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Practices and challenges of community engagement in health research in Ethiopia: a qualitative study

Por: Solomon · K. · Jibat · N. · Bekele · A. · Abdissa · A. · Kaba · M.
Objective

The role of the community in the research process in Ethiopia has not been documented. This study aims to explore the existing practices and challenges of community engagement in health research in Ethiopia.

Design

A qualitative study with a narrative approach was conducted. Data were audio-recorded, transcribed, inductively coded and analysed thematically.

Setting

Participants were recruited from members of institutional review boards, academic and research staff of Addis Ababa and Jimma universities, research institutions and key development partners.

Participants

Thirty-six participants were involved in the study. They were purposively selected on the basis of their diverse research experiences and disciplinary profiles with clinical, biomedical and public health representation.

Data collection

Twenty-two key informant interviews were conducted with members of the institutional review board, community representatives in the institutional review board, community engagement officers, and research focal persons of the universities, research intuitions and key development partners. Fourteen participants who were senior PhD students or senior researchers in academic and research institutions were involved in the in-depth interviews.

Results

Despite differences of justification, all participants believed in the importance of the participating research community not only to own the research outcome but also contribute to the research planning, sharing of evidence, managing the research process and dissemination of findings. However, it was argued that lack of guidance, skills and experience on how to engage the community at different levels of the research process and limitation of resources affect community engagement in research.

Conclusion

As an important component of the research process, community engagement facilitates the research process and ensures community ownership of the outcome. Nevertheless, lack of experience and limitation of resources affect operationalisation of community engagement in health research. This calls for building capacity and advocacy to consider community engagement as an integral component of the research process.

Key factors for effective implementation of healthcare worker support interventions after patient safety incidents in health organisations: a protocol for a scoping review

Por: Guerra-Paiva · S. · Lobao · M. J. · Simoes · J. D. · Donato · H. · Carrillo · I. · Mira · J. J. · Sousa · P.
Introduction

Health organisations should support healthcare workers who are physically and psychologically affected by patient safety incidents (second victims). There is a growing body of evidence which focuses on second victim support interventions. However, there is still limited research on the elements necessary to effectively implement and ensure the sustainability of these types of interventions. In this study, we propose to map and frame the key factors which underlie an effective implementation of healthcare worker support interventions in healthcare organisations when healthcare workers are physically and/or emotionally affected by patient safety incidents.

Methods and analysis

This scoping review will be guided by the established methodological Arksey and O’Malley framework, Levac and Joanna Briggs Institute (JBI) recommendations. We will follow the JBI three-step process: (1) a preliminary search conducted on two databases; (2) the definition of clear inclusion criteria and the creation of a list of search terms to be used in the subsequent running of the search on a larger number of databases; and (3) additional searches (cross-checking/cross-referencing of reference lists of eligible studies, hand-searching in target journals relevant to the topic, conference proceedings, institutional/organisational websites and networks repositories). We will undertake a comprehensive search strategy in relevant bibliographic databases (PubMed/MEDLINE, Embase, CINHAL, Web of Science, Scopus, PsycInfo, Epistemonikos, Scielo, Cochrane Library and Open Grey). We will use the Mixed Methods Appraisal Tool V.2018 for quality assessment of the eligible studies. Our scoping review will be guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Extension for Scoping Reviews.

Ethics and dissemination

This study will not require ethical approval. Results of the scoping review will be published in a peer-review journal, and findings will be presented in scientific conferences as well as in international forums and other relevant dissemination channels.

Trial registration number

10.17605/OSF.IO/RQAT6.

Preprint from medRxiv available: doi: https://doi.org/10.1101/2022.01.25.22269846.

Factors influencing adults who participate in a physical activity coaching intervention: a theoretically informed qualitative study

Por: Barrett · S. · Begg · S. · O'Halloran · P. · Breckon · J. · Rodda · K. · Barrett · G. · Kingsley · M.
Objective

Behaviour change interventions targeting changes in physical activity (PA) can benefit by examining the underlying mechanisms that promote change. This study explored the use of the Capability, Opportunity, Motivation and Behaviour (COM-B) model and the Theoretical Domains Framework (TDF) to code and contextualise the experiences of participants who completed a PA coaching intervention underpinned by motivational interviewing and cognitive–behavioural therapy.

Design

Semistructured interviews were conducted with a purposive sample of participants.

Setting

Interviews were conducted in a tertiary hospital in regional Victoria, Australia.

Participants

Eighteen participants who completed a PA coaching intervention were interviewed. The participants were recruited into the coaching intervention because they were insufficiently physically active at the time of recruitment.

