Search

ObjectivesA rapid review is a form of evidence synthesis considered a resource-efficient alternative to the conventional systematic review. Despite a dramatic rise in the number of rapid reviews commissioned and conducted in response to the coronavirus disease 2019 pandemic, published evidence on the optimal methods of planning, doing, and sharing the results of these reviews is lacking. The Priority III study aimed to identify the top 10 unanswered questions on rapid review methodology to be addressed by future research.Study Design and SettingA modified James Lind Alliance Priority Setting Partnership approach was adopted. This approach used two online surveys and a virtual prioritization workshop with patients and the public, reviewers, researchers, clinicians, policymakers, and funders to identify and prioritize unanswered questions.ResultsPatients and the public, researchers, reviewers, clinicians, policymakers, and funders identified and prioritized the top 10 unanswered research questions about rapid review methodology. Priorities were identified throughout the entire review process, from stakeholder involvement and formulating the question, to the methods of a systematic review that are appropriate to use, through to the dissemination of results.ConclusionThe results of the Priority III study will inform the future research agenda on rapid review methodology. We hope this will enhance the quality of evidence produced by rapid reviews, which will ultimately inform decision-making in the context of healthcare.

Background The process of developing a survey instrument to evaluate women’s experiences of their maternity care is complex given that maternity care encapsulates various contexts, services, professions and professionals across the antenatal, intranatal and postnatal periods. Aim To identify and prioritise items for inclusion in the National Maternity Experience Survey, a survey instrument to evaluate women’s experiences of their maternity care in the Republic of Ireland. Methods This study used an adapted two-phase exploratory sequential mixed methods design. Phase one identified items for possible inclusion and developed an exhaustive item pool through a systematic review, focus groups and one to one interviews, and a gap analysis. Phase two prioritised the items for inclusion in the final item bank through a Delphi study and consensus review. Findings Following iterative consultation with key stakeholder groups, a bank of 95 items have been prioritised and grouped within eight distinct care sections; care during your pregnancy, care during your labour and birth, care in hospital after the birth of your baby, specialised care for your baby, feeding your baby, care at home after the birth of your baby, overall care and you and your household. Conclusion Robust and rigorous methods have been used to develop a bank of 95 suitable items for inclusion in the National Maternity Experience Survey.

