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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).

Preoperative functional performance is the best predictor for loss of independence after major surgery among older adults

Por: Johnson · C. E. · Brooke · B. S.

Commentary on: Goeddel L, Murphy Z, Owodunni O, et al. Domains of Frailty Predict Loss of Independence in Older Adults after Non-Cardiac Surgery. Ann Surg. 2022 Sep 20. doi: 10.1097/SLA.0000000000005720. Epub ahead of print.

Implications for practice and research

  • Frailty screening with the Edmonton Frailty Scale can be used to identify risk factors for loss of independence after surgery, including a patient’s functional performance, functional dependence, social support and urinary incontinence.

  • Prospective studies are needed to test whether risk factors can be modified before surgery to prevent loss of independence among frail patients.

  • Context

    Frailty is a common syndrome of physiological decline among older adults characterised by vulnerability to adverse outcomes and loss of functional independence after major surgery.1 The study by Goeddel et al2 examined 11 geriatric domains associated with frailty that were collected before surgery using the Edmonton...

    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.

    Women Veterans’ Barriers to Care-Seeking for Cardiovascular Disease Prevention

    imageBackground Women veterans have a high prevalence of traditional and nontraditional risks for cardiovascular disease (CVD) including obesity and posttraumatic stress disorder. Experts from the U.S. Department of Veterans Affairs have called for actions to improve the cardiovascular health of this population. One approach is to assess women veterans’ barriers to care-seeking for CVD prevention, to inform future intervention research. Objective The objective of this study was to describe women veterans’ barriers to care-seeking for CVD prevention, guided by the theory of care-seeking behavior and concept awareness. Methods Using a cross-sectional, descriptive design, a national sample of 245 women veterans participated in an online survey about barriers to care-seeking. Participants provided narrative responses to open-ended items, endorsements to closed-ended items, and rankings of their top five barriers. Researchers conducted poststratification weighting of numerical data to reflect the women veteran population. Results Narrative responses described unaffordable and inaccessible services, feeling harassed or not respected in healthcare settings, and lack of awareness of risks for CVD. Frequently endorsed barriers were unaffordable and inaccessible services. Frequently ranked barriers were feeling not respected in healthcare settings and clinicians not recommending CVD prevention. Discussion Findings support concepts in theory of care-seeking behavior and concept awareness. Understanding women veterans’ barriers to care-seeking for CVD prevention can inform clinicians and researchers as they address these barriers.

    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.

    Evaluating niraparib versus active symptom control in patients with previously treated mesothelioma (NERO): a study protocol for a multicentre, randomised, two-arm, open-label phase II trial in UK secondary care centres

    Por: Fennell · D. · Griffiths · D. · Eminton · Z. · Morgan-Fox · A. · Hill · K. · Ewings · S. · Stuart · C. · Johnson · L. · Mallard · K. · Nye · M. · Darlison · L. · Dulloo · S. · Cave · J. · Luo · J.-L. · Taylor · P. · Spicer · J. · Poile · C. · Bzura · A. · Griffiths · G.
    Background

    Malignant mesothelioma is a rapidly lethal cancer that has been increasing at an epidemic rate over the last three decades. Targeted therapies for mesothelioma have been lacking. A previous study called MiST1 (NCT03654833), evaluated the efficacy of Poly (ADP-ribose) polymerase (PARP) inhibition in mesothelioma. This study met its primary endpoint with 15% of patients having durable responses exceeding 1 year. Therefore, there is a need to evaluate PARP inhibitors in relapsed mesothelioma patients, where options are limited. Niraparib is the PARP inhibitor used in NERO.

    Methods

    NERO is a multicentre, two-arm, open-label UK randomised phase II trial designed to evaluate the efficacy of PARP inhibition in relapsed mesothelioma. 84 patients are being recruited. NERO is not restricted by line of therapy; however, eligible participants must have been treated with an approved platinum based systemic therapy. Participants will be randomised 2:1, stratified according to histology and response to prior platinum-based chemotherapy, to receive either active symptom control (ASC) and niraparib or ASC alone, for up to 24 weeks. Participants will be treated until disease progression, withdrawal, death or development of significant treatment limiting toxicity. Participants randomised to niraparib will receive 200 or 300 mg daily in a 3-weekly cycle. The primary endpoint is progression-free survival, where progression is determined by modified Response Evaluation Criteria in Solid Tumors (mRECIST) or RECIST 1.1; investigator reported progression; or death from any cause, whichever comes first. Secondary endpoints include overall survival, best overall response, 12-week and 24 week disease control, duration of response, treatment compliance and safety/tolerability. If NERO shows niraparib to be safe and biologically effective, it may lead to future late phase randomised controlled trials in relapsed mesothelioma.

