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Utilising a 'Community of Practice to support pharmacists to work in residential aged care: protocol for a longitudinal evaluation

Por: Lee · K. · Etherton-Beer · C. · Johnson · J. · Lobo · E. · Wang · K. · Ailabouni · N. · Mavaddat · N. · Clifford · R. M. · Page · A. T.
Introduction

A Community of Practice is briefly defined as a group of people with a shared interest in a given area of practice who work collaboratively to grow collective knowledge. Communities of Practice have been used to facilitate knowledge exchange and improve evidence-based practice. Knowledge translation within the residential aged care sector is lacking, with barriers such as inadequate staffing and knowledge gaps commonly cited. In Australia, a Federal inquiry into residential aged care practices led to a recommendation to embed pharmacists within residential aged care facilities. Onsite practice in aged care is a new role for pharmacists in Australia. Thus, support is needed to enable pharmacists to practice in this role.

The primary aim is to evaluate the processes and outcomes of a Community of Practice designed to support pharmacists to work in aged care.

Methods and analysis

A longitudinal, single-group, pretest–post-test design in which the intervention is a Community of Practice. The Community of Practice will be established and made available for 3 years to all Australian pharmacists interested in, new to or established in aged care roles. The Community of Practice will be hosted on online discussion platforms, with additional virtual meetings and annual symposia. The following data will be collected from all members of the Community of Practice: self-evaluation of the processes and outcomes of the Community of Practice (via the CoPeval scale) and confidence in evidence-based practice (EPIC scale), collected via online questionnaires annually; and discussion platform usage statistics and discussion transcripts. A subset of members will be invited to participate in annual semi-structured individual interviews.

Data from the online questionnaire will be analysed descriptively. Discussion transcripts will be analysed using topic modelling and content analysis to identify the common topics discussed and their frequencies. Qualitative data from individual interviews will be thematically analysed to explore perceptions and experiences with the intervention for information/knowledge exchange, impact on practice, and sharing/promoting/implementing evidence-based practice.

Ethics and dissemination

Human ethics approval has been granted by the University of Western Australia’s Human Ethics Committee (2023/ET000000). No personal information will be included in any publications and reports to funding bodies.

Findings will be disseminated to all members of the Community of Practice, professional organisations, social and mass media, peer-review journals, research and professional conferences and annual reports to the funding body.

Did COVID-19 ICU patient mortality risk increase as Colorado hospitals filled? A retrospective cohort study

Por: Johnson · D. R. · Ghosh · D. · Wagner · B. D. · Carlton · E. J.
Objectives

To assess whether increasing levels of hospital stress—measured by intensive care unit (ICU) bed occupancy (primary), ventilators in use and emergency department (ED) overflow—were associated with decreasing COVID-19 ICU patient survival in Colorado ICUs during the pre-Delta, Delta and Omicron variant eras.

Design

A retrospective cohort study using discrete-time survival models, fit with generalised estimating equations.

Setting

34 hospital systems in Colorado, USA, with the highest patient volume ICUs during the COVID-19 pandemic.

Participants

9196 non-paediatric SARS-CoV-2 patients in Colorado hospitals admitted once to an ICU between 1 August 2020 and 1 March 2022 and followed for 28 days.

Outcome measures

Death or discharge to hospice.

Results

For Delta-era COVID-19 ICU patients in Colorado, the odds of death were estimated to be 26% greater for patients exposed every day of their ICU admission to a facility experiencing its all-era 75th percentile ICU fullness or above, versus patients exposed for none of their days (OR: 1.26; 95% CI: 1.04 to 1.54; p=0.0102), adjusting for age, sex, length of ICU stay, vaccination status and hospital quality rating. For both Delta-era and Omicron-era patients, we also detected significantly increased mortality hazard associated with high ventilator utilisation rates and (in a subset of facilities) states of ED overflow. For pre-Delta-era patients, we estimated relatively null or even protective effects for the same fullness exposures, something which provides a meaningful contrast to previous studies that found increased hazards but were limited to pre-Delta study windows.

Conclusions

Overall, and especially during the Delta era (when most Colorado facilities were at their fullest), increasing exposure to a fuller hospital was associated with an increasing mortality hazard for COVID-19 ICU patients.

Development of an enhanced scoring system to predict ICU readmission or in-hospital death within 24 hours using routine patient data from two NHS Foundation Trusts

Por: Pimentel · M. A. F. · Johnson · A. · Darbyshire · J. L. · Tarassenko · L. · Clifton · D. A. · Walden · A. · Rechner · I. · Watkinson · P. J. · Young · J. D.
Rationale

Intensive care units (ICUs) admit the most severely ill patients. Once these patients are discharged from the ICU to a step-down ward, they continue to have their vital signs monitored by nursing staff, with Early Warning Score (EWS) systems being used to identify those at risk of deterioration.

Objectives

We report the development and validation of an enhanced continuous scoring system for predicting adverse events, which combines vital signs measured routinely on acute care wards (as used by most EWS systems) with a risk score of a future adverse event calculated on discharge from the ICU.

