FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
AnteayerBMJ Open

Inter-reviewer reliability of human literature reviewing and implications for the introduction of machine-assisted systematic reviews: a mixed-methods review

Por: Hanegraaf · P. · Wondimu · A. · Mosselman · J. J. · de Jong · R. · Abogunrin · S. · Queiros · L. · Lane · M. · Postma · M. J. · Boersma · C. · van der Schans · J.
Objectives

Our main objective is to assess the inter-reviewer reliability (IRR) reported in published systematic literature reviews (SLRs). Our secondary objective is to determine the expected IRR by authors of SLRs for both human and machine-assisted reviews.

Methods

We performed a review of SLRs of randomised controlled trials using the PubMed and Embase databases. Data were extracted on IRR by means of Cohen’s kappa score of abstract/title screening, full-text screening and data extraction in combination with review team size, items screened and the quality of the review was assessed with the A MeaSurement Tool to Assess systematic Reviews 2. In addition, we performed a survey of authors of SLRs on their expectations of machine learning automation and human performed IRR in SLRs.

Results

After removal of duplicates, 836 articles were screened for abstract, and 413 were screened full text. In total, 45 eligible articles were included. The average Cohen’s kappa score reported was 0.82 (SD=0.11, n=12) for abstract screening, 0.77 (SD=0.18, n=14) for full-text screening, 0.86 (SD=0.07, n=15) for the whole screening process and 0.88 (SD=0.08, n=16) for data extraction. No association was observed between the IRR reported and review team size, items screened and quality of the SLR. The survey (n=37) showed overlapping expected Cohen’s kappa values ranging between approximately 0.6–0.9 for either human or machine learning-assisted SLRs. No trend was observed between reviewer experience and expected IRR. Authors expect a higher-than-average IRR for machine learning-assisted SLR compared with human based SLR in both screening and data extraction.

Conclusion

Currently, it is not common to report on IRR in the scientific literature for either human and machine learning-assisted SLRs. This mixed-methods review gives first guidance on the human IRR benchmark, which could be used as a minimal threshold for IRR in machine learning-assisted SLRs.

PROSPERO registration number

CRD42023386706.

Daily life activities of young adults with obesity living in highly accessible and compact urban environments in Seoul, South Korea: a spatiotemporal qualitative study protocol

Por: Kim · D. H. · Lee · E. H. L. · Jeong · J. Y. · Lee · J. · Yoo · S.
Introduction

Amid the growing global concern about obesity, young adults in South Korea are particularly affected, with 30.8% of people aged 19–34 classified as obese. Given the urban-centric lifestyle of Korean youth, understanding the relationship between daily life activities and the urban environment holds great promise for effective interventions. This study aims to explore the daily life activities of young adults with obesity in Seoul, a city known for its highly accessible and compact environment. The research questions explore the interaction between daily life activities and the neighbourhood environment and consider weight management in an urban context.

Methods and analysis

This study uses an extended qualitative geographic information system approach to explore a district in Seoul with a highly accessible and compact urban environment. The sample comprises young adults with obesity (aged 19–34) residing in the study area, with recruitment targeting up to 51 participants for data saturation. A qualitative, multimethod approach combines descriptive and spatiotemporal data collection. Descriptive data are being collected, including in-depth interviews and photographs of daily food consumption. Spatial data collection involves field observations, cognitive mapping and mobile Global Positioning System tracking. Temporal data is gathered through participants drawing round timetables, detailing their daily schedules. Data analysis will entail thematic analysis of the interview data and content analysis of the spatiotemporal data. For the integrated analysis, pattern finding will be used to synthesise the data.

Ethics and dissemination

This study was approved by the institutional review board of Seoul National University on 11 July 2022. Data collection and curation are currently underway, and the results of the analysis will be shared with the scientific community at international conferences and peer-reviewed journals. We are planning an open seminar to share our research findings with relevant policy-makers, community organisations and health professionals.

Perceptions and experiences of paramedics managing people with non-traumatic low back pain: a qualitative study of Australian paramedics

Por: Vella · S. P. · Simpson · P. · Bendall · J. C. · Pickles · K. · Copp · T. · Swain · M. S. · Maher · C. G. · Machado · G. C.
Background

Paramedics are often first providers of care to patients experiencing non-traumatic low back pain (LBP), though their perspectives and experiences with managing these cases remain unclear.

Objectives

This study explored paramedic views of the management of non-traumatic LBP including their role and experience with LBP management, barriers to referral and awareness of ambulance service guidelines.

Design

Qualitative study using semistructured interviews conducted between January and April 2023.

Setting

New South Wales Ambulance service.

Participants

A purposive sample of 30 paramedics of different specialities employed by New South Wales Ambulance were recruited.

Results

Paramedic accounts demonstrated the complexity, challenge, frustration and reward associated with managing non-traumatic LBP. Paramedics perceived that their primary role focused on the assessment of LBP, and that calls to ambulance services were often driven by misconceptions surrounding the management of LBP, and a person’s pain severity. Access to health services, patient factors, defensive medicine, paramedic training and education and knowledge of guidelines influenced paramedic management of LBP.

