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Hoy — Mayo 14th 2024Tus fuentes RSS

Impact evaluation of a cash-plus programme for children with disabilities in the Xiengkhouang Province in Lao PDR: study protocol for a non-randomised controlled trial

Por: Banks · L. M. · Soukkhaphone · B. · Scherer · N. · Siengsounthone · L. · Carew · M. T. · Shakespeare · T. · Chen · S. · Davey · C. · Goyal · D. · Zinke-Allmang · A. · Kuper · H. · Chanthakoumane · K.
Introduction

More than 170 countries have implemented disability-targeted social protection programmes, although few have been rigorously evaluated. Consequently, a non-randomised controlled trial is being conducted of a pilot ‘cash-plus’ programme implemented by UNICEF Laos and the Laos government for children with disabilities in the Xiengkhouang Province in Laos. The intervention combines a regular cash transfer with provision of assistive devices and access for caregivers to a family support programme.

Methods and analysis

The non-randomised controlled trial will involve 350 children with disabilities across 3 districts identified by programme implementers as eligible for the programme (intervention arm). Implementers have also identified approximately 180 children with disabilities in neighbouring districts, who would otherwise meet eligibility criteria but do not live in the project areas (control arm). The trial will assess the impact of the programme on child well-being (primary outcome), as well as household poverty, caregiver quality of life and time use (secondary outcomes). Baseline data are being collected May–October 2023, with endline 24 months later. Analysis will be intention to treat. A complementary process evaluation will explore the implementation, acceptability of the programme, challenges and enablers to its delivery and mechanisms of impact.

Ethics and dissemination

The study has received ethical approval from the London School of Hygiene and Tropical Medicine and the National Ethics Committee for Health Research in Laos. Informed consent and assent will be taken by trained data collectors. Data will be collected and stored on a secure, encrypted server and its use will follow a detailed data management plan. Findings will be disseminated in academic journals and in short briefs for policy and programmatic actors, and in online and in-person events.

Trial registration number

ISRCTN80603476.

Implementation of the WHO Safe Childbirth Checklist: a scoping review protocol

Introduction

The WHO Safe Childbirth Checklist (WHO SCC) was developed to accelerate adoption of essential practices that prevent maternal and neonatal morbidity and mortality during childbirth. This study aims to summarise the current landscape of organisations and facilities that have implemented the WHO SCC and compare the published strategies used to implement the WHO SCC implementation in both successful and unsuccessful efforts.

Methods and analysis

This scoping review protocol follows the guidelines of the Joanna Briggs Institute. Data will be collected and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews report. The search strategy will include publications from the databases Scopus, PubMed, Embase, CINAHL and Web of Science, in addition to a search in grey literature in The National Library of Australia’s Trobe, DART-Europe E-Theses Portal, Electronic Theses Online Service, Theses Canada, Google Scholar and Theses and dissertations from Latin America. Data extraction will include data on general information, study characteristics, organisations involved, sociodemographic context, implementation strategies, indicators of implementation process, frameworks used to design or evaluate the strategy, implementation outcomes and final considerations. Critical analysis of implementation strategies and outcomes will be performed with researchers with experience implementing the WHO SCC.

Ethics and dissemination

The study does not require an ethical review due to its design as a scoping review of the literature. The results will be submitted for publication to a scientific journal and all relevant data from this study will be made available in Dataverse.

Trial registration number

https://doi.org/10.17605/OSF.IO/RWY27.

How effective is topical miconazole or amorolfine for mild to moderately severe onychomycosis in primary care: the Onycho Trial - a randomised double-blind placebo-controlled trial

Por: Watjer · R. M. · Bonten · T. N. · Sayed · K. · Quint · K. D. · van der Beek · M. T. · Mertens · B. J. A. · Numans · M. E. · Eekhof · J. A. H.
Objectives

To evaluate the efficacy of topical miconazole or amorolfine compared to placebo for mild to moderately severe onychomycosis.

Design

Randomised, double-blind, placebo-controlled trial, with computer-generated treatment allocation at a 1:1:1 ratio.

Setting

Primary care, recruitment from February 2020 to August 2022.

Participants

193 patients with suspected mild to moderately severe onychomycosis were recruited via general practices and from the general public, 111 of whom met the study criteria. The mean age of participants was 51 (SD 13.1), 51% were female and onychomycosis was moderately severe (mean OSI 12.1 (SD 8.0)).

Interventions

Once-daily miconazole 20 mg/g or once-weekly amorolfine 5% nail lacquer solution was compared with placebo (denatonium benzoate solution).

Main outcome measures

Complete, clinical and mycological cure at 6 months. Secondary outcomes were clinical improvement, symptom burden, quality of life, adverse effects, compliance, patient-perceived improvement and treatment acceptability.

