Pregnant womens attitudes to and experiences with a smartphone-based self-test for prediction of pre-eclampsia: a qualitative descriptive study

Objectives
To explore attitudes to and experiences using a smartphone-based self-test for prediction of pre-eclampsia among pregnant women.

Design
A qualitative, descriptive study.

Setting
An obstetrical care unit at a university hospital in Denmark.

Participants
Twenty women who had participated in the Salurate trial, a clinical trial testing the efficacy of a smartphone-based self-test for prediction of pre-eclampsia, were purposefully chosen for the study, using maximum variation sampling.

Data collection and analysis
Data were collected by semistructured, individual, face-to-face interviews conducted from 4 October 2018 to 8 November 2018. Data were transcribed verbatim and analysed by means of thematic analysis.

Results
Qualitative thematic analysis resulted in the identification of three main themes: Raising awareness, self-testing has the potential to be an integrated part of pregnancy and trusting in technology. Two subthemes were identified under each main theme.

Conclusions
The smartphone-based self-test for prediction of pre-eclampsia has potential to be integrated into antenatal care, and women found it feasible to use. However, testing affected the participating women psychologically, leading to feelings of worry as well as safety. Therefore, if self-testing is implemented, it is important to take actions to handle adverse psychological side effects, including increasing knowledge on pre-eclampsia and having healthcare professionals ongoingly address the psychological state of women throughout pregnancy. In addition, it is essential to emphasise the importance of subjective bodily sensations during pregnancy, including fetal movements. Further studies on the experience of being labelled low risk versus high risk for pre-eclampsia are warranted since this was not investigated in this trial.

Leggi
Maggio 2023

'A Unique opportunity to test things out: a qualitative study of broad-based training in Scotland

Objectives
A recent review recommended UK postgraduate medical education should produce doctors capable of providing general care in broad specialties across a range of different settings. Responding to this, broad-based training (BBT) was introduced in Scotland in 2018 to provide postgraduate trainees with a grounding in four specialties. Introduced as an option for trainees after initial postgraduate ‘Foundation’ training, it comprises 6 months in general medicine, general practice, paediatrics and psychiatry.
This study addresses two key BBT outcomes. It examines how successful BBT is in developing trainees who perceive they are able to work beyond traditional specialty boundaries to care for patients with complex, multifactorial healthcare needs. Second, it explores how well BBT prepares trainees for their next stage in training.

Design
A longitudinal qualitative study using semistructured interviews to collect data from BBT trainees, trainers and ‘programme architects’. Fifty-one interviews were conducted, 31 with trainees (with up to three interviews per trainee across BBT and immediately afterwards (post-BBT)) and 20 with trainers. Data were subject to thematic analysis.

Results
Two overarching themes were identified: (1) trainees able to work beyond specialty boundaries and (2) preparation for the next stage in training. BBT trainees were able to see the links and overlap between different specialties and understand the interface between primary and secondary care. They did not perceive that BBT (as compared with single-specialty early-stage training) disadvantaged them, other than in terms of specialty examination preparation. BBT was seen as a way to keep career options open in a system where it is difficult to switch training pathway.

Conclusions
BBT has the capacity to create doctors who will carry on using their generalist skills to care for patients more holistically, even if they end up working in focused practice areas. BBT helps to keep options open for longer, which is beneficial in a highly structured training environment.

Leggi
Maggio 2023

Evaluating an audit and feedback intervention for reducing overuse of pathology test requesting by Australian general practitioners: protocol for a factorial cluster randomised controlled trial

Introduction
Consistent evidence shows pathology services are overused worldwide and that about one-third of testing is unnecessary. Audit and feedback (AF) is effective for improving care but few trials evaluating AF to reduce pathology test requesting in primary care have been conducted. The aim of this trial is to estimate the effectiveness of AF for reducing requests for commonly overused pathology test combinations by high-requesting Australian general practitioners (GPs) compared with no intervention control. A secondary aim is to evaluate which forms of AF are most effective.

Methods and analysis
This is a factorial cluster randomised trial conducted in Australian general practice. It uses routinely collected Medicare Benefits Schedule data to identify the study population, apply eligibility criteria, generate the interventions and analyse outcomes. On 12 May 2022, all eligible GPs were simultaneously randomised to either no intervention control or to one of eight intervention groups. GPs allocated to an intervention group received individualised AF on their rate of requesting of pathology test combinations compared with their GP peers. Three separate elements of the AF intervention will be evaluated when outcome data become available on 11 August 2023: (1) invitation to participate in continuing professional development-accredited education on appropriate pathology requesting, (2) provision of cost information on pathology test combinations and (3) format of feedback. The primary outcome is the overall rate of requesting of any of the displayed combinations of pathology tests of GPs over 6 months following intervention delivery. With 3371 clusters, assuming no interaction and similar effects for each intervention, we anticipate over 95% power to detect a difference of 4.4 requests in the mean rate of pathology test combination requests between the control and intervention groups.

Ethics and dissemination
Ethics approval was received from the Bond University Human Research Ethics Committee (#JH03507; approved 30 November 2021). The results of this study will be published in a peer-reviewed journal and presented at conferences. Reporting will adhere to Consolidated Standards of Reporting Trials.

