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Analysing the patient experience of COVID‐19: Exploring patients' experiences of hospitalisation and their quality of life post discharge

Abstract

Aims and Objectives

We sought to gain an understanding of the patient experience during their hospital stay for COVID-19, and the impact of COVID-19 on quality of life post discharge.

Background

Symptoms of COVID-19 include a persistent cough, dyspnoea and fatigue. Individuals with comorbidities such as cardiovascular disease have a higher risk of contracting COVID-19 and approximately 20% of those diagnosed with COVID-19 are admitted to hospital. Following discharge from hospital, 40% of patients report a worsened quality of life and up to 87% of those discharged from hospital have experienced ‘long COVID’.

Design

A qualitative design was used to understand patient experience of hospitalisation following a diagnosis of COVID-19, and their experiences following discharge from hospital.

Methods

Ten patients with a previous diagnosis of COVID-19 took part in semi-structured interviews regarding their experiences of hospitalisation and the impact on quality of life post-discharge.

Results

The results identified three key themes from the interviews: communication and the inpatient experience, symptoms following discharge and regaining independence. Patients discussed their experience of hospitalisation and how this continued to impact their emotional well-being post-discharge. However, patients appeared to push themselves physically to improve their health, despite continued COVID-19 symptoms.

Conclusion

Patients hospitalised following a diagnosis of COVID-19 experienced psychological distress during their hospital stay, as well as 3-months post-discharge. We suggest the use of psychosocial interventions to support patients post-discharge.

Relevance to Clinical Practice

The results of this study provide a greater understanding of the patient experience during their hospital stay, which can support nursing staff practice. Additionally, the study provides in depth knowledge of personal experiences of patients diagnosed with COVID-19 and the impact following hospital discharge.

Patient or Public Contribution

Patient's took part in semi-structured interviews via telephone to support the aims and objectives of this study.

Promoting resident thriving in nursing homes: A qualitative study

Abstract

Aim

To explore how staff promote resident thriving in an Australian nursing home.

Design

Qualitative research design using content analysis.

Methods

Interviews were held with 14 nursing staff working in an Australian nursing home in March/April 2018. Data were analysed using qualitative content analysis.

Results

Four themes were revealed: promoting personalized care; promoting opportunities for autonomy; promoting connection and meaning; and promoting a curated environment.

Conclusions

Staff promoted resident thriving in relation to everyday care, activities, capabilities, relationships and the lived environment. Interventions that were perceived to promote thriving were described relative to the nurse, the resident, the care team and the wider nursing home context.

Implications for the Profession and/or Patient Care

The findings provide novel insight into the understanding and application of the concept of thriving in long-term care from nursing staffs' perspective.

Impact

What Problem did the Study Address?

Nursing home staff are uniquely positioned to support resident thriving through person-centred care, yet little is known about how staff support promotion of thriving for nursing home residents in their everyday practice.

What were the Main Findings?

Nursing home staff perceived that they promoted thriving by personalizing care and supporting autonomy, connection, meaning and pleasure for residents.

Where and on Whom will the Research have an Impact?

These findings are of interest for the clinicians, educators and researchers who develop, implement and evaluate interventions to improve place-related well-being in nursing homes.

Reporting Method

CORE-Q checklist.

Patient or Public Contribution

No patient or public contribution occurred for this study as this research focused on exploring staffs' perspectives from the specific viewpoint of their personal experience.

Evaluation of different screening tools for detection of malnutrition in hospitalised patients

Abstract

Aims and Objectives

To assess the prevalence of malnutrition in hospitalised adult patients, and to evaluate the accuracy of the most commonly used nutritional screening tools for identifying individuals at risk of malnutrition.

Methods

A prospective cross-sectional study was conducted on a total of 248 hospitalised patients in internal medicine wards (mean age: 75.2 years; 39.5% females). Nutritional screening was performed within 48 h of admission using the following tools: Malnutrition Universal Screening Tool (MUST), Nutrition Risk Screening Tool (NRS-2002), Malnutrition Screening Tool (MST), Short Nutritional Assessment Questionnaire (SNAQ), and Mini Nutritional Assessment Short Form (MNA-SF). The criteria of the European Society for Clinical Nutrition and Metabolism (ESPEN) were used as the gold standard for defining malnutrition. Patients were also evaluated using the Subjective Global Assessment (SGA) and the Global Leadership Initiative on Malnutrition (GLIM) criteria. Accuracy was determined by examining sensitivity, specificity, and positive and negative predictive values, and diagnostic agreement was determined by calculation of Cohen's kappa (κ). The study is reported as per the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.

