Guidelines For Health Research Research Articles

Evaluation of the Implementation of Low-Low Hospital Beds With Respect to Fall Frequency and Patient Harms: ARetrospective Analysis.

To identify whether the introduction of low-low hospital beds resulted in changes in the incidence, associated patient harms and event characteristics of bed-related falls where implemented. This retrospective quality improvement study covered 36 months: 18 months pre-intervention and 18 months post-intervention. Our analysis incorporated patient fall data from a hospital in upstate New York. Pre-/post-intervention data covered 18 months on either side of introduction at the units of implementation. Data were sourced from contemporaneously recorded incident reports and the organisation's business intelligence records. Analysis addressed the incidence rate, frequency, patient harm classification and recurrence of bed-related falls, as well as Morse Fall Scale risk classification, patient age, gender and other individualised risk factors. Lastly, we reviewed the presence of individualised interventions, staff assistance during the event, patient census and staffing ratios. Chi-square goodness of fit tests were employed to compare the distribution, and Brunner-Munzel tests the stochastic equality, of the pre- and post-implementation categorical and continuous data. There were no significant differences in the incidence rate of bed-related falls, patient harms or in the need for medical intervention following implementation of the low-low hospital beds. Neither were there any significant differences in the proportion of events resulting in detectable harm or the need for medical intervention post-implementation. The total number of bed-involved falls substantively increased following implementation of the low-low beds, as did the number of events resulting in detectable harms and medical intervention. Among these, substantive increases were noted among events resulting in minor temporary harm and patients referred for diagnostic imaging. The number of events involved patients experiencing recurrent falls of any kind increased significantly post-implementation. We found that the introduction of low-low hospital beds preceded no change in the incidence of bed-related falls, associated patient harms or the need for post-event medical intervention where implemented. While data limitations precluded definitive determination with respect to certain event characteristics, several post-implementation changes, including substantive increases in the number of falls occurring during ingress and egress, may suggest a potential for relationship worthy of future study. Low-low hospital beds are purported to help reduce the occurrence and severity of bed-related falls, both serious problems in inpatient settings. This study describes null outcomes following an implementation of such beds, with implications for adoption in similar settings. We adhered to the relevant Enhancing the Quality and Transparency of Health Research guidelines, specifically following the Standards for Quality Improvement Reporting Excellence standards. No patient or public involvement in the design or conduct of the study. Nurses and medical staff were involved in intervention implementation, data collection and the conception, design and conduct of the study.

Community health promotion and medical provision and impact on neonates (CHAMPION2) and support to rural India’s public education system and impact on numeracy and literacy scores (STRIPES2): an update to the study protocol (v 11) for a cluster randomised trial in Madhya Pradesh, India

BackgroundThis update outlines amendments to the CHAMPION2/STRIPES2 cluster randomised trial protocol primarily made due to the COVID-19 pandemic and nationwide lockdown in India in 2020. These amendments were in line with national guidelines for health research during the COVID-19 pandemic.MethodsWe did not change the original trial design, eligibility, and outcomes. Amendments were introduced to minimise the risk of COVID-19 transmission and ensure safety and wellbeing of trial staff, participants, and other villagers. CHAMPION2 intervention: participatory learning and action (PLA) and fixed day service (FDS) meeting were revised to incorporate social distancing and hygiene precautions. During the COVID-19 pandemic, PLA participation was limited to pregnant women and birthing partners. STRIPES2 intervention: before/after-school classes were halted for a period and then modified temporarily (reducing class sizes, and/or changing meeting places) with hygiene and safe distancing practices introduced. Data collection: The research team gathered as much information as possible from participants by telephone. If the participant had no telephone or could not be contacted by telephone, data were collected in person. COVID-19 precautions: trial teams were trained on COVID-19 precautions and used personal protective equipment whilst in the villages for trial-related activities.After restarting the trial between June and September 2020 in a phased manner, some trial activities were suspended again in all the trial villages from April to June 2021 due to the second wave of COVID-19 cases and lockdown imposed in Satna, Madhya Pradesh. Trial timelines were also revised, with outcomes measured later than originally planned.Trial registrationClinical Trial Registry of India CTRI/2019/05/019296. Registered 23 May 2019.https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MzExOTg=&Enc=&userName=champion2.