Results

Based on intention-to-treat analysis, none of the participants receiving miconazole or amorolfine reached complete cure compared with two in the placebo group (OR not estimable (n.e.), p=0.493 and OR n.e., p=0.240, respectively). There was no evidence of a significant difference between groups regarding clinical cure (OR n.e., p=0.493 and OR 0.47, 95% CI 0.04 to 5.45, p=0.615) while miconazole and amorolfine were less effective than placebo at reaching both mycological cure (OR 0.25, 95% CI 0.06 to 0.98, p=0.037 and OR 0.23, 95% CI 0.06 to 0.92, p=0.029, respectively) and clinical improvement (OR 0.26, 95% CI 0.08 to 0.91, p=0.028 and OR 0.25, 95% CI 0.07 to 0.85, p=0.021, respectively). There was no evidence of a significant difference in disease burden, quality of life, adverse reactions, compliance, patient-perceived improvement or treatment acceptability.

Conclusions

Topical miconazole and amorolfine were not effective in achieving a complete, clinical or mycological cure of mild to moderately severe onychomycosis, nor did they significantly alleviate the severity or symptom burden. These treatments should, therefore, not be advised as monotherapy to treat onychomycosis.

Trial registration number

WHO ICTRP NL8193.

Cost analysis for initiating an integrated package of essential non-communicable disease interventions (PEN-Plus) in Kondoa District Hospital, Tanzania: a time-driven activity-based costing (TDABC) study protocol

Por: Ndumwa · H. P. · Mori · A. T. · Ruhago · G. M. · Willilo · R. · McBain · R. · Boudreaux · C. · Wroe · E. · Adler · A. J. · Bukhman · G. · Mayige · M. T. · Kaarboe · O.
Introduction

Non-communicable diseases (NCDs) constitute approximately 74% of global mortality, with 77% of these deaths occurring in low-income and middle-income countries. Tanzania exemplifies this situation, as the percentage of total disability-adjusted life years attributed to NCDs has doubled over the past 30 years, from 18% to 36%. To mitigate the escalating burden of severe NCDs, the Tanzanian government, in collaboration with local and international partners, seeks to extend the integrated package of essential interventions for severe NCDs (PEN-Plus) to district-level facilities, thereby improving accessibility. This study aims to estimate the cost of initiating PEN-Plus for rheumatic heart disease, sickle cell disease and type 1 diabetes at Kondoa district hospital in Tanzania.

Methods and analysis

We will employ time-driven activity-based costing (TDABC) to quantify the capacity cost rates (CCR), and capital and recurrent costs associated with the implementation of PEN-Plus. Data on resource consumption will be collected through direct observations and interviews with nurses, the medical officer in charge and the heads of laboratory and pharmacy units/departments. Data on contact times for targeted NCDs will be collected by observing a sample of patients as they move through the care delivery pathway. Data cleaning and analysis will be done using Microsoft Excel.

Ethics and dissemination

Ethical approval to conduct the study has been waived by the Norwegian Regional Ethics Committee and was granted by the Tanzanian National Health Research Ethics Committee NIMR/HQ/R.8a/Vol.IX/4475. A written informed consent will be provided to the study participants. This protocol has been disseminated in the Bergen Centre for Ethics and Priority Setting International Symposium, Norway and the 11th Muhimbili University of Health and Allied Sciences Scientific Conference, Tanzania in 2023. The findings will be published in peer-reviewed journals for use by the academic community, researchers and health practitioners.

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Prevalence of work-related musculoskeletal disorders and associated factors affecting emergency medical services professionals in Jordan: a cross-sectional study

Por: Nazzal · M. S. · Oteir · A. O. · Alrawashdeh · A. · Alwidyan · M. T. · Obiedat · Q. · Almhdawi · K. A. · Ismael · N. T. · Williams · B.
Objectives

Emergency medical services (EMSs) personnel are at high risk for developing work-related musculoskeletal disorders (WMSDs). However, no studies have yet investigated the prevalence and effect of these disorders on the Jordanian EMS personnel. Therefore, this study aimed to determine the prevalence of WMSDs among Jordanian EMS personnel and its associated factors.

Design

This study used a cross-sectional design. Participants were asked to complete a self-administrated and validated questionnaire to measure the WMSDs, including a demographic survey and the Nordic Musculoskeletal Questionnaire. Descriptive and multivariable regression analyses were used.

Setting

The Jordanian Civil Defence stations in the main cities of Jordan.

Participants

The sample consisted of 435 EMS workers which were obtained across the country of Jordan. A total of 79.0% of the participants were male, with a mean age of 27.9 (±4.3 SD) years.

Results

The pain in the lower back (308, 70.8%) and neck (252, 57.9%) were the most reported in the last 12 months. Furthermore, about half of the participants reported having pain in their upper back (234, 53.8%), knee (227, 52.2%) and shoulder (226, 52.0%) pain in the last 12 months. Overall, WMSDs in at least one body part were significantly associated with age, experience, being a male, increased body mass index and lower educational level.