Conclusion

Paramedics often provide care to non-traumatic LBP cases yet depending on the type of paramedic speciality find these cases to be frustrating, challenging or rewarding to manage due to barriers to referral including access to health services, location, patient factors and uncertainty relating to litigation. Future research should explore patient perspectives towards ambulance service use for the management of their LBP.

REKOVER study protocol: a pRospective patient treatment rEgistry of tramadol and dexKetoprofen trometamol oral fixed-dose combination (SKUDEXA) in mOderate to seVere acutE pain in Real-world setting in Asia

Por: Ho · K. Y. · Gyanwali · B. · Dimayuga · C. · Eufemio · E. M. · Bernardo · E. · Raju · G. · Chong · K. W. · Waithayayothin · K. · Ona · L. · Castro · M. A. L. · Sawaddiruk · P. · Salvador · R. C. · Roohi · S. A. · Tangwiwat · S. · Wilairatana · V. · Oon · Z. H. · Gupta · A. · Nagrale · D.
Introduction

Satisfactory management of acute pain remains a major medical challenge despite the availability of multiple therapeutic options including the fixed-dose combination (FDC) drugs. Tramadol and dexketoprofen trometamol (TRAM/DKP) 75/25 mg FDC was launched in 2018 in Asia and is widely used in the management of moderate to severe acute pain. There are limited data on its effectiveness and safety in Asian patients, and therefore, a need to better understand its usage patterns in clinical practice. We aim to understand the usage pattern of TRAM/DKP FDC, its effectiveness and tolerability in patients with moderate to severe acute pain in Asia.

Methods and analysis

REKOVER is a phase-IV, multicountry, multicentre, prospective, real-world observational study. A total of 750 postsurgical and non-surgical patients (male and female, aged 18–80 years) will be recruited from 13 tertiary-care hospitals (15 sites) in Singapore, Thailand, the Philippines and Malaysia. All patients prescribed with TRAM/DKP FDC and willing to participate in the study will be enrolled. The recruitment duration for each site will be 6 months. The severity of pain will be collected using Numeric Pain Rating Scale through the treatment period from day 1 to day 5, while satisfaction with the treatment will be evaluated using Patient Global Evaluation Scale at the end of treatment. Any adverse event reported during the study duration will be recorded for safety analysis (up to day 6). The study data will be entered into the ClaimIt portal and mobile application (app) (ObvioHealth, USA). All the inpatient data will be entered into the portal by the study site and for outpatient it will be done by patients through an app.

Ethics and dissemination

The study has been approved by the local ethics committee from each study sites in Singapore, Thailand, the Philippines and Malaysia. Findings will be disseminated through local and global conference presentations, publications in peer-reviewed scientific journals and continuing medical education.

Assessment of the methodological, recommendation and reporting quality of global guidelines for neck pain and synthesis of evidence and recommendations: a systematic review protocol

Por: Li · J. · Ou · J. · Liu · Y. · Shen · C. · Chen · X. · Li · Y. · Zhao · J. · Xu · J. · Zhang · Y. · Wang · L.
Introduction

Neck pain is a global health problem that can cause severe disability and a huge medical burden. Clinical practice guideline (CPG) is an important basis for clinical diagnosis and treatment. A high-quality CPG plays a significant role in clinical practice. However, the quality of the CPGs for neck pain lacks comprehensive assessment. This protocol aims to evaluate the methodological, recommendation, reporting quality of global CPGs for neck pain and identify key recommendations and gaps that limit evidence-based practice.

Method

CPGs from January 2013 to November 2023 will be identified through a systematic search on 13 scientific databases (PubMed, Cochrane Library, Embase, etc) and 7 online guideline repositories. Six reviewers will independently evaluate the quality of CPGs for neck pain by using the Appraisal of Guidelines for Research and Evaluation, the Appraisal of Guidelines Research and Evaluation-Recommendations Excellence and the Reporting Items for Practice Guidelines in Healthcare tools. Intraclass correlation coefficient will be used to test the consistency of the assessment. We will identify the distribution of evidence and recommendations in each evidence-based CPGs for neck pain and regrade the level of evidence and strength of recommendations by adopting the commonly used Grading of Recommendations, Assessment, Development and Evaluations system. The key recommendations based on high-quality evidence will be summarised. In addition, we will categorise CPGs by different characteristics and conduct a subgroup analysis of the results of assessment.

Ethics and dissemination

No subjects will be involved in this systematic review, so there is no need for ethical approval. The finding of this review will be summarised as a paper for publication in a peer-reviewed journal.

PROSPERO registration number

CRD42023417717.

