Application of Intervention Mapping to the Development of a Complex Physical Therapist Intervention.

PubMed

Jones, Taryn M; Dear, Blake F; Hush, Julia M; Titov, Nickolai; Dean, Catherine M

2016-12-01

Physical therapist interventions, such as those designed to change physical activity behavior, are often complex and multifaceted. In order to facilitate rigorous evaluation and implementation of these complex interventions into clinical practice, the development process must be comprehensive, systematic, and transparent, with a sound theoretical basis. Intervention Mapping is designed to guide an iterative and problem-focused approach to the development of complex interventions. The purpose of this case report is to demonstrate the application of an Intervention Mapping approach to the development of a complex physical therapist intervention, a remote self-management program aimed at increasing physical activity after acquired brain injury. Intervention Mapping consists of 6 steps to guide the development of complex interventions: (1) needs assessment; (2) identification of outcomes, performance objectives, and change objectives; (3) selection of theory-based intervention methods and practical applications; (4) organization of methods and applications into an intervention program; (5) creation of an implementation plan; and (6) generation of an evaluation plan. The rationale and detailed description of this process are presented using an example of the development of a novel and complex physical therapist intervention, myMoves-a program designed to help individuals with an acquired brain injury to change their physical activity behavior. The Intervention Mapping framework may be useful in the development of complex physical therapist interventions, ensuring the development is comprehensive, systematic, and thorough, with a sound theoretical basis. This process facilitates translation into clinical practice and allows for greater confidence and transparency when the program efficacy is investigated. © 2016 American Physical Therapy Association.

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

Managing Tensions between Evaluation and Research: Illustrative Cases of Developmental Evaluation in the Context of Research

ERIC Educational Resources Information Center

Rey, Lynda; Tremblay, Marie-Claude; Brousselle, Astrid

2014-01-01

Developmental evaluation (DE), essentially conceptualized by Patton over the past 30 years, is a promising evaluative approach intended to support social innovation and the deployment of complex interventions. Its use is often justified by the complex nature of the interventions being evaluated and the need to produce useful results in real time.…

Evaluation of complex community-based childhood obesity prevention interventions.

PubMed

Karacabeyli, D; Allender, S; Pinkney, S; Amed, S

2018-05-16

Multi-setting, multi-component community-based interventions have shown promise in preventing childhood obesity; however, evaluation of these complex interventions remains a challenge. The objective of the study is to systematically review published methodological approaches to outcome evaluation for multi-setting community-based childhood obesity prevention interventions and synthesize a set of pragmatic recommendations. MEDLINE, CINAHL and PsycINFO were searched from inception to 6 July 2017. Papers were included if the intervention targeted children ≤18 years, engaged at least two community sectors and described their outcome evaluation methodology. A single reviewer conducted title and abstract scans, full article review and data abstraction. Directed content analysis was performed by three reviewers to identify prevailing themes. Thirty-three studies were included, and of these, 26 employed a quasi-experimental design; the remaining were randomized control trials. Body mass index was the most commonly measured outcome, followed by health behaviour change and psychosocial outcomes. Six themes emerged, highlighting advantages and disadvantages of active vs. passive consent, quasi-experimental vs. randomized control trials, longitudinal vs. repeat cross-sectional designs and the roles of process evaluation and methodological flexibility in evaluating complex interventions. Selection of study designs and outcome measures compatible with community infrastructure, accompanied by process evaluation, may facilitate successful outcome evaluation. © 2018 World Obesity Federation.

Developing a Reporting Guideline for Social and Psychological Intervention Trials

ERIC Educational Resources Information Center

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

2013-01-01

Social and psychological interventions are often complex. Understanding randomized 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…

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.

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

Criteria for evaluating evidence on public health interventions.

PubMed

Rychetnik, L; Frommer, M; Hawe, P; Shiell, A

2002-02-01

Public health interventions tend to be complex, programmatic, and context dependent. The evidence for their effectiveness must be sufficiently comprehensive to encompass that complexity. This paper asks whether and to what extent evaluative research on public health interventions can be adequately appraised by applying well established criteria for judging the quality of evidence in clinical practice. It is adduced that these criteria are useful in evaluating some aspects of evidence. However, there are other important aspects of evidence on public health interventions that are not covered by the established criteria. The evaluation of evidence must distinguish between the fidelity of the evaluation process in detecting the success or failure of an intervention, and the success or failure of the intervention itself. Moreover, if an intervention is unsuccessful, the evidence should help to determine whether the intervention was inherently faulty (that is, failure of intervention concept or theory), or just badly delivered (failure of implementation). Furthermore, proper interpretation of the evidence depends upon the availability of descriptive information on the intervention and its context, so that the transferability of the evidence can be determined. Study design alone is an inadequate marker of evidence quality in public health intervention evaluation.

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.

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.

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.

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.

Unpacking the black box of improvement

PubMed Central

Ramaswamy, Rohit; Reed, Julie; Livesley, Nigel; Boguslavsky, Victor; Garcia-Elorrio, Ezequiel; Sax, Sylvia; Houleymata, Diarra; Kimble, Leighann; Parry, Gareth

2018-01-01

Abstract During the Salzburg Global Seminar Session 565—‘Better Health Care: How do we learn about improvement?’, participants discussed the need to unpack the ‘black box’ of improvement. The ‘black box’ refers to the fact that when quality improvement interventions are described or evaluated, there is a tendency to assume a simple, linear path between the intervention and the outcomes it yields. It is also assumed that it is enough to evaluate the results without understanding the process of by which the improvement took place. However, quality improvement interventions are complex, nonlinear and evolve in response to local settings. To accurately assess the effectiveness of quality improvement and disseminate the learning, there must be a greater understanding of the complexity of quality improvement work. To remain consistent with the language used in Salzburg, we refer to this as ‘unpacking the black box’ of improvement. To illustrate the complexity of improvement, this article introduces four quality improvement case studies. In unpacking the black box, we present and demonstrate how Cynefin framework from complexity theory can be used to categorize and evaluate quality improvement interventions. Many quality improvement projects are implemented in complex contexts, necessitating an approach defined as ‘probe-sense-respond’. In this approach, teams experiment, learn and adapt their changes to their local setting. Quality improvement professionals intuitively use the probe-sense-respond approach in their work but document and evaluate their projects using language for ‘simple’ or ‘complicated’ contexts, rather than the ‘complex’ contexts in which they work. As a result, evaluations tend to ask ‘How can we attribute outcomes to the intervention?’, rather than ‘What were the adaptations that took place?’. By unpacking the black box of improvement, improvers can more accurately document and describe their interventions, allowing evaluators to ask the right questions and more adequately evaluate quality improvement interventions. PMID:29462325

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

Evaluating a complex system-wide intervention using the difference in differences method: the Delivering Choice Programme

PubMed Central

Round, Jeff; Drake, Robyn; Kendall, Edward; Addicott, Rachael; Agelopoulos, Nicky; Jones, Louise

2015-01-01

Objectives We report the use of difference in differences (DiD) methodology to evaluate a complex, system-wide healthcare intervention. We use the worked example of evaluating the Marie Curie Delivering Choice Programme (DCP) for advanced illness in a large urban healthcare economy. Methods DiD was selected because a randomised controlled trial was not feasible. The method allows for before and after comparison of changes that occur in an intervention site with a matched control site. This enables analysts to control for the effect of the intervention in the absence of a local control. Any policy, seasonal or other confounding effects over the test period are assumed to have occurred in a balanced way at both sites. Data were obtained from primary care trusts. Outcomes were place of death, inpatient admissions, length of stay and costs. Results Small changes were identified between pre- and post-DCP outputs in the intervention site. The proportion of home deaths and median cost increased slightly, while the number of admissions per patient and the average length of stay per admission decreased slightly. None of these changes was statistically significant. Conclusions Effects estimates were limited by small numbers accessing new services and selection bias in sample population and comparator site. In evaluating the effect of a complex healthcare intervention, the choice of analysis method and output measures is crucial. Alternatives to randomised controlled trials may be required for evaluating large scale complex interventions and the DiD approach is suitable, subject to careful selection of measured outputs and control population. PMID:24644163

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.

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.

AHRQ series on complex intervention systematic reviews-paper 7: PRISMA-CI elaboration and explanation.

PubMed

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

2017-10-01

Complex interventions are widely used in health care, public health, education, criminology, social work, business, and welfare. They have increasingly become the subject of systematic reviews and are challenging to effectively report. The Complex Interventions Methods Workgroup developed an extension to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Complex Interventions (PRISMA-CI). Following the EQUATOR Network guidance for Preferred Reporting Items for Systematic Reviews and Meta-Analysis extensions, this Explanation and Elaboration (EE) document accompanies the PRISMA-CI checklist to promote consistency in reporting of systematic reviews of complex interventions. The EE document explains the meaning and rationale for each unique PRISMA-CI checklist item and provides examples to assist systematic review authors in operationalizing PRISMA-CI guidance. The Complex Interventions Workgroup developed PRISMA-CI as an important start toward increased consistency in reporting of systematic reviews of complex interventions. Because the field is rapidly expanding, the Complex Interventions Methods Workgroup plans to re-evaluate periodically for the need to add increasing specificity and examples as the field matures. Copyright © 2017 The Authors. Published by 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.

Evaluating a complex system-wide intervention using the difference in differences method: the Delivering Choice Programme.

PubMed

Round, Jeff; Drake, Robyn; Kendall, Edward; Addicott, Rachael; Agelopoulos, Nicky; Jones, Louise

2015-03-01

We report the use of difference in differences (DiD) methodology to evaluate a complex, system-wide healthcare intervention. We use the worked example of evaluating the Marie Curie Delivering Choice Programme (DCP) for advanced illness in a large urban healthcare economy. DiD was selected because a randomised controlled trial was not feasible. The method allows for before and after comparison of changes that occur in an intervention site with a matched control site. This enables analysts to control for the effect of the intervention in the absence of a local control. Any policy, seasonal or other confounding effects over the test period are assumed to have occurred in a balanced way at both sites. Data were obtained from primary care trusts. Outcomes were place of death, inpatient admissions, length of stay and costs. Small changes were identified between pre- and post-DCP outputs in the intervention site. The proportion of home deaths and median cost increased slightly, while the number of admissions per patient and the average length of stay per admission decreased slightly. None of these changes was statistically significant. Effects estimates were limited by small numbers accessing new services and selection bias in sample population and comparator site. In evaluating the effect of a complex healthcare intervention, the choice of analysis method and output measures is crucial. Alternatives to randomised controlled trials may be required for evaluating large scale complex interventions and the DiD approach is suitable, subject to careful selection of measured outputs and control population. 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.

