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Identifying and understanding challenges to inform new approaches to improve vaccination rates: A qualitative study in Indonesia

Abstract

Purpose

This study aimed to identify and understand challenges to inform new strategies to increase the COVID-19 vaccination rate according to involved vaccinators' perspectives in Belitung, Indonesia.

Design

A qualitative descriptive study design was used.

Methods

Online interviews and chatting were done among 11 vaccinators for data collection between August 2021 and January 2022. Data were analyzed using a content analysis model.

Findings

Four main themes emerged, including (1) communication strategies (evidence-based, electronic-based, and culturally based communication), (2) cross-sectoral strategies (collaboration with police, religious leaders, customary leaders, heads of village divisions, and non-governmental organizations), (3) “picking-up the ball” system (home visits for elderly and people with disability and school visits for children), and (4) setting-up priorities (between mandatory vaccines and boosters).

Conclusion

Despite making vaccination mandatory, the roles of communication, cross-sectoral innovations, “picking-up the ball” system, and priority setting may have useful potential to improve vaccination rates.

Clinical Relevance

The findings may serve as an input to overcome challenges and accelerate the vaccination coverage in Indonesia and beyond. However, further research is needed.

Hypertension and retinal microvascular dysfunction (HyperVasc): protocol of a randomised controlled exercise trial in patients with hypertension

Por: Streese · L. · Gander · J. · Carrard · J. · Hauser · C. · Hinrichs · T. · Schmidt-Trucksäss · A. · Gugleta · K. · Hanssen · H.
Introduction

Hypertension is a global healthcare burden that affects the structure and function of the macrocirculation and microcirculation and induces disease-specific end-organ damage. Vascular biomarkers are essential to timely diagnose this end-organ damage to improve cardiovascular (CV) risk stratification and medical decision making. Exercise therapy is an effective means to improve vascular health and reduce overall CV risk. However, it is still not clear whether high-intensity interval training (HIIT) is recommendable for patients with hypertension to reduce blood pressure, increase cardiorespiratory fitness and ameliorate vascular health.

Methods and analysis

The ‘Hypertension and retinal microvascular dysfunction’ trial will investigate macrovascular and microvascular impairments in hypertensive patients compared with healthy controls to investigate hypertension-induced end-organ damage by using gold-standard methods as well as newly developed unique retinal microvascular biomarkers. In addition, this trial will investigate the reversibility of retinal end-organ damage by assessing the effects of an 8-week supervised and walking based HIIT on blood pressure, cardiorespiratory fitness as well as macrovascular and microvascular health, compared with a control group following standard physical activity recommendations. Primary outcome will be the arteriolar-to-venular diameter ratio. Secondary outcomes will be arteriolar and venular diameters as well as the flicker-light-induced dilation. Further outcomes will be other retinal microvascular biomarkers, flow-mediated dilation of the brachial artery as well as blood pressure, cardiorespiratory fitness, microalbuminuria, hypertensive retinopathy and classical CV risk markers. Analysis of variance and analysis of covariance will be used to investigate group differences between healthy controls and hypertensive patients and training effects in hypertensive patients, respectively.

Ethics and dissemination

The Ethics Committee of Northwestern and Central Switzerland approved this study (EKNZ-2021-00086). All participants will give informed consent.

Trial registration number

NCT04763005.

I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design and operations

Por: Files · D. C. · Matthay · M. A. · Calfee · C. S. · Aggarwal · N. R. · Asare · A. L. · Beitler · J. R. · Berger · P. A. · Burnham · E. L. · Cimino · G. · Coleman · M. H. · Crippa · A. · Discacciati · A. · Gandotra · S. · Gibbs · K. W. · Henderson · P. T. · Ittner · C. A. G. · Jauregui
Introduction

The COVID-19 pandemic brought an urgent need to discover novel effective therapeutics for patients hospitalised with severe COVID-19. The Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis (ISPY COVID-19 trial) was designed and implemented in early 2020 to evaluate investigational agents rapidly and simultaneously on a phase 2 adaptive platform. This manuscript outlines the design, rationale, implementation and challenges of the ISPY COVID-19 trial during the first phase of trial activity from April 2020 until December 2021.

Methods and analysis

The ISPY COVID-19 Trial is a multicentre open-label phase 2 platform trial in the USA designed to evaluate therapeutics that may have a large effect on improving outcomes from severe COVID-19. The ISPY COVID-19 Trial network includes academic and community hospitals with significant geographical diversity across the country. Enrolled patients are randomised to receive one of up to four investigational agents or a control and are evaluated for a family of two primary outcomes—time to recovery and mortality. The statistical design uses a Bayesian model with ‘stopping’ and ‘graduation’ criteria designed to efficiently discard ineffective therapies and graduate promising agents for definitive efficacy trials. Each investigational agent arm enrols to a maximum of 125 patients per arm and is compared with concurrent controls. As of December 2021, 11 investigational agent arms had been activated, and 8 arms were complete. Enrolment and adaptation of the trial design are ongoing.

