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Synthesizing evidence on complex interventions: How meta-analytical, qualitative, and mixed-method approaches can contribute
Abstract
OBJECTIVES Although there is increasing interest in the evaluation of complex interventions, there is little guidance on how evidence from complex interventions may be reviewed and synthesized, and the relevance of the plethora of evidence synthesis methods to complexity is unclear. This article aims to explore how different meta-analytical approaches can be used to examine aspects of complexity; describe the contribution of various narrative, tabular, and graphical approaches to synthesis; and give an overview of the potential choice of selected qualitative and mixed-method evidence synthesis approaches.
STUDY DESIGN AND SETTING The methodological discussions presented here build on a 2-day workshop held in Montebello, Canada, in January 2012, involving methodological experts from the Campbell and Cochrane Collaborations and from other international review centers (Anderson L, Petticrew M, Chandler J, et al. Introduction: systematic reviews of complex interventions. In press). These systematic review methodologists discussed the broad range of existing methods and considered the relevance of these methods to reviews of complex interventions.
RESULTS The evidence from primary studies of complex interventions may be qualitative or quantitative. There is a wide range of methodological options for reviewing and presenting this evidence. Specific contributions of statistical approaches include the use of meta-analysis, meta-regression, and Bayesian methods, whereas narrative summary approaches provide valuable precursors or alternatives to these. Qualitative and mixed-method approaches include thematic synthesis, framework synthesis, and realist synthesis. A suitable combination of these approaches allows synthesis of evidence for understanding complex interventions.
CONCLUSION Reviewers need to consider which aspects of complex interventions should be a focus of their review and what types of quantitative and/or qualitative studies they will be including, and this will inform their choice of review methods. These may range from standard meta-analysis through to more complex mixed-method synthesis and synthesis approaches that incorporate theory and/or user's perspectives.
... This protocol has been developed in alignment with the 2015 PRISMA-P Preferred Reporting Items for Systematic review and Meta-Analysis Protocols: recommended items to address in a systematic review protocol [51,52]. Guidance from Petticrew et al. regarding synthesising evidence on complex interventions has been followed [53]. ...
... A systematic, narrative synthesis of evidence will be presented, based on data items captured in the data extraction table [53]. This analysis will involve descriptive data, for example frequency counts of the target population of documented apps, or of specific BCTs and theoretical frameworks utilised (e.g. ...
... (Across all ages, abilities) a Cost-effectiveness? Contextual influences on intervention success (economic factors, available resources, local healthcare system structure) [53] Conclusions, clinical implications, future directions? ...
Background
Rheumatic and musculoskeletal diseases (RMDs) cause significant burden to the individual and society, requiring lifelong management and specialist healthcare resource use. Costing over 200 billion euros per year in Europe, RMDs are the most expensive of all diseases for European healthcare systems. The incidence and burden of RMDs are projected to rise with the ageing global population and increase in sedentary, obesogenic lifestyles. In parallel, there is a global crisis in the rheumatology workforce, whereby capacity to deliver specialist care is being exceeded by demand. Pervasive, scalable mobile health technologies, such as apps, are being developed to support the self-management of RMDs and reduce pressure on healthcare services. However, it is unknown whether these apps are informed by theory or their use supported by an appropriate evidence base. The purpose of this review is therefore to provide a comprehensive overview of the development strategies, interventional components and theoretical underpinnings of existing smartphone apps, designed to support the self-management of RMDs.
Methods
Searches will be conducted within PubMed, Scopus, Web of Science, Embase, MEDLINE and PsycINFO. Reference lists and citing articles of the included studies will be searched. Identified publications will be screened for eligibility by two independent reviewers. Any discrepancies between reviewers will be resolved by consensus, with input from a third reviewer if required. Data will be extracted on study designs, methods, populations, setting, utilised theoretical frameworks, intervention components, behaviour change techniques, methods to evaluate effectiveness and barriers/facilitators to intervention engagement. Exploratory outcomes include reported effectiveness, acceptability and usability. A systematic, narrative synthesis of evidence will be presented. If appropriate (depending on quality and pool of evidence identified), qualitative meta-summary techniques will be used to combine and summarise qualitative findings regarding barriers/facilitators to intervention engagement.
Discussion
The results of this systematic literature review will provide insights for healthcare professionals, researchers, app designers and policy makers, to inform future development and implementation of smartphone apps to support self-management of RMDs. Evidence gaps for future research will be identified. Findings will be disseminated through a final manuscript/publication of results and via a conference abstract, patient organisations and social media.
Systematic review registration
PROSPERO CRD42022359704.
... From another angle, the adaptivity of the local context itself and the evolution of various systems involved with an intervention, including the behaviours of the implementers and intended beneficiaries, contribute to dynamic longitudinal processes inherent in complex population-based interventions . These features configure nonlinear relationships, especially feedback loops and phase transitions Petticrew et al., 2013), and are dependent on the classic ecologic models of transmission dynamics for infectious diseases 19 . Additional sources of complexity include differential moderating effects at individual and various cluster (e.g. ...
... 18 See Craig et al. (2008); Petticrew et al. (2013) for theoretical reviews on complexity in population health and Jones et al. (2006); Kaplan et al. (2002); Tengs et al. (2005) for a few examples of complexity identification in practice from diabetes, small pox, nicotine addiction, respectively. 19 See Earn et al. (2000) for a discussion of models of transmission dynamics, as they are referred to in this context, and Feng et al. (2002) for a specific example in the case of schistosomiasis. ...
... All of the parameters were put up for discussion and confirmation by the participants, though only the ones which generated comments, and the extent of the input, are noted in the Table S2 below. ages for death c (1,5,10,15,20,25,30,35,40,45,50,55,60,65,70,75,80,85,90,95,100,110) (8639,9082,6424,5074,4425,3847,3628,3062,2436,1770,1868,1066,743,518,355,144) ...
This thesis aims to understand how methodological and conceptual approaches to complexity in quantitative analysis can improve evidence and decision-making, specifically for schistosomiasis control in Uganda and more broadly within global health. Engaging directly with the complexity through methodological choices provided new insights into policies and practices in global health. In Paper 1, I provided an overview of actors and power dynamics in global health, by describing the changing landscape of global health actors as it relates to relative shifts in power over time. This is accomplished by capturing the emergent, dynamic network structure of development aid for health in the period encompassing the ‘MDG era’, between 1990 and 2015. This paper was published in the Journal of Health Policy and Planning (https://doi.org/10.1093/heapol/czac025). Paper 2 aimed to develop evidence for decision-making in response to the needs of policymakers and practitioners, with a focus on schistosomiasis transmission and control activities in Uganda. This was accomplished by (1) capturing the perspectives of national and sub-national decision-makers on schistosomiasis transmission using participatory modelling, and (2) using the participatory modelling outputs to inform mathematical model simulations in response to the evidence needs. The implementation of this approach challenged the balance of power between international and domestic actors in the development of evidence and decisions regarding the delivery of global health interventions. This paper was published in BMJ Global Health (http://dx.doi.org/10.1136/bmjgh-2021-007113). Paper 3 used the outcomes of the participatory systems mapping workshops and individual-based simulations to guide the scope and content of economic evaluations of schistosomiasis interventions. The results indicated that the most cost-effective scenario is a system of implementation reliant on volunteers from within communities and donated drugs. As anticipated, when all else is held equal, including these costs result in lower cost-effectiveness ratios relative to other interventions. Further, the results bring into question the purpose of continuing interventions which are not predicted to achieve the desired targets within the 30-year time horizon. This paper highlighted potential opportunities for schistosomiasis intervention design and implementation which is more aligned with the aims of equitable, country-led sustainable development. Paper 4 shifted the focus within the discussion of evidence for decision-making in global health to consider one particular type, peer-reviewed publications, which is most often considered as ‘best practice’ in evidence-based decision-making. A systematic review captured the network of authors who had published on MDA. These results constituted the sampling frame for a remote survey to elucidate perspectives on their roles in policy and practice related to MDA. The findings highlighted the ongoing structural disparities in research leadership and found broad concern about opportunities and about disconnects that limit engagement between researchers and decision-makers for use of primary research in policy and decision-making processes. Paper 4 was published in the Journal of Public Health Policy (https://doi.org/10.1057/s41271-021-00294-x). Broadly speaking, the papers in this thesis have shown that while reductionist, linear perspectives may be part of the reason for the continuation of ineffectual policies and practices, the confluence of politics, power relations, and economies in the context of a complex system of actors and processes also plays a significant role with regards to policy and practice decision making. This was observed in relation to schistosomiasis in Uganda and more broadly in global health at the system level. This thesis uses language and methods common in health sciences to communicate critiques in a way that can be engaged with by health policy-makers, practitioners, and many public health researchers. Finally, this thesis showed the possibilities for using network-based and computational models for understanding complexity within the global health 'system'.
... Beyond effectiveness, evaluation should inform the theory-based and the systems perspectives [17]. Many designs may help identifying key ingredients of complex interventions [29]. For example, different kinds of synthesis were conducted for case management with frequent users of healthcare services. ...
... An effective intervention needs to be designed to be useful, identifying important implementation considerations as the first phases of evaluation [17]. Identification of factors influencing implementation and effectiveness become a core element of research design [29,40]. Without being exhaustive, a few models can support research teams and stakeholders to consider implementation early in evaluation. ...
Responding to complex needs calls for integrating care across providers, settings and sectors. Among models to improve integrated care, case management demonstrates a good evidence base of facilitating the appropriate delivery of healthcare services. Since case management is a complex, multi component intervention, with its component parts interacting in a non-linear manner, effectiveness is largely influenced by the context in which the intervention is implemented. This paper discusses how to respond to implementation challenges to evaluating complex interventions for patients with complex needs. Building on the example of case management, we suggest that documenting innovation effectiveness remains important, but that evaluation needs to include theory-based and systems perspectives. We also suggest that implementation science needs to be part of intervention design while engaging stakeholders to define the most relevant research questions and implementation effectiveness, to optimize successful implementation and sustainability.
... 23 While the general principles of systematic reviews include 'the need for clear question(s), the need for transparency of methods and the use of wide-ranging, comprehensive searches to reduce the effects of publication bias' 24 , a realist review encompasses tighter inclusion and exclusion criteria, and a smaller number of articles relative to other approaches 25 . A realist review is applicable for 'complex interventions where evidence of effect may be lacking' 26 . ...
... The general limitation of the adapted realist review method, which is that it may not be reproducible and transparent, applies to this review. 26 Some key concepts with fluid definitions such as extreme heat and heatwaves were not explicitly defined, especially within the context of the continent which has predominantly warm/hot tropical and subtropical climates. In addition, the causal effects of heat impacts on health, for example, physiological or cardio-metabolic stress versus communicable diseases, were not fully explored. ...
Temperature extremes vary across Africa. A continent-wide examination of the impacts of heat on health in Africa, and a synthesis of Africa-informed evidence is, however, lacking. A systematic review of articles published in peer-reviewed journals between January 1992 and April 2019 was conducted. To be eligible, articles had to be Africa-specific, in English, and focused on how heatwaves and high ambient temperatures affect morbidity and mortality. A secondary systematic analysis on policies and interventions comprising 17 studies was also conducted, and the findings synthesised together with those of the 20 primary studies. Eleven studies showed that high ambient temperatures and heat waves are linked with increased mortality rates in Africa. These linkages are characterised by complex, linear and non-linear (J or U) relationships. Eight of the nine primary studies of morbidity outcome reported that an increase in temperature was accompanied by raised disease incidence. Children and the elderly were the population groups most vulnerable to extreme heat exposure. Location-specific interventions and policy suggestions include developing early warning systems, creating heat-health plans, changing housing conditions and implementing heat-health awareness campaigns. In summary, this review demonstrates that, while heat-health relationships in Africa are complex, extreme temperatures are associated with high mortality and morbidity, especially amongst vulnerable populations. As temperatures increase across Africa, there is an urgent need to develop heat-health plans and implement interventions. Future studies must document intervention effectiveness and quantify the costs of action and inaction on extreme heatrelated mortality and morbidity.
Significance:
• Empirical evidence shows that the relationship between heat and human health is complex in the African This complexity has implications for the development of interventions and policies for heathealth on the continent.
• This review is important for African policymakers, practitioners and others who support Africa’s adaptation to climate change. Through this review, a compendium of Africa-specific and relevant empirical information is aggregated and made readily available to various interested and affected parties.
... According to this framework, relevant factors fall within 7 broad categories, 4 of which comprise environmental factors and 3 of which comprise individual factors (see Table 1) [34]. A framework synthesis is a deductive approach that uses an a priori framework to categorise each key factor identified in the source articles [50]. It offers a means to reinforce, critique, and elaborate on an existing framework that may have been conceived for a different but relevant purpose [51]. ...
... In this process, numerous factors can be aggregated into their shared category and new categories can be derived from individual factors [52]. This enables a highly structured and transparent approach to organising and analysing large amounts of data [50,52]. Because the intention is to apply an existing framework to the data rather than to develop a new framework from the data for application elsewhere, concerns about the restricted geographic scope and the limited number of studies might be attenuated. ...
Supporting older people’s use of sustainable transport is important for both population health and sustainable development, especially in the context of global population ageing. This systematic review identifies individual and environmental factors that influence older people’s sustainable transport use and synthesises findings using a framework approach. Factors influencing older people’s walking (n = 10 studies), bus use (n = 11), community transport use (n = 1), bicycling (n = 1), and e-bicycling (n = 1) were found to be physical, geographical, facility-based, economic, time-based, fear-based, space-based, information-based, or interpersonal. Many factors were common across transport modes. One reason for this is that environmental features designed to facilitate the use of one particular transport mode also influenced the use of other modes (e.g., bus shelters influence not only bus use but also walking as they provide pedestrian seating). Thus, environments need to be considered from the perspective of multiple, different types of road users. Another reason is that many factors related to the ways individuals experienced their environment (e.g., finding information guiding behaviour in public spaces to be unclear), regardless of any specific transport mode. This review highlights the important need for greater cross-sectoral action and input from older people.
... We conduct a qualitative theme-based structured approach (i.e., thematic analysis) and quantitative (i.e., meta-analysis) approaches (Grant & Booth, 2009). While the mixed methods approach provides an enhanced and deeper understanding of the subject matter and is prominent in the medical field (Amgad et al., 2015;Petticrew et al., 2013), this approach is less common in the management field (Grant & Booth, 2009). The use of a mixed-method systematic review has gained popularity in recent years due to (a) the growing need for evidence-based-decision making, (b) the increased availability of data, (c) a significant increase in new publications in the management field, and (d) enhanced research tools (Geyskens et al., 2009;Point et al., 2017;Saiphoo & Vahedi, 2019). ...
Scholarly research on virtual reality (VR) is characterized by a dynamic tension between VR's potential and the challenges impeding its adoption. Grounded in a mixed‐methods systematic review, this research examines the drivers influencing consumer VR adoption by rigorously combining qualitative and quantitative analyses of 158 scholarly articles ranging from 1996 to 2023. Based on an extensive analysis of VR adoption literature, we introduce the Virtual Reality Integrated Adoption Framework (VRIAF), which is the first mixed‐methods systematic review focusing exclusively on VR adoption. This empirically substantiated model integrates key determinants of VR adoption such as consumer attitudes, perceived enjoyment, ease of use, social influences, and previous user experiences. The research identifies four pivotal themes through qualitative exploration, further elucidated by quantitative meta‐analyses and weight analyses. These themes encompass the user experience in VR environments, the role of VR in construction and design, the immersive attributes of VR technologies, and the ongoing technological advancements influencing adoption patterns. This research contributes significantly to the theoretical understanding of VR adoption and provides practical insights for VR professionals. By delineating future research directions, the study bridges the gap between theoretical exploration and practical application, offering a valuable resource for both scholars and practitioners in the field of VR.
