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Evolution of the data and methods in real-world COVID-19 vaccine effectiveness studies on mortality: a scoping review protocol

Por: Stehlik · P. · Dowsett · C. · Camacho · X. · Falster · M. O. · Lim · R. · Nasreen · S. · Pratt · N. L. · Pearson · S.-A. · Henry · D.
Background

Early evidence on COVID-19 vaccine efficacy came from randomised trials. Many important questions subsequently about vaccine effectiveness (VE) have been addressed using real-world studies (RWS) and have informed most vaccination policies globally. As the questions about VE have evolved during the pandemic so have data, study design, and analytical choices. This scoping review aims to characterise this evolution and provide insights for future pandemic planning—specifically, what kinds of questions are asked at different stages of a pandemic, and what data infrastructure and methods are used?

Methods and analysis

We will identify relevant studies in the Johns Hopkins Bloomberg School of Public Health VIEW-hub database, which curates both published and preprint VE RWS identified from PubMed, Embase, Scopus, Web of Science, the WHO COVID Database, MMWR, Eurosurveillance, medRxiv, bioRxiv, SSRN, Europe PMC, Research Square, Knowledge Hub, and Google. We will include RWS of COVID-19 VE that reported COVID-19-specific or all-cause mortality (coded as ‘death’ in the ‘effectiveness studies’ data set).

Information on study characteristics; study context; data sources; design and analytic methods that address confounding will be extracted by single reviewer and checked for accuracy and discussed in a small group setting by methodological and analytic experts. A timeline mapping approach will be used to capture the evolution of this body of literature.

By describing the evolution of RWS of VE through the COVID-19 pandemic, we will help identify options for VE studies and inform policy makers on the minimal data and analytic infrastructure needed to support rapid RWS of VE in future pandemics and of healthcare strategies more broadly.

Ethics and dissemination

As data is in the public domain, ethical approval is not required. Findings of this study will be disseminated through peer-reviewed publications, conference presentations, and working-papers to policy makers.

Registration

https://doi.org/10.17605/OSF.IO/ZHDKR

Clinical efficacy of crushed prednisolone and hydrocolloid powder in the primary treatment of peristomal pyoderma gangrenosum and correlation to in vitro drug release data

Abstract

We evaluated the primary application of crushed prednisolone combined with hydrocolloid powder for clinically diagnosed peristomal pyoderma gangrenosum (PPG). We present our data on this cohort and follow-up of our previous patients. Of the 23 patients who were commenced on this regime, 18 healed (78%). Twenty-two patients commenced on this regime as the primary treatment for their PPG, and for one, it was a rescue remedy after failed conventional therapy. Four patients with significant medical comorbidities failed to heal and one had their stomal reversal surgery before being fully healed. The proposed treatment regime for PPG is demonstrated to be effective, inexpensive and able to be managed in the patient's usual home environment. In vitro drug release analysis was undertaken, and data are presented to provide further insights into the efficacy of this regime.

Association between long-term use of calcium channel blockers (CCB) and the risk of breast cancer: a retrospective longitudinal observational study protocol

Por: Ho · C. · Ha · N. T. · Youens · D. · Abhayaratna · W. P. · Bulsara · M. K. · Hughes · J. D. · Mishra · G. · Pearson · S.-A. · Preen · D. B. · Reid · C. M. · Ruiter · R. · Saunders · C. M. · Stricker · B. H. · van Rooij · F. J. A. · Wright · C. · Moorin · R.
Introduction

Calcium channel blockers (CCB), a commonly prescribed antihypertensive (AHT) medicine, may be associated with increased risk of breast cancer. The proposed study aims to examine whether long-term CCB use is associated with the development of breast cancer and to characterise the dose–response nature of any identified association, to inform future hypertension management.