Towards precision cancer medicine for Aboriginal and Torres Strait Islander cancer health equity.

Delivering cancer control at scale for Aboriginal and Torres Strait Islander communities is a national priority that requires Aboriginal and Torres Strait Islander leadership and codesign, as well as significant involvement of the Aboriginal community-controlled health sector. The unique genomic variation observed among Aboriginal and Torres Strait Islander peoples may have implications for standard and precision medicine. Yet, Aboriginal and Torres Strait Islander peoples are absent from, or under-represented within, human reference genome resources, genomic studies, cancer studies, cancer cell lines, patient-derived xenografts and cancer clinical trials. Genomics-guided precision cancer medicine offers an opportunity to reduce cancer health disparities experienced by Aboriginal and Torres Strait Islander peoples through personalising prevention, diagnosis, treatment and long term management. Here, we describe what is required to ensure that Aboriginal and Torres Strait Islander peoples can receive the benefits of precision cancer medicine. Equity of access to care, an Aboriginal and Torres Strait Islander cancer workforce, and appropriate genome reference resources are important for safe and effective cancer medicine. Building Indigenous data sovereignty principles and Aboriginal and Torres Strait Islander governance into research is required to protect Aboriginal and Torres Strait Islander rights and collective interests. Aboriginal and Torres Strait Islander community engagement should be undertaken to develop an understanding of the unique cultural and ethical considerations for precision cancer research. Local and national genomic health research guidelines are needed to define a consensus best practice in genomics research with Aboriginal and Torres Strait Islander peoples.

A pathway to strengthening open science: comments on the draft South African Ethics in Health Research Guidelines.

The recently released draft South African Ethics in Health Research Guidelines: Principles, Processes and Structures (Draft Guidelines) by the National Health Research Ethics Council recognize open data and provide guiding principles for this in the context of health research in South Africa. While its inclusion is a positive development, there is room for improvement. Although the Draft Guidelines leverage the Draft National Policy on Data and Cloud, it lacks incorporation of other relevant government policies, notably the Draft National Open Science Policy, and fails to sufficiently detail the principles of open science and open access. This limited scope and lack of comprehensive definition and detailed guidance present challenges for researchers in conducting ethical and responsible health research in South Africa. It constrains the Draft Guidelines from fully aligning with national imperatives and from fostering African-centric approaches. To address these issues, it is recommended that the Draft Guidelines integrate broader policies and principles, enhance clarity through comprehensive definitions, provide detailed guidance on open access, and promote African-centric approaches. Implementing these solutions will strengthen the Draft Guidelines, aligning them with national visions of open science, and thereby harnessing the full potential of South Africa's diverse scientific community in advancing health research.

A cross-sectional analysis identified co-authorship networks and scientific collaboration on reporting guidelines for health research

ObjectivesTo investigate scientific collaboration and citation metrics of reporting guidelines for health research. Study Design and SettingA cross-sectional analysis of published articles of reporting guidelines for health research. A search of the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network Library (from inception to January 21, 2021) was supplemented by searching websites of guideline developers. For each article, metadata (e.g., authors, institutions, countries, citations) were extracted from the Web of Science and Scopus (up to October 25, 2021). Descriptive analyses were conducted. Network analyses of collaborations were presented. ResultsWe included 662 articles published in 332 journals. The BMJ (n = 50 articles; 8%), Annals of Internal Medicine (n = 29; 4%), and Journal of Clinical Epidemiology (n = 24; 4%) published the largest number of articles. Four thousand seven hundred twenty two authors, 1,647 institutions, and 83 countries were involved. The global productivity was led by the United States (n = 456 articles), the United Kingdom (n = 414), and Canada (n = 306). We found eight clusters of authors (e.g., one major group with 337 members) and three clusters of institutions (e.g., one major group with 256 members). The most prolific authors were affiliated with the Ottawa Hospital Research Institute (Canada), the University of Ottawa (Canada), the University of Oxford (the United Kingdom), and Stanford University (the United States). ConclusionOur analysis identified key actors producing reporting guidelines, most intense collaborations, and ‘citation classics’ in the field. These results could potentially be used to strengthen collaborations for developing and disseminating reporting guidelines for health research.