Evidence-informed and consensus-based statements about SAFEty of Physical Agent Modalities Practice in physiotherapy and rehabilitation medicine (SAFE PAMP): a national Delphi of healthcare scientific societies

Por: Gianola · S. · Bargeri · S. · Pellicciari · L. · Gambazza · S. · Rossettini · G. · Fulvio · A. · Genovese · V. · Benedini · M. · Proverbio · E. · Cecchetto · S. · Castellini · G. · Turolla · A. · SAFE PAMP Collaborators · Torresetti · Masturzo · Berliri · Roselli · Vercelli · Scorcu
Objective

A shared consensus on the safety about physical agent modalities (PAMs) practice in physiotherapy and rehabilitation is lacking. We aimed to develop evidence-informed and consensus-based statements about the safety of PAMs.

Study design and setting

A RAND-modified Delphi Rounds’ survey was used to reach a consensus. We established a steering committee of the Italian Association of Physiotherapy (Associazione Italiana di Fisioterapia) to identify areas and questions for developing statements about the safety of the most commonly used PAMs in physiotherapy and rehabilitation. We invited 28 National Scientific and Technical Societies, including forensics and lay members, as a multidisciplinary and multiprofessional panel of experts to evaluate the nine proposed statements and formulate additional inputs. The level of agreement was measured using a 9-point Likert scale, with consensus in the Delphi Rounds assessed using the rating proportion with a threshold of 75%.

Results

Overall, 17 (61%) out of 28 scientific and technical societies participated, involving their most representative members. The panel of experts mainly consisted of clinicians (88%) with expertise in musculoskeletal (47%), pelvic floor (24%), neurological (18%) and lymphatic (6%) disorders with a median experience of 30 years (IQR=17–36). Two Delphi rounds were necessary to reach a consensus. The final approved criteria list comprised nine statements about the safety of nine PAMs (ie, electrical stimulation neuromodulation, extracorporeal shock wave therapy, laser therapy, electromagnetic therapy, diathermy, hot thermal agents, cryotherapy and therapeutic ultrasound) in adult patients with a general note about populations subgroups.

Conclusions

The resulting consensus-based statements inform patients, healthcare professionals and policy-makers regarding the safe application of PAMs in physiotherapy and rehabilitation practice. Future research is needed to extend this consensus on paediatric and frail populations, such as immunocompromised patients.

Finerenone cardiovascular and kidney outcomes by age and sex: FIDELITY post hoc analysis of two phase 3, multicentre, double-blind trials

Por: Bansal · S. · Canziani · M. E. F. · Birne · R. · Anker · S. D. · Bakris · G. L. · Filippatos · G. · Rossing · P. · Ruilope · L. M. · Farjat · A. E. · Kolkhof · P. · Lage · A. · Brinker · M. · Pitt · B.
Objectives

This study aimed to evaluate the efficacy and safety of finerenone, a selective, non-steroidal mineralocorticoid receptor antagonist, on cardiovascular and kidney outcomes by age and/or sex.

Design

FIDELITY post hoc analysis; median follow-up of 3 years.

Setting

FIDELITY: a prespecified analysis of the FIDELIO-DKD and FIGARO-DKD trials.

Participants

Adults with type 2 diabetes and chronic kidney disease receiving optimised renin–angiotensin system inhibitors (N=13 026).

Interventions

Randomised 1:1; finerenone or placebo.

Primary and secondary outcome measures

Cardiovascular (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalisation for heart failure (HHF)) and kidney (kidney failure, sustained ≥57% estimated glomerular filtration rate (eGFR) decline or renal death) composite outcomes.

Results

Mean age was 64.8 years; 45.2%, 40.1% and 14.7% were aged interaction=0.42) and sex categories (HR 0.86 (95% CI 0.77 to 0.96) (male), HR 0.89 (95% CI 0.35 to 2.27) (premenopausal female), HR 0.87 (95% CI 0.73 to 1.05) (postmenopausal female); Pinteraction=0.99). Effects on HHF reduction were not modified by age (Pinteraction=0.70) but appeared more pronounced in males (Pinteraction=0.02). Kidney events were reduced with finerenone versus placebo in age groups interaction=0.51). In sex subgroups, finerenone consistently reduced kidney events (Pinteraction=0.85). Finerenone reduced albuminuria and eGFR decline regardless of age and sex. Hyperkalaemia increased with finerenone, but discontinuation rates were

Conclusions

Finerenone improved cardiovascular and kidney composite outcomes with no significant heterogeneity between age and sex subgroups; however, the effect on HHF appeared more pronounced in males. Finerenone demonstrated a similar safety profile across age and sex subgroups.

Trial registration numbers

NCT02540993, NCT02545049.

Emergency medical dispatchers experiences of using the Medical Priority Dispatch System telephone triage to identify maternity emergencies: a qualitative focus group study

Por: Shaw · J. · Bannister · C. · Ariyibi · A. · Fothergill · R.
Objectives

The ambulance service plays a pivotal role in the provision of care in out-of-hospital maternity emergencies. Telephone triage of this patient group is complex and must be sensitive to an emergency situation to prevent unnecessary delays in treatment. This study aimed to explore emergency medical dispatchers’ (EMDs) perceptions of the structured protocol they use.