Results

The ESPEN criteria classified 20.2% of the hospitalised patients as malnourished. Overall, the MUST had the highest sensitivity (80.0%), specificity (74.7%) and positive predictive value (44.4%). For the subgroup of patients aged >65 years, the MNA-SF had high sensitivity (94.4%) but low specificity (39.0%). Based on Cohen's κ, the SGA and GLIM criteria showed low agreement with the ESPEN criteria.

Conclusion

The MUST was the most accurate nutritional screening tool, through the MST is more easily applied in many clinical settings. A comprehensive assessment of malnutrition that considers muscle mass is crucial for the reliable diagnosis of malnutrition.

Implications for the profession and/or patient care

The present findings underscore the importance of accurate assessment of the malnutrition status of hospitalised patients and the need for a reliable screening tool.

No patient or public contribution.

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.

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

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.

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.

Evaluation of nurse‐reported missed care in a post‐anesthesia care unit: A mixed‐methods study

Abstract

Background

Nurse-reported missed care (NRMC) is considered as any significant delay or omission in provision of nursing care.

Aim

(i) Evaluate the frequency, types, and reasons for NRMC in the Post-anesthesia Care Unit (PACU). (ii) Evaluate associations between nurse demographic and workload factors with NRMC. (iii) Explore nurses' perception of NRMC in the PACU.

Methods

A cross-sectional study was conducted in the PACU in a tertiary acute care hospital over 3 months. Full-time PACU nurses were conveniently sampled to complete an anonymous survey after their daily shift over different shifts. It contained three sections: (i) nurse demographics; (ii) elements of NRMC; and (iii) reasons for NRMC. Qualitative interviews employed a semi-structured guide to explore perceptions and experiences of NRMC. Descriptive, inferential statistics, and thematic analyses were applied.

Results

Sixty-six survey responses were collected. 48.5% of respondents indicated at least one NRMC activity. Activities more clinically sensitive were less missed. Eight nurses were interviewed. Four main themes were identified: (i) communication with patients; (ii) communication and teamwork with colleagues; (iii) dual role of documentation; and (iv) staffing inadequacy. Language barriers made communication challenging. Staff shortage exacerbates workload but effective teamwork and documentation facilitates nursing care.

Conclusion

Communication and staffing concerns aggravate NRMC. Teamwork and personal contentment were satisfactory. Nurses' turnover intention may worsen staffing.

Clinical Relevance

Timeliness and quality of nursing care is impacted by elements such as manpower, allocation of resources, work processes, and workplace environmental or interpersonal factors such as culture and language fit. Re-evaluation of nursing resources and work processes may assist post-anesthesia care unit nurses in fulfilling their role, decreasing the prevalence of nurse-reported missed care.

Short-duration aerobic high-intensity intervals versus moderate exercise training intensity in patients with peripheral artery disease: study protocol for a randomised controlled trial (the Angiof-HIIT Study)

Por: Lanzi · S. · Pousaz · A. · Fresa · M. · Besson · C. · Desgraz · B. · Gremeaux-Bader · V. · Mazzolai · L.
Introduction

Supervised exercise training is among the first-line therapies for patients with peripheral artery disease (PAD). Current recommendations for exercise include guidance focusing on claudication pain, programme and session duration, and frequency. However, no guidance is offered regarding exercise training intensity. This study aims to compare the effects of 12-week-long supervised walking exercise training (high-intensity interval training (HIIT) vs moderate-intensity exercise (MOD)) in patients with chronic symptomatic PAD.

Methods and analysis

This study is a monocentric, interventional, non-blinded randomised controlled trial. 60 patients (30 in each group) will be randomly allocated (by using the random permuted blocks) to 12 weeks (three times a week) of HIIT or MOD. For HIIT, exercise sessions will consist of alternating brief high-intensity (≥85% of the peak heart rate (HRpeak)) periods (≤60 s) of work with periods of passive rest. Patients will be asked to complete 1 and then 2 sets of 5–7 (progressing to 10–15x60 s) walking intervals. For the MOD group, exercise training sessions will consist of an alternation of periods of work performed at moderate intensity (≤76% HRpeak) and periods of passive rest. Interventions will be matched by training load. The primary outcome will be the maximal walking distance. Secondary outcomes will include functional performance, functional capacity, heath-related quality of life, self-perceived walking abilities, physical activity and haemodynamic parameters.

