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Distribution and characteristics of bacteria on the hand during oropharyngeal swab collection: Which handwashing points are affected?

Abstract

Aims

To identify the contaminated areas of the hand collection and analyse the distribution characteristics of bacteria in the hand after swab collection.

Design

This study used a cross-sectional design.

Methods

A cross-sectional study sampling 50 pairs of hands (sampling hand and auxiliary hand) of healthcare workers was performed. Ten samples were collected from each participant. The optimal hand hygiene rates and bacterial colony counts of the whole hand and different hand sections without hand hygiene were identified as the primary outcomes.

Results

The optimal hand hygiene rates of the sampling hand and auxiliary hand were 88.8% (222/250) and 91.6% (229/250), respectively. The lowest optimal hand hygiene rates for the sampling hand and the auxiliary hand were both on the dorsal side of the finger and the dorsum of the hand (86.0%, 86.0% vs. 90.0%, 86.0%); the optimal hand hygiene rates for both sites of the sampling hand were 86.0% (43/50), and the optimal hand hygiene rates for the auxiliary hand were 90.0% (45/50) and 86.0% (43/50). The bacteria colony counts did not differ between the sampling hands and auxiliary hand.

Conclusions

The dorsal side of the finger and dorsum of the hand were the most likely to be contaminated during oropharyngeal swab collection. Therefore, it is essential to pay extra attention to hand hygiene care of these two sites during the collection process to minimize the risk of cross-contamination.

Reporting Method

The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines were adopted in this study.

Depression and anxiety among nurses during the COVID‐19 pandemic: Longitudinal results over 2 years from the multicentre VOICE–EgePan study

Abstract

Aims

To examine symptoms of depression and generalised anxiety among nurses over 2 years during the pandemic and compare them to the general population.

Background

The COVID-19 pandemic has led to a significant increase in mental stress among the population worldwide. Nursing staff have been identified as being under remarkable strain.

Design

A multicentre prospective longitudinal study.

Methods

Symptoms of depression and generalised anxiety in 507 nurses were examined at four different time points (T1: April–July 2020, T2: November 2020–January 2021, T3: May–July 2021, T4: February–May 2022). Results were compared with values of the German general population, presence of gender-specific differences was analysed and frequencies of clinically relevant levels of depression and anxiety were determined.

Results

Throughout the study (T1–T4), a significant increase in depressive and anxiety symptoms was observed. At all four measurement time points, nurses showed significantly higher prevalence for depression and anxiety compared to the German general population. No significant gender differences were found. Frequencies for probable depression and generalised anxiety disorder among nurses were: 21.6% and 18.5% (T1), 31.4% and 29.2% (T2), 29.5% and 26.2% (T3), 33.7% and 26.4% (T4).

Conclusion

During the pandemic, symptoms of depression and generalised anxiety among nurses increased significantly and remained elevated. Their symptom levels were permanently higher than in the general population. These findings strongly suggest that the circumstances of the pandemic severely affected nurses´ mental health.

Relevance to Clinical Practice

The COVID-19 pandemic caused a great mental strain on caregivers. This study was able to demonstrate the significant increase in depression and anxiety among nurses during the pandemic. It highlights the urgent need for prevention, screening and support systems in hospitals.

Implications for the Profession

Supportive programmes and preventive services should be developed, not least to prevent the growing shortage of nurses in the health care systems.

Reporting Method

The study adhered to relevant EQUATOR guidelines. The STROBE checklist for cohort study was used as the reporting method.

Patient Contribution

Five hundred and seven nurses completed the questionnaire and provided data for analysis.

Trial and Protocol Registration

The study was registered with the German Clinical Trials Register (https://drks.de/search/en) under the following ID: DRKS00021268.

Sustainable employability of long‐term care staff in self‐managing teams: A qualitative study

Abstract

Aim

To discover what long-term care (LTC) staff working in self-managing teams consider necessary to remain sustainably employable.

Design

Qualitative study with semi-structured interviews.