Conclusions

There is a high prevalence of musculoskeletal complaints among EMS personnel. Multiple variables may be incorporated into a national prevention campaign and professional development programme to educate EMS personnel on avoiding WMSDs.

Protocol for the Adolescent Menstrual Experiences and Health Cohort (AMEHC) Study in Khulna, Bangladesh: A Prospective cohort to quantify the influence of menstrual health on adolescent girls health and education outcomes.

Por: Hennegan · J. · Hasan · M. T. · Jabbar · A. · Jalil · T. · Kennedy · E. · Hunter · E. · Kaiser · A. · Akter · S. · Zaman · A. · Rahman · M.-u. · Dunstan · L. · Head · A. · Scott · N. · Weiss · H. A. · Win · T. M. · Melendez-Torres · G. J. · Than · K. K. · Hughes · C. L. · Grover · S. · Hasan
Background

Menstrual health is essential for gender equity and the well-being of women and girls. Qualitative research has described the burden of poor menstrual health on health and education; however, these impacts have not been quantified, curtailing investment. The Adolescent Menstrual Experiences and Health Cohort (AMEHC) Study aims to describe menstrual health and its trajectories across adolescence, and quantify the relationships between menstrual health and girls’ health and education in Khulna, Bangladesh.

Methods and analysis

AMEHC is a prospective longitudinal cohort of 2016 adolescent girls recruited at the commencement of class 6 (secondary school, mean age=12) across 101 schools selected through a proportional random sampling approach. Each year, the cohort will be asked to complete a survey capturing (1) girls’ menstrual health and experiences, (2) support for menstrual health, and (3) health and education outcomes. Survey questions were refined through qualitative research, cognitive interviews and pilot survey in the year preceding the cohort. Girls’ guardians will be surveyed at baseline and wave 2 to capture their perspectives and household demographics. Annual assessments will capture schools’ water, sanitation and hygiene, and support for menstruation and collect data on participants’ education, including school attendance and performance (in maths, literacy). Cohort enrolment and baseline survey commenced in February 2023. Follow-up waves are scheduled for 2024, 2025 and 2026, with plans for extension. A nested subcohort will follow 406 post-menarche girls at 2-month intervals throughout 2023 (May, August, October) to describe changes across menstrual periods. This protocol outlines a priori hypotheses regarding the impacts of menstrual health to be tested through the cohort.

Ethics and dissemination

AMEHC has ethical approval from the Alfred Hospital Ethics Committee (369/22) and BRAC James P Grant School of Public Health Institutional Review Board (IRB-06 July 22-024). Study materials and outputs will be available open access through peer-reviewed publication and study web pages.

Using digital tools in clinical, health and social care research: a mixed-methods study of UK stakeholders

Por: Clohessy · S. · Arvanitis · T. N. · Rashid · U. · Craddock · C. · Evans · M. · Toro · C. T. · Elliott · M. T.
Objective

The COVID-19 pandemic accelerated changes to clinical research methodology, with clinical studies being carried out via online/remote means. This mixed-methods study aimed to identify which digital tools are currently used across all stages of clinical research by stakeholders in clinical, health and social care research and investigate their experience using digital tools.

Design

Two online surveys followed by semistructured interviews were conducted. Interviews were audiorecorded, transcribed and analysed thematically.

Setting, participants

To explore the digital tools used since the pandemic, survey participants (researchers and related staff (n=41), research and development staff (n=25)), needed to have worked on clinical, health or social care research studies over the past 2 years (2020–2022) in an employing organisation based in the West Midlands region of England (due to funding from a regional clinical research network (CRN)). Survey participants had the opportunity to participate in an online qualitative interview to explore their experiences of digital tools in greater depth (n=8).

Results

Six themes were identified in the qualitative interviews: ‘definition of a digital tool in clinical research’; ‘impact of the COVID-19 pandemic’; ‘perceived benefits/drawbacks of digital tools’; ‘selection of a digital tool’; ‘barriers and overcoming barriers’ and ‘future digital tool use’. The context of each theme is discussed, based on the interview results.

Conclusions

Findings demonstrate how digital tools are becoming embedded in clinical research, as well as the breadth of tools used across different research stages. The majority of participants viewed the tools positively, noting their ability to enhance research efficiency. Several considerations were highlighted; concerns about digital exclusion; need for collaboration with digital expertise/clinical staff, research on tool effectiveness and recommendations to aid future tool selection. There is a need for the development of resources to help optimise the selection and use of appropriate digital tools for clinical research staff and participants.