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.

The contribution of qualitative research in designing a complex intervention for secondary prevention of coronary heart disease in two different healthcare systems.

PubMed

Corrrigan, Mairead; Cupples, Margaret E; Smith, Susan M; Byrne, Molly; Leathem, Claire S; Clerkin, Pauline; Murphy, Andrew W

2006-07-18

Developing complex interventions for testing in randomised controlled trials is of increasing importance in healthcare planning. There is a need for careful design of interventions for secondary prevention of coronary heart disease (CHD). It has been suggested that integrating qualitative research in the development of a complex intervention may contribute to optimising its design but there is limited evidence of this in practice. This study aims to examine the contribution of qualitative research in developing a complex intervention to improve the provision and uptake of secondary prevention of CHD within primary care in two different healthcare systems. In four general practices, one rural and one urban, in Northern Ireland and the Republic of Ireland, patients with CHD were purposively selected. Four focus groups with patients (N = 23) and four with staff (N = 29) informed the development of the intervention by exploring how it could be tailored and integrated with current secondary prevention activities for CHD in the two healthcare settings. Following an exploratory trial the acceptability and feasibility of the intervention were discussed in four focus groups (17 patients) and 10 interviews (staff). The data were analysed using thematic analysis. Integrating qualitative research into the development of the intervention provided depth of information about the varying impact, between the two healthcare systems, of different funding and administrative arrangements, on their provision of secondary prevention and identified similar barriers of time constraints, training needs and poor patient motivation. The findings also highlighted the importance to patients of stress management, the need for which had been underestimated by the researchers. The qualitative evaluation provided depth of detail not found in evaluation questionnaires. It highlighted how the intervention needed to be more practical by minimising administration, integrating role plays into behaviour change training, providing more practical information about stress management and removing self-monitoring of lifestyle change. Qualitative research is integral to developing the design detail of a complex intervention and tailoring its components to address individuals' needs in different healthcare systems. The findings highlight how qualitative research may be a valuable component of the preparation for complex interventions and their evaluation.

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

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.

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.

Tool for evaluating research implementation challenges: A sense-making protocol for addressing implementation challenges in complex research settings

PubMed Central

2013-01-01

Background Many challenges arise in complex organizational interventions that threaten research integrity. This article describes a Tool for Evaluating Research Implementation Challenges (TECH), developed using a complexity science framework to assist research teams in assessing and managing these challenges. Methods During the implementation of a multi-site, randomized controlled trial (RCT) of organizational interventions to reduce resident falls in eight nursing homes, we inductively developed, and later codified the TECH. The TECH was developed through processes that emerged from interactions among research team members and nursing home staff participants, including a purposive use of complexity science principles. Results The TECH provided a structure to assess challenges systematically, consider their potential impact on intervention feasibility and fidelity, and determine actions to take. We codified the process into an algorithm that can be adopted or adapted for other research projects. We present selected examples of the use of the TECH that are relevant to many complex interventions. Conclusions Complexity theory provides a useful lens through which research procedures can be developed to address implementation challenges that emerge from complex organizations and research designs. Sense-making is a group process in which diverse members interpret challenges when available information is ambiguous; the groups’ interpretations provide cues for taking action. Sense-making facilitates the creation of safe environments for generating innovative solutions that balance research integrity and practical issues. The challenges encountered during implementation of complex interventions are often unpredictable; however, adoption of a systematic process will allow investigators to address them in a consistent yet flexible manner, protecting fidelity. Research integrity is also protected by allowing for appropriate adaptations to intervention protocols that preserve the feasibility of ‘real world’ interventions. PMID:23281623

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.

Effectiveness of multicomponent interventions in primary healthcare settings to promote continuous smoking cessation in adults: a systematic review

PubMed Central

Martín Cantera, Carlos; Puigdomènech, Elisa; Ballvé, Jose Luis; Arias, Olga Lucía; Clemente, Lourdes; Casas, Ramon; Roig, Lydia; Pérez-Tortosa, Santiago; Díaz-Gete, Laura; Granollers, Sílvia

2015-01-01

Objective The objective of the present review is to evaluate multicomponent/complex primary care (PC) interventions for their effectiveness in continuous smoking abstinence by adult smokers. Design A systematic review of randomised and non-randomised controlled trials was undertaken. Eligibility criteria for included studies Selected studies met the following criteria: evaluated effects of a multicomponent/complex intervention (with 2 or more intervention components) in achieving at least 6-month abstinence in adult smokers who visited a PC, biochemical confirmation of abstinence, intention-to-treat analysis and results published in English/Spanish. Methods We followed PRISMA statement to report the review. We searched the following data sources: MEDLINE, Web of Science, Scopus (from inception to February 2014), 3 key journals and a tobacco research bulletin. The Scottish Intercollegiate Guidelines Network checklists were used to evaluate methodological quality. Data selection, evaluation and extraction were done independently, using a paired review approach. Owing to the heterogeneity of interventions in the studies included, a meta-analysis was not conducted. Results Of 1147 references identified, 9 studies were selected (10 204 participants, up to 48 months of follow-up, acceptable methodological quality). Methodologies used were mainly individual or group sessions, telephone conversations, brochures or quit-smoking kits, medications and economic incentives for doctors and no-cost medications for smokers. Complex interventions achieved long-term continuous abstinence ranging from 7% to 40%. Behavioural interventions were effective and had a dose–response effect. Both nicotine replacement and bupropion therapy were safe and effective, with no observed differences. Conclusions Multicomponent/complex interventions in PC are effective and safe, appearing to achieve greater long-term continuous smoking cessation than usual care and counselling alone. Selected studies were heterogeneous and some had significant losses to follow-up. Our results show that smoking interventions should include more than one component and a strong follow-up of the patient to maximise results. PMID:26428333

Preschoolers with Autism Spectrum Disorders: Evaluating the Impact of a Home-Based Intervention to Promote Their Communication

ERIC Educational Resources Information Center

McConkey, Roy; Truesdale-Kennedy, Maria; Crawford, Heather; McGreevy, Elaine; Reavey, Michaela; Cassidy, Arlene

2010-01-01

The complexities that practitioners face in evaluating interventions are illustrated in this article. An early intervention programme (known as Keyhole), based mainly around Treatment and Education of Autistic and related Communications handicapped CHildren (TEACCH), Picture Exchange Communication System (PECS) and Hanen approaches, was delivered…

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…

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

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 .

Application of systems thinking: 12-month postintervention evaluation of a complex health system intervention in Zambia: the case of the BHOMA.

PubMed

Mutale, Wilbroad; Ayles, Helen; Bond, Virginia; Chintu, Namwinga; Chilengi, Roma; Mwanamwenge, Margaret Tembo; Taylor, Angela; Spicer, Neil; Balabanova, Dina

2017-04-01

Strong health systems are said to be paramount to achieving effective and equitable health care. The World Health Organization has been advocating for using system-wide approaches such as 'systems thinking' to guide intervention design and evaluation. In this paper we report the system-wide effects of a complex health system intervention in Zambia known as Better Health Outcome through Mentorship and Assessment (BHOMA) that aimed to improve service quality. We conducted a qualitative study in three target districts. We used a systems thinking conceptual framework to guide the analysis focusing on intended and unintended consequences of the intervention. NVivo version 10 was used for data analysis. The addressed community responded positively to the BHOMA intervention. The indications were that in the short term there was increased demand for services but the health worker capacity was not severely affected. This means that the prediction that service demand would increase with implementation of BHOMA was correct and the workload also increased, but the help of clinic lay supporters meant that some of the work of clinicians was transferred to these lay workers. However, from a systems perspective, unintended consequences also occurred during the implementation of the BHOMA. We applied an innovative approach to evaluate a complex intervention in low-income settings, exploring empirically how systems thinking can be applied in the context of health system strengthening. Although the intervention had some positive outcomes by employing system-wide approaches, we also noted unintended consequences. © 2015 The Authors. Journal of Evaluation in Clinical Practice published by John Wiley & Sons, Ltd.

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).

Making sense of the emerging conversation in evaluation about systems thinking and complexity science.

PubMed

Gates, Emily F

2016-12-01

In the last twenty years, a conversation has emerged in the evaluation field about the potential of systems thinking and complexity science (STCS) to transform the practice of evaluating social interventions. Documenting and interpreting this conversation are necessary to advance our understanding of the significance of using STCS in planning, implementing, and evaluating social interventions. Guided by a generic framework for evaluation practice, this paper reports on an inter-disciplinary literature review and argues that STCS raises some new ways of thinking about and carrying out the following six activities: 1) supporting social problem solving; 2) framing interventions and contexts; 3) selecting and using methods; 4) engaging in valuing; 5) producing and justifying knowledge; and 6) facilitating use. Following a discussion of these issues, future directions for research and practice are suggested. Copyright © 2016 Elsevier Ltd. All rights reserved.

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.

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.

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.

75 FR 34997 - National Institute on Disability and Rehabilitation Research (NIDRR)-Disability and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-21

... trial research designs to evaluate the effectiveness of interventions or practices. NIDRR believes that randomized control trial research designs can be appropriate for research that involves evaluating specific interventions. However, in complex service delivery settings, other scientifically rigorous research designs may...

Identifying Mechanisms of Change in a Conversation Therapy for Aphasia Using Behaviour Change Theory and Qualitative Methods

ERIC Educational Resources Information Center

Johnson, Fiona M.; Best, Wendy; Beckley, Firle Christina; Maxim, Jane; Beeke, Suzanne

2017-01-01

Background: Conversation therapy for aphasia is a complex intervention comprising multiple components and targeting multiple outcomes. UK Medical Research Council (MRC) guidelines published in 2008 recommend that in addition to measuring the outcomes of complex interventions, evaluation should seek to clarify how such outcomes are produced,…

Grades of Evidence: Variability in Quality of Findings in Effectiveness Studies of Complex Field Interventions

ERIC Educational Resources Information Center

Chatterji, Madhabi

2007-01-01

This article argues with a literature review that a simplistic distinction between strong and weak evidence hinged on the use of randomized controlled trials (RCTs), the federal "gold standard" for generating rigorous evidence on social programs and policies, is not tenable with evaluative studies of complex, field interventions such as…

A case report of evaluating a large-scale health systems improvement project in an uncontrolled setting: a quality improvement initiative in KwaZulu-Natal, South Africa.

