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☐ ☆ ✇ BMJ Open

Efficiency assessment of follow-up methodology of patients with knee replacement to predict post-surgical functionality: a protocol for randomised control PROKnee trial

Por: San Martin Valenzuela · C. · Tabares-Seisdedos · R. · Paya Rubio · A. · Correa-Ghisays · P. · Pedrero-Sanchez · J.-F. · Silvestre Munoz · A. — Mayo 7th 2024 at 18:05
Introduction

Even when total knee arthroplasty (TKA) is an extended treatment, most patients experience a suboptimal evolution after TKA. The objectives of this study are the following: (1) to determine the effectiveness of two different prosthesis stabilisation systems on the functionality in activities of daily life, and (2) to determine prognostic biomarkers of knee prosthesis function based on radiological information, quantification of cytokines, intra-articular markers and biomechanical functional evaluation to predict successful evolution.

Methods and analysis

The PROKnee trial was designed as a randomised controlled patient-blinded trial with two parallel groups that are currently ongoing. The initial recruitment will be 99 patients scheduled for their first TKA, without previous prosthesis interventions in lower limbs, who will be randomly divided into two groups that differed in the stabilisation methodology incorporated in the knee prosthesis: the MEDIAL-pivot group and the CENTRAL-pivot group. The maximum walking speed will be reported as the primary outcome, and the secondary results will be patient-reported questionnaires related to physical status, cognitive and mental state, radiological test, laboratory analysis and biomechanical instrumented functional performance, such as the 6-minute walking test, timed up-and-go test, gait, sit-to-stand, step-over, and ability to step up and down stairs. All the results will be measured 1 week before TKA and at 1.5, 3, 6 and 12 months after surgery.

Ethics and dissemination

All procedures were approved by the Ethical Committee for Research with Medicines of the University Clinical Hospital of Valencia on 8 October 2020 (order no. 2020/181). Participants are required to provide informed consent for the study and for the surgical procedure. All the data collected will be treated confidentially since they will be blinded and encrypted. The results from the trial will be published in international peer-reviewed scientific journals, regardless of whether these results are negative or inconclusive.

Trial registration number

ClinicalTrials.gov Registry (NCT04850300).

☐ ☆ ✇ BMJ Open

Associations between knowledge of health issues and health care satisfaction and propensity to complain: a cross-sectional survey of adult men in Denmark

Por: Birkeland · S. · Bismark · M. · Barry · M. J. · Möller · S. — Mayo 6th 2024 at 18:42
Objectives

The objective of this study was to investigate associations between knowledge of health issues and healthcare satisfaction and propensity to complain including the association between knowledge and greater patient involvement.

Design

The present study is a secondary analysis of a larger cross-sectional case vignette survey.

Setting

Survey conducted in adult Danish men.

Participants

Participants included 6755 men aged 45–70 years.

Interventions

Participants responded to a survey with scenarios illustrating prostate-specific antigen (PSA) testing and different information provision.

Primary and secondary outcome measures

Using Likert scales (scored 1–5), participants rated their satisfaction with the care described and their inclination to complain and responded to a short quiz (scored 0–3) assessing their knowledge about the PSA test.

Results

Satisfaction with healthcare increased with better quiz performance (Likert difference 0.13 (95% CI .07 to 0.20), p

Conclusions

Mens’ knowledge of the benefits of screening varies with education, predicts satisfaction with care and the desire to complain, and may be improved through greater involvement in decision-making.

☐ ☆ ✇ BMJ Open

Financial protection and equity in the healthcare financing system in Iran: a cross-sectional study among slum dwellers with type 2 diabetes

Por: Ghammari · F. · Heidari · K. · Jalilian · H. — Mayo 3rd 2024 at 16:08
Objectives

This study was conducted to assess financial protection and equity in the healthcare financing system among slum dwellers with type 2 diabetes (T2D) in Iran in 2022.

Design

Cross-sectional study.

Setting

Primary care centres in Iran were selected from slums.

