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Sustainable UNiversity Life (SUN) study: protocol for a prospective cohort study of modifiable risk and prognostic factors for mental health problems and musculoskeletal pain among university students

Por: Edlund · K. · Sundberg · T. · Johansson · F. · Onell · C. · Rudman · A. · Holm · L. W. · Grotle · M. · Jensen · I. · Cote · P. · Skillgate · E.
Introduction

Mental health problems and musculoskeletal pain are common health problems among young adults including students. Little is known about the aetiology and prognosis of these problems in university students. We aim to determine the role of personal, sociodemographic, academic and environmental factors for risk and prognosis of symptoms of depression, anxiety and stress as well as musculoskeletal pain in university students. The constructs that will be studied are based on the biopsychosocial model and psychopathology associated with disabling pain. This model acknowledges illness to consist of interrelated mechanisms categorised into biological, psychological, environmental and social cues.

Methods and analysis

This cohort study aims to recruit around 5000 Swedish full-time students. Data will be collected using five online surveys during one academic year. A subgroup (n=1851) of the cohort, recruited before the COVID-19 pandemic, receive weekly text messages with three short questions assessing mood, worry and pain, sent through the web-based platform SMS-track . Statistical analyses will include Kaplan-Meier estimates, Cox regression analyses, multinomial logistic regression analyses and generalised estimating equations. We will assess effect measure modification when relevant and conduct sensitivity analyses to assess the impact of lost to follow-up.

Protocol amendments

Due to opportunity and timing of the study, with relevance to the outbreak of the COVID-19 pandemic, this study further aims to address mental health problems, musculoskeletal pain and lifestyle in university students before and during the pandemic.

Ethics and dissemination

The Sustainable UNiversity Life study was approved by the Swedish ethics authority (2019-03276; 2020-01449). Results will be disseminated through peer-reviewed research papers, reports, research conferences, student theses and stakeholder communications.

Trial registration number

NCT04465435.

Household food insecurity, maternal nutrition, environmental risks and infants health outcomes: protocol of the IMPALA birth cohort study in Uganda

Por: Terfa · Z. G. · Nantanda · R. · Lesosky · M. · Devereux · G. · Obasi · A. · Mortimer · K. · Khan · J. · Rylance · J. · Niessen · L. W. · IMPALA Consortium · Addo-Yobo · Allwood · Banda · Bates · Binegdie · Sony · Falade · Mbatchou · Meme · Mutayoba · Chakaya · Ntinginya · Bertel Squir
Introduction

In low- and middle-income countries (LMICs), food insecurity and undernutrition disproportionately affect women of reproductive age, infants and young children. The disease burden from undernutrition in these vulnerable sections of societies remains a major concern in LMICs. Biomass fuel use for cooking is also common in LMICs. Empirical evidence from high-income countries indicates that early life nutritional and environmental exposures and their effect on infant lung function are important; however, data from sub-Saharan Africa are scarce.

Aim

To estimate the association between infant lung function and household food insecurity, energy poverty and maternal dietary diversity.

Methods and analysis

Pregnant women will be recruited in an existing Health and Demographic Surveillance Site in South-West Uganda. Household food insecurity, sources and uses of energy, economic measures and maternal dietary diversity will be collected during pregnancy and after birth. Primary health outcomes will be infant lung function determined by tidal breath flow and volume analysis at 6–10 weeks of age. Infant weight and length will also be collected.

A household Food Consumption Score and Minimum Dietary Diversity for Women (MDD-W) indicator will be constructed. The involved cost of dietary diversity will be estimated based on MDD-W. The association between household level and mothers’ food access indicators and infant lung function will be evaluated using regression models. The Multidimensional Energy Poverty Index (MEPI) will be estimated and used as an indicator of households’ environmental exposures. The association between household MEPI and infant lung function will be assessed using econometric models.

Ethics and dissemination

Ethical approvals have been obtained from Liverpool School of Tropical Medicine (18-059), the Uganda Virus Research Institute Ethics Committee (097/2018) and Uganda National Council for Science and Technology (SS 4846). Study results will be shared with participants, policy-makers, other stakeholders and published in peer-reviewed journals.

