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De-imFAR phase II project: a study protocol for a cluster randomised implementation trial to evaluate the effectiveness of de-implementation strategies to reduce low-value statin prescribing in the primary prevention of cardiovascular disease

Por: Sanchez · A. · Pijoan · J. I. · Sainz de Rozas · R. · Lekue · I. · San Vicente · R. · Quindimil · J. A. · Rotaeche · R. · Etxeberria · A. · Mozo · C. · Martinez-Cengotitabengoa · M. · Monge · M. · Gomez-Ramirez · C. · Samper · R. · Ogueta Lana · M. · Celorrio · S. · Merino-Inda · N.
Introduction

This study aims to reduce potentially inappropriate prescribing (PIP) of statins and foster healthy lifestyle promotion in cardiovascular disease (CVD) primary prevention in low-risk patients. To this end, we will compare the effectiveness and feasibility of several de-implementation strategies developed following the structured design process of the Behaviour Change Wheel targeting key determinants of the clinical decision-making process in CVD prevention.

Methods and analysis

A cluster randomised implementation trial, with an additional control group, will be launched, involving family physicians (FPs) from 13 Integrated Healthcare Organisations (IHOs) of Osakidetza-Basque Health Service with non-zero incidence rates of PIP of statins in 2021. All FPs will be exposed to a non-reflective decision assistance strategy based on reminders and decision support tools. Additionally, FPs from two of the IHOs will be randomly assigned to one of two increasingly intensive de-implementation strategies: adding a decision information strategy based on knowledge dissemination and a reflective decision structure strategy through audit/feedback. The target population comprises women aged 45–74 years and men aged 40–74 years with moderately elevated cholesterol levels but no diagnosed CVD and low cardiovascular risk (REGICOR

Ethics and dissemination

The study was approved by the Basque Country Clinical Research Ethics Committee and was registered in ClinicalTrials.gov (NCT04022850). Results will be disseminated in scientific peer-reviewed journals.

Trial registration number

NCT04022850.

Professionals perspectives on interventions to reduce problematic alcohol use in older adults: a realist evaluation of working elements

Por: van den Bulck · F. A. E. · Knijff · R. · Crutzen · R. · van de Mheen · D. · Bovens · R. H. L. M. · Stutterheim · S. E. · Van de Goor · I. · Rozema · A. D.
Objectives

This study set out to understand how (which elements), in what context and why (which mechanisms) interventions are successful in reducing (problematic) alcohol use among older adults, from the perspective of professionals providing these interventions.

Design

Guided by a realist evaluation approach, an existing initial programme theory (IPT) on working elements in alcohol interventions was evaluated by conducting semistructured interviews with professionals.

Setting and participants

These professionals (N=20) provide interventions across several contexts: with or without practitioner involvement; in-person or not and in an individual or group setting. Data were coded and links between contexts, elements, mechanisms and outcomes were sought for to confirm, refute or refine the IPT.

Results

From the perspective of professionals, there are several general working elements in interventions for older adults: (1) pointing out risks and consequences of drinking behaviour; (2) paying attention to abstinence; (3) promoting contact with peers; (4) providing personalised content and (5) providing support. We also found context-specific working elements: (1) providing personalised conversations and motivational interviewing with practitioners; (2) ensuring safety, trust and a sense of connection and a location nearby home or a location that people are familiar with in person and (3) sharing experiences and tips in group interventions. Furthermore, the mechanisms awareness and accessible and low threshold participation were important contributors to positive intervention outcomes.

Conclusion

In addition to the IPT, our findings emphasise the need for social contact and support, personalised content, and strong relationships (both between client and practitioner, and client and peers) in interventions for older adults.

Factors influencing pregnancy care and institutional delivery in rural Mali: a secondary baseline analysis of a cluster-randomised trial

Por: Ghosh · R. · Konipo · A. · Treleaven · E. · Rozenshteyn · S. · Beckerman · J. · Whidden · C. · Johnson · A. · Kayentao · K. · Liu · J.
Objective

The vast majority of the 300 000 pregnancy-related deaths every year occur in South Asia and sub-Saharan Africa. Increased access to quality antepartum and intrapartum care can reduce pregnancy-related morbidity and mortality worldwide. We used a population-based cross-sectional cohort design to: (1) examine the sociodemographic risk factors and structural barriers associated with pregnancy care-seeking and institutional delivery, and (2) investigate the influence of residential distance to the nearest primary health facility in a rural population in Mali.

Methods

A baseline household survey of Malian women aged 15–49 years was conducted between December 2016 and January 2017, and those who delivereda baby in the 5 years preceding the survey were included. This study leverages the baseline survey data from a cluster-randomised controlled trial to conduct a secondary analysis. The outcomes were percentage of women who received any antenatal care (ANC) and institutional delivery; total number of ANC visits; four or more ANC visits; first ANC visit in the first trimester.