Methods

In 2020, semi-structured interviews were conducted one-on-one with 25 LTC workers from a medium-large Dutch organization providing long-term care. All interviews were audio-recorded, anonymously transcribed verbatim and analysed with thematic content analysis in the software program Atlas.ti.

Results

LTC workers indicated a need for autonomy. They wanted their control and involvement in decisions to be strengthened. Furthermore, LTC workers indicated a need for relatedness, by experiencing support, a feeling of togetherness and more time to have attention for the residents. Lastly, LTC workers expressed a need for (assistance in) further developing their competence.

Conclusion

In order to remain willing and able to work, LTC workers in self-managing teams want their needs for autonomy, relatedness and competence to be addressed. Working conditions are important to these LTC workers' sustainable employability since they can hinder or promote the satisfaction of their needs.

Implications

It is important that management in LTC is aware of the importance of LTC workers' needs for sustainable employability. We recommend that management critically reflect on and invest in addressing these needs by enhancing indicators and limiting inhibitors of the needs.

Impact

A robust LTC workforce is necessary to provide care to the aging population. In the context of the increasing implementation of self-managing teams in LTC organizations, understanding what workers in self-managing teams need in order to remain sustainably employable is crucial. For sustainable employability (i.e. to remain willing and able to work), interviewees indicated a need for autonomy, relatedness, and competence. Nearly all participants stressed the importance of belonging and feeling connected. Working conditions seemed to relate not only directly to the sustainable employability of LTC staff but also indirectly through their lack of contribution to the satisfaction of workers' psychological needs. The outcomes of this study primarily impact workers and management within LTC organizations with self-managing teams. They benefit from recognizing the significance of addressing workers' needs to ensure their essential and sustainable employability in the sector.

Reporting Method

The Standards for Reporting Qualitative Research and the Consolidated Criteria for Reporting Qualitative (COREQ) research were used.

Patient or Public Contribution

Two LTC workers provided advice and feedback regarding the materials and set up of the interviews. These two ambassadors additionally helped in reaching our population, by disseminating information about the study.

The prevalence of incivility in hospitals and the effects of incivility on patient safety culture and outcomes: A systematic review and meta‐analysis

Abstract

Aim

Workplace incivility is a barrier to safe and high-quality patient care in nursing workplaces and more broadly in tertiary hospitals. The present study aims to systematically review the existing evidence to provide a comprehensive understanding of the prevalence of co-worker incivility experienced and witnessed by nurses and other healthcare professionals, the effects of incivility on patient safety culture (PSC) and patient outcomes, and the factors which mediate the relationship between incivility and patient safety.

Methods

A systematic review with narrative synthesis and meta-analysis was undertaken to synthesize the data from 41 studies.

Data Sources

Databases searched included MEDLINE, PubMed, SCOPUS, CINAHL, PsycInfo, ProQuest, Emcare and Embase. Searches were conducted on 17 August 2021 and repeated on 15 March 2023.

Results

The pooled prevalence of experienced incivility was 25.0%. The pooled prevalence of witnessed incivility was 30.1%. Workplace incivility was negatively associated with the PSC domains of teamwork, reporting patient safety events, organization learning/improvement, management support for safety, leadership, communication openness and communication about error. The composite pooled effect size of incivility on these domains of PSC was OR = 0.590, 95% CI [0.515, 0.676]. Workplace incivility was associated with a range of patient safety outcomes (PSOs) including near misses, adverse events, reduced procedural and diagnostic performance, medical error and mortality. State depletion, profession, psychological responses to incivility, information sharing, help seeking, workload and satisfaction with organizational communication were found to mediate the relationship between incivility and patient safety.

Conclusion

Experienced and witnessed incivility is prevalent in tertiary hospitals and has a deleterious effect on PSC and PSOs. A better understanding of the mechanisms of this relationship will support the development of interventions aimed at reducing both incivility and patient harm.

Implications for the Profession and/or Patient Care Impact

This study quantifies the effect of incivility on PSC and outcomes. It provides support that interventions focusing on incivility are a valuable mechanism for improving patient care. It guides intervention design by highlighting which domains of PSC are most associated with incivility. It explores the profession-specific experiences of workplace incivility.