Protocol for a randomised controlled trial: optimisation of perioperative analgesia protocol for uniportal video-assisted thoracoscopic surgery

Por: Wang · L. F. · Feng · H. X. · Shi · Y. H. · Li · Y. · Zheng · M. T. · Bu · T. · Zhang · Z. R.
Introduction

Postoperative pain after thoracic surgery impairs patients’ quality of life and increases the incidence of respiratory complications. Optimised analgesia strategies include minimally invasive incisions, regional analgesia and early chest tube removal. However, little is known about the optimal analgesic regimen for uniportal video-assisted thoracoscopic surgery (uVATS).

Methods and analysis

We will conduct a single-centre, prospective, single-blind, randomised trial. The effects of postoperative analgesia will be tested using thoracic paravertebral block (PVB) in combination with patient-controlled intravenous analgesia (PVB+PCIA), erector spinae plane block (ESPB) in combination with patient-controlled intravenous analgesia (ESPB+PCIA) or PCIA alone; 102 patients undergoing uVATS will be enrolled in this study. Patients will be randomly assigned to the PVB group (30 mL of 0.33% ropivacaine with dexamethasone), ESPB group (40 mL of 0.25% ropivacaine with dexamethasone) or control groups. PCIA with sufentanil will be administered to all patients after surgery. The primary outcome will be total opioid consumption after surgery. Secondary outcomes include postoperative pain score; postoperative chronic pain at rest and during coughing; sensations of touch and pain in the chest wall, non-opioid analgesic consumption; length of stay; ambulation time, the total cost of hospitalisation and long-term postoperative analgesia. Adverse reactions to analgesics and adverse events related to the regional blocks will also be recorded. The statisticians will be blinded to the group allocation. Comparison of the continuous data among the three groups will be performed using a one-way analysis of variance to assess differences among the means.

Ethics and dissemination

The results will be published in patient education courses, academic conferences and peer-reviewed journals.

Trial registration number

NCT06016777.

Comprehensive quality assessment for aphasia rehabilitation after stroke: protocol for a multicentre, mixed-methods study

Por: Harvey · S. · Stone · M. · Zingelman · S. · Copland · D. A. · Kilkenny · M. F. · Godecke · E. · Cadilhac · D. A. · Kim · J. · Olaiya · M. T. · Rose · M. L. · Breitenstein · C. · Shrubsole · K. · OHalloran · R. · Hill · A. J. · Hersh · D. · Mainstone · K. · Mainstone · P. · Unsworth · C. A
Introduction

People with aphasia following stroke experience disproportionally poor outcomes, yet there is no comprehensive approach to measuring the quality of aphasia services. The Meaningful Evaluation of Aphasia SeRvicES (MEASuRES) minimum dataset was developed in partnership with people with lived experience of aphasia, clinicians and researchers to address this gap. It comprises sociodemographic characteristics, quality indicators, treatment descriptors and outcome measurement instruments. We present a protocol to pilot the MEASuRES minimum dataset in clinical practice, describe the factors that hinder or support implementation and determine meaningful thresholds of clinical change for core outcome measurement instruments.

Methods and analysis

This research aims to deliver a comprehensive quality assessment toolkit for poststroke aphasia services in four studies. A multicentre pilot study (study 1) will test the administration of the MEASuRES minimum dataset within five Australian health services. An embedded mixed-methods process evaluation (study 2) will evaluate the performance of the minimum dataset and explore its clinical applicability. A consensus study (study 3) will establish consumer-informed thresholds of meaningful change on core aphasia outcome constructs, which will then be used to establish minimal important change values for corresponding core outcome measurement instruments (study 4).

Ethics and dissemination

Studies 1 and 2 have been registered with the Australian and New Zealand Clinical Trial Registry (ACTRN12623001313628). Ethics approval has been obtained from the Royal Brisbane and Women’s Hospital (HREC/2023/MNHB/95293) and The University of Queensland (2022/HE001946 and 2023/HE001175). Study findings will be disseminated through peer-reviewed publications, conference presentations and engagement with relevant stakeholders including healthcare providers, policy-makers, stroke and rehabilitation audit and clinical quality registry custodians, consumer support organisations, and individuals with aphasia and their families.

Qualitative study of challenges with recruitment of hospitals into a cluster controlled trial of clinical decision support in Australia

Por: Baysari · M. T. · Van Dort · B. A. · Stanceski · K. · Hargreaves · A. · Zheng · W. Y. · Moran · M. · Day · R. O. · Li · L. · Westbrook · J. · Hilmer · S. N.
Objective

To identify barriers to hospital participation in controlled cluster trials of clinical decision support (CDS) and potential strategies for addressing barriers.

Design

Qualitative descriptive design comprising semistructured interviews.

Setting

Five hospitals in New South Wales and one hospital in Queensland, Australia.

Participants

Senior hospital staff, including department directors, chief information officers and those working in health informatics teams.

Results

20 senior hospital staff took part. Barriers to hospital-level recruitment primarily related to perceptions of risk associated with not implementing CDS as a control site. Perceived risks included reductions in patient safety, reputational risk and increased likelihood that benefits would not be achieved following electronic medical record (EMR) implementation without CDS alerts in place. Senior staff recommended clear communication of trial information to all relevant stakeholders as a key strategy for boosting hospital-level participation in trials.

