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Descriptive study of the challenges when implementing an app for patients with neovascular age-related macular degeneration to monitor their vision at home

Por: Reeves · B. C. · Wickens · R. · OConnor · S. R. · Gidman · E. A. · Ward · E. · Treanor · C. · Peto · T. · Burton · B. J. L. · Knox · P. C. · Lotery · A. · Sivaprasad · S. · Donnelly · M. · Rogers · C. A. · Hogg · R. E.
Objectives

Remote monitoring of health has the potential to reduce the burden to patients of face-to-face appointments and make healthcare more efficient. Apps are available for patients to self-monitor vision at home, for example, to detect reactivation of age-related macular degeneration (AMD). Describing the challenges when implementing apps for self-monitoring of vision at home was an objective of the MONARCH study to evaluate two vision-monitoring apps on an iPod Touch (Multibit and MyVisionTrack).

Design

Diagnostic Test Accuracy study.

Setting

Six UK hospitals.

Methods

The study provides an example of the real-world implementation of such apps across health sectors in an older population. Challenges described include the following: (1) frequency and reason for incoming calls made to a helpline and outgoing calls made to participants; (2) frequency and duration of events responsible for the tests being unavailable; and (3) other technical and logistical challenges.

Results

Patients (n=297) in the study were familiar with technology; 252/296 (85%) had internet at home and 197/296 (67%) had used a smartphone. Nevertheless, 141 (46%) called the study helpline, more often than anticipated. Of 435 reasons for calling, all but 42 (10%) related to testing with the apps or hardware, which contributed to reduced adherence. The team made at least one call to 133 patients (44%) to investigate why data had not been transmitted. Multibit and MyVisionTrack apps were unavailable for 15 and 30 of 1318 testing days for reasons which were the responsibility of the app providers. Researchers also experienced technical challenges with a multiple device management system. Logistical challenges included regulations for transporting lithium-ion batteries and malfunctioning chargers.

Conclusions

Implementation of similar technologies should incorporate a well-resourced helpline and build in additional training time for participants and troubleshooting time for staff. There should also be robust evidence that chosen technologies are fit for the intended purpose.

Trial registration number

ISRCTN79058224.

Serotype 3 Experimental Human Pneumococcal Challenge (EHPC) study protocol: dose ranging and reproducibility in a healthy volunteer population (challenge 3)

Por: Hazenberg · P. · Robinson · R. E. · Farrar · M. · Solorzano · C. · Hyder-Wright · A. · Liatsikos · K. · Brunning · J. · Fleet · H. · Bettam · A. · Howard · A. · Kenny-Nyazika · T. · Urban · B. · Mitsi · E. · El Safadi · D. · Davies · K. · Lesosky · M. · Gordon · S. B. · Ferreira · D. M.
Introduction

Since the introduction of pneumococcal conjugate vaccines, pneumococcal disease rates have declined for many vaccine-type serotypes. However, serotype 3 (SPN3) continues to cause significant disease and is identified in colonisation epidemiological studies as one of the top circulating serotypes in adults in the UK. Consequently, new vaccines that provide greater protection against SPN3 colonisation/carriage are urgently needed. The Experimental Human Pneumococcal Challenge (EHPC) model is a unique method of determining pneumococcal colonisation rates, understanding acquired immunity, and testing vaccines in a cost-effective manner. To enhance the development of effective pneumococcal vaccines against SPN3, we aim to develop a new relevant and safe SPN3 EHPC model with high attack rates which could be used to test vaccines using small sample size.

Methods and analysis

This is a human challenge study to establish a new SPN3 EHPC model, consisting of two parts. In the dose-ranging/safety study, cohorts of 10 healthy participants will be challenged with escalating doses of SPN3. If first challenge does not lead into colonisation, participants will receive a second challenge 2 weeks after. Experimental nasopharyngeal (NP) colonisation will be determined using nasal wash sampling. Using the dose that results in ≥50% of participants being colonised, with a high safety profile, we will complete the cohort with another 33 participants to check for reproducibility of the colonisation rate. The primary outcome of this study is to determine the optimal SPN3 dose and inoculation regime to establish the highest rates of NP colonisation in healthy adults. Secondary outcomes include determining density and duration of experimental SPN3 NP colonisation and characterising mucosal and systemic immune responses to SPN3 challenge.

Ethics and dissemination

This study is approved by the NHS Research and Ethics Committee (reference 22/NW/0051). Findings will be published in peer-reviewed journals and reports will be made available to participants.