PubMed

Mate, Kedar S; Ngidi, Wilbroda Hlolisile; Reddy, Jennifer; Mphatswe, Wendy; Rollins, Nigel; Barker, Pierre

2013-11-01

New approaches are needed to evaluate quality improvement (QI) within large-scale public health efforts. This case report details challenges to large-scale QI evaluation, and proposes solutions relying on adaptive study design. We used two sequential evaluative methods to study a QI effort to improve delivery of HIV preventive care in public health facilities in three districts in KwaZulu-Natal, South Africa, over a 3-year period. We initially used a cluster randomised controlled trial (RCT) design. During the RCT study period, tensions arose between intervention implementation and evaluation design due to loss of integrity of the randomisation unit over time, pressure to implement changes across the randomisation unit boundaries, and use of administrative rather than functional structures for the randomisation. In response to this loss of design integrity, we switched to a more flexible intervention design and a mixed-methods quasiexperimental evaluation relying on both a qualitative analysis and an interrupted time series quantitative analysis. Cluster RCT designs may not be optimal for evaluating complex interventions to improve implementation in uncontrolled 'real world' settings. More flexible, context-sensitive evaluation designs offer a better balance of the need to adjust the intervention during the evaluation to meet implementation challenges while providing the data required to evaluate effectiveness. Our case study involved HIV care in a resource-limited setting, but these issues likely apply to complex improvement interventions in other settings.

Too Much, Too Soon? Unanswered Questions from National Response to Intervention Evaluation

ERIC Educational Resources Information Center

Gersten, Russell; Jayanthi, Madhavi; Dimino, Joseph

2017-01-01

The report of the national response to intervention (RTI) evaluation study, conducted during 2011-2012, was released in November 2015. Anyone who has read the lengthy report can attest to its complexity and the design used in the study. Both these factors can influence the interpretation of the results from this evaluation. In this commentary, we…

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

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.

A synthetic computational environment: To control the spread of respiratory infections in a virtual university

NASA Astrophysics Data System (ADS)

Ge, Yuanzheng; Chen, Bin; liu, Liang; Qiu, Xiaogang; Song, Hongbin; Wang, Yong

2018-02-01

Individual-based computational environment provides an effective solution to study complex social events by reconstructing scenarios. Challenges remain in reconstructing the virtual scenarios and reproducing the complex evolution. In this paper, we propose a framework to reconstruct a synthetic computational environment, reproduce the epidemic outbreak, and evaluate management interventions in a virtual university. The reconstructed computational environment includes 4 fundamental components: the synthetic population, behavior algorithms, multiple social networks, and geographic campus environment. In the virtual university, influenza H1N1 transmission experiments are conducted, and gradually enhanced interventions are evaluated and compared quantitatively. The experiment results indicate that the reconstructed virtual environment provides a solution to reproduce complex emergencies and evaluate policies to be executed in the real world.

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.

Diagnosing Autism in Individuals with Known Genetic Syndromes: Clinical Considerations and Implications for Intervention

PubMed Central

Hepburn, Susan L.; Moody, Eric J.

2015-01-01

Assessing symptoms of autism in persons with known genetic syndromes associated with intellectual and/or developmental disability is a complex clinical endeavor. We suggest that a developmental approach to evaluation is essential to reliably teasing apart global impairments from autism-specific symptomology. In this chapter, we discuss our assumptions about autism spectrum disorders, the process of conducting a family-focused, comprehensive evaluation with behaviorally complex children and some implications for intervention in persons with co-occurring autism and known genetic syndromes. PMID:26269783

Exogenous factors matter when interpreting the results of an impact evaluation: a case study of rainfall and child health programme intervention in Rwanda.

PubMed

Mukabutera, Assumpta; Thomson, Dana R; Hedt-Gauthier, Bethany L; Atwood, Sidney; Basinga, Paulin; Nyirazinyoye, Laetitia; Savage, Kevin P; Habimana, Marcellin; Murray, Megan

2017-12-01

Public health interventions are often implemented at large scale, and their evaluation seems to be difficult because they are usually multiple and their pathways to effect are complex and subject to modification by contextual factors. We assessed whether controlling for rainfall-related variables altered estimates of the efficacy of a health programme in rural Rwanda and have a quantifiable effect on an intervention evaluation outcomes. We conducted a retrospective quasi-experimental study using previously collected cross-sectional data from the 2005 and 2010 Rwanda Demographic and Health Surveys (DHS), 2010 DHS oversampled data, monthly rainfall data collected from meteorological stations over the same period, and modelled output of long-term rainfall averages, soil moisture, and rain water run-off. Difference-in-difference models were used. Rainfall factors confounded the PIH intervention impact evaluation. When we adjusted our estimates of programme effect by controlling for a variety of rainfall variables, several effectiveness estimates changed by 10% or more. The analyses that did not adjust for rainfall-related variables underestimated the intervention effect on the prevalence of ARI by 14.3%, fever by 52.4% and stunting by 10.2%. Conversely, the unadjusted analysis overestimated the intervention's effect on diarrhoea by 56.5% and wasting by 80%. Rainfall-related patterns have a quantifiable effect on programme evaluation results and highlighted the importance and complexity of controlling for contextual factors in quasi-experimental design evaluations. © 2017 John Wiley & Sons Ltd.

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.

A tool for exploring the dynamics of innovative interventions for public health: the critical event card.

PubMed

Figueiro, Ana Claudia; de Araújo Oliveira, Sydia Rosana; Hartz, Zulmira; Couturier, Yves; Bernier, Jocelyne; do Socorro Machado Freire, Maria; Samico, Isabella; Medina, Maria Guadalupe; de Sa, Ronice Franco; Potvin, Louise

2017-03-01

Public health interventions are increasingly represented as complex systems. Research tools for capturing the dynamic of interventions processes, however, are practically non-existent. This paper describes the development and proof of concept process of an analytical tool, the critical event card (CEC), which supports the representation and analysis of complex interventions' evolution, based on critical events. Drawing on the actor-network theory (ANT), we developed and field-tested the tool using three innovative health interventions in northeastern Brazil. Interventions were aimed to promote health equity through intersectoral approaches; were engaged in participatory evaluation and linked to professional training programs. The CEC developing involve practitioners and researchers from projects. Proof of concept was based on document analysis, face-to-face interviews and focus groups. Analytical categories from CEC allow identifying and describing critical events as milestones in the evolution of complex interventions. Categories are (1) event description; (2) actants (human and non-human) involved; (3) interactions between actants; (4) mediations performed; (5) actions performed; (6) inscriptions produced; and (7) consequences for interventions. The CEC provides a tool to analyze and represent intersectoral internvetions' complex and dynamic evolution.

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.

A controlled trial of implementing a complex mental health intervention for carers of vulnerable young people living in out-of-home care: the ripple project.

PubMed

Herrman, Helen; Humphreys, Cathy; Halperin, Stephen; Monson, Katherine; Harvey, Carol; Mihalopoulos, Cathrine; Cotton, Susan; Mitchell, Penelope; Glynn, Tony; Magnus, Anne; Murray, Lenice; Szwarc, Josef; Davis, Elise; Havighurst, Sophie; McGorry, Patrick; Tyano, Sam; Kaplan, Ida; Rice, Simon; Moeller-Saxone, Kristen

2016-12-07

Out-of-home care (OoHC) refers to young people removed from their families by the state because of abuse, neglect or other adversities. Many of the young people experience poor mental health and social function before, during and after leaving care. Rigorously evaluated interventions are urgently required. This publication describes the protocol for the Ripple project and notes early findings from a controlled trial demonstrating the feasibility of the work. The Ripple project is implementing and evaluating a complex mental health intervention that aims to strengthen the therapeutic capacities of carers and case managers of young people (12-17 years) in OoHC. The study is conducted in partnership with mental health, substance abuse and social services in Melbourne, with young people as participants. It has three parts: 1. Needs assessment and implementation of a complex mental health intervention; 2. A 3-year controlled trial of the mental health, social and economic outcomes; and 3. Nested process evaluation of the intervention. Early findings characterising the young people, their carers and case managers and implementing the intervention are available. The trial Wave 1 includes interviews with 176 young people, 52% of those eligible in the study population, 104 carers and 79 case managers. Implementing and researching an affordable service system intervention appears feasible and likely to be applicable in other places and countries. Success of the intervention will potentially contribute to reducing mental ill-health among these young people, including suicide attempts, self-harm and substance abuse, as well as reducing homelessness, social isolation and contact with the criminal justice system. Australian New Zealand Clinical Trials Registry ACTRN12615000501549 . Retrospectively registered 19 May 2015.

Process evaluation of a community-based mental health promotion intervention for refugee children

PubMed Central

Nakkash, Rima T.; Alaouie, Hala; Haddad, Pascale; El Hajj, Taghreed; Salem, Heba; Mahfoud, Ziyad; Afifi, Rema A.

2012-01-01

Public health interventions are complex in nature and composed of multiple components. Evaluation of process and impact is necessary to build evidence of effectiveness. Process evaluation involves monitoring extent of implementation and comparison against the program plan. This article describes the process evaluation of the ‘Qaderoon’ (We are Capable) intervention; a community-based mental health promotion intervention for children living in a Palestinian refugee camp of Beirut, Lebanon. The manuscript describes the context of Palestinian refugees in Lebanon, the intervention, the process evaluation plan and results. The process evaluation was guided by the literature and by a Community Youth Committee. Findings indicated that attendance was 54 and 38% for summer and fall sessions, respectively. Session objectives and activities were commonly achieved. Over 78.4% of activities were reported to be implemented fully as planned. Over 90% of the children indicated high satisfaction with the sessions. Contextual facilitators and challenges to implementing the intervention are discussed. The most challenging were maintaining attendance and the actual implementation of the process evaluation plan. Findings from process evaluation will strengthen interpretation of impact evaluation results. PMID:21908850

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.

Process evaluation of a cluster-randomised trial testing a pressure ulcer prevention care bundle: a mixed-methods study.

