Setting Intentions

In this narrative medicine essay, an oncologist ruminates over a chemotherapy consent form about the goals of therapy for a young adult whose body is filled with an aggressive cancer most commonly seen in children.

Leggi
Gennaio 2024

Sequential multiple assignment randomised trial to develop an adaptive mobile health intervention to increase physical activity in people poststroke in the community setting in Ireland: TAPAS trial protocol

Introduction
Stroke is the second-leading cause of death and disability globally. Participation in physical activity (PA) is a cornerstone of secondary prevention in stroke care. Given the heterogeneous nature of stroke, PA interventions that are adaptive to individual performance are recommended. Mobile health (mHealth) has been identified as a potential approach to supporting PA poststroke. To this end, we aim to use a Sequential Multiple Assignment Randomised Trial (SMART) design to develop an adaptive, user-informed mHealth intervention to improve PA poststroke.

Methods and analysis
The components included in the 12-week intervention are based on empirical evidence and behavioural change theory and will include treatments to increase participation in Structured Exercise and Lifestyle or a combination of both. 117 participants will be randomly assigned to one of the two treatment components. At 6 weeks postinitial randomisation, participants will be classified as responders or non-responders based on participants’ change in step count. Non-responders to the initial treatment will be randomly assigned to a different treatment allocation. The primary outcome will be PA (steps/day), feasibility and secondary clinical and cost outcomes will also be included. A SMART design will be used to evaluate the optimum adaptive PA intervention among community-dwelling, ambulatory people poststroke.

Ethics and dissemination
Ethical approval has been granted by the Health Service Executive Mid-Western Ethics Committee (REC Ref: 026/2022). The findings will be submitted for publication and presented at relevant national and international academic conferences

Trials registration number
NCT05606770.

Leggi
Gennaio 2024

Potential impact of a new sepsis prediction model for the primary care setting: early health economic evaluation using an observational cohort

Objectives
To estimate the potential referral rate and cost impact at different cut-off points of a recently developed sepsis prediction model for general practitioners (GPs).

Design
Prospective observational study with decision tree modelling.

Setting
Four out-of-hours GP services in the Netherlands.

Participants
357 acutely ill adult patients assessed during home visits.

Primary and secondary outcome measures
The primary outcome is the cost per patient from a healthcare perspective in four scenarios based on different cut-off points for referral of the sepsis prediction model. Second, the number of hospital referrals for the different scenarios is estimated. The potential impact of referral of patients with sepsis on mortality and hospital admission was estimated by an expert panel. Using these study data, a decision tree with a time horizon of 1 month was built to estimate the referral rate and cost impact in case the model would be implemented.

Results
Referral rates at a low cut-off (score 2 or 3 on a scale from 0 to 6) of the prediction model were higher than observed for patients with sepsis (99% and 91%, respectively, compared with 88% observed). However, referral was also substantially higher for patients who did not need hospital assessment. As a consequence, cost-savings due to referral of patients with sepsis were offset by increased costs due to unnecessary referral for all cut-offs of the prediction model.

Conclusions
Guidance for referral of adult patients with suspected sepsis in the primary care setting using any cut-off point of the sepsis prediction model is not likely to save costs. The model should only be incorporated in sepsis guidelines for GPs if improvement of care can be demonstrated in an implementation study.

Trial registration number
Dutch Trial Register (NTR 7026).

Leggi
Gennaio 2024

Surrogate Decision-Making After Stroke in a Community Setting: The OASIS Project

Stroke, Ahead of Print. Background:Patients with severe stroke often rely on surrogate decision-makers for life-sustaining treatment decisions. We investigated ethnic differences between Mexican Americans (MAs) and non-Hispanic White (NHW) individuals in surrogate reports of physician quality of communication and shared decision-making from the OASIS study (Outcomes Among Surrogate Decision Makers in Stroke) project.Methods:Patients had ischemic stroke or intracerebral hemorrhage in Nueces County, TX. Surrogates self-identified as being involved in decisions about do-not-resuscitate orders, brain surgery, ventilator, feeding tube, or hospice/comfort care. Surrogate reports of physician quality of communication (scale score, range from 0 to 10) and shared decision-making (CollaboRATE scale score, binary score 1 versus 0) were compared by ethnicity with linear or logistic regression using generalized estimating equations, adjusted for prespecified demographics, clinical factors, and confounders.Results:Between April 2016 and September 2020, 320 surrogates for 257 patients with stroke enrolled (MA, 158; NHW, 85; and other, 14). Overall quality of communication score was better among surrogates of MA patients than NHW individuals after adjustment for demographics, stroke severity, and patient survival though the ethnic difference was attenuated (β, 0.47 [95% CI, −0.17 to 1.12];P=0.15) after adjustment for trust in the medical profession and frequency of personal prayer. High CollaboRATE scale scores were more common among surrogates of MA patients than NHW individuals (unadjusted odds ratio, 1.75 [95% CI, 1.04–2.95]). This association persisted after adjustment for demographic and clinical factors though there was an interaction between patient age and ethnicity (P=0.04), suggesting that this difference was primarily in older patients.Conclusions:Surrogate decision-makers of MA patients generally reported better outcomes on validated measures of quality of communication and shared decision-making than NHW individuals. Further study of outcomes among diverse populations of stroke surrogate decision-makers may help to identify sources of strength and resiliency that may be broadly applicable.