All-cause and cause-specific mortality among individuals imprisoned for driving under the influence of alcohol and drugs in Norway (2000-2016): a retrospective cohort study

Por: Jamt · R. E. G. · Bukten · A. · Stavseth · M. R. · Bogstrand · S. T. · Tverborgvik · T.
Aims

To describe all-cause and cause-specific mortality and to investigate factors associated with mortality among individuals imprisoned for driving under the influence (DUI) of alcohol and psychoactive drugs in the Norwegian prison population.

Design

Retrospective cohort study. The Norwegian prison registry was linked to the Norwegian Cause of Death Registry (2000–2016).

Setting

Norway.

Participants/cases

The cohort consisted of 96 856 individuals imprisoned in Norway over a 17-year period obtained from the Norwegian prison registry.

Primary and secondary outcome measures

Adjusted ORs (aOR) with 95% CI were calculated for death due to any, natural and unnatural causes of death. Analyses were stratified according to DUI convictions: no DUI convictions, only DUI convictions (DUI only), DUI and at least one other drug and alcohol conviction (DUI drug), and DUI and at least one conviction other than drug and alcohol conviction (DUI other).

Results

In total, 29.3% individuals had one or more imprisonments for DUI. The risk of all-cause mortality was elevated for those convicted for DUI, but only in combination with other types of crimes (DUI drug: aOR=1.5, 95% CI 1.4 to 1.6, DUI other: aOR=1.2, 95% CI 1.1 to 1.4). The risk of death from natural causes was significantly elevated for DUI drug (aOR: 1.8, 95% CI 1.6 to 2.0) and for DUI other (aOR=1.3, 95% CI 1.1 to 1.6). The risk of death from unnatural causes was lower for DUI only (aOR=0.8, 95% CI 0.7 to 0.9) and elevated for DUI drug (aOR=1.5, 95% CI 1.3 to 1.6).

Conclusions

The risk of all-cause mortality was significantly elevated for those convicted of DUI, but only in combination with other types of crimes.

Family-focused intervention to promote adolescent mental health and well-being in Moldova and North Macedonia (FLOURISH): feasibility study protocol

Por: Shenderovich · Y. · Piolanti · A. · Babii · V. · Calovska-Hertzog · N. · Evans · R. E. · Heinrichs · N. · Burgund Isakov · A. · Lesco · G. · Moore · G. · Mueller · J. · Raleva · M. · Shimbov · B. · Simon · J. · Waller · F. · Wienand · D. · Foran · H. M.
Introduction

Family-Focused Adolescent & Lifelong Health Promotion (FLOURISH) project will adapt, implement and evaluate a programme to support adolescent mental health and well-being through strategies, such as strengthening parenting practices, adolescent-caregiver relationships, adolescent and parent socioemotional skills, and social support.

Methods and analysis

The project will focus on adolescents aged 10–14 years and their caregivers in North Macedonia and Moldova. The countries were selected based on implementation readiness of two organisations and a need for accessible evidence-informed services to help mitigate health risks due to economic, social and political challenges. Parenting for Lifelong Health (PLH) for Parents and Teens is a family-based programme developed for low-resource settings. PLH has been adapted with input from advisory groups. The programme includes additional components to strengthen impacts on adolescents: adolescent mental health tools, based on UNICEF’s Helping Adolescents Thrive, adolescent peer support and participation booster. This pilot is first of three study phases. The pilot will be a feasibility testing of the adapted intervention and the assessment and implementation procedures to determine further refinements. The pilot will examine if the adapted programme is acceptable for adolescents, their families and providers, explore contextual factors relevant to embedding this programme into longer-term scale-up and investigate whether the programme can be delivered with fidelity and participation; whether the participants report changes in adolescent emotional and behavioural problems, well-being and other outcomes; and whether the study tools are feasible and appropriate. Pre-post adolescent and caregiver questionnaires will provide outcome data. Process evaluation will include attendance and fidelity data, and focus groups. We will examine delivery cost and resource requirements.

Ethics and dissemination

The study was approved at the University of Klagenfurt (Austria), Medical Faculty at St. Cyril and Methodius University (North Macedonia) and National Committee of Ethical Expertise for Clinical Trials (Moldova). Through stakeholder engagement and dissemination, FLOURISH will advance scale-up of open-source family interventions.