... Intersectoral approaches seem to be able to improve the health and development status off children and adolescents with socioeconomic disadvantages mainly by building networks, improving services and increasing access to support and information [17]. As interventions such as Präventionskette Freiham can be considered as complex interventions [18], their effectiveness should be evaluated carefully, taking into consideration the specific implementation context. Complex interventions usually feature multiple components, include multiple groups at differing organizational levels and operate through multiple, often long causal pathways [19]. ...
Background
Reducing health inequities for children from a disadvantaged background is an important task in public health. While intersectoral partnerships are a promising way to achieve this, few studies have examined the factors influencing the success of these interventions. In this study, we conducted a process evaluation of the integrated community-based intervention Präventionskette Freiham that the city of Munich, Germany, has implemented in a new residential development area. The aim was to investigate the implementation process as well as barriers and facilitators.
Methods
Following a mixed methods approach, we collected data from different core groups making up Präventionskette Freiham from April 2020 to August 2022, exploring their perspective on the implementation process. We conducted repeated qualitative interviews with the network coordinators and eleven local professionals from institutions engaged with or relevant for the intervention. We also undertook a focus group with four members of the advisory group representing the three municipal departments guiding the intervention. Ego-centered network maps were drawn by the network coordinators to chart the development of the network. Subsequently, we also conducted an online survey with local network members.
Results
At the early stage of the implementation process, the intervention was able to integrate actors from different sectors, serving as a platform for mutual exchange. However, the network produced limited output. According to the interviews, this may be mainly attributable to the early development status of the area. We identified seven topics that may act as facilitators or barriers to implementation of Präventionskette Freiham: (1) availability of resources, (2) political and administrative support, (3) the network coordinators, (4) network-internal processes, (5) trans-institutional cooperation, (6) perceived benefits of engagement, and (7) the output of the network.
Conclusions
The early development status of the area was a challenge for the intervention. This emphasizes the need to carefully consider context when planning and implementing integrated community-based public health interventions in new residential development areas.
... 68 If a statistical pooling (metaanalysis) appears to be inappropriate, for example, if Open access study designs differ considerably, a tabular, graphical or narrative synthesis will be provided. 69 ...
Introduction
The implementation of COVID-19 pandemic-related restrictions resulted in limitations for physical activity (PA) opportunities, which may have initiated a longer-term behavioural change. The protocol describes the methodology for a planned systematic review that aims to summarise changes in PA and physical fitness (PF) in children and adolescents in the WHO European Region after the onset of the COVID-19 pandemic.
Methods and analysis
The protocol adheres to the ‘Preferred Reporting Items for Systematic Review and Meta-Analysis for Protocols’ (PRISMA-P) statement. Using a peer-reviewed search strategy according to the evidence-based checklist ‘Peer Review of Electronic Search Strategies’ (PRESS), we will perform a systematic literature search in seven databases. Inclusion criteria are all primary studies that gathered data on children and adolescents ≤19 years living in the WHO European Region and made a comparison to pre-pandemic data. Primary outcomes are PA and PF. We will assess the risk of bias with the ‘Risk of Bias Instrument for Non-Randomized Studies of Exposures’ (ROBINS-E). The ‘Grading of Recommendations Assessment, Development and Evaluation’ (GRADE) approach will be used for the evaluation of the certainty of evidence. Also, subgroup analyses will be performed (eg, for gender, age, stringency of pandemic restrictions).
Ethics and dissemination
Ethical approval is not required, as primary data will not be collected in this study. The results will be presented in a peer-reviewed publication and at congresses relevant to the research field.
PROSPERO registration number
CRD42023395871.
... Step three aims to resolve any disagreements via discussion. Procedures were supported by the validated Mixed Method Appraisal Tool ( MMAT) consisting of 19 core criteria in a quality scoring system grouped into five methodological categories [30][31][32][33]. The analysis focused on a detailed presentation of the ratings for each criterion classified as "no" or "can´t tell", signalling a possible risk of bias, but no studies were excluded based on the degree of assessed quality. ...
Background
Universal recommendation for antiretroviral drugs and their effectiveness has put forward the challenge of assuring a chronic and continued care approach to PLHIV (People Living with HIV), pressured by aging and multimorbidity. Integrated approaches are emerging which are more responsive to that reality. Studying those approaches, and their relation to the what of delivery arrangements and the how of implementation processes, may support future strategies to attain more effective organizational responses.
Methods
We reviewed empirical studies on either HIV, multimorbidity, or both. The studies were published between 2011 and 2020, describing integrated approaches, their design, implementation, and evaluation strategy. Quantitative, qualitative, or mixed methods were included. Electronic databases reviewed cover PubMed, SCOPUS, and Web of Science. A narrative analysis was conducted on each study, and data extraction was accomplished according to the Effective Practice and Organisation of Care taxonomy of health systems interventions.
Results
A total of 30 studies, reporting 22 different interventions, were analysed. In general, interventions were grounded and guided by models and frameworks, and focused on specific subpopulations, or priority groups at increased risk of poorer outcomes. Interventions mixed multiple integrated components. Delivery arrangements targeted more frequently clinical integration (n = 13), and care in proximity, community or online-telephone based (n = 15). Interventions reported investments in the role of users, through self-management support (n = 16), and in coordination, through multidisciplinary teams (n = 9) and continuity of care (n = 8). Implementation strategies targeted educational and training activities (n = 12), and less often, mechanisms of iterative improvement (n = 3). At the level of organizational design and governance, interventions mobilised users and communities through representation, at boards and committees, and through consultancy, along different phases of the design process (n = 11).
Conclusion
The data advance important lessons and considerations to take steps forward from disease-focused care to integrated care at two critical levels: design and implementation. Multidisciplinary work, continuity of care, and meaningful engagement of users seem crucial to attain care that is comprehensive and more proximal, within or cross organizations, or sectors. Promising practices are advanced at the level of design, implementation, and evaluation, that set integration as a continued process of improvement and value professionals and users’ knowledge as assets along those phases.
Trial registration
PROSPERO number CRD42020194117.
... Thereafter, the researcher retrieved full-text articles that met the inclusion criteria for the systematic review. Critical appraisal ensures that the reader is directed to key aspects of the study such as its design, method, participants, and several other variables (Petticrew et al., 2013). If a critical appraisal score of satisfactory (34%-66%) to good (67%-100%) was obtained, the study was considered for inclusion in the systematic review. ...
A systematic review of contemporaneous empirical studies was conducted to identify the risk and protective factors of intrinsic and extrinsic religiosity in adolescents in relation to their sexual behaviour. In addition, a comprehensive review of social science literature was performed using a ten-year period as a parameter (from 2009 to 2019) to capture recent trends. The justification for the systematic review was to report the findings from the analyses of this subsample of studies. This essay explains the article search procedure, followed by an overview and meta-synthesis of reviewed studies. The significance of this article is that it extends the existing knowledge to the area under investigation.
... 40 We will integrate our qualitative and quantitative findings by using qualitative results to interrogate quantitative Open access results, aiding interpretation of heterogeneity as a rich source of information and to identify research gaps. 46 Deliverable Enriched understanding of the tool's usability, acceptability and perceived effectiveness and relevance to key sociodemographic differences in order to optimise tailored communication of the tool. ...
Introduction:
On 11 March 2020, WHO declared the novel coronavirus (COVID-19) disease a global pandemic. Governments globally implemented physical distancing measures and closure of public institutions that resulted in varying implications to youth mental well-being (eg, social isolation, reduced extracurricular activities). These impacts may have detrimental short-term and long-term effects on youth mental well-being; care for youth with mental health disorders was already overstretched, underfunded and fragmented before the pandemic and youth are not often considered in mental health initiatives. There is a pressing need to partner with youth and families to target and improve youth mental well-being prior to the onset of a mental health disorder, as well as to conduct research on youth mental well-being needs related to pandemic recovery. Here we present a protocol for partnering with youth and families to codesign a user-centred digital tool for youth mental well-being.
Methods and analysis:
We will conduct a national research study to develop a catalogue of recommendations specific to supporting youth mental well-being, and a digital tool to support youth mental well-being through three phases of work: (1) expert consultation on data related to supporting youth mental well-being existing within our Pandemic Preparedness Research Program; (2) codesign of an innovative digital tool for youth mental well-being; and (3) assessment of the tool's usability and acceptability.
Ethics and dissemination:
This study has been approved by the Dalhousie Research Ethics Board (2023-6538) and the Conjoint Health Research Ethics Board (23-0039). This study will complement ongoing foundational research in youth conducted by our team that involves partnering with youth and families to understand the unique implications of the pandemic on this population.
... If a statistical pooling (meta-analysis) appears to be inappropriate, e.g. if study designs differ considerably, a tabular, graphical or narrative synthesis will be provided [52]. ...
Background: A growing number of studies point to a high mental health burden among children and adolescents during the COVID-19 pandemic, particularly concerning anxiety. However, the study quality and effect direction are heterogeneous in the existing primary studies with a lacking overview for the European continent. Therefore, this systematic review aims to critically synthesise the evidence regarding the impact of the COVID-19 pandemic on anxiety among children and adolescents in Europe compared to a pre-pandemic baseline.
Methods: A systematic literature search will be performed in six databases (MEDLINE, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials, Web of Science, and WHO COVID-19 database) with a peer reviewed search strategy according to the evidence-based checklist Peer Review of Electronic Search Strategies (PRESS). Inclusion criteria are children and adolescents ≤ 19 years living in Europe and data report during the COVID-19 pandemic with an appropriate pre-pandemic baseline. Primary outcomes are general anxiety symptoms and clinically relevant anxiety rates. Risk of bias will be assessed using the 'Risk of Bias in Non-randomised Studies of Exposure' (ROBINS-E). Data extraction will systematically include information on study design, population characteristics, COVID-19 determinants, pre-pandemic baseline, diagnostic instruments and outcome. The certainty of evidence for each outcome will be evaluated by using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach adapted to the use of non-randomised studies. All process steps will be performed independently by two reviewers; any discrepancies will be discussed and, if necessary, resolved by a third author. Also, subgroup analysis, sensitivity analysis, publication bias analysis, and meta-regression analysis, if applicable, will be performed. The systematic review was registered in the Prospective Register of Systematic Reviews (PROSPERO) and the protocol was prepared in accordance to the Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) statement.
Discussion: This systematic review will address the lack of a critical and comprehensive summary of findings on the COVID-19 pandemic impact on anxiety among children and adolescents in Europe. In addition, it aims to identify pandemic-policy differences, such as the effect of school-closures, and identify particularly vulnerable risk groups.
Systematic review registration: CRD42022303714 (PROSPERO).
... In an attempt to critically appraise the quality of evidence, and in accordance with best practice (Petticrew et al., 2013), a bibliometric quality assessment was undertaken. However, there was little consensus within the research team of how best to conduct a reliable and robust quality assessment. ...
It is predicted that emergency responses to critical incidents will increase over the next few decades, as society faces unique and dynamic challenges (e.g., pandemics, migrant crises, terrorism). As such, it is necessary to breakdown, identify and evaluate the unique barriers associated with decision-making in the context of critical incident responses. The aim of the current study was to synthesise the bibliographic characteristics of the research on decision making and present a holistic narrative analysis of the multi-layered factors. Additionally, the systematic synthesis of evidence facilitated a critical appraisal of the quality and distribution of evidence across macro-, meso-, and micro- levels. Results suggested that research was moderately heterogeneous, as evidence captured diverse narrative factors. However, micro-centric characteristics (e.g., cognitive-related factors) were not well represented. Instead, research primarily focused toward intermediate meso-level characteristics, capturing factors such as ‘interoperability’ and ‘organisation policy and procedure’ as critical challenges to decision-making. Six key narratives were also identified and discussed. Both the quality appraisal and narrative findings suggested that research should seek opportunities to experimentally assess, evaluate and validate decision-making. Whilst this has previously appeared ethically and practically problematic, advances in technology, research and analysis have allowed high-fidelity simulation experimentation to recreate critical incidents.
... The narrative synthesis began with the construction of a clear descriptive summary of the included studies and a summarization of the findings of individual studies (Centre for Reviews and Dissemination, 2009). The primary aim of the narrative analysis was to develop a coherent textual narrative and to aggregate evidence on the effectiveness of the interventions (Petticrew et al., 2013). The studies were assessed systematically and logically, including highlighting important similarities and differences between the studies, and different components of the interventions were compiled in a matrix (Centre for Reviews and Dissemination, 2009;Pigott and Shepperd, 2013). ...
Background
Different types of educational approaches are needed to build a mentor's competence in guiding students during clinical practice; this education should be provided in an interprofessional setting.
Objectives
The objective of this review was to evaluate how effective mentoring education interventions are at improving mentoring competence among health care professionals.
Design
A systematic review.
Data sources
A systematic search was conducted across five electronic databases: CINAHL, PubMed, ProQuest, Scopus, and Medic. The search did not have any time limitations and included original studies published in English, Finnish or Swedish.
Review methods
JBI critical appraisal tools for quasi-experimental studies and randomized controlled trials were used to assess the quality of the selected studies. The eligibility of potentially relevant studies was assessed by two independent researchers based on title, abstract, and full text, along with overall methodological quality. The study findings were synthesized using data tabulation and narrative analysis.
Results
A total of two randomized controlled trials and six quasi-experimental studies were included in the review. The described mentoring education interventions were carried out in university hospitals, central hospitals, tertiary care centers, and other health service settings. All of the described educational interventions involved the pedagogical method of blended learning, while three studies also involved web-based learning. The presented educational interventions included versatile pedagogical frameworks, e.g., interactive practical training sessions, teaching workshops, and technology-mediated interactions. One study contained a control group.
Conclusion
This systematic review can provide insight and evidence-based that can be used to design effective mentoring education. Further research is needed and would ideally include randomized controlled trials and quasi-experimental studies with reference groups; this type of research could further elucidate which aspects of mentoring education are most important for improving the guidance skills of health care professionals.
... Eine Verzerrung durch die Beeinflussung der Ergebnisse einzelner Studien soll so vermieden werden [28]. In der Variante der Network-Meta-Analyse werden sogar mehrere Interventionen aus verschiedenen Studien gleichzeitig verglichen und statistisch analysiert [29]. ...
Zusammenfassung
Hintergrund
Seit Anfang der COVID-19-Pandemie zeigt sich ein hoher Bedarf an zügigen Evidenzzusammenstellungen zur Beantwortung dringender Public-Health-Fragen. Der vorliegende Beitrag gibt einen Überblick über verschiedene Review-Typen für Public-Health-relevante Fragestellungen sowie eine Synthese bestehender Empfehlungen zur Erstellung von Reviews. Ziel ist es, die Planung eines eigenen Reviews bzw. die kritische Beurteilung veröffentlichter Reviews zu unterstützen.
