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Evaluating the VOCORDER device for early disease detection through breath analysis: study protocol for a two-phase clinical study

Por: Kontopidou · F. · Swift · S. J. · Kokkotis · C. · Moustakidis · S. · Kavouras · I. · Vidaki · A. N. · Brebou · S. · Zavvos · V. · Panagiotou · A. · Iatrou · C. · Grosomanidis · D. · Zacharouli · Z. · Giannoukos · S.
Introduction

The survival rate of patients with life-threatening diseases primarily depends on the speed of diagnosis. Too often, diseases are detected only after symptoms appear, which usually occurs at later stages of a disease when available treatments may be less effective. Current detection techniques primarily depend on identifying metabolites in biofluids such as blood and urine. The analysis of these fluids is typically performed in laboratories, resulting in lengthy waiting times for patients to receive their results. In severe cases, invasive biopsies and radiative methods are used to diagnose conditions such as cancer. These biopsies can cause distress for patients who are already experiencing significant emotional or physical stress, while imaging techniques involving ionising radiation may pose additional health risks. Additionally, these methods can be costly. In recent years, exhaled breath has become a biofluid matrix of interest for disease detection, allowing for the identification of volatile organic compounds (VOCs) or VOC profiles associated with specific conditions. To improve early disease detection through breath analysis, the VOCORDER project aims to develop a device that provides a fast, simple, user-friendly and cost-effective method for continuous health monitoring to identify diseases in their early stages before symptoms appear.

Methods and analyses

A literature review was initially conducted to identify five reference diseases of interest (lung cancer, stomach/colon cancer, breast cancer and kidney insufficiency) and previously reported VOC profiles associated with these diseases. In this trial, the project team from the MITERA Hospital will select patients, and the hospital staff will conduct personal interviews with these subjects. Each participant will also complete a questionnaire for the acquisition of demographic and medical history data, after being informed in detail about the purposes of the questionnaire and signing a consent form. The study protocol consists of two phases. Phase 1 is a baseline study designed to detect and identify breath biomarkers for the early diagnosis of the diseases mentioned above using gas chromatography-mass spectrometry (GC-MS) and secondary electrospray ionisation high-resolution mass spectrometry (SESI-HR-MS). Prescreening will select 120 healthy controls and 175 patients for the baseline phase of the clinical trial, for which breath samples will be collected in 1 L Supel-Inert Multi-Layer Foil gas sampling bags. New biomarkers and VOC profiles will be extracted from these data, and further statistical analysis will allow for artificial intelligence (AI) models to be produced and tested. For phase 2 (validation phase), 120 healthy controls and 100 patients will be selected. Breath samples will again be collected in 1 L gas sampling bags for analyses with GC-MS and SESI-HR-MS. The VOCORDER device will also be used, and its functioning with the newly developed AI models will be evaluated.

Ethics and dissemination

This clinical study has been approved by the scientific council at the MITERA hospital in Athens, Greece (#513/2024). The outcomes will be disseminated through peer-reviewed journal publications and presentations at scientific conferences.

Trial registration number

NCT06711939.

Testing and evaluating updated variants of the rurality index for Japan: a nationwide methodological study

Por: Kaneko · M. · Ikeda · T. · Shimizu · S. · Sato · T. · Nomura · O. · Soma · Y. · Inoue · M. · Ishikawa · K. B. · Matsuda · S.
Objectives

To update the rurality index for Japan (RIJ) using the most recent national data and to test and evaluate the updated RIJ variants that incorporate alternative distance metrics and a modified classification of remote islands, thereby providing methodological guidance for their use in research and health policy.

Design

Nationwide methodological study.

Setting

Japan.

Participants

All postal code areas in Japan; analyses were aggregated into municipalities and secondary medical care areas for evaluation.

Exposure

Six RIJ variants (‘RIJ family’) constructed by combining three distance metrics (direct distance, road-based distance and travel time by car) and two island classifications (original RIJ and modified RIJ), standardised to a continuous 0–100 scale using percentile ranks.

Primary outcome measures

Concordance among RIJ variants was assessed using Spearman’s rank correlation coefficients, quintile reclassification matrices and rank-difference analyses; convergent validity was evaluated using the national physician distribution index. Criterion-related validity was assessed using municipal-level life expectancy for men and women.