Results

Of the 8575 women in the study, two-thirds received any ANC in their last pregnancy, one in 10 had four or more ANC visits and among those that received any ANC, about one-quarter received it in the first trimester. For every kilometre increase in distance to the nearest facility, the likelihood of the outcomes reduced by 5 percentage points (0.95; 95% CI 0.91 to 0.98) for any ANC; 4 percentage points (0.96; 95% CI 0.94 to 0.98) for an additional ANC visit; 10 percentage points (0.90; 95% CI 0.86 to 0.95) for four or more ANC visits; 6 percentage points (0.94; 95% CI 0.94 to 0.98) for first ANC in the first trimester. In addition, there was a 35 percentage points (0.65; 95% CI 0.56 to 0.76) decrease in likelihood of institutional delivery if the residence was within 6.5 km to the nearest facility, beyond which there was no association with the place of delivery. We also found evidence of increase in likelihood of receiving any ANC care and its intensity increased with having some education or owning a business.

Conclusion

The findings suggest that education, occupation and distance are important determinants of pregnancy and delivery care in a rural Malian context.

Trial registration number

NCT02694055.

Beliefs and practices of the nursing team related to pressure injury preventive measures: A analysis of social representations

Abstract

Aims and Objectives

To analyse the process of elaborating social representations about pressure injury preventive measures by the nursing team (nurses and nurse technicians) and how this process relates to preventive practices for hospitalized patients.

Design

Qualitative study, with the application of the theory of social representations in its procedural methodological approach.

Methods

The study was carried out in an inpatient clinic of a public hospital in the state of Rondônia, Brazil. Totally, 28 nursing professionals in the medical clinic sectors who had worked directly with patient care for more than 6 months participated. The data were collected between July and September 2021 via in-depth interviews with the application of a semi-structured instrument. Analysis was carried out with the help of ALCESTE software, which performed a lexicographic analysis, and also via thematic analysis. The COREQ guided the presentation of the research report.

Results

The social representations were developed based on the professionals' symbolic beliefs about the visibility/invisibility of the results of applying preventive care. These symbolic constructions mobilized positive and negative feelings among the nursing team, which guided the classification of prevention practices as being of greater or lesser priority among other care activities. There were favourable attitudes among professionals, which included applying prevention measures in their daily routines, and unfavourable attitudes of non-adherence to the institution's protocol for preventing pressure injuries.

Conclusions

The nursing team's perception of pressure injury prevention is influenced by symbolic, affective, values, and social dimensions. Non-adherence behaviours are attributed to the belief in the invisibility of prevention outcomes, resulting in a reluctance to implement preventive measures.

Relevance to Clinical Practice

Understanding the subjective logic that explains the thinking and actions of the nursing team suggests the need to incorporate discussions on beliefs, values, sentiments, and attitudes of nursing professionals into educational programs on pressure injury prevention.

Patient or Public Contribution

No public contribution.

Protocol for venoarterial ExtraCorporeal Membrane Oxygenation to reduce morbidity and mortality following bilateral lung TransPlantation: the ECMOToP randomised controlled trial

Por: Messika · J. · Eloy · P. · Boulate · D. · Charvet · A. · Fessler · J. · Jougon · J. · Lacoste · P. · Mercier · O. · Portran · P. · Roze · H. · Sage · E. · Thes · J. · Tronc · F. · Vourc'h · M. · Montravers · P. · Castier · Y. · Mal · H. · Mordant · P. · Investigators from the ECMOToP Study
Introduction

Lung transplantation (LTx) aims at improving survival and quality of life for patients with end-stage lung diseases. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is used as intraoperative support for LTx, despite no precise guidelines for its initiation. We aim to evaluate two strategies of VA-ECMO initiation in the perioperative period in patients with obstructive or restrictive lung disease requiring bilateral LTx. In the control ‘on-demand’ arm, high haemodynamic and respiratory needs will dictate VA-ECMO initiation; in the experimental ‘systematic’ arm, VA-ECMO will be pre-emptively initiated. We hypothesise a ‘systematic’ strategy will increase the number of ventilatory-free days at day 28.

Methods and analysis

We designed a multicentre randomised controlled trial in parallel groups. Adult patients with obstructive or restrictive lung disease requiring bilateral LTx, without a formal indication for pre-emptive VA-ECMO before LTx, will be included. Patients with preoperative pulmonary hypertension with haemodynamic collapse, ECMO as a bridge to transplantation, severe hypoxaemia or hypercarbia will be secondarily excluded. In the systematic group, VA-ECMO will be systematically implanted before the first pulmonary artery cross-clamp. In the on-demand group, VA-ECMO will be implanted intraoperatively if haemodynamic or respiratory indices meet preplanned criteria. Non-inclusion, secondary exclusion and VA-ECMO initiation criteria were validated by a Delphi process among investigators. Postoperative weaning of ECMO and mechanical ventilation will be managed according to best practice guidelines. The number of ventilator-free days at 28 days (primary endpoint) will be compared between the two groups in the intention-to-treat population. Secondary endpoints encompass organ failure occurrence, day 28, day 90 and year 1 vital status, and adverse events.