Results

Thirteen (72%) participants were women and the average age of participants was 54 (±5) years. Four participant themes mapped directly onto five components of the COM-B model, and ten of the TDF domains. Increases in PA were influenced by changes in motivation and psychological capability. The autonomy-supportive PA coaching intervention helped to evoke participants’ own reasons (and motives) for change and influenced PA behaviours. Participants reflected on their own social and/or professional strengths, and used these skills to set appropriate PA goals and action plans. The structure of the PA coaching intervention provided clarity on session determinants and a framework from which to set an appropriate agenda. Relational components (eg, non-judgemental listening, collaboration) were continually highlighted as influential for change, and should be considered in future behaviour change intervention design.

Conclusions

We demonstrate the beneficial effect of using theory-informed behaviour change techniques, and delivering them in a style that promotes autonomy and relatedness. The views of participants should be a key consideration in the design and implementation of PA coaching interventions

Trial registration number

ACTRN12619000036112. Post-results analysis.

Life satisfaction and its influencing factors of middle-aged and elderly stroke patients in China: a national cross-sectional survey

Por: Liu · Y. · Liu · J. · Zhou · S. · Xu · X. · Cheng · Y. · Yi · Y. · Zou · G.
Objectives

This study reports the life satisfaction of middle-aged and elderly patients who had a stroke in China, and explores its association with patients’ sociodemographic characteristics, health status, lifestyles and family relationship.

Design

Cross-sectional survey.

Setting and participants

The samples of this study were selected from the data of China Health and Retirement Longitudinal Study (CHARLS) in 2018, which covered 28 provinces, 150 countries/districts and 450 village/urban communities. 1154 patients who had a stroke aged 45 and over were included in this study as qualified samples.

Outcome measures

Descriptive analysis was used to report sociodemographic characteristics, health status, lifestyles, family relationship and life satisfaction of middle-aged and elderly patients who had a stroke. 2 analysis and binary logistic regression were used to analyse the factors influencing the life satisfaction of the patients who had a stroke.

Results

Overall, 83.1% of patients who had a stroke were satisfied with their lives, although only 8.7% rated their own health as being good. Patients who had a stroke who were male, elderly, married, living with their spouses and having a pension were more likely to report satisfaction with life (p

Conclusions

Our study indicates the importance of improving the overall health of patients who had a stroke and mediating factors, such as pain management, and work ability, spouse and children relationship in improving the life satisfaction of patients in the poststroke rehabilitation.

Exposure to risk and experiences of river flooding for people with disability and carers in rural Australia: a cross-sectional survey

Por: Bailie · J. · Matthews · V. · Bailie · R. · Villeneuve · M. · Longman · J.
Objectives

In this paper, we explore the exposure to risk and experiences of people with disability and carers during a flooding event and the subsequent mental health impacts.

Design

A cross-sectional survey between September and November 2017. Binary logistic regression models were used to investigate associations between the mental health of people with disability and carers and their exposure to the flood. Inductive content analysis was used to analyse qualitative data.

Setting

Flood-affected communities in the rural area of Northern Rivers, New South Wales, Australia, 6 months after river flooding in 2017.

Participants

People over 16 years and a resident in the Northern Rivers at the time of the flood were invited to participate. Using a purposive, snowballing sampling technique participants were drawn from a wide range of socioeconomic backgrounds and had experienced different degrees of flood exposure.

Results

Of 2252 respondents, there were 164 people with disability and 91 carers. Both groups had increased odds of having their home flooded (people with a disability: OR 2.41 95% CI 1.71 to 3.39; carers: OR 1.76 95% CI 1.10 to 2.84). On evacuation, respondents reported inaccessible, conflicting and confusing information regarding flood warnings. Essential services such as healthcare and social services were disrupted (people with a disability: OR 3.98 95% CI 2.82 to 5.60; carers 2.17 95% CI 1.33 to 3.54) and access to safe and mould free housing post flood event was limited. After taking sociodemographic factors into account, respondents with a disability and carers had greater odds of probable post-traumatic stress disorder compared with other respondents (people with a disability: 3.32 95% CI 2.22 to 4.96; carers: 1.87 95% CI 1.10 to 3.19).

Conclusion

Our findings show the profound impact and systemic neglect experienced by people with disability and carers during and after the 2017 flood event in the Northern Rivers. As people with disability will take longer to recover, they will require longer-term tailored supports and purposeful inclusion in flood preparedness and recovery efforts.

Healthcare workers perceptions on diabetic foot ulcers (DFU) and foot care in Fiji: a qualitative study

Por: Ranuve · M. S. · Mohammadnezhad · M.
Objectives

To explore the perception of healthcare workers (HCWs) on diabetic foot ulcers (DFU) and foot care in Rotuma, Fiji.

Design

Using a qualitative study design, two focus group discussions (FGDs) were conducted among HCWs. A semistructured open-ended questionnaire was used to guide the discussion session. Each FGD was audiorecorded and was transcribed. The transcriptions were then manually analysed using thematic analysis.

