Ethical analysis in HTA of complex health interventions.

PubMed

Lysdahl, Kristin Bakke; Oortwijn, Wija; van der Wilt, Gert Jan; Refolo, Pietro; Sacchini, Dario; Mozygemba, Kati; Gerhardus, Ansgar; Brereton, Louise; Hofmann, Bjørn

2016-03-22

In the field of health technology assessment (HTA), there are several approaches that can be used for ethical analysis. However, there is a scarcity of literature that critically evaluates and compares the strength and weaknesses of these approaches when they are applied in practice. In this paper, we analyse the applicability of some selected approaches for addressing ethical issues in HTA in the field of complex health interventions. Complex health interventions have been the focus of methodological attention in HTA. However, the potential methodological challenges for ethical analysis are as yet unknown. Six of the most frequently described and applied ethical approaches in HTA were critically assessed against a set of five characteristics of complex health interventions: multiple and changing perspectives, indeterminate phenomena, uncertain causality, unpredictable outcomes, and ethical complexity. The assessments are based on literature and the authors' experiences of developing, applying and assessing the approaches. The Interactive, participatory HTA approach is by its nature and flexibility, applicable across most complexity characteristics. Wide Reflective Equilibrium is also flexible and its openness to different perspectives makes it better suited for complex health interventions than more rigid conventional approaches, such as Principlism and Casuistry. Approaches developed for HTA purposes are fairly applicable for complex health interventions, which one could expect because they include various ethical perspectives, such as the HTA Core Model® and the Socratic approach. This study shows how the applicability for addressing ethical issues in HTA of complex health interventions differs between the selected ethical approaches. Knowledge about these differences may be helpful when choosing and applying an approach for ethical analyses in HTA. We believe that the study contributes to increasing awareness and interest of the ethical aspects of complex health interventions in general.

Promoting mental wellbeing: developing a theoretically and empirically sound complex intervention.

PubMed

Millar, S L; Donnelly, M

2014-06-01

This paper describes the development of a complex intervention to promote mental wellbeing using the revised framework for developing and evaluating complex interventions produced by the UK Medical Research Council (UKMRC). Application of the first two phases of the framework is described--development and feasibility and piloting. The theoretical case and evidence base were examined analytically to explicate the theoretical and empirical foundations of the intervention. These findings informed the design of a 12-week mental wellbeing promotion programme providing early intervention for people showing signs of mental health difficulties. The programme is based on the theoretical constructs of self-efficacy, self-esteem, purpose in life, resilience and social support and comprises 10 steps. A mixed methods approach was used to conduct a feasibility study with community and voluntary sector service users and in primary care. A significant increase in mental wellbeing was observed following participation in the intervention. Qualitative data corroborated this finding and suggested that the intervention was feasible to deliver and acceptable to participants, facilitators and health professionals. The revised UKMRC framework can be successfully applied to the development of public health interventions. © The Author 2013. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Developing a framework for a novel multi-disciplinary, multi-agency intervention(s), to improve medication management in community-dwelling older people on complex medication regimens (MEMORABLE)--a realist synthesis.

PubMed

Maidment, Ian; Booth, Andrew; Mullan, Judy; McKeown, Jane; Bailey, Sylvia; Wong, Geoffrey

2017-07-03

Medication-related adverse events have been estimated to be responsible for 5700 deaths and cost the UK £750 million annually. This burden falls disproportionately on older people. Outcomes from interventions to optimise medication management are caused by multiple context-sensitive mechanisms. The MEdication Management in Older people: REalist Approaches BAsed on Literature and Evaluation (MEMORABLE) project uses realist synthesis to understand how, why, for whom and in what context interventions, to improve medication management in older people on complex medication regimes residing in the community, work. This realist synthesis uses secondary data and primary data from interviews to develop the programme theory. A realist logic of analysis will synthesise data both within and across the two data sources to inform the design of a complex intervention(s) to help improve medication management in older people. 1. Literature review The review (using realist synthesis) contains five stages to develop an initial programme theory to understand why processes are more or less successful and under which situations: focussing of the research question; developing the initial programme theory; developing the search strategy; selection and appraisal based on relevance and rigour; and data analysis/synthesis to develop and refine the programme theory and context, intervention and mechanism configurations. 2. Realist interviews Realist interviews will explore and refine our understanding of the programme theory developed from the realist synthesis. Up to 30 older people and their informal carers (15 older people with multi-morbidity, 10 informal carers and 5 older people with dementia), and 20 care staff will be interviewed. 3. Developing framework for the intervention(s) Data from the realist synthesis and interviews will be used to refine the programme theory for the intervention(s) to identify: the mechanisms that need to be 'triggered', and the contexts related to these mechanisms. Intervention strategies that change the contexts so the mechanisms are triggered to produce desired outcomes will be developed. Feedback on these strategies will be obtained. This realist synthesis aims to develop a framework (underpinned by our programme theory) for a novel multi-disciplinary, multi-agency intervention(s), to improve medication management in community-dwelling older people on complex medication regimens. PROSPERO CRD42016043506.

The design and development of a complex multifactorial falls assessment intervention for falls prevention: The Prevention of Falls Injury Trial (PreFIT).

PubMed

Bruce, Julie; Ralhan, Shvaita; Sheridan, Ray; Westacott, Katharine; Withers, Emma; Finnegan, Susanne; Davison, John; Martin, Finbarr C; Lamb, Sarah E

2017-06-01

This paper describes the design and development of a complex multifactorial falls prevention (MFFP) intervention for implementation and testing within the framework of a large UK-based falls prevention randomised controlled trial (RCT). A complex intervention was developed for inclusion within the Prevention of Falls Injury Trial (PreFIT), a multicentre pragmatic RCT. PreFIT aims to compare the clinical and cost-effectiveness of three alternative primary care falls prevention interventions (advice, exercise and MFFP), on outcomes of fractures and falls. Community-dwelling adults, aged 70 years and older, were recruited from primary care in the National Health Service (NHS), England. Development of the PreFIT MFFP intervention was informed by the existing evidence base and clinical guidelines for the assessment and management of falls in older adults. After piloting and modification, the final MFFP intervention includes seven falls risk factors: a detailed falls history interview with consideration of 'red flags'; assessment of balance and gait; vision; medication screen; cardiac screen; feet and footwear screen and home environment assessment. This complex intervention has been fully manualised with clear, documented assessment and treatment pathways for each risk factor. Each risk factor is assessed in every trial participant referred for MFFP. Referral for assessment is based upon a screening survey to identify those with a history of falling or balance problems. Intervention delivery can be adapted to the local setting. This complex falls prevention intervention is currently being tested within the framework of a large clinical trial. This paper adheres to TIDieR and CONSORT recommendations for the comprehensive and explicit reporting of trial interventions. Results from the PreFIT study will be published in due course. The effectiveness and cost-effectiveness of the PreFIT MFFP intervention, compared to advice and exercise, on the prevention of falls and fractures, will be reported at the conclusion of the trial.

AHRQ series on complex intervention systematic reviews-paper 6: PRISMA-CI extension statement and checklist.

PubMed

Guise, Jeanne-Marie; Butler, Mary E; Chang, Christine; Viswanathan, Meera; Pigott, Terri; Tugwell, Peter

2017-10-01

Complex interventions are widely used in health systems, public health, education, and communities and are increasingly the subject of systematic reviews. Oversimplification and inconsistencies in reporting about complex interventions can limit the usability of review findings. Although guidance exists to ensure that reports of individual studies and systematic reviews adhere to accepted scientific standards, their design-specific focus leaves important reporting gaps relative to complex interventions in health care. This paper provides a stand-alone extension to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting tool for complex interventions-PRISMA-CI-to help authors, publishers, and readers understand and apply to systematic reviews of complex interventions. PRISMA-CI development followed the Enhancing the QUAlity and Transparency Of health Research Network guidance for extensions and focused on adding or modifying only essential items that are truly unique to complex interventions and are not covered by broader interpretation of current PRISMA guidance. PRISMA-CI provides an important structure and guidance for systematic reviews and meta-analyses for the highly prevalent and dynamic field of complex interventions. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Developing theory-informed behaviour change interventions to implement evidence into practice: a systematic approach using the Theoretical Domains Framework.

PubMed

French, Simon D; Green, Sally E; O'Connor, Denise A; McKenzie, Joanne E; Francis, Jill J; Michie, Susan; Buchbinder, Rachelle; Schattner, Peter; Spike, Neil; Grimshaw, Jeremy M

2012-04-24

There is little systematic operational guidance about how best to develop complex interventions to reduce the gap between practice and evidence. This article is one in a Series of articles documenting the development and use of the Theoretical Domains Framework (TDF) to advance the science of implementation research. The intervention was developed considering three main components: theory, evidence, and practical issues. We used a four-step approach, consisting of guiding questions, to direct the choice of the most appropriate components of an implementation intervention: Who needs to do what, differently? Using a theoretical framework, which barriers and enablers need to be addressed? Which intervention components (behaviour change techniques and mode(s) of delivery) could overcome the modifiable barriers and enhance the enablers? And how can behaviour change be measured and understood? A complex implementation intervention was designed that aimed to improve acute low back pain management in primary care. We used the TDF to identify the barriers and enablers to the uptake of evidence into practice and to guide the choice of intervention components. These components were then combined into a cohesive intervention. The intervention was delivered via two facilitated interactive small group workshops. We also produced a DVD to distribute to all participants in the intervention group. We chose outcome measures in order to assess the mediating mechanisms of behaviour change. We have illustrated a four-step systematic method for developing an intervention designed to change clinical practice based on a theoretical framework. The method of development provides a systematic framework that could be used by others developing complex implementation interventions. While this framework should be iteratively adjusted and refined to suit other contexts and settings, we believe that the four-step process should be maintained as the primary framework to guide researchers through a comprehensive intervention development process.

Developing theory-informed behaviour change interventions to implement evidence into practice: a systematic approach using the Theoretical Domains Framework

PubMed Central

2012-01-01

Background There is little systematic operational guidance about how best to develop complex interventions to reduce the gap between practice and evidence. This article is one in a Series of articles documenting the development and use of the Theoretical Domains Framework (TDF) to advance the science of implementation research. Methods The intervention was developed considering three main components: theory, evidence, and practical issues. We used a four-step approach, consisting of guiding questions, to direct the choice of the most appropriate components of an implementation intervention: Who needs to do what, differently? Using a theoretical framework, which barriers and enablers need to be addressed? Which intervention components (behaviour change techniques and mode(s) of delivery) could overcome the modifiable barriers and enhance the enablers? And how can behaviour change be measured and understood? Results A complex implementation intervention was designed that aimed to improve acute low back pain management in primary care. We used the TDF to identify the barriers and enablers to the uptake of evidence into practice and to guide the choice of intervention components. These components were then combined into a cohesive intervention. The intervention was delivered via two facilitated interactive small group workshops. We also produced a DVD to distribute to all participants in the intervention group. We chose outcome measures in order to assess the mediating mechanisms of behaviour change. Conclusions We have illustrated a four-step systematic method for developing an intervention designed to change clinical practice based on a theoretical framework. The method of development provides a systematic framework that could be used by others developing complex implementation interventions. While this framework should be iteratively adjusted and refined to suit other contexts and settings, we believe that the four-step process should be maintained as the primary framework to guide researchers through a comprehensive intervention development process. PMID:22531013

Potential uses of Bayesian networks as tools for synthesis of systematic reviews of complex interventions.

PubMed

Stewart, G B; Mengersen, K; Meader, N

2014-03-01

Bayesian networks (BNs) are tools for representing expert knowledge or evidence. They are especially useful for synthesising evidence or belief concerning a complex intervention, assessing the sensitivity of outcomes to different situations or contextual frameworks and framing decision problems that involve alternative types of intervention. Bayesian networks are useful extensions to logic maps when initiating a review or to facilitate synthesis and bridge the gap between evidence acquisition and decision-making. Formal elicitation techniques allow development of BNs on the basis of expert opinion. Such applications are useful alternatives to 'empty' reviews, which identify knowledge gaps but fail to support decision-making. Where review evidence exists, it can inform the development of a BN. We illustrate the construction of a BN using a motivating example that demonstrates how BNs can ensure coherence, transparently structure the problem addressed by a complex intervention and assess sensitivity to context, all of which are critical components of robust reviews of complex interventions. We suggest that BNs should be utilised to routinely synthesise reviews of complex interventions or empty reviews where decisions must be made despite poor evidence. Copyright © 2013 John Wiley & Sons, Ltd.

Fortuitous phenomena: on complexity, pragmatic randomised controlled trials, and knowledge for evidence-based practice.

PubMed

Thompson, Carl

2004-01-01

Many of the interventions that nurses develop and implement are in themselves complex and have to operate in situations of irreducible complexity and uncertainty. This article argues that the primary means of generating knowledge for the evidence-based deployment of complex interventions should be the pragmatic randomised controlled trial. Randomised controlled trials represent the only research design to adequately deal with that which we know and (far more importantly) that which we do not. Using the example of practice development as an exemplar for complexity, and drawing on the objections often voiced as a response to calls to make use of randomised controlled trials in nursing and nursing research, the article presents a developmental framework and some methodological solutions to problems often encountered. Randomised controlled trials, whilst undoubtedly methodologically and strategically challenging, offer the most robust basis for developing primary research knowledge on the effects of complex interventions in nursing and their active components.

Theories of how the school environment impacts on student health: systematic review and synthesis.

PubMed

Bonell, C P; Fletcher, A; Jamal, F; Wells, H; Harden, A; Murphy, S; Thomas, J

2013-11-01

Public-health interventions informed by theory can be more effective but complex interventions often use insufficiently complex theories. We systematically reviewed theories of how school environments influence health. We included 37 reports drawing on 24 theories. Narrative synthesis summarised and categorised theories. We then produced an integrated theory of school environment influences on student health. This integrated theory could inform complex interventions such as health promoting schools programmes. Using systematic reviews to develop theories of change might be useful for other types of 'complex' public-health interventions addressing risks at the individual and community levels. © 2013 Published by Elsevier Ltd.

Protocol for the process evaluation of a complex intervention designed to increase the use of research in health policy and program organisations (the SPIRIT study).

PubMed

Haynes, Abby; Brennan, Sue; Carter, Stacy; O'Connor, Denise; Schneider, Carmen Huckel; Turner, Tari; Gallego, Gisselle

2014-09-27

Process evaluation is vital for understanding how interventions function in different settings, including if and why they have different effects or do not work at all. This is particularly important in trials of complex interventions in 'real world' organisational settings where causality is difficult to determine. Complexity presents challenges for process evaluation, and process evaluations that tackle complexity are rarely reported. This paper presents the detailed protocol for a process evaluation embedded in a randomised trial of a complex intervention known as SPIRIT (Supporting Policy In health with Research: an Intervention Trial). SPIRIT aims to build capacity for using research in health policy and program agencies. We describe the flexible and pragmatic methods used for capturing, managing and analysing data across three domains: (a) the intervention as it was implemented; (b) how people participated in and responded to the intervention; and (c) the contextual characteristics that mediated this relationship and may influence outcomes. Qualitative and quantitative data collection methods include purposively sampled semi-structured interviews at two time points, direct observation and coding of intervention activities, and participant feedback forms. We provide examples of the data collection and data management tools developed. This protocol provides a worked example of how to embed process evaluation in the design and evaluation of a complex intervention trial. It tackles complexity in the intervention and its implementation settings. To our knowledge, it is the only detailed example of the methods for a process evaluation of an intervention conducted as part of a randomised trial in policy organisations. We identify strengths and weaknesses, and discuss how the methods are functioning during early implementation. Using 'insider' consultation to develop methods is enabling us to optimise data collection while minimising discomfort and burden for participants. Embedding the process evaluation within the trial design is facilitating access to data, but may impair participants' willingness to talk openly in interviews. While it is challenging to evaluate the process of conducting a randomised trial of a complex intervention, our experience so far suggests that it is feasible and can add considerably to the knowledge generated.

Using the Medical Research Council framework for development and evaluation of complex interventions in a low resource setting to develop a theory-based treatment support intervention delivered via SMS text message to improve blood pressure control.

PubMed

Bobrow, Kirsten; Farmer, Andrew; Cishe, Nomazizi; Nwagi, Ntobeko; Namane, Mosedi; Brennan, Thomas P; Springer, David; Tarassenko, Lionel; Levitt, Naomi

2018-01-23

Several frameworks now exist to guide intervention development but there remains only limited evidence of their application to health interventions based around use of mobile phones or devices, particularly in a low-resource setting. We aimed to describe our experience of using the Medical Research Council (MRC) Framework on complex interventions to develop and evaluate an adherence support intervention for high blood pressure delivered by SMS text message. We further aimed to describe the developed intervention in line with reporting guidelines for a structured and systematic description. We used a non-sequential and flexible approach guided by the 2008 MRC Framework for the development and evaluation of complex interventions. We reviewed published literature and established a multi-disciplinary expert group to guide the development process. We selected health psychology theory and behaviour change techniques that have been shown to be important in adherence and persistence with chronic medications. Semi-structured interviews and focus groups with various stakeholders identified ways in which treatment adherence could be supported and also identified key features of well-regarded messages: polite tone, credible information, contextualised, and endorsed by identifiable member of primary care facility staff. Direct and indirect user testing enabled us to refine the intervention including refining use of language and testing of interactive components. Our experience shows that using a formal intervention development process is feasible in a low-resource multi-lingual setting. The process enabled us to pre-test assumptions about the intervention and the evaluation process, allowing the improvement of both. Describing how a multi-component intervention was developed including standardised descriptions of content aimed to support behaviour change will enable comparison with other similar interventions and support development of new interventions. Even in low-resource settings, funders and policy-makers should provide researchers with time and resources for intervention development work and encourage evaluation of the entire design and testing process. The trial of the intervention is registered with South African National Clinical Trials Register number (SANCTR DOH-27-1212-386; 28/12/2012); Pan Africa Trial Register (PACTR201411000724141; 14/12/2013); ClinicalTrials.gov ( NCT02019823 ; 24/12/2013).

The evaluation of complex interventions in palliative care: an exploration of the potential of case study research strategies.

PubMed

Walshe, Catherine

2011-12-01

Complex, incrementally changing, context dependent and variable palliative care services are difficult to evaluate. Case study research strategies may have potential to contribute to evaluating such complex interventions, and to develop this field of evaluation research. This paper explores definitions of case study (as a unit of study, a process, and a product) and examines the features of case study research strategies which are thought to confer benefits for the evaluation of complex interventions in palliative care settings. Ten features of case study that are thought to be beneficial in evaluating complex interventions in palliative care are discussed, drawing from exemplars of research in this field. Important features are related to a longitudinal approach, triangulation, purposive instance selection, comprehensive approach, multiple data sources, flexibility, concurrent data collection and analysis, search for proving-disproving evidence, pattern matching techniques and an engaging narrative. The limitations of case study approaches are discussed including the potential for subjectivity and their complex, time consuming and potentially expensive nature. Case study research strategies have great potential in evaluating complex interventions in palliative care settings. Three key features need to be exploited to develop this field: case selection, longitudinal designs, and the use of rival hypotheses. In particular, case study should be used in situations where there is interplay and interdependency between the intervention and its context, such that it is difficult to define or find relevant comparisons.

TROPHI: development of a tool to measure complex, multi-factorial patient handling interventions.

PubMed

Fray, Mike; Hignett, Sue

2013-01-01

Patient handling interventions are complex and multi-factorial. It has been difficult to make comparisons across different strategies due to the lack of a comprehensive outcome measurement method. The Tool for Risk Outstanding in Patient Handling Interventions (TROPHI) was developed to address this gap by measuring outcomes and comparing performance across interventions. Focus groups were held with expert patient handling practitioners (n = 36) in four European countries (Finland, Italy, Portugal and the UK) to identify preferred outcomes to be measured for interventions. A systematic literature review identified 598 outcome measures; these were critically appraised and the most appropriate measurement tool was selected for each outcome. TROPHI was evaluated in the four EU countries (eight sites) and by an expert panel (n = 16) from the European Panel of Patient Handling Ergonomics for usability and practical application. This final stage added external validity to the research by exploring transferability potential and presenting the data and analysis to allow respondent (participant) validation. Patient handling interventions are complex and multi-factorial and it has been difficult to make comparisons due to the lack of a comprehensive outcome measurement method. The Tool for Risk Outstanding in Patient Handling Interventions (TROPHI) was developed to address this gap by measuring outcomes to compare performance across interventions.

Using the Medical Research Council framework for the development and evaluation of complex interventions in a theory-based infant feeding intervention to prevent childhood obesity: the baby milk intervention and trial.

PubMed

Lakshman, Rajalakshmi; Griffin, Simon; Hardeman, Wendy; Schiff, Annie; Kinmonth, Ann Louise; Ong, Ken K

2014-01-01

We describe our experience of using the Medical Research Council framework on complex interventions to guide the development and evaluation of an intervention to prevent obesity by modifying infant feeding behaviours. We reviewed the epidemiological evidence on early life risk factors for obesity and interventions to prevent obesity in this age group. The review suggested prevention of excess weight gain in bottle-fed babies and appropriate weaning as intervention targets; hence we undertook systematic reviews to further our understanding of these behaviours. We chose theory and behaviour change techniques that demonstrated evidence of effectiveness in altering dietary behaviours. We subsequently developed intervention materials and evaluation tools and conducted qualitative studies with mothers (intervention recipients) and healthcare professionals (intervention deliverers) to refine them. We developed a questionnaire to assess maternal attitudes and feeding practices to understand the mechanism of any intervention effects. In addition to informing development of our specific intervention and evaluation materials, use of the Medical Research Council framework has helped to build a generalisable evidence base for early life nutritional interventions. However, the process is resource intensive and prolonged, and this should be taken into account by public health research funders. This trial is registered with ISRTCN: 20814693 Baby Milk Trial.

How to and how not to develop a theory of change to evaluate a complex intervention: reflections on an experience in the Democratic Republic of Congo.

PubMed

Maini, Rishma; Mounier-Jack, Sandra; Borghi, Josephine

2018-01-01

Theories of change (ToCs) describe how interventions can bring about long-term outcomes through a logical sequence of intermediate outcomes and have been used to design and measure the impact of public health programmes in several countries. In recognition of their capacity to provide a framework for monitoring and evaluation, they are being increasingly employed in the development sector. The construction of a ToC typically occurs through a consultative process, requiring stakeholders to reflect on how their programmes can bring about change. ToCs help make explicit any underlying assumptions, acknowledge the role of context and provide evidence to justify the chain of causal pathways. However, while much literature exists on how to develop a ToC with respect to interventions in theory, there is comparatively little reflection on applying it in practice to complex interventions in the health sector. This paper describes the initial process of developing a ToC to inform the design of an evaluation of a complex intervention aiming to improve government payments to health workers in the Democratic Republic of Congo. Lessons learnt include: the need for the ToC to understand how the intervention produces effects on the wider system and having broad stakeholder engagement at the outset to maximise chances of the intervention's success and ensure ownership. Power relationships between stakeholders may also affect the ToC discourse but can be minimised by having an independent facilitator. We hope these insights are of use to other global public health practitioners using this approach to evaluate complex interventions.

A rehabilitation intervention to promote physical recovery following intensive care: a detailed description of construct development, rationale and content together with proposed taxonomy to capture processes in a randomised controlled trial.

PubMed

Ramsay, Pam; Salisbury, Lisa G; Merriweather, Judith L; Huby, Guro; Rattray, Janice E; Hull, Alastair M; Brett, Stephen J; Mackenzie, Simon J; Murray, Gordon D; Forbes, John F; Walsh, Timothy Simon

2014-01-29

Increasing numbers of patients are surviving critical illness, but survival may be associated with a constellation of physical and psychological sequelae that can cause ongoing disability and reduced health-related quality of life. Limited evidence currently exists to guide the optimum structure, timing, and content of rehabilitation programmes. There is a need to both develop and evaluate interventions to support and expedite recovery during the post-ICU discharge period. This paper describes the construct development for a complex rehabilitation intervention intended to promote physical recovery following critical illness. The intervention is currently being evaluated in a randomised trial (ISRCTN09412438; funder Chief Scientists Office, Scotland). The intervention was developed using the Medical Research Council (MRC) framework for developing complex healthcare interventions. We ensured representation from a wide variety of stakeholders including content experts from multiple specialties, methodologists, and patient representation. The intervention construct was initially based on literature review, local observational and audit work, qualitative studies with ICU survivors, and brainstorming activities. Iterative refinement was aided by the publication of a National Institute for Health and Care Excellence guideline (No. 83), publicly available patient stories (Healthtalkonline), a stakeholder event in collaboration with the James Lind Alliance, and local piloting. Modelling and further work involved a feasibility trial and development of a novel generic rehabilitation assistant (GRA) role. Several rounds of external peer review during successive funding applications also contributed to development. The final construct for the complex intervention involved a dedicated GRA trained to pre-defined competencies across multiple rehabilitation domains (physiotherapy, dietetics, occupational therapy, and speech/language therapy), with specific training in post-critical illness issues. The intervention was from ICU discharge to 3 months post-discharge, including inpatient and post-hospital discharge elements. Clear strategies to provide information to patients/families were included. A detailed taxonomy was developed to define and describe the processes undertaken, and capture them during the trial. The detailed process measure description, together with a range of patient, health service, and economic outcomes were successfully mapped on to the modified CONSORT recommendations for reporting non-pharmacologic trial interventions. The MRC complex intervention framework was an effective guide to developing a novel post-ICU rehabilitation intervention. Combining a clearly defined new healthcare role with a detailed taxonomy of process and activity enabled the intervention to be clearly described for the purpose of trial delivery and reporting. These data will be useful when interpreting the results of the randomised trial, will increase internal and external trial validity, and help others implement the intervention if the intervention proves clinically and cost effective.

A rehabilitation intervention to promote physical recovery following intensive care: a detailed description of construct development, rationale and content together with proposed taxonomy to capture processes in a randomised controlled trial

PubMed Central

2014-01-01

Background Increasing numbers of patients are surviving critical illness, but survival may be associated with a constellation of physical and psychological sequelae that can cause ongoing disability and reduced health-related quality of life. Limited evidence currently exists to guide the optimum structure, timing, and content of rehabilitation programmes. There is a need to both develop and evaluate interventions to support and expedite recovery during the post-ICU discharge period. This paper describes the construct development for a complex rehabilitation intervention intended to promote physical recovery following critical illness. The intervention is currently being evaluated in a randomised trial (ISRCTN09412438; funder Chief Scientists Office, Scotland). Methods The intervention was developed using the Medical Research Council (MRC) framework for developing complex healthcare interventions. We ensured representation from a wide variety of stakeholders including content experts from multiple specialties, methodologists, and patient representation. The intervention construct was initially based on literature review, local observational and audit work, qualitative studies with ICU survivors, and brainstorming activities. Iterative refinement was aided by the publication of a National Institute for Health and Care Excellence guideline (No. 83), publicly available patient stories (Healthtalkonline), a stakeholder event in collaboration with the James Lind Alliance, and local piloting. Modelling and further work involved a feasibility trial and development of a novel generic rehabilitation assistant (GRA) role. Several rounds of external peer review during successive funding applications also contributed to development. Results The final construct for the complex intervention involved a dedicated GRA trained to pre-defined competencies across multiple rehabilitation domains (physiotherapy, dietetics, occupational therapy, and speech/language therapy), with specific training in post-critical illness issues. The intervention was from ICU discharge to 3 months post-discharge, including inpatient and post-hospital discharge elements. Clear strategies to provide information to patients/families were included. A detailed taxonomy was developed to define and describe the processes undertaken, and capture them during the trial. The detailed process measure description, together with a range of patient, health service, and economic outcomes were successfully mapped on to the modified CONSORT recommendations for reporting non-pharmacologic trial interventions. Conclusions The MRC complex intervention framework was an effective guide to developing a novel post-ICU rehabilitation intervention. Combining a clearly defined new healthcare role with a detailed taxonomy of process and activity enabled the intervention to be clearly described for the purpose of trial delivery and reporting. These data will be useful when interpreting the results of the randomised trial, will increase internal and external trial validity, and help others implement the intervention if the intervention proves clinically and cost effective. PMID:24476530

Using a theory driven approach to develop and evaluate a complex mental health intervention: the friendship bench project in Zimbabwe.

PubMed

Chibanda, Dixon; Verhey, Ruth; Munetsi, Epiphany; Cowan, Frances M; Lund, Crick

2016-01-01

There is a paucity of data on how to deliver complex interventions that seek to reduce the treatment gap for mental disorders, particularly in sub-Saharan Africa. The need for well-documented protocols which clearly describe the development and the scale-up of programs and interventions is necessary if such interventions are to be replicated elsewhere. This article describes the use of a theory of change (ToC) model to develop a brief psychological intervention for common mental disorders and its' evaluation through a cluster randomized controlled trial in Zimbabwe. A total of eight ToC workshops were held with a range of stakeholders over a 6-month period with a focus on four key components of the program: formative work, piloting, evaluation and scale-up. A ToC map was developed as part of the process with defined causal pathways leading to the desired impact. Interventions, indicators, assumptions and rationale for each point along the causal pathway were considered. Political buy-in from stakeholders together with key resources, which included human, facility/infrastructure, communication and supervision were identified as critical needs using the ToC approach. Ten (10) key interventions with specific indicators, assumptions and rationale formed part of the final ToC map, which graphically illustrated the causal pathway leading to the development of a psychological intervention and the successful implementation of a cluster randomized controlled trial. ToC workshops can enhance stakeholder engagement through an iterative process leading to a shared vision that can improve outcomes of complex mental health interventions particularly where scaling up of the intervention is desired.

A Causal Modelling Approach to the Development of Theory-Based Behaviour Change Programmes for Trial Evaluation

ERIC Educational Resources Information Center

Hardeman, Wendy; Sutton, Stephen; Griffin, Simon; Johnston, Marie; White, Anthony; Wareham, Nicholas J.; Kinmonth, Ann Louise

2005-01-01

Theory-based intervention programmes to support health-related behaviour change aim to increase health impact and improve understanding of mechanisms of behaviour change. However, the science of intervention development remains at an early stage. We present a causal modelling approach to developing complex interventions for evaluation in…

Development of an interface-focused educational complex intervention.

PubMed

Sampson, Rod; MacVicar, Ronald; Wilson, Philip

2017-09-01

In many countries, the medical primary-secondary care interface is central to the delivery of quality patient care. There is prevailing interest in developing initiatives to improve interface working for the benefit of health care professionals and their patients. To describe the development of an educational intervention designed to improve working at the primary-secondary care interface in NHS Scotland (United Kingdom) within the context of the Medical Research Council framework for the development and evaluation of complex interventions. A primary-secondary care interface focused Practice-based Small Group Learning (PBSGL) module was developed building upon qualitative synthesis and original research. A 'meeting of experts' shaped the module, which was subsequently piloted with a group of interface clinicians. Reflections on the module were sought from clinicians across NHS Scotland to provide contextual information from other areas. The PBSGL approach can be usefully applied to the development of a primary-secondary care interface-focused medical educational intervention.

Pre-pregnancy community-based intervention for couples in Malaysia: application of intervention mapping.

PubMed

Norris, Shane A; Ho, Julius Cheah Chee; Rashed, Aswir Abd; Vinding, Vibeke; Skau, Jutta K H; Biesma, Regien; Aagaard-Hansen, Jens; Hanson, Mark; Matzen, Priya

2016-11-17

Malaysia is experiencing a nutrition transition with burgeoning obesity, particularly in women, and a growing prevalence of non-communicable disease. These health burdens have severe implications not only for adult health but also across generations. Pre-conception health promotion could address the intergenerational risk of metabolic disease. This paper describes the development of the "Jom Mama" intervention using Intervention Mapping (IM). The Jom Mama intervention aims to improve the health of young adult couples in Malaysia prior to conception. IM comprises of five steps prior to the last one, which involves the evaluation of the intervention. We used the five steps to develop the Jom Mama intervention. Both the process and evidence is documented providing the rationale to the selection of the key objectives of the intervention: (i) increasing healthy dietary practice; (ii) increasing physical activity levels, (iii) reducing sedentary activity; and (iv) improving social support to offset stressful lifestyles. From the IM process, Jom Mama will be health-system centred approach that uniquely combines both community health promoters and an electronic-health platform to deliver the complex intervention. IM is an iterative process that systematically gathers "best" evidence, selects appropriate theories of behaviour change, and facilitates formative research so as to develop a complex intervention. Though the IM process is time consuming, complex, and costly, it has enriched the Jom Mama intervention with a number of notable advantages: (i) intervention fashioned on formative work with stakeholders and in the target group; (ii) intervention combines research evidence with theory; (iii) intervention acknowledges multiple dynamics of influence; and (iv) intervention is embedded within health service priorities in Malaysia for greater scale-up possibility.

Strategies to Reduce Hospitalizations of Children With Medical Complexity Through Complex Care: Expert Perspectives.

PubMed

Coller, Ryan J; Nelson, Bergen B; Klitzner, Thomas S; Saenz, Adrianna A; Shekelle, Paul G; Lerner, Carlos F; Chung, Paul J

Interventions to reduce disproportionate hospital use among children with medical complexity (CMC) are needed. We conducted a rigorous, structured process to develop intervention strategies aiming to reduce hospitalizations within a complex care program population. A complex care medical home program used 1) semistructured interviews of caregivers of CMC experiencing acute, unscheduled hospitalizations and 2) literature review on preventing hospitalizations among CMC to develop key drivers for lowering hospital utilization and link them with intervention strategies. Using an adapted version of the RAND/UCLA Appropriateness Method, an expert panel rated each model for effectiveness at impacting each key driver and ultimately reducing hospitalizations. The complex care program applied these findings to select a final set of feasible intervention strategies for implementation. Intervention strategies focused on expanding access to familiar providers, enhancing general or technical caregiver knowledge and skill, creating specific and proactive crisis or contingency plans, and improving transitions between hospital and home. Activities aimed to facilitate family-centered, flexible implementation and consideration of all of the child's environments, including school and while traveling. Tailored activities and special attention to the highest utilizing subset of CMC were also critical for these interventions. A set of intervention strategies to reduce hospitalizations among CMC, informed by key drivers, can be created through a structured, reproducible process. Both this process and the results may be relevant to clinical programs and researchers aiming to reduce hospital utilization through the medical home for CMC. Copyright © 2017 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

Improving access to psychosocial interventions for common mental health problems in the United Kingdom: narrative review and development of a conceptual model for complex interventions

PubMed Central

2012-01-01

Background In the United Kingdom and worldwide, there is significant policy interest in improving the quality of care for patients with mental health disorders and distress. Improving quality of care means addressing not only the effectiveness of interventions but also the issue of limited access to care. Research to date into improving access to mental health care has not been strongly rooted within a conceptual model, nor has it systematically identified the different elements of the patient journey from identification of illness to receipt of care. This paper set out to review core concepts underlying patient access to mental health care, synthesise these to develop a conceptual model of access, and consider the implications of the model for the development and evaluation of interventions for groups with poor access to mental health care such as older people and ethnic minorities. Methods Narrative review of the literature to identify concepts underlying patient access to mental health care, and synthesis into a conceptual model to support the delivery and evaluation of complex interventions to improve access to mental health care. Results The narrative review adopted a process model of access to care, incorporating interventions at three levels. The levels comprise (a) community engagement (b) addressing the quality of interactions in primary care and (c) the development and delivery of tailored psychosocial interventions. Conclusions The model we propose can form the basis for the development and evaluation of complex interventions in access to mental health care. We highlight the key methodological challenges in evaluating the overall impact of access interventions, and assessing the relative contribution of the different elements of the model. PMID:22889290

Community Engagement in a complex intervention to improve access to primary mental health care for hard-to-reach groups.

PubMed

Lamb, Jonathan; Dowrick, Christopher; Burroughs, Heather; Beatty, Susan; Edwards, Suzanne; Bristow, Kate; Clarke, Pam; Hammond, Jonathan; Waheed, Waquas; Gabbay, Mark; Gask, Linda

2015-12-01

Despite the availability of effective evidence-based treatments for depression and anxiety, many 'harder-to-reach' social and patient groups experience difficulties accessing treatment. We developed a complex intervention, the AMP (Improving Access to Mental Health in Primary Care) programme, which combined community engagement (CE), tailored (individual and group) psychosocial interventions and primary care involvement. To develop and evaluate a model for community engagement component of the complex intervention. This paper focuses on the development of relationships between stakeholders, their engagement with the issue of access to mental health and with the programme through the CE model. Our evaluation draws on process data, qualitative interviews and focus groups, brought together through framework analysis to evaluate the issues and challenges encountered. A case study of the South Asian community project carried out in Longsight in Greater Manchester, United Kingdom. Complex problems require multiple local stakeholders to work in concert. Assets based approaches implicitly make demands on scarce time and resources. Community development approaches have many benefits, but perceptions of open-ended investment are a barrier. The time-limited nature of a CE intervention provides an impetus to 'do it now', allowing stakeholders to negotiate their investment over time and accommodating their wider commitments. Both tangible outcomes and recognition of process benefits were vital in maintaining involvement. CE interventions can play a key role in improving accessibility and acceptability by engaging patients, the public and practitioners in research and in the local service ecology. © 2014 John Wiley & Sons Ltd.

Developing a reporting guideline for social and psychological intervention trials

PubMed Central

2013-01-01

Social and psychological interventions are often complex. Understanding randomised controlled trials (RCTs) of these complex interventions requires a detailed description of the interventions tested and the methods used to evaluate them; however, RCT reports often omit, or inadequately report, this information. Incomplete and inaccurate reporting hinders the optimal use of research, wastes resources, and fails to meet ethical obligations to research participants and consumers. In this paper, we explain how reporting guidelines have improved the quality of reports in medicine, and describe the ongoing development of a new reporting guideline for RCTs: CONSORT-SPI (an Extension for social and psychological interventions). We invite readers to participate in the project by visiting our website, in order to help us reach the best-informed consensus on these guidelines (http://tinyurl.com/CONSORT-study). PMID:23915044

Design and development of a film-based intervention about teenage men and unintended pregnancy: applying the Medical Research Council framework in practice.

PubMed

Aventin, Áine; Lohan, Maria; O'Halloran, Peter; Henderson, Marion

2015-04-01

Following the UK Medical Research Council's (MRC) guidelines for the development and evaluation of complex interventions, this study aimed to design, develop and optimise an educational intervention about young men and unintended teenage pregnancy based around an interactive film. The process involved identification of the relevant evidence base, development of a theoretical understanding of the phenomenon of unintended teenage pregnancy in relation to young men, and exploratory mixed methods research. The result was an evidence-based, theory-informed, user-endorsed intervention designed to meet the much neglected pregnancy education needs of teenage men and intended to increase both boys' and girls' intentions to avoid an unplanned pregnancy during adolescence. In prioritising the development phase, this paper addresses a gap in the literature on the processes of research-informed intervention design. It illustrates the application of the MRC guidelines in practice while offering a critique and additional guidance to programme developers on the MRC prescribed processes of developing interventions. Key lessons learned were: (1) know and engage the target population and engage gatekeepers in addressing contextual complexities; (2) know the targeted behaviours and model a process of change; and (3) look beyond development to evaluation and implementation. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Do complexity-informed health interventions work? A scoping review.

PubMed

Brainard, Julii; Hunter, Paul R

2016-09-20

The lens of complexity theory is widely advocated to improve health care delivery. However, empirical evidence that this lens has been useful in designing health care remains elusive. This review assesses whether it is possible to reliably capture evidence for efficacy in results or process within interventions that were informed by complexity science and closely related conceptual frameworks. Systematic searches of scientific and grey literature were undertaken in late 2015/early 2016. Titles and abstracts were screened for interventions (A) delivered by the health services, (B) that explicitly stated that complexity science provided theoretical underpinning, and (C) also reported specific outcomes. Outcomes had to relate to changes in actual practice, service delivery or patient clinical indicators. Data extraction and detailed analysis was undertaken for studies in three developed countries: Canada, UK and USA. Data were extracted for intervention format, barriers encountered and quality aspects (thoroughness or possible biases) of evaluation and reporting. From 5067 initial finds in scientific literature and 171 items in grey literature, 22 interventions described in 29 articles were selected. Most interventions relied on facilitating collaboration to find solutions to specific or general problems. Many outcomes were very positive. However, some outcomes were measured only subjectively, one intervention was designed with complexity theory in mind but did not reiterate this in subsequent evaluation and other interventions were credited as compatible with complexity science but reported no relevant theoretical underpinning. Articles often omitted discussion on implementation barriers or unintended consequences, which suggests that complexity theory was not widely used in evaluation. It is hard to establish cause and effect when attempting to leverage complex adaptive systems and perhaps even harder to reliably find evidence that confirms whether complexity-informed interventions are usually effective. While it is possible to show that interventions that are compatible with complexity science seem efficacious, it remains difficult to show that explicit planning with complexity in mind was particularly valuable. Recommendations are made to improve future evaluation reports, to establish a better evidence base about whether this conceptual framework is useful in intervention design and implementation.

Qualitative "trial-sibling" studies and "unrelated" qualitative studies contributed to complex intervention reviews.

PubMed

Noyes, Jane; Hendry, Margaret; Lewin, Simon; Glenton, Claire; Chandler, Jackie; Rashidian, Arash

2016-06-01

To compare the contribution of "trial-sibling" and "unrelated" qualitative studies in complex intervention reviews. Researchers are using qualitative "trial-sibling" studies undertaken alongside trials to provide explanations to understand complex interventions. In the absence of qualitative "trial-sibling" studies, it is not known if qualitative studies "unrelated" to trials are helpful. Trials, "trial-sibling," and "unrelated" qualitative studies looking at three health system interventions were identified. We looked for similarities and differences between the two types of qualitative studies, such as participants, intervention delivery, context, study quality and reporting, and contribution to understanding trial results. Reporting was generally poor in both qualitative study types. We detected no substantial differences in participant characteristics. Interventions in qualitative "trial-sibling" studies were delivered using standardized protocols, whereas interventions in "unrelated" qualitative studies were delivered in routine care. Qualitative "trial-sibling" studies alone provided insufficient data to develop meaningful transferrable explanations beyond the trial context, and their limited focus on immediate implementation did not address all phenomena of interest. Together, "trial-sibling" and "unrelated" qualitative studies provided larger, richer data sets across contexts to better understand the phenomena of interest. Findings support inclusion of "trial-sibling" and "unrelated" qualitative studies to explore complexity in complex intervention reviews. Copyright © 2016 Elsevier Inc. All rights reserved.

Making sense of complexity in context and implementation: the Context and Implementation of Complex Interventions (CICI) framework.

PubMed

Pfadenhauer, Lisa M; Gerhardus, Ansgar; Mozygemba, Kati; Lysdahl, Kristin Bakke; Booth, Andrew; Hofmann, Bjørn; Wahlster, Philip; Polus, Stephanie; Burns, Jacob; Brereton, Louise; Rehfuess, Eva

2017-02-15

The effectiveness of complex interventions, as well as their success in reaching relevant populations, is critically influenced by their implementation in a given context. Current conceptual frameworks often fail to address context and implementation in an integrated way and, where addressed, they tend to focus on organisational context and are mostly concerned with specific health fields. Our objective was to develop a framework to facilitate the structured and comprehensive conceptualisation and assessment of context and implementation of complex interventions. The Context and Implementation of Complex Interventions (CICI) framework was developed in an iterative manner and underwent extensive application. An initial framework based on a scoping review was tested in rapid assessments, revealing inconsistencies with respect to the underlying concepts. Thus, pragmatic utility concept analysis was undertaken to advance the concepts of context and implementation. Based on these findings, the framework was revised and applied in several systematic reviews, one health technology assessment (HTA) and one applicability assessment of very different complex interventions. Lessons learnt from these applications and from peer review were incorporated, resulting in the CICI framework. The CICI framework comprises three dimensions-context, implementation and setting-which interact with one another and with the intervention dimension. Context comprises seven domains (i.e., geographical, epidemiological, socio-cultural, socio-economic, ethical, legal, political); implementation consists of five domains (i.e., implementation theory, process, strategies, agents and outcomes); setting refers to the specific physical location, in which the intervention is put into practise. The intervention and the way it is implemented in a given setting and context can occur on a micro, meso and macro level. Tools to operationalise the framework comprise a checklist, data extraction tools for qualitative and quantitative reviews and a consultation guide for applicability assessments. The CICI framework addresses and graphically presents context, implementation and setting in an integrated way. It aims at simplifying and structuring complexity in order to advance our understanding of whether and how interventions work. The framework can be applied in systematic reviews and HTA as well as primary research and facilitate communication among teams of researchers and with various stakeholders.

Exploring synergistic interactions and catalysts in complex interventions: longitudinal, mixed methods case studies of an optimised multi-level suicide prevention intervention in four european countries (Ospi-Europe).

PubMed

Harris, Fiona M; Maxwell, Margaret; O'Connor, Rory; Coyne, James C; Arensman, Ella; Coffey, Claire; Koburger, Nicole; Gusmão, Ricardo; Costa, Susana; Székely, András; Cserhati, Zoltan; McDaid, David; van Audenhove, Chantal; Hegerl, Ulrich

2016-03-15

The Medical Research Council (MRC) Framework for complex interventions highlights the need to explore interactions between components of complex interventions, but this has not yet been fully explored within complex, non-pharmacological interventions. This paper draws on the process evaluation data of a suicide prevention programme implemented in four European countries to illustrate the synergistic interactions between intervention levels in a complex programme, and to present our method for exploring these. A realist evaluation approach informed the process evaluation, which drew on mixed methods, longitudinal case studies. Data collection consisted of 47 semi-structured interviews, 12 focus groups, one workshop, fieldnoted observations of six programme meetings and 20 questionnaires (delivered at six month intervals to each of the four intervention sites). Analysis drew on the framework approach, facilitated by the use of QSR NVivo (v10). Our qualitative approach to exploring synergistic interactions (QuaSIC) also developed a matrix of hypothesised synergies that were explored within one workshop and two waves of data collection. All four implementation countries provided examples of synergistic interactions that added value beyond the sum of individual intervention levels or components in isolation. For instance, the launch ceremony of the public health campaign (a level 3 intervention) in Ireland had an impact on the community-based professional training, increasing uptake and visibility of training for journalists in particular. In turn, this led to increased media reporting of OSPI activities (monitored as part of the public health campaign) and also led to wider dissemination of editorial guidelines for responsible reporting of suicidal acts. Analysis of the total process evaluation dataset also revealed the new phenomenon of the OSPI programme acting as a catalyst for externally generated (and funded) activity that shared the goals of suicide prevention. The QuaSIC approach enabled us to develop and refine our definition of synergistic interactions and add the innovative concept of catalytic effects. This represents a novel approach to the evaluation of complex interventions. By exploring synergies and catalytic interactions related to a complex intervention or programme, we reveal the added value to planned activities and how they might be maximised.

Understanding Implementation of Complex Interventions in Primary Care Teams.

PubMed

Luig, Thea; Asselin, Jodie; Sharma, Arya M; Campbell-Scherer, Denise L

2018-01-01

The implementation of interventions to support practice change in primary care settings is complex. Pragmatic strategies, grounded in empiric data, are needed to navigate real-world challenges and unanticipated interactions with context that can impact implementation and outcomes. This article uses the example of the "5As Team" randomized control trial to explore implementation strategies to promote knowledge transfer, capacity building, and practice integration, and their interaction within the context of an interdisciplinary primary care team. We performed a qualitative evaluation of the implementation process of the 5As Team intervention study, a randomized control trial of a complex intervention in primary care. We conducted thematic analysis of field notes of intervention sessions, log books of the practice facilitation team members, and semistructured interviews with 29 interdisciplinary clinician participants. We used and further developed the Interactive Systems Framework for dissemination and implementation to interpret and structure findings. Three themes emerged that illuminate interactions between implementation processes, context, and outcomes: (1) facilitating team communication supported collective and individual sense-making and adoption of the innovation, (2) iterative evaluation of the implementation process and real-time feedback-driven adaptions of the intervention proved crucial for sustainable, context-appropriate intervention impact, (3) stakeholder engagement led to both knowledge exchange that contributes to local problem solving and to shaping a clinical context that is supportive to practice change. Our findings contribute pragmatic strategies that can help practitioners and researchers to navigate interactions between context, intervention, and implementation factors to increase implementation success. We further developed an implementation framework that includes sustained engagement with stakeholders, facilitation of team sense-making, and dynamic evaluation and intervention design as integral parts of complex intervention implementation. NCT01967797. 18 October 2013. © Copyright 2018 by the American Board of Family Medicine.

Reviewing evidence on complex social interventions: appraising implementation in systematic reviews of the health effects of organisational-level workplace interventions

PubMed Central

Egan, M; Bambra, C; Petticrew, M; Whitehead, M

2009-01-01

Background: The reporting of intervention implementation in studies included in systematic reviews of organisational-level workplace interventions was appraised. Implementation is taken to include such factors as intervention setting, resources, planning, collaborations, delivery and macro-level socioeconomic contexts. Understanding how implementation affects intervention outcomes may help prevent erroneous conclusions and misleading assumptions about generalisability, but implementation must be adequately reported if it is to be taken into account. Methods: Data on implementation were obtained from four systematic reviews of complex interventions in workplace settings. Implementation was appraised using a specially developed checklist and by means of an unstructured reading of the text. Results: 103 studies were identified and appraised, evaluating four types of organisational-level workplace intervention (employee participation, changing job tasks, shift changes and compressed working weeks). Many studies referred to implementation, but reporting was generally poor and anecdotal in form. This poor quality of reporting did not vary greatly by type or date of publication. A minority of studies described how implementation may have influenced outcomes. These descriptions were more usefully explored through an unstructured reading of the text, rather than by means of the checklist. Conclusions: Evaluations of complex interventions should include more detailed reporting of implementation and consider how to measure quality of implementation. The checklist helped us explore the poor reporting of implementation in a more systematic fashion. In terms of interpreting study findings and their transferability, however, the more qualitative appraisals appeared to offer greater potential for exploring how implementation may influence the findings of specific evaluations. Implementation appraisal techniques for systematic reviews of complex interventions require further development and testing. PMID:18718981

Reviewing evidence on complex social interventions: appraising implementation in systematic reviews of the health effects of organisational-level workplace interventions.

PubMed

Egan, M; Bambra, C; Petticrew, M; Whitehead, M

2009-01-01

The reporting of intervention implementation in studies included in systematic reviews of organisational-level workplace interventions was appraised. Implementation is taken to include such factors as intervention setting, resources, planning, collaborations, delivery and macro-level socioeconomic contexts. Understanding how implementation affects intervention outcomes may help prevent erroneous conclusions and misleading assumptions about generalisability, but implementation must be adequately reported if it is to be taken into account. Data on implementation were obtained from four systematic reviews of complex interventions in workplace settings. Implementation was appraised using a specially developed checklist and by means of an unstructured reading of the text. 103 studies were identified and appraised, evaluating four types of organisational-level workplace intervention (employee participation, changing job tasks, shift changes and compressed working weeks). Many studies referred to implementation, but reporting was generally poor and anecdotal in form. This poor quality of reporting did not vary greatly by type or date of publication. A minority of studies described how implementation may have influenced outcomes. These descriptions were more usefully explored through an unstructured reading of the text, rather than by means of the checklist. Evaluations of complex interventions should include more detailed reporting of implementation and consider how to measure quality of implementation. The checklist helped us explore the poor reporting of implementation in a more systematic fashion. In terms of interpreting study findings and their transferability, however, the more qualitative appraisals appeared to offer greater potential for exploring how implementation may influence the findings of specific evaluations. Implementation appraisal techniques for systematic reviews of complex interventions require further development and testing.

Methodological issues in oral health research: intervention studies.

PubMed

O'Mullane, Denis; James, Patrice; Whelton, Helen; Parnell, Carmel

2012-02-01

To provide a broad overview of methodological issues in the design and evaluation of intervention studies in dental public health, with particular emphasis on explanatory trials, pragmatic trials and complex interventions. We present a narrative summary of selected publications from the literature outlining both historical and recent challenges in the design and evaluation of intervention studies and describe some recent tools that may help researchers to address these challenges. It is now recognised that few intervention studies in dental public health are purely explanatory or pragmatic. We describe the PRECIS tool which can be used by trialists to assess and display the position of their trial on a continuum between the extremes of explanatory and pragmatic trials. The tool aims to help trialists make design decisions that are in line with their stated aims. The increasingly complex nature of dental public health interventions presents particular design and evaluation challenges. The revised Medical Research Council (MRC) guidance for the development and evaluation of complex interventions which emphasises the importance of planning and process evaluation is a welcome development. We briefly describe the MRC guidance and outline some examples of complex interventions in the field of oral health. The role of observational studies in monitoring public health interventions when the conduct of RCTs is not appropriate or feasible is acknowledged. We describe the STROBE statement and outline the implications of the STROBE guidelines for dental public health. The methodological challenges in the design, conduct and reporting of intervention studies in oral health are considerable. The need to provide reliable evidence to support innovative new strategies in oral health policy is a major impetus in these fields. No doubt the 'Methodological Issues in Oral Health Research' group will have further opportunities to highlight this work. © 2012 John Wiley & Sons A/S.

'I just wanted someone to tell me it wasn't all in my mind and do something for me': Qualitative exploration of acceptability of a CBT based intervention to manage chronic orofacial pain.

PubMed

Goldthorpe, J; Peters, S; Lovell, K; McGowan, L; Aggarwal, V

2016-05-13

Introduction Evidence suggests that psychosocial management may produce improved outcomes for patients suffering from chronic orofacial pain (COFP), when symptoms cannot be attributed to pathology. A complex intervention, based on cognitive behavioural therapy (CBT) was developed by a multi-disciplinary team, using evidence synthesis. An important element of developing and evaluating complex interventions is to establish acceptability to stakeholders; therefore qualitative interviews with patients were carried out.Objectives To explore levels of acceptability of a complex intervention to manage COFP.Method Semi-structured interviews were carried out with 17 participants who had been referred to the intervention. Thematic analysis was used to identify emerging issues and themes from the data.Results Themes relating to processes of engagement with the intervention emerged. Important processes were: identification with the intervention; feeling believed and understood; obtaining a plausible explanation for symptoms; degree of perceived effort required to engage; acceptance of having a long-term condition; and receiving demonstrative, positive feedback.Conclusion Patients presenting with unexplained COFP in a secondary care setting are able to accept a CBT based intervention to manage their condition. Findings may offer guidance for dentists who are not used to referring patients to psychosocial interventions and inform the way dentists communicate the nature of unexplained symptoms to patients.

Using intervention mapping to develop a theory-driven, group-based complex intervention to support self-management of osteoarthritis and low back pain (SOLAS).

PubMed

Hurley, Deirdre A; Murphy, Laura Currie; Hayes, David; Hall, Amanda M; Toomey, Elaine; McDonough, Suzanne M; Lonsdale, Chris; Walsh, Nicola E; Guerin, Suzanne; Matthews, James

2016-04-26

The Medical Research Council framework provides a useful general approach to designing and evaluating complex interventions, but does not provide detailed guidance on how to do this and there is little evidence of how this framework is applied in practice. This study describes the use of intervention mapping (IM) in the design of a theory-driven, group-based complex intervention to support self-management (SM) of patients with osteoarthritis (OA) and chronic low back pain (CLBP) in Ireland's primary care health system. The six steps of the IM protocol were systematically applied to develop the self-management of osteoarthritis and low back pain through activity and skills (SOLAS) intervention through adaptation of the Facilitating Activity and Self-management in Arthritis (FASA) intervention. A needs assessment including literature reviews, interviews with patients and physiotherapists and resource evaluation was completed to identify the programme goals, determinants of SM behaviour, consolidated definition of SM and required adaptations to FASA to meet health service and patient needs and the evidence. The resultant SOLAS intervention behavioural outcomes, performance and change objectives were specified and practical application methods selected, followed by organised programme, adoption, implementation and evaluation plans underpinned by behaviour change theory. The SOLAS intervention consists of six weekly sessions of 90-min education and exercise designed to increase participants' physical activity level and use of evidence-based SM strategies (i.e. pain self-management, pain coping, healthy eating for weight management and specific exercise) through targeting of individual determinants of SM behaviour (knowledge, skills, self-efficacy, fear, catastrophizing, motivation, behavioural regulation), delivered by a trained physiotherapist to groups of up to eight individuals using a needs supportive interpersonal style based on self-determination theory. Strategies to support SOLAS intervention adoption and implementation included a consensus building workshop with physiotherapy stakeholders, development of a physiotherapist training programme and a pilot trial with physiotherapist and patient feedback. The SOLAS intervention is currently being evaluated in a cluster randomised controlled feasibility trial. IM is a time-intensive collaborative process, but the range of methods and resultant high level of transparency is invaluable and allows replication by future complex intervention and trial developers.

Evaluation design for a complex intervention program targeting loneliness in non-institutionalized elderly Dutch people.

PubMed

de Vlaming, Rianne; Haveman-Nies, Annemien; Van't Veer, Pieter; de Groot, Lisette Cpgm

2010-09-13

The aim of this paper is to provide the rationale for an evaluation design for a complex intervention program targeting loneliness among non-institutionalized elderly people in a Dutch community. Complex public health interventions characteristically use the combined approach of intervening on the individual and on the environmental level. It is assumed that the components of a complex intervention interact with and reinforce each other. Furthermore, implementation is highly context-specific and its impact is influenced by external factors. Although the entire community is exposed to the intervention components, each individual is exposed to different components with a different intensity. A logic model of change is used to develop the evaluation design. The model describes what outcomes may logically be expected at different points in time at the individual level. In order to address the complexity of a real-life setting, the evaluation design of the loneliness intervention comprises two types of evaluation studies. The first uses a quasi-experimental pre-test post-test design to evaluate the effectiveness of the overall intervention. A control community comparable to the intervention community was selected, with baseline measurements in 2008 and follow-up measurements scheduled for 2010. This study focuses on changes in the prevalence of loneliness and in the determinants of loneliness within individuals in the general elderly population. Complementarily, the second study is designed to evaluate the individual intervention components and focuses on delivery, reach, acceptance, and short-term outcomes. Different means of project records and surveys among participants are used to collect these data. Combining these two evaluation strategies has the potential to assess the effectiveness of the overall complex intervention and the contribution of the individual intervention components thereto.

Evaluation design for a complex intervention program targeting loneliness in non-institutionalized elderly Dutch people

PubMed Central

2010-01-01

Background The aim of this paper is to provide the rationale for an evaluation design for a complex intervention program targeting loneliness among non-institutionalized elderly people in a Dutch community. Complex public health interventions characteristically use the combined approach of intervening on the individual and on the environmental level. It is assumed that the components of a complex intervention interact with and reinforce each other. Furthermore, implementation is highly context-specific and its impact is influenced by external factors. Although the entire community is exposed to the intervention components, each individual is exposed to different components with a different intensity. Methods/Design A logic model of change is used to develop the evaluation design. The model describes what outcomes may logically be expected at different points in time at the individual level. In order to address the complexity of a real-life setting, the evaluation design of the loneliness intervention comprises two types of evaluation studies. The first uses a quasi-experimental pre-test post-test design to evaluate the effectiveness of the overall intervention. A control community comparable to the intervention community was selected, with baseline measurements in 2008 and follow-up measurements scheduled for 2010. This study focuses on changes in the prevalence of loneliness and in the determinants of loneliness within individuals in the general elderly population. Complementarily, the second study is designed to evaluate the individual intervention components and focuses on delivery, reach, acceptance, and short-term outcomes. Different means of project records and surveys among participants are used to collect these data. Discussion Combining these two evaluation strategies has the potential to assess the effectiveness of the overall complex intervention and the contribution of the individual intervention components thereto. PMID:20836840

Developing a complex intervention for diet and activity behaviour change in obese pregnant women (the UPBEAT trial); assessment of behavioural change and process evaluation in a pilot randomised controlled trial.

PubMed

Poston, Lucilla; Briley, Annette L; Barr, Suzanne; Bell, Ruth; Croker, Helen; Coxon, Kirstie; Essex, Holly N; Hunt, Claire; Hayes, Louise; Howard, Louise M; Khazaezadeh, Nina; Kinnunen, Tarja; Nelson, Scott M; Oteng-Ntim, Eugene; Robson, Stephen C; Sattar, Naveed; Seed, Paul T; Wardle, Jane; Sanders, Thomas A B; Sandall, Jane

2013-07-15

Complex interventions in obese pregnant women should be theoretically based, feasible and shown to demonstrate anticipated behavioural change prior to inception of large randomised controlled trials (RCTs). The aim was to determine if a) a complex intervention in obese pregnant women leads to anticipated changes in diet and physical activity behaviours, and b) to refine the intervention protocol through process evaluation of intervention fidelity. We undertook a pilot RCT of a complex intervention in obese pregnant women, comparing routine antenatal care with an intervention to reduce dietary glycaemic load and saturated fat intake, and increase physical activity. Subjects included 183 obese pregnant women (mean BMI 36.3 kg/m2). Compared to women in the control arm, women in the intervention arm had a significant reduction in dietary glycaemic load (33 points, 95% CI -47 to -20), (p < 0.001) and saturated fat intake (-1.6% energy, 95% CI -2.8 to -0. 3) at 28 weeks' gestation. Objectively measured physical activity did not change. Physical discomfort and sustained barriers to physical activity were common at 28 weeks' gestation. Process evaluation identified barriers to recruitment, group attendance and compliance, leading to modification of intervention delivery. This pilot trial of a complex intervention in obese pregnant women suggests greater potential for change in dietary intake than for change in physical activity, and through process evaluation illustrates the considerable advantage of performing an exploratory trial of a complex intervention in obese pregnant women before undertaking a large RCT. ISRCTN89971375.

Improving medication management in multimorbidity: development of the MultimorbiditY COllaborative Medication Review And DEcision Making (MY COMRADE) intervention using the Behaviour Change Wheel.

PubMed

Sinnott, Carol; Mercer, Stewart W; Payne, Rupert A; Duerden, Martin; Bradley, Colin P; Byrne, Molly

2015-09-24

Multimorbidity, the presence of two or more chronic conditions, affects over 60 % of patients in primary care. Due to its association with polypharmacy, the development of interventions to optimise medication management in patients with multimorbidity is a priority. The Behaviour Change Wheel is a new approach for applying behavioural theory to intervention development. Here, we describe how we have used results from a review of previous research, original research of our own and the Behaviour Change Wheel to develop an intervention to improve medication management in multimorbidity by general practitioners (GPs), within the overarching UK Medical Research Council guidance on complex interventions. Following the steps of the Behaviour Change Wheel, we sought behaviours associated with medication management in multimorbidity by conducting a systematic review and qualitative study with GPs. From the modifiable GP behaviours identified, we selected one and conducted a focused behavioural analysis to explain why GPs were or were not engaging in this behaviour. We used the behavioural analysis to determine the intervention functions, behavioural change techniques and implementation plan most likely to effect behavioural change. We identified numerous modifiable GP behaviours in the systematic review and qualitative study, from which active medication review (rather than passive maintaining the status quo) was chosen as the target behaviour. Behavioural analysis revealed GPs' capabilities, opportunities and motivations relating to active medication review. We combined the three intervention functions deemed most likely to effect behavioural change (enablement, environmental restructuring and incentivisation) to form the MultimorbiditY COllaborative Medication Review And DEcision Making (MY COMRADE) intervention. MY COMRADE primarily involves the technique of social support: two GPs review the medications prescribed to a complex multimorbid patient together. Four other behavioural change techniques are incorporated: restructuring the social environment, prompts/cues, action planning and self-incentives. This study is the first to use the Behaviour Change Wheel to develop an intervention targeting multimorbidity and confirms the usability and usefulness of the approach in a complex area of clinical care. The systematic development of the MY COMRADE intervention will facilitate a thorough evaluation of its effectiveness in the next phase of this work.

Motivational Interviewing and Medication Review in Coronary Heart Disease (MIMeRiC): Intervention Development and Protocol for the Process Evaluation.

PubMed

Östbring, Malin Johansson; Eriksson, Tommy; Petersson, Göran; Hellström, Lina

2018-01-30

Trials of complex interventions are often criticized for being difficult to interpret because the effects of apparently similar interventions vary across studies dependent on context, targeted groups, and the delivery of the intervention. The Motivational Interviewing and Medication Review in Coronary heart disease (MIMeRiC) trial is a randomized controlled trial (RCT) of an intervention aimed at improving pharmacological secondary prevention. Guidelines for the development and evaluation of complex interventions have recently highlighted the need for better reporting of the development of interventions, including descriptions of how the intervention is assumed to work, how this theory informed the process evaluation, and how the process evaluation relates to the outcome evaluation. This paper aims to describe how the intervention was designed and developed. The aim of the process evaluation is to better understand how and why the intervention in the MIMeRiC trial was effective or not effective. The research questions for evaluating the process are based on the conceptual model of change processes assumed in the intervention and will be analyzed by qualitative and quantitative methods. Quantitative data are used to evaluate the medication review in terms of drug-related problems, to describe how patients' beliefs about medicines are affected by the intervention, and to evaluate the quality of motivational interviewing. Qualitative data will be used to analyze whether patients experienced the intervention as intended, how cardiologists experienced the collaboration and intervention, and how the intervention affected patients' overall experience of care after coronary heart disease. The development and piloting of the intervention are described in relation to the theoretical framework. Data for the process evaluation will be collected until March 2018. Some process evaluation questions will be analyzed before, and others will be analyzed after the outcomes of the MIMeRiC RCT are known. This paper describes the framework for the design of the intervention tested in the MIMeRiC trial, development of the intervention from the pilot stage to the complete trial intervention, and the framework and methods for the process evaluation. Providing the protocol of the process evaluation allows prespecification of the processes that will be evaluated, because we hypothesize that they will determine the outcomes of the MIMeRiC trial. This protocol also constitutes a contribution to the new field of process evaluations as made explicit in health services research and clinical trials of complex interventions. ©Malin Johansson Östbring, Tommy Eriksson, Göran Petersson, Lina Hellström. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 30.01.2018.

Activity matters: a web-based resource to enable people with multiple sclerosis to become more active.

PubMed

Casey, Blathin; Coote, Susan; Byrne, Molly

2018-03-27

Increasing physical activity (PA) through exercise is associated with improvements in many of the symptoms associated with multiple sclerosis (MS) such as fatigue, strength, balance, and mobility. Despite this, people with MS remain largely inactive. Interventions that are grounded in theory and that aim to change PA behavior need to be developed. The purpose of this study was to describe the development process of a web-based resource, namely, "Activity Matters," to enable people with MS to become more active. Development of the "Activity Matters" online intervention was guided by the UK's Medical Research Council (MRC) framework for the development and evaluation of complex interventions and the behavior change wheel (BCW). Seven sources of data were used to inform the process and were mapped on to both the MRC and BCW frameworks. The intervention is theoretically based, and constructs including knowledge, memory, attention and decision processes, skills, social influences, environmental context and resources, beliefs about capabilities, beliefs about consequences, goals, and emotions were recognized as important. "Activity Matters" is the first MS PA intervention to be developed using the theoretical approach outlined by the BCW and MRC complex interventions frameworks. The next phase of this work is to test the usability, acceptability, and preliminary effectiveness of "Activity Matters" among people with MS.

Exploration of dynamics in a complex person-centred intervention process based on health professionals' perspectives.

PubMed

Friberg, Febe; Wallengren, Catarina; Håkanson, Cecilia; Carlsson, Eva; Smith, Frida; Pettersson, Monica; Kenne Sarenmalm, Elisabeth; Sawatzky, Richard; Öhlén, Joakim

2018-06-13

The assessment and evaluation of practical and sustainable development of health care has become a major focus of investigation in health services research. A key challenge for researchers as well as decision-makers in health care is to understand mechanisms influencing how complex interventions work and become embedded in practice, which is significant for both evaluation and later implementation. In this study, we explored nurses' and surgeons' perspectives on performing and participating in a complex multi-centre person-centred intervention process that aimed to support patients diagnosed with colorectal cancer to feel prepared for surgery, discharge and recovery. Data consisted of retrospective interviews with 20 professionals after the intervention, supplemented with prospective conversational data and field notes from workshops and follow-up meetings (n = 51). The data were analysed to construct patterns in line with interpretive description. Although the participants highly valued components of the intervention, the results reveal influencing mechanisms underlying the functioning of the intervention, including multiple objectives, unclear mandates and competing professional logics. The results also reveal variations in processing the intervention focused on differences in using and talking about intervention components. The study indicates there are significant areas of ambiguity in understanding how theory-based complex clinical interventions work and in how interventions are socially constructed and co-created by professionals' experiences, assumptions about own professional practice, contextual conditions and the researchers' intentions. This process evaluation reveals insights into reasons for success or failure and contextual aspects associated with variations in outcomes. Thus, there is a need for further interpretive inquiry, and not only descriptive studies, of the multifaceted characters of complex clinical interventions and how the intervention components are actually shaped in constantly shifting contexts.

Application of system thinking concepts in health system strengthening in low-income settings: a proposed conceptual framework for the evaluation of a complex health system intervention: the case of the BHOMA intervention in Zambia.

PubMed

Mutale, Wilbroad; Balabanova, Dina; Chintu, Namwinga; Mwanamwenge, Margaret Tembo; Ayles, Helen

2016-02-01

The current drive to strengthen health systems provides an opportunity to develop new strategies that will enable countries to achieve targets for millennium development goals. In this paper, we present a proposed framework for evaluating a new health system strengthening intervention in Zambia known as Better Health Outcomes through Mentoring and Assessment. We briefly describe the intervention design and focus on the proposed evaluation approach through the lens of systems thinking. In this paper, we present a proposed framework to evaluate a complex health system intervention applying systems thinking concepts. We hope that lessons learnt from this process will help to adapt the intervention and limit unintended negative consequences while promoting positive effects. Emphasis will be paid to interaction and interdependence between health system building blocks, context and the community. © 2014 The Authors. Journal of Evaluation in Clinical Practice published by John Wiley & Sons, Ltd.

Effect assessment in work environment interventions: a methodological reflection.

PubMed

Neumann, W P; Eklund, J; Hansson, B; Lindbeck, L

2010-01-01

This paper addresses a number of issues for work environment intervention (WEI) researchers in light of the mixed results reported in the literature. If researchers emphasise study quality over intervention quality, reviews that exclude case studies with high quality and multifactorial interventions may be vulnerable to 'quality criteria selection bias'. Learning from 'failed' interventions is inhibited by both publication bias and reporting lengths that limit information on relevant contextual and implementation factors. The authors argue for the need to develop evaluation approaches consistent with the complexity of multifactorial WEIs that: a) are owned by and aimed at the whole organisation; and b) include intervention in early design stages where potential impact is highest. Context variety, complexity and instability in and around organisations suggest that attention might usefully shift from generalisable 'proof of effectiveness' to a more nuanced identification of intervention elements and the situations in which they are more likely to work as intended. STATEMENT OF RELEVANCE: This paper considers ergonomics interventions from perspectives of what constitutes quality and 'proof". It points to limitations of traditional experimental intervention designs and argues that the complexity of organisational change, and the need for multifactorial interventions that reach deep into work processes for greater impact, should be recognised.

Atypical Infant Development. Second Edition.

ERIC Educational Resources Information Center

Hanson, Marci J., Ed.

The 13 chapters of this text focus on the complex development issues and interdisciplinary service needs of infants and young children at risk and their families. The text is organized into four sections on: developmental and intervention principles, identification and assessment, developmental issues, and early intervention. Chapter titles and…

Mixed Methods Research in the Development and Evaluation of Complex Interventions in Palliative and End-of-Life Care: Report on the MORECare Consensus Exercise

PubMed Central

Preston, Nancy; Evans, Catherine J.; Grande, Gunn; Short, Vicky; Benalia, Hamid; Higginson, Irene J.; Todd, on behalf of MORECare, Chris

2013-01-01

Abstract Background: Complex interventions are common in palliative and end-of-life care. Mixed methods approaches sit well within the multiphase model of complex intervention development and evaluation. Generic mixed methods guidance is useful but additional challenges in the research design and operationalization within palliative and end-of-life care may have an impact on the use of mixed methods. Objective: The objective of the study was to develop guidance on the best methods for combining quantitative and qualitative methods for health and social care intervention development and evaluation in palliative and end-of-life care. Methods: A one-day workshop was held where experts participated in facilitated groups using Transparent Expert Consultation to generate items for potential recommendations. Agreement and consensus were then sought on nine draft recommendations (DRs) in a follow-up exercise. Results: There was at least moderate agreement with most of the DRs, although consensus was low. Strongest agreement was with DR1 (usefulness of mixed methods to palliative and end-of-life care) and DR5 (importance of attention to respondent burden), and least agreement was with DR2 (use of theoretical perspectives) and DR6 (therapeutic effects of research interviews). Narrative comments enabled recommendation refinement. Two fully endorsed, five partially endorsed, and two refined DRs emerged. The relationship of these nine to six key challenges of palliative and end-of-life care research was analyzed. Conclusions: There is a need for further discussion of these recommendations and their contribution to methodology. The recommendations should be considered when designing and operationalizing mixed methods studies of complex interventions in palliative care, and because they may have wider relevance, should be considered for other applications. PMID:24195755

Mixed methods research in the development and evaluation of complex interventions in palliative and end-of-life care: report on the MORECare consensus exercise.

PubMed

Farquhar, Morag; Preston, Nancy; Evans, Catherine J; Grande, Gunn; Short, Vicky; Benalia, Hamid; Higginson, Irene J; Todd, Chris

2013-12-01

Complex interventions are common in palliative and end-of-life care. Mixed methods approaches sit well within the multiphase model of complex intervention development and evaluation. Generic mixed methods guidance is useful but additional challenges in the research design and operationalization within palliative and end-of-life care may have an impact on the use of mixed methods. The objective of the study was to develop guidance on the best methods for combining quantitative and qualitative methods for health and social care intervention development and evaluation in palliative and end-of-life care. A one-day workshop was held where experts participated in facilitated groups using Transparent Expert Consultation to generate items for potential recommendations. Agreement and consensus were then sought on nine draft recommendations (DRs) in a follow-up exercise. There was at least moderate agreement with most of the DRs, although consensus was low. Strongest agreement was with DR1 (usefulness of mixed methods to palliative and end-of-life care) and DR5 (importance of attention to respondent burden), and least agreement was with DR2 (use of theoretical perspectives) and DR6 (therapeutic effects of research interviews). Narrative comments enabled recommendation refinement. Two fully endorsed, five partially endorsed, and two refined DRs emerged. The relationship of these nine to six key challenges of palliative and end-of-life care research was analyzed. There is a need for further discussion of these recommendations and their contribution to methodology. The recommendations should be considered when designing and operationalizing mixed methods studies of complex interventions in palliative care, and because they may have wider relevance, should be considered for other applications.

Harnessing complexity: taking advantage of context and relationships in dissemination of school-based interventions.

PubMed

Butler, Helen; Bowes, Glenn; Drew, Sarah; Glover, Sara; Godfrey, Celia; Patton, George; Trafford, Lea; Bond, Lyndal

2010-03-01

Schools and school systems are increasingly asked to use evidence-based strategies to promote the health and well-being of students. The dissemination of school-based health promotion research, however, offers particular challenges to conventional approaches to dissemination. Schools and education systems are multifaceted organizations that sit within constantly shifting broader contexts. This article argues that health promotion dissemination needs to be rethought for school communities as complex systems and that this requires understanding and harnessing the dynamic ecology of the sociopolitical context. In developing this argument, the authors draw on their experience of the dissemination process of a multilevel school-based intervention in a complex educational context. Building on this experience, they argue for the need to move beyond conventional dissemination strategies to a focus on active partnerships between developers and users of school-based intervention research and offer a conceptual tool for planning dissemination.

Current use was established and Cochrane guidance on selection of social theories for systematic reviews of complex interventions was developed.

PubMed

Noyes, Jane; Hendry, Maggie; Booth, Andrew; Chandler, Jackie; Lewin, Simon; Glenton, Claire; Garside, Ruth

2016-07-01

To identify examples of how social theories are used in systematic reviews of complex interventions to inform production of Cochrane guidance. Secondary analysis of published/unpublished examples of theories of social phenomena for use in reviews of complex interventions identified through scoping searches, engagement with key authors and methodologists supplemented by snowballing and reference searching. Theories were classified (low-level, mid-range, grand). Over 100 theories were identified with evidence of proliferation over the last 5 years. New low-level theories (tools, taxonomies, etc) have been developed for classifying and reporting complex interventions. Numerous mid-range theories are used; one example demonstrated how control theory had changed the review's findings. Review-specific logic models are increasingly used, but these can be challenging to develop. New low-level and mid-range psychological theories of behavior change are evolving. No reviews using grand theory (e.g., feminist theory) were identified. We produced a searchable Wiki, Mendeley Inventory, and Cochrane guidance. Use of low-level theory is common and evolving; incorporation of mid-range theory is still the exception rather than the norm. Methodological work is needed to evaluate the contribution of theory. Choice of theory reflects personal preference; application of theory is a skilled endeavor. Crown Copyright © 2016. Published by Elsevier Inc. All rights reserved.

Stop Stroke: development of an innovative intervention to improve risk factor management after stroke.

PubMed

Redfern, Judith; Rudd, Anthony D; Wolfe, Charles D A; McKevitt, Christopher

2008-08-01

Stroke survivors are at high risk of stroke recurrence yet current strategies to reduce recurrence risk are sub-optimal. The UK Medical Research Council (MRC) have proposed a framework for developing and evaluating complex interventions, such as community management of stroke secondary prevention. The Framework outlines a five-phased approach from theory through to implementation of effective interventions. This paper reports Phases I-III of the development of a novel intervention to improve risk factor management after stroke. The pre-clinical/theoretical phase entailed reviewing the literature and undertaking quantitative and qualitative studies to identify current practices and barriers to secondary prevention. In Phase I (modelling), findings were used to design an intervention with the potential to overcome barriers to effective stroke secondary prevention management. The feasibility of delivering the intervention and its acceptability were tested in the Phase II exploratory trial involving 25 stroke survivors and their general practitioners. This led to the development of the definitive risk factor management intervention. This comprises multiple components and involves using an on-going population stroke register to target patients, carers and health care professionals with tailored secondary prevention advice. Clinical, socio-demographic and service use data collected by the stroke register are transformed to provide an individualised secondary prevention package for patients, carers and health care professionals at three time points: within 10 weeks, 3 and 6 months post-stroke. The intervention is currently being evaluated in a randomised controlled trial. Further research is needed to test generalisability to other aspects of stroke management and for other chronic diseases. The MRC Framework for complex interventions provides a structured approach to guide the development of novel interventions in public health. Implications for practice in stroke secondary prevention will emerge when the results of our randomised controlled trial are published.

STARS experiential group intervention: a complex trauma treatment approach for survivors of human trafficking.

PubMed

Hopper, Elizabeth K; Azar, Naomi; Bhattacharyya, Sriya; Malebranche, Dominique A; Brennan, Kelsey E

2018-01-01

This is the abstract that was submitted online with the paper: Despite the fact that many survivors of human trafficking have experienced complex trauma, there are no established interventions designed to specifically address these impacts. Leaders in the field of complex trauma have advocated for the need for somatic approaches to intervention. This paper presents STARS Experiential Group treatment, the first structured bodybased group intervention that has been designed to address complex trauma in survivors of human trafficking. Three pilot groups were run in residential settings with adolescent and adult survivors of sex trafficking. Two adaptations were utilized, with one focusing on application of expressive arts modalities and the other incorporating theater games. Qualitative results, using thematic analysis, identified several themes related to challenges and potential benefits of these groups. Potential benefits of the STARS groups were found in the areas of Interpersonal Relationships, Regulation, and Self/ Identity, with fourteen sub-themes further describing positive impacts. Challenges within these areas are explored, to inform the development of group interventions for trafficking survivors. The results of this paper suggest that experiential, somatically-oriented group treatment shows promise as an important element of holistic intervention with trafficking survivors.

Child Welfare Design Teams: An Intervention to Improve Workforce Retention and Facilitate Organizational Development

ERIC Educational Resources Information Center

Caringi, James C.; Lawson, Hal A.; Strolin-Goltzman, Jessica; McCarthy, Mary; Briar-Lawson, Katharine; Claiborne, Nancy

2008-01-01

Workforce turnover in public child welfare is a national problem. Individual, supervisory, and organizational factors, individually and in combination, account for some of the turnover. Complex, comprehensive interventions are needed to address these several factors and their interactions. A research and development team is field testing one such…

Development of a complex intervention to improve participation of nursing home residents with joint contractures: a mixed-method study.

PubMed

Saal, Susanne; Meyer, Gabriele; Beutner, Katrin; Klingshirn, Hanna; Strobl, Ralf; Grill, Eva; Mann, Eva; Köpke, Sascha; Bleijlevens, Michel H C; Bartoszek, Gabriele; Stephan, Anna-Janina; Hirt, Julian; Müller, Martin

2018-02-28

Joint contractures in nursing home residents limit the capacity to perform daily activities and restrict social participation. The purpose of this study was to develop a complex intervention to improve participation in nursing home residents with joint contractures. The development followed the UK Medical Research Council framework using a mixed-methods design with re-analysis of existing interview data using a graphic modelling approach, group discussions with nursing home residents, systematic review of intervention studies, structured 2-day workshop with experts in geriatric, nursing, and rehabilitation, and group discussion with professionals in nursing homes. Graphic modelling identified restrictions in the use of transportation, walking within buildings, memory functions, and using the hands and arms as the central target points for the intervention. Seven group discussions with 33 residents revealed various aspects related to functioning and disability according the International Classification of Functioning, Disability and Health domains body functions, body structures, activities and participation, environmental factors, and personal factors. The systematic review included 17 studies with 992 participants: 16 randomised controlled trials and one controlled trial. The findings could not demonstrate any evidence in favour of an intervention. The structured 2-day expert workshop resulted in a variety of potential intervention components and implementation strategies. The group discussion with the professionals in nursing homes verified the feasibility of the components and the overall concept. The resulting intervention, Participation Enabling CAre in Nursing (PECAN), will be implemented during a 1-day workshop for nurses, a mentoring approach, and supportive material. The intervention addresses nurses and other staff, residents, their informal caregivers, therapists, and general practitioners. In view of the absence of any robust evidence, the decision to use mixed methods and to closely involve both health professionals and residents proved to be an appropriate means to develop a complex intervention to improve participation of and quality of life in nursing home residents. We will now evaluate the PECAN intervention for its impact and feasibility in a pilot study in preparation for an evaluation of its effectiveness in a definitive trial. German clinical trials register, reference number DRKS00010037 (12 February 2016).

Understanding a successful obesity prevention initiative in children under 5 from a systems perspective.