Participants

Our study included 400 participants with T2D using a systematic random sampling method. Patients were included if they lived in slums for at least five consecutive years, were over 18 years old and did not have intellectual disabilities.

Primary and secondary measures

A self-report questionnaire was used to assess cost-coping strategies vis-à-vis T2D expenditures and factors influencing them, as well as forgone care among slum dwellers.

Results

Of the 400 patients who participated, 53.8% were female. Among the participants, 27.8% were illiterate, but 30.3% could read and write. 75.8% had income below 40 million Rial. There was an association between age, education, income, basic insurance, supplemental insurance and cost-coping strategies (p

Conclusions

As a result of insufficient use of insurance, cost-coping strategies used by slum dwellers vis-à-vis T2D expenditures do not protect them from financial risks. Expanding universal health coverage and providing supplemental insurance for those with T2D living in slums are recommended. Iran Health Insurance should adequately cover the costs of T2D care for slum dwellers so that they do not need to use alternative strategies.

☐ ☆ ✇ BMJ Open

Burden of COVID-19 pandemic on tuberculosis hospitalisation patterns at a tertiary care hospital in Rajasthan, India: a retrospective analysis

Por: Rajotiya · S. · Mishra · S. · Singh · A. K. · Debnath · S. · Raj · P. · Singh · P. · Bareth · H. · Nakash · P. · Sharma · A. · Singh · M. · Nathiya · D. · Joshi · N. · Tomar · B. S. — Mayo 3rd 2024 at 16:08
Objective

This study aimed to investigate the burden of the COVID-19 pandemic on tuberculosis (TB) trends, patient demographics, disease types and hospitalisation duration within the Respiratory Medicine Department over three distinct phases: pre-COVID-19, COVID-19 and post-COVID-19.

Design

Retrospective analysis using electronic medical records of patients with TB admitted between June 2018 and June 2023 was done to explore the impact of COVID-19 on patients with TB. The study employed a meticulous segmentation into pre-COVID-19, COVID-19 and post-COVID-19 eras.

Setting

National Institute of Medical Science Hospital in Jaipur, Rajasthan, India.

Primary and secondary outcome measures

Primary outcome includes patients admitted to the Respiratory Medicine Department of the hospital and secondary outcome involves the duration of hospital stay.

Results

The study encompassed 1845 subjects across the three eras, revealing a reduction in TB incidence during the post-COVID-19 era compared with the pre-COVID-19 period (p

Conclusion

The study underscores the influence of the COVID-19 pandemic on the TB landscape and hospitalisation dynamics. Notably, patient burden of TB declined during the COVID-19 era, with a decline in the post-COVID-19 era compared with the pre-COVID-19 era. Prolonged hospitalisation in the post-COVID-19 period indicates the need for adaptive healthcare strategies and the formulation of public health policies in a post-pandemic context. These findings contribute to a comprehensive understanding of the evolving TB scenario, emphasising the necessity for tailored healthcare approaches in the aftermath of a global health crisis.

☐ ☆ ✇ BMJ Open

Role of virtual reality in examining the effect of fear of falling (FOF) on postural stability in individuals without and with Parkinsons disease in Egypt: a mixed-methods feasibility study protocol

Por: Gomaa · Y. S. · Awad · M. I. · Emara · T. · Elbokl · A. · Al-Yahya · E. · ElMeligie · M. M. — Mayo 1st 2024 at 16:46
Background

Falls are common in older people and individuals with neurological conditions. Parkinson’s disease (PD) is known for postural instability causing mobility disabilities, falls and reduced quality of life. The fear of falling (FOF), a natural response to unstable balance, can worsen postural control problems. Evaluating FOF relies largely on affected persons’ subjective accounts due to limited objective assessment methods available. The aim of this mixed-methods feasibility study is to develop an assessment method for FOF while in motion and walking within virtual environments. This study will assess a range of FOF-related responses, including cognitive factors, neuromuscular response and postural stability.

