Conectar
To characterise sex and gender-based analysis (SGBA) and diversity metric reporting, representation of female/women participants in acute care trials and temporal changes in reporting before and after publication of the 2016 Sex and Gender Equity in Research guideline.
Systematic review.
We searched MEDLINE for trials published in five leading medical journals in 2014, 2018 and 2020.
Trials that enrolled acutely ill adults, compared two or more interventions and reported at least one clinical outcome.
4 reviewers screened citations and 22 reviewers abstracted data, in duplicate. We compared reporting differences between intensive care unit (ICU) and cardiology trials.
We included 88 trials (75 (85.2%) ICU and 13 (14.8%) cardiology) (n=111 428; 38 140 (34.2%) females/women). Of 23 (26.1%) trials that reported an SGBA, most used a forest plot (22 (95.7%)), were prespecified (21 (91.3%)) and reported a sex-by-intervention interaction with a significance test (19 (82.6%)). Discordant sex and gender terminology were found between headings and subheadings within baseline characteristics tables (17/32 (53.1%)) and between baseline characteristics tables and SGBA (4/23 (17.4%)). Only 25 acute care trials (28.4%) reported race or ethnicity. Participants were predominantly white (78.8%) and male/men (65.8%). No trial reported gendered-social factors. SGBA reporting and female/women representation did not improve temporally. Compared with ICU trials, cardiology trials reported significantly more SGBA (15/75 (20%) vs 8/13 (61.5%) p=0.005).
Acute care trials in leading medical journals infrequently included SGBA, female/women and non-white trial participants, reported race or ethnicity and never reported gender-related factors. Substantial opportunity exists to improve SGBA and diversity metric reporting and recruitment of female/women participants in acute care trials.
CRD42022282565.
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.
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.
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.
A comprehensive patient assessment is essential for safe patient care. Patient assessment frameworks for nurses are generally restricted to patients who already have altered vital signs and are at risk of deterioration, or to specific risks or body systems such as falls, pressure injury and the Glasgow Coma Score. Comprehensive and structured evidence-based nursing assessment frameworks that consider the whole patient and extend beyond vital signs, specific risks and single systems are not routinely used in inpatient settings but are important to establish early risks for patient deterioration.
The aim of this review was to identify nursing assessment tools or frameworks used to holistically assess hospitalized patients and to identify the impact of these tools on patient and health service outcomes.
A scoping literature review was conducted. Medical Literature Analysis and Retrieval System Online (MEDLINE), Cumulative Index of Nursing and Allied Health Literature (CINAHL), ProQuest Dissertations and Thesis, Embase and Scopus were databases used in the search. The initial search was conducted in August 2021 and repeated in November 2022. No date parameters were set. The Participants, Concept, Context (PCC) framework was used to guide the development of the research question and consolidate inclusion and exclusion criteria. The PRISMA-ScR Checklist Item was followed to ensure a methodologically sound checklist was used.
Ten primary research studies evaluating six nursing assessment frameworks were included. Of the five nursing assessment frameworks, none were explicitly designed for general ward nursing, but rather the emergency department or specific patient cohorts, such as oncology. Four studies reported on reliability and/or validity; two reported on patient outcomes and four on staff satisfaction.
Evidence-based nursing patient assessment frameworks for use in general inpatient wards are lacking. Existing assessment tools are largely designed for specific patient cohorts, specific body systems or the already deteriorating patient.
A framework to enable a structured approach to patient assessment in this environment is needed for patient safety, consistency in assessment, nursing staff enablement and confidence to escalate care. Routine systematic nursing assessment could also aid timely patient escalation.
What problem did the study address? This study addresses the lack of evidence-based nursing assessment frameworks for use in hospitalized patients. The impact of this is that it highlights the need for an evidence-based, whole of patient assessment framework for use by nurses for patients admitted to a ward environment.
What were the main findings? This review identified limited comprehensive, patient assessment frameworks for use in general ward inpatient areas. Those identified were not validated for this patient cohort and are aimed at patients already deteriorating.
Where and on whom will the research have an impact? This review has the potential to impact future research and patient care. It highlights that most research is focussed on processes to detect and escalate care for the already deteriorating patient. There is a need for an evidence-based routine nursing assessment framework for patients admitted to a ward environment to promote positive patient outcomes and prevent deterioration.
This review contributes to existing knowledge of nursing patient assessment frameworks, yet it also highlights several gaps. Currently, there are no known, validated, holistic, structured nursing patient assessment frameworks for use in general ward inpatient settings. However, areas that do use such assessment frameworks (e.g. the emergency department) have shown positive patient outcomes and staff usability. Hospitalized ward patients would benefit from routine, structured nursing assessments targeting positive patient outcomes prior to the onset of deterioration.
The Strengthen the Management of Multidrug-Resistant Tuberculosis in Vietnam (V-SMART) trial is a randomised controlled trial of using mobile health (mHealth) technologies to improve adherence to medications and management of adverse events (AEs) in people with multidrug-resistant tuberculosis (MDR-TB) undergoing treatment in Vietnam. This economic evaluation seeks to quantify the cost-effectiveness of this mHealth intervention from a healthcare provider and societal perspective.
The V-SMART trial will recruit 902 patients treated for MDR-TB across seven participating provinces in Vietnam. Participants in both intervention and control groups will receive standard community-based therapy for MDR-TB. Participants in the intervention group will also have a purpose-designed App installed on their smartphones to report AEs to health workers and to facilitate timely management of AEs. This economic evaluation will compare the costs and health outcomes between the intervention group (mHealth) and the control group (standard of care). Costs associated with delivering the intervention and health service utilisation will be recorded, as well as patient out-of-pocket costs. The health-related quality of life (HRQoL) of study participants will be captured using the 36-Item Short Form Survey (SF-36) questionnaire and used to calculate quality-adjusted life-years (QALYs). Incremental cost-effectiveness ratios (ICERs) will be based on the primary outcome (proportion of patients with treatment success after 24 months) and QALYs gained. Sensitivity analysis will be conducted to test the robustness of the ICERs. A budget impact analysis will be conducted from a payer perspective to provide an estimate of the total budget required to scale-up delivery of the intervention.
Ethical approval for the study was granted by the University of Sydney Human Research Ethics Committee (2019/676), the Scientific Committee of the Ministry of Science and Technology, Vietnam (08/QD-HDQL-NAFOSTED) and the Institutional Review Board of the National Lung Hospital, Vietnam (13/19/CT-HDDD). Study findings will be published in peer-reviewed journals and conference proceedings.
ACTRN12620000681954.
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.
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.
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.
ClinicalTrials.gov NCT03653832.
FreshRSS 