Ethics and dissemination

The sponsor is the Assistance Publique–Hôpitaux de Paris. The ECMOToP protocol version 2.1 was approved by Comité de Protection des Personnes Ile de France VIII. Results will be published in international peer-reviewed medical journals.

Trial registration number

NCT05664204.

Mobile health biometrics to prescribe immediate remote physical activity for enhancing uptake to cardiac rehabilitation (MOTIVATE-CR+): protocol for a randomised controlled feasibility trial

Por: Crozier · A. · Cocks · M. · Hesketh · K. · Miller · G. · Mcgregor · G. · Thomas · L. · Jones · H.
Introduction

Cardiac rehabilitation (CR) can reduce cardiovascular mortality and improve health-related quality of life. In the United Kingdom, patient uptake of CR remains low (52%), falling well short of the target in the 2019 National Health Service long-term plan (85%). Mobile health (mHealth) technologies, offering biometric data to patients and healthcare professionals, may bridge the gap between supervised exercise and physical activity advice, enabling patients to engage in regular long-term physically active lifestyles. This randomised controlled trial (RCT) will evaluate the feasibility of mHealth technology when incorporated into a structured home-based walking intervention, in people with recent myocardial infarction.

Methods and analysis

This is a feasibility, assessor blinded, parallel group RCT. Participants will be allocated to either CR standard care (control group) or CR standard care+mHealth supported exercise counselling (mHealth intervention group). Feasibility outcomes will include the number of patients approached, screened and eligible; the percentage of patients who decline CR (including reasons for declining), agree to CR and consent to being part of the study; the percentage of patients who enrol in standard CR and reasons for drop out; and the percentage of participants who complete clinical, physical and psychosocial outcomes to identify a suitable primary outcome for a future definitive trial.

Ethics and dissemination

The trial was approved in the UK by the Northwest—Greater Manchester East Research Ethics Committee (22/NW/0301) and is being conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Results will be published in peer-reviewed journals and presented at national and international scientific meetings.

Trial registration numbers

NCT05774587

Implementing adaptive e-learning for newborn care in Tanzania: an observational study of provider engagement and knowledge gains

Por: Meaney · P. A. · Hokororo · A. · Ndosi · H. · Dahlen · A. · Jacob · T. · Mwanga · J. R. · Kalabamu · F. S. · Joyce · C. L. · Mediratta · R. · Rozenfeld · B. · Berg · M. · Smith · Z. H. · Chami · N. · Mkopi · N. · Mwanga · C. · Diocles · E. · Agweyu · A.
Introduction

To improve healthcare provider knowledge of Tanzanian newborn care guidelines, we developed adaptive Essential and Sick Newborn Care (aESNC), an adaptive e-learning environment. The objectives of this study were to (1) assess implementation success with use of in-person support and nudging strategy and (2) describe baseline provider knowledge and metacognition.

Methods

6-month observational study at one zonal hospital and three health centres in Mwanza, Tanzania. To assess implementation success, we used the Reach, Efficacy, Adoption, Implementation and Maintenance framework and to describe baseline provider knowledge and metacognition we used Howell’s conscious-competence model. Additionally, we explored provider characteristics associated with initial learning completion or persistent activity.

Results

aESNC reached 85% (195/231) of providers: 75 medical, 53 nursing and 21 clinical officers; 110 (56%) were at the zonal hospital and 85 (44%) at health centres. Median clinical experience was 4 years (IQR 1–9) and 45 (23%) had previous in-service training for both newborn essential and sick newborn care. Efficacy was 42% (SD ±17%). Providers averaged 78% (SD ±31%) completion of initial learning and 7% (SD ±11%) of refresher assignments. 130 (67%) providers had ≥1 episode of inactivity >30 day, no episodes were due to lack of internet access. Baseline conscious-competence was 53% (IQR: 38%–63%), unconscious-incompetence 32% (IQR: 23%–42%), conscious-incompetence 7% (IQR: 2%–15%), and unconscious-competence 2% (IQR: 0%–3%). Higher baseline conscious-competence (OR 31.6 (95% CI 5.8 to 183.5)) and being a nursing officer (aOR: 5.6 (95% CI 1.8 to 18.1)), compared with medical officer, were associated with initial learning completion or persistent activity.

Conclusion

aESNC reach was high in a population of frontline providers across diverse levels of care in Tanzania. Use of in-person support and nudging increased reach, initial learning and refresher assignment completion, but refresher assignment completion remains low. Providers were often unaware of knowledge gaps, and lower baseline knowledge may decrease initial learning completion or activity. Further study to identify barriers to adaptive e-learning normalisation is needed.