PubMed

Roberts, Shelley; McInnes, Elizabeth; Bucknall, Tracey; Wallis, Marianne; Banks, Merrilyn; Chaboyer, Wendy

2017-02-13

As pressure ulcers contribute to significant patient burden and increased health care costs, their prevention is a clinical priority. Our team developed and tested a complex intervention, a pressure ulcer prevention care bundle promoting patient participation in care, in a cluster-randomised trial. The UK Medical Research Council recommends process evaluation of complex interventions to provide insight into why they work or fail and how they might be improved. This study aimed to evaluate processes underpinning implementation of the intervention and explore end-users' perceptions of it, in order to give a deeper understanding of its effects. A pre-specified, mixed-methods process evaluation was conducted as an adjunct to the main trial, guided by a framework for process evaluation of cluster-randomised trials. Data was collected across eight Australian hospitals but mainly focused on the four intervention hospitals. Quantitative and qualitative data were collected across the evaluation domains: recruitment, reach, intervention delivery and response to intervention, at both cluster and individual patient level. Quantitative data were analysed using descriptive and inferential statistics. Qualitative data were analysed using thematic analysis. In the context of the main trial, which found a 42% reduction in risk of pressure ulcer with the intervention that was not significant after adjusting for clustering and covariates, this process evaluation provides important insights. Recruitment and reach among clusters and individuals was high, indicating that patients, nurses and hospitals are willing to engage with a pressure ulcer prevention care bundle. Of 799 intervention patients in the trial, 96.7% received the intervention, which took under 10 min to deliver. Patients and nurses accepted the care bundle, recognising benefits to it and describing how it enabled participation in pressure ulcer prevention (PUP) care. This process evaluation found no major failures relating to implementation of the intervention. The care bundle was found to be easy to understand and deliver, and it reached a large proportion of the target population and was found to be acceptable to patients and nurses; therefore, it may be an effective way of engaging patients in their pressure ulcer prevention care and promoting evidence-based practise.

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.

A Case Study of Multimethod Evaluation of Complex School Mental Health Promotion and Prevention: The Mindmatters Evaluation Suite

ERIC Educational Resources Information Center

Rowling, Louise; Mason, Jo

2005-01-01

There are a number of challenges and debates surrounding the implementation of mental health interventions in schools. These include recognising the complexity of influencing factors and the interdependency of key components; the critical importance of monitoring school-based implementation in particular contexts; employing multimethod evaluation…

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.

It's more complicated than that Comment on "Translating evidence into healthcare policy and practice: single versus multi-faceted implementation strategies - is there a simple answer to a complex question?".

PubMed

Rycroft-Malone, Jo

2015-03-17

In this commentary the findings from a systematic review that concluded there is no compelling evidence to suggest that implementing complicated, multi-faceted interventions is more effective than simple, single component interventions to changing healthcare professional's behaviour are considered through the lens of Harvey and Kitson's editorial. Whilst an appealing conclusion, it is one that hides a myriad of complexities. These include issues concerning how best to tailor interventions and how best to evaluate such efforts. These are complex issues that do not have simple solutions. © 2015 by Kerman University of Medical Sciences.

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.

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.

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.

Examining the Heterogeneity and Cost Effectiveness of a Complex Intervention by Segmentation of Patients with Chronic Obstructive Pulmonary Disease.

PubMed

Sørensen, Sabrina Storgaard; Jensen, Morten Berg; Pedersen, Kjeld Møller; Ehlers, Lars

2018-02-01

To examine the heterogeneity in cost-effectiveness analyses of patient-tailored complex interventions. Latent class analysis (LCA) was performed on data from a randomized controlled trial evaluating a patient-tailored case management strategy for patients suffering from chronic obstructive pulmonary disease (COPD). LCA was conducted on detailed process variables representing service variation in the intervention group. Features of the identified latent classes were compared for consistency with baseline demographic, clinical, and economic characteristics for each class. Classes for the control group, corresponding to the identified latent classes for the intervention group, were identified using multinomial logistic regression. Cost-utility analyses were then conducted at the class level, and uncertainty surrounding the point estimates was assessed by probabilistic sensitivity analysis. The LCA identified three distinct classes: the psychologically care class, the extensive COPD care class, and the limited COPD care class. Patient baseline characteristics were in line with the features identified in the LCA. Evaluation of cost-effectiveness revealed highly disparate results, and case management for only the extensive COPD care class appeared cost-effective with an incremental cost-effectiveness ratio of £26,986 per quality-adjusted life-year gained using the threshold value set by the National Institute of Health and Care Excellence. Findings indicate that researchers evaluating patient-tailored complex interventions need to address both supply-side variation and demand-side heterogeneity to link findings with outcome. The article specifically proposes the use of LCA because it is believed to have the potential to enable more appropriate targeting of complex care strategies. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

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.

The PD COMM trial: a protocol for the process evaluation of a randomised trial assessing the effectiveness of two types of SLT for people with Parkinson's disease.

PubMed

Masterson-Algar, Patricia; Burton, Christopher R; Brady, Marian C; Nicoll, Avril; Clarke, Carl E; Rick, Caroline; Hughes, Max; Au, Pui; Smith, Christina H; Sackley, Catherine M

2017-08-29

The PD COMM trial is a phase III multi-centre randomised controlled trial whose aim is to evaluate the effectiveness and cost-effectiveness of two approaches to speech and language therapy (SLT) compared with no SLT intervention (control) for people with Parkinson's disease who have self-reported or carer-reported problems with their speech or voice. Our protocol describes the process evaluation embedded within the outcome evaluation whose aim is to evaluate what happened at the time of the PD COMM intervention implementation and to provide findings that will assist in the interpretation of the PD COMM trial results. Furthermore, the aim of the PD COMM process evaluation is to investigate intervention complexity within a theoretical model of how the trialled interventions might work best and why. Drawing from the Normalization Process Theory and frameworks for implementation fidelity, a mixed method design will be used to address process evaluation research questions. Therapists' and participants' perceptions and experiences will be investigated via in-depth interviews. Critical incident reports, baseline survey data from therapists, treatment record forms and home practice diaries also will be collected at relevant time points throughout the running of the PD COMM trial. Process evaluation data will be analysed independently of the outcome evaluation before the two sets of data are then combined. To date, there are a limited number of published process evaluation protocols, and few are linked to trials investigating rehabilitation therapies. Providing a strong theoretical framework underpinning design choices and being tailored to meet the complex characteristics of the trialled interventions, our process evaluation has the potential to provide valuable insight into which components of the interventions being delivered in PD COMM worked best (and what did not), how they worked well and why. ISRCTN Registry, ISRCTN12421382 . Registered on 18 April 2016.

A proposed analytic framework for determining the impact of an antimicrobial resistance intervention.

PubMed

Grohn, Yrjo T; Carson, Carolee; Lanzas, Cristina; Pullum, Laura; Stanhope, Michael; Volkova, Victoriya

2017-06-01

Antimicrobial use (AMU) is increasingly threatened by antimicrobial resistance (AMR). The FDA is implementing risk mitigation measures promoting prudent AMU in food animals. Their evaluation is crucial: the AMU/AMR relationship is complex; a suitable framework to analyze interventions is unavailable. Systems science analysis, depicting variables and their associations, would help integrate mathematics/epidemiology to evaluate the relationship. This would identify informative data and models to evaluate interventions. This National Institute for Mathematical and Biological Synthesis AMR Working Group's report proposes a system framework to address the methodological gap linking livestock AMU and AMR in foodborne bacteria. It could evaluate how AMU (and interventions) impact AMR. We will evaluate pharmacokinetic/dynamic modeling techniques for projecting AMR selection pressure on enteric bacteria. We study two methods to model phenotypic AMR changes in bacteria in the food supply and evolutionary genotypic analyses determining molecular changes in phenotypic AMR. Systems science analysis integrates the methods, showing how resistance in the food supply is explained by AMU and concurrent factors influencing the whole system. This process is updated with data and techniques to improve prediction and inform improvements for AMU/AMR surveillance. Our proposed framework reflects both the AMR system's complexity, and desire for simple, reliable conclusions.

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.

Study protocol of a mixed-methods evaluation of a cluster randomized trial to improve the safety of NSAID and antiplatelet prescribing: data-driven quality improvement in primary care.

PubMed

Grant, Aileen; Dreischulte, Tobias; Treweek, Shaun; Guthrie, Bruce

2012-08-28

Trials of complex interventions are criticized for being 'black box', so the UK Medical Research Council recommends carrying out a process evaluation to explain the trial findings. We believe it is good practice to pre-specify and publish process evaluation protocols to set standards and minimize bias. Unlike protocols for trials, little guidance or standards exist for the reporting of process evaluations. This paper presents the mixed-method process evaluation protocol of a cluster randomized trial, drawing on a framework designed by the authors. This mixed-method evaluation is based on four research questions and maps data collection to a logic model of how the data-driven quality improvement in primary care (DQIP) intervention is expected to work. Data collection will be predominately by qualitative case studies in eight to ten of the trial practices, focus groups with patients affected by the intervention and quantitative analysis of routine practice data, trial outcome and questionnaire data and data from the DQIP intervention. We believe that pre-specifying the intentions of a process evaluation can help to minimize bias arising from potentially misleading post-hoc analysis. We recognize it is also important to retain flexibility to examine the unexpected and the unintended. From that perspective, a mixed-methods evaluation allows the combination of exploratory and flexible qualitative work, and more pre-specified quantitative analysis, with each method contributing to the design, implementation and interpretation of the other.As well as strengthening the study the authors hope to stimulate discussion among their academic colleagues about publishing protocols for evaluations of randomized trials of complex interventions. DATA-DRIVEN QUALITY IMPROVEMENT IN PRIMARY CARE TRIAL REGISTRATION: ClinicalTrials.gov: NCT01425502.

Exploring the value of mixed methods within the At Home/Chez Soi housing first project: a strategy to evaluate the implementation of a complex population health intervention for people with mental illness who have been homeless.

