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Alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B trial): protocol for a mixed-methods process evaluation of a randomised controlled trial

Por: Aitken · L. M. · Emerson · L. M. · Kydonaki · K. · Blackwood · B. · Creagh-Brown · B. · Lone · N. I. · McKenzie · C. A. · Reade · M. C. · Weir · C. J. · Wise · M. P. · Walsh · T. S.
Introduction

An association between deep sedation and adverse short-term outcomes has been demonstrated although this evidence has been inconsistent. The A2B (alpha-2 agonists for sedation in critical care) sedation trial is designed to determine whether the alpha-2 agonists clonidine and dexmedetomidine, compared with usual care, are clinically and cost-effective. The A2B intervention is a complex intervention conducted in 39 intensive care units (ICUs) in the UK. Multicentre organisational factors, variable cultures, perceptions and practices and the involvement of multiple members of the healthcare team add to the complexity of the A2B trial. From our pretrial contextual exploration it was apparent that routine practices such as type and frequency of pain, agitation and delirium assessment, as well as the common sedative agents used, varied widely across the UK. Anticipated challenges in implementing A2B focused on the impact of usual practice, perceptions of risk, ICU culture, structure and the presence of equipoise. Given this complexity, a process evaluation has been embedded in the A2B trial to uncover factors that could impact successful delivery and explore their impact on intervention delivery and interpretation of outcomes.

Methods and analysis

This is a mixed-methods process evaluation guided by the A2B intervention logic model. It includes two phases of data collection conducted during and at the end of trial. Data will be collected using a combination of questionnaires, stakeholder interviews and routinely collected trial data. A framework approach will be used to analyse qualitative data with synthesis of data within and across the phases. The nature of the relationship between delivery of the A2B intervention and the trial primary and secondary outcomes will be explored.

Ethics and dissemination

All elements of the A2B trial, including the process evaluation, are approved by Scotland A Research Ethics Committee (Ref. 18/SS/0085). Dissemination will be via publications, presentations and media engagement.

Trial registration number

NCT03653832.

Adequacy of cancer-related pain management using the Pain Management Index among patients with cancer in the Northwest oncology centres of Ethiopia: an institutional-based cross-sectional study

Por: Mihiretie · E. A. · Siyum · T. S. · Tamene · F. B.
Objective

The aim of this study was to assess the adequacy of cancer-related pain (CRP) management and associated factors among patients with cancer in the Northwest oncology centres of Ethiopia.

Design and setting

An institutional-based multicentre cross-sectional study was conducted among patients with cancer in the Northwest oncology centres of Ethiopia from May to July 2022.

Participants

All oncology patients at selected hospitals who fulfilled the inclusion criteria during the data collection period were the study population.

Main outcome measures

The main outcome of this study was the adequacy of CRP management, which was measured by the Pain Management Index (PMI). A systematic random sampling technique was used to select representatives from each study area. Data entry and analysis were done using EpiData V.4.6.1 and SPSS V.26, respectively. Binary logistic regression was conducted to determine independent predictors of the adequacy of CRP management. A p value of

Results

From a total of 422 included respondents, about 67.5% of the participants had adequate CRP management (95% CI 62.8 to 72). Good performance status (adjusted OR (AOR)=0.44; 95% CI 0.24 to 0.80), presence of comorbidity (AOR=3.28; 95% CI 1.68 to 6.38) and pain history (AOR=0.33; 95% CI 0.01 to 0.11) were significantly associated with the adequacy of cancer pain management.

Conclusion

Using PMI status in the Northwest oncology centre of Ethiopia, more than two-thirds of patients with CRP obtained adequate pain management. The adequacy of CRP management was found to be influenced by factors like comorbidity, past pain history and Eastern cooperative oncology group performance status.

Childhood and adolescent factors shaping vulnerability to underage entry into sex work: a quantitative hierarchical analysis of female sex workers in Nairobi, Kenya

Por: Shah · P. · Kabuti · R. · Beksinska · A. · Nyariki · E. · Babu · H. · Kungu · M. · Jama · Z. · Ngurukiri · P. · The Maisha Fiti Study Champions · Kaul · R. · Kyegombe · N. · Medley · G. F. · Devries · K. · Seeley · J. · Weiss · H. A. · Beattie · T. S. · Kimani · J. · Gwala · Oside · Kamen
Objective

To explore factors associated with early age at entry into sex work, among a cohort of female sex workers (FSWs) in Nairobi, Kenya.