PubMed

Owen, Brynle; Brown, Andrew D; Kuhlberg, Jill; Millar, Lynne; Nichols, Melanie; Economos, Christina; Allender, Steven

2018-01-01

Systems thinking represents an innovative and logical approach to understanding complexity in community-based obesity prevention interventions. We report on an approach to apply systems thinking to understand the complexity of a successful obesity prevention intervention in early childhood (children aged up to 5 years) conducted in a regional city in Victoria, Australia. A causal loop diagram (CLD) was developed to represent system elements related to a successful childhood obesity prevention intervention in early childhood. Key stakeholder interviews (n = 16) were examined retrospectively to generate purposive text data, create microstructures, and form a CLD. A CLD representing key stakeholder perceptions of a successful intervention comprised six key feedback loops explaining changes in project implementation over time. The loops described the dynamics of collaboration, network formation, community awareness, human resources, project clarity, and innovation. The CLD developed provides a replicable means to capture, evaluate and disseminate a description of the dynamic elements of a successful obesity prevention intervention in early childhood.

Using intervention mapping to develop a home-based parental-supervised toothbrushing intervention for young children.

PubMed

Gray-Burrows, K A; Day, P F; Marshman, Z; Aliakbari, E; Prady, S L; McEachan, R R C

2016-05-06

Dental caries in young children is a major public health problem impacting on the child and their family in terms of pain, infection and substantial financial burden on healthcare funders. In the UK, national guidance on the prevention of dental caries advises parents to supervise their child's brushing with fluoride toothpaste until age 7. However, there is a dearth of evidence-based interventions to encourage this practice in parents. The current study used intervention mapping (IM) to develop a home-based parental-supervised toothbrushing intervention to reduce dental caries in young children. The intervention was developed using the six key stages of the IM protocol: (1) needs assessment, including a systematic review, qualitative interviews, and meetings with a multi-disciplinary intervention development group; (2) identification of outcomes and change objectives following identification of the barriers to parental-supervised toothbrushing (PSB), mapped alongside psychological determinants outlined in the Theoretical Domains Framework (TDF); (3) selection of methods and practical strategies; (4) production of a programme plan; (5) adoption and implementation and (6) Evaluation. The comprehensive needs assessment highlighted key barriers to PSB, such as knowledge, skills, self-efficacy, routine setting and behaviour regulation and underlined the importance of individual, social and structural influences. Parenting skills (routine setting and the ability to manage the behaviour of a reluctant child) were emphasised as critical to the success of PSB. The multi-disciplinary intervention development group highlighted the need for both universal and targeted programmes, which could be implemented within current provision. Two intervention pathways were developed: a lower cost universal pathway utilising an existing national programme and an intensive targeted programme delivered via existing parenting programmes. A training manual was created to accompany each intervention to ensure knowledge and standardise implementation procedures. PSB is a complex behaviour and requires intervention across individual, social and structural levels. IM, although a time-consuming process, allowed us to capture this complexity and allowed us to develop two community-based intervention pathways covering both universal and targeted approaches, which can be integrated into current provision. Further research is needed to evaluate the acceptability and sustainability of these interventions.

Effects of a Conversation Intervention on the Expressive Vocabulary Development of Prekindergarten Children

ERIC Educational Resources Information Center

Ruston, Hilary P.; Schwanenflugel, Paula J.

2010-01-01

Purpose: The purpose of this study was to determine the effectiveness of a conversation intervention including 500 min of linguistically and cognitively complex talk on the expressive vocabulary growth of prekindergarten children. Method: Children (N = 73) were randomly assigned to control or a 10-week experimental intervention condition. Twice…

A Complex Quest: The Development and Research of Underachievement Interventions for Gifted Students

ERIC Educational Resources Information Center

Rubenstein, Lisa Davia; Siegle, Del; Reis, Sally M.; Mccoach, D. Betsy; Burton, Meredith Greene

2012-01-01

The seeming lack of motivation of many academically gifted students is an area of frustration and concern for many parents, teachers, and psychologists. This article explores two studies in which researchers designed interventions to improve academic achievement. Both interventions were created using the Achievement-Orientation Model. The first…

Mass Drug Administration and beyond: how can we strengthen health systems to deliver complex interventions to eliminate neglected tropical diseases?

PubMed

Macpherson, Eleanor E; Adams, Emily R; Bockarie, Moses J; Hollingsworth, T Deirdre; Kelly-Hope, Louise A; Lehane, Mike; Kovacic, Vanja; Harrison, Robert A; Paine, Mark Ji; Reimer, Lisa J; Torr, Stephen J

2015-01-01

Achieving the 2020 goals for Neglected Tropical Diseases (NTDs) requires scale-up of Mass Drug Administration (MDA) which will require long-term commitment of national and global financing partners, strengthening national capacity and, at the community level, systems to monitor and evaluate activities and impact. For some settings and diseases, MDA is not appropriate and alternative interventions are required. Operational research is necessary to identify how existing MDA networks can deliver this more complex range of interventions equitably. The final stages of the different global programmes to eliminate NTDs require eliminating foci of transmission which are likely to persist in complex and remote rural settings. Operational research is required to identify how current tools and practices might be adapted to locate and eliminate these hard-to-reach foci. Chronic disabilities caused by NTDs will persist after transmission of pathogens ceases. Development and delivery of sustainable services to reduce the NTD-related disability is an urgent public health priority. LSTM and its partners are world leaders in developing and delivering interventions to control vector-borne NTDs and malaria, particularly in hard-to-reach settings in Africa. Our experience, partnerships and research capacity allows us to serve as a hub for developing, supporting, monitoring and evaluating global programmes to eliminate NTDs.

Applying Behavior Change Theories and Qualitative Methods in Substance Misuse Implementation Research: Conceptualizing the Adoption of Breaking Free Online in Real-World Clinical Practice.

PubMed

Dugdale, Stephanie; Elison, Sarah; Davies, Glyn; Ward, Jonathan

2017-06-01

There is insufficient research examining the implementation of complex novel interventions within health care. This may be due to a lack of qualitative research providing subjective insights into these implementation processes. The authors investigate the advantages of applying behavior change theories to conceptualize qualitative data describing the processes of implementation of complex interventions. Breaking Free Online (BFO), a digital treatment intervention for substance misuse, is described as an example of a complex intervention. The authors review previous qualitative research which explored initial diffusion, or spread, of the BFO program, and its subsequent normalization as part of standard treatment for substance misuse within the health and social care charity, "Change, Grow, Live" (CGL). The use of behavior change models to structure qualitative interview findings enabled identification of facilitators and barriers to the use of BFO within CGL. These findings have implications for the development of implementation research in novel health care interventions.

Treatment of complex dissociative disorders: a comparison of interventions reported by community therapists versus those recommended by experts.

PubMed

Myrick, Amie C; Chasson, Gregory S; Lanius, Ruth A; Leventhal, Barry; Brand, Bethany L

2015-01-01

There is a paucity of empirical data to assist clinicians in choosing interventions to use with patients with complex dissociative disorder (DD; i.e., dissociative identity disorder and dissociative disorder not otherwise specified) at different stages in treatment. This study compared interventions used by a sample of international outpatient therapists treating DD clients in the 1st 2 stages of treatment with those recommended by expert DD therapists. There were many similarities between therapists' and experts' interventions, including the use of several emotion regulation and dissociation-focused interventions. However, community therapists reported significantly less focus on relationally oriented interventions, teaching and using grounding and containment skills, and stabilizing patients after revictimization by alleged perpetrators. This study has important implications for the development and implementation of training opportunities for DD therapists.

Patient-centred communication intervention study to evaluate nurse-patient interactions in complex continuing care

PubMed Central

2012-01-01

Background Communication impairment is a frequent consequence of stroke. Patients who cannot articulate their needs respond with frustration and agitation, resulting in poor optimization of post-stroke functions. A key component of patient-centred care is the ability of staff to communicate in a way that allows them to understand the patient’s needs. We developed a patient-centred communication intervention targeting registered and unregulated nursing staff caring for complex continuing care patients with communication impairments post stroke. Research objectives include 1) examining the effects of the intervention on patients’ quality of life, depression, satisfaction with care, and agitation; and (2) examining the extent to which the intervention improves staff’s attitudes and knowledge in caring for patients with communication impairments. The intervention builds on a previous pilot study. Methods/design A quasi-experimental repeated measures non-equivalent control group design in a complex continuing care facility is being used. Patients with a communication impairment post-stroke admitted to the facility are eligible to participate. All staff nurses are eligible. Baseline data are collected from staff and patients. Follow-up will occur at 1 and 3 months post-intervention. Subject recruitment and data collection from 60 patients and 30 staff will take approximately 36 months. The Patient-Centred Communication Intervention consists of three components: (1) development of an individualized patient communication care plan; (2) a one-day workshop focused on communication and behavioural management strategies for nursing staff; and (3) a staff support system. The intervention takes comprehensive patient assessments into account to inform the development of communication and behavioural strategies specifically tailored to each patient. Discussion The Patient-Centred Communication Intervention will provide staff with strategies to facilitate interactions with patients and to minimize agitation associated with considerable stress. The improvement of these interactions will lead to a reduction of agitation, which has the additional significance of increasing patients’ well-being, quality of life, and satisfaction with care. Trial registration ClinicalTrials.gov Identifier NCT01654029 PMID:23050517

MAP-IT: A Practical Tool for Planning Complex Behavior Modification Interventions.

PubMed

Hansen, Sylvia; Kanning, Martina; Lauer, Romy; Steinacker, Jürgen M; Schlicht, Wolfgang

2017-09-01

Health research often aims to prevent noncommunicable diseases and to improve individual and public health by discovering intervention strategies that are effective in changing behavior and/or environments that are detrimental to one's health. Ideally, findings from original research support practitioners in planning and implementing effective interventions. Unfortunately, interventions often fail to overcome the translational block between science and practice. They often ignore theoretical knowledge, overlook empirical evidence, and underrate the impact of the environment. Accordingly, sustainable changes in individual behavior and/or the environment are difficult to achieve. Developing theory-driven and evidence-based interventions in the real world is a complex task. Existing implementation frameworks and theories often do not meet the needs of health practitioners. The purpose of this article is to synthesize existing frameworks and to provide a tool, the Matrix Assisting Practitioner's Intervention Planning Tool (MAP-IT), that links research to practice and helps practitioners to design multicomponent interventions. In this article, we use physical activity of older adults as an example to explain the rationale of MAP-IT. In MAP-IT, individual as well as environmental mechanisms are listed and behavior change techniques are linked to these mechanisms and to intervention components. MAP-IT is theory-driven and evidence-based. It is time-saving and helpful for practitioners when planning complex interventions.

Tailoring Healthy Workplace Interventions to Local Healthcare Settings: A Complexity Theory-Informed Workplace of Well-Being Framework

PubMed Central

Brand, Sarah L.; Fleming, Lora E.; Wyatt, Katrina M.

2015-01-01

Many healthy workplace interventions have been developed for healthcare settings to address the consistently low scores of healthcare professionals on assessments of mental and physical well-being. Complex healthcare settings present challenges for the scale-up and spread of successful interventions from one setting to another. Despite general agreement regarding the importance of the local setting in affecting intervention success across different settings, there is no consensus on what it is about a local setting that needs to be taken into account to design healthy workplace interventions appropriate for different local settings. Complexity theory principles were used to understand a workplace as a complex adaptive system and to create a framework of eight domains (system characteristics) that affect the emergence of system-level behaviour. This Workplace of Well-being (WoW) framework is responsive and adaptive to local settings and allows a shared understanding of the enablers and barriers to behaviour change by capturing local information for each of the eight domains. We use the results of applying the WoW framework to one workplace, a UK National Health Service ward, to describe the utility of this approach in informing design of setting-appropriate healthy workplace interventions that create workplaces conducive to healthy behaviour change. PMID:26380358

Tailoring Healthy Workplace Interventions to Local Healthcare Settings: A Complexity Theory-Informed Workplace of Well-Being Framework.

PubMed

Brand, Sarah L; Fleming, Lora E; Wyatt, Katrina M

2015-01-01

Many healthy workplace interventions have been developed for healthcare settings to address the consistently low scores of healthcare professionals on assessments of mental and physical well-being. Complex healthcare settings present challenges for the scale-up and spread of successful interventions from one setting to another. Despite general agreement regarding the importance of the local setting in affecting intervention success across different settings, there is no consensus on what it is about a local setting that needs to be taken into account to design healthy workplace interventions appropriate for different local settings. Complexity theory principles were used to understand a workplace as a complex adaptive system and to create a framework of eight domains (system characteristics) that affect the emergence of system-level behaviour. This Workplace of Well-being (WoW) framework is responsive and adaptive to local settings and allows a shared understanding of the enablers and barriers to behaviour change by capturing local information for each of the eight domains. We use the results of applying the WoW framework to one workplace, a UK National Health Service ward, to describe the utility of this approach in informing design of setting-appropriate healthy workplace interventions that create workplaces conducive to healthy behaviour change.

Systematic evaluation of implementation fidelity of complex interventions in health and social care

PubMed Central

2010-01-01

Background Evaluation of an implementation process and its fidelity can give insight into the 'black box' of interventions. However, a lack of standardized methods for studying fidelity and implementation process have been reported, which might be one reason for the fact that few prior studies in the field of health service research have systematically evaluated interventions' implementation processes. The aim of this project is to systematically evaluate implementation fidelity and possible factors influencing fidelity of complex interventions in health and social care. Methods A modified version of The Conceptual Framework for Implementation Fidelity will be used as a conceptual model for the evaluation. The modification implies two additional moderating factors: context and recruitment. A systematic evaluation process was developed. Multiple case study method is used to investigate implementation of three complex health service interventions. Each case will be investigated in depth and longitudinally, using both quantitative and qualitative methods. Discussion This study is the first attempt to empirically test The Conceptual Framework for Implementation Fidelity. The study can highlight mechanism and factors of importance when implementing complex interventions. Especially the role of the moderating factors on implementation fidelity can be clarified. Trial Registration Supported Employment, SE, among people with severe mental illness -- a randomized controlled trial: NCT00960024. PMID:20815872

A psychological approach to providing self-management education for people with type 2 diabetes: the Diabetes Manual

PubMed Central

Sturt, Jackie; Taylor, Hafrun; Docherty, Andrea; Dale, Jeremy; Louise, Taylor

2006-01-01

Background The objectives of this study were twofold (i) to develop the Diabetes Manual, a self-management educational intervention aimed at improving biomedical and psychosocial outcomes (ii) to produce early phase evidence relating to validity and clinical feasibility to inform future research and systematic reviews. Methods Using the UK Medical Research Council's complex intervention framework, the Diabetes Manual and associated self management interventions were developed through pre-clinical, and phase I evaluation phases guided by adult-learning and self-efficacy theories, clinical feasibility and health policy protocols. A qualitative needs assessment and an RCT contributed data to the pre-clinical phase. Phase I incorporated intervention development informed by the pre-clinical phase and a feasibility survey. Results The pre-clinical and phase I studies resulted in the production in the Diabetes Manual programme for trial evaluation as delivered within routine primary care consultations. Conclusion This complex intervention shows early feasibility and face validity for both diabetes health professionals and people with diabetes. Randomised trial will determine effectiveness against clinical and psychological outcomes. Further study of some component parts, delivered in alternative combinations, is recommended. PMID:17129376

Violence, violence prevention, and safety: a research agenda for South Africa.

PubMed

Ward, Catherine L; Artz, Lillian; Berg, Julie; Boonzaier, Floretta; Crawford-Browne, Sarah; Dawes, Andrew; Foster, Donald; Matzopoulos, Richard; Nicol, Andrew; Seekings, Jeremy; Van As, Arjan B Sebastian; Van der Spuy, Elrena

2012-03-07

Violence is a serious problem in South Africa with many effects on health services; it presents complex research problems and requires interdisciplinary collaboration. Two key meta-questions emerge: (i) violence must be understood better to develop effective interventions; and (ii) intervention research (evaluating interventions, assessing efficacy and effectiveness, how best to scale up interventions in resource-poor settings) is necessary. A research agenda to address violence is proposed.

Enhancing communication in surgery through team training interventions: a systematic literature review.

PubMed

Gillespie, Brigid M; Chaboyer, Wendy; Murray, Patrick

2010-12-01

In surgery, up to 70% of adverse events are attributable to failures in communication. The purpose of this systematic literature review was to critically assess the results of team training interventions used in the OR. In the 12 studies that met the inclusion criteria, there were statistically significant before-and-after improvements in teamwork practices and in some secondary outcomes such as complication rates. Our findings suggest that team training interventions have utility in enhancing team communication and cohesion. Team training interventions that are developed in response to the nuances of the context are more likely to become embedded in clinical practice. The introduction of more complex interventions has implications for resources and staffing. Further research is needed to identify and evaluate strategies that address the sustainability of complex team training interventions across multiple OR contexts. Published by Elsevier Inc. All rights reserved.

Developing an active implementation model for a chronic disease management program.

PubMed

Smidth, Margrethe; Christensen, Morten Bondo; Olesen, Frede; Vedsted, Peter

2013-04-01

Introduction and diffusion of new disease management programs in healthcare is usually slow, but active theory-driven implementation seems to outperform other implementation strategies. However, we have only scarce evidence on the feasibility and real effect of such strategies in complex primary care settings where municipalities, general practitioners and hospitals should work together. The Central Denmark Region recently implemented a disease management program for chronic obstructive pulmonary disease (COPD) which presented an opportunity to test an active implementation model against the usual implementation model. The aim of the present paper is to describe the development of an active implementation model using the Medical Research Council's model for complex interventions and the Chronic Care Model. We used the Medical Research Council's five-stage model for developing complex interventions to design an implementation model for a disease management program for COPD. First, literature on implementing change in general practice was scrutinised and empirical knowledge was assessed for suitability. In phase I, the intervention was developed; and in phases II and III, it was tested in a block- and cluster-randomised study. In phase IV, we evaluated the feasibility for others to use our active implementation model. The Chronic Care Model was identified as a model for designing efficient implementation elements. These elements were combined into a multifaceted intervention, and a timeline for the trial in a randomised study was decided upon in accordance with the five stages in the Medical Research Council's model; this was captured in a PaTPlot, which allowed us to focus on the structure and the timing of the intervention. The implementation strategies identified as efficient were use of the Breakthrough Series, academic detailing, provision of patient material and meetings between providers. The active implementation model was tested in a randomised trial (results reported elsewhere). The combination of the theoretical model for complex interventions and the Chronic Care Model and the chosen specific implementation strategies proved feasible for a practice-based active implementation model for a chronic-disease-management-program for COPD. Using the Medical Research Council's model added transparency to the design phase which further facilitated the process of implementing the program. http://www.clinicaltrials.gov/(NCT01228708).

What theory, for whom and in which context? Reflections on the application of theory in the development and evaluation of complex population health interventions.

PubMed

Moore, Graham F; Evans, Rhiannon E

2017-12-01

Recent years have seen a growing emphasis on the value of building and testing middle range theory throughout the development and evaluation of complex population health interventions. We agree that a coherent theoretical basis for intervention development, and use of evaluation to test key causal assumptions and build theory, are crucial. However, in this editorial, we argue that such recommendations have often been operationalised in somewhat simplistic terms with potentially perverse consequences, and that an uncritical assumption that an intervention explicitly based on theory is inherently superior carries significant risks. We first argue that the drive for theory-based approaches may have exacerbated a propensity to select 'off-the-shelf' theories, leading to the selection of inappropriate theories which distract attention from the mechanisms through which a problem is actually sustained. Second, we discuss a tendency toward over-reliance on individual-level theorising. Finally, we discuss the relatively slow progress of population health intervention research in attending to issues of context, and the ecological fit of interventions with the systems whose functioning they attempt to change. We argue that while researchers should consider a broad range of potential theoretical perspectives on a given population health problem, citing a popular off-the-shelf theory as having informed an intervention and its evaluation does not inherently make for better science. Before identifying or developing a theory of change, researchers should develop a clear understanding of how the problem under consideration is created and sustained in context. A broader conceptualisation of theory that reaches across disciplines is vital if theory is to enhance, rather than constrain, the contribution of intervention research. Finally, intervention researchers need to move away from viewing interventions as discrete packages of components which can be described in isolation from their contexts, and better understand the systems into which change is being introduced.

Development, modelling, and pilot testing of a complex intervention to support end-of-life care provided by Danish general practitioners.

PubMed

Winthereik, Anna Kirstine; Neergaard, Mette Asbjoern; Jensen, Anders Bonde; Vedsted, Peter

2018-06-20

Most patients in end-of-life with life-threatening diseases prefer to be cared for and die at home. Nevertheless, the majority die in hospitals. GPs have a pivotal role in providing end-of-life care at patients' home, and their involvement in the palliative trajectory enhances the patient's possibility to stay at home. The aim of this study was to develop and pilot-test an intervention consisting of continuing medical education (CME) and electronic decision support (EDS) to support end-of-life care in general practice. We developed an intervention in line with the first phases of the guidelines for complex interventions drawn up by the Medical Research Council. Phase 1 involved the development of the intervention including identification of key barriers to provision of end-of-life care for GPs and of facilitators of change. Furthermore the actual modelling of two components: CME meeting and EDS. Phase 2 focused on pilot-testing and intervention assessment by process evaluation. In phase 1 lack of identification of patients at the end of life and limited palliative knowledge among GPs were identified as barriers. The CME meeting and the EDS were developed. The CME meeting was a four-hour educational meeting performed by GPs and specialists in palliative care. The EDS consisted of two parts: a pop-up window for each patient with palliative needs and a list of all patients with palliative needs in the practice. The pilot testing in phase 2 showed that the CME meeting was performed as intended and 120 (14%) of the GPs in the region attended. The EDS was integrated in existing electronic records but was shut down early for external reasons; 50 (5%) GPs signed up. The pilot-testing demonstrated a need to strengthen the implementation as attending rate was low in the current set-up. We developed a complex intervention to support GPs in providing end-of-life care. The pilot-test showed general acceptance of the CME meetings. The EDS was shut down early and needs further evaluation before examining the whole intervention in a larger study, where evaluation could be based on patient-related outcomes and impact on end-of-life care. Clinicaltrials.gov ( NCT02050256 ) January 30, 2014.

Modeling the Complexities of Water and Hygiene in Limpopo Province South Africa

NASA Astrophysics Data System (ADS)

Mellor, J. E.; Smith, J. A.; Learmonth, G.; Netshandama, V.; Dillingham, R.

2012-12-01

Access to sustainable water and sanitation services is one of the biggest challenges the developing world faces as an increasing number of people inhabit those areas. Inadequate access to water and sanitation infrastructure often leads children to drink poor quality water which can result in early childhood diarrhea (ECD). Repeated episodes of ECD can cause serious problems such as growth stunting, cognitive impairment, and even death. Although researchers have long studied the connection between poor access to water and hygiene facilities and ECD, most studies have relied on intervention-control methods to study the effects of singular interventions. Such studies are time-consuming, costly, and fail to acknowledge that the causes and prevention strategies for ECD are numerous and complex. An alternate approach is to think of a community as a complex system in which the engineered, natural and social environments interact in ways that are not easily predicted. Such complex systems have no central or coordinating mechanism and may exhibit emergent behavior which can be counterintuitive and lead to valuable insights. The goal of this research is to develop a robust, quantitative understanding of the complex pathogen transmission chain that leads to ECD. To realize this goal, we have developed an Agent-Based Model (ABM) which simulates individual community member behavior. We have validated this transdisciplinary model with four years of field data from a community in Limpopo Province, South Africa. Our model incorporates data such as household water source preferences, collection habits, household- and source-water quality, water-source reliability and biological regrowth. Our outcome measures are household water quality, ECD incidences, and child growth stunting. This technique allows us to test hypotheses on the computer. Future researchers can implement promising interventions with our partner institution, the University of Venda, and the model can be refined as the results of those interventions become available. Our model accurately reproduces current pathogen transport through the communities and child growth stunting. An intensive sensitivity analysis found that biological regrowth, biofilm layers and collection habits are all factors in pathogen transmission. We also report on the effects of multiple interventions and our exploration of emergent behavior. Our results indicate that the dominant source of fecal-oral transmission is through the contamination of drinking water after collection, but before consumption. Furthermore sub-optimal interventions such as improved, but still inconsistent water treatment have little protective effect against ECD. Finally, interventions such as the introduction of point-of-use water treatment technologies or improved water-storage practices are the best ECD prevention strategies. The complexities of the causes and prevention strategies of pathogen loading and ECD in the developing world are poorly understood. This project goes beyond previous studies through its ability to model the complex engineered/natural/social pathogen transmission chain using an ABM informed by field data. We hope that this and similar tools may be used by scientists, policy-makers and humanitarian organizations when designing community-level interventions to prevent ECD in similar settings around the world.

Using the Medical Research Council framework to develop a complex intervention to improve delivery of care for young people with type 1 diabetes.

PubMed

Eiser, C; Johnson, B; Brierley, S; Ayling, K; Young, V; Bottrell, K; Whitehead, V; Elliott, J; Scott, A; Heller, S

2013-06-01

We describe how we have used the development phase of the Medical Research Council (MRC) Guidelines to construct a complex intervention to improve physical and psychological health among young people (16-21 years) with Type 1 diabetes. We consulted previous reviews where available and conducted systematic searches of electronic databases to determine physical and mental health among the population, audited medical records, surveyed self-reported psychological health among our clinic population; and interviewed staff (n = 13), young people (n = 27) and parents (n = 18) about their views of current care. Our audit (n = 96) confirmed a high HbA1c [86 mmol/mol (10.0%)] and one third (36.1%) reported significant eating problems. Young people did not attend 12% of their clinic appointments. Staff described difficulties communicating with young people who wanted staff to take account of their individual lifestyle when giving information. Based on the findings of the systematic reviews and our audit, we concluded that there was sufficient evidence to justify development of a model of care specific to this age group. The components of the complex intervention include changes to standard care, an optional 5-day self-management course directed at young people and a separate family communication programme. The MRC Guidelines provided a valuable structure to guide development and evaluation of this intervention. © 2013 The Authors. Diabetic Medicine © 2013 Diabetes UK.

Service user experiences of REFOCUS: a process evaluation of a pro-recovery complex intervention.

PubMed

Wallace, Genevieve; Bird, Victoria; Leamy, Mary; Bacon, Faye; Le Boutillier, Clair; Janosik, Monika; MacPherson, Rob; Williams, Julie; Slade, Mike

2016-09-01

Policy is increasingly focused on implementing a recovery-orientation within mental health services, yet the subjective experience of individuals receiving a pro-recovery intervention is under-studied. The aim of this study was to explore the service user experience of receiving a complex, pro-recovery intervention (REFOCUS), which aimed to encourage the use of recovery-supporting tools and support recovery-promoting relationships. Interviews (n = 24) and two focus groups (n = 13) were conducted as part of a process evaluation and included a purposive sample of service users who received the complex, pro-recovery intervention within the REFOCUS randomised controlled trial (ISRCTN02507940). Thematic analysis was used to analyse the data. Participants reported that the intervention supported the development of an open and collaborative relationship with staff, with new conversations around values, strengths and goals. This was experienced as hope-inspiring and empowering. However, others described how the recovery tools were used without context, meaning participants were unclear of their purpose and did not see their benefit. During the interviews, some individuals struggled to report any new tasks or conversations occurring during the intervention. Recovery-supporting tools can support the development of a recovery-promoting relationship, which can contribute to positive outcomes for individuals. The tools should be used in a collaborative and flexible manner. Information exchanged around values, strengths and goals should be used in care-planning. As some service users struggled to report their experience of the intervention, alternative evaluation approaches need to be considered if the service user experience is to be fully captured.

Communication with young people in paediatric and adult endocrine consultations: an intervention development and feasibility study.

PubMed

Downing, J; Gleeson, H; Clayton, P E; Davis, J R E; Dimitri, P; Wales, J; Young, B; Callery, P

2017-06-15

Communication is complex in endocrine care, particularly during transition from paediatric to adult services. The aims of this study were to examine the feasibility of interventions to support young people to interact with clinicians. Development and evaluation of a complex intervention in 2 phases: Pre-intervention observational study; Intervention feasibility study. Purposive sample of recordings of 62 consultations with 58 young people aged 11-25 years with long-term endocrine conditions in two paediatric and two adult endocrine clinics. Proportion of time talked during consultations, number and direction of questions asked; Paediatric Consultation Assessment Tool (PCAT); OPTION shared decision making tool; Medical Information Satisfaction Scale (MISS- 21). Young people were invited to use one or more of: a prompt sheet to help them influence consultation agendas and raise questions; a summary sheet to record key information; and the www.explain.me.uk website. Nearly two thirds of young people (63%) chose to use at least one communication intervention. Higher ratings for two PCAT items (95% CI 0.0 to 1.1 and 0.1 to 1.7) suggest interventions can support consultation skills. A higher proportion of accompanying persons (83%) than young people (64%) directed questions to clinicians. The proportion of young people asking questions was higher (84%) in the intervention phase than in the observation phase (71%). Interventions were acceptable and feasible. The Intervention phase was associated with YP asking more questions, which implies that the availability of interventions could promote interactivity.

Research design issues for evaluating complex multicomponent interventions in neighborhoods and communities.

PubMed

Komro, Kelli A; Flay, Brian R; Biglan, Anthony; Wagenaar, Alexander C

2016-03-01

Major advances in population health will not occur unless we translate existing knowledge into effective multicomponent interventions, implement and maintain these in communities, and develop rigorous translational research and evaluation methods to ensure continual improvement and sustainability. We discuss challenges and offer approaches to evaluation that are key for translational research stages 3 to 5 to advance optimized adoption, implementation, and maintenance of effective and replicable multicomponent strategies. The major challenges we discuss concern (a) multiple contexts of evaluation/research, (b) complexity of packages of interventions, and (c) phases of evaluation/research questions. We suggest multiple alternative research designs that maintain rigor but accommodate these challenges and highlight the need for measurement systems. Longitudinal data collection and a standardized continuous measurement system are fundamental to the evaluation and refinement of complex multicomponent interventions. To be useful to T3-T5 translational research efforts in neighborhoods and communities, such a system would include assessments of the reach, implementation, effects on immediate outcomes, and effects of the comprehensive intervention package on more distal health outcomes.

Development of a behaviour change intervention: a case study on the practical application of theory.

PubMed

Porcheret, Mark; Main, Chris; Croft, Peter; McKinley, Robert; Hassell, Andrew; Dziedzic, Krysia

2014-04-03

Use of theory in implementation of complex interventions is widely recommended. A complex trial intervention, to enhance self-management support for people with osteoarthritis (OA) in primary care, needed to be implemented in the Managing Osteoarthritis in Consultations (MOSAICS) trial. One component of the trial intervention was delivery by general practitioners (GPs) of an enhanced consultation for patients with OA. The aim of our case study is to describe the systematic selection and use of theory to develop a behaviour change intervention to implement GP delivery of the enhanced consultation. The development of the behaviour change intervention was guided by four theoretical models/frameworks: i) an implementation of change model to guide overall approach, ii) the Theoretical Domains Framework (TDF) to identify relevant determinants of change, iii) a model for the selection of behaviour change techniques to address identified determinants of behaviour change, and iv) the principles of adult learning. Methods and measures to evaluate impact of the behaviour change intervention were identified. The behaviour change intervention presented the GPs with a well-defined proposal for change; addressed seven of the TDF domains (e.g., knowledge, skills, motivation and goals); incorporated ten behaviour change techniques (e.g., information provision, skills rehearsal, persuasive communication); and was delivered in workshops that valued the expertise and professional values of GPs. The workshops used a mixture of interactive and didactic sessions, were facilitated by opinion leaders, and utilised 'context-bound communication skills training.' Methods and measures selected to evaluate the behaviour change intervention included: appraisal of satisfaction with workshops, GP report of intention to practise and an assessment of video-recorded consultations of GPs with patients with OA. A stepped approach to the development of a behaviour change intervention, with the utilisation of theoretical frameworks to identify determinants of change matched with behaviour change techniques, has enabled a systematic and theory-driven development of an intervention designed to enhance consultations by GPs for patients with OA. The success of the behaviour change intervention in practice will be evaluated in the context of the MOSAICS trial as a whole, and will inform understanding of practice level and patient outcomes in the trial.

Improving Collaborative Behaviour Planning in Adult Auditory Rehabilitation: Development of the I-PLAN Intervention Using the Behaviour Change Wheel.

PubMed

Barker, Fiona; Lusignan, Simon de; Deborah, Cooke

2018-05-18

The consequences of poorly managed hearing loss can be ameliorated with hearing aid use but rates of use are sub-optimal. The impact of audiologist behaviour on subsequent use, particularly over the long term, is unknown. This study aimed to describe the role of the behaviour change wheel in developing an intervention to introduce and embed particular clinical behaviours into adult hearing aid fitting consultations, within the framework of the Medical Research Council guidance on complex interventions. Following the steps of the behaviour change wheel, audiologist behaviours that might influence hearing aid use were identified based on a systematic review and qualitative work with audiologists. An analysis, using the COM-B model, identified potential drivers of the target behaviours. This was used to select intervention functions and behaviour change techniques likely to influence behaviour in this context. The target behaviours were as follows: giving information about the benefits of hearing aid use and the negative consequences of non-use, providing prompts for use and engaging in collaborative behavioural planning for use. The behavioural analysis suggested that psychological capability, opportunity and motivation were potential drivers of these behaviours. The intervention functions of education, coercion, training, environmental restructuring, modelling and enablement were selected and combined to develop a single complex intervention that seeks to address the target behaviours.

Implementation of a school-based social and emotional learning intervention: understanding diffusion processes within complex systems.

PubMed

Evans, Rhiannon; Murphy, Simon; Scourfield, Jonathan

2015-07-01

Sporadic and inconsistent implementation remains a significant challenge for social and emotional learning (SEL) interventions. This may be partly explained by the dearth of flexible, causative models that capture the multifarious determinants of implementation practices within complex systems. This paper draws upon Rogers (2003) Diffusion of Innovations Theory to explain the adoption, implementation and discontinuance of a SEL intervention. A pragmatic, formative process evaluation was conducted in alignment with phase 1 of the UK Medical Research Council's framework for Developing and Evaluating Complex Interventions. Employing case-study methodology, qualitative data were generated with four socio-economically and academically contrasting secondary schools in Wales implementing the Student Assistance Programme. Semi-structured interviews were conducted with 15 programme stakeholders. Data suggested that variation in implementation activity could be largely attributed to four key intervention reinvention points, which contributed to the transformation of the programme as it interacted with contextual features and individual needs. These reinvention points comprise the following: intervention training, which captures the process through which adopters acquire knowledge about a programme and delivery expertise; intervention assessment, which reflects adopters' evaluation of an intervention in relation to contextual needs; intervention clarification, which comprises the cascading of knowledge through an organisation in order to secure support in delivery; and intervention responsibility, which refers to the process of assigning accountability for sustainable delivery. Taken together, these points identify opportunities to predict and intervene with potential implementation problems. Further research would benefit from exploring additional reinvention activity.

Integrating Evidence From Systematic Reviews, Qualitative Research, and Expert Knowledge Using Co-Design Techniques to Develop a Web-Based Intervention for People in the Retirement Transition

PubMed Central

O'Brien, Nicola; Heaven, Ben; Teal, Gemma; Evans, Elizabeth H; Cleland, Claire; Moffatt, Suzanne; Sniehotta, Falko F; White, Martin; Mathers, John C

2016-01-01

Background Integrating stakeholder involvement in complex health intervention design maximizes acceptability and potential effectiveness. However, there is little methodological guidance about how to integrate evidence systematically from various sources in this process. Scientific evidence derived from different approaches can be difficult to integrate and the problem is compounded when attempting to include diverse, subjective input from stakeholders. Objective The intent of the study was to describe and appraise a systematic, sequential approach to integrate scientific evidence, expert knowledge and experience, and stakeholder involvement in the co-design and development of a complex health intervention. The development of a Web-based lifestyle intervention for people in retirement is used as an example. Methods Evidence from three systematic reviews, qualitative research findings, and expert knowledge was compiled to produce evidence statements (stage 1). Face validity of these statements was assessed by key stakeholders in a co-design workshop resulting in a set of intervention principles (stage 2). These principles were assessed for face validity in a second workshop, resulting in core intervention concepts and hand-drawn prototypes (stage 3). The outputs from stages 1-3 were translated into a design brief and specification (stage 4), which guided the building of a functioning prototype, Web-based intervention (stage 5). This prototype was de-risked resulting in an optimized functioning prototype (stage 6), which was subject to iterative testing and optimization (stage 7), prior to formal pilot evaluation. Results The evidence statements (stage 1) highlighted the effectiveness of physical activity, dietary and social role interventions in retirement; the idiosyncratic nature of retirement and well-being; the value of using specific behavior change techniques including those derived from the Health Action Process Approach; and the need for signposting to local resources. The intervention principles (stage 2) included the need to facilitate self-reflection on available resources, personalization, and promotion of links between key lifestyle behaviors. The core concepts and hand-drawn prototypes (stage 3) had embedded in them the importance of time use and work exit planning, personalized goal setting, and acceptance of a Web-based intervention. The design brief detailed the features and modules required (stage 4), guiding the development of wireframes, module content and functionality, virtual mentors, and intervention branding (stage 5). Following an iterative process of intervention testing and optimization (stage 6), the final Web-based intervention prototype of LEAP (Living, Eating, Activity, and Planning in retirement) was produced (stage 7). The approach was resource intensive and required a multidisciplinary team. The design expert made an invaluable contribution throughout the process. Conclusions Our sequential approach fills an important methodological gap in the literature, describing the stages and techniques useful in developing an evidence-based complex health intervention. The systematic and rigorous integration of scientific evidence, expert knowledge and experience, and stakeholder input has resulted in an intervention likely to be acceptable and feasible. PMID:27489143

Integrating Evidence From Systematic Reviews, Qualitative Research, and Expert Knowledge Using Co-Design Techniques to Develop a Web-Based Intervention for People in the Retirement Transition.

PubMed

O'Brien, Nicola; Heaven, Ben; Teal, Gemma; Evans, Elizabeth H; Cleland, Claire; Moffatt, Suzanne; Sniehotta, Falko F; White, Martin; Mathers, John C; Moynihan, Paula

2016-08-03

Integrating stakeholder involvement in complex health intervention design maximizes acceptability and potential effectiveness. However, there is little methodological guidance about how to integrate evidence systematically from various sources in this process. Scientific evidence derived from different approaches can be difficult to integrate and the problem is compounded when attempting to include diverse, subjective input from stakeholders. The intent of the study was to describe and appraise a systematic, sequential approach to integrate scientific evidence, expert knowledge and experience, and stakeholder involvement in the co-design and development of a complex health intervention. The development of a Web-based lifestyle intervention for people in retirement is used as an example. Evidence from three systematic reviews, qualitative research findings, and expert knowledge was compiled to produce evidence statements (stage 1). Face validity of these statements was assessed by key stakeholders in a co-design workshop resulting in a set of intervention principles (stage 2). These principles were assessed for face validity in a second workshop, resulting in core intervention concepts and hand-drawn prototypes (stage 3). The outputs from stages 1-3 were translated into a design brief and specification (stage 4), which guided the building of a functioning prototype, Web-based intervention (stage 5). This prototype was de-risked resulting in an optimized functioning prototype (stage 6), which was subject to iterative testing and optimization (stage 7), prior to formal pilot evaluation. The evidence statements (stage 1) highlighted the effectiveness of physical activity, dietary and social role interventions in retirement; the idiosyncratic nature of retirement and well-being; the value of using specific behavior change techniques including those derived from the Health Action Process Approach; and the need for signposting to local resources. The intervention principles (stage 2) included the need to facilitate self-reflection on available resources, personalization, and promotion of links between key lifestyle behaviors. The core concepts and hand-drawn prototypes (stage 3) had embedded in them the importance of time use and work exit planning, personalized goal setting, and acceptance of a Web-based intervention. The design brief detailed the features and modules required (stage 4), guiding the development of wireframes, module content and functionality, virtual mentors, and intervention branding (stage 5). Following an iterative process of intervention testing and optimization (stage 6), the final Web-based intervention prototype of LEAP (Living, Eating, Activity, and Planning in retirement) was produced (stage 7). The approach was resource intensive and required a multidisciplinary team. The design expert made an invaluable contribution throughout the process. Our sequential approach fills an important methodological gap in the literature, describing the stages and techniques useful in developing an evidence-based complex health intervention. The systematic and rigorous integration of scientific evidence, expert knowledge and experience, and stakeholder input has resulted in an intervention likely to be acceptable and feasible.

Fidelity in complex behaviour change interventions: a standardised approach to evaluate intervention integrity

PubMed Central

Mars, Tom; Ellard, David; Carnes, Dawn; Homer, Kate; Underwood, Martin; Taylor, Stephanie J C

2013-01-01

Objectives The aim of this study was to (1) demonstrate the development and testing of tools and procedures designed to monitor and assess the integrity of a complex intervention for chronic pain (COping with persistent Pain, Effectiveness Research into Self-management (COPERS) course); and (2) make recommendations based on our experiences. Design Fidelity assessment of a two-arm randomised controlled trial intervention, assessing the adherence and competence of the facilitators delivering the intervention. Setting The intervention was delivered in the community in two centres in the UK: one inner city and one a mix of rural and urban locations. Participants 403 people with chronic musculoskeletal pain were enrolled in the intervention arm and 300 attended the self-management course. Thirty lay and healthcare professionals were trained and 24 delivered the courses (2 per course). We ran 31 courses for up to 16 people per course and all were audio recorded. Interventions The course was run over three and a half days; facilitators delivered a semistructured manualised course. Outcomes We designed three measures to evaluate fidelity assessing adherence to the manual, competence and overall impression. Results We evaluated a random sample of four components from each course (n=122). The evaluation forms were reliable and had good face validity. There were high levels of adherence in the delivery: overall adherence was two (maximum 2, IQR 1.67–2.00), facilitator competence exhibited more variability, and overall competence was 1.5 (maximum 2, IQR 1.25–2.00). Overall impression was three (maximum 4, IQR 2.00–3.00). Conclusions Monitoring and assessing adherence and competence at the point of intervention delivery can be realised most efficiently by embedding the principles of fidelity measurement within the design stage of complex interventions and the training and assessment of those delivering the intervention. More work is necessary to ensure that more robust systems of fidelity evaluation accompany the growth of complex interventions. Trial Registration ISRCTN No ISRCTN24426731. PMID:24240140

Developing and implementing a complex Complementary and Alternative (CAM) nursing intervention for breast and gynecologic cancer patients undergoing chemotherapy--report from the CONGO (complementary nursing in gynecologic oncology) study.

PubMed

Klafke, Nadja; Mahler, Cornelia; von Hagens, Cornelia; Blaser, Gisela; Bentner, Martina; Joos, Stefanie

2016-05-01

The purpose of this study was to develop a complex nursing intervention including complementary and alternative medicine (CAM) for breast and gynecologic cancer patients during chemotherapy to improve quality of life. Data sources Theoretical framework and concepts, practical nursing knowledge, and evidence-based studies were compiled in interprofessional meetings. Data synthesis The final complex intervention consists of three autonomous, but interacting components: (1) CAM nursing package, (2) resource-oriented counseling, and (3) evidence-based information material on CAM. CAM interventions include acupressure, aromatherapy, compress, and massage, targeting 14 clinically relevant symptoms during chemotherapy. Participants receive these interventions during chemotherapy with instructions for self care. During a counseling interview, the patient's needs and preferences are assessed by trained nurses. Furthermore, participants are equipped with evidence-based information material (booklet and DVD). Prior to study start, nurses attended training modules for administering CAM therapies and for communicating and counseling within the salutogenic approach. It was possible to design a multimodal CAM nursing intervention based on a theoretical concept, evidence-based studies, and practical nursing experience targeting the prevention or relief of side-effects women suffer during chemotherapy. The systematic analysis of the CONGO study will contribute to evidence-based CAM nursing care within supportive cancer care. Oncology nurses play an important role in supportive CAM care of breast and gynecologic cancer patients in daily clinical practice. Within oncology outpatient services, the implementation of evidence-based CAM nursing interventions and counseling may contribute to understand the impact of nursing on patient quality of life and symptom relief. This can lead to a new understanding of the nurse's professional role.

Analysis of Complex Intervention Effects in Time-Series Experiments.

ERIC Educational Resources Information Center

Bower, Cathleen

An iterative least squares procedure for analyzing the effect of various kinds of intervention in time-series data is described. There are numerous applications of this design in economics, education, and psychology, although until recently, no appropriate analysis techniques had been developed to deal with the model adequately. This paper…

Written Language Expression: Assessment Instruments and Teacher Tools

ERIC Educational Resources Information Center

Penner-Williams, Janet; Smith, Tom E. C.; Gartin, Barbara C.

2009-01-01

Written language is a complex set of skills that facilitate communication and that are developed in a predictable sequence. It is therefore possible to analyze current skills, identify deficits, plan interventions, and determine the effectiveness of the intervention. To effectively accomplish these tasks, educators need to choose appropriate…

Development and preliminary testing of a web-based, self-help application for disaster-affected families

PubMed Central

Yuen, Erica K; Gros, Kirstin; Welsh, Kyleen E; McCauley, Jenna; Resnick, Heidi S; Danielson, Carla K; Price, Matthew; Ruggiero, Kenneth J

2015-01-01

Technology-based self-help interventions have the potential to increase access to evidence-based mental healthcare, especially for families affected by natural disasters. However, development of these interventions is a complex process and poses unique challenges. Usability testing, which assesses the ability of individuals to use an application successfully, can have a significant impact on the quality of a self-help intervention. This article describes (a) the development of a novel web-based multi-module self-help intervention for disaster-affected adolescents and their parents and (b) a mixed-methods formal usability study to evaluate user response. A total of 24 adolescents were observed, videotaped, and interviewed as they used the depressed mood component of the self-help intervention. Quantitative results indicated an above-average user experience, and qualitative analysis identified 120 unique usability issues. We discuss the challenges of developing self-help applications, including design considerations and the value of usability testing in technology-based interventions, as well as our plan for widespread dissemination. PMID:25933798

Developing Internet-Based Health Interventions: A Guide for Public Health Researchers and Practitioners

PubMed Central

Ecklund, Alexandra M; Hunt, Shanda L; Nelson, Toben F; Toomey, Traci L

2015-01-01

Background Researchers and practitioners interested in developing online health interventions most often rely on Web-based and print resources to guide them through the process of online intervention development. Although useful for understanding many aspects of best practices for website development, missing from these resources are concrete examples of experiences in online intervention development for health apps from the perspective of those conducting online health interventions. Objective This study aims to serve as a series of case studies in the development of online health interventions to provide insights for researchers and practitioners who are considering technology-based interventional or programmatic approaches. Methods A convenience sample of six study coordinators and five principal investigators at a large, US-based land grant university were interviewed about the process of developing online interventions in the areas of alcohol policy, adolescent health, medication adherence, and human immunodeficiency virus prevention in transgender persons and in men who have sex with men. Participants were asked questions that broadly addressed each of the four phases of the User-Centered Design Process Map from the US Department of Health and Human Services' Research-Based Web Design & Usability Guidelines. Interviews were audio recorded and transcribed. Qualitative codes were developed using line-by-line open coding for all transcripts, and all transcripts were coded independently by at least 2 authors. Differences among coders were resolved with discussion. Results We identified the following seven themes: (1) hire a strong (or at least the right) research team, (2) take time to plan before beginning the design process, (3) recognize that vendors and researchers have differing values, objectives, and language, (4) develop a detailed contract, (5) document all decisions and development activities, (6) use a content management system, and (7) allow extra time for testing and debugging your intervention. Each of these areas is discussed in detail, with supporting quotations from principal investigators and study coordinators. Conclusions The values held by members of each participating organization involved in the development of the online intervention or program, as well as the objectives that are trying to be met with the website, must be considered. These defined values and objectives should prompt an open and explicit discussion about the scope of work, budget, and other needs from the perspectives of each organization. Because of the complexity of developing online interventions, researchers and practitioners should become familiar with the process and how it may differ from the development and implementation of in-person interventions or programs. To assist with this, the intervention team should consider expanding the team to include experts in computer science or learning technologies, as well as taking advantage of institutional resources that will be needed for successful completion of the project. Finally, we describe the tradeoff between funds available for online intervention or program development and the complexity of the project. PMID:25650702

Developing Internet-based health interventions: a guide for public health researchers and practitioners.

PubMed

Horvath, Keith J; Ecklund, Alexandra M; Hunt, Shanda L; Nelson, Toben F; Toomey, Traci L

2015-01-23

Researchers and practitioners interested in developing online health interventions most often rely on Web-based and print resources to guide them through the process of online intervention development. Although useful for understanding many aspects of best practices for website development, missing from these resources are concrete examples of experiences in online intervention development for health apps from the perspective of those conducting online health interventions. This study aims to serve as a series of case studies in the development of online health interventions to provide insights for researchers and practitioners who are considering technology-based interventional or programmatic approaches. A convenience sample of six study coordinators and five principal investigators at a large, US-based land grant university were interviewed about the process of developing online interventions in the areas of alcohol policy, adolescent health, medication adherence, and human immunodeficiency virus prevention in transgender persons and in men who have sex with men. Participants were asked questions that broadly addressed each of the four phases of the User-Centered Design Process Map from the US Department of Health and Human Services' Research-Based Web Design & Usability Guidelines. Interviews were audio recorded and transcribed. Qualitative codes were developed using line-by-line open coding for all transcripts, and all transcripts were coded independently by at least 2 authors. Differences among coders were resolved with discussion. We identified the following seven themes: (1) hire a strong (or at least the right) research team, (2) take time to plan before beginning the design process, (3) recognize that vendors and researchers have differing values, objectives, and language, (4) develop a detailed contract, (5) document all decisions and development activities, (6) use a content management system, and (7) allow extra time for testing and debugging your intervention. Each of these areas is discussed in detail, with supporting quotations from principal investigators and study coordinators. The values held by members of each participating organization involved in the development of the online intervention or program, as well as the objectives that are trying to be met with the website, must be considered. These defined values and objectives should prompt an open and explicit discussion about the scope of work, budget, and other needs from the perspectives of each organization. Because of the complexity of developing online interventions, researchers and practitioners should become familiar with the process and how it may differ from the development and implementation of in-person interventions or programs. To assist with this, the intervention team should consider expanding the team to include experts in computer science or learning technologies, as well as taking advantage of institutional resources that will be needed for successful completion of the project. Finally, we describe the tradeoff between funds available for online intervention or program development and the complexity of the project.

Intervention description is not enough: evidence from an in-depth multiple case study on the untold role and impact of context in randomised controlled trials of seven complex interventions

PubMed Central

2012-01-01

Background A number of single case reports have suggested that the context within which intervention studies take place may challenge the assumptions that underpin randomised controlled trials (RCTs). However, the diverse ways in which context may challenge the central tenets of the RCT, and the degree to which this information is known to researchers or subsequently reported, has received much less attention. In this paper, we explore these issues by focusing on seven RCTs of interventions varying in type and degree of complexity, and across diverse contexts. Methods This in-depth multiple case study using interviews, focus groups and documentary analysis was conducted in two phases. In phase one, a RCT of a nurse-led intervention provided a single exploratory case and informed the design, sampling and data collection within the main study. Phase two consisted of a multiple explanatory case study covering a spectrum of trials of different types of complex intervention. A total of eighty-four data sources across the seven trials were accessed. Results We present consistent empirical evidence across all trials to indicate that four key elements of context (personal, organisational, trial and problem context) are crucial to understanding how a complex intervention works and to enable both assessments of internal validity and likely generalisability to other settings. The ways in which context challenged trial operation was often complex, idiosyncratic, and subtle; often falling outside of current trial reporting formats. However, information on such issues appeared to be available via first hand ‘insider accounts’ of each trial suggesting that improved reporting on the role of context is possible. Conclusions Sufficient detail about context needs to be understood and reported in RCTs of complex interventions, in order for the transferability of complex interventions to be assessed. Improved reporting formats that require and encourage the clarification of both general and project-specific threats to the likely internal and external validity need to be developed. In addition, a cultural change is required in which the open and honest reporting of such issues is seen as an indicator of study strength and researcher integrity, rather than a symbol of a poor quality study or investigator ability. PMID:22742939

Developing a theoretical framework for complex community-based interventions.

PubMed

Angeles, Ricardo N; Dolovich, Lisa; Kaczorowski, Janusz; Thabane, Lehana

2014-01-01

Applying existing theories to research, in the form of a theoretical framework, is necessary to advance knowledge from what is already known toward the next steps to be taken. This article proposes a guide on how to develop a theoretical framework for complex community-based interventions using the Cardiovascular Health Awareness Program as an example. Developing a theoretical framework starts with identifying the intervention's essential elements. Subsequent steps include the following: (a) identifying and defining the different variables (independent, dependent, mediating/intervening, moderating, and control); (b) postulating mechanisms how the independent variables will lead to the dependent variables; (c) identifying existing theoretical models supporting the theoretical framework under development; (d) scripting the theoretical framework into a figure or sets of statements as a series of hypotheses, if/then logic statements, or a visual model; (e) content and face validation of the theoretical framework; and (f) revising the theoretical framework. In our example, we combined the "diffusion of innovation theory" and the "health belief model" to develop our framework. Using the Cardiovascular Health Awareness Program as the model, we demonstrated a stepwise process of developing a theoretical framework. The challenges encountered are described, and an overview of the strategies employed to overcome these challenges is presented.

Using qualitative comparative analysis (QCA) in systematic reviews of complex interventions: a worked example.

PubMed

Thomas, James; O'Mara-Eves, Alison; Brunton, Ginny

2014-06-20

Systematic reviews that address policy and practice questions in relation to complex interventions frequently need not only to assess the efficacy of a given intervention but to identify which intervention - and which intervention components - might be most effective in particular situations. Here, intervention replication is rare, and commonly used synthesis methods are less useful when the focus of analysis is the identification of those components of an intervention that are critical to its success. Having identified initial theories of change in a previous analysis, we explore the potential of qualitative comparative analysis (QCA) to assist with complex syntheses through a worked example. Developed originally in the area of political science and historical sociology, a QCA aims to identify those configurations of participant, intervention and contextual characteristics that may be associated with a given outcome. Analysing studies in these terms facilitates the identification of necessary and sufficient conditions for the outcome to be obtained. Since QCA is predicated on the assumption that multiple pathways might lead to the same outcome and does not assume a linear additive model in terms of changes to a particular condition (that is, it can cope with 'tipping points' in complex interventions), it appears not to suffer from some of the limitations of the statistical methods often used in meta-analysis. The worked example shows how the QCA reveals that our initial theories of change were unable to distinguish between 'effective' and 'highly effective' interventions. Through the iterative QCA process, other intervention characteristics are identified that better explain the observed results. QCA is a promising alternative (or adjunct), particularly to the standard fall-back of a 'narrative synthesis' when a quantitative synthesis is impossible, and should be considered when reviews are broad and heterogeneity is significant. There are very few examples of its use with systematic review data at present, and further methodological work is needed to establish optimal conditions for its use and to document process, practice, and reporting standards.

A systematic grounded approach to the development of complex interventions: the Australian WorkHealth Program--arthritis as a case study.

PubMed

Reavley, Nicola; Livingston, Jenni; Buchbinder, Rachelle; Bennell, Kim; Stecki, Chris; Osborne, Richard Harry

2010-02-01

Despite demands for evidence-based research and practice, little attention has been given to systematic approaches to the development of complex interventions to tackle workplace health problems. This paper outlines an approach to the initial stages of a workplace program development which integrates health promotion and disease management. The approach commences with systematic and genuine processes of obtaining information from key stakeholders with broad experience of these interventions. This information is constructed into a program framework in which practice-based and research-informed elements are both valued. We used this approach to develop a workplace education program to reduce the onset and impact of a common chronic disease - osteoarthritis. To gain information systematically at a national level, a structured concept mapping workshop with 47 participants from across Australia was undertaken. Participants were selected to maximise the whole-of-workplace perspective and included health education providers, academics, clinicians and policymakers. Participants generated statements in response to a seeding statement: Thinking as broadly as possible, what changes in education and support should occur in the workplace to help in the prevention and management of arthritis? Participants grouped the resulting statements into conceptually coherent groups and a computer program was used to generate a 'cluster map' along with a list of statements sorted according to cluster membership. In combination with research-based evidence, the concept map informed the development of a program logic model incorporating the program's guiding principles, possible service providers, services, training modes, program elements and the causal processes by which participants might benefit. The program logic model components were further validated through research findings from diverse fields, including health education, coaching, organisational learning, workplace interventions, workforce development and osteoarthritis disability prevention. In summary, wide and genuine consultation, concept mapping, and evidence-based program logic development were integrated to develop a whole-of-system complex intervention in which potential effectiveness and assimilation into the workplace for which optimised. Copyright 2009 Elsevier Ltd. All rights reserved.

Metacognition in speech and language therapy for children with social (pragmatic) communication disorders: implications for a theory of therapy.

PubMed

Gaile, Jacqueline; Adams, Catherine

2018-01-01

Metacognition is a significant component of complex interventions for children who have developmental language disorders. Research into how metacognition operates in the content or process of developmental language therapy delivery is limited. Identification and description of proposed active therapy components, such as metacognition, may contribute to our understanding of how to deliver complex communication interventions in an optimal manner. To analyse aspects of metacognition during therapy derived from a manualized speech and language intervention (the Social Communication Intervention Programme-SCIP) as delivered to children who have social (pragmatic) communication disorder (SPCD) and to examine the dynamic process of delivering therapy. A purposive sample of eight filmed therapy sessions was selected from the video data corpus of intervention-arm participants within a randomized controlled trial. The child-therapist interactions during therapy sessions from five children (aged between 5;11 and 10;3) in the SCIP trial were transcribed. Filmed sessions represented a variety of communication profiles and SCIP therapy content. Starting from existing theory on metacognition, cycles of iterative analysis were performed using a mixed inductive-deductive qualitative analysis. A preliminary list of metacognitive content embedded in the intervention was developed into a metacognitive coding framework (MCF). A thematic analysis of the identified metacognitive content of the intervention was then carried out across the whole sample. Thematic analysis revealed the presence of metacognition in the content and delivery of SCIP intervention. Four main themes of metacognitive person, task and strategy knowledge, and monitoring/control were identified. Metacognition was a feature of how children's ability to monitor language, pragmatic and social interaction skills, in themselves and other people, was developed. Task design and delivery methods were found to play a particular role in adjusting the metacognitive content of the therapy activities. This study makes explicit the metacognitive content and delivery within a complex developmental communication intervention. Discussion of the findings about metacognitive content provides an explanation of how the skilled speech and language therapist manipulates task demands, person knowledge and therapy methods towards the therapy goal. Clinical applications of the metacognitive framework are discussed. We suggest that the process of making the tacit knowledge of the therapist explicit can contribute to the implementation of complex evidence-based interventions. © 2017 Royal College of Speech and Language Therapists.

Behaviour change in overweight and obese pregnancy: a decision tree to support the development of antenatal lifestyle interventions.

PubMed

Ainscough, Kate M; Lindsay, Karen L; O'Sullivan, Elizabeth J; Gibney, Eileen R; McAuliffe, Fionnuala M

2017-10-01

Antenatal healthy lifestyle interventions are frequently implemented in overweight and obese pregnancy, yet there is inconsistent reporting of the behaviour-change methods and behavioural outcomes. This limits our understanding of how and why such interventions were successful or not. The current paper discusses the application of behaviour-change theories and techniques within complex lifestyle interventions in overweight and obese pregnancy. The authors propose a decision tree to help guide researchers through intervention design, implementation and evaluation. The implications for adopting behaviour-change theories and techniques, and using appropriate guidance when constructing and evaluating interventions in research and clinical practice are also discussed. To enhance the evidence base for successful behaviour-change interventions during pregnancy, adoption of behaviour-change theories and techniques, and use of published guidelines when designing lifestyle interventions are necessary. The proposed decision tree may be a useful guide for researchers working to develop effective behaviour-change interventions in clinical settings. This guide directs researchers towards key literature sources that will be important in each stage of study development.

Brief Report: Does Gender Matter in Intervention for ASD? Examining the Impact of the PEERS® Social Skills Intervention on Social Behavior among Females with ASD

ERIC Educational Resources Information Center

McVey, Alana J.; Schiltz, Hillary; Haendel, Angela; Dolan, Bridget K.; Willar, Kirsten S.; Pleiss, Sheryl; Karst, Jeffrey S.; Carson, Audrey M.; Caiozzo, Christina; Vogt, Elisabeth; Van Hecke, Amy Vaughan

2017-01-01

A paucity of research has been conducted to examine the effect of social skills intervention on females with ASD. Females with ASD may have more difficulty developing meaningful friendships than males, as the social climate can be more complex (Archer, Coyne, "Personality and Social Psychology Review" 9(3):212-230, 2005). This study…

Implementing a complex rehabilitation intervention in a stroke trial: a qualitative process evaluation of AVERT.

PubMed

Luker, Julie A; Craig, Louise E; Bennett, Leanne; Ellery, Fiona; Langhorne, Peter; Wu, Olivia; Bernhardt, Julie

2016-05-10

The implementation of multidisciplinary stroke rehabilitation interventions is challenging, even when the intervention is evidence-based. Very little is known about the implementation of complex interventions in rehabilitation clinical trials. The aim of study was to better understand how the implementation of a rehabilitation intervention in a clinical trial within acute stroke units is experienced by the staff involved. This qualitative process evaluation was part of a large Phase III stroke rehabilitation trial (AVERT). A descriptive qualitative approach was used. We purposively sampled 53 allied health and nursing staff from 19 acute stroke units in Australia, New Zealand and Scotland. Semi-structured interviews were conducted by phone, voice-internet, or face to face. Digitally recorded interviews were transcribed and analysed by two researchers using rigorous thematic analysis. Our analysis uncovered ten important themes that provide insight into the challenges of implementing complex new rehabilitation practices within complex care settings, plus factors and strategies that assisted implementation. Themes were grouped into three main categories: staff experience of implementing the trial intervention, barriers to implementation, and overcoming the barriers. Participation in the trial was challenging but had personal rewards and improved teamwork at some sites. Over the years that the trial ran some staff perceived a change in usual care. Barriers to trial implementation at some sites included poor teamwork, inadequate staffing, various organisational barriers, staff attitudes and beliefs, and patient-related barriers. Participants described successful implementation strategies that were built on interdisciplinary teamwork, education and strong leadership to 'get staff on board', and developing different ways of working. The AVERT stroke rehabilitation trial required commitment to deliver an intervention that needed strong collaboration between nurses and physiotherapists and was different to current care models. This qualitative process evaluation contributes unique insights into factors that may be critical to successful trials teams, and as AVERT was a pragmatic trial, success factors to delivering complex intervention in clinical practice. AVERT registered with Australian New Zealand Clinical Trials Registry ACTRN12606000185561 .

Developing an active implementation model for a chronic disease management program

PubMed Central

Smidth, Margrethe; Christensen, Morten Bondo; Olesen, Frede; Vedsted, Peter

2013-01-01

Background Introduction and diffusion of new disease management programs in healthcare is usually slow, but active theory-driven implementation seems to outperform other implementation strategies. However, we have only scarce evidence on the feasibility and real effect of such strategies in complex primary care settings where municipalities, general practitioners and hospitals should work together. The Central Denmark Region recently implemented a disease management program for chronic obstructive pulmonary disease (COPD) which presented an opportunity to test an active implementation model against the usual implementation model. The aim of the present paper is to describe the development of an active implementation model using the Medical Research Council’s model for complex interventions and the Chronic Care Model. Methods We used the Medical Research Council’s five-stage model for developing complex interventions to design an implementation model for a disease management program for COPD. First, literature on implementing change in general practice was scrutinised and empirical knowledge was assessed for suitability. In phase I, the intervention was developed; and in phases II and III, it was tested in a block- and cluster-randomised study. In phase IV, we evaluated the feasibility for others to use our active implementation model. Results The Chronic Care Model was identified as a model for designing efficient implementation elements. These elements were combined into a multifaceted intervention, and a timeline for the trial in a randomised study was decided upon in accordance with the five stages in the Medical Research Council’s model; this was captured in a PaTPlot, which allowed us to focus on the structure and the timing of the intervention. The implementation strategies identified as efficient were use of the Breakthrough Series, academic detailing, provision of patient material and meetings between providers. The active implementation model was tested in a randomised trial (results reported elsewhere). Conclusion The combination of the theoretical model for complex interventions and the Chronic Care Model and the chosen specific implementation strategies proved feasible for a practice-based active implementation model for a chronic-disease-management-program for COPD. Using the Medical Research Council’s model added transparency to the design phase which further facilitated the process of implementing the program. Trial registration: http://www.clinicaltrials.gov/(NCT01228708). PMID:23882169

Development and formative evaluation of an innovative mHealth intervention for improving coverage of community-based maternal, newborn and child health services in rural areas of India

PubMed Central

Modi, Dhiren; Gopalan, Ravi; Shah, Shobha; Venkatraman, Sethuraman; Desai, Gayatri; Desai, Shrey; Shah, Pankaj

2015-01-01

Background A new cadre of village-based frontline health workers, called Accredited Social Health Activists (ASHAs), was created in India. However, coverage of selected community-based maternal, newborn and child health (MNCH) services remains low. Objective This article describes the process of development and formative evaluation of a complex mHealth intervention (ImTeCHO) to increase the coverage of proven MNCH services in rural India by improving the performance of ASHAs. Design The Medical Research Council (MRC) framework for developing complex interventions was used. Gaps were identified in the usual care provided by ASHAs, based on a literature search, and SEWA Rural's1 three decades of grassroots experience. The components of the intervention (mHealth strategies) were designed to overcome the gaps in care. The intervention, in the form of the ImTeCHO mobile phone and web application, along with the delivery model, was developed to incorporate these mHealth strategies. The intervention was piloted through 45 ASHAs among 45 villages in Gujarat (population: 45,000) over 7 months in 2013 to assess the acceptability, feasibility, and usefulness of the intervention and to identify barriers to its delivery. Results Inadequate supervision and support to ASHAs were noted as a gap in usual care, resulting in low coverage of selected MNCH services and care received by complicated cases. Therefore, the ImTeCHO application was developed to integrate mHealth strategies in the form of job aid to ASHAs to assist with scheduling, behavior change communication, diagnosis, and patient management, along with supervision and support of ASHAs. During the pilot, the intervention and its delivery were found to be largely acceptable, feasible, and useful. A few changes were made to the intervention and its delivery, including 1) a new helpline for ASHAs, 2) further simplification of processes within the ImTeCHO incentive management system and 3) additional web-based features for enhancing value and supervision of Primary Health Center (PHC) staff. Conclusions The effectiveness of the improved ImTeCHO intervention will be now tested through a cluster randomized trial. PMID:25697233

Identifying novel interventional strategies for psychiatric disorders: integrating genomics, 'enviromics' and gene-environment interactions in valid preclinical models.

PubMed

McOmish, Caitlin E; Burrows, Emma L; Hannan, Anthony J

2014-10-01

Psychiatric disorders affect a substantial proportion of the population worldwide. This high prevalence, combined with the chronicity of the disorders and the major social and economic impacts, creates a significant burden. As a result, an important priority is the development of novel and effective interventional strategies for reducing incidence rates and improving outcomes. This review explores the progress that has been made to date in establishing valid animal models of psychiatric disorders, while beginning to unravel the complex factors that may be contributing to the limitations of current methodological approaches. We propose some approaches for optimizing the validity of animal models and developing effective interventions. We use schizophrenia and autism spectrum disorders as examples of disorders for which development of valid preclinical models, and fully effective therapeutics, have proven particularly challenging. However, the conclusions have relevance to various other psychiatric conditions, including depression, anxiety and bipolar disorders. We address the key aspects of construct, face and predictive validity in animal models, incorporating genetic and environmental factors. Our understanding of psychiatric disorders is accelerating exponentially, revealing extraordinary levels of genetic complexity, heterogeneity and pleiotropy. The environmental factors contributing to individual, and multiple, disorders also exhibit breathtaking complexity, requiring systematic analysis to experimentally explore the environmental mediators and modulators which constitute the 'envirome' of each psychiatric disorder. Ultimately, genetic and environmental factors need to be integrated via animal models incorporating the spatiotemporal complexity of gene-environment interactions and experience-dependent plasticity, thus better recapitulating the dynamic nature of brain development, function and dysfunction. © 2014 The British Pharmacological Society.

Extended use of the GuideLiner in complex coronary interventions.

PubMed

Chan, Pak Hei; Alegria-Barrero, Eduardo; Foin, Nicholas; Paulo, Manuel; Lindsay, Alistair C; Viceconte, Nicola; Di Mario, Carlo

2015-07-01

Challenging coronary anatomies including chronic total occlusions (CTO), extreme vessel tortuosity, diseased bypass grafts, and anomalous coronary arteries pose difficulties in coronary interventions. The GuideLiner is a monorail catheter originally developed to facilitate delivery of stents to target lesions in tortuous vessels. We conducted a study on the feasibility and safety of utilising this catheter in a wider array of complex coronary interventions. Consecutive patients undergoing coronary or peripheral interventions where a GuideLiner was used were recruited into this study. Patient demographics, lesion and vessel characteristics, procedural details and outcomes were prospectively entered into our database and analysed. From September 2009 to October 2011, 54 consecutive patients underwent coronary intervention in our institution using a GuideLiner; 21 out of 54 coronary applications were motivated by the need to increase support to cross CTOs, predominantly of the RCA. Anomalous or angulated take-off of the treatment vessels (31%), previously deployed proximal stents (15%), heavy proximal calcification (9%) and tortuosity (7%) accounted for the remaining reasons. One patient had successful renal denervation with the aid of a GuideLiner catheter. Procedural success was 98% in our series with no device-related periprocedural complications such as ostial dissection or myocardial necrosis. The use of a GuideLiner facilitates the approach to complex coronary interventions including chronic total occlusion and saphenous vein graft intervention by providing greater back-up support and easier engagement of coronary ostia.

Touch massage: a pilot study of a complex intervention.

PubMed

Lindgren, Lenita; Lehtipalo, Stefan; Winsö, Ola; Karlsson, Marcus; Wiklund, Urban; Brulin, Christine

2013-11-01

To report and evaluate a complex touch massage intervention according to the British Medical Research Council framework. This study aimed to evaluate the effects of touch massage on levels of anxiety and physiological stress in patients scheduled for elective aortic surgery. The use of touch massage has increased during the past decade but no systematic studies have been implemented to investigate the effectiveness of such treatment. It is important to conduct multidisciplinary investigations into the effects of complex interventions such as touch massage. For this, the British Medical Research Council has provided a useful framework to guide the development, piloting, evaluation and reporting of complex intervention studies. A pilot study with a randomized controlled design including 20 patients (10 + 10) scheduled for elective aortic surgery. Selected outcome parameters included; self-reported anxiety, measured by the State-Trait Anxiety Inventory Form Y instrument, and physiological stress, measured by heart rate variability, blood pressure, respiratory frequency, oxygen saturation and concentrations of cortisol, insulin and glucose in serum. There were significant differences in self-reported anxiety levels before and after touch massage (p = 0.007), this was not observed in the control group (p = 0.833). There was a significant difference in self-reported anxiety levels between the touch massage group and the control group after touch massage and rest (p = 0.001). There were no significant differences in physiological stress-related outcome parameters between patients who received touch massage and controls. In our study, touch massage decreased anxiety levels in patients scheduled for elective aortic surgery, and the British Medical Research Council framework was a useful guideline for the development, evaluation and reporting of a touch massage intervention. Touch massage can reduce patients' anxiety levels and is thus an important nursing intervention in intensive and post-operative care. © 2013 The Authors. Nursing in Critical Care © 2013 British Association of Critical Care Nurses.

Developing Seventh Grade Students' Understanding of Complex Environmental Problems with Systems Tools and Representations: A Quasi-Experimental Study

ERIC Educational Resources Information Center

Doganca Kucuk, Zerrin; Saysel, Ali Kerem

2018-01-01

A systems-based classroom intervention on environmental education was designed for seventh grade students; the results were evaluated to see its impact on the development of systems thinking skills and standard science achievement and whether the systems approach is a more effective way to teach environmental issues that are dynamic and complex. A…

El Ambiente del Nino (The Environment of the Child). Occasional Paper No. 6.

ERIC Educational Resources Information Center

Nunes, Terezinha

This Spanish-language report offers a framework for the analysis and evaluation of intervention on children's behalf against which to analyze actions upon their environment. The first section looks at the complex issue of defining suitable child development outcomes for intervention programs, noting that because the concept of childhood varies…

User Centered Reading Intervention for Individuals with Autism and Intellectual Disability.

PubMed

Yakkundi, Anita; Dillenburger, Karola; Goodman, Lizbeth; Dounavi, Katerina

2017-01-01

Individuals with autism and intellectual disability (ID) have complex learning needs and often have difficulty in acquiring reading comprehension skills using conventional teaching tools. Evidence based reading interventions for these learners and the use of assistive technology and application of behaviour analysis to develop user-centered teaching is discussed in this paper.

How can pharmacists develop patient-pharmacist communication skills? A realist review protocol.

PubMed

Kerr, Aisling; Strawbridge, Judith; Kelleher, Caroline; Mertens, Fien; Pype, Peter; Deveugele, Myriam; Pawlikowska, Teresa

2017-01-23

Good patient-pharmacist communication improves health outcomes. There is, however, room for improving pharmacists' communication skills. These develop through complex interactions during undergraduate pharmacy education, practice-based learning and continuing professional development. Research is needed to determine how best to approach teaching patient-pharmacist communication. The aim of the research is to understand how educational interventions develop patient-pharmacist interpersonal communication skills produce their effects. A realist review approach will be used to synthesise the literature to make sense of the complexities of educational interventions. Our review will iteratively progress through the various stages of clarifying scope, locating existing theories, searching for evidence, appraisal of papers, data extraction and synthesis. A scoping review revealed a number of substantive theories, which will be used to build an initial programme theory. This will be explored through available published evidence, which we will find by searching databases such as Medline, EMBASE, PsychInfo, ERIC, Scopus and Web of Science. Judgements will be made on the relevance and rigour of the retrieved literature and will be taken into consideration during analysis and synthesis. Synthesis, testing and refinement of the theories will describe and explain the links between contexts, mechanisms and outcomes of educational interventions for communication development in pharmacy. The realist review will provide an analysis of what works when, for whom, how and why, for educational interventions for interpersonal patient-pharmacist communication development. We will also explore barriers to successful communications training and acknowledge any limitations. Ultimately, we plan to provide pharmacy educators with evidence for how best to incorporate educational interventions for communications skills development into pharmacy curricula and for life-long learning opportunities for pharmacists.

Development of an exercise intervention for the prevention of musculoskeletal shoulder problems after breast cancer treatment: the prevention of shoulder problems trial (UK PROSPER).

PubMed

Richmond, Helen; Lait, Clare; Srikesavan, Cynthia; Williamson, Esther; Moser, Jane; Newman, Meredith; Betteley, Lauren; Fordham, Beth; Rees, Sophie; Lamb, Sarah E; Bruce, Julie

2018-06-18

Musculoskeletal shoulder problems are common after breast cancer treatment. There is some evidence to suggest that early postoperative exercise is safe and may improve shoulder function. We describe the development and delivery of a complex intervention for evaluation within a randomised controlled trial (RCT), designed to target prevention of musculoskeletal shoulder problems after breast cancer surgery (The Prevention of Shoulder Problems Trial; PROSPER). A pragmatic, multicentre RCT to compare the clinical and cost-effectiveness of best practice usual care versus a physiotherapy-led exercise and behavioural support intervention in women at high risk of shoulder problems after breast cancer treatment. PROSPER will recruit 350 women from approximately 15 UK centres, with follow-up at 6 and 12 months. The primary outcome is shoulder function at 12 months; secondary outcomes include postoperative pain, health related quality of life, adverse events and healthcare resource use. A multi-phased approach was used to develop the PROSPER intervention which was underpinned by existing evidence and modified for implementation after input from clinical experts and women with breast cancer. The intervention was tested and refined further after qualitative interviews with patients newly diagnosed with breast cancer; a pilot RCT was then conducted at three UK clinical centres. The PROSPER intervention incorporates three main components: shoulder-specific exercises targeting range of movement and strength; general physical activity; and behavioural strategies to encourage adherence and support exercise behaviour. The final PROSPER intervention is fully manualised with clear, documented pathways for clinical assessment, exercise prescription, use of behavioural strategies, and with guidance for treatment of postoperative complications. This paper adheres to TIDieR and CERT recommendations for the transparent, comprehensive and explicit reporting of complex interventions. International Standard Randomised Controlled Trial Number: ISRCTN 35358984 .

Increasing chlamydia screening tests in general practice: a modified Zelen prospective Cluster Randomised Controlled Trial evaluating a complex intervention based on the Theory of Planned Behaviour.

PubMed

McNulty, Cliodna A M; Hogan, Angela H; Ricketts, Ellie J; Wallace, Louise; Oliver, Isabel; Campbell, Rona; Kalwij, Sebastian; O'Connell, Elaine; Charlett, Andre

2014-05-01

To determine if a structured complex intervention increases opportunistic chlamydia screening testing of patients aged 15-24 years attending English general practitioner (GP) practices. A prospective, Cluster Randomised Controlled Trial with a modified Zelen design involving 160 practices in South West England in 2010. The intervention was based on the Theory of Planned Behaviour (TPB). It comprised of practice-based education with up to two additional contacts to increase the importance of screening to GP staff and their confidence to offer tests through skill development (including videos). Practical resources (targets, posters, invitation cards, computer reminders, newsletters including feedback) aimed to actively influence social cognitions of staff, increasing their testing intention. Data from 76 intervention and 81 control practices were analysed. In intervention practices, chlamydia screening test rates were 2.43/100 15-24-year-olds registered preintervention, 4.34 during intervention and 3.46 postintervention; controls testing rates were 2.61/100 registered patients prior intervention, 3.0 during intervention and 2.82 postintervention. During the intervention period, testing in intervention practices was 1.76 times as great (CI 1.24 to 2.48) as controls; this persisted for 9 months postintervention (1.57 times as great, CI 1.27 to 2.30). Chlamydia infections detected increased in intervention practices from 2.1/1000 registered 15-24-year-olds prior intervention to 2.5 during the intervention compared with 2.0 and 2.3/1000 in controls (Estimated Rate Ratio intervention versus controls 1.4 (CI 1.01 to 1.93). This complex intervention doubled chlamydia screening tests in fully engaged practices. The modified Zelen design gave realistic measures of practice full engagement (63%) and efficacy of this educational intervention in general practice; it should be used more often. The trial was registered on the UK Clinical Research Network Study Portfolio database. UKCRN number 9722.

Interventions Used by Nurse Preceptors to Develop Critical Thinking of New Graduate Nurses: A Systematic Review.

PubMed

Schuelke, Sue; Barnason, Susan

Healthcare complexity and patient acuity necessitate competent nurses with critical thinking abilities. However, these skill sets are less developed among newly hired graduate nurses. The overall purpose of this systematic review was to examine interventions/strategies implemented by preceptors in healthcare organizations to promote critical thinking of new graduate nurses. A systematic search of the literature resulted in 602 citations, with nine studies meeting the inclusion criteria. Educational interventions were varied and will be described in this article. Preceptor education was a key component in the studies reviewed.

Development of a behaviour change intervention: a case study on the practical application of theory

PubMed Central

2014-01-01

Background Use of theory in implementation of complex interventions is widely recommended. A complex trial intervention, to enhance self-management support for people with osteoarthritis (OA) in primary care, needed to be implemented in the Managing Osteoarthritis in Consultations (MOSAICS) trial. One component of the trial intervention was delivery by general practitioners (GPs) of an enhanced consultation for patients with OA. The aim of our case study is to describe the systematic selection and use of theory to develop a behaviour change intervention to implement GP delivery of the enhanced consultation. Methods The development of the behaviour change intervention was guided by four theoretical models/frameworks: i) an implementation of change model to guide overall approach, ii) the Theoretical Domains Framework (TDF) to identify relevant determinants of change, iii) a model for the selection of behaviour change techniques to address identified determinants of behaviour change, and iv) the principles of adult learning. Methods and measures to evaluate impact of the behaviour change intervention were identified. Results The behaviour change intervention presented the GPs with a well-defined proposal for change; addressed seven of the TDF domains (e.g., knowledge, skills, motivation and goals); incorporated ten behaviour change techniques (e.g., information provision, skills rehearsal, persuasive communication); and was delivered in workshops that valued the expertise and professional values of GPs. The workshops used a mixture of interactive and didactic sessions, were facilitated by opinion leaders, and utilised ‘context-bound communication skills training.’ Methods and measures selected to evaluate the behaviour change intervention included: appraisal of satisfaction with workshops, GP report of intention to practise and an assessment of video-recorded consultations of GPs with patients with OA. Conclusions A stepped approach to the development of a behaviour change intervention, with the utilisation of theoretical frameworks to identify determinants of change matched with behaviour change techniques, has enabled a systematic and theory-driven development of an intervention designed to enhance consultations by GPs for patients with OA. The success of the behaviour change intervention in practice will be evaluated in the context of the MOSAICS trial as a whole, and will inform understanding of practice level and patient outcomes in the trial. PMID:24708880

[Health services Research Faces New Challenges: Consequences for Definition and Concept].

PubMed

Schrappe, M; Pfaff, H

2016-11-01

In Germany, Health Services Research (HSR) is undergoing rapid and impressive development. Starting from the translation of methods in individual health care (efficacy-effectiveness gap) and the social-scientific description as well as analysis of health care structures and processes, now it is the implementation of complex interventions on the organizational and system level that is the center of interest. This development is mainly triggered by the establishment of the so-called innovation funds by means of legislation in 2015, which has the task to evaluate structural changes and reforms in outpatient and integrated health care. Moreover, benefit and improvement at patient and population level is getting attention. Against this background, in this paper the current definition of HSR is modified so that the term "intervention" is extended to include organizational and system interventions, the focus on population is added to the patient perspective, and the orientation to appropriateness of care and improvement is integrated. Parallel to this, the theoretical throughput model as established by Pfaff in 2003 is updated, including 4 aspects: (1) the input factors of first order (resources of stakeholders) are expanded by complex interventions and active context as input factors of second order, (2) both undergoing modulation during the following throughput, (3) the final outcome is expanded by the population perspective, and (4) feedback loops from output and outcome to input and throughput are established. The "double complexity" of intervention and context as well as their interaction during throughput is the central and most important issue, because the interventions are highly context-sensitive and the complex context is most potent and poorly anticipated at the same time. Improvement science and implementation research represent fields of research from the perspective of improvement and the translation of knowledge and change of attitude, respectively, which are of great importance for HSR. Insofar as HSR is dealing with improvement and translation of complex interventions, the health care politics constitute an important transfer factor itself. Considering that, in the present situation, the political level represents both the main sponsor and the main demander of HSR results, improving methodological standards and further expansion of research structures of HSR are urgently needed. © Georg Thieme Verlag KG Stuttgart · New York.