Reporting Method

This report adheres to PRISMA reporting guidelines.

Patient or Public Contribution

No patient or public contribution. The focus of this study is the nursing and healthcare workforce, therefore, patient or public involvement not required.

Using the Power Wheel as a transformative tool to promote equity through spaces and places of patient engagement

Por: Sayani · A. · Cordeaux · E. · Wu · K. · Awil · F. · Garcia · V. · Hinds · R. · Jeji · T. · Khan · O. · Soh · B.-L. · Mensah · D. · Monteith · L. · Musawi · M. · Rathbone · M. · Robinson · J. · Sterling · S. · Wardak · D. · Amsdr · I. · Khawari · M. · Niwe · S. · Hussain · A. · Forster · V. · May
Background

Patient engagement is the active collaboration between patient partners and health system partners towards a goal of making decisions that centre patient needs—thus improving experiences of care, and overall effectiveness of health services in alignment with the Quintuple Aim. An important but challenging aspect of patient engagement is including diverse perspectives particularly those experiencing health inequities. When such populations are excluded from decision-making in health policy, practice and research, we risk creating a healthcare ecosystem that reinforces structural marginalisation and perpetuates health inequities.

Approach

Despite the growing body of literature on knowledge coproduction, few have addressed the role of power relations in patient engagement and offered actionable steps for engaging diverse patients in an inclusive way with a goal of improving health equity. To fill this knowledge gap, we draw on theoretical concepts of power, our own experience codesigning a novel model of patient engagement that is equity promoting, Equity Mobilizing Partnerships in Community, and extensive experience as patient partners engaged across the healthcare ecosystem. We introduce readers to a new conceptual tool, the Power Wheel, that can be used to analyse the interspersion of power in the places and spaces of patient engagement.

Conclusion

As a tool for ongoing praxis (reflection +action), the Power Wheel can be used to report, reflect and resolve power asymmetries in patient-partnered projects, thereby increasing transparency and illuminating opportunities for equitable transformation and social inclusion so that health services can meet the needs and priorities of all people.

Predictors of recovery time from severe community-acquired pneumonia among paediatrics patients in selected hospitals in Addis Ababa, Ethiopia: an institution-based retrospective cohort study

Por: Sinishaw · K. M. · Sebsbie · G. · Kebede · M. A.
Objective

Severe community-acquired pneumonia (SCAP) is a significant cause of morbidity worldwide and a major cause of morbidity and mortality in developing countries. Ethiopia ranks 6th out of 15 countries with the highest mortality rate due to pneumonia in children under 5 years of age. The aim of this study was to determine the recovery time from SCAP and factors in paediatric patients in selected hospitals in Addis Ababa.

Design, participants and setting

A retrospective cohort study was conducted among 407 randomly selected paediatric patients admitted with SCAP in Addis Ababa public hospitals from 1 January 2018 to 31 December 2020.

Primary and secondary outcomes

Recovery time and recovery rate from SCAP were estimated using Kaplan-Meier and simple frequency statistics, respectively, and the adjusted HR with a 95% CI was used to identify associated factors for recovery.

Results

91.5% (95% CI: 88.3% to 94.1%) of children recovered from SCAP with an overall recovery rate of 11.5 (95% CI: 10.37 to 12.76) per 100 person-day observation, and the median recovery time was 6 days. In the multivariable analysis, older age and the absence of comorbidities were protective factors for early recovery, while stunting and late utilisation of medical care were risk factors.

Conclusion

The median recovery time after SCAP was very long compared with the optimal recovery time of 3 days given in the British Thoracic Society guidelines. Older age and absence of comorbidities were found to shorten recovery time, whereas stunting and late initiation of treatment delayed recovery. Therefore, measures that increase the recovery rate and shorten the recovery time, such as primary prevention to eliminate malnutrition and increase the utilisation of medical care in the community, should be strengthened, and health workers should focus on the early detection and treatment of comorbid diseases.