Methods and analysis

This feasibility study will consist of four phases: the first two phases will include people without PD, while the other two will include people diagnosed with PD. Participants will be assessed for direct and indirect responses to real life, as well as virtual environment walking scenarios that may induce FOF. Data from questionnaires, different neurophysiological assessments, movement and gait parameters, alongside evaluations of usability and acceptability, will be collected. Semistructured interviews involving both participants and research assistants shall take place to elicit their experiences throughout different phases of the assessments undertaken. Demographic data, the scores of assessment scales, as well as feasibility, usability and acceptability of the measurement methods, will be illustrated via descriptive statistics. Movement and gait outcomes, together with neurophysiological data, will be extracted and calculated. Exploring relationships between different factors in the study will be achieved using a regression model. Thematic analysis will be the approach used to manage qualitative data.

Ethics and dissemination

This feasibility study was approved by the Ethics Committee of the Faculty of Physical Therapy, Kafr El Sheikh University, Egypt (number: P.T/NEUR/3/2023/46). The results of this study will be published in a peer-reviewed journal.

Trial registration number

ClinicalTrials.gov Registry (NCT05931692).

☐ ☆ ✇ International Wound Journal

Characterization of a full‐thickness decellularized and lyophilized human placental membrane for clinical applications

Abstract

Allografts derived from live-birth tissue obtained with donor consent have emerged as an important treatment option for wound and soft tissue repairs. Placental membrane derived from the amniotic sac consists of the amnion and chorion, the latter of which contains the trophoblast layer. For ease of cleaning and processing, these layers are often separated with or without re-lamination and the trophoblast layer is typically discarded, both of which can negatively affect the abundance of native biological factors and make the grafts difficult to handle. Thus, a full-thickness placental membrane that includes a fully-intact decellularized trophoblast layer was developed for homologous clinical use as a protective barrier and scaffold in soft tissue repairs. Here, we demonstrate that this full-thickness placental membrane is effectively decellularized while retaining native extracellular matrix (ECM) scaffold and biological factors, including the full trophoblast layer. Following processing, it is porous, biocompatible, supports cell proliferation in vitro, and retains its biomechanical strength and the ability to pass through a cannula without visible evidence of movement or damage. Finally, it was accepted as a natural scaffold in vivo with evidence of host-cell infiltration, angiogenesis, tissue remodelling, and structural layer retention for up to 10 weeks in a murine subcutaneous implant model.

☐ ☆ ✇ Journal of Clinical Nursing

The impact of mandated use early warning system tools on the development of nurses' higher‐order thinking: A systematic review

Por: Tracy Flenady · Justine Connor · Amy‐Louise Byrne · Deb Massey · Marie Danielle Le Lagadec — Abril 25th 2024 at 13:18

Abstract

Aim

Ascertain the impact of mandated use of early warning systems (EWSs) on the development of registered nurses' higher-order thinking.

Design

A systematic literature review was conducted, following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and checklist (Page et al., 2021).

Data Sources

CINAHL, Medline, Embase, PyscInfo.

Review Methods

Eligible articles were quality appraised using the MMAT tool. Data extraction was conducted independently by four reviewers. Three investigators thematically analysed the data.

Results

Our review found that EWSs can support or suppress the development of nurses' higher-order thinking. EWS supports the development of higher-order thinking in two ways; by confirming nurses' subjective clinical assessment of patients and/or by providing a rationale for the escalation of care. Of note, more experienced nurses expressed their view that junior nurses are inhibited from developing effective higher-order thinking due to reliance on the tool.

Conclusion

EWSs facilitate early identification of clinical deterioration in hospitalised patients. The impact of EWSs on the development of nurses' higher-order thinking is under-explored. We found that EWSs can support and suppress nurses' higher-order thinking. EWS as a supportive factor reinforces the development of nurses' heuristics, the mental shortcuts experienced clinicians call on when interpreting their subjective clinical assessment of patients. Conversely, EWS as a suppressive factor inhibits the development of nurses' higher-order thinking and heuristics, restricting the development of muscle memory regarding similar presentations they may encounter in the future. Clinicians' ability to refine and expand on their catalogue of heuristics is important as it endorses the future provision of safe and effective care for patients who present with similar physiological signs and symptoms.