Design

Voluntary participation in semistructured phenomenological focus groups. The participants were asked to discuss their experiences of using Medical Priority Dispatch System Protocol 24 (pregnancy, childbirth and miscarriage). Thematic analysis was applied to code and group topics. Discussion between the EMDs is presented for each theme and their experiences, including quotes, are presented to offer an overview of the maternity protocol and its use.

Setting

A large urban UK ambulance service.

Participants

23 control room staff.

Results

Perceptions of maternity emergencies, challenges with key questions, the need for sensitivity surrounding miscarriage, using prearrival instructions and postdispatch instructions to help patients and ideas for additional ProQA functionality emerged as the five overarching themes. Protocol 24 was considered to reflect many of the clinical factors EMDs associate with maternity emergencies although further factors, including some non-clinical, were suggested for inclusion. Miscarriage and termination-related calls were thought to be challenging as the language of the protocol is designed for pregnancy. However, instructions were generally considered well written and user-friendly, although some were thought to be unnecessary. EMDs were largely positive regarding the ProQA software, but felt backward navigation was difficult if a situation changed.

Conclusions

Maternity calls were considered rewarding but complex by EMDs. We suggest changes including the use of more sensitive language in response to miscarriage and termination and make recommendations for the omission and inclusion of specific instructions, as well as enhancements to key questions and functionality. Further research is needed to ensure focus group findings are generalisable to other services, particularly in other countries.

Exploring the pharmacists role in optimising antithrombotic therapy in primary care: a qualitative study

Por: van Paassen · J. G. · Tan · J. P. · Deneer · V. H. M. · Bouvy · M. L.
Objective

In antithrombotic therapy, the balance between efficacy and safety is delicate, which makes it challenging for healthcare professionals, including pharmacists, to optimise therapy. Pharmacists may play an important role in optimising antithrombotic therapy, but especially in primary care, this role has not been elucidated. Here, we study how community pharmacists (pharmacists in primary care) perceive their current and future role in antithrombotic therapy.

Design

We conducted a qualitative study using semi-structured interviews. The interview protocol and subsequent analysis were based on the Theoretical Domains Framework, and the findings were interpreted with the Capability Opportunity Motivation – Behaviour System.

Setting and participants

The interview participants were community pharmacists, located across the Netherlands, from the Utrecht Pharmacy Practice network for Education and Research.

Results

We interviewed 16 community pharmacists between February and August 2021 and identified several major themes which were important for the pharmacist’s role in antithrombotic therapy. Pharmacists felt responsible for the outcome of antithrombotic treatment and intended to invest in their role in antithrombotic therapy. Pharmacists did, however, experience barriers to their role in antithrombotic therapy, like a lack of access to clinical information such as the indication of antithrombotic treatment and a lack of specific knowledge on this treatment.

Conclusion

Community pharmacists perceive a role for themselves in antithrombotic therapy. To fulfil this role, several preconditions must be met.

What Matters to Aboriginal and Torres Strait Islander Youth (WM2Y): a study protocol to develop a national youth well-being measure

Por: Garvey · G. · Howard · K. · Garvey · D. · Dickson · M. · Howell · M. · Butler · T. L. · Cadet-James · Y. · Cunningham · J. · Bainbridge · R. · McGorry · P. · Williamson · A. · Anderson · K. M.
Introduction

Adolescents face challenges associated with unprecedented environmental, social and technological changes. The impacts of colonisation, intergenerational trauma, racism and socioeconomic disadvantage intensify these challenges for many Aboriginal and Torres Strait Islander adolescents. However, Aboriginal and Torres Strait Islander adolescents also have cultural, spiritual, family and community capital that fosters their well-being.

To date, little research has focused on understanding and appropriately measuring the well-being of Aboriginal and Torres Strait Islander adolescents, a pivotal factor in informing and guiding programmes and interventions that support them. This study will identify the domains of well-being and develop a new preference-based well-being measure based on the values and preferences of Aboriginal and Torres Strait Islander youth (aged 12–17 years).

Methods and analysis

This project will be conducted across three research phases: (1) qualitative exploration of well-being using PhotoYarning and yarns with adult mentors to develop candidate items; (2) Think Aloud study, quantitative survey, psychometric analysis, validity testing of candidate items and finalisation of the descriptive system; and (3) scoring development using a quantitative preference-based approach. A multinomial (conditional) logit framework will be used to analyse responses and generate a scoring algorithm for the new preference-based well-being measure.

Ethics and dissemination

Ethics approvals have been obtained from: the Human Research Ethics Committees for each state and territory where data are being collected, the institutions where the research is being conducted and from the relevant Departments of Education. The new well-being measure will have wide applicability and can be used in assessing the effectiveness of programmes and services. This new national measure will ensure benefit and positive impact through the ability to identify and measure the aspects of well-being important to and valued by Aboriginal and Torres Strait Islander youth. Results will be published in international peer-reviewed journals and presented at conferences, and summaries will be provided to the study partner organisations and other relevant organisations.