Results

All RIJ variants had extremely high concordance (Spearman’s ≥0.99 across all pairwise comparisons). Compared with the previous RIJ classification, >98% of the geographic units remained in the same rurality quintile and

Conclusions

Despite differences in distance metrics and island classification, all RIJ variants captured highly similar underlying dimensions of rurality and demonstrated comparable validity. These findings indicate that rurality measurement in Japan is stable regardless of methodological refinements, allowing RIJ variants to be flexibly selected according to specific research or policy purposes without materially affecting conclusions.

Do publicly supported generic pharmacies improve financial risk protection? Findings from a nationally representative cross-sectional survey in India

Por: Purohit · N. · Goyal · A. · Jyani · G. · Soman · B. · Kar · S. S. · Verma · R. · Singh · K. · Albert · S. · Patel · P. · Rana · S. K. · Kumar · S. · Biswal · S. B. · Prinja · S.
Objectives

The Government of India launched the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) to expand access to affordable generics through private retail outlets named as Jan Aushadhi Kendras (JAKs). This study examines the association of PMBJP with out-of-pocket expenditure (OOPE), catastrophic health expenditure (CHE) and impoverishment rate (IR) attributable to medicines.

Design

A cross-sectional observational study was conducted across nine Indian states in 2022–2023.

Setting

Outpatient (OPD) and inpatient (IPD) departments of secondary and tertiary government hospitals, private pharmacies and JAKs in 18 districts of India

Participants

A total of 10 336 patients were recruited from OPD (n=2881) and IPD (n=1009) departments of government hospitals as well as pharmacy settings (n=6446). Data on sociodemographics, disease severity, number of generic prescriptions, source of acquiring medicines and medicine-related OOPE were collected through semistructured interviews and periodic follow-ups.

Primary and secondary outcomes

Primary outcomes included mean OOPE on medicines, incidence of CHE (≥40% of non-food consumption expenditure on medicines), IR among JAK and non-JAK users were the primary outcomes of the study. Secondary outcomes comprised awareness of JAKs, generic prescribing rates in hospitals and the factors associated with OOPE, CHE and IR.

Results

Patients procuring medicines exclusively from JAKs reported the lower mean OOPE (OPD: 172; IPD: 275; pharmacy: 307), compared with significantly higher spending at private pharmacies (OPD: 1085; IPD: 3165; pharmacy: 1031). After adjusting for covariates, OOPE among exclusive JAK users was significantly lower relative to private pharmacy users by 60.6%–89.3%. Furthermore, matched analysis confirmed 42% lower expenses, compared with private pharmacies. The likelihood of CHE was also significantly greater among private pharmacy users. However, utilisation of JAKs remained limited, mainly due to low awareness, perceived stock shortages and low rates of generic prescribing.

Conclusion

PMBJP is associated with significant reduction in OOPE and financial hardship, positioning it as an effective cost-containment intervention within India’s universal health coverage framework. Strengthening supply chains, promoting generic prescribing and integrating JAKs with public facilities would further maximise its impact.

Seasonality of scabies and its association with climatic factors in Rohingya refugee camps, Coxs Bazar: a retrospective observational study, 2021-2023

Por: Halder · C. E. · Hasan · M. A. · Okello · J. C. · Khan · M. F. · Soma · E. R. · Poly · J. T. · Tassdik · H. · Hosen · M. S. · Prue · U. M. · Hannan · A.
Background

Scabies is a common skin condition and poses a substantial disease burden in resource-poor tropical settings. The Rohingya refugee camps in Cox’s Bazar, Bangladesh represent one of the world’s largest and most protracted humanitarian crises. Using 3 years of data from 2021 to 2023, this study analysed the seasonality of scabies and examined its association with climatic factors.

Methods

This is a retrospective observational study conducted in the Rohingya refugee camps and adjacent host communities in Ukhiya and Teknaf, Cox’s Bazar. All patients clinically diagnosed with scabies and who received treatment at 35 International Organization for Migration (IOM)-supported health facilities between 1 January 2021 and 31 December 2023 were included. Climate data, including daily mean, minimum and maximum temperature and total and maximum rainfall, were obtained from the Bangladesh Meteorological Department. Seasonal–Trend decomposition using LOESS (locally estimated scatterplot smoothing) (STL) was applied. Associations between climatic variables and the decomposed seasonal component of scabies cases and corresponding attack rate, as well as overall scabies case counts and overall attack rate, were assessed using Pearson’s correlation tests.