Ethics and dissemination

ISPY COVID-19 operates under a central institutional review board via Wake Forest School of Medicine IRB00066805. Data generated from this trial will be reported in peer-reviewed medical journals.

Trial registration number

NCT04488081.

Multicentre, prospective, randomised controlled trial to evaluate hexaminolevulinate photodynamic therapy (Cevira) as a novel treatment in patients with high-grade squamous intraepithelial lesion: APRICITY phase 3 study protocol

Por: Chen · F. · Novak · Z. · Dannecker · C. · Mokras · C. · Sui · L. · Zhang · Y. · You · Z. · Han · L. · Lang · J. · Hillemanns · P.
Introduction

High-risk human papilloma virus (HPV)-associated cervical cancer is the fourth most common cancer in women worldwide. Current treatments of high-grade squamous intraepithelial lesion (HSIL) of the cervix are based on invasive surgical interventions, compromising cervical competence and functionality. APRICITY is a multicentre, prospective, double-blind, randomised controlled phase 3 study further evaluating the efficacy and safety of Cevira, an integrated drug-delivery and light-delivery device for hexaminolevulinate photodynamic therapy, which shows promise as a novel, non-invasive outpatient therapy for women with HSIL.

Methods and analysis

Patients with biopsy-confirmed HSIL histology are invited to participate in the study planned to be conducted at 47 sites in China and 25 sites in Ukraine, Russia and the European Union. The aim is to include at least 384 patients, which will be randomised to either Cevira or placebo group (2:1). All patients will be assessed 3 months after first treatment and a second treatment will be administered in patients who are HPV positive or have at least low-grade squamous intraepithelial lesion. Primary endpoint is the proportion of the responders 6 months after first treatment. Secondary efficacy and safety endpoints will be assessed at 6 months, and data for secondary performance endpoints of the Cevira device will be collected at 3 months and 6 months, in case second treatment was administered. All patients in the Cevira group will be enrolled in an open, long-term extension study for 6 months to collect additional efficacy and safety data (study extension endpoints).

Ethics and dissemination

The study was approved by the ethics committee of the Peking Union Medical College Hospital and Hannover Medical University, Germany. Findings will be disseminated through peer review publications and conference presentations.

Trial registration number

NCT04484415; clinicaltrials.gov.

Value-based healthcare in Latin America: a survey of 70 healthcare provider organisations from Argentina, Brazil, Chile, Colombia and Mexico

Por: Makdisse · M. · Ramos · P. · Malheiro · D. · Katz · M. · Novoa · L. · Cendoroglo Neto · M. · Ferreira · J. H. G. · Klajner · S.
Objectives

Value-based healthcare (VBHC) is a health system reform gradually being implemented in health systems worldwide. A previous national-level survey has shown that Latin American countries were in the early stages of alignment with VBHC. Data at the healthcare provider organisations (HPOs) level are lacking. This study aim was to investigate how HPOs in five Latin American countries are implementing VBHC.

Design

Mixed-methods research was conducted using online questionnaire, semistructured interviews based on selected elements of the value agenda (from December 2018 to June 2020), analyses of aggregated data and documents. Qualitative analysis was performed using NVivo QSR International, 1.6.1 (4830). Quantitative analysis used Fisher’s exact test. Univariate analysis was used to compare organisations in relation to the implementation of VBHC initiatives. A p≤0.05 was considered significant.

Participants

Top and middle-level executives from 70 HPOs from Argentina, Brazil, Chile, Colombia and Mexico.

Results

The definition of VBHC varied across participating organisations. Although the value equation had been cited by 24% of participants, its composition differed in most case from the original Equation. Most VBHC initiatives were related to care delivery organisation (56.9%) and outcomes measurement (22.4%) but in most cases, integrated practice unit features had not been fully developed and outcome data was not used to guide improvement. Information, stakeholders buy-in, compensation and fragmented care delivery were the most cited challenges to VBHC implementation. Fee-for-service predominated, although one-third of organisations were experimenting with alternative payment models.

Conclusions

A wide variation in the definition and level of VBHC implementation existed across organisations. Our finding suggests investments in information systems and on education of key stakeholders will be key to foster VBHC implementation in the region. Further research is needed to identify successful implementation cases that may serve as regional benchmark for other Latin American organisations advancing with VBHC.

