Rapid Review Protocol Research Articles

What contextual factors and mechanisms facilitate male involvement in women's sexual and reproductive health in Sub-Saharan Africa? A rapid realist review protocol

Background: Sexual and reproductive health (SRH) outcomes of women within low resource contexts continue to be of concern to policymakers. Notably, sub-Saharan Africa (SSA) continues to lag behind other regions of the world in improving SRH outcomes for women in the region. A key suggested strategy is male involvement through interventions that respect, promote and facilitate women in taking care of themselves and their new-borns. However, factors such as social-cultural barriers may preclude men's involvement in these programmes. There is a need for a context-specific understanding of gender dynamics and interaction and the mechanisms that enhance or impede men's involvement. Methods: We will employ a rapid realist review (RRR) methodology to examine what mechanisms and contextual factors are essential to facilitate the involvement of men in women's SRH programmes in SSA. In keeping with the realist literature we will follow six steps, which will include: (1) developing a theory, (2) developing a search strategy, (3) selecting and appraising documents, (4) extracting data, (5) analysing data and synthesising the evidence, and (6) presenting and disseminating a revised theory. We will also engage with key stakeholders who will provide local contextual insights and with experts in the subject area. The review findings will be shared with relevant stakeholders using a variety of avenues including through publications, at conferences and on social media platforms. Discussion: This review will identify the mechanisms and contextual factors that facilitate or hinder men's involvement in women's SRH programmes in SSA. The rationale for adopting an RRR approach is to help gather the information within a relatively short period to ensure relevance of findings to policymakers in SSA. Results from this work also have the potential to be adapted to the other contexts, for example, Ireland and the UK, which have a growing population of people from SSA.

Ethical Considerations for safeguarding human participants in pandemic research: a rapid review protocol.

COVID-19 is a respiratory disease caused by a coronavirus, designated SARS-CoV-2, which is responsible for a global pandemic in 2020. Public interest in this disease has led to the publication of thousands of articles in the medical literature in a very short timeframe. It is imperative that medical research into COVID-19 is conducted quickly and safely, and that due reference is given to the ethical considerations enshrined in the ICH GCP guidelines, according to the Declaration of Helsinki. In order to review the reporting of ethical considerations in these papers, we hereby propose a protocol for a systematic review of COVID-19 papers up to April 14 th 2020. The search criteria proposed for the review are based upon what would be a reasonable search conducted by a lay member of the public with access to PubMed.gov. Institutional Research Ethics Committees (RECs) face significant challenges in providing thorough and timely ethical review during the COVID-19 pandemic. It is proposed to publish the findings of this rapid review along with a summary of an institutional REC response to the challenges of reviewing and approving clinical research proposals in the time of a pandemic.

Ethical Considerations for safeguarding human participants in pandemic research: a rapid review protocol

COVID-19 is a respiratory disease caused by a coronavirus, designated SARS-CoV-2, which is responsible for a global pandemic in 2020. Public interest in this disease has led to the publication of thousands of articles in the medical literature in a very short timeframe. It is imperative that medical research into COVID-19 is conducted quickly and safely, and that due reference is given to the ethical considerations enshrined in the ICH GCP guidelines, according to the Declaration of Helsinki. In order to review the reporting of ethical considerations in these papers, we hereby propose a protocol for a systematic review of COVID-19 papers up to April 14 th 2020. The search criteria proposed for the review are based upon what would be a reasonable search conducted by a lay member of the public with access to PubMed.gov. Institutional Research Ethics Committees (RECs) face significant challenges in providing thorough and timely ethical review during the COVID-19 pandemic. It is proposed to publish the findings of this rapid review along with a summary of an institutional REC response to the challenges of reviewing and approving clinical research proposals in the time of a pandemic.

Rapid review protocol: Zinc for the prevention or treatment of COVID-19 and other coronavirus-related respiratory tract infections