Setting

Rotuma hospital, Fiji.

Participants

HCWs who were working in Rotuma hospital for at least a year and were involved in clinical foot care of type 2 diabetes mellitus patients were included.

Results

There were five main themes, namely, depth of knowledge, quality of care in practice, factors of influence on practice, lack of resources and capacity building. Participants had superficial knowledge that showed lack of in-depth scientific knowledge. A lack of staffing in the clinics affected the delivery of service. Additionally, patients defaulting clinics, late presentations with DFU and traditional medicine also affected the quality of healthcare service in clinics. There was also a need for a multidisciplinary team to prevent and manage DFU. HCWs mostly advised on glycaemic control and ignored offering foot care advice in clinics due mainly to the lack of sound knowledge on foot care. There was also a lack of resources, infrastructure, space and professional development opportunities, which negatively impacted how HCWs deliver foot care services to patients.

Conclusion

HCWs lack significant in-depth knowledge on DFU and foot care. In addition, these are the availability of traditional medicine that delays presentations to hospital, further reducing the quality of services. HCWs need to keep their knowledge and skills updated through regular in-service training on foot care. Resources, infrastructure and supply chains need to be maintained by those in power to ensure HCWs deliver quality foot care services.

Interventions delivered in secondary or tertiary medical care settings to improve routine vaccination uptake in children and young people: a scoping review

Por: Blagden · S. · Newell · K. · Ghazarians · N. · Sulaiman · S. · Tunn · L. · Odumala · M. · Isba · R. · Edge · R.
Objective

To identify and analyse the interventions delivered opportunistically in secondary or tertiary medical settings, focused on improving routine vaccination uptake in children and young people.

Design

Scoping review.

Search strategy

We searched CINAHL, Web of Science, Medline, Embase and Cochrane Database of Systematic Reviews for studies in English published between 1989 and 2021 detailing interventions delivered in secondary or tertiary care that aimed to improve childhood vaccination coverage. Title, abstract and full-text screening were performed by two independent reviewers.

Results

After deduplication, the search returned 3456 titles. Following screening and discussion between reviewers, 53 studies were included in the review. Most papers were single-centre studies from high-income countries and varied considerably in terms of their study design, population, target vaccination, clinical setting and intervention delivered. To present and analyse the study findings, and to depict the complexity of vaccination interventions in hospital settings, findings were presented and described as a sequential pathway to opportunistic vaccination in secondary and tertiary care comprising the following stages: (1) identify patients eligible for vaccination; (2) take consent and offer immunisations; (3) order/prescribe vaccine; (4) dispense vaccine; (5) administer vaccine; (6) communicate with primary care; and (7) ongoing benefits of vaccination.

Conclusions

Most published studies report improved vaccination coverage associated with opportunistic vaccination interventions in secondary and tertiary care. Children attending hospital appear to have lower baseline vaccination coverage and are likely to benefit from vaccination interventions in these settings. Checking immunisation status is challenging, however, and electronic immunisation registers are required to enable this to be done quickly and accurately in hospital settings. Further research is required in this area, particularly multicentre studies and cost-effectiveness analysis of interventions.

How COVID-19 has impacted access to healthcare and social resources among individuals experiencing homelessness in Canada: a scoping review

Por: Maretzki · M. · Geiger · R. · Buxton · J. A.
Objectives

In Canada, individuals experiencing homelessness (IEH) rely on public health and social services for healthcare, food and basic necessities. The COVID-19 pandemic has disproportionately affected marginalised populations, in part by impacting their access to such services. We performed a scoping review to identify from the published literature how access to services has changed for Canadian IEH during the pandemic.

Data sources

OVID Medline, Web of Science, Sociological Abstracts, CINAHL and OVID EmCare databases, and websites for the Salvation Army, Homeless Hub, Canadian Alliance to End Homelessness, Canadian Network for the Health and Housing of People Experiencing Homelessness and BC Centre for Disease Control.

Study design

We used the scoping review methodology developed by the Joanna Briggs Institute framework and defined access to healthcare and social services using the 10-component Levesque framework. Academic databases and grey literature searches were used, with the final searches for each taking place 24 May and 1 June 2021, respectively. Data were compiled into an Excel spreadsheet. Title and abstract screening and full-text review were completed by two independent reviewers (RG and MM). Data extraction was completed by MM and cross checked by RG.

Results

In total, 17 academic and grey literature articles were included. Positive and negative changes in service access were reported in the literature. During the COVID-19 pandemic, access to social and healthcare resources was generally reduced for Canadian IEH. A new component of access, digital connectivity, was identified. Unexpectedly, coordination and collaboration of services improved, as did the number of outreach services.

Conclusions

Positive changes to service access such as improved coordination of services should be scaled up. Further work should be done to improve access to digital technologies for IEH.

