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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

Primary care quality for older adults: Practice-based quality measures derived from a RAND/UCLA appropriateness method study

by Rebecca H. Correia, Darly Dash, Aaron Jones, Meredith Vanstone, Komal Aryal, Henry Yu-Hin Siu, Aquila Gopaul, Andrew P. Costa

We established consensus on practice-based metrics that characterize quality of care for older primary care patients and can be examined using secondary health administrative data. We conducted a two-round RAND/UCLA Appropriateness Method (RAM) study and recruited 10 Canadian clinicians and researchers with expertise relevant to the primary care of elderly patients. Informed by a literature review, the first RAM round evaluated the appropriateness and importance of candidate quality measures in an online questionnaire. Technical definitions were developed for each endorsed indicator to specify how the indicator could be operationalized using health administrative data. In a virtual synchronous meeting, the expert panel offered feedback on the technical specifications for the endorsed indicators. Panelists then completed a second (final) questionnaire to rate each indicator and corresponding technical definition on the same criteria (appropriateness and importance). We used statistical integration to combine technical expert panelists’ judgements and content analysis of open-ended survey responses. Our literature search and internal screening resulted in 61 practice-based quality indicators for rating. We developed technical definitions for indicators endorsed in the first questionnaire (n = 55). Following the virtual synchronous meeting and second questionnaire, we achieved consensus on 12 practice-based quality measures across four Priority Topics in Care of the Elderly. The endorsed indicators provide a framework to characterize practice- and population-level encounters of family physicians delivering care to older patients and will offer insights into the outcomes of their care provision. This study presented a case of soliciting expert feedback to develop measurable practice-based quality indicators that can be examined using administrative data to understand quality of care within population-based data holdings. Future work will refine and operationalize the technical definitions established through this process to examine primary care provision for older adults in a particular context (Ontario, Canada).

Sleep and cognition in South African patients with non-functioning pituitary adenomas

by Olivia de Villiers, Claudia Elliot-Wilson, Kevin G. F. Thomas, Patrick L. Semple, Thurandrie Naiker, Michelle Henry, Ian L. Ross

Strong lines of evidence in the neuroscience literature indicate that (a) healthy sleep facilitates cognitive processing, and (b) sleep disruption is associated with cognitive dysfunction. Despite the fact that patients with pituitary disease often display both disrupted sleep and cognitive dysfunction, few previous studies investigate whether these clinical characteristics in these patients might be related. Hence, we explored whether sleep disruption in patients with pituitary disease mediates their cognitive dysfunction. We recruited 18 patients with non-functioning pituitary adenomas (NFPA) and 19 sociodemographically matched healthy controls. They completed the Global Sleep Assessment Questionnaire (thus providing self-report data regarding sleep disruption) and were administered the Brief Test of Adult Cognition by Telephone, which assesses cognitive functioning in the domains of processing speed, working memory, episodic memory, inhibition, and reasoning. We found no significant differences in cognition between patients and controls. Furthermore, spectra of sleep disturbance did not differ significantly between patients and controls. Our data suggest that NFPA patients’ cognition and sleep quality is relatively intact, and that sleep disruption does not mediate cognitive dysfunction. Larger studies should characterize sleep and cognition in patients with NFPA (and other pituitary diseases) to confirm whether disruption of the former mediates impairment in the latter.

Exploring NICU nurses' views of a novel genetic point‐of‐care test identifying neonates at risk of antibiotic‐induced ototoxicity: A qualitative study

Abstract

Aim

To explore the views of neonatal intensive care nursing staff on the deliverability of a novel genetic point-of-care test detecting a genetic variant associated with antibiotic-induced ototoxicity.

Design

An interpretive, descriptive, qualitative interview study.

Methods

Data were collected using semi-structured interviews undertaken between January and November 2020. Participants were neonatal intensive care nursing staff taking part in the Pharmacogenetics to Avoid Loss of Hearing trial.

Results

Thematic analysis resulted in four themes: perceived clinical utility; the golden hour; point-of-care device; training and support. Recommendations were made to streamline the protocol and ongoing training and support were considered key to incorporating the test into routine care.

Conclusion

Exploring the views of nurses involved in the delivery of the point-of-care test was essential in its implementation. By the study endpoint, all participants could see the value of routine clinical introduction of the point-of care test.

Implications for the Profession and/or Patient Care

Nurses are in a key position to support the delivery of point-of-care genetic testing into mainstream settings. This study has implications for the successful integration of other genetic point-of-care tests in acute healthcare settings.

Impact

The study will help to tailor the training and support required for routine deployment of the genetic point-of-care test. The study has relevance for nurses involved in the development and delivery of genetic point-of-care tests in other acute hospital settings.