Characteristics of nursing homes and early preventive measures associated with risk of infection from COVID-19 in Lazio region, Italy: a retrospective case-control study

Por: Orlando · S. · Mazhari · T. · Abbondanzieri · A. · Cerone · G. · Ciccacci · F. · Liotta · G. · Mancinelli · S. · Marazzi · M. C. · Palombi · L.
Objectives

To understand which organisational–structural characteristics of nursing homes—also referred to as long-term care facilities (LTCFs)—and the preventative measures adopted in response to the pandemic are associated with the risk of a COVID-19 outbreak.

Setting

LTCFs in Lazio region in Italy.

Design

The study adopts a case–control design.

Participants

We included 141 facilities and 100 provided information for the study. Cases were defined as facilities reporting a COVID-19 outbreak (two or more cases) in March–December 2020; controls were defined as LTCFs reporting one case or zero. The exposures include the structural–organisational characteristics of the LTCFs as reported by the facilities, preventative measures employed and relevant external factors.

Results

Twenty facilities reported an outbreak of COVID-19. In binary logistic regression models, facilities with more than 15 beds were five times more likely to experience an outbreak than facilities with less than 15 beds OR=5.60 (CI 1.61 to 25.12; p value 0.002); admitting new residents to facilities was associated with a substantially higher risk of an outbreak: 6.46 (CI 1.58 to 27.58, p value 0.004). In a multivariable analysis, facility size was the only variable that was significantly associated with a COVID-19 outbreak OR= 5.37 (CI 1.58 to 22.8; p value 0.012) for larger facilities (>15 beds) versus smaller (

Conclusion

There was evidence of a higher risk of COVID-19 in larger facilities and when new patients were admitted during the pandemic. All other structural–organisational characteristics and preventative measures were not associated with an outbreak. This finding calls into question existing policies, especially where there is a risk of harm to residents. One such example is the restriction of visitor access to facilities, resulting in the social isolation of residents.

Physical functioning outcome measures in the lumbar spinal surgery population and measurement properties of the physical outcome measures: protocol for a systematic review

Por: Kowalski · K. L. · Lukacs · M. J. · Mistry · J. · Goodman · M. · Rushton · A. B.
Introduction

Low back pain can lead to substantial decline in physical functioning. For disabling pain not responsive to conservative management, surgical intervention can enhance physical functioning. Measurements of physical functioning include patient-reported outcome measures and physical outcome measures using evaluations of impairments, performance on a standardised task or activity in a natural environment. Selecting outcome measures with adequate measurement properties is fundamental to evaluating effectiveness of interventions. The purpose of this systematic review is to identify outcome measures (patient reported and physical) used to evaluate physical functioning (stage 1) and assess the measurement properties of physical outcome measures of physical functioning (stage 2) in the lumbar spinal surgery population.

Methods and analysis

This protocol aligns with the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines and Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. Using a two-staged approach, searches will be performed in MEDLINE, EMBASE, Health and Psychosocial Instruments, CINAHL, Web of Science, Scopus, PEDro and the grey literature from inception until 15 December 2021. Stage 1 will identify studies evaluating physical functioning with patient-reported or physical outcome measures in the lumbar spinal surgery population. Stage 2 will search for studies evaluating measurement properties (validity, reliability, responsiveness) of the physical outcome measures identified in stage 1 in the lumbar spinal surgery population. Two independent reviewers will evaluate studies for inclusion, extract data, assess risk of bias (COSMIN risk of bias tool and checklist) and quality of evidence (modified Grading of Recommendations Assessment, Development and Evaluation approach). Results for each measurement property per physical outcome measure will be quantitatively pooled if there is adequate clinical and methodological homogeneity or qualitatively synthesised if there is high heterogeneity in studies.

Ethics and dissemination

Ethics approval is not required. Results will be disseminated through peer-reviewed journal publication and conference presentation.

PROSPERO registration number

CRD42021293880.

Evidence mapping and overview of systematic reviews of the effects of acupuncture therapies

Por: Lu · L. · Zhang · Y. · Ge · S. · Wen · H. · Tang · X. · Zeng · J. c. · Wang · L. · Zeng · Z. · Rada · G. · Avila · C. · Vergara · C. · Chen · R. · Dong · Y. · Wei · X. · Luo · W. · Wang · L. · Guyatt · G. · Tang · C.-Z. · Xu · N.-G.
Objective

To provide a route map regarding systematic reviews (SRs) of acupuncture therapies that will meet two goals: (1) to identify areas in which more or better evidence is required and (2) to identify acupuncture applications that, although proven effective, remain underused in practice, and thus warrant more effective knowledge dissemination.

Eligibility criteria

We included SRs that conducted meta-analyses (MAs) of randomised controlled trials (RCTs) for this overview.