Prevalence and impact of sarcopenia in individuals with heart failure with reduced ejection fraction (the SARC-HF study): A prospective observational study protocol

by Pablo Marino Corrêa Nascimento, Luiz Fernando Rodrigues Junior, Mauro Felippe Felix Mediano, Valéria Gonçalves da Silva, Bernardo Rangel Tura, Fabio César Sousa Nogueira, Gilberto Domont, Adriana Bastos Carvalho, Antônio Carlos Campos de Carvalho, Taís Hanae Kasai-Brunswick, Claudio Tinoco Mesquita, Humberto Villacorta Junior, Helena Cramer Veiga Rey

Sarcopenia, a clinical syndrome primarily associated with reduced muscle mass in the elderly, has a negative impact on quality of life and survival. It can occur secondarily to other diseases such as heart failure (HF), a complex clinical syndrome with high morbidity and mortality. The simultaneous occurrence of these two conditions can worsen the prognosis of their carriers, especially in the most severe cases of HF, as in patients with reduced left ventricular ejection fraction (LVEF). However, due to the heterogeneous diagnostic criteria for sarcopenia, estimates of its prevalence present a wide variation, leading to new criteria having been recently proposed for its diagnosis, emphasizing muscle strength and function rather than skeletal muscle mass. The primary objective of this study is to evaluate the prevalence of sarcopenia and/or dynapenia in individuals with HF with reduced LVEF according to the most recent criteria, and compare the gene and protein expression of those patients with and without sarcopenia. The secondary objectives are to evaluate the association of sarcopenia and/or dynapenia with the risk of clinical events and death, quality of life, cardiorespiratory capacity, ventilatory efficiency, and respiratory muscle strength. The participants will answer questionnaires to evaluate sarcopenia and quality of life, and will undergo the following tests: handgrip strength, gait speed, dual-energy X-ray absorptiometry, respiratory muscle strength, cardiopulmonary exercise, as well as genomic and proteomic analysis, and dosage of N-terminal pro-B-type natriuretic peptide and growth differentiation factor-15. An association between sarcopenia and/or dynapenia with unfavorable clinical evolution is expected to be found, in addition to reduced quality of life, cardiorespiratory capacity, ventilatory efficiency, and respiratory muscle strength.

Effect of the red uniform on the judgment of position or movement used in Wushu Routine, evaluated by practitioners of the modality

by Jinkun Li, Jingmin Zhang, Shuo Tao, Xiaoying Zeng, Rong Zou, Xiaobin Hong

In the artistic sports program, the referee’ scores directly determine the final results of the athletes. Wushu is a artistic sport that has a Chinese characteristic and has the potential to become an official competition at the Summer Olympic. In this study we tested whether a red uniform color affects Wushu Routine practitioners’ ratings of athletes’ position or movement of Wushu Routine. We also tested whether the effect varied depending on the gender of the athlete and the practitioner, and depending on whether female practitioners were in the ovulation phase of their menstrual cycle. Male (Experiment 1: N = 72) and female (Experiment 1: N = 72; Experiment 2: N = 52) participants who major in Wushu Routine were recruited to take a referee’s perspective and rate the movement quality of male and female athletes wearing red or blue uniforms. The results of Experiment 1 showed that both male and female athletes wearing red uniform (compared to blue uniform) received higher ratings (p = .002, η2 = .066; p = .014, η2 = .043), and the red effect was especially strong when male practitioners rated female athletes (p = .002, η2 = .069). The results of Experiment 2, in an all-female sample, showed that in most cases there was no difference in ratings made by women in the ovulation and non-ovulation phases of their menstrual cycle, with the exception of their ratings of male athletes wearing red; in this condition, women gave higher ratings when they were in the ovulation phase of their cycle (p = .026). The results suggest that there is a red effect in an artistic sport like Wushu Routine, in which gender and the female menstrual cycle play an important role.

Prevalence and risk factors of work-related musculoskeletal disorders among shopkeepers in Ethiopia: Evidence from a workplace cross-sectional study

by Amensisa Hailu Tesfaye, Gebisa Guyasa Kabito, Fantu Mamo Aragaw, Tesfaye Hambisa Mekonnen

Introduction

Work-related musculoskeletal disorders (WRMSDs) are the leading cause of disability worldwide. Shopkeepers are prone to developing work-related musculoskeletal disorders, but they are largely overlooked in research and policy actions, particularly in developing countries. So far, there is a lack of data on the magnitude and factors influencing work-related musculoskeletal disorders among shopkeepers in Ethiopia. Therefore, the current study aimed to explore the prevalence and risk factors of work-related musculoskeletal disorders among shopkeepers in Gondar City, Ethiopia.