Ethics and dissemination

The Angiof-HIIT Study was approved by the Human Research Ethics Committee of the Canton de Vaud (study number: 2022-01752). Written consent is mandatory prior to enrolment and randomisation. The results will be disseminated via national and international scientific meetings, scientific peer-reviewed journals and social media.

Trial registration number

NCT05612945.

Restrictive use of Restraints and Delirium Duration in the Intensive Care Unit (R2D2-ICU): protocol for a French multicentre parallel-group open-label randomised controlled trial

Por: Sonneville · R. · Couffignal · C. · Sigaud · F. · Godard · V. · Audibert · J. · Contou · D. · Celier · A. · Djibre · M. · Schmidt · J. · Jaquet · P. · Mekontso Dessap · A. · Bourel · C. · Bellot · R. · Roy · C. · Lamara · F. · Essardy · F. · Timsit · J.-F. · Cornic · R. · Bouadma · L. · On b
Introduction

Physical restraint (PR) is prescribed in patients receiving invasive mechanical ventilation in the intensive care unit (ICU) to avoid unplanned removal of medical devices. However, it is associated with an increased risk of delirium. We hypothesise that a restrictive use of PR, as compared with a systematic use, could reduce the duration of delirium in ICU patients receiving invasive mechanical ventilation.

Methods and analysis

The Restrictive use of Restraints and Delirium Duration in ICU (R2D2-ICU) study is a national multicentric, parallel-group, randomised (1:1) open-label, controlled, superiority trial, which will be conducted in 10 ICUs. A total of 422 adult patients requiring invasive mechanical ventilation for an expected duration of at least 48 hours and eligible for prescription of PR will be randomly allocated within 6 hours from intubation to either the restrictive PR use group or the systematic PR use group, until day 14, ICU discharge or death, whichever comes first. In both groups, PR will consist of the use of wrist straps. The primary endpoint will be delirium or coma-free days, defined as the number of days spent alive in the ICU without coma or delirium within the first 14 days after randomisation. Delirium will be assessed using the Confusion Assessment Method-ICU twice daily. Key secondary endpoints will encompass agitation episodes, opioid, propofol, benzodiazepine and antipsychotic drug exposure during the 14-day intervention period, along with a core outcome set of measures evaluated 90 days postrandomisation.

Ethics and dissemination

The R2D2-ICU study has been approved by the Comité de Protection des Personnes (CPP) ILE DE FRANCE III—PARIS (CPP19.09.06.37521) on June 10th, 2019). Participant recruitment started on 25 January 2021. Results will be published in international peer-reviewed medical journals and presented at conferences.

Trial registration number

NCT04273360.

Impact of supplementation with iron-folic acid (IFA) and vitamin D3 compared with IFA alone on haemoglobin levels in elderly people with mild-to-moderate anaemia: protocol for the double-blind, randomised, placebo-controlled Iron and vitamin D trial in El

Por: Ahamed · F. · Jaiswal · A. · Sahoo · S. · Ghosh · T. · Kaur · A. · Rehman · T. · Goswami · K.
Introduction

Anaemia in the elderly is often difficult to treat with iron supplementation alone as prevalence of anaemia of chronic disease (ACD) alone or mixed with iron-deficiency anaemia (IDA) is high in this age group. Hepcidin remains high in ACD, preventing utilisation of iron for heme synthesis. Vitamin D3 has shown hepcidin suppression activity in both in vitro and in vivo studies. As there is no study assessing the effect of iron–folic acid (IFA) with vitamin D3 on haemoglobin levels in the elderly in India, we want to conduct this study to estimate the impact of supplementation of a therapeutic package of IFA and vitamin D3 on haemoglobin levels in the elderly with mild-to-moderate anaemia in comparison with IFA only. The study will also assess the impact of the proposed intervention on ferritin, hepcidin, 25-hydroxyvitamin D, C reactive protein (CRP) and parathyroid hormone (PTH) levels.