PubMed

Macnaughton, Eric L; Goering, Paula N; Nelson, Geoffrey B

2012-05-02

This paper is a methodological case study that describes the At Home/Chez Soi (Housing First) Initiative's mixed-methods strategy for implementation evaluation and discusses the value of these methods in evaluating the implementation of such complex population health interventions. The Housing First (HF) model is being implemented in five cities: Vancouver, Winnipeg, Toronto, Montréal and Moncton. At Home/Chez Soi is an intervention trial that aims to address the issue of homelessness in people with mental health issues. The HF model emphasizes choices, hopefulness and connecting people with resources that make a difference to their quality of life. A component of HF is supported housing, which provides a rent subsidy and rapid access to housing of choice in private apartments; a second component is support. Quantitative and qualitative methods were used to evaluate HF implementation. The findings of this case study illustrate how the critical ingredients of complex interventions, such as HF, can be adapted to different contexts while implementation fidelity is maintained at a theoretical level. The findings also illustrate how the project's mixed methods approach helped to facilitate the adaptation process. Another value of this approach is that it identifies systemic and organizational factors (e.g., housing supply, discrimination, housing procurement strategy) that affect implementation of key elements of HF. In general, the approach provides information about both whether and how key aspects of the intervention are implemented effectively across different settings. It thus provides implementation data that are rigorous, contextually relevant and practical.

Adapting, piloting and evaluating complex public health interventions: lessons learned from the Nurse-Family Partnership in Canadian public health settings.

PubMed

Jack, S M; Catherine, N; Gonzalez, A; MacMillan, H L; Sheehan, D; Waddell, D

2015-01-01

The Nurse-Family Partnership (NFP) is a home-visit program for young and first-time, socially and economically disadvantaged mothers. Evidence from three United States randomized controlled trials (RCTs) on the effectiveness of this intervention at improving pregnancy outcomes, improving child health and development, and increasing maternal economic self-sufficiency is robust. However, the effectiveness of the NFP in Canada, with its different health and social care context, needs to be determined. The purpose of this article is to describe the complex process for moving the NFP from the research arena to full implementation in Canada. This process of evaluation in Canada includes (1) adapting the intervention; (2) piloting the intervention in small-scale feasibility and acceptability studies; and (3) conducting an RCT and process evaluation through a study called the British Columbia Healthy Connections Project (BCHCP). This large-scale evaluation also creates an opportunity to expand the NFP evidence base by conducting an additional study to examine potential biological mechanisms linking intervention and behavioural outcomes in children. Adaptation of the NFP home-visit materials is a continuous process. A pilot project determined that it was feasible to enrol eligible women into the NFP. This pilot also determined that, in Canada, it was most appropriate for public health agencies to implement the NFP and for public health nurses to deliver the intervention. Finally, the pilot showed that this intensive home-visit program was acceptable to clients, their family members and health care providers. Through the BCHCP, the next steps - the RCT and process evaluation - are currently underway. The BCHCP will also set the foundation for long-term evaluation of key public health outcomes in a highly vulnerable population of families.

Stemming the Tide of Antibiotic Resistance (STAR): A protocol for a trial of a complex intervention addressing the 'why' and 'how' of appropriate antibiotic prescribing in general practice

PubMed Central

Simpson, Sharon A; Butler, Christopher C; Hood, Kerry; Cohen, David; Dunstan, Frank; Evans, Meirion R; Rollnick, Stephen; Moore, Laurence; Hare, Monika; Bekkers, Marie-Jet; Evans, John

2009-01-01

Background After some years of a downward trend, antibiotic prescribing rates in the community have tended to level out in many countries. There is also wide variation in antibiotic prescribing between general practices, and between countries. There are still considerable further gains that could be made in reducing inappropriate antibiotic prescribing, but complex interventions are required. Studies to date have generally evaluated the effect of interventions on antibiotic prescribing in a single consultation and pragmatic evaluations that assess maintenance of new skills are rare. This paper describes the protocol for a pragmatic, randomized evaluation of a complex intervention aimed at reducing antibiotic prescribing by primary care clinicians. Methods and design We developed a Social Learning Theory based, blended learning program (on-line learning, a practice based seminar, and context bound learning) called the STAR Educational Program. The 'why of change' is addressed by providing clinicians in general practice with information on antibiotic resistance in urine samples submitted by their practice and their antibiotic prescribing data, and facilitating a practice-based seminar on the implications of this data. The 'how of change' is addressed through context-bound communication skills training and information on antibiotic indication and choice. This intervention will be evaluated in a trial involving 60 general practices, with general practice as the unit of randomization (clinicians from each practice to either receive the STAR Educational Program or not) and analysis. The primary outcome will be the number of antibiotic items dispensed over one year. An economic and process evaluation will also be conducted. Discussion This trial will be the first to evaluate the effectiveness of this type of theory-based, blended learning intervention aimed at reducing antibiotic prescribing by primary care clinicians. Novel aspects include feedback of practice level data on antimicrobial resistance and prescribing, use of principles from motivational interviewing, training in enhanced communication skills that incorporates context-bound experience and reflection, and using antibiotic dispensing over one year (as opposed to antibiotic prescribing in a single consultation) as the main outcome. Trial registration Current Controlled Trials ISRCTN63355948. PMID:19309493

Stemming the Tide of Antibiotic Resistance (STAR): a protocol for a trial of a complex intervention addressing the 'why' and 'how' of appropriate antibiotic prescribing in general practice.

PubMed

Simpson, Sharon A; Butler, Christopher C; Hood, Kerry; Cohen, David; Dunstan, Frank; Evans, Meirion R; Rollnick, Stephen; Moore, Laurence; Hare, Monika; Bekkers, Marie-Jet; Evans, John

2009-03-23

After some years of a downward trend, antibiotic prescribing rates in the community have tended to level out in many countries. There is also wide variation in antibiotic prescribing between general practices, and between countries. There are still considerable further gains that could be made in reducing inappropriate antibiotic prescribing, but complex interventions are required. Studies to date have generally evaluated the effect of interventions on antibiotic prescribing in a single consultation and pragmatic evaluations that assess maintenance of new skills are rare. This paper describes the protocol for a pragmatic, randomized evaluation of a complex intervention aimed at reducing antibiotic prescribing by primary care clinicians. We developed a Social Learning Theory based, blended learning program (on-line learning, a practice based seminar, and context bound learning) called the STAR Educational Program. The 'why of change' is addressed by providing clinicians in general practice with information on antibiotic resistance in urine samples submitted by their practice and their antibiotic prescribing data, and facilitating a practice-based seminar on the implications of this data. The 'how of change' is addressed through context-bound communication skills training and information on antibiotic indication and choice. This intervention will be evaluated in a trial involving 60 general practices, with general practice as the unit of randomization (clinicians from each practice to either receive the STAR Educational Program or not) and analysis. The primary outcome will be the number of antibiotic items dispensed over one year. An economic and process evaluation will also be conducted. This trial will be the first to evaluate the effectiveness of this type of theory-based, blended learning intervention aimed at reducing antibiotic prescribing by primary care clinicians. Novel aspects include feedback of practice level data on antimicrobial resistance and prescribing, use of principles from motivational interviewing, training in enhanced communication skills that incorporates context-bound experience and reflection, and using antibiotic dispensing over one year (as opposed to antibiotic prescribing in a single consultation) as the main outcome. Current Controlled Trials ISRCTN63355948.

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.

Using Complexity Theory to Guide Medical School Evaluations.

PubMed

Jorm, Christine; Roberts, Chris

2018-03-01

Contemporary medical school evaluations are narrow in focus and often do not consider the wider systems implications of the relationship between learning and teaching, research, clinical care, and community engagement. The result is graduates who lack the necessary knowledge and skills for the modern health care system and an educational system that is limited in its ability to learn and change.To address this issue, the authors apply complexity theory to medical school evaluation, using four key factors-nesting, diversity, self-organization, and emergent outcomes. To help medical educators apply this evaluation approach in their own settings, the authors offer two tools-a modified program logic model and sensemaking. In sensemaking, they use the organic metaphor of the medical school as a neuron situated within a complex neural network to enable medical educators to reframe the way they think about program evaluation. The authors then offer practical guidance for applying this model, including describing the example of addressing graduates' engagement in the health care system. The authors consider the input of teachers, the role of culture and curriculum, and the clinical care system in this example.Medical school evaluation is reframed as an improvement science for complex social interventions (medical school is such an intervention) in this model. With complexity theory's focus on emergent outcomes, evaluation takes on a new focus, reimagining medical students as reaching their future potential as change agents, who transform health systems and the lives of patients.

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

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

The use of segmented regression in analysing interrupted time series studies: an example in pre-hospital ambulance care.

PubMed

Taljaard, Monica; McKenzie, Joanne E; Ramsay, Craig R; Grimshaw, Jeremy M

2014-06-19

An interrupted time series design is a powerful quasi-experimental approach for evaluating effects of interventions introduced at a specific point in time. To utilize the strength of this design, a modification to standard regression analysis, such as segmented regression, is required. In segmented regression analysis, the change in intercept and/or slope from pre- to post-intervention is estimated and used to test causal hypotheses about the intervention. We illustrate segmented regression using data from a previously published study that evaluated the effectiveness of a collaborative intervention to improve quality in pre-hospital ambulance care for acute myocardial infarction (AMI) and stroke. In the original analysis, a standard regression model was used with time as a continuous variable. We contrast the results from this standard regression analysis with those from segmented regression analysis. We discuss the limitations of the former and advantages of the latter, as well as the challenges of using segmented regression in analysing complex quality improvement interventions. Based on the estimated change in intercept and slope from pre- to post-intervention using segmented regression, we found insufficient evidence of a statistically significant effect on quality of care for stroke, although potential clinically important effects for AMI cannot be ruled out. Segmented regression analysis is the recommended approach for analysing data from an interrupted time series study. Several modifications to the basic segmented regression analysis approach are available to deal with challenges arising in the evaluation of complex quality improvement interventions.

Integrating family work into the treatment of young people with severe and complex depression: a developmentally focused model.

PubMed

Rice, Simon; Halperin, Stephen; Blaikie, Simon; Monson, Katherine; Stefaniak, Rachel; Phelan, Mark; Davey, Christopher

2018-04-01

Although models of family intervention are clearly articulated in the child and early adolescent literature, there is less clarity regarding family intervention approaches in later adolescence and emerging adulthood. This study provides the rationale and intervention framework for a developmentally sensitive model of time-limited family work in the outpatient treatment of complex youth depression (15-25 years). Derived from current practice in the Youth Mood Clinic (YMC) at Orygen Youth Health, Melbourne, a stepped model of family intervention is discussed. YMC aims to provide comprehensive orientation, assessment and education to all families. For some, a family-based intervention, delivered either by the treating team or through the integration of a specialist family worker, offers an important adjunct in supporting the recovery of the young person. Developmental phases and challenges experienced by the young person with respect to family/caregiver involvement are discussed in the context of two case studies. A developmentally sensitive model is presented with particular attention to the developmental needs and preferences of young people. Formal evaluation of this model is required. Evaluation perspectives should include young people, caregivers, the broader family system (i.e. siblings) and the treating team (i.e. case manager, doctor and family worker) incorporating outcome measurement. Such work determines how best to apply a time-limited family-based intervention approach in strengthening family/caregiver relationships as part of the young person's recovery from severe and complex depression. © 2016 John Wiley & Sons Australia, Ltd.

