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Implementing a contextually appropriate foot-ankle exercise programme in primary care for the prevention of modifiable risk factors for ulcers in people with diabetes: protocol for a hybrid type 2 study

Por: Rodrigues · C. B. · Soares · P. N. C. · Schmitt · A. C. B. · Sacco · I. C. N.
Introduction

Diabetes is a highly prevalent disease that negatively impacts people’s health and quality of life. It can result in diabetic peripheral neuropathy (DPN) and foot complications, which in turn lead to ulcers and amputations. The international guidelines on diabetic foot included specific foot-ankle exercises as preventive strategy capable of modifying the risk factors for ulcers. Our aim is to test the effectiveness and to implement a contextually appropriate preventive intervention—a foot-ankle exercises programme alongside educational strategies—in a primary care setting to improve range of motion (ROM), strength, functionality of foot-ankle, and quality of life in people with diabetes.

Methods and analysis

This is a hybrid type 2 implementation-effectiveness study organised in four phases, being undertaken in Limeira, São Paulo. Phase 1, preimplementation, aims to gather information about the contextual characteristics, barriers, and facilitators and to form the implementation team. In phase 2, the implementation team will structure the foot-ankle programme, adapting it to the context of primary healthcare, and develop the training for health professionals. In phase 3, effectiveness of the 12 week group-based intervention will be tested by a cluster randomised controlled trial. Primary care units (18 clusters) will be randomly allocated to a control or intervention group, with a total sample of 356 people. Primary outcomes will be DPN symptoms and ankle and first metatarsal phalangeal joint ROM. Reach, adoption, and implementation will be evaluated by Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. In phase 4, maintenance and expansion of the programme in the municipality will be assessed.

Ethics and dissemination

This protocol and the informed consent to be signed by the participants were approved by the Ethics Committee of the School of Medicine of the University of São Paulo (CAAE:63457822.0.0000.0068, 29 November 2022). The project will generate and share data in a public repository. Results will be disseminated through peer-reviewed journals, conference proceedings, and electronic communications for health professionals.

Trial registration number

NCT05639478.

Cohort profile: The Scottish SHARE Mental Health (SHARE-MH) cohort - linkable survey, genetic and routinely collected data for mental health research

Por: Iveson · M. H. · Ball · E. L. · Doherty · J. · Pugh · C. · Vashishta · S. · Palmer · C. N. A. · McIntosh · A.
Purpose

The SHARE Mental Health (SHARE-MH) cohort was established to address the paucity of clinical and genetic data available for mental health research. The cohort brings together detailed mental health questionnaire responses, routinely collected electronic health data and genetic data to provide researchers with an unprecedented linkable dataset. This combination of data sources allows researchers to track mental health longitudinally, across multiple settings. It will be of interest to researchers investigating the genetic and environmental determinants of mental health, the experiences of those interacting with healthcare services, and the overlap between self-reported and clinically derived mental health outcomes.

Participants

The cohort consists of individuals sampled from the Scottish Health Research Register (SHARE). To register for SHARE, individuals had to be over the age of 16 years and living in Scotland. Cohort participants were recruited by email and invited to take part in an online mental health survey. When signing up for SHARE, participants also provided written consent to the use of their electronic health records and genetic data—derived from spare blood samples—for research purposes.

Findings to date

From 5 February 2021 to 27 November 2021, 9829 individuals completed a survey of various mental health topics, capturing information on symptoms, diagnoses, impact and treatment. Survey responses have been made linkable to electronic health records and genetic data using a single patient identifier. Linked data have been used to describe the cohort in terms of their demographics, self-reported mental health, inpatient and outpatient hospitalisations and dispensed prescriptions.

Future plans

The cohort will be improved through linkage to a broader variety of routinely collected data and to increasing amounts of genetic data obtained through blood sample diversion. We see the SHARE-MH cohort being used to drive forward novel areas of mental health research and to contribute to global efforts in psychiatric genetics.