Methods and analysis

This study is a community-based, double-blind, placebo-controlled, randomised trial. The study will be done in the Kalyani municipality area. Individuals aged ≥60 years with mild-to-moderate anaemia and normal vitamin D3 levels will be randomised into the intervention (IFA and vitamin D3 supplementation) group or the control group (IFA and olive oil as placebo). All medications will be self-administered. Follow-up will be done on a weekly basis for 12 weeks. The calculated sample size is 150 in each arm. Block randomisation will be done. The primary outcome is change in haemoglobin levels from baseline to 12 weeks. Secondary outcome is change in serum ferritin, 25-hydroxyvitamin D, hepcidin, CRP and PTH levels from baseline to 12 weeks.

Ethics and dissemination

Ethical approval from the Institutional Ethics Committee of All India Institute of Medical Sciences Kalyani has been obtained (IEC/AIIMS/Kalyani/Meeting/2022/03). Written informed consent will be obtained from each study participant. The trial results will be reported through publication in a reputable journal and disseminated through health talks within the communities.

Trial registration number

CTRI/2022/05/042775.

Protocol version

Version 1.0.

Rationale and protocol for a prospective cohort study of respiratory viral infections in patients admitted from emergency departments of community hospitals: Effect of respiratory Virus infection on EmeRgencY admission (EVERY) study

Por: Morimoto · T. · Morikawa · T. · Imura · H. · Nezu · M. · Hamazaki · K. · Sakuma · M. · Chaumont · A. · Moitinho de Almeida · M. · Moreno · V. P. · Ho · Y. · Harrington · L. · Matsuki · T. · Nakamura · T.
Introduction

Respiratory syncytial virus (RSV) is a causative virus for the common cold worldwide and can result in hospitalisations and even death in patients with high-risk conditions and older adults. However, the relationship between RSV or other incidental respiratory infections and acute exacerbations of underlying conditions has not been well investigated. The primary objective of this study is to estimate RSV prevalence, risk factors for adverse outcomes or hospitalisation and their effect on the hospital course of patients with acute respiratory symptoms admitted from emergency departments. Furthermore, we evaluate the prevalence of other respiratory viruses associated with respiratory symptoms.

Methods and analysis

We are conducting a multicentre prospective cohort study in Japan. We plan to enrol 3000 consecutive patients admitted from emergency departments with acute respiratory symptoms or signs from 1 July 2023 to 30 June 2024. A nasopharyngeal swab is obtained within 24 hours of admission and the prevalence of RSV and other respiratory viruses is measured using the FilmArray Respiratory 2.1 panel. Paired serum samples are collected from patients with suspected lower respiratory infections to measure RSV antibodies at admission and 30 days later. Information on patients’ hospital course is retrieved from the electronic medical records at discharge, death or 30 days after admission. Furthermore, information on readmission to the hospital and all-cause mortality is collected 180 days after admission. We assess the differences in clinical outcomes between patients with RSV or other respiratory viruses and those without, adjusting for baseline characteristics. Clinical outcomes include in-hospital mortality, length of hospital stay, disease progression, laboratory tests and management of respiratory symptoms or underlying conditions.

Ethics and dissemination

The study protocol was approved by the institutional review boards of participating hospitals. Our study reports will be published in academic journals as well as international meetings.

Trial registration number

NCT05913700.

Chronic disease prevention and screening outcomes for patients with and without financial difficulty: a secondary analysis of the BETTER WISE cluster randomised controlled trial

Por: Aubrey-Bassler · K. · Patel · D. · Fernandes · C. · Lofters · A. K. · Campbell-Scherer · D. · Meaney · C. · Moineddin · R. · Wong · T. · Pinto · A. D. · Shea-Budgell · M. · McBrien · K. · Grunfeld · E. · Manca · D. P.
Objective

Building on Existing Tools To improvE chronic disease pRevention and screening in primary care Wellness of cancer survIvorS and patiEnts (BETTER WISE) was designed to assess the effectiveness of a cancer and chronic disease prevention and screening (CCDPS) programme. Here, we compare outcomes in participants living with and without financial difficulty.

Design

Secondary analysis of a cluster-randomised controlled trial.