Seeing the forests and the trees—innovative approaches to exploring heterogeneity in systematic reviews of complex interventions to enhance health system decision-making: a protocol

PubMed Central

2014-01-01

Background To improve quality of care and patient outcomes, health system decision-makers need to identify and implement effective interventions. An increasing number of systematic reviews document the effects of quality improvement programs to assist decision-makers in developing new initiatives. However, limitations in the reporting of primary studies and current meta-analysis methods (including approaches for exploring heterogeneity) reduce the utility of existing syntheses for health system decision-makers. This study will explore the role of innovative meta-analysis approaches and the added value of enriched and updated data for increasing the utility of systematic reviews of complex interventions. Methods/Design We will use the dataset from our recent systematic review of 142 randomized trials of diabetes quality improvement programs to evaluate novel approaches for exploring heterogeneity. These will include exploratory methods, such as multivariate meta-regression analyses and all-subsets combinatorial meta-analysis. We will then update our systematic review to include new trials and enrich the dataset by surveying authors of all included trials. In doing so, we will explore the impact of variables not, reported in previous publications, such as details of study context, on the effectiveness of the intervention. We will use innovative analytical methods on the enriched and updated dataset to identify key success factors in the implementation of quality improvement interventions for diabetes. Decision-makers will be involved throughout to help identify and prioritize variables to be explored and to aid in the interpretation and dissemination of results. Discussion This study will inform future systematic reviews of complex interventions and describe the value of enriching and updating data for exploring heterogeneity in meta-analysis. It will also result in an updated comprehensive systematic review of diabetes quality improvement interventions that will be useful to health system decision-makers in developing interventions to improve outcomes for people with diabetes. Systematic review registration PROSPERO registration no. CRD42013005165 PMID:25115289

A complex breastfeeding promotion and support intervention in a developing country: study protocol for a randomized clinical trial

PubMed Central

2014-01-01

Background Breastfeeding has countless benefits to mothers, children and community at large, especially in developing countries. Studies from Lebanon report disappointingly low breastfeeding exclusivity and continuation rates. Evidence reveals that antenatal breastfeeding education, professional lactation support, and peer lay support are individually effective at increasing breastfeeding duration and exclusivity, particularly in low-income settings. Given the complex nature of the breastfeeding ecosystem and its barriers in Lebanon, we hypothesize that a complex breastfeeding support intervention, which is centered on the three components mentioned above, would significantly increase breastfeeding rates. Methods/Design A multi-center randomized controlled trial. Study population: 443 healthy pregnant women in their first trimester will be randomized to control or intervention group. Intervention: A “prenatal/postnatal” professional and peer breastfeeding support package continuing till 6 months postpartum, guided by the Social Network and Social Support Theory. Control group will receive standard prenatal and postnatal care. Mothers will be followed up from early pregnancy till five years after delivery. Outcome measures: Total and exclusive breastfeeding rates, quality of life at 1, 3 and 6 months postpartum, maternal breastfeeding knowledge and attitudes at 6 months postpartum, maternal exclusive breastfeeding rates of future infants up to five years from baseline, cost-benefit and cost-effectiveness analyses of the intervention. Statistical analysis: Descriptive and regression analysis will be conducted under the intention to treat basis using the most recent version of SPSS. Discussion Exclusive breastfeeding is a cost-effective public health measure that has a significant impact on infant morbidity and mortality. In a country with limited healthcare resources like Lebanon, developing an effective breastfeeding promotion and support intervention that is easily replicated across various settings becomes a priority. If positive, the results of this study would provide a generalizable model to bolster breastfeeding promotion efforts and contribute to improved child health in Lebanon and the Middle East and North Africa (MENA) region. Trial registration Current Controlled Trials ISRCTN17875591 PMID:24428951

Scaffolding the Communication of People With Congenital Deafblindness: An Analysis of Sequential Interaction Patterns.

PubMed

Damen, Saskia; Janssen, Marleen J; Ruijssenaars, Wied A; Schuengel, Carlo

2017-01-01

The High Quality Communication intervention aims to stimulate interpersonal communication between individuals with congenital deaf-blindness (CDB) and their social partners. Found effective in multiple-case experiments, the intervention is based on Trevarthen's theory of inter-subjective development (Bråten & Trevarthen, 2007), which describes children's innate and developing ability to share subjective states in interpersonal communication and social partners' mediating role in this development. One implication of this theory is that social partners can support the emergence of higher-complexity communication behaviors in individuals who are still developing these behaviors. To test this proposition, communication patterns between individuals with CDB and their parents, teachers, and professional caregivers were analyzed. Analysis of two-event sequences of communicative behaviors showed a highly significant correspondence between the behavior of the social partner and the subsequent behavior of the individual with CDB, confirming that social partners can scaffold higher-complexity communication within interpersonal communication.

Advancing the Science of Community-Level Interventions

PubMed Central

Beehler, Sarah; Deutsch, Charles; Green, Lawrence W.; Hawe, Penelope; McLeroy, Kenneth; Miller, Robin Lin; Rapkin, Bruce D.; Schensul, Jean J.; Schulz, Amy J.; Trimble, Joseph E.

2011-01-01

Community interventions are complex social processes that need to move beyond single interventions and outcomes at individual levels of short-term change. A scientific paradigm is emerging that supports collaborative, multilevel, culturally situated community interventions aimed at creating sustainable community-level impact. This paradigm is rooted in a deep history of ecological and collaborative thinking across public health, psychology, anthropology, and other fields of social science. The new paradigm makes a number of primary assertions that affect conceptualization of health issues, intervention design, and intervention evaluation. To elaborate the paradigm and advance the science of community intervention, we offer suggestions for promoting a scientific agenda, developing collaborations among professionals and communities, and examining the culture of science. PMID:21680923

Using the Behavior Change Technique Taxonomy v1 to conceptualize the clinical content of Breaking Free Online: a computer-assisted therapy program for substance use disorders.

PubMed

Dugdale, Stephanie; Ward, Jonathan; Hernen, Jan; Elison, Sarah; Davies, Glyn; Donkor, Daniel

2016-07-22

In recent years, research within the field of health psychology has made significant progress in terms of advancing and standardizing the science of developing, evaluating and reporting complex behavioral change interventions. A major part of this work has involved the development of an evidence-based Behavior Change Technique Taxonomy v1 (BCTTv1), as a means of describing the active components contained within such complex interventions. To date, however, this standardized approach derived from health psychology research has not been applied to the development of complex interventions for the treatment of substance use disorders (SUD). Therefore, this paper uses Breaking Free Online (BFO), a computer-assisted therapy program for SUD, as an example of how the clinical techniques contained within such an intervention might be mapped onto the BCTTv1. The developers of BFO were able to produce a full list of the clinical techniques contained within BFO. Exploratory mapping of the BCTTv1 onto the clinical content of the BFO program was conducted separately by the authors of the paper. This included the developers of the BFO program and psychology professionals working within the SUD field. These coded techniques were reviewed by the authors and any discrepancies in the coding were discussed between all authors until an agreement was reached. The BCTTv1 was mapped onto the clinical content of the BFO program. At least one behavioral change technique was found in 12 out of 16 grouping categories within the BCTTv1. A total of 26 out of 93 behavior change techniques were identified across the clinical content of the program. This exploratory mapping exercise has identified the specific behavior change techniques contained within BFO, and has provided a means of describing these techniques in a standardized way using the BCTTv1 terminology. It has also provided an opportunity for the BCTTv1 mapping process to be reported to the wider SUD treatment community, as it may have real utility in the development and evaluation of other psychosocial and behavioral change interventions within this field.

Managing Complexity in Evidence Analysis: A Worked Example in Pediatric Weight Management.

PubMed

Parrott, James Scott; Henry, Beverly; Thompson, Kyle L; Ziegler, Jane; Handu, Deepa

2018-05-02

Nutrition interventions are often complex and multicomponent. Typical approaches to meta-analyses that focus on individual causal relationships to provide guideline recommendations are not sufficient to capture this complexity. The objective of this study is to describe the method of meta-analysis used for the Pediatric Weight Management (PWM) Guidelines update and provide a worked example that can be applied in other areas of dietetics practice. The effects of PWM interventions were examined for body mass index (BMI), body mass index z-score (BMIZ), and waist circumference at four different time periods. For intervention-level effects, intervention types were identified empirically using multiple correspondence analysis paired with cluster analysis. Pooled effects of identified types were examined using random effects meta-analysis models. Differences in effects among types were examined using meta-regression. Context-level effects are examined using qualitative comparative analysis. Three distinct types (or families) of PWM interventions were identified: medical nutrition, behavioral, and missing components. Medical nutrition and behavioral types showed statistically significant improvements in BMIZ across all time points. Results were less consistent for BMI and waist circumference, although four distinct patterns of weight status change were identified. These varied by intervention type as well as outcome measure. Meta-regression indicated statistically significant differences between the medical nutrition and behavioral types vs the missing component type for both BMIZ and BMI, although the pattern varied by time period and intervention type. Qualitative comparative analysis identified distinct configurations of context characteristics at each time point that were consistent with positive outcomes among the intervention types. Although analysis of individual causal relationships is invaluable, this approach is inadequate to capture the complexity of dietetics practice. An alternative approach that integrates intervention-level with context-level meta-analyses may provide deeper understanding in the development of practice guidelines. Copyright © 2018 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

From bricks to buildings: adapting the Medical Research Council framework to develop programs of research in simulation education and training for the health professions.

PubMed

Haji, Faizal A; Da Silva, Celina; Daigle, Delton T; Dubrowski, Adam

2014-08-01

Presently, health care simulation research is largely conducted on a study-by-study basis. Although such "project-based" research generates a plethora of evidence, it can be chaotic and contradictory. A move toward sustained, thematic, theory-based programs of research is necessary to advance knowledge in the field. Recognizing that simulation is a complex intervention, we present a framework for developing research programs in simulation-based education adapted from the Medical Research Council (MRC) guidance. This framework calls for an iterative approach to developing, refining, evaluating, and implementing simulation interventions. The adapted framework guidance emphasizes: (1) identification of theory and existing evidence; (2) modeling and piloting interventions to clarify active ingredients and identify mechanisms linking the context, intervention, and outcomes; and (3) evaluation of intervention processes and outcomes in both the laboratory and real-world setting. The proposed framework will aid simulation researchers in developing more robust interventions that optimize simulation-based education and advance our understanding of simulation pedagogy.

Development and preliminary testing of a web-based, self-help application for disaster-affected families.

PubMed

Yuen, Erica K; Gros, Kirstin; Welsh, Kyleen E; McCauley, Jenna; Resnick, Heidi S; Danielson, Carla K; Price, Matthew; Ruggiero, Kenneth J

2016-09-01

Technology-based self-help interventions have the potential to increase access to evidence-based mental healthcare, especially for families affected by natural disasters. However, development of these interventions is a complex process and poses unique challenges. Usability testing, which assesses the ability of individuals to use an application successfully, can have a significant impact on the quality of a self-help intervention. This article describes (a) the development of a novel web-based multi-module self-help intervention for disaster-affected adolescents and their parents and (b) a mixed-methods formal usability study to evaluate user response. A total of 24 adolescents were observed, videotaped, and interviewed as they used the depressed mood component of the self-help intervention. Quantitative results indicated an above-average user experience, and qualitative analysis identified 120 unique usability issues. We discuss the challenges of developing self-help applications, including design considerations and the value of usability testing in technology-based interventions, as well as our plan for widespread dissemination. © The Author(s) 2015.

A Meta-Analysis of Single Subject Design Writing Intervention Research

ERIC Educational Resources Information Center

Rogers, Leslie Ann; Graham, Steve

2008-01-01

There is considerable concern that students do not develop the writing skills needed for school, occupational, or personal success. A frequent explanation for this is that schools do not do a good job of teaching this complex skill. A recent meta-analysis of true- and quasi-experimental writing intervention research (S. Graham & D. Perin,…

“Because we all trust and care about each other”: Exploring Tensions Translating a Theater-based HIV Prevention Intervention into a New Context

PubMed Central

Mouw, Mary Sherwyn; Taboada, Arianna; Steinert, Scarlett; Willis, Stephanie; Lightfoot, Alexandra F.

2016-01-01

Background A theater-based HIV prevention intervention developed in urban California was piloted with a new partnership in North Carolina. Objectives To describe the experience of translating a complex program with an enhanced partnership approach; barriers and facilitators of implementation in the new setting; and challenges and benefits of interdisciplinary, collaborative interventions. Methods We gathered perspectives of local stakeholders involved in program implementation through process evaluation interviews and focus groups with undergraduates, a college instructor, school district administrators, and high school teachers. Results Implementing the intervention in a new setting proved feasible and successful; however, mistaken assumptions and unrecognized similarities about teaching priorities, philosophies, and values produced latent tensions amongst stakeholder groups, and were a limiting factor in partnership functioning. Conclusions Implementing a cross-disciplinary intervention in a new setting is best achieved through a local community-engaged process, with active involvement of relevant stakeholders. We suggest strategies to strengthen community partnerships cooperating in implementation of complex, context-tailored interventions. PMID:27346770

Developing a complex intervention for the outpatient management of incidentally diagnosed pulmonary embolism in cancer patients.

PubMed

Palmer, June; Bozas, George; Stephens, Andrew; Johnson, Miriam; Avery, Ged; O'Toole, Lorcan; Maraveyas, Anthony

2013-06-27

Most patients with pulmonary embolism (PE) spend 5-7 days in hospital even though only 4.5% will develop serious complications during this time. In particular, the group of patients with incidentally diagnosed PE (i-PE) includes many patients with low risk features potentially ideal for outpatient management; however the evidence for their optimal management is lacking hence relative practices may vary considerably. We describe the development process, components, links and function of a nurse-led service for the management of patients with i-PE, developed in accordance to the UK Medical Research Council complex intervention guidance. Phase 0 (Theoretical underpinning): The Pulmonary Embolism Severity Index (PESI) was selected for patient risk assessment and the American Society of Clinical Oncology (ASCO) guideline for the management of PE in cancer patients (2007) was selected as quality measure. Historical registry and audit data from our centre regarding i-PE incidence and management for the period between 2006 and 2009 illustrating the then current practices were reviewed. Phase 1 (Modelling): Modelling of the pathway included the following: a) Identification of training needs, planning and implementation of training schemes and development of transferable competencies and training materials. b) Mapping patient pathways and flow and c) Production of key documentation and Standard Operating Procedures for the delivery of the service. Phase 2 (Implementation and testing of the intervention): During the initial 12 months of implementation, remedial action was taken to address identified deficiencies regarding patient referral to the pathway, compliance with treatment protocol, patient follow up, selection challenges from the use of PESI in cancer patients and challenges regarding the "first-pass" identification of i-PE. We have developed and piloted a complex intervention to manage cancer patients with incidental PE in an outpatient setting. Adherence to evidence- based care, improvement of communication between professionals and patients, and improved quality of data is demonstrated.

Developing a complex intervention for the outpatient management of incidentally diagnosed pulmonary embolism in cancer patients

PubMed Central

2013-01-01

Background Most patients with pulmonary embolism (PE) spend 5–7 days in hospital even though only 4.5% will develop serious complications during this time. In particular, the group of patients with incidentally diagnosed PE (i-PE) includes many patients with low risk features potentially ideal for outpatient management; however the evidence for their optimal management is lacking hence relative practices may vary considerably. We describe the development process, components, links and function of a nurse-led service for the management of patients with i-PE, developed in accordance to the UK Medical Research Council complex intervention guidance. Methods Phase 0 (Theoretical underpinning): The Pulmonary Embolism Severity Index (PESI) was selected for patient risk assessment and the American Society of Clinical Oncology (ASCO) guideline for the management of PE in cancer patients (2007) was selected as quality measure. Historical registry and audit data from our centre regarding i-PE incidence and management for the period between 2006 and 2009 illustrating the then current practices were reviewed. Phase 1 (Modelling): Modelling of the pathway included the following: a) Identification of training needs, planning and implementation of training schemes and development of transferable competencies and training materials. b) Mapping patient pathways and flow and c) Production of key documentation and Standard Operating Procedures for the delivery of the service. Results Phase 2 (Implementation and testing of the intervention): During the initial 12 months of implementation, remedial action was taken to address identified deficiencies regarding patient referral to the pathway, compliance with treatment protocol, patient follow up, selection challenges from the use of PESI in cancer patients and challenges regarding the “first-pass” identification of i-PE. Conclusion We have developed and piloted a complex intervention to manage cancer patients with incidental PE in an outpatient setting. Adherence to evidence- based care, improvement of communication between professionals and patients, and improved quality of data is demonstrated. PMID:23806053

Immersive communication intervention for speaking and non-speaking children with intellectual disabilities.

PubMed

van der Schuit, Margje; Segers, Eliane; van Balkom, Hans; Stoep, Judith; Verhoeven, Ludo

2010-09-01

The current study demonstrates the effectiveness of an intervention that addresses both home care and day care for children with intellectual disabilities while also taking the large individual differences between the children into account. The KLINc Studio intervention was designed to improve the language development, communication skills, and emergent literacy of 10 children with complex communication needs. The focus of the anchor-based intervention program was on the stimulation of vocabulary learning via the incorporation of AAC into the learning environment in the most natural manner possible. While all of the children showed significant progress across the intervention period of 2 years, the group of speaking children showed greater development in the domains of receptive language and productive syntax than the group of non-speaking children. For heterogeneous groups of children with disabilities, the use of a combined intervention such as that described here appears to be promising.

Improving the Prediction of Mortality and the Need for Life-Saving Interventions in Trauma Patients Using Standard Vital Signs With Heart-Rate Variability and Complexity

DTIC Science & Technology

2015-06-01

Trauma 69:S10YS13, 2010. 2. Liu NT, Holcomb JB, Wade CE, Darrah MI, Salinas J: Utility of vital signs, heart-rate variability and complexity, and machine ... learning for identifying the need for life-saving interventions in trauma patients. Shock 42:108Y114, 2014. 3. Pickering TG, Shimbo D, Hass D...Ann Emerg Med 45:68Y76, 2005. 8. Liu NT, Holcomb JB, Wade CE, Batchinsky AI, Cancio LC, Darrah MI, Salinas J: Development and validation of a machine

Complex interventions can increase osteoporosis investigations and treatment: a systematic review and meta-analysis.

PubMed

Kastner, M; Perrier, L; Munce, S E P; Adhihetty, C C; Lau, A; Hamid, J; Treister, V; Chan, J; Lai, Y; Straus, S E

2018-01-01

Osteoporosis is affecting over 200 million people worldwide. Despite available guidelines, care for these patients remains sub-optimal. We developed an osteoporosis tool to address the multiple dimensions of chronic disease management. Findings from its evaluation showed a significant increase from baseline in osteoporosis investigations and treatment, so we are revising this tool to include multiple chronic conditions including an update of evidence about osteoporosis. Our objectives were to conduct a systematic review of osteoporosis interventions in adults at risk for osteoporosis. We searched bibliometric databases for randomized controlled trials (RCTs) in any language evaluating osteoporosis disease management interventions in adults at risk for osteoporosis. Reviewer pairs independently screened citations and full-text articles, extracted data, and assessed risk of bias. Analysis included random effects meta-analysis. Primary outcomes were osteoporosis investigations and treatment, and fragility fractures. Fifty-five RCTs and one companion report were included in the analysis representing 165,703 patients. Our findings from 55 RCTs and 18 sub-group meta-analyses showed that complex implementation interventions with multiple components consisting of at least education + feedback + follow-up significantly increased the initiation of osteoporosis medications, and interventions with at least education + follow-up significantly increased the initiation of osteoporosis investigations. No significant impact was found for any type of intervention to reduce fracture. Complex interventions that include at least education + follow-up or feedback have the most potential for increasing osteoporosis investigations and treatment. Patient education appears to be an important component in osteoporosis disease management.

Lymphatic Anatomy.

PubMed

Hsu, Michael C; Itkin, Maxim

2016-12-01

Recent development of new lymphatic imaging and intervention techniques, such as intranodal lymphangiogram, dynamic contrast enhanced magnetic resonance lymphangiography and lymphatic embolization, have resulted in the resurgence of interest in the lymphatic anatomy. The lymphatic system is a continuous maze of interlacing vessels and lymph nodes and is extremely complex and variable. This presents a significant challenge for interpretation of imaging and performance of interventions on this system. There is an embryological reason for this complexity and variability; the lymphatic system sprouts off of primordia from several locations in the body, which later fuse together at different stages of development of the embryo. The lymphatic system can be divided in three distinct parts: soft tissue lymphatics, intestinal lymphatics, and liver lymphatics. Liver and intestinal lymphatics generate approximately 80% of the body lymph and are functionally the most important parts of the lymphatic system. However, their normal anatomy and pathological changes are relatively unknown. In this chapter we will explore the anatomy of these three systems relevant to lymphatic imaging and interventions. Copyright © 2016 Elsevier Inc. All rights reserved.

The University-Public Health Partnership for Public Health Research Training in Quebec, Canada.

PubMed

Paradis, Gilles; Hamelin, Anne-Marie; Malowany, Maureen; Levy, Joseph; Rossignol, Michel; Bergeron, Pierre; Kishchuk, Natalie

2017-01-01

Enhancing effective preventive interventions to address contemporary public health problems requires improved capacity for applied public health research. A particular need has been recognized for capacity development in population health intervention research to address the complex multidisciplinary challenges of developing, implementing, and evaluating public health practices, intervention programs, and policies. Research training programs need to adapt to these new realities. We have presented an example of a 2003 to 2015 training program in transdisciplinary research on public health interventions that embedded doctoral and postdoctoral trainees in public health organizations in Quebec, Canada. This university-public health partnership for research training is an example of how to link science and practice to meet emerging needs in public health.

Using qualitative comparative analysis (QCA) in systematic reviews of complex interventions: a worked example

PubMed Central

2014-01-01

Background Systematic reviews that address policy and practice questions in relation to complex interventions frequently need not only to assess the efficacy of a given intervention but to identify which intervention - and which intervention components - might be most effective in particular situations. Here, intervention replication is rare, and commonly used synthesis methods are less useful when the focus of analysis is the identification of those components of an intervention that are critical to its success. Methods Having identified initial theories of change in a previous analysis, we explore the potential of qualitative comparative analysis (QCA) to assist with complex syntheses through a worked example. Developed originally in the area of political science and historical sociology, a QCA aims to identify those configurations of participant, intervention and contextual characteristics that may be associated with a given outcome. Analysing studies in these terms facilitates the identification of necessary and sufficient conditions for the outcome to be obtained. Since QCA is predicated on the assumption that multiple pathways might lead to the same outcome and does not assume a linear additive model in terms of changes to a particular condition (that is, it can cope with ‘tipping points’ in complex interventions), it appears not to suffer from some of the limitations of the statistical methods often used in meta-analysis. Results The worked example shows how the QCA reveals that our initial theories of change were unable to distinguish between ‘effective’ and ‘highly effective’ interventions. Through the iterative QCA process, other intervention characteristics are identified that better explain the observed results. Conclusions QCA is a promising alternative (or adjunct), particularly to the standard fall-back of a ‘narrative synthesis’ when a quantitative synthesis is impossible, and should be considered when reviews are broad and heterogeneity is significant. There are very few examples of its use with systematic review data at present, and further methodological work is needed to establish optimal conditions for its use and to document process, practice, and reporting standards. PMID:24950727

Development of a Self-Management Theory-Guided Discharge Intervention for Parents of Hospitalized Children.

PubMed

Sawin, Kathleen J; Weiss, Marianne E; Johnson, Norah; Gralton, Karen; Malin, Shelly; Klingbeil, Carol; Lerret, Stacee M; Thompson, Jamie J; Zimmanck, Kim; Kaul, Molly; Schiffman, Rachel F

2017-03-01

Parents of hospitalized children, especially parents of children with complex and chronic health conditions, report not being adequately prepared for self-management of their child's care at home after discharge. No theory-based discharge intervention exists to guide pediatric nurses' preparation of parents for discharge. To develop a theory-based conversation guide to optimize nurses' preparation of parents for discharge and self-management of their child at home following hospitalization. Two frameworks and one method influenced the development of the intervention: the Individual and Family Self-Management Theory, Tanner's Model of Clinical Judgment, and the Teach-Back method. A team of nurse scientists, nursing leaders, nurse administrators, and clinical nurses developed and field tested the electronic version of a nine-domain conversation guide for use in acute care pediatric hospitals. The theory-based intervention operationalized self-management concepts, added components of nursing clinical judgment, and integrated the Teach-Back method. Development of a theory-based intervention, the translation of theoretical knowledge to clinical innovation, is an important step toward testing the effectiveness of the theory in guiding clinical practice. Clinical nurses will establish the practice relevance through future use and refinement of the intervention. © 2017 Sigma Theta Tau International.

The global security perspective on the effects of executive cognitive function on complex behavioral screening intervention and HIV/AIDS.

PubMed

Kim, Suk-Hee

2010-11-01

The purpose of this quantitative study is to understand the global security perspective on the effects of executive cognitive function (ECF) on Complex Behavioral Screening Intervention and HIV/AIDS. The HIV/AIDS pandemic is as much a social, political, economic, and cultural problem as a biomedical one. HIV/AIDS is associated centrally with the collapse not just of communities and families but potentially of states, with some of the largest public health interventions ever and enormous questions about governance, a huge population of orphans, and deep questions about intergenerational relations and cultural transmission. This study also is to develop a screening instrument that improves quality of life for individuals with executive cognitive impairments and behavior problems in our communities and the global society.

Effective, clinically feasible and sustainable: Key design features of psycho-educational and supportive care interventions to promote individualised self-management in cancer care.

PubMed

Schofield, Penelope; Chambers, Suzanne

2015-05-01

As the global burden of cancer increases healthcare services will face increasing challenges in meet the complex needs of these patients, their families and the communities in which they live. This raises the question of how to meet patient need where direct clinical contact may be constrained or not readily available. Patients and families require resources and skills to manage their illness outside of the hospital setting within their own communities. To propose a framework for the development and delivery of psycho-educational and supportive care interventions drawing on theoretical principles of behaviour change and evidence-based interventions, and based on extensive experience in developing and testing complex interventions in oncology. At the core of this intervention framework are considerations of efficiency: interventions are designed to cater for individuals' unique needs; to place minimal demands on the health system infrastructure and to be rapidly disseminated into usual care if successful. There are seven key features: 1) Targeting cancer type and stage; 2) Tailoring to unique individual needs; 3) Promotion of patient self-management of their disease and treatment side effects; 4) Efficient delivery of the intervention; 5) Training and adherence to protocol; 6) Ensuring the intervention is evidence-based; 7) Confirming stakeholder acceptability of the intervention. A case study of a randomised controlled trial which tested psycho-educational oncology interventions using this framework is presented. These interventions were designed to cater for individuals' unique needs and promote self-management while placing minimal demands on the acute health care setting. Innovative ways to realise the potentially major impact that psycho-educational and supportive care interventions can have on psychological morbidity, coping, symptoms and quality of life in serious and chronic illness are needed. This framework, which is driven by theory, evidence, and experience, is designed to ensure that interventions are effective, clinically feasible and sustainable.

A framework for developing an evidence-based, comprehensive tobacco control program

PubMed Central

2010-01-01

Background Tobacco control is an area where the translation of evidence into policy would seem to be straightforward, given the wealth of epidemiological, behavioural and other types of research available. Yet, even here challenges exist. These include information overload, concealment of key (industry-funded) evidence, contextualization, assessment of population impact, and the changing nature of the threat. Methods In the context of Israel's health targeting initiative, Healthy Israel 2020, we describe the steps taken to develop a comprehensive tobacco control strategy. We elaborate on the following: a) scientific issues influencing the choice of tobacco control strategies; b) organization of existing evidence of effectiveness of interventions into a manageable form, and c) consideration of relevant philosophical and political issues. We propose a framework for developing a plan and illustrate this process with a case study in Israel. Results Broad consensus exists regarding the effectiveness of most interventions, but current recommendations differ in the emphasis they place on different strategies. Scientific challenges include integration of complex and sometimes conflicting information from authoritative sources, and lack of estimates of population impact of interventions. Philosophical and political challenges include the use of evidence-based versus innovative policymaking, the importance of individual versus governmental responsibility, and whether and how interventions should be prioritized. The proposed framework includes: 1) compilation of a list of potential interventions 2) modification of that list based on local needs and political constraints; 3) streamlining the list by categorizing interventions into broad groupings of related interventions; together these groupings form the basis of a comprehensive plan; and 4) refinement of the plan by comparing it to existing comprehensive plans. Conclusions Development of a comprehensive tobacco control plan is a complex endeavour, involving crucial decisions regarding intervention components. "Off the shelf" plans, which need to be adapted to local settings, are available from a variety of sources, and a multitude of individual recommendations are available. The proposed framework for adapting existing approaches to the local social and political climate may assist others planning for smoke-free societies. Additionally, this experience has implications for development of evidence-based health plans addressing other risk factors. PMID:20507612

A framework for developing an evidence-based, comprehensive tobacco control program.

PubMed

Rosen, Laura; Rosenberg, Elliot; McKee, Martin; Gan-Noy, Shosh; Levin, Diane; Mayshar, Elana; Shacham, Galia; Borowski, John; Nun, Gabi Bin; Lev, Boaz

2010-05-27

Tobacco control is an area where the translation of evidence into policy would seem to be straightforward, given the wealth of epidemiological, behavioural and other types of research available. Yet, even here challenges exist. These include information overload, concealment of key (industry-funded) evidence, contextualization, assessment of population impact, and the changing nature of the threat. In the context of Israel's health targeting initiative, Healthy Israel 2020, we describe the steps taken to develop a comprehensive tobacco control strategy. We elaborate on the following: a) scientific issues influencing the choice of tobacco control strategies; b) organization of existing evidence of effectiveness of interventions into a manageable form, and c) consideration of relevant philosophical and political issues. We propose a framework for developing a plan and illustrate this process with a case study in Israel. Broad consensus exists regarding the effectiveness of most interventions, but current recommendations differ in the emphasis they place on different strategies. Scientific challenges include integration of complex and sometimes conflicting information from authoritative sources, and lack of estimates of population impact of interventions. Philosophical and political challenges include the use of evidence-based versus innovative policymaking, the importance of individual versus governmental responsibility, and whether and how interventions should be prioritized.The proposed framework includes: 1) compilation of a list of potential interventions 2) modification of that list based on local needs and political constraints; 3) streamlining the list by categorizing interventions into broad groupings of related interventions; together these groupings form the basis of a comprehensive plan; and 4) refinement of the plan by comparing it to existing comprehensive plans. Development of a comprehensive tobacco control plan is a complex endeavour, involving crucial decisions regarding intervention components. "Off the shelf" plans, which need to be adapted to local settings, are available from a variety of sources, and a multitude of individual recommendations are available. The proposed framework for adapting existing approaches to the local social and political climate may assist others planning for smoke-free societies. Additionally, this experience has implications for development of evidence-based health plans addressing other risk factors.

Incorporating Budget Impact Analysis in the Implementation of Complex Interventions: A Case of an Integrated Intervention for Multimorbid Patients within the CareWell Study.

PubMed

Soto-Gordoa, Myriam; Arrospide, Arantzazu; Merino Hernández, Marisa; Mora Amengual, Joana; Fullaondo Zabala, Ane; Larrañaga, Igor; de Manuel, Esteban; Mar, Javier

2017-01-01

To develop a framework for the management of complex health care interventions within the Deming continuous improvement cycle and to test the framework in the case of an integrated intervention for multimorbid patients in the Basque Country within the CareWell project. Statistical analysis alone, although necessary, may not always represent the practical significance of the intervention. Thus, to ascertain the true economic impact of the intervention, the statistical results can be integrated into the budget impact analysis. The intervention of the case study consisted of a comprehensive approach that integrated new provider roles and new technological infrastructure for multimorbid patients, with the aim of reducing patient decompensations by 10% over 5 years. The study period was 2012 to 2020. Given the aging of the general population, the conventional scenario predicts an increase of 21% in the health care budget for care of multimorbid patients during the study period. With a successful intervention, this figure should drop to 18%. The statistical analysis, however, showed no significant differences in costs either in primary care or in hospital care between 2012 and 2014. The real costs in 2014 were by far closer to those in the conventional scenario than to the reductions expected in the objective scenario. The present implementation should be reappraised, because the present expenditure did not move closer to the objective budget. This work demonstrates the capacity of budget impact analysis to enhance the implementation of complex interventions. Its integration in the context of the continuous improvement cycle is transferable to other contexts in which implementation depth and time are important. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Development and Delivery of a Physical Activity Intervention for People With Huntington Disease: Facilitating Translation to Clinical Practice

PubMed Central

Quinn, Lori; Trubey, Rob; Gobat, Nina; Dawes, Helen; Edwards, Rhiannon Tudor; Jones, Carys; Townson, Julia; Drew, Cheney; Kelson, Mark; Poile, Vincent; Rosser, Anne; Hood, Kerenza

2016-01-01

Background and Purpose: We studied the development and delivery of a 14-week complex physical activity intervention for people with Huntington disease, where detailed information about the intervention was fully embedded in the trial design process. Methods: Intervention Development: The intervention was developed through a series of focus groups. The findings from the focus groups informed the development of a logic model for the physical activity intervention that was broadly consistent with the framework of self-determination theory. Intervention Delivery: Key components underpinning the delivery of the intervention were implemented including a defined coach training program and intervention fidelity assessment methods. Training of coaches (physical therapists, occupational therapists, research nurses, and exercise trainers) was delivered via group and 1:1 training sessions using a detailed coach's manual, and with ongoing support via video calls, and e-mail communication as needed. Detailed documentation was provided to determine costs of intervention development and coach training. Results: Intervention delivery coaches at 8 sites across the United Kingdom participated in the face-to-face training. Self-report checklists completed by each of the coaches indicated that all components of the intervention were delivered in accordance with the protocol. Mean (standard deviation) intervention fidelity scores (n = 15), as measured using a purpose-developed rating scale, was 11 (2.4) (out of 16 possible points). Coaches' perceptions of intervention fidelity were similarly high. The total cost of developing the intervention and providing training was £30,773 ($47,042 USD). Discussion and Conclusions: An important consideration in promoting translation of clinical research into practice is the ability to convey the detailed components of how the intervention was delivered to facilitate replication if the results are favorable. This report presents an illustrative example of a physical activity intervention, including the development and the training required to deliver it. This approach has the potential to facilitate reproducibility, evidence synthesis, and implementation in clinical practice. Video Abstract available for more insights from the authors (see Supplemental Digital Content 1, http://links.lww.com/JNPT/A122). PMID:26863152

Integrated and Early Childhood Education: Preparation for Social Development. Theme D: Looking Forward - Integrated Participation in Processes of Change.

ERIC Educational Resources Information Center

Springer, Hugh

This seminar paper presents an analysis of the many complex issues inherent in planning and implementing those educational interventions designed to accelerate human change so that it matches the pace of external change in traditional societies. After establishing the importance of sensitive periods when learning can be massive and intervention is…

Fidelity and moderating factors in complex interventions: a case study of a continuum of care program for frail elderly people in health and social care

PubMed Central

2012-01-01

Background Prior studies measuring fidelity of complex interventions have mainly evaluated adherence, and not taken factors affecting adherence into consideration. A need for studies that clarify the concept of fidelity and the function of factors moderating fidelity has been emphasized. The aim of the study was to systematically evaluate implementation fidelity and possible factors influencing fidelity of a complex care continuum intervention for frail elderly people. Methods The intervention was a systematization of the collaboration between a nurse with geriatric expertise situated at the emergency department, the hospital ward staff, and a multi-professional team with a case manager in the municipal care services for older people. Implementation was evaluated between September 2008 and May 2010 with observations of work practices, stakeholder interviews, and document analysis according to a modified version of The Conceptual Framework for Implementation Fidelity. Results A total of 16 of the 18 intervention components were to a great extent delivered as planned, while some new components were added to the model. No changes in the frequency or duration of the 18 components were observed, but the dose of the added components varied over time. Changes in fidelity were caused in a complex, interrelated fashion by all the moderating factors in the framework, i.e., context, staff and participant responsiveness, facilitation, recruitment, and complexity. Discussion The Conceptual Framework for Implementation Fidelity was empirically useful and included comprehensive measures of factors affecting fidelity. Future studies should focus on developing the framework with regard to how to investigate relationships between the moderating factors and fidelity over time. Trial registration ClinicalTrials.gov, NCT01260493. PMID:22436121

Integrating transition theory and bioecological theory: a theoretical perspective for nurses supporting the transition to adulthood for young people with medical complexity.

PubMed

Joly, Elizabeth

2016-06-01

To present a discussion of a theoretical perspective developed through integrating Meleis' Transition Theory and Bronfenbrenner's Bioecological Theory of Human Development to inform nursing and advanced nursing practice supporting the transition to adulthood for young people with medical complexity. Theoretical perspectives to inform nursing practice in supporting successful transition are limited, yet nurses frequently encounter young people with medical complexity during the transition to adulthood. Discussion paper. A literature search of CINAHL and Medline was conducted in 2014 and included articles from 2003-2014; informal discussions with families; the author's experiences in a transition program. The integrated theoretical perspective described in this paper can inform nurses and advanced practice nurses on contextual influences, program and intervention development across spheres of influence and outcomes for the transition to adulthood for young people with medical complexity. Young people and their families require effective reciprocal interactions with individuals and services across sectors to successfully transition to adulthood and become situated in the adult world. Intervention must also extend beyond the young person to include providers, services and health and social policy. Nurses can take a leadership role in supporting the transition to adulthood for young people with medical complexity through direct care, case management, education and research. It is integral that nurses holistically consider developmental processes, complexity and contextual conditions that promote positive outcomes during and beyond the transition to adulthood. © 2016 John Wiley & Sons Ltd.

Multi-criteria decision analysis as an innovative approach to managing zoonoses: results from a study on Lyme disease in Canada

PubMed Central

2013-01-01

Background Zoonoses are a growing international threat interacting at the human-animal-environment interface and call for transdisciplinary and multi-sectoral approaches in order to achieve effective disease management. The recent emergence of Lyme disease in Quebec, Canada is a good example of a complex health issue for which the public health sector must find protective interventions. Traditional preventive and control interventions can have important environmental, social and economic impacts and as a result, decision-making requires a systems approach capable of integrating these multiple aspects of interventions. This paper presents the results from a study of a multi-criteria decision analysis (MCDA) approach for the management of Lyme disease in Quebec, Canada. MCDA methods allow a comparison of interventions or alternatives based on multiple criteria. Methods MCDA models were developed to assess various prevention and control decision criteria pertinent to a comprehensive management of Lyme disease: a first model was developed for surveillance interventions and a second was developed for control interventions. Multi-criteria analyses were conducted under two epidemiological scenarios: a disease emergence scenario and an epidemic scenario. Results In general, we observed a good level of agreement between stakeholders. For the surveillance model, the three preferred interventions were: active surveillance of vectors by flagging or dragging, active surveillance of vectors by trapping of small rodents and passive surveillance of vectors of human origin. For the control interventions model, basic preventive communications, human vaccination and small scale landscaping were the three preferred interventions. Scenarios were found to only have a small effect on the group ranking of interventions in the control model. Conclusions MCDA was used to structure key decision criteria and capture the complexity of Lyme disease management. This facilitated the identification of gaps in the scientific literature and enabled a clear identification of complementary interventions that could be used to improve the relevance and acceptability of proposed prevention and control strategy. Overall, MCDA presents itself as an interesting systematic approach for public health planning and zoonoses management with a “One Health” perspective. PMID:24079303

Multi-criteria decision analysis as an innovative approach to managing zoonoses: results from a study on Lyme disease in Canada.

PubMed

Aenishaenslin, Cécile; Hongoh, Valérie; Cissé, Hassane Djibrilla; Hoen, Anne Gatewood; Samoura, Karim; Michel, Pascal; Waaub, Jean-Philippe; Bélanger, Denise

2013-09-30

Zoonoses are a growing international threat interacting at the human-animal-environment interface and call for transdisciplinary and multi-sectoral approaches in order to achieve effective disease management. The recent emergence of Lyme disease in Quebec, Canada is a good example of a complex health issue for which the public health sector must find protective interventions. Traditional preventive and control interventions can have important environmental, social and economic impacts and as a result, decision-making requires a systems approach capable of integrating these multiple aspects of interventions. This paper presents the results from a study of a multi-criteria decision analysis (MCDA) approach for the management of Lyme disease in Quebec, Canada. MCDA methods allow a comparison of interventions or alternatives based on multiple criteria. MCDA models were developed to assess various prevention and control decision criteria pertinent to a comprehensive management of Lyme disease: a first model was developed for surveillance interventions and a second was developed for control interventions. Multi-criteria analyses were conducted under two epidemiological scenarios: a disease emergence scenario and an epidemic scenario. In general, we observed a good level of agreement between stakeholders. For the surveillance model, the three preferred interventions were: active surveillance of vectors by flagging or dragging, active surveillance of vectors by trapping of small rodents and passive surveillance of vectors of human origin. For the control interventions model, basic preventive communications, human vaccination and small scale landscaping were the three preferred interventions. Scenarios were found to only have a small effect on the group ranking of interventions in the control model. MCDA was used to structure key decision criteria and capture the complexity of Lyme disease management. This facilitated the identification of gaps in the scientific literature and enabled a clear identification of complementary interventions that could be used to improve the relevance and acceptability of proposed prevention and control strategy. Overall, MCDA presents itself as an interesting systematic approach for public health planning and zoonoses management with a "One Health" perspective.

Participation in physical play and leisure: developing a theory- and evidence-based intervention for children with motor impairments.

PubMed

Kolehmainen, Niina; Francis, Jillian J; Ramsay, Craig R; Owen, Christine; McKee, Lorna; Ketelaar, Marjolijn; Rosenbaum, Peter

2011-11-07

Children with motor impairments (e.g. difficulties with motor control, muscle tone or balance) experience significant difficulties in participating in physical play and leisure. Current interventions are often poorly defined, lack explicit hypotheses about why or how they might work, and have insufficient evidence about effectiveness. This project will identify (i) the 'key ingredients' of an effective intervention to increase participation in physical play and leisure in children with motor impairments; and (ii) how these ingredients can be combined in a feasible and acceptable intervention. The project draws on the WHO International Classification of Functioning, Disability and Health and the UK Medical Research Council guidance for developing 'complex interventions'. There will be five steps: 1) identifying biomedical, personal and environmental factors proposed to predict children's participation in physical play and leisure; 2) developing an explicit model of the key predictors; 3) selecting intervention strategies to target the predictors, and specifying the pathways to change; 4) operationalising the strategies in a feasible and acceptable intervention; and 5) modelling the intervention processes and outcomes within single cases. The primary output from this project will be a detailed protocol for an intervention. The intervention, if subsequently found to be effective, will support children with motor difficulties to attain life-long well-being and participation in society. The project will also be an exemplar of methodology for a systematic development of non-drug interventions for children.

Participation in physical play and leisure: developing a theory- and evidence-based intervention for children with motor impairments

PubMed Central

2011-01-01

Background Children with motor impairments (e.g. difficulties with motor control, muscle tone or balance) experience significant difficulties in participating in physical play and leisure. Current interventions are often poorly defined, lack explicit hypotheses about why or how they might work, and have insufficient evidence about effectiveness. This project will identify (i) the 'key ingredients' of an effective intervention to increase participation in physical play and leisure in children with motor impairments; and (ii) how these ingredients can be combined in a feasible and acceptable intervention. Methods/Design The project draws on the WHO International Classification of Functioning, Disability and Health and the UK Medical Research Council guidance for developing 'complex interventions'. There will be five steps: 1) identifying biomedical, personal and environmental factors proposed to predict children's participation in physical play and leisure; 2) developing an explicit model of the key predictors; 3) selecting intervention strategies to target the predictors, and specifying the pathways to change; 4) operationalising the strategies in a feasible and acceptable intervention; and 5) modelling the intervention processes and outcomes within single cases. Discussion The primary output from this project will be a detailed protocol for an intervention. The intervention, if subsequently found to be effective, will support children with motor difficulties to attain life-long well-being and participation in society. The project will also be an exemplar of methodology for a systematic development of non-drug interventions for children. PMID:22061203

Using realist review to inform intervention development: methodological illustration and conceptual platform for collaborative care in offender mental health.

PubMed

Pearson, M; Brand, S L; Quinn, C; Shaw, J; Maguire, M; Michie, S; Briscoe, S; Lennox, C; Stirzaker, A; Kirkpatrick, T; Byng, R

2015-09-28

This paper reports how we used a realist review, as part of a wider project to improve collaborative mental health care for prisoners with common mental health problems, to develop a conceptual platform. The importance of offenders gaining support for their mental health, and the need for practitioners across the health service, the criminal justice system, and the third sector to work together to achieve this is recognised internationally. However, the literature does not provide coherent analyses of how these ambitions can be achieved. This paper demonstrates how a realist review can be applied to inform complex intervention development that spans different locations, organisations, professions, and care sectors. We applied and developed a realist review for the purposes of intervention development, using a three-stage process. (1) An iterative database search strategy (extending beyond criminal justice and offender health) and groups of academics, practitioners, and people with lived experience were used to identify explanatory accounts (n = 347). (2) From these accounts, we developed consolidated explanatory accounts (n = 75). (3) The identified interactions between practitioners and offenders (within their organisational, social, and cultural contexts) were specified in a conceptual platform. We also specify, step by step, how these explanatory accounts were documented, consolidated, and built into a conceptual platform. This addresses an important methodological gap for social scientists and intervention developers about how to develop and articulate programme and implementation theory underpinning complex interventions. An integrated person-centred system is proposed to improve collaborative mental health care for offenders with common mental health problems (near to and after release) by achieving consistency between the goals of different sectors and practitioners, enabling practitioners to apply scientific and experiential knowledge in working judiciously and reflectively, and building systems and aligning resources that are centred on offenders' health and social care needs. As part of a broader programme of work, a realist review can make an important contribution to the specification of theoretically informed interventions that have the potential to improve health outcomes. Our conceptual platform has potential application in related systems of health and social care where integrated, and person-centred care is a goal.

Learning by Preparing to Teach: Fostering Self-Regulatory Processes and Achievement during Complex Mathematics Problem Solving

ERIC Educational Resources Information Center

Muis, Krista R.; Psaradellis, Cynthia; Chevrier, Marianne; Di Leo, Ivana; Lajoie, Susanne P.

2016-01-01

We developed an intervention based on the learning by teaching paradigm to foster self-regulatory processes and better learning outcomes during complex mathematics problem solving in a technology-rich learning environment. Seventy-eight elementary students were randomly assigned to 1 of 2 conditions: learning by preparing to teach, or learning for…

A complex breastfeeding promotion and support intervention in a developing country: study protocol for a randomized clinical trial.

PubMed

Nabulsi, Mona; Hamadeh, Haya; Tamim, Hani; Kabakian, Tamar; Charafeddine, Lama; Yehya, Nadine; Sinno, Durriyah; Sidani, Saadieh

2014-01-15

Breastfeeding has countless benefits to mothers, children and community at large, especially in developing countries. Studies from Lebanon report disappointingly low breastfeeding exclusivity and continuation rates. Evidence reveals that antenatal breastfeeding education, professional lactation support, and peer lay support are individually effective at increasing breastfeeding duration and exclusivity, particularly in low-income settings. Given the complex nature of the breastfeeding ecosystem and its barriers in Lebanon, we hypothesize that a complex breastfeeding support intervention, which is centered on the three components mentioned above, would significantly increase breastfeeding rates. A multi-center randomized controlled trial. 443 healthy pregnant women in their first trimester will be randomized to control or intervention group. A "prenatal/postnatal" professional and peer breastfeeding support package continuing till 6 months postpartum, guided by the Social Network and Social Support Theory. Control group will receive standard prenatal and postnatal care. Mothers will be followed up from early pregnancy till five years after delivery. Total and exclusive breastfeeding rates, quality of life at 1, 3 and 6 months postpartum, maternal breastfeeding knowledge and attitudes at 6 months postpartum, maternal exclusive breastfeeding rates of future infants up to five years from baseline, cost-benefit and cost-effectiveness analyses of the intervention. Descriptive and regression analysis will be conducted under the intention to treat basis using the most recent version of SPSS. Exclusive breastfeeding is a cost-effective public health measure that has a significant impact on infant morbidity and mortality. In a country with limited healthcare resources like Lebanon, developing an effective breastfeeding promotion and support intervention that is easily replicated across various settings becomes a priority. If positive, the results of this study would provide a generalizable model to bolster breastfeeding promotion efforts and contribute to improved child health in Lebanon and the Middle East and North Africa (MENA) region. Current Controlled Trials ISRCTN17875591.

Implementation fidelity of a self-management course for epilepsy: method and assessment.

PubMed

Wojewodka, G; Hurley, S; Taylor, S J C; Noble, A J; Ridsdale, L; Goldstein, L H

2017-07-11

Complex interventions such as self-management courses are difficult to evaluate due to the many interacting components. The way complex interventions are delivered can influence the effect they have for patients, and can impact the interpretation of outcomes of clinical trials. Implementation fidelity evaluates whether complex interventions are delivered according to protocol. Such assessments have been used for one-to-one psychological interventions; however, the science is still developing for group interventions. We developed and tested an instrument to measure implementation fidelity of a two-day self-management course for people with epilepsy, SMILE(UK). Using audio recordings, we looked at adherence and competence of course facilitators. Adherence was assessed by checklists. Competence was measured by scoring group interaction, an overall impression score and facilitator "didacticism". To measure "didacticism", we developed a novel way to calculate facilitator speech using computer software. Using this new instrument, implementation fidelity of SMILE(UK) was assessed on three modules of the course, for 28% of all courses delivered. Using the instrument for adherence, scores from two independent raters showed substantial agreement with weighted Kappa of 0.67 and high percent agreement of 81.2%. For didacticism, the results from both raters were highly correlated with an intraclass coefficient of 0.97 (p < 0.0001). We found that the courses were delivered with a good level of adherence (> 50% of scored items received the maximum of 2 points) and high competence. Groups were interactive (mean score: 1.9-2.0 out of 2) and the overall impression was on average assessed as "good". Didacticism varied from 42% to 93% of total module time and was not associated with the other competence scores. The instrument devised to measure implementation fidelity was reproducible and easy to use. The courses for the SMILE(UK) study were delivered with a good level of adherence to protocol while not compromising facilitator competence. ISRCTN57937389 .

Developing a Reporting Guideline for Social and Psychological Intervention Trials

PubMed Central

Mayo-Wilson, Evan; Hopewell, Sally; Macdonald, Geraldine; Moher, David; Grant, Sean

2013-01-01

Understanding randomized controlled trials of complex social and psychological interventions requires a detailed description of the interventions tested and the methods used to evaluate them. However, randomized controlled trial reports often omit, or inadequately report, this information. Incomplete and inaccurate reporting hinders the optimal use of research, wastes resources, and fails to meet ethical obligations to research participants and consumers. We explain how reporting guidelines have improved the quality of reports in medicine, and describe the ongoing development of a new reporting guideline for randomized controlled trials: an extension of the Consolidated Standards of Reporting Trials for social and psychological interventions. We invite readers to participate in the project by visiting our Web site, to help us reach the best-informed consensus on these guidelines (http://tinyurl.com/consort-study). PMID:23947317

A Systematic Review of Conceptual Frameworks of Medical Complexity and New Model Development.

PubMed

Zullig, Leah L; Whitson, Heather E; Hastings, Susan N; Beadles, Chris; Kravchenko, Julia; Akushevich, Igor; Maciejewski, Matthew L

2016-03-01

Patient complexity is often operationalized by counting multiple chronic conditions (MCC) without considering contextual factors that can affect patient risk for adverse outcomes. Our objective was to develop a conceptual model of complexity addressing gaps identified in a review of published conceptual models. We searched for English-language MEDLINE papers published between 1 January 2004 and 16 January 2014. Two reviewers independently evaluated abstracts and all authors contributed to the development of the conceptual model in an iterative process. From 1606 identified abstracts, six conceptual models were selected. One additional model was identified through reference review. Each model had strengths, but several constructs were not fully considered: 1) contextual factors; 2) dynamics of complexity; 3) patients' preferences; 4) acute health shocks; and 5) resilience. Our Cycle of Complexity model illustrates relationships between acute shocks and medical events, healthcare access and utilization, workload and capacity, and patient preferences in the context of interpersonal, organizational, and community factors. This model may inform studies on the etiology of and changes in complexity, the relationship between complexity and patient outcomes, and intervention development to improve modifiable elements of complex patients.

Case Management for Patients with Complex Multimorbidity: Development and Validation of a Coordinated Intervention between Primary and Hospital Care

PubMed Central

Giménez-Campos, María Soledad; Villar-López, Julia; Faubel-Cava, Raquel; Donat-Castelló, Lucas; Valdivieso-Martínez, Bernardo; Soriano-Melchor, Elisa; Bahamontes-Mulió, Amparo; García-Gómez, Juan M.

2017-01-01

In the past few years, healthcare systems have been facing a growing demand related to the high prevalence of chronic diseases. Case management programs have emerged as an integrated care approach for the management of chronic disease. Nevertheless, there is little scientific evidence on the impact of using a case management program for patients with complex multimorbidity regarding hospital resource utilisation. We evaluated an integrated case management intervention set up by community-based care at outpatient clinics with nurse case managers from a telemedicine unit. The hypothesis to be tested was whether improved continuity of care resulting from the integration of community-based and hospital services reduced the use of hospital resources amongst patients with complex multimorbidity. A retrospective cohort study was performed using a sample of 714 adult patients admitted to the program between January 2012 and January 2015. We found a significant decrease in the number of emergency room visits, unplanned hospitalizations, and length of stay, and an expected increase in the home care hospital-based episodes. These results support the hypothesis that case management interventions can reduce the use of unplanned hospital admissions when applied to patients with complex multimorbidity. PMID:28970745

From theory to 'measurement' in complex interventions: methodological lessons from the development of an e-health normalisation instrument.

PubMed

Finch, Tracy L; Mair, Frances S; O'Donnell, Catherine; Murray, Elizabeth; May, Carl R

2012-05-17

Although empirical and theoretical understanding of processes of implementation in health care is advancing, translation of theory into structured measures that capture the complex interplay between interventions, individuals and context remain limited. This paper aimed to (1) describe the process and outcome of a project to develop a theory-based instrument for measuring implementation processes relating to e-health interventions; and (2) identify key issues and methodological challenges for advancing work in this field. A 30-item instrument (Technology Adoption Readiness Scale (TARS)) for measuring normalisation processes in the context of e-health service interventions was developed on the basis on Normalization Process Theory (NPT). NPT focuses on how new practices become routinely embedded within social contexts. The instrument was pre-tested in two health care settings in which e-health (electronic facilitation of healthcare decision-making and practice) was used by health care professionals. The developed instrument was pre-tested in two professional samples (N=46; N=231). Ratings of items representing normalisation 'processes' were significantly related to staff members' perceptions of whether or not e-health had become 'routine'. Key methodological challenges are discussed in relation to: translating multi-component theoretical constructs into simple questions; developing and choosing appropriate outcome measures; conducting multiple-stakeholder assessments; instrument and question framing; and more general issues for instrument development in practice contexts. To develop theory-derived measures of implementation process for progressing research in this field, four key recommendations are made relating to (1) greater attention to underlying theoretical assumptions and extent of translation work required; (2) the need for appropriate but flexible approaches to outcomes measurement; (3) representation of multiple perspectives and collaborative nature of work; and (4) emphasis on generic measurement approaches that can be flexibly tailored to particular contexts of study.

The brain injury case management taxonomy (BICM-T); a classification of community-based case management interventions for a common language.

PubMed

Lukersmith, Sue; Fernandez, Ana; Millington, Michael; Salvador-Carulla, Luis

2016-04-01

Case management is a complex intervention. Complexity arises from the interaction of different components: the model (theoretical basis), implementation context (service), population and health condition, focus for the intervention (client and/or their family), case manager's actions (interventions) and the target of case management (integrated care and support, client's community participation). There is a lack of understanding and a common language. To our knowledge there is no classification (taxonomy) for community-based case management. To develop a community-based case management in brain injury taxonomy (BICM-T), as a common language and understanding of case management for use in quality analysis, policy, planning and practice. The mixed qualitative methods used multiple sources of knowledge including scoping, framing and a nominal group technique to iteratively develop the Beta version (draft) of the taxonomy. A two part developmental evaluation involving case studies and mapping to international frameworks assessed the applicability and acceptability (feasibility) before finalization of the BICM-T. The BICM-T includes a definition of community-based case management, taxonomy trees, tables and a glossary. The interventions domain tree has 9 main actions (parent category): engagement, holistic assessment, planning, education, training and skills development, emotional and motivational support, advising, coordination, monitoring; 17 linked actions (children category); 8 related actions; 63 relevant terms defined in the glossary. The BICM-T provides a knowledge map with the definitions and relationships between the core actions (interventions domain). Use of the taxonomy as a common language will benefit practice, quality analysis, evaluation, policy, planning and resource allocation. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Designing an Agent-Based Model for Childhood Obesity Interventions: A Case Study of ChildObesity180.

PubMed

Hennessy, Erin; Ornstein, Joseph T; Economos, Christina D; Herzog, Julia Bloom; Lynskey, Vanessa; Coffield, Edward; Hammond, Ross A

2016-01-07

Complex systems modeling can provide useful insights when designing and anticipating the impact of public health interventions. We developed an agent-based, or individual-based, computation model (ABM) to aid in evaluating and refining implementation of behavior change interventions designed to increase physical activity and healthy eating and reduce unnecessary weight gain among school-aged children. The potential benefits of applying an ABM approach include estimating outcomes despite data gaps, anticipating impact among different populations or scenarios, and exploring how to expand or modify an intervention. The practical challenges inherent in implementing such an approach include data resources, data availability, and the skills and knowledge of ABM among the public health obesity intervention community. The aim of this article was to provide a step-by-step guide on how to develop an ABM to evaluate multifaceted interventions on childhood obesity prevention in multiple settings. We used data from 2 obesity prevention initiatives and public-use resources. The details and goals of the interventions, overview of the model design process, and generalizability of this approach for future interventions is discussed.

Representing causal knowledge in environmental policy interventions: Advantages and opportunities for qualitative influence diagram applications.

PubMed

Carriger, John F; Dyson, Brian E; Benson, William H

2018-01-15

This article develops and explores a methodology for using qualitative influence diagrams in environmental policy and management to support decision making efforts that minimize risk and increase resiliency. Influence diagrams are representations of the conditional aspects of a problem domain. Their graphical properties are useful for structuring causal knowledge relevant to policy interventions and can be used to enhance inference and inclusivity of multiple viewpoints. Qualitative components of influence diagrams are beneficial tools for identifying and examining the interactions among the critical variables in complex policy development and implementation. Policy interventions on social-environmental systems can be intuitively diagrammed for representing knowledge of critical relationships among economic, environmental, and social attributes. Examples relevant to coastal resiliency issues in the U.S. Gulf Coast region are developed to illustrate model structures for developing qualitative influence diagrams useful for clarifying important policy intervention issues and enhancing transparency in decision making. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

[Transparency and replicability of nursing intervention studies in long-term care: A selective literature review].

PubMed

Gspörer, Irene; Schrems, Berta M

2018-05-01

The development and evaluation of interventions in long-term care is time-consuming and expensive due to their complexity. To ensure reproducibility and successful implementation, these interventions must be described and published in a comprehensible and qualitative manner. The aim of this study is to analyze intervention studies from the inpatient long-term care setting with regard to their completeness, reporting quality, transparency and thus reproducibility. The completeness and the reporting quality of the interventions described in the publications were examined in the context of a selective literature review by means of intervention studies from the long-term care setting (n=22). To this end, the Template for Intervention Description and Replication (TIDieR) checklist and the Criteria for Reporting the Development and Evaluation of Complex Interventions in Healthcare 2 (CReDECI2-DE) list were used. Transparency criteria included study registration and access to study protocols. The TIDieR checklist examination revealed that only three studies contained all the information necessary; the CReDECI2 test provided a complete description for only one study. Frequent shortcomings were observed concerning the information on modifications and titrations for the study participants and the location. Protocols were available for eight studies, 14 studies were registered. In terms of science, this means that the reproducibility of scientific findings is limited, which is why they cannot provide secure knowledge. As a result, the practical benefit to be derived from published studies that are accessible to decision-makers is limited as well. As far as publishers are concerned they should pay more attention to the completeness, registration and availability of materials. Copyright © 2018. Published by Elsevier GmbH.

Ethical issues in the development and implementation of nutrition-related public health policies and interventions: A scoping review.

PubMed

Hurlimann, Thierry; Peña-Rosas, Juan Pablo; Saxena, Abha; Zamora, Gerardo; Godard, Béatrice

2017-01-01

The limited integration of ethics in nutrition-related public health policies and interventions is one major concern for those who have the task of implementing them. Ethical challenges that are overlooked during the development of such interventions could raise serious ethical issues during their implementation and even after. As a result, these decision makers need technical support and ethical guidance for adaptation of interventions to local (cultural, social, economic, etc.) contexts. The goal of this scoping review is to delineate and "map" the range of ethical issues in nutrition-related public health interventions, as well as the range of the various fields in which they may arise. A scoping review of empirical research and conceptual literature was conducted following the framework of Arksey and O'Malley. Searches using PubMed with Medical Subject Headings (MeSH) categories and Advanced Search Builder as well as in the Global Health Library were performed. The final sample consists of 169 publications. The ethics of public health prevention or treatment of obesity and non-communicable diseases is the most explicitly and frequently discussed subject. In comparison, ethical issues raised by public health interventions in the fields of undernutrition, breastfeeding, vitamin/mineral supplementation and food fortification, food security, food sustainability and food safety are addressed in a lower proportion of the sample. The results illustrate the various natures, types, and scopes of existing public health nutrition-related interventions, and the various ethical issues that may be raised by these interventions, in addition to the numerous and different contexts in which they may be implemented. The ethical issues faced in the development and implementation of nutrition-related public health interventions are varied and cannot be equated with, nor generalized about, when dealing with specific activities in this field. More importantly, these ethical issues cannot be managed without a careful consideration for the complexity of contexts in which nutrition-related interventions are expected to be implemented. These interventions engage a variety of actors with diverse perspectives and interests. We discuss these challenges and also comment on the importance of considering ethical impacts in the monitoring and evaluation of such interventions. General ethical frameworks or recommendations-although useful-cannot be expected to provide policy makers, implementators and other public health personnel with sufficient practical ethical guidance as they cannot consider and anticipate the particularities of all specific nutrition-related public health interventions and the complexity of the contexts in which they are implemented. Further research is needed in order to develop more targeted ethical frameworks.

Precursors to language development in typically and atypically developing infants and toddlers: the importance of embracing complexity.

PubMed

D'Souza, Dean; D'Souza, Hana; Karmiloff-Smith, Annette

2017-05-01

In order to understand how language abilities emerge in typically and atypically developing infants and toddlers, it is important to embrace complexity in development. In this paper, we describe evidence that early language development is an experience-dependent process, shaped by diverse, interconnected, interdependent developmental mechanisms, processes, and abilities (e.g. statistical learning, sampling, functional specialization, visual attention, social interaction, motor ability). We also present evidence from our studies on neurodevelopmental disorders (e.g. Down syndrome, fragile X syndrome, Williams syndrome) that variations in these factors significantly contribute to language delay. Finally, we discuss how embracing complexity, which involves integrating data from different domains and levels of description across developmental time, may lead to a better understanding of language development and, critically, lead to more effective interventions for cases when language develops atypically.

Sarcopenia: designing phase IIb trials: international working group on sarcopenia

USDA-ARS?s Scientific Manuscript database

Sarcopenia is the age-related involuntary loss of skeletal muscle mass and functionality that can lead to the development of disability, frailty and increased health care costs. The development of interventions aimed at preventing and/or treating sarcopenia is complex, requiring the adoption of assu...

Living With Dementia in Correctional Settings: A Case Report.

PubMed

Peacock, Shelley; Hodson, Alexandra; MacRae, Rhoda; Peternelj-Taylor, Cindy

2018-04-24

The prison population is aging at an alarming rate and many older persons have the potential to develop dementia while in prison. This case report aims to explore the needs of older people living with dementia in prison and discusses the interventions that exist to address these needs. As the condition progresses, persons with dementia become increasingly reliant on the support of others for their health and well-being because of the increasing complexity of physical healthcare and psychosocial needs. Very few interventions are cited in the research literature regarding the use, acceptability, and/or effectiveness of programming for people living with dementia in prison. To support the unique and complex needs of these persons, research is needed to guide the development of evidence-informed dementia programs and services as well as consideration of interdisciplinary collaboration with community organizations.

Studying complex interventions: reflections from the FEMHealth project on evaluating fee exemption policies in West Africa and Morocco.

PubMed

Marchal, Bruno; Van Belle, Sara; De Brouwere, Vincent; Witter, Sophie

2013-11-08

The importance of complexity in health care policy-making and interventions, as well as research and evaluation is now widely acknowledged, but conceptual confusion reigns and few applications of complexity concepts in research design have been published. Taking user fee exemption policies as an entry point, we explore the methodological consequences of 'complexity' for health policy research and evaluation. We first discuss the difference between simple, complicated and complex and introduce key concepts of complex adaptive systems theory. We then apply these to fee exemption policies. We describe how the FEMHealth research project attempts to address the challenges of complexity in its evaluation of fee exemption policies for maternal care. We present how the development of a programme theory for fee exemption policies was used to structure the overall design. This allowed for structured discussions on the hypotheses held by the researchers and helped to structure, integrate and monitor the sub-studies. We then show how the choice of data collection methods and tools for each sub-study was informed by the overall design. Applying key concepts from complexity theory proved useful in broadening our view on fee exemption policies and in developing the overall research design. However, we encountered a number of challenges, including maintaining adaptiveness of the design during the evaluation, and ensuring cohesion in the disciplinary diversity of the research teams. Whether the programme theory can fulfil its claimed potential to help making sense of the findings is yet to be tested. Experience from other studies allows for some moderate optimism. However, the biggest challenge complexity throws at health system researchers may be to deal with the unknown unknowns and the consequence that complex issues can only be understood in retrospect. From a complexity theory point of view, only plausible explanations can be developed, not predictive theories. Yet here, theory-driven approaches may help.

Silence, shame and abuse in health care: theoretical development on basis of an intervention project among staff.

PubMed

Wijma, Barbro; Zbikowski, Anke; Brüggemann, A Jelmer

2016-02-27

As health care exists to alleviate patients' suffering it is unacceptable that it inflicts unnecessary suffering on patients. We therefore have developed and evaluated a drama pedagogical model for staff interventions using Forum Play, focusing on staff's experiences of failed encounters where they have perceived that the patient felt abused. In the current paper we present how our preliminary theoretical framework of intervening against abuse in health care developed and was revised during this intervention. During and after the intervention, five important lessons were learned and incorporated in our present theoretical framework. First, a Forum Play intervention may break the silence culture that surrounds abuse in health care. Second, organizing staff training in groups was essential and transformed abuse from being an individual problem inflicting shame into a collective responsibility. Third, initial theoretical concepts "moral resources" and "the vicious violence triangle" proved valuable and became useful pedagogical tools during the intervention. Four, the intervention can be understood as having strengthened staff's moral resources. Five, regret appeared to be an underexplored resource in medical training and clinical work.The occurrence of abuse in health care is a complex phenomenon and the research area is in need of theoretical understanding. We hope this paper can inspire others to further develop theories and interventions in order to counteract abuse in health care.

Interventions developed with the Intervention Mapping protocol in the field of cancer: A systematic review.

PubMed

Lamort-Bouché, Marion; Sarnin, Philippe; Kok, Gerjo; Rouat, Sabrina; Péron, Julien; Letrilliart, Laurent; Fassier, Jean-Baptiste

2018-04-01

The Intervention Mapping (IM) protocol provides a structured framework to develop, implement, and evaluate complex interventions. The main objective of this review was to identify and describe the content of the interventions developed in the field of cancer with the IM protocol. Secondary objectives were to assess their fidelity to the IM protocol and to review their theoretical frameworks. Medline, Web of Science, PsycINFO, PASCAL, FRANCIS, and BDSP databases were searched. All titles and abstracts were reviewed. A standardized extraction form was developed. All included studies were reviewed by 2 reviewers blinded to each other. Sixteen studies were identified, and these reported 15 interventions. The objectives were to increase cancer screening participation (n = 7), early consultation (n = 1), and aftercare/quality of life among cancer survivors (n = 7). Six reported a complete participatory planning group, and 7 described a complete logic model of the problem. Ten studies described a complete logic model of change. The main theoretical frameworks used were the theory of planned behaviour (n = 8), the transtheoretical model (n = 6), the health belief model (n = 6), and the social cognitive theory (n = 6). The environment was rarely integrated in the interventions (n = 4). Five interventions were reported as effective. Culturally relevant interventions were developed with the IM protocol that were effective to increase cancer screening and reduce social disparities, particularly when they were developed through a participative approach and integrated the environment. Stakeholders' involvement and the role of the environment were heterogeneously integrated in the interventions. Copyright © 2017 John Wiley & Sons, Ltd.

Adaptation and Evaluation of a Multi-Criteria Decision Analysis Model for Lyme Disease Prevention

PubMed Central

Aenishaenslin, Cécile; Gern, Lise; Michel, Pascal; Ravel, André; Hongoh, Valérie; Waaub, Jean-Philippe; Milord, François; Bélanger, Denise

2015-01-01

Designing preventive programs relevant to vector-borne diseases such as Lyme disease (LD) can be complex given the need to include multiple issues and perspectives into prioritizing public health actions. A multi-criteria decision aid (MCDA) model was previously used to rank interventions for LD prevention in Quebec, Canada, where the disease is emerging. The aim of the current study was to adapt and evaluate the decision model constructed in Quebec under a different epidemiological context, in Switzerland, where LD has been endemic for the last thirty years. The model adaptation was undertaken with a group of Swiss stakeholders using a participatory approach. The PROMETHEE method was used for multi-criteria analysis. Key elements and results of the MCDA model are described and contrasted with the Quebec model. All criteria and most interventions of the MCDA model developed for LD prevention in Quebec were directly transferable to the Swiss context. Four new decision criteria were added, and the list of proposed interventions was modified. Based on the overall group ranking, interventions targeting human populations were prioritized in the Swiss model, with the top ranked action being the implementation of a large communication campaign. The addition of criteria did not significantly alter the intervention rankings, but increased the capacity of the model to discriminate between highest and lowest ranked interventions. The current study suggests that beyond the specificity of the MCDA models developed for Quebec and Switzerland, their general structure captures the fundamental and common issues that characterize the complexity of vector-borne disease prevention. These results should encourage public health organizations to adapt, use and share MCDA models as an effective and functional approach to enable the integration of multiple perspectives and considerations in the prevention and control of complex public health issues such as Lyme disease or other vector-borne and zoonotic diseases. PMID:26295344

Achieving change in primary care--causes of the evidence to practice gap: systematic reviews of reviews.

PubMed

Lau, Rosa; Stevenson, Fiona; Ong, Bie Nio; Dziedzic, Krysia; Treweek, Shaun; Eldridge, Sandra; Everitt, Hazel; Kennedy, Anne; Qureshi, Nadeem; Rogers, Anne; Peacock, Richard; Murray, Elizabeth

2016-03-22

This study is to identify, summarise and synthesise literature on the causes of the evidence to practice gap for complex interventions in primary care. This study is a systematic review of reviews. MEDLINE, EMBASE, CINAHL, Cochrane Library and PsychINFO were searched, from inception to December 2013. Eligible reviews addressed causes of the evidence to practice gap in primary care in developed countries. Data from included reviews were extracted and synthesised using guidelines for meta-synthesis. Seventy reviews fulfilled the inclusion criteria and encompassed a wide range of topics, e.g. guideline implementation, integration of new roles, technology implementation, public health and preventative medicine. None of the included papers used the term "cause" or stated an intention to investigate causes at all. A descriptive approach was often used, and the included papers expressed "causes" in terms of "barriers and facilitators" to implementation. We developed a four-level framework covering external context, organisation, professionals and intervention. External contextual factors included policies, incentivisation structures, dominant paradigms, stakeholders' buy-in, infrastructure and advances in technology. Organisation-related factors included culture, available resources, integration with existing processes, relationships, skill mix and staff involvement. At the level of individual professionals, professional role, underlying philosophy of care and competencies were important. Characteristics of the intervention that impacted on implementation included evidence of benefit, ease of use and adaptability to local circumstances. We postulate that the "fit" between the intervention and the context is critical in determining the success of implementation. This comprehensive review of reviews summarises current knowledge on the barriers and facilitators to implementation of diverse complex interventions in primary care. To maximise the uptake of complex interventions in primary care, health care professionals and commissioning organisations should consider the range of contextual factors, remaining aware of the dynamic nature of context. Future studies should place an emphasis on describing context and articulating the relationships between the factors identified here. PROSPERO CRD42014009410.

Adaptation and Evaluation of a Multi-Criteria Decision Analysis Model for Lyme Disease Prevention.

PubMed

Aenishaenslin, Cécile; Gern, Lise; Michel, Pascal; Ravel, André; Hongoh, Valérie; Waaub, Jean-Philippe; Milord, François; Bélanger, Denise

2015-01-01

Designing preventive programs relevant to vector-borne diseases such as Lyme disease (LD) can be complex given the need to include multiple issues and perspectives into prioritizing public health actions. A multi-criteria decision aid (MCDA) model was previously used to rank interventions for LD prevention in Quebec, Canada, where the disease is emerging. The aim of the current study was to adapt and evaluate the decision model constructed in Quebec under a different epidemiological context, in Switzerland, where LD has been endemic for the last thirty years. The model adaptation was undertaken with a group of Swiss stakeholders using a participatory approach. The PROMETHEE method was used for multi-criteria analysis. Key elements and results of the MCDA model are described and contrasted with the Quebec model. All criteria and most interventions of the MCDA model developed for LD prevention in Quebec were directly transferable to the Swiss context. Four new decision criteria were added, and the list of proposed interventions was modified. Based on the overall group ranking, interventions targeting human populations were prioritized in the Swiss model, with the top ranked action being the implementation of a large communication campaign. The addition of criteria did not significantly alter the intervention rankings, but increased the capacity of the model to discriminate between highest and lowest ranked interventions. The current study suggests that beyond the specificity of the MCDA models developed for Quebec and Switzerland, their general structure captures the fundamental and common issues that characterize the complexity of vector-borne disease prevention. These results should encourage public health organizations to adapt, use and share MCDA models as an effective and functional approach to enable the integration of multiple perspectives and considerations in the prevention and control of complex public health issues such as Lyme disease or other vector-borne and zoonotic diseases.

Complex Case Conferences Associated with Reduced Hospital Admissions for High-Risk Patients with Multiple Comorbidities

PubMed Central

Tuso, Philip; Watson, Heather L; Garofalo-Wright, Lynn; Lindsay, Gail; Jackson, Ana; Taitano, Maria; Koyama, Sandra; Kanter, Michael

2014-01-01

Objectives: Reducing avoidable hospital readmissions presents an opportunity to improve health care quality and reduce avoidable costs. We studied the effect person-focused care may have on reducing avoidable admissions to the hospital. Methods: Among patients with heart failure discharged from the hospital, we evaluated the effect on 30-day readmissions of transitions-in-care interventions: home health visits, follow-up phone calls, and physician office visits. We also used a standardized diagnostic tool to interview readmitted patients to identify social reasons that may have contributed to the readmission. Finally, we used the learnings from both interventions to develop a new intervention: a single complex disease case conference that included the entire health care team. We measured hospital admissions for 21 patients during the 6 months before and after their complex case conferences. Results: Observed-over-expected hospital readmission rates were lowest for patients receiving a postdischarge visit with a home health nurse and a follow-up visit with their physician (0.54), compared with solely a physician visit (0.81), home health visit (1.2), or phone call (1.55). Various social issues may contribute to hospital readmissions, including caregiver knowledge, ability to care for oneself at home, and issues related to medications (adherence, ability to pay, and knowledge about potential side effects). Substantially fewer hospital admissions occurred after complex case conferences. Conclusions: Complex case conferences with disease-focused and person-focused interventions may be associated with reduced hospital admissions for patients with heart failure and multiple comorbidities. PMID:24626071

A Review of Interventions Designed to Increase Sharing Behaviors in Children with Social Delays or Deficits

ERIC Educational Resources Information Center

Lane, Justin D.; Ledford, Jennifer R.

2016-01-01

Sharing materials is a complex social behavior that may lead to long-term development of friendships and concomitant increases in related prosocial behaviors. Given the complexities of sharing behaviors, children with social delays or deficits may not recognize when, how, and with whom to share. Because children with social delays or deficits,…

Enhancing Learning Performance and Adaptability for Complex Tasks

DTIC Science & Technology

2005-03-30

development of active learning interventions and techniques that influence the focus and quality of learner regulatory activity (Kozlowski Toney et al...what are the effects of these goal representations on learning strategies, performance, and adaptability? Can active learning inductions, that influence...and mindful process - active learning - are generally associated with improved skill acquisition and adaptability for complex tasks (Smith et al

Effects of a brief media intervention on expectations, attitudes, and intentions of mental health help seeking.

PubMed

Demyan, Amy L; Anderson, Timothy

2012-04-01

This study examined the effects of a mass-media video intervention on expectations, attitudes, and intentions to seek help from professional mental health care services. A public service announcement-style, mass-media video intervention was developed, with prior empirical research on help-seeking behaviors organized according to the theory of reasoned action/planned behavior. In total, 228 participants were randomly assigned to 1 of 2 conditions: (a) the media-exposed intervention group, who watched programming in which the media intervention was inserted, and (b) the control group, who watched the same programming without the media intervention. The media intervention was not influential on expectation and belief-based barrier variables. However, the media intervention was effective at increasing positive attitudes toward help seeking. Findings regarding the intervention's ability to increase help-seeking intentions for interpersonal problems were complex. Implications of these findings for future research are discussed.

Application of loop analysis for evaluation of malaria control interventions.

PubMed

Yasuoka, Junko; Jimba, Masamine; Levins, Richard

2014-04-09

Despite continuous efforts and recent rapid expansion in the financing and implementation of malaria control interventions, malaria still remains one of the most devastating global health issues. Even in countries that have been successful in reducing the incidence of malaria, malaria control is becoming more challenging because of the changing epidemiology of malaria and waning community participation in control interventions. In order to improve the effectiveness of interventions and to promote community understanding of the necessity of continued control efforts, there is an urgent need to develop new methodologies that examine the mechanisms by which community-based malaria interventions could reduce local malaria incidence. This study demonstrated how the impact of community-based malaria control interventions on malaria incidence can be examined in complex systems by qualitative analysis combined with an extensive review of literature. First, sign digraphs were developed through loop analysis to analyse seven interventions: source reduction, insecticide/larvicide use, biological control, treatment with anti-malarials, insecticide-treated mosquito net/long-lasting insecticidal net, non-chemical personal protection measures, and educational intervention. Then, for each intervention, the sign digraphs and literature review were combined to analyse a variety of pathways through which the intervention can influence local malaria incidence as well as interactions between variables involved in the system. Through loop analysis it is possible to see whether increases in one variable qualitatively increases or decreases other variables or leaves them unchanged and the net effect of multiple, interacting variables. Qualitative analysis, specifically loop analysis, can be a useful tool to examine the impact of community-based malaria control interventions. Without relying on numerical data, the analysis was able to describe pathways through which each intervention could influence malaria incidence on the basis of the qualitative patterns of the interactions between variables in complex systems. This methodology is generalizable to various disease control interventions at different levels, and can be utilized by a variety of stakeholders such as researchers, community leaders and policy makers to better plan and evaluate their community-based disease control interventions.

Application of loop analysis for evaluation of malaria control interventions

PubMed Central

2014-01-01

Background Despite continuous efforts and recent rapid expansion in the financing and implementation of malaria control interventions, malaria still remains one of the most devastating global health issues. Even in countries that have been successful in reducing the incidence of malaria, malaria control is becoming more challenging because of the changing epidemiology of malaria and waning community participation in control interventions. In order to improve the effectiveness of interventions and to promote community understanding of the necessity of continued control efforts, there is an urgent need to develop new methodologies that examine the mechanisms by which community-based malaria interventions could reduce local malaria incidence. Methods This study demonstrated how the impact of community-based malaria control interventions on malaria incidence can be examined in complex systems by qualitative analysis combined with an extensive review of literature. First, sign digraphs were developed through loop analysis to analyse seven interventions: source reduction, insecticide/larvicide use, biological control, treatment with anti-malarials, insecticide-treated mosquito net/long-lasting insecticidal net, non-chemical personal protection measures, and educational intervention. Then, for each intervention, the sign digraphs and literature review were combined to analyse a variety of pathways through which the intervention can influence local malaria incidence as well as interactions between variables involved in the system. Through loop analysis it is possible to see whether increases in one variable qualitatively increases or decreases other variables or leaves them unchanged and the net effect of multiple, interacting variables. Results Qualitative analysis, specifically loop analysis, can be a useful tool to examine the impact of community-based malaria control interventions. Without relying on numerical data, the analysis was able to describe pathways through which each intervention could influence malaria incidence on the basis of the qualitative patterns of the interactions between variables in complex systems. This methodology is generalizable to various disease control interventions at different levels, and can be utilized by a variety of stakeholders such as researchers, community leaders and policy makers to better plan and evaluate their community-based disease control interventions. PMID:24713031

A qualitative study exploring the views, attitudes and beliefs of patients and health professionals towards exercise intervention for people who are surgically treated for lung cancer.

PubMed

Crandall, K; Maguire, R; Campbell, A; Kearney, N

2018-03-01

Surgical removal remains the best curative option for patients diagnosed with early-stage lung cancer. However, it is also associated with significant morbidity and reduced quality of life. Interventions to improve patient outcomes are required. This study aimed to explore the views, attitudes and beliefs of key stakeholders on exercise intervention for people who are surgically treated for lung cancer to inform the development of future interventions. Focus groups and individual interviews were carried out at two Scottish sites. The study was guided by the Health Action Process Approach behaviour change model. A total of 23 (12 patients and 11 health professionals) participated in the study. The data analysis resulted in three main themes: attitudes and beliefs, external factors and intervention design. The results highlighted certain key elements that should be included in an exercise intervention, such as the need for supervised sessions, an element of individualisation and the perceived social benefits of exercising with others. This study emphasises the importance of including key stakeholders in the development of complex interventions such as exercise and provides important information for the development of future exercise intervention trials for people who are surgically treated for lung cancer. © 2018 John Wiley & Sons Ltd.

Reconceptualizing children's complex discharge with health systems theory: novel integrative review with embedded expert consultation and theory development.