    Ethics and dissemination

    The study received ethical approval from London-Hampstead Research Ethics Committee on 06-May-2022 (22/LO/0281). Data from all centres will be analysed together and published as soon as possible.

    Trial registration number

    ISCRTN16171129; NCT05455424.

    Implementing paediatric patient-reported outcome measures in outpatient asthma clinics: a feasibility assessment study

    Por: Bele · S. · Paolucci · E. O. · Johnson · D. W. · Quan · H. · Santana · M.-J.
    Objective

    Implementation of patient-reported outcome measures (PROMs) is limited in paediatric routine clinical care. The KidsPRO programme has been codesigned to facilitate the implementation of PROMs in paediatric healthcare settings. Therefore, this study (1) describes the development of innovative KidsPRO programme and (2) reports on the feasibility of implementing PedsQL (Pediatric Quality of Life Inventory) PROM in asthma clinics using the KidsPRO programme.

    Design

    Feasibility assessment study.

    Setting

    Outpatient paediatric asthma clinics in the city of Calgary, Canada.

    Participants

    Five paediatric patients, four family caregivers and three healthcare providers were recruited to pilot the implementation of PedsQL PROM using KidsPRO. Then, a survey was used to assess its feasibility among these study participants.

    Main outcome measures

    Participants’ understanding of using PROMs, the adequacy of support provided to them, the utility of using PROMs as part of their appointment, and their satisfaction with using PROMs.

    Analyses

    The quantitative data generated through closed-ended questions was analysed and represented in the form of bar charts for each category of study participants (ie, patients, their family caregivers and healthcare providers). The qualitative data generated through the open-ended questions were content analysed and categorised into themes.

    Results

    The experience of using PROMs was overwhelmingly positive among patients and their family caregivers, results were mixed among healthcare providers. Qualitative data collected through open-ended questions also complemented the quantitative findings.

    Conclusion

    The evidence from this study reveals that the implementation of PROMs in routine paediatric clinical care asthma clinics in Alberta is seems to be feasible.

    Evaluating the performance of artificial intelligence software for lung nodule detection on chest radiographs in a retrospective real-world UK population

    Por: Maiter · A. · Hocking · K. · Matthews · S. · Taylor · J. · Sharkey · M. · Metherall · P. · Alabed · S. · Dwivedi · K. · Shahin · Y. · Anderson · E. · Holt · S. · Rowbotham · C. · Kamil · M. A. · Hoggard · N. · Balasubramanian · S. P. · Swift · A. · Johns · C. S.
    Objectives

    Early identification of lung cancer on chest radiographs improves patient outcomes. Artificial intelligence (AI) tools may increase diagnostic accuracy and streamline this pathway. This study evaluated the performance of commercially available AI-based software trained to identify cancerous lung nodules on chest radiographs.

    Design

    This retrospective study included primary care chest radiographs acquired in a UK centre. The software evaluated each radiograph independently and outputs were compared with two reference standards: (1) the radiologist report and (2) the diagnosis of cancer by multidisciplinary team decision. Failure analysis was performed by interrogating the software marker locations on radiographs.

    Participants

    5722 consecutive chest radiographs were included from 5592 patients (median age 59 years, 53.8% women, 1.6% prevalence of cancer).

    Results

    Compared with radiologist reports for nodule detection, the software demonstrated sensitivity 54.5% (95% CI 44.2% to 64.4%), specificity 83.2% (82.2% to 84.1%), positive predictive value (PPV) 5.5% (4.6% to 6.6%) and negative predictive value (NPV) 99.0% (98.8% to 99.2%). Compared with cancer diagnosis, the software demonstrated sensitivity 60.9% (50.1% to 70.9%), specificity 83.3% (82.3% to 84.2%), PPV 5.6% (4.8% to 6.6%) and NPV 99.2% (99.0% to 99.4%). Normal or variant anatomy was misidentified as an abnormality in 69.9% of the 943 false positive cases.