Efficacy of the integrative Body-Mind-Spirit group intervention for improving quality of life in parent-child dyads adjusting to atopic dermatitis: protocol for a randomised controlled trial

Por: Hui · V. K. Y. · Chan · C. H. Y. · Fung · Y. L. · Chan · C. L. W. · Luk · M. S. K.
Introduction

Atopic dermatitis (AD) is the most common childhood inflammatory skin problem affecting 15%–30% of children. Although AD adversely impacts the psychosocial well-being of children and their parent caregivers, parents’ psychosocial well-being is seldom mentioned in most non-pharmacological education programmes. A family-based psychosocial intervention, Integrative Body–Mind–Spirit (I-BMS) intervention, is examined. This study compares the efficacy of two versions of the I-BMS intervention (one delivered to both parents and children; one delivered to parents only) with a health education active control (delivered to parents only) in promoting adaptive emotional regulation and quality of life of children with AD and their parent caregivers.

Methods and analysis

This is a three-arm, with equal randomisation, parallel randomised controlled trial. 192 parent–child dyads will be recruited through hospitals and non-governmental organisations in Hong Kong. Each dyad will complete an individual pre-group screening interview. Eligible dyads will be randomised in a ratio of 1:1:1 into one of the three arms. Each arm consists of six weekly sessions. A computer-generated list of random numbers will be used to perform randomisation. The primary outcomes are quality of life and emotional regulation. Assessments are administered at baseline, post-intervention and 6-week follow-up. Mixed factorial Analysis of Covariance (ANCOVAs) based on intention-to-treat principle will be conducted to examine the efficacy of the two I-BMS interventions. Structural equation modelling will be conducted to examine the parent–child interdependent effects of intervention.

Ethics and dissemination

Ethics approval was obtained from the Human Research Ethics Committee of the University of Hong Kong (EA2001001) and the Institutional Review Board of the Hospital Authority of Hong Kong (UW 21-400, KC/KE-20-0360/FR-2, NTEC-2021-0408). Consent will be sought from participating parents and children. Parental consent for child participants will also be obtained. Findings will be presented in peer-reviewed journals and at conferences in medical dermatology, paediatrics and social work.

Trial registration number

ClinicalTrials.gov Registry (NCT04617977).

Identification of the optimal treatment strategy for complex appendicitis in the paediatric population: a protocol for a multicentre prospective cohort study (CAPP study)

Introduction

In daily practice large heterogeneity in the treatment of children with complex appendicitis exists. Complex appendicitis can be divided into two subtypes; complex appendicitis with and without appendiceal mass and/or abscess. As complex appendicitis is associated with high morbidity and costs, identification of the optimal treatment strategy is essential. In this article, we present the study protocol for the CAPP (Complex Appendicitis in the Pediatric Population) study.

Methods and analysis

This nation-wide, multi-centre, comparative, non-randomised prospective cohort study includes all children

Ethics and dissemination

The Medical Ethics Review Committee of the Amsterdam UMC, location AMC, declared that the Medical Research involving Human Subjects Act (WMO) did not apply to this study. Therefore, no official approval was required by national law. Study results will be presented in peer-reviewed scientific journals and at (inter)national conferences.

Trial registration numbers

NCT04755179; NL9371.

Can achievement at medical admission tests predict future performance in postgraduate clinical assessments? A UK-based national cohort study

Por: Paton · L. W. · McManus · I. C. · Cheung · K. Y. F. · Smith · D. T. · Tiffin · P. A.
Objective

To determine whether scores on two undergraduate admissions tests (BioMedical Admissions Test (BMAT) and University Clinical Aptitude Test (UCAT)) predict performance on the postgraduate Membership of the Royal Colleges of Physicians (MRCP) examination, including the clinical examination Practical Assessment of Clinical Examination Skills (PACES).

Design

National cohort study.

Setting

Doctors who graduated medical school between 2006 and 2018.

Participants

3045 doctors who had sat BMAT, UCAT and the MRCP.

Primary outcome measures

Passing each section of the MRCP at the first attempt, including the clinical assessment PACES.

Results

Several BMAT and UCAT subtest scores displayed incremental predictive validity for performance on the first two (written) parts of the MRCP. Only aptitude and skills on BMAT (OR 1.34, 1.08 to 1.67, p=0.01) and verbal reasoning on UCAT (OR 1.34, 1.04 to 1.71, p=0.02) incrementally predicted passing PACES at the first attempt.

Conclusions

Our results imply that the abilities assessed by aptitude and skills and verbal reasoning may be the most important cognitive attributes, of those routinely assessed at selection, for predicting future clinical performance. Selectors may wish to consider placing particular weight on scales assessing these attributes if they wish to select applicants likely to become more competent clinicians. These results are potentially relevant in an international context too, since many admission tests used globally, such as the Medical College Admission Test, assess similar abilities.