BackgroundThe global COVID-19 pandemic has prompted an urgent search for effective interventions. SARS-CoV-2 mortality/morbidity risk increases with age and for those chronic disease co-morbidities, both of which are associated with lower zinc status, as is the risk of infection. MethodsRapid review methods will be applied to a systematic review of zinc for the prevention or treatment of SARS-CoV-2 and viral respiratory tract infections in humans. Included are published studies reporting randomised and quasi-randomised controlled trials that compare zinc intervention to placebo and/or other comparator interventions. English and Chinese language databases will be searched for primary studies of viral respiratory tract infections and clinical trial registries for SARS-CoV-2 infections. Due to concerns about indirectness, studies evaluating non-SARS-CoV-2 coronavirus infections will be rated down by one level, and non-specific or confirmed non-coronavirus viral infections will be rated down by two levels. Review constraints include (1) using Google translate when screening articles published in languages other than English or Chinese and limited translation (2) following calibration, only one reviewer will screen articles, extract data, appraise quality and conduct the analysis, (3) prioritising data extraction and meta-analyses of SARS-CoV-2 studies and critical outcomes of other viral infections, followed by high risk groups and (4) reporting important preliminary findings prior to peer review if necessary. DiscussionThe application of these rapid review methods and broadening the inclusion criteria to include other coronavirus-related viral respiratory tract infections aims to enable a timely evidence appraisal of priority research questions and dissemination of results. Study registrationPROSPERO CRD42020182044.

Differentiated models of service delivery for antiretroviral treatment of HIV in sub-Saharan Africa: a rapid review protocol

BackgroundTo meet global targets for the treatment of HIV, high-prevalence countries are launching or expanding differentiated models of service delivery (DSD) for antiretroviral therapy (ART). Ongoing studies report on metrics specific to individual models of care, but little is known about the overall scale, impact, costs, and benefits of widespread implementation of DSD. We will conduct a rapid review of recent literature on DSD currently in use in sub-Saharan Africa and identify gaps in the literature with respect to the description of delivery models, coverage, effectiveness, and cost.MethodsWe will use an adapted version of the preferred reporting items for systematic reviews and meta-analysis protocols (PRISMA-P) for reporting. To avoid repeating earlier reviews, only sources reporting data on interventions conducted and/or patients starting antiretroviral treatment since 1 January 2016 will be included. Other inclusion criteria: must report on HIV-positive patients receiving antiretroviral therapy (ART) for the treatment of HIV/AIDS in sub-Saharan Africa; must describe an antiretroviral care intervention and identify the location, visit frequency, provider, patient group, and intervention intensity; and must report at least one of the following outcomes: population coverage, intervention uptake, treatment outcomes, cost or resource allocation, acceptability, or feasibility. Exclusion criteria: receiving ART as part of prevention of mother-to-child transmission (PMTCT) program or receiving preventive ART (PEP or PrEP). This review will include peer-reviewed articles and conference abstracts. Publication databases to be searched include PubMed, EMBASE, and Web of Science. For analysis, where possible, we will group the DSD by key characteristics (e.g., population served, visit frequency, visit location) and then report means and/or medians of coverage and outcomes with confidence intervals or IQRs. We will also descriptively compare and contrast different models of care, implementation challenges, and other non-quantitative information.DiscussionThis review will provide an initial picture of the status quo for the implementation of DSD in sub-Saharan Africa and identify directions for research and implementation support in the future. This big-picture analysis will be useful for ministries of health, implementers, and donor agencies to inform decision-making on DSD scale-up.Systematic review registrationPROSPERO: CRD42019118230

How does feedback shared with interprofessional health care teams shape nursing performance improvement systems? A rapid realist review protocol

BackgroundNursing care quality varies between hospitals, and even between departments within the same institution. Suboptimal care can have deleterious consequences for patients such as lengthened hospital stay, nosocomial infection, pressure ulcers or death. Experts recommend the implementation of nursing performance improvement systems to assess team performance and monitor patient outcomes and efficiency savings. In practice, these systems are expected to include feedback processes directed towards nursing teams and interprofessional staff in order to facilitate adjustments and improve their performance. Unfortunately, feedback appears somewhat haphazard and, at times, overlooked. This could be explained by an ongoing absence of clear recommendations. As a result, feedback effects are inconclusive: some teams improve their practice, others do not. Although feedback has been conceptualised and studied from different theoretical perspectives, ongoing empirical inconsistencies remain unexplained. The goal of this rapid realist review protocol is to develop a theory that explains how feedback shared with interprofessional health care teams shape nursing performance improvement systems.MethodThis study follows standard guidelines established for realist reviews. Mechanisms at work will be analysed using Actor-Network Theory. All scientific documents are selected from five databases, are published in both English and French between 2010 and 2018, and include empirical research, reviews and grey literature. First, selection of documents will proceed on the basis of titles and abstracts; followed by a second selection by reading the remaining full texts. Inclusion criteria and a data extraction form will be pilot tested with 40 articles prior to completion by two reviewers. Data will be summarised in the form of [context, mechanism, outcome] equations to theorise operational feedback.DiscussionThe innovative combination of Actor-Network Theory with a realist methodology holds promise for the identification of explanatory equations in complex systems and theory development. A rapid realist review is relevant to address an enduring knowledge gap which requires theory development. This preliminary study lays the groundwork for a pioneering theory on feedback in nursing performance improvement systems that will subsequently inform a multiple case study.Systematic review registrationProspero CRD42018110128

