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Post Intensive Care Syndrome in Swiss Paediatric survivors and their Families (PICSS-PF): a national, multicentre, longitudinal study protocol

Por: Rahmaty · Z. · Manning · J. C. · Perez · M.-H. · Ramelet · A.-S.
Introduction

Paediatric intensive care units (PICUs) survivors and their families often experience widespread morbidity and psychosocial consequences after discharge, known as post-intensive care syndrome in paediatrics (PICS-p). In Switzerland, more than 5000 children are admitted to PICUs each year, and despite the high survival rate, there are no data on post-PICU recovery. This study aims to investigate PICS in children and families and identify its associated factors.

Methods and analysis

This is a national, multicentre, longitudinal, observational study that includes PICU survivors, main family caregivers and siblings (n=1300) recruited from the eight Swiss accredited PICUs with follow-up at discharge, 1, 3 and 6 months after discharge from the PICU. Data will be collected on the domains of physical, emotional, social and cognitive health, as well as factors affecting the outcome related to demographics, clinical specification, PICU and family environment, as well as community and social resources. Structural equation models and growth mixture models will analyse the outcomes, and the heterogeneity of recovery that shed light on the diverse recovery experiences of children and their families. The study identifies risk and protective factors with a focus on the influence of social and familial resources. It will also explore the mutual impact of the child’s recovery and parent/sibling psychosocial health.

Ethics and dissemination

The protocol is approved by the CER-VD ethics committee. Participants will be provided with verbal and written explanations of the study, and their privacy and anonymity will be protected throughout the process. The results will be presented at local and international conferences.

Approval number

Swiss ethics committees ID: 2022-02128, representing the eight cantons for both French and German-speaking parts of Switzerland.

REVISE: Re-Evaluating the Inhibition of Stress Erosions in the ICU: a randomised trial protocol

Por: Deane · A. M. · Alhazzani · W. · Guyatt · G. · Finfer · S. · Marshall · J. C. · Myburgh · J. · Zytaruk · N. · Hardie · M. · Saunders · L. · Knowles · S. · Lauzier · F. · Chapman · M. J. · English · S. · Muscedere · J. · Arabi · Y. · Ostermann · M. · Venkatesh · B. · Young · P. · Thabane · L
Introduction

The Re-Evaluating the Inhibition of Stress Erosions (REVISE) Trial aims to determine the impact of the proton pump inhibitor pantoprazole compared with placebo on clinically important upper gastrointestinal (GI) bleeding in the intensive care unit (ICU), 90-day mortality and other endpoints in critically ill adults. The objective of this report is to describe the rationale, methodology, ethics and management of REVISE.

Methods and analysis

REVISE is an international, randomised, concealed, stratified, blinded parallel-group individual patient trial being conducted in ICUs in Canada, Australia, Saudi Arabia, UK, US, Kuwait, Pakistan and Brazil. Patients≥18 years old expected to remain invasively mechanically ventilated beyond the calendar day after enrolment are being randomised to either 40 mg pantoprazole intravenously or an identical placebo daily while mechanically ventilated in the ICU. The primary efficacy outcome is clinically important upper GI bleeding within 90 days of randomisation. The primary safety outcome is 90-day all-cause mortality. Secondary outcomes include rates of ventilator-associated pneumonia, Clostridioides difficile infection, new renal replacement therapy, ICU and hospital mortality, and patient-important GI bleeding. Tertiary outcomes are total red blood cells transfused, peak serum creatinine level in the ICU, and duration of mechanical ventilation, ICU and hospital stay. The sample size is 4800 patients; one interim analysis was conducted after 2400 patients had complete 90-day follow-up; the Data Monitoring Committee recommended continuing the trial.

Ethics and dissemination

All participating centres receive research ethics approval before initiation by hospital, region or country, including, but not limited to – Australia: Northern Sydney Local Health District Human Research Ethics Committee and Mater Misericordiae Ltd Human Research Ethics Committee; Brazil: Comissão Nacional de Ética em Pesquisa; Canada: Hamilton Integrated Research Ethics Board; Kuwait: Ministry of Health Standing Committee for Coordination of Health and Medical Research; Pakistan: Maroof Institutional Review Board; Saudi Arabia: Ministry of National Guard Health Affairs Institutional Review Board: United Kingdom: Hampshire B Research Ethics Committee; United States: Institutional Review Board of the Nebraska Medical Centre. The results of this trial will inform clinical practice and guidelines worldwide.

Trial registration number

NCT03374800.

Investigating the ability to adhere to cardiometabolic medications with different properties: a retrospective cohort study of >500 000 patients in the USA

Por: Lauffenburger · J. C. · Tesfaye · H. · Solomon · D. H. · Antman · E. M. · Glynn · R. J. · Lee · S. B. · Tong · A. · Choudhry · N. K.
Objective

Poor medication adherence remains highly prevalent and adversely affects health outcomes. Patients frequently describe properties of the pills themselves, like size and shape, as barriers, but this has not been evaluated objectively. We sought to determine the extent to which oral medication properties thought to be influential translate into lower objectively-measured adherence.

Design

Retrospective cohort study.

Setting

US nationwide commercial claims database, 2016–2019.

Participants

Among patients initiating first-line hypertension, diabetes or hyperlipidaemia treatment based on clinical guidelines, we measured pill size, shape, colour and flavouring, number of pills/day and fixed-dose combination status as properties.