Impact

This research impacts health services and education providers as EWS and nurses' development of higher-order thinking skills are essential aspects of delivering safe, quality care.

No Patient or Public Contribution

This is a systematic review, and therefore, comprises no contribution from patients or the public.

☐ ☆ ✇ Journal of Advanced Nursing

First‐line managers' experience of guideline implementation during the COVID‐19 pandemic

Abstract

Aim(s)

To explore first-line managers' experience of guideline implementation in orthopaedic care during the COVID-19 pandemic.

Design

A descriptive, qualitative study.

Methods

Semi-structured interviews with 30 first-line nursing and rehabilitation managers in orthopaedic healthcare at university, regional and local hospitals. The interviews were analysed by thematic analysis.

Results

First-line managers described the implementation of guidelines related to the pandemic as different from everyday knowledge translation, with a swifter uptake and time freed from routine meetings in order to support staff in adoption and adherence. The urgent need to address the crisis facilitated guideline implementation, even though there were specific pandemic-related barriers such as staffing and communication issues. An overarching theme, Hanging on to guidelines for dear life, is substantiated by three themes: Adapting to facilitate change, Anchoring safety through guidelines and Embracing COVID guidelines.

Conclusion

A health crisis such as the COVID-19 pandemic can generate enabling elements for guideline implementation in healthcare, despite prevailing or new hindering components. The experience of guideline implementation during the COVID-19 pandemic can improve understanding of context aspects that can benefit organizations in everyday translation of evidence into practice.

Implications for the Profession and/or Patient Care

Recognizing what enabled guideline implementation in a health crisis can help first-line managers to identify local enabling context elements and processes. This can facilitate future guideline implementation.

Impact

During the COVID-19 pandemic, the healthcare context and staff's motivation for guideline recognition and adoption changed. Resources and ways to bridge barriers in guideline implementation emerged, although specific challenges arose. Nursing managers can draw on experiences from the COVID-19 pandemic to support implementation of new evidence-based practices in the future.

Reporting Method

This study adheres to the EQUATOR guidelines by using Standards for Reporting Qualitative Research (SRQR).

No Patient or Public Contribution.

☐ ☆ ✇ Journal of Clinical Nursing

Protective and risk factors of workplace violence against nurses: A cross‐sectional study

Abstract

Aims

To describe how workplace violence (WPV) is experienced by nurses in hospitals and community services and identify protective and risk factors.

Methods

An online cross-sectional national study was conducted from January to April 2021 in Italy. Hospitals and community services were involved in the study. The survey combined the adapted and validated Italian version of the Violence in Emergency Nursing and Triage (VENT) questionnaire, which explores the episodes of WPV experienced during the previous 12 months, the Practice Environment Scale of the Nursing Work Index (PES-NWI) and some additional questions about staffing levels extracted from a previous RN4CAST study. Nurses working in all clinical settings and community services were invited to participate in the survey. Descriptive and inferential statistics were used for data analysis. We adhered to the STROBE reporting guidelines.

Results

A total of 6079 nurses completed the survey, 32.4% (n = 1969) had experienced WPV in the previous 12 months, and 46% (n = 920) reported WPV only in the previous week. The most significant protective factors were nurses' age, patients' use of illegal substances, attitude of individual nurses and considering effective the organization's procedures for preventing and managing episodes of violence. The most significant risk factors included workload, recognizing violence as an inevitable part of the job, patients' cultural aspects and patients' agitated behaviour. The frequency of WPV was significantly higher in certain areas, such as the emergency department and in mental health wards.

Conclusion

Workplace violence (WPV) against nurses is a very frequent and concerning issue, especially in hospitals and community services. Based on our findings, integrated and multimodal programmes for prevention and management of WPV are recommended. More attention and resources need to be allocated to reduce WPV by improving the quality of nurses' workplace environment and implementing violence-free policies for hospitals.