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Gennaio 2024

Social prescribing for children and young people with neurodisability and their families initiated in a hospital setting: a systematic review

Objectives
Social prescribing (SP) is a non-medical intervention in which professionals refer patients to a link worker (LW), who connects them with appropriate support. Children and young people (CYP) with neurodisability often have unmet needs and may bypass community initiatives. We undertook a review of hospital-initiated SP for CYP with neurodisability.

Design
Systematic review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance and using Mixed Methods Appraisal Tool.

Data sources
Medline, PsycINFO, PsycARTICLES, Embase, CINAHL, Scopus, Web of Science and FutureNHS, searched from 1 January 2000 to 19 October 2023, with no language restrictions.

Eligibility criteria
Studies describing SP interventions for CYP (ages 0–25 years) with neurodisability/neurodivergence. Exclusions: interventions outside of secondary care; with no description; or no LW.

Data extraction and synthesis
Two researchers independently screened references. Data were charted, summarised, quality assessments performed and narratively reviewed.

Results
After removal of duplicates, 518 references were identified. Following screening, eight articles (covering five SP schemes) were included. Rahi et al connected 68 families of CYP newly diagnosed with visual impairment to a community LW. Families needed information about social and educational services, and emotional support. Healthcare professionals had more time for clinical issues. Six papers described three different digital interventions supporting in total 86 CYP with traumatic brain injury and their families. Wade et al (2004, 2005a, 2005b) provided a website with core and individualised sessions, and weekly therapist support. Wade et al (2018) provided a smartphone application, website and weekly meetings with an online coach. These interventions boosted social behaviours. Wade et al (2014, 2015) found that online family problem-solving therapy improved overall child functioning compared with self-guided resources. Toutain et al (2009) provided non-medical support to 11 children with fetal alcohol syndrome and their mothers. No outcome data were provided. Studies reported benefits to health, well-being, healthcare usage, knowledge, skills, satisfaction and service delivery.

Conclusion
Literature describing hospital-initiated SP schemes for CYP with neurodisability, while sparse, suggests potential benefit.

PROSPERO registration number
CRD42022384188.

Leggi
Dicembre 2023

Impact of a pharmacy-led screening and intervention in people at risk of or living with chronic kidney disease in a primary care setting: a cluster randomised trial protocol

Introduction
Chronic kidney disease (CKD) is increasingly recognised as a growing global public health problem. Early detection and management can significantly reduce the loss of kidney function. The proposed trial aims to evaluate the impact of a community pharmacy-led intervention combining CKD screening and medication review on CKD detection and quality use of medicines (QUM) for patients with CKD. We hypothesise that the proposed intervention will enhance detection of newly diagnosed CKD cases and reduce potentially inappropriate medications use by people at risk of or living with CKD.

Methods and analysis
This study is a multicentre, pragmatic, two-level cluster randomised controlled trial which will be conducted across different regions in Australia. Clusters of community pharmacies from geographical groups of co-located postcodes will be randomised. The project will be conducted in 122 community pharmacies distributed across metropolitan and rural areas. The trial consists of two arms: (1) Control Group: a risk assessment using the QKidney CKD risk assessment tool, and (2) Intervention Group: a risk assessment using the QKidney CKD plus Point-of-Care Testing for kidney function markers (serum creatinine and estimated glomerular filtration rate), followed by a QUM service. The primary outcomes of the study are the proportion of patients newly diagnosed with CKD at the end of the study period (12 months); and rates of changes in the number of medications considered problematic in kidney disease (number of medications prescribed at inappropriate doses based on kidney function and/or number of nephrotoxic medications) over the same period. Secondary outcomes include proportion of people on potentially inappropriate medications, types of recommendations provided by the pharmacist (and acceptance rate by general practitioners), proportion of people who were screened, referred, and took up the referral to visit their general practitioners, and economic and other patient-centred outcomes.

Ethics and dissemination
The trial protocol has been approved by the Human Research Ethics Committee at the University of Sydney (2022/044) and the findings of the study will be presented at scientific conferences and published in peer-reviewed journal(s).

Trial registration number
Australian New Zealand Clinical Trials Registry (ACTRN12622000329763).

Leggi
Dicembre 2023

Research priorities for childrens cancer: a James Lind Alliance Priority Setting Partnership in the UK

Objectives
To engage children who have experienced cancer, childhood cancer survivors, their families and professionals to systematically identify and prioritise research questions about childhood cancer to inform the future research agenda.