Methode
Die Basis bildete eine ausführliche Recherche zu Leitlinien und Empfehlungen für unterschiedliche Review-Typen. Des Weiteren wurden institutsinterne Journal Clubs zur Bedarfsermittlung und zur kritischen Auseinandersetzung mit den verschiedenen Review-Typen durchgeführt. Zur Dissemination der Ergebnisse wurden für die einzelnen Review-Typen Fact Sheets mit den wichtigsten Informationen, Voraussetzungen und Arbeitsschritten sowie ein Entscheidungsbaum zur Identifizierung des für die jeweilige Fragestellung geeigneten Review-Typs entwickelt.
Ergebnisse
Von den identifizierten Review-Typen wurden Systematic, Rapid, Scoping, Umbrella und Narrative Reviews näher betrachtet, weil sie für Fragestellungen im Public-Health-Bereich besonders relevant sind. Zusammen mit Scoping und Umbrella Reviews weisen Systematic Reviews aufgrund der Anforderungen an eine umfangreiche, systematische Evidenzsynthese und Reproduzierbarkeit den höchsten Ressourcenbedarf auf. Rapid-Methoden können den Review-Prozess beschleunigen, beispielsweise durch eine sehr eng formulierte Fragestellung, eine eingeschränkte Literatursuche oder die Durchführung bestimmter Schritte durch eine anstatt zwei Personen.
Diskussion
Systematic Reviews können als „Goldstandard“ angesehen werden, wurden jedoch in erster Linie für klinische Fragestellungen zu Interventionen entwickelt. Dagegen wurde in diesem Artikel der Fokus auf Review-Typen gelegt, die die Vielfalt der Fragestellungen sowie die vorwiegende Verwendung quantitativer Methoden im Public-Health-Bereich berücksichtigen. Die entwickelten Fact Sheets sowie der Entscheidungsbaum sollen einen niedrigschwelligen Zugang zu Reviews ermöglichen und dabei Perspektiven der Forschung und Ressourcenplanung verknüpfen. Sie ergänzen bestehende Leitlinien und Empfehlungen.
Schlussfolgerung
Für Reviews im Public-Health-Kontext stehen hinsichtlich der Vielfalt an Fragestellungen verschiedene Review-Typen inklusive ihrer unterschiedlichen Anforderungen und Abläufe zur Verfügung. Angesichts dieser Vielfalt kann eine systematische Einführung für Forschende, die ein Review planen oder beurteilen, hilfreich sein.
... We conducted semi-structured qualitative interviews with stakeholders in Scotland after the introduction of MUP (we also interviewed people experiencing homelessness and/or street drinking; their experiences will be reported in a separate paper). Qualitative methods are appropriate for exploring the views and experiences of study participants and can identify emergent themes not considered at the research design stage [34]. MUP may lead to multiple anticipated and unanticipated outcomes in different populations and contexts, and a qualitative design allows for a more nuanced exploration of these phenomena from the perspective of different stakeholders. ...
Introduction:
Minimum unit pricing (MUP) may reduce harmful drinking in the general population, but there is little evidence regarding its impact on marginalised groups. Our study is the first to explore the perceptions of MUP among stakeholders working with people experiencing homelessness following its introduction in Scotland in May 2018.
Methods:
Qualitative semi-structured interviews were conducted with 41 professional stakeholders from statutory and third sector organisations across Scotland. We explored their views on MUP and its impact on people experiencing homelessness, service provision and implications for policy. Data were analysed using thematic analysis.
Results:
Participants suggested that the introduction of MUP in Scotland had negligible if any discernible impact on people experiencing homelessness and services that support them. Most service providers felt insufficiently informed about MUP prior to its implementation. Participants reported that where consequences for these populations were evident, they were primarily anticipated although some groups were negatively affected. People experiencing homelessness have complex needs in addition to alcohol addiction, and changes in the way services work need to be considered in future MUP-related discussions.
Discussion and conclusions:
This study suggests that despite initial concerns about potential unintended consequences of MUP, many of these did not materialise to the levels anticipated. As a population-level health policy, MUP is likely to have little beneficial impact on people experiencing homelessness without the provision of support to address their alcohol use and complex needs. The additional needs of certain groups (e.g., people with no recourse to public funds) need to be considered.
... In contrast, narrative reviews on the use of VR in ASD research and practice account for only a tiny proportion. It is widely acknowledged that systematic reviews and narrative reviews provide complementary contributions [12,13]. They are both useful and indispensable in summarizing current knowledge and promoting further development in a newly emerging field. ...
Virtual reality (VR) technology gains theoretical support from rehabilitation and pedagogical theories and offers a variety of capabilities in educational and interventional contexts with affordable products. VR is attracting increasing attention in the medical and healthcare industry as it provides fully interactive three-dimensional simulations of real-world settings and social situations, which are particularly suitable for cognitive and performance training including social and interaction skills. The worldwide rising trend in the prevalence of autism spectrum disorder calls for innovative and efficacious techniques for assessment and treatment. The article offers a summary of current perspectives and evidence-based applications of VR technology as an educational and intervention tool for individuals with autism spectrum disorder, with a primary focus on social communication including social functioning, emotion recognition, and speech and language. Technology- and design-related limitations as well as the disputes over the application of virtual reality to autism research and therapy are discussed and future directions of this emerging field are highlighted with regards to application expansion and improvement, technology enhancement, and the development of brain-based research and theoretical models.
... A network meta-analysis is a technique that can be used to gather evidence from both direct and indirect comparisons. 27 To date, no network meta-analysis has compared EX to multiple psychotherapies. The objective of this NMA was to compare the efficacy of EX and three evidence-supported behavioral therapies: cognitive-behavioral therapy (CBT), behavioral activation therapy (BA), and non-directive supportive therapy (NDST). ...
Objective:
An estimated 3.8% of the global population experiences depression, according to the [2019] WHO report. Evidence supports the efficacy of exercise training (EX) for depression; however, its comparative efficacy to conventional, evidence-supported psychotherapies remains understudied. Therefore, we conducted a network meta-analysis to compare the efficacy of exercise training (EX), behavioral activation therapy (BA), cognitive-behavioral therapy (CBT), and non-directive supportive therapy (NDST).
Methods:
Our search was performed in seven relevant databases (inception to March 10, 2020) and targeted randomized trials comparing psychological interventions head-to-head and/or to a treatment as usual (TAU) or waitlist (WL) control for the treatment of adults (18 years or older) with depression. Included trials assessed depression using a validated psychometric tool.
Results:
From 28,716 studies, 133 trials with 14,493 patients (mean age of 45.8 years; 71.9% female) were included. All treatment arms significantly outperformed TAU (standard mean difference [SMD] range, -0.49 to -0.95) and WL (SMD range, -0.80 to -1.26) controls. According to surface under the cumulative ranking (SUCRA) probabilities, BA was mostly likely to have the highest efficacy (1.6), followed by CBT (1.9), EX (2.8), and NDST (3.8). Effect size estimates between BA and CBT (SMD = -0.09, 95% CI [-0.50 to 0.31]), BA and EX (-0.22, [-0.68 to 0.24]), and CBT and EX (-0.12, [-0.42 to 0.17]) were very small, suggesting comparable treatment effects of BA, CBT, and EX. With individual comparisons of EX, BA, and CBT to NDST, we found small to moderate effect sizes (0.09 to 0.46), suggesting EX, BA, and CBT may equally outperform NDST.
Conclusions:
Findings provide preliminary yet cautionary support for the clinical use of exercise training for adult depression. High study heterogeneity and lack of sound investigations of exercise must be considered. Continued research is needed to position exercise training as an evidence-based therapy.
... outputs, outcomes, impacts). Finally, to generate insight in how the publications inform on success, an inductive approach was used to identify the main theme of each publication in relation to success (Bryman, 2016;Petticrew et al., 2013). ...
The success of climate services for adaptation to climate change is increasingly studied, but there exists a varying understanding of what climate services are and what makes them successful. This study systematically mapped the breadth and depth of peer-reviewed literature on the subject and synthesized evidence on what we know, don’t know and need to know about successful climate services. The study focusses on services that are based on long-term climate information or aim to inform decision-making on longer time scales and includes papers that inform on success, including evaluation studies, empirical investigations in the factors and practices that influence success, and conceptual discussions on what constitutes success.
Results show that insights on climate service success are scattered and most often originate from western and developed countries. Conceptualizations of success in the literature are diverse and focus on processes for production and use, product characteristics and process elements of the service itself, and/or on contextual factors. Studies that assess the results of climate services tend to focus on evaluating (perceived) usability, though uptake, impacts and outcomes of services are rarely assessed systematically. Frequently reported success factors include brokering functions, user-producer interactions and iterative and flexible development processes. To be successful, services themselves should be contextualized and tailored to the user and its decision-making context. We conclude that whilst context emerges as a critical determinant of success, the configuration of factors and processes leading to success demand further investigation.
... We used a narrative approach to synthesize the diverse range of studies in a structured manner. A narrative systematic organization and presentation of data can help to identify themes across studies (Petticrew et al., 2013). The students assessed their knowledge as basic but improving year by year. ...
Background
: Practical skills are complex procedures integrating communication and caring, as well as technical and manual aspects. Simulation at a simulation/skills center offers a wide range of learning activities and aims to imitate patient situations.
Objectives
: To investigate the international research literature on practical skills learning in simulation/skills centers in nursing education. Research questions: 1. What are the range and type of practical skills studied? 2. What learning activities are focused on in the studies included in the review? 3. What are the learning outcomes and how are they assessed?
Design
: Narrative review
Methods
: We searched electronically and included studies from Medline Ovid, CINAHL, Eric, Embase, Academic Search Premiere, and Cochrane. Unique indexing terms and search strategies were developed for each database. The criteria for inclusion were bachelor nursing students as the study population and practical nursing skills learning in simulation/skills centers. We used Rayyan QCRIt for the initial screening and the Mixed Method Appraisal Tool for quality assessment. We used a narrative approach to synthesize the diverse range of studies.
Findings
: One hundred and twenty-one studies from 26 countries published between January 2013 and March 2022 were included. The amount of quantitative research was overwhelming (n=108). A total of 50 different practical skills were represented. The studies focused on which learning modalities result in the best learning outcomes. Only 8.5% (n= 7) of the included studies concerned students’ learning processes. Skill performance (n=101), knowledge (n=57), confidence (n=34), and satisfaction (n=32) were the main learning outcomes measured.
Discussion
: The quality assessment indicated that 10 of the studies achieved 100% on the mixed method appraisal tool criteria. In many of the studies with quasi-experimental and randomized controlled trial designs, the intervention group received some form of educational treatment while the control group received no treatment. The choice of no treatment for the control group in pedagogical research seems to disregard the inherent purpose and effect of teaching and learning.
Conclusion
: Heterogeneity in the use of learning modalities and measuring instruments precludes the possibility of building on other research. Technical skills are the preferred choice of skill, while skills that involve a fair measure of communication and collaboration are only sparingly studied. Students’ learning processes are barely touched on in the included studies. More focus should be placed on this area in further research, since the choice of learning modalities may affect the students’ learning processes in significant ways.
... If appropriate, a statistical synthesis (meta-analysis) will be performed as random-effects meta-analysis developed by DerSimonian and Laird [37] using a statistical software. If a statistical pooling (meta-analysis) appears to be inappropriate, e.g. if data are highly heterogeneous or if study designs differ considerably, a tabular, graphical or narrative synthesis will be provided [38]. Finally, an interpretation description of the results will be performed, including consideration of the direction of effect and size of the effect. ...
Background: A growing number of studies point to a high mental health burden among children and adolescents during the COVID-19 pandemic, particularly concerning depression and anxiety. However, the study quality and effect direction are heterogeneous in the existing studies with a lacking overview for the European continent. Therefore, research gaps exist particular regarding (1) the impact of the COVID-19 pandemic on depression and anxiety among children and adolescents in European countries with (2) a methodologically high-quality summarizing review of studies. Therefore, the planned systematic review aims to close these gaps.
Methods: The systematic review was registered in the Prospective Register of Systematic Reviews (PROSPERO) and the protocol was prepared in accordance to the Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) statement. Search strategy was peer reviewed according to the evidence-based checklist Peer Review of Electronic Search Strategies (PRESS). Systematic search was conducted in six databases (MEDLINE, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials, Web of Science and WHO COVID-19 database). Literature screening will be conducted independent by two authors, disagreement will be solved by a third author. Risk of bias (RoB) will be assessed using the RoB instrument for non-randomized studies of exposures. Certainty of evidence will be evaluated by using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach adapted to the use of non-randomized studies. Also, subgroup analysis, sensitivity analysis, and publication bias will be performed.
Discussion: This systematic review will summarize the actual overall prevalence of depression and anxiety among children and adolescents in European countries compared to a pre-pandemic baseline with an expert opinion on the clinical relevance and extrapolation of depression and anxiety in children and adolescents in the next years. In addition, it aims identifying geographic and pandemic-policy differences and designate particularly vulnerable risk groups within European children and adolescents.
... If appropriate, a statistical synthesis (meta-analysis) will be performed as random-effects meta-analysis developed by DerSimonian and Laird [37] using a statistical software. If a statistical pooling (meta-analysis) appears to be inappropriate, e.g. if data are highly heterogeneous or if study designs differ considerably, a tabular, graphical or narrative synthesis will be provided [38]. Finally, an interpretation description of the results will be performed, including consideration of the direction of effect and size of the effect. ...
Some studies point to a high mental health burden among children and adolescents (CA) during the COVID-19 pandemic, particularly concerning depression and anxiety (DA). However, the quality of existing studies and some results are heterogeneous. Research gaps exist regarding (1) a high-quality summarizing overview on studies with (2) a pre-pandemic baseline on the impact of the COVID-19 pandemic on DA among CA in Europe. Therefore, the planned systematic review (SR) aims to close these gaps.
SR was registered in the Prospective Register of Systematic Reviews (PROSPERO) and the protocol was prepared in accordance to the Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) statement. Search strategy was peer reviewed. Systematic search was conducted in six databases (MEDLINE, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials, Web of Science and WHO COVID-19 database). Risk of bias (RoB) will be assessed using the RoB instrument for non-randomized studies of exposures. Certainty of evidence will be evaluated by using the GRADE approach adapted to the use of non-randomized studies. Also, subgroup analysis, sensitivity analysis, and publication bias will be performed.
Results of this SR could contribute to determine the actual overall prevalence of DA among CA in European countries with an expert opinion on the clinical relevance and extrapolation of DA in CA in the next years. In addition, it aims identifying geographic and pandemic-policy differences and designate particularly vulnerable risk groups within European CA.
... In contrast, narrative reviews on the use of VR in ASD research and practice account for only a tiny proportion. It is widely acknowledged that systematic reviews and narrative reviews provide complementary contributions [12,13]. They are both useful and indispensable in summarizing current knowledge and promoting further development in a newly emerging field. ...
The worldwide rising trend of autism spectrum disorder (ASD) calls for innovative and efficacious techniques for assessment and treatment. Virtual reality (VR) technology gains support from rehabilitation and pedagogical theories and offers a variety of capabilities in educational and interventional contexts with affordable products. VR is attracting increasing attention in the medical and healthcare industry, as it provides fully interactive three-dimensional simulations of real-world settings and social situations, which are particularly suitable for cognitive and performance training, including social and interaction skills. This review article offers a summary of current perspectives and evidence-based VR applications for children with ASD, with a primary focus on social communication, including social functioning, emotion recognition, and speech and language. Technology- and design-related limitations, as well as disputes over the application of VR to autism research and therapy, are discussed, and future directions of this emerging field are highlighted with regards to application expansion and improvement, technology enhancement, linguistic diversity, and the development of theoretical models and brain-based research.