Implications for the Profession and/or Patient Care

Impact

Workplace verbal and physical violence is a widespread phenomenon, both in hospital and community settings, and even during COVID-19 pandemic. This problem is exacerbated by the lack of effective reporting systems, fear of retaliation and the tendency to consider violence as an inevitable part of the job. The characteristics of professionals, patients, work environment and organizational factors are involved in the spread of workplace violence, determining its multifactorial nature. Integrated and multimodal programmes to prevent and manage of workplace violence are probably the only way to effectively counteract workplace violence against nurses. Healthcare policymakers, managers of hospital and community services need to proactively prevent and effectively manage and monitor episodes of violence. Nurses need to feel protected and safeguarded against any form of verbal or physical violence, to provide high-quality care in a totally safe environment.

Patient or Public Contribution

No patient or public contribution.

☐ ☆ ✇ PLOS ONE Medicine&Health

Multiparameter immunoprofiling for the diagnosis and differentiation of progressive versus nonprogressive nontuberculous mycobacterial lung disease–A pilot study

by Paige K. Marty, Balaji Pathakumari, Thomas M. Cox, Virginia P. Van Keulen, Courtney L. Erskine, Maleeha Shah, Mounika Vadiyala, Pedro Arias-Sanchez, Snigdha Karnakoti, Kelly M. Pennington, Elitza S. Theel, Cecilia S. Lindestam Arlehamn, Tobias Peikert, Patricio Escalante

Clinical prediction of nontuberculous mycobacteria lung disease (NTM-LD) progression remains challenging. We aimed to evaluate antigen-specific immunoprofiling utilizing flow cytometry (FC) of activation-induced markers (AIM) and IFN-γ enzyme-linked immune absorbent spot assay (ELISpot) accurately identifies patients with NTM-LD, and differentiate those with progressive from nonprogressive NTM-LD. A Prospective, single-center, and laboratory technician-blinded pilot study was conducted to evaluate the FC and ELISpot based immunoprofiling in patients with NTM-LD (n = 18) and controls (n = 22). Among 18 NTM-LD patients, 10 NTM-LD patients were classified into nonprogressive, and 8 as progressive NTM-LD based on clinical and radiological features. Peripheral blood mononuclear cells were collected from patients with NTM-LD and control subjects with negative QuantiFERON results. After stimulation with purified protein derivative (PPD), mycobacteria-specific peptide pools (MTB300, RD1-peptides), and control antigens, we performed IFN-γ ELISpot and FC AIM assays to access their diagnostic accuracies by receiver operating curve (ROC) analysis across study groups. Patients with NTM-LD had significantly higher percentage of CD4+/CD8+ T-cells co-expressing CD25+CD134+ in response to PPD stimulation, differentiating between NTM-LD and controls. Among patients with NTM-LD, there was a significant difference in CD25+CD134+ co-expression in MTB300-stimulated CD8+ T-cells (p
☐ ☆ ✇ PLOS ONE Medicine&Health

Knowledge, attitudes, and practices about HIV and other sexually transmitted infections among High School students in Southern Italy: A cross-sectional survey

by Francesco Di Gennaro, Francesco Vladimiro Segala, Giacomo Guido, Mariacristina Poliseno, Laura De Santis, Alessandra Belati, Carmen Rita Santoro, Irene Francesca Bottalico, Carmen Pellegrino, Roberta Novara, Luisa Frallonardo, Mariangela Cormio, Michele Camporeale, Sergio Cotugno, Vincenzo Giliberti, Stefano Di Gregorio, Valentina Totaro, Nicola Catucci, Anna De Giosa, Roberta Giusto, Ilaria Viviana Lanera, Gioacchino Angarano, Sergio Lo Caputo, Annalisa Saracino