Methods

A workplace-based cross-sectional study was conducted from July to August 2022, in Gondar city, Northwest Ethiopia. A multistage sampling technique was used to select 625 shopkeepers. The data were collected using an interviewer-administered standardized Nordic Musculoskeletal Questionnaire. Analysis was made using Stata version 14. Factors associated with the prevalence of work-related musculoskeletal disorders were identified using the multivariable Poisson regression model. The adjusted prevalence ratio with 95% confidence intervals (CIs) and p-value Results

The overall prevalence of work-related musculoskeletal disorders among shopkeepers in the past 12 months was found to be 81.1% (N = 507). The most frequently affected body part was the lower back (46.6%), followed by the upper back (43.8%) and shoulder (35.4%). Being female (p = 0.043), being in the age group of ≥40 years (p = 0.028), being overweight (p = 0.035), experiencing job stress (p = 0.006) and prolonged sitting (p = 0.045) were significant factors for the prevalence of work-related musculoskeletal disorders among shopkeepers.

Conclusion

This study revealed that shopkeepers face an alarmingly high prevalence of work-related musculoskeletal disorders. Female, older, overweight, stressed and shopkeepers who sit in the same position for long periods of time were identified as particularly vulnerable groups. These findings call for the urgent development and implementation of preventive measures, including ergonomic adjustments, education and training programs, stress management techniques and the promotion of physical activity, to protect this vulnerable workforce from the debilitating effects of work-related musculoskeletal disorders and to ensure their long-term health and well-being.

Anxiety disorders among youth with substance use and associated factors in Northwest Ethiopia: A community-based study

by Mamaru Melkam, Demeke Demilew, Tilahun Kassew, Biruk Fanta, Sewbesew Yitayih, Kassahun Alemu, Yassin Muhammed, Berhanie Getnet, Eden Abetu, Gebrekidan Ewnetu Tarekeg, Mohammed Oumer, Goshu Nenko

Introduction

Anxiety disorder is an unpleasant emotional feeling with symptoms related to psychological and autonomic symptoms such as headache, perspiration, palpitations, dizziness, and stomach discomfort. The use of substances become a worldwide problem among youth which brings situation that leads to serious social and health-related problems. Anxiety disorders with substance use have a huge impact on their high prevalence, therapeutic issues, and poor prognosis on clinical effects. Although the prevalence of anxiety disorders is significant among young people who use substances, limited studies were conducted. Therefore, this study revealed the burden of anxiety disorders among youth with substance use and associated factors in Ethiopia.

Method

A community-based multi-stage with a simple random sampling technique was conducted. A total of 372 substance users study participants were recruited for this study. Alcohol, Smoking, and Substance Involvement Screening Tests, Depression Anxiety Stress Scales, and other tools were used to assess anxiety disorders with substance use and associated factors. Data were entered into Epi-data version 4.6, and exported to SPSS version 20 for further analysis. Bi-variables logistic regression analysis was employed to identify variables with a p-value of Results

From a total of 372 respondents the overall prevalence of anxiety disorders with substance use was 48.1%. Male sex [AOR = 1.99; 95% CI: (1.01–3.93)], low educational status of the father [AOR = 6.38 95%CI: (1.50–7.08)], and the presence of stress [AOR = 2.48; 95% CI: 2.48(2.43–4.40)] were significantly associated factors with anxiety disorders with substances use.

Conclusions and recommendations

The prevalence of anxiety disorders with substance use was 48.1% therefore; it is recommended that the zonal administration give collaborative work with the health bureau and facilitate awareness creation about the impact of substance abuse. Clinicians are recommended to mitigate anxiety disorders with substance use to get a good prognosis for clients with controlling their stress.