Methods and analysis

The study will use data from 2 of Australia’s largest cohort studies; the Australian Longitudinal Study on Women’s Health, and the 45 and Up Study, combined with the Rotterdam Study. Eligible women will be those with diagnosed hypertension, no history of breast cancer and no prior CCB use at start of follow-up (2004–2009). Cumulative dose-duration exposure to CCB and other AHT medicines will be captured at the earliest date of: the outcome (a diagnosis of invasive breast cancer); a competing risk event (eg, bilateral mastectomy without a diagnosis of breast cancer, death prior to any diagnosis of breast cancer) or end of follow-up (censoring event). Fine and Gray competing risks regression will be used to assess the association between CCB use and development of breast cancer using a generalised propensity score to adjust for baseline covariates. Time-varying covariates related to interaction with health services will also be included in the model. Data will be harmonised across cohorts to achieve identical protocols and a two-step random effects individual patient-level meta-analysis will be used.

Ethics and dissemination

Ethical approval was obtained from the following Human research Ethics Committees: Curtin University (ref No. HRE2022-0335), NSW Population and Health Services Research Ethics Committee (2022/ETH01392/2022.31), ACT Research Ethics and Governance Office approval under National Mutual Acceptance for multijurisdictional data linkage research (2022.STE.00208). Results of the proposed study will be published in high-impact journals and presented at key scientific meetings.

Trial registration number

NCT05972785.

Systematic review of best practices for GPS data usage, processing, and linkage in health, exposure science and environmental context research

Por: Pearson · A. L. · Tribby · C. · Brown · C. D. · Yang · J.-A. · Pfeiffer · K. · Jankowska · M. M.

Global Positioning System (GPS) technology is increasingly used in health research to capture individual mobility and contextual and environmental exposures. However, the tools, techniques and decisions for using GPS data vary from study to study, making comparisons and reproducibility challenging.

Objectives

The objectives of this systematic review were to (1) identify best practices for GPS data collection and processing; (2) quantify reporting of best practices in published studies; and (3) discuss examples found in reviewed manuscripts that future researchers may employ for reporting GPS data usage, processing and linkage of GPS data in health studies.

Design

A systematic review.

Data sources

Electronic databases searched (24 October 2023) were PubMed, Scopus and Web of Science (PROSPERO ID: CRD42022322166).

Eligibility criteria

Included peer-reviewed studies published in English met at least one of the criteria: (1) protocols involving GPS for exposure/context and human health research purposes and containing empirical data; (2) linkage of GPS data to other data intended for research on contextual influences on health; (3) associations between GPS-measured mobility or exposures and health; (4) derived variable methods using GPS data in health research; or (5) comparison of GPS tracking with other methods (eg, travel diary).

Data extraction and synthesis

We examined 157 manuscripts for reporting of best practices including wear time, sampling frequency, data validity, noise/signal loss and data linkage to assess risk of bias.

Results

We found that 6% of the studies did not disclose the GPS device model used, only 12.1% reported the per cent of GPS data lost by signal loss, only 15.7% reported the per cent of GPS data considered to be noise and only 68.2% reported the inclusion criteria for their data.

Conclusions

Our recommendations for reporting on GPS usage, processing and linkage may be transferrable to other geospatial devices, with the hope of promoting transparency and reproducibility in this research.

PROSPERO registration number

CRD42022322166.

Exploring the patient experience of remote hypertension management in Scotland during COVID-19: a qualitative study

Por: Mchale · S. · Paterson · M. · Pearsons · A. · Neubeck · L. · Atherton · I. · Guthrie · B. · McKinstry · B. · Hanley · J.
Objectives

The aim of this study was to understand how patients experienced hypertension management, with or without blood pressure (BP) telemonitoring, during the COVID-19 pandemic.

Design, methods, participants and setting

This qualitative study conducted between April and November 2022 consisted of 43 semistructured telephone interviews (23 men and 20 women) from 6 primary care practices in one area of Scotland.