Setting

Patients of 59 physicians from 13 clinics enrolled between September 2018 and August 2019.

Participants

596 of 1005 trial participants who responded to a financial difficulty screening question at enrolment.

Intervention

1-hour CCDPS visit versus usual care.

Outcome measures

Eligibility for a possible 24 CCDPS actions was assessed at baseline and the primary outcome was the percentage of eligible items that were completed at 12-month follow-up. We also compared the change in response to the financial difficulty screening question between baseline and follow-up.

Results

55 of 265 participants (20.7%) in the control group and 69 of 331 participants (20.8%) in the intervention group reported living with financial difficulty. The primary outcome was 29% (95% CI 26% to 33%) for intervention and 23% (95% CI 21% to 26%) for control participants without financial difficulty (p=0.01). Intervention and control participants with financial difficulty scored 28% (95% CI 24% to 32%) and 32% (95% CI 27% to 38%), respectively (p=0.14). In participants who responded to the financial difficulty question at both time points (n=302), there was a net decrease in the percentage of participants who reported financial difficulty between baseline (21%) and follow-up (12%, p

Conclusion

The BETTER intervention improved uptake of CCDPS manoeuvres in participants without financial difficulty, but not in those living with financial difficulty. Improving CCDPS for people living with financial difficulty may require a different clinical approach or that social determinants be addressed concurrently with clinical and lifestyle needs or both.

Trial registration number

ISRCTN21333761.

Study protocol: improving response to malaria in the Amazon through identification of inter-community networks and human mobility in border regions of Ecuador, Peru and Brazil

Por: Janko · M. M. · Araujo · A. L. · Ascencio · E. J. · Guedes · G. R. · Vasco · L. E. · Santos · R. O. · Damasceno · C. P. · Medrano · P. G. · Chacon-Uscamaita · P. R. · Gunderson · A. K. · OMalley · S. · Kansara · P. H. · Narvaez · M. B. · Coombes · C. · Pizzitutti · F. · Salmon-Mulano
Introduction

Understanding human mobility’s role in malaria transmission is critical to successful control and elimination. However, common approaches to measuring mobility are ill-equipped for remote regions such as the Amazon. This study develops a network survey to quantify the effect of community connectivity and mobility on malaria transmission.

Methods

We measure community connectivity across the study area using a respondent driven sampling design among key informants who are at least 18 years of age. 45 initial communities will be selected: 10 in Brazil, 10 in Ecuador and 25 in Peru. Participants will be recruited in each initial node and administered a survey to obtain data on each community’s mobility patterns. Survey responses will be ranked and the 2–3 most connected communities will then be selected and surveyed. This process will be repeated for a third round of data collection. Community network matrices will be linked with each country’s malaria surveillance system to test the effects of mobility on disease risk.

Ethics and dissemination

This study protocol has been approved by the institutional review boards of Duke University (USA), Universidad San Francisco de Quito (Ecuador), Universidad Peruana Cayetano Heredia (Peru) and Universidade Federal Minas Gerais (Brazil). Results will be disseminated in communities by the end of the study.

Artificial intelligence-based prediction of diabetic retinopathy evolution (EviRed): protocol for a prospective cohort

Por: Tadayoni · R. · Massin · P. · Bonnin · S. · Magazzeni · S. · Lay · B. · Le Guilcher · A. · Vicaut · E. · Couturier · A. · Quellec · G. · Investigators · E.
Introduction

An important obstacle in the fight against diabetic retinopathy (DR) is the use of a classification system based on old imaging techniques and insufficient data to accurately predict its evolution. New imaging techniques generate new valuable data, but we lack an adapted classification based on these data. The main objective of the Evaluation Intelligente de la Rétinopathie Diabétique, Intelligent evaluation of DR (EviRed) project is to develop and validate a system assisting the ophthalmologist in decision-making during DR follow-up by improving the prediction of its evolution.

Methods and analysis

A cohort of up to 5000 patients with diabetes will be recruited from 18 diabetology departments and 14 ophthalmology departments, in public or private hospitals in France and followed for an average of 2 years. Each year, systemic health data as well as ophthalmological data will be collected. Both eyes will be imaged by using different imaging modalities including widefield photography, optical coherence tomography (OCT) and OCT-angiography. The EviRed cohort will be divided into two groups: one group will be randomly selected in each stratum during the inclusion period to be representative of the general diabetic population. Their data will be used for validating the algorithms (validation cohort). The data for the remaining patients (training cohort) will be used to train the algorithms.