COVID-19 in the context of pregnancy, infancy and parenting (CoCoPIP) study: protocol for a longitudinal study of parental mental health, social interactions, physical growth and cognitive development of infants during the pandemic

Por: Aydin · E. · Weiss · S. M. · Glasgow · K. A. · Barlow · J. · Austin · T. · Johnson · M. H. · Lloyd-Fox · S.
Introduction

While the secondary impact of the COVID-19 pandemic on the psychological well-being of pregnant women and parents has become apparent over the past year, the impact of these changes on early social interactions, physical growth and cognitive development of their infants is unknown, as is the way in which a range of COVID-19-related changes have mediated this impact. This study (CoCoPIP) will investigate: (1) how parent’s experiences of the social, medical and financial changes during the pandemic have impacted prenatal and postnatal parental mental health and parent–infant social interaction; and (2) the extent to which these COVID-19-related changes in parental prenatal and postnatal mental health and social interaction are associated with fetal and infant development.

Methods and analysis

The CoCoPIP study is a national online survey initiated in July 2020. This ongoing study (n=1700 families currently enrolled as of 6 May 2021) involves both quantitative and qualitative data being collected across pregnancy and infancy. It is designed to identify the longitudinal impact of the pandemic from pregnancy to 2 years of age as assessed using a range of parent- and self-report measures, with the aim of identifying if stress-associated moderators (ie, loss of income, COVID-19 illness, access to ante/postnatal support) appear to impact parental mental health, and in turn, infant development. In addition, we aim to document individual differences in social and cognitive development in toddlers who were born during restrictions intended to mitigate COVID-19 spread (eg, social distancing, national lockdowns).

Ethics and dissemination

Ethical approval was given by the University of Cambridge, Psychology Research Ethics Committee (PRE.2020.077). Findings will be made available via community engagement, public forums (eg, social media,) and to national (eg, NHS England) and local (Cambridge Universities Hospitals NHS Foundation Trust) healthcare partners. Results will be submitted for publication in peer-reviews journals.

Impact of the COVID-19 pandemic on utilisation of facility-based essential maternal and child health services from March to August 2020 compared with pre-pandemic March-August 2019: a mixed-methods study in North Shewa Zone, Ethiopia

Por: Bekele · C. · Bekele · D. · Hunegnaw · B. M. · Van Wickle · K. · Gebremeskel · F. A. · Korte · M. · Tedijanto · C. · Taddesse · L. · Chan · G. J.
Introduction

Health systems are often weakened by public health emergencies that make it harder to access health services. We aimed to assess maternal, newborn and child health (MNCH) service utilisation during the first 6 months of the COVID-19 pandemic compared with prior to the pandemic.

Methods

We conducted a mixed study design in eight health facilities that are part of the Birhan field site in Amhara, Ethiopia and compared the trend of service utilisation in the first 6 months of COVID-19 with the corresponding time and data points of the preceding year.

Result

New family planning visits (43.2 to 28.5/month, p=0.014) and sick under 5 child visits (225.0 to 139.8/month, p=0.007) declined over the first 6 months of the pandemic compared with the same period in the preceding year. Antenatal (208.9 to 181.7/month, p=0.433) and postnatal care (26.6 to 19.8/month, p=0.155) visits, facility delivery rates (90.7 to 84.2/month, p=0.776), and family planning visits (313.3 to 273.4/month, p=0.415) declined, although this did not reach statistical significance. Routine immunisation visits (37.0 to 36.8/month, p=0.982) for children were maintained. Interviews with healthcare providers and clients highlighted several barriers to service utilisation during COVID-19, including fear of disease transmission, economic hardship, and transport service disruptions and restrictions. Enablers of service utilisation included communities’ decreased fear of COVID-19 and awareness-raising activities.

Conclusion

We observed a decline in essential MNCH services particularly in sick children and new family planning visits. To improve the resiliency of fragile health systems, resources are needed to continuously monitor service utilisation and clients’ evolving concerns during public health emergencies.

Association of Chlamydia trachomatis infection with cervical atypia in adolescent women with short-term or long-term use of oral contraceptives: a longitudinal study in HPV vaccinated women

Por: Adhikari · I. · Eriksson · T. · Harjula · K. · Hokkanen · M. · Apter · D. · Nieminen · P. · Luostarinen · T. · Lehtinen · M.
Objective

We assessed the relationship between Chlamydia trachomatis infection, duration of oral contraceptive (OC) use and cervical atypia among young adult Finnish women.

Design

A longitudinal study.

Setting and participants

Women who were included in this study participated in a community-randomised trial on the effectiveness of human papillomavirus (HPV) vaccination and C. trachomatis screening at ages 18.5 and 22 years in Finland. They completed questionnaires on both visits about sexual behaviours. The cytology test results at age 18.5 and 22 years were also available for those women. The total number of participants in this study at 18.5 years of age were 11 701 and at 22 years of age were 6618.