Results

From the views of 25 participants with experience of using the Connect Me telemonitoring service and 18 participants without such experience, 5 themes were developed. These were: (1) navigating access to services. There were challenges to gaining timely and/or in-person access to services and a reluctance to attend clinical settings because participants were aware of their increased risk of contracting the COVID-19 virus. (2) Adapting National Health Service services. All six practices had adapted care provision in response to potential COVID-19 transmission; however, these adaptations disrupted routine management of in-person primary care hypertension, diabetes and/or asthma checks. (3) Telemonitoring feedback. Telemonitoring reduced the need to attend in-person primary care practices and supported access to remote healthcare monitoring and feedback. (4) Self-management. Many non-telemonitoring participants were motivated to use self-management strategies to track their BP using home monitoring equipment. Also, participants were empowered to self-manage lifestyle and hypertension medication. (5) Experience of having COVID-19. Some participants contracting the COVID-19 virus experienced an immediate increase in their BP while a few experienced ongoing increased BP readings.

Conclusions

The COVID-19 pandemic disrupted routine in-person care for patients with hypertension. Both telemonitoring and some non-telemonitoring patients were motivated to self-manage hypertension, including self-adjusting medication; however, only those with access to telemonitoring had increased access to hypertension monitoring and feedback. BP telemonitoring permitted routine care to continue for participants in this study and may offer a service useful in pandemic proofing hypertension healthcare in the future.

How can NHS trusts in England optimise strategies to improve the mental health and well-being of hospital doctors? The Care Under Pressure 3 (CUP3) realist evaluation study protocol

Por: Bramwell · C. · Carrieri · D. · Melvin · A. · Pearson · A. · Scott · J. · Hancock · J. · Pearson · M. · Papoutsi · C. · Wong · G. · Mattick · K.
Introduction

The growing incidence of mental ill health in doctors was a major issue in the UK and internationally, even prior to the COVID-19 pandemic. It has significant and far-reaching implications, including poor quality or inconsistent patient care, absenteeism, workforce attrition and retention issues, presenteeism, and increased risk of suicide. Existing approaches to workplace support do not take into account the individual, organisational and social factors contributing to mental ill health in doctors, nor how interventions/programmes might interact with each other within the workplace. The aim of this study is to work collaboratively with eight purposively selected National Health Service (NHS) trusts within England to develop an evidence-based implementation toolkit for all NHS trusts to reduce doctors’ mental ill health and its impacts on the workforce.

Methods and analysis

The project will incorporate three phases. Phase 1 develops a typology of interventions to reduce doctors’ mental ill health. Phase 2 is a realist evaluation of the existing combinations of strategies being used by acute English healthcare trusts to reduce doctors’ mental ill health (including preventative promotion of well-being), based on 160 interviews with key stakeholders. Phase 3 synthesises the insights gained through phases 1 and 2, to create an implementation toolkit that all UK healthcare trusts can use to optimise their strategies to reduce doctors’ mental ill health and its impact on the workforce and patient care.

Ethics and dissemination

Ethical approval has been granted for phase 2 of the project from the NHS Research Ethics Committee (REC reference number 22/WA/0352). As part of the conditions for our ethics approval, the sites included in our study will remain anonymous. To ensure the relevance of the study’s outputs, we have planned a wide range of dissemination strategies: an implementation toolkit for healthcare leaders, service managers and doctors; conventional academic outputs such as journal manuscripts and conference presentations; plain English summaries; cartoons and animations; and a media engagement campaign.

“Are you doing your pelvic floor?” An ethnographic exploration of the interaction between women and midwives about pelvic floor muscle exercises (PFME) during pregnancy

Many women experience urinary incontinence (UI) during and after pregnancy. Pelvic floor muscle exercises (PFME) can prevent and reduce the symptoms of UI. The objective of the study was to explore challenges, opportunities and concerns for women and health care professionals (HCPs), related to the implementation of PFME training for women in current antenatal care.
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