Effectiveness of an adaptive, multifaceted intervention to enhance care for patients with complex multimorbidity in general practice: protocol for a pragmatic cluster randomised controlled trial (the MM600 trial)

Por: Holm · A. · Lyhnebeck · A. B. · Rozing · M. · Buhl · S. F. · Willadsen · T. G. · Prior · A. · Christiansen · A.-K. L. · Kristensen · J. · Andersen · J. S. · Waldorff · F. B. · Siersma · V. · Brodersen · J. B. · Reventlow · S. · The MM600 project team · Prior · Stockmarr · Guassora
Introduction

Patients with complex multimorbidity face a high treatment burden and frequently have low quality of life. General practice is the key organisational setting in terms of offering people with complex multimorbidity integrated, longitudinal, patient-centred care. This protocol describes a pragmatic cluster randomised controlled trial to evaluate the effectiveness of an adaptive, multifaceted intervention in general practice for patients with complex multimorbidity.

Methods and analysis

In this study, 250 recruited general practices will be randomly assigned 1:1 to either the intervention or control group. The eligible population are adult patients with two or more chronic conditions, at least one contact with secondary care within the last year, taking at least five repeat prescription drugs, living independently, who experience significant problems with their life and health due to their multimorbidity. During 2023 and 2024, intervention practices are financially incentivised to provide an extended consultation based on a patient-centred framework to eligible patients. Control practices continue care as usual. The primary outcome is need-based quality of life. Outcomes will be evaluated using linear and logistic regression models, with clustering considered. The analysis will be performed as intention to treat. In addition, a process evaluation will be carried out and reported elsewhere.

Ethics and dissemination

The trial will be conducted in compliance with the protocol, the Helsinki Declaration in its most recent form and good clinical practice recommendations, as well as the regulation for informed consent. The study was submitted to the Danish Capital Region Ethical Committee (ref: H-22041229). As defined by Section 2 of the Danish Act on Research Ethics in Research Projects, this project does not constitute a health research project but is considered a quality improvement project that does not require formal ethical approval. All results from the study (whether positive, negative or inconclusive) will be published in peer-reviewed journals.

Trial registration number

NCT05676541.

Barriers to uptake of cataract surgery among elderly patients in rural China: a cross-sectional study

Por: Ma · X. · Hao · J. · Jan · C. · Wan · Y. · Xie · Y. · Liu · C. · Shi · Y. · Hu · A. · Cao · K. · Congdon · N. · Rozelle · S. · Dong · Z. · Wang · N.
Objective

To investigate factors that differentiate elderly adults in rural China who accept free vision screening and cataract surgery from those who could benefit from vision care but refuse it when offered.

Design

We conducted a population-based, cross-sectional study between October and December 2016. Logistic regression models were used to examine the predictors of accepting free vision screening and cataract surgery.

Setting

Rural communities in Handan, China.

Participants

Adults aged 50 years or older, with presenting visual acuity ≤6/18 in the better seeing eye, suspected by examining ophthalmologist to be due to cataract.

Results

Among 613 persons with cataract identified on a population basis, 596 (97.2%) completed the household survey (mean (SD) age, 71.5 (10.0) years; 79.8% female). A total of 214 persons (35.9%) refused participation, while 382 (64.1%) took part in the vision screening. A total of 193 (50.5%) participants were found eligible for surgery, while 189 (49.5%) were not. Among 99 randomly selected participants who were offered immediate free surgery, surgery was accepted by 77 participants (77.8%) and refused by 22 (22.2%). In the multivariate model, being engaged in income-generating activities (p

Conclusion

Our results suggest that refusal of basic eye examinations may be at least as important a determinant of low surgical rates in rural China as lack of acceptance of surgery itself.

Strategic replacement of soybean meal with local cotton seed meal on growth performance, body composition, and metabolic health status indicators in the major South Asian carp <i>Catla catla</i> for aquaculture

by Muhammad Haroon Aslam, Noor Khan, Mahroze Fatima, Muhammad Afzal Rashid, Simon J. Davies

This study assessed the effect of substituting soybean meal (SBM) with cotton seed meal (CSM) on different biological traits in thaila (Catla catla). Fish (n = 225) with an average initial body weight of 41.53±0.68 g were shifted into hapas (3 (L) x 2 (W) x 1 (D) m) in triplicate (15 fish/replicate). Hapas were divided into five dietary groups: 0CSM, 25CSM, 50CSM, 75CSM, and 100CSM diet treatments were administered diets for a period of 90 days. SBM was replaced by CSM at the levels of 0, 25, 50, 75, and 100%. The results showed that fish survival and growth performance were not affected by the inclusion of CSM in the fish diet up to 50% as a replacement of SBM, but higher replacement levels showed a negative effect. Similarly, body composition and most of the muscle amino acid profiles were not affected significantly (P>0.05) by replacing SBM with CSM. Digestive enzyme activities were significantly (P.05) decreased by increasing the level of CSM in the fish diet. Alanine transaminase (ALT) and aspartate transaminase (AST) levels increased significantly (P.05) with increasing dietary CSM levels, while alkaline phosphatase (ALP) levels remained the same. Malondialdehyde (MDA) and catalase (CAT) activity decreased significantly (P.05), but superoxide dismutase (SOD) activity showed no change. For the intestine, the villus height to villus width ratio and thickness of Tunica muscularis were also better in 25CSM, and their values decreased as the CSM inclusion level increased in the fish diet. In conclusion, SBM could be replaced partially (up to 50%) with CSM without compromising growth performance, whole body proximate composition or immunity of C. catla.