Results

A total of 323 106 new scabies cases were reported from IOM-supported health facilities between January 2021 and December 2023. Children aged under 5 years and 6–18 years accounted for the highest proportion of cases (32.08% and 38.95%, respectively). The average monthly number of scabies cases was highest in November (12 625) and lowest in May (5862). Case numbers increased from November to February (high season), with a peak between October and November, and declined between April and June (low season). An inverse relationship was observed between temperature and scabies incidence, with higher case numbers during cooler months and lower numbers during warmer months. Pearson’s correlation analysis demonstrated a strong and significant negative correlation between the seasonal components of both scabies cases and attack rate and temperature variables, including maximum (cases: r=–0.492, p=0.002; attack rate: r=–0.484, p=0.003), minimum (cases: r=–0.506, p=0.002; attack rate: r=–0.489, p=0.002) and mean temperature (cases: r=–0.525, p=0.001; attack rate: r=–0.511, p=0.001). No significant association was observed between the seasonal component of scabies cases or attack rate and humidity or rainfall.

Conclusion

This study identified a distinct seasonal pattern of scabies, with higher caseloads and attack rate during late autumn and winter (October to February) and lower caseloads and attack rate during summer months (April to June). Temperature showed a strong negative association with the seasonal component of scabies burden. These findings may inform the timing of public health strategies, including mass drug administration, intensified case management and social and behavioural change communication, in humanitarian settings.

Facilitators and barriers to recruitment and retention in a feasibility trial of encapsulated faecal microbiota transplant to eradicate carriage of antibiotic-resistant bacteria at an academic hospital in central London: a nested qualitative study

Por: Merrick · B. · Prossomariti · D. · Kertanegara · M. · Wyatt · D. · Goldenberg · S.
Objectives

This nested qualitative study (NQS) aimed to identify facilitators and barriers to the delivery of a substantive randomised controlled trial investigating the eradication of gastrointestinal tract carriage of antibiotic-resistant organisms using encapsulated faecal microbiota transplant (FMT).

Design

NQS within a participant-blinded, randomised, placebo-controlled, single-centre, feasibility trial (RCT)—Feasibility of ERadicating gastrointestinal carriage of Antibiotic-Resistant Organisms (FERARO) (ISRCTN reg. no. 34 467 677)—with data collected via focus groups and analysed using thematic analysis.

Setting

RCT participants were recruited from a large academic tertiary referral hospital in central London. Focus groups were held at the hospital or via videoconferencing for those unable to travel.

Participants

This study included 13 FERARO study participants across two focus groups. 11 participants were under RCT follow-up and unaware of their treatment allocation, two participants had completed 6-month follow-up and knew whether they had received FMT or matched placebo. Additional data were opportunistically collected on reasons for declining RCT participation.

Results

Participants found FMT to be an acceptable and holistic management strategy and noted positive impacts from RCT participation including enhanced personal health awareness and valuable support from the research team. The time and travel commitment presented the most substantial barrier to RCT participation. Many participants were motivated by a desire to give something back to the UK National Health Service and/or research. Patients’ current health status also influenced the decision-making process, and, while infrequently cited, the COVID-19 pandemic added extra complexity likely impacting individuals’ willingness to participate.

Conclusions

While FMT is generally acceptable to participants, logistical barriers such as the time and travel commitment associated with RCT participation need consideration. Effective communication, personal connections and participant education on antimicrobial resistance are likely to be crucial for enhancing recruitment and retention in future trials.

Trial registration number

ISRCTN registration number 34 467 677 and EudraCT number 2019-001618-41.

Do opportunities exist to improve the use of the WHO Surgical Safety Checklist in cardiology and cardiothoracic surgery? Perspectives of patients and staff in a multimethod study in New Zealand

Por: Jowsey · T. · Ward · K. · Baradi · A. · Gargiulo · D. · Henderson · K. · Mitchell · S. J. · Moore · M. · Somaratne · J. · Merry · A. F.
Objectives

The WHO Surgical Safety Checklist (SSC) can improve patient outcomes through checks and enhancing the safety climate, provided the team engage. Patients are central to that team and may be awake during part or all of many procedures. Their greater inclusion in the SSC process could enhance its checking objectives by using patient knowledge of details relevant to proposed procedures, and its objective of improving culture by emphasising patient identity, seeing patients as individuals rather than items on a production line. We aimed to evaluate SSC use, including clinicians’ and patients’ perspectives, in cardiothoracic operating rooms (CTORs) and cardiac catheterisation laboratories (CCLs), and to identify opportunities to refine its use in these spaces.