High School students, recognized as a high-risk group for sexually transmitted infections (STIs), were the focal point of an educational campaign in Southern Italy to share information and good practices about STIs and HIV/AIDS. A baseline survey comprising 76 items was conducted via the REDCap platform to assess students’ initial knowledge, attitudes, and practices (KAP) related to STIs and HIV/AIDS. Sociodemographic variables were also investigated. The association between variables and KAP score was assessed by Kruskal-Wallis’ or Spearman’s test, as appropriate. An ordinal regression model was built to estimate the effect size, reported as odds ratio (OR) with a 95% confidence interval (CI), for achieving higher KAP scores among students features. On a scale of 0 to 29, 1702 participants achieved a median KAP score of 14 points. Higher scores were predominantly reported by students from classical High Schools (OR 3.19, 95% C.I. 1.60–6.33, p
☐ ☆ ✇ PLOS ONE Medicine&Health

Relying on the French territorial offer of thermal spa therapies to build a care pathway for long COVID-19 patients

by Milhan Chaze, Laurent Mériade, Corinne Rochette, Mélina Bailly, Rea Bingula, Christelle Blavignac, Martine Duclos, Bertrand Evrard, Anne Cécile Fournier, Lena Pelissier, David Thivel, on behalf of CAUVIM-19 Group

Background

Work on long COVID-19 has mainly focused on clinical care in hospitals. Thermal spa therapies represent a therapeutic offer outside of health care institutions that are nationally or even internationally attractive. Unlike local care (hospital care, general medicine, para-medical care), their integration in the care pathways of long COVID-19 patients seems little studied. The aim of this article is to determine what place french thermal spa therapies can take in the care pathway of long COVID-19 patients.

Methods

Based on the case of France, we carry out a geographic mapping analysis of the potential care pathways for long COVID-19 patients by cross-referencing, over the period 2020–2022, the available official data on COVID-19 contamination, hospitalisations in intensive care units and the national offer of spa treatments. This first analysis allows us, by using the method for evaluating the attractiveness of an area defined by David Huff, to evaluate the accessibility of each French department to thermal spas.

Results

Using dynamic geographical mapping, this study describes two essential criteria for the integration of the thermal spa therapies offer in the care pathways of long COVID-19 patients (attractiveness of spa areas and accessibility to thermal spas) and three fundamental elements for the success of these pathways (continuity of the care pathways; clinical collaborations; adaptation of the financing modalities to each patient). Using a spatial attractiveness method, we make this type of geographical analysis more dynamic by showing the extent to which a thermal spa is accessible to long COVID-19 patients.

Conclusion

Based on the example of the French spa offer, this study makes it possible to place the care pathways of long COVID-19 patients in a wider area (at least national), rather than limiting them to clinical and local management in a hospital setting. The identification and operationalization of two geographical criteria for integrating a type of treatment such as a spa cure into a care pathway contributes to a finer conceptualization of the construction of healthcare pathways.

☐ ☆ ✇ PLOS ONE Medicine&Health

Test-retest reliability of Latin American Group for Maturity (GDLAM) protocol in older women

by Álvaro Huerta Ojeda, Emilio Jofré-Saldía, Jimena Arriagada Molina, Patricia Rojas Quinchavil, María Paz Parada Toledo, Sergio Galdames Maliqueo, María-Mercedes Yeomans-Cabrera, Carlos Jorquera-Aguilera, Frano Giakoni-Ramirez, Maximiliano Bravo