... A systematic mixed studies review (SMSR; Pluye & Hong, 2014) was conducted. Conducting an SMSR is a highly interpretative protocol (Petticrew et al., 2013) that is bestsuited for reviews that aim to synthesize data from studies that vary in methodology (e.g., quantitative, qualitative), that consider more than one type of outcome or research question, and that are interested in illuminating issues related to intervention reception (see Harden, 2010). This approach can facilitate knowledge synthesis by providing processes for considering methodologically distinct studies to contribute data to the same evidence (literature) analysis. ...
Unlabelled:
Mindfulness-based interventions (MBIs) are associated with increased psychological wellbeing. The literature suggests that individuals exposed to adverse childhood experiences (ACEs) may benefit greatly from MBIs. However, research has tended to focus on universal MBIs for this population with less attention on the effectiveness of targeted approaches. Moreover, there is growing concern regarding the methodological rigor of MBI research. This systematic mixed studies review (SMRS) reports the effectiveness of MBIs for improving mental health and cognition among individuals with ACE histories. Additionally, the review reports the quality and rigor of the included research. Systematic searches of PsycInfo, EMBASE, MEDLINE, ProQuest Dissertations and Theses, ProQuest Social Science database and the Child Development and Adolescent Studies database were conducted. Results were screened and data were extracted then synthesized using a data-based convergent synthesis design. Thirteen studies were included in the final review. Six prominent themes emerged. Themes indicated that MBIs were effective for improving mental health and cognition for individuals with ACEs. For example, improvements in mood and anxieties, as well as a better ability to manage emotions. Shortcomings in the quality of MBI research included lack of reporting of methodological details (e.g., randomization procedures) and not systematically reporting adverse event evaluations. Recommendations are made for future research to strengthen the evidence base for MBIs for individuals with ACEs.
Supplementary information:
The online version contains supplementary material available at 10.1007/s40653-022-00454-5.
... Complexity-informed designs using a range of methods would greatly benefit the future of modern slavery research and evaluation. 39 Several interventions had more than one function, reflecting their multicomponent nature. Action to improve survivor's safety through the provision of safe accommodation was, for example, often linked to education and training support and opportunities to consider police involvement for possible prosecution and redress. ...
Background: Substantial resources are invested globally for deploying personnel with technical and operational skillsets to support outbreak response in the low- and middle-income countries (LMICs). In deploying to a country there is an underlying commitment to strengthen national outbreak response capacity. However, eliciting specific impacts of an international deployment on enhancing a country’s outbreak response, readiness, and preparedness capacities remain a challenge. This review examines how deployments contribute to containing public health threats in LMICs. Specifically, this review aims to: (i) explore the different international deployment models and/or approaches; (ii) identify and describe the impacts of international deployments to support national outbreak preparedness, readiness and response; and (iii) identify the facilitators and the barriers to improving public health emergency response and recovery capacities of the LMICs.
Methods: The reviewers will search the following databases for peer-reviewed articles published between January 2012 and June 2023: MEDLINE, Embase, Global Health, Globus Index Medicus, Web of Science and Google Scholar using Medical Subject Headings (MeSH) and keywords. ReliefWeb and websites of relevant humanitarian and health organisations will be searched for grey literature. The identified articles will be assessed for meeting the eligibility criteria. Two independent reviewers will screen the titles and abstracts and review the full texts of the selected articles. A customised data extraction form will be utilised. The quality of included peer-reviewed articles will be assessed using the Quality Assessment with Diverse Studies (QuADS)appraisal tool. Grey literature will be assessed using the AACODS checklist. Results from eligible articles will be analysed qualitatively using thematic synthesis. Descriptive statistics will be generated to summarise quantitative results. A parallel-results convergent synthesis approach will be used to narratively triangulate the qualitative and the quantitative findings. The results will be reported according to the preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement and synthesis without meta-analysis (SWiM) guideline.
Discussion: This systematic review will identify the contributions of international deployments in improving LMICs’ public health emergency response capacities. The findings may help to refine international assistance strategies to support outbreak response efforts in the LMICs.
Systematic review registration:PROSPERO CRD42023404346
Objective
How interventions are reported can impact the ability to implement these intervention in clinical practice. Therefore, our aim is to assess the reporting of massage interventions in randomised controlled trials for patients with neck pain.
Data sources
This manuscript concerns a secondary analysis of trials evaluating massage for neck pain selected for a scoping review. An updated literature search was completed using four databases to 31 July 2023.
Review methods
Trials were selected that evaluate massage interventions. Two independent assessors extracted descriptive information, methodological quality (PEDro-scale) and assessed completeness of reporting of the intervention using the Template for Intervention Description and Replication (TIDier-checklist). We present frequencies of the extracted data.
Results
We included 35 trials (2840 patients) with neck pain. Most trials (n = 23) included patients with chronic non-specific neck pain. We found a wide variety of massage interventions from Chinese massage, Swedish massage to myofascial release. In addition, the dose, number of sessions and the duration of the intervention varied widely. The methodological quality overall was fair to good (varied between 4–8/10), and we found a moderate completeness of reporting. All trials provided the name of the intervention, 30 (86%) provided a rationale and 26 (74%) trials described details of the massage intervention.
Conclusion
The massage interventions were moderately described in trials in patients with neck pain, but provided enough information to guide the decision making for designing future Network Meta-analysis as to what trials need to be considered when grouping massage interventions in a clinically relevant way.
Purpose: To compare the risk of sinus membrane perforation (SMP) among lateral window sinus floor elevation (LSFE) and transcrestal sinus floor elevation (TSFE) techniques in prospective and retrospective studies for patients who underwent sinus augmentation for dental implant placement. Materials and Methods: A database search was conducted to screen the literature published from January 1960 to August 2021. The associations between SMP and surgical techniques as well as other clinical factors were evaluated via network meta-analysis. The impact of SMP on vertical ridge gain and implant survival was also evaluated. Results: Eighty-five studies with 5,551 SFE procedures were included. In LSFE techniques, using rotary burs showed the highest risk of SMP (surface under the cumulative ranking area [SUCRA] = 0.0745). In TSFE techniques, using reamers had the lowest risk of SMP (SUCRA = 0.9444). Increased SMP prevalence was significantly associated with reduced implant survival rate (odds ratio [OR] = 0.45 per 10% increase of SMP rate [95% credible interval (CreI): 0.21, 0.71], P < .001). Conclusions: With the inherent limitations, this network meta-analysis suggested that some techniques within either the LSFE or TSFE group may reduce SMP risk. Additional randomized controlled trials and better assessment of SMP are required to directly compare the risk of SMP between LSFE and TSFE.
Basic principles in designing studies to assess the effects of interventions
Background:
People with tuberculosis (TB) face multi-dimensional barriers when accessing and engaging with care. There is evidence that providing psychosocial support within people-centered models of care can improve TB outcomes, however, there is limited consensus on what works. It remains important for such interventions to be rigorously assessed, and mixed methods systematic reviews are one way of synthesising data for policy makers to be able to access such evidence. Mixed methods reviews take a complexity perspective, with qualitative data being used to contextualise the quantitative findings and giving an insight into how interventions are contingent on variations in design and context.
Methods:
Five electronic databases were searched from January 1 2015 to 14 January 2023 for randomised controlled trials, quasi-experimental trials, cohort studies and qualitative studies of interventions providing psychosocial support (material and/or psychological-based support) to adults with any clinical form of active TB. Studies with inpatient treatment as the standard of care were excluded. Quantitative studies reporting pre-specified standard TB outcomes were eligible. In line with established mixed methods review methodology, a convergent parallel-results synthesis design was followed: quantitative and qualitative syntheses were distinct and carried out using appropriate methods. A convergent coding matrix was then used to integrate the results. The protocol was registered on PROSPERO (CRD42021235211).
Findings:
Twenty-three studies of interventions were included (12 quantitative, 10 qualitative, and 1 mixed methods study) were included. Most studies were conducted in low-and middle-income countries with a high-burden of TB. Three explanatory and contextual middle-range theories from the integration of qualitative and quantitative data were developed: effective interventions provide multi-dimensional support; psychological-based support is transformative but there is insufficient evidence that it improves treatment outcomes on its own; intervention delivery shapes a logic of care.
Interpretation:
This review takes a complexity perspective to provide actionable and timely insight to inform the design and implementation of locally-appropriate and people-centered psychosocial support interventions within national TB programmes.
Funding:
There was no funding source for this study.
Objective:
The significant impact of fatigue on the lives of patients with chronic conditions has demanded a response. One response has been the development and testing of self-management programs. Little is known about what these programs have in common or how they differ. This scoping review compared the key components of fatigue self-management programs.
Methods:
Scoping review methodology was employed. Databases of CINAHL, Academic Search Premier, PsycINFO, Cochrane and Medline were searched to identify relevant sources.
Results:
Included fatigue programs were compared using a three-component framework: 1) self-management strategies; 2) active patient participation; and 3) self-management support. Although all programs included some aspects of these components, the extent varied with only a few domains of these components found across all programs.
Conclusion:
The three self-management components employed in this study showed potential benefits in identifying similarities and differences across fatigue programs with comparable and distinct underlying theories. This three-component framework could facilitate identification of domains associated with positive outcomes.
Practice implications:
It is essential that authors of programs provide detailed descriptions to enable inter-program comparison. The three-component framework chosen for this review was capable of describing and comparing fatigue self-management programs, paving the way for more effective interventions.
The concept of race or ethnic concordance between health care provider and patient has emerged as a dimension of the patient-physician relationship that could influence health outcomes for patients from minoritized groups, particularly through differences in the way physicians communicate with patients based on race or ethnicity. However, two decades of study on concordance and physician-patient communication have produced contradictory results. Given the heightened societal awareness of racism and the persistence of health disparities, there is a need for a comprehensive review of the current state of knowledge. This review sets out to determine how communication patterns differ in race/ethnicity concordant versus discordant patient-physician medical encounters. Thirty-three studies employing a range of methodologies were identified. In most analyses, after accounting for covariates, no relationship was found between race/ethnicity concordance and communication variables. Race/ethnicity concordance with their physician does not appear to influence the quality of communication for most patients from minoritized groups. A number of methodological weaknesses were identified in existing research, among them: few studies investigated potential explanatory variables, the heterogeneity of ethnic and cultural experience was over-simplified, there was little consistency in operationalization of communication variables, and the physician-patient dynamic was inadequately conceptualized.
Antimicrobial resistance (AMR) is often referred to as a complex problem embedded in a complex system. Despite this insight, interventions in AMR, and in particular in antibiotic prescribing, tend to be narrowly focused on the behaviour of individual prescribers using the tools of performance monitoring and management rather than attempting to bring about more systemic change. In this paper, we aim to elucidate the nature of the local antibiotic prescribing ‘system’ based on 71 semi-structured interviews undertaken in six local areas across the United Kingdom (UK). We applied complex systems theory and systems mapping methods to our qualitative data to deepen our understanding of the interactions among antibiotic prescribing interventions and the wider health system. We found that a complex and interacting set of proximal and distal factors can have unpredictable effects in different local systems in the UK. Ultimately, enacting performance management-based interventions in the absence of in-depth contextual understandings about other pressures prescribers face is a recipe for temporary solutions, waning intervention effectiveness, and unintended consequences. We hope our insights will enable policy makers and academics to devise and evaluate interventions in future in a manner that better reflects and responds to the dynamics of complex local prescribing systems.
Background:
Telehealth approaches are promising for the delivery of rehabilitation services but may be under-used or under-implemented.
Objective:
To report a review protocol to identify how much telerehabilitation (telehealth approaches to the delivery of rehabilitation services) have been used and implemented, and which factors have affected such implementation.
Methods:
A mixed-methods systematic review with a framework synthesis. Six databases for the scientific literature will be searched, complemented by snowballing searches and additional references coming from key informants (i.e., rehabilitation researchers from a networking group in health services research). We will include English-language empirical research examining the routine use or implementation of telehealth technologies in physical rehabilitation services or by physical rehabilitation professionals from a range of study designs, excepting case studies, case reports, and qualitative studies with n < 5. Two independent reviewers will perform the screenings, quality appraisals (using the Joanna Briggs Institutes' appraisal checklists), and the data extractions. The Consolidated Framework for Implementation Research will be used to synthesize the data on the enablers and barriers of the implementation of telerehabilitation approaches. All the authors will be involved at this synthesis, and key informants will provide feedback.
Conclusion:
The results can inform further implementation endeavours.
Background
Planning for injury prevention and control activities relies upon good quality data from Road Traffic Injury Registry System (RTIRS). This study aimed at performing a meta-synthesis through a scoping review approach that sought a more comprehensive understanding of the existing global experiences on how to manage and assess data quality in the RTIRS.
Methods
This meta-synthesis study was conducted as a scoping review based on Arksey and O'Malley's framework, 2005. Ten international and national databases, including PubMed/MEDLINE, Scopus, Science Direct and Web of Science, Scientific Information Database (SID), Safety Literature of Iran (SafeLir), SafetyLit, Magiran, IranMedex, and Barakat knowledge network system (BKNS), were searched for studies up to 31 December 2021. References were independently screened by two researchers based on title and abstract, full-text review, and manual bibliography of included studies. Disputes that could not be resolved through discussion between the researchers were arbitrated by the lead researcher. The findings were synthesized through the meta-narrative analysis method.
Results
Out of 3487 studies, 33 studies were included for data synthesis. The synthesis of literature resulted in the emergence of four themes and 14 sub-themes. The main themes included dimensions of quality measurement (Individual approach to data quality measurement and systemic approach to quality measurement of the registry system); data quality strategies (data quality assurance strategies and data quality control strategies); challenges and solutions for each data quality characteristic (physical resources, human resources, guidelines and protocols, and training); and barriers and facilitators of data quality (equipment and technology, human resources, organization, management, and support processes, infrastructure, and individual factors).
Conclusion
This review provides a meta-synthesis of existing evidence related to the experiences of different countries on how to manage and evaluate the quality of data in the RTIRS, as well as identify the features that are effective in measuring data quality.
Foster carers require high quality evidence-based psychoeducational programs to support them in the care of children with complex trauma-related difficulties. However, there is a lack of systematic development of such programs which may explain mixed results. This paper presents a detailed account of the development of a complex intervention. This program was developed to address a practice gap of evidenced-based foster care programs in the Irish context. It aims to improve foster carers' capacity to provide children with trauma-informed care and in turn improve emotional and behavioural difficulties. The framework of the Medical Research Council (MRC) for the development and evaluation of complex interventions was used to develop Fostering Connections: The Trauma-informed Foster Care Programme. A prior narrative review of the evidence base of similar programs was combined with a prior qualitative study. A Stakeholder Group provided expert feedback during the development process. The development of a promising psychoeducational programs for foster carers using the MRC framework is described
Background
People who identify as LGBTQ+ are more likely to drink excessively compared to heterosexual and cisgender people. Perceived barriers to accessing alcohol services may further increase the potential for alcohol related harm for LGBTQ+ people. This qualitative study explores the experiences of LGBTQ+ people who have used alcohol services, including peer support groups, in Scotland and their suggestions for how alcohol services could be improved.