Conclusion

Hospital participation in controlled cluster trials of CDS is hindered by perceptions that adopting an EMR without CDS is risky for both patients and organisations. The improvements in safety expected to follow CDS implementation makes it challenging and counterintuitive for hospitals to implement EMR without incorporating CDS alerts for the purposes of a research trial. To counteract these barriers, clear communication regarding the evidence base and rationale for a controlled trial is needed.

Association between sleep quality and blood pressure control among hypertensive patients at a rural tertiary hospital in Southern Nigeria: a cross-sectional study

Por: Oseni · T. I. A. · Udonwa · N. E. · Oku · A. O. · Makinde · M. T. · Archibong · F.
Objectives

Restorative sleep is critical in preventing hypertension and other chronic diseases. Limited research has explored the relationship between sleep quality and hypertension in Africa. This study investigated the association between sleep quality and blood pressure control among hypertensive patients in Southern Nigeria.

Design

Cross-sectional study.

Setting

A rural tertiary hospital in Southern Nigeria, April to June 2023.

Participants

250 systematically selected hypertensive adults. Participants completed a validated semistructured interviewer-administered questionnaire to assess their sleep patterns, including sleep duration, self-reported trouble sleeping and a history of clinical diagnosis of sleep disorders. Sleep patterns were categorised as restorative (healthy) or non-restorative (unhealthy). The blood pressure of respondents was checked and categorised as controlled (

Outcome measures

Quality of sleep and blood pressure control.

Results

Respondents had a mean age of 51.5±10.0 years, with the majority being female (156, 62.4%), married (135, 54.0%) and belonging to the Esan tribe (125, 50.0%). The prevalence of restorative sleep was 36%, while the blood pressure control rate was 23.6%. An association was found between restorative sleep and blood pressure control (adjusted OR =4.38; 95% CI=2.37–8.10; p

Conclusion

The study found an association between poor quality sleep and poor blood pressure control. Incorporating sleep assessments and interventions into comprehensive hypertension management strategies could be explored as a possible approach to improve sleep quality and enhance blood pressure control.

Trial registration number

PACTR202301917477205.

Knowledge, attitude and practices of insulin therapy among patients with type 2 diabetes: a cross-sectional study

Por: Almheiri · A. · Binjab · E. A. · Albloushi · M. M. · Alshamsi · M. T. · Khansaheb · H. H. · Zidan · M. · Hassoun · A. A. K.
Objectives

This study aimed to assess the knowledge, attitude and practices of patients with type 2 diabetes on insulin regarding insulin therapy.

Design

A cross-sectional study.

Setting

This study was conducted at the Dubai Diabetes Center from 1 December 2018 to 1 March 2020.

Participants

Face-to-face interviews were conducted for 350 participants with type 2 diabetes at the Dubai Diabetes Center. Interviews followed the structured format of a questionnaire designed to obtain demographic details and score participants on knowledge, attitude and practices. We included patients aged >18 years and receiving insulin therapy. Patients with type 1 diabetes, pregnant women with gestational diabetes, those aged

Results

The median age of participants was 61 years (first quartile, 53 years; third quartile, 67 years); 35.7% were male individuals and 64.3% were female individuals. The median percentage scores for knowledge, attitude and practices were 62.5% (62.5%, 75%), 85.7% (71.4%, 100%) and 77.7% (66.6%, 88.8%), respectively. Highly educated participants had a high level of knowledge. Significant negative correlations were found between the percentage knowledge scores and participants’ age and between the participants’ percentage attitude scores and haemoglobin A1C levels; Spearman’s correlations were –0.182 (p

Conclusion

Patients with type 2 diabetes receiving insulin therapy and attending the Dubai Diabetes Center had adequate knowledge, a positive attitude and correct practice regarding insulin therapy. However, knowledge of specific facts did not always translate into correct behaviours and practices.

Prevalence and determinants of antibiotics self-medication among indigenous people of Bangladesh: a cross-sectional study

Por: Mannan · A. · Chakma · K. · Dewan · G. · Saha · A. · Chy · N. U. H. A. · Mehedi · H. M. H. · Hossain · A. · Wnaiza · J. · Ahsan · M. T. · Rana · M. M. · Alam · N.
Objectives

Self-medication with antibiotics (SMA) contributes significantly to the emergence of antimicrobial resistance (AMR), especially in low-income countries including Bangladesh. This study aimed to generate evidence on the self-reported prevalence of antibiotic self-medication and its determinants among indigenous people residing in Bangladesh’s Chittagong Hill Tracts (CHT) districts.

Design

This study used a cross-sectional design with data collected through a survey using a semi-structured questionnaire.