Functional autonomy (FA) is a critical factor in determining the quality of life of older adults (OA), especially in the case of older women (OW), as they face a decline in FA in their later years of life. FA should be assessed early, using valid, reliable, and low-cost tests. This study evaluated the test-retest reliability of GDLAM and GDLAM autonomy index (GI) in OW. Thirty-nine OW (71.2 ± 6.50 years) participated in the study. A repeated measures design was used to compare the interday test-retest reliability of the five GDLAM tests (seconds) and the GI (points). The five tests represent activities of daily living, such as dressing or wandering around the house, while the GI provides a weighting of the results of the five tests. The analysis consisted of the intraclass correlation coefficient (ICC), standard error of measurement (SEM), and coefficient of variation (CV). A CV ≤ 10% and an ICC ≥ 0.80 were considered acceptable reliability, whereas a CV ≤ 5% and an ICC ≥ 0.90 were considered high reliability. The outcome of the five tests, represented by the GI, showed high interday test-retest reliability (CV = 6.00% and ICC = 0.91). The results of this study demonstrate that the five tests of the GDLAM protocol and the GI have high interday test-retest reliability and good interday reproducibility. From a practical point of view, the GDLAM protocol allows the assessment of FA of community-dwelling OW, providing background for early diagnosis and, with it, the possibility of developing an individualized physical exercise prescription.
☐ ☆ ✇ PLOS ONE Medicine&Health

Changes in parenting behavior in the time of COVID—19: A mixed method approach

by Luiza Mesesan-Schmitz, Claudiu Coman, Carmen Stanciu, Venera Bucur, Laurentiu Gabriel Tiru, Maria Cristina Bularca

This study was designed to explore mothers’ perceptions about changes in parenting behavior in the middle of the pandemic COVID 19 period. Based on the convergent mixed-method design and Parental Stress model, we illustrated these changes by taking into account the impact of the pandemic perceived by mothers and the resources they had available. Research on parenting changes was important in the Romanian context because, in that challenging period, there were no regulations to safeguard parents, especially single parents as mothers. Mothers experienced increased levels of stress, some of them having to leave their jobs to stay at home with their children. Other mothers needed to work from home and in the meantime to take care of their children. In this context we wanted to illustrate the possible changes that occurred in their parenting behavior during the pandemic period. Results from the quantitative survey showed that there is a moderate correlation between the negative impact felt by mothers and the negative changes in their parenting behavior, and this correlation was diminished by a series of resources such as: social support, parenting alliance, or high income. Qualitative data provided better understanding of mothers’ parenting behavior by showing that mothers shared both positive and negative experiences during the pandemic, regardless of the general trend mentioned. As shown by the quantitative data, the qualitative data also showed that mothers who felt more strongly the impact of the pandemic reported more negative changes in their parenting behavior. The positive changes most frequently stated involved expressing affection and communicating more often on various topics, carrying out leisure activities or activities meant to help with the personal development of the child, and involving children in domestic activities. Mothers mostly described negative aspects such as too much involvement in school life, increased control and surveillance of children, especially when it comes to school related activities and to the time children were allowed to spend on their digital devices. These changes led to conflicts and sometimes, mothers resorted to discipline practices. In addition to the resources identified in quantitative research, mothers with higher education and medium–high income also turned to specialized resources (psychologists, online courses, support groups) in order to manage conflicts, them being able to see the challenges of the pandemic as an opportunity to develop and improve the relationship with their children.
☐ ☆ ✇ BMJ Open

Defining predictors of responsiveness to advanced therapies in Crohns disease and ulcerative colitis: protocol for the IBD-RESPONSE and nested CD-metaRESPONSE prospective, multicentre, observational cohort study in precision medicine

Por: Wyatt · N. J. · Watson · H. · Anderson · C. A. · Kennedy · N. A. · Raine · T. · Ahmad · T. · Allerton · D. · Bardgett · M. · Clark · E. · Clewes · D. · Cotobal Martin · C. · Doona · M. · Doyle · J. A. · Frith · K. · Hancock · H. C. · Hart · A. L. · Hildreth · V. · Irving · P. M. · Iqbal · S — Abril 17th 2024 at 17:18
Introduction

Characterised by chronic inflammation of the gastrointestinal tract, inflammatory bowel disease (IBD) symptoms including diarrhoea, abdominal pain and fatigue can significantly impact patient’s quality of life. Therapeutic developments in the last 20 years have revolutionised treatment. However, clinical trials and real-world data show primary non-response rates up to 40%. A significant challenge is an inability to predict which treatment will benefit individual patients.