PubMed

Noyes, Jane; Brenner, Maria; Fox, Patricia; Guerin, Ashleigh

2014-05-01

To report a novel review to develop a health systems model of successful transition of children with complex healthcare needs from hospital to home. Children with complex healthcare needs commonly experience an expensive, ineffectual and prolonged nurse-led discharge process. Children gain no benefit from prolonged hospitalization and are exposed to significant harm. Research to enable intervention development and process evaluation across the entire health system is lacking. Novel mixed-method integrative review informed by health systems theory. DATA  CINAHL, PsychInfo, EMBASE, PubMed, citation searching, personal contact. REVIEW  Informed by consultation with experts. English language studies, opinion/discussion papers reporting research, best practice and experiences of children, parents and healthcare professionals and purposively selected policies/guidelines from 2002-December 2012 were abstracted using Framework synthesis, followed by iterative theory development. Seven critical factors derived from thirty-four sources across five health system levels explained successful discharge (new programme theory). All seven factors are required in an integrated care pathway, with a dynamic communication loop to facilitate effective discharge (new programme logic). Current health system responses were frequently static and critical success factors were commonly absent, thereby explaining ineffectual discharge. The novel evidence-based model, which reconceptualizes 'discharge' as a highly complex longitudinal health system intervention, makes a significant contribution to global knowledge to drive practice development. Research is required to develop process and outcome measures at different time points in the discharge process and future trials are needed to determine the effectiveness of integrated health system discharge models. © 2013 John Wiley & Sons Ltd.

Synthesizing evidence on complex interventions: how meta-analytical, qualitative, and mixed-method approaches can contribute.

PubMed

Petticrew, Mark; Rehfuess, Eva; Noyes, Jane; Higgins, Julian P T; Mayhew, Alain; Pantoja, Tomas; Shemilt, Ian; Sowden, Amanda

2013-11-01

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. 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. 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. 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. 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. Copyright © 2013 Elsevier Inc. All rights reserved.

Motivational interviewing for HIV risk reduction among gay men in commercial and public sex settings.

PubMed

Harding, R; Dockrell, M J; Dockrell, J; Corrigan, N

2001-08-01

The present paper addresses the feasibility of combining motivational interviewing and cognitive interventions to HIV risk reduction in commercial venues and public sex environments (PSEs). The logic for these two approaches is considered and an intervention combining key elements of the two is presented. The intervention uses a questionnaire format to encourage individuals to compare their desired versus actual behaviour (i.e. chosen personal risk reduction strategy versus 'slip-ups'/unwanted risk taking), and to recognize their risk-related cognitions. High-risk individuals are identified, and health-focused conversations developed from the brief schedule. The structure and key design issues in the development of a feasible, acceptable and evidence-based tool are reviewed. The limitations of more complex, focused interventions in the context of commercial and PSE settings are discussed.

Development of minimally invasive techniques for management of medically-complicated obesity

PubMed Central

Rashti, Farzin; Gupta, Ekta; Ebrahimi, Suzan; Shope, Timothy R; Koch, Timothy R; Gostout, Christopher J

2014-01-01

The field of bariatric surgery has been rapidly growing and evolving over the past several decades. During the period that obesity has become a worldwide epidemic, new interventions have been developed to combat this complex disorder. The development of new laparoscopic and minimally invasive treatments for medically-complicated obesity has made it essential that gastrointestinal physicians obtain a thorough understanding of past developments and possible future directions in bariatrics. New laparoscopic advancements provide patients and practitioners with a variety of options that have an improved safety profile and better efficacy without open, invasive surgery. The mechanisms of weight loss after bariatric surgery are complex and may in part be related to altered release of regulatory peptide hormones from the gut. Endoscopic techniques designed to mimic the effects of bariatric surgery and endolumenal interventions performed entirely through the gastrointestinal tract offer potential advantages. Several of these new techniques have demonstrated promising, preliminary results. We outline herein historical and current trends in the development of bariatric surgery and its transition to safer and more minimally invasive procedures designed to induce weight loss. PMID:25309074

Developing an instrument to measure heart failure disease management program intensity and complexity.

PubMed

Riegel, Barbara; Lee, Christopher S; Sochalski, Julie

2010-05-01

Comparing disease management programs and their effects is difficult because of wide variability in program intensity and complexity. The purpose of this effort was to develop an instrument that can be used to describe the intensity and complexity of heart failure (HF) disease management programs. Specific composition criteria were taken from the American Heart Association (AHA) taxonomy of disease management and hierarchically scored to allow users to describe the intensity and complexity of the domains and subdomains of HF disease management programs. The HF Disease Management Scoring Instrument (HF-DMSI) incorporates 6 of the 8 domains from the taxonomy: recipient, intervention content, delivery personnel, method of communication, intensity/complexity, and environment. The 3 intervention content subdomains (education/counseling, medication management, and peer support) are described separately. In this first test of the HF-DMSI, overall intensity (measured as duration) and complexity were rated using an ordinal scoring system. Possible scores reflect a clinical rationale and differ by category, with zero given only if the element could potentially be missing (eg, surveillance by remote monitoring). Content validity was evident as the instrument matches the existing AHA taxonomy. After revision and refinement, 2 authors obtained an inter-rater reliability intraclass correlation coefficient score of 0.918 (confidence interval, 0.880 to 0.944, P<0.001) in their rating of 12 studies. The areas with most variability among programs were delivery personnel and method of communication. The HF-DMSI is useful for describing the intensity and complexity of HF disease management programs.

Developing a Postgraduate Work-Based Curriculum Using an Intervention Mapping Approach

ERIC Educational Resources Information Center

Stewart, Victoria; Campbell, Matthew; Wheeler, Amanda J.

2016-01-01

Advanced practitioner skill development has become an important focus in health service delivery as increasingly complex consumer needs, practice environments and national professional registration requirements impact on professional work practices. Increasingly, work-based or workplace learning experiences are being seen as an effective means for…

The Partnership and Coping Enhancement Programme for couples undergoing in vitro fertilization treatment: the development of a complex intervention in China.

PubMed

Ying, Liying; Chen, Xiaomin; Wu, Lai Har; Shu, Jing; Wu, Xiangli; Loke, Alice Yuen

2017-01-01

Couples as dyads suffer from the diagnosis of infertility and related treatment. These couples commonly experience emotional and physical pain and tension in their marital lives. The purpose of this study is to report on the process of developing a potentially feasible and effective complex intervention for couples undergoing in vitro fertilization treatment in China. The Medical Research Council (MRC) framework for developing and evaluating the complex intervention was adopted to guide the development of the Partnership and Coping Enhancement Programme (PCEP). In developing the PCEP, three steps were taken, namely, (1) identifying evidence by conducting literature reviews, a concept analysis and a qualitative study; (2) identifying/developing a theory-in this case, a preliminary Endurance with Partnership Conceptual Framework (P-EPCF) was proposed; and (3) modelling the process and outcomes of the PCEP. The PCEP that was developed is targeted mainly at the domains of the partnership mediators of stress in the P-EPCF. It consists of two sections-partnership and coping-and will be delivered to infertile couples on the day of embryo transfer. The main focuses of the programme are to facilitate mutual sharing and support in infertile couples, and to improve their individual and dyadic coping strategies while undergoing IVF treatment, especially in the period when they are waiting for the results of a pregnancy test and after the disclosure of a negative treatment outcome. The programme is couple-based, consisting of experience sharing, psychoeducation, meditation exercise, skill practise and supplemental written materials. The Partnership and Coping Enhancement Programme (PCEP) for couples undergoing in vitro fertilization treatment was developed according to the guideline of the MRC framework. It is recommended that a pilot study be conducted to evaluate its feasibility and to model the process and outcomes of the programme.

Knowledge transfer on complex social interventions in public health: a scoping study.

PubMed

Dagenais, Christian; Malo, Marie; Robert, Émilie; Ouimet, Mathieu; Berthelette, Diane; Ridde, Valéry

2013-01-01

Scientific knowledge can help develop interventions that improve public health. The objectives of this review are (1) to describe the status of research on knowledge transfer strategies in the field of complex social interventions in public health and (2) to identify priorities for future research in this field. A scoping study is an exploratory study. After searching databases of bibliographic references and specialized periodicals, we summarized the relevant studies using a predetermined assessment framework. In-depth analysis focused on the following items: types of knowledge transfer strategies, fields of public health, types of publics, types of utilization, and types of research specifications. From the 1,374 references identified, we selected 26 studies. The strategies targeted mostly administrators of organizations and practitioners. The articles generally dealt with instrumental utilization and most often used qualitative methods. In general, the bias risk for the studies is high. Researchers need to consider the methodological challenges in this field of research in order to improve assessment of more complex knowledge transfer strategies (when they exist), not just diffusion/dissemination strategies and conceptual and persuasive utilization.

Knowledge Transfer on Complex Social Interventions in Public Health: A Scoping Study

PubMed Central

Dagenais, Christian; Malo, Marie; Robert, Émilie; Ouimet, Mathieu; Berthelette, Diane; Ridde, Valéry

2013-01-01

Objectives Scientific knowledge can help develop interventions that improve public health. The objectives of this review are (1) to describe the status of research on knowledge transfer strategies in the field of complex social interventions in public health and (2) to identify priorities for future research in this field. Method A scoping study is an exploratory study. After searching databases of bibliographic references and specialized periodicals, we summarized the relevant studies using a predetermined assessment framework. In-depth analysis focused on the following items: types of knowledge transfer strategies, fields of public health, types of publics, types of utilization, and types of research specifications. Results From the 1,374 references identified, we selected 26 studies. The strategies targeted mostly administrators of organizations and practitioners. The articles generally dealt with instrumental utilization and most often used qualitative methods. In general, the bias risk for the studies is high. Conclusion Researchers need to consider the methodological challenges in this field of research in order to improve assessment of more complex knowledge transfer strategies (when they exist), not just diffusion/dissemination strategies and conceptual and persuasive utilization. PMID:24324593

Toward Dynamic Adaptation of Psychological Interventions for Child and Adolescent Development and Mental Health.

PubMed

Malti, Tina; Noam, Gil G; Beelmann, Andreas; Sommer, Simon

2016-01-01

Children's and adolescents' mental health needs emphasize the necessity of a new era of translational research to enhance development and yield better lives for children, families, and communities. Developmental, clinical, and translational research serves as a powerful tool for managing the inevitable complexities in pursuit of these goals. This article proposes key ideas that will strengthen current evidence-based intervention practices by creating stronger links between research, practice, and complex systems contexts, with the potential of extending applicability, replicability, and impact. As exemplified in some of the articles throughout this special issue, new research and innovative implementation models will likely contribute to better ways of assessing and dynamically adapting structure and intervention practice within mental health systems. We contend that future models for effective interventions with children and adolescents will involve increased attention to (a) the connection of research on the developmental needs of children and adolescents to practice models; (b) consideration of informed contextual and cultural adaptation in implementation; and (c) a rational model of evidence-based planning, using a dynamic, inclusive approach with high support for adaptation, flexibility, and implementation fidelity. We discuss future directions for translational research for researchers, practitioners, and administrators in the field to continue and transform these ideas and their illustrations.

Designing a complex intervention for dementia case management in primary care

PubMed Central

2013-01-01

Background Community-based support will become increasingly important for people with dementia, but currently services are fragmented and the quality of care is variable. Case management is a popular approach to care co-ordination, but evidence to date on its effectiveness in dementia has been equivocal. Case management interventions need to be designed to overcome obstacles to care co-ordination and maximise benefit. A successful case management methodology was adapted from the United States (US) version for use in English primary care, with a view to a definitive trial. Medical Research Council guidance on the development of complex interventions was implemented in the adaptation process, to capture the skill sets, person characteristics and learning needs of primary care based case managers. Methods Co-design of the case manager role in a single NHS provider organisation, with external peer review by professionals and carers, in an iterative technology development process. Results The generic skills and personal attributes were described for practice nurses taking up the case manager role in their workplaces, and for social workers seconded to general practice teams, together with a method of assessing their learning needs. A manual of information material for people with dementia and their family carers was also created using the US intervention as its source. Conclusions Co-design produces rich products that have face validity and map onto the complexities of dementia and of health and care services. The feasibility of the case manager role, as described and defined by this process, needs evaluation in ‘real life’ settings. PMID:23865537

Co-creative development of an eHealth nursing intervention: Self-management support for outpatients with cancer pain.

PubMed

Hochstenbach, Laura M J; Courtens, Annemie M; Zwakhalen, Sandra M G; Vermeulen, Joan; van Kleef, Maarten; de Witte, Luc P

2017-08-01

Co-creative methods, having an iterative character and including different perspectives, allow for the development of complex nursing interventions. Information about the development process is essential in providing justification for the ultimate intervention and crucial in interpreting the outcomes of subsequent evaluations. This paper describes a co-creative method directed towards the development of an eHealth intervention delivered by registered nurses to support self-management in outpatients with cancer pain. Intervention development was divided into three consecutive phases (exploration of context, specification of content, organisation of care). In each phase, researchers and technicians addressed five iterative steps: research, ideas, prototyping, evaluation, and documentation. Health professionals and patients were consulted during research and evaluation steps. Collaboration of researchers, health professionals, patients and technicians was positive and valuable in optimising outcomes. The intervention includes a mobile application for patients and a web application for nurses. Patients are requested to monitor pain, adverse effects and medication intake, while being provided with graphical feedback, education and contact possibilities. Nurses monitor data, advise patients, and collaborate with the treating physician. Integration of patient self-management and professional care by means of eHealth key into well-known barriers and seem promising in improving cancer pain follow-up. Nurses are able to make substantial contributions because of their expertise, focus on daily living, and their bridging function between patients and health professionals in different care settings. Insights from the intervention development as well as the intervention content give thought for applications in different patients and care settings. Copyright © 2017 Elsevier Inc. All rights reserved.

What qualitative research can contribute to a randomized controlled trial of a complex community intervention.

PubMed

Nelson, Geoffrey; Macnaughton, Eric; Goering, Paula

2015-11-01

Using the case of a large-scale, multi-site Canadian Housing First research demonstration project for homeless people with mental illness, At Home/Chez Soi, we illustrate the value of qualitative methods in a randomized controlled trial (RCT) of a complex community intervention. We argue that quantitative RCT research can neither capture the complexity nor tell the full story of a complex community intervention. We conceptualize complex community interventions as having multiple phases and dimensions that require both RCT and qualitative research components. Rather than assume that qualitative research and RCTs are incommensurate, a more pragmatic mixed methods approach was used, which included using both qualitative and quantitative methods to understand program implementation and outcomes. At the same time, qualitative research was used to examine aspects of the intervention that could not be understood through the RCT, such as its conception, planning, sustainability, and policy impacts. Through this example, we show how qualitative research can tell a more complete story about complex community interventions. Copyright © 2015 Elsevier Inc. All rights reserved.

Defining the Relationship Between Human Error Classes and Technology Intervention Strategies

NASA Technical Reports Server (NTRS)

Wiegmann, Douglas A.; Rantanen, Eas M.

2003-01-01

The modus operandi in addressing human error in aviation systems is predominantly that of technological interventions or fixes. Such interventions exhibit considerable variability both in terms of sophistication and application. Some technological interventions address human error directly while others do so only indirectly. Some attempt to eliminate the occurrence of errors altogether whereas others look to reduce the negative consequences of these errors. In any case, technological interventions add to the complexity of the systems and may interact with other system components in unforeseeable ways and often create opportunities for novel human errors. Consequently, there is a need to develop standards for evaluating the potential safety benefit of each of these intervention products so that resources can be effectively invested to produce the biggest benefit to flight safety as well as to mitigate any adverse ramifications. The purpose of this project was to help define the relationship between human error and technological interventions, with the ultimate goal of developing a set of standards for evaluating or measuring the potential benefits of new human error fixes.

How Effective Is Peer Education in Addressing Young People's Sexual and Reproductive Health Needs in Developing Countries?

ERIC Educational Resources Information Center

Price, Neil; Knibbs, Sarah

2009-01-01

This review article questions the assumptions at the core of peer education interventions adopted in young people's sexual and reproductive health programmes in developing countries. Peer education is a more complex and problematic approach than its popularity with development agencies and practitioners implies. Its rise to prominence is more…

Implementing a Complex Intervention to Support Personal Recovery: A Qualitative Study Nested within a Cluster Randomised Controlled Trial

PubMed Central

Leamy, Mary; Clarke, Eleanor; Le Boutillier, Clair; Bird, Victoria; Janosik, Monika; Sabas, Kai; Riley, Genevieve; Williams, Julie; Slade, Mike

2014-01-01

Objective To investigate staff and trainer perspectives on the barriers and facilitators to implementing a complex intervention to help staff support the recovery of service users with a primary diagnosis of psychosis in community mental health teams. Design Process evaluation nested within a cluster randomised controlled trial (RCT). Participants 28 interviews with mental health care staff, 3 interviews with trainers, 4 focus groups with intervention teams and 28 written trainer reports. Setting 14 community-based mental health teams in two UK sites (one urban, one semi-rural) who received the intervention. Results The factors influencing the implementation of the intervention can be organised under two over-arching themes: Organisational readiness for change and Training effectiveness. Organisational readiness for change comprised three sub-themes: NHS Trust readiness; Team readiness; and Practitioner readiness. Training effectiveness comprised three sub-themes: Engagement strategies; Delivery style and Modelling recovery principles. Conclusions Three findings can inform future implementation and evaluation of complex interventions. First, the underlying intervention model predicted that three areas would be important for changing practice: staff skill development; intention to implement; and actual implementation behaviour. This study highlighted the importance of targeting the transition from practitioners' intent to implement to actual implementation behaviour, using experiential learning and target setting. Second, practitioners make inferences about organisational commitment by observing the allocation of resources, Knowledge Performance Indicators and service evaluation outcome measures. These need to be aligned with recovery values, principles and practice. Finally, we recommend the use of organisational readiness tools as an inclusion criteria for selecting both organisations and teams in cluster RCTs. We believe this would maximise the likelihood of adequate implementation and hence reduce waste in research expenditure. Trial Registration Controlled-Trials.com ISRCTN02507940 PMID:24875748

Implementing a complex intervention to support personal recovery: a qualitative study nested within a cluster randomised controlled trial.

PubMed

Leamy, Mary; Clarke, Eleanor; Le Boutillier, Clair; Bird, Victoria; Janosik, Monika; Sabas, Kai; Riley, Genevieve; Williams, Julie; Slade, Mike

2014-01-01

To investigate staff and trainer perspectives on the barriers and facilitators to implementing a complex intervention to help staff support the recovery of service users with a primary diagnosis of psychosis in community mental health teams. Process evaluation nested within a cluster randomised controlled trial (RCT). 28 interviews with mental health care staff, 3 interviews with trainers, 4 focus groups with intervention teams and 28 written trainer reports. 14 community-based mental health teams in two UK sites (one urban, one semi-rural) who received the intervention. The factors influencing the implementation of the intervention can be organised under two over-arching themes: Organisational readiness for change and Training effectiveness. Organisational readiness for change comprised three sub-themes: NHS Trust readiness; Team readiness; and Practitioner readiness. Training effectiveness comprised three sub-themes: Engagement strategies; Delivery style and Modelling recovery principles. Three findings can inform future implementation and evaluation of complex interventions. First, the underlying intervention model predicted that three areas would be important for changing practice: staff skill development; intention to implement; and actual implementation behaviour. This study highlighted the importance of targeting the transition from practitioners' intent to implement to actual implementation behaviour, using experiential learning and target setting. Second, practitioners make inferences about organisational commitment by observing the allocation of resources, Knowledge Performance Indicators and service evaluation outcome measures. These need to be aligned with recovery values, principles and practice. Finally, we recommend the use of organisational readiness tools as an inclusion criteria for selecting both organisations and teams in cluster RCTs. We believe this would maximise the likelihood of adequate implementation and hence reduce waste in research expenditure. Controlled-Trials.com ISRCTN02507940.

Forced displacement and women's security in Colombia.

PubMed

Meertens, Donny

2010-04-01

In the protracted Colombian conflict, assistance to internally displaced persons has developed in the context of contradictory political processes. The Colombian government's launching of a transitional justice process in the midst of armed conflict has generated a complex situation displaying both conflict and post-conflict characteristics. The progressive Constitutional Court rulings on internal displacement, in particular the gender-sensitive Auto 092, constitute an attempt to bring together humanitarian interventions and transitional justice measures in a rights-based framework. However, the national government is reluctant to adopt them fully and local realities still hamper their integrated implementation. Displaced women, therefore, remain in an especially vulnerable position. This paper argues that gender-sensitive humanitarian interventions must take into account all of these complexities of scale and political process in order to make legal frameworks more effective at the local level. In these contexts, interventions should pay particular attention to strategies that contribute to transforming pre-existing gender regimes.

Reporting of complex interventions in clinical trials: development of a taxonomy to classify and describe fall-prevention interventions.

PubMed

Lamb, Sarah E; Becker, Clemens; Gillespie, Lesley D; Smith, Jessica L; Finnegan, Susanne; Potter, Rachel; Pfeiffer, Klaus

2011-05-17

Interventions for preventing falls in older people often involve several components, multidisciplinary teams, and implementation in a variety of settings. We have developed a classification system (taxonomy) to describe interventions used to prevent falls in older people, with the aim of improving the design and reporting of clinical trials of fall-prevention interventions, and synthesis of evidence from these trials. Thirty three international experts in falls prevention and health services research participated in a series of meetings to develop consensus. Robust techniques were used including literature reviews, expert presentations, and structured consensus workshops moderated by experienced facilitators. The taxonomy was refined using an international test panel of five health care practitioners. We assessed the chance corrected agreement of the final version by comparing taxonomy completion for 10 randomly selected published papers describing a variety of fall-prevention interventions. The taxonomy consists of four domains, summarized as the "Approach", "Base", "Components" and "Descriptors" of an intervention. Sub-domains include; where participants are identified; the theoretical approach of the intervention; clinical targeting criteria; details on assessments; descriptions of the nature and intensity of interventions. Chance corrected agreement of the final version of the taxonomy was good to excellent for all items. Further independent evaluation of the taxonomy is required. The taxonomy is a useful instrument for characterizing a broad range of interventions used in falls prevention. Investigators are encouraged to use the taxonomy to report their interventions.

Reporting of complex interventions in clinical trials: development of a taxonomy to classify and describe fall-prevention interventions

PubMed Central

2011-01-01

Background Interventions for preventing falls in older people often involve several components, multidisciplinary teams, and implementation in a variety of settings. We have developed a classification system (taxonomy) to describe interventions used to prevent falls in older people, with the aim of improving the design and reporting of clinical trials of fall-prevention interventions, and synthesis of evidence from these trials. Methods Thirty three international experts in falls prevention and health services research participated in a series of meetings to develop consensus. Robust techniques were used including literature reviews, expert presentations, and structured consensus workshops moderated by experienced facilitators. The taxonomy was refined using an international test panel of five health care practitioners. We assessed the chance corrected agreement of the final version by comparing taxonomy completion for 10 randomly selected published papers describing a variety of fall-prevention interventions. Results The taxonomy consists of four domains, summarized as the "Approach", "Base", "Components" and "Descriptors" of an intervention. Sub-domains include; where participants are identified; the theoretical approach of the intervention; clinical targeting criteria; details on assessments; descriptions of the nature and intensity of interventions. Chance corrected agreement of the final version of the taxonomy was good to excellent for all items. Further independent evaluation of the taxonomy is required. Conclusions The taxonomy is a useful instrument for characterizing a broad range of interventions used in falls prevention. Investigators are encouraged to use the taxonomy to report their interventions. PMID:21586143

The food choice at work study: effectiveness of complex workplace dietary interventions on dietary behaviours and diet-related disease risk - study protocol for a clustered controlled trial

PubMed Central

2013-01-01

Background Dietary behaviour interventions have the potential to reduce diet-related disease. Ample opportunity exists to implement these interventions in the workplace. The overall aim is to assess the effectiveness and cost-effectiveness of complex dietary interventions focused on environmental dietary modification alone or in combination with nutrition education in large manufacturing workplace settings. Methods/design A clustered controlled trial involving four large multinational manufacturing workplaces in Cork will be conducted. The complex intervention design has been developed using the Medical Research Council’s framework and the National Institute for Health and Clinical Excellence (NICE) guidelines and will be reported using the TREND statement for the transparent reporting of evaluations with non-randomized designs. It will draw on a soft paternalistic “nudge” theoretical perspective. Nutrition education will include three elements: group presentations, individual nutrition consultations and detailed nutrition information. Environmental dietary modification will consist of five elements: (a) restriction of fat, saturated fat, sugar and salt, (b) increase in fibre, fruit and vegetables, (c) price discounts for whole fresh fruit, (d) strategic positioning of healthier alternatives and (e) portion size control. No intervention will be offered in workplace A (control). Workplace B will receive nutrition education. Workplace C will receive nutrition education and environmental dietary modification. Workplace D will receive environmental dietary modification alone. A total of 448 participants aged 18 to 64 years will be selected randomly. All permanent, full-time employees, purchasing at least one main meal in the workplace daily, will be eligible. Changes in dietary behaviours, nutrition knowledge, health status with measurements obtained at baseline and at intervals of 3 to 4 months, 7 to 9 months and 13 to 16 months will be recorded. A process evaluation and cost-effectiveness economic evaluation will be undertaken. Discussion A 'Food Choice at Work’ toolbox (concise teaching kit to replicate the intervention) will be developed to inform and guide future researchers, workplace stakeholders, policy makers and the food industry. Trial registration Current Controlled Trials, ISRCTN35108237 PMID:24192134

The food choice at work study: effectiveness of complex workplace dietary interventions on dietary behaviours and diet-related disease risk - study protocol for a clustered controlled trial.

PubMed

Geaney, Fiona; Scotto Di Marrazzo, Jessica; Kelly, Clare; Fitzgerald, Anthony P; Harrington, Janas M; Kirby, Ann; McKenzie, Ken; Greiner, Birgit; Perry, Ivan J

2013-11-06

Dietary behaviour interventions have the potential to reduce diet-related disease. Ample opportunity exists to implement these interventions in the workplace. The overall aim is to assess the effectiveness and cost-effectiveness of complex dietary interventions focused on environmental dietary modification alone or in combination with nutrition education in large manufacturing workplace settings. A clustered controlled trial involving four large multinational manufacturing workplaces in Cork will be conducted. The complex intervention design has been developed using the Medical Research Council's framework and the National Institute for Health and Clinical Excellence (NICE) guidelines and will be reported using the TREND statement for the transparent reporting of evaluations with non-randomized designs. It will draw on a soft paternalistic 'nudge' theoretical perspective. It will draw on a soft paternalistic "nudge" theoretical perspective. Nutrition education will include three elements: group presentations, individual nutrition consultations and detailed nutrition information. Environmental dietary modification will consist of five elements: (a) restriction of fat, saturated fat, sugar and salt, (b) increase in fibre, fruit and vegetables, (c) price discounts for whole fresh fruit, (d) strategic positioning of healthier alternatives and (e) portion size control. No intervention will be offered in workplace A (control). Workplace B will receive nutrition education. Workplace C will receive nutrition education and environmental dietary modification. Workplace D will receive environmental dietary modification alone. A total of 448 participants aged 18 to 64 years will be selected randomly. All permanent, full-time employees, purchasing at least one main meal in the workplace daily, will be eligible. Changes in dietary behaviours, nutrition knowledge, health status with measurements obtained at baseline and at intervals of 3 to 4 months, 7 to 9 months and 13 to 16 months will be recorded. A process evaluation and cost-effectiveness economic evaluation will be undertaken. A 'Food Choice at Work' toolbox (concise teaching kit to replicate the intervention) will be developed to inform and guide future researchers, workplace stakeholders, policy makers and the food industry. Current Controlled Trials, ISRCTN35108237.

A theory-informed approach to developing visually mediated interventions to change behaviour using an asthma and physical activity intervention exemplar.

PubMed

Murray, Jennifer; Williams, Brian; Hoskins, Gaylor; Skar, Silje; McGhee, John; Treweek, Shaun; Sniehotta, Falko F; Sheikh, Aziz; Brown, Gordon; Hagen, Suzanne; Cameron, Linda; Jones, Claire; Gauld, Dylan

2016-01-01

Visualisation techniques are used in a range of healthcare interventions. However, these frequently lack a coherent rationale or clear theoretical basis. This lack of definition and explicit targeting of the underlying mechanisms may impede the success of and evaluation of the intervention. We describe the theoretical development, deployment, and pilot evaluation, of a complex visually mediated behavioural intervention. The exemplar intervention focused on increasing physical activity among young people with asthma. We employed an explicit five-stage development model, which was actively supported by a consultative user group. The developmental stages involved establishing the theoretical basis, establishing a narrative structure, visual rendering, checking interpretation, and pilot testing. We conducted in-depth interviews and focus groups during early development and checking, followed by an online experiment for pilot testing. A total of 91 individuals, including young people with asthma, parents, teachers, and health professionals, were involved in development and testing. Our final intervention consisted of two components: (1) an interactive 3D computer animation to create intentions and (2) an action plan and volitional help sheet to promote the translation of intentions to behaviour. Theory was mediated throughout by visual and audio forms. The intervention was regarded as highly acceptable, engaging, and meaningful by all stakeholders. The perceived impact on asthma understanding and intentions was reported positively, with most individuals saying that the 3D computer animation had either clarified a range of issues or made them more real. Our five-stage model underpinned by extensive consultation worked well and is presented as a framework to support explicit decision-making for others developing theory informed visually mediated interventions. We have demonstrated the ability to develop theory-based visually mediated behavioural interventions. However, attention needs to be paid to the potential ambiguity associated with images and thus the concept of visual literacy among patients. Our revised model may be helpful as a guide to aid development, acceptability, and ultimately effectiveness.

Evaluating Educational Interventions That Induce Service Receipt: A Case Study Application of "City Connects"

ERIC Educational Resources Information Center

Bowden, A. Brooks; Shand, Robert; Belfield, Clive R.; Wang, Anyi; Levin, Henry M.

2017-01-01

Educational interventions are complex: Often they combine a diagnostic component (identifying student need) with a service component (ensuring appropriate educational resources are provided). This complexity raises challenges for program evaluation. These interventions, which we refer to as "service mediation interventions," affect…

Effectiveness of exercise intervention on improving fundamental movement skills and motor coordination in overweight/obese children and adolescents: A systematic review.

PubMed

Han, Ahreum; Fu, Allan; Cobley, Stephen; Sanders, Ross H

2018-01-01

Childhood obesity is negatively associated with fundamental movement skill and motor coordination, which in turn constrains physical activity participation and adherence thereby forming a 'vicious cycle'. However, developing motor skill and coordination in childhood could help to break the vicious cycle to reduce childhood obesity. The objective of this systematic review was to determine the effectiveness of exercise and physical activity interventions on improving fundamental movement skill and motor coordination in overweight/obese children and adolescents. A systematic review with quality assessment. A comprehensive systematic search was conducted from MEDLINE, SPORTDiscus, CINAHL, Scopus, Web of Science, EMBASE without date restriction for randomized control trials, interventions or longitudinal studies of movement skill/motor skill/motor coordination in overweight/obese participants between 0-18 years of age. A total of 3944 publications were screened, and 17 published studies were included. Altogether 38 tests for locomotor, object-control, balance and complex task tests were examined in selected studies, with 33 reporting increases after interventions, while only five tests indicated no change. The evidence strongly suggests that exercise/physical activity interventions were effective in improving locomotor skill, object-control skill and complex tasks in overweight/obese peers. However, the results for balance were equivocal. Results from existing studies suggest overweight/obese peers have lower levels of fundamental movement skill than their healthy weight peers. However, exercise/physical activity interventions are effective in improving their skills. To maximize skill improvement, we recommend focused fundamental movement skill and motor coordination activities for skill development. These progressions in interventions may help break the vicious cycle of childhood obesity. Copyright © 2017 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Sapphire implant based neuro-complex for deep-lying brain tumors phototheranostics

NASA Astrophysics Data System (ADS)

Sharova, A. S.; Maklygina, YU S.; Yusubalieva, G. M.; Shikunova, I. A.; Kurlov, V. N.; Loschenov, V. B.

2018-01-01

The neuro-complex as a combination of sapphire implant optical port and osteoplastic biomaterial "Collapan" as an Aluminum phthalocyanine nanoform photosensitizer (PS) depot was developed within the framework of this study. The main goals of such neuro-complex are to provide direct access of laser radiation to the brain tissue depth and to transfer PS directly to the pathological tissue location that will allow multiple optical phototheranostics of the deep-lying tumor region without repeated surgical intervention. The developed complex spectral-optical properties research was carried out by photodiagnostics method using the model sample: a brain tissue phantom. The optical transparency of sapphire implant allows obtaining a fluorescent signal with high accuracy, comparable to direct measurement "in contact" with the tissue.

Impact of nutrition interventions on pediatric mortality and nutrition outcomes in humanitarian emergencies: A systematic review.

PubMed

Balhara, Kamna S; Silvestri, David M; Tyler Winders, W; Selvam, Anand; Kivlehan, Sean M; Becker, Torben K; Levine, Adam C

2017-12-01

Malnutrition contributes to paediatric morbidity and mortality in disasters and complex emergencies, but summary data describing specific nutritional interventions in these settings are lacking. This systematic review aimed to characterise such interventions and their effects on paediatric mortality, anthropometric measures and serum markers of nutrition. A systematic search of OVID MEDLINE, Cochrane Library and relevant grey literature was conducted. We included all randomised controlled trials and observational controlled studies evaluating effectiveness of nutritional intervention(s) on defined health outcomes in children and adolescents (0-18 years) within a disaster or complex emergency. We extracted study characteristics, interventions and outcomes data. Study quality was assessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria. A total of 31 studies met inclusion criteria. Most were conducted in Africa (17), during periods of conflict or hunger gaps (14), and evaluated micronutrient supplementation (14) or selective feeding (10). Overall study quality was low, with only two high and four moderate quality studies. High- and medium-quality studies demonstrated positive impact of fortified spreads, ready-to-use therapeutic foods, micronutrient supplementation, and food and cash transfers. In disasters and complex emergencies, high variability and low quality of controlled studies on paediatric malnutrition limit meaningful data aggregation. If existing research gaps are to be addressed, the inherent unpredictability of humanitarian emergencies and ethical considerations regarding controls may warrant a paradigm shift in what constitutes adequate methods. Periodic hunger gaps may offer a generalisable opportunity for robust trials, but consensus on meaningful nutritional endpoints is needed. © 2017 John Wiley & Sons Ltd.

Prevention of overweight and obesity in early life.

PubMed

Lanigan, Julie

2018-05-29

Childhood obesity is a serious challenge for public health. The problem begins early with most excess childhood weight gained before starting school. In 2016, the WHO estimated that 41 million children under 5 were overweight or obese. Once established, obesity is difficult to reverse, likely to persist into adult life and is associated with increased risk of CVD, type 2 diabetes and certain cancers. Preventing obesity is therefore of high importance. However, its development is multi-factorial and prevention is a complex challenge. Modifiable lifestyle behaviours such as diet and physical activity are the most well-known determinants of obesity. More recently, early-life factors have emerged as key influencers of obesity in childhood. Understanding risk factors and how they interact is important to inform interventions that aim to prevent obesity in early childhood. Available evidence supports multi-component interventions as effective in obesity prevention. However, relatively few interventions are available in the UK and only one, TrimTots, has been evaluated in randomised controlled trials and shown to be effective at reducing obesity risk in preschool children (age 1-5 years). BMI was lower in children immediately after completing TrimTots compared with waiting list controls and this effect was sustained at long-term follow-up, 2 years after completion. Developing and evaluating complex interventions for obesity prevention is a challenge for clinicians and researchers. In addition, parents encounter barriers engaging with interventions. This review considers early-life risk factors for obesity, highlights evidence for preventative interventions and discusses barriers and facilitators to their success.

Community embedded reproductive health interventions for adolescents in Latin America: development and evaluation of a complex multi-centre intervention

PubMed Central

2013-01-01

Background Adolescents in Latin America are at high risk for unwanted and unplanned pregnancies, which often result in unsafe abortions or poor maternal health outcomes. Both young men and women in the region face an increased risk of sexually transmitted infections due to inadequate sexual and reproductive health information, services and counselling. To date, many adolescent health programmes have targeted a single determinant of sexual and reproductive health. However, recent evidence suggests that the complexity of sexual and reproductive health issues demands an equally multi-layered and comprehensive approach. Methods This article describes the development, implementation and evaluation design of the community-embedded reproductive health care for adolescents (CERCA) study in three Latin American cities: Cochabamba (Bolivia), Cuenca (Ecuador) and Managua (Nicaragua). Project CERCA’s research methodology builds on existing methodological frameworks, namely: action research, community based participatory research and intervention-mapping. The interventions in each country address distinct target groups (adolescents, parents, local authorities and health providers) and seek improvement of the following sexual health behaviours: communication about sexuality, sexual and reproductive health information-seeking, access to sexual and reproductive health care and safe sexual relationships. In Managua, we implemented a randomised controlled study, and in Cochabamba and Cuenca we adopted a non-randomised controlled study to evaluate the effectiveness of Project CERCA interventions, in addition to a process evaluation. Discussion This research will result in a methodological framework that will contribute to the improved design and implementation of future adolescent sexual and reproductive health interventions. Trial registration ClinicalTrials.gov (NCT01722084) PMID:23311647

Exploring complex causal pathways between urban renewal, health and health inequality using a theory-driven realist approach.

PubMed

Mehdipanah, Roshanak; Manzano, Ana; Borrell, Carme; Malmusi, Davide; Rodriguez-Sanz, Maica; Greenhalgh, Joanne; Muntaner, Carles; Pawson, Ray

2015-01-01

Urban populations are growing and to accommodate these numbers, cities are becoming more involved in urban renewal programs to improve the physical, social and economic conditions in different areas. This paper explores some of the complexities surrounding the link between urban renewal, health and health inequalities using a theory-driven approach. We focus on an urban renewal initiative implemented in Barcelona, the Neighbourhoods Law, targeting Barcelona's (Spain) most deprived neighbourhoods. We present evidence from two studies on the health evaluation of the Neighbourhoods Law, while drawing from recent urban renewal literature, to follow a four-step process to develop a program theory. We then use two specific urban renewal interventions, the construction of a large central plaza and the repair of streets and sidewalks, to further examine this link. In order for urban renewal programs to affect health and health inequality, neighbours must use and adapt to the changes produced by the intervention. However, there exist barriers that can result in negative outcomes including factors such as accessibility, safety and security. This paper provides a different perspective to the field that is largely dominated by traditional quantitative studies that are not always able to address the complexities such interventions provide. Furthermore, the framework and discussions serve as a guide for future research, policy development and evaluation. Copyright © 2014 Elsevier Ltd. All rights reserved.

Validation and Verification of Future Integrated Safety-Critical Systems Operating under Off-Nominal Conditions

NASA Technical Reports Server (NTRS)

Belcastro, Christine M.

2010-01-01

Loss of control remains one of the largest contributors to aircraft fatal accidents worldwide. Aircraft loss-of-control accidents are highly complex in that they can result from numerous causal and contributing factors acting alone or (more often) in combination. Hence, there is no single intervention strategy to prevent these accidents and reducing them will require a holistic integrated intervention capability. Future onboard integrated system technologies developed for preventing loss of vehicle control accidents must be able to assure safe operation under the associated off-nominal conditions. The transition of these technologies into the commercial fleet will require their extensive validation and verification (V and V) and ultimate certification. The V and V of complex integrated systems poses major nontrivial technical challenges particularly for safety-critical operation under highly off-nominal conditions associated with aircraft loss-of-control events. This paper summarizes the V and V problem and presents a proposed process that could be applied to complex integrated safety-critical systems developed for preventing aircraft loss-of-control accidents. A summary of recent research accomplishments in this effort is also provided.

Using an Adaptive Expertise Lens to Understand the Quality of Teachers' Classroom Implementation of Computer-Supported Complex Systems Curricula in High School Science

ERIC Educational Resources Information Center

Yoon, Susan A.; Koehler-Yom, Jessica; Anderson, Emma; Lin, Joyce; Klopfer, Eric

2015-01-01

Background: This exploratory study is part of a larger-scale research project aimed at building theoretical and practical knowledge of complex systems in students and teachers with the goal of improving high school biology learning through professional development and a classroom intervention. Purpose: We propose a model of adaptive expertise to…

Strengthening the evidence base for health programming in humanitarian crises.

PubMed

Ager, A; Burnham, G; Checchi, F; Gayer, M; Grais, R F; Henkens, M; Massaquoi, M B F; Nandy, R; Navarro-Colorado, C; Spiegel, P

2014-09-12

Given the growing scale and complexity of responses to humanitarian crises, it is important to develop a stronger evidence base for health interventions in such contexts. Humanitarian crises present unique challenges to rigorous and effective research, but there are substantial opportunities for scientific advance. Studies need to focus where the translation of evidence from noncrisis scenarios is not viable and on ethical ways of determining what happens in the absence of an intervention. Robust methodologies suited to crisis settings have to be developed and used to assess interventions with potential for delivery at scale. Strengthening research capacity in the low- to middle-income countries that are vulnerable to crises is also crucial. Copyright © 2014, American Association for the Advancement of Science.

Probabilistic cost-benefit analysis of disaster risk management in a development context.

PubMed

Kull, Daniel; Mechler, Reinhard; Hochrainer-Stigler, Stefan

2013-07-01

Limited studies have shown that disaster risk management (DRM) can be cost-efficient in a development context. Cost-benefit analysis (CBA) is an evaluation tool to analyse economic efficiency. This research introduces quantitative, stochastic CBA frameworks and applies them in case studies of flood and drought risk reduction in India and Pakistan, while also incorporating projected climate change impacts. DRM interventions are shown to be economically efficient, with integrated approaches more cost-effective and robust than singular interventions. The paper highlights that CBA can be a useful tool if certain issues are considered properly, including: complexities in estimating risk; data dependency of results; negative effects of interventions; and distributional aspects. The design and process of CBA must take into account specific objectives, available information, resources, and the perceptions and needs of stakeholders as transparently as possible. Intervention design and uncertainties should be qualified through dialogue, indicating that process is as important as numerical results. © 2013 The Author(s). Journal compilation © Overseas Development Institute, 2013.

Aboriginal Suicidal Behaviour Research: From Risk Factors to Culturally-Sensitive Interventions

PubMed Central

Katz, Laurence Y.; Elias, Brenda; O’Neil, John; Enns, Murray; Cox, Brian J.; Belik, Shay-Lee; Sareen, Jitender

2006-01-01

Introduction There is a significant amount of research demonstrating that the rate of completed suicide among Aboriginal populations is much higher than in the general population. Unfortunately, there is a paucity of research evaluating the risk factors for completed suicide and suicidal behavior in this population. There is an even greater shortage of research on evidence-based interventions for suicidal behaviour. Method A literature review was conducted to facilitate the development of an approach to the study of this complex problem. Results An approach to developing a research program that informs each step of the process with evidence from the previous steps was developed. The study of risk factors and interventions is described. Conclusions Research into the risk factors and evidence-based interventions for Aboriginal suicidal behavior are required. A programmatic approach is described in detail in this paper. It is hoped this informed approach would systematically address this important public health issue that afflicts a significant proportion of the Canadian population. PMID:18392204

Development of a peer-supported, self-management intervention for people following mental health crisis.

PubMed

Milton, Alyssa; Lloyd-Evans, Brynmor; Fullarton, Kate; Morant, Nicola; Paterson, Bethan; Hindle, David; Kelly, Kathleen; Mason, Oliver; Lambert, Marissa; Johnson, Sonia

2017-11-09

A documented gap in support exists for service users following discharge from acute mental health services, and structured interventions to reduce relapse are rarely provided. Peer-facilitated self-management interventions have potential to meet this need, but evidence for their effectiveness is limited. This paper describes the development of a peer-provided self-management intervention for mental health service users following discharge from crisis resolution teams (CRTs). A five-stage iterative mixed-methods approach of sequential data collection and intervention development was adopted, following the development and piloting stages of the MRC framework for developing and evaluating complex interventions. Evidence review (stage 1) included systematic reviews of both peer support and self-management literature. Interviews with CRT service users (n = 41) regarding needs and priorities for support following CRT discharge were conducted (stage 2). Focus group consultations (n = 12) were held with CRT service-users, staff and carers to assess the acceptability and feasibility of a proposed intervention, and to refine intervention organisation and content (stage 3). Qualitative evaluation of a refined, peer-provided, self-management intervention involved qualitative interviews with CRT service user participants (n = 9; n = 18) in feasibility testing (stage 4) and a pilot trial (stage 5), and a focus group at each stage with the peer worker providers (n = 4). Existing evidence suggests self-management interventions can reduce relapse and improve recovery. Initial interviews and focus groups indicated support for the overall purpose and planned content of a recovery-focused self-management intervention for people leaving CRT care adapted from an existing resource: The personal recovery plan (developed by Repper and Perkins), and for peer support workers (PSWs) as providers. Participant feedback after feasibility testing was positive regarding facilitation of the intervention by PSWs; however, the structured self-management booklet was underutilised. Modifications to the self-management intervention manual and PSWs' training were made before piloting, which confirmed the acceptability and feasibility of the intervention for testing in a future, definitive trial. A manualised intervention and operating procedures, focusing on the needs and priorities of the target client group, have been developed through iterative stages of intervention development and feedback for testing in a trial context. Trial Registration ISRCTN01027104 date of registration: 11/10/2012.

Interventions to support people with dementia and their caregivers during the transition from home care to nursing home care: A systematic review.

PubMed

Müller, Christian; Lautenschläger, Sindy; Meyer, Gabriele; Stephan, Astrid

2017-06-01

During the transition of people with dementia from home to nursing home family caregivers often feel burdened. We aimed to 1) identify interventions which support people with dementia and their caregivers in the transition from home care to nursing home care, 2) synthesize the evidence for efficacy of these interventions, and 3) examine whether the identified interventions have been systematically developed, evaluated and implemented according to the Medical Research Council guidance on complex interventions. A systematic review of randomised controlled trials was conducted according to the recommendations specified in the Cochrane Handbook for Intervention Reviews. The review protocol was registered in PROSPERO (2015: CRD42015019839). Reporting follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses: the PRISMA statement. MEDLINE, CENTRAL, PsycINFO, CINAHL, OTseeker, and PEDro, were searched. Other sources included Google Scholar, and ALOIS. Two reviewers independently assessed the eligibility of the articles. Data extraction was performed by one reviewer and verified independently by another. The Cochrane Risk of Bias tool was used for critical appraisal. Development and evaluation of the identified interventions were assessed, taking the Medical Research Council guidance into account. Review findings were synthesized narratively. The search yielded 1278 records. Five studies were included, all conducted in the United States (4 RCTs and 1 cRCT with a total of 695 participants). The psychosocial interventions were individual and family counseling via telephone or ad hoc all of which addressed only informal caregivers. The intervention components, content and mode of delivery differed widely with inconsistent results. Significant intervention effects were found for the reduction of caregivers' depressive symptoms, burden, feeling of guilt, emotional distress, overload, and interactions with staff. Other outcomes, i.e. stress, placement adaptation, role overload, and role captivity, were not statistically significantly affected. The assessment for bias risk across studies varied from moderate to low. Only two studies tested the feasibility of the intervention before full scale evaluation, none evaluated the implementation process according to the Medical Research Council framework. We identified only a few studies with heterogeneous outcomes; evidence regarding the effectiveness of psychosocial interventions is thus insufficient. Further research is needed focusing on the development and evaluation of complex psychosocial interventions and more well-designed RCTs with larger sample sizes based on a rigorous methodology. Reporting on feasibility and implementation processes of interventions should be guaranteed, since it is crucial to evaluate transferability across care settings. Copyright © 2017 Elsevier Ltd. All rights reserved.

Consensus Statement of Standards for Interventional Cardiovascular Nursing Practice.

PubMed

White, Kevin; Macfarlane, Heather; Hoffmann, Bernadette; Sirvas-Brown, Helene; Hines, Kathryn; Rolley, John Xavier; Graham, Sandi

2018-05-01

Interventional cardiovascular nursing is a critical care nursing specialty providing complex nursing interventions to patients prone to clinical deterioration, through the combined risks of the pathophysiology of their illness and undergoing technically complex interventional cardiovascular procedures. No guidelines were identified worldwide to assist health care providers and educational institutions in workforce development and education guidelines to minimise patients' risk of adverse events. The Interventional Nurses Council (INC) developed a definition and scope of practice for interventional cardiac nursing (ICN's) in 2013. The INC executive committee established a working party of seven representatives from Australia and New Zealand. Selection was based on expertise in interventional cardiovascular nursing and experience providing education and mentoring in the clinical and postgraduate environment. A literature search of the electronic databases Science Direct, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Medline and Health Source was performed, using the search terms: clinical deterioration, ST elevation myocardial infarction, vital signs, primary percutaneous coronary intervention, PCI, AMI, STEMI, acute coronary syndrome, peri-procedural care, unstable angina, PCI complications, structural heart disease, TAVI, TAVR, cardiac rhythm management, pacing, electrophysiology studies, vascular access, procedural sedation. Articles were limited to the cardiac catheterisation laboratory and relevance to nursing based outcomes. Reference lists were examined to identify relevant articles missed in the initial search. The literature was compared with national competency standards, quality and safety documents and the INC definition and scope of practice. Consensus of common themes, a taxonomy of education and seven competency domains were achieved via frequent teleconferences and two face-to-face meetings. The working party finalised the standards on 14 July 2017, following endorsement from the CSANZ, INC, Heart Rhythm Council, CSANZ Quality Standards Committee and the Australian College of Critical Care Nurses (ACCCN). The resulting document provides clinical practice and education standards for interventional cardiac nursing practice. Copyright © 2017. Published by Elsevier B.V.

Capturing the experiences of patients across multiple complex interventions: a meta-qualitative approach

PubMed Central

Webster, Fiona; Christian, Jennifer; Mansfield, Elizabeth; Bhattacharyya, Onil; Hawker, Gillian; Levinson, Wendy; Naglie, Gary; Pham, Thuy-Nga; Rose, Louise; Schull, Michael; Sinha, Samir; Stergiopoulos, Vicky; Upshur, Ross; Wilson, Lynn

2015-01-01

Objectives The perspectives, needs and preferences of individuals with complex health and social needs can be overlooked in the design of healthcare interventions. This study was designed to provide new insights on patient perspectives drawing from the qualitative evaluation of 5 complex healthcare interventions. Setting Patients and their caregivers were recruited from 5 interventions based in primary, hospital and community care in Ontario, Canada. Participants We included 62 interviews from 44 patients and 18 non-clinical caregivers. Intervention Our team analysed the transcripts from 5 distinct projects. This approach to qualitative meta-evaluation identifies common issues described by a diverse group of patients, therefore providing potential insights into systems issues. Outcome measures This study is a secondary analysis of qualitative data; therefore, no outcome measures were identified. Results We identified 5 broad themes that capture the patients’ experience and highlight issues that might not be adequately addressed in complex interventions. In our study, we found that: (1) the emergency department is the unavoidable point of care; (2) patients and caregivers are part of complex and variable family systems; (3) non-medical issues mediate patients’ experiences of health and healthcare delivery; (4) the unanticipated consequences of complex healthcare interventions are often the most valuable; and (5) patient experiences are shaped by the healthcare discourses on medically complex patients. Conclusions Our findings suggest that key assumptions about patients that inform intervention design need to be made explicit in order to build capacity to better understand and support patients with multiple chronic diseases. Across many health systems internationally, multiple models are being implemented simultaneously that may have shared features and target similar patients, and a qualitative meta-evaluation approach, thus offers an opportunity for cumulative learning at a system level in addition to informing intervention design and modification. PMID:26351182

Development and testing of an implementation strategy for a complex housing intervention: protocol for a mixed methods study.

PubMed

Watson, Dennis P; Young, Jeani; Ahonen, Emily; Xu, Huiping; Henderson, Macey; Shuman, Valery; Tolliver, Randi

2014-10-17

There is currently a lack of scientifically designed and tested implementation strategies. Such strategies are particularly important for highly complex interventions that require coordination between multiple parts to be successful. This paper presents a protocol for the development and testing of an implementation strategy for a complex intervention known as the Housing First model (HFM). Housing First is an evidence-based practice for chronically homeless individuals demonstrated to significantly improve a number of outcomes. Drawing on practices demonstrated to be useful in implementation and e-learning theory, our team is currently adapting a face-to-face implementation strategy so that it can be delivered over a distance. Research activities will be divided between Chicago and Central Indiana, two areas with significantly different barriers to HFM implementation. Ten housing providers (five from Chicago and five from Indiana) will be recruited to conduct an alpha test of each of four e-learning modules as they are developed. Providers will be requested to keep a detailed log of their experience completing the modules and participate in one of two focus groups. After refining the modules based on alpha test results, we will test the strategy among a sample of four housing organizations (two from Chicago and two from Indiana). We will collect and analyze both qualitative and quantitative data from administration and staff. Measures of interest include causal factors affecting implementation, training outcomes, and implementation outcomes. This project is an important first step in the development of an evidence-based implementation strategy to increase scalability and impact of the HFM. The project also has strong potential to increase limited scientific knowledge regarding implementation strategies in general.

Behaviour change techniques: the development and evaluation of a taxonomic method for reporting and describing behaviour change interventions (a suite of five studies involving consensus methods, randomised controlled trials and analysis of qualitative data).

PubMed

Michie, Susan; Wood, Caroline E; Johnston, Marie; Abraham, Charles; Francis, Jill J; Hardeman, Wendy

2015-11-01

Meeting global health challenges requires effective behaviour change interventions (BCIs). This depends on advancing the science of behaviour change which, in turn, depends on accurate intervention reporting. Current reporting often lacks detail, preventing accurate replication and implementation. Recent developments have specified intervention content into behaviour change techniques (BCTs) - the 'active ingredients', for example goal-setting, self-monitoring of behaviour. BCTs are 'the smallest components compatible with retaining the postulated active ingredients, i.e. the proposed mechanisms of change. They can be used alone or in combination with other BCTs' (Michie S, Johnston M. Theories and techniques of behaviour change: developing a cumulative science of behaviour change. Health Psychol Rev 2012;6:1-6). Domain-specific taxonomies of BCTs have been developed, for example healthy eating and physical activity, smoking cessation and alcohol consumption. We need to build on these to develop an internationally shared language for specifying and developing interventions. This technology can be used for synthesising evidence, implementing effective interventions and testing theory. It has enormous potential added value for science and global health. (1) To develop a method of specifying content of BCIs in terms of component BCTs; (2) to lay a foundation for a comprehensive methodology applicable to different types of complex interventions; (3) to develop resources to support application of the taxonomy; and (4) to achieve multidisciplinary and international acceptance for future development. Four hundred participants (systematic reviewers, researchers, practitioners, policy-makers) from 12 countries engaged in investigating, designing and/or delivering BCIs. Development of the taxonomy involved a Delphi procedure, an iterative process of revisions and consultation with 41 international experts; hierarchical structure of the list was developed using inductive 'bottom-up' and theory-driven 'top-down' open-sort procedures (n = 36); training in use of the taxonomy (1-day workshops and distance group tutorials) (n = 161) was evaluated by changes in intercoder reliability and validity (agreement with expert consensus); evaluating the taxonomy for coding interventions was assessed by reliability (intercoder; test-retest) and validity (n = 40 trained coders); and evaluating the taxonomy for writing descriptions was assessed by reliability (intercoder; test-retest) and by experimentally testing its value (n = 190). Ninety-three distinct, non-overlapping BCTs with clear labels and definitions formed Behaviour Change Technique Taxonomy version 1 (BCTTv1). BCTs clustered into 16 groupings using a 'bottom-up' open-sort procedure; there was overlap between these and groupings produced by a theory-driven, 'top-down' procedure. Both training methods improved validity (both p < 0.05), doubled the proportion of coders achieving competence and improved confidence in identifying BCTs in workshops (both p < 0.001) but did not improve intercoder reliability. Good intercoder reliability was observed for 80 of the 93 BCTs. Good within-coder agreement was observed after 1 month (p < 0.001). Validity was good for 14 of 15 BCTs in the descriptions. The usefulness of BCTTv1 to report descriptions of observed interventions had mixed results. The developed taxonomy (BCTTv1) provides a methodology for identifying content of complex BCIs and a foundation for international cross-disciplinary collaboration for developing more effective interventions to improve health. Further work is needed to examine its usefulness for reporting interventions. This project was funded by the Medical Research Council Ref: G0901474/1. Funding also came from the Peninsula Collaboration for Leadership in Applied Health Research and Care.

A decision-support tool to inform Australian strategies for preventing suicide and suicidal behaviour.

PubMed

Page, Andrew; Atkinson, Jo-An; Heffernan, Mark; McDonnell, Geoff; Hickie, Ian

2017-04-27

Dynamic simulation modelling is increasingly being recognised as a valuable decision-support tool to help guide investments and actions to address complex public health issues such as suicide. In particular, participatory system dynamics (SD) modelling provides a useful tool for asking high-level 'what if' questions, and testing the likely impacts of different combinations of policies and interventions at an aggregate level before they are implemented in the real world. We developed an SD model for suicide prevention in Australia, and investigated the hypothesised impacts over the next 10 years (2015-2025) of a combination of current intervention strategies proposed for population interventions in Australia: 1) general practitioner (GP) training, 2) coordinated aftercare in those who have attempted suicide, 3) school-based mental health literacy programs, 4) brief-contact interventions in hospital settings, and 5) psychosocial treatment approaches. Findings suggest that the largest reductions in suicide were associated with GP training (6%) and coordinated aftercare approaches (4%), with total reductions of 12% for all interventions combined. This paper highlights the value of dynamic modelling methods for managing complexity and uncertainty, and demonstrates their potential use as a decision-support tool for policy makers and program planners for community suicide prevention actions.

What is the strength of evidence for heart failure disease-management programs?

PubMed

Clark, Alexander M; Savard, Lori A; Thompson, David R

2009-07-28

Heart failure (HF) disease-management programs are increasingly common. However, some large and recent trials of programs have not reported positive findings. There have also been parallel recent advances in reporting standards and theory around complex nonpharmacological interventions. These developments compel reconsideration in this Viewpoint of how research into HF-management programs should be evaluated, the quality, specificity, and usefulness of this evidence, and the recommendations for future research. Addressing the main determinants of intervention effectiveness by using the PICO (Patient, Intervention, Comparison, and Outcome) approach and the recent CONSORT (Consolidated Standards of Reporting Trials) statement on nonpharmacological trials, we will argue that in both current trials and meta-analyses, interventions and comparisons are not sufficiently well described; that complex programs have been excessively oversimplified; and that potentially salient differences in programs, populations, and settings are not incorporated into analyses. In preference to more general meta-analyses of programs, adequate descriptions are first needed of populations, interventions, comparisons, and outcomes in past and future trials. This could be achieved via a systematic survey of study authors based on the CONSORT statement. These more detailed data on studies should be incorporated into future meta-analyses of comparable trials and used with other techniques such as patient-based outcomes data and meta-regression. Although trials and meta-analyses continue to have potential to generate useful evidence, a more specific evidence base is needed to support the development of effective programs for different populations and settings.

Development and Nature of Preservice Chemistry Teachers' Pedagogical Content Knowledge for Nature of Science

ERIC Educational Resources Information Center

Demirdögen, Betül; Hanuscin, Deborah L.; Uzuntiryaki-Kondakci, Esen; Köseoglu, Fitnat

2016-01-01

The purpose of this case study is to delve into the complexities of the early development of preservice chemistry teachers' science teaching orientations, knowledge of learners, knowledge of instructional strategies, and knowledge of assessment during a two-semester intervention designed to enhance their pedagogical content knowledge (PCK) for…

Social Networks and Smoking: Exploring the Effects of Peer Influence and Smoker Popularity through Simulations

ERIC Educational Resources Information Center

Schaefer, David R.; adams, jimi; Haas, Steven A.

2013-01-01

Adolescent smoking and friendship networks are related in many ways that can amplify smoking prevalence. Understanding and developing interventions within such a complex system requires new analytic approaches. We draw on recent advances in dynamic network modeling to develop a technique that explores the implications of various intervention…

Equipping community pharmacy workers as agents for health behaviour change: developing and testing a theory-based smoking cessation intervention.

PubMed

Steed, Liz; Sohanpal, Ratna; James, Wai-Yee; Rivas, Carol; Jumbe, Sandra; Chater, Angel; Todd, Adam; Edwards, Elizabeth; Macneil, Virginia; Macfarlane, Fraser; Greenhalgh, Trisha; Griffiths, Chris; Eldridge, Sandra; Taylor, Stephanie; Walton, Robert

2017-08-11

To develop a complex intervention for community pharmacy staff to promote uptake of smoking cessation services and to increase quit rates. Following the Medical Research Council framework, we used a mixed-methods approach to develop, pilot and then refine the intervention. Phase I : We used information from qualitative studies in pharmacies, systematic literature reviews and the Capability, Opportunity, Motivation-Behaviour framework to inform design of the initial version of the intervention. Phase II : We then tested the acceptability of this intervention with smoking cessation advisers and assessed fidelity using actors who visited pharmacies posing as smokers, in a pilot study. Phase III : We reviewed the content and associated theory underpinning our intervention, taking account of the results of the earlier studies and a realist analysis of published literature. We then confirmed a logic model describing the intended operation of the intervention and used this model to refine the intervention and associated materials. Eight community pharmacies in three inner east London boroughs. 12 Stop Smoking Advisers. Two, 150 min, skills-based training sessions focused on communication and behaviour change skills with between session practice. The pilot study confirmed acceptability of the intervention and showed preliminary evidence of benefit; however, organisational barriers tended to limit effective operation. The pilot data and realist review pointed to additional use of Diffusion of Innovations Theory to seat the intervention in the wider organisational context. We have developed and refined an intervention to promote smoking cessation services in community pharmacies, which we now plan to evaluate in a randomised controlled trial. UKCRN ID 18446, Pilot. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

AAC technologies for young children with complex communication needs: state of the science and future research directions.

PubMed

Light, Janice; Drager, Kathryn

2007-09-01

Augmentative and alternative communication (AAC) technologies offer the potential to provide children who have complex communication needs with access to the magic and power of communication. This paper is intended to (a) summarize the research related to AAC technologies for young children who have complex communication needs; and (b) define priorities for future research to improve AAC technologies and interventions for children with complex communication needs. With the realization of improved AAC technologies, young children with complex communication needs will have better tools to maximize their development of communication, language, and literacy skills, and attain their full potential.

Factors influencing the introduction of physical activity interventions in primary health care: a qualitative study.

PubMed

Huijg, Johanna M; van der Zouwe, Nicolette; Crone, Mathilde R; Verheijden, Marieke W; Middelkoop, Barend J C; Gebhardt, Winifred A

2015-06-01

The introduction of efficacious physical activity (PA) interventions in routine primary health care (PHC) is a complex process. Understanding factors influencing the process can enhance the development of successful introduction strategies. The aim of this qualitative study was to explore stakeholders' perceptions on factors influencing the introduction, i.e., adoption, implementation, and continuation, of PA interventions in PHC. Twenty-eight semistructured interviews were held with intervention managers, PHC advisors, intervention providers, and referring general practitioners of five PA interventions delivered in PHC. A theoretical framework on the introduction of innovations in health care was used to guide the data collection. Influencing factors were identified using thematic analysis. Stakeholders reported preconditions for the introduction of PA interventions in PHC (e.g., support, resources, and networks and collaborations), in addition to characteristics of PA interventions (e.g., compatibility, flexibility, and intervention materials) and characteristics of PHC professionals (e.g., knowledge, positive attitudes, and beliefs about capabilities) perceived to enhance the introduction process. Furthermore, they proposed strategies for the development of PA interventions (e.g., involvement of future stakeholders, full development, and refinement) and strategies to introduce PA interventions in PHC (e.g., training, assistance, and reinforcement). The majority of the influencing factors were discussed specifically in relation to one or two stages. This study presents an overview of factors that are perceived to influence the introduction of PA interventions in PHC. It underscores the importance of taking these factors into account when designing introduction strategies and of giving special attention to the distinct stages of the process.

Evaluating an early intervention in psychosis service for 'high-risk' adolescents: symptomatic and social recovery outcomes.

PubMed

Lower, Rebecca; Wilson, Jonathan; Medin, Evelina; Corlett, Emma; Turner, Ruth; Wheeler, Karen; Fowler, David

2015-06-01

This study presents client characteristics and treatment outcomes for a group of young people seen by Central Norfolk Early Intervention Team (CNEIT). The team offers an intensive outreach model of treatment to young people with complex co-morbid emotional, behavioural and social problems, as well as the presence of psychotic symptoms. Outcomes include both client self-report and clinician-rated measures. Data are routinely collected at acceptance into service, after 12 months of service and at point of discharge. Data show that clients seen by the CNEIT youth team are a group of young people at high risk of developing long-term mental illness and social disability. Outcomes show significant reductions in not only psychotic symptomatology, but also co-morbid anxiety and depression, as well as improvements in social recovery. At the end of their time with the service, the majority of clients are discharged back to the care of their general practitioner, which indicates that the team successfully managed to reduce the complexity of needs and difficulties associated with this client group. Outcomes support the use of an intensive outreach approach for young people at high risk of developing psychotic disorders. It has been suggested that this model may be successfully broadened to young people with other emerging, potentially severe or complex mental disorders. Norfolk and Suffolk NHS Foundation Trust has built on the success of its youth early intervention team and innovatively redesigned its services in line with this model by developing a specific youth mental health service. © 2014 Wiley Publishing Asia Pty Ltd.

Dynamic simulation modelling of policy responses to reduce alcohol-related harms: rationale and procedure for a participatory approach.

PubMed

Atkinson, Jo-An; O'Donnell, Eloise; Wiggers, John; McDonnell, Geoff; Mitchell, Jo; Freebairn, Louise; Indig, Devon; Rychetnik, Lucie

2017-02-15

Development of effective policy responses to address complex public health problems can be challenged by a lack of clarity about the interaction of risk factors driving the problem, differing views of stakeholders on the most appropriate and effective intervention approaches, a lack of evidence to support commonly implemented and acceptable intervention approaches, and a lack of acceptance of effective interventions. Consequently, political considerations, community advocacy and industry lobbying can contribute to a hotly contested debate about the most appropriate course of action; this can hinder consensus and give rise to policy resistance. The problem of alcohol misuse and its associated harms in New South Wales (NSW), Australia, provides a relevant example of such challenges. Dynamic simulation modelling is increasingly being valued by the health sector as a robust tool to support decision making to address complex problems. It allows policy makers to ask 'what-if' questions and test the potential impacts of different policy scenarios over time, before solutions are implemented in the real world. Participatory approaches to modelling enable researchers, policy makers, program planners, practitioners and consumer representatives to collaborate with expert modellers to ensure that models are transparent, incorporate diverse evidence and perspectives, are better aligned to the decision-support needs of policy makers, and can facilitate consensus building for action. This paper outlines a procedure for embedding stakeholder engagement and consensus building in the development of dynamic simulation models that can guide the development of effective, coordinated and acceptable policy responses to complex public health problems, such as alcohol-related harms in NSW.

An Action Research to Optimize the Well-Being of Older People in Nursing Homes: Challenges and Strategies for Implementing a Complex Intervention.

PubMed

Bourbonnais, Anne; Ducharme, Francine; Landreville, Philippe; Michaud, Cécile; Gauthier, Marie-Andrée; Lavallée, Marie-Hélène

2018-03-01

Few studies have been conducted on strategies to promote the implementation of complex interventions in nursing homes (NHs). This article presents a pilot study intended to assess the strategies that would enable the optimal implementation of a complex intervention approach in NHs based on the meanings of screams of older people living with Alzheimer's disease. An action research approach was used with 19 formal and family caregivers from five NHs. Focus groups and individual interviews were held to assess different implementation strategies. A number of challenges were identified, as were strategies to overcome them. These latter included interactive training, intervention design, and external support. This study shows the feasibility of implementing a complex intervention to optimize older people's well-being. The article shares strategies that may promote the implementation of these types of interventions in NHs.

Aging, the Central Nervous System, and Mobility in Older Adults: Interventions

PubMed Central

Hausdorff, Jeffrey M.; Studenski, Stephanie A.; Rosano, Caterina; Camicioli, Richard; Alexander, Neil B.; Chen, Wen G.; Lipsitz, Lewis A.; Carlson, Michelle C.

2016-01-01

Background: Research suggests that the central nervous system (CNS) and mobility are closely linked. CNS-mediated mobility impairment may represent a potentially new and prevalent syndrome within the older adult populations. Interventions targeting this group may have the potential to improve mobility and cognition and prevent disability. Methods: In 2012, the Gerontological Society of America (GSA) and the National Institute on Aging (NIA) sponsored a 3-year conference workshop series, “Aging, the CNS, and Mobility.” The goal of this third and final conference was to (i) report on the state of the science of interventions targeting CNS-mediated mobility impairment among community-dwelling older adults and (ii) partnering with the NIA, explore the future of research and intervention design focused on a potentially novel aging syndrome. Results: Evidence was presented in five main intervention areas: (i) pharmacology and diet; (ii) exercise; (iii) electrical stimulation; (iv) sensory stimulation/deprivation; and (v) a combined category of multimodal interventions. Workshop participants identified important gaps in knowledge and key recommendations for future interventions related to recruitment and sample selection, intervention design, and methods to measure effectiveness. Conclusions: In order to develop effective preventive interventions for this prevalent syndrome, multidisciplinary teams are essential particularly because of the complex nature of the syndrome. Additionally, integrating innovative methods into the design of interventions may help researchers better measure complex mechanisms, and finally, the value of understanding the link between the CNS and mobility should be conveyed to researchers across disciplines in order to incorporate cognitive and mobility measurements into study protocols. PMID:27154905

Ethical issues in the development and implementation of nutrition-related public health policies and interventions: A scoping review

PubMed Central

Peña-Rosas, Juan Pablo; Saxena, Abha; Zamora, Gerardo

2017-01-01

Background The limited integration of ethics in nutrition-related public health policies and interventions is one major concern for those who have the task of implementing them. Ethical challenges that are overlooked during the development of such interventions could raise serious ethical issues during their implementation and even after. As a result, these decision makers need technical support and ethical guidance for adaptation of interventions to local (cultural, social, economic, etc.) contexts. Aim The goal of this scoping review is to delineate and “map” the range of ethical issues in nutrition-related public health interventions, as well as the range of the various fields in which they may arise. Methods A scoping review of empirical research and conceptual literature was conducted following the framework of Arksey and O’Malley. Searches using PubMed with Medical Subject Headings (MeSH) categories and Advanced Search Builder as well as in the Global Health Library were performed. The final sample consists of 169 publications. Results The ethics of public health prevention or treatment of obesity and non-communicable diseases is the most explicitly and frequently discussed subject. In comparison, ethical issues raised by public health interventions in the fields of undernutrition, breastfeeding, vitamin/mineral supplementation and food fortification, food security, food sustainability and food safety are addressed in a lower proportion of the sample. The results illustrate the various natures, types, and scopes of existing public health nutrition-related interventions, and the various ethical issues that may be raised by these interventions, in addition to the numerous and different contexts in which they may be implemented. Discussion The ethical issues faced in the development and implementation of nutrition-related public health interventions are varied and cannot be equated with, nor generalized about, when dealing with specific activities in this field. More importantly, these ethical issues cannot be managed without a careful consideration for the complexity of contexts in which nutrition-related interventions are expected to be implemented. These interventions engage a variety of actors with diverse perspectives and interests. We discuss these challenges and also comment on the importance of considering ethical impacts in the monitoring and evaluation of such interventions. Conclusion General ethical frameworks or recommendations–although useful–cannot be expected to provide policy makers, implementators and other public health personnel with sufficient practical ethical guidance as they cannot consider and anticipate the particularities of all specific nutrition-related public health interventions and the complexity of the contexts in which they are implemented. Further research is needed in order to develop more targeted ethical frameworks. PMID:29073186

Mediation, moderation, and context: Understanding complex relations among cognition, affect, and health behaviour.

PubMed

Kiviniemi, Marc T; Ellis, Erin M; Hall, Marissa G; Moss, Jennifer L; Lillie, Sarah E; Brewer, Noel T; Klein, William M P

2018-01-01

Researchers have historically treated cognition and affect as separate constructs in motivating health behaviour. We present a framework and empirical evidence for complex relations between cognition and affect in predicting health behaviour. Main Outcome, Design and Results: First, affect and cognition can mediate each other's relation to health behaviour. Second, affect and cognition can moderate the other's impact. Third, context can change the interplay of affect and cognition. Fourth, affect and cognition may be indelibly fused in some psychological constructs (e.g. worry, anticipated regret and reactance). These four propositions in our framework are not mutually exclusive. Examination of the types of complex relations described here can benefit theory development, empirical testing of theories and intervention design. Doing so will advance the understanding of mechanisms involved in regulation of health behaviours and the effectiveness of interventions to change health behaviours.

Telephone calls postdischarge from hospital to home: a literature review.

PubMed

Hand, Kristin E; Cunningham, Regina S

2014-02-01

The oncology population is particularly affected by hospital readmissions because hospitalized patients with cancer often have complex needs. The complexity and diversity of care requirements create substantial challenges in planning for appropriate postdischarge support. Implementing postdischarge telephone calls in the population of patients with cancer could offer a low-cost intervention to address the complex needs of patients during the transition from hospital to home. The goal of the current literature review is to provide an understanding about postdischarge telephone calls in patients with cancer. Findings from this review support the notion that discharge phone calls could improve care continuity for patients transitioning from hospital to home. The literature review outlines information related to telephone call content, timing, and structure for healthcare systems that want to use a postdischarge telephone intervention for patients with cancer. However, additional research is needed to develop and test cancer-specific protocols.

Putting people first: re-thinking the role of technology in augmentative and alternative communication intervention.

PubMed

Light, Janice; McNaughton, David

2013-12-01

Current technologies provide individuals with complex communication needs with a powerful array of communication, information, organization, and social networking options. However, there is the danger that the excitement over these new devices will result in a misplaced focus on the technology, to the neglect of what must be the central focus - the people with complex communication needs who require augmentative and alternative communication (AAC). In order to truly harness the power of technology, rehabilitation and educational professionals must ensure that AAC intervention is driven, not by the devices, but rather by the communication needs of the individual. Furthermore, those involved in AAC research and development activities must ensure that the design of AAC technologies is driven by an understanding of motor, sensory, cognitive, and linguistic processing, in order to minimize learning demands and maximize communication power for individuals with complex communication needs across the life span.

Complex self-management interventions in chronic disease unravelled: a review of lessons learned from an individual patient data meta-analysis.

PubMed

Jonkman, Nini H; Groenwold, Rolf H H; Trappenburg, Jaap C A; Hoes, Arno W; Schuurmans, Marieke J

2017-03-01

Meta-analyses using individual patient data (IPD) rather than aggregated data are increasingly applied to analyze sources of heterogeneity between trials and have only recently been applied to unravel multicomponent, complex interventions. This study reflects on methodological challenges encountered in two IPD meta-analyses on self-management interventions in patients with heart failure or chronic obstructive pulmonary disease. Critical reflection on prior IPD meta-analyses and discussion of literature. Experience from two IPD meta-analyses illustrates methodological challenges. Despite close collaboration with principal investigators, assessing the effect of characteristics of complex interventions on the outcomes of trials is compromised by lack of sufficient details on intervention characteristics and limited data on fidelity and adherence. Furthermore, trials collected baseline variables in a highly diverse way, limiting the possibilities to study subgroups of patients in a consistent manner. Possible solutions are proposed based on lessons learnt from the methodological challenges. Future researchers of complex interventions should pay considerable attention to the causal mechanism underlying the intervention and conducting process evaluations. Future researchers on IPD meta-analyses of complex interventions should carefully consider their own causal assumptions and availability of required data in eligible trials before undertaking such resource-intensive IPD meta-analysis. Copyright © 2017 Elsevier Inc. All rights reserved.

Problematisations of Complexity: On the Notion and Production of Diverse Complexities in Healthcare Interventions and Evaluations

PubMed Central

Broer, Tineke; Bal, Roland; Pickersgill, Martyn

2017-01-01

Abstract Within the literature on the evaluation of health (policy) interventions, complexity is a much-debated issue. In particular, many claim that so-called ‘complex interventions’ pose different challenges to evaluation studies than apparently ‘simple interventions’ do. Distinct ways of doing evaluation entail particular ontologies and epistemologies of complexity. They differ in terms of whether they define complexity as a quantitative trait of interventions, whether they see evaluation as part of or outside the intervention, and whether complexity can be regarded as an emergent property of the intervention and its evaluation. In practice, evaluators and commissioners of large health care improvement programmes rely on different, sometimes contradictory, repertoires about what it means to conduct a ‘good’ evaluation. This is an ongoing matter negotiated between and among commissioners, researchers, and—sometimes—programme managers. In particular, notions of evaluability, usefulness and distance/independence are problematised in different ways and with diverse consequences, which, in turn, produce other notions and layers of complexity such as temporal, institutional and affective complexities. When (social science) researchers claim that one method or another is better able to grasp complexity, they elide the issue that any methodological choice emphasises some complexities and lets others fade into the background. Analysing the practicalities and emotions involved in evaluation studies opens up the notion of complexity to analytical scrutiny, and suggests a basis for co-theorising between biomedical, public health and social scientists (including Science and Technology Studies scholars). PMID:28515573

Return of the JITAI: Applying a Just-in-Time Adaptive Intervention Framework to the Development of m-Health Solutions for Addictive Behaviors

PubMed Central

Evans, Brittney C.; Flack, Daniel; Juarascio, Adrienne; Manasse, Stephanie; Zhang, Fengqing; Forman, Evan M.

2018-01-01

Purpose Lapses are strong indicators of later relapse among individuals with addictive disorders, and thus are an important intervention target. However, lapse behavior has proven resistant to change due to the complex interplay of lapse triggers that are present in everyday life. It could be possible to prevent lapses before they occur by using m-Health solutions to deliver interventions in real-time. Method Just-in-time adaptive intervention (JITAI) is an intervention design framework that could be delivered via mobile app to facilitate in-the-moment monitoring of triggers for lapsing, and deliver personalized coping strategies to the user to prevent lapses from occurring. An organized framework is key for successful development of a JITAI. Results Nahum-Shani and colleagues (2014) set forth six core elements of a JITAI and guidelines for designing each: distal outcomes, proximal outcomes, tailoring variables, decision points, decision rules, and intervention options. The primary aim of this paper is to illustrate the use of this framework as it pertains to developing a JITAI that targets lapse behavior among individuals following a weight control diet. Conclusion We will detail our approach to various decision points during the development phases, report on preliminary findings where applicable, identify problems that arose during development, and provide recommendations for researchers who are currently undertaking their own JITAI development efforts. Issues such as missing data, the rarity of lapses, advantages/disadvantages of machine learning, and user engagement are discussed. PMID:28083725

Return of the JITAI: Applying a Just-in-Time Adaptive Intervention Framework to the Development of m-Health Solutions for Addictive Behaviors.

PubMed

Goldstein, Stephanie P; Evans, Brittney C; Flack, Daniel; Juarascio, Adrienne; Manasse, Stephanie; Zhang, Fengqing; Forman, Evan M

2017-10-01

Lapses are strong indicators of later relapse among individuals with addictive disorders, and thus are an important intervention target. However, lapse behavior has proven resistant to change due to the complex interplay of lapse triggers that are present in everyday life. It could be possible to prevent lapses before they occur by using m-Health solutions to deliver interventions in real-time. Just-in-time adaptive intervention (JITAI) is an intervention design framework that could be delivered via mobile app to facilitate in-the-moment monitoring of triggers for lapsing, and deliver personalized coping strategies to the user to prevent lapses from occurring. An organized framework is key for successful development of a JITAI. Nahum-Shani and colleagues (2014) set forth six core elements of a JITAI and guidelines for designing each: distal outcomes, proximal outcomes, tailoring variables, decision points, decision rules, and intervention options. The primary aim of this paper is to illustrate the use of this framework as it pertains to developing a JITAI that targets lapse behavior among individuals following a weight control diet. We will detail our approach to various decision points during the development phases, report on preliminary findings where applicable, identify problems that arose during development, and provide recommendations for researchers who are currently undertaking their own JITAI development efforts. Issues such as missing data, the rarity of lapses, advantages/disadvantages of machine learning, and user engagement are discussed.

Effectiveness of Psychosocial Interventions in Complex Palliative Care Patients: A Quasi-Experimental, Prospective Multicenter Study.

PubMed

Mateo-Ortega, Dolors; Gómez-Batiste, Xavier; Maté, Jorge; Beas, Elba; Ela, Sara; Lasmarias, Cristina; Limonero, Joaquín T

2018-03-13

To determine whether specific psychosocial interventions can ease discomfort in palliative care (PC) patients, particularly in those with high levels of pain or emotional distress. Changes in the psychological parameters of 8333 patients were assessed in a quasi-experimental, prospective, multicenter, single group pretest/post-test study. Psychosocial care was delivered by 29 psychosocial care teams (PSTs; 137 professionals). Pre- and post-intervention changes in these variables were assessed: mood, anxiety, and emotional distress. Patients were classified as complex, when presented with high levels of anxiety, mood, suffering (or perception of time as slow), and distress (or unease, or discomfort), or noncomplex. These groups were compared to assess changes in suffering-related parameters from baseline. Psychosocial interventions reduced patients' suffering. These interventions were more effective in complex patients. After successive psychosocial interventions, the level of suffering in complex patients decreased until close to parity with noncomplex patients, suggesting that patients with major complexity could benefit most from specific psychosocial treatment. These findings support the importance of assessing and treating patients' psychosocial needs.

Diet, Gut Microbiome and Epigenetics: Emerging Links with Inflammatory Bowel Diseases and Prospects for Management and Prevention.

PubMed

Aleksandrova, Krasimira; Romero-Mosquera, Beatriz; Hernandez, Vicent

2017-08-30

Inflammatory bowel diseases (IBD) represent a growing public health concern due to increasing incidence worldwide. The current notion on the pathogenesis of IBD is that genetically susceptible individuals develop intolerance to dysregulated gut microflora (dysbiosis) and chronic inflammation develops as a result of environmental triggers. Among the environmental factors associated with IBD, diet plays an important role in modulating the gut microbiome, influencing epigenetic changes, and, therefore, could be applied as a therapeutic tool to improve the disease course. Nevertheless, the current dietary recommendations for disease prevention and management are scarce and have weak evidence. This review summarises the current knowledge on the complex interactions between diet, microbiome and epigenetics in IBD. Whereas an overabundance of calories and some macronutrients increase gut inflammation, several micronutrients have the potential to modulate it. Immunonutrition has emerged as a new concept putting forward the importance of vitamins such as vitamins A, C, E, and D, folic acid, beta carotene and trace elements such as zinc, selenium, manganese and iron. However, when assessed in clinical trials, specific micronutrients exerted a limited benefit. Beyond nutrients, an anti-inflammatory dietary pattern as a complex intervention approach has become popular in recent years. Hence, exclusive enteral nutrition in paediatric Crohn's disease is the only nutritional intervention currently recommended as a first-line therapy. Other nutritional interventions or specific diets including the Specific Carbohydrate Diet (SCD), the low fermentable oligosaccharides, disaccharides, monosaccharides, and polyol (FODMAP) diet and, most recently, the Mediterranean diet have shown strong anti-inflammatory properties and show promise for improving disease symptoms. More work is required to evaluate the role of individual food compounds and complex nutritional interventions with the potential to decrease inflammation as a means of prevention and management of IBD.