FAIR Equivalency, Regulatory Framework and Adoption Potential of FAIR Guidelines in Health in Kenya

AbstractThis study explored the regulatory framework in Kenya that may facilitate the implementation of the FAIR Guidelines in health research, as well as the possibility of adopting the FAIR Guidelines at the national level. Fourteen key documents pivotal to the emerging digital health sector in Kenya were identified and analysed using a comprehensive coding and labelling approach based on a binary system for whether or not they mention the FAIR Guidelines or terms and vocabulary related to the FAIR Guidelines. The analysis revealed gaps in data stewardship that could be filled by the implementation of the FAIR Guidelines and, although the documents analysed do not explicitly mention the FAIR Guidelines, FAIR Equivalent terminology and practices are mentioned in varying detail. However, our analysis shows that there are still no provisions for the introduction and implementation of the FAIR Guidelines in health research in Kenya. Therefore, we recommend that the leadership be provided with a comprehensive introduction to the FAIR Guidelines, success stories about the FAIRification of data and research infrastructure in other parts of the world, and a demonstration of the steps needed for the FAIRification of health data in Kenya.

Reporting guideline for overviews of reviews of healthcare interventions: development of the PRIOR statement

ObjectiveTo develop a reporting guideline for overviews of reviews of healthcare interventions.DesignDevelopment of the preferred reporting items for overviews of reviews (PRIOR) statement.ParticipantsCore team (seven individuals) led day-to-day operations, and...

Developing a Health Care Transition Intervention With Young People With Spinal Cord Injuries: Co-design Approach

BackgroundSuccessful transition from pediatric to adult health care settings supports long-term health management and better overall outcomes in all domains. However, young people with spinal cord injuries (SCIs) continue to report challenges and unmet needs during the transition process. Including end users in health care research and intervention design is paramount as interventions designed in this way better meet their specific needs and are often more innovative. Although studies have reported involving young people with chronic conditions in the development of health care transition (HCT) interventions, few details have been provided as to how this was achieved.ObjectiveThis study outlined the co-design and development of an HCT intervention to support young people with SCIs. It contextualized the co-design process, methods, materials used, and steps implemented from defining the problem to conceiving and designing the solution. This was accomplished by understanding and listening to end users’ needs and recommendations for HCT.MethodsUsing participatory methods, this qualitative study reports the co-design of an HCT intervention to support young people with SCIs and parents or caregivers. Two co-design workshops were conducted: one with young people with SCIs and one with parents and caregivers. Categories were defined through a hybrid deductive and inductive qualitative content analysis process that was informed by the Care Transitions Framework and guided the development of the HCT intervention. Following the creation of a prototype intervention, young people with SCIs, parents and caregivers, and key pediatric SCI stakeholders provided feedback on the intervention content and design in focus groups. Similar to the workshops, the focus groups were analyzed using a hybrid deductive and inductive qualitative content analysis process informed by the Care Transitions Framework. The Enhancing the Quality and Transparency of Health Research guidelines for qualitative research (Consolidated Criteria for Reporting Qualitative Research) were applied.ResultsOverall, 4 young people and 4 parents or caregivers participated in the co-design workshops. Key recommendations for the HCT intervention were that participants wanted a “one-stop shop” for all their transition information needs and an editable portable medical summary to take with them to appointments. On the basis of the analysis of participants’ recommendations from the workshops, it was determined that a website would be an appropriate hosting platform for the interventions. The focus group feedback on the design and content of the prototype website was extremely positive, with minor recommendations for improvement.ConclusionsThis is the first study to co-design and develop an HCT intervention in partnership with young people with SCIs and parents and caregivers. Although the study sample was small, it has shown that it is possible to meaningfully engage and empower young people with SCIs and parents and caregivers in the co-design of an HCT intervention.International Registered Report Identifier (IRRID)RR2-10.1136/bmjopen-2021-053212

Risk of Subsequent Stroke Among Patients Receiving Outpatient vs Inpatient Care for Transient Ischemic Attack