Design

We undertook a multimethod study based on positivism and interpretivism, with evaluation of SSC administration and interviews. We evaluated SSC administration during 20 Sign Ins, 20 Time Outs and 20 Sign Outs in CTORs and 20 Time Outs in CCLs (11 coronary angiography and 9 electrophysiology cases) using the WHO Behaviourally Anchored Rating Scale (WHOBARS, 1–7, where higher scores indicate better practice). We additionally interviewed 10 clinicians and 17 patients about their experiences and perceptions of safety and SSC use. We undertook thematic analysis of interview data.

Setting

CTORs and CCLs in an Auckland public hospital.

Participants

We observed 171 clinicians during 20 cases. We interviewed 10 clinicians (Pakeha/New Zealand/European n=6; male n=5; doctor n=5). We interviewed 17 patients (Pakeha/New Zealand/European n=12; male n=10; age range 45–81 years).

Results

In CTORs, the SSC was used in full: median (IQR) WHOBARS score was 5.9 (5.2, 6.5). In CCLs, its use differed between electrophysiology and angiography CCLs: median (IQR) WHOBARS score was 4.50 (3.2, 5.6). In both CTORs and CCLs, high levels of carefulness and respect between team members were observed. Clinicians described the SSC as valuable and identified context-related reasons for variations in its use. Patients wanted to feel cared for and respected (including culturally). The SSC contributed positively to this. Clinicians expressed reservations about increasing patients’ involvement with the SSC. However, patients’ comments supported their increased engagement in the SSC process (including establishing their preferred names).

Conclusions

The SSC is used at Auckland City Hospital with some variation between services and with high levels of carefulness and respect. The SSC increased patients’ sense of being cared for. With modification (eg, by verifying their preferred name during the Sign In phase), the SSC could enhance patients’ perception of being seen as individuals, their cultural safety and the safety climate in operating and procedure rooms, and hence potentially improve patient outcomes. Our findings reinforce the value of regular evaluation and context-relevant modification of SSC for its effective use.

Postnatal care utilisation and health beliefs among mothers in the Jazan region of Saudi Arabia: a cross-sectional study

Por: Altraifi · A. A. · Albasheer · O. · Abdelwahab · S. I. · Chourasia · U. · Abdelmageed · M. M. · Hakami · A. M. · Khormi · A. H. · Medani · I. E. · Ali · S. A. · Habeeb · S. A. · Shebaly · G. A. · Somaily · M. M. · Harshan · S. M. · Ali · S. M. · Hukma · S. H.
Background

The postnatal period is critical for preventing maternal and neonatal morbidity and mortality. Globally, a significant proportion of maternal and neonatal deaths occur within the first 6 weeks after delivery. Timely and adequate postnatal care (PNC) can detect and manage life-threatening complications; however, service utilisation remains alarmingly low in many low- and middle-income countries, including Saudi Arabia. Addressing the behavioural and perceptual factors that influence service use is essential for improving health outcomes.

Objectives

This study aimed to assess mothers’ utilisation of PNC services and examine how their health beliefs and sociodemographic characteristics influence this behaviour.

Design

A cross-sectional study guided by the Health Belief Model (HBM) was conducted to explore predictors of PNC utilisation.

Setting

Eight primary healthcare (PHC) centres were randomly selected from 179 PHC centres distributed in the different governorates of the Jazan region of Saudi Arabia.

Participants

A total of 464 mothers were surveyed between October and December 2023 using an interviewer-administered questionnaire.

Primary and secondary outcome measures

The primary outcome was PNC utilisation, defined by the number of postnatal visits. The independent variables included sociodemographic characteristics and HBM constructs (perceived susceptibility, benefits, barriers and cues to action).