Methods
Participants were recruited using social media adverts, dating websites, organisations that work with LGBTQ+ clients and snowball sampling. Participants’ (n = 14) experiences of alcohol services and peer support groups were explored through semi-structured interviews. Data were analysed using the Framework Approach and thematic analysis.
Results
Many participants thought their drinking was closely associated with their LGBTQ+ identity, as a response to shame, stigma, or family rejection. Some service users had positive experiences of alcohol services. However, participants were rarely asked about their sexuality / gender identity and some reported a lack of discussion about how identity might impact drinking. There were common views across the sample that barriers experienced by others in the LGBTQ+ community were amplified for trans people. Service users recommended that services need to signal LGBTQ+ inclusivity and provide a safe space to discuss multiple issues (e.g., alcohol use, mental health, gender identity). Participants highlighted the importance of alcohol-free spaces in the LGBTQ+ communities.
Conclusion
The study has clear practice and policy implications. Alcohol services should provide a safe space for LGBTQ+ people and clearly indicate that. Service providers should be trained to discuss potential connections between LGBTQ+ identity and substance use. At a broader level, alcohol-free social spaces would help reduce alcohol-related harm in LGBTQ+ communities.
Background
Almost half of the under-5 deaths occur in the neonatal period and most can be prevented with quality newborn care. The already vulnerable state of newborns is exacerbated in humanitarian settings. This review aims to assess the current evidence of the interventions being provided in these contexts, identify strategies that increase their utilisation and their effects on health outcomes in order to inform involved actors in the field and to guide future research.
Methods
Searched for peer-reviewed and grey literature in four databases and in relevant websites, for published studies between 1990 and 15 November 2021. Search terms were related to newborns, humanitarian settings, low-income and middle-income countries and newborn health interventions. Quality assessment using critical appraisal tools appropriate to the study design was conducted. Data were extracted and analysed using a narrative synthesis approach.
Results
A total of 35 articles were included in this review, 33 peer-reviewed and 2 grey literature publications. The essential newborn care (ENC) interventions reported varied across the studies and only three used the Newborn Health in Humanitarian Settings: Field Guide as a guideline document. The ENC interventions most commonly reported were thermal care and feeding support whereas delaying of cord clamping and administration of vitamin K were the least. Training of healthcare workers was the most frequent strategy reported to increase utilisation. Community interventions, financial incentives and the provision of supplies and equipment were also reported.
Conclusion
There is insufficient evidence documenting the reality of newborn care in humanitarian settings in low-income and middle-income countries. There is a need to improve the reporting of these interventions, including when there are gaps in service provision. More evidence is needed on the strategies used to increase their utilisation and the effect on health outcomes.
PROSPERO registration number
CRD42020199639.
Background:
More than half of the global population is not effectively covered by any type of social protection benefit and women's coverage lags behind. Most girls and boys living in low-resource settings have no effective social protection coverage. Interest in these essential programmes in low and middle-income settings is rising and in the context of the COVID-19 pandemic the value of social protection for all has been undoubtedly confirmed. However, evidence on whether the impact of different social protection programmes (social assistance, social insurance and social care services and labour market programmes) differs by gender has not been consistently analysed. Evidence is needed on the structural and contextual factors that determine differential impacts. Questions remain as to whether programme outcomes vary according to intervention implementation and design.
Objectives:
This systematic review aims to collect, appraise, and synthesise the evidence from available systematic reviews on the differential gender impacts of social protection programmes in low and middle-income countries. It answers the following questions: 1.What is known from systematic reviews on the gender-differentiated impacts of social protection programmes in low and middle-income countries?2.What is known from systematic reviews about the factors that determine these gender-differentiated impacts?3.What is known from existing systematic reviews about design and implementation features of social protection programmes and their association with gender outcomes?
Search methods:
We searched for published and grey literature from 19 bibliographic databases and libraries. The search techniques used were subject searching, reference list checking, citation searching and expert consultations. All searches were conducted between 10 February and 1 March 2021 to retrieve systematic reviews published within the last 10 years with no language restrictions.
Selection criteria:
We included systematic reviews that synthesised evidence from qualitative, quantitative or mixed-methods studies and analysed the outcomes of social protection programmes on women, men, girls, and boys with no age restrictions. The reviews included investigated one or more types of social protection programmes in low and middle-income countries. We included systematic reviews that investigated the effects of social protection interventions on any outcomes within any of the following six core outcome areas of gender equality: economic security and empowerment, health, education, mental health and psychosocial wellbeing, safety and protection and voice and agency.
Data collection and analysis:
A total of 6265 records were identified. After removing duplicates, 5250 records were screened independently and simultaneously by two reviewers based on title and abstract and 298 full texts were assessed for eligibility. Another 48 records, identified through the initial scoping exercise, consultations with experts and citation searching, were also screened. The review includes 70 high to moderate quality systematic reviews, representing a total of 3289 studies from 121 countries. We extracted data on the following areas of interest: population, intervention, methodology, quality appraisal, and findings for each research question. We also extracted the pooled effect sizes of gender equality outcomes of meta-analyses. The methodological quality of the included systematic reviews was assessed, and framework synthesis was used as the synthesis method. To estimate the degree of overlap, we created citation matrices and calculated the corrected covered area.
Main results:
Most reviews examined more than one type of social protection programme. The majority investigated social assistance programmes (77%, N = 54), 40% (N = 28) examined labour market programmes, 11% (N = 8) focused on social insurance interventions and 9% (N = 6) analysed social care interventions. Health was the most researched (e.g., maternal health; 70%, N = 49) outcome area, followed by economic security and empowerment (e.g., savings; 39%, N = 27) and education (e.g., school enrolment and attendance; 24%, N = 17). Five key findings were consistent across intervention and outcomes areas: (1) Although pre-existing gender differences should be considered, social protection programmes tend to report higher impacts on women and girls in comparison to men and boys; (2) Women are more likely to save, invest and share the benefits of social protection but lack of family support is a key barrier to their participation and retention in programmes; (3) Social protection programmes with explicit objectives tend to demonstrate higher effects in comparison to social protection programmes without broad objectives; (4) While no reviews point to negative impacts of social protection programmes on women or men, adverse and unintended outcomes have been attributed to design and implementation features. However, there are no one-size-fits-all approaches to design and implementation of social protection programmes and these features need to be gender-responsive and adapted; and (5) Direct investment in individuals and families' needs to be accompanied by efforts to strengthen health, education, and child protection systems. Social assistance programmes may increase labour participation, savings, investments, the utilisation of health care services and contraception use among women, school enrolment among boys and girls and school attendance among girls. They reduce unintended pregnancies among young women, risky sexual behaviour, and symptoms of sexually transmitted infections among women. Social insurance programmes increase the utilisation of sexual, reproductive, and maternal health services, and knowledge of reproductive health; improve changes in attitudes towards family planning; increase rates of inclusive and early initiation of breastfeeding and decrease poor physical wellbeing among mothers. Labour market programmes increase labour participation among women receiving benefits, savings, ownership of assets, and earning capacity among young women. They improve knowledge and attitudes towards sexually transmitted infections, increase self-reported condom use among boys and girls, increase child nutrition and overall household dietary intake, improve subjective wellbeing among women. Evidence on the impact of social care programmes on gender equality outcomes is needed.
Authors' conclusions:
Although effectiveness gaps remain, current programmatic interests are not matched by a rigorous evidence base demonstrating how to appropriately design and implement social protection interventions. Advancing current knowledge of gender-responsive social protection entails moving beyond effectiveness studies to test packages or combinations of design and implementation features that determine the impact of these interventions on gender equality. Systematic reviews investigating the impact of social care programmes, old age pensions and parental leave on gender equality outcomes in low and middle-income settings are needed. Voice and agency and mental health and psychosocial wellbeing remain under-researched gender equality outcome areas.
Introduction
The number of people living with multiple long-term conditions (MLTCs) is predicted to rise. Within this population, those also living with frailty are particularly vulnerable to poor outcomes, including decreased function. Increased physical activity, including exercise, has the potential to improve function in those living with both MLTCs and frailty but, to date, the focus has remained on older people and may not reflect outcomes for the growing number of younger people living with MLTCs and frailty. For those with higher burdens of frailty and MLTCs, physical activity may be challenging. Tailoring physical activity in response to symptoms and periods of ill-health, involving family and reducing sedentary behaviour may be important in this population. How the tailoring of interventions has been approached within existing studies is currently unclear. This scoping review aims to map the available evidence regarding these interventions in people living with both frailty and MLTCs.
Methods and analysis
We will use a six-stage process: (1) identifying the research questions; (2) identifying relevant studies (via database searches); (3) selecting studies; (4) charting the data; (5) collating and summarising and (6) stakeholder consultation. Studies will be critically appraised using the Mixed Methods Appraisal Tool.
Ethics and dissemination
All data in this project will be gathered through database searches. Stakeholder consultation will be undertaken with an established patient and public involvement group. We will disseminate our findings via social media, publication and engagement meetings.
Background
People with severe mental illness die 15–20 years earlier than the general population. Reasons why include that people with severe mental illness are more likely to smoke and be physically inactive as a result of social inequalities.
Objectives
(1) Evaluate the clinical effectiveness of multiple risk behaviour interventions on behaviour change (e.g. smoking abstinence), and outcomes affected by behaviours (e.g. weight loss). (2) Compare the clinical effectiveness of interventions targeting multiple and single risk behaviours. (3) Examine the factors affecting outcomes (e.g. intervention content). (4) Assess the factors affecting experiences of interventions (e.g. barriers and facilitators).
Data sources
The Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE™ (Elsevier, Amsterdam, the Netherlands), MEDLINE, PsycInfo ® (American Psychological Association, Washington, DC, USA) and Science Citation Index (Clarivate Analytics, Philadelphia, PA, USA) were searched from inception to October 2018, and an updated search was conducted in March 2020. An Applied Social Sciences Index and Abstracts (ASSIA) search and an updated Cochrane Central Register of Controlled Trials search were undertaken in September 2020.
Study selection
Randomised controlled trials targeting single or multiple health risk behaviours among people with severe mental illness were included. Qualitative evidence on factors affecting the effectiveness of risk behaviour interventions was included.
Study appraisal
Network meta-analyses were conducted to compare the effectiveness of multiple and single risk behaviour interventions. The mean differences were estimated for continuous outcomes; if this was not possible, standardised mean differences were calculated. Thematic syntheses of qualitative studies were conducted.
Results
A total of 101 studies (67 randomised controlled trials and 34 qualitative studies) were included. Most outcomes were smoking abstinence, weight and body mass index. Just over half of studies were rated as having a high overall risk of bias. Trials focusing on smoking alone led to greater abstinence than targeting smoking and other behaviours. However, heterogeneity means that other explanations cannot be ruled out. For weight loss and body mass index, single risk behaviour (e.g. physical activity alone) and multiple risk behaviour (e.g. diet and physical activity) interventions had positive but modest benefits. For example, any risk behaviour intervention led to a 2 kg greater weight loss (–2.10 kg, 95% credible interval –3.14 to –1.06 kg) and approximately half a point (i.e. 0.5 kg/m ² ) greater body mass index reduction (–0.49 kg/m ² , 95% credible interval –0.97 to –0.01 kg/m ² ) than treatment as usual. There were potential synergies for targeting multiple health behaviours for reduction in systolic and diastolic blood pressure. No evidence was found of a deterioration in mental health for people with severe mental illness engaging in interventions to reduce health risk behaviours. Qualitative studies found that people with severe mental illness favoured interventions promoting physical and mental health together, and that took their condition into account. However, trials focused mainly on promoting physical health.
Limitations
Most quantitative studies focused on weight and body mass index; few assessed behavioural outcomes. Qualitative studies often addressed different aims.
Conclusions
Multiple and single risk behaviour interventions were associated with positive but modest benefits on most outcomes. Interventions seeking to promote physical health were not associated with deterioration in mental health. There was a lack of overlap between quantitative and qualitative studies.
Future work
Further research is needed to investigate whether or not health behaviour changes are maintained long term; tailoring weight-loss interventions for people with severe mental illness; and in terms of methods, co-production and mixed-methods approaches in future trials.
Study registration
This study is registered as PROSPERO CRD42018104724.
Funding
This project was funded by the National Institute for Health Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research ; Vol. 10, No. 6. See the NIHR Journals Library website for further project information.
Background
Cotrimoxazole and isoniazid preventive therapy (CPT, IPT) have been shown to be efficacious therapies for the prevention of opportunistic infections and tuberculosis (TB) among people living with human immunodeficiency virus (HIV). Despite governments’ efforts to translate World Health Organization recommendations into practice, implementation remains challenging. This review aimed to explore and compare CPT and IPT with respect to similarities and differences of barriers identified across high TB/HIV burden countries. A secondary objective was to identify facilitators for implementing both preventive therapies.
Methods
We searched MEDLINE, Web of Science and SCOPUS databases for peer-reviewed literature published before September 2020. We extracted and synthesized our findings using Maxqda software. We applied framework synthesis in conjunction with metasummary to compare both therapies with respect to similarities and differences of barriers identified across seven health system components (in line with the modified WHO’s Framework for action). Protocol registration: PROSPERO (CRD42019137778).
Findings
We identified four hundred and eighty-two papers, of which we included forty for review. Although most barrier themes were identical for both preventive therapies, we identified seven intervention-specific themes. Like for CPT, barriers identified for IPT were most frequently classified as ‘service delivery-related barriers’ and ‘patient & community-related barriers’. ‘Health provider-related barriers’ played an important role for implementing IPT. Most facilitators identified referred to health system strengthening activities.
Conclusions
For researchers with limited working experience in high TB/HIV burden countries, this review can provide valuable insights about barriers that may arise at different levels of the health system. For policymakers in high TB/HIV burden countries, this review offers strategies for improving the delivery of IPT (or any newer therapy regimen) for the prevention of TB. Based on our findings, we suggest initial and continuous stakeholder involvement, focusing on the efficient use and reinforcement of existing resources for health.
Aim: De novo relapsed and/or refractory acute myeloid leukemia (rrAML) has limited treatment options for patients not eligible (‘unfit’) to receive intensive chemotherapy-based interventions. The authors aimed to summarize outcomes for licensed therapies in this setting. Materials & methods: A systematic literature review identified licensed therapies in this setting. A feasibility assessment was made to conduct a network meta-analysis to evaluate comparative efficacy. Results: Seven unique trials were identified. Median survival months were 13.8 for gemtuzumab ozogamicin (GO), 9.3 for gilteritinib (FLT3 mutated rrAML), 5.6 for low-dose cytarabine and 3.2 for best supportive care; transplant rates with gilteritinib and GO were 25.5% and 19%, respectively. A network meta-analysis was not feasible. Conclusion: There remains a high unmet need in de novo rrAML patients not eligible for intensive therapy, with GO and gilteritinib (only FLT3 mutated AML) providing the best current options.
Introduction
The Independent Review of the Mental Health Act (MHA) in England and Wales confirmed increasing levels of compulsory detentions, especially for racialised communities. This research aims to: (a) understand the causes of and propose preventive opportunities to reduce the disproportionate use of the MHA, (b) use an adapted form of experience-based codesign (EBCD) to facilitate system-wide changes and (c) foreground the voices of service users at risk of detention to radically reform policy and implement new legislation to ensure the principles of equity are retained.