Information sources

We searched for SRs without language restrictions from January 2015 to November 2020 in four Chinese electronic databases and Epistemonikos database. And we also searched for newly published RCTs that were eligible for selected best SRs in PubMed, Medline, Cochrane Central Register of Controlled Trials, Embase and four Chinese electronic databases from its lasted search dates to November 2020.

Synthesis of results

We reanalysed the selected MAs if new primary studies were added. We used random-effect model to calculate the overall effect.

Results

Our search identified 120 SRs published in the last 5 years addressing acupuncture therapies across 12 therapeutic areas and 77 diseases and conditions. The SRs included 205 outcomes and involved 138 995 participants from 1402 RCTs. We constructed 77 evidence matrices, including 120 SRs and their included RCTs in the Epistemonikos database. Seventy-seven SRs represented the effect estimate of acupuncture therapies. Finally, we system summarised the areas of possible underutilisation of acupuncture therapies (high or moderate certainty evidence of large or moderate effects), and the areas of warranting additional investigation of acupuncture therapies (low or very low certainty evidence of moderate or large effects).

Conclusion

The evidence maps and overview of SRs on acupuncture therapies identified both therapies with substantial benefits that may require more assertive evidence dissemination and promising acupuncture therapies that require further investigation.

Risk of SARS-CoV-2 infection among front-line healthcare workers in Northeast Brazil: a respondent-driven sampling approach

Objectives

We assessed the prevalence of SARS-CoV-2 infection, personal protective equipment (PPE) shortages and occurrence of biological accidents among front-line healthcare workers (HCW).

Design, setting and participants

Using respondent-driven sampling, the study recruited distinct categories of HCW attending suspected or confirmed patients with COVID-19 from May 2020 to February 2021, in the Recife metropolitan area, Northeast Brazil.

Outcome measures

The criterion to assess SARS-CoV-2 infection among HCW was a positive self-reported PCR test.

Results

We analysed 1525 HCW: 527 physicians, 471 registered nurses, 263 nursing assistants and 264 physical therapists. Women predominated in all categories (81.1%; 95% CI: 77.8% to 84.1%). Nurses were older with more comorbidities (hypertension and overweight/obesity) than the other staff. The overall prevalence of SARS-CoV-2 infection was 61.8% (95% CI: 55.7% to 67.5%) after adjustment for the cluster random effect, weighted by network, and the reference population size. Risk factors for a positive RT-PCR test were being a nursing assistant (OR adjusted: 2.56; 95% CI: 1.42 to 4.61), not always using all recommended PPE while assisting patients with COVID-19 (OR adj: 2.15; 95% CI: 1.02 to 4.53) and reporting a splash of biological fluid/respiratory secretion in the eyes (OR adj: 3.37; 95% CI: 1.10 to 10.34).

Conclusions

This study shows the high frequency of SARS-CoV2 infection among HCW presumably due to workplace exposures. In our setting, nursing assistant comprised the most vulnerable category. Our findings highlight the need for improving healthcare facility environments, specific training and supervision to cope with public health emergencies.

Effects of social determinants on childrens health in informal settlements in Bangladesh and Kenya through an intersectionality lens: a study protocol

Por: Kibuchi · E. · Barua · P. · Chumo · I. · Teixeira de Siqueira Filha · N. · Phillips-Howard · P. · Mithu · M. I. H. · Kabaria · C. · Quayyum · Z. · Whittaker · L. · Dean · L. · Forsyth · R. · Selim · T. · Aktar · B. · Sai · V. · Garimella · S. · Saidu · S. · Gandi · I. · Josyula · L. K. · M
Introduction

Several studies have shown that residents of urban informal settlements/slums are usually excluded and marginalised from formal social systems and structures of power leading to disproportionally worse health outcomes compared to other urban dwellers. To promote health equity for slum dwellers, requires an understanding of how their lived realities shape inequities especially for young children 0–4 years old (ie, under-fives) who tend to have a higher mortality compared with non-slum children. In these proposed studies, we aim to examine how key Social Determinants of Health (SDoH) factors at child and household levels combine to affect under-five health conditions, who live in slums in Bangladesh and Kenya through an intersectionality lens.

Methods and analysis

The protocol describes how we will analyse data from the Nairobi Cross-sectional Slum Survey (NCSS 2012) for Kenya and the Urban Health Survey (UHS 2013) for Bangladesh to explore how SDoH influence under-five health outcomes in slums within an intersectionality framework. The NCSS 2012 and UHS 2013 samples will consist of 2199 and 3173 under-fives, respectively. We will apply Multilevel Analysis of Individual Heterogeneity and Discriminatory Accuracy approach. Some of SDoH characteristics to be considered will include those of children, head of household, mothers and social structure characteristics of household. The primary outcomes will be whether a child had diarrhoea, cough, fever and acute respiratory infection (ARI) 2 weeks preceding surveys.