Closing the loop in person-centered care: patient experiences of a chronic kidney disease self-management intervention.

PubMed

Havas, Kathryn; Douglas, Clint; Bonner, Ann

2017-01-01

The provision of self-management support (SMS) for people with earlier stages (1-4) of chronic kidney disease (CKD) can improve patient outcomes and extend time to dialysis. However, attempts to deliver such support have often not taken patient preferences into account. After the development, implementation, and quantitative evaluation of the person-centered CKD-SMS intervention, the aim of this study was to investigate participant experiences and perceptions of the program, as well as to seek suggestions to improve future SMS attempts. Semi-structured, face-to-face interviews were conducted with almost all (63/66) participants in the CKD-SMS. Deductive categories were derived from previous research into self-management from the CKD patient's perspective, and this was supplemented by categories that emerged inductively during multiple readings of interview transcripts. Content analysis was used to analyze interview data. Participants recognized self-management of CKD as complex and multifaceted. They felt that the CKD-SMS helped them develop skills to engage in necessary self-management tasks, as well as their knowledge about their condition and confidence to take an active role in their healthcare. These participants experience a healthcare environment that is characterized by complexity and inconsistency, and participation in the intervention helped them to navigate it. The benefit of participating in this research to contribute to the scientific literature was also recognized by participants. Overall, participants found the CKD-SMS useful in its current format, and made some suggestions for future interventions. People with CKD must engage in self-management behavior within a complex health environment. Individualized SMS such as the CKD-SMS provides an opportunity to support patients to manage their health effectively.

Development of a taxonomy of interventions to organise the evidence on consumers' medicines use.

PubMed

Lowe, Dianne; Ryan, Rebecca; Santesso, Nancy; Hill, Sophie

2011-11-01

Safe, effective (quality) medicines use remains problematic worldwide, yet consumers' medicines use research is not well organised. This creates difficulties for decision makers in identifying evidence or research gaps and in understanding how or why interventions work. Developing a conceptual framework for this evidence helps to organise the evidence for application and raise awareness of the range of possible interventions. To scope the aims of interventions to improve consumers' medicines use we searched for and iteratively analysed policy documents, systematic reviews, and an existing consumer-oriented communication intervention taxonomy. We identified eight recurrent themes associated with the purpose of the interventions: to inform and educate; to support behaviour change; to teach skills; to facilitate communication and/or decision making; to support; to minimise risk and harms; to involve consumers at the system level; and to improve health care quality. The taxonomy accommodates the complexity and diversity of interventions in this field, by focussing on the purposes of interventions, rather than the intervention type. Currently used to organise the evidence on consumers' medicines use, the taxonomy provides a conceptual and practical map of the evidence which will aid decision making and future research investment in the area. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Breaking bad news is a teachable skill in pediatric residents: A feasibility study of an educational intervention.

PubMed

Reed, Suzanne; Kassis, Karyn; Nagel, Rollin; Verbeck, Nicole; Mahan, John D; Shell, Richard

2015-06-01

Patients and physicians identify communication of bad news as a skill in need of improvement. Our objectives were to measure change in performance of first-year pediatric residents in the delivery of bad news after an educational intervention and to measure if changes in performance were sustained over time. Communication skills of 29 residents were assessed via videotaped standardized patient (SP) encounters at 3 time points: baseline, immediately post-intervention, and 3 months post-intervention. Educational intervention used was the previously published "GRIEV_ING Death Notification Protocol." The intraclass correlation coefficient demonstrated substantial inter-rater agreement with the assessment tool. Performance scores significantly improved from baseline to immediate post-intervention. Performance at 3 months post-intervention showed no change in two subscales and small improvement in one subscale. We concluded that breaking bad news is a complex and teachable skill that can be developed in pediatric residents. Improvement was sustained over time, indicating the utility of this educational intervention. This study brings attention to the need for improved communication training, and the feasibility of an education intervention in a large training program. Further work in development of comprehensive communication curricula is necessary in pediatric graduate medical education programs. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Application of theory to enhance audit and feedback interventions to increase the uptake of evidence-based transfusion practice: an intervention development protocol.

PubMed

Gould, Natalie J; Lorencatto, Fabiana; Stanworth, Simon J; Michie, Susan; Prior, Maria E; Glidewell, Liz; Grimshaw, Jeremy M; Francis, Jill J

2014-07-29

Audits of blood transfusion demonstrate around 20% transfusions are outside national recommendations and guidelines. Audit and feedback is a widely used quality improvement intervention but effects on clinical practice are variable, suggesting potential for enhancement. Behavioural theory, theoretical frameworks of behaviour change and behaviour change techniques provide systematic processes to enhance intervention. This study is part of a larger programme of work to promote the uptake of evidence-based transfusion practice. The objectives of this study are to design two theoretically enhanced audit and feedback interventions; one focused on content and one on delivery, and investigate the feasibility and acceptability. Study A (Content): A coding framework based on current evidence regarding audit and feedback, and behaviour change theory and frameworks will be developed and applied as part of a structured content analysis to specify the key components of existing feedback documents. Prototype feedback documents with enhanced content and also a protocol, describing principles for enhancing feedback content, will be developed. Study B (Delivery): Individual semi-structured interviews with healthcare professionals and observations of team meetings in four hospitals will be used to specify, and identify views about, current audit and feedback practice. Interviews will be based on a topic guide developed using the Theoretical Domains Framework and the Consolidated Framework for Implementation Research. Analysis of transcripts based on these frameworks will form the evidence base for developing a protocol describing an enhanced intervention that focuses on feedback delivery. Study C (Feasibility and Acceptability): Enhanced interventions will be piloted in four hospitals. Semi-structured interviews, questionnaires and observations will be used to assess feasibility and acceptability. This intervention development work reflects the UK Medical Research Council's guidance on development of complex interventions, which emphasises the importance of a robust theoretical basis for intervention design and recommends systematic assessment of feasibility and acceptability prior to taking interventions to evaluation in a full-scale randomised study. The work-up includes specification of current practice so that, in the trials to be conducted later in this programme, there will be a clear distinction between the control (usual practice) conditions and the interventions to be evaluated.

Combination therapeutics in complex diseases.

PubMed

He, Bing; Lu, Cheng; Zheng, Guang; He, Xiaojuan; Wang, Maolin; Chen, Gao; Zhang, Ge; Lu, Aiping

2016-12-01

The biological redundancies in molecular networks of complex diseases limit the efficacy of many single drug therapies. Combination therapeutics, as a common therapeutic method, involve pharmacological intervention using several drugs that interact with multiple targets in the molecular networks of diseases and may achieve better efficacy and/or less toxicity than monotherapy in practice. The development of combination therapeutics is complicated by several critical issues, including identifying multiple targets, targeting strategies and the drug combination. This review summarizes the current achievements in combination therapeutics, with a particular emphasis on the efforts to develop combination therapeutics for complex diseases. © 2016 The Authors. Journal of Cellular and Molecular Medicine published by John Wiley & Sons Ltd and Foundation for Cellular and Molecular Medicine.

Implementing resilience engineering for healthcare quality improvement using the CARE model: a feasibility study protocol.

PubMed

Anderson, J E; Ross, A J; Back, J; Duncan, M; Snell, P; Walsh, K; Jaye, P

2016-01-01

Resilience engineering (RE) is an emerging perspective on safety in complex adaptive systems that emphasises how outcomes emerge from the complexity of the clinical environment. Complexity creates the need for flexible adaptation to achieve outcomes. RE focuses on understanding the nature of adaptations, learning from success and increasing adaptive capacity. Although the philosophy is clear, progress in applying the ideas to quality improvement has been slow. The aim of this study is to test the feasibility of translating RE concepts into practical methods to improve quality by designing, implementing and evaluating interventions based on RE theory. The CARE model operationalises the key concepts and their relationships to guide the empirical investigation. The settings are the Emergency Department and the Older Person's Unit in a large London teaching hospital. Phases 1 and 2 of our work, leading to the development of interventions to improve the quality of care, are described in this paper. Ethical approval has been granted for these phases. Phase 1 will use ethnographic methods, including observation of work practices and interviews with staff, to understand adaptations and outcomes. The findings will be used to collaboratively design, with clinical staff in interactive design workshops, interventions to improve the quality of care. The evaluation phase will be designed and submitted for ethical approval when the outcomes of phases 1 and 2 are known. Study outcomes will be knowledge about the feasibility of applying RE to improve quality, the development of RE theory and a validated model of resilience in clinical work which can be used to guide other applications. Tools, methods and practical guidance for practitioners will also be produced, as well as specific knowledge of the potential effectiveness of the implemented interventions in emergency and older people's care. Further studies to test the application of RE at a larger scale will be required, including studies of other healthcare settings, organisational contexts and different interventions.

The Context, Process, and Outcome Evaluation Model for Organisational Health Interventions

PubMed Central

Fridrich, Annemarie; Jenny, Gregor J.; Bauer, Georg F.

2015-01-01

To facilitate evaluation of complex, organisational health interventions (OHIs), this paper aims at developing a context, process, and outcome (CPO) evaluation model. It builds on previous model developments in the field and advances them by clearly defining and relating generic evaluation categories for OHIs. Context is defined as the underlying frame that influences and is influenced by an OHI. It is further differentiated into the omnibus and discrete contexts. Process is differentiated into the implementation process, as the time-limited enactment of the original intervention plan, and the change process of individual and collective dynamics triggered by the implementation process. These processes lead to proximate, intermediate, and distal outcomes, as all results of the change process that are meaningful for various stakeholders. Research questions that might guide the evaluation of an OHI according to the CPO categories and a list of concrete themes/indicators and methods/sources applied within the evaluation of an OHI project at a hospital in Switzerland illustrate the model's applicability in structuring evaluations of complex OHIs. In conclusion, the model supplies a common language and a shared mental model for improving communication between researchers and company members and will improve the comparability and aggregation of evaluation study results. PMID:26557665

The Context, Process, and Outcome Evaluation Model for Organisational Health Interventions.

PubMed

Fridrich, Annemarie; Jenny, Gregor J; Bauer, Georg F

2015-01-01

To facilitate evaluation of complex, organisational health interventions (OHIs), this paper aims at developing a context, process, and outcome (CPO) evaluation model. It builds on previous model developments in the field and advances them by clearly defining and relating generic evaluation categories for OHIs. Context is defined as the underlying frame that influences and is influenced by an OHI. It is further differentiated into the omnibus and discrete contexts. Process is differentiated into the implementation process, as the time-limited enactment of the original intervention plan, and the change process of individual and collective dynamics triggered by the implementation process. These processes lead to proximate, intermediate, and distal outcomes, as all results of the change process that are meaningful for various stakeholders. Research questions that might guide the evaluation of an OHI according to the CPO categories and a list of concrete themes/indicators and methods/sources applied within the evaluation of an OHI project at a hospital in Switzerland illustrate the model's applicability in structuring evaluations of complex OHIs. In conclusion, the model supplies a common language and a shared mental model for improving communication between researchers and company members and will improve the comparability and aggregation of evaluation study results.

Positive Psychological Interventions for Patients with Type 2 Diabetes: Rationale, Theoretical Model, and Intervention Development

PubMed Central

Huffman, Jeff C.; DuBois, Christina M.; Millstein, Rachel A.; Celano, Christopher M.; Wexler, Deborah

2015-01-01

Most patients with type 2 diabetes (T2D) have suboptimal adherence to recommended diet, physical activity, and/or medication. Current approaches to improve health behaviors in T2D have been variably effective, and successful interventions are often complex and intensive. It is therefore vital to develop interventions that are simple, well-accepted, and applicable to a wide range of patients who suffer from T2D. One approach may be to boost positive psychological states, such as positive affect or optimism, as these constructs have been prospectively and independently linked to improvements in health behaviors. Positive psychology (PP) interventions, which utilize systematic exercises to increase optimism, well-being, and positive affect, consistently increase positive states and are easily delivered to patients with chronic illnesses. However, to our knowledge, PP interventions have not been formally tested in T2D. In this paper, we review a theoretical model for the use of PP interventions to target health behaviors in T2D, describe the structure and content of a PP intervention for T2D patients, and describe baseline data from a single-arm proof-of-concept (N = 15) intervention study in T2D patients with or without depression. We also discuss how PP interventions could be combined with motivational interviewing (MI) interventions to provide a blended psychological-behavioral approach. PMID:26064980

Composite Configuration Interventional Therapy Robot for the Microwave Ablation of Liver Tumors

NASA Astrophysics Data System (ADS)

Cao, Ying-Yu; Xue, Long; Qi, Bo-Jin; Jiang, Li-Pei; Deng, Shuang-Cheng; Liang, Ping; Liu, Jia

2017-11-01

The existing interventional therapy robots for the microwave ablation of liver tumors have a poor clinical applicability with a large volume, low positioning speed and complex automatic navigation control. To solve above problems, a composite configuration interventional therapy robot with passive and active joints is developed. The design of composite configuration reduces the size of the robot under the premise of a wide range of movement, and the robot with composite configuration can realizes rapid positioning with operation safety. The cumulative error of positioning is eliminated and the control complexity is reduced by decoupling active parts. The navigation algorithms for the robot are proposed based on solution of the inverse kinematics and geometric analysis. A simulation clinical test method is designed for the robot, and the functions of the robot and the navigation algorithms are verified by the test method. The mean error of navigation is 1.488 mm and the maximum error is 2.056 mm, and the positioning time for the ablation needle is in 10 s. The experimental results show that the designed robot can meet the clinical requirements for the microwave ablation of liver tumors. The composite configuration is proposed in development of the interventional therapy robot for the microwave ablation of liver tumors, which provides a new idea for the structural design of medical robots.

An embedded longitudinal multi-faceted qualitative evaluation of a complex cluster randomized controlled trial aiming to reduce clinically important errors in medicines management in general practice.

PubMed

Cresswell, Kathrin M; Sadler, Stacey; Rodgers, Sarah; Avery, Anthony; Cantrill, Judith; Murray, Scott A; Sheikh, Aziz

2012-06-08

There is a need to shed light on the pathways through which complex interventions mediate their effects in order to enable critical reflection on their transferability. We sought to explore and understand key stakeholder accounts of the acceptability, likely impact and strategies for optimizing and rolling-out a successful pharmacist-led information technology-enabled (PINCER) intervention, which substantially reduced the risk of clinically important errors in medicines management in primary care. Data were collected at two geographical locations in central England through a combination of one-to-one longitudinal semi-structured telephone interviews (one at the beginning of the trial and another when the trial was well underway), relevant documents, and focus group discussions following delivery of the PINCER intervention. Participants included PINCER pharmacists, general practice staff, researchers involved in the running of the trial, and primary care trust staff. PINCER pharmacists were interviewed at three different time-points during the delivery of the PINCER intervention. Analysis was thematic with diffusion of innovation theory providing a theoretical framework. We conducted 52 semi-structured telephone interviews and six focus group discussions with 30 additional participants. In addition, documentary data were collected from six pharmacist diaries, along with notes from four meetings of the PINCER pharmacists and feedback meetings from 34 practices. Key findings that helped to explain the success of the PINCER intervention included the perceived importance of focusing on prescribing errors to all stakeholders, and the credibility and appropriateness of a pharmacist-led intervention to address these shortcomings. Central to this was the face-to-face contact and relationship building between pharmacists and a range of practice staff, and pharmacists' explicitly designated role as a change agent. However, important concerns were identified about the likely sustainability of this new model of delivering care, in the absence of an appropriate support network for pharmacists and career development pathways. This embedded qualitative inquiry has helped to understand the complex organizational and social environment in which the trial was undertaken and the PINCER intervention was delivered. The longitudinal element has given insight into the dynamic changes and developments over time. Medication errors and ways to address these are high on stakeholders' agendas. Our results further indicate that pharmacists were, because of their professional standing and skill-set, able to engage with the complex general practice environment and able to identify and manage many clinically important errors in medicines management. The transferability of the PINCER intervention approach, both in relation to other prescribing errors and to other practices, is likely to be high.

An embedded longitudinal multi-faceted qualitative evaluation of a complex cluster randomized controlled trial aiming to reduce clinically important errors in medicines management in general practice

PubMed Central

2012-01-01

Background There is a need to shed light on the pathways through which complex interventions mediate their effects in order to enable critical reflection on their transferability. We sought to explore and understand key stakeholder accounts of the acceptability, likely impact and strategies for optimizing and rolling-out a successful pharmacist-led information technology-enabled (PINCER) intervention, which substantially reduced the risk of clinically important errors in medicines management in primary care. Methods Data were collected at two geographical locations in central England through a combination of one-to-one longitudinal semi-structured telephone interviews (one at the beginning of the trial and another when the trial was well underway), relevant documents, and focus group discussions following delivery of the PINCER intervention. Participants included PINCER pharmacists, general practice staff, researchers involved in the running of the trial, and primary care trust staff. PINCER pharmacists were interviewed at three different time-points during the delivery of the PINCER intervention. Analysis was thematic with diffusion of innovation theory providing a theoretical framework. Results We conducted 52 semi-structured telephone interviews and six focus group discussions with 30 additional participants. In addition, documentary data were collected from six pharmacist diaries, along with notes from four meetings of the PINCER pharmacists and feedback meetings from 34 practices. Key findings that helped to explain the success of the PINCER intervention included the perceived importance of focusing on prescribing errors to all stakeholders, and the credibility and appropriateness of a pharmacist-led intervention to address these shortcomings. Central to this was the face-to-face contact and relationship building between pharmacists and a range of practice staff, and pharmacists’ explicitly designated role as a change agent. However, important concerns were identified about the likely sustainability of this new model of delivering care, in the absence of an appropriate support network for pharmacists and career development pathways. Conclusions This embedded qualitative inquiry has helped to understand the complex organizational and social environment in which the trial was undertaken and the PINCER intervention was delivered. The longitudinal element has given insight into the dynamic changes and developments over time. Medication errors and ways to address these are high on stakeholders’ agendas. Our results further indicate that pharmacists were, because of their professional standing and skill-set, able to engage with the complex general practice environment and able to identify and manage many clinically important errors in medicines management. The transferability of the PINCER intervention approach, both in relation to other prescribing errors and to other practices, is likely to be high. PMID:22682095

Population health intervention research training: the value of public health internships and mentorship.

PubMed

Hamelin, Anne-Marie; Paradis, Gilles

2018-01-01

Better alignment between academia and public health practice and policies are critical to improve public health actions. Training of future researchers to address complex issues and to conduct transdisciplinary and collaborative research will help improve this alignment. In this paper, we describe the role of internship placements and mentorship for trainees' skills development in population health intervention research and the benefits of embedding research trainees within public health organizations. This qualitative descriptive study assessed the perceptions of the role and benefits of internships and mentorship for population health intervention research training among former doctoral and postdoctoral students, public health mentors, and senior public health managers who participated in the 4P Program, a research training program which bridges academic training and the public health system in Quebec, Canada. Two types of interviews were conducted: telephone semi-structured interviews by an external evaluator and face-to-face trainee "exit" interviews by the Program co-director. Semi-annual evaluation reports from each trainee were also reviewed. Qualitative data were subjected to a thematic analysis. Internships provided trainees with a working knowledge of the public health system and the context in which decisions and public health interventions are implemented. It was an opportunity for trainees to interact with knowledge-user partners and assess the gap between research and practice. Effective mentorship was key to help trainees interpret the public health reality and develop population health intervention research skills. Trainees learned to ask the "how" questions that are critical for in-depth understanding of complex interventions and the conditions under which they can be best implemented. Conditions of success of internships and mentorship for population health intervention research included the alignment of the interests between the trainee, the mentor and the public health organization, quality mentoring, and the acquisition of specific population health intervention skills, especially collaborative research skills. The findings suggest that public health internships and mentorship facilitate trainee engagement in applied public health research.

Necessary but not sufficient? Engaging young people in the development of an avatar-based online intervention designed to provide psychosocial support to young people affected by their own or a family member's cancer diagnosis.

PubMed

Phelps, Ceri; Minou, Masoumeh; Baker, Andrew; Hughes, Carol; French, Helen; Hawkins, Wayne; Leeuwenberg, Andrew; Crabtree, Rebecca; Hutchings, Paul B

2017-06-01

This study discusses the challenges and successes of engaging young people in a project aimed at developing an online counselling intervention for young people affected by cancer. For younger people with a diagnosis of cancer or who are caring for someone with cancer, the psychosocial consequences can create significant challenges for their social and educational development. Whilst young people have been shown to be reluctant to make use of traditional face-to-face counselling, research is beginning to suggest that effective therapeutic relationships can be formed with young people online. The first phase of the study involved working with a 'Young Persons' Panel' of healthy school pupils and university students to develop and pilot an online counselling intervention and study materials in preparation for a pilot evaluation of the intervention. An avatar-based virtual reality counselling world was created where young people can create their own avatar and receive counselling over the Internet from a qualified counsellor via an avatar in a virtual reality world. The process of engaging young people in the C:EVOLVE project enabled a unique intervention to be developed and demonstrated positive developmental opportunities. However, despite the rigorous approach to the development of the intervention, initial attempts within the pilot evaluation phase of the study showed difficulties recruiting to the study, and this phase of the study has currently ceased whilst further exploratory work takes place. This study has demonstrated the complexities of intervention development and evaluation research targeted at young people and the challenges created when attempting to bring clinical practice and research evaluation together. © 2016 The Authors. Health Expectations Published by John Wiley & Sons Ltd.

Systematic development of a theory-informed multifaceted behavioural intervention to increase physical activity of adults with type 2 diabetes in routine primary care: Movement as Medicine for Type 2 Diabetes.

PubMed

Avery, Leah; Charman, Sarah J; Taylor, Louise; Flynn, Darren; Mosely, Kylie; Speight, Jane; Lievesley, Matthew; Taylor, Roy; Sniehotta, Falko F; Trenell, Michael I

2016-07-19

Despite substantial evidence for physical activity (PA) as a management option for type 2 diabetes, there remains a lack of PA behavioural interventions suitable for delivery in primary care. This paper describes the systematic development of an evidence-informed PA behavioural intervention for use during routine primary care consultations. In accordance with the Medical Research Council Framework for the Development and Evaluation of Complex Interventions, a four-stage systematic development process was undertaken: (1) exploratory work involving interviews and workshop discussions identified training needs of healthcare professionals and support needs of adults with type 2 diabetes; (2) a systematic review with meta- and moderator analyses identified behaviour change techniques and optimal intervention intensity and duration; (3) usability testing identified strategies to increase implementation of the intervention in primary care and (4) an open pilot study in two primary care practices facilitated intervention optimisation. Healthcare professional training needs included knowledge about type, intensity and duration of PA sufficient to improve glycaemic control and acquisition of skills to promote PA behaviour change. Patients lacked knowledge about type 2 diabetes and skills to enable them to make sustainable changes to their level of PA. An accredited online training programme for healthcare professionals and a professional-delivered behavioural intervention for adults with type 2 diabetes were subsequently developed. This multifaceted intervention was informed by the theory of planned behaviour and social cognitive theory and consisted of 15 behaviour change techniques. Intervention intensity and duration were informed by a systematic review. Usability testing resolved technical problems with the online training intervention that facilitated use on practice IT systems. An open pilot study of the intervention with fidelity of delivery assessment informed optimisation and identified mechanisms to enhance implementation of the intervention during routine diabetes consultations. Movement as Medicine for Type 2 diabetes represents an evidence-informed multifaceted behavioural intervention targeting PA for management of type 2 diabetes developed for delivery in primary care. The structured development process undertaken enhances transparency of intervention content, replicability and scalability. Movement as Medicine for Type 2 diabetes is currently undergoing evaluation in a pilot RCT. ISRCTN67997502.

Simulating indoor concentrations of NO(2) and PM(2.5) in multifamily housing for use in health-based intervention modeling.

PubMed

Fabian, P; Adamkiewicz, G; Levy, J I

2012-02-01

Residents of low-income multifamily housing can have elevated exposures to multiple environmental pollutants known to influence asthma. Simulation models can characterize the health implications of changing indoor concentrations, but quantifying the influence of interventions on concentrations is challenging given complex airflow and source characteristics. In this study, we simulated concentrations in a prototype multifamily building using CONTAM, a multizone airflow and contaminant transport program. Contaminants modeled included PM(2.5) and NO(2) , and parameters included stove use, presence and operability of exhaust fans, smoking, unit level, and building leakiness. We developed regression models to explain variability in CONTAM outputs for individual sources, in a manner that could be utilized in simulation modeling of health outcomes. To evaluate our models, we generated a database of 1000 simulated households with characteristics consistent with Boston public housing developments and residents and compared the predicted levels of NO(2) and PM(2.5) and their correlates with the literature. Our analyses demonstrated that CONTAM outputs could be readily explained by available parameters (R(2) between 0.89 and 0.98 across models), but that one-compartment box models would mischaracterize concentrations and source contributions. Our study quantifies the key drivers for indoor concentrations in multifamily housing and helps to identify opportunities for interventions. Many low-income urban asthmatics live in multifamily housing that may be amenable to ventilation-related interventions such as weatherization or air sealing, wall and ceiling hole repairs, and exhaust fan installation or repair, but such interventions must be designed carefully given their cost and their offsetting effects on energy savings as well as indoor and outdoor pollutants. We developed models to take into account the complex behavior of airflow patterns in multifamily buildings, which can be used to identify and evaluate environmental and non-environmental interventions targeting indoor air pollutants which can trigger asthma exacerbations. © 2011 John Wiley & Sons A/S.

Can theory be embedded in visual interventions to promote self-management? A proposed model and worked example.

PubMed

Williams, B; Anderson, A S; Barton, K; McGhee, J

2012-12-01

Nurses are increasingly involved in a range of strategies to encourage patient behaviours that improve self-management. If nurses are to be involved in, or indeed lead, the development of such interventions then processes that enhance the likelihood that they will lead to evidence that is both robust and usable in practice are required. Although behavioural interventions have been predominantly based on written text or the spoken word increasing numbers are now drawing on visual media to communicate their message, despite only a growing evidence base to support it. The use of such media in health interventions is likely to increase due to technological advances enabling easier and cheaper production, and an increasing social preference for visual forms of communication. However, the development of such media is often highly pragmatic and developed intuitively rather than with theory and evidence informing their content and form. Such a process may be at best inefficient and at worst potentially harmful. This paper performs two functions. Firstly, it discusses and argues why visual based interventions may be a powerful media for behaviour change; and secondly, it proposes a model, developed from the MRC Framework for the Development and Evaluation of Complex Interventions, to guide the creation of theory informed visual interventions. It employs a case study of the development of an intervention to motivate involvement in a lifestyle intervention among people with increased cardiovascular risk. In doing this we argue for a step-wise model which includes: (1) the identification of a theoretical basis and associated concepts; (2) the development of visual narrative to establish structure; (3) the visual rendering of narrative and concepts; and (4) the assessment of interpretation and impact among the intended patient group. We go on to discuss the theoretical and methodological limitations of the model. Copyright © 2012 Elsevier Ltd. All rights reserved.

Evaluation of complex integrated care programmes: the approach in North West London

PubMed Central

Greaves, Felix; Pappas, Yannis; Bardsley, Martin; Harris, Matthew; Curry, Natasha; Holder, Holly; Blunt, Ian; Soljak, Michael; Gunn, Laura; Majeed, Azeem; Car, Josip

2013-01-01

Background Several local attempts to introduce integrated care in the English National Health Service have been tried, with limited success. The Northwest London Integrated Care Pilot attempts to improve the quality of care of the elderly and people with diabetes by providing a novel integration process across primary, secondary and social care organisations. It involves predictive risk modelling, care planning, multidisciplinary management of complex cases and an information technology tool to support information sharing. This paper sets out the evaluation approach adopted to measure its effect. Study design We present a mixed methods evaluation methodology. It includes a quantitative approach measuring changes in service utilization, costs, clinical outcomes and quality of care using routine primary and secondary data sources. It also contains a qualitative component, involving observations, interviews and focus groups with patients and professionals, to understand participant experiences and to understand the pilot within the national policy context. Theory and discussion This study considers the complexity of evaluating a large, multi-organisational intervention in a changing healthcare economy. We locate the evaluation within the theory of evaluation of complex interventions. We present the specific challenges faced by evaluating an intervention of this sort, and the responses made to mitigate against them. Conclusions We hope this broad, dynamic and responsive evaluation will allow us to clarify the contribution of the pilot, and provide a potential model for evaluation of other similar interventions. Because of the priority given to the integrated agenda by governments internationally, the need to develop and improve strong evaluation methodologies remains strikingly important. PMID:23687478

Development of a composite outcome score for a complex intervention - measuring the impact of Community Health Workers.

PubMed

Watt, Hilary; Harris, Matthew; Noyes, Jane; Whitaker, Rhiannon; Hoare, Zoe; Edwards, Rhiannon Tudor; Haines, Andy

2015-03-21

In health services research, composite scores to measure changes in health-seeking behaviour and uptake of services do not exist. We describe the rationale and analytical considerations for a composite primary outcome for primary care research. We simulate its use in a large hypothetical population and use it to calculate sample sizes. We apply it within the context of a proposed cluster randomised controlled trial (RCT) of a Community Health Worker (CHW) intervention. We define the outcome as the proportion of the services (immunizations, screening tests, stop-smoking clinics) received by household members, of those that they were eligible to receive. First, we simulated a population household structure (by age and sex), based on household composition data from the 2011 England and Wales census. The ratio of eligible to received services was calculated for each simulated household based on published eligibility criteria and service uptake rates, and was used to calculate sample size scenarios for a cluster RCT of a CHW intervention. We assume varying intervention percentage effects and varying levels of clustering. Assuming no disease risk factor clustering at the household level, 11.7% of households in the hypothetical population of 20,000 households were eligible for no services, 26.4% for 1, 20.7% for 2, 15.3% for 3 and 25.8% for 4 or more. To demonstrate a small CHW intervention percentage effect (10% improvement in uptake of services out of those who would not otherwise have taken them up, and additionally assuming intra-class correlation of 0.01 between households served by different CHWs), around 4,000 households would be needed in each of the intervention and control arms. This equates to 40 CHWs (each servicing 100 households) needed in the intervention arm. If the CHWs were more effective (20%), then only 170 households would be needed in each of the intervention and control arms. This is a useful first step towards a process-centred composite score of practical value in complex community-based interventions. Firstly, it is likely to result in increased statistical power compared with multiple outcomes. Second, it avoids over-emphasis of any single outcome from a complex intervention.

A feasibility study of a theory-based intervention to improve appropriate polypharmacy for older people in primary care.

PubMed

Cadogan, Cathal A; Ryan, Cristín; Gormley, Gerard J; Francis, Jill J; Passmore, Peter; Kerse, Ngaire; Hughes, Carmel M

2018-01-01

A general practitioner (GP)-targeted intervention aimed at improving the prescribing of appropriate polypharmacy for older people was previously developed using a systematic, theory-based approach based on the UK Medical Research Council's complex intervention framework. The primary intervention component comprised a video demonstration of a GP prescribing appropriate polypharmacy during a consultation with an older patient. The video was delivered to GPs online and included feedback emphasising the positive outcomes of performing the behaviour. As a complementary intervention component, patients were invited to scheduled medication review consultations with GPs. This study aimed to test the feasibility of the intervention and study procedures (recruitment, data collection). GPs from two general practices were given access to the video, and reception staff scheduled consultations with older patients receiving polypharmacy (≥4 medicines). Primary feasibility study outcomes were the usability and acceptability of the intervention to GPs. Feedback was collected from GP and patient participants using structured questionnaires. Clinical data were also extracted from recruited patients' medical records (baseline and 1 month post-consultation). The feasibility of applying validated assessment of prescribing appropriateness (STOPP/START criteria, Medication Appropriateness Index) and medication regimen complexity (Medication Regimen Complexity Index) to these data was investigated. Data analysis was descriptive, providing an overview of participants' feedback and clinical assessment findings. Four GPs and ten patients were recruited across two practices. The intervention was considered usable and acceptable by GPs. Some reservations were expressed by GPs as to whether the video truly reflected resource and time pressures encountered in the general practice working environment. Patient feedback on the scheduled consultations was positive. Patients welcomed the opportunity to have their medications reviewed. Due to the short time to follow-up and a lack of detailed clinical information in patient records, it was not feasible to detect any prescribing changes or to apply the assessment tools to patients' clinical data. The findings will help to further refine the intervention and study procedures (including time to follow-up) which will be tested in a randomised pilot study that will inform the design of a definitive trial to evaluate the intervention's effectiveness. ISRCTN18176245.

Implementing trials of complex interventions in community settings: the USC-Rancho Los Amigos pressure ulcer prevention study (PUPS).

PubMed

Clark, Florence; Pyatak, Elizabeth A; Carlson, Mike; Blanche, Erna Imperatore; Vigen, Cheryl; Hay, Joel; Mallinson, Trudy; Blanchard, Jeanine; Unger, Jennifer B; Garber, Susan L; Diaz, Jesus; Florindez, Lucia I; Atkins, Michal; Rubayi, Salah; Azen, Stanley Paul

2014-04-01

Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)-Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to (1) participant recruitment and retention, (2) intervention delivery and fidelity, (3) randomization and assessment, and (4) potential inadvertent treatment effects. We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury. Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes. PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accordance with a rigorous plan. Finally, we have overcome unanticipated assessment and design concerns related to (1) determining pressure ulcer incidence/severity, (2) randomization imbalance, and (3) inadvertent potential control group contamination. We have addressed the most daunting challenges encountered in the recruitment, assessment, and intervention phases of PUPS. Some challenges and solutions may not apply to trials conducted in other settings. Overcoming challenges has required a multifaceted approach incorporating individualization, flexibility, and persistence, as well as the ability to implement needed mid-course corrections.

Systems thinking perspectives applied to healthcare transition for youth with disabilities: a paradigm shift for practice, policy and research.

PubMed

Hamdani, Y; Jetha, A; Norman, C

2011-11-01

Healthcare transition (HCT) for youth with disabilities is a complex phenomenon influenced by multiple interacting factors, including health, personal and environmental factors. Current research on the transition to adulthood for disabled youth has primarily focused on identifying these multilevel factors to guide the development of interventions to improve the HCT process. However, little is known about how this complex array of factors interacts and contributes to successful HCT. Systems thinking provides a theoretically informed perspective that accounts for complexity and can contribute to enhanced understanding of the interactions among HCT factors. The objective of this paper is to introduce general concepts of systems thinking as applied to HCT practice and research. Several systems thinking concepts and principles are introduced and a discussion of HCT as a complex system is provided. Systems dynamics methodology is described as one systems method for conceptualizing HCT. A preliminary systems dynamics model is presented to facilitate discourse on the application of systems thinking principles to HCT practice, policy and research. An understanding of the complex interactions and patterns of relationships in HCT can assist health policy makers and practitioners in determining key areas of intervention, the impact of these interventions on the system and the potential intended and unintended consequences of change. This paper provides initial examination of applying systems thinking to inform future research and practice on HCT. © 2011 Blackwell Publishing Ltd.

Development and Pilot Testing of a Standardized Training Program for a Patient-Mentoring Intervention to Increase Adherence to Outpatient HIV Care

PubMed Central

Mignogna, Joseph; Stanley, Melinda A.; Davila, Jessica; Wear, Jackie; Amico, K. Rivet; Giordano, Thomas P.

2012-01-01

Abstract Although peer interventionists have been successful in medication treatment-adherence interventions, their role in complex behavior-change approaches to promote entry and reentry into HIV care requires further investigation. The current study sought to describe and test the feasibility of a standardized peer-mentor training program used for MAPPS (Mentor Approach for Promoting Patient Self-Care), a study designed to increase engagement and attendance at HIV outpatient visits among high-risk HIV inpatients using HIV-positive peer interventionists to deliver a comprehensive behavioral change intervention. Development of MAPPS and its corresponding training program included collaborations with mentors from a standing outpatient mentor program. The final training program included (1) a half-day workshop; (2) practice role-plays; and (3) formal, standardized patient role-plays, using trained actors with “real-time” video observation (and ratings from trainers). Mentor training occurred over a 6-week period and required demonstration of adherence and skill, as rated by MAPPS trainers. Although time intensive, ultimate certification of mentors suggested the program was both feasible and effective. Survey data indicated mentors thought highly of the training program, while objective rating data from trainers indicated mentors were able to understand and display standards associated with intervention fidelity. Data from the MAPPS training program provide preliminary evidence that peer mentors can be trained to levels necessary to ensure intervention fidelity, even within moderately complex behavioral-change interventions. Although additional research is needed due to limitations of the current study (e.g., limited generalizability due to sample size and limited breadth of clinical training opportunities), data from the current trial suggest that training programs such as MAPPS appear both feasible and effective. PMID:22248331

Application of a theoretical framework to foster a cardiac-diabetes self-management programme.

PubMed

Wu, C-J Jo; Chang, A M

2014-09-01

This paper analyses and illustrates the application of Bandura's self-efficacy construct to an innovative self-management programme for patients with both type 2 diabetes and coronary heart disease. Using theory as a framework for any health intervention provides a solid and valid foundation for aspects of planning and delivering such an intervention; however, it is reported that many health behaviour intervention programmes are not based upon theory and are consequently limited in their applicability to different populations. The cardiac-diabetes self-management programme has been specifically developed for patients with dual conditions with the strategies for delivering the programme based upon Bandura's self-efficacy theory. This patient group is at greater risk of negative health outcomes than that with a single chronic condition and therefore requires appropriate intervention programmes with solid theoretical foundations that can address the complexity of care required. The cardiac-diabetes self-management programme has been developed incorporating theory, evidence and practical strategies. This paper provides explicit knowledge of the theoretical basis and components of a cardiac-diabetes self-management programme. Such detail enhances the ability to replicate or adopt the intervention in similar or differing populations and/or cultural contexts as it provides in-depth understanding of each element within the intervention. Knowledge of the concepts alone is not sufficient to deliver a successful health programme. Supporting patients to master skills of self-care is essential in order for patients to successfully manage two complex, chronic illnesses. Valuable information has been provided to close the theory-practice gap for more consistent health outcomes, engaging with patients for promoting holistic care within organizational and cultural contexts. © 2014 International Council of Nurses.

The Promise of Systems Biology Approaches for Revealing Host Pathogen Interactions in Malaria

PubMed Central

Zuck, Meghan; Austin, Laura S.; Danziger, Samuel A.; Aitchison, John D.; Kaushansky, Alexis

2017-01-01

Despite global eradication efforts over the past century, malaria remains a devastating public health burden, causing almost half a million deaths annually (WHO, 2016). A detailed understanding of the mechanisms that control malaria infection has been hindered by technical challenges of studying a complex parasite life cycle in multiple hosts. While many interventions targeting the parasite have been implemented, the complex biology of Plasmodium poses a major challenge, and must be addressed to enable eradication. New approaches for elucidating key host-parasite interactions, and predicting how the parasite will respond in a variety of biological settings, could dramatically enhance the efficacy and longevity of intervention strategies. The field of systems biology has developed methodologies and principles that are well poised to meet these challenges. In this review, we focus our attention on the Liver Stage of the Plasmodium lifecycle and issue a “call to arms” for using systems biology approaches to forge a new era in malaria research. These approaches will reveal insights into the complex interplay between host and pathogen, and could ultimately lead to novel intervention strategies that contribute to malaria eradication. PMID:29201016

Leadership Development for Organizational Change in a "New" UK University

ERIC Educational Resources Information Center

Turnbull, Sharon; Edwards, Gareth

2005-01-01

This paper reports on the findings of a case study of an Organizational Development (OD) intervention within a new university in the UK. Previous research into the leadership of higher education has highlighted a number of apparently inevitable tensions. The findings of the case study uncovered a number of complex and interrelated tensions. The…

Building a Model Program for Substance-Exposed Newborns and Their Families: From Needs Assessment to Intervention, Evaluation, and Consultation

ERIC Educational Resources Information Center

Spielman, Eda; Herriott, Anna; Paris, Ruth; Sommer, Amy R.

2015-01-01

Despite growing concern about substance misuse in pregnancy and infants born substance-exposed, few programs have been developed that address the complex needs of this vulnerable population. This article describes the process of developing Project NESST® (Newborns Exposed to Substances: Support and Therapy), from needs assessment to program…

Effect evaluation of a two-year complex intervention to reduce loneliness in non-institutionalised elderly Dutch people

PubMed Central

2013-01-01

Background Public health policy calls for intervention programmes to reduce loneliness in the ageing population. So far, numerous loneliness interventions have been developed, with effectiveness demonstrated for few of these interventions. The loneliness intervention described in this manuscript distinguishes itself from others by including multiple intervention components and targeting individuals and their environment. Intervention components included a mass media campaign, information meetings, psychosocial group courses, social activities organised by neighbours, and training of intermediaries. The aim of this manuscript is to study the effects of this integrated approach on initial and long-term outcomes. Methods A quasi-experimental pre-test post-test intervention study was conducted among non-institutionalised elderly people aged 65 years and over to evaluate the effectiveness of the intervention by comparing the intervention community and the control community. Data on outputs, initial and long-term outcomes, and the overall goal were collected by self-administered questionnaires. Data of 858 elderly people were available for the analyses. To assess the effect linear regression analyses with adjustments for age, gender, church attendance, and mental health were used. In addition, the process evaluation provided information about the reach of the intervention components. Results After two years, 39% of the elderly people were familiar with the intervention programme. The intervention group scored more favourably than the control group on three subscales of the initial outcome, motivation (−4.4%, 95% CI−8.3-−0.7), perceived social support (−8.2%, 95% CI−13.6-−2.4), and subjective norm (−11.5%, 95% CI−17.4-−5.4). However, no overall effects were observed for the long-term outcome, social support, and overall goal, loneliness. Conclusions Two years after its initiation the reach of the intervention programme was modest. Though no effect of the complex intervention was found on social support and loneliness, more favourable scores on loneliness literacy subscales were induced. PMID:24139287

Intervention Mapping Approach in the Design of an Interactive Mobile Health Application to Improve Self-care in Heart Failure.

PubMed

Athilingam, Ponrathi; Clochesy, John M; Labrador, Miguel A

2018-02-01

Heart failure is a complex syndrome among older adults who may experience and interpret symptoms differently. These differences in symptom interpretation may influence decision-making in symptom management. A well-informed and motivated person may develop the knowledge and skills needed to successfully manage symptoms. Therefore, the patient-centered mobile health application HeartMapp was designed to engage patients with heart failure in self-care management by offering tailored alerts and feedback using mobile phones. The main objective of this article is to describe the six-step intervention mapping approach including (1) the initial needs assessment, (2) proximal program objective, (3) selection of theory-based methods, (4) the translation of objectives into an actual program plan for mobile health intervention, (5) adaptation and implementation plan, and (6) evaluation plan that assisted the team in the development of a conceptual framework and intervention program matrix during the development of HeartMapp. The HeartMapp intervention takes the information, motivation, and behavioral skills model as the theoretical underpinning, with "patient engagement" as the key mediator in achieving targeted and persistent self-care behavioral changes in patients with heart failure. The HeartMapp intervention is proposed to improve self-care management and long-term outcomes.

A holistic conceptual framework model to describe medication adherence in and guide interventions in diabetes mellitus.

PubMed

Jaam, Myriam; Awaisu, Ahmed; Mohamed Ibrahim, Mohamed Izham; Kheir, Nadir

2018-04-01

Nonadherence to medications in patients with diabetes, which results in poor treatment outcomes and increased healthcare costs, is commonly reported globally. Factors associated with medication adherence have also been widely studied. However, a clear and comprehensive, disease-specific conceptual framework model that captures all possible factors has not been established. This study aimed to develop a conceptual framework that addresses the complex network of barriers to medication adherence in patients with diabetes. Fourteen databases and grey literature sources were systematically searched for systematic reviews reporting barriers to medication adherence in patients with diabetes. A thematic approach was used to categorize all identified barriers from the reviews and to create a matrix representing the complex network and relations of the different barriers. Eighteen systematic reviews were identified and used for the development of the conceptual framework. Overall, six major themes emerged: patient-, medication-, disease-, provider-, system-, and societal-related factors. Each of these themes was further classified into different sub-categories. It was noted that most interactions were identified to be within the patient-related factors, which not only interact with other themes but also within the same theme. Patient's demographics as well as cultural beliefs were the most notable factors in terms of interactions with other categories and themes. The intricate network and interaction of factors identified between different themes and within individual themes indicate the complexity of the problem of adherence. This framework will potentially enhance the understanding of the complex relation between different barriers for medication adherence in diabetes and will facilitate design of more effective interventions. Future interventions for enhancing medication adherence should look at the overall factors and target multiple themes of barriers to improve patient outcomes. Copyright © 2017 Elsevier Inc. All rights reserved.

Interdisciplinary collaboration in the use of a music-with-movement intervention to promote the wellbeing of people with dementia and their families: Development of an evidence-based intervention protocol.

PubMed

Lai, Claudia K Y; Lai, Daniel L L; Ho, Jacqueline S C; Wong, Kitty K Y; Cheung, Daphne S K

2016-03-01

The music-with-movement intervention is particularly suitable for people with dementia because their gross motor ability is preserved until the later stage of dementia. This study examines the effect of music-with-movement on reducing anxiety, sleep disturbances, and improving the wellbeing of people with dementia. This paper reports the first stage of the study - developing the intervention protocol that staff can use to teach family caregivers. A registered music therapist developed a music-with-movement protocol and taught staff of two social service centers over five weekly 1.5 h sessions, with center-in-charges (social workers and occupational therapists) and our research team joining these sessions to provide comments from their professional perspective. Each discipline had different expectations about the content; therefore, numerous meetings and discussions were held to bridge these differences and fine-tune the protocol. Few healthcare professionals doubt the merits of interdisciplinary collaboration at all levels of health promotion. In practice, interdisciplinary collaboration is complex and requires commitment. Openness and persistence is required from all stakeholders to achieve a successful intervention for consumers. © 2015 Wiley Publishing Asia Pty Ltd.

A psychosocial intervention for the management of functional dysphonia: complex intervention development and pilot randomised trial.

PubMed

Deary, Vincent; McColl, Elaine; Carding, Paul; Miller, Tracy; Wilson, Janet

2018-01-01

Medically unexplained loss or alteration of voice-functional dysphonia-is the commonest presentation to speech and language therapists (SLTs). Besides the impact on personal and work life, functional dysphonia is also associated with increased levels of anxiety and depression and poor general health. Voice therapy delivered by SLTs improves voice but not these associated symptoms. The aims of this research were the systematic development of a complex intervention to improve the treatment of functional dysphonia, and the trialling of this intervention for feasibility and acceptability to SLTs and patients in a randomised pilot study. A theoretical model of medically unexplained symptoms (MUS) was elaborated through literature review and synthesis. This was initially applied as an assessment format in a series of patient interviews. Data from this stage and a small consecutive cohort study were used to design and refine a brief cognitive behavioural therapy (CBT) training intervention for a SLT. This was then implemented in an external pilot patient randomised trial where one SLT delivered standard voice therapy or voice therapy plus CBT to 74 patients. The primary outcomes were of the acceptability of the intervention to patients and the SLT, and the feasibility of changing the SLT's clinical practice through a brief training. This was measured through monitoring treatment flow and through structured analysis of the content of intervention for treatment fidelity and inter-treatment contamination. As measured by treatment flow, the intervention was as acceptable as standard voice therapy to patients. Analysis of treatment content showed that the SLT was able to conduct a complex CBT formulation and deliver novel treatment strategies for fatigue, sleep, anxiety and depression in the majority of patients. On pre-post measures of voice and quality of life, patients in both treatment arms improved. These interventions were acceptable to patients. Emotional and psychosocial issues presented routinely in the study patient group and CBT techniques were used, deliberately and inadvertently, in both treatment arms. This CBT "contamination" of the voice therapy only arm reflects the chief limitation of the study: one therapist delivered both treatments. Registered with the ISRCTN under the title: Training a Speech and Language Therapist in Cognitive Behavioural Therapy to treat Functional Dysphonia - A Randomised Controlled Trial .Trial Identifier: ISRCTN20582523 Registered 19/05/2010; retrospectively registered. http://www.isrctn.com/ISRCTN20582523.

The Social Living Complex: A New, All Day, Yearlong Intervention Model for Individuals with Autism Spectrum Disorder and Their Parents

ERIC Educational Resources Information Center

Doenyas, Ceymi

2016-01-01

We propose an unprecedented intervention for individuals with autism spectrum disorder (ASD) and their parents: the social living complex. Unlike existing social skills interventions, peer-mediated interventions here are not limited to the school/experiment duration and setting. Whereas other supported living services house adults with ASD only,…

'Healthy Eating and Lifestyle in Pregnancy (HELP)' trial: Process evaluation framework.

PubMed

Simpson, Sharon A; Cassidy, Dunla; John, Elinor

2014-07-01

We developed and tested in a cluster RCT a theory-driven group-based intervention for obese pregnant women. It was designed to support women to moderate weight gain during pregnancy and reduce BMI one year after birth, in addition to targeting secondary health and wellbeing outcomes. In line with MRC guidance on developing and evaluating complex interventions in health, we conducted a process evaluation alongside the trial. This paper describes the development of the process evaluation framework. This cluster RCT recruited 598 pregnant women. Women in the intervention group were invited to attend a weekly weight-management group. Following a review of relevant literature, we developed a process evaluation framework which outlined key process indicators that we wanted to address and how we would measure these. Central to the process evaluation was to understand the mechanism of effect of the intervention. We utilised a logic-modelling approach to describe the intervention which helped us focus on what potential mediators of intervention effect to measure, and how. The resulting process evaluation framework was designed to address 9 core elements; context, reach, exposure, recruitment, fidelity, recruitment, retention, contamination and theory-testing. These were assessed using a variety of qualitative and quantitative approaches. The logic model explained the processes by which intervention components bring about change in target outcomes through various mediators and theoretical pathways including self-efficacy, social support, self-regulation and motivation. Process evaluation is a key element in assessing the effect of any RCT. We developed a process evaluation framework and logic model, and the results of analyses using these will offer insights into why the intervention is or is not effective. Copyright © 2014.

Adaptive Intervention Design in Mobile Health: Intervention Design and Development in the Cell Phone Intervention for You (CITY) Trial

PubMed Central

Lin, Pao-Hwa; Intille, Stephen; Bennett, Gary; Bosworth, Hayden B; Corsino, Leonor; Voils, Corrine; Grambow, Steven; Lazenka, Tony; Batch, Bryan C; Tyson, Crystal; Svetkey, Laura P

2015-01-01

Background/Aims The obesity epidemic has spread to young adults, and obesity is a significant risk factor for cardiovascular disease. The prominence and increasing functionality of mobile phones may provide an opportunity to deliver longitudinal and scalable weight management interventions in young adults. The aim of this manuscript is to describe the design and development of the intervention tested in the Cell Phone Intervention for You (CITY) study and to highlight the importance of adaptive intervention design (AID) that made it possible. The CITY study was an NHLBI-sponsored, controlled 24-month randomized clinical trial (RCT) comparing two active interventions to a usual-care control group. Participants were 365 overweight or obese (BMI ≥ 25 kg/m2) young adults. Methods Both active interventions were designed based on social cognitive theory and incorporated techniques for behavioral self-management and motivational enhancement. Initial intervention development occurred during a 1-year formative phase utilizing focus groups and iterative, participatory design. During the intervention testing, AID, where an intervention is updated or extended throughout a trial while assuring the delivery of exactly the same intervention to each cohort, was employed. The AID strategy distributed technical work and allowed introduction of novel components in phases intended to help promote and sustain participant engagement. AID was made possible by exploiting the mobile phone's remote data capabilities so that adoption of particular application components could be continuously monitored and components subsequently added or updated remotely. Results The cellphone intervention was delivered almost entirely via cell phone and was always-present, proactive, and interactive – providing passive and active reminders, frequent opportunities for knowledge dissemination, and multiple tools for self-tracking and receiving tailored feedback. The intervention changed over two years to promote and sustain engagement. The personal coaching intervention, alternatively, was primarily personal coaching with trained coaches based on a proven intervention, enhanced with a mobile application, but where all interaction with the technology was participant-initiated. Conclusions The complexity and length of the technology-based RCT created challenges in engagement and technology adaptation, which were generally discovered using novel remote monitoring technology and addressed using the AID. Investigators should plan to develop tools and procedures that explicitly support continuous remote monitoring of interventions to support AID in long-term, technology-based studies, as well as developing the interventions themselves. PMID:26229119

Developing and pilot testing a shared decision-making intervention for dialysis choice.

PubMed

Finderup, Jeanette; Jensen, Jens K D; Lomborg, Kirsten

2018-04-17

Evidence is inconclusive on how best to guide the patient in decision-making around haemodialysis and peritoneal dialysis choice. International guidelines recommend involvement of the patient in the decision to choose the dialysis modality most suitable for the individual patient. Nevertheless, studies have shown lack of involvement of the patient in decision-making. To develop and pilot test an intervention for shared decision-making targeting the choice of dialysis modality. This study reflects the first two phases of a complex intervention design: phase 1, the development process and phase 2, feasibility and piloting. Because decision aids were a part of the intervention, the International Patient Decision Aid Standards were considered. The pilot test included both the intervention and the feasibility of the validated shared decision-making questionnaire (SDM Q9) and the Decision Quality Measure (DQM) applied to evaluate the intervention. A total of 137 patients tested the intervention. After the intervention, 80% of the patients chose dialysis at home reflecting an increase of 23% in starting dialysis at home prior to the study. The SDM Q9 showed the majority of the patients experienced this intervention as shared decision-making. An intervention based on shared decision-making supported by decision aids seemed to increase the number of patients choosing home dialysis. The SDM Q9 and DQM were feasible evaluation tools. Further research is needed to gain insight into the patients' experiences of involvement and the implications for their choice of dialysis modality. © 2018 European Dialysis and Transplant Nurses Association/European Renal Care Association.

Evidence synthesis in international development: a critique of systematic reviews and a pragmatist alternative.

PubMed

Cornish, Flora

2015-12-01

Systematic reviews are an instrument of Evidence-Based Policy designed to produce comprehensive, unbiased, transparent and clear assessments of interventions' effectiveness. From their origins in medical fields, systematic reviews have recently been promoted as offering important advances in a range of applied social science fields, including international development. Drawing on a case study of a systematic review of the effectiveness of community mobilisation as an intervention to tackle HIV/AIDS, this article problematises the use of systematic reviews to summarise complex and context-specific bodies of evidence. Social development interventions, such as 'community mobilisation' often take different forms in different interventions; are made successful by their situation in particular contexts, rather than being successful or unsuccessful universally; and have a rhetorical value that leads to the over-application of positively valued terms (e.g. 'community mobilisation'), invalidating the keyword search process of a systematic review. The article suggests that the policy interest in definitive summary statements of 'the evidence' is at odds with academic assessments that evidence takes multiple, contradictory and complex forms, and with practitioner experience of the variability of practice in context. A pragmatist philosophy of evidence is explored as an alternative. Taking this approach implies expanding the definition of forms of research considered to be 'useful evidence' for evidence-based policy-making; decentralising decisions about 'what works' to allow for the use of local practical wisdom; and prioritising the establishment of good processes for the critical use of evidence, rather than producing context-insensitive summaries of 'the evidence'.

The feasibility of implementing recovery, psychosocial and pharmacological interventions for psychosis: comparison study.

PubMed

van der Krieke, Lian; Bird, Victoria; Leamy, Mary; Bacon, Faye; Dunn, Rebecca; Pesola, Francesca; Janosik, Monika; Le Boutillier, Clair; Williams, Julie; Slade, Mike

2015-05-23

Clinical guidelines for the treatment of people experiencing psychosis have existed for over a decade, but implementation of recommended interventions is limited. Identifying influences on implementation may help to reduce this translational gap. The Structured Assessment of Feasibility (SAFE) measure is a standardised assessment of implementation blocks and enablers. The aim of this study was to characterise and compare the implementation blocks and enablers for recommended psychosis interventions. SAFE was used to evaluate and compare three groups of interventions recommended in the 2014 NICE psychosis guideline: pharmacological (43 trials testing 5 interventions), psychosocial (65 trials testing 5 interventions), and recovery (19 trials testing 5 interventions). The 127 trial reports rated with SAFE were supplemented by published intervention manuals, research protocols, trial registrations and design papers. Differences in the number of blocks and enablers across the three interventions were tested statistically, and feasibility profiles were generated. There was no difference between psychosocial and recovery interventions in the number of blocks or enablers to implementation. Pharmacological interventions (a) had fewer blocks than both psychosocial interventions (χ (2)(3) = 133.77, p < 0.001) and recovery interventions (χ (2)(3) = 104.67, p < 0.001) and (b) did not differ in number of enablers from recovery interventions (χ (2)(3) = 0.74, p = 0.863) but had fewer enablers than psychosocial interventions (χ (2)(3) = 28.92, p < 0.001). Potential adverse events associated with the intervention tend to be a block for pharmacological interventions, whereas complexity of the intervention was the most consistent block for recovery and psychosocial interventions. Feasibility profiles show that pharmacological interventions are relatively easy to implement but can sometimes involve risks. Psychosocial and recovery interventions are relatively complex but tend to be more flexible and more often manualised. SAFE ratings can contribute to tackling the current implementation challenges in mental health services, by providing a reporting guideline structure for researchers to maximise the potential for implementation and by informing prioritisation decisions by clinical guideline developers and service managers.

Virtual Reality As a Training Tool to Treat Physical Inactivity in Children.

PubMed

Kiefer, Adam W; Pincus, David; Richardson, Michael J; Myer, Gregory D

2017-01-01

Lack of adequate physical activity in children is an epidemic that can result in obesity and other poor health outcomes across the lifespan. Physical activity interventions focused on motor skill competence continue to be developed, but some interventions, such as neuromuscular training (NMT), may be limited in how early they can be implemented due to dependence on the child's level of cognitive and perceptual-motor development. Early implementation of motor-rich activities that support motor skill development in children is critical for the development of healthy levels of physical activity that carry through into adulthood. Virtual reality (VR) training may be beneficial in this regard. VR training, when grounded in an information-based theory of perceptual-motor behavior that modifies the visual information in the virtual world, can promote early development of motor skills in youth akin to more natural, real-world development as opposed to strictly formalized training. This approach can be tailored to the individual child and training scenarios can increase in complexity as the child develops. Ultimately, training in VR may help serve as a precursor to "real-world" NMT, and once the child reaches the appropriate training age can also augment more complex NMT regimens performed outside of the virtual environment.

Virtual Reality As a Training Tool to Treat Physical Inactivity in Children

PubMed Central

Kiefer, Adam W.; Pincus, David; Richardson, Michael J.; Myer, Gregory D.

2017-01-01

Lack of adequate physical activity in children is an epidemic that can result in obesity and other poor health outcomes across the lifespan. Physical activity interventions focused on motor skill competence continue to be developed, but some interventions, such as neuromuscular training (NMT), may be limited in how early they can be implemented due to dependence on the child’s level of cognitive and perceptual-motor development. Early implementation of motor-rich activities that support motor skill development in children is critical for the development of healthy levels of physical activity that carry through into adulthood. Virtual reality (VR) training may be beneficial in this regard. VR training, when grounded in an information-based theory of perceptual-motor behavior that modifies the visual information in the virtual world, can promote early development of motor skills in youth akin to more natural, real-world development as opposed to strictly formalized training. This approach can be tailored to the individual child and training scenarios can increase in complexity as the child develops. Ultimately, training in VR may help serve as a precursor to “real-world” NMT, and once the child reaches the appropriate training age can also augment more complex NMT regimens performed outside of the virtual environment. PMID:29376045

Agency for Healthcare Research and Quality Evidence-based Practice Center methods for systematically reviewing complex multicomponent health care interventions.

PubMed

Guise, Jeanne-Marie; Chang, Christine; Viswanathan, Meera; Glick, Susan; Treadwell, Jonathan; Umscheid, Craig A; Whitlock, Evelyn; Fu, Rongwei; Berliner, Elise; Paynter, Robin; Anderson, Johanna; Motu'apuaka, Pua; Trikalinos, Tom

2014-11-01

The purpose of this Agency for Healthcare Research and Quality Evidence-based Practice Center methods white paper was to outline approaches to conducting systematic reviews of complex multicomponent health care interventions. We performed a literature scan and conducted semistructured interviews with international experts who conduct research or systematic reviews of complex multicomponent interventions (CMCIs) or organizational leaders who implement CMCIs in health care. Challenges identified include lack of consistent terminology for such interventions (eg, complex, multicomponent, multidimensional, multifactorial); a wide range of approaches used to frame the review, from grouping interventions by common features to using more theoretical approaches; decisions regarding whether and how to quantitatively analyze the interventions, from holistic to individual component analytic approaches; and incomplete and inconsistent reporting of elements critical to understanding the success and impact of multicomponent interventions, such as methods used for implementation the context in which interventions are implemented. We provide a framework for the spectrum of conceptual and analytic approaches to synthesizing studies of multicomponent interventions and an initial list of critical reporting elements for such studies. This information is intended to help systematic reviewers understand the options and tradeoffs available for such reviews. Copyright © 2014 Elsevier Inc. All rights reserved.

Multi-Family Group Intervention for OEF/OIF Traumatic Brain Injury Survivors and Their Families

DTIC Science & Technology

2010-10-01

information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden...considerable layer of complexity to recruitment, especially as the PI and study clinicians were based in psychiatry. It has taken many months to develop...coordination or recruitment efforts by psychiatry with the services diagnosing and treating the vets is complex and time-consuming. In New Jersey

Aging, the Central Nervous System, and Mobility in Older Adults: Interventions.

PubMed

Varma, Vijay R; Hausdorff, Jeffrey M; Studenski, Stephanie A; Rosano, Caterina; Camicioli, Richard; Alexander, Neil B; Chen, Wen G; Lipsitz, Lewis A; Carlson, Michelle C

2016-11-01

Research suggests that the central nervous system (CNS) and mobility are closely linked. CNS-mediated mobility impairment may represent a potentially new and prevalent syndrome within the older adult populations. Interventions targeting this group may have the potential to improve mobility and cognition and prevent disability. In 2012, the Gerontological Society of America (GSA) and the National Institute on Aging (NIA) sponsored a 3-year conference workshop series, "Aging, the CNS, and Mobility." The goal of this third and final conference was to (i) report on the state of the science of interventions targeting CNS-mediated mobility impairment among community-dwelling older adults and (ii) partnering with the NIA, explore the future of research and intervention design focused on a potentially novel aging syndrome. Evidence was presented in five main intervention areas: (i) pharmacology and diet; (ii) exercise; (iii) electrical stimulation; (iv) sensory stimulation/deprivation; and (v) a combined category of multimodal interventions. Workshop participants identified important gaps in knowledge and key recommendations for future interventions related to recruitment and sample selection, intervention design, and methods to measure effectiveness. In order to develop effective preventive interventions for this prevalent syndrome, multidisciplinary teams are essential particularly because of the complex nature of the syndrome. Additionally, integrating innovative methods into the design of interventions may help researchers better measure complex mechanisms, and finally, the value of understanding the link between the CNS and mobility should be conveyed to researchers across disciplines in order to incorporate cognitive and mobility measurements into study protocols. © The Author 2016. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Fatherhood and Intimate Partner Violence: Bringing the Parenting Role into Intervention Strategies

PubMed Central

Stover, Carla Smith; Morgos, Dorothy

2013-01-01

A large percentage of men who perpetrate intimate partner violence (IPV) are fathers who continue to live with or have visitation with their children. Yet, providers rarely consider that fathers who perpetrate IPV may benefit from a parent-child focused intervention. Therapeutic work with men, who perpetrate IPV, especially with their children, is complex with issues of child safety taking precedence. This article is meant to provide: 1) a rationale for considering father-child intervention in the context of IPV; 2) specific strategies for assessment; 3) guidelines for determining if a father is appropriate for such intervention; and 4) a review of treatment approaches that have been developed that may assist clinicians in work with this population. PMID:23956491

Fatherhood and Intimate Partner Violence: Bringing the Parenting Role into Intervention Strategies.

PubMed

Stover, Carla Smith; Morgos, Dorothy

2013-08-01

A large percentage of men who perpetrate intimate partner violence (IPV) are fathers who continue to live with or have visitation with their children. Yet, providers rarely consider that fathers who perpetrate IPV may benefit from a parent-child focused intervention. Therapeutic work with men, who perpetrate IPV, especially with their children, is complex with issues of child safety taking precedence. This article is meant to provide: 1) a rationale for considering father-child intervention in the context of IPV; 2) specific strategies for assessment; 3) guidelines for determining if a father is appropriate for such intervention; and 4) a review of treatment approaches that have been developed that may assist clinicians in work with this population.

Challenges in designing, conducting, and reporting oral health behavioral intervention studies in primary school age children: methodological issues

PubMed Central

Cooper, Anna Mary; Coffey, Margaret; Dugdill, Lindsey

2014-01-01

Often within oral health, clinical outcome measures dominate trial design rather than behavioral outcome measures, and often there is a reliance on proxy self-reporting of children’s behavior with no corroboration through triangulation of measures. The complexity of the interventions involved in oral health intervention is often overlooked in trial design, and more flexible pragmatic designs that take account of the research context may be more appropriate. Some of the limitations in oral health behavioral intervention studies (trials) in primary school age children were reported in a recently published Cochrane review. This paper aims to critically discuss the findings of a recent Cochrane review in terms of the methodological implications that arise for future design, development, measurement, and reporting of oral health trials in primary school age children. Key components of the UK Medical Research Council’s framework for the design and evaluation of complex interventions are discussed in relation to using taxonomies of behavior change. This paper is not designed to be a definitive guide but aims to bring learning from other areas of public health and health promotion into dental public health. Ultimately, the aim is to aid the design of more successful interventions that produce long-term behavioral changes in children in relation to toothbrushing and nighttime sugar snacking. PMID:27774028

Adaptive intervention design in mobile health: Intervention design and development in the Cell Phone Intervention for You trial.

PubMed

Lin, Pao-Hwa; Intille, Stephen; Bennett, Gary; Bosworth, Hayden B; Corsino, Leonor; Voils, Corrine; Grambow, Steven; Lazenka, Tony; Batch, Bryan C; Tyson, Crystal; Svetkey, Laura P

2015-12-01

The obesity epidemic has spread to young adults, and obesity is a significant risk factor for cardiovascular disease. The prominence and increasing functionality of mobile phones may provide an opportunity to deliver longitudinal and scalable weight management interventions in young adults. The aim of this article is to describe the design and development of the intervention tested in the Cell Phone Intervention for You study and to highlight the importance of adaptive intervention design that made it possible. The Cell Phone Intervention for You study was a National Heart, Lung, and Blood Institute-sponsored, controlled, 24-month randomized clinical trial comparing two active interventions to a usual-care control group. Participants were 365 overweight or obese (body mass index≥25 kg/m2) young adults. Both active interventions were designed based on social cognitive theory and incorporated techniques for behavioral self-management and motivational enhancement. Initial intervention development occurred during a 1-year formative phase utilizing focus groups and iterative, participatory design. During the intervention testing, adaptive intervention design, where an intervention is updated or extended throughout a trial while assuring the delivery of exactly the same intervention to each cohort, was employed. The adaptive intervention design strategy distributed technical work and allowed introduction of novel components in phases intended to help promote and sustain participant engagement. Adaptive intervention design was made possible by exploiting the mobile phone's remote data capabilities so that adoption of particular application components could be continuously monitored and components subsequently added or updated remotely. The cell phone intervention was delivered almost entirely via cell phone and was always-present, proactive, and interactive-providing passive and active reminders, frequent opportunities for knowledge dissemination, and multiple tools for self-tracking and receiving tailored feedback. The intervention changed over 2 years to promote and sustain engagement. The personal coaching intervention, alternatively, was primarily personal coaching with trained coaches based on a proven intervention, enhanced with a mobile application, but where all interactions with the technology were participant-initiated. The complexity and length of the technology-based randomized clinical trial created challenges in engagement and technology adaptation, which were generally discovered using novel remote monitoring technology and addressed using the adaptive intervention design. Investigators should plan to develop tools and procedures that explicitly support continuous remote monitoring of interventions to support adaptive intervention design in long-term, technology-based studies, as well as developing the interventions themselves. © The Author(s) 2015.

Towards evidence-based practice in medical training: making evaluations more meaningful.

PubMed

Drescher, Uta; Warren, Fiona; Norton, Kingsley

2004-12-01

The evaluation of training is problematic and the evidence base inconclusive. This situation may arise for 2 main reasons: training is not understood as a complex intervention and, related to this, the evaluation methods applied are often overly simplistic. This paper makes the case for construing training, especially in the field of specialist medical education, as a complex intervention. It also selectively reviews the available literature in order to match evaluative techniques with the demonstrated complexity. Construing training as a complex intervention can provide a framework for selecting the most appropriate methodology to evaluate a given training intervention and to appraise the evidence base for training fairly, choosing from among both quantitative and qualitative approaches and applying measurement at multiple levels of training impact.

Complex adaptive chronic care - typologies of patient journey: a case study.

PubMed

Martin, Carmel M; Grady, Deirdre; Deaconking, Susan; McMahon, Catherine; Zarabzadeh, Atieh; O'Shea, Brendan

2011-06-01

Complex adaptive chronic care (CACC) is a framework based upon complex adaptive systems' theory developed to address different stages in the patient journey in chronic illness. Simple, complicated, complex and chaotic phases are proposed as diagnostic types. To categorize phases of the patient journey and evaluate their utility as diagnostic typologies. A qualitative case study of two cohorts, identified as being at risk of avoidable hospitalization: 12 patients monitored to establish typologies, followed by 46 patients to validate the typologies. Patients were recruited from a general practitioner out-of-hours service. Self-rated health, medical and psychological health, social support, environmental concerns, medication adherence and health service use were monitored with phone calls made 3-5 times per week for an average of 4 weeks. Analysis techniques included frequency distributions, coding and categorization of patients' longitudinal data using a CACC framework. Twelve and 46 patients, mean age 69 years, were monitored for average of 28 days in cohorts 1 and 2 respectively. Cohorts 1 and 2 patient journeys were categorized as being: stable complex 66.66% vs. 67.4%, unstable complex 25% vs. 26.08% and unstable complex chaotic 8.3% vs. 6.52% respectively. An average of 0.48, 0.75 and 2 interventions per person were provided in the stable, unstable and chaotic journeys. Instability was related to complex interactions between illness, social support, environment, as well as medication and medical care issues. Longitudinal patient journeys encompass different phases with characteristic dynamics and are likely to require different interventions and strategies - thus being 'adaptive' to the changing complex dynamics of the patient's illness and care needs. CACC journey types provide a clinical tool for health professionals to focus time and care interventions in response to patterns of instability in multiple domains in chronic illness care. © 2011 Blackwell Publishing Ltd.

The implementation of mindfulness in healthcare systems: a theoretical analysis.

PubMed

Demarzo, M M P; Cebolla, A; Garcia-Campayo, J

2015-01-01

Evidence regarding the efficacy of mindfulness-based interventions (MBIs) is increasing exponentially; however, there are still challenges to their integration in healthcare systems. Our goal is to provide a conceptual framework that addresses these challenges in order to bring about scholarly dialog and support health managers and practitioners with the implementation of MBIs in healthcare. This is an opinative narrative review based on theoretical and empirical data that address key issues in the implementation of mindfulness in healthcare systems, such as the training of professionals, funding and costs of interventions, cost effectiveness and innovative delivery models. We show that even in the United Kingdom, where mindfulness has a high level of implementation, there is a high variability in the access to MBIs. In addition, we discuss innovative approaches based on "complex interventions," "stepped-care" and "low intensity-high volume" concepts that may prove fruitful in the development and implementation of MBIs in national healthcare systems, particularly in Primary Care. In order to better understand barriers and opportunities for mindfulness implementation in healthcare systems, it is necessary to be aware that MBIs are "complex interventions," which require innovative approaches and delivery models to implement these interventions in a cost-effective and accessible way. Copyright © 2015 Elsevier Inc. All rights reserved.

Development and implementation of an integrated chronic disease model in South Africa: lessons in the management of change through improving the quality of clinical practice

PubMed Central

Asmall, Shaidah

2015-01-01

Background South Africa is facing a complex burden of disease arising from a combination of chronic infectious illness and non-communicable diseases. As the burden of chronic diseases (communicable and non-communicable) increases, providing affordable and effective care to the increasing numbers of chronic patients will be an immense challenge. Methods The framework recommended by the Medical Research Council of the United Kingdom for the development and evaluation of complex health interventions was used to conceptualise the intervention. The breakthrough series was utilised for the implementation process. These two frameworks were embedded within the clinical practice improvement model that served as the overarching framework for the development and implementation of the model. Results The Chronic Care Model was ideally suited to improve the facility component and patient experience; however, the deficiencies in other aspects of the health system building blocks necessitated a hybrid model. An integrated chronic disease management model using a health systems approach was initiated across 42 primary health care facilities. The interventions were implemented in a phased approach using learning sessions and action periods to introduce the planned and targeted changes. Conclusion The implementation of the integrated chronic disease management model is feasible at primary care in South Africa provided that systemic challenges and change management are addressed during the implementation process. PMID:26528101

Development and implementation of an integrated chronic disease model in South Africa: lessons in the management of change through improving the quality of clinical practice.

PubMed

Mahomed, Ozayr Haroon; Asmall, Shaidah

2015-01-01

South Africa is facing a complex burden of disease arising from a combination of chronic infectious illness and non-communicable diseases. As the burden of chronic diseases (communicable and non-communicable) increases, providing affordable and effective care to the increasing numbers of chronic patients will be an immense challenge. The framework recommended by the Medical Research Council of the United Kingdom for the development and evaluation of complex health interventions was used to conceptualise the intervention. The breakthrough series was utilised for the implementation process. These two frameworks were embedded within the clinical practice improvement model that served as the overarching framework for the development and implementation of the model. The Chronic Care Model was ideally suited to improve the facility component and patient experience; however, the deficiencies in other aspects of the health system building blocks necessitated a hybrid model. An integrated chronic disease management model using a health systems approach was initiated across 42 primary health care facilities. The interventions were implemented in a phased approach using learning sessions and action periods to introduce the planned and targeted changes. The implementation of the integrated chronic disease management model is feasible at primary care in South Africa provided that systemic challenges and change management are addressed during the implementation process.

A complex systems science perspective for whole systems of complementary and alternative medicine research.

PubMed

Koithan, Mary; Bell, Iris R; Niemeyer, Kathryn; Pincus, David

2012-01-01

Whole systems complementary and alternative medicine (WS-CAM) approaches share a basic worldview that embraces interconnectedness; emergent, non-linear outcomes to treatment that include both local and global changes in the human condition; a contextual view of human beings that are inseparable from and responsive to their environments; and interventions that are complex, synergistic, and interdependent. These fundamental beliefs and principles run counter to the assumptions of reductionism and conventional biomedical research methods that presuppose unidimensional simple causes and thus dismantle and individually test various interventions that comprise only single aspects of the WSCAM system. This paper will demonstrate the superior fit and practical advantages of using complex adaptive systems (CAS) and related modeling approaches to develop the scientific basis for WS-CAM. Furthermore, the details of these CAS models will be used to provide working hypotheses to explain clinical phenomena such as (a) persistence of changes for weeks to months between treatments and/or after cessation of treatment, (b) nonlocal and whole systems changes resulting from therapy, (c) Hering's law, and (d) healing crises. Finally, complex systems science will be used to offer an alternative perspective on cause, beyond the simple reductionism of mainstream mechanistic ontology and more parsimonious than the historical vitalism of WS-CAM. Rather, complex systems science provides a scientifically rigorous, yet essentially holistic ontological perspective with which to conceptualize and empirically explore the development of disease and illness experiences, as well as experiences of healing and wellness. Copyright © 2012 S. Karger AG, Basel.

Cognitive Illusions as Hindrances to Learning Complex Environmental Issues.

ERIC Educational Resources Information Center

Groves, Fred H.; Pugh, Ava F.

2002-01-01

Describes a study investigating the effects of short-term interventions on preservice elementary teachers' understanding of the topic of ozone depletion and whether complex issues can be dealt with successfully through short-term intervention. Reports that preservice teachers' understanding improved through a short-term intervention using a mix of…

Intervention Fidelity for a Complex Behaviour Change Intervention in Community Pharmacy Addressing Cardiovascular Disease Risk

ERIC Educational Resources Information Center

McNamara, K. P.; O'Reilly, S. L.; George, J.; Peterson, G. M.; Jackson, S. L.; Duncan, G.; Howarth, H.; Dunbar, J. A.

2015-01-01

Background: Delivery of cardiovascular disease (CVD) prevention programs by community pharmacists appears effective and enhances health service access. However, their capacity to implement complex behavioural change processes during patient counselling remains largely unexplored. This study aims to determine intervention fidelity by pharmacists…

A Framework for the Study of Complex mHealth Interventions in Diverse Cultural Settings

PubMed Central

Yeates, Karen; Perkins, Nancy; Boesch, Lisa; Hua-Stewart, Diane; Liu, Peter; Sleeth, Jessica; Tobe, Sheldon W

2017-01-01

Background To facilitate decision-making capacity between options of care under real-life service conditions, clinical trials must be pragmatic to evaluate mobile health (mHealth) interventions under the variable conditions of health care settings with a wide range of participants. The mHealth interventions require changes in the behavior of patients and providers, creating considerable complexity and ambiguity related to causal chains. Process evaluations of the implementation are necessary to shed light on the range of unanticipated effects an intervention may have, what the active ingredients in everyday practice are, how they exert their effect, and how these may vary among recipients or between sites. Objective Building on the CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth) statement and participatory evaluation theory, we present a framework for the process evaluations for mHealth interventions in multiple cultural settings. We also describe the application of this evaluation framework to the implementation of DREAM-GLOBAL (Diagnosing hypertension—Engaging Action and Management in Getting Lower BP in Indigenous and LMIC [low- and middle-income countries]), a pragmatic randomized controlled trial (RCT), and mHealth intervention designed to improve hypertension management in low-resource environments. We describe the evaluation questions and the data collection processes developed by us. Methods Our literature review revealed that there is a significant knowledge gap related to the development of a process evaluation framework for mHealth interventions. We used community-based participatory research (CBPR) methods and formative research data to develop a process evaluation framework nested within a pragmatic RCT. Results Four human organizational levels of participants impacted by the mHealth intervention were identified that included patients, providers, community and organizations actors, and health systems and settings. These four levels represent evaluation domains and became the core focus of the evaluation. In addition, primary implementation themes to explore in each of the domains were identified as follows: (1) the major active components of the intervention, (2) technology of the intervention, (3) cultural congruence, (4) task shifting, and (5) unintended consequences. Using the four organizational domains and their interaction with primary implementation themes, we developed detailed evaluation research questions and identified the data or information sources to best answer our questions. Conclusions Using DREAM-GLOBAL to illustrate our approach, we succeeded in developing an uncomplicated process evaluation framework for mHealth interventions that provide key information to stakeholders, which can optimize implementation of a pragmatic trial as well as inform scale up. The human organizational level domains used to focus the primary implementation themes in the DREAM-GLOBAL process evaluation framework are sufficiently supported in our research, and the literature and can serve as a valuable tool for other mHealth process evaluations. Trial Registration ClinicalTrials.gov NCT02111226; https://clinicaltrials.gov/ct2/show/NCT02111226 (Archived by WebCite at http://www.webcitation.org/6oxfHXege) PMID:28428165

A theory-based educational intervention targeting nurses' attitudes and knowledge concerning cancer-related pain management: a study protocol of a quasi-experimental design.

PubMed

Borglin, Gunilla; Gustafsson, Markus; Krona, Hans

2011-09-23

Pain is one of the most frequent problems among patients diagnosed with cancer. Despite the availability of effective pharmacological treatments, this group of patients often receives less than optimal treatment. Research into nurses' pain management highlights certain factors, such as lack of knowledge and attitudes and inadequate procedures for systematic pain assessment, as common barriers to effective pain management. However, educational interventions targeting nurses' pain management have shown promise. As cancer-related pain is also known to have a negative effect on vital aspects of the patient's life, as well as being commonly associated with problems such as sleep, fatigue, depression and anxiety, further development of knowledge within this area is warranted. A quasi-experimental study design will be used to investigate whether the implementation of guidelines for systematic daily pain assessments following a theory-based educational intervention will result in an improvement in knowledge and attitude among nurses. A further aim is to investigate whether the intervention that targets nurses' behaviour will improve hospital patients' perception of pain. Data regarding nurses' knowledge and attitudes to pain (primary outcome), patient perception regarding pain (secondary outcome), together with socio-demographic variables, will be collected at baseline and at four weeks and 12 weeks following the intervention. Nursing care is nowadays acknowledged as an increasingly complicated activity and "nursing complexity is such that it can be seen as the quintessential complex intervention." To be able to change and improve clinical practice thus requires multiple points of attack appropriate to meet complex challenges. Consequently, we expect the theory-based intervention used in our quasi-experimental study to improve care as well as quality of life for this group of patients and we also envisage that evidence-based guidelines targeting this patient group's pain will be implemented more widely. ClinicalTrials.gov NCT01313234.

Promoting Recruitment using Information Management Efficiently (PRIME): a stepped-wedge, cluster randomised trial of a complex recruitment intervention embedded within the REstart or Stop Antithrombotics Randomised Trial.

PubMed

Maxwell, Amy E; Parker, Richard A; Drever, Jonathan; Rudd, Anthony; Dennis, Martin S; Weir, Christopher J; Al-Shahi Salman, Rustam

2017-12-28

Few interventions are proven to increase recruitment in clinical trials. Recruitment to RESTART, a randomised controlled trial of secondary prevention after stroke due to intracerebral haemorrhage, has been slower than expected. Therefore, we sought to investigate an intervention to boost recruitment to RESTART. We conducted a stepped-wedge, cluster randomised trial of a complex intervention to increase recruitment, embedded within the RESTART trial. The primary objective was to investigate if the PRIME complex intervention (a recruitment co-ordinator who conducts a recruitment review, provides access to bespoke stroke audit data exports, and conducts a follow-up review after 6 months) increases the recruitment rate to RESTART. We included 72 hospital sites located in England, Wales, or Scotland that were active in RESTART in June 2015. All sites began in the control state and were allocated using block randomisation stratified by hospital location (Scotland versus England/Wales) to start the complex intervention in one of 12 different months. The primary outcome was the number of patients randomised into RESTART per month per site. We quantified the effect of the complex intervention on the primary outcome using a negative binomial, mixed model adjusting for site, December/January months, site location, and background time trends in recruitment rate. We recruited and randomised 72 sites and recorded their monthly recruitment to RESTART over 24 months (March 2015 to February 2017 inclusive), providing 1728 site-months of observations for the primary analysis. The adjusted rate ratio for the number of patients randomised per month after allocation to the PRIME complex intervention versus control time before allocation to the PRIME complex intervention was 1.06 (95% confidence interval 0.55 to 2.03, p = 0.87). Although two thirds of respondents to the 6-month follow-up questionnaire agreed that the audit reports were useful, only six patients were reported to have been randomised using the audit reports. Respondents frequently reported resource and time pressures as being key barriers to running the audit reports. The PRIME complex intervention did not significantly improve the recruitment rate to RESTART. Further research is needed to establish if PRIME might be beneficial at an earlier stage in a prevention trial or for prevention dilemmas that arise more often in clinical practice.