Impact of the COVID-19 pandemic on vaccine coverage for early childhood vaccines in Alberta, Canada: a population-based retrospective cohort study

Por: MacDonald · S. E. · Paudel · Y. R. · Kiely · M. · Rafferty · E. · Sadarangani · M. · Robinson · J. L. · Driedger · S. M. · Svenson · L. W. · on behalf of the COVImm study team
Objective

To assess the impact of the COVID-19 pandemic on early childhood vaccination coverage in Alberta, Canada.

Setting

Alberta, a western Canadian province, which has a population of 4.4 million and approximately 50 000 births annually.

Design

In this retrospective cohort study, population-based administrative health data were analysed to determine the vaccination coverage for measles-containing, pertussis-containing and rotavirus vaccines.

Primary outcome measure

We measured monthly and cumulative vaccine coverage. We assessed the absolute difference in monthly and cumulative coverage for each vaccine dose by comparing children due for vaccination in each month of 2019 and 2020, with follow-up to determine if missed doses were caught up later.

Participants

We included 114 178 children in the 2019 analysis cohort and 106 530 children in the 2020 analysis cohort.

Results

Monthly vaccination coverage in 2020 was higher than 2019 until March, when coverage significantly declined. Comparing April 2020 to 2019, coverage was 9.9% (95% CI 7.9% to 12.0%) lower for measles vaccine; 4.9% (95% CI 3.3% to 6.5%), 7.1% (95% CI 5.2% to 9.1%), 5.2% (95% CI 3.1% to 7.4%) and 8.8% (95% CI 6.6% to 10.9%) lower for first, second, third and fourth doses of pertussis-containing vaccine, respectively; and 4.0% (95% CI 2.3% to 5.7%), 7.1% (95% CI 5.1% to 9.2%) and 4.6% (95% CI 2.4% to 6.7%) lower for first, second and third doses of rotavirus vaccine, respectively. Monthly coverage improved during May to July 2020; however, some doses experienced a second decline during September to October 2020. The cumulative coverage analysis showed that the measles-containing vaccine had the largest difference in coverage at the end of follow-up.

Conclusions

Children who were due for vaccination early in the pandemic and in Fall 2020, especially those due for measles vaccination, may require additional catch-up.

Qualitative study exploring the feasibility, usability and acceptability of neonatal continuous monitoring technologies at a public tertiary hospital in Nairobi, Kenya

Por: Kinshella · M.-L. W. · Naanyu · V. · Chomba · D. · Waiyego · M. · Rigg · J. · Coleman · J. · Hwang · B. · Ansermino · J. M. · Macharia · W. M. · Ginsburg · A. S.
Objective

To assess the feasibility, usability and acceptability of two non-invasive, multiparameter, continuous physiological monitoring (MCPM) technologies for use in neonates within a resource-constrained healthcare setting in sub-Saharan Africa.

Design

A qualitative study using in-depth interviews and direct observations to describe healthcare professional and caregiver perspectives and experiences with investigational MCPM technologies from EarlySense and Sibel compared with selected reference technologies.

Setting

Pumwani Maternity Hospital is a public, high-volume, tertiary hospital in Nairobi, Kenya.

Participants

In-depth interviews were conducted with five healthcare administrators, 12 healthcare providers and 10 caregivers. Direct observations were made of healthcare providers using the technologies on 12 neonates overall.

Results

Design factors like non-invasiveness, portability, ease-of-use and ability to measure multiple vital signs concurrently emerged as key themes supporting the usability and acceptability of the investigational technologies. However, respondents also reported feasibility challenges to implementation, including overcrowding in the neonatal unit, lack of reliable access to electricity and computers, and concerns about cost and maintenance needs. To improve acceptability, respondents highlighted the need for adequate staffing to appropriately engage caregivers and dispel misconceptions about the technologies.

Conclusion

Study participants were positive about the usefulness of the investigational technologies to strengthen clinical care quality and identification of at-risk neonates for better access to timely interventions. These technologies have the potential to improve equity of access to appropriate healthcare services and neonatal outcomes in sub-Saharan African healthcare facilities. However, health system strengthening is also critical to support sustainable uptake of technologies into routine care.

Trial registration number

NCT03920761.

Integrating health services for HIV infection, diabetes and hypertension in sub-Saharan Africa: a cohort study

Por: Birungi · J. · Kivuyo · S. · Garrib · A. · Mugenyi · L. · Mutungi · G. · Namakoola · I. · Mghamba · J. · Ramaiya · K. · Wang · D. · Maongezi · S. · Musinguzi · J. · Mugisha · K. · Etukoit · B. M. · Kakande · A. · Niessen · L. W. · Okebe · J. · Shiri · T. · Meshack · S. · Lutale · J. · Gill
Background

HIV, diabetes and hypertension have a high disease burden in sub-Saharan Africa. Healthcare is organised in separate clinics, which may be inefficient. In a cohort study, we evaluated integrated management of these conditions from a single chronic care clinic.