Implementation of a Scalable Online Weight Management Programme in Clinical Settings: Protocol for the PROPS 2.0 Programme (Partnerships for Reducing Overweight and Obesity with Patient-Centered Strategies 2.0)

Por: Cho · J. · Noonan · S. H. · Fay · R. · Apovian · C. M. · McCarthy · A. C. · Blood · A. J. · Samal · L. · Fisher · N. · Orav · J. E. · Plutzky · J. · Block · J. P. · Bates · D. W. · Rozenblum · R. · Tucci · M. · McPartlin · M. · Gordon · W. J. · McManus · K. D. · Morrison-Deutsch · C. · Sci
Introduction

There is an urgent need for scalable strategies for treating overweight and obesity in clinical settings. PROPS 2.0 (Partnerships for Reducing Overweight and Obesity with Patient-Centered Strategies 2.0) aims to adapt and implement the combined intervention from the PROPS Study at scale, in a diverse cross-section of patients and providers.

Methods and analysis

We are implementing PROPS 2.0 across a variety of clinics at Brigham and Women’s Hospital, targeting enrolment of 5000 patients. Providers can refer patients or patients can self-refer. Eligible patients must be ≥20 years old and have a body mass index (BMI) of ≥30 kg/m2 or a BMI of 25–29.9 kg/m2 plus another cardiovascular risk factor or obesity-related condition. After enrolment, patients register for the RestoreHealth online programme/app (HealthFleet Inc.) and participate for 12 months. Patients can engage with the programme and receive personalized feedback from a coach. Patient navigators help to enrol patients, enter updates in the electronic health record, and refer patients to additional resources. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework is guiding the evaluation.

Ethics and dissemination

The Mass General Brigham Human Research Committee approved this protocol. An implementation guide will be created and disseminated, to help other sites adopt the intervention in the future.

Trial registration number

NCT0555925.

Dietary magnesium, C-reactive protein and interleukin-6: The Strong Heart Family Study

by Nandana D. Rao, Rozenn N. Lemaitre, Colleen M. Sitlani, Jason G. Umans, Karin Haack, Veronica Handeland, Ana Navas-Acien, Shelley A. Cole, Lyle G. Best, Amanda M. Fretts

Objectives

To examine the associations of dietary Mg intake with inflammatory biomarkers (C-reactive protein (CRP) and interleukin 6 (IL-6)), and the interaction of dietary Mg intake with single nucleotide polymorphism (SNP) rs3740393, a SNP related to Mg metabolism and transport, on CRP and IL-6 among American Indians (AIs).

Methods

This cross-sectional study included AI participants (n = 1,924) from the Strong Heart Family Study (SHFS). Mg intake from foods and dietary supplements was ascertained using a 119-item Block food frequency questionnaire, CRP and IL-6 were measured from blood, and SNP rs3740393 was genotyped using MetaboChip. Generalized estimating equations were used to examine associations of Mg intake, and the interaction between rs3740393 and dietary Mg, with CRP and IL-6.

Results

Reported Mg intake was not associated with CRP or IL-6, irrespective of genotype. A significant interaction (p-interaction = 0.018) was observed between Mg intake and rs3740393 on IL-6. Among participants with the C/C genotype, for every 1 SD higher in log-Mg, log-IL-6 was 0.04 (95% CI: -0.10 to 0.17) pg/mL higher. Among participants with the C/G genotype, for every 1 SD higher in log-Mg, log-IL-6 was 0.08 (95% CI: -0.21 to 0.05) pg/mL lower, and among participants with the G/G genotype, for every 1 SD higher in log-Mg, log-IL-6 was 0.19 (95% CI: -0.38 to -0.01) pg/mL lower.

Conclusions

Mg intake may be associated with lower IL-6 with increasing dosage of the G allele at rs3740393. Future research is necessary to replicate this finding and examine other Mg-related genes that influence associations of Mg intake with inflammation.

"I thought I was going to die": Experiences of COVID-19 patients managed at home in Uganda

by Susan Nakireka, David Mukunya, Crescent Tumuhaise, Ronald Olum, Edith Namulema, Agnes Napyo, Quraish Serwanja, Prossie Merab Ingabire, Asad Muyinda, Felix Bongomin, Milton Musaba, Vivian Mutaki, Ritah Nantale, Phillip Akunguru, Rozen Ainembabazi, Derrick Nomujuni, William Olwit, Aisha Nakawunde, Specioza Nyiramugisha, Pamela Mwa Aol, Joseph Rujumba, Ian Munabi, Sarah Kiguli

Background

In Uganda, approximately 170,000 confirmed COVID-19 cases and 3,630 deaths have been reported as of January 2023. At the start of the second COVID-19 wave, the Ugandan health system was overwhelmed with a sudden increase in the number of COVID-19 patients who needed care, and the Ministry of Health resorted to home-based isolation and care for patients with mild to moderate disease. Before its rollout, the COVID-19 home-based care strategy had neither been piloted nor tested in Uganda.