Evaluations of Structural Interventions for HIV Prevention: A Review of Approaches and Methods.

PubMed

Iskarpatyoti, Brittany S; Lebov, Jill; Hart, Lauren; Thomas, Jim; Mandal, Mahua

2018-04-01

Structural interventions alter the social, economic, legal, political, and built environments that underlie processes affecting population health. We conducted a systematic review of evaluations of structural interventions for HIV prevention in low- and middle-income countries (LMICs) to better understand methodological and other challenges and identify effective evaluation strategies. We included 27 peer-reviewed articles on interventions related to economic empowerment, education, and substance abuse in LMICs. Twenty-one evaluations included clearly articulated theories of change (TOCs); 14 of these assessed the TOC by measuring intermediary variables in the causal pathway between the intervention and HIV outcomes. Although structural interventions address complex interactions, no evaluation included methods designed to evaluate complex systems. To strengthen evaluations of structural interventions, we recommend clearly articulating a TOC and measuring intermediate variables between the predictor and outcome. We additionally recommend adapting study designs and analytic methods outside traditional epidemiology to better capture complex results, influences external to the intervention, and unintended consequences.

Representing causal knowledge in environmental policy interventions: Advantages and opportunities for qualitative influence diagram applications.

PubMed

Carriger, John F; Dyson, Brian E; Benson, William H

2018-05-01

This article develops and explores a methodology for using qualitative influence diagrams in environmental policy and management to support decision-making efforts that minimize risk and increase resiliency. Influence diagrams are representations of the conditional aspects of a problem domain. Their graphical properties are useful for structuring causal knowledge relevant to policy interventions and can be used to enhance inference and inclusivity of multiple viewpoints. Qualitative components of influence diagrams are beneficial tools for identifying and examining the interactions among the critical variables in complex policy development and implementation. Policy interventions on social-environmental systems can be intuitively diagrammed for representing knowledge of critical relationships among economic, environmental, and social attributes. Examples relevant to coastal resiliency issues in the US Gulf Coast region are developed to illustrate model structures for developing qualitative influence diagrams useful for clarifying important policy intervention issues and enhancing transparency in decision making. Integr Environ Assess Manag 2018;14:381-394. Published 2018. This article is a US Government work and is in the public domain in the USA. Published 2018. This article is a US Government work and is in the public domain in the USA.

Positive Psychology School-Based Interventions: A Reflection on Current Success and Future Directions

ERIC Educational Resources Information Center

Chodkiewicz, Alicia R.; Boyle, Christopher

2017-01-01

An increased focus on youth development has led to an understanding of the importance of the wellbeing, resilience and mental health of children and young people. As a result there is a growing body of research, especially over the last two decades, which increasingly recognises the complexities of learning and development across the years spent…

Training preschoolers on first-order false belief understanding: transfer on advanced ToM skills and metamemory.

PubMed

Lecce, Serena; Bianco, Federica; Demicheli, Patrizia; Cavallini, Elena

2014-01-01

This study investigated the relation between theory of mind (ToM) and metamemory knowledge using a training methodology. Sixty-two 4- to 5-year-old children were recruited and randomly assigned to one of two training conditions: A first-order false belief (ToM) and a control condition. Intervention and control groups were equivalent at pretest for age, parents' education, verbal ability, inhibition, and ToM. Results showed that after the intervention children in the ToM group improved in their first-order false belief understanding significantly more than children in the control condition. Crucially, the positive effect of the ToM intervention was stable over 2 months and generalized to more complex ToM tasks and metamemory. © 2014 The Authors. Child Development © 2014 Society for Research in Child Development, Inc.

Cochrane Qualitative and Implementation Methods Group guidance series-paper 2: methods for question formulation, searching, and protocol development for qualitative evidence synthesis.

PubMed

Harris, Janet L; Booth, Andrew; Cargo, Margaret; Hannes, Karin; Harden, Angela; Flemming, Kate; Garside, Ruth; Pantoja, Tomas; Thomas, James; Noyes, Jane

2018-05-01

This paper updates previous Cochrane guidance on question formulation, searching, and protocol development, reflecting recent developments in methods for conducting qualitative evidence syntheses to inform Cochrane intervention reviews. Examples are used to illustrate how decisions about boundaries for a review are formed via an iterative process of constructing lines of inquiry and mapping the available information to ascertain whether evidence exists to answer questions related to effectiveness, implementation, feasibility, appropriateness, economic evidence, and equity. The process of question formulation allows reviewers to situate the topic in relation to how it informs and explains effectiveness, using the criterion of meaningfulness, appropriateness, feasibility, and implementation. Questions related to complex questions and interventions can be structured by drawing on an increasingly wide range of question frameworks. Logic models and theoretical frameworks are useful tools for conceptually mapping the literature to illustrate the complexity of the phenomenon of interest. Furthermore, protocol development may require iterative question formulation and searching. Consequently, the final protocol may function as a guide rather than a prescriptive route map, particularly in qualitative reviews that ask more exploratory and open-ended questions. Copyright © 2017 Elsevier Inc. All rights reserved.

Ethics interventions for healthcare professionals and students: A systematic review.

PubMed

Stolt, Minna; Leino-Kilpi, Helena; Ruokonen, Minka; Repo, Hanna; Suhonen, Riitta

2018-03-01

The ethics and value bases in healthcare are widely acknowledged. There is a need to improve and raise awareness of ethics in complex systems and in line with competing needs, different stakeholders and patients' rights. Evidence-based strategies and interventions for the development of procedures and practice have been used to improve care and services. However, it is not known whether and to what extent ethics can be developed using interventions. To examine ethics interventions conducted on healthcare professionals and healthcare students to achieve ethics-related outcomes. A systematic review. Five electronic databases were searched: CINAHL, the Cochrane Library, Philosopher's Index, PubMed and PsycINFO. We searched for published articles written in English without a time limit using the keywords: ethic* OR moral* AND intervention OR program OR pre-post OR quasi-experimental OR rct OR experimental AND nurse OR nursing OR health care. In the four-phased retrieval process, 23 full texts out of 4675 citations were included in the review. Data were analysed using conventional content analysis. Ethical consideration: This systematic review was conducted following good scientific practice in every phase. It is possible to affect the ethics of healthcare practices through professionals and students. All the interventions were educational in type. Many of the interventions were related to the ethical or moral sensitivity of the professionals, such as moral courage and empowerment. A few of the interventions focused on identifying ethical problems or research ethics. Patient-related outcomes followed by organisational outcomes can be improved by ethics interventions targeting professionals. Such outcomes are promising in developing ethical safety for healthcare patients and professionals.

The cost of a knowledge silo: a systematic re-review of water, sanitation and hygiene interventions.

PubMed

Loevinsohn, Michael; Mehta, Lyla; Cuming, Katie; Nicol, Alan; Cumming, Oliver; Ensink, Jeroen H J

2015-06-01

Divisions between communities, disciplinary and practice, impede understanding of how complex interventions in health and other sectors actually work and slow the development and spread of more effective ones. We test this hypothesis by re-reviewing a Cochrane-standard systematic review (SR) of water, sanitation and hygiene (WASH) interventions' impact on child diarrhoea morbidity: can greater understanding of impacts and how they are achieved be gained when the same papers are reviewed jointly from health and development perspectives? Using realist review methods, researchers examined the 27 papers for evidence of other impact pathways operating than assumed in the papers and SR. Evidence relating to four questions was judged on a scale of likelihood. At the 'more than possible' or 'likely' level, 22% of interventions were judged to involve substantially more actions than the SR's label indicated; 37% resulted in substantial additional impacts, beyond reduced diarrhoea morbidity; and unforeseen actions by individuals, households or communities substantially contributed to the impacts in 48% of studies. In 44%, it was judged that these additional impacts and actions would have substantially affected the intervention's effect on diarrhoea morbidity. The prevalence of these impacts and actions might well be found greater in studies not so narrowly selected. We identify six impact pathways suggested by these studies that were not considered by the SR: these are tentative, given the limitations of the literature we reviewed, but may help stimulate wider review and primary evaluation efforts. This re-review offers a fuller understanding of the impacts of these interventions and how they are produced, pointing to several ways in which investments might enhance health and wellbeing. It suggests that some conclusions of the SR and earlier reviews should be reconsidered. Moreover, it contributes important experience to the continuing debate on appropriate methods to evaluate and synthesize evidence on complex interventions. Published by Oxford University Press in association with The London School of Hygiene and Tropical Medicine © The Author 2014; all rights reserved.

A complex behavioural change intervention to reduce the risk of diabetes and prediabetes in the pre-conception period in Malaysia: study protocol for a randomised controlled trial.

PubMed

Skau, Jutta K H; Nordin, Awatef Binti Amer; Cheah, Julius C H; Ali, Roslinah; Zainal, Ramli; Aris, Tahir; Ali, Zainudin Mohd; Matzen, Priya; Biesma, Regien; Aagaard-Hansen, Jens; Hanson, Mark A; Norris, Shane A

2016-04-27

Over the past two decades, the population of Malaysia has grown rapidly and the prevalence of diabetes mellitus in Malaysia has dramatically increased, along with the frequency of obesity, hyperlipidaemia and hypertension. Early-life influences play an important role in the development of non-communicable diseases. Indeed, maternal lifestyle and conditions such as gestational diabetes mellitus or obesity can affect the risk of diabetes in the next generation. Lifestyle changes can help to prevent the development of type 2 diabetes mellitus. This is a protocol for an unblinded, community-based, randomised controlled trial in two arms to evaluate the efficacy of a complex behavioural change intervention, combining motivational interviewing provided by a community health promoter and access to a habit formation mobile application, among young Malaysian women and their spouses prior to pregnancy. Eligible subjects will be Malaysian women in the age group 20 to 39 years, who are nulliparous, not diagnosed with diabetes and own a smartphone. With an alpha-value of 0.05, a statistical power of 90 %, 264 subjects will need to complete the study. Subjects with their spouses will be randomised to either the intervention or the control arm for an 8-month period. The primary endpoint is change in waist circumference from baseline to end of intervention period and secondary endpoints are changes in anthropometric parameters, biochemical parameters, change in health literacy level, dietary habits, physical activity and stress level. Primary endpoint and the continuous secondary endpoints will be analysed in a linear regression model, whereas secondary endpoints on an ordinal scale will be analysed by using the chi-squared test. A multivariate linear model for the primary endpoint will be undertaken to account for potential confounders. This study has been approved by the Medical Research and Ethics Committee of the Ministry of Health Malaysia (protocol number: NMRR-14-904-21963) on 21 September 2015. This study protocol describes the first community-based randomised controlled trial, to examine the efficacy of a complex intervention in improving the pre-pregnancy health of young Malaysian women and their spouses. Results from this trial will contribute to improve policy and practices regarding complex behavioural change interventions to prevent diabetes in the pre-conception period in Malaysia and other low- and middle-income country settings. This trial is registered with ClinicalTrials.gov (www.clinicaltrials.gov) on 30 November 2015, Identifier: NCT02617693 .

Development and Feasibility of an Academic Detailing Intervention to Improve Prescription Drug Monitoring Program Use Among Physicians

PubMed Central

Barth, Kelly S.; Ball, Sarah; Adams, Rachel Sayko; Nikitin, Ruslan; Wooten, Nikki R.; Qureshi, Zaina P.; Larson, Mary Jo

2017-01-01

Background South Carolina (SC) ranks 10th in opioid prescriptions per capita - 33% higher than the national average. SC is also home to a large military and veteran population, and prescription opioid use for chronic pain is alarmingly common among veterans, especially those returning from Afghanistan and Iraq. This paper describes the background and development of an Academic Detailing (AD) educational intervention to improve use of a Prescription Drug Monitoring Program (PDMP) among SC physicians who serve military members and veterans. The aim of this intervention was to improve safe opioid prescribing practices and prevent prescription opioid misuse among this high-risk population. Methods A multidisciplinary study team of physicians, pharmacists, psychologists, epidemiologists, and representatives from the SCs Prescription Monitoring Program (PMP) utilized the Medical Research Council (MRC) complex interventions framework to guide the development of the educational intervention. The theoretical and modelling phases of the AD intervention development are described and preliminary evidence of feasibility and acceptability is provided. Results Ninety-three physicians consented to the study from 2 practice sites. Eighty-seven academic detailing visits were completed, and 59 one-month follow-up surveys were received. Participants rated the academic detailing intervention high in helpfulness of information, intention to use information, and overall satisfaction with the intervention. The component of the intervention felt to be most helpful was the academic detailing visit itself. Characteristics of the participants and the intervention, as well as anticipated barriers to behavior change are detailed. Conclusions Preliminary results support the feasibility of AD delivery to veteran and community patient settings, the feasibility of facilitating PDMP registration during an AD visit, and that AD visits were generally found satisfying to participants and helpful in improving knowledge and confidence about safe opioid prescribing practices. The component of the intervention felt to be most helpful to the participants was the actual academic detailing visit, and most participants rated their intentions high to use the information and tools from the visit. Intervention key messages, preliminary outcome measures, as well as successes and challenges in developing and delivering this intervention are discussed in order to advance best practices in developing educational interventions in this important area of public health. PMID:28562498

Mental Health Interventions for Children in Foster Care: A Systematic Review

PubMed Central

Hambrick, Erin P.; Oppenheim-Weller, Shani; N’zi, Amanda M.; Taussig, Heather N.

2016-01-01

Children in foster care have high rates of adverse childhood experiences and are at risk for mental health problems. These problems can be difficult to ameliorate, creating a need for rigorous intervention research. Previous research suggests that intervening with children in foster care can be challenging for several reasons, including the severity and complexity of their mental health problems, and challenges engaging this often transitory population in mental health services. The goal of this article was to systematically review the intervention research that has been conducted with children in foster care, and to identify future research directions. This review was conducted on mental health interventions for children, ages 0 to 12, in foster care, using ERIC, CINAHL, PsycINFO, PubMed, ProQuest’s Dissertation and Theses Database, Social Services Abstracts, and Social Work Abstracts. It was restricted to interventions that are at least “possibly efficacious” (i.e., supported by evidence from at least one randomized controlled trial). Studies were evaluated for risk of bias. Ten interventions were identified, with diverse outcomes, including mental health and physiological. Six interventions were developed for children in foster care. Interventions not developed for children in foster care were typically adapted to the foster context. Most interventions have yet to be rigorously evaluated in community-based settings with children in foster care. Little research has been conducted on child and family engagement within these interventions, and there is a need for more research on moderators of intervention outcomes and subgroups that benefit most from these interventions. In addition, there is not consensus regarding how to adapt interventions to this population. Future research should focus on developing and testing more interventions with this population, rigorously evaluating their effectiveness in community-based settings, determining necessary adaptations, and identifying which interventions work best for whom. PMID:28496286

Using qualitative comparative analysis in a systematic review of a complex intervention.

PubMed

Kahwati, Leila; Jacobs, Sara; Kane, Heather; Lewis, Megan; Viswanathan, Meera; Golin, Carol E

2016-05-04

Systematic reviews evaluating complex interventions often encounter substantial clinical heterogeneity in intervention components and implementation features making synthesis challenging. Qualitative comparative analysis (QCA) is a non-probabilistic method that uses mathematical set theory to study complex phenomena; it has been proposed as a potential method to complement traditional evidence synthesis in reviews of complex interventions to identify key intervention components or implementation features that might explain effectiveness or ineffectiveness. The objective of this study was to describe our approach in detail and examine the suitability of using QCA within the context of a systematic review. We used data from a completed systematic review of behavioral interventions to improve medication adherence to conduct two substantive analyses using QCA. The first analysis sought to identify combinations of nine behavior change techniques/components (BCTs) found among effective interventions, and the second analysis sought to identify combinations of five implementation features (e.g., agent, target, mode, time span, exposure) found among effective interventions. For each substantive analysis, we reframed the review's research questions to be designed for use with QCA, calibrated sets (i.e., transformed raw data into data used in analysis), and identified the necessary and/or sufficient combinations of BCTs and implementation features found in effective interventions. Our application of QCA for each substantive analysis is described in detail. We extended the original review findings by identifying seven combinations of BCTs and four combinations of implementation features that were sufficient for improving adherence. We found reasonable alignment between several systematic review steps and processes used in QCA except that typical approaches to study abstraction for some intervention components and features did not support a robust calibration for QCA. QCA was suitable for use within a systematic review of medication adherence interventions and offered insights beyond the single dimension stratifications used in the original completed review. Future prospective use of QCA during a review is needed to determine the optimal way to efficiently integrate QCA into existing approaches to evidence synthesis of complex interventions.

Process evaluation of the implementation of scorecard-based antenatal risk assessment, care pathways and interdisciplinary consultation: the Healthy Pregnancy 4 All study.

PubMed

Vos, A A; van Voorst, S F; Posthumus, A G; Waelput, A J M; Denktaş, S; Steegers, E A P

2017-09-01

To evaluate the implementation of a complex intervention in the antenatal healthcare field in 14 Dutch municipalities. The intervention consisted of the implementation of a systematic scorecard-based risk assessment in pregnancy, subsequent patient-tailored care pathways, and consultations of professionals from different medical and social disciplines. Saunders's seven-step method was used for the development of a programme implementation monitoring plan, with specific attention to the setting and context of the programme. Data were triangulated from multiple sources, and prespecified criteria were applied to examine the evidence for implementation. Six out of 11 municipalities (54%) met the implementation criteria for the entire risk assessment programme, whereas three municipalities (27%) met the criteria if the three components of implementation were analysed separately. A process evaluation of implementation of a complex intervention is possible. The results can be used to improve understanding of the associations between specific programme elements and programme outcomes on effectiveness of the intervention. Additionally, the results are important for formative purposes to assess how future implementation of antenatal risk assessment can be improved in comparable contexts. Copyright © 2017. Published by Elsevier Ltd.

Evaluating an Online Resourcefulness Training Intervention Pilot Test Using Six Critical Parameters.

PubMed

Musil, Carol M; Zauszniewski, Jaclene A; Burant, Christopher J; Toly, Valerie B; Warner, Camille B

2015-12-01

Few resources are available to help grandmother caregivers to grandchildren manage their complex family situations that may have immediate and long-term consequences for themselves and their families. Resourcefulness training is an intervention designed to help grandmothers improve their ability to deal with these problems. The purpose of this pilot study was to evaluate the necessity, feasibility, acceptability, fidelity, safety, and effectiveness (i.e., effect sizes) of an online, computer-based resourcefulness training intervention that was adapted from a face-to-face intervention. Twelve grandmothers raising or living with grandchildren participated in the pilot intervention that included (a) watching an instructional video on resourcefulness, (b) completing two online questionnaires over a 6-week time period, and (c) writing in an online journal every day for 4 weeks. Data are evaluated within the context of the six parameters important to intervention development. Qualitative and quantitative results provide initial support for all six parameters. Recommendations to improve aspects of the intervention are discussed. © The Author(s) 2015.

Developing the personal narratives of children with complex communication needs associated with intellectual disabilities: What is the potential of Storysharing® ?

PubMed

Bunning, Karen; Gooch, Lynsey; Johnson, Miranda

2017-07-01

Sharing personal experience in narrative is challenging for individuals with intellectual disabilities. The aim was to investigate the potential of Storysharing ® (Storysharing is an innovative communication method based on personal narrative, which has been developed to support conversations with people who have severe difficulties in communication) intervention. The study involved eleven pupil-educational supporter dyads at a special school. Storysharing ® was implemented over a 15-week period. Personal narratives were captured on video pre- and post-intervention. The data were analysed for discourse and narrative. Significant differences revealed a decline in 'query-answer' sequences and an increase in supporter use of 'prompts'. After intervention, there were fewer story episodes. Narrative structure showed gains in action sequences leading to climax, and in closing elements, indicating a more complete narrative. The Storysharing ® intervention appears to be associated with changes to the dyadic, personal narratives illustrating its potential. © 2016 John Wiley & Sons Ltd.

Open-source platforms for navigated image-guided interventions.

PubMed

Ungi, Tamas; Lasso, Andras; Fichtinger, Gabor

2016-10-01

Navigation technology is changing the clinical standards in medical interventions by making existing procedures more accurate, and new procedures possible. Navigation is based on preoperative or intraoperative imaging combined with 3-dimensional position tracking of interventional tools registered to the images. Research of navigation technology in medical interventions requires significant engineering efforts. The difficulty of developing such complex systems has been limiting the clinical translation of new methods and ideas. A key to the future success of this field is to provide researchers with platforms that allow rapid implementation of applications with minimal resources spent on reimplementing existing system features. A number of platforms have been already developed that can share data in real time through standard interfaces. Complete navigation systems can be built using these platforms using a layered software architecture. In this paper, we review the most popular platforms, and show an effective way to take advantage of them through an example surgical navigation application. Copyright © 2016 Elsevier B.V. All rights reserved.

Development of a positive psychology intervention to improve adherence in adolescents with type 1 diabetes.

PubMed

Jaser, Sarah S; Patel, Niral; Linsky, Rebecca; Whittemore, Robin

2014-01-01

Novel interventions are needed to improve adherence to treatment in adolescents with type 1 diabetes. In this article, we describe the development, feasibility, and acceptability of a positive psychology intervention for this population. Adolescents and their parents (n = 39) were randomly assigned to either a positive psychology intervention or an attention control group. Quantitative and qualitative data were collected on feasibility and acceptability. Descriptive and content analysis methods were used. Recruitment was successful, participation and satisfaction were high in both groups, and retention was excellent over 6 months. In the positive psychology group, adolescents and their parents noted benefits related to increased positive communication and thinking more about diabetes care. We also identified challenges to implementation. Although more research is indicated, a positive psychology framework emphasizing positive emotions and strengths, rather than problems, may be beneficial to adolescents living with a complex chronic illness. Copyright © 2014 National Association of Pediatric Nurse Practitioners. Published by Elsevier Inc. All rights reserved.

Measuring health systems strength and its impact: experiences from the African Health Initiative.

PubMed

Sherr, Kenneth; Fernandes, Quinhas; Kanté, Almamy M; Bawah, Ayaga; Condo, Jeanine; Mutale, Wilbroad

2017-12-21

Health systems are essential platforms for accessible, quality health services, and population health improvements. Global health initiatives have dramatically increased health resources; however, funding to strengthen health systems has not increased commensurately, partially due to concerns about health system complexity and evidence gaps demonstrating health outcome improvements. In 2009, the African Health Initiative of the Doris Duke Charitable Foundation began supporting Population Health Implementation and Training Partnership projects in five sub-Saharan African countries (Ghana, Mozambique, Rwanda, Tanzania, and Zambia) to catalyze significant advances in strengthening health systems. This manuscript reflects on the experience of establishing an evaluation framework to measure health systems strength, and associate measures with health outcomes, as part of this Initiative. Using the World Health Organization's health systems building block framework, the Partnerships present novel approaches to measure health systems building blocks and summarize data across and within building blocks to facilitate analytic procedures. Three Partnerships developed summary measures spanning the building blocks using principal component analysis (Ghana and Tanzania) or the balanced scorecard (Zambia). Other Partnerships developed summary measures to simplify multiple indicators within individual building blocks, including health information systems (Mozambique), and service delivery (Rwanda). At the end of the project intervention period, one to two key informants from each Partnership's leadership team were asked to list - in rank order - the importance of the six building blocks in relation to their intervention. Though there were differences across Partnerships, service delivery and information systems were reported to be the most common focus of interventions, followed by health workforce and leadership and governance. Medical products, vaccines and technologies, and health financing, were the building blocks reported to be of lower focus. The African Health Initiative experience furthers the science of evaluation for health systems strengthening, highlighting areas for further methodological development - including the development of valid, feasible measures sensitive to interventions in multiple contexts (particularly in leadership and governance) and describing interactions across building blocks; in developing summary statistics to facilitate testing intervention effects on health systems and associations with health status; and designing appropriate analytic models for complex, multi-level open health systems.

The balanced incomplete block design is not suitable for the evaluation of complex interventions.

PubMed

Trietsch, Jasper; Leffers, Pieter; van Steenkiste, Ben; Grol, Richard; van der Weijden, Trudy

2014-12-01

In quality of care research, the balanced incomplete block (BIB) design is regularly claimed to have been used when evaluating complex interventions. In this article, we reflect on the appropriateness of using this design for evaluating complex interventions. Literature study using PubMed and handbooks. After studying various articles on health services research that claim to have applied the BIB and the original methodological literature on this design, it became clear that the applied method is in fact not a BIB design. We conclude that the use of this design is not suited for evaluating complex interventions. We stress that, to prevent improper use of terms, more attention should be paid to proper referencing of the original methodological literature. Copyright © 2014 Elsevier Inc. All rights reserved.

Capturing the experiences of patients across multiple complex interventions: a meta-qualitative approach.

PubMed

Webster, Fiona; Christian, Jennifer; Mansfield, Elizabeth; Bhattacharyya, Onil; Hawker, Gillian; Levinson, Wendy; Naglie, Gary; Pham, Thuy-Nga; Rose, Louise; Schull, Michael; Sinha, Samir; Stergiopoulos, Vicky; Upshur, Ross; Wilson, Lynn

2015-09-08

The perspectives, needs and preferences of individuals with complex health and social needs can be overlooked in the design of healthcare interventions. This study was designed to provide new insights on patient perspectives drawing from the qualitative evaluation of 5 complex healthcare interventions. Patients and their caregivers were recruited from 5 interventions based in primary, hospital and community care in Ontario, Canada. We included 62 interviews from 44 patients and 18 non-clinical caregivers. Our team analysed the transcripts from 5 distinct projects. This approach to qualitative meta-evaluation identifies common issues described by a diverse group of patients, therefore providing potential insights into systems issues. This study is a secondary analysis of qualitative data; therefore, no outcome measures were identified. We identified 5 broad themes that capture the patients' experience and highlight issues that might not be adequately addressed in complex interventions. In our study, we found that: (1) the emergency department is the unavoidable point of care; (2) patients and caregivers are part of complex and variable family systems; (3) non-medical issues mediate patients' experiences of health and healthcare delivery; (4) the unanticipated consequences of complex healthcare interventions are often the most valuable; and (5) patient experiences are shaped by the healthcare discourses on medically complex patients. Our findings suggest that key assumptions about patients that inform intervention design need to be made explicit in order to build capacity to better understand and support patients with multiple chronic diseases. Across many health systems internationally, multiple models are being implemented simultaneously that may have shared features and target similar patients, and a qualitative meta-evaluation approach, thus offers an opportunity for cumulative learning at a system level in addition to informing intervention design and modification. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Structured recording of intraoperative surgical workflows

NASA Astrophysics Data System (ADS)

Neumuth, T.; Durstewitz, N.; Fischer, M.; Strauss, G.; Dietz, A.; Meixensberger, J.; Jannin, P.; Cleary, K.; Lemke, H. U.; Burgert, O.

2006-03-01

Surgical Workflows are used for the methodical and scientific analysis of surgical interventions. The approach described here is a step towards developing surgical assist systems based on Surgical Workflows and integrated control systems for the operating room of the future. This paper describes concepts and technologies for the acquisition of Surgical Workflows by monitoring surgical interventions and their presentation. Establishing systems which support the Surgical Workflow in operating rooms requires a multi-staged development process beginning with the description of these workflows. A formalized description of surgical interventions is needed to create a Surgical Workflow. This description can be used to analyze and evaluate surgical interventions in detail. We discuss the subdivision of surgical interventions into work steps regarding different levels of granularity and propose a recording scheme for the acquisition of manual surgical work steps from running interventions. To support the recording process during the intervention, we introduce a new software architecture. Core of the architecture is our Surgical Workflow editor that is intended to deal with the manifold, complex and concurrent relations during an intervention. Furthermore, a method for an automatic generation of graphs is shown which is able to display the recorded surgical work steps of the interventions. Finally we conclude with considerations about extensions of our recording scheme to close the gap to S-PACS systems. The approach was used to record 83 surgical interventions from 6 intervention types from 3 different surgical disciplines: ENT surgery, neurosurgery and interventional radiology. The interventions were recorded at the University Hospital Leipzig, Germany and at the Georgetown University Hospital, Washington, D.C., USA.

[Documenting a rehabilitation program using a logic model: an advantage to the assessment process].

PubMed

Poncet, Frédérique; Swaine, Bonnie; Pradat-Diehl, Pascale

2017-03-06

The cognitive and behavioral disorders after brain injury can result in severe limitations of activities and restrictions of participation. An interdisciplinary rehabilitation program was developed in physical medicine and rehabilitation at the Pitié-Salpêtriere Hospital, Paris, France. Clinicians believe this program decreases activity limitations and improves participation in patients. However, the program’s effectiveness had never been assessed. To do this, we had to define/describe this program. However rehabilitation programs are holistic and thus complex making them difficult to describe. Therefore, to facilitate the evaluation of complex programs, including those for rehabilitation, we illustrate the use of a theoretical logic model, as proposed by Champagne, through the process of documentation of a specific complex and interdisciplinary rehabilitation program. Through participatory/collaborative research, the rehabilitation program was analyzed using three “submodels” of the logic model of intervention: causal model, intervention model and program theory model. This should facilitate the evaluation of programs, including those for rehabilitation.

Development of a novel motivational interviewing (MI) informed peer-support intervention to support mothers to breastfeed for longer.

PubMed

Phillips, Rhiannon; Copeland, Lauren; Grant, Aimee; Sanders, Julia; Gobat, Nina; Tedstone, Sally; Stanton, Helen; Merrett, Laura; Rollnick, Stephen; Robling, Michael; Brown, Amy; Hunter, Billie; Fitzsimmons, Deborah; Regan, Sian; Trickey, Heather; Paranjothy, Shantini

2018-04-11

Many women in the UK stop breastfeeding before they would like to, and earlier than is recommended by the World Health Organization (WHO). Given the potential health benefits for mother and baby, new ways of supporting women to breastfeed for longer are required. The purpose of this study was to develop and characterise a novel Motivational Interviewing (MI) informed breastfeeding peer-support intervention. Qualitative interviews with health professionals and service providers (n = 14), and focus groups with mothers (n = 14), fathers (n = 3), and breastfeeding peer-supporters (n = 15) were carried out to understand experiences of breastfeeding peer-support and identify intervention options. Data were audio-recorded, transcribed, and analysed thematically. Consultation took place with a combined professional and lay Stakeholder Group (n = 23). The Behaviour Change Wheel (BCW) guided intervention development process used the findings of the qualitative research and stakeholder consultation, alongside evidence from existing literature, to identify: the target behaviour to be changed; sources of this behaviour based on the Capability, Opportunity and Motivation (COM-B) model; intervention functions that could alter this behaviour; and; mode of delivery for the intervention. Behaviour change techniques included in the intervention were categorised using the Behaviour Change Technique Taxonomy Version 1 (BCTTv1). Building knowledge, skills, confidence, and providing social support were perceived to be key functions of breastfeeding peer-support interventions that aim to decrease early discontinuation of breastfeeding. These features of breastfeeding peer-support mapped onto the BCW education, training, modelling and environmental restructuring intervention functions. Behaviour change techniques (BCTTv1) included social support, problem solving, and goal setting. The intervention included important inter-personal relational features (e.g. trust, honesty, kindness), and the BCTTv1 needed adaptation to incorporate this. The MI-informed breastfeeding peer-support intervention developed using this systematic and user-informed approach has a clear theoretical basis and well-described behaviour change techniques. The process described could be useful in developing other complex interventions that incorporate peer-support and/or MI.

Potential Uses of Bayesian Networks as Tools for Synthesis of Systematic Reviews of Complex Interventions

ERIC Educational Resources Information Center

Stewart, G. B.; Mengersen, K.; Meader, N.

2014-01-01

Bayesian networks (BNs) are tools for representing expert knowledge or evidence. They are especially useful for synthesising evidence or belief concerning a complex intervention, assessing the sensitivity of outcomes to different situations or contextual frameworks and framing decision problems that involve alternative types of intervention.…

Education: A Complex and Empowering Social Work Intervention at the End of Life

ERIC Educational Resources Information Center

Cagle, John G.; Kovacs, Pamela J.

2009-01-01

Education is a frequently used social work intervention. Yet it seems to be an underappreciated and a deceptively complex intervention that social workers may not be adequately prepared to use. Reliable, accessible information is essential as it helps prevent unnecessary crises, facilitates coping, and promotes self-determination. This article…

Qualitative research building real-life interventions: user-involving development of a mindfulness-based lifestyle change support program for overweight citizens.

PubMed

Hansen, N V; Brændgaard, P; Hjørnholm, C; la Cour, S

2014-10-01

This study is an experiment of putting social sciences to work in developing a support intervention for healthy lifestyle changes that would be attractive and manageable in real-life settings. Starting with a hypothesis that a class of intervention methods based on an unconventional 'low-tension' strategy may offer an effective support of stable, long-term changes well integrated in everyday life, difficult to maintain with conventional dieting and self-control approaches, this study focuses on designing and optimizing an intervention model combining several low-tension methods: mindfulness, small steps and group support. In three consecutive 'action research' cycles, the intervention was run in practice with groups of 20 overweight or obese citizens. Qualitative data, mainly in the form of recorded group sessions and individual interviews with group participants and group leaders, were systematically collected and analyzed, using a framework of social psychological theory to focus on difficulties, resources and meanings connected with habits and everyday life. This information was recycled into the design process for the next version of the intervention. We describe the user-involving development processes toward a more attractive and manageable intervention model. The model now exists as a well-articulated package whose effectiveness is being tested in a randomized controlled trial study. Social science can be put to work in systematically integrating real-life experience in a development process. It answers a very different kind of question than clinical trials-filling another place in an overall research program to create useful knowledge of what helps-in complex, everyday, real life.

Feasibility of a Preventive Parenting Intervention for Very Preterm Children at 18 Months Corrected Age: A Randomized Pilot Trial.

PubMed

Flierman, Monique; Koldewijn, Karen; Meijssen, Dominique; van Wassenaer-Leemhuis, Aleid; Aarnoudse-Moens, Cornelieke; van Schie, Petra; Jeukens-Visser, Martine

2016-09-01

To evaluate the feasibility and potential efficacy of an age-appropriate additional parenting intervention for very preterm born toddlers. In a randomized controlled pilot study, 60 of 94 eligible very preterm born children who had received a responsive parenting intervention in their first year were randomized to usual care or the additional intervention, consisting of 4-6 home visits between 18 and 22 months' corrected gestational age (CA). Parents were supported to responsively interact during increasingly complex daily activities and play. Parental satisfaction with the intervention was evaluated with a questionnaire. At baseline and 24 months CA, parents completed the Infant Toddler Social and Emotional Assessment, the Ages and Stages Questionnaire, and the Dutch Schlichting Lexilist for receptive language. At 24 months CA, motor, and cognitive development was measured by the Bayley Scales of Infant and Toddler Development, Third Edition Dutch version, and parent-child interaction was evaluated by the Emotional Availability Scales. Parental compliance and satisfaction with the intervention was high. Effect sizes (after correction for baseline variables) were small for internalizing and competence behavior, receptive language, and problem solving; medium for cognitive development and parent-child interaction; and large for externalizing and dysregulation behavior and motor development. After a postdischarge intervention during the first year, an additional responsive parenting support at toddler-age is feasible and associated with positive outcomes in a broad array of parental and child outcome measures. www.toetsingonline.nl: NL40208.018.12. Copyright © 2016 Elsevier Inc. All rights reserved.

Development of a theory-informed implementation intervention to improve the triage, treatment and transfer of stroke patients in emergency departments using the Theoretical Domains Framework (TDF): the T3 Trial.

PubMed

Craig, Louise E; Taylor, Natalie; Grimley, Rohan; Cadilhac, Dominique A; McInnes, Elizabeth; Phillips, Rosemary; Dale, Simeon; O'Connor, Denise; Levi, Chris; Fitzgerald, Mark; Considine, Julie; Grimshaw, Jeremy M; Gerraty, Richard; Cheung, N Wah; Ward, Jeanette; Middleton, Sandy

2017-07-17

Theoretical frameworks and models based on behaviour change theories are increasingly used in the development of implementation interventions. Development of an implementation intervention is often based on the available evidence base and practical issues, i.e. feasibility and acceptability. The aim of this study was to describe the development of an implementation intervention for the T 3 Trial (Triage, Treatment and Transfer of patients with stroke in emergency departments (EDs)) using theory to recommend behaviour change techniques (BCTs) and drawing on the research evidence base and practical issues of feasibility and acceptability. A stepped method for developing complex interventions based on theory, evidence and practical issues was adapted using the following steps: (1) Who needs to do what, differently? (2) Using a theoretical framework, which barriers and enablers need to be addressed? (3) Which intervention components (behaviour change techniques and mode(s) of delivery) could overcome the modifiable barriers and enhance the enablers? A researcher panel was convened to review the list of BCTs recommended for use and to identify the most feasible and acceptable techniques to adopt. Seventy-six barriers were reported by hospital staff who attended the workshops (step 1: thirteen TDF domains likely to influence the implementation of the T 3 Trial clinical intervention were identified by the researchers; step 2: the researcher panellists then selected one third of the BCTs recommended for use as appropriate for the clinical context of the ED and, using the enabler workshop data, devised enabling strategies for each of the selected BCTs; and step 3: the final implementation intervention consisted of 27 BCTs). The TDF was successfully applied in all steps of developing an implementation intervention for the T 3 Trial clinical intervention. The use of researcher panel opinion was an essential part of the BCT selection process to incorporate both research evidence and expert judgment. It is recommended that this stepped approach (theory, evidence and practical issues of feasibility and acceptability) is used to develop highly reportable implementation interventions. The classifying of BCTs using recognised implementation intervention components will facilitate generalisability and sharing across different conditions and clinical settings.

Tailoring Multicomponent Writing Interventions: Effects of Coupling Self-Regulation and Transcription Training.

PubMed

Limpo, Teresa; Alves, Rui A

Writing proficiency is heavily based on acquisition and development of self-regulation and transcription skills. The present study examined the effects of combining transcription training with a self-regulation intervention (self-regulated strategy development [SRSD]) in Grade 2 (ages 7-8). Forty-three students receiving self-regulation plus transcription (SRSD+TR) intervention were compared with 37 students receiving a self-regulation only (SRSD only) intervention and 39 students receiving the standard language arts curriculum. Compared with control instruction, SRSD instruction-with or without transcription training-resulted in more complex plans; longer, better, and more complete stories; and the effects transferred to story written recall. Transcription training produced an incremental effect on students' composing skills. In particular, the SRSD+TR intervention increased handwriting fluency, spelling accuracy for inconsistent words, planning and story completeness, writing fluency, clause length, and burst length. Compared with the SRSD-only intervention, the SRSD+TR intervention was particularly effective in raising the writing quality of poorer writers. This pattern of findings suggests that students benefit from writing instruction coupling self-regulation and transcription training from very early on. This seems to be a promising instructional approach not only to ameliorate all students' writing ability and prevent future writing problems but also to minimize struggling writers' difficulties and support them in mastering writing.

Virtual reality games for rehabilitation of people with stroke: perspectives from the users.

PubMed

Lewis, Gwyn N; Woods, Claire; Rosie, Juliet A; McPherson, Kathryn M

2011-01-01

PURPOSE. The purpose of this study is to evaluate the feasibility and users' perspectives of a novel virtual reality (VR) game-based rehabilitation intervention for people with stroke. METHOD. Six people with upper limb hemiplegia participated in a 6-week intervention that involved VR games. A series of eight progressively complex games was developed that required participants to navigate a submarine in a virtual ocean environment. Movement of the submarine was directed by forces applied to an arm interface by the affected limb. Outcome measures included assessments of arm function, questionnaires evaluating the intervention and a semi-structured interview concerning the participants' opinion of the intervention. RESULTS. All participants improved their performance on the games, although there were limited changes in clinical measures of arm function. All participants reported that they enjoyed the intervention with a wide range of overall perceptions of the experience of using VR. Three themes emerging from the interview data were: stretching myself, purpose and expectations of the intervention and future improvements. CONCLUSIONS. Participants found that taking part in this pilot study was enjoyable and challenging. Participants' feedback suggested that the games may be motivating and engaging for future users and have provided a basis for further development of the intervention.

Effectiveness of interventions for preventing occupational irritant hand dermatitis: a quantitative systematic review protocol.

PubMed

Papadatou, Zoi; Cooper, Kay; Klein, Susan; MacDuff, Colin; Steiner, Markus

2016-10-01

The objective of this quantitative systematic review is to identify, appraise and synthesize the best available evidence on the effectiveness of moisturizers, barrier creams, protective gloves, skin protection education and complex interventions (a combination of two or more of the interventions listed) in preventing occupational irritant hand dermatitis (OIHD) in wet workers. These interventions will be compared to an alternative intervention or to usual care (workers regular skin care regime). The specific review question is: "What is the effectiveness of moisturizers, barrier creams, protective gloves, skin protection education and complex interventions in preventing OIHD in wet workers?"

Handwriting Development, Competency, and Intervention

ERIC Educational Resources Information Center

Feder, Katya P.; Majnemer, Annette

2007-01-01

Failure to attain handwriting competency during the school-age years often has far-reaching negative effects on both academic success and self-esteem. This complex occupational task has many underlying component skills that may interfere with handwriting performance. Fine motor control, bilateral and visual-motor integration, motor planning,…

Interfacing theories of program with theories of evaluation for advancing evaluation practice: Reductionism, systems thinking, and pragmatic synthesis.

PubMed

Chen, Huey T

2016-12-01

Theories of program and theories of evaluation form the foundation of program evaluation theories. Theories of program reflect assumptions on how to conceptualize an intervention program for evaluation purposes, while theories of evaluation reflect assumptions on how to design useful evaluation. These two types of theories are related, but often discussed separately. This paper attempts to use three theoretical perspectives (reductionism, systems thinking, and pragmatic synthesis) to interface them and discuss the implications for evaluation practice. Reductionism proposes that an intervention program can be broken into crucial components for rigorous analyses; systems thinking view an intervention program as dynamic and complex, requiring a holistic examination. In spite of their contributions, reductionism and systems thinking represent the extreme ends of a theoretical spectrum; many real-world programs, however, may fall in the middle. Pragmatic synthesis is being developed to serve these moderate- complexity programs. These three theoretical perspectives have their own strengths and challenges. Knowledge on these three perspectives and their evaluation implications can provide a better guide for designing fruitful evaluations, improving the quality of evaluation practice, informing potential areas for developing cutting-edge evaluation approaches, and contributing to advancing program evaluation toward a mature applied science. Copyright © 2016 Elsevier Ltd. All rights reserved.

Effectiveness of a 16 week gymnastics curriculum at developing movement competence in children.

PubMed

Rudd, James R; Barnett, Lisa M; Farrow, Damian; Berry, Jason; Borkoles, Erika; Polman, Remco

2017-02-01

Internationally, children's movement competence levels are low. This study's aim was to evaluate the effectiveness of a 16 week gymnastics curriculum on stability, locomotive and object control skills and general body coordination. It was hypothesised that the gymnastics intervention group would demonstrate significant improvements beyond a PE comparison group. This study used a non-randomised control design. The intervention and comparison groups were drawn from three primary schools. The study followed the transparent reporting of evaluations with nonrandomized designs (TREND) statement for reporting. A total of 333 children (51% girls, 41% intervention) with a mean age of 8.1 years (SD=1.1) participated. Intervention children (16 weeks×2h of gymnastics) were compared to children who received (16×2h) standard PE curriculum. Children's movement competence was assessed using the Test of Gross Motor Development-2, Stability Skills Assessment and the Körper-Koordinationstest für Kinder. Multilevel linear mixed models, accounting for variation at the class level and adjusted for age and sex, were used to assess intervention relative to comparison differences in all aspects of movement competence. Stability and object control skills showed a significant (p<0.05) intervention×time interaction effect. No difference was found in locomotor skills or general coordination. Gymnastics is effective at developing stability skills and object control skills without hindering the development of locomotor skills or general coordination. Accelerated learning of stability skills may support the development of more complex movement skills. Copyright © 2016 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Study protocol for Enhancing Parenting In Cancer (EPIC): development and evaluation of a brief psycho-educational intervention to support parents with cancer who have young children.

PubMed

Stafford, Lesley; Sinclair, Michelle; Turner, Jane; Newman, Louise; Wakefield, Claire; Krishnasamy, Mei; Mann, G Bruce; Gilham, Leslie; Mason, Kylie; Rauch, Paula; Cannell, Julia; Schofield, Penelope

2017-01-01

Parents with cancer have high rates of psychological morbidity, and their children are at risk of poor psychosocial outcomes, particularly in the context of parental distress and poor family communication. Parents express concerns about the impact of cancer on their children and report a lack of professional guidance in meeting their children's needs. Few parenting interventions exist and current interventions have extensive infrastructure demands making them unsuitable for routine use in most health settings. The aims of this study are to develop and establish the feasibility and acceptability of a novel and accessible psycho-educational intervention to improve parenting efficacy and decrease parental stress among adults with cancer who have children aged 3-12 years. The intervention will be suitable for parents with cancer who are receiving treatment with a view to longer term survival, irrespective of cancer diagnosis, and their respective co-parents. This study comprises two phases using the UK Medical Research Council framework for developing complex interventions. In the development phase, intervention content will be iteratively developed and evaluated in consultation with consumers, and in the piloting phase, feasibility will be tested in a clinical sample of 20 parents with cancer and their co-parents using a single arm, pre-test post-test design. The intervention will comprise an audiovisual resource (DVD), a question prompt list, and a telephone call with a clinical psychologist. Questionnaires administered pre- and 1 month post-intervention will assess parental stress, psychological morbidity, quality of life, self-efficacy and perceptions of child adjustment, and family functioning. Intervention feasibility will be determined by mixed-method participant evaluation of perceived usefulness, benefits, and acceptability. This new initiative will translate existing descriptive evidence into an accessible intervention that supports parenting during cancer treatment and meets the information needs of parents with cancer and their families. This is an important advance: despite increasing recognition of the impact of parental cancer on the family, intervention research lags behind the descriptive literature. This low-intensity, accessible, and targeted intervention places minimal burden on infrastructure and promotes patient autonomy and self-management. If feasible, this style of intervention may be a template for future interventions with similar populations.

Introducing Evidence Through Research "Push": Using Theory and Qualitative Methods.

PubMed

Morden, Andrew; Ong, Bie Nio; Brooks, Lauren; Jinks, Clare; Porcheret, Mark; Edwards, John J; Dziedzic, Krysia S

2015-11-01

A multitude of factors can influence the uptake and implementation of complex interventions in health care. A plethora of theories and frameworks recognize the need to establish relationships, understand organizational dynamics, address context and contingency, and engage key decision makers. Less attention is paid to how theories that emphasize relational contexts can actually be deployed to guide the implementation of an intervention. The purpose of the article is to demonstrate the potential role of qualitative research aligned with theory to inform complex interventions. We detail a study underpinned by theory and qualitative research that (a) ensured key actors made sense of the complex intervention at the earliest stage of adoption and (b) aided initial engagement with the intervention. We conclude that using theoretical approaches aligned with qualitative research can provide insights into the context and dynamics of health care settings that in turn can be used to aid intervention implementation. © The Author(s) 2015.

Social Interface Model: Theorizing Ecological Post-Delivery Processes for Intervention Effects.

PubMed

Pettigrew, Jonathan; Segrott, Jeremy; Ray, Colter D; Littlecott, Hannah

2018-01-03

Successful prevention programs depend on a complex interplay among aspects of the intervention, the participant, the specific intervention setting, and the broader set of contexts with which a participant interacts. There is a need to theorize what happens as participants bring intervention ideas and behaviors into other life-contexts, and theory has not yet specified how social interactions about interventions may influence outcomes. To address this gap, we use an ecological perspective to develop the social interface model. This paper presents the key components of the model and its potential to aid the design and implementation of prevention interventions. The model is predicated on the idea that intervention message effectiveness depends not only on message aspects but also on the participants' adoption and adaptation of the message vis-à-vis their social ecology. The model depicts processes by which intervention messages are received and enacted by participants through social processes occurring within and between relevant microsystems. Mesosystem interfaces (negligible interface, transference, co-dependence, and interdependence) can facilitate or detract from intervention effects. The social interface model advances prevention science by theorizing that practitioners can create better quality interventions by planning for what occurs after interventions are delivered.

Diagnostic reference levels and complexity indices in interventional radiology: a national programme.

PubMed

Ruiz-Cruces, R; Vano, E; Carrera-Magariño, F; Moreno-Rodriguez, F; Soler-Cantos, M M; Canis-Lopez, M; Hernández-Armas, J; Diaz-Romero, F J; Rosales-Espizua, F; Fernandez-Soto, J M; Sanchez-Casanueva, R; Martin-Palanca, A; Perez-Martinez, M; Gil-Agudo, A; Zarca-Diaz, M A; Parra-Osorio, V; Muñoz Ruiz-Canela, J J; Moreno-Sanchez, T; Lopez-Medina, A; Moreno-Saiz, C; Galan-Montenegro, P; Gallego-Beuter, J J; Gonzalez-de-Garay, M; Zapata-Jimenez, J C; Pastor-Vega, J M; Cañete, S

2016-12-01

To propose national diagnostic reference levels (DRLs) for interventional radiology and to evaluate the impact of the procedural complexity on patient doses. Eight interventional radiology units from Spanish hospitals were involved in this project. The participants agreed to undergo common quality control procedures for X-ray systems. Kerma area product (KAP) was collected from a sample of 1,649 procedures. A consensus document established the criteria to evaluate the complexity of seven types of procedures. DRLs were set as the 3rd quartile of KAP values. The KAP (3rd quartile) in Gy cm 2 for the procedures included in the survey were: lower extremity arteriography (n = 784) 78; renal arteriography (n = 37) 107; transjugular hepatic biopsies (THB) (n = 30) 45; biliary drainage (BD) (n = 314) 30; uterine fibroid embolization (UFE) (n = 56) 214; colon endoprostheses (CE) (n = 31) 169; hepatic chemoembolization (HC) (n = 269) 303; femoropopliteal revascularization (FR) (n = 62) 119; and iliac stent (n = 66) 170. The complexity involved the increases in the following KAP factors from simple to complex procedures: THB x4; BD x13; UFE x3; CE x3; HC x5; FR x5 and IS x4. The evaluation of the procedure complexity in patient doses will allow the proper use of DRLs for the optimization of interventional radiology. • National DRLs for interventional procedures have been proposed given level of complexity • For clinical audits, the level of complexity should be taken into account. • An evaluation of the complexity levels of the procedure should be made.

Development of a minimization instrument for allocation of a hospital-level performance improvement intervention to reduce waiting times in Ontario emergency departments.

PubMed

Leaver, Chad Andrew; Guttmann, Astrid; Zwarenstein, Merrick; Rowe, Brian H; Anderson, Geoff; Stukel, Therese; Golden, Brian; Bell, Robert; Morra, Dante; Abrams, Howard; Schull, Michael J

2009-06-08

Rigorous evaluation of an intervention requires that its allocation be unbiased with respect to confounders; this is especially difficult in complex, system-wide healthcare interventions. We developed a short survey instrument to identify factors for a minimization algorithm for the allocation of a hospital-level intervention to reduce emergency department (ED) waiting times in Ontario, Canada. Potential confounders influencing the intervention's success were identified by literature review, and grouped by healthcare setting specific change stages. An international multi-disciplinary (clinical, administrative, decision maker, management) panel evaluated these factors in a two-stage modified-delphi and nominal group process based on four domains: change readiness, evidence base, face validity, and clarity of definition. An original set of 33 factors were identified from the literature. The panel reduced the list to 12 in the first round survey. In the second survey, experts scored each factor according to the four domains; summary scores and consensus discussion resulted in the final selection and measurement of four hospital-level factors to be used in the minimization algorithm: improved patient flow as a hospital's leadership priority; physicians' receptiveness to organizational change; efficiency of bed management; and physician incentives supporting the change goal. We developed a simple tool designed to gather data from senior hospital administrators on factors likely to affect the success of a hospital patient flow improvement intervention. A minimization algorithm will ensure balanced allocation of the intervention with respect to these factors in study hospitals.

Contribution of parenting to complex syntax development in preschool children with developmental delays or typical development.

PubMed

Moody, C T; Baker, B L; Blacher, J

2018-05-10

Despite studies of how parent-child interactions relate to early child language development, few have examined the continued contribution of parenting to more complex language skills through the preschool years. The current study explored how positive and negative parenting behaviours relate to growth in complex syntax learning from child age 3 to age 4 years, for children with typical development or developmental delays (DDs). Participants were children with or without DD (N = 60) participating in a longitudinal study of development. Parent-child interactions were transcribed and coded for parenting domains and child language. Multiple regression analyses were used to identify the contribution of parenting to complex syntax growth in children with typical development or DD. Analyses supported a final model, F(9,50) = 11.90, P < .001, including a significant three-way interaction between positive parenting behaviours, negative parenting behaviours and child delay status. This model explained 68.16% of the variance in children's complex syntax at age 4. Simple two-way interactions indicated differing effects of parenting variables for children with or without DD. Results have implications for understanding of complex syntax acquisition in young children, as well as implications for interventions. © 2018 MENCAP and International Association of the Scientific Study of Intellectual and Developmental Disabilities and John Wiley & Sons Ltd.

Ethnographic methods for process evaluations of complex health behaviour interventions.

PubMed

Morgan-Trimmer, Sarah; Wood, Fiona

2016-05-04

This article outlines the contribution that ethnography could make to process evaluations for trials of complex health-behaviour interventions. Process evaluations are increasingly used to examine how health-behaviour interventions operate to produce outcomes and often employ qualitative methods to do this. Ethnography shares commonalities with the qualitative methods currently used in health-behaviour evaluations but has a distinctive approach over and above these methods. It is an overlooked methodology in trials of complex health-behaviour interventions that has much to contribute to the understanding of how interventions work. These benefits are discussed here with respect to three strengths of ethnographic methodology: (1) producing valid data, (2) understanding data within social contexts, and (3) building theory productively. The limitations of ethnography within the context of process evaluations are also discussed.

Realizing the potential of empowerment: the impact of a feedback intervention on the performance of complex technology.

PubMed

Leach, D J; Jackson, P R; Wall, T D

2001-07-15

An empowerment initiative involving enhanced fault-management responsibility for operators of complex technology had not led to expected increases in performance, and investigations suggested that this was due to a lack of appropriate feedback. Thus, a feedback intervention was designed to provide specific, timely feedback on operator-correctable faults. It was hypothesized that the intervention would increase operator self-reliance in operating complex technology and promote system performance. Moreover, given the feedback was continuous from the point of intervention, it was predicted that gains would increase over time. Time series analysis of data on engineer call-outs (self-reliance) and machine utilization (performance) showed clear positive effects of the feedback intervention, with call-outs also showing progressive improvement. Self-report data showed no change over time in motivation, but an increase in knowledge dissemination and a reduction in the likelihood of making expensive mistakes. There were no detrimental effects on operator well being. Implications for theory and practice in the management of complex technology are discussed.

Adapting practice-based intervention research to electronic environments: opportunities and complexities at two institutions.

PubMed

Stille, Christopher J; Lockhart, Steven A; Maertens, Julie A; Madden, Christi A; Darden, Paul M

2015-01-01

Primary care practice-based research has become more complex with increased use of electronic health records (EHRs). Little has been reported about changes in study planning and execution that are required as practices change from paper-based to electronic-based environments. We describe the evolution of a pediatric practice-based intervention study as it was adapted for use in the electronic environment, to enable other practice-based researchers to plan efficient, effective studies. We adapted a paper-based pediatric office-level intervention to enhance parent-provider communication about subspecialty referrals for use in two practice-based research networks (PBRNs) with partially and fully electronic environments. We documented the process of adaptation and its effect on study feasibility and efficiency, resource use, and administrative and regulatory complexities, as the study was implemented in the two networks. Considerable time and money was required to adapt the paper-based study to the electronic environment, requiring extra meetings with institutional EHR-, regulatory-, and administrative teams, and increased practice training. Institutional unfamiliarity with using EHRs in practice-based research, and the consequent need to develop new policies, were major contributors to delays. Adapting intervention tools to the EHR and minimizing practice disruptions was challenging, but resulted in several efficiencies as compared with a paper-based project. In particular, recruitment and tracking of subjects and data collection were easier and more efficient. Practice-based intervention research in an electronic environment adds considerable cost and time at the outset of a study, especially for centers unfamiliar with such research. Efficiencies generated have the potential of easing the work of study enrollment, subject tracking, and data collection.

Community, intervention and provider support influences on implementation: reflections from a South African illustration of safety, peace and health promotion.

PubMed

van Niekerk, Ashley; Seedat, Mohamed; Kramer, Sherianne; Suffla, Shahnaaz; Bulbulia, Samed; Ismail, Ghouwa

2014-01-01

The development, implementation and evaluation of community interventions are important for reducing child violence and injuries in low- to middle-income contexts, with successful implementation critical to effective intervention outcomes. The assessment of implementation processes is required to identify the factors that influence effective implementation. This article draws on a child safety, peace and health initiative to examine key factors that enabled or hindered its implementation, in a context characterised by limited resources. A case study approach was employed. The research team was made up of six researchers and intervention coordinators, who led the development and implementation of the Ukuphepha Child Study in South Africa, and who are also the authors of this article. The study used author observations, reflections and discussions of the factors perceived to influence the implementation of the intervention. The authors engaged in an in-depth and iterative dialogic process aimed at abstracting the experiences of the intervention, with a recursive cycle of reflection and dialogue. Data were analysed utilising inductive content analysis, and categorised using classification frameworks for understanding implementation. The study highlights key factors that enabled or hindered implementation. These included the community context and concomitant community engagement processes; intervention compatibility and adaptability issues; community service provider perceptions of intervention relevance and expectations; and the intervention support system, characterised by training and mentorship support. This evaluation illustrated the complexity of intervention implementation. The study approach sought to support intervention fidelity by fostering and maintaining community endorsement and support, a prerequisite for the unfolding implementation of the intervention.

Community, intervention and provider support influences on implementation: reflections from a South African illustration of safety, peace and health promotion

PubMed Central

2014-01-01

Background The development, implementation and evaluation of community interventions are important for reducing child violence and injuries in low- to middle-income contexts, with successful implementation critical to effective intervention outcomes. The assessment of implementation processes is required to identify the factors that influence effective implementation. This article draws on a child safety, peace and health initiative to examine key factors that enabled or hindered its implementation, in a context characterised by limited resources. Methods A case study approach was employed. The research team was made up of six researchers and intervention coordinators, who led the development and implementation of the Ukuphepha Child Study in South Africa, and who are also the authors of this article. The study used author observations, reflections and discussions of the factors perceived to influence the implementation of the intervention. The authors engaged in an in-depth and iterative dialogic process aimed at abstracting the experiences of the intervention, with a recursive cycle of reflection and dialogue. Data were analysed utilising inductive content analysis, and categorised using classification frameworks for understanding implementation. Results The study highlights key factors that enabled or hindered implementation. These included the community context and concomitant community engagement processes; intervention compatibility and adaptability issues; community service provider perceptions of intervention relevance and expectations; and the intervention support system, characterised by training and mentorship support. Conclusions This evaluation illustrated the complexity of intervention implementation. The study approach sought to support intervention fidelity by fostering and maintaining community endorsement and support, a prerequisite for the unfolding implementation of the intervention. PMID:25081088

The role of cost-effectiveness analysis in developing nutrition policy.

PubMed

Cobiac, Linda J; Veerman, Lennert; Vos, Theo

2013-01-01

Concern about the overconsumption of unhealthy foods is growing worldwide. With high global rates of noncommunicable diseases related to poor nutrition and projections of more rapid increases of rates in low- and middle-income countries, it is vital to identify effective but low-cost interventions. Cost-effectiveness studies show that individually targeted dietary interventions can be effective and cost-effective, but a growing number of modeling studies suggest that population-wide approaches may bring larger and more sustained benefits for population health at a lower cost to society. Mandatory regulation of salt in processed foods, in particular, is highly recommended. Future research should focus on lacunae in the current evidence base: effectiveness of interventions addressing the marketing, availability, and price of healthy and unhealthy foods; modeling health impacts of complex dietary changes and multi-intervention strategies; and modeling health implications in diverse subpopulations to identify interventions that will most efficiently and effectively reduce health inequalities.

[In-patient (early) rehabilitation].

PubMed

Wallesch, Claus-W; Lautenschläger, Sindy

2017-04-01

It is difficult to develop the financing and hospital provision of interventions for early rehabilitation within the diagnosis-related group (DRG) system. In addition to a range of partially rehabilitative complex interventions, the system recognizes three main forms of early rehabilitative interventions: geriatric, neurological/neurosurgical, and interdisciplinary and others. In this article, the appropriate definitions and cost-effectiveness of these procedures are analyzed and compared. The early rehabilitative interventions are characterized by constant cooperation in the therapeutic team, especially neurological early rehabilitation through the incorporation of nursing as a therapeutic profession. Whereas geriatric and neurological early rehabilitation are reflected in the DRG system, the former provided in many general hospitals and the latter mainly in specialized institutions, interdisciplinary early rehabilitation has only occasionally been represented in the DRG system so far. If all acute in-patients who require early rehabilitation should receive such an intervention, an additional fee must be implemented for this this interdisciplinary service.

Inventory and perspectives of chronic disease management programs in Switzerland: an exploratory survey.

PubMed

Peytremann-Bridevaux, Isabelle; Burnand, Bernard

2009-10-07

To describe chronic disease management programs active in Switzerland in 2007, using an exploratory survey. We searched the internet (Swiss official websites and Swiss web-pages, using Google), a medical electronic database (Medline), reference lists of pertinent articles, and contacted key informants. Programs met our operational definition of chronic disease management if their interventions targeted a chronic disease, included a multidisciplinary team (>/=2 healthcare professionals), lasted at least six months, and had already been implemented and were active in December 2007. We developed an extraction grid and collected data pertaining to eight domains (patient population, intervention recipient, intervention content, delivery personnel, method of communication, intensity and complexity, environment, clinical outcomes). We identified seven programs fulfilling our operational definition of chronic disease management. Programs targeted patients with diabetes, hypertension, heart failure, obesity, psychosis and breast cancer. Interventions were multifaceted; all included education and half considered planned follow-ups. The recipients of the interventions were patients, and healthcare professionals involved were physicians, nurses, social workers, psychologists and case managers of various backgrounds. In Switzerland, a country with universal healthcare insurance coverage and little incentive to develop new healthcare strategies, chronic disease management programs are scarce. For future developments, appropriate evaluations of existing programs, involvement of all healthcare stakeholders, strong leadership and political will are, at least, desirable.

Addressing weight stigma in physiotherapy: Development of a theory-driven approach to (re)thinking weight-related interactions.

PubMed

Setchell, J; Gard, M; Jones, L; Watson, B M

2017-08-01

In this article, we propose a theory-driven approach to developing interventions for reducing weight stigma in physiotherapy and discuss the design and exploratory trial of such an intervention. Weight stigma has been identified in physiotherapists in empirical investigations. However, there has been little consideration of how this stigma might be addressed. We highlight Goffman's work on stigma that provides social and embodied understandings of stigma. Goffman's approach, however, is notably apolitical, ahistorical and lacks mechanisms for understanding power. We suggest that post-structuralist perspectives can provide insight into these areas. Drawing on these theories, we critically examine the literature on weight stigma reduction, finding that trials have largely been unsuccessful. We argue that this may be due to overly passive and simplistic intervention designs. As context-specific understandings are desirable, we examine the nature of physiotherapy to determine what might be relevant to (re)thinking weight in this profession. We then discuss the development of a multifactorial, active weight stigma intervention we trialed with eight physiotherapists. Supported by theory, the outcomes of the exploratory study suggest that physiotherapy-specific factors such as fostering professional reflexivity and improving understandings of stigma need to be incorporated into an active intervention that considers the complex determinants of weight stigma.

Keeping a Step Ahead: formative phase of a workplace intervention trial to prevent obesity.

PubMed

Zapka, Jane; Lemon, Stephenie C; Estabrook, Barbara B; Jolicoeur, Denise G

2007-11-01

Ecological interventions hold promise for promoting overweight and obesity prevention in worksites. Given the paucity of evaluative research in the hospital worksite setting, considerable formative work is required for successful implementation and evaluation. This paper describes the formative phases of Step Ahead, a site-randomized controlled trial of a multilevel intervention that promotes physical activity and healthy eating in six hospitals in central Massachusetts. The purpose of the formative research phase was to increase the feasibility, effectiveness, and likelihood of sustainability of the intervention. The Step Ahead ecological intervention approach targets change at the organization, interpersonal work environment, and individual levels. The intervention was developed using fundamental steps of intervention mapping and important tenets of participatory research. Formative research methods were used to engage leadership support and assistance and to develop an intervention plan that is both theoretically and practically grounded. This report uses observational data, program minutes and reports, and process tracking data. Leadership involvement (key informant interviews and advisory boards), employee focus groups and advisory boards, and quantitative environmental assessments cultivated participation and support. Determining multiple foci of change and designing measurable objectives and generic assessment tools to document progress are complex challenges encountered in planning phases. Multilevel trials in diverse organizations require flexibility and balance of theory application and practice-based perspectives to affect impact and outcome objectives. Formative research is an essential component.

Homelessness among older african-american women: interpreting a serious social issue through the arts in community-based participatory action research.

PubMed

Feen-Calligan, Holly; Washington, Olivia G M; Moxley, David P

2009-01-01

This article describes the incorporation of the arts into a community-based participatory action research (CBPAR) project formulated to develop and test practices for helping homeless older African-American women. Studying how older African-American women become homeless has evolved into developing and testing promising interventions by the Leaving Homelessness Intervention Research Project (LHIRP). The women's participation in creative group activities helped them to communicate their experience with homelessness, express their concerns, develop personal strengths, and obtained mutual understanding. The use of multiple art forms has revealed a number of creative strengths among the participants, which have in turn inspired innovative artistic strategies and methodologies as part of the multiple methods that LHIRP incorporates. These interventions have been useful in helping participants resolve their homelessness. The role and benefit of the arts in CBPAR is described to show how creative activities help researchers and the public to better understand the complexities of homelessness.

Implementing trials of complex interventions in community settings: The USC – Rancho Los Amigos Pressure Ulcer Prevention Study (PUPS)

PubMed Central

Clark, Florence; Pyatak, Elizabeth A.; Carlson, Mike; Blanche, Erna Imperatore; Vigen, Cheryl; Hay, Joel; Mallinson, Trudy; Blanchard, Jeanine; Unger, Jennifer B.; Garber, Susan L.; Diaz, Jesus; Florindez, Lucia I.; Atkins, Michal; Rubayi, Salah; Azen, Stanley Paul

2014-01-01

Background Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)–Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to: (a) participant recruitment and retention, (b) intervention delivery and fidelity, (c) randomization and assessment, and (d) potential inadvertent treatment effects. Purpose We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury. Method Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes. Results PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accord with a rigorous plan. Finally, we have overcome unanticipated assessment and design concerns related to: (a) determining pressure ulcer incidence/severity, (b) randomization imbalance, and (c) inadvertent potential control group contamination. Limitations We have addressed the most daunting challenges encountered in the recruitment, assessment, and intervention phases of PUPS. Some challenges and solutions may not apply to trials conducted in other settings. Conclusions Overcoming challenges has required a multifaceted approach incorporating individualization, flexibility, and persistence as well as the ability to implement needed mid-course corrections. PMID:24577972

The importance of design thinking in medical education.

PubMed

Badwan, Basil; Bothara, Roshit; Latijnhouwers, Mieke; Smithies, Alisdair; Sandars, John

2018-04-01

Design thinking provides a creative and innovate approach to solve a complex problem. The discover, define, develop and delivery phases of design thinking lead to the most effective solution and this approach can be widely applied in medical education, from technology intervention projects to curriculum development. Participants in design thinking acquire essential transferable life-long learning skills in dealing with uncertainty and collaborative team working.

CURRENT CONCEPTS IN BIOMECHANICAL INTERVENTIONS FOR PATELLOFEMORAL PAIN

PubMed Central

Meira, Erik P.

2016-01-01

Patellofemoral pain (PFP) has historically been a complex and enigmatic issue. Many of the factors thought to relate to PFP remain after patients' symptoms have resolved making their clinical importance difficult to determine. The tissue homeostasis model proposed by Dye in 2005 can assist with understanding and implementing biomechanical interventions for PFP. Under this model, the goal of interventions for PFP should be to re-establish patellofemoral joint (PFJ) homeostasis through a temporary alteration of load to the offended tissue, followed by incrementally restoring the envelope of function to the baseline level or higher. High levels of PFJ loads, particularly in the presence of an altered PFJ environment, are thought to be a factor in the development of PFP. Clinical interventions often aim to alter the biomechanical patterns that are thought to result in elevated PFJ loads while concurrently increasing the load tolerance capabilities of the tissue through therapeutic exercise. Biomechanics may play a role in PFJ load modification not only when addressing proximal and distal components, but also when considering the involvement of more local factors such as the quadriceps musculature. Biomechanical considerations should consider the entire kinetic chain including the hip and the foot/ankle complex, however the beneficial effects of these interventions may not be the result of long-term biomechanical changes. Biomechanical alterations may be achieved through movement retraining, but the interventions likely need to be task-specific to alter movement patterns. The purpose of this commentary is to describe biomechanical interventions for the athlete with PFP to encourage a safe and complete return to sport. Level of Evidence 5 PMID:27904791

Multilevel dynamic systems affecting introduction of HIV/STI prevention innovations among Chinese women in sex work establishments.

PubMed

Weeks, Margaret R; Li, Jianghong; Liao, Susu; Zhang, Qingning; Dunn, Jennifer; Wang, Yanhong; Jiang, Jingmei

2013-10-01

Social and public health scientists are increasingly interested in applying system dynamics theory to improve understanding and to harness the forces of change within complex, multilevel systems that affect community intervention implementation, effects, and sustainability. Building a system dynamics model based on ethnographic case study has the advantage of using empirically documented contextual factors and processes of change in a real-world and real-time setting that can then be tested in the same and other settings. System dynamics modeling offers great promise for addressing persistent problems like HIV and other sexually transmitted epidemics, particularly in complex rapidly developing countries such as China. We generated a system dynamics model of a multilevel intervention we conducted to promote female condoms for HIV/sexually transmitted infection (STI) prevention among Chinese women in sex work establishments. The model reflects factors and forces affecting the study's intervention, implementation, and effects. To build this conceptual model, we drew on our experiences and findings from this intensive, longitudinal mixed-ethnographic and quantitative four-town comparative case study (2007-2012) of the sex work establishments, the intervention conducted in them, and factors likely to explain variation in process and outcomes in the four towns. Multiple feedback loops in the sex work establishments, women's social networks, and the health organization responsible for implementing HIV/STI interventions in each town and at the town level directly or indirectly influenced the female condom intervention. We present the conceptual system dynamics model and discuss how further testing in this and other settings can inform future community interventions to reduce HIV and STIs.

Multilevel Dynamic Systems Affecting Introduction of HIV/STI Prevention Innovations among Chinese Women in Sex-work Establishments

PubMed Central

Weeks, Margaret R.; Li, Jianghong; Liao, Susu; Zhang, Qingning; Dunn, Jennifer; Wang, Yanhong; Jiang, Jingmei

2015-01-01

Social and public health scientists are increasingly interested in applying system dynamics theory to improve understanding and to harness the forces of change within complex, multilevel systems that affect community intervention implementation, effects, and sustainability. Building a system dynamics model based on ethnographic case study has the advantage of using empirically documented contextual factors and processes of change in a real world and real time setting that can then be tested in the same and other settings. System dynamics modeling offers great promise for addressing persistent problems like HIV and other sexually transmitted epidemics, particularly in complex rapidly developing countries like China. We generated a system dynamics model of a multilevel intervention we conducted to promote female condoms (FC) for HIV/STI prevention among Chinese women in sex-work establishments. The model reflects factors and forces affecting the study’s intervention implementation and effects. To build this conceptual model, we drew on our experiences and findings from this intensive, longitudinal mixed ethnographic and quantitative four-town comparative case study (2007–2012) of the sex-work establishments, the intervention conducted in them, and factors likely to explain variation in process and outcomes in the four towns. Multiple feedback loops in the sex-work establishments, women’s social networks, and the health organization responsible for implementing HIV/STI interventions in each town and at the town level directly or indirectly influenced the FC intervention. We present the conceptual system dynamics model and discuss how further testing in this and other settings can inform future community interventions to reduce HIV and STIs. PMID:24084394

Developing the Coach Analysis and Intervention System (CAIS): establishing validity and reliability of a computerised systematic observation instrument.

PubMed

Cushion, Christopher; Harvey, Stephen; Muir, Bob; Nelson, Lee

2012-01-01

We outline the evolution of a computerised systematic observation tool and describe the process for establishing the validity and reliability of this new instrument. The Coach Analysis and Interventions System (CAIS) has 23 primary behaviours related to physical behaviour, feedback/reinforcement, instruction, verbal/non-verbal, questioning and management. The instrument also analyses secondary coach behaviour related to performance states, recipient, timing, content and questioning/silence. The CAIS is a multi-dimensional and multi-level mechanism able to provide detailed and contextualised data about specific coaching behaviours occurring in complex and nuanced coaching interventions and environments that can be applied to both practice sessions and competition.

Societal interventions to prevent child abuse and neglect.

PubMed

Hay, T; Jones, L

1994-01-01

A framework for understanding child maltreatment in terms of complex and interacting factors from the individual to the societal level can aid in conceptualizing and implementing prevention efforts. Research on interventions at the societal level can guide a broad range of activities, increasing their effectiveness and viability. Fundamental approaches include evaluation of specific interventions and systems-level research on implementation and development of best practice in prevention activities for different portions of society. Research can indicate the roles that each individual, agency, organization, community, and level of government can play. The U.N. Convention on the Rights of the Child provides a useful framework for societal level change to improve the welfare of children and families.

Total skin self-examination at home for people treated for cutaneous melanoma: development and pilot of a digital intervention

PubMed Central

Murchie, Peter; Allan, Julia L; Brant, William; Dennis, Matthew; Hall, Susan; Masthoff, Judith; Walter, Fiona M; Johnston, Marie

2015-01-01

Objectives To develop a digital intervention to prompt, support, and respond to the outcomes of total skin self-examinations (TSSEs) at home by people treated for cutaneous melanoma. Design A complex intervention development study. Setting Northeast Scotland. Participants Semistructured scoping interviews; people previously treated for cutaneous melanoma (n=21). Pilot testing: people treated for melanoma stages 0–2C (n=20); general practitioners (n=6); and a nurse specialist in dermatology (n=1). Intervention A tablet-based digital intervention designed to prompt and support TSSEs comprising instructional videos and electronic reporting (including photographs) to a clinical nurse specialist in dermatology, with subsequent clinical triage. Primary and secondary outcome measures Qualitative assessment of intervention feasibility and acceptability, and quantitative assessment of intentions and confidence to perform TSSEs in pilot participants. Results The majority of pilot participants were strongly positive and adhered well to the intervention (n=15), with 7 of these reporting symptoms of concern at some point during the 6-month pilot. 4 patients complied intermittently, 3 reporting skin problems at least once during the pilot, and 1 withdrew. 2 patients underwent skin surgery as a result of participating in the pilot, with 1 diagnosed as having a recurrent melanoma and the other, a benign lesion. A number of practical issues to improve the usability of the intervention were identified. The proportion of participants reporting intention to check their skin at least monthly increased during the intervention as did confidence to conduct a skin check. Conclusions People previously treated for cutaneous melanoma are prepared to use digital technology to support them in conducting TSSE. An intervention has been developed which is practical, effective and safe, and after addressing minor practical issues, could now be evaluated for clinical outcomes in a randomised clinical trial. PMID:26251412

From complex questionnaire and interviewing data to intelligent Bayesian Network models for medical decision support

PubMed Central

Constantinou, Anthony Costa; Fenton, Norman; Marsh, William; Radlinski, Lukasz

2016-01-01

Objectives 1) To develop a rigorous and repeatable method for building effective Bayesian network (BN) models for medical decision support from complex, unstructured and incomplete patient questionnaires and interviews that inevitably contain examples of repetitive, redundant and contradictory responses; 2) To exploit expert knowledge in the BN development since further data acquisition is usually not possible; 3) To ensure the BN model can be used for interventional analysis; 4) To demonstrate why using data alone to learn the model structure and parameters is often unsatisfactory even when extensive data is available. Method The method is based on applying a range of recent BN developments targeted at helping experts build BNs given limited data. While most of the components of the method are based on established work, its novelty is that it provides a rigorous consolidated and generalised framework that addresses the whole life-cycle of BN model development. The method is based on two original and recent validated BN models in forensic psychiatry, known as DSVM-MSS and DSVM-P. Results When employed with the same datasets, the DSVM-MSS demonstrated competitive to superior predictive performance (AUC scores 0.708 and 0.797) against the state-of-the-art (AUC scores ranging from 0.527 to 0.705), and the DSVM-P demonstrated superior predictive performance (cross-validated AUC score of 0.78) against the state-of-the-art (AUC scores ranging from 0.665 to 0.717). More importantly, the resulting models go beyond improving predictive accuracy and into usefulness for risk management purposes through intervention, and enhanced decision support in terms of answering complex clinical questions that are based on unobserved evidence. Conclusions This development process is applicable to any application domain which involves large-scale decision analysis based on such complex information, rather than based on data with hard facts, and in conjunction with the incorporation of expert knowledge for decision support via intervention. The novelty extends to challenging the decision scientists to reason about building models based on what information is really required for inference, rather than based on what data is available and hence, forces decision scientists to use available data in a much smarter way. PMID:26830286

From complex questionnaire and interviewing data to intelligent Bayesian network models for medical decision support.

PubMed

Constantinou, Anthony Costa; Fenton, Norman; Marsh, William; Radlinski, Lukasz

2016-02-01

(1) To develop a rigorous and repeatable method for building effective Bayesian network (BN) models for medical decision support from complex, unstructured and incomplete patient questionnaires and interviews that inevitably contain examples of repetitive, redundant and contradictory responses; (2) To exploit expert knowledge in the BN development since further data acquisition is usually not possible; (3) To ensure the BN model can be used for interventional analysis; (4) To demonstrate why using data alone to learn the model structure and parameters is often unsatisfactory even when extensive data is available. The method is based on applying a range of recent BN developments targeted at helping experts build BNs given limited data. While most of the components of the method are based on established work, its novelty is that it provides a rigorous consolidated and generalised framework that addresses the whole life-cycle of BN model development. The method is based on two original and recent validated BN models in forensic psychiatry, known as DSVM-MSS and DSVM-P. When employed with the same datasets, the DSVM-MSS demonstrated competitive to superior predictive performance (AUC scores 0.708 and 0.797) against the state-of-the-art (AUC scores ranging from 0.527 to 0.705), and the DSVM-P demonstrated superior predictive performance (cross-validated AUC score of 0.78) against the state-of-the-art (AUC scores ranging from 0.665 to 0.717). More importantly, the resulting models go beyond improving predictive accuracy and into usefulness for risk management purposes through intervention, and enhanced decision support in terms of answering complex clinical questions that are based on unobserved evidence. This development process is applicable to any application domain which involves large-scale decision analysis based on such complex information, rather than based on data with hard facts, and in conjunction with the incorporation of expert knowledge for decision support via intervention. The novelty extends to challenging the decision scientists to reason about building models based on what information is really required for inference, rather than based on what data is available and hence, forces decision scientists to use available data in a much smarter way. Copyright © 2016 Elsevier B.V. All rights reserved.

A Framework for Chaos Theory Career Counselling

ERIC Educational Resources Information Center

Pryor, Robert G. L.

2010-01-01

Theory in career development counselling provides a map that counsellors can use to understand and structure the career counselling process. It also provides a means to communicate this understanding and structuring to their clients as part of the counselling intervention. The chaos theory of careers draws attention to the complexity,…

Evaluating Infrastructure Development in Complex Home Visiting Systems

ERIC Educational Resources Information Center

Hargreaves, Margaret; Cole, Russell; Coffee-Borden, Brandon; Paulsell, Diane; Boller, Kimberly

2013-01-01

In recent years, increased focus on the effectiveness and accountability of prevention and intervention programs has led to greater government funding for the implementation and spread of evidence-based health and human service delivery models. In particular, attention has been paid to programs that require significant infrastructure investment…

Managing Risk in Complex Adult Professional Learning: The Facilitator's Role

ERIC Educational Resources Information Center

Ince, Amanda

2017-01-01

This article reports on the recognition and management of risk within the context of an intensive literacy intervention professional development programme, designed to enable expert literacy teachers become teacher-educators. The article suggests a conceptual model for recognising risk within professional learning opportunities and skills for…

School Dropout Indicators, Trends, and Interventions for School Counselors

ERIC Educational Resources Information Center

Dockery, Donna J.

2012-01-01

School counselors are expected to develop programs that promote academic success for all students, including those at risk for dropping out of school. Knowledge of key indicators of potential dropouts and current trends in dropout prevention research may assist school counselors in better understanding this complex issue. Implementing recommended…

Assessing intervention fidelity in a multi-level, multi-component, multi-site program: the Children's Healthy Living (CHL) program.

PubMed

Butel, Jean; Braun, Kathryn L; Novotny, Rachel; Acosta, Mark; Castro, Rose; Fleming, Travis; Powers, Julianne; Nigg, Claudio R

2015-12-01

Addressing complex chronic disease prevention, like childhood obesity, requires a multi-level, multi-component culturally relevant approach with broad reach. Models are lacking to guide fidelity monitoring across multiple levels, components, and sites engaged in such interventions. The aim of this study is to describe the fidelity-monitoring approach of The Children's Healthy Living (CHL) Program, a multi-level multi-component intervention in five Pacific jurisdictions. A fidelity-monitoring rubric was developed. About halfway during the intervention, community partners were randomly selected and interviewed independently by local CHL staff and by Coordinating Center representatives to assess treatment fidelity. Ratings were compared and discussed by local and Coordinating Center staff. There was good agreement between the teams (Kappa = 0.50, p < 0.001), and intervention improvement opportunities were identified through data review and group discussion. Fidelity for the multi-level, multi-component, multi-site CHL intervention was successfully assessed, identifying adaptations as well as ways to improve intervention delivery prior to the end of the intervention.