Objectives

To determined the feasibility and acceptability of integrated management of chronic conditions in terms of retention in care and clinical indicators.

Design and setting

Prospective cohort study comprising patients attending 10 health facilities offering primary care in Dar es Salaam and Kampala.

Intervention

Clinics within health facilities were set up to provide integrated care. Patients with either HIV, diabetes or hypertension had the same waiting areas, the same pharmacy, were seen by the same clinical staff, had similar provision of adherence counselling and tracking if they failed to attend appointments.

Primary outcome measures

Retention in care, plasma viral load.

Findings

Between 5 August 2018 and 21 May 2019, 2640 patients were screened of whom 2273 (86%) were enrolled into integrated care (832 with HIV infection, 313 with diabetes, 546 with hypertension and 582 with multiple conditions). They were followed up to 30 January 2020. Overall, 1615 (71.1%)/2273 were female and 1689 (74.5%)/2266 had been in care for 6 months or more. The proportions of people retained in care were 686/832 (82.5%, 95% CI: 79.9% to 85.1%) among those with HIV infection, 266/313 (85.0%, 95% CI: 81.1% to 89.0%) among those with diabetes, 430/546 (78.8%, 95% CI: 75.4% to 82.3%) among those with hypertension and 529/582 (90.9%, 95% CI: 88.6 to 93.3) among those with multimorbidity. Among those with HIV infection, the proportion with plasma viral load

Conclusion

Integrated management of chronic diseases is a feasible strategy for the control of HIV, diabetes and hypertension in Africa and needs evaluation in a comparative study.

Integrating HIV, diabetes and hypertension services in Africa: study protocol for a cluster randomised trial in Tanzania and Uganda

Por: Mfinanga · S. G. · Nyirenda · M. J. · Mutungi · G. · Mghamba · J. · Maongezi · S. · Musinguzi · J. · Okebe · J. · Kivuyo · S. · Birungi · J. · van Widenfelt · E. · Van Hout · M.-C. · Bachmann · M. · Garrib · A. · Bukenya · D. · Cullen · W. · Lazarus · J. V. · Niessen · L. W. · Katahoire
Introduction

HIV programmes in sub-Saharan Africa are well funded but programmes for diabetes and hypertension are weak with only a small proportion of patients in regular care. Healthcare provision is organised from stand-alone clinics. In this cluster randomised trial, we are evaluating a concept of integrated care for people with HIV infection, diabetes or hypertension from a single point of care.

Methods and analysis

32 primary care health facilities in Dar es Salaam and Kampala regions were randomised to either integrated or standard vertical care. In the integrated care arm, services are organised from a single clinic where patients with either HIV infection, diabetes or hypertension are managed by the same clinical and counselling teams. They use the same pharmacy and laboratory and have the same style of patient records. Standard care involves separate pathways, that is, separate clinics, waiting and counselling areas, a separate pharmacy and separate medical records. The trial has two primary endpoints: retention in care of people with hypertension or diabetes and plasma viral load suppression. Recruitment is expected to take 6 months and follow-up is for 12 months. With 100 participants enrolled in each facility with diabetes or hypertension, the trial will provide 90% power to detect an absolute difference in retention of 15% between the study arms (at the 5% two-sided significance level). If 100 participants with HIV infection are also enrolled in each facility, we will have 90% power to show non-inferiority in virological suppression to a delta=10% margin (ie, that the upper limit of the one-sided 95% CI of the difference between the two arms will not exceed 10%). To allow for lost to follow-up, the trial will enrol over 220 persons per facility. This is the only trial of its kind evaluating the concept of a single integrated clinic for chronic conditions in Africa.

Ethics and dissemination

The protocol has been approved by ethics committee of The AIDS Support Organisation, National Institute of Medical Research and the Liverpool School of Tropical Medicine. Dissemination of findings will be done through journal publications and meetings involving study participants, healthcare providers and other stakeholders.

Trial registration number

ISRCTN43896688.