Objective

To explore the experiences of COVID-19 patients managed at home in Uganda.

Methods

This was a qualitative study that was conducted to explore the lived experiences of COVID-19 patients managed at home. The study was carried out among patients who presented to three hospitals that were designated for treating COVID-19 patients in Uganda. COVID-19 patients diagnosed at these hospitals and managed at home were followed up and contacted for in-depth telephone interviews. The data were analysed using thematic content analysis with the aid of NVIVO 12.0.0 (QRS International, Cambridge, MA).

Results

Participants experienced feelings of fear and anxiety: fear of death, fear of losing jobs, fear of infecting loved ones and fear of adverse events such as loss of libido. Participants also reported feelings of loneliness, hopelessness and depression on top of the debilitating and sometimes worsening symptoms. In addition to conventional medicines, participants took various kinds of home remedies and herbal concoctions to alleviate their symptoms. Furthermore, COVID-19 care resulted in a high economic burden, which persisted after the COVID-19 illness. Stigma was a major theme reported by participants. Participants recommended that COVID-19 care should include counselling before testing and during and after the illness to combat the fear and stigma associated with the diagnosis. Another recommendation was that health workers should carry out home visits to patients undergoing home-based care and that COVID-19 treatment should be free of charge.

Conclusion

COVID-19 home-based care was associated with fear, anxiety, loneliness, depression, economic loss and stigma. Policymakers should consider various home-based follow-up strategies and strengthen counselling of COVID-19 patients at all stages of care.

Effectiveness of a government-led, multiarm intervention on early childhood development and caregiver mental health: a study protocol for a factorial cluster-randomised trial in rural China

Por: Jiang · Q. · Wang · B. · Qian · Y. · Emmers · D. · Li · S. · Pappas · L. · Tsai · E. · Sun · L. · Singh · M. · Fernald · L. · Rozelle · S.
Introduction

The high incidences of both the developmental delay among young children and the mental health problems of their caregivers are major threats to public health in low-income and middle-income countries. Parental training interventions during early childhood have been shown to benefit early development, yet evidence on strategies to promote caregiver mental health remains limited. In addition, evidence on the optimal design of scalable interventions that integrate early child development and maternal mental health components is scarce.

Methods and analysis

We design a single-blind, factorial, cluster-randomised controlled, superiority trial that will be delivered and supervised by local agents of the All China Women’s Federation (ACWF), the nationwide, government-sponsored social protection organisation that aims to safeguard the rights and interests of women and children. We randomise 125 villages in rural China into four arms: (1) a parenting stimulation arm; (2) a caregiver mental health arm; (3) a combined parenting stimulation and caregiver mental health arm and (4) a pure control arm. Caregivers and their children (aged 6–24 months at the time of baseline data collection) are selected and invited to participate in the 12-month-long study. The parenting stimulation intervention consists of weekly, one-on-one training sessions that follow a loose adaptation of the Reach Up and Learn curriculum. The caregiver mental health intervention is comprised of fortnightly group activities based on an adaptation of the Thinking Healthy curriculum from the WHO. Primary outcomes include measures of child development and caregiver mental health. Secondary outcomes include a comprehensive set of physical, psychological and behavioural outcomes. This protocol describes the design and evaluation plan for this programme.

Ethics and dissemination

This study received approval from the Institutional Review Board of Stanford University (IRB Protocol #63680) and the Institutional Review Board of the Southwestern University of Finance and Economics in Chengdu, Sichuan, China. Informed oral consent will be obtained from all caregivers for their own and their child’s participation in the study. The full protocol will be publicly available in an open-access format. The study findings will be published in economics, medical and public health journals, as well as Chinese or English policy briefs.

Trial registration number

AEA RCT Registry (AEARCTR-0010078) and ISRCTN registry (ISRCTN84864201).

Prehospital acute life-threatening cardiovascular disease in elderly: an observational, prospective, multicentre, ambulance-based cohort study

Objective

The aim was to explore the association of demographic and prehospital parameters with short-term and long-term mortality in acute life-threatening cardiovascular disease by using a hazard model, focusing on elderly individuals, by comparing patients under 75 years versus patients over 75 years of age.

Design

Prospective, multicentre, observational study.

Setting

Emergency medical services (EMS) delivery study gathering data from two back-to-back studies between 1 October 2019 and 30 November 2021. Six advanced life support (ALS), 43 basic life support and five hospitals in Spain were considered.

Participants

Adult patients suffering from acute life-threatening cardiovascular disease attended by the EMS.

Primary and secondary outcome measures

The primary outcome was in-hospital mortality from any cause within the first to the 365 days following EMS attendance. The main measures included prehospital demographics, biochemical variables, prehospital ALS techniques used and syndromic suspected conditions.