Methods and analysis
This is a qualitative study, using a comparative case study design. This study is composed of five work packages; photovoice workshops will be conducted in eight local systems with service users and healthcare professionals separately (WP1); a series of three EBCD workshops in each local system to develop approaches that reduce detentions and improve the experience of people from racialised communities. This will inform a comparative analysis and national knowledge exchange workshop (WP2); an evaluation led by the patient and public involvement group to better understand what it is like for people to participate in photovoice, codesign and participatory research (WP3); an economic evaluation (WP4) and dissemination strategy (WP5). The impact of the involvement of patients and public will be independently evaluated.
Ethics and dissemination
This study is sponsored by the University of Oxford and granted ethical approval from the NHS Research Ethics Committee and Health Research Authority (21/SC/0204). The outputs from this study will be shared through several local and national channels.
A considerable number of journal publications using a range of qualitative synthesis approaches has been published. Mary Dixon-Woods and colleagues (Mary Dixon-Woods, Booth, & Sutton, 2007) identified 42 qualitative evidence synthesis papers published in health care literature between 1990 and 2004. An ongoing update by Hannes and Macaitis (2010)identified around 100 additional qualitative or mixed methods syntheses. Yet these generally lack a clear, detailed description of what was done and why (Greenhalgh et al, 2007; McInnes & Wimpenny, 2008) . Choices are most commonly influenced by what others have successfully used in the past or by a particular school of thought (Atkins et al, 2008; Britten et al, 2002). This is a substantive limitation. This book brings balance to the options available to researchers, including approaches that have not had a substantial uptake among researchers. It provides arguments for when and why researchers or other parties of interest should opt for a certain approach to synthesis, which challenges they might face in adopting it and what the potential strengths and weaknesses are compared with other approaches. This book acts as a resource for readers who would otherwise have to piece together the methodology from a range of journal articles. In addition, it should stimulate further development and documentation of synthesis methodology in a field that is characterized by diversity.
Globally, 2.8 billion people rely on household solid fuels. Reducing the resulting adverse health, environmental and development consequences will involve transitioning through a mix of clean fuels and improved solid fuel stoves (IS) of demonstrable effectiveness. To date, achieving uptake of IS has presented significant challenges.
Conduct a systematic review of factors enabling or limiting large-scale uptake of IS.
Systematic searches were conducted through multi-disciplinary databases, specialist websites and contacting experts. The review drew on qualitative, quantitative and case studies, with standardized methods for screening, data extraction, critical appraisal and synthesis. Findings were summarized as "factors", each relating to one of seven domains (households and settings; knowledge and perceptions; fuel and technology; finance, tax and subsidy; market development; regulation and standards; programmatic and policy mechanisms). Issues impacting equity were recorded.
A total of 31 factors influencing uptake were identified from 57 studies conducted in Asia, Africa and Latin America. All domains matter: while factors such as offering technologies that meet household needs and save fuel, user training and support, effective financing and facilitative government action appear critical for success, none guarantee this, and all factors can be influential depending on context. The nature of available evidence did not permit further prioritization.
Achieving adoption and sustained use of IS at scale requires that all factors, spanning household/community and programme/societal levels, be assessed and supported by policy; proposals are made for a planning tool to aid this process and for further research which should incorporate effectiveness evaluation.
We derive a general relation between the ground state entanglement
Hamiltonian and the physical stress tensor within the path integral formalism.
For spherical entangling surfaces in a CFT, we reproduce the \emph{local}
ground state entanglement Hamiltonian derived by Casini, Huerta and Myers. The
resulting reduced density matrix can be characterized by a spatially varying
"entanglement temperature." Using the entanglement Hamiltonian, we calculate
the first order change in the entanglement entropy due to changes in conserved
charges of the ground state, and find a local first law-like relation for the
entanglement entropy. Our approach provides a field theory derivation and
generalization of recent results obtained by holographic techniques. However,
we note a discrepancy between our field theoretically derived results for the
entanglement entropy of excited states with a non-uniform energy density and
current holographic results in the literature. Finally, we give a CFT
derivation of a set of constraint equations obeyed by the entanglement entropy
of excited states in any dimension. Previously, these equations were derived in
the context of holography.
Background:
Meta-narrative review is one of an emerging menu of new approaches to qualitative and mixed-method systematic review. A meta-narrative review seeks to illuminate a heterogeneous topic area by highlighting the contrasting and complementary ways researchers have studied the same or a similar topic. No previous publication standards exist for the reporting of meta-narrative reviews. This publication standard was developed as part of the RAMESES (Realist And MEta-narrative Evidence Syntheses: Evolving Standards) project. The project's aim is to produce preliminary publication standards for meta-narrative reviews.
Design:
A mixed method study synthesising data between 2011 to 2012 from a literature review, online Delphi panel and feedback from training, workshops and email list.
Methods:
We: (a) collated and summarized existing literature on the principles of good practice in meta-narrative reviews; (b) considered the extent to which these principles had been followed by published reviews, thereby identifying how rigor may be lost and how existing methods could be improved; (c) used a three-round online Delphi method with an interdisciplinary panel of national and international experts in evidence synthesis, meta-narrative reviews, policy, and/or publishing to produce and iteratively refine a draft set of methodological steps, and publication standards; (d) provided real-time support to ongoing meta-narrative reviews and the open-access RAMESES online discussion list so as to capture problems and questions as they arose; and (e) synthesized expert input, evidence review, and real-time problem analysis into a definitive set of standards.
Results:
We identified nine published meta-narrative reviews, provided real-time support to four ongoing reviews, and captured questions raised in the RAMESES discussion list. Through analysis and discussion within the project team, we summarized the published literature, and common questions and challenges into briefing materials for the Delphi panel, comprising 33 members. Within three rounds this panel had reached consensus on 20 key publication standards, with an overall response rate of 90%.
Conclusions:
This project used multiple sources to draw together evidence and expertise in meta-narrative reviews. For each item we have included an explanation for why it is important and guidance on how it might be reported. Meta-narrative review is a relatively new method for evidence synthesis and as experience and methodological developments occur, we anticipate that these standards will evolve to reflect further theoretical and methodological developments. We hope that these standards will act as a resource that will contribute to improving the reporting of meta-narrative reviews.
Clinical practice does not always reflect best practice and evidence, partly because of unconscious acts of omission, information overload, or inaccessible information. Reminders may help clinicians overcome these problems by prompting the doctor to recall information that they already know or would be expected to know and by providing information or guidance in a more accessible and relevant format, at a particularly appropriate time.
To evaluate the effects of reminders automatically generated through a computerized system and delivered on paper to healthcare professionals on processes of care (related to healthcare professionals' practice) and outcomes of care (related to patients' health condition).
For this update the EPOC Trials Search Co-ordinator searched the following databases between June 11-19, 2012: The Cochrane Central Register of Controlled Trials (CENTRAL) and Cochrane Library (Economics, Methods, and Health Technology Assessment sections), Issue 6, 2012; MEDLINE, OVID (1946- ), Daily Update, and In-process; EMBASE, Ovid (1947- ); CINAHL, EbscoHost (1980- ); EPOC Specialised Register, Reference Manager, and INSPEC, Engineering Village. The authors reviewed reference lists of related reviews and studies.
We included individual or cluster-randomized controlled trials (RCTs) and non-randomized controlled trials (NRCTs) that evaluated the impact of computer-generated reminders delivered on paper to healthcare professionals on processes and/or outcomes of care.
Review authors working in pairs independently screened studies for eligibility and abstracted data. We contacted authors to obtain important missing information for studies that were published within the last 10 years. For each study, we extracted the primary outcome when it was defined or calculated the median effect size across all reported outcomes. We then calculated the median absolute improvement and interquartile range (IQR) in process adherence across included studies using the primary outcome or median outcome as representative outcome.
In the 32 included studies, computer-generated reminders delivered on paper to healthcare professionals achieved moderate improvement in professional practices, with a median improvement of processes of care of 7.0% (IQR: 3.9% to 16.4%). Implementing reminders alone improved care by 11.2% (IQR 6.5% to 19.6%) compared with usual care, while implementing reminders in addition to another intervention improved care by 4.0% only (IQR 3.0% to 6.0%) compared with the other intervention. The quality of evidence for these comparisons was rated as moderate according to the GRADE approach. Two reminder features were associated with larger effect sizes: providing space on the reminder for provider to enter a response (median 13.7% versus 4.3% for no response, P value = 0.01) and providing an explanation of the content or advice on the reminder (median 12.0% versus 4.2% for no explanation, P value = 0.02). Median improvement in processes of care also differed according to the behaviour the reminder targeted: for instance, reminders to vaccinate improved processes of care by 13.1% (IQR 12.2% to 20.7%) compared with other targeted behaviours. In the only study that had sufficient power to detect a clinically significant effect on outcomes of care, reminders were not associated with significant improvements.
There is moderate quality evidence that computer-generated reminders delivered on paper to healthcare professionals achieve moderate improvement in process of care. Two characteristics emerged as significant predictors of improvement: providing space on the reminder for a response from the clinician and providing an explanation of the reminder's content or advice. The heterogeneity of the reminder interventions included in this review also suggests that reminders can improve care in various settings under various conditions.
The association between poor housing and poor health is widely accepted, but there is a lack of evidence on the health impact of housing interventions. In particular, evidence on mechanisms linking housing interventions to health is lacking. Scotland's Housing and Regeneration Project (SHARP) evaluated the health impacts of new-build social housing using a quasi-experimental survey design. Qualitative interviews were also conducted with a sub-sample of survey respondents. The qualitative data indicated that changes in dwelling type influenced key psychosocial processes such as control, with consequent impacts on well-being. This study provided insights into the psychosocial impacts of housing design, whilst also demonstrating the utility of qualitative methods for enhancing understanding of the mechanisms linking housing change with improved well-being.
This is the first in a series of four articlesAcross all disciplines, at all levels, and throughout the world, health care is becoming more complex. Just 30 years ago the typical general practitioner in the United Kingdom practised from privately owned premises with a minimum of support staff, subscribed to a single journal, phoned up a specialist whenever he or she needed advice, and did around an hour's paperwork per week. The specialist worked in a hospital, focused explicitly on a particular system of the body, was undisputed leader of his or her “firm,” and generally left administration to the administrators. These individuals often worked long hours, but most of their problems could be described in biomedical terms and tackled using the knowledge and skills they had acquired at medical school.You used to go to the doctor when you felt ill, to find out what was wrong with you and get some medicine that would make you better. These days you are as likely to be there because the doctor (or the nurse, the care coordinator, or even the computer) has sent for you. Your treatment will now be dictated by the evidence—but this may well be imprecise, equivocal, or conflicting. Your declared values and preferences may be used, formally or informally, in a shared management decision about your illness. The solution to your problem is unlikely to come in a bottle and may well involve a multidisciplinary team.Not so long ago public health was the science of controlling infectious diseases by identifying the “cause” (an alien organism) and taking steps to remove or contain it. Today's epidemics have fuzzier boundaries (one is even known as “syndrome X”1): they are the result of the interplay of genetic predisposition, environmental context, and lifestyle choices.The experience of …
Systematic review has developed as a specific methodology for searching for, appraising and synthesizing findings of primary studies, and has rapidly become a cornerstone of the evidence-based practice and policy movement. Qualitative research has traditionally been excluded from systematic reviews, and much effort is now being invested in resolving the daunting methodological and epistemological challenges associated with trying to move towards more inclusive forms of review. We describe our experiences, as a very diverse multidisciplinary group, in attempting to incorporate qualitative research in a systematic review of support for breastfeeding. We show how every stage of the review process, from asking the review question through to searching for and sampling the evidence, appraising the evidence and producing a synthesis, provoked profound questions about whether a review that includes qualitative research can remain consistent with the frame offered by current systematic review methodology. We conclude that more debate and dialogue between the different communities that wish to develop review methodology is needed, and that attempts to impose dominant views about the appropriate means of conducting reviews of qualitative research should be resisted so that innovation can be fostered.
Audit and feedback is widely used as a strategy to improve professional practice either on its own or as a component of multifaceted quality improvement interventions. This is based on the belief that healthcare professionals are prompted to modify their practice when given performance feedback showing that their clinical practice is inconsistent with a desirable target. Despite its prevalence as a quality improvement strategy, there remains uncertainty regarding both the effectiveness of audit and feedback in improving healthcare practice and the characteristics of audit and feedback that lead to greater impact.
To assess the effects of audit and feedback on the practice of healthcare professionals and patient outcomes and to examine factors that may explain variation in the effectiveness of audit and feedback.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) 2010, Issue 4, part of The Cochrane Library. www.thecochranelibrary.com, including the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register (searched 10 December 2010); MEDLINE, Ovid (1950 to November Week 3 2010) (searched 09 December 2010); EMBASE, Ovid (1980 to 2010 Week 48) (searched 09 December 2010); CINAHL, Ebsco (1981 to present) (searched 10 December 2010); Science Citation Index and Social Sciences Citation Index, ISI Web of Science (1975 to present) (searched 12-15 September 2011).
Randomised trials of audit and feedback (defined as a summary of clinical performance over a specified period of time) that reported objectively measured health professional practice or patient outcomes. In the case of multifaceted interventions, only trials in which audit and feedback was considered the core, essential aspect of at least one intervention arm were included.
All data were abstracted by two independent review authors. For the primary outcome(s) in each study, we calculated the median absolute risk difference (RD) (adjusted for baseline performance) of compliance with desired practice compliance for dichotomous outcomes and the median percent change relative to the control group for continuous outcomes. Across studies the median effect size was weighted by number of health professionals involved in each study. We investigated the following factors as possible explanations for the variation in the effectiveness of interventions across comparisons: format of feedback, source of feedback, frequency of feedback, instructions for improvement, direction of change required, baseline performance, profession of recipient, and risk of bias within the trial itself. We also conducted exploratory analyses to assess the role of context and the targeted clinical behaviour. Quantitative (meta-regression), visual, and qualitative analyses were undertaken to examine variation in effect size related to these factors.
We included and analysed 140 studies for this review. In the main analyses, a total of 108 comparisons from 70 studies compared any intervention in which audit and feedback was a core, essential component to usual care and evaluated effects on professional practice. After excluding studies at high risk of bias, there were 82 comparisons from 49 studies featuring dichotomous outcomes, and the weighted median adjusted RD was a 4.3% (interquartile range (IQR) 0.5% to 16%) absolute increase in healthcare professionals' compliance with desired practice. Across 26 comparisons from 21 studies with continuous outcomes, the weighted median adjusted percent change relative to control was 1.3% (IQR = 1.3% to 28.9%). For patient outcomes, the weighted median RD was -0.4% (IQR -1.3% to 1.6%) for 12 comparisons from six studies reporting dichotomous outcomes and the weighted median percentage change was 17% (IQR 1.5% to 17%) for eight comparisons from five studies reporting continuous outcomes. Multivariable meta-regression indicated that feedback may be more effective when baseline performance is low, the source is a supervisor or colleague, it is provided more than once, it is delivered in both verbal and written formats, and when it includes both explicit targets and an action plan. In addition, the effect size varied based on the clinical behaviour targeted by the intervention.
Audit and feedback generally leads to small but potentially important improvements in professional practice. The effectiveness of audit and feedback seems to depend on baseline performance and how the feedback is provided. Future studies of audit and feedback should directly compare different ways of providing feedback.
Methods of diagrammatic modelling have been greatly developed in the past two decades. Outside the context of infectious diseases, systematic use of diagrams in epidemiology has been mainly confined to the analysis of a single link: that between a disease outcome and its proximal determinant(s). Transmitted causes ("causes of causes") tend not to be systematically analysed.
