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What works for whom and why? Treatment effects and their moderators among forcibly displaced people receiving psychological and psychosocial interventions: study protocol for an individual patient data meta-analysis

Por: Kurath · J. · Akhtar · A. · Karyotaki · E. · Sijbrandij · M. · Cuijpers · P. · Bryant · R. · Morina · N.
Introduction

Forcibly displaced people (FDP) have a high risk of developing mental disorders such as post-traumatic stress (PTS) disorder. Providing adequate mental healthcare for FDP is crucial but despite overall efficacy of many existing interventions, a large proportion of FDP does not benefit from treatment, highlighting the necessity of further investigating factors contributing to individual differences in treatment outcome. Yet, the few studies that have explored moderators of treatment effects are often insufficiently powered. Therefore, the present Individual Patient Data meta-analysis (IPD-MA) will investigate treatment effects and their moderators—variables related to beneficiaries, providers, intervention and study characteristics in relation to PTS outcomes.

Methods and analysis

A systematic literature search will be conducted from database inception in the databases PsycINFO, Cochrane, Embase, PTSDpubs and Web of Science. Only studies published in English, German, French, Spanish, Portuguese, and Dutch will be considered. Retrieved records will be screened for eligibility. Randomised controlled trials on adult FDP receiving psychological and psychosocial interventions aimed at alleviating symptoms such as PTS compared with a control condition without intervention will be included in this IPD-MA. Subsequently, authors of eligible studies will be contacted to request individual patient data (IPD). All datasets obtained will be synthesised into one large dataset which will be analysed using a one-stage approach by conducting mixed-effects linear regression models (ie, primary analysis). Additionally, aggregate data meta-analyes will be run using a two-stage approach by conducting multivariate regression models including all IPD (transformed) and available meta-data from study reports (ie, secondary analysis). PTS will serve as primary outcome measure, while mental health outcomes other than PTS, attendance, attrition, treatment non-response and adverse outcomes will be examined as secondary outcomes.

Ethics and dissemination

This IPD-MA does not require ethical approval. The results will be published in international peer-reviewed journals.

PROSPERO registration number

CRD42022299510.

Evaluation of the implementation of advanced practice nursing roles in France: A multiple case study

Abstract

Aims

The aims of the study were to describe the processes used to introduce advanced practice nursing roles and factors that facilitated or hindered role implementation, examine the time advanced practice nurses (APNs) spend in role activities and how these activities relate to domains of advanced practice nursing and examine how implementation processes influenced APN integration within healthcare teams.

Design

A multiple case study was conducted.

Methods

Five cases were included, representing the four population areas approved for advanced practice nursing in France. Data were collected from January to March 2021 using observation, interview and document analysis methods. Data were examined using thematic analysis.

Results

Participants included APNs (n = 5), nurses/allied health providers (n = 5), physicians (n = 5), managers (n = 4) and decision-makers (n = 4). Stakeholder engagement and leadership provided by decision-makers, managers, physicians and APNs facilitated role implementation. Poor stakeholder role understanding, uncertain role funding, and the COVID-19 pandemic hindered role implementation. APNs spent the most time in clinical activities. Participants perceived the integration of APNs within the healthcare team and their impact on patient care to be positive.

Conclusion

Stakeholder engagement and organizational and APN leadership facilitated the implementation of the roles, especially related to team-based patient care. Further efforts are needed to strengthen APN involvement in non-clinical activities and address role barriers.

Implications for nursing and patient care

Systematic and system-wide approaches are needed to improve role clarity, role autonomy and health systems integration of APNs. Research should examine patient perspectives about APNs in France.

Impact

The results highlight how policies can create favourable conditions for advanced practice nursing role implementation in France. Internationally, this study serves as a reminder to APNs and nurse leaders about the strategies for and importance of implementation evaluation to support the optimal development of advanced practice nursing roles.

Reporting Method

The study reporting followed the Consolidated Criteria for Reporting Qualitative Research.

Patient or Public Contribution

No Patient or Public Contribution.

Sustained delirium reduction in an inpatient neuroscience unit

Abstract

Background

Delirium is described as acute brain dysfunction that often fluctuates throughout the day and is highly prevalent in hospitalized adults. Delirium negatively affects patient outcomes with consequences including decreased cognitive functioning and increased mortality and healthcare costs. Furthermore, neurological patients are at increased risk for developing delirium due to their underlying diagnoses.