Psychosocial safety climate (PSC) and working conditions, predictors of mental health and antidepressant and opioid use in Australia: a study protocol for longitudinal data linkage

Por: Crispin · C. N. · Afsharian · A. · Loh · M. Y. · Dollard · M. F. · Dormann · C. · Glozier · N. · Gill · T. · Taylor · A. W.
Introduction

Work-related stress is a social determinant of global health that represents a huge cost to workers’ health and reduces work performance. In Australia, mental well-being is a pressing national issue—with one in five Australians experiencing mental disorders. Antidepressants are a first-line medication commonly used to treat mental disorders. Recently, Australia has seen a dramatic increase in the use of prescribed antidepressant medications to treat mental health related illnesses. Australia has also seen a dramatic increase in the use of prescribed opioid analgesics for non-cancer pain including opioid use for psychological distress and social stressors. It is plausible a rise in mental health problems and antidepressant and opioid medication use is partly attributable to the corporate climate for worker mental health (ie, the psychosocial safety climate, PSC). This research aims to identify how PSC and workplace conditions contribute to employee well-being and distress that culminate in antidepressant and opioid medication use.

Methods/analysis

Data will be collected through creative data linkage from the Australian Workplace Barometer (AWB), to medication data (via the Pharmaceutical Benefits Scheme, PBS). The participant sample will include 1372 working Australians from the AWB project from 2009 to 2021. Four waves of longitudinal data from 2009 to 2021 will be used to investigate the plausible link between Australia’s high levels of antidepressant and opioid use and distress at work. The project advances theory by probing the role corporate climate plays in work design, distress, mental health problems and antidepressant and opioid use. It will determine if antidepressant and opioid use has led to an underestimation of work stress effects. Proposed theoretical models will be analysed through linked data, using continuous time structural equation modelling, hierarchical linear modelling, logistic regression and cost estimation.

Ethics and dissemination

The study has been approved by the Human Research Ethics Committee of the University of South Australia (Ethics Protocol: 203003). Further, approval from the Australian Institute of Health and Welfare Ethics Committee was also granted for linkage of AWB data and PBS data (EthOS Application EO2022/1/1190).

Results of the study will be disseminated through worldwide keynotes, key international settings, high-impact peer-reviewed journals, industry conference presentations and media outlets to reach managers, workers, and industry partners. Further, UniSA requires publications from public projects to be held in an institutional repository which fulfils the Australian Research Council’s Open Access Policy.

Longitudinal outcome monitoring in patients with chronic gastroduodenal symptoms investigated using the Gastric Alimetry system: study protocol

Por: Varghese · C. · Dachs · N. · Schamberg · G. · McCool · K. · Law · M. · Xu · W. · Calder · S. · Foong · D. · Ho · V. · Daker · C. · Andrews · C. N. · Gharibans · A. A. · O'Grady · G.
Introduction

The Gastric Alimetry platform offers a multimodal assessment of gastric function through body surface gastric mapping (BSGM) and concurrent symptom-tracking via a validated App. We aim to perform a longitudinal cohort study to examine the impact of Gastric Alimetry, and changes in clinical management on patient symptoms, quality of life and psychological health.

Methods and analysis

This is a prospective multicentre longitudinal observational cohort study of participants with chronic gastroduodenal symptoms. Consecutive participants undergoing Gastric Alimetry will be invited to participate. Quality of life will be assessed via EuroQol-5D and the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life score. Gastrointestinal symptoms will be assessed via the Patient Assessment of Upper Gastrointestinal Symptom Severity index, and the Gastroparesis Cardinal Symptom Index. Psychometrics will be assessed, including anxiety via the General Anxiety Disorder-7, perceived stress using the Perceived Stress Scale 4, and depression via the Patient Health Questionnaire 9. Clinical parameters including diagnoses, investigations and treatments (medication and procedures) will also be captured. Assessments will be made the week after the BSGM test, at 30 days, 90 days, 180 days and 360 days thereafter. The primary outcome is feasibility of longitudinal follow-up of a cohort that have undergone Gastric Alimetry testing; from which patients’ continuum of care can be characterised. Secondary outcomes include changes in patient-reported symptoms, quality of life and psychometrics (anxiety, stress and depression). Inferential causal analyses will be performed at the within patient level to explore causal associations between treatment changes and clinical outcomes. The impact of Gastric Alimetry on clinical management will also be captured.