Main outcome measure

ORs with 95% CIs using univariable and multivariable logistic regression were used to assess the association between C. trachomatis infection, duration of OC and squamous intraepithelial lesions (SIL).

Results

There were 940 cytological SIL cases at the first screening visit and 129 cytological SIL cases at the second screening visit. Among the 22 years old, more than fourfold adjusted risk of SIL was associated with C. trachomatis positivity. The HPV16/18, condom use, smoking and number of sexual partners adjusted joint effect of prolonged OC use and C. trachomatis was significantly increased (OR 4.7, 95% CI 1.7 to 12.8) in the 22-year-old women. This observed joint effect was 1.6 times higher than expected on a multiplicative scale. On additive scale, the observed relative excess risk from interaction was 1.8.

Conclusion

The risk of SIL in HPV vaccinated women is significantly increased if they are C. trachomatis positive and have used OC for 5 or more years. The biological basis may be lack of condom facilitated protection against sexually transmitted diseases.

Trial registration number

NCT00534638.

COVID-19 among staff and their family members of a healthcare research institution in Bangladesh between March 2020 and April 2021: a test-negative case-control study

Por: Mahfuz · M. · Alam · M. A. · Fahim · S. M. · Hasan · S. M. T. · Sarmin · M. · Das · S. · Mostafa · I. · Parveen · S. · Rahman · M. · Arifeen · S. E. · Clemens · J. D. · Ahmed · T.
Objective

To identify factors associated with COVID-19 positivity among staff and their family members of icddr,b, a health research institute located in Bangladesh.

Setting

Dhaka, Bangladesh.

Participants

A total of 4295 symptomatic people were tested for SARS-CoV-2 by reverse-transcription PCR between 19 March 2020 and 15 April 2021. Multivariable logistic regression was done to identify the factors associated with COVID-19 positivity by contrasting test positives with test negatives.

Result

Forty-three per cent of the participants were tested positive for SARS-CoV-2. The median age was high in positive cases (37 years vs 34 years). Among the positive cases, 97% were recovered, 2.1% had reinfections, 24 died and 41 were active cases as of 15 April 2021. Multivariable regression analysis showed that age more than 60 years (adjusted OR (aOR)=2.1, 95% CI 1.3 to 3.3; p

Conclusions

The study findings suggest that older age, fever, cough and anosmia were associated with COVID-19 among the study participants.

Cohort profile: maternal and child health and parenting practices during the COVID-19 pandemic in Ceara, Brazil: birth cohort study (Iracema-COVID)

Por: Castro · M. C. · Farias-Antunez · S. · Araujo · D. A. B. S. · Penna · A. L. · Oliveira · F. A. · de Aquino · C. M. · Lima Neto · A. S. · de Sousa · G. d. S. · Tavares Machado · M. M.
Purpose

Maternal and child health and parenting practices during the COVID-19 pandemic in Ceará (Iracema-COVID) is a longitudinal, prospective population-based birth cohort designed to understand the effects of the pandemic and social withdrawal in maternal mental health, child development and parenting practices of mothers and families.

Participants

A sample of mothers who gave birth in July and August 2020 (n=351) was enrolled in the study in January 2021. Interviews were conducted by telephone. Data were collected through standardised questionnaires that, in addition to sociodemographic and economic data, collected information on breast feeding, mental health status and COVID-19.

Findings to date

Results from the first wave show that the majority of participants have 9–11 years of schooling (54.4%; 95% CI 61.0 to 70.9) and are of mixed race (71.5%; 95% CI 66.5 to 76.0). At the time of the survey, 27.9% of the participants were out of the labor force (95% CI 23.5 to 32.9) and 78.6% reported a decrease in family income after restrictions imposed due to the pandemic (95% CI 74.0 to 82.6). The prevalence of maternal common mental disorder symptoms was 32.5% (95% CI 27.8 to 37.6).

Future plans

Follow-up visits are planned to occur every 6 months for the next five years (2021–2025). Additional topics will be included in future waves (eg, food insecurity and parenting practices). Communication strategies for bonding, such as picture cards, pictures of mothers with their children and phone calls to the participants, will be used to minimise attrition. Results of this prospective cohort will generate novel knowledge on the impact of the COVID-19 pandemic on maternal and child health and parenting practices in a population of women and children living in fifth largest city of Brazil.