Design
James Lind Alliance Priority Setting Partnership.

Setting
UK health service and community.

Methods
A steering group oversaw the initiative. Potential research questions were collected in an online survey, then checked to ensure they were unanswered. Shortlisting via a second online survey identified the highest priority questions. A parallel process with children was undertaken. A final consensus workshop was held to determine the Top 10 priorities.

Participants
Children and survivors of childhood cancer, diagnosed before age 16, their families, friends and professionals who work with this population.

Results
Four hundred and eighty-eight people submitted 1299 potential questions. These were refined into 108 unique questions; 4 were already answered and 3 were under active study, therefore, removed. Three hundred and twenty-seven respondents completed the shortlisting survey. Seventy-one children submitted questions in the children’s surveys, eight children attended a workshop to prioritise these questions. The Top 5 questions from children were taken to the final workshop where 23 questions in total were discussed by 25 participants (young adults, carers and professionals). The top priority was ‘can we find effective and kinder (less burdensome, more tolerable, with fewer short and long-term effects) treatments for children with cancer, including relapsed cancer?’

Conclusions
We have identified research priorities for children’s cancer from the perspectives of children, survivors, their families and the professionals who care for them. Questions reflect the breadth of the cancer experience, including diagnosis, relapse, hospital experience, support during/after treatment and the long-term impact of cancer. These should inform funding of future research as they are the questions that matter most to the people who could benefit from research.

Leggi
Dicembre 2023

Shared decision-making improving efficacy in diarrhoea-dominant irritable bowel syndrome in Chinese outpatient setting: protocol of a prospective, randomised controlled trial

Introduction
Diarrhoea-dominant irritable bowel syndrome (IBS-D) is a disorder with multiple pathogenesis; many people with IBS-D may have psychosocial issues which can make assessment and treatment more difficult. Routine treatment procedure might not always achieve the desired outcome. Therefore, patients may not be satisfied with the conventional experience and would like to be more involved in clinical decision-making. A shared decision-making (SDM) model, that requires patient participation, has been demonstrated to have a powerful effect on the diagnosis and treatment of other diseases, which improves patients’ compliance, satisfaction, thus refining the clinical outcome. However, there is no corresponding evidence in IBS-D. Herein, we hope to verify the effect of SDM through clinical studies, and we anticipate that SDM can improve the therapeutic effect in patients with IBS-D.

Methods
The study is a prospective, randomised, single-centre trial. 166 IBS-D outpatients who attend Peking Union Medical College Hospital will be allocated into routine treatment group and SDM group. The primary endpoint is the severity of bowel symptoms, measured by the IBS symptom severity scale. Secondary endpoints include impact of disease and quality of life, negative psychology and the evaluation of diagnosis and treatment process.

Ethics and dissemination
Ethical approval has been obtained from the research ethics committee of Peking Union Medical College Hospital (I-23PJ470). This protocol has been approved by Chinese Clinical Trial Register (ChiCTR2300073681) in July 2023. The results of this trial will be published in an open-access way and disseminated among gastrointestinal physicians.

Trial registration number
Chinese Clinical Trial Register (ChiCTR2300073681).

Leggi
Dicembre 2023

Patient experience of a virtual reality calm room in a psychiatric inpatient care setting in Sweden: a qualitative study with inpatients

Objective
Calm rooms have been developed and implemented in psychiatric inpatient care settings to offer patients a dedicated space for relaxation in a convenient and safe environment. Recent technology developments have enabled virtual reality (VR) equivalents of calm rooms that can be feasibly deployed in psychiatric care settings. While research has shown VR environments to be efficacious in inducing relaxation, little is known how these virtual calm rooms are perceived by patients. The aim of this study was to elucidate patient experiences of using a VR calm room in a psychiatric inpatient setting.

Design
Qualitative interview study. Semi-structured interviews were analysed using qualitive inductive content analysis, which focuses on the interpretation of texts for making replicable and valid inferences.

Setting
Swedish hospital psychiatric inpatient care setting with a wireless, three degrees-of-freedom VR head-mounted display running a calm room application simulating nature environment.

Participants
20 adult patients (12 women) with bipolar disorder (n=18) or unipolar depression (n=2).

Results
Participants experienced the use of the VR calm room as having a positive impact on them, inducing awareness, calmness and well-being. They were thankful to be offered a non-pharmacological alternative for anxiety relief. Participants also expressed that they had some concerns about how they would react emotionally before using the VR device. However, after use, they highlighted that their overall experience was positive. They also expressed that they could see potential for further development of VR technology in psychiatric care.

Conclusions
VR technology has the potential to solve pressing logistic issues in offering calm rooms in psychiatric inpatient care. VR calm rooms appear to be appreciated by psychiatric inpatients, who value their accessibility, convenience and variety of modalities offered. Participants perceived an increase in their well-being after use.

Leggi
Dicembre 2023