Ethics and dissemination

The protocol has been approved in Aotearoa New Zealand by the Auckland Health Research Ethics Committee. Results will be submitted for conference presentation and peer-reviewed publication.

Barriers to and facilitators of effective management of fever episodes in hospitalised Kenyan children with cancer: protocol for convergent mixed methods study

Por: Nessle · C. N. · Njuguna · F. · Dettinger · J. · Koima · R. · Nyamusi · L. · Kisembe · E. · Kinja · S. · Ndungu · M. · Njenga · D. · Langat · S. · Olbara · G. · Moyer · C. · Vik · T.
Introduction

Febrile neutropenia is an oncological emergency in children with cancer, associated with serious infections and complications. In low-resourced settings, death from infections in children with cancer is 20 times higher than in high-resourced treatment settings, thought to be related to delays in antibiotic administration and management. The barriers to effective management of fever episodes in children with cancer have not previously been described. This convergent mixed-methods study will provide the evidence to develop fever treatment guidelines and to inform their effective implementation in children with cancer at Moi Teaching and Referral Hospital (MTRH), a level 6 referral hospital in western Kenya.

Methods and analysis

Prospective data collection of paediatric patients with cancer with new fever episodes admitted to MTRH will be performed during routine treatment. Clinical variables will be collected from 50 fever episodes, including cancer diagnosis and infectious characteristics of the fever episode, and elapsed time from fever onset to various milestones in the management workflow. Semistructured qualitative interviews with healthcare providers (estimated 20 to reach saturation) will explore the barriers to and facilitators of appropriate management of fever episodes in children with cancer. The interview guide was informed by a theoretical framework and Consolidated Framework for Implementation Research. A mixed-methods analysis use of joint display tables and process mapping will link and integrate the two types of data with meta-inferences.

Ethics and dissemination

Institutional review board approval was obtained from the MTRH (0004273) and the University of Michigan (HUM0225674), and the study was registered with National Commission for Science Technology and Innovation (P/23/22885). Written consent will be obtained from all participants. Results will be formally shared with local and national policy leadership and local end users, presented at relevant national academic conferences and submitted for publication in a peer-reviewed journal.

What health inequalities exist in access to, outcomes from and experience of treatment for lung cancer? A scoping review

Por: Lennox · L. · Lambe · K. · Hindocha · C. N. · Coronini-Cronberg · S.
Objectives

Lung cancer (LC) continues to be the leading cause of cancer-related deaths and while there have been significant improvements in overall survival, this gain is not equally distributed. To address health inequalities (HIs), it is vital to identify whether and where they exist. This paper reviews existing literature on what HIs impact LC care and where these manifest on the care pathway.

Design

A systematic scoping review based on Arksey and O’Malley’s five-stage framework.

Data sources

Multiple databases (EMBASE, HMIC, Medline, PsycINFO, PubMed) were used to retrieve articles.

Eligibility criteria

Search limits were set to retrieve articles published between January 2012 and April 2022. Papers examining LC along with domains of HI were included. Two authors screened papers and independently assessed full texts.

Data extraction and synthesis

HIs were categorised according to: (a) HI domains: Protected Characteristics (PC); Socioeconomic and Deprivation Factors (SDF); Geographical Region (GR); Vulnerable or Socially Excluded Groups (VSG); and (b) where on the LC pathway (access to, outcomes from, experience of care) inequalities manifest. Data were extracted by two authors and collated in a spreadsheet for structured analysis and interpretation.

Results

41 papers were included. The most studied domain was PC (32/41), followed by SDF (19/41), GR (18/41) and VSG (13/41). Most studies investigated differences in access (31/41) or outcomes (27/41), with few (4/41) exploring experience inequalities. Evidence showed race, rural residence and being part of a VSG impacted the access to LC diagnosis, treatment and supportive care. Additionally, rural residence, older age or male sex negatively impacted survival and mortality. The relationship between outcomes and other factors (eg, race, deprivation) showed mixed results.

Conclusions

Findings offer an opportunity to reflect on the understanding of HIs in LC care and provide a platform to consider targeted efforts to improve equity of access, outcomes and experience for patients.

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