underserved populations. Findings identify an urgent need for the design, implementation, and evaluation of policies specifically directed to address the inequities of racism, social injustices, and social determinants of health that impact childhood obesity in the United States. Future work needs to identify who was reached by the policy, who benefitted from the policy, and how policies were implemented to address obesity-related health disparities. Nurses should advocate for the evaluation of childhood obesity policies, particularly in underserved populations, to determine effectiveness. Nurses, particularly those trained in population and community health and research, should advocate for policy research that considers inequities rather than controls for these variables. Multi-layered interventions can then be tailored to sub-populations and evaluated more effectively.
Despite the high number of operations and surgical advancement, rehabilitation after rotator cuff repair has not progressed for over 20 years. The traditional cautious approach might be contributing to suboptimal outcomes. Our aim is to assess whether individualised (early) patient-directed rehabilitation results in less shoulder pain and disability at 12 weeks after surgical repair of full-thickness tears of the rotator cuff compared with current standard (delayed) rehabilitation.
The rehabilitation after rotator cuff repair (RaCeR 2) study is a pragmatic multicentre, open-label, randomised controlled trial with internal pilot phase. It has a parallel group design with 1:1 allocation ratio, full health economic evaluation and quintet recruitment intervention. Adults awaiting arthroscopic surgical repair of a full-thickness tear are eligible to participate. On completion of surgery, 638 participants will be randomised. The intervention (individualised early patient-directed rehabilitation) includes advice to the patient to remove their sling as soon as they feel able, gradually begin using their arm as they feel able and a specific exercise programme. Sling removal and movement is progressed by the patient over time according to agreed goals and within their own pain and tolerance. The comparator (standard rehabilitation) includes advice to the patient to wear the sling for at least 4 weeks and only to remove while eating, washing, dressing or performing specific exercises. Progression is according to specific timeframes rather than as the patient feels able. The primary outcome measure is the Shoulder Pain and Disability Index total score at 12-week postrandomisation. The trial timeline is 56 months in total, from September 2022.
Globally, guideline-recommended antenatal care for smoking cessation is not routinely delivered by antenatal care providers. Implementation strategies have been shown to improve the delivery of clinical practices across a variety of clinical services but there is an absence of evidence in applying such strategies to support improvements to antenatal care for smoking cessation in pregnancy. This study aims to determine the effectiveness and cost effectiveness of implementation strategies in increasing the routine provision of recommended antenatal care for smoking cessation in public maternity services.
A non-randomised stepped-wedge cluster-controlled trial will be conducted in maternity services across three health sectors in New South Wales, Australia. Implementation strategies including guidelines and procedures, reminders and prompts, leadership support, champions, training and monitoring and feedback will be delivered sequentially to each sector over 4 months. Primary outcome measures will be the proportion of: (1) pregnant women who report receiving a carbon monoxide breath test; (2) smokers or recent quitters who report receiving quit/relapse advice; and (3) smokers who report offer of help to quit smoking (Quitline referral or nicotine replacement therapy). Outcomes will be measured via cross-sectional telephone surveys with a random sample of women who attend antenatal appointments each week. Economic analyses will be undertaken to assess the cost effectiveness of the implementation intervention. Process measures including acceptability, adoption, fidelity and reach will be reported.
Ethics approval was obtained through the Hunter New England Human Research Ethics Committee (16/11/16/4.07; 16/10/19/5.15) and the Aboriginal Health and Medical Research Council (1236/16). Trial findings will be disseminated to health policy-makers and health services to inform best practice processes for effective guideline implementation. Findings will also be disseminated at scientific conferences and in peer-reviewed journals.
Australian New Zealand Clinical Trials Registry—ACTRN12622001010785.
Preoperative anxiety and depression symptoms among older surgical patients are associated with poor postoperative outcomes, yet evidence-based interventions for anxiety and depression have not been applied within this setting. We present a protocol for randomised controlled trials (RCTs) in three surgical cohorts: cardiac, oncological and orthopaedic, investigating whether a perioperative mental health intervention, with psychological and pharmacological components, reduces perioperative symptoms of depression and anxiety in older surgical patients.
Adults ≥60 years undergoing cardiac, orthopaedic or oncological surgery will be enrolled in one of three-linked type 1 hybrid effectiveness/implementation RCTs that will be conducted in tandem with similar methods. In each trial, 100 participants will be randomised to a remotely delivered perioperative behavioural treatment incorporating principles of behavioural activation, compassion and care coordination, and medication optimisation, or enhanced usual care with mental health-related resources for this population. The primary outcome is change in depression and anxiety symptoms assessed with the Patient Health Questionnaire-Anxiety Depression Scale from baseline to 3 months post surgery. Other outcomes include quality of life, delirium, length of stay, falls, rehospitalisation, pain and implementation outcomes, including study and intervention reach, acceptability, feasibility and appropriateness, and patient experience with the intervention.
The trials have received ethics approval from the Washington University School of Medicine Institutional Review Board. Informed consent is required for participation in the trials. The results will be submitted for publication in peer-reviewed journals, presented at clinical research conferences and disseminated via the Center for Perioperative Mental Health website.
NCT05575128,
FreshRSS 