Design

A modified Delphi process identified candidate variables commonly available in electronic records as the basis for a ‘static’ score of the patient’s condition immediately after discharge from the ICU. L1-regularised logistic regression was used to estimate the in-hospital risk of future adverse event. We then constructed a model of physiological normality using vital sign data from the day of hospital discharge. This is combined with the static score and used continuously to quantify and update the patient’s risk of deterioration throughout their hospital stay.

Setting

Data from two National Health Service Foundation Trusts (UK) were used to develop and (externally) validate the model.

Participants

A total of 12 394 vital sign measurements were acquired from 273 patients after ICU discharge for the development set, and 4831 from 136 patients in the validation cohort.

Results

Outcome validation of our model yielded an area under the receiver operating characteristic curve of 0.724 for predicting ICU readmission or in-hospital death within 24 hours. It showed an improved performance with respect to other competitive risk scoring systems, including the National EWS (0.653).

Conclusions

We showed that a scoring system incorporating data from a patient’s stay in the ICU has better performance than commonly used EWS systems based on vital signs alone.

Trial registration number

ISRCTN32008295.

Factors influencing pregnancy care and institutional delivery in rural Mali: a secondary baseline analysis of a cluster-randomised trial

Por: Ghosh · R. · Konipo · A. · Treleaven · E. · Rozenshteyn · S. · Beckerman · J. · Whidden · C. · Johnson · A. · Kayentao · K. · Liu · J.
Objective

The vast majority of the 300 000 pregnancy-related deaths every year occur in South Asia and sub-Saharan Africa. Increased access to quality antepartum and intrapartum care can reduce pregnancy-related morbidity and mortality worldwide. We used a population-based cross-sectional cohort design to: (1) examine the sociodemographic risk factors and structural barriers associated with pregnancy care-seeking and institutional delivery, and (2) investigate the influence of residential distance to the nearest primary health facility in a rural population in Mali.

Methods

A baseline household survey of Malian women aged 15–49 years was conducted between December 2016 and January 2017, and those who delivereda baby in the 5 years preceding the survey were included. This study leverages the baseline survey data from a cluster-randomised controlled trial to conduct a secondary analysis. The outcomes were percentage of women who received any antenatal care (ANC) and institutional delivery; total number of ANC visits; four or more ANC visits; first ANC visit in the first trimester.

Results

Of the 8575 women in the study, two-thirds received any ANC in their last pregnancy, one in 10 had four or more ANC visits and among those that received any ANC, about one-quarter received it in the first trimester. For every kilometre increase in distance to the nearest facility, the likelihood of the outcomes reduced by 5 percentage points (0.95; 95% CI 0.91 to 0.98) for any ANC; 4 percentage points (0.96; 95% CI 0.94 to 0.98) for an additional ANC visit; 10 percentage points (0.90; 95% CI 0.86 to 0.95) for four or more ANC visits; 6 percentage points (0.94; 95% CI 0.94 to 0.98) for first ANC in the first trimester. In addition, there was a 35 percentage points (0.65; 95% CI 0.56 to 0.76) decrease in likelihood of institutional delivery if the residence was within 6.5 km to the nearest facility, beyond which there was no association with the place of delivery. We also found evidence of increase in likelihood of receiving any ANC care and its intensity increased with having some education or owning a business.

Conclusion

The findings suggest that education, occupation and distance are important determinants of pregnancy and delivery care in a rural Malian context.

Trial registration number

NCT02694055.

REST: a preoperative tailored sleep intervention for patients undergoing total knee replacement - feasibility study for a randomised controlled trial

Por: Bertram · W. · Penfold · C. · Glynn · J. · Johnson · E. · Burston · A. · Rayment · D. · Howells · N. · White · S. · Wylde · V. · Gooberman-Hill · R. · Blom · A. · Whale · K.
Objectives

To test the feasibility of a randomised controlled trial (RCT) of a novel preoperative tailored sleep intervention for patients undergoing total knee replacement.

Design

Feasibility two-arm two-centre RCT using 1:1 randomisation with an embedded qualitative study.

Setting

Two National Health Service (NHS) secondary care hospitals in England and Wales.

Participants

Preoperative adult patients identified from total knee replacement waiting lists with disturbed sleep, defined as a score of 0–28 on the Sleep Condition Indicator questionnaire.

Intervention

The REST intervention is a preoperative tailored sleep assessment and behavioural intervention package delivered by an Extended Scope Practitioner (ESP), with a follow-up phone call 4 weeks postintervention. All participants received usual care as provided by the participating NHS hospitals.

Outcome measures

The primary aim was to assess the feasibility of conducting a full trial. Patient-reported outcomes were assessed at baseline, 1-week presurgery, and 3 months postsurgery. Data collected to determine feasibility included the number of eligible patients, recruitment rates and intervention adherence. Qualitative work explored the acceptability of the study processes and intervention delivery through interviews with ESPs and patients.

Results

Screening packs were posted to 378 patients and 57 patients were randomised. Of those randomised, 20 had surgery within the study timelines. An appointment was attended by 25/28 (89%) of participants randomised to the intervention. Follow-up outcomes measures were completed by 40/57 (70%) of participants presurgery and 15/57 (26%) postsurgery. Where outcome measures were completed, data completion rates were 80% or higher for outcomes at all time points, apart from the painDETECT: 86% complete at baseline, 72% at presurgery and 67% postsurgery. Interviews indicated that most participants found the study processes and intervention acceptable.