Purpose

The purpose of this evidence-based practice project was to evaluate the long-term impact of nursing education and use of trained volunteers to prevent the development of delirium in an inpatient neuroscience unit.

Implementation Plan

This was a pre–post designed evidence-based practice project to educate and prioritize nursing care interventions for delirium prevention compared to a delirium management framework. The interventions included delirium education for nurses and nursing assistants along with the development of a specialized volunteer program to implement non-pharmacological, multi-component delirium prevention interventions. Long-term sustainment and enculturation occurred over the subsequent year.

Outcomes

The baseline data collection period included 2520 patients. The intervention period included 4515 patients, with both groups being similar in age, race, gender, and length of stay. The total number of patients with a discharge diagnosis of delirium decreased from 29.2% to 19.8% (p < .001). Fewer patients in the intervention group were discharged to a skilled nursing facility (p < .001) and other post-acute facility (p = .008), along with more patients being discharged to home care (p < .001).

Linking Evidence to Action

This evidence-based practice project demonstrates long-term sustained reduction of delirium in the neuroscience population. Despite the challenges during the COVID-19 pandemic, delirium prevention strategies were found to be effective in decreasing the rate at which patients develop delirium.

Multiocular defect in the Old English Sheepdog: A canine form of Stickler syndrome type II associated with a missense variant in the collagen-type gene <i>COL11A1</i>

by Katherine Stanbury, Renata Stavinohova, Louise Pettitt, Chris Dixon, Ellen C. Schofield, Bryan Mclaughlin, Inka Pettinen, Hannes Lohi, Sally L. Ricketts, James A. Oliver, Cathryn S. Mellersh

Multiocular defect has been described in different canine breeds, including the Old English Sheepdog. Affected dogs typically present with multiple and various ocular abnormalities. We carried out whole genome sequencing on an Old English Sheepdog that had been diagnosed with hereditary cataracts at the age of five and then referred to a board-certified veterinary ophthalmologist due to owner-reported visual deterioration. An ophthalmic assessment revealed that there was bilateral vitreal degeneration, macrophthalmos, and spherophakia in addition to cataracts. Follow-up consultations revealed cataract progression, retinal detachment, uveitis and secondary glaucoma. Whole genome sequence filtered variants private to the case, shared with another Old English Sheepdog genome and predicted to be deleterious were genotyped in an initial cohort of six Old English Sheepdogs (three affected by multiocular defect and three control dogs without evidence of inherited eye disease). Only one of the twenty-two variants segregated correctly with multiocular defect. The variant is a single nucleotide substitution, located in the collagen-type gene COL11A1, c.1775T>C, that causes an amino acid change, p.Phe1592Ser. Genotyping of an additional 14 Old English Sheepdogs affected by multiocular defect revealed a dominant mode of inheritance with four cases heterozygous for the variant. Further genotyping of hereditary cataract-affected Old English Sheepdogs revealed segregation of the variant in eight out of nine dogs. In humans, variants in the COL11A1 gene are associated with Stickler syndrome type II, also dominantly inherited.

Effectiveness of a midwife-led continuity of care model on birth outcomes and maternal mental health in vulnerable women: study protocol for a randomised controlled trial with an internal pilot, process evaluation and economic analysis

Por: Willan · K. · Moss · R. H. · Santorelli · G. · Ahern · S. · Bryant · M. · Bywater · T. · Blower · S. L. · Richardson · G. · Hinde · S. · Huo · D. · Wright · J. · Dickerson · J. · Innovation Hub · B. S. B.
Introduction

Women from social disadvantage are at greater risk of poor birth outcomes. The midwife-led continuity of care (MCC) model, which offers flexible and relational care from a small team of midwives, has demonstrated improved birth outcomes. In the general population, the impact of MCC on socially disadvantaged women and on birth outcomes is still unclear. This protocol describes a pragmatic evaluation of the MCC model in a socially disadvantaged population.

Methods and analysis

An open-labelled individual prospective randomised controlled trial with an internal pilot, process evaluation and economic analysis, from 1 April 2022 to 31 March 2024.

Women will be randomly allocated to MCC or standard care as part of usual midwifery practice. Participants and midwives will not be blinded, but researchers will be. An internal pilot will test the feasibility of this process.

Participants are those randomised into MCC or standard care, who consent to participate in one of two Born in Bradford (BiB) birth cohort studies. Outcomes are taken from routinely linked health data, supplemented by additional data capture. The sample size is fixed by the capacity of MCC teams, commissioning duration and numbers recruited into the cohort. The estimated maximum fixed sample size is 1,410 pregnancies (minimum 734).