Transient ischemic attack (TIA) often indicates a high risk of subsequent cerebral ischemic events. Timely preventive measures improve the outcome. To estimate and compare the risk of subsequent ischemic stroke among patients with TIA or minor ischemic stroke (mIS) by care setting. MEDLINE, Web of Science, Scopus, Embase, International Clinical Trials Registry Platform, ClinicalTrials.gov, Trip Medical Database, CINAHL, and all Evidence-Based Medicine review series were searched from the inception of each database until October 1, 2020. Studies evaluating the occurrence of ischemic stroke after TIA or mIS were included. Cohorts without data on evaluation time for reporting subsequent stroke, with retrospective diagnosis of the index event after stroke occurrence, and with a report of outcomes that were not limited to patients with TIA or mIS were excluded. Two authors independently screened the titles and abstracts and provided the list of candidate studies for full-text review; discrepancies and disagreements in all steps of the review were addressed by input from a third reviewer. The study was prepared and reported following the Preferred Reporting Items for Systematic Reviews and Meta-analyses, Meta-analysis of Observational Studies in Epidemiology, Methodological Expectations of Cochrane Intervention Reviews, and Enhancing the Quality and Transparency of Health Research guidelines. The Risk of Bias in Nonrandomized Studies-of Exposures (ROBINS-E) tool was used for critical appraisal of cohorts, and funnel plots, Begg-Mazumdar rank correlation, Kendall τ2, and the Egger bias test were used for evaluating the publication bias. All meta-analyses were conducted under random-effects models. Risk of subsequent ischemic stroke among patients with TIA or mIS who received care at rapid-access TIA or neurology clinics, inpatient units, emergency departments (EDs), and unspecified or multiple settings within 4 evaluation intervals (ie, 2, 7, 30, and 90 days). The analysis included 226 683 patients from 71 articles recruited between 1981 and 2018; 5636 patients received care at TIA clinics (mean [SD] age, 65.7 [3.9] years; 2291 of 4513 [50.8%] men), 130 139 as inpatients (mean [SD] age, 78.3 [4.0] years; 49 458 of 128 745 [38.4%] men), 3605 at EDs (mean [SD] age, 68.9 [3.9] years; 1596 of 3046 [52.4%] men), and 87 303 patients received care in an unspecified setting (mean [SD] age, 70.8 [3.8] years, 43 495 of 87 303 [49.8%] men). Among the patients who were treated at a TIA clinic, the risk of subsequent stroke following a TIA or mIS was 0.3% (95% CI, 0.0%-1.2%) within 2 days, 1.0% (95% CI, 0.3%-2.0%) within 7 days, 1.3% (95% CI, 0.4%-2.6%) within 30 days, and 2.1% (95% CI, 1.4%-2.8%) within 90 days. Among the patients who were treated as inpatients, the risk of subsequent stroke was to 0.5% (95% CI, 0.1%-1.1%) within 2 days, 1.2% (95% CI, 0.4%-2.2%) within 7 days, 1.6% (95% CI, 0.6%-3.1%) within 30 days, and 2.8% (95% CI, 2.1%-3.5%) within 90 days. The risk of stroke among patients treated at TIA clinics was not significantly different from those hospitalized. Compared with the inpatient cohort, TIA clinic patients were younger and had had lower ABCD2 (age, blood pressure, clinical features, duration of TIA, diabetes) scores (inpatients with ABCD2 score >3, 1101 of 1806 [61.0%]; TIA clinic patients with ABCD2 score >3, 1933 of 3703 [52.2%]). In this systematic review and meta-analysis, the risk of subsequent stroke among patients who were evaluated in a TIA clinic was not higher than those hospitalized. Patients who received treatment in EDs without further follow-up had a higher risk of subsequent stroke. These findings suggest that TIA clinics can be an effective component of the TIA care component pathway.

Evaluating the intended and unintended consequences of opioid-prescribing interventions on primary care in British Columbia, Canada: protocol for a retrospective population-based cohort study

IntroductionBetween 2015 and 2018, there were over 40 000 opioid-related overdose events and 4551 deaths among residents in British Columbia (BC). During this time the province mobilised a variety of...