Health systems analysis and evaluation of the barriers to availability, utilisation and readiness of sexual and reproductive health services in COVID-19-affected areas: a WHO mixed-methods study protocol

Por: Kouanda · S. · Nahyuha Chomi · E. · Kim · C. · Jen · S. · Bahamondes · L. · Cecatti · J. G. · Lumbiganon · P. · Emefa · M. · Brizuela · V. · Kuganantham · H. · Seuc · A. H. · Ali · M. · WHO HRP Social Science Research Team · Bahamondes · Cecatti · Chomi · Kouanda · Tang · Zhang · Zhu
Introduction

COVID-19 has led to an unprecedented increase in demand on health systems to care for people infected, necessitating the allocation of significant resources, especially medical resources, towards the response. This, compounded by the restrictions on movement instituted may have led to disruptions in the provision of essential services, including sexual and reproductive health (SRH) services. This study aims to assess the availability of contraception, comprehensive abortion care, sexually transmitted infection prevention and treatment and sexual and gender-based violence care and support services in local health facilities during COVID-19 pandemic. This is a standardised generic protocol designed for use across different global settings.

Methods and analysis

This study adopts both quantitative and qualitative methods to assess health facilities’ SRH service availability and readiness, and clients’ and providers’ perceptions of the availability and readiness of these services in COVID-19-affected areas. The study has two levels: (1) perceptions of clients (and the partners) and healthcare providers, using qualitative methods, and (2) assessment of infrastructure availability and readiness to provide SRH services through reviews, facility service statistics for clients and a qualitative survey for healthcare provider perspectives. The health system assessment will use a cross-sectional panel survey design with two data collection points to capture changes in SRH services availability as a result of the COVID-19 epidemic. Data will be collected using focus group discussions, in-depth interviews and a health facility assessment survey.

Ethics and dissemination

Ethical approval for this study was obtained from the WHO Scientific and Ethics Review Committee (protocol ID CERC.0103). Each study site is required to obtain the necessary ethical and regulatory approvals that are required in each specific country.

Effectiveness of a personal health coaching intervention (diabetescoach) in patients with type 2 diabetes: protocol for an open-label, pragmatic randomised controlled trial

Por: Hohberg · V. · Kreppke · J.-N. · Kohl · J. · Seelig · E. · Zahner · L. · Streckmann · F. · Gerber · M. · König · D. · Faude · O.
Introduction

The widespread prevalence of type 2 diabetes (T2D) not only influences patients’ daily lives but also has an economic impact on society. Increasing physical activity and a healthy diet can delay the progression of T2D. Although there are evidence-based recommendations on diet and physical activity, patients with T2D have difficulties implementing them. An appropriate lifestyle intervention can address this problem.

Methods and analysis

This study is based on the need to develop an intervention that helps patients to establish behavioural changes in order to achieve glycaemic control. The intervention will be evaluated in a monocentric, open-label, pragmatic, two-arm randomised controlled trial with a sample ratio of 1:1 and a parallel design. This superiority study will be conducted in Switzerland. All enrolled patients (n=90) will receive the standard medical treatment for T2D. The intervention group will receive personal health coaching by telephone and access to a smartphone and web application for 1 year. The control group will receive access to the application for 1 year and a one-time written diet and exercise recommendation. The primary outcomes are objectively measured physical activity and glycated haemoglobin. Secondary outcomes are self-reported physical activity, nutrition, cognitive mediators of changes in sport-related behaviour, blood values, medication and nutritional supplements, anthropometric data, quality of life, neuropathy and cost-effectiveness. All outcomes will be measured at baseline, at 27 weeks after inclusion and at 54 weeks after inclusion. The recruitment of participants and the measurements will be completed after 2 years. Linear mixed-effects models will be applied for each outcome variable to analyse the intervention effects.

Ethics and dissemination

This study was approved by the Ethics Committee North-western and Central Switzerland in February 2021 (ref: 2020-02755). All participants will be required to provide written informed consent. The results will be published in international peer-reviewed journals.

Trial registration number

ISRCTN79457541.

Hydroxychloroquine plus personal protective equipment versus personal protective equipment alone for the prevention of laboratory-confirmed COVID-19 infections among healthcare workers: a multicentre, parallel-group randomised controlled trial from India

Por: Tirupakuzhi Vijayaraghavan · B. K. · Jha · V. · Rajbhandari · D. · Myatra · S. N. · Ghosh · A. · Bhattacharya · A. · Arfin · S. · Bassi · A. · Donaldson · L. H. · Hammond · N. E. · John · O. · Joshi · R. · Kunigari · M. · Amrutha · C. · Husaini · S. H. M. · Ghosh · S. · Nag · S. K. · Sel
Objectives

To determine whether hydroxychloroquine when used with personal protective equipment reduces the proportion of laboratory-confirmed COVID-19 among healthcare workers in comparison to the use of personal protective equipment alone.

Design

Multicentre, parallel-group, open-label randomised trial. Enrolment started on 29 June 2020 and stopped on 4 February 2021. Participants randomised in HydrOxychloroquine Prophylaxis Evaluation were followed for 6 months.