Outcome measures

Outcomes included discontinuation after the first fill (ie, never filling again over a minimum of 1-year follow-up) and long-term non-adherence (1-year proportion of days covered

Results

Across 604 323 patients, 14.6% discontinued after filling once (ie, were non-persistent), and 54.0% were non-adherent over 1-year follow-up. Large pill size was associated with non-adherence, except for thiazides (eg, metformin adjusted OR (aOR): 1.12, 95% CI: 1.06 to 1.18). Greater pill burden was associated with a higher risk of non-adherence across all classes (eg, metformin aOR: 1.58, 95% CI: 1.53 to 1.64 for two pills/day). Taking less than one pill/day was also associated with higher risk of non-adherence and non-persistence (eg, non-persistence statin aOR: 1.29, 95% CI: 1.20 to 1.38). Pill shape, colour, flavouring and combination status were associated with mixed effects across classes.

Conclusions

Pill burden and pill size are key properties affecting adherence for almost all classes; others, like size and combination, could modestly affect medication adherence. Clinical interventions could screen patients for potential intolerance to medication and potentially implement more convenient dosing schedules.

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.

Systematic literature review and network meta-analysis of therapies for psoriatic arthritis on patient-reported outcomes

Por: Nash · P. · Dutz · J. P. · Peterson · S. · Patel · B. P. · Eaton · K. · Shawi · M. · Zazzetti · F. · Wei · J. C.-C.
Objectives

Head-to-head clinical trials are common in psoriasis, but scarce in psoriatic arthritis (PsA), making treatment comparisons between therapeutic classes difficult. This study describes the relative effectiveness of targeted synthetic (ts) and biologic (b) disease-modifying antirheumatic drugs (DMARDs) on patient-reported outcomes (PROs) through network meta-analysis (NMA).

Design

A systematic literature review (SLR) was conducted in January 2020. Bayesian NMAs were conducted to compare treatments on Health Assessment Questionnaire Disability Index (HAQ-DI) and 36-item Short Form (SF-36) Health Survey including Mental Component Summary (MCS) and Physical Component Summary (PCS) scores.

Data sources

Ovid MEDLINE (including Epub Ahead of Print, In-Process & Other Non-Indexed Citations and Daily),Embase and Cochrane Central Register of Controlled Trials.

Eligibility criteria

Phase III randomised controlled trials (RCTs) evaluating patients with PsA receiving tsDMARDS, bDMARDs or placebo were included in the SLR; there was no restriction on outcomes.

Data extraction and synthesis

Two independent researchers reviewed all citations. Data for studies meeting all inclusion criteria were extracted into a standardised Excel-based form by one reviewer and validated by a second reviewer. A third reviewer was consulted to resolve any discrepancies, as necessary. Risk of bias was assessed using the The National Institute for Health and Care Excellence clinical effectiveness quality assessment checklist.

Results

In total, 26 RCTs were included. For HAQ-DI, SF-36 PCS and SF-36 MCS scores, intravenous tumour necrosis factor (TNF) alpha inhibitors generally ranked higher than most other classes of therapies available to treat patients with PsA. For almost all outcomes, several interleukin (IL)-23, IL-17A, subcutaneous TNF and IL-12/23 agents offered comparable improvement, while cytotoxic T-lymphocyte-associated antigen 4, phosphodiesterase-4 and Janus kinase inhibitors often had the lowest efficacy.

Conclusions

While intravenous TNFs may provide some improvements in PROs relative to several other tsDMARDs and bDMARDs for the treatment of patients with PsA, differences between classes of therapies across outcomes were small.

Relationship between work‐related psychosocial factors and self‐leadership in advanced nurse practitioners: A cross‐sectional study

Abstract

Aim

The aim of this study was to investigate the relationship between advanced nurse practitioners' self-leadership and commitment to the workplace, work engagement and influence at work.

Background

The concept of self-leadership is particularly suited to ANPs, who are required to take responsibility for their work roles. An optimum balance between the ANPs' psychosocial work environment and self-leadership may positively impact work ability in this group and can be compromised by interactions between and among these variables.

Design

A cross-sectional correlational study was conducted from July 2020 to August 2020 on 153 ANPs across a national health service.

Methods

The survey was distributed to respondents online. The revised self-leadership questionnaire was used to measure self-leadership, and three scales from the Copenhagen Psychosocial Questionnaire were used to measure commitment to the workplace, work engagement and influence at work. Multiple linear regression was used to examine the association between self-leadership and the psychosocial variables.

Results

ANPs with high levels of self-leadership reported high levels of work engagement and commitment to the workplace. No relationship was found between self-leadership and influence at work.

Conclusion

Improving self-leadership among ANPs by involving them in strategic leadership activities at an organizational level could be an effective strategy for optimizing the role and facilitating ANPs to contribute at an organizational level beyond the clinical interface. However, organizational support is required to ensure that ANPs practise to the full potential of their training and capability.

Patient or Public Contribution

No patient or public contribution.

Impact

This study provided new evidence of a relationship between ANPs' self-leadership and psychosocial factors. This study found that ANPs with high levels of self-leadership reported high levels of work engagement and commitment to the workplace. Policymakers and organizational leaders can optimize the ANP role and facilitate ANPs to contribute strategically to improve care systems. This study identifies a relationship between ANPs' self-leadership and specific psychosocial variables.

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