The infectious disease epidemiology modelling tradition models the human population in its environment, typically with the exposure-health relationship and the determinants of exposure being considered at individual and group/ecological levels, respectively. Some properties of the resulting systems are quite general, and are seen in unrelated contexts such as biochemical pathways. Confining analysis to a single link misses the opportunity to discover such properties.
The structure of a causal diagram is derived from knowledge about how the world works, as well as from statistical evidence. A single diagram can be used to characterise a whole research area, not just a single analysis - although this depends on the degree of consistency of the causal relationships between different populations - and can therefore be used to integrate multiple datasets.
Additional advantages of system-wide models include: the use of instrumental variables - now emerging as an important technique in epidemiology in the context of mendelian randomisation, but under-used in the exploitation of "natural experiments"; the explicit use of change models, which have advantages with respect to inferring causation; and in the detection and elucidation of feedback.
Flaws in the design, conduct, analysis, and reporting of randomised trials can cause the effect of an intervention to be underestimated or overestimated. The Cochrane Collaboration’s tool for assessing risk of bias aims to make the process clearer and more accurate
There is growing interest in theory-driven, qualitative and mixed-method approaches to systematic review as an alternative to (or to extend and supplement) conventional Cochrane-style reviews. These approaches offer the potential to expand the knowledge base in policy-relevant areas - for example by explaining the success, failure or mixed fortunes of complex interventions. However, the quality of such reviews can be difficult to assess. This study aims to produce methodological guidance, publication standards and training resources for those seeking to use the realist and/or meta-narrative approach to systematic review.
We will: [a] collate and summarise existing literature on the principles of good practice in realist and meta-narrative systematic review; [b] consider the extent to which these principles have been followed by published and in-progress reviews, thereby identifying how rigour may be lost and how existing methods could be improved; [c] using an online Delphi method with an interdisciplinary panel of experts from academia and policy, produce a draft set of methodological steps and publication standards; [d] produce training materials with learning outcomes linked to these steps; [e] pilot these standards and training materials prospectively on real reviews-in-progress, capturing methodological and other challenges as they arise; [f] synthesise expert input, evidence review and real-time problem analysis into more definitive guidance and standards; [g] disseminate outputs to audiences in academia and policy. The outputs of the study will be threefold:1. Quality standards and methodological guidance for realist and meta-narrative reviews for use by researchers, research sponsors, students and supervisors2. A 'RAMESES' (Realist and Meta-review Evidence Synthesis: Evolving Standards) statement (comparable to CONSORT or PRISMA) of publication standards for such reviews, published in an open-access academic journal.3. A training module for researchers, including learning outcomes, outline course materials and assessment criteria.
Realist and meta-narrative review are relatively new approaches to systematic review whose overall place in the secondary research toolkit is not yet fully established. As with all secondary research methods, guidance on quality assurance and uniform reporting is an important step towards improving quality and consistency of studies.
A variety of different approaches to the synthesis of qualitative data are advocated in the literature. The aim of this paper is to describe the application of a pragmatic method of qualitative evidence synthesis and the lessons learned from adopting this "best fit" framework synthesis approach.
An evaluation of framework synthesis as an approach to the qualitative systematic review of evidence exploring the views of adults to the taking of potential agents within the context of the primary prevention of colorectal cancer.
Twenty papers from North America, Australia, the UK and Europe met the criteria for inclusion. Fourteen themes were identified a priori from a related, existing conceptual model identified in the literature, which were then used to code the extracted data. Further analysis resulted in the generation of a more sophisticated model with additional themes. The synthesis required a combination of secondary framework and thematic analysis approaches and was conducted within a health technology assessment timeframe.
The novel and pragmatic "best fit" approach to framework synthesis developed and described here was found to be fit for purpose. Future research should seek to test further this approach to qualitative data synthesis.
The multivariate random effects model is a generalization of the standard univariate model. Multivariate meta-analysis is becoming more commonly used and the techniques and related computer software, although continually under development, are now in place. In order to raise awareness of the multivariate methods, and discuss their advantages and disadvantages, we organized a one day 'Multivariate meta-analysis' event at the Royal Statistical Society. In addition to disseminating the most recent developments, we also received an abundance of comments, concerns, insights, critiques and encouragement. This article provides a balanced account of the day's discourse. By giving others the opportunity to respond to our assessment, we hope to ensure that the various view points and opinions are aired before multivariate meta-analysis simply becomes another widely used de facto method without any proper consideration of it by the medical statistics community. We describe the areas of application that multivariate meta-analysis has found, the methods available, the difficulties typically encountered and the arguments for and against the multivariate methods, using four representative but contrasting examples. We conclude that the multivariate methods can be useful, and in particular can provide estimates with better statistical properties, but also that these benefits come at the price of making more assumptions which do not result in better inference in every case. Although there is evidence that multivariate meta-analysis has considerable potential, it must be even more carefully applied than its univariate counterpart in practice. Copyright © 2011 John Wiley & Sons, Ltd.
Interpretation of meta-analyses of published observational studies is problematic because of numerous sources of bias. We develop bias assessment, elicitation and adjustment methods, and apply them to a systematic review of longitudinal observational studies of the relationship between objectively measured physical activity and subsequent change in adiposity in children.
We separated internal biases that reflect study quality from external biases that reflect generalizability to a target setting. Since published results were presented in different formats, these were all converted to correlation coefficients. Biases were considered as additive or proportional on the correlation scale. Opinions about the extent of each bias in each study, together with its uncertainty, were elicited in a formal process from quantitatively trained assessors for the internal biases and subject-matter specialists for the external biases. Bias-adjusted results for each study were combined across assessors using median pooling, and results combined across studies by random-effects meta-analysis.
Before adjusting for bias, the pooled correlation is difficult to interpret because the studies varied substantially in quality and design, and there was considerable heterogeneity. After adjusting for both the internal and external biases, the pooled correlation provides a meaningful quantitative summary of all available evidence, and the confidence interval incorporates the elicited uncertainties about the extent of the biases. In the adjusted meta-analysis, there was no apparent heterogeneity.
This approach provides a viable method of bias adjustment for meta-analyses of observational studies, allowing the quantitative synthesis of evidence from otherwise incompatible studies. From the meta-analysis of longitudinal observational studies, we conclude that there is no evidence that physical activity is associated with gain in body fat.
Background:
While maternal, infant and under-five child mortality rates in developing countries have declined significantly in the past two to three decades, newborn mortality rates have reduced much more slowly. While it is recognised that almost half of the newborn deaths can be prevented by scaling up evidence-based available interventions (such as tetanus toxoid immunisation to mothers, clean and skilled care at delivery, newborn resuscitation, exclusive breastfeeding, clean umbilical cord care, and/or management of infections in newborns), many require facility-based and outreach services. It has also been stated that a significant proportion of these mortalities and morbidities could also be potentially addressed by developing community-based packaged interventions which should also be supplemented by developing and strengthening linkages with the local health systems. Some of the recent community-based studies of interventions targeting women of reproductive age have shown variable impacts on maternal outcomes and hence it is uncertain if these strategies have consistent benefit across the continuum of maternal and newborn care.
Objectives:
To assess the effectiveness of community-based intervention packages in reducing maternal and neonatal morbidity and mortality; and improving neonatal outcomes.
Search methods:
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2014), World Bank's JOLIS (25 May 2014), BLDS at IDS and IDEAS database of unpublished working papers (25 May 2014), Google and Google Scholar (25 May 2014).
Selection criteria:
All prospective randomised, cluster-randomised and quasi-randomised trials evaluating the effectiveness of community-based intervention packages in reducing maternal and neonatal mortality and morbidities, and improving neonatal outcomes.
Data collection and analysis:
Two review authors independently assessed trials for inclusion, assessed trial quality and extracted the data. Data were checked for accuracy.
Main results:
The review included 26 cluster-randomised/quasi-randomised trials, covering a wide range of interventional packages, including two subsets from three trials. Assessment of risk of bias in these studies suggests concerns regarding insufficient information on sequence generation and regarding failure to adequately address incomplete outcome data, particularly from randomised controlled trials. We incorporated data from these trials using generic inverse variance method in which logarithms of risk ratio (RR) estimates were used along with the standard error of the logarithms of RR estimates.Our review showed a possible effect in terms of a reduction in maternal mortality (RR 0.80; 95% confidence interval (CI) 0.64 to 1.00, random-effects (11 studies, n = 167,311; random-effects, Tau² = 0.03, I² 20%). However, significant reduction was observed in maternal morbidity (average RR 0.75; 95% CI 0.61 to 0.92; four studies, n = 138,290; random-effects, Tau² = 0.02, I² = 28%); neonatal mortality (average RR 0.75; 95% CI 0.67 to 0.83; 21 studies, n = 302,646; random-effects, Tau² = 0.06, I² = 85%) including both early and late mortality; stillbirths (average RR 0.81; 95% CI 0.73 to 0.91; 15 studies, n = 201,181; random-effects, Tau² = 0.03, I² = 66%); and perinatal mortality (average RR 0.78; 95% CI 0.70 to 0.86; 17 studies, n = 282,327; random-effects Tau² = 0.04, I² = 88%) as a consequence of implementation of community-based interventional care packages.Community-based intervention packages also increased the uptake of tetanus immunisation by 5% (average RR 1.05; 95% CI 1.02 to 1.09; seven studies, n = 71,622; random-effects Tau² = 0.00, I² = 52%); use of clean delivery kits by 82% (average RR 1.82; 95% CI 1.10 to 3.02; four studies, n = 54,254; random-effects, Tau² = 0.23, I² = 90%); rates of institutional deliveries by 20% (average RR 1.20; 95% CI 1.04 to 1.39; 14 studies, n = 147,890; random-effects, Tau² = 0.05, I² = 80%); rates of early breastfeeding by 93% (average RR 1.93; 95% CI 1.55 to 2.39; 11 studies, n = 72,464; random-effects, Tau² = 0.14, I² = 98%), and healthcare seeking for neonatal morbidities by 42% (average RR 1.42; 95% CI 1.14 to 1.77, nine studies, n = 66,935, random-effects, Tau² = 0.09, I² = 92%). The review also showed a possible effect on increasing the uptake of iron/folic acid supplementation during pregnancy (average RR 1.47; 95% CI 0.99 to 2.17; six studies, n = 71,622; random-effects, Tau² = 0.26; I² = 99%).It has no impact on improving referrals for maternal morbidities, healthcare seeking for maternal morbidities, iron/folate supplementation, attendance of skilled birth attendance on delivery, and other neonatal care-related outcomes. We did not find studies that reported the impact of community-based intervention package on improving exclusive breastfeeding rates at six months of age. We assessed our primary outcomes for publication bias and observed slight asymmetry on the funnel plot for maternal mortality.
Authors' conclusions:
Our review offers encouraging evidence that community-based intervention packages reduce morbidity for women, mortality and morbidity for babies, and improves care-related outcomes particularly in low- and middle-income countries. It has highlighted the value of integrating maternal and newborn care in community settings through a range of interventions, which can be packaged effectively for delivery through a range of community health workers and health promotion groups. While the importance of skilled delivery and facility-based services for maternal and newborn care cannot be denied, there is sufficient evidence to scale up community-based care through packages which can be delivered by a range of community-based workers.
To determine whether home visits for neonatal care by community health workers can reduce infant and neonatal deaths and stillbirths in resource-limited settings.
We conducted a systematic review up to 2008 of controlled trials comparing various intervention packages, one of them being home visits for neonatal care by community health workers. We performed meta-analysis to calculate the pooled risk of outcomes.
Five trials, all from south Asia, satisfied the inclusion criteria. The intervention packages included in them comprised antenatal home visits (all trials), home visits during the neonatal period (all trials), home-based treatment for illness (3 trials) and community mobilization efforts (4 trials). Meta-analysis showed a reduced risk of neonatal death (relative risk, RR: 0.62; 95% confidence interval, CI: 0.44-0.87) and stillbirth (RR: 0.76; 95% CI: 0.65-0.89), and a significant improvement in antenatal and neonatal practice indicators (> 1 antenatal check-up, 2 doses of maternal tetanus toxoid, clean umbilical cord care, early breastfeeding and delayed bathing). Only one trial recorded infant deaths (RR: 0.41; 0.30-0.57). Subgroup analyses suggested a greater survival benefit when home visit coverage was ≥ 50% (P < 0.001) and when both preventive and curative interventions (injectable antibiotics) were conducted (P = 0.088).
Home visits for antenatal and neonatal care, together with community mobilization activities, are associated with reduced neonatal mortality and stillbirths in southern Asian settings with high neonatal mortality and poor access to facility-based health care.
How can we tell the difference between spurious and real subgroup effects? This article identifies new criteria and proposes a checklist for judging the credibility of subgroup analyses
Evaluating complex interventions is complicated. The Medical Research Council's evaluation framework (2000) brought welcome clarity to the task. Now the council has updated its guidance
Identifying biological and behavioural causes of diseases has been one of the central concerns of epidemiology for the past half century. This has led to the development of increasingly sophisticated conceptual and analytical approaches focused on the isolation of single causes of disease states. However, the growing recognition that (i) factors at multiple levels, including biological, behavioural and group levels may influence health and disease, and (ii) that the interrelation among these factors often includes dynamic feedback and changes over time challenges this dominant epidemiological paradigm. Using obesity as an example, we discuss how the adoption of complex systems dynamic models allows us to take into account the causes of disease at multiple levels, reciprocal relations and interrelation between causes that characterize the causation of obesity. We also discuss some of the key difficulties that the discipline faces in incorporating these methods into non-infectious disease epidemiology. We conclude with a discussion of a potential way forward.
In recent years, a growing number of methods for synthesising qualitative research have emerged, particularly in relation to health-related research. There is a need for both researchers and commissioners to be able to distinguish between these methods and to select which method is the most appropriate to their situation.
A number of methodological and conceptual links between these methods were identified and explored, while contrasting epistemological positions explained differences in approaches to issues such as quality assessment and extent of iteration. Methods broadly fall into 'realist' or 'idealist' epistemologies, which partly accounts for these differences.
Methods for qualitative synthesis vary across a range of dimensions. Commissioners of qualitative syntheses might wish to consider the kind of product they want and select their method - or type of method - accordingly.
Background to the debate
The UK Medical Research Council defines complex interventions as those comprising “a number of separate elements which seem essential to the proper functioning of the interventions although the ‘active ingredient’ of the intervention that is effective is difficult to specify.” A typical example is specialist care on a stroke unit, which involves a wide range of health professionals delivering a variety of treatments. Michelle Campbell and colleagues have argued that there are “specific difficulties in defining, developing, documenting, and reproducing complex interventions that are subject to more variation than a drug” [10]. These difficulties are one of the reasons why it is challenging for researchers to systematically review complex interventions and synthesize data from separate studies. This PLoS Medicine Debate considers the challenges facing systematic reviewers and suggests several ways of addressing them.
Conventional thinking about preventive interventions focuses over simplistically on the "package" of activities and/or their educational messages. An alternative is to focus on the dynamic properties of the context into which the intervention is introduced. Schools, communities and worksites can be thought of as complex ecological systems. They can be theorised on three dimensions: (1) their constituent activity settings (e.g., clubs, festivals, assemblies, classrooms); (2) the social networks that connect the people and the settings; and (3) time. An intervention may then be seen as a critical event in the history of a system, leading to the evolution of new structures of interaction and new shared meanings. Interventions impact on evolving networks of person-time-place interaction, changing relationships, displacing existing activities and redistributing and transforming resources. This alternative view has significant implications for how interventions should be evaluated and how they could be made more effective. We explore this idea, drawing on social network analysis and complex systems theory.