Ethics and dissemination

The results will be disseminated in international peer-reviewed journals and presented in events organised by the Accountability and Responsiveness in Informal Settlements for Equity consortium and international conferences. Ethical approval was not required for these studies. Access to the NCSS 2012 has been given by Africa Population and Health Center and UHS 2013 is freely available.

Evaluating novel approaches for estimating awake and sleep blood pressure: design of the Better BP Study - a randomised, crossover trial

Por: Cepeda · M. · Hubbard · D. · Oparil · S. · Schwartz · J. E. · Jaeger · B. C. · Hardy · S. T. · Medina · J. · Chen · L. · Muntner · P. · Shimbo · D.
Introduction

For many people, blood pressure (BP) levels differ when measured in a medical office versus outside of the office setting. Out-of-office BP has a stronger association with cardiovascular disease (CVD) events compared with BP measured in the office. Many BP guidelines recommend measuring BP outside of the office to confirm the levels obtained in the office. Ambulatory BP monitoring (ABPM) can assess out-of-office BP but is not available in many US practices and some individuals find it uncomfortable. The aims of the Better BP Study are to (1) test if unattended office BP is closer to awake BP on ABPM compared with attended office BP, (2) assess if sleep BP assessed by home BP monitoring (HBPM) agrees with sleep BP from a full night of ABPM and (3) compare the strengths of associations of unattended versus attended office BP, unattended office BP versus awake BP on ABPM and sleep BP on HBPM versus ABPM with markers of end-organ damage.

Methods and analysis

We are recruiting 630 adults not taking antihypertensive medication in Birmingham, Alabama, and New York, New York. Participants are having their office BP measured with (attended) and without (unattended) a technician present, in random order, using an automated oscillometric office BP device during each of two visits within one week. Following these visits, participants complete 24 hours of ABPM and one night of HBPM, in random order. Psychosocial factors, anthropometrics, left ventricular mass index and albumin-to-creatinine ratio are also being assessed.

Ethics and dissemination

This study was approved by the University of Alabama at Birmingham and the Columbia University Medical Center Institutional Review Boards. The study results will be disseminated at scientific conferences and published in peer-reviewed journals.

Trial registration number

NCT04307004.

Protocol for Rhapsody: a longitudinal observational study examining the feasibility of speech phenotyping for remote assessment of neurodegenerative and psychiatric disorders

Por: Hampsey · E. · Meszaros · M. · Skirrow · C. · Strawbridge · R. · Taylor · R. H. · Chok · L. · Aarsland · D. · Al-Chalabi · A. · Chaudhuri · R. · Weston · J. · Fristed · E. · Podlewska · A. · Awogbemila · O. · Young · A. H.
Introduction

Neurodegenerative and psychiatric disorders (NPDs) confer a huge health burden, which is set to increase as populations age. New, remotely delivered diagnostic assessments that can detect early stage NPDs by profiling speech could enable earlier intervention and fewer missed diagnoses. The feasibility of collecting speech data remotely in those with NPDs should be established.

Methods and analysis

The present study will assess the feasibility of obtaining speech data, collected remotely using a smartphone app, from individuals across three NPD cohorts: neurodegenerative cognitive diseases (n=50), other neurodegenerative diseases (n=50) and affective disorders (n=50), in addition to matched controls (n=75). Participants will complete audio-recorded speech tasks and both general and cohort-specific symptom scales. The battery of speech tasks will serve several purposes, such as measuring various elements of executive control (eg, attention and short-term memory), as well as measures of voice quality. Participants will then remotely self-administer speech tasks and follow-up symptom scales over a 4-week period. The primary objective is to assess the feasibility of remote collection of continuous narrative speech across a wide range of NPDs using self-administered speech tasks. Additionally, the study evaluates if acoustic and linguistic patterns can predict diagnostic group, as measured by the sensitivity, specificity, Cohen’s kappa and area under the receiver operating characteristic curve of the binary classifiers distinguishing each diagnostic group from each other. Acoustic features analysed include mel-frequency cepstrum coefficients, formant frequencies, intensity and loudness, whereas text-based features such as number of words, noun and pronoun rate and idea density will also be used.

Ethics and dissemination

The study received ethical approval from the Health Research Authority and Health and Care Research Wales (REC reference: 21/PR/0070). Results will be disseminated through open access publication in academic journals, relevant conferences and other publicly accessible channels. Results will be made available to participants on request.

Trial registration number

NCT04939818.