Background

Younger age at sex work initiation increases the risk of HIV acquisition, condom non-use, violence victimisation and alcohol and/or substance use problems. This study aimed to understand factors in childhood and adolescence that shape the vulnerability to underage sex work initiation.

Design

Building on previous qualitative research with this cohort, analysis of behavioural–biological cross-sectional data using hierarchical logistic regression.

Participants and measures

FSWs aged 18–45 years were randomly selected from seven Sex Workers Outreach Programme clinics in Nairobi, and between June and December 2019, completed a baseline behavioural–biological survey. Measurement tools included WHO Adverse Childhood Experiences, Alcohol, Smoking and Substance Involvement Screening Test and questionnaires on sociodemographic information, sexual risk behaviours and gender-based violence. Descriptive statistics and logistic regression were conducted using hierarchical modelling.

Results

Of the 1003 FSWs who participated in the baseline survey (response rate 96%), 176 (17.5%) initiated sex work while underage (

Conclusions

Lower education level and childhood homelessness, combined with sexual violence and sexual risk behaviours in childhood, create pathways to underage initiation into sex work. Interventions designed for girls and young women at these pivotal points in their lives could help prevent underage sex work initiation and their associated health, social and economic consequences.

Exploring disease-related and treatment-related issues and concerns experienced by adults with spondyloarthritis, inflammatory bowel disease and psoriasis to identify unmet needs: a qualitative clinical concept mapping study

Por: Stisen · Z. R. · Skougaard · M. · Christensen · K. R. · Ainsworth · M. A. · Hansen · R. L. · Thomsen · S. F. · Mogensen · M. · Dreyer · L. · Kristensen · L. E. · Jorgensen · T. S.
Objectives

Exploring patients’ perspectives for significant factors of relevance in living with a chronic disease is important to discover unmet needs and challenges. The primary objective of this study was to explore disease-related and treatment-related issues and concerns experienced by adults with spondyloarthropathies (SpA) and associated diseases. As a secondary objective, we wanted to explore whether these factors were generic or disease dependent.

Design

We used group concept mapping (GCM), a validated qualitative method, to identify disease-related and treatment-related issues and concerns. Participants generated statements in the GCM workshops and organised them into clusters to develop concepts. Furthermore, participants rated each statement for importance from 1: ‘not important at all’ to 5: ‘of great importance’.

Setting

Participants were recruited during routine care at the outpatient clinic at the hospitals in the period from May 2018 to July 2022.

Participants

Eligible participants were adults ≥18 years and diagnosed with axial spondyloarthritis (AxSpA), psoriatic arthritis (PsA), psoriasis (PsO) or inflammatory bowel disease —split into Crohn’s disease (CD) and ulcerative colitis (UC).

Results

52 patients participated in the 11 workshops divided into groups according to their diagnosis. They created a total of 1275 statements that generated 10 AxSpA concepts, 7 PsA concepts, 7 PsO concepts, 10 CD concepts and 11 UC concepts. The highest rated concepts within each disease group were: AxSpA, ‘lack of understanding/to be heard and seen by healthcare professionals’ (mean rating 4.0); PsA, ‘medication (effects and side effects)’ (mean rating 3.8); PsO, ‘social and psychological problems, the shame’ (mean rating 4.0); CD, ‘positive attitudes’ (mean rating 4.3) and UC; ‘take responsibility and control over your life’ (mean rating 4.0).

Conclusion

People with SpA and associated diseases largely agree on which concepts describe their disease-related and treatment-related issues and concerns with a few of them being more disease-specific.

Alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B Trial): protocol for a multicentre phase 3 pragmatic clinical and cost-effectiveness randomised trial in the UK

Por: Walsh · T. S. · Aitken · L. M. · McKenzie · C. A. · Boyd · J. · Macdonald · A. · Giddings · A. · Hope · D. · Norrie · J. · Weir · C. · Parker · R. A. · Lone · N. I. · Emerson · L. · Kydonaki · K. · Creagh-Brown · B. · Morris · S. · McAuley · D. F. · Dark · P. · Wise · M. P. · Gordon · A. C.
Introduction

Almost all patients receiving mechanical ventilation (MV) in intensive care units (ICUs) require analgesia and sedation. The most widely used sedative drug is propofol, but there is uncertainty whether alpha2-agonists are superior. The alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B) trial aims to determine whether clonidine or dexmedetomidine (or both) are clinically and cost-effective in MV ICU patients compared with usual care.

Methods and analysis

Adult ICU patients within 48 hours of starting MV, expected to require at least 24 hours further MV, are randomised in an open-label three arm trial to receive propofol (usual care) or clonidine or dexmedetomidine as primary sedative, plus analgesia according to local practice. Exclusions include patients with primary brain injury; postcardiac arrest; other neurological conditions; or bradycardia. Unless clinically contraindicated, sedation is titrated using weight-based dosing guidance to achieve a Richmond-Agitation-Sedation score of –2 or greater as early as considered safe by clinicians. The primary outcome is time to successful extubation. Secondary ICU outcomes include delirium and coma incidence/duration, sedation quality, predefined adverse events, mortality and ICU length of stay. Post-ICU outcomes include mortality, anxiety and depression, post-traumatic stress, cognitive function and health-related quality of life at 6-month follow-up. A process evaluation and health economic evaluation are embedded in the trial.

The analytic framework uses a hierarchical approach to maximise efficiency and control type I error. Stage 1 tests whether each alpha2-agonist is superior to propofol. If either/both interventions are superior, stages 2 and 3 testing explores which alpha2-agonist is more effective. To detect a mean difference of 2 days in MV duration, we aim to recruit 1437 patients (479 per group) in 40–50 UK ICUs.

Ethics and dissemination

The Scotland A REC approved the trial (18/SS/0085). We use a surrogate decision-maker or deferred consent model consistent with UK law. Dissemination will be via publications, presentations and updated guidelines.

Trial registration number

ClinicalTrials.gov NCT03653832.

Health-related quality of life and associated factors among patients with schizophrenia at comprehensive specialised hospitals in the Northwest Ethiopia: a multicentre cross-sectional study

Por: Tamene · F. B. · Sema · F. D. · Mihiretie · E. A. · Siyum · T. S. · Sendekie · A. K.
Objectives

The aim of this study was to assess the health-related quality of life (HRQoL) and associated factors among patients with schizophrenia at comprehensive specialised hospitals in Northwest Ethiopia.

Design and setting

A cross-sectional study was conducted among 422 patients with schizophrenia who were followed at comprehensive specialised hospitals in Northwest Ethiopia from 1 June to 30 August 2022.

Participants

All adult patients with schizophrenia who had regular follow-up in the outpatient departments of the selected hospitals were study participants.

Main outcome measures

The main outcome of this study was HRQoL which was measured using the WHO Quality of Life Scale–Bref Version. Data entry and analysis were done using Epi-data version 4.6.1 and SPSS version 24, respectively. Linear regression was used to assess the association between quality of life and independent variables. Variables with a p value

Results

The mean score of the overall Quality of Life Scale–Brief Version was 22.42±3.60. No formal education (ß=–1.53; 95% CI: –2.80 to –0.27), duration of treatment (ß = –3.08; 95% CI: –4.71 to –1.45), comorbidity (ß=–1.14; 95% CI: –1.99 to –0.29), substance use (ß=–0.89; 95% CI: –1.56 to –0.23), extrapyramidal side effects (ß=–2.02; 95% CI: –2.90 to –1.14), non-adherence (ß=–0.83; 95% CI: –1.44 to –0.23), and antipsychotic polypharmacy (ß=–1.77; CI: –2.57 to –0.96) were negatively associated with quality of life.

Conclusion and recommendation

In this study, the social domain was recorded as having the lowest mean score, which may indicate that patients with schizophrenia could need better psychosocial support. Patients with a longer duration of treatment, who had comorbid illnesses, were substance users, developed EPS, were non-adherent to medications and were on antipsychotic polypharmacy, needs critical follow-up to improve HRQoL.

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