Setting

This study was conducted from late January to early July 2021; among different indigenous group populations aged 18 years or more olders residing in the three districts of CHT.

Participants

A total of 1336 indigenous people residing in Bangladesh’s CHT districts were included.

Primary outcome and explanatory variables

The primary outcome measure was SMA while explanatory variables were socio-demographic characteristics, health status of participants, and knowledge of antibiotics usage and its side effects.

Results

Among the study participants, more males (60.54%) than females (51.57%) reported using antibiotics. The SMA rate was high among individuals with education levels below secondary (over 50%) and those in the low-income group (55.19%). The most common diseases reported were cough, cold and fever, with azithromycin being the most frequently used antibiotic. Levels of education, family income, having a chronic illness and place of residence were found to be the significant predictors of having good knowledge of antibiotic use as found in the ordered logit model. Findings from a logistic regression model revealed that men had 1.6 times higher odds (adjusted OR (AOR) 1.57; 95% CI 1.12 to 2.19) of SMA than women. Participants with ≥US$893 per month family income had lowest odds (AOR 0.14; 95% CI 0.03 to 0.64) of SMA than those who earned

Conclusion

Male gender, family income, place of residence and knowledge of antibiotics were the significant predictors of antibiotic self-medication. Hence, it is important to streamline awareness-raising campaigns at the community level to mitigate the practice of SMA in indigenous people and ultimately address the devastating effects of Antimicrobial resistance (AMR) in Bangladesh.

AI assisted reader evaluation in acute CT head interpretation (AI-REACT): protocol for a multireader multicase study

Por: Fu · H. · Novak · A. · Robert · D. · Kumar · S. · Tanamala · S. · Oke · J. · Bhatia · K. · Shah · R. · Romsauerova · A. · Das · T. · Espinosa · A. · Grzeda · M. T. · Narbone · M. · Dharmadhikari · R. · Harrison · M. · Vimalesvaran · K. · Gooch · J. · Woznitza · N. · Salik · N. · Campbell · A.
Introduction

A non-contrast CT head scan (NCCTH) is the most common cross-sectional imaging investigation requested in the emergency department. Advances in computer vision have led to development of several artificial intelligence (AI) tools to detect abnormalities on NCCTH. These tools are intended to provide clinical decision support for clinicians, rather than stand-alone diagnostic devices. However, validation studies mostly compare AI performance against radiologists, and there is relative paucity of evidence on the impact of AI assistance on other healthcare staff who review NCCTH in their daily clinical practice.

Methods and analysis

A retrospective data set of 150 NCCTH will be compiled, to include 60 control cases and 90 cases with intracranial haemorrhage, hypodensities suggestive of infarct, midline shift, mass effect or skull fracture. The intracranial haemorrhage cases will be subclassified into extradural, subdural, subarachnoid, intraparenchymal and intraventricular. 30 readers will be recruited across four National Health Service (NHS) trusts including 10 general radiologists, 15 emergency medicine clinicians and 5 CT radiographers of varying experience. Readers will interpret each scan first without, then with, the assistance of the qER EU 2.0 AI tool, with an intervening 2-week washout period. Using a panel of neuroradiologists as ground truth, the stand-alone performance of qER will be assessed, and its impact on the readers’ performance will be analysed as change in accuracy (area under the curve), median review time per scan and self-reported diagnostic confidence. Subgroup analyses will be performed by reader professional group, reader seniority, pathological finding, and neuroradiologist-rated difficulty.

Ethics and dissemination

The study has been approved by the UK Healthcare Research Authority (IRAS 310995, approved 13 December 2022). The use of anonymised retrospective NCCTH has been authorised by Oxford University Hospitals. The results will be presented at relevant conferences and published in a peer-reviewed journal.

Trial registration number

NCT06018545.

Use of drugs for hyperlipidaemia and diabetes and risk of primary and secondary brain tumours: nested case-control studies using the UK Clinical Practice Research Datalink (CPRD)

Por: Robinson · J. W. · Martin · R. · Ozawa · M. · Elwenspoek · M. M. C. · Redaniel · M. T. · Kurian · K. · Ben-Shlomo · Y.
Objectives

Previous studies have suggested that fibrates and glitazones may have a role in brain tumour prevention. We examined if there is support for these observations using primary care records from the UK Clinical Practice Research Datalink (CPRD).

Design

We conducted two nested case–control studies using primary and secondary brain tumours identified within CPRD between 2000 and 2016. We selected cases and controls among the population of individuals who had been treated with any anti-diabetic or anti-hyperlipidaemic medication to reduce confounding by indication.

Setting

Adults older than 18 years registered with a general practitioner in the UK contributing data to CPRD.