Work environment and hypertension in industrial settings in Benin in 2019: a cross-sectional study

Por: Adjobimey · M. · Houehanou · C. Y. · Cisse · I. M. · Mikponhoue · R. · Hountohotegbe · E. · Tchibozo · C. · Adjogou · A. · Dossougbete · V. · Gounongbe · F. · Ayelo · P. A. · Hinson · V. · Houinato · D. S.
Objective

To determine the association between occupational factors, particularly psychosocial factors, and hypertension.

Design

Descriptive and analytical cross-sectional study using logistic multivariate regression.

Setting

Fifteen cotton ginning plants in Benin.

Participants

Permanent and occasional workers in the cotton ginning industry.

Data collection

Data on sociodemographic, occupational, behavioural and clinical history characteristics were collected using a number of standardised, interviewer-administered questionnaires. These questionnaires were based on the WHO’s non-communicable disease questionnaire, Karasek questionnaire and Siegrist questionnaire. Weight, height and blood pressure were measured. Any worker with systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg according to the WHO criteria was considered hypertensive, as was any subject on antihypertensive treatment even if blood pressure was normal.

Results

A total of 1883 workers were included, with a male to female ratio of 9.08. Of these, 510 suffered from hypertension (27.1%, 95% CI 25.1 to 29.2). In the multivariate analysis, the risk factors identified were occupational stress (adjusted OR (aOR)=3.96, 95% CI 1.28 to 12.2), age ≥25 years (aOR=2.77, 95% CI 1.55 to 4.96), body mass index of 25–30 kg/m2 (aOR=1.71, 95% CI 1.32 to 2.2), body mass index >30 kg/m2 (aOR=2.74, 95% CI 1.84 to 4.09), permanent worker status (aOR=1.66, 95% CI 1.44 to 2.41) and seniority in the textile sector >5 years (aOR=2.18, 95% CI 1.7 to 2.8). Recognition at work emerged as an effect-modifying factor subject to stratification.

Conclusions

Occupational factors, particularly job strain and recognition at work, are modifiable factors associated with hypertension in the ginning plants sector and deserve to be corrected through occupational health promotion and prevention.

Temporal trends of ambulance time intervals for suspected stroke/transient ischaemic attack (TIA) before and during the COVID-19 pandemic in Ireland: a quasi-experimental study

Por: Burton · E. · Quinn · R. · Crosbie-Staunton · K. · Deasy · C. · Masterson · S. · O'Donnell · C. · Merwick · A. · Willis · D. · Kearney · P. M. · Mc Carthy · V. J. C. · Buckley · C. M.
Objectives

Time is a fundamental component of acute stroke and transient ischaemic attack (TIA) care, thus minimising prehospital delays is a crucial part of the stroke chain of survival. COVID-19 restrictions were introduced in Ireland in response to the pandemic, which resulted in major societal changes. However, current research on the effects of the COVID-19 pandemic on prehospital care for stroke/TIA is limited to early COVID-19 waves. Thus, we aimed to investigate the effect of the COVID-19 pandemic on ambulance time intervals and suspected stroke/TIA call volume for adults with suspected stroke and TIA in Ireland, from 2018 to 2021.

Design

We conducted a secondary data analysis with a quasi-experimental design.

Setting

We used data from the National Ambulance Service in Ireland. We defined the COVID-19 period as ‘1 March 2020–31 December 2021’ and the pre-COVID-19 period ‘1 January 2018–29 February 2020’.

Primary and secondary outcome measures

We compared five ambulance time intervals: ‘allocation performance’, ‘mobilisation performance’, ‘response time’, ‘on scene time’ and ‘conveyance time’ between the two periods using descriptive and regression analyses. We also compared call volume for suspected stroke/TIA between the pre-COVID-19 and COVID-19 periods using interrupted time series analysis.

Participants

We included all suspected stroke/TIA cases ≥18 years who called the National Ambulance Service from 2018 to 2021.