Conclusions

This feasibility study has demonstrated that with some amendments to processes and design, an RCT to evaluate the clinical and cost-effectiveness of the REST intervention is feasible.

Trial registration number

ISRCTN14233189.

Country uptake of WHO recommendations on differentiated HIV testing services approaches: a global policy review

Por: Kadye · T. · Jamil · M. S. · Johnson · C. · Baggaley · R. · Barr-DiChiara · M. · Cambiano · V.
Objectives

In 2015 and 2016, WHO issued guidelines on HIV testing services (HTS) highlighting recommendations for a strategic mix of differentiated HTS approaches. The policy review examines the uptake of differentiated HTS approaches recommendations in national policies.

Methods

Data were extracted from national policies published between January 2015 and June 2019. The WHO-recommended HTS approaches included facility-based testing, community-based testing, HIV self-testing and provider-assisted referral (or assisted partner notification). Other supportive recommendations include pre-test information, post-test counselling, lay provider testing and rapid testing. Descriptive analyses were conducted to examine inclusion of recommendations in national policies.

Results

Of 194 countries worldwide, 65 published policies were identified; 24 WHO Africa region (AFR) countries (51%, 24/47), 21 WHO European region (EUR) (40%, 21/53), 6 WHO Eastern Mediterranean region (EMR) (29%, 6/21), 5 Pan-American region (AMR) (14%, 5/35), 5 Western Pacific Region (WPR) (19%, 5/27) and 4 WHO South East Asia Region (SEAR) (36%, 4/11). Only five countries included all recommendations. 63 included a minimum of one. 85% (n=55) included facility-based testing for pregnant women, 75% (n=49) facility-based testing for key populations, 74% (n=48) community-based testing for key populations, 69% (n=45) rapid testing, 57% (n=37) post-test counselling, 45% (n=29) lay provider testing, 38% (n=25) HIV self-testing, 29% (n=19) pre-test information and 25% (n=16) provider-assisted referral. The proportion in each region that included at least one recommendation were: 100% AFR (24/47), 100% EMR (6/6), 100% AMR (5/5), 100% WPR (5/5), 100% SEAR (4/4) and 95% EUR (20/21). AFR followed by EMR included the highest number of reccomendations.

Conclusion

There was substantial variability in the uptake of the WHO-differentiated HTS recommendations. Those in EMR included the most WHO-differentiated HTS recommendation followed by AFR. Countries within AMR included the least number of recommendations. Ongoing advocacy and efforts are needed to support the uptake of the WHO-differentiated HTS recommendations in country policies as well as their implementation.

Nephrologists perspectives on communication and decision-making regarding technique survival in peritoneal dialysis: an international qualitative interview study

Por: Yudianto · B. · Jaure · A. · Shen · J. · Cho · Y. · Brown · E. · Dong · J. · Dunning · T. · Mehrotra · R. · Naicker · S. · Pecoits-Filho · R. · Perl · J. · Wang · A. Y.-M. · Wilkie · M. · Guha · C. · Scholes-Robertson · N. · Craig · J. · Johnson · D. · Manera · K.
Objectives

Peritoneal dialysis (PD) allows patients increased autonomy and flexibility; however, both infectious and non-infectious complications may lead to technique failure, which shortens treatment longevity. Maintaining patients on PD remains a major challenge for nephrologists. This study aims to describe nephrologists’ perspectives on technique survival in PD.

Design

Qualitative semistructured interview study. Transcripts were thematically analysed.

Setting and participants

30 nephrologists across 11 countries including Australia, the USA, the UK, Hong Kong, Canada, Singapore, Japan, New Zealand, Thailand, Colombia and Uruguay were interviewed from April 2017 to November 2019.

Results

We identified four themes: defining patient suitability (confidence in capacity for self-management, ensuring clinical stability and expected resilience), building endurance (facilitating access to practical support, improving mental well-being, optimising quality of care and training to reduce risk of complications), establishing rapport through effective communications (managing expectations to enhance trust, individualising care and harnessing a multidisciplinary approach) and confronting fear and acknowledging barriers to haemodialysis (preventing crash landing to haemodialysis, facing concerns of losing independence and positive framing of haemodialysis).

Conclusion

Nephrologists reported that technique survival in PD is influenced by patients’ medical circumstances, psychological motivation and positively influenced by the education and support provided by treating clinicians and families. Strategies to enhance patients’ knowledge on PD and communication with patients about technique survival in PD are needed to build trust, set patient expectations of treatment and improve the process of transition off PD.

Management of long bone fractures and traumatic hip dislocations in paediatric patients: study protocol for a prospective global multicentre observational cohort registry

Introduction

Management controversy and clinical equipoise exist in treatments of long bone fractures and traumatic hip dislocation in paediatric patients due to the lack of high-quality clinical evidence. This protocol describes the effort of a large prospective global multicentre cohort study (registry) aiming at providing quality data to assist evidence-based treatment decision-making.