SummaryBackgroundA large number of studies have been carried out involving passive antibody administration for the treatment and prophylaxis of COVID-19 and have shown variable efficacy. However, the determinants of treatment effectiveness have not been identified. Here we aimed to aggregate all available data on randomised controlled trials of passive antibody treatment for COVID-19 to understand how the dose and timing affect treatment outcome.MethodsWe analysed published studies of passive antibody treatment from inception to 7 January 2022 that were identified after searching various databases such as MEDLINE, Pubmed, ClinicalTrials.gov. We extracted data on treatment, dose, disease stage at treatment, and effectiveness for different clinical outcomes from these studies. To compare administered antibody levels between different treatments, we used data on in vitro neutralisation of pseudovirus to normalise the administered dose of antibody. We used a mixed-effects regression model to understand the relationship between disease stage at treatment and effectiveness. We used a logistic model to analyse the relationship between administered antibody dose (normalised to the mean convalescent titre) and outcome, and to predict efficacy of antibodies against different Omicron subvariants.FindingsWe found that clinical stage at treatment was highly predictive of the effectiveness of both monoclonal antibodies and convalescent plasma therapy in preventing progression to subsequent stages (pInterpretationEarly administration of passive antibody therapy is crucial to achieving high efficacy in preventing clinical progression. A dose-response curve was derived for passive antibody therapy administered to ambulant symptomatic subjects to prevent hospitalisation. For many of the monoclonal antibody regimens analysed, the administered doses are estimated to be between 7 and >1000 fold higher than necessary to achieve 90% of the maximal efficacy against the ancestral (Wuhan-like) virus. This suggests that a number of current treatments should maintain high efficacy against Omicron subvariants despite reduction in in vitro neutralisation potency. This work provides a framework for the rational assessment of future passive antibody prophylaxis and treatment strategies for COVID-19.FundingThis work is supported by an Australian government Medical Research Future Fund awards GNT2002073 and MRF2005544 (to MPD, SJK), MRF2005760 (to MPD), an NHMRC program grant GNT1149990 (SJK and MPD), and the Victorian Government (SJK). SJK is supported by a NHMRC fellowship. DC, MPD, ZKM and EMW are supported by NHMRC Investigator grants and ZKM and EMW by an NHMRC Synergy grant (1189490). DSK is supported by a University of New South Wales fellowship. KLC is supported by PhD scholarships from Monash University, the Haematology Society of Australia and New Zealand and the Leukaemia Foundation. TT, HW and CB are members of the National COVID-19 Clinical Evidence Taskforce which is funded by the Australian Government Department of Health.Research in contextEvidence before this studyWe identified randomised controlled trials (RCTs) evaluating the effectiveness of SARS-CoV-2-specific neutralising monoclonal antibodies, hyperimmune immunoglobulin and convalescent plasma in the treatment of participants with a confirmed diagnosis of COVID-19 and in uninfected participants with or without potential exposure to SARS-CoV-2. The RCTs were identified from published searches conducted by the Cochrane Haematology living systematic review teams.A total of 37 randomised controlled trials (RCT) of passive antibody administration for COVID-19 were identified. This included 12 trials on monoclonal antibodies, 21 trials of convalescent plasma treatment, and 4 trials of hyperimmune globulin. These trials involved treatment of individuals either prophylactically or at different stages of infection including post-exposure prophylaxis, symptomatic infection, and hospitalisation. The level of antibody administered ranged from a 250 ml volume of convalescent plasma through to 8 grams of monoclonal antibodies. Data for analysis was extracted from the original publications including dose and antibody levels of antibody administered, disease stage and timing of administration, primary outcome of study and whether they reported on our prespecified outcomes of interest, which include protection against symptomatic infection, hospitalisation, need for invasive mechanical ventilation (IMV) and death (all-cause mortality at 30 days).Added value of this studyOur study included data across all 37 RCTs of passive antibody interventions for COVID-19 and aggregated the studies by the stage of infection at initiation of treatment. We found that prophylactic administration or treatment in earlier stages of infection had significantly higher effectiveness than later treatment. We also estimated the dose-response relationship between administered antibody dose and protection from progression from symptomatic ambulant COVID-19 to hospitalisation. We used this relationship to predict the efficacy of different monoclonal antibody treatment regimes against the Omicron subvariants BA.1, BA.2, and BA.4/5. We also used this dose-response relationship to estimate the maximal efficacy of monoclonal antibody therapy in the context of pre-existing endogenous neutralising antibodies.Implications of all the available evidenceThis work identifies that both prophylactic therapy and treatment in the early stages of symptomatic infection can achieve significant protection from infection or hospitalisation respectively. The dose-response relationship provides a quantitative means to predict the change in efficacy of different monoclonal antibodies against new variants and in semi-immune populations based on in vitro neutralisation data. We predict a number of existing monoclonal antibodies will be effective for preventing severe outcomes when administered early in BA.4/5 infections. It is likely that these therapies will provide little protection in individuals with high levels of endogenous neutralising antibodies, such as healthy individuals who have recently received a third dose of an mRNA vaccine.

Background Uncomplicated urinary tract infections (UTIs) are amongst the most frequent infections presenting in the outpatient setting. A growing number of clinical trials are assessing the most effective treatment interventions for uncomplicated UTI. Due to the heterogeneity of the outcomes reported in these trials, however, comparing these outcomes is challenging. Objectives Identify the core outcomes that have been reported in trials and systematic reviews of interventions treating uncomplicated UTI in adults. Methods We conducted a systematic search for core outcomes used to evaluate treatments of UTIs. We searched the Cochrane Database of Systematic Reviews, PubMed and Embase. One researcher independently screened each article for inclusion, and the Core Outcome Set for treatment of Urinary Tract Infections (COSUTI) team acted as second reviewers. All included articles were screened by two reviewers. All outcomes were extracted verbatim, and similar outcomes were grouped into domains and subdomains. Results In total, 334 outcomes were reported across 41 papers, the average number of outcomes reported being 8. Outcomes were categorized across 18 domains, the majority of which were related to clinical cure outcomes. Many outcomes varied in the timepoints within which the outcome was measured and reported. Conclusions Comparing the outcomes of trials investigating uncomplicated UTI treatment remains challenging due to the difference in outcomes currently reported. Consistency of reporting of outcomes would be improved by developing a minimum number of consistent outcomes that should be reported in all trials.