Ethics and dissemination

The study protocol was approved by the French South-West and Overseas Ethics Committee 4 on 28 August 2020 (CPP2020-07-060b/2020-A01725-34/20.06.16.41433). Prior to the start of the study, each patient will provide a written informed consent documenting his or her agreement to participate in the clinical trial. Results of this research will be disseminated in peer-reviewed publications and conference presentations. The database will also be available for further study or development that could benefit patients.

Trial registration number

NCT04624737

The role of orthobiologics in chronic wound healing

Abstract

Chronic wounds, characterized by prolonged healing processes, pose a significant medical challenge with multifaceted aetiologies, including local and systemic factors. Here, it explores the complex pathogenesis of chronic wounds, emphasizing the disruption in the normal phases of wound healing, particularly the inflammatory phase, leading to an imbalance in extracellular matrix (ECM) dynamics and persistent inflammation. Senescent cell populations further contribute to impaired wound healing in chronic lesions. Traditional medical management focuses on addressing underlying causes, but many chronic wounds resist to conventional treatments, necessitating innovative approaches. Recent attention has turned to autologous orthobiologics, such as platelet-rich plasma (PRP), platelet-rich fibrin (PRF) and mesenchymal stem cells (MSCs), as potential regenerative interventions. These biologically derived materials, including bone marrow aspirate/concentrate (BMA/BMAC) and adipose tissue-derived stem cells (ADSCs), exhibit promising cytokine content and regenerative potential. MSCs, in particular, have emerged as key players in wound healing, influencing inflammation and promoting tissue regeneration. This paper reviews relevant scientific literature regarding basic science and brings real-world evidence regarding the use of orthobiologics in the treatment of chronic wounds, irrespective of aetiology. The discussion highlights the regenerative properties of PRP, PRF, BMA, BMAC and SVF, showcasing their potential to enhance wound healing. Despite advancements, further research is essential to elucidate the specific roles of each orthobiologic and determine optimal applications for different wound types. The conclusion underscores the evolving landscape in chronic wound management, with a call for more comprehensive studies to refine treatment strategies and maximize the benefits of regenerative medicine.

A purified reconstituted bilayer matrix shows improved outcomes in treatment of non‐healing diabetic foot ulcers when compared to the standard of care: Final results and analysis of a prospective, randomized, controlled, multi‐centre clinical trial

Abstract

As the incidence of diabetic foot ulcers (DFU) increases, better treatments that improve healing should reduce complications of these ulcers including infections and amputations. We conducted a randomized controlled trial comparing outcomes between a novel purified reconstituted bilayer membrane (PRBM) to the standard of care (SOC) in the treatment of non-healing DFUs. This study included 105 patients who were randomized to either of two treatment groups (n = 54 PRBM; n = 51 SOC) in the intent to treat (ITT) group and 80 who completed the study per protocol (PP) (n = 47 PRBM; n = 33 SOC). The primary endpoint was the percentage of wounds closed after 12 weeks. Secondary outcomes included percent area reduction, time to healing, quality of life, and cost to closure. The DFUs that had been treated with PRBM healed at a higher rate than those treated with SOC (ITT: 83% vs. 45%, p = 0.00004, PP: 92% vs. 67%, p = 0.005). Wounds treated with PRBM also healed significantly faster than those treated with SOC with a mean of 42 versus 62 days for SOC (p = 0.00074) and achieved a mean wound area reduction within 12 weeks of 94% versus 51% for SOC (p = 0.0023). There were no adverse events or serious adverse events that were related to either the PRBM or the SOC. In comparison to the SOC, DFUs healed faster when treated with PRBM. Thus, the use of this PRBM is an effective option for the treatment of chronic DFUs.

Do patients with type 2 diabetes mellitus included in randomised clinical trials differ from general-practice patients? A cross-sectional comparative study

Por: Dugard · A. · Giraudeau · B. · Dibao-Dina · C.
Objectives

To compare the characteristics of patients with type 2 diabetes mellitus in general practice and those included in randomised controlled trials on which clinical practice guidelines are based.