Vitamin D-mediated effects on airway innate immunity <i>in vitro</i>

by Emma M. Stapleton, Kathy Keck, Robert Windisch, Mallory R. Stroik, Andrew L. Thurman, Joseph Zabner, Ian M. Thornell, Alejandro A. Pezzulo, Julia Klesney-Tait, Alejandro P. Comellas

Introduction

Vitamin D supplementation has been suggested to enhance immunity during respiratory infection season. We tested the effect of active vitamin D (calcitriol) supplementation on key airway innate immune mechanisms in vitro.

Methods

Primary human airway epithelial cells (hAECs) grown at the air liquid interface were supplemented with 10−7 M calcitriol for 24 hours (or a time course) and their antimicrobial airway surface liquid (ASL) was tested for pH, viscoscity, and antibacterial and antiviral properties. We also tested hAEC ciliary beat frequency (CBF). Next, we assessed alterations to hAEC gene expression using RNA sequencing, and based on results, we measured neutrophil migration across hAECs.

Results

Calcitriol supplementation enhanced ASL bacterial killing of Staphylococcus aureus (p = 0.02) but did not enhance its antiviral activity against 229E-CoV. It had no effect on ASL pH or viscosity at three timepoints. Lastly, it did not affect hAEC CBF or neutrophil migration, although there was a trend of enhanced migration in the presence of a neutrophil chemokine (p = 0.09). Supplementation significantly altered hAEC gene expression, primarily of AMP-related genes including CAMP and TREM1.

Conclusion

While vitamin D supplementation did not have effects on many airway innate immune mechanisms, it may provide a useful tool to resolve respiratory bacterial infections.

Harm minimisation for self-harm: a cross-sectional survey of British clinicians perspectives and practises

Por: Haris · A. M. · Pitman · A. · Mughal · F. · Bakanaite · E. · Morant · N. · Rowe · S. L.
Objective

Harm minimisation for self-harm is an alternative to preventive strategies and focuses on maximising safety when self-harming. We explored the views of clinicians on harm minimisation for self-harm to describe reported use and acceptability in clinical practice.

Design

A cross-sectional study using an online survey consisting of fixed-choice and open-ended questions.

Setting

Primary and secondary care practices in England, Scotland and Wales.

Participants

Snowball sampling of UK-based clinicians (n=90; 67% female) working with people who self-harm and who have or have not previously recommended harm minimisation methods to patients.

Results

Of the 90 clinicians sampled, 76 (84%) reported having recommended harm minimisation techniques to people in their care who self-harm. Commonly recommended techniques were snapping rubber bands on one’s wrist and squeezing ice. Other techniques, such as teaching use of clean instruments when self-harming, were less likely to be recommended. Perceived client benefits included harm reduction and promotion of the therapeutic relationship. Perceived potential limitations of a harm minimisation approach for self-harm were (a) potential worsening of self-harm outcomes; (b) ethical reservations; (c) doubts about its effectiveness and appropriateness; and (d) lack of training and clear policies within the workplace.

Conclusions

In our sample of UK-based clinicians in various settings, harm minimisation for self-harm was broadly recommended for clients who self-harm due to perceived client benefits. However, future policies on harm minimisation must address clinicians’ perceived needs for training, well-defined guidelines, and clear evidence of effectiveness and safety to mitigate some clinician concerns about the potential for further harm.

Evaluation of two electronic-rehabilitation programmes for persistent knee pain: protocol for a randomised feasibility trial

Por: Groves-Williams · D. · McHugh · G. A. · Bennell · K. L. · Comer · C. · Hensor · E. M. A. · Conner · M. · Nelligan · R. K. · Hinman · R. S. · Kingsbury · S. R. · Conaghan · P. G.
Introduction

Persistent, knee pain is a common cause of disability. Education and exercise treatment are advocated in all clinical guidelines; however, the increasing prevalence of persistent knee pain presents challenges for health services regarding appropriate and scalable delivery of these treatments. Digital technologies may help address this, and this trial will evaluate the feasibility and acceptability of two electronic-rehabilitation interventions: ‘My Knee UK’ and ‘Group E-Rehab’.

Methods and analysis

This protocol describes a non-blinded, randomised feasibility trial with three parallel groups. The trial aims to recruit 90 participants (45 years or older) with a history of persistent knee pain consistent with a clinical diagnosis of knee osteoarthritis. Participants will be randomly assigned in a 1:1:1 allocation ratio. The ‘My Knee UK’ intervention arm will receive a self-directed unsupervised internet-based home exercise programme plus short message service support (targeting exercise behaviour change) for 12 weeks; the ‘Group E-Rehab’ intervention arm will receive group-based physiotherapist-prescribed home exercises delivered via videoconferencing accompanied by internet-interactive educational sessions for 12 weeks; the control arm will receive usual physiotherapy care or continue with their usual self-management (depending on their recruitment path). Feasibility variables, patient-reported outcomes and clinical findings measured at baseline, 3 and 9 months will be assessed and integrated with qualitative interview data from a subset of Group E-Rehab and My Knee UK participants. If considered feasible and acceptable, a definitive randomised controlled trial can be conducted to investigate the clinical effectiveness and cost-effectiveness of one or both interventions with a view to implementation in routine care.