Six easy steps on how to create a lean sigma value stream map for a multidisciplinary clinical operation.

PubMed

Lee, Emily; Grooms, Richard; Mamidala, Soumya; Nagy, Paul

2014-12-01

Value stream mapping (VSM) is a very useful technique to visualize and quantify the complex workflows often seen in clinical environments. VSM brings together multidisciplinary teams to identify parts of processes, collect data, and develop interventional ideas. An example involving pediatric MRI with general anesthesia VSM is outlined. As the process progresses, the map shows a large delay between the fax referral and the date of the scheduled and registered appointment. Ideas for improved efficiency and metrics were identified to measure improvement within a 6-month period, and an intervention package was developed for the department. Copyright © 2014. Published by Elsevier Inc.

Community-based approaches to address childhood undernutrition and obesity in developing countries.

PubMed

Shetty, Prakash

2009-01-01

Community-based approaches have been the mainstay of interventions to address the problem of child malnutrition in developing societies. Many programs have been in operation in several countries for decades and originated largely as social welfare, food security and poverty eradication programs. Increasingly conceptual frameworks to guide this activity have been developed as our understanding of the complex nature of the determinants of undernutrition improves. Alongside this evolution, is the accumulation of evidence on the types of interventions in the community that are effective, practical and sustainable. The changing environment is probably determining the altering scenario of child nutrition in developing societies, with rapid developmental transition and urbanization being responsible for the emerging problems of obesity and other metabolic disorders that are largely the result of the now well-recognized linkages between child undernutrition and early onset adult chronic diseases. This dramatic change is contributing to the double burden of malnutrition in developing countries. Community interventions hence need to be integrated and joined up to reduce both aspects of malnutrition in societies. The evidence that community-based nutrition interventions can have a positive impact on pregnancy outcomes and child undernutrition needs to be evaluated to enable programs to prioritize and incorporate the interventions that work in the community. Programs that are operational and successful also need to be evaluated and disseminated in order to enable countries to generate their own programs tailored to tackling the changing nutritional problems of the children in their society. Copyright (c) 2009 S. Karger AG, Basel.

Integrating technology into complex intervention trial processes: a case study.

PubMed

Drew, Cheney J G; Poile, Vincent; Trubey, Rob; Watson, Gareth; Kelson, Mark; Townson, Julia; Rosser, Anne; Hood, Kerenza; Quinn, Lori; Busse, Monica

2016-11-17

Trials of complex interventions are associated with high costs and burdens in terms of paperwork, management, data collection, validation, and intervention fidelity assessment occurring across multiple sites. Traditional data collection methods rely on paper-based forms, where processing can be time-consuming and error rates high. Electronic source data collection can potentially address many of these inefficiencies, but has not routinely been used in complex intervention trials. Here we present the use of an on-line system for managing all aspects of data handling and for the monitoring of trial processes in a multicentre trial of a complex intervention. We custom built a web-accessible software application for the delivery of ENGAGE-HD, a multicentre trial of a complex physical therapy intervention. The software incorporated functionality for participant randomisation, data collection and assessment of intervention fidelity. It was accessible to multiple users with differing levels of access depending on required usage or to maintain blinding. Each site was supplied with a 4G-enabled iPad for accessing the system. The impact of this system was quantified through review of data quality and collation of feedback from site coordinators and assessors through structured process interviews. The custom-built system was an efficient tool for collecting data and managing trial processes. Although the set-up time required was significant, using the system resulted in an overall data completion rate of 98.5% with a data query rate of 0.1%, the majority of which were resolved in under a week. Feedback from research staff indicated that the system was highly acceptable for use in a research environment. This was a reflection of the portability and accessibility of the system when using the iPad and its usefulness in aiding accurate data collection, intervention fidelity and general administration. A combination of commercially available hardware and a bespoke online database designed to support data collection, intervention fidelity and trial progress provides a viable option for streamlining trial processes in a multicentre complex intervention trial. There is scope to further extend the system to cater for larger trials and add further functionality such as automatic reporting facilities and participant management support. ISRCTN65378754 , registered on 13 March 2014.

Implementing communication and decision-making interventions directed at goals of care: a theory-led scoping review

PubMed Central

Cummings, Amanda; Lund, Susi; Campling, Natasha; May, Carl; Richardson, Alison; Myall, Michelle

2017-01-01

Objectives To identify the factors that promote and inhibit the implementation of interventions that improve communication and decision-making directed at goals of care in the event of acute clinical deterioration. Design and methods A scoping review was undertaken based on the methodological framework of Arksey and O’Malley for conducting this type of review. Searches were carried out in Medline and Cumulative Index to Nursing and Allied Health Literature (CINAHL) to identify peer-reviewed papers and in Google to identify grey literature. Searches were limited to those published in the English language from 2000 onwards. Inclusion and exclusion criteria were applied, and only papers that had a specific focus on implementation in practice were selected. Data extracted were treated as qualitative and subjected to directed content analysis. A theory-informed coding framework using Normalisation Process Theory (NPT) was applied to characterise and explain implementation processes. Results Searches identified 2619 citations, 43 of which met the inclusion criteria. Analysis generated six themes fundamental to successful implementation of goals of care interventions: (1) input into development; (2) key clinical proponents; (3) training and education; (4) intervention workability and functionality; (5) setting and context; and (6) perceived value and appraisal. Conclusions A broad and diverse literature focusing on implementation of goals of care interventions was identified. Our review recognised these interventions as both complex and contentious in nature, making their incorporation into routine clinical practice dependent on a number of factors. Implementing such interventions presents challenges at individual, organisational and systems levels, which make them difficult to introduce and embed. We have identified a series of factors that influence successful implementation and our analysis has distilled key learning points, conceptualised as a set of propositions, we consider relevant to implementing other complex and contentious interventions. PMID:28988176

Evidences to validate public policies: a review with an international research perspective.

PubMed

Gregori, Dario

2014-01-01

Nutrition and related health issues are nowadays topics of general interest. The prevalence of overweight and obesity has increased with alarming speed over the past twenty years, being described by the World Health Organization as a global epidemic. An evidence-based approach to public health interventions should be based on the best available information. Given the substantial investment of society in fundamental and applied health research, and the high expectations of society for reducing the burden of illness, attention to these matters should have high priority. There's an urgent need to foster the development of international standards, such as food labeling and profiling. Considering the complex network involved in obesity development, it is necessary to promote multiple-concurrent interventions, taking into account that by focusing on a single intervention in isolation, all other factors being constant, each individual policy change is likely to appear ineffective.

Unraveling the complexities of disaster management: a framework for critical social infrastructure to promote population health and resilience.

PubMed

O'Sullivan, Tracey L; Kuziemsky, Craig E; Toal-Sullivan, Darene; Corneil, Wayne

2013-09-01

Complexity is a useful frame of reference for disaster management and understanding population health. An important means to unraveling the complexities of disaster management is to recognize the interdependencies between health care and broader social systems and how they intersect to promote health and resilience before, during and after a crisis. While recent literature has expanded our understanding of the complexity of disasters at the macro level, few studies have examined empirically how dynamic elements of critical social infrastructure at the micro level influence community capacity. The purpose of this study was to explore empirically the complexity of disasters, to determine levers for action where interventions can be used to facilitate collaborative action and promote health among high risk populations. A second purpose was to build a framework for critical social infrastructure and develop a model to identify potential points of intervention to promote population health and resilience. A community-based participatory research design was used in nine focus group consultations (n = 143) held in five communities in Canada, between October 2010 and March 2011, using the Structured Interview Matrix facilitation technique. The findings underscore the importance of interconnectedness of hard and soft systems at the micro level, with culture providing the backdrop for the social fabric of each community. Open coding drawing upon the tenets of complexity theory was used to develop four core themes that provide structure for the framework that evolved; they relate to dynamic context, situational awareness and connectedness, flexible planning, and collaboration, which are needed to foster adaptive responses to disasters. Seven action recommendations are presented, to promote community resilience and population health. Copyright © 2012 Elsevier Ltd. All rights reserved.

Complex families, the social determinants of health and psychosocial interventions: Deconstruction of a day in the life of hospital social workers.

PubMed

Muskat, Barbara; Craig, Shelley L; Mathai, Biju

2017-09-01

The roles of hospital social workers are delineated in the literature; however, their daily interventions have only been described anecdotally. This study analyzes the daily work of social workers in a pediatric hospital through a survey completed which examined factors related to interventions utilized and time spent per case over a 1-day period. Length and types of interventions were associated with the social determinants of health, time since diagnosis, biopsychosocial issues, and perception of complexity. The study offers a snapshot of the personalized expertise, provided by social workers that addresses complex contextual and biopsychosocial concerns of patient and families.

Model describing the effect of employment of the United States military in a complex emergency.

PubMed

MacMillan, Donald S

2005-01-01

The end of the Cold War vastly altered the worldwide political landscape. With the loss of a main competitor, the United States (US) military has had to adapt its strategic, operational, and tactical doctrines to an ever-increasing variety of non-traditional missions, including humanitarian operations. Complex emergencies (CEs) are defined in this paper from a political and military perspective, various factors that contribute to their development are described, and issues resulting from the employment of US military forces are discussed. A model was developed to illustrate the course of a humanitarian emergency and the potential impact of a military response. The US intervention in Haiti, Northern Iraq, Kosovo, Somalia, Bosnia, and Rwanda serve as examples. A CE develops when there is civil conflict, loss of national governmental authority, a mass population movement, and massive economic failure, each leading to a general decline in food security. The military can alleviate a CE in four ways: (1) provide security for relief efforts; (2) enforce negotiated settlements; (3) provide security for non-combatants; and/or (4) employ logistical capabilities. The model incorporates Norton and Miskel's taxonomy of identifying failing states and helps illustrate the factors that lead to a CE. The model can be used to determine if and when military intervention will have the greatest impact. The model demonstrates that early military intervention and mission assignment within the core competencies of the forces can reverse the course of a CE. Further study will be needed to verify the model.

Case managers for older persons with multi-morbidity and their everyday work – a focused ethnography

PubMed Central

2013-01-01

Background Modern-day health systems are complex, making it difficult to assure continuity of care for older persons with multi-morbidity. One way of intervening in a health system that is leading to fragmented care is by utilising Case Management (CM). CM aims to improve co-ordination of healthcare and social services. To better understand and advance the development of CM, there is a need for additional research that provides rich descriptions of CM in practice. This knowledge is important as there could be unknown mechanisms, contextual or interpersonal, that contribute to the success or failure of a CM intervention. Furthermore, the CM intervention in this study is conducted in the context of the Swedish health system, which prior to this intervention was unfamiliar with this kind of coordinative service. The aim of this study was to explore the everyday work undertaken by case managers within a CM intervention, with a focus on their experiences. Methods The study design was qualitative and inductive, utilising a focused ethnographic approach. Data collection consisted of participant observations with field notes as well as a group interview and individual interviews with nine case managers, conducted in 2012/2013. The interviews were recorded, transcribed verbatim and subjected to thematic analysis. Results An overarching theme emerged from the data: Challenging current professional identity, with three sub-themes. The sub-themes were 1) Adjusting to familiar work in an unfamiliar role; 2) Striving to improve the health system through a new role; 3) Trust is vital to advocacy. Conclusions Findings from this study shed some light on the complexity of CM for older persons with multi-morbidity, as seen from the perspective of case managers. The findings illustrate how their everyday work as case managers represents a challenge to their current professional identity. These findings could help to understand and promote the development of CM models aimed at a population of older persons with complex health needs. PMID:24279695

Behavioral health coaching for rural veterans with diabetes and depression: a patient randomized effectiveness implementation trial.

PubMed

Cully, Jeffrey A; Breland, Jessica Y; Robertson, Suzanne; Utech, Anne E; Hundt, Natalie; Kunik, Mark E; Petersen, Nancy J; Masozera, Nicholas; Rao, Radha; Naik, Aanand D

2014-04-28

Depression and diabetes cause significant burden for patients and the healthcare system and, when co-occurring, result in poorer self-care behaviors and worse glycemic control than for either condition alone. However, the clinical management of these comorbid conditions is complicated by a host of patient, provider, and system-level barriers that are especially problematic for patients in rural locations. Patient-centered medical homes provide an opportunity to integrate mental and physical health care to address the multifaceted needs of complex comorbid conditions. Presently, there is a need to not only develop robust clinical interventions for complex medically ill patients but also to find feasible ways to embed these interventions into the frontlines of existing primary care practices. This randomized controlled trial uses a hybrid effectiveness-implementation design to evaluate the Healthy Outcomes through Patient Empowerment (HOPE) intervention, which seeks to simultaneously address diabetes and depression for rural veterans in Southeast Texas. A total of 242 Veterans with uncontrolled diabetes and comorbid symptoms of depression will be recruited and randomized to either the HOPE intervention or to a usual-care arm. Participants will be evaluated on a host of diabetes and depression-related measures at baseline and 6- and 12-month follow-up. The trial has two primary goals: 1) to examine the effectiveness of the intervention on both physical (diabetes) and emotional health (depression) outcomes and 2) to simultaneously pilot test a multifaceted implementation strategy designed to increase fidelity and utilization of the intervention by coaches interfacing within the primary care setting. This ongoing blended effectiveness-implementation design holds the potential to advance the science and practice of caring for complex medically ill patients within the constraints of a busy patient-centered medical home. Behavioral Activation Therapy for Rural Veterans with Diabetes and Depression: NCT01572389.

Education: a complex and empowering social work intervention at the end of life.

PubMed

Cagle, John G; Kovacs, Pamela J

2009-02-01

Education is a frequently used social work intervention. Yet it seems to be an underappreciated and a deceptively complex intervention that social workers may not be adequately prepared to use. Reliable, accessible information is essential as it helps prevent unnecessary crises, facilitates coping, and promotes self-determination. This article conceptualizes education as a fundamental social work intervention and discusses the role social workers play in providing information that is both empowering and culturally sensitive. In particular, this article focuses on social workers working with patients and families facing life-threatening situations, including those in hospice and other end-of-life care settings. After reviewing the relevant literature and theory and exploring the inherent complexities of educational interventions, the authors recommend strategies for more effectively helping patients and families access the information they need.

A Framework for the Study of Complex mHealth Interventions in Diverse Cultural Settings.

PubMed

Maar, Marion A; Yeates, Karen; Perkins, Nancy; Boesch, Lisa; Hua-Stewart, Diane; Liu, Peter; Sleeth, Jessica; Tobe, Sheldon W

2017-04-20

To facilitate decision-making capacity between options of care under real-life service conditions, clinical trials must be pragmatic to evaluate mobile health (mHealth) interventions under the variable conditions of health care settings with a wide range of participants. The mHealth interventions require changes in the behavior of patients and providers, creating considerable complexity and ambiguity related to causal chains. Process evaluations of the implementation are necessary to shed light on the range of unanticipated effects an intervention may have, what the active ingredients in everyday practice are, how they exert their effect, and how these may vary among recipients or between sites. Building on the CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth) statement and participatory evaluation theory, we present a framework for the process evaluations for mHealth interventions in multiple cultural settings. We also describe the application of this evaluation framework to the implementation of DREAM-GLOBAL (Diagnosing hypertension-Engaging Action and Management in Getting Lower BP in Indigenous and LMIC [low- and middle-income countries]), a pragmatic randomized controlled trial (RCT), and mHealth intervention designed to improve hypertension management in low-resource environments. We describe the evaluation questions and the data collection processes developed by us. Our literature review revealed that there is a significant knowledge gap related to the development of a process evaluation framework for mHealth interventions. We used community-based participatory research (CBPR) methods and formative research data to develop a process evaluation framework nested within a pragmatic RCT. Four human organizational levels of participants impacted by the mHealth intervention were identified that included patients, providers, community and organizations actors, and health systems and settings. These four levels represent evaluation domains and became the core focus of the evaluation. In addition, primary implementation themes to explore in each of the domains were identified as follows: (1) the major active components of the intervention, (2) technology of the intervention, (3) cultural congruence, (4) task shifting, and (5) unintended consequences. Using the four organizational domains and their interaction with primary implementation themes, we developed detailed evaluation research questions and identified the data or information sources to best answer our questions. Using DREAM-GLOBAL to illustrate our approach, we succeeded in developing an uncomplicated process evaluation framework for mHealth interventions that provide key information to stakeholders, which can optimize implementation of a pragmatic trial as well as inform scale up. The human organizational level domains used to focus the primary implementation themes in the DREAM-GLOBAL process evaluation framework are sufficiently supported in our research, and the literature and can serve as a valuable tool for other mHealth process evaluations. ClinicalTrials.gov NCT02111226; https://clinicaltrials.gov/ct2/show/NCT02111226 (Archived by WebCite at http://www.webcitation.org/6oxfHXege). ©Marion A Maar, Karen Yeates, Nancy Perkins, Lisa Boesch, Diane Hua-Stewart, Peter Liu, Jessica Sleeth, Sheldon W Tobe. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 20.04.2017.

Flexible robotic catheters in the visceral segment of the aorta: advantages and limitations.

PubMed

Li, Mimi M; Hamady, Mohamad S; Bicknell, Colin D; Riga, Celia V

2018-06-01

Flexible robotic catheters are an emerging technology which provide an elegant solution to the challenges of conventional endovascular intervention. Originally developed for interventional cardiology and electrophysiology procedures, remotely steerable robotic catheters such as the Magellan system enable greater precision and enhanced stability during target vessel navigation. These technical advantages facilitate improved treatment of disease in the arterial tree, as well as allowing execution of otherwise unfeasible procedures. Occupational radiation exposure is an emerging concern with the use of increasingly complex endovascular interventions. The robotic systems offer an added benefit of radiation reduction, as the operator is seated away from the radiation source during manipulation of the catheter. Pre-clinical studies have demonstrated reduction in force and frequency of vessel wall contact, resulting in reduced tissue trauma, as well as improved procedural times. Both safety and feasibility have been demonstrated in early clinical reports, with the first robot-assisted fenestrated endovascular aortic repair in 2013. Following from this, the Magellan system has been used to successfully undertake a variety of complex aortic procedures, including fenestrated/branched endovascular aortic repair, embolization, and angioplasty.

Anorexia of aging and its role for frailty.

PubMed

Sanford, Angela M

2017-01-01

The purpose of this review is to examine the concept of anorexia of aging, including its complex pathophysiology and the multifaceted interventions required to prevent adverse health consequences from this geriatric syndrome. Anorexia of aging is extremely common, occurring in up to 30% of elderly individuals; however, this diagnosis is frequently missed or erroneously attributed to a normal part of the aging process. With aging, impairments in smell and taste can limit the desire to eat. Alterations in stress hormones and inflammatory mediators can lead to excess catabolism, cachexia, and reduced appetite. In addition, mood disorders, such as anxiety and depression, are powerful inhibitors of appetite. Anorexia of aging, with its negative consequences on weight and muscle mass, is a risk factor for the development of frailty and is important to screen for, as early intervention is key to reversing this debilitating condition. Anorexia of aging is a complex geriatric syndrome and a direct risk factor for frailty and thus should not be accepted as normal consequence of aging. Early diagnosis and formulating a plan for targeted interventions is critical to prevent disability and preserve function in elderly patients.

Development of an existential support training program for healthcare professionals.

PubMed

Henoch, Ingela; Strang, Susann; Browall, Maria; Danielson, Ella; Melin-Johansson, Christina

2015-12-01

Our aim was to describe the developmental process of a training program for nurses to communicate existential issues with severely ill patients. The Medical Research Council (MRC) framework for the development and evaluation of complex interventions was used to develop a training program for nurses to communicate about existential issues with their patients. The steps in the framework were employed to describe the development of the training intervention, and the development, feasibility and piloting, evaluation, and implementation phases. The development and feasibility phases are described in the Methods section. The evaluation and implementation phases are described in the Results section. In the evaluation phase, the effectiveness of the intervention was shown as nurses' confidence in communication increased after training. The understanding of the change process was considered to be that the nurses could describe their way of communicating in terms of prerequisites, process, and content. Some efforts have been made to implement the training intervention, but these require further elaboration. Existential and spiritual issues are very important to severely ill patients, and healthcare professionals need to be attentive to such questions. It is important that professionals be properly prepared when patients need this communication. An evidence-based training intervention could provide such preparation. Healthcare staff were able to identify situations where existential issues were apparent, and they reported that their confidence in communication about existential issues increased after attending a short-term training program that included reflection. In order to design a program that should be permanently implemented, more knowledge is needed of patients' perceptions of the quality of the healthcare staff's existential support.

Process evaluation of a patient-centred, patient-directed, group-based education program for the management of type 2 diabetes mellitus.

PubMed

Odgers-Jewell, Kate; Isenring, Elisabeth; Thomas, Rae; Reidlinger, Dianne P

2017-07-01

The present study developed and evaluated a patient-centred, patient-directed, group-based education program for the management of type 2 diabetes mellitus. Two frameworks, the Medical Research Council (MRC) framework for developing and evaluating complex interventions and the RE-AIM framework were followed. Data to develop the intervention were sourced from scoping of the literature and formative evaluation. Program evaluation comprised analysis of primary recruitment of participants through general practitioners, baseline and end-point measures of anthropometry, four validated questionnaires, contemporaneous facilitator notes and telephone interviews with participants. A total of 16 participants enrolled in the intervention. Post-intervention results were obtained from 13 participants, with an estimated mean change from baseline in weight of -0.72 kg (95%CI -1.44 to -0.01), body mass index of -0.25 kg/m 2 (95%CI -0.49 to -0.01) and waist circumference of -1.04 cm (95%CI -4.52 to 2.44). The group education program was acceptable to participants. The results suggest that recruitment through general practitioners is ineffective, and alternative recruitment strategies are required. This patient-centred, patient-directed, group-based intervention for the management of type 2 diabetes mellitus was both feasible and acceptable to patients. Health professionals should consider the combined use of the MRC and RE-AIM frameworks in the development of interventions to ensure a rigorous design process and to enable the evaluation of all phases of the intervention, which will facilitate translation to other settings. Further research with a larger sample trialling additional recruitment strategies, evaluating further measures of effectiveness and utilising lengthier follow-up periods is required. © 2016 Dietitians Association of Australia.

A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse

PubMed Central

2013-01-01

Background Current Medical Research Council (MRC) guidance on complex interventions advocates pilot trials and feasibility studies as part of a phased approach to the development, testing, and evaluation of healthcare interventions. In this paper we discuss the results of a recent feasibility study and pilot trial for a randomized controlled trial (RCT) of pelvic floor muscle training for prolapse (ClinicalTrials.gov: NCT01136889). The ways in which researchers decide to respond to the results of feasibility work may have significant repercussions for both the nature and degree of tension between internal and external validity in a definitive trial. Methods We used methodological issues to classify and analyze the problems that arose in the feasibility study. Four centers participated with the aim of randomizing 50 women. Women were eligible if they had prolapse of any type, of stage I to IV, and had a pessary successfully fitted. Postal questionnaires were administered at baseline, 6 months, and 7 months post-randomization. After identifying problems arising within the pilot study we then sought to locate potential solutions that might minimize the trade-off between a subsequent explanatory versus pragmatic trial. Results The feasibility study pointed to significant potential problems in relation to participant recruitment, features of the intervention, acceptability of the intervention to participants, and outcome measurement. Finding minimal evidence to support our decision-making regarding the transition from feasibility work to a trial, we developed a systematic process (A process for Decision-making after Pilot and feasibility Trials (ADePT)) which we subsequently used as a guide. The process sought to: 1) encourage the systematic identification and appraisal of problems and potential solutions; 2) improve the transparency of decision-making processes; and 3) reveal the tensions that exist between pragmatic and explanatory choices. Conclusions We have developed a process that may aid researchers in their attempt to identify the most appropriate solutions to problems identified within future pilot and feasibility RCTs. The process includes three key steps: a decision about the type of problem, the identification of all solutions (whether addressed within the intervention, trial design or clinical context), and a systematic appraisal of these solutions. PMID:24160371

Post-graduate education for medical specialists focused on patients with medically unexplained physical symptoms; development of a communication skills training programme.

PubMed

Weiland, Anne; Blankenstein, Annette H; Willems, Mariëtte H A; Van Saase, Jan L C M; Van der Molen, Henk T; Van Dulmen, Alexandra M; Arends, Lidia R

2013-09-01

Stepwise description of the development of a post-graduate communication skills training programme for medical specialists focused on patients with medically unexplained physical symptoms (MUPS) to improve specialist interaction with MUPS patients. Using the 'intervention mapping approach' we accomplished a needs assessment (literature study and pilot) to formulate intervention objectives and identify methods and techniques for a MUPS-focused communication skills training programme for medical specialists. A 14-h training programme which consists of experiential learning, role-play and feedback. Using skills from Cognitive Behavioural Therapy, medical specialists are stimulated to explore interrelating factors that reinforce symptoms, to reassure patients effectively and to provide plausible and understandable explanations for MUPS. Dealing with complex referrals and informing GPs properly are also practiced. By applying the 'intervention mapping approach' we were able to create a feasible and promising intervention to improve specialist interaction with MUPS patients. Intervention effects are currently being assessed in a randomized controlled trial. If the RCT demonstrates sufficient effectiveness and efficiency of the MUPS focused communication skills training programme for medical specialists the intervention could be embedded in post-graduate education of medical specialists and residents. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Sexual behavior, risk perception, and HIV transmission can respond to HIV antiviral drugs and vaccines through multiple pathways.

PubMed

Tully, Stephen; Cojocaru, Monica; Bauch, Chris T

2015-10-28

There has been growing use of highly active antiretroviral treatment (HAART) for HIV and significant progress in developing prophylactic HIV vaccines. The simplest theories of counterproductive behavioral responses to such interventions tend to focus on single feedback mechanisms: for instance, HAART optimism makes infection less scary and thus promotes risky sexual behavior. Here, we develop an agent based, age-structured model of HIV transmission, risk perception, and partner selection in a core group to explore behavioral responses to interventions. We find that interventions can activate not one, but several feedback mechanisms that could potentially influence decision-making and HIV prevalence. In the model, HAART increases the attractiveness of unprotected sex, but it also increases perceived risk of infection and, on longer timescales, causes demographic impacts that partially counteract HAART optimism. Both HAART and vaccination usually lead to lower rates of unprotected sex on the whole, but intervention effectiveness depends strongly on whether individuals over- or under-estimate intervention coverage. Age-specific effects cause sexual behavior and HIV prevalence to change in opposite ways in old and young age groups. For complex infections like HIV-where interventions influence transmission, demography, sexual behavior and risk perception-we conclude that evaluations of behavioral responses should consider multiple feedback mechanisms.

Integrating evidence-based treatments for common mental disorders in routine primary care: feasibility and acceptability of the MANAS intervention in Goa, India

PubMed Central

CHATTERJEE, SUDIPTO; CHOWDHARY, NEERJA; PEDNEKAR, SULOCHANA; COHEN, ALEX; ANDREW, GRACY; ANDREW, GRACY; ARAYA, RICARDO; SIMON, GREGORY; KING, MICHAEL; TELLES, SHIRLEY; VERDELI, HELENA; CLOUGHERTY, KATHLEEN; KIRKWOOD, BETTY; PATEL, VIKRAM

2008-01-01

Common mental disorders, such as depression and anxiety, pose a major public health burden in developing countries. Although these disorders are thought to be best managed in primary care settings, there is a dearth of evidence about how this can be achieved in low resource settings. The MANAS project is an attempt to integrate an evidence based package of treatments into routine public and private primary care settings in Goa, India. Before initiating the trial, we carried out extensive preparatory work, over a period of 15 months, to examine the feasibility and acceptability of the planned intervention. This paper describes the systematic development and evaluation of the intervention through this preparatory phase. The preparatory stage, which was implemented in three phases, utilized quantitative and qualitative methods to inform our understanding of the potential problems and possible solutions in implementing the trial and led to critical modifications of the original intervention plan. Investing in systematic formative work prior to conducting expensive trials of the effectiveness of complex interventions is a useful exercise which potentially improves the likelihood of a positive result of such trials. PMID:18458786

Common procedures and strategies for anaesthesia in interventional radiology.

PubMed

Landrigan-Ossar, Mary

2015-08-01

This review describes the range of cases now available in the interventional radiology suite and summarizes suggestions for their anaesthetic and perioperative management. The type and complexity of interventional radiology cases being performed increases from year to year. Anaesthesiologists' presence in interventional radiology is increasing in turn, due to increasingly ill patients and intricate procedures requiring more than local anaesthesia for well tolerated completion. The literature available describing this is largely written by radiologists, with little attention paid to anaesthetic considerations. Cases in interventional radiology are complex in terms of the logistics of working in an unfamiliar area, frequency of patient comorbidity and unfamiliar procedures. Ensuring familiarity with the variety of interventional radiology procedures and their periprocedure requirements can increase anaesthesiologists' comfort in interventional radiology.

Using Normalization Process Theory in feasibility studies and process evaluations of complex healthcare interventions: a systematic review.

PubMed

May, Carl R; Cummings, Amanda; Girling, Melissa; Bracher, Mike; Mair, Frances S; May, Christine M; Murray, Elizabeth; Myall, Michelle; Rapley, Tim; Finch, Tracy

2018-06-07

Normalization Process Theory (NPT) identifies, characterises and explains key mechanisms that promote and inhibit the implementation, embedding and integration of new health techniques, technologies and other complex interventions. A large body of literature that employs NPT to inform feasibility studies and process evaluations of complex healthcare interventions has now emerged. The aims of this review were to review this literature; to identify and characterise the uses and limits of NPT in research on the implementation and integration of healthcare interventions; and to explore NPT's contribution to understanding the dynamics of these processes. A qualitative systematic review was conducted. We searched Web of Science, Scopus and Google Scholar for articles with empirical data in peer-reviewed journals that cited either key papers presenting and developing NPT, or the NPT Online Toolkit ( www.normalizationprocess.org ). We included in the review only articles that used NPT as the primary approach to collection, analysis or reporting of data in studies of the implementation of healthcare techniques, technologies or other interventions. A structured data extraction instrument was used, and data were analysed qualitatively. Searches revealed 3322 citations. We show that after eliminating 2337 duplicates and broken or junk URLs, 985 were screened as titles and abstracts. Of these, 101 were excluded because they did not fit the inclusion criteria for the review. This left 884 articles for full-text screening. Of these, 754 did not fit the inclusion criteria for the review. This left 130 papers presenting results from 108 identifiable studies to be included in the review. NPT appears to provide researchers and practitioners with a conceptual vocabulary for rigorous studies of implementation processes. It identifies, characterises and explains empirically identifiable mechanisms that motivate and shape implementation processes. Taken together, these mean that analyses using NPT can effectively assist in the explanation of the success or failure of specific implementation projects. Ten percent of papers included critiques of some aspect of NPT, with those that did mainly focusing on its terminology. However, two studies critiqued NPT emphasis on agency, and one study critiqued NPT for its normative focus. This review demonstrates that researchers found NPT useful and applied it across a wide range of interventions. It has been effectively used to aid intervention development and implementation planning as well as evaluating and understanding implementation processes themselves. In particular, NPT appears to have offered a valuable set of conceptual tools to aid understanding of implementation as a dynamic process.

Development and preliminary evaluation of an ultrasonic motor actuated needle guide for 3T MRI-guided transperineal prostate interventions

NASA Astrophysics Data System (ADS)

Song, Sang-Eun; Tokuda, Junichi; Tuncali, Kemal; Tempany, Clare; Hata, Nobuhiko

2012-02-01

Image guided prostate interventions have been accelerated by Magnetic Resonance Imaging (MRI) and robotic technologies in the past few years. However, transrectal ultrasound (TRUS) guided procedure still remains as vast majority in clinical practice due to engineering and clinical complexity of the MRI-guided robotic interventions. Subsequently, great advantages and increasing availability of MRI have not been utilized at its maximum capacity in clinic. To benefit patients from the advantages of MRI, we developed an MRI-compatible motorized needle guide device "Smart Template" that resembles a conventional prostate template to perform MRI-guided prostate interventions with minimal changes in the clinical procedure. The requirements and specifications of the Smart Template were identified from our latest MRI-guided intervention system that has been clinically used in manual mode for prostate biopsy. Smart Template consists of vertical and horizontal crossbars that are driven by two ultrasonic motors via timing-belt and mitergear transmissions. Navigation software that controls the crossbar position to provide needle insertion positions was also developed. The software can be operated independently or interactively with an open-source navigation software, 3D Slicer, that has been developed for prostate intervention. As preliminary evaluation, MRI distortion and SNR test were conducted. Significant MRI distortion was found close to the threaded brass alloy components of the template. However, the affected volume was limited outside the clinical region of interest. SNR values over routine MRI scan sequences for prostate biopsy indicated insignificant image degradation during the presence of the robotic system and actuation of the ultrasonic motors.

Improving access to high-quality primary care for socioeconomically disadvantaged older people in rural areas: a mixed method study protocol

PubMed Central

Ford, John A; Jones, Andrew P; Wong, Geoff; Clark, Allan B; Porter, Tom; Shakespeare, Tom; Swart, Ann Marie; Steel, Nicholas

2015-01-01

Introduction The UK has an ageing population, especially in rural areas, where deprivation is high among older people. Previous research has identified this group as at high risk of poor access to healthcare. The aim of this study is to generate a theory of how socioeconomically disadvantaged older people from rural areas access primary care, to develop an intervention based on this theory and test it in a feasibility trial. Methods and analysis On the basis of the MRC Framework for Developing and Evaluating Complex Interventions, three methods will be used to generate the theory. First, a realist review will elucidate the patient pathway based on existing literature. Second, an analysis of the English Longitudinal Study of Ageing will be completed using structural equation modelling. Third, 15 semistructured interviews will be undertaken with patients and four focus groups with health professionals. A triangulation protocol will be used to allow each of these methods to inform and be informed by each other, and to integrate data into one overall realist theory. Based on this theory, an intervention will be developed in discussion with stakeholders to ensure that the intervention is feasible and practical. The intervention will be tested within a feasibility trial, the design of which will depend on the intervention. Lessons from the feasibility trial will be used to refine the intervention and gather the information needed for a definitive trial. Ethics and dissemination Ethics approval from the regional ethics committee has been granted for the focus groups with health professionals and interviews with patients. Ethics approval will be sought for the feasibility trial after the intervention has been designed. Findings will be disseminated to the key stakeholders involved in intervention development, to researchers, clinicians and health planners through peer-reviewed journal articles and conference publications, and locally through a dissemination event. PMID:26384728

Total skin self-examination at home for people treated for cutaneous melanoma: development and pilot of a digital intervention.

PubMed

Murchie, Peter; Allan, Julia L; Brant, William; Dennis, Matthew; Hall, Susan; Masthoff, Judith; Walter, Fiona M; Johnston, Marie

2015-08-06

To develop a digital intervention to prompt, support, and respond to the outcomes of total skin self-examinations (TSSEs) at home by people treated for cutaneous melanoma. A complex intervention development study. Northeast Scotland. Semistructured scoping interviews; people previously treated for cutaneous melanoma (n=21). Pilot testing: people treated for melanoma stages 0-2C (n=20); general practitioners (n=6); and a nurse specialist in dermatology (n=1). A tablet-based digital intervention designed to prompt and support TSSEs comprising instructional videos and electronic reporting (including photographs) to a clinical nurse specialist in dermatology, with subsequent clinical triage. Qualitative assessment of intervention feasibility and acceptability, and quantitative assessment of intentions and confidence to perform TSSEs in pilot participants. The majority of pilot participants were strongly positive and adhered well to the intervention (n=15), with 7 of these reporting symptoms of concern at some point during the 6-month pilot. 4 patients complied intermittently, 3 reporting skin problems at least once during the pilot, and 1 withdrew. 2 patients underwent skin surgery as a result of participating in the pilot, with 1 diagnosed as having a recurrent melanoma and the other, a benign lesion. A number of practical issues to improve the usability of the intervention were identified. The proportion of participants reporting intention to check their skin at least monthly increased during the intervention as did confidence to conduct a skin check. People previously treated for cutaneous melanoma are prepared to use digital technology to support them in conducting TSSE. An intervention has been developed which is practical, effective and safe, and after addressing minor practical issues, could now be evaluated for clinical outcomes in a randomised clinical trial. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Addressing complexity in population health intervention research: the context/intervention interface.

PubMed

Minary, Laetitia; Alla, François; Cambon, Linda; Kivits, Joelle; Potvin, Louise

2018-04-01

Public health interventions are increasingly being recognised as complex and context dependent. Related to this is the need for a systemic and dynamic conception of interventions that raises the question of delineating the scope and contours of interventions in complex systems. This means identifying which elements belong to the intervention (and therefore participate in its effects and can be transferred), which ones belong to the context and interact with the former to influence results (and therefore must be taken into account when transferring the intervention) and which contextual elements are irrelevant to the intervention. This paper, from which derives criteria based on a network framework, operationalises how the context and intervention systems interact and identify what needs to be replicated as interventions are implemented in different contexts. Representing interventions as networks (composed of human and non-human entities), we introduce the idea that the density of interconnections among the various entities provides a criterion for distinguishing core intervention from intervention context without disconnecting the two systems. This differentiates endogenous and exogenous intervention contexts and the mediators that connect them, which form the fuzzy and constantly changing intervention/context interface. We propose that a network framework representing intervention/context systems constitutes a promising approach for deriving empirical criteria to delineate the scope and contour of what is replicable in an intervention. This approach should allow better identification and description of the entities that have to be transferred to ensure the potential effectiveness of an intervention in a specific context. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Meeting the challenges of micronutrient malnutrition in the developing world.

PubMed

Bhutta, Zulfiqar A; Salam, Rehana A; Das, Jai K

2013-01-01

Malnutrition still remains one of the major public health challenges, particularly in developing countries. Major risk factors for undernutrition such as suboptimal breastfeeding and micronutrient deficiencies (vitamin A and zinc) are responsible for more than one-third of all under five child deaths and 11% of the global total disease burden. Several strategies have been employed to supplement micronutrients. These include education, dietary modification, food provision, supplementation and fortification either alone or in combination. Supplementation is the most widely practiced intervention while fortification can also be a potentially cost-effective public health intervention and target a larger population through a single strategy. Universal coverage with the full bundle of interventions including micronutrient provision, complementary foods, treatments for worms and diarrheal diseases and behavior change programs package could be the way forward in achieving the Millennium Development Goals (MDGs). Bio-fortification and agricultural interventions including home and school gardening are relatively newer strategies and require further research as they have the potential to impact nutritional status of populations at large. Effectiveness of the various interventions is well recognized; however, consensus needs to be built around approaches to scale up coverage and delivery strategies to reduce disparities and provide equitable access. Future studies should focus on evaluating various approaches to address malnutrition with a standard methodology and defined outcomes. This will help gauge the actual morbidity and mortality impacts of these specific interventions and the long-term viability of these programs. On a broader scale, strategies to address food insecurity and poverty alleviation are the key as these are complex sustainable development issues, linked to health through malnutrition, but also to sustainable economic development, environment and trade.

Constructing a Theory- and Evidence-Based Treatment Rationale for Complex eHealth Interventions: Development of an Online Alcohol Intervention Using an Intervention Mapping Approach.

PubMed

Brendryen, Håvar; Johansen, Ayna; Nesvåg, Sverre; Kok, Gerjo; Duckert, Fanny

2013-01-23

Due to limited reporting of intervention rationale, little is known about what distinguishes a good intervention from a poor one. To support improved design, there is a need for comprehensive reports on novel and complex theory-based interventions. Specifically, the emerging trend of just-in-time tailoring of content in response to change in target behavior or emotional state is promising. The objective of this study was to give a systematic and comprehensive description of the treatment rationale of an online alcohol intervention called Balance. We used the intervention mapping protocol to describe the treatment rationale of Balance. The intervention targets at-risk drinking, and it is delivered by email, mobile phone text messaging, and tailored interactive webpages combining text, pictures, and prerecorded audio. The rationale of the current treatment was derived from a self-regulation perspective, and the overarching idea was to support continued self-regulation throughout the behavior change process. Maintaining the change efforts over time and coping adaptively during critical moments (eg, immediately before and after a lapse) are key factors to successful behavior change. Important elements of the treatment rationale to achieving these elements were: (1) emotion regulation as an inoculation strategy against self-regulation failure, (2) avoiding lapses by adaptive coping, and (3) avoiding relapse by resuming the change efforts after a lapse. Two distinct and complementary delivery strategies were used, including a day-to-day tunnel approach in combination with just-in-time therapy. The tunnel strategy was in accordance with the need for continuous self-regulation and it functions as a platform from which just-in-time therapy was launched. Just-in-time therapy was used to support coping during critical moments, and started when the client reports either low self-efficacy or that they were drinking above target levels. The descriptions of the treatment rationale for Balance, the alcohol intervention reported herein, provides an intervention blueprint that will aid in interpreting the results from future program evaluations. It will ease comparisons of program rationales across interventions, and may assist intervention development. By putting just-in-time therapy within a complete theoretical and practical context, including the tunnel delivery strategy and the self-regulation perspective, we have contributed to an understanding of how multiple delivery strategies in eHealth interventions can be combined. Additionally, this is a call for action to improve the reporting practices within eHealth research. Possible ways to achieve such improvement include using a systematic and structured approach, and for intervention reports to be published after peer-review and separately from evaluation reports.

Constructing a Theory- and Evidence-Based Treatment Rationale for Complex eHealth Interventions: Development of an Online Alcohol Intervention Using an Intervention Mapping Approach

PubMed Central

Johansen, Ayna; Nesvåg, Sverre; Kok, Gerjo; Duckert, Fanny

2013-01-01

Background Due to limited reporting of intervention rationale, little is known about what distinguishes a good intervention from a poor one. To support improved design, there is a need for comprehensive reports on novel and complex theory-based interventions. Specifically, the emerging trend of just-in-time tailoring of content in response to change in target behavior or emotional state is promising. Objective The objective of this study was to give a systematic and comprehensive description of the treatment rationale of an online alcohol intervention called Balance. Methods We used the intervention mapping protocol to describe the treatment rationale of Balance. The intervention targets at-risk drinking, and it is delivered by email, mobile phone text messaging, and tailored interactive webpages combining text, pictures, and prerecorded audio. Results The rationale of the current treatment was derived from a self-regulation perspective, and the overarching idea was to support continued self-regulation throughout the behavior change process. Maintaining the change efforts over time and coping adaptively during critical moments (eg, immediately before and after a lapse) are key factors to successful behavior change. Important elements of the treatment rationale to achieving these elements were: (1) emotion regulation as an inoculation strategy against self-regulation failure, (2) avoiding lapses by adaptive coping, and (3) avoiding relapse by resuming the change efforts after a lapse. Two distinct and complementary delivery strategies were used, including a day-to-day tunnel approach in combination with just-in-time therapy. The tunnel strategy was in accordance with the need for continuous self-regulation and it functions as a platform from which just-in-time therapy was launched. Just-in-time therapy was used to support coping during critical moments, and started when the client reports either low self-efficacy or that they were drinking above target levels. Conclusions The descriptions of the treatment rationale for Balance, the alcohol intervention reported herein, provides an intervention blueprint that will aid in interpreting the results from future program evaluations. It will ease comparisons of program rationales across interventions, and may assist intervention development. By putting just-in-time therapy within a complete theoretical and practical context, including the tunnel delivery strategy and the self-regulation perspective, we have contributed to an understanding of how multiple delivery strategies in eHealth interventions can be combined. Additionally, this is a call for action to improve the reporting practices within eHealth research. Possible ways to achieve such improvement include using a systematic and structured approach, and for intervention reports to be published after peer-review and separately from evaluation reports. PMID:23612478

Lay health workers perceptions of an anemia control intervention in Karnataka, India: a qualitative study.

PubMed

Shet, Arun S; Rao, Abha; Jebaraj, Paul; Mascarenhas, Maya; Zwarenstein, Merrick; Galanti, Maria Rosaria; Atkins, Salla

2017-09-18

Lay health workers (LHWs) are increasingly used to complement health services internationally. Their perceptions of the interventions they implement and their experiences in delivering community based interventions in India have been infrequently studied. We developed a novel LHW led intervention to improve anemia cure rates in rural community dwelling children attending village day care centers in South India. Since the intervention is delivered by the village day care center LHW, we sought to understand participating LHWs' acceptance of and perspectives regarding the intervention, particularly in relation to factors affecting daily implementation. We conducted a qualitative study alongside a cluster randomized controlled trial evaluating a complex community intervention for childhood anemia control in Karnataka, South India. Focus group discussions (FGDs) were conducted with trained LHWs assigned to deliver the educational intervention. These were complemented by non-participant observations of LHWs delivering the intervention. Transcripts of the FGDs were translated and analyzed using the framework analysis method. Several factors made the intervention acceptable to the LHWs and facilitated its implementation including pre-implementation training modules, intervention simplicity, and ability to incorporate the intervention into the routine work schedule. LHWs felt that the intervention impacted negatively on their preexisting workload. Fluctuating relationships with mothers weakened the LHWs position as providers of the intervention and hampered efficient implementation, despite the LHWs' highly valued position in the community. Modifiable barriers to the successful implementation of this intervention were seen at two levels. At a broader contextual level, hindering factors included the LHW being overburdened, inadequately reimbursed, and receiving insufficient employer support. At the health system level, lack of streamlining of LHW duties, inability of LHWs to diagnose anemia and temporary shortfalls in the availability of iron supplements constituted potentially modifiable barriers. This qualitative study identified some of the practical challenges as experienced by LHWs while delivering a community health intervention in India. Methodologically, it highlights the value of qualitative research in understanding implementation of complex community interventions. On the contextual level, the results indicate that efficient delivery of community interventions will require streamlining of LHW workloads and improved health system infrastructure support. This trial was registered with ISRCTN.com (identifier: ISRCTN68413407 ) on 23 September 2013.

Methodological idiosyncracies, frameworks and challenges of non-pharmaceutical and non-technical treatment interventions.

PubMed

Schünemann, Holger J

2013-01-01

In this brief article which summarises a presentation given at the "6. Diskussionsforum zur Nutzenbewertung im Gesundheitswesen" of the German Ministry of Education and Research "Gesundheitsforschungsrat (GFR)" and the Institute for Quality and Efficiency in Healthcare (IQWiG) I will analyse some methodological idiosyncrasies of studies evaluating non-pharmacological non-technical interventions (NPNTI). I will focus on how the methodological framework of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group may support design and appraisal of NPNTI. Specific design features that may be of particular value in NPNTI research, such as expertise-based randomised controlled trials, will be briefly described. Finally, based on an example, I will argue that - despite the methodological idiosyncrasies - there is neither a sufficient reason to accept different standards for the assessment of the confidence in the evidence from NPNTI nor for using study designs that are less rigorous compared to "simpler" interventions but that special measures have to be taken to reduce the risk of bias. The example that will be used in this article will primarily come from the field of respiratory rehabilitation, a typical multi-component or complex intervention and by definition a complex NPNTI, which has been evaluated in many randomised controlled trials. (As supplied by publisher). Copyright © 2013. Published by Elsevier GmbH.

Modeling the Complexities of Water, Hygiene, and Health in Limpopo Province, South Africa

PubMed Central

Mellor, Jonathan E.; Smith, James A.; Learmonth, Gerard P.; Netshandama, Vhonani O.; Dillingham, Rebecca A.

2013-01-01

Researchers have long studied the causes and prevention strategies of poor household water quality and early childhood diarrhea using intervention-control trials. Although the results of such trails can lead to useful information, they do not capture the complexity of this natural/engineered/social system. We report on the development of an agent-based model (ABM) to study such a system in Limpopo, South Africa. The study is based on four years of field data collection to accurately capture essential elements of the communities and their water contamination chain. An extensive analysis of those elements explored behaviors including water collection and treatment frequency as well as biofilm buildup in water storage containers, source water quality, and water container types. Results indicate that interventions must be optimally implemented in order to see significant reductions in early childhood diarrhea (ECD). Household boiling frequency, source water quality, water container type and the biofilm layer contribution were deemed to have significant impacts on ECD. Furthermore, concurrently implemented highly effective interventions were shown to reduce diarrhea rates to very low levels even when other, less important practices were sub-optimal. This technique can be used by a variety of stakeholders when designing interventions to reduce ECD incidences in similar settings. PMID:23186073

Modeling the complexities of water, hygiene, and health in Limpopo Province, South Africa.

PubMed

Mellor, Jonathan E; Smith, James A; Learmonth, Gerard P; Netshandama, Vhonani O; Dillingham, Rebecca A

2012-12-18

Researchers have long studied the causes and prevention strategies of poor household water quality and early childhood diarrhea using intervention-control trials. Although the results of such trails can lead to useful information, they do not capture the complexity of this natural/engineered/social system. We report on the development of an agent-based model (ABM) to study such a system in Limpopo, South Africa. The study is based on four years of field data collection to accurately capture essential elements of the communities and their water contamination chain. An extensive analysis of those elements explored behaviors including water collection and treatment frequency as well as biofilm buildup in water storage containers, source water quality, and water container types. Results indicate that interventions must be optimally implemented in order to see significant reductions in early childhood diarrhea (ECD). Household boiling frequency, source water quality, water container type, and the biofilm layer contribution were deemed to have significant impacts on ECD. Furthermore, concurrently implemented highly effective interventions were shown to reduce diarrhea rates to very low levels even when other, less important practices were suboptimal. This technique can be used by a variety of stakeholders when designing interventions to reduce ECD incidences in similar settings.

Health system strengthening: a qualitative evaluation of implementation experience and lessons learned across five African countries.

PubMed

Rwabukwisi, Felix Cyamatare; Bawah, Ayaga A; Gimbel, Sarah; Phillips, James F; Mutale, Wilbroad; Drobac, Peter

2017-12-21

Achieving the United Nations Sustainable Development Goals in sub-Saharan Africa will require substantial improvements in the coverage and performance of primary health care delivery systems. Projects supported by the Doris Duke Charitable Foundation's (DDCF) African Health Initiative (AHI) created public-private-academic and community partnerships in five African countries to implement and evaluate district-level health system strengthening interventions. In this study, we captured common implementation experiences and lessons learned to understand core elements of successful health systems interventions. We used qualitative data from key informant interviews and annual progress reports from the five Population Health Implementation and Training (PHIT) partnership projects funded through AHI in Ghana, Mozambique, Rwanda, Tanzania, and Zambia. Four major overarching lessons were highlighted. First, variety and inclusiveness of concerned key players (public, academic and private) are necessary to address complex health system issues at all levels. Second, a learning culture that promotes evidence creation and ability to efficiently adapt were key in order to meet changing contextual needs. Third, inclusion of strong implementation science tools and strategies allowed informed and measured learning processes and efficient dissemination of best practices. Fourth, five to seven years was the minimum time frame necessary to effectively implement complex health system strengthening interventions and generate the evidence base needed to advocate for sustainable change for the PHIT partnership projects. The AHI experience has raised remaining, if not overlooked, challenges and potential solutions to address complex health systems strengthening intervention designs and implementation issues, while aiming to measurably accomplish sustainable positive change in dynamic, learning, and varied contexts.

The Obstetric Hemorrhage Initiative (OHI) in Florida: The Role of Intervention Characteristics in Influencing Implementation Experiences among Multidisciplinary Hospital Staff.

PubMed

Vamos, Cheryl A; Cantor, Allison; Thompson, Erika L; Detman, Linda A; Bronson, Emily A; Phelps, Annette; Louis, Judette M; Gregg, Anthony R; Curran, John S; Sappenfield, William M

2016-10-01

Objectives Obstetric hemorrhage is one of the leading causes of maternal mortality. The Florida Perinatal Quality Collaborative coordinates a state-wide Obstetric Hemorrhage Initiative (OHI) to assist hospitals in implementing best practices related to this preventable condition. This study examined intervention characteristics that influenced the OHI implementation experiences among Florida hospitals. Methods Purposive sampling was employed to recruit diverse hospitals and multidisciplinary staff members. A semi-structured interview guide was developed based on the following constructs from the intervention characteristics domain of the Consolidated Framework for Implementation Research: evidence strength; complexity; adaptability; and packaging. Interviews were audio-recorded, transcribed and analyzed using Atlas.ti. Results Participants (n = 50) across 12 hospitals agreed that OHI is evidence-based and supported by various information sources (scientific literature, experience, and other epidemiologic or quality improvement data). Participants believed the OHI was 'average' in complexity, with variation depending on participant's role and intervention component. Participants discussed how the OHI is flexible and can be easily adapted and integrated into different hospital settings, policies and resources. The packaging was also found to be valuable in providing materials and supports (e.g., toolkit; webinars; forms; technical assistance) that assisted implementation across activities. Conclusions for Practice Participants reflected positively with regards to the evidence strength, adaptability, and packaging of the OHI. However, the complexity of the initiative adversely affected implementation experiences and required additional efforts to maximize the initiative effectiveness. Findings will inform future efforts to facilitate implementation experiences of evidence-based practices for hemorrhage prevention, ultimately decreasing maternal morbidity and mortality.

Effecting change in primary care management of respiratory conditions: a global scoping exercise and literature review of educational interventions to inform the IPCRG's E-Quality initiative.

PubMed

McDonnell, Juliet; Williams, Siân; Chavannes, Niels H; Correia de Sousa, Jaime; Fardy, H John; Fletcher, Monica; Stout, James; Tomlins, Ron; Yusuf, Osman M; Pinnock, Hilary

2012-12-01

This discussion paper describes a scoping exercise and literature review commissioned by the International Primary Care Respiratory Group (IPCRG) to inform their E-Quality programme which seeks to support small-scale educational projects to improve respiratory management in primary care. Our narrative review synthesises information from three sources: publications concerning the global context and health systems development; a literature search of Medline, CINAHL and Cochrane databases; and a series of eight interviews conducted with members of the IPCRG faculty. Educational interventions sit within complex healthcare, economic, and policy contexts. It is essential that any development project considers the local circumstances in terms of economic resources, political circumstances, organisation and administrative capacities, as well as the specific quality issue to be addressed. There is limited evidence (in terms of changed clinician behaviour and/or improved health outcomes) regarding the merits of different educational and quality improvement approaches. Features of educational interventions that were most likely to show some evidence of effectiveness included being carefully designed, multifaceted, engaged health professionals in their learning, provided ongoing support, were sensitive to local circumstances, and delivered in combination with other quality improvement strategies. To be effective, educational interventions must consider the complex healthcare systems within which they operate. The criteria for the IPCRG E-Quality awards thus require applicants not only to describe their proposed educational initiative but also to consider the practical and local barriers to successful implementation, and to propose a robust evaluation in terms of changed clinician behaviour or improved health outcomes.

Student for Student: Peer Learning in Music Higher Education

ERIC Educational Resources Information Center

Reid, Anna; Duke, Michael

2015-01-01

Students of piano and saxophone were asked to explore what peer learning meant to them. Following instrumental-based discussions, and with no intervention from faculty, the students developed a series of videos intended for use with incoming students. This article analyses the students' discussions and videos, and describes the complexity of…

The Emerging Field of Executive and Organizational Coaching: An Overview

ERIC Educational Resources Information Center

Ciporen, Rachel

2015-01-01

In recent years coaching has become an increasingly popular intervention used in both personal and professional development spheres. This chapter draws on industry research from scholars as well as professional organizations to map the history, definitions, and trends of executive and organizational coaching to provide clarity on a complex and…

Agroforestry adoption in the Calakmul biosphere reserve, Campeche, Mexico

Treesearch

D. Evan Mercer; Jeremy Haggar; Ann Snook; Mauricio Sosa

2005-01-01

Since farmers engage in a complex, dynamic process of learning-by-doing, evaluating economic incentives, and assessing risks in deciding whether to adopt agroforestry systems, a multi-pronged research approach is required for a complete analysis of adoption potential and to develop effective technological and institutional interventions. A case study is presented for...

The Effects of Supplemental Sentence-Level Instruction for Fourth-Grade Students Identified as Struggling Writers

ERIC Educational Resources Information Center

Furey, William M.; Marcotte, Amanda M.; Wells, Craig S.; Hintze, John M.

2017-01-01

The Language and Writing strands of the Common Core State Standards place a heavy emphasis on sentence-level conventions including syntax/grammar and mechanics. Interventions targeting these foundational skills are necessary to support struggling writers, as poorly developed sentence construction skills inhibit more complex writing tasks. This…

A Technology-Enhanced Intervention for Self-Regulated Learning in Science

ERIC Educational Resources Information Center

Berglas-Shapiro, Tali; Eylon, Bat-Sheva; Scherz, Zahava

2017-01-01

This article describes the development of a technology-enhanced self-regulated learning (Te- SRL) environment designed to foster students' SRL of complex science topics. The environment consists of three components, one of which is a specially designed computerized system that offers students a choice between different types of scaffolding and…

Assessment of a web-based Guided Self-Determination intervention for adults with type 2 diabetes in general practice: a study protocol

PubMed Central

Karlsen, Bjørg; Oftedal, Bjørg; Stangeland Lie, Silje; Rokne, Berit; Peyrot, Mark; Zoffmann, Vibeke; Graue, Marit

2016-01-01

Introduction Self-management is deemed the cornerstone in overall diabetes management. Web-based self-management interventions have potential to support adults with type 2 diabetes (T2DM) in managing their disease. Owing to somewhat ambiguous results of such interventions, interventions should be theory-based and incorporate well-defined counselling methods and techniques for behavioural change. This study is designed to assess the effectiveness of a theory-driven web-based Guided Self-Determination (GSD) intervention among adults with T2DM in general practice to improve diabetes self-management behaviours and glycosylated haemoglobin (HbA1c). Methods and analysis A complex intervention design based on the framework of the UK Medical Research Council is employed as a guide for developing the intervention, assessing its feasibility and evaluating its effectiveness. The study consists of three phases: (1) the modelling phase adapting the original GSD programme for adults with T2DM, using a qualitative design, (2) feasibility assessment of the adapted intervention on the web, employing qualitative and quantitative methods and (3) evaluating the effectiveness of the intervention on diabetes self-management behaviours and HbA1c, using a quasi-experimental design. The first phase, which is completed, and the second phase, which is underway, will provide important information about the development of the intervention and its acceptability, whereas the third phase will assess the effectiveness of this systematically developed intervention. Ethics and dissemination The Norwegian Regional Committee for Medical and Health Research Ethics (REK west number 2015/60) has approved the study design. Patients recruited in the different phases will fill out an informed consent form prior to inclusion and will be guaranteed anonymity and the right to withdraw from the study at any time. The results of the study will be published in peer-reviewed journals, electronically and in print, and presented at research conferences. Trial registration number: NCT02575599. PMID:27965253

Developing preventive mental health interventions for refugee families in resettlement.

PubMed

Weine, Stevan Merrill

2011-09-01

In refugee resettlement, positive psychosocial outcomes for youth and adults depend to a great extent on their families. Yet refugee families find few empirically based services geared toward them. Preventive mental health interventions that aim to stop, lessen, or delay possible negative individual mental health and behavioral sequelae through improving family and community protective resources in resettled refugee families are needed. This paper describes 8 characteristics that preventive mental health interventions should address to meet the needs of refugee families, including: Feasibility, Acceptability, Culturally Tailored, Multilevel, Time Focused, Prosaicness, Effectiveness, and Adaptability. To address these 8 characteristics in the complex environment of refugee resettlement requires modifying the process of developmental research through incorporating innovative mental health services research strategies, including: resilience framework, community collaboration, mixed methods with focused ethnography, and the comprehensive dynamic trial. A preventive intervention development cycle for refugee families is proposed based on a program of research on refugees and migrants using these services research strategies. Furthering preventive mental health for refugee families also requires new policy directives, multisystemic partnerships, and research training. 2011 © FPI, Inc.

Developing Preventive Mental Health Interventions for Refugee Families in Resettlement

PubMed Central

WEINE, STEVAN MERRILL

2014-01-01

In refugee resettlement, positive psychosocial outcomes for youth and adults depend to a great extent on their families. Yet refugee families find few empirically based services geared toward them. Preventive mental health interventions that aim to stop, lessen, or delay possible negative individual mental health and behavioral sequelae through improving family and community protective resources in resettled refugee families are needed. This paper describes 8 characteristics that preventive mental health interventions should address to meet the needs of refugee families, including: Feasibility, Acceptability, Culturally Tailored, Multilevel, Time Focused, Prosaicness, Effectiveness, and Adaptability. To address these 8 characteristics in the complex environment of refugee resettlement requires modifying the process of developmental research through incorporating innovative mental health services research strategies, including: resilience framework, community collaboration, mixed methods with focused ethnography, and the comprehensive dynamic trial. A preventive intervention development cycle for refugee families is proposed based on a program of research on refugees and migrants using these services research strategies. Furthering preventive mental health for refugee families also requires new policy directives, multisystemic partnerships, and research training. PMID:21884078

A Model for Usability Evaluation for the Development and Implementation of Consumer eHealth Interventions.

PubMed

Parry, David; Carter, Philip; Koziol-McLain, Jane; Feather, Jacqueline

2015-01-01

Consumer eHealth products are often used by people in their own homes or other settings without dedicated clinical supervision, and often with minimal training and limited support--much as eCommerce and eGovernment applications are currently deployed. Internet based self-care systems have been advocated for over a decade as a way to reduce costs and allow more convenient care, and--because of the expectation that they will be used to reduced health cost--, by increasing self-care and avoiding hospitalization. However, the history of consumer eHealth interventions is mixed, with many unsuccessful implementations. Many consumer eHealth products will form part of a broader complex intervention, with many possible benefits and effects on both individuals and society. This poster describes a model of consumer eHealth assessment based on multiple methods of usability evaluation at different stages in the design and fielding of eHealth systems. We argue that different methods of usability evaluation are able to give valuable insights into the likely effects of an intervention in a way that is congruent with software development processes.

Physical activity interventions and children's mental function: An introduction and overview

PubMed Central

Tomporowski, Phillip D.; Lambourne, Kate; Okumura, Michelle S.

2011-01-01

Background This review provides a historical overview of physical activity interventions designed by American educators and an evaluation of research that has assessed the effects of exercise on children's mental function. Method Historical descriptions of the emergence of American physical education doctrine throughout the 20th century were evaluated. Prior reviews of studies that assessed the effects of single acute bouts of exercise and the effects of chronic exercise training on children's mental function were examined and the results of recent studies were summarized. Results Physical activity interventions designed for American children have reflected two competing views: activities should promote physical fitness and activities should promote social, emotional, and intellectual development. Research results indicate that exercise fosters the emergence of children's mental function; particularly executive functioning. The route by which physical activity impacts mental functioning is complex and is likely moderated by several variables, including physical fitness level, health status, and numerous psycho-social factors. Conclusion Physical activity interventions for children should be designed to meet multiple objectives; e.g., optimize physical fitness, promote health-related behaviors that offset obesity, and facilitate mental development. PMID:21420981

Intervention fidelity for a complex behaviour change intervention in community pharmacy addressing cardiovascular disease risk.

PubMed

McNamara, K P; O'Reilly, S L; George, J; Peterson, G M; Jackson, S L; Duncan, G; Howarth, H; Dunbar, J A

2015-12-01

Delivery of cardiovascular disease (CVD) prevention programs by community pharmacists appears effective and enhances health service access. However, their capacity to implement complex behavioural change processes during patient counselling remains largely unexplored. This study aims to determine intervention fidelity by pharmacists for behavioural components of a complex educational intervention for CVD prevention. After receiving training to improve lifestyle and medicines adherence, pharmacists recruited 70 patients aged 50-74 years without established CVD, and taking antihypertensive or lipid lowering therapy. Patients received five counselling sessions, each at monthly intervals. Researchers assessed biomedical and behavioural risk factors at baseline and six months. Pharmacists documented key outcomes from counselling after each session. Most patients (86%) reported suboptimal cardiovascular diets, 41% reported suboptimal medicines adherence, and 39% were physically inactive. Of those advised to complete the intervention, 85% attended all five sessions. Pharmacists achieved patient agreement with most recommended goals for behaviour change, and overwhelmingly translated goals into practical behavioural strategies. Barriers to changing behaviours were regularly documented, and pharmacists reported most behavioural strategies as having had some success. Meaningful improvements to health behaviours were observed post-intervention. Findings support further exploration of pharmacists' potential roles for delivering interventions with complex behaviour change requirements. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Skp1: Implications in cancer and SCF-oriented anti-cancer drug discovery.

PubMed

Hussain, Muzammal; Lu, Yongzhi; Liu, Yong-Qiang; Su, Kai; Zhang, Jiancun; Liu, Jinsong; Zhou, Guang-Biao

2016-09-01

In the last decade, the ubiquitin proteasome system (UPS), in general, and E3 ubiquitin ligases, in particular, have emerged as valid drug targets for the development of novel anti-cancer therapeutics. Cullin RING Ligases (CRLs), which can be classified into eight groups (CRL1-8) and comprise approximately 200 members, represent the largest family of E3 ubiquitin ligases which facilitate the ubiquitination-derived proteasomal degradation of a myriad of functionally and structurally diverse substrates. S phase kinase-associated protein 1 (Skp1)-Cullin1-F-Box protein (SCF) complexes are the best characterized among CRLs, which play crucial roles in numerous cellular processes and physiological dysfunctions, such as in cancer biology. Currently, there is growing interest in developing SCF-targeting anti-cancer therapies for clinical application. Indeed, the research in this field has seen some progress in the form of cullin neddylation- and Skp2-inhibitors. However, it still remains an underdeveloped area and needs to design new strategies for developing improved form of therapy. In this review, we venture a novel strategy that rational pharmacological targeting of Skp1, a central regulator of SCF complexes, may provide a novel avenue for SCF-oriented anti-cancer therapy, expected: (i) to simultaneously address the critical roles that multiple SCF oncogenic complexes play in cancer biology, (ii) to selectively target cancer cells with minimal normal cell toxicity, and (iii) to offer multiple chemical series, via therapeutic interventions at the Skp1 binding interfaces in SCF complex, thereby maximizing chances of success for drug discovery. In addition, we also discuss the challenges that might be posed regarding rational pharmacological interventions against Skp1. Copyright © 2016 Elsevier Ltd. All rights reserved.

Development of Intervention Materials for Individuals With Limited English Proficiency

PubMed Central

Tu, Shin-Ping; Yip, Mei-Po; Chun, Alan; Choe, John; Bastani, Roshan; Taylor, Vicky

2013-01-01

Background According to recent US census data, 52 million people reported speaking a language other than English at home, and almost 45% of this population reported limited English proficiency (LEP). Colorectal cancer (CRC) ranks among the top 3 most common cancers for several Asian ethnic groups, yet screening remains underutilized by Asian Americans. Objectives This article describes the development of culturally and linguistically appropriate intervention materials for individuals with LEP. We discuss lessons learned from this research and implications for the translation of research into practice. Methods The Health Behavior Framework served as the conceptual model for this study, and qualitative findings guided the development of our intervention materials (a video and pamphlet). To recommend Western preventive behaviors, the research team bridged the gap between Western and Chinese values and beliefs by devoting particular attention to: (1) the target population's sociocul-tural values and health beliefs; and (2) unique linguistic features of the Chinese language. Results Key lessons learned from this study include the importance of: (1) a conceptual framework to guide intervention development; (2) incorporating sociocultural values and health beliefs into the intervention; (3) addressing and capitalizing on complex linguistics issues; (4) using qualitative methodology in cross-cultural research; and (5) contributions from a multicultural and multilingual research team. Other lessons relate to the translation of research findings into practice. We surmise that lessons learned from this study may be pertinent to the promotion of CRC screening among other patient groups with LEP and applicable to additional cancer screening tests. PMID:18725834

Supervision, support and mentoring interventions for health practitioners in rural and remote contexts: an integrative review and thematic synthesis of the literature to identify mechanisms for successful outcomes.

PubMed

Moran, Anna M; Coyle, Julia; Pope, Rod; Boxall, Dianne; Nancarrow, Susan A; Young, Jennifer

2014-02-13

To identify mechanisms for the successful implementation of support strategies for health-care practitioners in rural and remote contexts. This is an integrative review and thematic synthesis of the empirical literature that examines support interventions for health-care practitioners in rural and remote contexts. This review includes 43 papers that evaluated support strategies for the rural and remote health workforce. Interventions were predominantly training and education programmes with limited evaluations of supervision and mentoring interventions. The mechanisms associated with successful outcomes included: access to appropriate and adequate training, skills and knowledge for the support intervention; accessible and adequate resources; active involvement of stakeholders in programme design, implementation and evaluation; a needs analysis prior to the intervention; external support, organisation, facilitation and/or coordination of the programme; marketing of the programme; organisational commitment; appropriate mode of delivery; leadership; and regular feedback and evaluation of the programme. Through a synthesis of the literature, this research has identified a number of mechanisms that are associated with successful support interventions for health-care practitioners in rural and remote contexts. This research utilised a methodology developed for studying complex interventions in response to the perceived limitations of traditional systematic reviews. This synthesis of the evidence will provide decision-makers at all levels with a collection of mechanisms that can assist the development and implementation of support strategies for staff in rural and remote contexts.

Supervision, support and mentoring interventions for health practitioners in rural and remote contexts: an integrative review and thematic synthesis of the literature to identify mechanisms for successful outcomes

PubMed Central

2014-01-01

Objective To identify mechanisms for the successful implementation of support strategies for health-care practitioners in rural and remote contexts. Design This is an integrative review and thematic synthesis of the empirical literature that examines support interventions for health-care practitioners in rural and remote contexts. Results This review includes 43 papers that evaluated support strategies for the rural and remote health workforce. Interventions were predominantly training and education programmes with limited evaluations of supervision and mentoring interventions. The mechanisms associated with successful outcomes included: access to appropriate and adequate training, skills and knowledge for the support intervention; accessible and adequate resources; active involvement of stakeholders in programme design, implementation and evaluation; a needs analysis prior to the intervention; external support, organisation, facilitation and/or coordination of the programme; marketing of the programme; organisational commitment; appropriate mode of delivery; leadership; and regular feedback and evaluation of the programme. Conclusion Through a synthesis of the literature, this research has identified a number of mechanisms that are associated with successful support interventions for health-care practitioners in rural and remote contexts. This research utilised a methodology developed for studying complex interventions in response to the perceived limitations of traditional systematic reviews. This synthesis of the evidence will provide decision-makers at all levels with a collection of mechanisms that can assist the development and implementation of support strategies for staff in rural and remote contexts. PMID:24521004

KEEPING A STEP AHEAD - FORMATIVE PHASE OF A WORKPLACE INTERVENTION TRIAL TO PREVENT OBESITY

PubMed Central

Zapka, Jane; Lemon, Stephenie C.; Estabrook, Barbara B.; Jolicoeur, Denise G.

2008-01-01

Background Ecological interventions hold promise for promoting overweight and obesity prevention in worksites. Given the paucity of evaluative research in the hospital worksite setting, considerable formative work is required for successful implementation and evaluation. Purpose This paper describes the formative phases of Step Ahead, a site-randomized controlled trial of a multi-level intervention that promotes physical activity and healthy eating in 6 hospitals in central Massachusetts. The purpose of the formative research phase was to increase the feasibility, effectiveness and likelihood of sustainability of the intervention. Design and Procedures The Step Ahead ecological intervention approach targets change at the organization, the interpersonal work environment and the individual levels. The intervention was developed using fundamental steps of intervention mapping and important tenets of participatory research. Formative research methods were used to engage leadership support and assistance and to develop an intervention plan that is both theoretically and practically grounded. This report uses observational data, program minutes and reports, and process tracking data. Developmental Strategies and Observations Leadership involvement (key informant interviews and advisory boards), employee focus groups and advisory boards, and quantitative environmental assessments cultivated participation and support. Determining multiple foci of change and designing measurable objectives and generic assessment tools to document progress are complex challenges encountered in planning phases. Lessons Learned Multi-level trials in diverse organizations require flexibility and balance of theory application and practice-based perspectives to affect impact and outcome objectives. Formative research is an essential component. PMID:18073339

Multilevel and Community-Level Interventions with Native Americans: Challenges and Opportunities.

PubMed

Blue Bird Jernigan, Valarie; D'Amico, Elizabeth J; Duran, Bonnie; Buchwald, Dedra

2018-06-02

Multilevel and community-level interventions that target the social determinants of health and ultimately health disparities are seldom conducted in Native American communities. To contextualize the importance of multilevel and community-level interventions, major contributors to and causes of health disparities in Native communities are highlighted. Among the many documented socioeconomic factors influencing health are poverty, low educational attainment, and lack of insurance. Well-recognized health disparities include obesity, diabetes, and hypertension. Selected challenges of implementing community-level and multilevel interventions in Native communities are summarized such as the shortage of high-quality population health data and validated measurement tools. To address the lack of multilevel and community-level interventions, the National Institutes of Health created the Intervention Research to Improve Native American Health (IRINAH) program which solicits proposals that develop, adapt, and test strategies to address these challenges and create interventions appropriate for Native populations. A discussion of the strategies that four of the IRINAH grantees are implementing underscores the importance of community-based participatory policy work, the development of new partnerships, and reconnection with cultural traditions. Based on the work of the nearly 20 IRINAH grantees, ameliorating the complex social determinants of health disparities among Native people will require (1) support for community-level and multilevel interventions that examine contemporary and historical factors that shape current conditions; (2) sustainability plans; (3) forefronting the most challenging issues; (4) financial resources and time to collaborate with tribal leaders; and (5) a solid evidence base.

The development and optimisation of a primary care-based whole system complex intervention (CARE Plus) for patients with multimorbidity living in areas of high socioeconomic deprivation

PubMed Central

O'Brien, Rosaleen; Fitzpatrick, Bridie; Higgins, Maria; Guthrie, Bruce; Watt, Graham; Wyke, Sally

2016-01-01

Objectives To develop and optimise a primary care-based complex intervention (CARE Plus) to enhance the quality of life of patients with multimorbidity in the deprived areas. Methods Six co-design discussion groups involving 32 participants were held separately with multimorbid patients from the deprived areas, voluntary organisations, general practitioners and practice nurses working in the deprived areas. This was followed by piloting in two practices and further optimisation based on interviews with 11 general practitioners, 2 practice nurses and 6 participating multimorbid patients. Results Participants endorsed the need for longer consultations, relational continuity and a holistic approach. All felt that training and support of the health care staff was important. Most participants welcomed the idea of additional self-management support, though some practitioners were dubious about whether patients would use it. The pilot study led to changes including a revised care plan, the inclusion of mindfulness-based stress reduction techniques in the support of practitioners and patients, and the stream-lining of the written self-management support material for patients. Discussion We have co-designed and optimised an augmented primary care intervention involving a whole-system approach to enhance quality of life in multimorbid patients living in the deprived areas. CARE Plus will next be tested in a phase 2 cluster randomised controlled trial. PMID:27068113

Development of the Andalusian Registry of Patients Receiving Community Case Management, for the follow-up of people with complex chronic diseases.

PubMed

Morales-Asencio, Jose M; Kaknani-Uttumchandani, Shakira; Cuevas-Fernández-Gallego, Magdalena; Palacios-Gómez, Leopoldo; Gutiérrez-Sequera, José L; Silvano-Arranz, Agustina; Batres-Sicilia, Juan Pedro; Delgado-Romero, Ascensión; Cejudo-Lopez, Ángela; Trabado-Herrera, Manuel; García-Lara, Esteban L; Martin-Santos, Francisco J; Morilla-Herrera, Juan C

2015-10-01

Complex chronic diseases are a challenge for the current configuration of health services. Case management is a service frequently provided for people with chronic conditions, and despite its effectiveness in many outcomes, such as mortality or readmissions, uncertainty remains about the most effective form of team organization, structures and the nature of the interventions. Many processes and outcomes of case management for people with complex chronic conditions cannot be addressed with the information provided by electronic clinical records. Registries are frequently used to deal with this weakness. The aim of this study was to generate a registry-based information system of patients receiving case management to identify their clinical characteristics, their context of care, events identified during their follow-up, interventions developed by case managers and services used. The study was divided into three phases, covering the detection of information needs, the design and its implementation in the health care system, using literature review and expert consensus methods to select variables that would be included in the registry. A total of 102 variables representing structure, processes and outcomes of case management were selected for their inclusion in the registry after the consensus phase. A web-based registry with modular and layered architecture was designed. The framework follows a pattern based on the model-view-controller approach. In its first 6 months after the implementation, 102 case managers have introduced an average number of 6.49 patients each one. The registry permits a complete and in-depth analysis of the characteristics of the patients who receive case management, the interventions delivered and some major outcomes as mortality, readmissions or adverse events. © 2015 John Wiley & Sons, Ltd.

A robust interrupted time series model for analyzing complex health care intervention data.

PubMed

Cruz, Maricela; Bender, Miriam; Ombao, Hernando

2017-12-20

Current health policy calls for greater use of evidence-based care delivery services to improve patient quality and safety outcomes. Care delivery is complex, with interacting and interdependent components that challenge traditional statistical analytic techniques, in particular, when modeling a time series of outcomes data that might be "interrupted" by a change in a particular method of health care delivery. Interrupted time series (ITS) is a robust quasi-experimental design with the ability to infer the effectiveness of an intervention that accounts for data dependency. Current standardized methods for analyzing ITS data do not model changes in variation and correlation following the intervention. This is a key limitation since it is plausible for data variability and dependency to change because of the intervention. Moreover, present methodology either assumes a prespecified interruption time point with an instantaneous effect or removes data for which the effect of intervention is not fully realized. In this paper, we describe and develop a novel robust interrupted time series (robust-ITS) model that overcomes these omissions and limitations. The robust-ITS model formally performs inference on (1) identifying the change point; (2) differences in preintervention and postintervention correlation; (3) differences in the outcome variance preintervention and postintervention; and (4) differences in the mean preintervention and postintervention. We illustrate the proposed method by analyzing patient satisfaction data from a hospital that implemented and evaluated a new nursing care delivery model as the intervention of interest. The robust-ITS model is implemented in an R Shiny toolbox, which is freely available to the community. Copyright © 2017 John Wiley & Sons, Ltd.

Sustaining complex interventions in long-term care: a qualitative study of direct care staff and managers.

PubMed

Colón-Emeric, Cathleen; Toles, Mark; Cary, Michael P; Batchelor-Murphy, Melissa; Yap, Tracey; Song, Yuting; Hall, Rasheeda; Anderson, Amber; Burd, Andrew; Anderson, Ruth A

2016-07-16

Little is known about the sustainability of behavioral change interventions in long-term care (LTC). Following a cluster randomized trial of an intervention to improve staff communication (CONNECT), we conducted focus groups of direct care staff and managers to elicit their perceptions of factors that enhance or reduce sustainability in the LTC setting. The overall aim was to generate hypotheses about how to sustain complex interventions in LTC. In eight facilities, we conducted 15 focus groups with 83 staff who had participated in at least one intervention session. Where possible, separate groups were conducted with direct care staff and managers. An interview guide probed for staff perceptions of intervention salience and sustainability. Framework analysis of coded transcripts was used to distill insights about sustainability related to intervention features, organizational context, and external supports. Staff described important factors for intervention sustainability that are particularly challenging in LTC. Because of the tremendous diversity in staff roles and education level, interventions should balance complexity and simplicity, use a variety of delivery methods and venues (e.g., group and individual sessions, role-play/storytelling), and be inclusive of many work positions. Intervention customizability and flexibility was particularly prized in this unpredictable and resource-strapped environment. Contextual features noted to be important include addressing the frequent lack of trust between direct care staff and managers and ensuring that direct care staff directly observe manager participation and support for the program. External supports suggested to be useful for sustainability include formalization of changes into facility routines, using "train the trainer" approaches and refresher sessions. High staff turnover is common in LTC, and providing materials for new staff orientation was reported to be important for sustainability. When designing or implementing complex behavior change interventions in LTC, consideration of these particularly salient intervention features, contextual factors, and external supports identified by staff may enhance sustainability. ClinicalTrial.gov, NCT00636675.

Attention-deficit hyperactivity disorder (ADHD): an updated review of the essential facts.

PubMed

Tarver, J; Daley, D; Sayal, K

2014-11-01

Attention-deficit hyperactivity disorder (ADHD) is a complex disorder that can affect individuals across the lifespan. It is associated with substantial heterogeneity in terms of aetiology, clinical presentation and treatment outcome and is the subject of extensive research. Because of this, it can be difficult for clinicians to stay up to date with the most relevant findings and know how best to respond to parents' questions and concerns about the disorder and interventions. This is a narrative review that aims to summarize key findings from recent research into ADHD and its treatment that clinicians can share with families in order to increase their knowledge about ADHD and intervention options. ADHD develops as a result of complex interplay between interdependent genetic and non-genetic factors. The disorder is associated with substantial impairments in functioning and poor long-term outcomes. Pharmacological and non-pharmacological treatment options are available for symptom management and to improve function, but functioning outcomes often fail to normalize in children with ADHD. Despite extensive advances in understanding this complex disorder, it is clear that there is still a long way to go. In particular, we address the need for future non-pharmacological interventions to be more specifically targeted for ADHD symptoms and its commonly associated functioning deficits in order to ensure the best long-term outcomes for children with ADHD. © 2014 John Wiley & Sons Ltd.

A realist synthesis of the effect of social accountability interventions on health service providers' and policymakers' responsiveness.

PubMed

Lodenstein, Elsbet; Dieleman, Marjolein; Gerretsen, Barend; Broerse, Jacqueline Ew

2013-11-07

Accountability has center stage in the current post-Millennium Development Goals (MDG) debate. One of the effective strategies for building equitable health systems and providing quality health services is the strengthening of citizen-driven or social accountability processes. The monitoring of actions and decisions of policymakers and providers by citizens is regarded as a right in itself but also as an alternative to weak administrative accountability mechanisms, in particular in settings with poor governance. The effects of social accountability interventions are often based on assumptions and are difficult to evaluate because of their complex nature and context sensitivity. This study aims to review and assess the available evidence for the effect of social accountability interventions on policymakers' and providers' responsiveness in countries with medium to low levels of governance capacity and quality. For policymakers and practitioners engaged in health system strengthening, social accountability initiatives and rights-based approaches to health, the findings of this review may help when reflecting on the assumptions and theories of change behind their policies and interventions. Little is known about social accountability interventions, their outcomes and the circumstances under which they produce outcomes for particular groups or issues. In this study, social accountability interventions are conceptualized as complex social interventions for which a realist synthesis is considered the most appropriate method of systematic review. The synthesis is based on a preliminary program theory of social accountability that will be tested through an iterative process of primary study searches, data extraction, analysis and synthesis. Published and non-published (grey) quantitative and qualitative studies in English, French and Spanish will be included. Quality and validity will be enhanced by continuous peer review and team reflection among the reviewers. The authors believe the advantages of a realist synthesis for social accountability lie in the possibility of overcoming disciplinary or paradigmatic boundaries often found in public health and development. In addition, they argue that this approach fills the knowledge gap left by conventional synthesis or evaluation exercises of participatory programs. Finally, the authors describe the practical strategies adopted to address methodological challenges and validity.