Results

We identified 7496 individuals with any brain tumour (4471 primary; 3025 secondary) in total. After restricting cases and controls to those prescribed any anti-diabetic or anti-hyperlipidaemic medication, there were 1950 cases and 7791 controls in the fibrate and 480 cases with 1920 controls in the glitazone analyses. Longer use of glitazones compared with all other anti-diabetic medications was associated with a reduced risk of primary (adjusted OR (aOR) 0.89 per year, 95% CI 0.80 to 0.98), secondary (aOR 0.87 per year, 95% CI 0.77 to 0.99) or combined brain tumours (aOR 0.88 per year, 95% CI 0.81 to 0.95). There was little evidence that fibrate exposure was associated with risk of either primary or secondary brain tumours.

Conclusions

Longer exposure to glitazones was associated with reduced primary and secondary brain tumour risk. Further basic science and population-based research should explore this finding in greater detail, in terms of replication and mechanistic studies.

Forecasting disease trajectories in critical illness: comparison of probabilistic dynamic systems to static models to predict patient status in the intensive care unit

Por: Duggal · A. · Scheraga · R. · Sacha · G. L. · Wang · X. · Huang · S. · Krishnan · S. · Siuba · M. T. · Torbic · H. · Dugar · S. · Mucha · S. · Veith · J. · Mireles-Cabodevila · E. · Bauer · S. R. · Kethireddy · S. · Vachharajani · V. · Dalton · J. E.
Objective

Conventional prediction models fail to integrate the constantly evolving nature of critical illness. Alternative modelling approaches to study dynamic changes in critical illness progression are needed. We compare static risk prediction models to dynamic probabilistic models in early critical illness.

Design

We developed models to simulate disease trajectories of critically ill COVID-19 patients across different disease states. Eighty per cent of cases were randomly assigned to a training and 20% of the cases were used as a validation cohort. Conventional risk prediction models were developed to analyse different disease states for critically ill patients for the first 7 days of intensive care unit (ICU) stay. Daily disease state transitions were modelled using a series of multivariable, multinomial logistic regression models. A probabilistic dynamic systems modelling approach was used to predict disease trajectory over the first 7 days of an ICU admission. Forecast accuracy was assessed and simulated patient clinical trajectories were developed through our algorithm.

Setting and participants

We retrospectively studied patients admitted to a Cleveland Clinic Healthcare System in Ohio, for the treatment of COVID-19 from March 2020 to December 2022.

Results

5241 patients were included in the analysis. For ICU days 2–7, the static (conventional) modelling approach, the accuracy of the models steadily decreased as a function of time, with area under the curve (AUC) for each health state below 0.8. But the dynamic forecasting approach improved its ability to predict as a function of time. AUC for the dynamic forecasting approach were all above 0.90 for ICU days 4–7 for all states.

Conclusion

We demonstrated that modelling critical care outcomes as a dynamic system improved the forecasting accuracy of the disease state. Our model accurately identified different disease conditions and trajectories, with a

Study protocol for the validation of a new pictorial functional scale in patients with knee osteoarthritis: the functional activity scoring tool (FAST)

Por: Tang · Z. Y. · Ng · K. S. · Koh · Y. L. E. · Yeung · M. T.
Background

Patient-reported outcome measures (PROMs) are required for patient-centred care. There are limited PROMs with good psychometric properties, and limitations to any language-based scale are often constrained by the written words or numerals used. Therefore, we developed the Functional Activity Scoring Tool (FAST), a self-reporting pictorial scale. FAST measures the impact of knee osteoarthritis on essential activities of daily living (ADL) and the significant changes in the self-perceived functional status over time.

Objectives

This study aims to (1) develop FAST with adaptation from the Wong-Baker FACES pain rating scale, (2) validate FAST against the Patient-Specific Functional Scale (PSFS) and Knee Injury and Osteoarthritis Outcome Score (KOOS) and (3) establish the reliability, validity and responsiveness of FAST in individuals with knee osteoarthritis.

Methods and analysis

The prospective study protocol investigates the validity, responsiveness and reliability of FAST. The PSFS and KOOS will be gold standard comparisons. Participant recruitment will occur at four public polyclinics that offer physiotherapy outpatient services in Singapore. Onsite physiotherapists familiar with the study eligibilities will refer potential participants to the investigators after the routine physiotherapy assessment. After providing written consent, eligible participants will complete outcome measurements with FAST, the PSFS and KOOS during baseline and follow-up assessments. The Global Rating of Change (GROC) scale will determine how the participant’s knee status was changed compared with the beginning of the physiotherapy intervention.

Ethics and dissemination

SingHealth Centralised Institutional Review Board approved the study (CIRB reference number: 2022/2602). The final results will be published via scientific publication. FAST will benefit the evaluation and management of those who suffer knee osteoarthritis regardless of English proficiency or language barriers.