Ethics and dissemination

The trial was approved by the West of Scotland Research Ethics Committee 5 (Reference: 20/WS/0006). The results of the study will be disseminated to study participants, the study grant funder and will be submitted for publication in peer-reviewed journals.

Trial registration number

ISRCTN15564385.

Interventions to promote the implementation of pressure injuries prevention measures in nursing homes: a scoping review protocol

Por: Yang · L.-F. · Liu · Y.-L. · Wu · C.-T. · Ni · C.-P. · Liu · Y.
Introduction

Currently, various guidelines and documents on the prevention of pressure injuries have been published, but there are many serious lags in the actual practice in nursing homes. So some interventions are required to promote the implementation of normative practices. There was a review of preventive interventions for pressure injuries in long-term care facilities, but there is no systematic review of how to promote the implementation of preventive measures. This review aims to summarise interventions that promote the implementation of pressure injuries prevention measures in nursing homes, explore the research scope and gaps in this field and provide evidence and striving direction for global nursing homes to improve existing preventive behaviours.

Methods and analysis

This scoping review will combine the Arksey and O’Malley framework with further clarification and advice of the scoping review by Levac et al as methodological guidance. Systematic retrieval of relevant literature databases, grey literature and references included studies will be conducted. Two reviewers will screen titles and abstracts independently, and then screen the full text of potentially relevant articles to determine final inclusion. After that, two reviewers will extract data based on a predesigned data extraction table independently. Inductive analysis and narrative analysis will be used to collate, summarise and report the results. Finally, managers of nursing homes in China will be consulted for additional information and their viewpoints on the research findings.

Ethics and dissemination

Since the scoping review is a secondary analysis of the literature, there is no need to apply for ethical approval. Our goal is to share the results with key stakeholders to help them find the direction of effort and improve clinical practice. Therefore, dissemination plans include publication in international journals and sharing it at conferences to inform more healthcare workers about the scope and gaps of the studies.

Rationale and design of a prospective study evaluating population pharmacokinetics and pharmacodynamics of rivaroxaban in Chinese patients with non-valvular atrial fibrillation

Por: Liu · X.-Q. · Zhang · Y.-F. · Ding · H.-Y. · Yan · M.-M. · Zhong · M.-K. · Ma · C.-L.
Introduction

Rivaroxaban is one of the most commonly used non-vitamin K antagonists for stroke prevention in patients with non-valvular atrial fibrillation (NVAF). Different individual exposures exist for Asian and non-Asian populations, and dose selection is different for Japanese and non-Japanese subjects. Few studies have investigated the pharmacokinetics (PK) and pharmacodynamics (PD) of rivaroxaban in Chinese patients and provided a solid reference for dose selection and individualised therapy.

Methods and analysis

This is a single-centre prospective study. Rivaroxaban-treated Chinese NVAF patients will be recruited according to predetermined inclusion criteria. Blood samples will be collected from both outpatients and inpatients with different sampling strategies at steady state. Rivaroxaban plasma concentration, factor Xa activity, prothrombin time and single-nucleotide polymorphisms of candidate genes will be evaluated. Follow-up will be conducted following 3 and 6 months after enrolment to collect information about the safety and efficacy outcomes. A nonlinear mixed-effects modelling strategy will be used to develop a population PK-PD model of rivaroxaban.

Ethics and dissemination

The study has been approved by the Ethics Committee of Huashan Hospital, Fudan University (KY2020-016). The study findings will be submitted to peer-reviewed journals and shared with public health authorities.

Trial registration number

ChiCTR2100046685.

Development and validation of a social vulnerabilities survey for medical inpatients

Por: Tang · K. L. · Sajobi · T. · Santana · M.-J. · Lawal · O. · Tesorero · L. · Ghali · W. A.
Objectives

Our objective was to validate a Social Vulnerabilities Survey that was developed to identify patient barriers in the following domains: (1) salience or priority of health; (2) social support; (3) transportation; and (4) finances.

Design

Cross-sectional psychometric study.

Questions for one domain (health salience) were developed de novo while questions for the other domains were derived from national surveys and/or previously validated questionnaires. We tested construct (ie, convergent and discriminative) validity for these new questions through hypothesis testing of correlations between question responses and patient characteristics. Exploratory factor analysis was conducted to determine structural validity of the survey as a whole.