    Conclusions

    The software demonstrated considerable underperformance in this real-world patient cohort. Failure analysis suggested a lack of generalisability in the training and testing datasets as a potential factor. The low PPV carries the risk of over-investigation and limits the translation of the software to clinical practice. Our findings highlight the importance of training and testing software in representative datasets, with broader implications for the implementation of AI tools in imaging.

    Elopement: Evidence‐based mitigation and management

    Abstract

    Background

    Elopement jeopardizes patient safety, affects the hospital's reputation, and results in financial ramifications. In an academic community hospital, executive leadership approached a team of nurse leaders for expertise following the elopement of a vulnerable patient.

    Aim of the Initiative

    The team's goal was to identify evidence-based strategies to mitigate future elopement events. Following an extensive literature review and gap analysis, the organization recognized opportunities pertaining to elopement management, including patient assessment, prevention strategies, and facility-wide response when events occur. The nurse leader team thoroughly searched current literature to answer the Population, Intervention, Comparison, and Outcome (i.e., PICO) questions of interest. Following a critical appraisal of 55 articles, 26 were utilized to make practice change recommendations. The body of evidence included a variety of age groups and diagnoses.

    Implementation Plan

    After the synthesis of the literature, the team provided recommendations to the organization. These recommendations included the assessment of patient-specific risks and the implementation of elopement prevention measures as fundamental elements for incidence reduction. The team partnered with multidisciplinary stakeholders for the revision of policies, processes, and electronic medical record documentation.

    Outcomes

    The organization monitored elopement events and the duration of each event throughout the phases of implementation. Pre-implementation data, collected from January to June 2021, demonstrated 34 individual elopement cases lasting an average of 118 min each. In comparison, post-implementation data collected during the same time frame in 2022 found only 12 events lasting an average of 24 min each.

    Implications for Practice

    The organization implemented evidence-based recommendations to standardize the facility's approach to elopement. With structured assessment, precautions, and response, the organization demonstrated a notable decline in the number and duration of elopement events. Hardwiring processes, analyzing data, and adjusting expectations within an evidence-based framework should assist the organization's drive to further enhance patient safety surrounding elopement events.

    Critical care nursing workforce in crisis: A discussion paper examining contributing factors, the impact of the COVID‐19 pandemic and potential solutions

    Abstract

    Aims and Objectives

    The critical care nursing workforce is in crisis, with one-third of critical care nurses worldwide intending to leave their roles. This paper aimed to examine the problem from a wellbeing perspective, offering implications for research, and potential solutions for organisations.

    Design

    Discursive/Position paper.

    Method

    The discussion is based on the nursing and wellbeing literature. It is guided by the authors' collaborative expertise as both clinicians and researchers. Data were drawn from nursing and wellbeing peer-reviewed literature, such as reviews and empirical studies, national surveys and government and thinktank publications/reports.

    Results

    Critical care nurses have been disproportionately affected by the COVID-19 pandemic with studies consistently showing critical care nurses to have the worst psychological outcomes on wellbeing measures, including depression, burnout and post-traumatic stress disorder (PTSD). These findings are not only concerning for the mental wellbeing of critical care nurses, they also raise significant issues for healthcare systems/organisations: poor wellbeing, increased burnout and PTSD are directly linked with critical care nurses intending to leave the profession. Thus, the wellbeing of critical care nurses must urgently be supported. Resilience has been identified as a protective mechanism against the development of PTSD and burnout, thus offering evidence-based interventions that address resilience and turnover have much to offer in tackling the workforce crisis. However, turnover data must be collected by studies evaluating resilience interventions, to further support their evidence base. Organisations cannot solely rely on the efficacy of these interventions to address their workforce crisis but must concomitantly engage in organisational change.

    Conclusions

    We conclude that critical care nurses are in urgent need of preventative, evidence-based wellbeing interventions, and make suggestions for research and practice.

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