Setting

9 hospitals across India.

Participants

Healthcare workers in an environment with exposure to COVID-19 were randomised in a 1:1 ratio to hydroxychloroquine plus use of personal protective equipment or personal protective equipment alone. 886 participants were screened and 416 randomised (213 hydroxychloroquine arm and 203 personal protective equipment).

Intervention

Participants in intervention arm received 800 mg of hydroxychloroquine on day of randomisation and then 400 mg once a week for 12 weeks in addition to the use of personal protective equipment. In the control arm, participants continued to use personal protective equipment alone.

Main outcome

Proportion of laboratory-confirmed COVID-19 in the 6 months after randomisation.

Results

Participants were young (mean age 32.1 years, SD 9.1 years) with low-comorbid burden. 47.4% were female. In the 6 months after randomisation (primary analysis population=413), 11 participants assigned to the hydroxychloroquine group and 12 participants assigned to the standard practice group met the primary endpoint (5.2% vs 5.9%; OR 0.85, 95% CI 0.35 to 2.07, p=0.72). There was no heterogeneity of treatment effect in any prespecified subgroup. There were no significant differences in the secondary outcomes. The adverse event rates were 9.9% and 6.9% in the hydroxychloroquine and standard practice arms, respectively. There were no serious adverse events in either group.

Conclusions and relevance

Hydroxychloroquine along with personal protective equipment was not superior to personal protective equipment alone on the proportion of laboratory-confirmed COVID-19. Definitive conclusions are precluded as the trial stopped early for futility, and hence was underpowered.

Trial registration number

CTRI/2020/05/025067.

Socioeconomic risk factors of hypertension and blood pressure among persons aged 15-49 in Nepal: a cross-sectional study

Por: Joshi · S. · Thapa · B. B.
Objectives

This study estimated the prevalence of hypertension, in accordance with the American College of Cardiology and American Heart Association’s 2017 guidelines, and examined the association between various socioeconomic factors and systolic blood pressure (SBP), diastolic blood pressure (DBP) and hypertension.

Setting and design

We used nationally representative data from the 2016 Nepal Demographic and Health Survey. Multivariate analysis was used to study the association of hypertension with socioeconomic factors: logistic regression was used for hypertension and linear regression was used for DBP and SBP.

Participants

Our sample consisted of 9827 adults between the ages of 15 and 49 years.

Results

The prevalence of hypertension was 36%. The mean DBP and SBP were 76.4 and 111.5, respectively. Janjatis (adjusted OR (AOR): 1.34, CI: 1.12 to 1.59), Other Terai castes (AOR: 1.38, CI: 1.03 to 1.84), Muslim and other ethnicities (AOR: 1.64, CI: 1.15 to 2.33) and Dalits (AOR: 1.26, CI: 1.00 to 1.58) had higher odds of hypertension. Individuals employed in professional, technical and managerial professions collectively (AOR: 1.62; CI: 1.18 to 2.21) also had higher odds of hypertension. Moderately food insecure household had lower odds of hypertension (AOR: 0.84; CI: 0.72 to 0.99) compared with households with no issue of food insecurity. Results were similar for SBP and DBP. When stratified by sex, there were differences mainly in terms of occupation and ethnicity.

Conclusion

There are substantial disparities in hypertension prevalence in Nepal. These disparities extend across ethnic groups, occupational status and food security status. Differences also persist across different provinces. As hypertension continues to be increasingly more significant, more research is needed to better understand the disparities and gradients that exist across various socioeconomic factors.

What the public in England know about antibiotic use and resistance in 2020: a face-to-face questionnaire survey

Por: McNulty · C. · Read · B. · Quigley · A. · Verlander · N. Q. · Lecky · D. M.
Objectives

To describe public attitudes and knowledge around antibiotic activity, resistance and use.

Design

Face-to-face household 18 question survey using computer-assisted data collection undertaken by Ipsos Market and Opinion Research International.

Setting

Randomly selected households across England, January–February 2020.

Participants

2022 adults (aged 15+,) including 521 black, Asian and minority ethnic (BAME) participants, and 406 aged 15–25 years olds.

Main outcome measures

Responses to questions about antibiotic activity, resistance and expectations for antibiotics and trust in healthcare professionals. Analyses were weighted to obtain estimates representative of the population with multivariable analysis undertaken for questions with five or more significant univariate variables.

Results

84% stated they would be pleased if their general practitioner (GP) said they did not need antibiotics. Trust in GPs to make antibiotic decisions remains high (89%) and has increased for nurses (76%) and pharmacists (71%). Only 21% would challenge an antibiotic decision; this was significantly greater in BAME participants (OR 2.5; 95% CI 1.89 to 3.35). 70% reported receiving advice when prescribed antibiotics. Belief in benefits of antibiotics for ear infections was very high (68%). Similar to 2017, 81% agreed that antibiotics work for bacterial, 28% cold and influenza viruses. 84% agreed antibiotic resistant bacteria (ARB) are increasing, only 50% agreed healthy people can carry ARB and 39% agreed there was nothing they personally could do about ARB. Social grade DE and BAME participants, and those with less education had significantly less understanding about antibiotics and resistance.