BackgroundThe current standard of care in rheumatoid arthritis (RA) requires regular assessment of disease activity (DA). All standard RA DA measurement instruments require joint counts to be undertaken by a healthcare professional with/without a blood test. Few healthcare providers have the capacity to assess patients as frequently as stipulated by guidelines. Patient Reported Outcome Measures (PROMs) could be an efficient and informative way to assess RA DA, which is highlighted by the SARS-COV-2 pandemic, as most consultations are remote rather than face-to-face. We aimed to assess all PROMs for RA DA against the internationally recognised COSMIN guidelines to provide evidence‐based recommendations to select the most suitable PROMs.MethodsReview registered on PROSPERO as CRD42020176176. The search strategy was based on a previous similar systematic review and expanded to include all articles up to January 2019. All identified articles were rated by two independent assessors following the COSMIN guidelines.Results668 abstracts were identified, with 10 articles included. A further 21 were identified from a previous review. Ten PROMs were identified. There was insufficient evidence to place any of the identified PROMs into recommendation for use category A due to lack of evidence for content validity, as stipulated by the COSMIN guidelines.ConclusionLack of evidence of content validity limits suitable PROM selection, therefore none can be recommended for use. It is acknowledged that all included PROMs were developed before the COSMIN guidelines were published. Future research on PROMs for RA DA must provide evidence of content validity.

Background Recognition of the measurement of women's experiences of their maternity care as a critical component of care quality evaluation has led to a proliferation of instruments to measure this concept. However, the suboptimal methodological and psychometric quality of these instruments, or the lack of reporting of same, hinders the credibility and efficient use of the arising results, which often serve as an indicator for the direction of limited resources within maternity services. Aim To review systematically and critically appraise self-report survey instruments measuring women's experiences of their maternity care. Methods A systematic review was conducted using comprehensive searches of the CINAHL, OVID MEDLINE and EMBASE citation databases. Inclusion and exclusion criteria were applied, and a stepped approach employed to facilitate evaluation of the methodological and psychometric quality of included instruments. Findings 4905 records were obtained from database searches. Additional records were obtained via reference checking and by expert suggestion. Following stepped screening, 40 papers related to 20 instruments are included in this review. Findings indicate that evidence of the methodological and psychometric quality have not been reported for many included instruments. Conclusions Published evidence of the methodological and psychometric quality of self-report survey instruments to evaluate women's experiences of their maternity care is lacking. The conduct and reporting of future development processes of such instruments can be improved. Systematic review PROSPERO registration: CRD42018105325.

Background Despite many countries employing the use of national and large scale regional surveys to explore women’s experiences of their maternity care, with the results informing national maternity policy and practice, the concept itself is ambiguous and ill-defined having not been subject of a structured concept development endeavour. Aim The aim of this review is to report on an in-depth analysis conducted on the concept of ‘women’s experiences of their maternity care’. Methods Using the principle-based method of concept analysis by Penrod and Hupcey (2005), the concept of ‘women’s experiences of their maternity care’ was analysed under the epistemological, pragmatic, linguistic and logical principles. The final dataset included 87 items of literature published between 1990 and 2017 retrieved from a systematic search of the MEDLINE, CINAHL, EMBASE and PSYCinfo databases. Findings The epistemological principle identified that a theoretical definition of the concept is elusive with a variety of implicit meanings. The pragmatic principle supports the utility of the concept in scientific literature, however the lack of a theoretical definition has led to inconsistent use of the concept, as highlighted by the linguistic principle. Furthermore, the logical principle highlighted that as the concept lacks definition blurring is identifiable when theoretically positioned with related concepts. Conclusion The outcome of this concept analysis is a theoretical definition of a previously undefined concept. This definition highlights the subjective nature of the concept, its dependency upon a woman’s individual needs, expectations and circumstances and the influence of the organisation and delivery of maternity care.