Current understanding of IBD pathogenesis implicates complex interactions between host genetics and the gut microbiome. Most cohorts studying the gut microbiota to date have been underpowered, examined single treatments and produced heterogeneous results. Lack of cross-treatment comparisons and well-powered independent replication cohorts hampers the ability to infer real-world utility of predictive signatures.

IBD-RESPONSE will use multi-omic data to create a predictive tool for treatment response. Future patient benefit may include development of biomarker-based treatment stratification or manipulation of intestinal microbial targets. IBD-RESPONSE and downstream studies have the potential to improve quality of life, reduce patient risk and reduce expenditure on ineffective treatments.

Methods and analysis

This prospective, multicentre, observational study will identify and validate a predictive model for response to advanced IBD therapies, incorporating gut microbiome, metabolome, single-cell transcriptome, human genome, dietary and clinical data. 1325 participants commencing advanced therapies will be recruited from ~40 UK sites. Data will be collected at baseline, week 14 and week 54. The primary outcome is week 14 clinical response. Secondary outcomes include clinical remission, loss of response in week 14 responders, corticosteroid-free response/remission, time to treatment escalation and change in patient-reported outcome measures.

Ethics and dissemination

Ethical approval was obtained from the Wales Research Ethics Committee 5 (ref: 21/WA/0228). Recruitment is ongoing. Following study completion, results will be submitted for publication in peer-reviewed journals and presented at scientific meetings. Publications will be summarised at www.ibd-response.co.uk.

Trial registration number

ISRCTN96296121.

☐ ☆ ✇ BMJ Open

Cost of SARS-CoV-2 self-test distribution programmes by different modalities: a micro-costing study in five countries (Brazil, Georgia, Malaysia, Ethiopia and the Philippines)

Por: Hansen · M. A. · Lekodeba · N. A. · Chevalier · J. M. · Ockhuisen · T. · del Rey-Puech · P. · Marban-Castro · E. · Martinez-Perez · G. Z. · Shilton · S. · Radzi Abu Hassan · M. · Getia · V. · Weinert-Mizuschima · C. · Tenorio Bezerra · M. I. · Chala · L. · Leong · R. · Peregino · R. — Abril 17th 2024 at 17:18
Objective

Diagnostic testing is an important tool to combat the COVID-19 pandemic, yet access to and uptake of testing vary widely 3 years into the pandemic. The WHO recommends the use of COVID-19 self-testing as an option to help expand testing access. We aimed to calculate the cost of providing COVID-19 self-testing across countries and distribution modalities.

Design

We estimated economic costs from the provider perspective to calculate the total cost and the cost per self-test kit distributed for three scenarios that differed by costing period (pilot, annual), the number of tests distributed (actual, planned, scaled assuming an epidemic peak) and self-test kit costs (pilot purchase price, 50% reduction).

Setting

We used data collected between August and December 2022 in Brazil, Georgia, Malaysia, Ethiopia and the Philippines from pilot implementation studies designed to provide COVID-19 self-tests in a variety of settings—namely, workplace and healthcare facilities.

Results

Across all five countries, 173 000 kits were distributed during pilot implementation with the cost/test distributed ranging from $2.44 to $12.78. The cost/self-test kit distributed was lowest in the scenario that assumed implementation over a longer period (year), with higher test demand (peak) and a test kit price reduction of 50% ($1.04–3.07). Across all countries and scenarios, test procurement occupied the greatest proportion of costs: 58–87% for countries with off-site self-testing (outside the workplace, for example, home) and 15–50% for countries with on-site self-testing (at the workplace). Staffing was the next key cost driver, particularly for distribution modalities that had on-site self-testing (29–35%) versus off-site self-testing (7–27%).

Conclusions

Our results indicate that it is likely to cost between $2.44 and $12.78 per test to distribute COVID-19 self-tests across common settings in five heterogeneous countries. Cost-effectiveness analyses using these results will allow policymakers to make informed decisions on optimally scaling up COVID-19 self-test distribution programmes across diverse settings and evolving needs.

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