P084: The sky is not the limit! Protocol for a rapid systematic review on the use of drones in emergency medicine

Introduction: Drones are already being used in medicine. They are employed to transport blood products and laboratory samples in rural and remote areas and they are increasingly being tested to deliver external defibrillators outside the hospital to patients with cardiac arrest. As this technology rapidly develops and attracts the attention of the scientific community, we present a rapid systematic review protocol that aims to synthesize the scientific evidence that has tested the use of drones to provide emergency medical care. Methods: A search strategy incorporating the concepts of ‘drone’ and ‘emergency medicine’ was launched in 52 bibliographic databases, including CINAHL and PubMed. Using the artificial intelligence module included in DistillerSR, a reviewer completed the first screening phase by reading the title and abstract of the retrieved articles. To be included, articles had to report empirical research projects that tested the potential uses of drones to improve the quality and accessibility of emergency medical care. These selection criteria were applied to the full text of the included articles during the second screening phase by a single reviewer. The results of these two screening phases will be validated by a second independent reviewer. The bibliography of included studies, relevant scientific journals and literature reviews will be manually searched for relevant articles. Results: The search strategy retrieved 1809 articles, of which 22 met our inclusion criteria in the first and second screening phases. Of these, one study used an empirical research design (qualitative interviews) to evaluate the usefulness of drones in emergency medicine, 17 used simulations or scenarios, and four were comprehensive literature reviews on the use of drones to provide healthcare. The final review will synthesize evidence related to the use of drones in emergency medicine and its impact on emergency medical services: nature of the emergency situation (cardiac arrest, blood transfusion), type of drone (fixed wing, quadcopter), tasks performed by drones (transport, surveillance), improvement in access or quality of care (patient's health, time saved in providing services). Conclusion: Drone technology is evolving rapidly and the indications for its use in providing emergency care is increasing. This rapid systematic review will focus on scientific studies aimed at testing the effectiveness of drones to improve the quality and access to emergency medical care.

OP136 Provision Of A Chimeric Antigen Receptor T-Cell Program: A Rapid Review

IntroductionThe recent European Medicines Agency (EMA) approval of chimeric antigen receptor (CAR) T-cell therapies, axicabtagene ciloleucel and tisagenlecleucel, means the imminent arrival of health technology assessment (HTA) submissions to HTA agencies. HTA requires identification of all resources and organizational impacts pertaining to an intervention. Rapid review is a form of knowledge synthesis that abbreviates certain methodological aspects of systematic reviews to produce information in a timelier manner. Considering the time-sensitive nature of CAR T-cell HTAs, the aim of this research was to conduct a rapid review to identify the institutional requirements for the provision of a CAR T-cell program.MethodsA Rapid Review protocol was developed and registered in PROSPERO. Electronic databases, EMBASE and MEDLINE, and grey literature were searched. All study designs published in English after the year 2000 were included. Studies pertained to the use of CAR T-cells in adult and pediatric patients with solid and hematological malignancies. No restrictions were placed on the comparators or study setting. Primary outcomes were organized into two categories: (i) resource use, (ii) processes relating to implementation of CAR T-cell programs. Secondary outcomes included associated costs of implementation and barriers to successful implementation. Screening, review, and extraction of relevant data was conducted by a single reviewer. Extracted data included publication details, population and setting, study characteristics, outcomes and outcome measures, and strengths and limitations of research. Data was synthesized by means of thematic analysis.ResultsResults indicate that the provision of a CAR T-cell program in Ireland will require the establishment of bespoke infrastructural support. This includes additional outpatient facilities, ICU resources, and nursing capacity. Close relationships will need to be formed between hematology, ICU and neurology.ConclusionsThe findings of this Rapid Review will inform the assessment of organizational impacts associated with the introduction of a CAR T-cell program, ensuring a robust HTA assessment.