Womens acceptability of and experience with primary human papillomavirus testing for cervix screening: HPV FOCAL trial cross-sectional online survey results

Por: Smith · L. W. · Racey · C. S. · Gondara · L. · Krajden · M. · Lee · M. · Martin · R. E. · Stuart · G. · Peacock · S. · Coldman · A. J. · Franco · E. L. · van Niekerk · D. · Ogilvie · G. S.
Objective

To study participant’s acceptability of and attitudes towards human papillomavirus (HPV) testing compared with cytology for cervical cancer screening and what impact having an HPV positive result may have in future acceptability of screening.

Design

Cross-sectional online survey of clinical trial participants.

Setting

Primary care, population-based Cervix Screening Program, British Columbia, Canada.

Participants

A total of 5532 participants from the HPV FOCAL trial, in which women received HPV and cytology testing at study exit, were included in the analysis. Median age was 54 years. The median time of survey completion was 3 years after trial exit.

Outcome measures

Acceptability of HPV testing for primary cervical cancer screening (primary); attitudes and patient perceptions towards HPV testing and receipt of HPV positive screen results (secondary).

Results

Most respondents (63%) were accepting of HPV testing, with the majority (69%) accepting screening to begin at age 30 years with HPV testing. Only half of participants (54%) were accepting of an extended screening interval of 4–5 years. In multivariable logistic regression, women who received an HPV positive screen test result during the trial (OR=1.41 95% CI 1.11 to 1.80) or were older (OR=1.01, 95% CI 1.00 to 1.02) were more likely to report HPV testing as acceptable.

Conclusions

In this evaluation of acceptability and attitudes regarding HPV testing for cervix screening, most are accepting of HPV testing for screening; however, findings indicate heterogeneity in concerns and experiences surrounding HPV testing and receipt of HPV positive results. These findings provide insights for the development of education, information and communication strategies during implementation of HPV-based cervical cancer screening.

Trial registration numbers

ISRCTN79347302 and NCT00461760.

International study to develop the WOUND‐Q patient‐reported outcome measure for all types of chronic wounds

Abstract

Patient-reported outcome measures (PROMs) for chronic wounds mainly focus on specific types of wounds. Our team developed the WOUND-Q for use with all types of wounds in any anatomic location. We conducted 60 concept elicitation interviews with patients in Canada, Denmark, the Netherlands, and the United States. Analysis identified concepts of interest to patients and scales were formed and refined through cognitive interviews with 20 patients and input from 26 wound care experts. Scales were translated into Danish and Dutch. An international field-test study collected data from 881 patients (1020 assessments) with chronic wounds. Rasch measurement theory (RMT) analysis was used to refine the scales and examine psychometric properties. RMT analysis supported the reliability and validity of 13 WOUND-Q scales that measure wound characteristics (assessment, discharge, and smell), health-related quality of life (life impact, psychological, sleep impact, and social), experience of care (information, home care nurses, medical team, and office staff), and wound treatment (dressing and suction device). The WOUND-Q can be used to measure outcomes in research and clinical practice from the perspective of patients with any type of wound.

Patient‐reported experience measures are essential to improving quality of care for chronic wounds: An international qualitative study

Abstract

Traditional quality measures for chronic wounds have focused on objective outcomes that are challenging to risk adjust, lack patient input, and have limited ability to inform quality improvement interventions. Patient‐reported experience measures (PREMs) provide information from the patient perspective regarding health care quality and have potential to improve patient‐centredness, increase care efficiency, and generate actionable data for quality improvement. The purpose of this study was to understand patient experiences and health care processes that impact quality of care among patients with chronic wounds. Sixty patients at least 18 years of age with various wound aetiologies were recruited from Canada, Denmark, The Netherlands, and the United States as part of a larger phase 1 qualitative study to develop a patient‐reported outcome measure for chronic wounds (WOUND‐Q). All patients had a chronic wound for at least 3 months, were fluent in their native speaking language, and able to participate in a one‐on‐one semi‐structured interview. Interviews were digitally recorded and transcribed verbatim. Interpretive description was used to identify recurrent themes relating to patient experience and quality of care. We identified five domains (care coordination, establishing/obtaining care, information delivery, patient‐provider interaction, and treatment delivery) and 21 sub‐domains (access to patient information, interdisciplinary communication, encounter efficiency, provider availability, specialist referral, staff professionalism, travel/convenience, modality, reciprocity, understandability/consistency, accountability, continuity, credentials, rapport, appropriateness, complication management, continuity, environment/setting, equipment and supply needs, expectation, and patient‐centred) as potential opportunities to measure and improve quality of care in the chronic wound population. PREMs for chronic wounds represent an important opportunity to engage patients and longitudinally assess quality across clinical settings and providers. Future research should focus on developing PREMs to complement traditional objective and patient‐reported outcome measures for chronic wounds.

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