Trial registration number
ACTRN12622000566730.

Leggi
Maggio 2023

Feasibility and efficacy of ultrasound in the diagnosis of discoid lateral meniscus and its classification in children: protocol for a prospective, multicentre, diagnostic test study

Introduction
Although ultrasound can reportedly diagnose discoid lateral meniscus (DLM) in children, its widespread application is challenging because the diagnostic criteria are based on qualitative descriptions of DLM morphology rather than quantitative parameters. Additionally, no studies have applied ultrasound in classifying DLM. Therefore, this study aims to establish the quantitative ultrasound parameters that reflect DLM morphology, evaluate the feasibility and validity of these parameters for identifying DLM and their classification, and develop the quantitative ultrasound diagnostic criteria for DLM and their classification in children.

Methods and analysis
Patients will be recruited from the outpatient clinics of the orthopaedics department at West China Hospital, Sichuan University, the Fourth Medical Center of the Chinese People’s Liberation Army General Hospital, Xinhua Hospital affiliated with Shanghai Jiao Tong University School of Medicine, Yibin Hospital affiliated with West China Hospital Sichuan University, Suining Central Hospital and the Third Hospital of Mianyang from August 2022 to July 2024. Eligible patients are those aged ≤14 years, with knee symptoms such as pain, locking and limited extension, and who planned to undergo arthroscopic surgery. Exclusion criteria are patients with contraindications to ultrasound examination, such as severe skin damage or fracture around the knee. The sample size is estimated to be 576 cases with a power of 0.9 for hypothesis testing, a two-sided α of 0.05, and an expected sensitivity and specificity of 95%. Three days before surgery, ultrasound will be used to observe the morphology of the lateral meniscus and measure its width, angle α formed by the chord of upper and lower arc-shaped articular surface at the free edge, and the movement distance of the peripheral rim. Participants will be categorised according to the arthroscopy results for the DLM and its classification. The diagnostic performance of each parameter will be assessed and compared in terms of the area under the curve, sensitivity, specificity, and positive and negative predictive values.

Ethics and dissemination
This study was approved by the Ethics Committee of West China Hospital, Sichuan University (approval no. 2022-923), and this approval covers all study hospitals. Written informed consent is required from all participants before enrolment in the study. The study’s findings will be disseminated through peer-reviewed publications and conference presentations.

Trial registration number
Chinese Clinical Trial Registry (ChiCTR2200062000).

Leggi
Maggio 2023

Validation of a rapid SARS-CoV-2 antibody test in general practice

Objectives
To validate a rapid serological test (RST) for SARS-CoV-2 antibodies used in seroprevalence studies in healthcare providers, including primary healthcare providers (PHCPs) in Belgium.

Design
A phase III validation study of the RST (OrientGene) within a prospective cohort study.

Setting
Primary care in Belgium.

Participants
Any general practitioner (GP) working in primary care in Belgium and any other PHCP from the same GP practice who physically manages patients were eligible in the seroprevalence study. For the validation study, all participants who tested positive (376) on the RST at the first testing timepoint (T1) and a random sample of those who tested negative (790) and unclear (24) were included.

Intervention
At T2, 4 weeks later, PHCPs performed the RST with fingerprick blood (index test) immediately after providing a serum sample to be analysed for the presence of SARS-CoV-2 immunoglobulin G antibodies using a two-out-of-three assay (reference test).

Primary and secondary outcome measures
The RST accuracy was estimated using inverse probability weighting to correct for missing reference test data, and considering unclear RST results as negative for the sensitivity and positive for the specificity. Using these conservative estimates, the true seroprevalence was estimated both for T2 and RST-based prevalence values found in a cohort study with PHCPs in Belgium.

Results
1073 paired tests (403 positive on the reference test) were included. A sensitivity of 73% (a specificity of 92%) was found considering unclear RST results as negative (positive). For an RST-based prevalence at T1 (13.9), T2 (24.9) and T7 (70.21), the true prevalence was estimated to be 9.1%, 25.9% and 95.7%, respectively.

Conclusion
The RST sensitivity (73%) and specificity (92%) make an RST-based seroprevalence below (above) 23% overestimate (underestimate) the true seroprevalence.

Trial registration number
NCT04779424.

Leggi
Maggio 2023

Calibrating the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) for detecting alcohol-related problems among Canadian, UK and US soldiers: cross-sectional pre-deployment and post-deployment survey results

Objectives
Excessive alcohol use can bring about adverse health and work-related consequences in civilian and military populations. Screening for excessive drinking can help identify individuals at risk for alcohol-related problems who may require clinical interventions. The brief validated measures of alcohol use such as the Alcohol Use Disorders Identification Test (AUDIT), or abbreviated AUDIT-Consumption (AUDIT-C), are often included in military deployment screening and epidemiologic surveys, but appropriate cut-points must be used to effectively identify individuals at risk. Although the conventional AUDIT-C cut-points ≥4 for men and ≥3 for women are commonly used, recent validation studies of veterans and civilians recommend higher cut-points to minimise misclassification and overestimation of alcohol-related problems. This study aims to ascertain optimal AUDIT-C cut-points for detecting alcohol-related problems among serving Canadian, UK and US soldiers.