Aboriginal Human Research Ethics Committees ensuring culturally appropriate research

Abstract Aboriginal and Torres Strait Islander people, Australia's Indigenous peoples, make up three percent of the population of Australia. Like many other Indigenous peoples in colonised countries, they suffer the worst health and social status of any population group. Australian Indigenous people have a lower life expectancy (8.6 years lower for men and 7.8 years for women) compared with other Australians (ABS 2018a). The reasons for the poorer health outcomes are complex and include historical, political and social factors (AIHW 2015a). The health disparity has driven a high number of research projects with a focus on Australian Indigenous people or mainstream research projects where Australian Indigenous people are overrepresented. Given the uniqueness of Australian Indigenous cultures as well as the historical, political and social context, in 1998, the Aboriginal Health and Medical Research Council of New South Wales (AH&MRC) established an Australian Indigenous-specific human research ethics committee (HREC). The AH&MRC is the Indigenous peak health body of New South Wales. This presentation will outline the role and benefit of the AH&MRC HREC as a specialised HREC. The AH&MRC HREC is fully constituted and registered under the National Health and Medical Research Council (NHMRC). The NHMRC is the leading expert body in health and medical research in Australia and develops health research guidelines. The AH&MRC HREC is one of three AHRECs in Australia. The AH&MRC Ethics Committee not only guarantees that research is conducted ethically but also ensures research involving Indigenous people is undertaken in a culturally appropriate manner. One of the key elements required by the AH&MRC is that researchers consult Indigenous communities across all stages of the project from the design, implementation, analysis and write up. The AH&MRC HREC is essential, ensuring the research is of benefit to the Indigenous community in NSW and is conducted in a culturally safe manner. Key messages Specialised Indigenous human resarch ethics committees are vital to enuring research is culturally appropriate. Spscialised human resarch ethics committees can be of benefit for other disctinct populations.

A Principled Approach to Research Conducted with Inuit, Métis, and First Nations People: Promoting Engagement Inspired by the CIHR Guidelines for Health Research Involving Aboriginal People (2007-2010)

Research to address the health burdens experienced by Indigenous populations is essential. In the Canadian context, the Truth and Reconciliation Commission of Canada determined that these health burdens are the result of policies that have undermined opportunities to address community-level health needs. The Canadian Institutes of Health Research Guidelines for Health Research Involving Aboriginal People (2007-2010), or“CIHR Guidelines,” were prepared in a national consultation process involving Inuit, Métis, and First Nations communities, researchers, and institutions. This paper asserts that the principles espoused in the CIHR Guidelines hold ongoing potential to guide health research with Indigenous people in ways that promote equitable research partnerships. We encourage those in research environments to engage with the spirit and content of the CIHR Guidelines.

Child Protective Services and University-Based Partnerships: A Participatory Action-Based Model for Creating and Sharing Knowledge

This paper presents one model for building and sustaining a research partnership between researchers and professional staff in child protection (CPS) agencies. The Maltreatment and Adolescent Pathways (MAP) study was designed to assess the health and well-being of the population of adolescents involved in the child welfare system of a major urban area. The study involved the collaboration between university based researchers and a range of child welfare staff, from administration to front-line workers. A key factor supporting collaboration was reciprocity with expertise, with CPS practitioner knowledge yielding intervention-relevant study queries and constructs, and researcher knowledge on health content and best practices yielding tailored training opportunities and increased climate for knowledge uptake. The MAP study combined a Participatory Action Research (PAR) model with a traditional, scientific positivist model, including the scientific elements of standardized measures, explicit evaluation of the participatory process, and research impact on the community members. This study: 1) provides information on the process of creating effective researcher-CPC agency partnerships, 2) considers key ethics issues, such as the participant’s reactivity to research of child welfare- involved clients, and 3) examines the implications of implanting a PAR approach in research with Aboriginal CPS agencies, as per the required use of the Canadian Institutes of Health Research (CIHR) Guidelines for Health Research Involving Aboriginal People for future community- university partnerships.

Health and Demographic Surveillance System Sites: Reflections on Global Health Research Ethics