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.

Evaluating social outcomes of HIV/AIDS interventions: a critical assessment of contemporary indicator frameworks

PubMed Central

Mannell, Jenevieve; Cornish, Flora; Russell, Jill

2014-01-01

Introduction Contemporary HIV-related theory and policy emphasize the importance of addressing the social drivers of HIV risk and vulnerability for a long-term response. Consequently, increasing attention is being given to social and structural interventions, and to social outcomes of HIV interventions. Appropriate indicators for social outcomes are needed in order to institutionalize the commitment to addressing social outcomes. This paper critically assesses the current state of social indicators within international HIV/AIDS monitoring and evaluation frameworks. Methods We analyzed the indicator frameworks of six international organizations involved in efforts to improve and synchronize the monitoring and evaluation of the HIV/AIDS response. Our analysis classifies the 328 unique indicators according to what they measure and assesses the degree to which they offer comprehensive measurement across three dimensions: domains of the social context, levels of change and organizational capacity. Results and discussion The majority of indicators focus on individual-level (clinical and behavioural) interventions and outcomes, neglecting structural interventions, community interventions and social outcomes (e.g. stigma reduction; community capacity building; policy-maker sensitization). The main tool used to address social aspects of HIV/AIDS is the disaggregation of data by social group. This raises three main limitations. Indicator frameworks do not provide comprehensive coverage of the diverse social drivers of the epidemic, particularly neglecting criminalization, stigma, discrimination and gender norms. There is a dearth of indicators for evaluating the social impacts of HIV interventions. Indicators of organizational capacity focus on capacity to effectively deliver and manage clinical services, neglecting capacity to respond appropriately and sustainably to complex social contexts. Conclusions Current indicator frameworks cannot adequately assess the social outcomes of HIV interventions. This limits knowledge about social drivers and inhibits the institutionalization of social approaches within the HIV/AIDS response. We conclude that indicator frameworks should expand to offer a more comprehensive range of social indicators for monitoring and evaluation and to include indicators of organizational capacity to tackle social drivers. While such expansion poses challenges for standardization and coordination, we argue that the complexity of interventions producing social outcomes necessitates capacity for flexibility and local tailoring in monitoring and evaluation. PMID:25160645

Introducing rapid diagnostic tests for malaria into drug shops in Uganda: design and implementation of a cluster randomized trial.

PubMed

Mbonye, Anthony K; Magnussen, Pascal; Chandler, Clare I R; Hansen, Kristian S; Lal, Sham; Cundill, Bonnie; Lynch, Caroline A; Clarke, Siân E

2014-07-29

An intervention was designed to introduce rapid diagnostics tests for malaria (mRDTs) into registered drug shops in Uganda to encourage rational and appropriate treatment of malaria with artemisinin-based combination therapy (ACT). We conducted participatory training of drug shop vendors and implemented supporting interventions to orientate local communities (patients) and the public sector (health facility staff and district officials) to the behavioral changes in diagnosis, treatment and referral being introduced in drug shops. The intervention was designed to be evaluated through a cluster randomized trial. In this paper, we present detailed design, implementation and evaluation experiences in order to help inform future studies of a complex nature. Three preparatory studies (formative, baseline and willingness-to-pay) were conducted to explore perceptions on diagnosis and treatment of malaria at drug shops, and affordable prices for mRDTs and ACTs in order to inform the design of the intervention and implementation modalities. The intervention required careful design with the intention to be acceptable, sustainable and effective. Critical components of intervention were: community sensitization and creating awareness, training of drug shop vendors to diagnose malaria with mRDTs, treat and refer customers to formal health facilities, giving pre-referral rectal artesunate and improved record-keeping. The primary outcome was the proportion of patients receiving appropriately-targeted treatment with ACT, evaluated against microscopy on a research blood slide. Introducing mRDTs in drug shops may seem simple, but our experience of intervention design, conduct and evaluation showed this to be a complex process requiring multiple interventions and evaluation components drawing from a combination of epidemiological, social science and health economics methodologies. The trial was conducted in phases sequenced such that each benefited from the other. The main challenges in designing this trial were maintaining a balance between a robust intervention to support effective behaviour change and introducing practices that would be sustainable in a real-life situation in tropical Africa; as well as achieving a detailed evaluation without inadvertently influencing prescribing behaviour. NCT01194557 registered with ClinicalTrials.gov 2 September 2010.

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.

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.

Adapting, piloting and evaluating complex public health interventions: lessons learned from the Nurse–Family Partnership in Canadian public health settings

PubMed Central

Jack, S. M.; Catherine, N.; Gonzalez, A.; MacMillan, H. L.; Sheehan, D.; Waddell, C.

2015-01-01

Abstract Introduction: The Nurse–Family Partnership (NFP) is a home-visit program for young and first-time, socially and economically disadvantaged mothers. Evidence from three United States randomized controlled trials (RCTs) on the effectiveness of this intervention at improving pregnancy outcomes, improving child health and development, and increasing maternal economic self-sufficiency is robust. However, the effectiveness of the NFP in Canada, with its different health and social care context, needs to be determined. The purpose of this article is to describe the complex process for moving the NFP from the research arena to full implementation in Canada. Methods: This process of evaluation in Canada includes (1) adapting the intervention; (2) piloting the intervention in small-scale feasibility and acceptability studies; and (3) conducting an RCT and process evaluation through a study called the British Columbia Healthy Connections Project (BCHCP). This large-scale evaluation also creates an opportunity to expand the NFP evidence base by conducting an additional study to examine potential biological mechanisms linking intervention and behavioural outcomes in children. Results: Adaptation of the NFP home-visit materials is a continuous process. A pilot project determined that it was feasible to enrol eligible women into the NFP. This pilot also determined that, in Canada, it was most appropriate for public health agencies to implement the NFP and for public health nurses to deliver the intervention. Finally, the pilot showed that this intensive home-visit program was acceptable to clients, their family members and health care providers. Through the BCHCP, the next steps—the RCT and process evaluation—are currently underway. The BCHCP will also set the foundation for long-term evaluation of key public health outcomes in a highly vulnerable population of families. PMID:26605564

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.

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

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.

Language Program Evaluation

ERIC Educational Resources Information Center

Norris, John M.

2016-01-01

Language program evaluation is a pragmatic mode of inquiry that illuminates the complex nature of language-related interventions of various kinds, the factors that foster or constrain them, and the consequences that ensue. Program evaluation enables a variety of evidence-based decisions and actions, from designing programs and implementing…

Use of family management styles in family intervention research.

PubMed

Alderfer, Melissa A

2006-01-01

Family management styles (FMSs) explain some of the complexities embedded in a family with a child who has chronic illness. The FMS typologies provide descriptions of family adjustment and management of care. These 5 distinct patterns may be valuable in tailoring and evaluating family interventions in research.

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.

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.

Circular instead of hierarchical: methodological principles for the evaluation of complex interventions

PubMed Central

Walach, Harald; Falkenberg, Torkel; Fønnebø, Vinjar; Lewith, George; Jonas, Wayne B

2006-01-01

Background The reasoning behind evaluating medical interventions is that a hierarchy of methods exists which successively produce improved and therefore more rigorous evidence based medicine upon which to make clinical decisions. At the foundation of this hierarchy are case studies, retrospective and prospective case series, followed by cohort studies with historical and concomitant non-randomized controls. Open-label randomized controlled studies (RCTs), and finally blinded, placebo-controlled RCTs, which offer most internal validity are considered the most reliable evidence. Rigorous RCTs remove bias. Evidence from RCTs forms the basis of meta-analyses and systematic reviews. This hierarchy, founded on a pharmacological model of therapy, is generalized to other interventions which may be complex and non-pharmacological (healing, acupuncture and surgery). Discussion The hierarchical model is valid for limited questions of efficacy, for instance for regulatory purposes and newly devised products and pharmacological preparations. It is inadequate for the evaluation of complex interventions such as physiotherapy, surgery and complementary and alternative medicine (CAM). This has to do with the essential tension between internal validity (rigor and the removal of bias) and external validity (generalizability). Summary Instead of an Evidence Hierarchy, we propose a Circular Model. This would imply a multiplicity of methods, using different designs, counterbalancing their individual strengths and weaknesses to arrive at pragmatic but equally rigorous evidence which would provide significant assistance in clinical and health systems innovation. Such evidence would better inform national health care technology assessment agencies and promote evidence based health reform. PMID:16796762

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.

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.

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.

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

The Health and Sport Engagement (HASE) Intervention and Evaluation Project: protocol for the design, outcome, process and economic evaluation of a complex community sport intervention to increase levels of physical activity.