Trial registration number

NCT05590663

Rural caregivers preparedness for detecting and responding to the signs of worsening health conditions in recently hospitalised patients at risk for readmission: a qualitative descriptive study

Por: Fox · M. T. · Butler · J. I.
Objectives

This study aimed to explore informal rural caregivers’ perceived preparedness to detect and respond to the signs of worsening health conditions in patients recently discharged from hospital and at risk for readmission.

Design

A qualitative descriptive design and semistructured interviews were used. Data were thematically analysed.

Setting

Data collection occurred in 2018 and 2019 in rural communities in Southwestern and Northeastern Ontario, Canada.

Participants

The study included sixteen informal caregivers who were all family members of a relative discharged from hospital at high risk for readmission following hospitalisation mostly for a medical illness (63%). Participants were mostly women (87.5%), living with their relative (62.5%) who was most often a parent (56.3%).

Results

Three themes were identified: (1) warning signs and rural communities, (2) perceived preparedness, and (3) improving preparedness. The first theme elucidates informal caregivers’ view that they needed to be prepared because they were taking over care previously provided by hospital healthcare professionals yet lacked accessible medical help in rural communities. The second theme captures informal caregivers’ perceptions that they lacked knowledge of how to detect warning signs and how to respond to them appropriately. The last theme illuminates informal caregivers’ suggestions for improving preparation related to warning signs.

Conclusions

Informal caregivers in rural communities were largely unprepared for detecting and responding to the signs of worsening health conditions for patients at high risk for hospital readmission. Healthcare professionals can anticipate that informal caregivers, particularly those whose relatives live far from medical help, need information on how to detect and respond to warning signs, and may prioritise their time to this aspect of postdischarge care for these caregivers.

Development and application of simulation modelling for orthopaedic elective resource planning in England

Por: Harper · A. · Monks · T. · Wilson · R. · Redaniel · M. T. · Eyles · E. · Jones · T. · Penfold · C. · Elliott · A. · Keen · T. · Pitt · M. · Blom · A. · Whitehouse · M. R. · Judge · A.
Objectives

This study aimed to develop a simulation model to support orthopaedic elective capacity planning.

Methods

An open-source, generalisable discrete-event simulation was developed, including a web-based application. The model used anonymised patient records between 2016 and 2019 of elective orthopaedic procedures from a National Health Service (NHS) Trust in England. In this paper, it is used to investigate scenarios including resourcing (beds and theatres) and productivity (lengths of stay, delayed discharges and theatre activity) to support planning for meeting new NHS targets aimed at reducing elective orthopaedic surgical backlogs in a proposed ring-fenced orthopaedic surgical facility. The simulation is interactive and intended for use by health service planners and clinicians.

Results

A higher number of beds (65–70) than the proposed number (40 beds) will be required if lengths of stay and delayed discharge rates remain unchanged. Reducing lengths of stay in line with national benchmarks reduces bed utilisation to an estimated 60%, allowing for additional theatre activity such as weekend working. Further, reducing the proportion of patients with a delayed discharge by 75% reduces bed utilisation to below 40%, even with weekend working. A range of other scenarios can also be investigated directly by NHS planners using the interactive web app.

Conclusions

The simulation model is intended to support capacity planning of orthopaedic elective services by identifying a balance of capacity across theatres and beds and predicting the impact of productivity measures on capacity requirements. It is applicable beyond the study site and can be adapted for other specialties.

Non-specific effects of Pneumococcal and Haemophilus vaccines in children aged 5 years and under: a systematic review

Por: Geraghty · K. · Rooney · D. · Watson · C. · Ledwidge · M. T. · Glynn · L. · Gallagher · J.
Objective

To determine the evidence for non-specific effects of the Pneumococcal and Haemophilus influenza vaccine in children aged 5 years and under.

Data sources

A key word literature search of MEDLINE, EMBASE, The Cochrane Central Register of Controlled Trials, the European Union Clinical Trials Register and ClinicalTrials.gov up to June 2023.

Study eligibility criteria

Randomised controlled trials (RCTs), quasi-RCT or cohort studies.

Participants

Children aged 5 or under.

Study appraisal and synthesis methods

Studies were independently screened by two reviewers, with a third where disagreement arose. Risk of bias assessment was performed by one reviewer and confirmed by a second. Results were tabulated and a narrative description performed.

Results

Four articles were identified and included in this review. We found a reduction in hospitalisations from influenza A (44%), pulmonary tuberculosis (42%), metapneumovirus (45%), parainfluenza virus type 1–3 (44%), along with reductions in mortality associated with pneumococcal vaccine. No data on the Haemophilus vaccine was found.

Conclusions and implications

In this systematic review, we demonstrate that there is a reduction in particular viral infections in children aged 5 years and under who received the 9-valent pneumococcal conjugate vaccine which differ from those for which the vaccine was designed to protect against. While limited studies have demonstrated a reduction in infections other than those which the vaccine was designed to protect against, substantial clinical trials are required to solidify these findings.

PROSPERO registration number

CRD42020146640.

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