Results

A total of 1744 patients fulfilled the inclusion criteria. The 365-day cumulative mortality in the elderly amounted to 26.1% (229 cases) versus 11.6% (11.6%) in patients under 75 years old. Elderly patients (≥75 years) presented a twofold risk of mortality compared with patients ≤74 years. Life-threatening interventions (mechanical ventilation, cardioversion and defibrillation) were also related to a twofold increased risk of mortality. Importantly, patients suffering from acute heart failure presented a more than twofold increased risk of mortality.

Conclusions

This study revealed the prehospital variables associated with the long-term mortality of patients suffering from acute cardiovascular disease. Our results provide important insights for the development of specific codes or scores for cardiovascular diseases to facilitate the risk of mortality characterisation.

Factors associated with continuation of hormonal contraceptives among married women of reproductive age in Gilgit, Pakistan: a community-based case-control study

Por: Bibi · F. · Saleem · S. · Tikmani · S. S. · Rozi · S.
Objective

This study aimed to determine the factors associated with continuation of hormonal contraceptive methods among married women of Gilgit, Pakistan at least 6 months after their initiation.

Design

Unmatched case–control study.

Setting

Community settings of Gilgit, Pakistan from 1 April 2021 to 30 July 2021.

Participants

The cases were married women of reproductive age who, at the time of interview, were using a hormonal method of contraception for at least 6 months continuously, and controls were married women of reproductive age who had used a hormonal method in the past and currently were using a non-hormonal method for at least 6 months.

Primary and secondary outcome measures

OR for continuation of hormonal contraceptive.

Results

The factors significantly associated with continuous use of hormonal contraceptive methods for our sample from Gilgit were the family planning centre’s distance from home (adjusted OR (AOR) 6.33, 95% CI 3.74 to 10.71), satisfaction with current method used (AOR 3.64, 95% CI 2.06 to 6.44), visits to the family planning centre to avail services (AOR 1.86, 95% CI 1.07 to 3.45) and relatively older age of women (AOR 1.07, 95% CI 1.02 to 1.12). In addition, women with formal education (AOR 0.27, 95% CI 0.12 to 0.6) were less likely to use a modern contraceptive method.

Conclusion

Continuation of using a hormonal method was associated with easy access to family planning centres, satisfaction with the current method and frequent visits to the family planning centres. Continuation of using a hormonal method was also seen in women with low education status. The importance of the presence of family planning centres near residential areas cannot be emphasised more. This does not only provide easy access to family planning methods, but also reassure women of continuation of modern methods when they face any unpleasant effects while using these.

Resistome and virulome of high-risk pandemic clones of multidrug-resistant extra-intestinal pathogenic <i>Escherichia coli</i> (ExPEC) isolated from tertiary healthcare settings in Uganda

by Denis K. Byarugaba, Bernard Erima, Godfrey Wokorach, Stephen Alafi, Hannah Kibuuka, Edison Mworozi, Ambrose K. Musinguzi, James Kiyengo, Florence Najjuka, Fred Wabwire-Mangen

Multi-drug resistant (MDR) globally disseminated extraintestinal pathogenic high-risk Escherichia coli (ExPEC) clones are threatening the gains in bacterial disease management. In this study, we evaluated the genomic structure including the resistome and virulome of the E. coli isolates from extraintestinal infections using whole genome sequencing (WGS). The results highlight that isolates were highly resistant (≥ 90.0%) to commonly used antibiotics (Ampicillin, Trimethoprim-Sulfamethoxazole, Nalidixic acid, and Piperacillin) and were less (E. coli isolates belonged to phylogroup B2 (30.52%) and phylogroup A (27.37%). The sequence types ST131 of phylogroup B2 (21.05%) and ST648 of phylogroup F (9.3%) were the dominant pandemic high-risk clones identified in addition to the ST1193, ST410, ST69, ST38, ST405, and ST10. Many of the isolates were MDR and most (64.58%) carried the blaCTX-M-15 gene for extended-spectrum β-lactamases. There was a high correlation between phylogroups and the occurrence of both antimicrobial resistance and virulence genes. The cephalosporin-resistance gene blaEC-5 was only found in phylogroup B2 while blaEC-8 and blaEC-19, were only found within phylogroup D and phylogroup F respectively. Aminoglycoside gene (aadA1) was only associated with phylogroups D and C. The isolates were armed with a broad range of virulence genes including adhesins, toxins, secreted proteases, iron uptake genes, and others. The yfcv, chuA, and kpsE genes preferentially occurred among isolates of phylogroup B2. The study underlines the predominance of MDR internationally disseminated high-risk ExPEC clones with a broad range of virulence genes known to be highly transmissible in healthcare and community settings.

The CLoCk study: A retrospective exploration of loneliness in children and young people during the COVID-19 pandemic, in England

by Kelsey McOwat, Snehal M. Pinto Pereira, Manjula D. Nugawela, Shamez N. Ladhani, Fiona Newlands, Terence Stephenson, Ruth Simmons, Malcolm G. Semple, Terry Segal, Marta Buszewicz, Isobel Heyman, Trudie Chalder, Tamsin Ford, Emma Dalrymple, Consortium , Roz Shafran

Background

During the COVID-19 pandemic children and young people (CYP) were socially restricted during a stage of life crucial to development, potentially putting an already vulnerable population at higher risk of loneliness, social isolation, and poorer wellbeing. The objectives of this study are to conduct an exploratory analysis into loneliness before and during the pandemic, and determine which self-reported factors are associated with loneliness.