PubMed

Mansfield, Louise; Anokye, Nana; Fox-Rushby, Julia; Kay, Tess

2015-10-26

Sport is being promoted to raise population levels of physical activity for health. National sport participation policy focuses on complex community provision tailored to diverse local users. Few quality research studies exist that examine the role of community sport interventions in raising physical activity levels and no research to date has examined the costs and cost-effectiveness of such provision. This study is a protocol for the design, outcome, process and economic evaluation of a complex community sport intervention to increase levels of physical activity, the Health and Sport Engagement (HASE) project part of the national Get Healthy Get Active programme led by Sport England. The HASE study is a collaborative partnership between local community sport deliverers and sport and public health researchers. It involves designing, delivering and evaluating community sport interventions. The aim is to engage previously inactive people in sustained sporting activity for 1×30 min a week and to examine associated health and well-being outcomes. The study uses mixed methods. Outcomes (physical activity, health, well-being costs to individuals) will be measured by a series of self-report questionnaires and attendance data and evaluated using interrupted time series analysis controlling for a range of sociodemographic factors. Resource use will be identified and measured using diaries, interviews and records and presented alongside effectiveness data as incremental cost-effectiveness ratios and cost-effectiveness acceptability curves. A longitudinal process evaluation (focus groups, structured observations, in-depth interview methods) will examine the efficacy of the project for achieving its aim using the principles of thematic analysis. The results of this study will be disseminated through peer-reviewed publications, academic conference presentations, Sport England and national public health organisation policy conferences, and practice-based case studies. Ethical approval was obtained through Brunel University London's research ethics committee (reference number RE33-12). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

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

Evaluation of a complex intervention (Engager) for prisoners with common mental health problems, near to and after release: study protocol for a randomised controlled trial

PubMed Central

Lennox, Charlotte; Taylor, Rod; Anderson, Rob; Maguire, Michael; Haddad, Mark; Michie, Susan; Owens, Christabel; Durcan, Graham; Stirzaker, Alex; Henley, William; Stevenson, Caroline; Carroll, Lauren; Quinn, Cath; Brand, Sarah Louise; Harris, Tirril; Stewart, Amy; Todd, Roxanne; Rybczynska-Bunt, Sarah; Greer, Rebecca; Pearson, Mark; Shaw, Jenny; Byng, Richard

2018-01-01

Introduction The ‘Engager’ programme is a ‘through-the-gate’ intervention designed to support prisoners with common mental health problems as they transition from prison back into the community. The trial will evaluate the clinical and cost-effectiveness of the Engager intervention. Methods and analysis The study is a parallel two-group randomised controlled trial with 1:1 individual allocation to either: (a) the Engager intervention plus standard care (intervention group) or (b) standard care alone (control group) across two investigation centres (South West and North West of England). Two hundred and eighty prisoners meeting eligibility criteria will take part. Engager is a person-centred complex intervention delivered by practitioners and aimed at addressing offenders’ mental health and social care needs. It comprises one-to-one support for participants prior to release from prison and for up to 20 weeks postrelease. The primary outcome is change in psychological distress measured by the Clinical Outcomes in Routine Evaluation-Outcome Measure at 6 months postrelease. Secondary outcomes include: assessment of subjective met/unmet need, drug and alcohol use, health-related quality of life and well-being-related quality of life measured at 3, 6 and 12 months postrelease; change in objective social domains, drug and alcohol dependence, service utilisation and perceived helpfulness of services and change in psychological constructs related to desistence at 6 and 12 months postrelease; and recidivism at 12 months postrelease. A process evaluation will assess fidelity of intervention delivery, test hypothesised mechanisms of action and look for unintended consequences. An economic evaluation will estimate the cost-effectiveness. Ethics and dissemination This study has been approved by the Wales Research Ethics Committee 3 (ref: 15/WA/0314) and the National Offender Management Service (ref: 2015–283). Findings will be disseminated to commissioners, clinicians and service users via papers and presentations. Trial registration number ISRCTN11707331; Pre-results. PMID:29463586

Applying the results based management framework to the CERCA multi-component project in adolescent sexual and reproductive health: a retrospective analysis.

PubMed

Cordova-Pozo, Kathya; Hoopes, Andrea J; Cordova, Freddy; Vega, Bernardo; Segura, Zoyla; Hagens, Arnold

2018-02-08

Adolescent sexual and reproductive health (SRH), problems such as unplanned pregnancies are complex and multifactorial, thus requiring multifaceted prevention interventions. Evaluating the impact of such interventions is important to ensure efficiency, effectiveness and accountability for project funders and community members. In this study, we propose Results Based Management (RBM) as a framework for project management, using the Community Embedded Reproductive Health Care for Adolescents (CERCA) as a case study for RBM. The CERCA Project (2010-2014) tested interventions to reduce adolescent pregnancy in three Latin American countries, Bolivia, Ecuador and Nicaragua. Activities were designed to increase adolescent SRH behaviors in four domains: communication with parents, partners and peers; access to SRH information; access to SRH services; and use of contraception. When the project ended, the outcome evaluation showed limited impact with concerns about accuracy of monitoring and attrition of participants. We reviewed and analyzed a series of CERCA documents and related data sources. Key findings from these documents were organized within an RBM framework (planning, monitoring, and impact evaluation) to understand how CERCA methodology and performance might have reaped improved results. Strengths and weaknesses were identified in all three elements of the RBM framework. In Planning, the proposed Theory of Change (ToC) differed from that which was carried out in the intervention package. Each country implemented a different intervention package without articulated assumptions on how the activities of intervention would bring about change. In Monitoring, the project oversight was mainly based on administrative and financial requirements rather than monitoring fidelity and quality of intervention activities. In Impact Evaluation, the original CERCA evaluation assessed intervention effects among adolescents, without identifying success and failure factors related to the outcomes, the nature of the outcomes, or cost-effectiveness of interventions. This analysis showed that multi-country projects are complex, entail risks in execution and require robust project management. RBM can be a useful tool to ensure a systematic approach at different phases within a multi-country setting.

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.

'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.

[Modality of combined methods of quantitative and qualitative research in evaluation of therapeutic effects of Chinese medicine].

PubMed

Liu, Jian-ping

2011-05-01

The core of evidence-based medicine lies in implementing the current best available evidence of clinical research to direct the decision making in clinical practice, incorporation of individual experience and value and preference of patients. However, the current evaluation method for clinical therapeutic effect cannot reflect the humanity and wholesomeness as well as individualized tailored treatment of Chinese medicine (CM) by using randomized controlled trials. This assay addressed the complex intervention of highly individualized treatment of CM and its societal characteristics, and the author proposes a model for the evaluation of therapeutic effects of CM in which quantitative and qualitative methods are combined, embodying the characteristics of the social and natural sciences in CM. The model can show the dynamic process of CM diagnosis and treatment from a perspective of the whole system and can be used for the evaluation of complex intervention of CM. We hope to raise a different thinking and method from the new drug development in the therapeutic effect evaluation.

Evaluation of a complex healthcare intervention to increase smoking cessation in pregnant women: interrupted time series analysis with economic evaluation.

PubMed

Bell, Ruth; Glinianaia, Svetlana V; Waal, Zelda van der; Close, Andrew; Moloney, Eoin; Jones, Susan; Araújo-Soares, Vera; Hamilton, Sharon; Milne, Eugene Mg; Shucksmith, Janet; Vale, Luke; Willmore, Martyn; White, Martin; Rushton, Steven

2018-01-01

To evaluate the effectiveness of a complex intervention to improve referral and treatment of pregnant smokers in routine practice, and to assess the incremental costs to the National Health Service (NHS) per additional woman quitting smoking. Interrupted time series analysis of routine data before and after introducing the intervention, within-study economic evaluation. Eight acute NHS hospital trusts and 12 local authority areas in North East England. 37 726 records of singleton delivery including 10 594 to mothers classified as smoking during pregnancy. A package of measures implemented in trusts and smoking cessation services, aimed at increasing the proportion of pregnant smokers quitting during pregnancy, comprising skills training for healthcare and smoking cessation staff; universal carbon monoxide monitoring with routine opt-out referral for smoking cessation support; provision of carbon monoxide monitors and supporting materials; and an explicit referral pathway and follow-up protocol. Referrals to smoking cessation services; probability of quitting smoking during pregnancy; additional costs to health services; incremental cost per additional woman quitting. After introduction of the intervention, the referral rate increased more than twofold (incidence rate ratio=2.47, 95% CI 2.16 to 2.81) and the probability of quitting by delivery increased (adjusted OR=1.81, 95% CI 1.54 to 2.12). The additional cost per delivery was £31 and the incremental cost per additional quit was £952; 31 pregnant women needed to be treated for each additional quitter. The implementation of a system-wide complex healthcare intervention was associated with significant increase in rates of quitting by delivery. © 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.

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…

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.

Ethnographic process evaluation in primary care: explaining the complexity of implementation.

PubMed

Bunce, Arwen E; Gold, Rachel; Davis, James V; McMullen, Carmit K; Jaworski, Victoria; Mercer, MaryBeth; Nelson, Christine

2014-12-05

The recent growth of implementation research in care delivery systems has led to a renewed interest in methodological approaches that deliver not only intervention outcome data but also deep understanding of the complex dynamics underlying the implementation process. We suggest that an ethnographic approach to process evaluation, when informed by and integrated with quantitative data, can provide this nuanced insight into intervention outcomes. The specific methods used in such ethnographic process evaluations are rarely presented in detail; our objective is to stimulate a conversation around the successes and challenges of specific data collection methods in health care settings. We use the example of a translational clinical trial among 11 community clinics in Portland, OR that are implementing an evidence-based, health-information technology (HIT)-based intervention focused on patients with diabetes. Our ethnographic process evaluation employed weekly diaries by clinic-based study employees, observation, informal and formal interviews, document review, surveys, and group discussions to identify barriers and facilitators to implementation success, provide insight into the quantitative study outcomes, and uncover lessons potentially transferable to other implementation projects. These methods captured the depth and breadth of factors contributing to intervention uptake, while minimizing disruption to clinic work and supporting mid-stream shifts in implementation strategies. A major challenge is the amount of dedicated researcher time required. The deep understanding of the 'how' and 'why' behind intervention outcomes that can be gained through an ethnographic approach improves the credibility and transferability of study findings. We encourage others to share their own experiences with ethnography in implementation evaluation and health services research, and to consider adapting the methods and tools described here for their own research.

Assessment of the urban water system with an open, reproducible process applied to Chicago

EPA Science Inventory

Urban water systems convey complex environmental and man-made flows. The relationships among water flows and networked storages remains difficult to comprehensively evaluate. Such evaluation is important, however, as interventions are designed (e.g, conservation measures, green...

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.

Causal inferences on the effectiveness of complex social programs: Navigating assumptions, sources of complexity and evaluation design challenges.

PubMed

Chatterji, Madhabi

2016-12-01

This paper explores avenues for navigating evaluation design challenges posed by complex social programs (CSPs) and their environments when conducting studies that call for generalizable, causal inferences on the intervention's effectiveness. A definition is provided of a CSP drawing on examples from different fields, and an evaluation case is analyzed in depth to derive seven (7) major sources of complexity that typify CSPs, threatening assumptions of textbook-recommended experimental designs for performing impact evaluations. Theoretically-supported, alternative methodological strategies are discussed to navigate assumptions and counter the design challenges posed by the complex configurations and ecology of CSPs. Specific recommendations include: sequential refinement of the evaluation design through systems thinking, systems-informed logic modeling; and use of extended term, mixed methods (ETMM) approaches with exploratory and confirmatory phases of the evaluation. In the proposed approach, logic models are refined through direct induction and interactions with stakeholders. To better guide assumption evaluation, question-framing, and selection of appropriate methodological strategies, a multiphase evaluation design is recommended. Copyright © 2016 Elsevier Ltd. All rights reserved.