Setting

Patients admitted to the inpatient internal medicine service at a tertiary care hospital in Calgary, Canada.

Participants

A total of 406 patients were included in the study.

Results

The mean age of respondents was 55.5 (SD 18.6) years, with the majority being men (55.4%). In feasibility testing of the first 107 patients, the Social Vulnerabilities Survey was felt to be acceptable, comprehensive and met face validity. Hypothesis testing of the health salience questions revealed that the majority of observed correlations were exactly as predicted. Exploratory factor analysis of the global survey revealed the presence of five factors (eigenvalue >1): social support, health salience, drug insurance, transportation barriers and drug costs. All but four questions loaded to these five factors.

Conclusions

The Social Vulnerabilities Survey has face, construct and structural validity. It can be used to measure modifiable social vulnerabilities, such that their effects on health outcomes can be explored and understood.

Protocol for a qualitative study exploring haemodialysis dependent patients arteriovenous fistula experience, values and concerns in Sydney, Australia

Por: Stavert · B. M. · Monaro · S. · Tienstra · L. · Naganathan · V. · Aitken · S. J.
Introduction

The experiences of patients from culturally and linguistically diverse backgrounds, with chronic mental illness, disabilities or who identify as sexual or religious minorities are under-represented in clinical research on arteriovenous fistula (AVF) for haemodialysis access. A greater understanding of the experiences, values and concerns of these diverse patient groups are needed to provide haemodialysis access care that addresses the needs of all haemodialysis-dependent patients. This study seeks to describe a broad range of patient experiences related to the creation, care and surveillance of AVFs, including interactions with healthcare teams.

Methods and analysis

This qualitative study will use semistructured interviews with individual patients purposefully selected to provide a diverse patient population. A deliberate strategy will be used to recruit a demographically broad range of participants. Thematic analysis of interview transcripts, using a constant comparative methodology, will generate themes that describe patient experiences, values and concerns. Findings from this study will give a nuanced insight into the experiences of patients on haemodialysis with respect to their AVF.

Ethics and dissemination

Ethical approval for this study was provided by the Sydney Local Health District Human Research Ethics Committee (REGIS identifier: 2021/ETH00362, CH reference number: CH62/6/2021-033). Results will be made available to the participants, local health district, funders and other researchers through various hospital and academic forums. Data will also be published in peer-reviewed journals and be part of a larger body of work looking into patient-reported outcome measures for patients with AVF.

Real-time seizure detection in paediatric intensive care patients: the RESET child brain protocol

Por: Waak · M. · Gibbons · K. · Sparkes · L. · Harnischfeger · J. · Gurr · S. · Schibler · A. · Slater · A. · Malone · S.
Introduction

Approximately 20%–40% of comatose children with risk factors in intensive care have electrographic-only seizures; these go unrecognised due to the absence of continuous electroencephalography (EEG) monitoring (cEEG). Utility of cEEG with high-quality assessment is currently limited due to high-resource requirements. New software analysis tools are available to facilitate bedside cEEG assessment using quantitative EEG (QEEG) trends. The primary aim of this study is to describe accuracy of interpretation of QEEG trends by paediatric intensive care unit (PICU) nurses compared with cEEG assessment by neurologist (standard clinical care) in children at risk of seizures and status epilepticus utilising diagnostic test statistics. The secondary aims are to determine time to seizure detection for QEEG users compared with standard clinical care and describe impact of confounders on accuracy of seizure detection.

Methods and analysis

This will be a single-centre, prospective observational cohort study evaluating a paediatric QEEG programme utilising the full 19 electrode set. The setting will be a 36-bed quaternary PICU with medical, cardiac and general surgical cases. cEEG studies in PICU patients identified as ‘at risk of seizures’ will be analysed. Trained bedside clinical nurses will interpret the QEEG. Seizure events will be marked as seizures if >3 QEEG criteria occur. Post-hoc dedicated neurologists, who remain blinded to the QEEG analysis, will interpret the cEEG. Determination of standard test characteristics will assess the primary hypothesis. To calculate 95% (CIs) around the sensitivity and specificity estimates with a CI width of 10%, the sample size needed for sensitivity is 80 patients assuming each EEG will have approximately 9 to 18 1-hour epochs.

Ethics and dissemination

The study has received approval by the Children’s Health Queensland Human Research Ethics Committee (HREC/19/QCHQ/58145). Results will be made available to the funders, critical care survivors and their caregivers, the relevant societies, and other researchers.

Trial registration number

Australian New Zealand Clinical Trials Registry (ANZCTR) 12621001471875.

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