Background Recruiting the target number of participants within the pre-specified time frame agreed with funders remains a common challenge in the completion of a successful clinical trial and addressing this is an important methodological priority. While there is growing research around recruitment, navigating this literature to support an evidence-based approach remains difficult. The Online resource for Recruitment Research in Clinical triAls project aims to create an online searchable database of recruitment research to improve access to existing evidence and to identify gaps for future research. Methods MEDLINE (Ovid), Scopus, Cochrane Database of Systematic Reviews and Cochrane Methodology Register, Science Citation Index Expanded and Social Sciences Citation Index within the ISI Web of Science and Education Resources Information Center were searched in January 2015. Search strategy results were screened by title and abstract, and full text obtained for potentially eligible articles. Studies reporting or evaluating strategies, interventions or methods used to recruit patients were included along with case reports and studies exploring reasons for patient participation or non-participation. Eligible articles were categorised as systematic reviews, nested randomised controlled trials and other designs evaluating the effects of recruitment strategies (Level 1); studies that report the use of recruitment strategies without an evaluation of impact (Level 2); or articles reporting factors affecting recruitment without presenting a particular recruitment strategy (Level 3). Articles were also assigned to 1, or more, of 42 predefined recruitment domains grouped under 6 categories. Results More than 60,000 records were retrieved by the search, resulting in 56,030 unique titles and abstracts for screening, with a further 23 found through hand searches. A total of 4570 full text articles were checked; 2804 were eligible. Six percent of the included articles evaluated the effectiveness of a recruitment strategy (Level 1), with most of these assessing aspects of participant information, either its method of delivery (33%) or its content and format (28%). Discussion Recruitment to clinical trials remains a common challenge and an important area for future research. The online resource for Recruitment Research in Clinical triAls project provides a searchable, online database of research relevant to recruitment. The project has identified the need for researchers to evaluate their recruitment strategies to improve the evidence base and broaden the narrow focus of existing research to help meet the complex challenges faced by those recruiting to clinical trials.

Over the past four decades, there has been a growing focus on the resolution of conceptual problems through the process of concept development. As the focus on this area has grown, so too has the number of debates in the literature on methodological aspects of concept development.To provide an overview of the essential methodological considerations of concept development.Discussion paper. An overview is presented of the methodological considerations of commonly used concept development strategies and methods within nursing and midwifery.Literature dating from the inception of concept development in nursing and midwifery.The robust development of concepts is a vital component in advancing the knowledge base of nursing and midwifery theory and practice. However, the complexity of the concept development literature may serve to exacerbate the challenges of developing a given concept, in particular for the novice researcher.The methodological considerations discussed provides guidance in determining the most appropriate strategy and method of concept development.

There is international interest in, and continued concern about, the potential long-term impact of involuntary admission to psychiatric institutions, and the effect this coercive action has on a person's well-being and human rights. Involuntary detention in hospital remains a controversial process that involves stakeholders with competing concerns and who often describe negative experiences of the process, which can have long-lasting effects on the therapeutic relationship with service users. The aim of the present study was to explore the perspectives of key stakeholders involved in the involuntary admission and detention of people under the Mental Health Act 2001 in Ireland. Focus groups were used to collect data. Stakeholders interviewed were service users, relatives, general practitioners, psychiatrists, mental health nurses, solicitors, tribunal members, and police. Data were analysed using a general inductive approach. Three key categories emerged: (i) getting help; (ii) detention under the Act; and (iii) experiences of the tribunal process. This research highlights gaps in information and uncertainty about the involuntary admission process for stakeholders, but particularly for service users who are most affected by inadequate processes and supports. Mental health law has traditionally focussed on narrower areas of detention and treatment, but human rights law requires a greater refocussing on supporting service users to ensure a truly voluntary approach to care. The recent human rights treaty, the UN Convention on the Rights of Persons with Disabilities, is to guarantee a broad range of fundamental rights, such as liberty and integrity, which can be affected by coercive processes of involuntary admission and treatment.

Claire Beecher (corresponding author) is being funded by the Programme for Health Service Improvement, Health Service Executive. Dr Mark White, Programme Integration Manager, of this programme has contributed as a co‐author on this manuscript. No other contribution by this funding body was made to this manuscript.