Methods and analysis

Eligible paediatric patients (N=750–1000) with open physes suffering from proximal humerus fractures, distal humerus fractures, proximal radius fractures, forearm shaft fractures, traumatic hip dislocations, femoral neck fractures or tibial shaft fractures will be recruited over a period of 24–36 months. Hospitalisation and treatment details (including materials and implants) will be captured in a cloud-based, searchable database. Outcome measures include radiographic assessments, clinical outcomes (such as range of motion, limb length discrepancies and implant removal), patient-reported outcomes (Patient Reported Outcomes Of Fracture, Patient-Reported Outcomes Measurement Information System (PROMIS) and EuroQol-5D (EQ-5D-Y)) and adverse events.

Aside from descriptive statistics on patient demographics, baseline characteristics, types of fractures and adverse event rates, research questions will be formulated based on data availability and quality. A statistical analysis plan will be prepared before the statistical analysis.

Ethics and dissemination

Ethics approval will be obtained before patients are enrolled at each participating site. Patient enrolment will follow an informed consent process approved by the responsible ethics committee. Peer-reviewed publication is planned to disseminate the study results.

Trial registration number

NCT04207892.

Institutional capacity assessment in the lens of implementation research: Capacity of the local institutions in delivering WASH services at Cox’s Bazar district, Bangladesh

by Mahbubur Rahman, Mahbub-Ul Alam, Sharmin Khan Luies, Sharika Ferdous, Zahidul Mamun, Musarrat Jabeen Rahman, Debashish Biswas, Tazrina Ananya, Asadullah, Abul Kamal, Ritthick Chowdhury, Eheteshamul Russel Khan, Dara Johnston, Martin Worth, Umme Farwa Daisy, Tanvir Ahmed

Background

The influx of Forcibly Displaced Myanmar Nationals (FDMNs) has left the Southwest coastal district of Cox’s Bazar with one of the greatest contemporary humanitarian crises, stressing the existing water, sanitation, and hygiene (WASH) resources and services. This study aimed to assess the existing capacity of local institutions involved in delivering WASH services and identify relevant recommendations for intervention strategies.

Methods

We used a qualitative approach, including interviews and capacity assessment workshops with institutions engaged in WASH service delivery. We conducted five key informant interviews (KII) with sub-district level officials of the Department of Public Health Engineering (DPHE), Directorate General of Health Services (DGHS), Directorate of Primary Education (DPE) and Bangladesh Rural Advancement Committee (BRAC) to have a general idea of WASH service mechanisms. Seven capacity assessment workshops were organized with the relevant district and sub-district level stakeholders from August 2019 to September 2019. These workshops followed three key areas: i) knowledge of policy, organizational strategy, guidelines, and framework; ii) institutional arrangements for service delivery such as planning, implementation, coordination, monitoring, and reporting; and iii) availability and management of human, financial and infrastructural resources. Data were categorized using thematic content analysis.

Results

The majority of stakeholders lacked awareness of national WASH policies. Furthermore, the top-down planning approaches resulted in activities that were not context-specific, and lack of coordination between multiple institutions compromised the optimal WASH service delivery at the local level. Shortage of human resources in delivering sustainable WASH services, inadequate supervision, and inadequate evaluation of activities also required further improvement, as identified by WASH stakeholders.

Conclusion

Research evidence suggests that decision-makers, donors, and development partners should consider learning from the WASH implementers and stakeholders about their existing capacity, gaps, and opportunities before planning for any WASH intervention in any particular area.

Oral Probiotic Supplementation in Pregnancy to Reduce Group B Streptococcus Colonisation (OPSiP trial): study protocol for a double-blind parallel group randomised placebo trial

Por: Hayes · K. · Janssen · P. · Payne · B. A. · Jevitt · C. · Johnston · W. · Johnson · P. · Butler · M.
Introduction

Group B streptococcus (GBS), or Streptococcus agalactiae, remains a leading cause of neonatal morbidity and mortality. Canadian guidelines advise universal maternal screening for GBS colonisation in pregnancy in conjunction with selective antibiotic therapy. This results in over 1000 pregnant individuals receiving antibiotic therapy to prevent one case of early-onset neonatal GBS disease, and over 20 000 pregnant individuals receiving antibiotic therapy to prevent one neonatal death. Given the growing concern regarding the risk of negative sequela from antibiotic exposure, it is vital that alternative approaches to reduce maternal GBS colonisation are explored.

Preliminary studies suggest some probiotic strains could confer protection in pregnancy against GBS colonisation.

Methods and analysis

This double-blind parallel group randomised trial aims to recruit 450 pregnant participants in Vancouver, BC, Canada and will compare GBS colonisation rates in those who have received a daily oral dose of three strains of probiotics with those who have received a placebo. The primary outcome will be GBS colonisation status, measured using a vaginal/rectal swab obtained between 35 weeks’ gestation and delivery. Secondary outcomes will include maternal antibiotic exposure and urogenital infections. Analysis will be on an intention-to-treat basis.

Patient or public involvement

There was no patient or public involvement in the design of the study protocol.

Ethics and dissemination

This study protocol received ethics approval from the University of British Columbia’s Clinical Research Ethics Board, Dublin City University and Health Canada. Findings will be presented at research rounds, conferences and in peer-reviewed publications.