Intention to treat (ITT) analysis will be undertaken to assess the impact of MCC on two independent primary outcomes. An economic evaluation will explore the impact on health resource use and a process evaluation will explore fidelity to the MCC model, and barriers/facilitators to implementation from midwives’ and women’s perspectives.

Ethics and dissemination

Ethical approval has been obtained for the randomisation in midwifery practice, use of the cohort data for evaluation and for the process evaluation. Findings will be published in peer-reviewed journals, presented at conferences and translated into policy briefings.

Trial registration number

IsRCTNhttps://doi.org/10.1186/ISRCTN31836167

Exploring the outcomes of research engagement using the observation method in an online setting

Por: Marshall · D. A. · Suryaprakash · N. · Lavallee · D. C. · Barker · K. L. · Mackean · G. · Zelinsky · S. · McCarron · T. L. · Santana · M. J. · Moayyedi · P. · Bryan · S.
Objective

The objective of this study was to explore the outcomes of research engagement (patient engagement, PE) in the context of qualitative research.

Design

We observed engagement in two groups comprised of patients, clinicians and researchers tasked with conducting a qualitative preference exploration project in inflammatory bowel disease. One group was led by a patient research partner (PLG, partner led group) and the other by an academic researcher (RLG, researcher led group). A semistructured guide and a set of critical outcomes of research engagement were used as a framework to ground our analysis.

Setting

The study was conducted online.

Participants

Patient research partners (n=5), researchers (n=5) and clinicians (n=4) participated in this study.

Main outcome measures

Transcripts of meetings, descriptive and reflective observation data of engagement during meetings and email correspondence between group members were analysed to identify the outcomes of PE.

Results

Both projects were patient-centred, collaborative, meaningful, rigorous, adaptable, ethical, legitimate, understandable, feasible, timely and sustainable. Patient research partners (PRPs) in both groups wore dual hats as patients and researchers and influenced project decisions wearing both hats. They took on advisory and operational roles. Collaboration seemed easier in the PLG than in the RLG. The RLG PRPs spent more time than their counterparts in the PLG sharing their experience with biologics and helping their group identify a meaningful project question. A formal literature review informed the design, project materials and analysis in the RLG, while the formal review informed the project materials and analysis in the PLG. A PRP in the RLG and the PLG lead leveraged personal connections to facilitate recruitment. The outcomes of both projects were meaningful to all members of the groups.

Conclusions

Our findings show that engagement of PRPs in research has a positive influence on the project design and delivery in the context of qualitative research in both the patient-led and researcher-led group.

Time for You: A process evaluation of the rapid implementation of a multi-level mental health support intervention for frontline workers during the COVID-19 pandemic

by Bryan McCann, Simon C. Hunter, Kareena McAloney-Kocaman, Paul McCarthy, Jan Smith, Eileen Calveley

The coronavirus (COVID-19) pandemic had wide-ranging negative impacts on mental health. The pandemic also placed extraordinary strain on frontline workers who were required to continue working and putting themselves at risk to provide essential services at a time when their normal support mechanisms may not have been available. This paper presents an evaluation of the Time for You service, a rapidly developed and implemented intervention aimed at providing frontline workers with quick access to flexible online mental health support. Time for You provided service users with three service options: self-guided online cognitive behavioural therapy (CBT) resources; guided engagement with online CBT resources; 1–1 psychological therapy with trainee sport and exercise psychologists and trainee health psychologists. A process evaluation informed by the Consolidated Framework for Implementation Research considered service fidelity, adaptations, perceived impact, reach, barriers, and facilitators. Interviews with project managers (n = 5), delivery staff (n = 10), and service users (n = 14) explored perceptions of the service implementation and outcomes, supported by data regarding engagement with the online CBT platform (n = 217). Findings indicated that service users valued the flexibility of the service and the speed with which they were able to access support. The support offered by Trainee Psychologists was perceived to be of high quality, and the service was perceived by service users to have improved mental health and wellbeing. The rapid implementation contributed to issues regarding appropriate service user screening that led to trainee psychologists being unable to provide the service users with the support they needed as the presenting issues were outside of trainees’ competencies. Overall, the findings suggest that interventions offering flexible, online psychological support to frontline workers can be an effective model for future interventions. Trainee psychologists are also able to play an important role in delivering such services when clear screening processes are in place.
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