Talking in primary care (TIP): protocol for a cluster-randomised controlled trial in UK primary care to assess clinical and cost-effectiveness of communication skills e-learning for practitioners on patients musculoskeletal pain and enablement

Por: Bishop · F. L. · Cross · N. · Dewar-Haggart · R. · Teasdale · E. · Herbert · A. · Robinson · M. E. · Ridd · M. J. · Mallen · C. · Clarson · L. · Bostock · J. · Becque · T. · Stuart · B. · Garfield · K. · Morrison · L. · Pollet · S. · Vennik · J. · Atherton · H. · Howick · J. · Leydon · G. M
Introduction

Effective communication can help optimise healthcare interactions and patient outcomes. However, few interventions have been tested clinically, subjected to cost-effectiveness analysis or are sufficiently brief and well-described for implementation in primary care. This paper presents the protocol for determining the effectiveness and cost-effectiveness of a rigorously developed brief eLearning tool, EMPathicO, among patients with and without musculoskeletal pain.

Methods and analysis

A cluster randomised controlled trial in general practitioner (GP) surgeries in England and Wales serving patients from diverse geographic, socioeconomic and ethnic backgrounds. GP surgeries are randomised (1:1) to receive EMPathicO e-learning immediately, or at trial end. Eligible practitioners (eg, GPs, physiotherapists and nurse practitioners) are involved in managing primary care patients with musculoskeletal pain. Patient recruitment is managed by practice staff and researchers. Target recruitment is 840 adults with and 840 without musculoskeletal pain consulting face-to-face, by telephone or video. Patients complete web-based questionnaires at preconsultation baseline, 1 week and 1, 3 and 6 months later. There are two patient-reported primary outcomes: pain intensity and patient enablement. Cost-effectiveness is considered from the National Health Service and societal perspectives. Secondary and process measures include practitioner patterns of use of EMPathicO, practitioner-reported self-efficacy and intentions, patient-reported symptom severity, quality of life, satisfaction, perceptions of practitioner empathy and optimism, treatment expectancies, anxiety, depression and continuity of care. Purposive subsamples of patients, practitioners and practice staff take part in up to two qualitative, semistructured interviews.

Ethics approval and dissemination

Approved by the South Central Hampshire B Research Ethics Committee on 1 July 2022 and the Health Research Authority and Health and Care Research Wales on 6 July 2022 (REC reference 22/SC/0145; IRAS project ID 312208). Results will be disseminated via peer-reviewed academic publications, conference presentations and patient and practitioner outlets. If successful, EMPathicO could quickly be made available at a low cost to primary care practices across the country.

Trial registration number

ISRCTN18010240.

Protocol for the process evaluation of an intervention to improve antenatal smoking cessation support (MOHMQuit) in maternity services in New South Wales, Australia

Por: Longman · J. · Paul · C. · Cashmore · A. · Twyman · L. · Barnes · L. A. J. · Adams · C. · Bonevski · B. · Milat · A. · Passey · M. E.
Introduction

Smoking cessation in pregnancy remains a public health priority. Our team used the Behaviour Change Wheel to develop the Midwives and Obstetricians Helping Mothers to Quit smoking (MOHMQuit) intervention with health system, leader (including managers and educators) and clinician components. MOHMQuit addresses a critical evidence to practice gap in the provision of smoking cessation support in antenatal care. It involves nine maternity services in New South Wales in a cluster randomised stepped-wedge controlled trial of effectiveness. This paper describes the design and rationale for the process evaluation of MOHMQuit. The process evaluation aims to assess to what extent and how MOHMQuit is being implemented (acceptability; adoption/uptake; appropriateness; feasibility; fidelity; penetration and sustainability), and the context in which it is implemented, in order to support further refinement of MOHMQuit throughout the trial, and aid understanding and interpretation of the results of the trial.

Methods and analysis

The process evaluation is an integral part of the stepped-wedge trial. Its design is underpinned by implementation science frameworks and adopts a mixed methods approach. Quantitative evidence from participating leaders and clinicians in our study will be used to produce individual and site-level descriptive statistics. Qualitative evidence of leaders’ perceptions about the implementation will be collected using semistructured interviews and will be analysed descriptively within-site and thematically across the dataset. The process evaluation will also use publicly available data and observations from the research team implementing MOHMQuit, for example, training logs. These data will be synthesised to provide site-level as well as individual-level implementation outcomes.

Ethics and dissemination

The study received ethical approval from the Population Health Services Research Ethics Committee for NSW, Australia (Reference 2021/ETH00887). Results will be communicated via the study’s steering committee and will also be published in peer-reviewed journals and presented at conferences.

Trial registration number

Australian New Zealand Trials Registry ACTRN12622000167763. https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12622000167763.