Trial registration number

NCT03407157.

Cohort profile: the National Congenital Anomaly Registration Dataset in England

Por: Broughan · J. M. · Wreyford · B. · Martin · D. · Melis · G. · Randall · K. · Obaro · E. · Broggio · J. · Aldridge · N. · Stoianova · S. · Johnson · C. · Gibbard · D. · Stevens · S. · Fleming · K. M.
Purpose

The National Congenital Anomaly and Rare Disease Registration Service (NCARDRS), part of National Disease Registration Service in National Health Service England, quality assures, curates and analyses individual data on the pregnancies, fetuses, babies, children and adults with congenital anomalies and rare diseases across England. The congenital anomaly (CA) register provides a resource for patients and their families, clinicians, researchers and public health professionals in furthering the understanding of CAs.

Participants

NCARDRS registers CAs occurring in babies born alive and stillborn, fetal losses and terminations in England. NCARDRS collects data from secondary and tertiary healthcare providers, private providers and laboratories covering fetal medicine, maternity or paediatric services. Data describe the pregnancy, mother, baby and anomaly. Established in 2015, NCARDRS expanded CA registration coverage from 22% of total births in England in 2015 to national coverage, which was achieved in 2018. Prior to 2015, data collection was performed independently by regional registers in England; these data are also held by NCARDRS.

Findings to date

NCARDRS registers approximately 21 000 babies with CAs per year with surveillance covering around 600 000 total births, the largest birth coverage for a CA register globally. Data on prevalence, risk factors and survival for children with CAs are available. Data have been used in several peer-reviewed publications. Birth prevalence statistics, including public health indicators such as the association with maternal age, infant and perinatal mortality, are published annually. NCARDRS supports clinical audit for screening programmes and service evaluation.

Future plans

NCARDRS provides a valuable resource for the understanding of the epidemiology, surveillance, prevention and treatment of CAs. Currently, approximately 21 000 new registrations of babies or fetuses with suspected or confirmed CAs are added each year. Identifiers are collected, enabling linkage to routinely collected healthcare and population statistics, further enhancing the value of the data.

Fibroids and unexplained infertility treatment with epigallocatechin gallate: a natural compound in green tea (FRIEND) - protocol for a randomised placebo-controlled US multicentre clinical trial of EGCG to improve fertility in women with uterine fibroids

Por: Al-Hendy · A. · Segars · J. H. · Taylor · H. S. · Gonzalez · F. · Siblini · H. · Zamah · M. · Alkelani · H. · Singh · B. · Flores · V. A. · Christman · G. M. · Johnson · J. J. · Huang · H. · Zhang · H.
Introduction

Uterine fibroids affect 30%–77% of reproductive-age women and are a significant cause of infertility. Surgical myomectomies can restore fertility, but they often have limited and temporary benefits, with postoperative complications such as adhesions negatively impacting fertility. Existing medical therapies, such as oral contraceptives, gonadotropin hormone-releasing hormone (GnRH) analogues and GnRH antagonists, can manage fibroid symptoms but are not fertility friendly. This study addresses the pressing need for non-hormonal, non-surgical treatment options for women with fibroids desiring pregnancy. Previous preclinical and clinical studies have shown that epigallocatechin gallate (EGCG) effectively reduces uterine fibroid size. We hypothesise that EGCG from green tea extract will shrink fibroids, enhance endometrial quality and increase pregnancy likelihood. To investigate this hypothesis, we initiated a National Institute of Child Health and Human Development Confirm-funded trial to assess EGCG’s efficacy in treating women with fibroids and unexplained infertility.

Methods and analysis

This multicentre, prospective, interventional, randomised, double-blinded clinical trial aims to enrol 200 participants with fibroids and unexplained infertility undergoing intrauterine insemination (IUI). Participants will be randomly assigned in a 3:1 ratio to two groups: green tea extract (1650 mg daily) or a matched placebo, combined with clomiphene citrate-induced ovarian stimulation and timed IUI for up to four cycles. EGCG constitutes approximately 45% of the green tea extract. The primary outcome is the cumulative live birth rate, with secondary outcomes including conception rate, time to conception, miscarriage rate, change in fibroid volume and symptom severity scores and health-related quality of life questionnaire scores.

Ethics and dissemination

The FRIEND trial received approval from the Food and Drug adminstration (FDA) (investigational new drug number 150951), the central Institutional Review Board (IRB) at Johns Hopkins University and FRIEND-collaborative site local IRBs. The data will be disseminated at major conferences, published in peer-reviewed journals and support a large-scale clinical trial.

Trial registration number

NCT05364008.

Staying Active with Multimorbidity In Acute hospital settings (StAMInA) trial: protocol for a feasibility randomised controlled trial of allied health assistant mobility rehabilitation for patients with multimorbidity

Por: Snowdon · D. A. · Wang · Y. T. · Callisaya · M. L. · Collyer · T. A. · Jolliffe · L. · Johns · N. · Vincent · P. · Pragash · N. · Taylor · N. F.
Introduction

Key to improving outcomes for patients with multimorbidity is increasing mobility through prescription of a physical activity programme, but this can be difficult to achieve in acute hospital settings. One approach that would assist physiotherapists to increase levels of physical activity is delegation of rehabilitation to allied health assistants. We aim to conduct a randomised controlled trial to determine the feasibility of an allied health assistant providing daily inpatient mobility rehabilitation for patients with multimorbidity.