Results

In terms of PNC utilisation, 80.0% of participants had two or fewer postnatal visits, whereas 20.0% had three or more postnatal visits. Perceived barriers had the strongest influence (mean score 2.51±0.87), followed by cues to action (2.43±0.89), susceptibility (1.92±0.72) and benefits (1.86±0.64). In the multivariate analysis, perceived barriers, cues to action and perceived susceptibility were significantly associated with PNC utilisation, with adjusted ORs of 1.679 (95% CI: 1.007 to 2.799), 0.470 (95% CI: 0.256 to 0.863) and 0.405 (95% CI: 0.197 to 0.832), respectively.

Conclusions

PNC utilisation in the Jazan region remains suboptimal. Perceptual factors, particularly barriers and cues to action, play a central role in service use. Health interventions targeting these beliefs and improving follow-up mechanisms may help increase PNC engagement and improve maternal and infant health outcomes in Saudi Arabia.

Investigating the relationship between Pfkelch13 mutations and response to artemisinin-based treatment for uncomplicated falciparum malaria: a protocol for a systematic review and individual patient data meta-analysis

Por: van Wyk · S. · Dahal · P. · Vouvoungui · C. · Ayuen · D. S. · Shokraneh · F. · Soma · A. · Watson · J. A. · Guerin · P. · Barnes · K. I.
Introduction

Artemisinin-based combination therapies (ACTs) remain the WHO-recommended treatment for uncomplicated Plasmodium falciparum malaria. However, the emergence and spread of artemisinin resistance (ART-R) threatens ACT efficacy. ART-R is phenotypically expressed as delayed parasite clearance, which can facilitate ACT partner drug resistance. ART-R has been causally linked to specific mutations in the Pfkelch13 gene.

Methods and analysis

The systematic review and associated meta-analysis aim to determine the correlation between Pfkelch13 (alleles present in the Kelch13 gene region of the P. falciparum parasite) genotypes and clinical and parasitological response to ACTs from a globally representative data set pooling individual patient data (IPD) from eligible published and unpublished studies. The eligibility criteria include Pfkelch13 genotyping results at baseline complemented by individually linked parasitological and clinical assessments following artemisinin-based treatment. The data will be curated, standardised and analysed using this proposed statistical analysis plan (SAP), adhering to PRISMA-IPD (PRISMA, Preferred Reporting Items for Systematic reviews and Meta-Analyses) guidelines. Our SAP will apply hierarchical modelling to assess the effect of the P. falciparum parasite Pfkelch13 mutations on parasite clearance half-life and therapeutic efficacy across different regions. This will include study sites as random effects in the model and potential predictors such as age, sex, baseline parasite load and other potential effect modifiers as fixed effects. This analysis will enhance the understanding of the influence of Pfkelch13 mutations on malaria treatment outcomes.

Ethics and dissemination

Data were obtained with informed consent and ethical approvals from the relevant countries and were pseudonymised before curation in the Infectious Diseases Data Observatory (IDDO)/WorldWide Antimalarial Resistance Network (WWARN) repository. Data ownership remains with contributors. This IPD meta-analysis met the Oxford Tropical Research Ethics Committee criteria for waiving ethical review, as it is a secondary analysis of existing pseudonymised data. The resulting peer-reviewed publication and conference proceedings will help strengthen and enhance the efficiency of ART-R surveillance and response and support policy decisions.

PROSPERO registration number

CRD42019133366.

Data Trauma: A Concept Analysis

imageToday's healthcare landscape is becoming increasingly data-centric, with artificial intelligence and advanced computer algorithms becoming inextricably embedded in patient care. Although these technologies promise to make care more efficient and effective, they heighten the risk for unintended consequences. Using Walker and Avant's framework for concept analysis, we propose and explicate the emerging concept of iatrogenic data trauma, or ways in which the collection, storage, and use of sensitive and potentially stigmatizing patient data can cause harm. We conducted a careful and exhaustive review of traditional academic publications, as well as nontraditional digital sources to generate a rich and intersectional corpus of information pertaining to data justice, digital rights, and potential risks associated with the “datafication” of individuals. Using evidence synthesis and practical examples, we discuss how flawed data processes in healthcare settings can lead to data trauma among patients and explore how its presence can perpetuate health disparities, marginalization, loss of privacy, and breach of trust in patient-provider relationships. We discuss how this phenomenon arises and manifests across the healthcare continuum and is an important issue for professionals in multiple disciplines. We conclude by suggesting future opportunities for research through a trauma-informed lens.
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