Health risks of exposure to air pollution in areas where coal-fired power plants are located: protocol for a scoping review

Por: Mahlangeni · N. · Kapwata · T. · Laban · T. · Wright · C. Y.
Introduction

Coal-fired power plants are major sources of air pollution which impact human health. Coal combustion byproducts released into the air include particulate matter, nitrogen oxides and sulphur dioxide. Exposure to fine particulate matter is associated with increased risk of mortality. This scoping review will examine and summarise the current literature on the health risks of exposure to air pollution in areas in which coal-fired power plants exist.

Methods and analysis

This scoping review will be conducted according to the Joanna Briggs Institute methodological framework and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. Five electronic databases (PubMed, ScienceDirect, Scopus, Web of Science and Google Scholar) will be searched for relevant articles. Studies will be included up until 31 January 2024. There will be no restriction on geographical area. The searches will be limited to studies published in English. Title, abstract, full-text screening and data extraction of relevant articles will be done by two independent reviewers. Discrepancies will be resolved by group discussion. The findings will be presented in tables with a narrative summary. This review will consider epidemiological studies and grey literature that report on the health risks of exposure to air pollution in areas where coal-fired power plants exist.

Ethics and dissemination

All data will be collected from published and grey literature. Ethics approval is therefore not required. We will submit our findings for publication in a peer-reviewed journal.

IMproving psYchosocial adjustment to Traumatic Brain Injury from acute to chronic injury through development and evaluation of the myTBI online psychoeducation platform: protocol for a mixed-methods study

Por: Troeung · L. · Sarunga Raja · T. L. · Mann · G. · Wagland · J. · MacLeod · C. · Martini · A.
Introduction

This protocol describes the myTBI study which aims to: (1) develop an online psychoeducation platform for people with traumatic brain injury (TBI), their family members/caregivers, and healthcare staff to improve psychosocial adjustment to TBI across different phases of injury (acute, postacute, and chronic), and (2) undertake an evaluation of efficacy, acceptability, and feasibility.

Methods and analysis

A three-stage mixed-methods research design will be used. The study will be undertaken across four postacute community-based neurorehabilitation and disability support services in Western Australia. Stage 1 (interviews and surveys) will use consumer-driven qualitative methodology to: (1) understand the recovery experiences and psychosocial challenges of people with TBI over key stages (acute, postacute, and chronic), and (2) identify required areas of psychosocial support to inform the psychoeducation platform development. Stage 2 (development) will use a Delphi expert consensus method to: (1) determine the final psychoeducation modules, and (2) perform acceptance testing of the myTBI platform. Finally, stage 3 (evaluation) will be a randomised stepped-wedge trial to evaluate efficacy, acceptability, and feasibility. Outcomes will be measured at baseline, postintervention, follow-up, and at final discharge from services. Change in outcomes will be analysed using multilevel mixed-effects modelling. Follow-up surveys will be conducted to evaluate acceptability and feasibility.

Ethics and dissemination

Ethics approval was granted by North Metropolitan Health Service Mental Health Research Ethics and Governance Office (RGS0000005877). Study findings will be relevant to clinicians, researchers, and organisations who are seeking a cost-effective solution to deliver ongoing psychoeducation and support to individuals with TBI across the recovery journey.

Trial registration number

ACTRN12623000990628.

Artificial intelligence tools for optimising recruitment and retention in clinical trials: a scoping review protocol

Por: Lu · X. · Chen · M. · Lu · Z. · Shi · X. · Liang · L.
Introduction

In recent years, the influence of artificial intelligence technology on clinical trials has been steadily increasing. It has brought about significant improvements in the efficiency and cost reduction of clinical trials. The objective of this scoping review is to systematically map, describe and summarise the current utilisation of artificial intelligence in recruitment and retention process of clinical trials that has been reported in research. Additionally, the review aims to identify benefits and drawbacks, as well as barriers and facilitators associated with the application of artificial intelligence in optimising recruitment and retention in clinical trials. The findings of this review will provide insights and recommendations for future development of artificial intelligence in the context of clinical trials.

Methods and analysis

The review of relevant literature will follow the methodological framework for scoping studies provided by the Joanna Briggs Institute. A comprehensive electronic search will be conducted using the search strategy developed by the authors. Leading medical and computer science databases such as PubMed, Embase, Scopus, IEEE Xplore and Web of Science Core Collection will be searched. The search will encompass analytical observational studies, descriptive observational studies, experimental and quasi-experimental studies published in all languages, without any time limitations, which use artificial intelligence tools in the recruitment and retention process of clinical trials. The review team will screen the identified studies and import them into a dedicated electronic library specifically created for this review. Data extraction will be performed using a data charting table.

Ethics and dissemination

Secondary data will be attained in this scoping review; therefore, no ethical approval is required. The results of the final review will be published in a peer-reviewed journal. It is expected that results will inform future artificial intelligence and clinical trials research.