Methods and analysis

Using a parallel group randomised controlled design, participants will be allocated to allied health assistant mobility rehabilitation or physiotherapist mobility rehabilitation. Adult inpatients (n=60) in an acute hospital with a diagnosis of multimorbidity who walked independently preadmission will be included. The experimental group will receive routine mobility rehabilitation, including daily mobilisation, from an allied health assistant under the supervision of a physiotherapist. The comparison group will receive routine rehabilitation from a physiotherapist. Feasibility will be determined using the following areas of focus in Bowen’s feasibility framework: Acceptability (patient satisfaction); demand (proportion of patients who participate); implementation (time allied health assistant/physiotherapist spends with participant, occasions of service); and practicality (cost, adverse events). Staff involved in the implementation of allied health assistant rehabilitation will be interviewed to explore their perspectives on feasibility. Secondary outcomes include: Physical activity (daily time spent walking); daily mobilisation (Y/N); discharge destination; hospital readmission; falls; functional activity (Modified Iowa Level of Assistance Scale); and length of stay. Descriptive statistics will be used to describe feasibility. Secondary outcomes will be compared between groups using Poisson or negative binomial regression, Cox proportional hazards regression, survival analysis, linear regression or logistic regression.

Ethics and dissemination

Ethics approval was obtained from Peninsula Health (HREC/97 431/PH-2023). Findings will be disseminated in peer-reviewed journals and conference presentations.

Trial registration number

Australian and New Zealand Clinical Trial Registry ACTRN12623000584639p.

Qualitative interview study of strategies to support healthcare personnel mental health through an occupational health lens

Por: Brown-Johnson · C. · DeShields · C. · McCaa · M. · Connell · N. · Giannitrapani · S. N. · Thanassi · W. · Yano · E. M. · Singer · S. J. · Lorenz · K. A. · Giannitrapani · K.
Background

Employee Occupational Health (‘occupational health’) clinicians have expansive perspectives of the experience of healthcare personnel. Integrating mental health into the purview of occupational health is a newer approach that could combat historical limitations of healthcare personnel mental health programmes, which have been isolated and underused.

Objective

We aimed to document innovation and opportunities for supporting healthcare personnel mental health through occupational health clinicians. This work was part of a national qualitative needs assessment of employee occupational health clinicians during COVID-19 who were very much at the centre of organisational responses.

Design

This qualitative needs assessment included key informant interviews obtained using snowball sampling methods.

Participants

We interviewed 43 US Veterans Health Administration occupational health clinicians from 29 facilities.

Approach

This analysis focused on personnel mental health needs and opportunities, using consensus coding of interview transcripts and modified member checking.

Key results

Three major opportunities to support mental health through occupational health involved: (1) expanded mental health needs of healthcare personnel, including opportunities to support work-related concerns (eg, traumatic deployments), home-based concerns and bereavement (eg, working with chaplains); (2) leveraging expanded roles and protocols to address healthcare personnel mental health concerns, including opportunities in expanding occupational health roles, cross-disciplinary partnerships (eg, with employee assistance programmes (EAP)) and process/protocol (eg, acute suicidal ideation pathways) and (3) need for supporting occupational health clinicians’ own mental health, including opportunities to address overwork/burn-out with adequate staffing/resources.

Conclusions

Occupational health can enact strategies to support personnel mental health: to structurally sustain attention, use social cognition tools (eg, suicidality protocols or expanded job descriptions); to leverage distributed attention, enhance interdisciplinary collaboration (eg, chaplains for bereavement support or EAP) and to equip systems with resources and allow for flexibility during crises, including increased staffing.

Primary care system-level training and support programme for the secondary prevention of domestic violence and abuse: a cost-effectiveness feasibility model

Por: Cochrane · M. · Szilassy · E. · Coope · C. · Emsley · E. · Johnson · M. · Feder · G. · Barbosa · E. C.
Objectives

This study aimed to evaluate the prospective cost-effectiveness of the Identification and Referral to Improve Safety plus (IRIS+) intervention compared with usual care using feasibility data derived from seven UK general practice sites.

Method

A cost–utility analysis was conducted to assess the potential cost-effectiveness of IRIS+, an enhanced model of the UK’s usual care. IRIS+ assisted primary care staff in identifying, documenting and referring not only women, but also men and children who may have experienced domestic violence/abuse as victims, perpetrators or both. A perpetrator group programme was not part of the intervention per se but was linked to the IRIS+ intervention via a referral pathway and signposting. A Markov model was constructed from a societal perspective to estimate mean incremental costs and quality-adjusted life years (QALYs) of IRIS+ compared with to usual care over a 10-year time horizon.

Results

The IRIS+ intervention saved £92 per patient and produced QALY gains of 0.003. The incremental net monetary benefit was positive (£145) and the IRIS+ intervention was cost-effective in 55% of simulations at a cost-effectiveness threshold of £20 000 per QALY.