Methods and findings

Participants from The Children with Long COVID (CLoCk) national study were invited to take part via an online survey, with a total of 31,017 participants taking part, 31,016 of which reported on their experience of loneliness. Participants retrospectively answered questions on demographics, lifestyle, physical health and mental health and loneliness before the pandemic and at the time of answering the survey. Before the pandemic 6.5% (2,006/31,016) of participants reported experiencing loneliness “Often/Always” and at the time of survey completion 17.4% (5,395/31,016) reported feeling lonelier. There was an association between meeting the research definition of long COVID and loneliness [3.49 OR, 95%CI 3.28–3.72]. CYP who reported feeling lonelier at the time of the survey than before the pandemic were assigned female at birth, older CYP, those from Black/African/Caribbean/Black British or other ethnicity groups, those that had 3–4 siblings and lived in more deprived areas.

Conclusions

We demonstrate associations between multiple factors and experiences of loneliness during the pandemic. There is a need for a multi-faceted integrated approach when developing interventions targeted at loneliness. It is important to follow up the CYP involved at regular intervals to investigate the progression of their experience of loneliness over time.

Dysfunction of peripheral somatic and autonomic nervous system in patients with severe forms of Crohn’s disease on biological therapy with TNFα inhibitors–A single center study

by Martin Wasserbauer, Sarka Mala, Katerina Stechova, Stepan Hlava, Pavlina Cernikova, Jan Stovicek, Jiri Drabek, Jan Broz, Dita Pichlerova, Barbora Kucerova, Petra Liskova, Jan Kral, Lucia Bartuskova, Radan Keil

Objective

Crohn’s disease (CD) can be associated with a wide range of extraintestinal manifestations (EIMs), including neurological ones. Published studies differ in their conclusions about the epidemiology and etiopathogenesis of neurological EIMs. The aims of this study were to demonstrate the presence and find risk factors of peripheral (somatic and autonomic) neuropathy patients with severe CD on anti-TNFα biological therapy.

Material and methods

A clinical examination focusing on detection of peripheral sensor-motor nervous dysfunction (including Sudoscan) and examination of autonomic nervous system dysfunction (using Ewing´s battery tests and spectral analysis) together with laboratory tests and collection of demographic data followed by administration of questionnaires were performed on a total of 30 neurologically asymptomatic outpatients with severe CD on anti-TNFα biological therapy.

Results

Peripheral sensor-motor nervous function via clinical neurological examination was pathological in 36.7% and Sudoscan in 33.3% of cases. Statistically significant associations between vibration perception test and age, CD and biological therapy duration, body mass index and Crohn’s Disease Activity Index were proved while statistically significant associations between temperature perception test and age and BMI were proved as well. Additionally, a decrease of total protein in a patient´s serum below the physiological cut-off in the 6 months prior to measurement was associated with a pathological result of a Sudoscan. Cardiovascular autonomic neuropathy based on Ewing´s battery tests was present in 56.7% of patients, no statistically significant risk factors were found. Our peripheral neuropathy questionnaire correlated with the results of the Sudoscan test and some tests of the clinical examination of peripheral sensor-motor nervous function (discriminatory contact perception test, temperature perception test).

Conclusions

This study demonstrated a relatively high prevalence of peripheral (especially autonomic) neuropathy and verified some risk factors for the development of peripheral somatic neuropathy in asymptomatic patients with severe form of CD on anti-TNFα biological therapy.

Factors of parental investment in the home language environment in peri-urban China: A mixed methods study

by Tianli Feng, Jingruo Guo, Sarah-Eve Dill, Dongming Zhang, Yuchen Liu, Yue Ma, Lucy Pappas, Scott Rozelle

The home language environment is a critical point of investment in early language skills. However, few studies have quantitatively measured the home language environment of low-socioeconomic-status households in non-western settings. This mixed methods study describes the home language environment and early child language skills among households in a low-socioeconomic-status, peri-urban district of Chengdu, China, and identifies factors influencing parental investment in the home language environment. Audio recordings were collected from 81 peri-urban households with children ages 18–24 months and analysed using the Language Environment Analysis (LENATM) system. The Mandarin version of the MacArthur-Bates Communicative Development Inventory was administered to each child’s primary caregiver. The quantitative results revealed large variation in home language environments and child language skills among the sample, with relatively low average scores when compared to other Chinese samples. Qualitative interviews with a subset of 31 caregivers revealed that many caregivers face constraints on their knowledge of interactive parenting, compounded, in some households, by time constraints due to work or household responsibilities. The findings indicate a need for increased sources of credible parenting information for peri-urban caregivers of young children to promote investment in the home language environment.
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