Can glycated haemoglobin (HbA1c) be used as a predictor of left ventricular diastolic dysfunction in non-hypertensive patients with newly diagnosed type 2 diabetes mellitus: a cross-sectional study at a tertiary care centre in Eastern India

Por: Porel · R. · Shyama · S. · Ahmad · S. · Kumar · N. · Ahmad · S. · Biswas · R. · Ojha · V. S.
Objectives

This study was conducted to establish the association between glycated haemoglobin (HbA1c) and left ventricular diastolic dysfunction (LVDD) in non-hypertensive patients with newly diagnosed type 2 diabetes mellitus (DM) and determine the cut-off value of HbA1c for detecting LVDD.

Design

Cross-sectional study.

Setting

This study was conducted in General Medicine Department in collaboration with the Cardiology Department at All India Institute of Medical Sciences, Patna.

Participants

The study population comprised patients with newly diagnosed type 2 DM within the past 3 months, aged between 18 years and 80 years, who were not hypertensive and without any systemic diseases and who presented to the General Medicine Department.

Primary and secondary outcome measures

The presence of LVDD was the primary outcome measure.

Results

Among the total of 60 participants, it was observed that age (adjusted odds ratio (AOR): 1.169, 95% CI: 1.066 to 1.283) and HbA1c (AOR: 2.625, 95% CI: 1.264 to 5.450) were found to be independent predictors for the presence of LVDD. Receiver operating characteristic analysis identified a cut-off value of HbA1c at 9.5% (80 mmol/mol) for detecting LVDD, with a specificity of 96.43%, a sensitivity of 37.5% and a positive predictive value (PPV) of 91.62%.

Conclusions

This study demonstrated that age and HbA1c levels are independent predictors of LVDD in patients with newly diagnosed type 2 DM without hypertension. A cut-off value of 9.5% for HbA1c was identified with a high specificity and PPV for predicting LVDD in patients with newly diagnosed type 2 diabetes. This underscores the importance of conducting echocardiography in patients with newly diagnosed asymptomatic type 2 diabetes with HbA1c 9.5% or more to assess LVDD, allowing for prompt interventions if necessary and to decelerate the progression towards heart failure.

Evolution of the data and methods in real-world COVID-19 vaccine effectiveness studies on mortality: a scoping review protocol

Por: Stehlik · P. · Dowsett · C. · Camacho · X. · Falster · M. O. · Lim · R. · Nasreen · S. · Pratt · N. L. · Pearson · S.-A. · Henry · D.
Background

Early evidence on COVID-19 vaccine efficacy came from randomised trials. Many important questions subsequently about vaccine effectiveness (VE) have been addressed using real-world studies (RWS) and have informed most vaccination policies globally. As the questions about VE have evolved during the pandemic so have data, study design, and analytical choices. This scoping review aims to characterise this evolution and provide insights for future pandemic planning—specifically, what kinds of questions are asked at different stages of a pandemic, and what data infrastructure and methods are used?

Methods and analysis

We will identify relevant studies in the Johns Hopkins Bloomberg School of Public Health VIEW-hub database, which curates both published and preprint VE RWS identified from PubMed, Embase, Scopus, Web of Science, the WHO COVID Database, MMWR, Eurosurveillance, medRxiv, bioRxiv, SSRN, Europe PMC, Research Square, Knowledge Hub, and Google. We will include RWS of COVID-19 VE that reported COVID-19-specific or all-cause mortality (coded as ‘death’ in the ‘effectiveness studies’ data set).

Information on study characteristics; study context; data sources; design and analytic methods that address confounding will be extracted by single reviewer and checked for accuracy and discussed in a small group setting by methodological and analytic experts. A timeline mapping approach will be used to capture the evolution of this body of literature.

By describing the evolution of RWS of VE through the COVID-19 pandemic, we will help identify options for VE studies and inform policy makers on the minimal data and analytic infrastructure needed to support rapid RWS of VE in future pandemics and of healthcare strategies more broadly.

Ethics and dissemination

As data is in the public domain, ethical approval is not required. Findings of this study will be disseminated through peer-reviewed publications, conference presentations, and working-papers to policy makers.

Registration

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

Latent class analysis of Chinese healthcare providers attitudes towards oocyte cryopreservation: a cross-sectional study

Por: Lu · J. · Tian · X. · Wang · Z.
Objectives

The present study was designed to examine the attitudes towards oocyte cryopreservation among healthcare providers working in hospitals across specialties and potential influencing factors.

Design

A cross-sectional study.

Setting

The questionnaire was distributed among Chinese healthcare providers via the Credamo platform.

Participants

There were 877 respondents recruited from 8 April to 8 May 2022, among whom 160 were identified as unqualified because of inconsistency between the IP and work addresses.

Outcome measures

Individual attitudes towards oocyte cryopreservation under four different settings, familiarity with oocyte cryopreservation and perceived risks about oocyte cryopreservation of healthcare providers were measured using a self-designed questionnaire.