Conclusion

The IRIS+ intervention could be cost-effective or even cost saving from a societal perspective in the UK, though there are large uncertainties, reflected in the confidence intervals and simulation results.

Country adoption of WHO 2019 guidance on HIV testing strategies and algorithms: a policy review across the WHO African region

Por: Fajardo · E. · Lastrucci · C. · Bah · N. · Mingiedi · C. M. · Ba · N. S. · Mosha · F. · Lule · F. J. · Paul · M. A. S. · Hughes · L. · Barr-DiChiara · M. · Jamil · M. S. · Sands · A. · Baggaley · R. · Johnson · C.
Objectives

In 2019, the WHO released guidelines on HIV testing service (HTS). We aim to assess the adoption of six of these recommendations on HIV testing strategies among African countries.

Design

Policy review.

Setting

47 countries within the WHO African region.

Participants

National HTS policies from the WHO African region as of December 2021.

Primary and secondary outcome measures: Uptake of WHO recommendations across national HTS policies including the standard three-test strategy; discontinuation of a tiebreaker test to rule in HIV infection; discontinuation of western blotting (WB) for HIV diagnosis; retesting prior to antiretroviral treatment (ART) initiation and the use of dual HIV/syphilis rapid diagnostic tests (RDTs) in antenatal care. Country policy adoption was assessed on a continuum, based on varying levels of complete adoption.

Results

National policies were reviewed for 96% (n=45/47) of countries in the WHO African region, 38% (n=18) were published before 2019 and 60% (n=28) adopted WHO guidance. Among countries that had not fully adopted WHO guidance, not yet adopting a three-test strategy was the most common reason for misalignment (45%, 21/47); of which 31% and 22% were in low-prevalence (

Conclusions

Many countries in the African region have adopted WHO-recommended HIV testing strategies; however, efforts are still needed to fully adopt WHO guidance. Countries should accelerate their efforts to adopt and implement a three-test strategy, retesting prior to ART initiation and the use of dual HIV/syphilis RDTs.

Randomised, placebo-controlled, double-blinded trial of fecal microbiota transplantation in severe obesity: a study protocol

Por: Hanssen · H. M. · Fjellstad · M. S. · Skjevling · L. · Johnsen · P. H. · Kulseng · B. · Goll · R. · Alma · K. H. · Valle · P.-C.
Introduction

Obesity is one of the main threats to public health in western countries and increases the risk of several diseases, overall morbidity and mortality. Sustained weight loss will reduce risk factors and improve several obesity comorbidities. Options are conservative treatment such as lifestyle changes, bariatric surgery or medications. Conservative treatment has a low success rate, and bariatric surgery is typically not reversible, with the risk of complications and recurrences. Treatment of obesity with medications has in recent years shown great promise, but the side effects are many, and the long-term effect is unknown. There is also a need for an option for patients where surgery has contraindications and conservative follow-up does not succeed.

The research on obesity and gut microbiota has yielded promising results regarding weight reduction and metabolic health, but more research is needed to better understand the relationship between gut microbiota and severe obesity. This study could show proof of concept that gut microbiota from a lean donor could, in addition to lifestyle intervention, contribute to weight reduction in people suffering from severe obesity.

Method and analysis

This study aims to investigate if a fecal microbiota transplantation (FMT) from a lean donor leads to weight reduction in participants suffering from severe obesity. The study is a single-centre, double-blinded, placebo-controlled, parallel-group study with 60 participants. Participants will be randomised 1:1 for FMT from a lean donor or placebo. FMT or placebo will be delivered once by enema.

We will include participants from the outpatient clinic for severe obesity, at the Medical Department, University Hospital of North Norway, Harstad, by invitation only. The study has a follow-up period of 12 months, with study visits of 3, 6 and 12 months post FMT. The primary endpoint is a weight reduction of ≥10%, 12 months after intervention.

The results of the study will be published in open access journals. At the end of the study, the participants will receive information on which treatment group they belong to.

Ethics and dissemination

The Regional Ethical Committee in North Norway (REK) approved the study protocol (2017/1655/REK Nord). We plan to present the results from the study at (inter)national conferences and publish in open-access general peer-reviewed journals. The enema method for FMT administration used in this study was developed by our study team.

Trial registration number

NCT03273855.

Impact of a pharmacy-led screening and intervention in people at risk of or living with chronic kidney disease in a primary care setting: a cluster randomised trial protocol

Por: Tesfaye · W. · Krass · I. · Sud · K. · Johnson · D. W. · Van · C. · Versace · V. L. · McMorrow · R. · Fethney · J. · Mullan · J. · Tran · A. · Robson · B. · Vagholkar · S. · Kairaitis · L. · Gisev · N. · Fathima · M. · Tong · V. · Coric · N. · Castelino · R. L.
Introduction

Chronic kidney disease (CKD) is increasingly recognised as a growing global public health problem. Early detection and management can significantly reduce the loss of kidney function. The proposed trial aims to evaluate the impact of a community pharmacy-led intervention combining CKD screening and medication review on CKD detection and quality use of medicines (QUM) for patients with CKD. We hypothesise that the proposed intervention will enhance detection of newly diagnosed CKD cases and reduce potentially inappropriate medications use by people at risk of or living with CKD.