Design
Cross-sectional pre/post-deployment survey data were used.

Settings
Comprised Army locations in Canada and UK, and selected US Army units.

Participants
Included soldiers in each of the above-mentioned settings.

Outcome measures
Soldiers’ AUDIT scores for hazardous and harmful alcohol use or high levels of alcohol problems served as a benchmark against which optimal sex-specific AUDIT-C cut-points were assessed.

Results
Across the three-nation samples, AUDIT-C cut-points of ≥6/7 for men and ≥5/6 for women performed well in detecting hazardous and harmful alcohol use and provided comparable prevalence estimates to AUDIT scores ≥8 for men and ≥7 for women. The AUDIT-C cut-point ≥8/9 for both men and women performed fair-to-good when benchmarked against AUDIT ≥16, although inflated AUDIT-C-derived prevalence estimates and low positive predictive values were observed.

Conclusion
This multi-national study provides valuable information regarding appropriate AUDIT-C cut-points for detecting hazardous and harmful alcohol use, and high levels of alcohol problems among soldiers. Such information can be useful for population surveillance, pre-deployment/post-deployment screening of military personnel, and clinical practice.

Leggi
Maggio 2023

COVID-19 vaccine effectiveness and variants in Nepal: study protocol for a test-negative case-control study with SARS-CoV-2 genetic sequencing

Introduction
Inactivated, viral vector and mRNA vaccines have been used in the Nepali COVID-19 vaccination programme but there is little evidence on the effectiveness of these vaccines in this setting. The aim of this study is to describe COVID-19 vaccine effectiveness in Nepal and provide information on infections with SARS-CoV-2 variants.

Methods and analysis
This is a hospital-based, prospective test-negative case–control study conducted at Patan Hospital, Kathmandu. All patients >18 years of age presenting to Patan Hospital with COVID-19-like symptoms who have received a COVID-19 antigen/PCR test are eligible for inclusion. The primary outcome is vaccine effectiveness of licensed COVID-19 vaccines against laboratory-confirmed COVID-19 disease.
After enrolment, information will be collected on vaccine status, date of vaccination, type of vaccine, demographics and other medical comorbidities. The primary outcome of interest is laboratory-confirmed SARS-CoV-2 infection. Cases (positive for SARS-CoV-2) and controls (negative for SARS-CoV-2) will be enrolled in a 1:4 ratio. Vaccine effectiveness against COVID-19 disease will be analysed by comparing vaccination status with SARS-CoV-2 test results.
Positive SARS-CoV-2 samples will be sequenced to identify circulating variants and estimate vaccine effectiveness against common variants.
Measuring vaccine effectiveness and identifying SARS-CoV-2 variants in Nepal will help to inform public health efforts. Describing disease severity in relation to specific SARS-CoV-2 variants and vaccine status will also inform future prevention and care efforts.

Ethics and dissemination
Ethical approval was obtained from the University of Oxford Tropical Ethics Committee (OxTREC) (ref: 561-21) and the Patan Academy of Health Sciences Institutional Review Board (ref: drs2111121578). The protocol and supporting study documents were approved for use by the Nepal Health Research Council (NHRC 550-2021). Results will be disseminated in peer-reviewed journals and to the public health authorities in Nepal.

Leggi
Aprile 2023

Diagnostic accuracy of cryptococcal antigen test in pulmonary cryptococcosis: a protocol for a systematic review and meta-analysis

Background
The cryptococcal antigen (CrAg) test was proposed as a rapid diagnostic tool to identify cryptococcal meningitis in patients suffering from AIDS. Several studies have demonstrated its diagnostic performance in cryptococcal meningitis. However, the diagnostic performance of the CrAg test in serum or bronchoalveolar lavage fluid in patients with pulmonary cryptococcosis remains uncertain. Therefore, the purpose of this systematic review is to summarise the evidence concerning diagnostic performance of the CrAg test in patients with pulmonary cryptococcosis.

Methods and analysis
Databases such as PubMed, EMBASE, Cochrane Database of Systematic Reviews, Web of Science, ClinicalTrials.gov, International Clinical Trials Registry Platform, Wanfang Database and China National Knowledge Infrastructure will be searched systematically. The titles and abstracts will be reviewed by two independent reviewers. The Quality Assessment of Diagnostic Accuracy Studies 2 tool will be used to evaluate the risk of bias and clinical applicability of each study. Potential sources of heterogeneity will be investigated through visual inspection of the paired forest plots and summary receiver operating characteristic plots. The pooled summary statistics for the area under the curve, sensitivities, specificities, likelihood ratios and diagnostic ORs with 95% CI will be reported.

Ethics and dissemination
The underlying study is based on published articles thus does not require ethical approval. The findings of the systematic review and meta-analysis will be published in a peer-reviewed journal and disseminated in various scientific conferences and seminars.

PROSPERO registration number
CRD42022373321.

Leggi
Aprile 2023