The effects of interventions targeting multiple health behaviors on smoking cessation outcomes: a rapid realist review protocol

BackgroundHealth behaviors directly impact the health of individuals, and populations. Since individuals tend to engage in multiple unhealthy behaviors such as smoking, excessive alcohol use, physical inactivity, and eating an unhealthy diet simultaneously, many large community-based interventions have been implemented to reduce the burden of disease through the modification of multiple health behaviors. Smoking cessation can be particularly challenging as the odds of becoming dependent on nicotine increase with every unhealthy behavior a smoker exhibits. This paper presents a protocol for a rapid realist review which aims to identify factors associated with effectively changing tobacco use and target two or more additional unhealthy behaviors.MethodsAn electronic literature search will be conducted using the following bibliographic databases: MEDLINE, Embase, PsycINFO, Cumulative Index to Nursing and Allied Health Literature (CINAHL), The Cochrane Library, Social Science s, Social Work s, and Web of Science. Two reviewers will screen titles and abstracts for relevant research, and the selected full papers will be used to extract data and assess the quality of evidence. Throughout this process, the rapid realist approach proposed by Saul et al., 2013 will be used to refine our initial program theory and identify contextual factors and mechanisms that are associated with successful multiple health behavior change.DiscussionThis review will provide evidence-based research on the context and mechanisms that may drive the success or failure of interventions designed to support multiple health behavior change. This information will be used to guide curriculum and program development for a government funded project on improving smoking cessation by addressing multiple health behaviors in people in Canada.Systematic review registrationPROSPERO CRD42017064430

What are the mechanisms that enable the reciprocal involvement of seldom heard groups in health and social care research? A rapid realist review protocol

Background: The University College Dublin (UCD) PPI Ignite Connect Network will fundamentally embed public and patient involvement (PPI) in health-related research, education and training, professional practice and administration in UCD’s institutional structures and procedures. A significant focus of the programme of work is on actively engaging and developing long-term reciprocal relationships with seldom heard groups, via our ten inaugural partners. Methods: This rapid realist review will explore what are the mechanisms that are important in actively engaging seldom heard groups in health and social care research. The review process will follow five iterative steps: (1) clarify scope, (2) search for evidence, (3) appraise primary studies and extract data, (4) synthesise evidence and draw conclusions, and (5) disseminate findings. The reviewers will consult with expert and reference panels to focus the review, provide local contextual insights and develop a programme theory consisting of context–mechanism–outcome configurations. The expert panel will oversee the review process and agree, via consensus, the final programme theory. Review findings will follow the adopted RAMESES guideline and will be disseminated via a report, presentations and peer-reviewed publication. Discussion: The review will update and consolidate evidence on the mechanisms that enable the reciprocal engagement and participation of ‘seldom heard’ groups in health and social care research. Via the expert and reference process, we will draw from a sizeable body of published and unpublished research and grey literature. The local contextual insights provided will aid the development of our programme theories. This new evidence will inform the design and development of the UCD PPI Ignite program focused on ensuring sustained reciprocal partnerships.

PP097 Challenges Of Rapid Reviews In Health Technology Assessment: Case Study From An Italian Region

INTRODUCTION:Rapid reviews are an attractive tool for Health Technology Assessment (HTA) as they may be a support in decision making when time and resources are limited. Rapid reviews are carried out in few weeks (from 3 weeks to 6 months) and require adjustments from standard systematic review methods. Methodology on how to carry out rapid reviews is still debated and guidance regarding the most suitable method to apply is lacking. Kaltenthaler (1) has recently proposed a checklist of items to be considered when undertaking a rapid review. We appraised our rapid assessment on the use of frequency domain (FD)-optical coherence tomography in percutaneous coronary interventions, based on a rapid review of the literature, using the items proposed (1).METHODS:The checklist reports four key points to consider when planning a rapid review: (i) scoping search - needed to quantify the available evidence and to inform rapid review protocol, (ii) results reporting – considering heterogeneity of intervention, comparators, and outcomes, (iii) clear communication with policy makers - ensuring that review responds to the policy question and (iv) reporting on methods - methodology used, strengths and limitations.RESULTS:When we applied the checklist proposed by Kaltenthaler (1) to our rapid review on the use of FD-optical coherences tomography it resulted that: the scoping search revealed no useful systematic reviews to answer policy-makers questions and a high number of relevant studies. For results presentation, we used a narrative synthesis reporting outcome data grouped in domains previously defined by an evidence profile. Domains consisted of technical performance, safety, efficacy, and change in management. No meta-analysis was performed due to paucity of randomized controlled trials (RCTs) for the efficacy domain and high heterogeneity in outcomes measures for technical performance. Analysis of some of the outcomes was extremely time-consuming (technical performance) and did not provide particularly useful information for the commissioning body. A clearer and more intensive dialog with policy makers to adjust extent of research question and/or outcomes to be investigated would have probably improved usability for final users. Description of methods was partial.CONCLUSIONS:The checklist by Kaltenthaler (1) helped us to reflect on the method we used to carry out rapid reviews and to pinpoint possible solutions to improve it.