Methods and analysis

This study is a multicentre, pragmatic, two-level cluster randomised controlled trial which will be conducted across different regions in Australia. Clusters of community pharmacies from geographical groups of co-located postcodes will be randomised. The project will be conducted in 122 community pharmacies distributed across metropolitan and rural areas. The trial consists of two arms: (1) Control Group: a risk assessment using the QKidney CKD risk assessment tool, and (2) Intervention Group: a risk assessment using the QKidney CKD plus Point-of-Care Testing for kidney function markers (serum creatinine and estimated glomerular filtration rate), followed by a QUM service. The primary outcomes of the study are the proportion of patients newly diagnosed with CKD at the end of the study period (12 months); and rates of changes in the number of medications considered problematic in kidney disease (number of medications prescribed at inappropriate doses based on kidney function and/or number of nephrotoxic medications) over the same period. Secondary outcomes include proportion of people on potentially inappropriate medications, types of recommendations provided by the pharmacist (and acceptance rate by general practitioners), proportion of people who were screened, referred, and took up the referral to visit their general practitioners, and economic and other patient-centred outcomes.

Ethics and dissemination

The trial protocol has been approved by the Human Research Ethics Committee at the University of Sydney (2022/044) and the findings of the study will be presented at scientific conferences and published in peer-reviewed journal(s).

Trial registration number

Australian New Zealand Clinical Trials Registry (ACTRN12622000329763).

Defining conditions for effective interdisciplinary care team communication in an open surgical intensive care unit: a qualitative study

Por: Diaz · C. M. · Egide · A. · Berry · A. · Rafferty · M. · Amro · A. · Tesorero · K. · Shapiro · M. · Ko · B. · Jones · W. · Slocum · J. D. · Johnson · J. · Stey · A. M.
Objective

Poor interdisciplinary care team communication has been associated with increased mortality. The study aimed to define conditions for effective interdisciplinary care team communication.

Design

An observational cross-sectional qualitative study.

Setting

A surgical intensive care unit in a large, urban, academic referral medical centre.

Participants

A total 6 interviews and 10 focus groups from February to June 2021 (N=33) were performed. Interdisciplinary clinicians who cared for critically ill patients were interviewed. Participants included intensivist, transplant, colorectal, vascular, surgical oncology, trauma faculty surgeons (n=10); emergency medicine, surgery, gynaecology, radiology physicians-in-training (n=6), advanced practice providers (n=5), nurses (n=7), fellows (n=1) and subspecialist clinicians such as respiratory therapists, pharmacists and dieticians (n=4). Audiorecorded content of interviews and focus groups were deidentified and transcribed verbatim. The study team iteratively generated the codebook. All transcripts were independently coded by two team members.

Primary outcome

Conditions for effective interdisciplinary care team communication.

Results

We identified five themes relating to conditions for effective interdisciplinary care team communication in our surgical intensive care unit setting: role definition, formal processes, informal communication pathways, hierarchical influences and psychological safety. Participants reported that clear role definition and standardised formal communication processes empowered clinicians to engage in discussions that mitigated hierarchy and facilitated psychological safety.

Conclusions

Standardising communication and creating defined roles in formal processes can promote effective interdisciplinary care team communication by fostering psychological safety.

Stratification of risk for emergent intracranial abnormalities in children with headaches: a Pediatric Emergency Care Applied Research Network (PECARN) study protocol

Por: Tsze · D. S. · Kuppermann · N. · Casper · T. C. · Barney · B. J. · Richer · L. P. · Liberman · D. B. · Okada · P. J. · Morris · C. R. · Myers · S. R. · Soung · J. K. · Mistry · R. D. · Babcock · L. · Spencer · S. P. · Johnson · M. D. · Klein · E. J. · Quayle · K. S. · Steele · D. W. · Cr
Introduction

Headache is a common chief complaint of children presenting to emergency departments (EDs). Approximately 0.5%–1% will have emergent intracranial abnormalities (EIAs) such as brain tumours or strokes. However, more than one-third undergo emergent neuroimaging in the ED, resulting in a large number of children unnecessarily exposed to radiation. The overuse of neuroimaging in children with headaches in the ED is driven by clinician concern for life-threatening EIAs and lack of clarity regarding which clinical characteristics accurately identify children with EIAs. The study objective is to derive and internally validate a stratification model that accurately identifies the risk of EIA in children with headaches based on clinically sensible and reliable variables.

Methods and analysis

Prospective cohort study of 28 000 children with headaches presenting to any of 18 EDs in the Pediatric Emergency Care Applied Research Network (PECARN). We include children aged 2–17 years with a chief complaint of headache. We exclude children with a clear non-intracranial alternative diagnosis, fever, neuroimaging within previous year, neurological or developmental condition such that patient history or physical examination may be unreliable, Glasgow Coma Scale score

Ethics and dissemination

Ethics approval was obtained for all participating sites from the University of Utah single Institutional Review Board. A waiver of informed consent was granted for collection of ED data. Verbal consent is obtained for follow-up contact. Results will be disseminated through international conferences, peer-reviewed publications, and open-access materials.

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