Meta-analyses of psychological interventions typically find a pooled effect of "psychological intervention" compared with usual care. This answers the research question, "Are psychological interventions in general effective?" In fact, psychological interventions are usually complex with several different components. The authors propose that mixed treatment comparison meta-analysis methods may be a valuable tool when exploring the efficacy of interventions with different components and combinations of components, as this allows one to answer the research question, "Are interventions with a particular component (or combination of components) effective?" The authors illustrate the methods using a meta-analysis of psychological interventions for patients with coronary heart disease for a variety of outcomes. The authors carried out systematic literature searches to update an earlier Cochrane review and classified components of interventions into 6 types: usual care, educational, behavioral, cognitive, relaxation, and support. Most interventions were a combination of these components. There was some evidence that psychological interventions were effective in reducing total cholesterol and standardized mean anxiety scores, that interventions with behavioral components were effective in reducing the odds of all-cause mortality and nonfatal myocardial infarction, and that interventions with behavioral and/or cognitive components were associated with reduced standardized mean depression scores.
To examine the impact of a system of presumed consent for organ donation on donation rates and to review data on attitudes towards presumed consent.
Systematic review.
Studies retrieved by online searches to January 2008 of Medline, Medline In-Process, Embase, CINAHL, PsycINFO, HMIC, PAIS International, and OpenSIGLE. Studies reviewed Five studies comparing donation rates before and after the introduction of legislation for presumed consent (before and after studies); eight studies comparing donation rates in countries with and without presumed consent systems (between country comparisons); 13 surveys of public and professional attitudes to presumed consent.
The five before and after studies represented three countries: all reported an increase in donation rates after the introduction of presumed consent, but there was little investigation of any other changes taking place concurrently with the change in legislation. In the four best quality between country comparisons, presumed consent law or practice was associated with increased organ donation-increases of 25-30%, 21-26%, 2.7 more donors per million population, and 6.14 more donors per million population in the four studies. Other factors found to be important in at least one study were mortality from road traffic accidents and cerebrovascular causes, transplant capacity, gross domestic product per capita, health expenditure per capita, religion (Catholicism), education, public access to information, and a common law legal system. Eight surveys of attitudes to presumed consent were of the UK public. These surveys varied in the level of support for presumed consent, with surveys conducted before 2000 reporting the lowest levels of support (28-57%). The most recent survey, in 2007, reported that 64% of respondents supported a change to presumed consent.
Presumed consent alone is unlikely to explain the variation in organ donation rates between countries. Legislation, availability of donors, organisation and infrastructure of the transplantation service, wealth and investment in health care, and public attitudes to and awareness of organ donation may all play a part, but their relative importance is unclear. Recent UK surveys show support for presumed consent, though with variation in results that may reflect differences in survey methods.
Randomised controlled trials are widely accepted as the most reliable method of determining effectiveness, but most trials have evaluated the effects of a single intervention such as a drug. Recognition is increasing that other, non›pharmacological interventions should also be rigorously evaluated. 1-3 This paper examines the design and execution of research required to address the additional problems resulting from evalua› tion of complex interventions—that is, those "made up of various interconnecting parts." 4 The issues dealt with are discussed in a longer Medical Research Council paper (www.mrc.ac.uk/complex_packages.html). We focus on randomised trials but believe that this approach could be adapted to other designs when they are more appropriate.
Such diverse thinkers as Lao-Tze, Confucius, and U.S. Defense Secretary Donald Rumsfeld have all pointed out that we need to be able to tell the difference between real and assumed knowledge. The systematic review is a scientific tool that can help with this difficult task. It can help, for example, with appraising, summarising, and communicating the results and implications of otherwise unmanageable quantities of data. This book, written by two highly-respected social scientists, provides an overview of systematic literature review methods: Outlining the rationale and methods of systematic reviews; Giving worked examples from social science and other fields; Applying the practice to all social science disciplines; It requires no previous knowledge, but takes the reader through the process stage by stage; Drawing on examples from such diverse fields as psychology, criminology, education, transport, social welfare, public health, and housing and urban policy, among others. Including detailed sections on assessing the quality of both quantitative, and qualitative research; searching for evidence in the social sciences; meta-analytic and other methods of evidence synthesis; publication bias; heterogeneity; and approaches to dissemination.
Systematic review has developed as a specific methodology for searching for, appraising and synthesizing findings of primary studies, and has rapidly become a cornerstone of the evidence-based practice and policy movement. Qualitative research has traditionally been excluded from systematic reviews, and much effort is now being invested in resolving the daunting methodological and epistemological challenges associated with trying to move towards more inclusive forms of review. We describe our experiences, as a very diverse multidisciplinary group, in attempting to incorporate qualitative research in a systematic review of support for breastfeeding. We show how every stage of the review process, from asking the review question through to searching for and sampling the evidence, appraising the evidence and producing a synthesis, provoked profound questions about whether a review that includes qualitative research can remain consistent with the frame offered by current systematic review methodology. We conclude that more debate and dialogue between the different communities that wish to develop review methodology is needed, and that attempts to impose dominant views about the appropriate means of conducting reviews of qualitative research should be resisted so that innovation can be fostered.
Methods to calculate bias-adjusted estimates for meta-analyses are becoming more popular. The objective of this paper is to use the structural approach to bias and causal diagrams to show that (i) the current use of the bias-adjusted estimating tools may sometimes introduce bias rather than reduce it and (ii) the Cochrane collaboration risk of bias tool, which was designed for randomized studies, is also applicable to non-randomized studies with only minimal changes. Causal diagrams are used to illustrate each of the items in the current risk of bias tool and how they apply to both randomized and non-randomized studies. With the exception of confounding by indication, the structure of all potential biases present in non-randomized studies may also be present in randomized studies. In addition, causal diagrams demonstrate important limitations to the methods currently being developed to provide bias-adjusted estimates of individual studies in meta-analyses. Finally, causal diagrams can be helpful in deciding when it is appropriate to combine studies in a meta-analysis of non-randomized studies even though the studies may use different adjustment sets. Copyright © 2012 John Wiley & Sons, Ltd.
Copyright © 2012 John Wiley & Sons, Ltd.
The first and most important decision in preparing any systematic review is to clearly frame the question the review team seeks to answer. However, this is not always straightforward, particularly if synthesis teams are interested in the effects of complex interventions. In this article, we discuss how to formulate good systematic review questions of complex interventions. We describe the rationale for developing well-formulated review questions and review the existing guidance on formulating review questions. We discuss that complex interventions can contain a mix of effective and ineffective (or even harmful) actions, which may interact synergistically or dysynergistically or be interdependent, and how these interactions and interdependencies need to be considered when formulating systematic review questions. We discuss complexity specifically in terms of how it relates to the type of question, the scope of the review (i.e., lumping vs. splitting debate), and specification of the intervention. We offer several recommendations to assist review authors in developing a definition for their complex intervention of interest, which is an essential first step in formulating the review question. We end by identifying areas in which future methodological research aimed at improving question formulation, especially as it relates to complex interventions, is needed.
Complex interventions present unique challenges for systematic reviews. Current debates tend to center around describing complexity, rather than providing guidance on what to do about it. At a series of meetings during 2009-2012, we met to review the challenges and practical steps reviewer could take to incorporate a complexity perspective into systematic reviews. Based on this, we outline a pragmatic approach to dealing with complexity, beginning, as for any review, with clearly defining the research question(s). We argue that reviews of complex interventions can themselves be simple or complex, depending on the question to be answered. In systematic reviews and evaluations of complex interventions, it will be helpful to start by identifying the sources of complexity, then mapping aspects of complexity in the intervention onto the appropriate sources of evidence (such as specific types of quantitative or qualitative study). Although we focus on systematic reviews, the general approach is also applicable to primary research that is aimed at evaluating complex interventions. Although the examples are drawn from health care, the approach may also be applied to other sectors (e.g., social policy or international development). We end by concluding that systematic reviews should follow the principle of Occam's razor: explanations should be as complex as they need to be and no more.
This article describes approaches for planning, dealing, and analyzing heterogeneity in a systematic review of complex interventions. Approaches aim to generate a priori hypotheses of the mechanism of action of a complex intervention to identify the key variables that might contribute to variation among studies and guide statistical analysis. In addition to characteristics related to the population, intervention, and outcomes, we describe study-related variables, such as the way the interventions have been implemented and the context and conduct of studies. These approaches will guide reviewers planning a meta-analysis and provide a rationale for not meta-analyzing data if there is too much variability. Potential difficulties in applying meta-analytical techniques to examine statistical association among study results and sources of potential heterogeneity are described; these include the selection of a fixed or random-effects model, the risk of multiple testing and confounding when studies include different aspects of a complex intervention or different subsamples of the intended participant pool.
Logic models have long been used to understand complex programs to improve social and health outcomes. They illustrate how a program is designed to achieve its intended outcomes. They also can be used to describe connections between determinants of outcomes, for example, low high-school graduation rates or spiraling obesity rates, thus aiding the development of interventions that target causal factors. However, these models have not often been used in systematic reviews. This paper argues that logic models can be valuable in the systematic review process. First, they can aid in the conceptualization of the review focus and illustrate hypothesized causal links, identify effect mediators or moderators, specify intermediate outcomes and potential harms, and justify a priori subgroup analyses when differential effects are anticipated. Second, logic models can be used to direct the review process more specifically. They can help justify narrowing the scope of a review, identify the most relevant inclusion criteria, guide the literature search, and clarify interpretation of results when drawing policy-relevant conclusions about review findings. We present examples that explain how logic models have been used and how they can be applied at different stages in a systematic review. Copyright © 2011 John Wiley & Sons, Ltd.
Copyright © 2011 John Wiley & Sons, Ltd.
Objective To describe the development of a multidimensional conceptual framework capable of drawing out the implications for policy and practice of what is known about public involvement in research agenda setting.
Background Public involvement in research is growing in western and developing countries. There is a need to learn from collective experience and a diverse literature of research, policy documents and reflective reports.
Methods Systematic searches of research literature, policy and lay networks identified reports of public involvement in research agenda setting. Framework analysis, previously described for primary research, was used to develop the framework, which was then applied to reports of public involvement in order to analyse and compare these.
Findings The conceptual framework takes into account the people involved; the people initiating the involvement; the degree of public involvement; the forum for exchange; and methods used for decision making. It also considers context (in terms of the research focus and the historical, geographical or institutional setting), and theoretical basis.
Conclusions The framework facilitates learning across diverse experiences, whether reported in policy documents, reflections or formal research, to generate a policy- and practice-relevant overview. A further advantage is that it identifies gaps in the literature which need to be filled in order to inform future research about public involvement.
The issue of complexity, and how one evaluates complex interventions, remains a key one for health service and public health researchers. The underlying question—what makes complex interventions complex?—is particularly interesting, and it has implications for the sorts of research we do. The MRC guidance1 provides one detailed answer: complexity resides (among other things) in the number of interacting components; the number and difficulty of behaviours required by those delivering or receiving the intervention; the number of groups or organizational levels targeted by the intervention; the number and variability of outcomes; and the degree of flexibility or tailoring of the intervention permitted. Other definitions also emphasize other aspects including the degree of flexibility and non-standardization which complex interventions are subject to; as explained by Hawe et al.2 (2004), complex interventions are non-standard, having different forms in different contexts, while still conforming to specific, theory driven processes.
There are many other definitions of complex interventions. These tend frequently to emphasize that they have multiple interacting components, and non-linear causal pathways. …
Policy decisions often require synthesis of evidence from multiple sources, and the source studies typically vary in rigour and in relevance to the target question. We present simple methods of allowing for differences in rigour (or lack of internal bias) and relevance (or lack of external bias) in evidence synthesis. The methods are developed in the context of reanalysing a UK National Institute for Clinical Excellence technology appraisal in antenatal care, which includes eight comparative studies. Many were historically controlled, only one was a randomized trial and doses, populations and outcomes varied between studies and differed from the target UK setting. Using elicited opinion, we construct prior distributions to represent the biases in each study and perform a bias-adjusted meta-analysis. Adjustment had the effect of shifting the combined estimate away from the null by approximately 10%, and the variance of the combined estimate was almost tripled. Our generic bias modelling approach allows decisions to be based on all available evidence, with less rigorous or less relevant studies downweighted by using computationally simple methods.
We present models for the combined analysis of evidence from randomized controlled trials categorized as being at either low or high risk of bias due to a flaw in their conduct. We formulate a bias model that incorporates between-study and between-meta-analysis heterogeneity in bias, and uncertainty in overall mean bias. We obtain algebraic expressions for the posterior distribution of the bias-adjusted treatment effect, which provide limiting values for the information that can be obtained from studies at high risk of bias. The parameters of the bias model can be estimated from collections of previously published meta-analyses. We explore alternative models for such data, and alternative methods for introducing prior information on the bias parameters into a new meta-analysis. Results from an illustrative example show that the bias-adjusted treatment effect estimates are sensitive to the way in which the meta-epidemiological data are modelled, but that using point estimates for bias parameters provides an adequate approximation to using a full joint prior distribution. A sensitivity analysis shows that the gain in precision from including studies at high risk of bias is likely to be low, however numerous or large their size, and that little is gained by incorporating such studies, unless the information from studies at low risk of bias is limited. We discuss approaches that might increase the value of including studies at high risk of bias, and the acceptability of the methods in the evaluation of health care interventions. Copyright (c) 2009 Royal Statistical Society.
This paper reviews the use of Bayesian methods in meta-analysis. Whilst there has been an explosion in the use of meta-analysis over the last few years, driven mainly by the move towards evidence-based healthcare, so too Bayesian methods are being used increasingly within medical statistics. Whilst in many meta-analysis settings the Bayesian models used mirror those previously adopted in a frequentist formulation, there are a number of specific advantages conferred by the Bayesian approach. These include: full allowance for all parameter uncertainty in the model, the ability to include other pertinent information that would otherwise be excluded, and the ability to extend the models to accommodate more complex, but frequently occurring, scenarios. The Bayesian methods discussed are illustrated by means of a meta-analysis examining the evidence relating to electronic fetal heart rate monitoring and perinatal mortality in which evidence is available from a variety of sources.
Appropriate methods for meta-regression applied to a set of clinical trials, and the limitations and pitfalls in interpretation, are insufficiently recognized. Here we summarize recent research focusing on these issues, and consider three published examples of meta-regression in the light of this work. One principal methodological issue is that meta-regression should be weighted to take account of both within-trial variances of treatment effects and the residual between-trial heterogeneity (that is, heterogeneity not explained by the covariates in the regression). This corresponds to random effects meta-regression. The associations derived from meta-regressions are observational, and have a weaker interpretation than the causal relationships derived from randomized comparisons. This applies particularly when averages of patient characteristics in each trial are used as covariates in the regression. Data dredging is the main pitfall in reaching reliable conclusions from meta-regression. It can only be avoided by prespecification of covariates that will be investigated as potential sources of heterogeneity. However, in practice this is not always easy to achieve. The examples considered in this paper show the tension between the scientific rationale for using meta-regression and the difficult interpretative problems to which such analyses are prone.