Trial registration number

Trial registration: ID101095528; project page: https://www.flourish-study.org/about.html; https://www.linkedin.com/company/flourish-study/

Mapping Oral health and Local Area Resources (MOLAR): protocol for a randomised controlled trial connecting emergency department patients with social and dental resources

Por: Simon · L. · Marsh · R. · Sanchez · L. D. · Camargo · C. · Donoff · B. · Cardenas · V. · Manning · W. · Loo · S. · Cash · R. E. · Samuels-Kalow · M. E.
Introduction

There are substantial inequities in oral health access and outcomes in the USA, including by income and racial and ethnic identity. People with adverse social determinants of health (aSDoH), such as housing or food insecurity, are also more likely to have unmet dental needs. Many patients with dental problems present to the emergency department (ED), where minimal dental care or referral is usually available. Nonetheless, the ED represents an important point of contact to facilitate screening and referral for unmet oral health needs and aSDoH, particularly for patients who may not otherwise have access to care.

Methods and analysis

Mapping Oral health and Local Area Resources is a randomised controlled trial enrolling 2049 adult and paediatric ED patients with unmet oral health needs into one of three trial arms: (a) a standard handout of nearby dental and aSDoH resources; (b) a geographically matched listing of aSDoH resources and a search link for identification of geographically matched dental resources; or (c) geographically matched resources along with personalised care navigation. Follow-up at 3, 6, 9 and 12 months will evaluate oral health-related quality of life, linkage to resources and dental treatment, ED visits for dental problems and the association between linkage and neighbourhood resource density.

Ethics and dissemination

All sites share a single human subjects review board protocol which has been fully approved by the Mass General Brigham Human Subjects Review Board. Informed consent will be obtained from all adults and adult caregivers, and assent will be obtained from age-appropriate child participants. Results will demonstrate the impact of addressing aSDoH on oral health access and the efficacy of various forms of resource navigation compared with enhanced standard care. Our findings will facilitate sustainable, scalable interventions to identify and address aSDoH in the ED to improve oral health and reduce oral health inequities.

Trial registration number

NCT05688982.

Prevalence and correlates of burn-out among Nigerian medical doctors during the COVID-19 pandemic: a cross-sectional study

Por: Pius · R. E. · Ajuluchukwu · J. N. · Roberts · A. A.
Introduction

Physician burn-out was an issue before the pandemic. Medical personnel have faced several clinical and non-clinical challenges because of the novel coronavirus (SARS-CoV-2) pandemic, which predisposes them to burn-out. There is a paucity of studies that shed light on the level of burn-out and its association with work-related factors for Nigerian medical doctors. This study aims to examine the level of burn-out among Nigerian medical doctors during the COVID-19 pandemic and explore possible associations between burn-out and sociodemographic, work-related and COVID-19-related factors.

Methodology

A cross-sectional study was conducted among 251 medical doctors in a tertiary hospital in Nigeria. A questionnaire was used to obtain sociodemographic history, work-associated factors, COVID-19-related parameters and burn-out history. Personal, work-related and patient-related burn-out were evaluated with the use of the Copenhagen Burnout Inventory.

Results

The number of doctors enrolled in this study was 251 with a median age of 34; 51.4% were males. The percentage of doctors who had personal, work-related and patient-related burn-out were 62.2%, 52.2 % and 27.5%, respectively. The univariate analysis revealed a correlation between burn-out scores and cadre, age, sex, years of experience, marital status, weekly work hours and number of calls. After multiple regression, female gender (p=0.012), those with less than 6 years of work experience (p=0.004) and those working for at least 71 hours in a week (p=0.0001) remained correlated with higher burn-out scores. Additionally, physicians who had a person with COVID-19 in their immediate environment had an independent correlation with higher work-related burn-out scores (p=0.043).

Conclusion

The prevalence of burn-out is high among Nigerian doctors and is linked to some sociodemographic, work-related and COVID-19-related factors. Due to the adverse effects of burn-out on physician well-being and patient care, strategies need to be put in place to identify and mitigate burn-out among Nigerian physicians.

Six month incidence of major adverse cardiovascular events among adults with HIV in northern Tanzania: a prospective observational study

Por: Stark · K. · O'Leary · P. R. E. · Sakita · F. M. · Ford · J. S. · Mmbaga · B. T. · Blass · B. · Gedion · K. · Coaxum · L. A. · Rutta · A. · Galson · S. W. · Rugakingira · A. · Manavalan · P. · Bloomfield · G. S. · Hertz · J. T.
Objectives

We aimed to prospectively describe incident cardiovascular events among people living with HIV (PLWH) in northern Tanzania. Secondary aims of this study were to understand non-communicable disease care-seeking behaviour and patient preferences for cardiovascular care and education.