Results

There were 877 respondents recruited, and 717 were identified as qualified respondents. Two latent classes of healthcare providers characterised by different attitudes towards oocyte cryopreservation under four different settings were identified, the supportive and reluctant. Familiarity with oocyte cryopreservation had a significant direct effect on perceived risks, with better familiarity predicting lower perceived risks (β=–0.102, pβ=0.165, p

Conclusions

The majority of healthcare providers held a reluctant attitude towards oocyte cryopreservation of unmarried women for non-medical reasons, which might relate to their worries about the risks to offspring’s health and lack of knowledge about a reproductive technique.

Rituximab-combined anthracycline-free chemotherapy in newly diagnosed paediatric and adolescent patients with non-high-risk aggressive mature B cell lymphoma: protocol for a single-arm, open-label, multicentre, phase II study (the Japan Childrens Cancer G

Por: Sekimizu · M. · Fukano · R. · Koga · Y. · Mitsui · T. · Fujita · N. · Mori · T. · Hori · D. · Tanaka · M. · Ohki · K. · Iwafuchi · H. · Nakazawa · A. · Mori · T. · Kobayashi · R. · Hashimoto · H. · M. Saito · A. · Kamei · M. · on behalf of Lymphoma Committee of Japan Childrens Cancer G
Introduction

Children and adolescents with mature B cell non-Hodgkin lymphoma (B-NHL) are treated with short-intensive chemotherapy. The burden of short-term and long-term toxicity is highly relative to its high cure rate in good-risk patients. Although the addition of rituximab to standard lymphome Malin B (LMB) chemotherapy markedly prolongs event-free survival and overall survival in high-risk patients, the benefit of rituximab in good-risk patients remains to be elucidated. This clinical trial will examine whether the addition of rituximab eliminates anthracyclines in good-risk patients without compromising treatment outcomes.

Methods and analysis

We will perform a single-arm, open-label, multicentre phase II study. Low-risk (stage I – completely resected, stage II abdominal) and intermediate-risk (stages I and II – incompletely resected; stage II – resected, other than abdominal; stage III with LDH x upper limit of normal) patients with newly diagnosed B-NHL are eligible. Low-risk patients receive two courses of R-COM1P (rituximab, cyclophosphamide, vincristine, methotrexate, prednisolone and intrathecal methotrexate with hydrocortisone), and intermediate-risk patients receive COP (cyclophosphamide, vincristine, prednisolone and intrathecal methotrexate with hydrocortisone) followed by two courses each of R-COM3P and R-CYM (rituximab, cytarabine, methotrexate and intrathecal methotrexate with hydrocortisone). The primary endpoint is a 3-year event-free survival rate in paediatric patients (

Ethics and dissemination

This research was approved by the Certified Review Board at NHO Nagoya Medical Center (Nagoya, Japan) on 21 September 2021. Written informed consent is obtained from all patients and/or their guardians. The results of this study will be disseminated through peer-reviewed publications and conference presentations.

Study registration

Japan Registry of Clinical Trials, jRCTs041210104.

Systematic review of individual-level, community-level, and healthcare system-level factors contributing to socioeconomic differences in healthcare utilisation in OECD countries with universal health coverage

Por: Meulman · I. · Uiters · E. · Cloin · M. · Polder · J. · Stadhouders · N.
Objectives

Countries with universal health coverage (UHC) strive for equal access for equal needs without users getting into financial distress. However, differences in healthcare utilisation (HCU) between socioeconomic groups have been reported in countries with UHC. This systematic review provides an overview individual-level, community-level, and system-level factors contributing to socioeconomic status-related differences in HCU (SES differences in HCU).

Design

Systematic review following the Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) guidelines. The review protocol was published in advance.

Data sources

Embase, PubMed, Web of Science, Scopus, Econlit, and PsycInfo were searched on 9 March 2021 and 9 November 2022.

Eligibility criteria

Studies that quantified the contribution of one or more factors to SES difference in HCU in OECD countries with UHC.

Data extraction and synthesis

Studies were screened for eligibility by two independent reviewers. Data were extracted using a predeveloped data-extraction form. Risk of bias (ROB) was assessed using a tailored version of Hoy’s ROB-tool. Findings were categorised according to level and a framework describing the pathway of HCU.

Results

Of the 7172 articles screened, 314 were included in the review. 64% of the studies adjusted for differences in health needs between socioeconomic groups. The contribution of sex (53%), age (48%), financial situation (25%), and education (22%) to SES differences in HCU were studied most frequently. For most factors, mixed results were found regarding the direction of the contribution to SES differences in HCU.

Conclusions

SES differences in HCU extensively correlated to factors besides health needs, suggesting that equal access for equal needs is not consistently accomplished. The contribution of factors seemed highly context dependent as no unequivocal patterns were found of how they contributed to SES differences in HCU. Most studies examined the contribution of individual-level factors to SES differences in HCU, leaving the influence of healthcare system-level characteristics relatively unexplored.

❌