Design

Cross-sectional comparative study.

Setting

We asked 45 general practitioners from three French Departments to identify the 15 patients with type 2 diabetes mellitus they most recently saw in consultation. In parallel, we selected randomised controlled trials included in the Cochrane systematic review on which the clinical practice guidelines for type 2 diabetes mellitus were based.

Participants

We included 675 patients with type 2 diabetes mellitus, and data were collected from 23 randomised controlled trials, corresponding to 36 059 patients.

Outcome measures

Characteristics of general-practice patients were extracted from medical records by a unique observer. The same baseline characteristics of patients included in randomised controlled trials from the Cochrane systematic review were extracted and meta-analysed. We assessed standardised differences between these two series of baseline characteristics. A difference greater than 0.10 in absolute value was considered meaningful.

Results

General-practice patients were older than randomised controlled trial patients (mean (SD) 68.8 (1.1) vs 59.9 years (standardised difference 0.8)) and had a higher body mass index (mean (SD) 31.5 (6.9) vs 28.2 kg/m2 (standardised difference 0.5)) but smoked less (11.0% vs 29.3% (standardised difference –0.6)). They more frequently used antihypertensive drugs (82.1% vs 37.5% (standardised difference 1.2)) but less frequently had a myocardial infarction (7.6% vs 23.1% (standardised difference –1.1)).

Conclusions

Patients with type 2 diabetes mellitus cared for in general practice differ in a number of important aspects from patients included in randomised controlled trials on which clinical practice guidelines are based. This situation hampers the applicability of these guidelines. Future randomised trials should include patients who better fit the ‘average’ general-practice patient with type 2 diabetes mellitus to help improve the translation of study findings in daily practice.

Robustness of radiomic features in <sup>123</sup>I-ioflupane-dopamine transporter single-photon emission computer tomography scan

by Viktor Laskov, David Rothbauer, Hana Malikova

Radiomic features are usually used to predict target variables such as the absence or presence of a disease, treatment response, or time to symptom progression. One of the potential clinical applications is in patients with Parkinson’s disease. Robust radiomic features for this specific imaging method have not yet been identified, which is necessary for proper feature selection. Thus, we are assessing the robustness of radiomic features in dopamine transporter imaging (DaT). For this study, we made an anthropomorphic head phantom with tissue heterogeneity using a personal 3D printer (polylactide 82% infill); the bone was subsequently reproduced with plaster. A surgical cotton ball with radiotracer (123I-ioflupane) was inserted. Scans were performed on the two-detector hybrid camera with acquisition parameters corresponding to international guidelines for DaT single photon emission tomography (SPECT). Reconstruction of SPECT was performed on a clinical workstation with iterative algorithms. Open-source LifeX software was used to extract 134 radiomic features. Statistical analysis was made in RStudio using the intraclass correlation coefficient (ICC) and coefficient of variation (COV). Overall, radiomic features in different reconstruction parameters showed a moderate reproducibility rate (ICC = 0.636, p 0.9, p

Using explainable AI to investigate electrocardiogram changes during healthy aging—From expert features to raw signals

by Gabriel Ott, Yannik Schaubelt, Juan Miguel Lopez Alcaraz, Wilhelm Haverkamp, Nils Strodthoff

Cardiovascular diseases remain the leading global cause of mortality. Age is an important covariate whose effect is most easily investigated in a healthy cohort to properly distinguish the former from disease-related changes. Traditionally, most of such insights have been drawn from the analysis of electrocardiogram (ECG) feature changes in individuals as they age. However, these features, while informative, may potentially obscure underlying data relationships. In this paper we present the following contributions: (1) We employ a deep-learning model and a tree-based model to analyze ECG data from a robust dataset of healthy individuals across varying ages in both raw signals and ECG feature format. (2) We use explainable AI methods to identify the most discriminative ECG features across age groups.(3) Our analysis with tree-based classifiers reveals age-related declines in inferred breathing rates and identifies notably high SDANN values as indicative of elderly individuals, distinguishing them from younger adults. (4) Furthermore, the deep-learning model underscores the pivotal role of the P-wave in age predictions across all age groups, suggesting potential changes in the distribution of different P-wave types with age. These findings shed new light on age-related ECG changes, offering insights that transcend traditional feature-based approaches.
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