Although there should be no ambivalence regarding the importance of the Health and demographic surveillance System (HDSS), surveillance and research on human populations is beset with a variety of ethical issues. This is particularly true in the area of global health research, which merits attention in health policies related to research ethics. The objective of this paper is to analyse the use of HDSS sites to obtain data and to resolve ethical conflicts over HDSS approaches, such as those related to data collection, surveillance, and research. This analysis is done in light of guidance on central ethical issues relating to health research such as the International Ethical Guidelines for Health Research. This paper is a critical review of literature of ethics in health and demographic research and surveillance, which has identified and analyzed the major areas of contemporary ethical concerns with respect to surveillance and research conducted by HDSS in accordance with existing ethical guidelines for health research. Concerns addressed in this paper are an overt admonishment about the importance of a range of issues from informed consent, beneficence, and justice, to advice on the best means to utilize surveillance data. Although use of HDSS allows for invaluable contributions by providing longitudinal data for in-depth understanding of surveillance areas, which indirectly guides policies, programs, and interventions at national and international levels, studies using this means of gathering data are beset with multidimensional ethical concerns with respect to the research and surveillance they carry out. Many of the ethical concerns cannot be resolved under the broader ethical standards set by the major sources of international ethical guidelines or frameworks. Thus, the paper stresses that different and innovative lines of thinking and approaches are required for studies employing HDSS to ensure the best ethical conduct in health research for the improvement of global health.

Advancing research ethics systems in Latin America and the Caribbean: a path for other LMICs?

Advancing research ethics systems in Latin America and the Caribbean: a path for other LMICs?

Preferred Reporting Items for Overviews of Reviews (PRIOR): a protocol for development of a reporting guideline for overviews of reviews of healthcare interventions

BackgroundOverviews of reviews (i.e., overviews) compile information from multiple systematic reviews to provide a single synthesis of relevant evidence for healthcare decision-making. Despite their increasing popularity, there are currently no systematically developed reporting guidelines for overviews. This is problematic because the reporting of published overviews varies considerably and is often substandard. Our objective is to use explicit, systematic, and transparent methods to develop an evidence-based and agreement-based reporting guideline for overviews of reviews of healthcare interventions (PRIOR, Preferred Reporting Items for Overviews of Reviews).MethodsWe will develop the PRIOR reporting guideline in four stages, using established methods for developing reporting guidelines in health research. First, we will establish an international and multidisciplinary expert advisory board that will oversee the conduct of the project and provide methodological support. Second, we will use the results of comprehensive literature reviews to develop a list of prospective checklist items for the reporting guideline. Third, we will use a modified Delphi exercise to achieve a high level of expert agreement on the list of items to be included in the PRIOR reporting guideline. We will identify and recruit a group of up to 100 international experts who will provide input into the guideline in three Delphi rounds: the first two rounds will occur via online survey, and the third round will occur during a smaller (8 to 10 participants) in-person meeting that will use a nominal group technique. Fourth, we will produce and publish the PRIOR reporting guideline.DiscussionA systematically developed reporting guideline for overviews could help to improve the accuracy, completeness, and transparency of overviews. This, in turn, could help maximize the value and impact of overviews by allowing more efficient interpretation and use of their research findings.

Scoping review on interventions to improve adherence to reporting guidelines in health research

Scoping review on interventions to improve adherence to reporting guidelines in health research

Scoping review on interventions to improve adherence to reporting guidelines in health research

ObjectivesThe goal of this study is to identify, analyse and classify interventions to improve adherence to reporting guidelines in order to obtain a wide picture of how the problem of...

Reporting guidelines for health research: protocol for a cross-sectional analysis of the EQUATOR Network Library

IntroductionTransparency and completeness of health research is highly variable, with important deficiencies in the reporting of methods and results of studies. Reporting guidelines aim to improve transparency and quality of...

Building on strengths in Naujaat: the process of engaging Inuit youth in suicide prevention

ABSTRACTDeath by suicide and attempted suicide among Inuit youth is now considered a public health emergency of epidemic proportion, with rates among the highest worldwide. A strong sense of cultural identity and pride, as well as social capital, has been identified as being protective against suicide. The Canadian Institute for Health Research (CIHR) Guidelines for Health Research Involving Aboriginal People call for communities to be included in the conception, planning and implementation of research. The authors took first steps towards sharing the responsibility of designing a community initiative with the youth of Naujaat, Nunavut, a community located directly on the Arctic Circle. With the objectives of promoting open listening and exploration of community needs and enhancing self-determination and sustainability, we postulated a youth resiliency project that will be co-authored by the community. This paper describes the joint work process. We recount how Inuit youth take ownership of the project with the guidance of Ms. Elizabeth Haqpi, a Naujaat Elder. The article will particularly reflect on the process of balancing the different perspectives and expectations while enjoying the richness of mutual learning through keeping each other accountable.