Conclusions

As trust in healthcare practitioners is high, we need to continue antibiotic education and other interventions at GP surgeries and community pharmacies but highlight that most ear infections are not benefitted by antibiotics. Targeted interventions are needed for socioeconomic DE, BAME groups and previous antibiotic users. We need to explore if increasing perceived personal responsibility for preventing ARB reduces antibiotic use.

What research evidence exists about physical activity in parents? A systematic scoping review

Por: Simpson · R. F. · Hesketh · K. R. · Ellis · K. · van Sluijs · E. M.
Objectives

Despite the known benefits of physical activity (PA) to physical and mental health, many people fail to achieve recommended PA levels. Parents are less active than non-parent contemporaries and constitute a large potential intervention population. However, little is known about the breadth and scope of parental PA research. This scoping review therefore aimed to provide an overview of the current evidence base on parental PA.

Methods

Four databases (MEDLINE, Embase, PsycINFO and Scopus) were systematically searched to identify peer-reviewed articles focusing on parental PA from 2005 onwards, including interventional, observational or qualitative study designs. Title and abstract screening was followed by duplicate full-text screening. Data extracted for all articles (100% checked by a second reviewer) included study design, proportion of fathers and ages of children. For interventional/observational studies, PA assessment method and factors examined or targeted based on the socio-ecological model were extracted, and questions addressed in qualitative studies.

Results

Of 14 913 unique records retrieved, 213 articles were included; 27 articles reported on more than one study design; 173 articles reported on quantitative (81 cross-sectional, 26 longitudinal and 76 interventional) and 58 on qualitative data. Most articles originated from North America (62%), and 53% included only mothers, while 2% included only fathers. Articles most frequently represented parents of infants (56% of articles), toddlers (43%), preschoolers (50%) and primary-school aged children (49%). Most quantitative articles only reported self-reported PA (70%). Observational articles focused on individual correlates/determinants (88%). Likewise, most interventions (88% of articles) targeted individual factors. Most qualitative articles explored PA barriers and facilitators (57%).

Conclusions

A range of quantitative and qualitative research has been conducted on parental PA. This review highlights opportunities for evidence synthesis to inform intervention development (such as barriers and facilitators of parental PA) and identifies gaps in the literature, for example, around paternal PA.

Review registration

osf.io/qt9up.

Development of a multicomponent intervention to increase parental vaccine confidence and young peoples access to the universal HPV vaccination programme in England: protocol for a co-design study

Por: Fisher · H. · Chantler · T. · Denford · S. · Finn · A. · Hickman · M. · Mounier-Jack · S. · Roderick · M. · Tucker · L. · Yates · J. · Audrey · S.
Introduction

Persistent infection with HPV can result in cancers affecting men and, especially, women. Lower uptake exists by area and different population groups. Increasing parental confidence about, and adolescent access to, the universal HPV vaccination programme may help reduce inequalities in uptake. However, the evidence-base for interventions to address uptake for schools-based HPV vaccination programmes is currently lacking. This study protocol outlines how a multicomponent intervention to address this evidence gap will be codesigned with parents.

Methods and analysis

The proposed research will be undertaken in localities covered by two immunisation teams in London and the south-west of England. The ‘person-based approach’ to intervention development will be followed. In the first phase, an exploratory qualitative study will be undertaken with key stakeholders (n=8) and parents (n=40) who did not provide consent for their adolescent child to be vaccinated. During the interviews, parents’ views on ways to improve parental confidence about, and adolescents’ access to, HPV vaccination will be sought. The findings will be used to inform the co-design of a preliminary plan for a targeted, multicomponent intervention. In the second phase, at least two parent working groups (n=8) will be convened and will work with creative designers to co-design communication materials aimed at increasing parents’ confidence in vaccination. At least two workshops with each parent group will be organised to obtain feedback on the intervention plan and communication materials to ensure they are fit for purpose. These findings will inform a protocol for a future study to test the effectiveness of the intervention at increasing HPV vaccination uptake.

Ethics and dissemination

The National Health Services Research Ethics Service and London School of Hygiene & Tropical Medicine Observational / Interventions Research Ethics Committee provided approvals for the study (reference 22/SW/0003 & 26902, respectively). We will work with parent advisory groups to inform our dissemination strategy and co-present our findings (eg, at community events or through social media). We will disseminate our findings with academics and healthcare professionals through webinars and academic conferences, as well as peer-reviewed publications.

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