Design

A prospective observational study.

Setting

This study was conducted at the Majengo HIV Care and Treatment Clinic, an outpatient government-funded clinic in Moshi, Tanzania

Participants

Adult patients presenting to an HIV clinic for routine care in northern Tanzania were enrolled from 1 September 2020 to 1 March 2021.

Interventions

At enrolment, participants completed a survey and a resting 12-lead ECG was obtained. At 6 month follow-up, a repeat survey regarding interim health events and repeat ECG was obtained.

Primary and secondary outcome measures

Interim major adverse cardiovascular events (MACE) were defined by: self-reported interim stroke, self-reported hospitalisation for heart failure, self-reported interim myocardial infarction, interim myocardial infarction by ECG criteria (new pathologic Q waves in two contiguous leads) or death due to cardiovascular disease (CVD).

Results

Of 500 enrolled participants, 477 (95.4%) completed 6 month follow-up and 3 (0.6%) died. Over the 6 month follow-up period, 11 MACE occurred (3 strokes, 6 myocardial infarctions, 1 heart failure hospitalisation and 1 cardiovascular death), resulting in an incidence rate of 4.58 MACE per 100 person-years. Of participants completing 6 month follow-up, 31 (6.5%) reported a new non-communicable disease diagnosis, including 23 (4.8%) with a new hypertension diagnosis.

Conclusions

The incidence of MACE among PLWH in Tanzania is high. These findings are an important preliminary step in understanding the landscape of CVD among PLWH in Tanzania and highlight the need for interventions to reduce cardiovascular risk in this population.

What are effective vaccine distribution approaches for equity-deserving and high-risk populations during COVID-19? Exploring best practices and recommendations in Canada: protocol for a mixed-methods multiple case codesign study

Por: Aggarwal · M. · Katz · A. · Kokorelias · K. M. · Wong · S. T. · Aghajafari · F. · Ivers · N. M. · Martin-Misener · R. · Aubrey-Bassler · K. · Breton · M. · Upshur · R. E. G. · Kwong · J. C.
Introduction

The WHO has stated that vaccine hesitancy is a serious threat to overcoming COVID-19. Vaccine hesitancy among underserved and at-risk communities is an ongoing challenge in Canada. Public confidence in vaccine safety and effectiveness and the principles of equity need to be considered in vaccine distribution. In Canada, governments of each province or territory manage their own healthcare system, providing an opportunity to compare and contrast distribution strategies. The overarching objective of this study is to identify effective vaccine distribution approaches and advance knowledge on how to design and implement various strategies to meet the different needs of underserved communities.

Methods and analysis

Multiple case studies in seven Canadian provinces will be conducted using a mixed-methods design. The study will be informed by Experience-Based CoDesign techniques and theoretically guided by the Socio-Ecological Model and the Vaccine Hesitancy Matrix frameworks. Phase 1 will involve a policy document review to systematically explore the vaccine distribution strategy over time in each jurisdiction. This will inform the second phase, which will involve (2a) semistructured, in-depth interviews with policymakers, public health officials, researchers, providers, groups representing patients, researchers and stakeholders and (2b) an analysis of population-based administrative health data of vaccine administration. Integration of qualitative and quantitative data will inform the identification of effective vaccine distribution approaches for various populations. Informed by this evidence, phase 3 of the study will involve conducting focus groups with multiple stakeholders to codesign recommendations for the design and implementation of effective vaccine delivery strategies for equity-deserving and at-risk populations.

Ethics and dissemination

This study is approved by the University of Toronto’s Health Sciences Research Ethics Board (#42643), University of British Columbia Behavioural Research Ethics Board (#H22-01750-A002), Research Ethics Board of the Nova Scotia Health Authority (#48272), Newfoundland and Labrador Health Research Ethics Board (#2022.126), Conjoint Health Research Ethics Board, University of Calgary (REB22-0207), and University of Manitoba Health Research Board (H2022-239). The outcome of this study will be to produce a series of recommendations for implementing future vaccine distribution approaches from the perspective of various stakeholders, including equity-deserving and at-risk populations.

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