Results

40 004 cases were included: 19 826 in the pre-COVID-19 period and 19 731 in the COVID-19 period. All ambulance time intervals increased during the pandemic period compared with pre-COVID-19 (p

Conclusions

A ’shock' like a pandemic has a negative impact on the prehospital phase of care for time-sensitive conditions like stroke/TIA. System evaluation and public awareness campaigns are required to ensure maintenance of prehospital stroke pathways amidst future healthcare crises. Thus, this research is relevant to routine and extraordinary prehospital service planning.

Decentralising chronic disease management in sub-Saharan Africa: a protocol for the qualitative process evaluation of community-based integrated management of HIV, diabetes and hypertension in Tanzania and Uganda

Por: Van Hout · M.-C. · Akugizibwe · M. · Shayo · E. H. · Namulundu · M. · Kasujja · F. X. · Namakoola · I. · Birungi · J. · Okebe · J. · Murdoch · J. · Mfinanga · S. G. · Jaffar · S.
Introduction

Sub-Saharan Africa continues to experience a syndemic of HIV and non-communicable diseases (NCDs). Vertical (stand-alone) HIV programming has provided high-quality care in the region, with almost 80% of people living with HIV in regular care and 90% virally suppressed. While integrated health education and concurrent management of HIV, hypertension and diabetes are being scaled up in clinics, innovative, more efficient and cost-effective interventions that include decentralisation into the community are required to respond to the increased burden of comorbid HIV/NCD disease.

Methods and analysis

This protocol describes procedures for a process evaluation running concurrently with a pragmatic cluster-randomised trial (INTE-COMM) in Tanzania and Uganda that will compare community-based integrated care (HIV, diabetes and hypertension) with standard facility-based integrated care. The INTE-COMM intervention will manage multiple conditions (HIV, hypertension and diabetes) in the community via health monitoring and adherence/lifestyle advice (medicine, diet and exercise) provided by community nurses and trained lay workers, as well as the devolvement of NCD drug dispensing to the community level. Based on Bronfenbrenner’s ecological systems theory, the process evaluation will use qualitative methods to investigate sociostructural factors shaping care delivery and outcomes in up to 10 standard care facilities and/or intervention community sites with linked healthcare facilities. Multistakeholder interviews (patients, community health workers and volunteers, healthcare providers, policymakers, clinical researchers and international and non-governmental organisations), focus group discussions (community leaders and members) and non-participant observations (community meetings and drug dispensing) will explore implementation from diverse perspectives at three timepoints in the trial implementation. Iterative sampling and analysis, moving between data collection points and data analysis to test emerging theories, will continue until saturation is reached. This process of analytic reflexivity and triangulation across methods and sources will provide findings to explain the main trial findings and offer clear directions for future efforts to sustain and scale up community-integrated care for HIV, diabetes and hypertension.

Ethics and dissemination

The protocol has been approved by the University College of London (UK), the London School of Hygiene and Tropical Medicine Ethics Committee (UK), the Uganda National Council for Science and Technology and the Uganda Virus Research Institute Research and Ethics Committee (Uganda) and the Medical Research Coordinating Committee of the National Institute for Medical Research (Tanzania). The University College of London is the trial sponsor. Dissemination of findings will be done through journal publications and stakeholder meetings (with study participants, healthcare providers, policymakers and other stakeholders), local and international conferences, policy briefs, peer-reviewed journal articles and publications.

Trial registration number

ISRCTN15319595.

Implementation of an antibiotic resistance surveillance tool in Madagascar, the TSARA project: a prospective, observational, multicentre, hospital-based study protocol

Por: Elias · C. · Raad · M. · Rasoanandrasana · S. · Raherinandrasana · A. H. · Andriananja · V. · Raberahona · M. · Moore · C. E. · Randria · M. · Raskine · L. · Vanhems · P. · Babin · F.-X.
Introduction

Antimicrobial resistance (AMR) has become a significant public health threat. Without any interventions, it has been modelled that AMR will account for an estimated 10 million deaths annually by 2050, this mainly affects low/middle-income countries. AMR has a systemic negative perspective affecting the overall healthcare system down to the patient’s personal outcome. In response to this issue, the WHO urged countries to provide antimicrobial stewardship programmes (ASPs). ASPs in hospitals are a vital component of national action plans for AMR, and have been shown to significantly reduce AMR, in particular in low-income countries such as Madagascar.