Development of a novel coding scheme (SABICS) to record nurse-child interactive behaviours in a community dental preventive intervention.

PubMed

Zhou, Yuefang; Cameron, Elaine; Forbes, Gillian; Humphris, Gerry

2012-08-01

To develop and validate the St Andrews Behavioural Interaction Coding Scheme (SABICS): a tool to record nurse-child interactive behaviours. The SABICS was developed primarily from observation of video recorded interactions; and refined through an iterative process of applying the scheme to new data sets. Its practical applicability was assessed via implementation of the scheme on specialised behavioural coding software. Reliability was calculated using Cohen's Kappa. Discriminant validity was assessed using logistic regression. The SABICS contains 48 codes. Fifty-five nurse-child interactions were successfully coded through administering the scheme on The Observer XT8.0 system. Two visualization results of interaction patterns demonstrated the scheme's capability of capturing complex interaction processes. Cohen's Kappa was 0.66 (inter-coder) and 0.88 and 0.78 (two intra-coders). The frequency of nurse behaviours, such as "instruction" (OR = 1.32, p = 0.027) and "praise" (OR = 2.04, p = 0.027), predicted a child receiving the intervention. The SABICS is a unique system to record interactions between dental nurses and 3-5 years old children. It records and displays complex nurse-child interactive behaviours. It is easily administered and demonstrates reasonable psychometric properties. The SABICS has potential for other paediatric settings. Its development procedure may be helpful for other similar coding scheme development. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Primary Care Practice Transformation Is Hard Work

PubMed Central

Crabtree, Benjamin F.; Nutting, Paul A.; Miller, William L.; McDaniel, Reuben R.; Stange, Kurt C.; Jaén, Carlos Roberto; Stewart, Elizabeth

2010-01-01

Background Serious shortcomings remain in clinical care in the United States despite widespread use of improvement strategies for enhancing clinical performance based on knowledge transfer approaches. Recent calls to transform primary care practice to a patient-centered medical home present even greater challenges and require more effective approaches. Methods Our research team conducted a series of National Institutes of Health funded descriptive and intervention projects to understand organizational change in primary care practice settings, emphasizing a complexity science perspective. The result was a developmental research effort that enabled the identification of critical lessons relevant to enabling practice change. Results A summary of findings from a 15-year program of research highlights the limitations of viewing primary care practices in the mechanistic terms that underlie current or traditional approaches to quality improvement. A theoretical perspective that views primary care practices as dynamic complex adaptive systems with “agents” who have the capacity to learn, and the freedom to act in unpredictable ways provides a better framework for grounding quality improvement strategies. This framework strongly emphasizes that quality improvement interventions should not only use a complexity systems perspective, but also there is a need for continual reflection, careful tailoring of interventions, and ongoing attention to the quality of interactions among agents in the practice. Conclusions It is unlikely that current strategies for quality improvement will be successful in transforming current primary care practice to a patient-centered medical home without a stronger guiding theoretical foundation. Our work suggests that a theoretical framework guided by complexity science can help in the development of quality improvement strategies that will more effectively facilitate practice change. PMID:20856145

The applicability of normalisation process theory to speech and language therapy: a review of qualitative research on a speech and language intervention.

PubMed

James, Deborah M

2011-08-12

The Bercow review found a high level of public dissatisfaction with speech and language services for children. Children with speech, language, and communication needs (SLCN) often have chronic complex conditions that require provision from health, education, and community services. Speech and language therapists are a small group of Allied Health Professionals with a specialist skill-set that equips them to work with children with SLCN. They work within and across the diverse range of public service providers. The aim of this review was to explore the applicability of Normalisation Process Theory (NPT) to the case of speech and language therapy. A review of qualitative research on a successfully embedded speech and language therapy intervention was undertaken to test the applicability of NPT. The review focused on two of the collective action elements of NPT (relational integration and interaction workability) using all previously published qualitative data from both parents and practitioners' perspectives on the intervention. The synthesis of the data based on the Normalisation Process Model (NPM) uncovered strengths in the interpersonal processes between the practitioners and parents, and weaknesses in how the accountability of the intervention is distributed in the health system. The analysis based on the NPM uncovered interpersonal processes between the practitioners and parents that were likely to have given rise to successful implementation of the intervention. In previous qualitative research on this intervention where the Medical Research Council's guidance on developing a design for a complex intervention had been used as a framework, the interpersonal work within the intervention had emerged as a barrier to implementation of the intervention. It is suggested that the design of services for children and families needs to extend beyond the consideration of benefits and barriers to embrace the social processes that appear to afford success in embedding innovation in healthcare.

Telehealth methods to deliver multifactorial dietary interventions in adults with chronic disease: a systematic review protocol.

PubMed

Kelly, Jaimon T; Reidlinger, Dianne P; Hoffmann, Tammy C; Campbell, Katrina L

2015-12-22

The long-term management of chronic diseases requires adoption of complex dietary recommendations, which can be facilitated by regular coaching to support sustained behaviour change. Telehealth interventions can overcome patient-centred barriers to accessing face-to-face programs and provide feasible delivery methods, ubiquitous and accessible regardless of geographic location. The protocol for this systematic review explains the methods that will be utilised to answer the review question of whether telehealth interventions are effective at promoting change in dietary intake and improving diet quality in people with chronic disease. A structured search of Medline, EMBASE, CINAHL, and PsychINFO, from their inception, will be conducted. We will consider randomised controlled trials which evaluate complex dietary interventions in adults with chronic disease. Studies must provide diet education in an intervention longer than 4 weeks in duration, and at least half of the intervention contact must be delivered via telehealth. Comparisons will be made against usual care or a non-telehealth intervention. The primary outcome of interest is dietary change with secondary outcomes relating to clinical markers pre-specified in the methodology. The process for selecting studies, extracting data, and resolving conflicts will follow a set protocol. Two authors will independently appraise the studies and extract the data, using specified methods. Meta-analyses will be conducted where appropriate, with parameters for determining statistical heterogeneity pre-specified. The GRADE tool will be used for determining the quality of evidence for analysed outcomes. To date, there has been a considerable variability in the strategies used to deliver dietary education, and the overall effectiveness of telehealth dietary interventions for facilitating dietary change has not been reviewed systematically in adults with chronic disease. A systematic synthesis of telehealth strategies will inform the development of evidence-based telehealth programs that can be tailored to deliver dietary interventions specific to chronic disease conditions. PROSPERO CRD42015026398.

Can Vocabulary Lessons Increase the Amount of Complex Syntax Produced by Head Start Teachers? A Pilot Study

ERIC Educational Resources Information Center

Van Horne, Amanda Owen; Curran, Maura; Hall, Jessica

2017-01-01

In this pilot study, we examine the suitability of materials for a vocabulary intervention designed to influence the amount of complex syntax teachers use in at-risk preschool classrooms. Six Head Start classrooms were assigned to one of two vocabulary interventions: a condition using cognitive verbs, which are biased toward complex syntax (e.g.…

Explaining high and low performers in complex intervention trials: a new model based on diffusion of innovations theory.

PubMed

McMullen, Heather; Griffiths, Chris; Leber, Werner; Greenhalgh, Trisha

2015-05-31

Complex intervention trials may require health care organisations to implement new service models. In a recent cluster randomised controlled trial, some participating organisations achieved high recruitment, whereas others found it difficult to assimilate the intervention and were low recruiters. We sought to explain this variation and develop a model to inform organisational participation in future complex intervention trials. The trial included 40 general practices in a London borough with high HIV prevalence. The intervention was offering a rapid HIV test as part of the New Patient Health Check. The primary outcome was mean CD4 cell count at diagnosis. The process evaluation consisted of several hundred hours of ethnographic observation, 21 semi-structured interviews and analysis of routine documents (e.g., patient leaflets, clinical protocols) and trial documents (e.g., inclusion criteria, recruitment statistics). Qualitative data were analysed thematically using--and, where necessary, extending--Greenhalgh et al.'s model of diffusion of innovations. Narrative synthesis was used to prepare case studies of four practices representing maximum variety in clinicians' interest in HIV (assessed by level of serological testing prior to the trial) and performance in the trial (high vs. low recruiters). High-recruiting practices were, in general though not invariably, also innovative practices. They were characterised by strong leadership, good managerial relations, readiness for change, a culture of staff training and available staff time ('slack resources'). Their front-line staff believed that patients might benefit from the rapid HIV test ('relative advantage'), were emotionally comfortable administering it ('compatibility'), skilled in performing it ('task issues') and made creative adaptations to embed the test in local working practices ('reinvention'). Early experience of a positive HIV test ('observability') appeared to reinforce staff commitment to recruiting more participants. Low-performing practices typically had less good managerial relations, significant resource constraints, staff discomfort with the test and no positive results early in the trial. An adaptation of the diffusion of innovations model was an effective analytical tool for retrospectively explaining high and low-performing practices in a complex intervention research trial. Whether the model will work prospectively to predict performance (and hence shape the design of future trials) is unknown. ISRCTN Registry number: ISRCTN63473710. Date assigned: 22 April 2010.

WHO policy development processes for a new vaccine: case study of malaria vaccines.

PubMed

Milstien, Julie; Cárdenas, Vicky; Cheyne, James; Brooks, Alan

2010-06-24

Recommendations from the World Health Organization (WHO) are crucial to inform developing country decisions to use, or not, a new intervention. This article analysed the WHO policy development process to predict its course for a malaria vaccine. The decision-making processes for one malaria intervention and four vaccines were classified through (1) consultations with staff and expert advisors to WHO's Global Malaria Programme (GMP) and Immunization, Vaccines and Biologicals Department (IVB); (2) analysis of the procedures and recommendations of the major policy-making bodies of these groups; (3) interviews with staff of partnerships working toward new vaccine availability; and (4) review and analyses of evidence informing key policy decisions. WHO policy formulation related to use of intermittent preventive treatment in infancy (IPTi) and the following vaccine interventions: Haemophilus influenzae type b conjugate vaccine (Hib), pneumococcal conjugate vaccine (PCV), rotavirus vaccine (RV), and human papillomavirus vaccine (HPV), five interventions which had relatively recently been through systematic WHO policy development processes as currently constituted, was analysed. Required information was categorized in three areas defined by a recent WHO publication on development of guidelines: safety and efficacy in relevant populations, implications for costs and population health, and localization of data to specific epidemiological situations. Data needs for a malaria vaccine include safety; the demonstration of efficacy in a range of epidemiological settings in the context of other malaria prevention interventions; and information on potential rebound in which disease increases subsequent to the intervention. In addition, a malaria vaccine would require attention to additional factors, such as costs and cost-effectiveness, supply and demand, impact of use on other interventions, and distribution issues. Although policy issues may be more complex for future vaccines, the lead-time between the date of product regulatory approval and a recommendation for its use in developing countries is decreasing. This study presents approaches to define in advance core data needs to support evidence-based decisions, to further decrease this lead-time, accelerating the availability of a malaria vaccine. Specific policy areas for which information should be collected are defined, including studying its use within the context of other malaria interventions.

Nanoparticles for Imaging, Sensing, and Therapeutic Intervention

PubMed Central

2014-01-01

Nanoparticles have the potential to contribute to new modalities in molecular imaging and sensing as well as in therapeutic interventions. In this Nano Focus article, we identify some of the current challenges and knowledge gaps that need to be confronted to accelerate the developments of various applications. Using specific examples, we journey from the characterization of these complex hybrid nanomaterials; continue with surface design and (bio)physicochemical properties, their fate in biological media and cells, and their potential for cancer treatment; and finally reflect on the role of animal models to predict their behavior in humans. PMID:24641589

Advances in assessment, diagnosis, and treatment of hyperthyroidism in children.

PubMed

Amer, Kim Siarkowski

2005-04-01

The thyroid gland is responsible for regulating multiple complex metabolic processes that affect most organs. Physical growth and cognitive development are dependent on proper levels of thyroid hormone. This article will review common challenges in the diagnosis of hyperthyroidism in children, the approaches to treatment, and the nursing interventions guided toward child and family responses to thyroid disease. A comparison of signs and symptoms of hypothyroidism and hyperthyroidism is also included. The nursing interventions addressed in the article integrate the biological, psychological, social, and environmental stresses and adaptations necessary to cope with hyperthyroid disease.

Application of Intervention Mapping to develop a community-based health promotion pre-pregnancy intervention for adolescent girls in rural South Africa: Project Ntshembo (Hope).

PubMed

Draper, Catherine E; Micklesfield, Lisa K; Kahn, Kathleen; Tollman, Stephen M; Pettifor, John M; Dunger, David B; Norris, Shane A

2014-01-01

South Africa (SA) is undergoing multiple transitions with an increasing burden of non-communicable diseases and high levels of overweight and obesity in adolescent girls and women. Adolescence is key to addressing trans-generational risk and a window of opportunity to intervene and positively impact on individuals' health trajectories into adulthood. Using Intervention Mapping (IM), this paper describes the development of the Ntshembo intervention, which is intended to improve the health and well-being of adolescent girls in order to limit the inter-generational transfer of risk of metabolic disease, in particular diabetes risk. This paper describes the application of the first four steps of IM. Evidence is provided to support the selection of four key behavioural objectives: viz. to eat a healthy, balanced diet, increase physical activity, reduce sedentary behaviour, and promote reproductive health. Appropriate behaviour change techniques are suggested and a theoretical framework outlining components of relevant behaviour change theories is presented. It is proposed that the Ntshembo intervention will be community-based, including specialist adolescent community health workers who will deliver a complex intervention comprising of individual, peer, family and community mobilisation components. The Ntshembo intervention is novel, both in SA and globally, as it is: (1) based on strong evidence, extensive formative work and best practice from evaluated interventions; (2) combines theory with evidence to inform intervention components; (3) includes multiple domains of influence (community through to the individual); (4) focuses on an at-risk target group; and (5) embeds within existing and planned health service priorities in SA.

A systematic review of educational interventions to change behaviour of prescribers in hospital settings, with a particular emphasis on new prescribers

PubMed Central

Brennan, Nicola; Mattick, Karen

2013-01-01

Aims Prescribing is a complex task and a high risk area of clinical practice. Poor prescribing occurs across staff grades and settings but new prescribers are attributed much of the blame. New prescribers may not be confident or even competent to prescribe and probably have different support and development needs than their more experienced colleagues. Unfortunately, little is known about what interventions are effective in this group. Previous systematic reviews have not distinguished between different grades of staff, have been narrow in scope and are now out of date. Therefore, to inform the design of educational interventions to change prescribing behaviour, particularly that of new prescibers, we conducted a systematic review of existing hospital-based interventions. Methods Embase, Medline, SIGLE, Cinahl and PsychINFO were searched for relevant studies published 1994–2010. Studies describing interventions to change the behaviour of prescribers in hospital settings were included, with an emphasis on new prescibers. The bibliographies of included papers were also searched for relevant studies. Interventions and effectiveness were classified using existing frameworks and the quality of studies was assessed using a validated instrument. Results Sixty-four studies were included in the review. Only 13% of interventions specifically targeted new prescribers. Most interventions (72%) were deemed effective in changing behaviour but no particular type stood out as most effective. Conclusion Very few studies have tailored educational interventions to meet needs of new prescribers, or distinguished between new and experienced prescribers. Educational development and research will be required to improve this important aspect of early clinical practice. PMID:22831632

The Safer Delivery of Surgical Services Program (S3): Explaining Its Differential Effectiveness and Exploring Implications for Improving Quality in Complex Systems.

PubMed

Flynn, Lorna C; McCulloch, Peter G; Morgan, Lauren J; Robertson, Eleanor R; New, Steve J; Stedman, Francesca E; Martin, Graham P

2016-12-01

To analyze the challenges encountered during surgical quality improvement interventions, and explain the relative success of different intervention strategies. Understanding why and how interventions work is vital for developing improvement science. The S3 Program of studies tested whether combining interventions addressing culture and system was more likely to result in improvement than either approach alone. Quantitative results supported this theory. This qualitative study investigates why this happened, what aspects of the interventions and their implementation most affected improvement, and the implications for similar programs. Semistructured interviews were conducted with hospital staff (23) and research team members (11) involved in S3 studies. Analysis was based on the constant comparative method, with coding conducted concurrently with data collection. Themes were identified and developed in relation to the program theory behind S3. The superior performance of combined intervention over single intervention arms appeared related to greater awareness and ability to act, supporting the S3 hypothesis. However, we also noted unforeseen differences in implementation that seemed to amplify this difference. The greater ambition and more sophisticated approach in combined intervention arms resulted in requests for more intensive expert support, which seemed crucial in their success. The contextual challenges encountered have potential implications for the replicability and sustainability of the approach. Our findings support the S3 hypothesis, triangulating with quantitative results and providing an explanatory account of the causal relationship between interventions and outcomes. They also highlight the importance of implementation strategies, and of factors outside the control of program designers.

An exploration of clinical interventions provided by pharmacists within a complex asthma service.

PubMed

Lemay, Kate S; Saini, Bandana; Bosnic-Anticevich, Sinthia; Smith, Lorraine; Stewart, Kay; Emmerton, Lynne; Burton, Deborah L; Krass, Ines; Armour, Carol L

2015-01-01

Pharmacists in Australia are accessible health care professionals, and their provision of clinical pharmacy interventions in a range of areas has been proven to improve patient outcomes. Individual clinical pharmacy interventions in the area of asthma management have been very successful. An understanding of the nature of these interventions will inform future pharmacy services. What we do not know is when pharmacists provide a complex asthma service, what elements of that service (interventions) they choose to deliver. To explore the scope and frequency of asthma-related clinical interventions provided by pharmacists to patients in an evidence-based complex asthma service. Pharmacists from 4 states/territories of Australia were trained in asthma management. People with asthma had 3 or 4 visits to the pharmacy. Guided by a structured patient file, the pharmacist assessed the patient's asthma and management and provided interventions where and when considered appropriate, based on their clinical decision making skills. The interventions were recorded in a checklist in the patient file. They were then analysed descriptively and thematically. Pharmacists provided 22,909 clinical pharmacy interventions over the service to 570 patients (398 of whom completed the service). The most frequently delivered interventions were in the themes 'Education on asthma', 'Addressing trigger factors', 'Medications - safe and effective use' and 'Explore patient perspectives'. The patients had a high and ongoing need for interventions. Pharmacists selected interventions based on their assessment of perceived need then revisited and reinforced these interventions. Pharmacists identified a number of areas in which patients required interventions to assist with their asthma management. Many of these were perceived to require continuing reinforcement over the duration of the service. Pharmacists were able to use their clinical judgement to assess patients and provide clinical pharmacy interventions across a range of asthma management needs.

Redistribution of knee stress using laterally wedged insole intervention: Finite element analysis of knee-ankle-foot complex.

PubMed

Liu, Xuan; Zhang, Ming

2013-01-01

Laterally wedged insoles are widely applied in the conservative treatment for medial knee osteoarthritis. Experimental studies have been conducted to understand the effectiveness of such an orthotic intervention. However, the information was limited to the joint external loading such as knee adduction moment. The internal stress distribution is difficult to be obtained from in vivo experiment alone. Thus, a three-dimensional finite element model of the human knee-ankle-foot complex, together with orthosis, was developed in this study and used to investigate the redistribution of knee stress using laterally wedged insole intervention. Laterally wedged insoles with wedge angles of 0, 5, and 10° were fabricated for intervention. The subject-specific geometry of the lower extremity with details was characterized in the reconstruction of MR images. Motion analysis data and muscle forces were input to drive the model. The established finite element model was employed to investigate the loading responses of tibiofemoral articulation in three wedge angle conditions during simulated walking stance phase. With either of the 5° or 10° laterally wedged insole, significant decreases in von Mises stress and contact force at the medial femur cartilage region and the medial meniscus were predicted comparing with the 0° insole. The diminished stress and contact force at the medial compartment of the knee joint demonstrate the immediate effect of the laterally wedged insoles. The intervention may contribute to medial knee osteoarthritis rehabilitation. Copyright © 2012 Elsevier Ltd. All rights reserved.

A Scoping Review of Physical Rehabilitation in Long-Term Care: Interventions, Outcomes, Tools.

PubMed

McArthur, Caitlin; Gibbs, Jenna C; Patel, Ruchit; Papaioannou, Alexandra; Neves, Paula; Killingbeck, Jaimie; Hirdes, John; Milligan, James; Berg, Katherine; Giangregorio, Lora

2017-12-01

Residents in long-term care (LTC) often require physical rehabilitation (PR) to maintain/improve physical function. This scoping review described the breadth of literature regarding PR in LTC to date, synthesizing PR interventions that have been evaluated, outcomes used, and tools for determining service eligibility. A structured search, conducted in six licensed databases and grey literature, identified 381 articles for inclusion. Most interventions were delivered and evaluated at the resident level and typically were multicomponent exercise programs. Performance-based measures, activities of daily living, and mood were the most frequently reported outcomes. A key knowledge gap was PR in relation to goals, such as quality of life. Future studies should reflect medically complex residents who live in LTC, and length of residents' stay should be differentiated. Intervention studies should also explore realistic delivery methods; moreover, tool development for determining service eligibility is necessary to ensure equality in rehabilitative care across the LTC sector.

Brief Report: Does Gender Matter in Intervention for ASD? Examining the Impact of the PEERS® Social Skills Intervention on Social Behavior Among Females with ASD.

PubMed

McVey, Alana J; Schiltz, Hillary; Haendel, Angela; Dolan, Bridget K; Willar, Kirsten S; Pleiss, Sheryl; Karst, Jeffrey S; Carson, Audrey M; Caiozzo, Christina; Vogt, Elisabeth; Van Hecke, Amy Vaughan

2017-07-01

A paucity of research has been conducted to examine the effect of social skills intervention on females with ASD. Females with ASD may have more difficulty developing meaningful friendships than males, as the social climate can be more complex (Archer, Coyne, Personality and Social Psychology Review 9(3):212-230, 2005). This study examined whether treatment response among females differed from males. One hundred and seventy-seven adolescents and young adults with ASD (N = 177) participated in this study. When analyzed by group, no significant differences by gender emerged: PEERS ® knowledge (TASSK/TYASSK, p = .494), direct interactions (QSQ, p = .762), or social responsiveness (SRS, p = .689; SSIS-RS, p = .482). Thus, females and males with ASD respond similarly to the PEERS ® intervention.

Advancing Models and Theories for Digital Behavior Change Interventions.

PubMed

Hekler, Eric B; Michie, Susan; Pavel, Misha; Rivera, Daniel E; Collins, Linda M; Jimison, Holly B; Garnett, Claire; Parral, Skye; Spruijt-Metz, Donna

2016-11-01

To be suitable for informing digital behavior change interventions, theories and models of behavior change need to capture individual variation and changes over time. The aim of this paper is to provide recommendations for development of models and theories that are informed by, and can inform, digital behavior change interventions based on discussions by international experts, including behavioral, computer, and health scientists and engineers. The proposed framework stipulates the use of a state-space representation to define when, where, for whom, and in what state for that person, an intervention will produce a targeted effect. The "state" is that of the individual based on multiple variables that define the "space" when a mechanism of action may produce the effect. A state-space representation can be used to help guide theorizing and identify crossdisciplinary methodologic strategies for improving measurement, experimental design, and analysis that can feasibly match the complexity of real-world behavior change via digital behavior change interventions. Copyright © 2016 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Towards an Evidence Framework for Design-Based Implementation Research

ERIC Educational Resources Information Center

Means, Barbara; Harris, Christopher J.

2013-01-01

Educational interventions typically are complex combinations of human actions, organizational supports, and instructional resources that play out differently in different contexts and with different kinds of students. The complexity and variability of outcomes undermines the notion that interventions either "work" or "don't…

Engaging participants in a complex intervention trial in Australian General Practice

PubMed Central

Perkins, David; Harris, Mark F; Tan, Jocelyn; Christl, Bettina; Taggart, Jane; Fanaian, Mahnaz

2008-01-01

Background The paper examines the key issues experienced in recruiting and retaining practice involvement in a large complex intervention trial in Australian General Practice. Methods Reflective notes made by research staff and telephone interviews with staff from general practices which expressed interest, took part or withdrew from a trial of a complex general practice intervention. Results Recruitment and retention difficulties were due to factors inherent in the demands and context of general practice, the degree of engagement of primary care organisations (Divisions of General Practice), perceived benefits by practices, the design of the trial and the timing and complexity of data collection. Conclusion There needs to be clearer articulation to practices of the benefits of the research to participants and streamlining of the design and processes of data collection and intervention to fit in with their work practices. Ultimately deeper engagement may require additional funding and ongoing participation through practice research networks. Trial Registration Current Controlled Trials ACTRN12605000788673 PMID:18700984

Evidence synthesis in international development: a critique of systematic reviews and a pragmatist alternative

PubMed Central

Cornish, Flora

2015-01-01

Systematic reviews are an instrument of Evidence-Based Policy designed to produce comprehensive, unbiased, transparent and clear assessments of interventions’ effectiveness. From their origins in medical fields, systematic reviews have recently been promoted as offering important advances in a range of applied social science fields, including international development. Drawing on a case study of a systematic review of the effectiveness of community mobilisation as an intervention to tackle HIV/AIDS, this article problematises the use of systematic reviews to summarise complex and context-specific bodies of evidence. Social development interventions, such as ‘community mobilisation’ often take different forms in different interventions; are made successful by their situation in particular contexts, rather than being successful or unsuccessful universally; and have a rhetorical value that leads to the over-application of positively valued terms (e.g. ‘community mobilisation’), invalidating the keyword search process of a systematic review. The article suggests that the policy interest in definitive summary statements of ‘the evidence’ is at odds with academic assessments that evidence takes multiple, contradictory and complex forms, and with practitioner experience of the variability of practice in context. A pragmatist philosophy of evidence is explored as an alternative. Taking this approach implies expanding the definition of forms of research considered to be ‘useful evidence’ for evidence-based policy-making; decentralising decisions about ‘what works’ to allow for the use of local practical wisdom; and prioritising the establishment of good processes for the critical use of evidence, rather than producing context-insensitive summaries of ‘the evidence’. PMID:26426502

Primary health care nurses implement and evaluate a community outreach approach to health care in the South African agricultural sector.

PubMed

Dick, J; Clarke, M; van Zyl, H; Daniels, K

2007-12-01

Early detection and effective case management of tuberculosis (TB) among a high-risk group of materially poor farm workers in an area of the Cape Winelands, South Africa, presents special challenges to the health community, where resource constraints lead to service reduction. In order to address this problem, local nurses established a collaborative partnership between permanent farm workers and their families, their employers, selected non-governmental organizations and the public health sector. In consultation with stakeholders, they developed an intervention primarily focusing on having peer selected trained lay health workers (LHWs) on farms, mentored and managed by nurses. To describe the complex process of implementation and evaluation of the LHW project, and provide a summary of a number of discrete studies evaluating the effectiveness, cost implications, and the perceptions and experiences of key stakeholders of the intervention. Quantitative and qualitative research methods conducted within the context of a pragmatic unblinded community cluster randomized control trial were used. Emphasis was placed on an iterative participatory interaction between the researchers and key stakeholders. The intervention contributed to significantly better successful treatment completion rates among adult new smear-positive TB cases. The process implemented proved cost-effective and was pivotal in initiating a community-based social development programme. The use of peer-selected LHWs within a wider programme of integrated care designed to merge technical biomedical approaches to disease management with more holistic social development activities, appears essential to meet the complex health needs in conjunction with public health of the rural poor.

Defining the external implementation context: an integrative systematic literature review.

PubMed

Watson, Dennis P; Adams, Erin L; Shue, Sarah; Coates, Heather; McGuire, Alan; Chesher, Jeremy; Jackson, Joanna; Omenka, Ogbonnaya I

2018-03-27

Proper implementation of evidence-based interventions is necessary for their full impact to be realized. However, the majority of research to date has overlooked facilitators and barriers existing outside the boundaries of the implementing organization(s). Better understanding and measurement of the external implementation context would be particularly beneficial in light of complex health interventions that extend into and interact with the larger environment they are embedded within. We conducted a integrative systematic literature review to identify external context constructs likely to impact implementation of complex evidence-based interventions. The review process was iterative due to our goal to inductively develop the identified constructs. Data collection occurred in four primary stages: (1) an initial set of key literature across disciplines was identified and used to inform (2) journal and (3) author searches that, in turn, informed the design of the final (4) database search. Additionally, (5) we conducted citation searches of relevant literature reviews identified in each stage. We carried out an inductive thematic content analysis with the goal of developing homogenous, well-defined, and mutually exclusive categories. We identified eight external context constructs: (1) professional influences, (2) political support, (3) social climate, (4) local infrastructure, (5) policy and legal climate, (6) relational climate, (7) target population, and (8) funding and economic climate. This is the first study to our knowledge to use a systematic review process to identify empirically observed external context factors documented to impact implementation. Comparison with four widely-utilized implementation frameworks supports the exhaustiveness of our review process. Future work should focus on the development of more stringent operationalization and measurement of these external constructs.

Twinning "Practices of Change" with "Theory of Change": Room for Emergence in Advocacy Evaluation

ERIC Educational Resources Information Center

Arensman, Bodille; van Waegeningh, Cornelie; van Wessel, Margit

2018-01-01

Theory of change (ToC) is currently "the" approach for the evaluation and planning of international development programs. This approach is considered especially suitable for complex interventions. We question this assumption and argue that ToC's focus on cause-effect logic and intended outcomes does not do justice to the recursive nature…

Examining the Efficacy of Peer Network Interventions on the Social Interactions of High School Students with Autism Spectrum Disorder

ERIC Educational Resources Information Center

Sreckovic, Melissa A.; Hume, Kara; Able, Harriet

2017-01-01

Developing positive peer relationships is important. Unfortunately, due to challenges in social communication and increased complexity of peer groups during adolescence, many secondary students with autism spectrum disorder (ASD) engage in limited positive social interactions with peers. This study examined the effects of a peer network…

Engaging Adolescents through Participatory and Qualitative Research Methods to Develop a Digital Communication Intervention to Reduce Adolescent Obesity

ERIC Educational Resources Information Center

Livingood, William C.; Monticalvo, David; Bernhardt, Jay M.; Wells, Kelli T.; Harris, Todd; Kee, Kadra; Hayes, Johnathan; George, Donald; Woodhouse, Lynn D.

2017-01-01

Background: The complexity of the childhood obesity epidemic requires the application of community-based participatory research (CBPR) in a manner that can transcend multiple communities of stakeholders, including youth, the broader community, and the community of health care providers. Aim: To (a) describe participatory processes for engaging…

Screening for Psychosocial Distress amongst War-Affected Children: Cross-Cultural Construct Validity of the CPDS

ERIC Educational Resources Information Center

Jordans, M. J. D.; Komproe, I. H.; Tol, W. A.; De Jong, J. T. V. M.

2009-01-01

Background: Large-scale psychosocial interventions in complex emergencies call for a screening procedure to identify individuals at risk. To date there are no screening instruments that are developed within low- and middle-income countries and validated for that purpose. The present study assesses the cross-cultural validity of the brief,…

Student Teachers' Pedagogical Content Knowledge for Teaching Systems Thinking: Effects of Different Interventions

ERIC Educational Resources Information Center

Rosenkränzer, Frank; Hörsch, Christian; Schuler, Stephan; Riess, Werner

2017-01-01

Systems' thinking has become increasingly relevant not only in education for sustainable development but also in everyday life. Even if teachers know the dynamics and complexity of living systems in biology and geography, they might not be able to effectively explain it to students. Teachers need an understanding of systems and their behaviour…

Comparing Service Use and Costs among Adolescents with Autism Spectrum Disorders, Special Needs and Typical Development

ERIC Educational Resources Information Center

Barrett, Barbara; Mosweu, Iris; Jones, Catherine R. G.; Charman, Tony; Baird, Gillian; Simonoff, Emily; Pickles, Andrew; Happé, Francesca; Byford, Sarah

2015-01-01

Autism spectrum disorder is a complex condition that requires specialised care. Knowledge of the costs of autism spectrum disorder, especially in comparison with other conditions, may be useful to galvanise policymakers and leverage investment in education and intervention to mitigate aspects of autism spectrum disorder that negatively impact…

NETIMIS: Dynamic Simulation of Health Economics Outcomes Using Big Data.

PubMed

Johnson, Owen A; Hall, Peter S; Hulme, Claire

2016-02-01

Many healthcare organizations are now making good use of electronic health record (EHR) systems to record clinical information about their patients and the details of their healthcare. Electronic data in EHRs is generated by people engaged in complex processes within complex environments, and their human input, albeit shaped by computer systems, is compromised by many human factors. These data are potentially valuable to health economists and outcomes researchers but are sufficiently large and complex enough to be considered part of the new frontier of 'big data'. This paper describes emerging methods that draw together data mining, process modelling, activity-based costing and dynamic simulation models. Our research infrastructure includes safe links to Leeds hospital's EHRs with 3 million secondary and tertiary care patients. We created a multidisciplinary team of health economists, clinical specialists, and data and computer scientists, and developed a dynamic simulation tool called NETIMIS (Network Tools for Intervention Modelling with Intelligent Simulation; http://www.netimis.com ) suitable for visualization of both human-designed and data-mined processes which can then be used for 'what-if' analysis by stakeholders interested in costing, designing and evaluating healthcare interventions. We present two examples of model development to illustrate how dynamic simulation can be informed by big data from an EHR. We found the tool provided a focal point for multidisciplinary team work to help them iteratively and collaboratively 'deep dive' into big data.

Developing a service user informed intervention to improve participation and ability to perform daily activities in primary Sjögren's syndrome: a mixed-methods study protocol

PubMed Central

Hackett, Katie L; Newton, Julia L; Deane, Katherine H O; Rapley, Tim; Deary, Vincent; Kolehmainen, Niina; Lendrem, Dennis; Ng, Wan-Fai

2014-01-01

Introduction A significant proportion of patients with primary Sjögren's syndrome (PSS) is functionally impaired and experience difficulties participating in various aspects of everyday life. There is currently no evidence of efficacy for non-pharmacological interventions aimed specifically at supporting the patients with PSS to improve their participation and ability to perform daily activities. This paper describes a research protocol for a mixed-methods study to develop an intervention to improve these outcomes. The protocol follows the Medical Research Council framework for complex interventions. Methods and analysis We will use group concept mapping with the patients, adults who live with them and healthcare professionals to identify factors which prevent people with PSS from participating in daily life and performing daily activities. The factors will be prioritised by participants for importance and feasibility and will inform an intervention to be delivered within a National Health Service (NHS) setting. Evidence-based intervention techniques will be identified for the prioritised factors and combined into a deliverable intervention package. Key stakeholders will comment on the intervention content and mode of delivery through focus groups, and the data will be used to refine the intervention. The acceptability and feasibility of the refined intervention will be evaluated in a future study. Ethics and dissemination The study has been approved by an NHS Research Ethics Committee, REC Reference: 13/NI/0190. The findings of this study will be disseminated in peer-reviewed journals and through presentation at national and international conferences. Trial registration number UKCRN Study ID: 15939. PMID:25146718

Well-being, health and fitness of children who use wheelchairs: feasibility study protocol to develop child-centred 'keep-fit' exercise interventions.

PubMed

O'Brien, Thomas D; Noyes, Jane; Spencer, Llinos Haf; Kubis, Hans-Peter; Edwards, Rhiannon T; Bray, Nathan; Whitaker, Rhiannon

2015-02-01

To undertake the pre-clinical and modelling phases of the Medical Research Council complex intervention framework to underpin development of child-centred 'keep-fit', exercise and physical activity interventions for children and young people who use wheelchairs. Children who use wheelchairs face many barriers to participation in physical activity, which compromises fitness, obesity, well-being and health. 'Keep-fit' programmes that are child-centred and engaging are urgently required to enhance participation of disabled children and their families as part of a healthy lifestyle. Nurses will likely be important in promoting and monitoring 'keep-fit' intervention(s) when implemented in the community. Mixed-method (including economic analysis) feasibility study to capture child and family preferences and keep-fit needs and to determine outcome measures for a 'keep-fit' intervention. The study comprises three stages. Stage 1 includes a mixed-method systematic review of effectiveness, cost effectiveness and key stakeholder views and experiences of keep-fit interventions, followed by qualitative interviews with children, young people and their parents to explore preferences and motivations for physical activity. Stage 2 will identify standardized outcome measures and test their application with children who use wheelchairs to obtain baseline fitness data. Options for an exercise-based keep-fit intervention will then be designed based on Stage 1 and 2 findings. In stage 3, we will present intervention options for feedback and further refinement to children and parents/carers in focus groups. (Project funded October 2012). At completion, this study will lead to the design of the intervention and a protocol to test its efficacy. © 2014 John Wiley & Sons Ltd.

Integrated package approach in delivering interventions during immunisation campaigns in a complex environment in Papua New Guinea: a case study.

PubMed

Vince, John David; Datta, Siddhartha Sankar; Toikilik, Steven; Lagani, William

2014-08-06

Papua New Guinea's difficult and varied topography, poor transport infrastructure, changing dynamics of population and economy in recent times and understaffed and poorly financed health service present major challenges for successful delivery of vaccination and other preventative health interventions to both the rural majority and urban populations, thereby posing risks for vaccine preventable disease outbreaks in the country. The country has struggled to meet the vaccination coverage targets required for the eradication of poliomyelitis and elimination of measles. Escalation of inter and intra country migration resulting from major industrial developments, particularly in extraction industries, has substantially increased the risk of infectious disease importation. This case study documents the evolution of immunisation programmes since the introduction of supplementary immunisation activities (SIAs). Single antigen SIAs have advantages and disadvantages. In situations in which the delivery of preventative health interventions is difficult, it is likely that the cost benefit is greater for multiple than for single intervention. The lessons learned from the conduct of single antigen SIAs can be effectively used for programmes delivering multiple SIA antigens, routine immunisations, and other health interventions. This paper describes a successful and cost effective multiple intervention programme in Papua New Guinea. The review of the last SIA in Papua New Guinea showed relatively high coverage of all the interventions and demonstrated the operational feasibility of delivering multiple interventions in resource constrained settings. Studies in other developing countries such as Lesotho and Ethiopia have also successfully integrated health interventions with SIA. In settings such as Papua New Guinea there is a strong case for integrating supplementary immunisation activity with routine immunisation and other health interventions through a comprehensive outreach programme. Copyright © 2014 World Health Organization. Published by Elsevier Ltd.. All rights reserved.

Developing a service user informed intervention to improve participation and ability to perform daily activities in primary Sjögren's syndrome: a mixed-methods study protocol.

PubMed

Hackett, Katie L; Newton, Julia L; Deane, Katherine H O; Rapley, Tim; Deary, Vincent; Kolehmainen, Niina; Lendrem, Dennis; Ng, Wan-Fai

2014-08-21

A significant proportion of patients with primary Sjögren's syndrome (PSS) is functionally impaired and experience difficulties participating in various aspects of everyday life. There is currently no evidence of efficacy for non-pharmacological interventions aimed specifically at supporting the patients with PSS to improve their participation and ability to perform daily activities. This paper describes a research protocol for a mixed-methods study to develop an intervention to improve these outcomes. The protocol follows the Medical Research Council framework for complex interventions. We will use group concept mapping with the patients, adults who live with them and healthcare professionals to identify factors which prevent people with PSS from participating in daily life and performing daily activities. The factors will be prioritised by participants for importance and feasibility and will inform an intervention to be delivered within a National Health Service (NHS) setting. Evidence-based intervention techniques will be identified for the prioritised factors and combined into a deliverable intervention package. Key stakeholders will comment on the intervention content and mode of delivery through focus groups, and the data will be used to refine the intervention. The acceptability and feasibility of the refined intervention will be evaluated in a future study. The study has been approved by an NHS Research Ethics Committee, REC Reference: 13/NI/0190. The findings of this study will be disseminated in peer-reviewed journals and through presentation at national and international conferences. UKCRN Study ID: 15939. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Implications of learning theory for developing programs to decrease overeating

PubMed Central

Boutelle, Kerri N.; Bouton, Mark E.

2015-01-01

Childhood obesity is associated with medical and psychological comorbidities, and interventions targeting overeating could be pragmatic and have a significant impact on weight. Calorically dense foods are easily available, variable, and tasty which allows for effective opportunities to learn to associate behaviors and cues in the environment with food through fundamental conditioning processes, resulting in measurable psychological and physiological food cue reactivity in vulnerable children. Basic research suggests that initial learning is difficult to erase, and that it is vulnerable to a number of phenomena that will allow the original learning to re-emerge after it is suppressed or replaced. These processes may help explain why it may be difficult to change food cue reactivity and overeating over the long term. Extinction theory may be used to develop effective cue-exposure treatments to decrease food cue reactivity through inhibitory learning, although these processes are complex and require an integral understanding of the theory and individual differences. Additionally, learning theory can be used to develop other interventions that may prove to be useful. Through an integration of learning theory, basic and translational research, it may be possible to develop interventions that can decrease the urges to overeat, and improve the weight status of children. PMID:25998235

Children with medical complexity: a scoping review of interventions to support caregiver stress.

PubMed

Edelstein, H; Schippke, J; Sheffe, S; Kingsnorth, S

2017-05-01

Caring for children with chronic and complex medical needs places extraordinary stress on parents and other family members. A scoping review was undertaken to identify and describe the full range of current interventions for reducing caregiver stress. Applying a broad definition of caregiver stress, a systematic search of three scientific databases (CINAHL, Embase and Ovid Medline), a general internet search and hand searching of key peer-reviewed articles were conducted. Inclusion criteria were as follows: (i) published in English between 2004-2016; (ii) focused on familial caregivers, defined as parents, siblings or extended family; (iii) targeted children/youth with medical complexity between the ages of 1-24 years; and (iv) described an intervention and impact on caregiver stress. Data on type of intervention, study design and methods, measures and overall findings were extracted. Forty-nine studies were included from a list of 22 339 unique titles. Six domains of interventions were found: care coordination models (n = 23); respite care (n = 8); telemedicine (n = 5); peer and emotional support (n = 6); insurance and employment benefits (n = 4); and health and related supports (n = 3). Across studies, there was a wide variety of designs, outcomes and measures used. Positive findings of reductions in caregiver stress were noted within an emerging body of evidence on effective interventions for families of children with medical complexity. A commonality across domains was a significant focus on streamlining services and reducing the burden of care related to varied pressures experienced, including time, finances, care needs and service access, among others. There was non-conclusive evidence however around which of the six identified intervention domains or combination thereof are most effective for reducing stress. These promising findings demonstrate that stress reduction is possible with the right support and that multiple interventions may be effective in reducing burdens of care experienced by families of children with medical complexity. © 2016 John Wiley & Sons Ltd.

A Pragmatic Approach to Guide Implementation Evaluation Research: Strategy Mapping for Complex Interventions.

PubMed

Huynh, Alexis K; Hamilton, Alison B; Farmer, Melissa M; Bean-Mayberry, Bevanne; Stirman, Shannon Wiltsey; Moin, Tannaz; Finley, Erin P

2018-01-01

Greater specification of implementation strategies is a challenge for implementation science, but there is little guidance for delineating the use of multiple strategies involved in complex interventions. The Cardiovascular (CV) Toolkit project entails implementation of a toolkit designed to reduce CV risk by increasing women's engagement in appropriate services. The CV Toolkit project follows an enhanced version of Replicating Effective Programs (REP), an evidence-based implementation strategy, to implement the CV Toolkit across four phases: pre-conditions, pre-implementation, implementation, and maintenance and evolution. Our current objective is to describe a method for mapping implementation strategies used in real time as part of the CV Toolkit project. This method supports description of the timing and content of bundled strategies and provides a structured process for developing a plan for implementation evaluation. We conducted a process of strategy mapping to apply Proctor and colleagues' rubric for specification of implementation strategies, constructing a matrix in which we identified each implementation strategy, its conceptual group, and the corresponding REP phase(s) in which it occurs. For each strategy, we also specified the actors involved, actions undertaken, action targets, dose of the implementation strategy, and anticipated outcome addressed. We iteratively refined the matrix with the implementation team, including use of simulation to provide initial validation. Mapping revealed patterns in the timing of implementation strategies within REP phases. Most implementation strategies involving the development of stakeholder interrelationships and training and educating stakeholders were introduced during the pre-conditions or pre-implementation phases. Strategies introduced in the maintenance and evolution phase emphasized communication, re-examination, and audit and feedback. In addition to its value for producing valid and reliable process evaluation data, mapping implementation strategies has informed development of a pragmatic blueprint for implementation and longitudinal analyses and evaluation activities. We update recent recommendations on specification of implementation strategies by considering the implications for multi-strategy frameworks and propose an approach for mapping the use of implementation strategies within complex, multi-level interventions, in support of rigorous evaluation. Developing pragmatic tools to aid in operationalizing the conduct of implementation and evaluation activities is essential to enacting sound implementation research.

Psycho-Cognitive Intervention for ASD from Cross-Species Behavioral Analyses of Infants, Chicks and Common Marmosets.

PubMed

Koshiba, Mamiko; Karino, Genta; Mimura, Koki; Nakamura, Shun; Yui, Kunio; Kunikata, Tetsuya; Yamanouchi, Hideo

2016-01-01

Educational treatment to support social development of children with autism spectrum disorder (ASD) is an important topic in developmental psychiatry. However, it remains difficult to objectively quantify the socio-emotional development of ASD children. To address this problem, we developed a novel analytical method that assesses subjects' complex behaviors using multivariate analysis, 'Behavior Output analysis for Quantitative Emotional State Translation' (BOUQUET). Here, we examine the potential for psycho-cognitive ASD therapy based on comparative evaluations of clinical (human) and experimental (animal) models. Our observations of ASD children (vs. their normally developing siblings) and the domestic chick in socio-sensory deprivation models show the importance of unimodal sensory stimulation, particularly important for tactile- and auditory-biased socialization. Identifying psycho-cognitive elements in early neural development, human newborn infants in neonatal intensive care unit as well as a New World monkey, the common marmoset, also prompted us to focus on the development of voluntary movement against gravity. In summary, striking behavioral similarities between children with ASD and domestic chicks' socio-sensory deprivation models support the role of multimodal sensory-motor integration as a prerequisite step for normal development of socio-emotional and psycho-cognitive functions. Data obtained in the common marmoset model also suggest that switching from primitive anti-gravity reflexes to complex voluntary movement may be a critical milestone for psycho-cognitive development. Combining clinical findings with these animal models, and using multivariate integrative analyses may facilitate the development of effective interventions to improve social functions in infants and in children with neurodevelopmental disorders.

AAC Intervention as an Immersion Model

ERIC Educational Resources Information Center

Dodd, Janet L.; Gorey, Megan

2014-01-01

Augmentative and alternative communication based interventions support individuals with complex communication needs in becoming effective and efficient communicators. However, there is often a disconnect between language models, communication opportunities, and desired intervention outcomes in the intervention process. This article outlines a…

DNA methylation in complex disease: applications in nursing research, practice, and policy.

PubMed

Wright, Michelle L; Ralph, Jody L; Ohm, Joyce E; Anderson, Cindy M

2013-01-01

DNA methylation is an epigenomic modification that is essential to normal human development and biological processes. DNA methylation patterns are heritable and dynamic throughout the life span. Environmental exposures can alter DNA methylation patterns, contributing to the development of complex disease. Identification and modulation of environmental factors influencing disease susceptibility through alterations in DNA methylation are amenable to nursing intervention and form the basis for individualized patient care. Here we describe the evidence supporting the translation of DNA methylation analyses as a tool for screening, diagnosis, and treatment of complex disease in nursing research and practice. The ethical, legal, social, and economic considerations of advances in genomics are considered as a model for epigenomic policy. We conclude that contemporary and informed nurse scientists and clinicians are uniquely poised to apply innovations in epigenomic research to clinical populations and develop appropriate policies that guide equitable and ethical use of new strategies to improve patient care. Copyright © 2013 Elsevier Inc. All rights reserved.

The Cancer, Educate to Prevent Model-the Potential of School Environment for Primary Prevention of Cancer.

PubMed

Barros, A; Santos, H; Moreira, L; Ribeiro, N; Silva, L; Santos-Silva, F

2016-12-01

Cancer represents one of the main causes of death worldwide; consequently, preventive interventions are of utmost importance in public health education. The leading model of cancer prevention campaigns is based on general and undifferentiated actions mediated by health professionals, focusing on the technical and scientific information but rather ineffective in changing the symbolic, cognitive and practical relationship with the disease. New intervention models are thus required to address cancer literacy, being early interventions targeted to specific groups an elective counterpoint to contribute to positive and durable changes in cancer prevention. Our aim is to evaluate the feasibility and impact of cancer prevention programmes planned as focused interventions in restricted targets and mediated by non-healthcare professionals to increase cancer literacy and promote preventive behaviours. This pilot study evaluates schools' potential as a vehicle for cancer prevention education in a reality shaped by traditional health prevention campaigns. We developed a protocol of systematic surveying in order to review and, in the future, optimize and replicate this ecological model of intervention to other groups and contexts. The implementation of this model has been successful in which concerns to the effectiveness of the training programme for teachers. This led to the development of impactful cancer prevention education projects by trainees targeted to their students, allowing us to argue that it contributes to knowledge and practice in this complex as consensual priority area of intervention.

The development of a lay health worker delivered collaborative community based intervention for people with schizophrenia in India

PubMed Central

2012-01-01

Background Care for schizophrenia in low and middle income countries is predominantly facility based and led by specialists, with limited use of non-pharmacological treatments. Although community based psychosocial interventions are emphasised, there is little evidence about their acceptability and feasibility. Furthermore, the shortage of skilled manpower is a major barrier to improving access to these interventions. Our study aimed to develop a lay health worker delivered community based intervention in three sites in India. This paper describes how the intervention was developed systematically, following the MRC framework for the development of complex interventions. Methods We reviewed the lierature on the burden of schizophrenia and the treatment gap in low and middle income countries and the evidence for community based treatments, and identified intervention components. We then evaluated the acceptability and feasibility of this package of care through formative case studies with individuals with schizophrenia and their primary caregivers and piloted its delivery with 30 families. Results Based on the reviews, our intervention comprised five components (psycho-education; adherence management; rehabilitation; referral to community agencies; and health promotion) to be delivered by trained lay health workers supervised by specialists. The intervention underwent a number of changes as a result of formative and pilot work. While all the components were acceptable and most were feasible, experiences of stigma and discrimination were inadequately addressed; some participants feared that delivery of care at home would lead to illness disclosure; some participants and providers did not understand how the intervention related to usual care; some families were unwilling to participate; and there were delivery problems, for example, in meeting the targeted number of sessions. Participants found delivery by health workers acceptable, and expected them to have knowledge about the subject matter. Some had expectations regarding their demographic and personal characteristics, for example, preferring only females or those who are understanding/friendly. New components to address stigma were then added to the intervention, the collaborative nature of service provision was strengthened, a multi-level supervision system was developed, and delivery of components was made more flexible. Criteria were evolved for the selection and training of the health workers based on participants' expectations. Conclusions A multi-component community based intervention, targeting multiple outcomes, and delivered by trained lay health workers, supervised by mental health specialists, is an acceptable and feasible intervention for treating schizophrenia in India. PMID:22340662

An overview of the nature, causes, and consequences of abusive family relationships. Toward differentiating maltreatment and violence.

PubMed

Emery, R E; Laumann-Billings, L

1998-02-01

Despite gaps in research, this review argues for distinguishing family maltreatment from family violence, a differentiation between minimal or moderate abuse and serious endangerment, physical injury, or sexual violation. Most acts now defined as violent or abusive are moderate, and stressful life circumstances contribute to their development. Research suggests that abuse may develop through multiple pathways. The consequences of abuse appear to be general, but more commonalities may be found by examining more subtle and complex effects. Many interventions have attempted to prevent or treat family violence and its consequences, and several show promise. More systematic research is needed, but several changes in intervention seem warranted now. For instance, (a) mental health professionals should not be required to report maltreatment while a family is engaged in therapy; (b) the social service system needs to rediscover its roots in supporting families under stress, including in cases of moderate maltreatment; and (c) swift and decisive legal intervention is needed in cases of serious family violence.

Partnership work between Public Health and Health Psychology: introduction to a novel training programme

PubMed Central

2010-01-01

Background Public health services implement individual, community and population level interventions to change health behaviours, improve healthy life expectancy and reduce health inequalities. Understanding and changing health behaviour is complex. Integrating behaviour change theory and evidence into interventions has the potential to improve services. Methods Health Psychologists apply evidence and theories aimed at understanding and changing health behaviour. A Scottish programme is piloting the training of Health Psychologists within NHS contexts to address prominent public health challenges. Results This article outlines the details of this novel programme. Two projects are examined to illustrate the potential of partnership working between public health and health psychology. Conclusion In order to develop and improve behaviour change interventions and services, public health planners may want to consider developing and using the knowledge and skills of Health Psychologists. Supporting such training within public health contexts is a promising avenue to build critical NHS internal mass to tackle the major public health challenges ahead. PMID:21070643

Implementation of knowledge-based palliative care in nursing homes and pre-post post evaluation by cross-over design: a study protocol.

PubMed

Ahlström, Gerd; Nilsen, Per; Benzein, Eva; Behm, Lina; Wallerstedt, Birgitta; Persson, Magnus; Sandgren, Anna

2018-03-22

The demography of the world is changing as the population is ageing. Because of this change to a higher proportion of older people, the WHO has called for improved palliative care for older persons. A large number of all deaths in the industrialised world occur while older people are living in nursing homes and therefore a key question becomes how the principles of palliative care can be implemented in that context. The aims of this study are: a) to describe a model of an educational intervention with the goal of implementing knowledge-based palliative care in nursing homes, and b) to describe the design of the evaluation of the effectiveness regarding the implementation of knowledge-based palliative care. A complex intervention is evaluated by means of a cross-over design. An educational intervention concerning palliative care consisting of five seminars during 6 months for staff and managers has been developed and conducted in 20 nursing homes in two counties. Before the intervention started, the feasibility was tested in a pilot study conducted in nursing homes not included in the main study. The intervention is evaluated through a non-randomized experimental design with intervention and control groups and pre- and post-assessments. The evaluation includes older persons living in nursing homes, next-of-kin, staff and managers. Data collection consists of quantitative methods such as questionnaires and register data and qualitative methods in the form of individual interviews, focus-group interviews and participant observations. The research will contribute to new knowledge about how to implement knowledge-based palliative care in a nursing home setting. A strength of this project is that the Medical Research Council framework of complex intervention is applied. The four recommended stages, Development, Feasibility and piloting, Evaluation and Implementation, are combined for the educational intervention, which functions as a strategy to achieve knowledge-based palliative care in the nursing homes. Implementation is always a question of change and a good theoretical understanding is needed for drawing valid conclusions about the causal mechanisms of change. The topic is highly relevant considering the world's ageing population. The data collection is completed and the analysis is ongoing. NCT02708498 .

Understanding how pain education causes changes in pain and disability: protocol for a causal mediation analysis of the PREVENT trial.

PubMed

Lee, Hopin; Moseley, G Lorimer; Hübscher, Markus; Kamper, Steven J; Traeger, Adrian C; Skinner, Ian W; McAuley, James H

2015-07-01

Pain education is a complex intervention developed to help clinicians manage low back pain. Although complex interventions are usually evaluated by their effects on outcomes, such as pain or disability, most do not directly target these outcomes; instead, they target intermediate factors that are presumed to be associated with the outcomes. The mechanisms underlying treatment effects, or the effect of an intervention on an intermediate factor and its subsequent effect on outcome, are rarely investigated in clinical trials. This leaves a gap in the evidence for understanding how treatments exert their effects on outcomes. Mediation analysis provides a method for identifying and quantifying the mechanisms that underlie interventions. To determine whether the effect of pain education on pain and disability is mediated by changes in self-efficacy, catastrophisation and back pain beliefs. Causal mediation analysis of the PREVENT randomised controlled trial. Two hundred and two participants with acute low back pain from primary care clinics in the Sydney metropolitan area. Participants will be randomised to receive either 'pain education' (intervention group) or 'sham education' (control group). All outcome measures (including patient characteristics), primary outcome measures (pain and disability), and putative mediating variables (self-efficacy, catastrophisation and back pain beliefs) will be measured prior to randomisation. Putative mediators and primary outcome measures will be measured 1 week after the intervention, and primary outcome measures will be measured 3 months after the onset of low back pain. Causal mediation analysis under the potential outcomes framework will be used to test single and multiple mediator models. A sensitivity analysis will be conducted to evaluate the robustness of the estimated mediation effects on the influence of violating sequential ignorability--a critical assumption for causal inference. Mediation analysis of clinical trials can estimate how much the total effect of the treatment on the outcome is carried through an indirect path. Using mediation analysis to understand these mechanisms can generate evidence that can be used to tailor treatments and optimise treatment effects. In this study, the causal mediation effects of a pain education intervention for acute non-specific low back pain will be estimated. This knowledge is critical for further development and refinement of interventions for conditions such as low back pain. Copyright © 2015 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.

A realist review of one-to-one breastfeeding peer support experiments conducted in developed country settings.

PubMed

Trickey, Heather; Thomson, Gill; Grant, Aimee; Sanders, Julia; Mann, Mala; Murphy, Simon; Paranjothy, Shantini

2018-01-01

The World Health Organisation guidance recommends breastfeeding peer support (BFPS) as part of a strategy to improve breastfeeding rates. In the UK, BFPS is supported by National Institute for Health and Care Excellence guidance and a variety of models are in use. The experimental evidence for BFPS in developed countries is mixed and traditional methods of systematic review are ill-equipped to explore heterogeneity, complexity, and context influences on effectiveness. This review aimed to enhance learning from the experimental evidence base for one-to-one BFPS intervention. Principles of realist review were applied to intervention case studies associated with published experimental studies. The review aimed (a) to explore heterogeneity in theoretical underpinnings and intervention design for one-to-one BFPS intervention; (b) inform design decisions by identifying transferable lessons developed from cross-case comparison of context-mechanism-outcome relationships; and (c) inform evaluation design by identifying context-mechanism-outcome relationships associated with experimental conditions. Findings highlighted poor attention to intervention theory and considerable heterogeneity in BFPS intervention design. Transferable mid-range theories to inform design emerged, which could be grouped into seven categories: (a) congruence with local infant feeding norms, (b) integration with the existing system of health care, (c) overcoming practical and emotional barriers to access, (d) ensuring friendly, competent, and proactive peers, (e) facilitating authentic peer-mother interactions, (f) motivating peers to ensure positive within-intervention amplification, and (g) ensuring positive legacy and maintenance of gains. There is a need to integrate realist principles into evaluation design to improve our understanding of what forms of BFPS work, for whom and under what circumstances. © 2017 John Wiley & Sons Ltd.

Development and preliminary evaluation of a rehabilitation consult for survivors of head and neck cancer: an intervention mapping protocol.

PubMed

McEwen, Sara E; Davis, Aileen M; Jones, Jennifer M; Martino, Rosemary; Poon, Ian; Rodriguez, Ana Maria; Ringash, Jolie

2015-01-09

Evidence suggests that rehabilitation interventions can improve function and quality of life in survivors of head and neck cancer (HNC), but there is a lack of coordinated, integrated services, and those offered are inconsistent. To address these gaps, we will develop and conduct preliminary evaluation of a rehabilitation consult, built on the theoretical foundations of goal setting and self-management, and composed of a brief functional evaluation, a resource compendium, and collaborative goal-setting and action planning processes. The development of the rehabilitation consult will be guided by intervention mapping, which consists of six steps: 1. Needs assessment; 2. Definition of program objectives; 3. Selection of theory-based intervention methods; 4. Production and pretesting; 5. Adoption, implementation and sustainability planning; 6. Process and effect evaluation. Within the intervention mapping framework, an iterative process of constructing drafts and mini-evaluations with consumers and experts will be used, modifying the rehabilitation consult intervention until a version suitable for formal evaluation is established. The rehabilitation consult will then be evaluated using a prospective, mixed method, single group design with 30 survivors of head and neck cancer. Outcomes will be assessed pre- and post-intervention and at 6-month follow-up. Survivors of head and neck cancer have among the most complex rehabilitation needs of all cancer patients. The rehabilitation consult is expected to improve knowledge and uptake of rehabilitation resources and strategies in survivors of head and neck cancer and thereby improve long-term function and quality of life. If the rehabilitation consult is effective in cancer patients with such high and diverse needs, this project will produce a toolkit that will be adaptable for other types of cancer in other jurisdictions.

Modelling the Interplay between Lifestyle Factors and Genetic Predisposition on Markers of Type 2 Diabetes Mellitus Risk.

PubMed

Walker, Celia G; Solis-Trapala, Ivonne; Holzapfel, Christina; Ambrosini, Gina L; Fuller, Nicholas R; Loos, Ruth J F; Hauner, Hans; Caterson, Ian D; Jebb, Susan A

2015-01-01

The risk of developing type 2 diabetes mellitus (T2DM) is determined by a complex interplay involving lifestyle factors and genetic predisposition. Despite this, many studies do not consider the relative contributions of this complex array of factors to identify relationships which are important in progression or prevention of complex diseases. We aimed to describe the integrated effect of a number of lifestyle changes (weight, diet and physical activity) in the context of genetic susceptibility, on changes in glycaemic traits in overweight or obese participants following 12-months of a weight management programme. A sample of 353 participants from a behavioural weight management intervention were included in this study. A graphical Markov model was used to describe the impact of the intervention, by dividing the effects into various pathways comprising changes in proportion of dietary saturated fat, physical activity and weight loss, and a genetic predisposition score (T2DM-GPS), on changes in insulin sensitivity (HOMA-IR), insulin secretion (HOMA-B) and short and long term glycaemia (glucose and HbA1c). We demonstrated the use of graphical Markov modelling to identify the importance and interrelationships of a number of possible variables changed as a result of a lifestyle intervention, whilst considering fixed factors such as genetic predisposition, on changes in traits. Paths which led to weight loss and change in dietary saturated fat were important factors in the change of all glycaemic traits, whereas the T2DM-GPS only made a significant direct contribution to changes in HOMA-IR and plasma glucose after considering the effects of lifestyle factors. This analysis shows that modifiable factors relating to body weight, diet, and physical activity are more likely to impact on glycaemic traits than genetic predisposition during a behavioural intervention.

Improving the simple, complicated and complex realities of community-acquired pneumonia.

PubMed

Liu, S K; Homa, K; Butterly, J R; Kirkland, K B; Batalden, P B

2009-04-01

This paper first describes efforts to improve the care for patients hospitalised with community-acquired pneumonia and the associated changes in quality measures at a rural academic medical centre. The results of the improvement interventions and the associated clinical realities, expected outcomes, measures, improvement interventions and improvement aims are then re-examined using the Glouberman and Zimmerman typology of healthcare problems--simple, complicated and complex. The typology is then used to explore the future design and assessment of improvement interventions, which may allow better matching with the types of problem healthcare providers and organisations are confronted with. Matching improvement interventions with problem category has the possibility of improving the success of improvement efforts and the reliability of care while at the same time preserving needed provider autonomy and judgement to adapt care for more complex problems.

Expanding the base for teaching of percutaneous coronary interventions: the explicit approach.

PubMed

Lanzer, Peter; Prechelt, Lutz

2011-02-15

Accelerate and improve the training and learning process of operators performing percutaneous coronary interventions (PCI). Operator cognitive, in particular decision-making skills and technical skills are a major factor for the success of coronary interventions. Currently, cognitive skills are commonly developed by three methods: (1) Cognitive learning of rules for which statistical evidence is available. This is very incomprehensive and isolates cognitive learning from skill acquisition. (2) Informal tutoring received from experienced operators, and (3) personal experience by trial-and-error are both very slow. We propose in this concept article a conceptual framework to elicit, capture, and transfer expert PCI skills to complement the current approach. This includes the development of an in-depth understanding of the nature of PCI skills, terminology, and nomenclature needed to streamline communication, propensity of reproducible performance assessment, and in particular an explication of intervention planning and intra-intervention decision-making. We illustrate the impact of improved decision-making by simulation results based on a stochastic model of intervention risk. We identify several key concepts that form the basis of this conceptual framework, in particular different risk types and the notions of strategy, interventional module, and tactic. The increasing complexity of cases have brought PCI to the point where the decision-making skills of master operators need to be made explicit to make them systematically learnable such that the skills of beginner and intermediate operators can be improved much faster than is currently possible. Copyright © 2010 Wiley-Liss, Inc.

Using logic model methods in systematic review synthesis: describing complex pathways in referral management interventions

PubMed Central

2014-01-01

Background There is increasing interest in innovative methods to carry out systematic reviews of complex interventions. Theory-based approaches, such as logic models, have been suggested as a means of providing additional insights beyond that obtained via conventional review methods. Methods This paper reports the use of an innovative method which combines systematic review processes with logic model techniques to synthesise a broad range of literature. The potential value of the model produced was explored with stakeholders. Results The review identified 295 papers that met the inclusion criteria. The papers consisted of 141 intervention studies and 154 non-intervention quantitative and qualitative articles. A logic model was systematically built from these studies. The model outlines interventions, short term outcomes, moderating and mediating factors and long term demand management outcomes and impacts. Interventions were grouped into typologies of practitioner education, process change, system change, and patient intervention. Short-term outcomes identified that may result from these interventions were changed physician or patient knowledge, beliefs or attitudes and also interventions related to changed doctor-patient interaction. A range of factors which may influence whether these outcomes lead to long term change were detailed. Demand management outcomes and intended impacts included content of referral, rate of referral, and doctor or patient satisfaction. Conclusions The logic model details evidence and assumptions underpinning the complex pathway from interventions to demand management impact. The method offers a useful addition to systematic review methodologies. Trial registration number PROSPERO registration number: CRD42013004037. PMID:24885751

Using logic model methods in systematic review synthesis: describing complex pathways in referral management interventions.

PubMed

Baxter, Susan K; Blank, Lindsay; Woods, Helen Buckley; Payne, Nick; Rimmer, Melanie; Goyder, Elizabeth

2014-05-10

There is increasing interest in innovative methods to carry out systematic reviews of complex interventions. Theory-based approaches, such as logic models, have been suggested as a means of providing additional insights beyond that obtained via conventional review methods. This paper reports the use of an innovative method which combines systematic review processes with logic model techniques to synthesise a broad range of literature. The potential value of the model produced was explored with stakeholders. The review identified 295 papers that met the inclusion criteria. The papers consisted of 141 intervention studies and 154 non-intervention quantitative and qualitative articles. A logic model was systematically built from these studies. The model outlines interventions, short term outcomes, moderating and mediating factors and long term demand management outcomes and impacts. Interventions were grouped into typologies of practitioner education, process change, system change, and patient intervention. Short-term outcomes identified that may result from these interventions were changed physician or patient knowledge, beliefs or attitudes and also interventions related to changed doctor-patient interaction. A range of factors which may influence whether these outcomes lead to long term change were detailed. Demand management outcomes and intended impacts included content of referral, rate of referral, and doctor or patient satisfaction. The logic model details evidence and assumptions underpinning the complex pathway from interventions to demand management impact. The method offers a useful addition to systematic review methodologies. PROSPERO registration number: CRD42013004037.

Adolescent development and risk of injury: Using developmental science to improve interventions

PubMed Central

Johnson, Sara B.; Jones, Vanya C.

2015-01-01

In adolescence, there is a complex interaction among physical, cognitive, and psychosocial developmental processes, culminating in greater risk-taking and novelty-seeking. Concurrently, adolescents face an increasingly demanding environment, which results in heightened vulnerability to injury. In this paper, we provide an overview of developmental considerations for adolescent injury interventions based on developmental science including findings from behavioral neuroscience and psychology. We examine the role that typical developmental processes play in the way adolescents perceive and respond to risk and how this integrated body of developmental research adds to our understanding of how to do injury prevention with adolescents. We then highlight strategies to improve the translation of developmental research into adolescent injury prevention practice, calling on examples of existing interventions including graduated driver licensing. PMID:20876765

Confronting structural violence in sex work: lessons from a community-led HIV prevention project in Mysore, India.

PubMed

Argento, Elena; Reza-Paul, Sushena; Lorway, Robert; Jain, Jinendra; Bhagya, M; Fathima, Mary; Sreeram, S V; Hafeezur, Rahman Syed; O'Neil, John

2011-01-01

Evidence from community-led HIV prevention projects suggests that structural interventions may result in reduced rates of HIV and STIs. The complex relationship between empowerment and confronting stigma, discrimination and physical abuse necessitates further investigation into the impact that such interventions have on the personal risks for sex workers. This article aims to describe lived experiences of members from a sex worker's collective in Mysore, India and how they have confronted structural violence. The narratives highlight experiences of violence and the development and implementation of strategies that have altered the social, physical, and emotional environment for sex workers. Building an enabling environment was key to reducing personal risks inherent to sex work, emphasizing the importance of community-led structural interventions for sex workers in India.

Natural Compounds as a Therapeutic Intervention following Traumatic Brain Injury: The Role of Phytochemicals.

PubMed

Scheff, Stephen W; Ansari, Mubeen A

2017-04-15

There has been a tremendous focus on the discovery and development of neuroprotective agents that might have clinical relevance following traumatic brain injury (TBI). This type of brain injury is very complex and is divided into two major components. The first component, a primary injury, occurs at the time of impact and is the result of the mechanical insult itself. This primary injury is thought to be irreversible and resistant to most treatments. A second component or secondary brain injury, is defined as cellular damage that is not immediately obvious after trauma, but that develops after a delay of minutes, hours, or even days. This injury appears to be amenable to treatment. Because of the complexity of the secondary injury, any type of therapeutic intervention needs to be multi-faceted and have the ability to simultaneously modulate different cellular changes. Because of diverse pharmaceutical interactions, combinations of different drugs do not work well in concert and result in adverse physiological conditions. Research has begun to investigate the possibility of using natural compounds as a therapeutic intervention following TBI. These compounds normally have very low toxicity and have reduced interactions with other pharmaceuticals. In addition, many natural compounds have the potential to target numerous different components of the secondary injury. Here, we review 33 different plant-derived natural compounds, phytochemicals, which have been investigated in experimental animal models of TBI. Some of these phytochemicals appear to have potential as possible therapeutic interventions to offset key components of the secondary injury cascade. However, not all studies have used the same scientific rigor, and one should be cautious in the interpretation of studies using naturally occurring phytochemical in TBI research.

Effectiveness of training in evidence-based medicine skills for healthcare professionals: a systematic review.

PubMed

Hecht, Lars; Buhse, Susanne; Meyer, Gabriele

2016-04-04

Basic skills in evidence-based medicine (EbM) are indispensable for healthcare professionals to promote consumer-centred, evidence-based treatment. EbM training courses are complex interventions - a fact that has not been methodologically reflected by previous systematic reviews. This review evaluates the effects of EbM training for healthcare professionals as well as the quality of reporting of such training interventions. We searched PubMed, EMBASE, CINAHL, Cochrane Library, ERIC, Campbell Library and PsycINFO up to 9/2014. Randomised controlled trials, controlled clinical trials as well as before-after trials were included. Authors were contacted in order to obtain missing data. Two independent reviewers extracted data and assessed risk of bias. We reviewed 14.507 articles; n = 61 appeared potentially eligible; n = 13 involving 1,120 participants were included. EbM training shows some impact on knowledge and skills, whereas the impact on practical EbM application remains unclear. Risk of bias of included trials raises uncertainty about the effects. Description of complex interventions was poor. EbM training has some positive effects on knowledge and skills of healthcare professionals. Appropriate methods for development, piloting, evaluation, reporting and implementation of the training should be applied.

Health system capacity: maternal health policy implementation in the state of Gujarat, India

PubMed Central

Sanneving, Linda; Kulane, Asli; Iyer, Aditi; Ahgren, Bengt

2013-01-01

Introduction The Government of Gujarat has for the past couple of decades continuously initiated several interventions to improve access to care for pregnant and delivering women within the state. Data from the last District Family Heath survey in Gujarat in 2007–2008 show that 56.4% of women had institutional deliveries and 71.5% had at least one antenatal check-up, indicating that challenges remain in increasing use of and access to maternal health care services. Objective To explore the perceptions of high-level stakeholders on the process of implementing maternal health interventions in Gujarat. Method Using the policy triangle framework developed by Walt and Gilson, the process of implementation was approached using in-depth interviews and qualitative content analysis. Result Based on the analysis, three themes were developed: lack of continuity; the complexity of coordination; and lack of confidence and underutilization of the monitoring system. The findings suggest that decisions made and actions advocated and taken are more dependent on individual actors than on sustainable structures. The findings also indicate that the context in which interventions are implemented is challenged in terms of weak coordination and monitoring systems that are not used to evaluate and develop interventions on maternal health. Conclusions The implementation of interventions on maternal health is dependent on the capacity of the health system to implement evidence-based policies. The capacity of the health system in Gujarat to facilitate implementation of maternal health interventions needs to be improved, both in terms of the role of actors and in terms of structures and processes. PMID:23522352

Knowledge translation strategies to improve the use of evidence in public health decision making in local government: intervention design and implementation plan

PubMed Central

2013-01-01

Background Knowledge translation strategies are an approach to increase the use of evidence within policy and practice decision-making contexts. In clinical and health service contexts, knowledge translation strategies have focused on individual behavior change, however the multi-system context of public health requires a multi-level, multi-strategy approach. This paper describes the design of and implementation plan for a knowledge translation intervention for public health decision making in local government. Methods Four preliminary research studies contributed findings to the design of the intervention: a systematic review of knowledge translation intervention effectiveness research, a scoping study of knowledge translation perspectives and relevant theory literature, a survey of the local government public health workforce, and a study of the use of evidence-informed decision-making for public health in local government. A logic model was then developed to represent the putative pathways between intervention inputs, processes, and outcomes operating between individual-, organizational-, and system-level strategies. This formed the basis of the intervention plan. Results The systematic and scoping reviews identified that effective and promising strategies to increase access to research evidence require an integrated intervention of skill development, access to a knowledge broker, resources and tools for evidence-informed decision making, and networking for information sharing. Interviews and survey analysis suggested that the intervention needs to operate at individual and organizational levels, comprising workforce development, access to evidence, and regular contact with a knowledge broker to increase access to intervention evidence; develop skills in appraisal and integration of evidence; strengthen networks; and explore organizational factors to build organizational cultures receptive to embedding evidence in practice. The logic model incorporated these inputs and strategies with a set of outcomes to measure the intervention’s effectiveness based on the theoretical frameworks, evaluation studies, and decision-maker experiences. Conclusion Documenting the design of and implementation plan for this knowledge translation intervention provides a transparent, theoretical, and practical approach to a complex intervention. It provides significant insights into how practitioners might engage with evidence in public health decision making. While this intervention model was designed for the local government context, it is likely to be applicable and generalizable across sectors and settings. Trial registration Australia New Zealand Clinical Trials Register ACTRN12609000953235. PMID:24107358

Interventions in randomised controlled trials in surgery: issues to consider during trial design.

PubMed

Blencowe, Natalie S; Brown, Julia M; Cook, Jonathan A; Metcalfe, Chris; Morton, Dion G; Nicholl, Jon; Sharples, Linda D; Treweek, Shaun; Blazeby, Jane M

2015-09-04

Until recently, insufficient attention has been paid to the fact that surgical interventions are complex. This complexity has several implications, including the way in which surgical interventions are described and delivered in trials. In order for surgeons to adopt trial findings, interventions need to be described in sufficient detail to enable accurate replication; however, it may be permissible to allow some aspects to be delivered according to local practice. Accumulating work in this area has identified the need for general guidance on the design of surgical interventions in trial protocols and reports. Key issues to consider when designing surgical interventions include the identification of each surgical intervention and their components, who will deliver the interventions, and where and how the interventions will be standardised and monitored during the trial. The trial design (pragmatic and explanatory), comparator and stage of innovation may also influence the extent of detail required. Thoughtful consideration of surgical interventions in this way may help with the interpretation of trial results and the adoption of successful interventions into clinical practice.

Achieving Developmental Synchrony in Young Children With Hearing Loss

PubMed Central

Mellon, Nancy K.; Ouellette, Meredith; Greer, Tracy; Gates-Ulanet, Patricia

2009-01-01

Children with hearing loss, with early and appropriate amplification and intervention, demonstrate gains in speech, language, and literacy skills. Despite these improvements many children continue to exhibit disturbances in cognitive, behavioral, and emotional control, self-regulation, and aspects of executive function. Given the complexity of developmental learning, educational settings should provide services that foster the growth of skills across multiple dimensions. Transdisciplinary intervention services that target the domains of language, communication, psychosocial functioning, motor, and cognitive development can promote academic and social success. Educational programs must provide children with access to the full range of basic skills necessary for academic and social achievement. In addition to an integrated curriculum that nurtures speech, language, and literacy development, innovations in the areas of auditory perception, social emotional learning, motor development, and vestibular function can enhance student outcomes. Through ongoing evaluation and modification, clearly articulated curricular approaches can serve as a model for early intervention and special education programs. The purpose of this article is to propose an intervention model that combines best practices from a variety of disciplines that affect developmental outcomes for young children with hearing loss, along with specific strategies and approaches that may help to promote optimal development across domains. Access to typically developing peers who model age-appropriate skills in language and behavior, small class sizes, a co-teaching model, and a social constructivist perspective of teaching and learning, are among the key elements of the model. PMID:20150187

Parent perspectives and preferences for strategies regarding nonsedated MRI scans in a pediatric oncology population.

PubMed

Walker, Breya; Conklin, Heather M; Anghelescu, Doralina L; Hall, Lacey P; Reddick, Wilburn E; Ogg, Robert; Jacola, Lisa M

2018-06-01

Children with cancer frequently require MRI scans for clinical purposes. Sedation with general anesthesia (GA) is often used to promote compliance, reduce motion, and alleviate anxiety. The use of GA for MRI scans is costly in terms of time, personnel, and medications. In addition, prominent risks are associated with anesthesia exposure in patients with complex medical conditions. Successful behavioral interventions have been implemented in clinical research settings to promote scan success and compliance. To our knowledge, parent/caregiver acceptability of behavioral interventions to promote nonsedated MRI has not been systematically investigated in a medically complex population. As a first step toward developing a protocol-based intervention to promote nonsedated scanning, we conducted a survey to explore parental perspectives regarding acceptability of nonsedated scanning and to gain information regarding preference for specific behavioral interventions to facilitate nonsedated MRI exams. Parents or guardians of 101 patients diagnosed with childhood cancer participated in a semi-structured survey via telephone. The sample was stratified by age group (8-12 years; 13-18 years), gender, and diagnosis (solid tumor (ST), brain tumor (BT), and acute lymphoblastic leukemia (ALL)). The majority of parents indicated that nonsedated MRI scans would be acceptable. Reduced anesthesia exposure was the most frequently identified benefit, followed by decreased irritability post-MRI scan, and shorter appointment time. Challenges included fear of movement and noise during scans and change in routine, with parents of younger children and those with a history of sedated exams identifying more challenges. Behavioral intervention preference differed by patient age and gender; however, education was ranked as most preferred overall. Parents of children treated for cancer consider behavior interventions to promote nonsedated scanning as acceptable. Patient characteristics should be considered when tailoring behavioral interventions. Results can inform future studies of behavioral interventions to promote nonsedated MRI scans. Future research should also investigate the risks associated with failed exams, both in terms of patient medical care and cost effectiveness.

Implementing communication and decision-making interventions directed at goals of care: a theory-led scoping review.

PubMed

Cummings, Amanda; Lund, Susi; Campling, Natasha; May, Carl R; Richardson, Alison; Myall, Michelle

2017-10-06

To identify the factors that promote and inhibit the implementation of interventions that improve communication and decision-making directed at goals of care in the event of acute clinical deterioration. A scoping review was undertaken based on the methodological framework of Arksey and O'Malley for conducting this type of review. Searches were carried out in Medline and Cumulative Index to Nursing and Allied Health Literature (CINAHL) to identify peer-reviewed papers and in Google to identify grey literature. Searches were limited to those published in the English language from 2000 onwards. Inclusion and exclusion criteria were applied, and only papers that had a specific focus on implementation in practice were selected. Data extracted were treated as qualitative and subjected to directed content analysis. A theory-informed coding framework using Normalisation Process Theory (NPT) was applied to characterise and explain implementation processes. Searches identified 2619 citations, 43 of which met the inclusion criteria. Analysis generated six themes fundamental to successful implementation of goals of care interventions: (1) input into development; (2) key clinical proponents; (3) training and education; (4) intervention workability and functionality; (5) setting and context; and (6) perceived value and appraisal. A broad and diverse literature focusing on implementation of goals of care interventions was identified. Our review recognised these interventions as both complex and contentious in nature, making their incorporation into routine clinical practice dependent on a number of factors. Implementing such interventions presents challenges at individual, organisational and systems levels, which make them difficult to introduce and embed. We have identified a series of factors that influence successful implementation and our analysis has distilled key learning points, conceptualised as a set of propositions, we consider relevant to implementing other complex and contentious interventions. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

The Space From Heart Disease Intervention for People With Cardiovascular Disease and Distress: A Mixed-Methods Study

PubMed Central

Clifton, Abigail; Lee, Geraldine; Norman, Ian J; O'Callaghan, David; Tierney, Karen; Richards, Derek

2015-01-01

Background Poor self-management of symptoms and psychological distress leads to worse outcomes and excess health service use in cardiovascular disease (CVD). Online-delivered therapy is effective, but generic interventions lack relevance for people with specific long-term conditions, such as cardiovascular disease. Objective To develop a comprehensive online CVD-specific intervention to improve both self-management and well-being, and to test acceptability and feasibility. Methods Informed by the Medical Research Council (MRC) guidance for the development of complex interventions, we adapted an existing evidence-based generic intervention for depression and anxiety for people with CVD. Content was informed by a literature review of existing resources and trial evidence, and the findings of a focus group study. Think-aloud usability testing was conducted to identify improvements to design and content. Acceptability and feasibility were tested in a cross-sectional study. Results Focus group participants (n=10) agreed that no existing resource met all their needs. Improvements such as "collapse and expand" features were added based on findings that participants’ information needs varied, and specific information, such as detecting heart attacks and when to seek help, was added. Think-aloud testing (n=2) led to changes in font size and design changes around navigation. All participants of the cross-sectional study (10/10, 100%) were able to access and use the intervention. Reported satisfaction was good, although the intervention was perceived to lack relevance for people without comorbid psychological distress. Conclusions We have developed an evidence-based, theory-informed, user-led online intervention for improving self-management and well-being in CVD. The use of multiple evaluation tests informed improvements to content and usability. Preliminary acceptability and feasibility has been demonstrated. The Space from Heart Disease intervention is now ready to be tested for effectiveness. This work has also identified that people with CVD symptoms and comorbid distress would be the most appropriate sample for a future randomized controlled trial to evaluate its effectiveness. PMID:26133739