Reporting Method

This qualitative study adheres to the Standards for Reporting Qualitative Research EQUATOR guidelines and utilizes COREQ and SRQR checklists.

Patient or Public Contribution

All staff working on the participating neonatal intensive care units were trained to use the genetic point-of-care test. All inpatients on the participating units were eligible to have testing via the point-of-care test. The Pharmacogenetics to Avoid Loss of Hearing Patient and Public Involvement and Engagement group provided valuable feedback.

Trial and Protocol Registration

Registered within the University of Manchester. Ethics approval reference numbers: IRAS: 253102 REC reference: 19/NW/0400. Also registered with the ISRCTN ref: ISRCTN13704894.

Research priorities for childrens cancer: a James Lind Alliance Priority Setting Partnership in the UK

Por: Aldiss · S. · Hollis · R. · Phillips · B. · Ball-Gamble · A. · Brownsdon · A. · Chisholm · J. · Crowther · S. · Dommett · R. · Gower · J. · Hall · N. J. · Hartley · H. · Hatton · J. · Henry · L. · Langton · L. · Maddock · K. · Malik · S. · McEvoy · K. · Morgan · J. E. · Morris · H. · Parke
Objectives

To engage children who have experienced cancer, childhood cancer survivors, their families and professionals to systematically identify and prioritise research questions about childhood cancer to inform the future research agenda.

Design

James Lind Alliance Priority Setting Partnership.

Setting

UK health service and community.

Methods

A steering group oversaw the initiative. Potential research questions were collected in an online survey, then checked to ensure they were unanswered. Shortlisting via a second online survey identified the highest priority questions. A parallel process with children was undertaken. A final consensus workshop was held to determine the Top 10 priorities.

Participants

Children and survivors of childhood cancer, diagnosed before age 16, their families, friends and professionals who work with this population.

Results

Four hundred and eighty-eight people submitted 1299 potential questions. These were refined into 108 unique questions; 4 were already answered and 3 were under active study, therefore, removed. Three hundred and twenty-seven respondents completed the shortlisting survey. Seventy-one children submitted questions in the children’s surveys, eight children attended a workshop to prioritise these questions. The Top 5 questions from children were taken to the final workshop where 23 questions in total were discussed by 25 participants (young adults, carers and professionals). The top priority was ‘can we find effective and kinder (less burdensome, more tolerable, with fewer short and long-term effects) treatments for children with cancer, including relapsed cancer?’

Conclusions

We have identified research priorities for children’s cancer from the perspectives of children, survivors, their families and the professionals who care for them. Questions reflect the breadth of the cancer experience, including diagnosis, relapse, hospital experience, support during/after treatment and the long-term impact of cancer. These should inform funding of future research as they are the questions that matter most to the people who could benefit from research.

Experiences of mothers and health workers with MomCare and SafeCare bundles in Kenya and Tanzania: A qualitative evaluation

by Jonathan Izudi, Henry Odero Owoko, Moussa Bagayoko, Damazo Kadengye

Between 2019 and 2022, the digital dividend project (DDP), a technology-based intervention that combined care (MomCare) and quality improvement (SafeCare) bundles to empower mothers to access quality care during pregnancy, labor, and delivery, and postnatally, was implemented in Kenya and Tanzania aiming to improve maternal and newborn health outcomes. We describe the experiences of the mothers in accessing and utilizing health services under the bundles, and the experiences of the health workers in providing the services. Between November and December 2022, we conducted a qualitative evaluation across health facilities in Kenya and Tanzania. We held Interviews with mothers (pregnant and postpartum women who had benefited from the care bundles) and health workers (physicians, nurses, and midwives who provided the care bundles, including health facility In-Charges) at the antenatal care (ANC), skilled birth attendance (SBA), and postnatal care (PNC) service delivery points. We performed content analysis. Findings are reported using themes and quotes from the participants. We included 127 mothers (Kenya = 76, Tanzania = 51) and 119 health workers. Findings revealed that among mothers, the care bundles eased access to health services, ensured easy access and optimal ANC use, provision of respectful care, removed financial constraints, and led to the receipt of sufficient health education. Health workers reported that the care bundles offered them a new opportunity to provide quality maternal and newborn care and to adhere to the standard of care besides experiencing a positive and fulfilling practice. Health systems improvements included prompt emergency response and continual care, infrastructural developments, medical supplies and logistics, staffing, and increased documentation. Overall, the care bundles led to the strengthening of the healthcare system (staffing, service delivery, financing, supplies/logistics, and information management) in order to deliver quality maternal and child health services. The bundles should be replicated in settings with similar maternal and child health challenges.
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