As part of an ASP, AMR surveillance provides essential information needed to guide medical practice. We developed an AMR surveillance tool—Technique de Surveillance Actualisée de la Résistance aux Antimicrobiens (TSARA)—with the support of the Mérieux Foundation. TSARA combines bacteriological and clinical information to provide a better understanding of the scope and the effects of AMR in Madagascar, where no such surveillance tool exists.

Methods and analysis

A prospective, observational, hospital-based study was carried out for data collection using a standardised data collection tool, called TSARA deployed in 2023 in 10 hospitals in Madagascar participating in the national Malagasy laboratory network (Réseau des Laboratoires à Madagascar (RESAMAD)). Any hospitalised patient where the clinician decided to take a bacterial sample is included. As a prospective study, individual isolate-level data and antimicrobial susceptibility information on pathogens were collected routinely from the bacteriology laboratory and compiled with clinical information retrieved from face-to-face interviews with the patient and completed using medical records where necessary. Analysis of the local ecology, resistance rates and antibiotic prescription patterns were collected.

Ethics and dissemination

This protocol obtained ethical approval from the Malagasy Ethical Committee n°07-MSANP/SG/AGMED/CNPV/CERBM on 24 January 2023. Findings generated were shared with national health stakeholders, microbiologists, members of the RESAMAD network and the Malagasy academic society of infectious diseases.

Exploring the barriers to, and importance of, participant diversity in early-phase clinical trials: an interview-based qualitative study of professionals and patient and public representatives

Por: Chatters · R. · Dimairo · M. · Cooper · C. · Ditta · S. · Woodward · J. · Biggs · K. · Ogunleye · D. · Thistlethwaite · F. · Yap · C. · Rothman · A.
Objectives

To explore the importance of, and barriers to achieving, diversity in early-phase clinical trials.

Design

Qualitative interviews analysed using thematic analysis.

Setting and participants

Five professionals (clinical researchers and methodologists) and three patient and public representatives (those with experience of early-phase clinical trials and/or those from ethnic minority backgrounds) were interviewed between June and August 2022. Participants were identified via their institutional web page, existing contacts or social media (eg, X, formerly known as Twitter).

Results

Professionals viewed that diversity is not currently considered in all early-phase clinical trials but felt that it should always be taken into account. Such trials are primarily undertaken at a small number of centres, thus limiting the populations they can access. Referrals from clinicians based in the community may increase diversity; however, those referred are often not from underserved groups. Referrals may be hindered by the extra resources required to approach and recruit underserved groups and participants often having to undertake ‘self-driven’ referrals. Patient and public representatives stated that diversity is important in research staff and that potential participants should be informed of the need for diversity. Those from underserved groups may require clarification regarding the potential harms of a treatment, even if these are unknown. Education may improve awareness and perception of early-phase clinical trials. We provide 14 recommendations to improve diversity in early-phase clinical trials.

Conclusions

Diversity should be considered in all early-phase trials. Consideration is required regarding the extent of diversity and how it is addressed. The increased resources needed to recruit those from underserved groups may warrant funders to increase the funds to support the recruitment of such participants. The potential harms and societal benefits of the research should be presented to potential participants in a balanced but accurate way to increase transparency.

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

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

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

Study design and setting

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

Results

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

Conclusions

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

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

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

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

Design

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

Setting

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

Participants

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

Interventions

Randomised 1:1; finerenone or placebo.

Primary and secondary outcome measures

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

Results

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

Conclusions

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

Trial registration numbers

NCT02540993, NCT02545049.

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

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

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

Design

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

Setting

A large urban UK ambulance service.

Participants

23 control room staff.

Results

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

Conclusions

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

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

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

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

Methods and analysis

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

Ethics approval and dissemination

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

Trial registration number

ISRCTN18010240.

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

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

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

Design

Cross-sectional study.

Setting

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

Participants

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

Primary and secondary outcome measures

The presence of LVDD was the primary outcome measure.

Results

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

Conclusions

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

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