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.

Barriers to and facilitators of implementing complex workplace dietary interventions: process evaluation results of a cluster controlled trial.

PubMed

Fitzgerald, Sarah; Geaney, Fiona; Kelly, Clare; McHugh, Sheena; Perry, Ivan J

2016-04-21

Ambiguity exists regarding the effectiveness of workplace dietary interventions. Rigorous process evaluation is vital to understand this uncertainty. This study was conducted as part of the Food Choice at Work trial which assessed the comparative effectiveness of a workplace environmental dietary modification intervention and an educational intervention both alone and in combination versus a control workplace. Effectiveness was assessed in terms of employees' dietary intakes, nutrition knowledge and health status in four large manufacturing workplaces. The study aimed to examine barriers to and facilitators of implementing complex workplace interventions, from the perspectives of key workplace stakeholders and researchers involved in implementation. A detailed process evaluation monitored and evaluated intervention implementation. Interviews were conducted at baseline (27 interviews) and at 7-9 month follow-up (27 interviews) with a purposive sample of workplace stakeholders (managers and participating employees). Topic guides explored factors which facilitated or impeded implementation. Researchers involved in recruitment and data collection participated in focus groups at baseline and at 7-9 month follow-up to explore their perceptions of intervention implementation. Data were imported into NVivo software and analysed using a thematic framework approach. Four major themes emerged; perceived benefits of participation, negotiation and flexibility of the implementation team, viability and intensity of interventions and workplace structures and cultures. The latter three themes either positively or negatively affected implementation, depending on context. The implementation team included managers involved in coordinating and delivering the interventions and the researchers who collected data and delivered intervention elements. Stakeholders' perceptions of the benefits of participating, which facilitated implementation, included managers' desire to improve company image and employees seeking health improvements. Other facilitators included stakeholder buy-in, organisational support and stakeholder cohesiveness with regards to the level of support provided to the intervention. Anticipation of employee resistance towards menu changes, workplace restructuring and target-driven workplace cultures impeded intervention implementation. Contextual factors such as workplace structures and cultures need to be considered in the implementation of future workplace dietary interventions. Negotiation and flexibility of key workplace stakeholders plays an integral role in overcoming the barriers of workplace cultures, structures and resistance to change. Current Controlled Trials: ISRCTN35108237. Date of registration: 02/07/2013.

Evidence-Based Evaluation of Practice and Innovation in Physical Therapy Using the IDEAL-Physio Framework.

PubMed

Beard, David; Hamilton, David; Davies, Loretta; Cook, Jonathan; Hirst, Allison; McCulloch, Peter; Paez, Arsenio

2018-02-01

The IDEAL framework is an established method for initial and ongoing evaluations of innovation and practice for complex health care interventions. First derived for surgical sciences and embedded at a global level for evaluating surgery/surgical devices, the IDEAL framework is based on the principle that innovation and evaluation in clinical practice can, and should, evolve together in an ordered manner: from conception to development and then to validation by appropriate clinical studies and, finally, longer-term follow-up. This framework is highly suited to other complex, nonpharmacological interventions, such as physical therapist interventions. This perspective outlines the application of IDEAL to physical therapy in the new IDEAL-Physio framework. The IDEAL-Physio framework comprises 5 stages. In stage 1, the idea phase, formal data collection should begin. Stage 2a is the phase for iterative improvement and adjustment with thorough data recording. Stage 2b involves the onset of formal evaluation using systematically collected group or cohort data. Stage 3 is the phase for formal comparative assessment of treatment, usually involving randomized studies. Stage 4 involves long-term follow-up. The IDEAL-Physio framework is recommended as a method for guiding and evaluating both innovation and practice in physical therapy, with the overall goal of providing better evidence-based care. © 2017 American Physical Therapy Association.

'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.

Applying dynamic simulation modeling methods in health care delivery research-the SIMULATE checklist: report of the ISPOR simulation modeling emerging good practices task force.

PubMed

Marshall, Deborah A; Burgos-Liz, Lina; IJzerman, Maarten J; Osgood, Nathaniel D; Padula, William V; Higashi, Mitchell K; Wong, Peter K; Pasupathy, Kalyan S; Crown, William

2015-01-01

Health care delivery systems are inherently complex, consisting of multiple tiers of interdependent subsystems and processes that are adaptive to changes in the environment and behave in a nonlinear fashion. Traditional health technology assessment and modeling methods often neglect the wider health system impacts that can be critical for achieving desired health system goals and are often of limited usefulness when applied to complex health systems. Researchers and health care decision makers can either underestimate or fail to consider the interactions among the people, processes, technology, and facility designs. Health care delivery system interventions need to incorporate the dynamics and complexities of the health care system context in which the intervention is delivered. This report provides an overview of common dynamic simulation modeling methods and examples of health care system interventions in which such methods could be useful. Three dynamic simulation modeling methods are presented to evaluate system interventions for health care delivery: system dynamics, discrete event simulation, and agent-based modeling. In contrast to conventional evaluations, a dynamic systems approach incorporates the complexity of the system and anticipates the upstream and downstream consequences of changes in complex health care delivery systems. This report assists researchers and decision makers in deciding whether these simulation methods are appropriate to address specific health system problems through an eight-point checklist referred to as the SIMULATE (System, Interactions, Multilevel, Understanding, Loops, Agents, Time, Emergence) tool. It is a primer for researchers and decision makers working in health care delivery and implementation sciences who face complex challenges in delivering effective and efficient care that can be addressed with system interventions. On reviewing this report, the readers should be able to identify whether these simulation modeling methods are appropriate to answer the problem they are addressing and to recognize the differences of these methods from other modeling approaches used typically in health technology assessment applications. Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

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

Intensive Care Syndrome: Promoting Independence and Return to Employment (InS:PIRE). Early evaluation of a complex intervention

PubMed Central

Shaw, Martin; Iwashyna, Theodore J.; Daniel, Malcolm; Devine, Helen; Jarvie, Lyndsey; Kinsella, John; MacTavish, Pamela; Quasim, Tara

2017-01-01

Background Many patients suffer significant physical, social and psychological problems in the months and years following critical care discharge. At present, there is minimal evidence of any effective interventions to support this patient group following hospital discharge. The aim of this project was to understand the impact of a complex intervention for ICU survivors. Methods Quality improvement project conducted between September 2014 and June 2016, enrolling 49 selected patients from one ICU in Scotland. To evaluate the impact of this programme outcomes were compared to an existing cohort of patients from the same ICU from 2008–2009. Patients attended a five week peer supported rehabilitation programme. This multidisciplinary programme included pharmacy, physiotherapy, nursing, medical, and psychology input. The primary outcome in this evaluation was the EQ-5D, a validated measure of health-related quality of life. The minimally clinically important difference (MCID) in the EQ-5D is 0.08. We also measured change in self-efficacy over the programme duration. Based on previous research, this study utilised a 2.4 (6%) point change in self-efficacy scores as a MCID. Results 40 patients (82%) completed follow-up surveys at 12 months. After regression adjustment for those factors known to impact recovery from critical care, there was a 0.07–0.16 point improvement in quality of life for those patients who took part in the intervention compared to historical controls from the same institution, depending on specific regression strategy used. Self-efficacy scores increased by 2.5 points (6.25%) over the duration of the five week programme (p = 0.003), and was sustained at one year post intervention. In the year following ICU, 15 InS:PIRE patients returned to employment or volunteering roles (88%) compared with 11 (46%) in the historical control group (p = 0.15). Conclusions and relevance This historical control study suggests that a complex intervention may improve quality of life and self-efficacy in survivors of ICU. A larger, multi-centre study is needed to investigate this intervention further. PMID:29186177

Intensive Care Syndrome: Promoting Independence and Return to Employment (InS:PIRE). Early evaluation of a complex intervention.

PubMed

McPeake, Joanne; Shaw, Martin; Iwashyna, Theodore J; Daniel, Malcolm; Devine, Helen; Jarvie, Lyndsey; Kinsella, John; MacTavish, Pamela; Quasim, Tara

2017-01-01

Many patients suffer significant physical, social and psychological problems in the months and years following critical care discharge. At present, there is minimal evidence of any effective interventions to support this patient group following hospital discharge. The aim of this project was to understand the impact of a complex intervention for ICU survivors. Quality improvement project conducted between September 2014 and June 2016, enrolling 49 selected patients from one ICU in Scotland. To evaluate the impact of this programme outcomes were compared to an existing cohort of patients from the same ICU from 2008-2009. Patients attended a five week peer supported rehabilitation programme. This multidisciplinary programme included pharmacy, physiotherapy, nursing, medical, and psychology input. The primary outcome in this evaluation was the EQ-5D, a validated measure of health-related quality of life. The minimally clinically important difference (MCID) in the EQ-5D is 0.08. We also measured change in self-efficacy over the programme duration. Based on previous research, this study utilised a 2.4 (6%) point change in self-efficacy scores as a MCID. 40 patients (82%) completed follow-up surveys at 12 months. After regression adjustment for those factors known to impact recovery from critical care, there was a 0.07-0.16 point improvement in quality of life for those patients who took part in the intervention compared to historical controls from the same institution, depending on specific regression strategy used. Self-efficacy scores increased by 2.5 points (6.25%) over the duration of the five week programme (p = 0.003), and was sustained at one year post intervention. In the year following ICU, 15 InS:PIRE patients returned to employment or volunteering roles (88%) compared with 11 (46%) in the historical control group (p = 0.15). This historical control study suggests that a complex intervention may improve quality of life and self-efficacy in survivors of ICU. A larger, multi-centre study is needed to investigate this intervention further.

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 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

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

Interprofessional teamwork and team interventions in chronic care: A systematic review.

PubMed

Körner, Mirjam; Bütof, Sarah; Müller, Christian; Zimmermann, Linda; Becker, Sonja; Bengel, Jürgen

2016-01-01

To identify key features of teamwork and interventions for enhancing interprofessional teamwork (IPT) in chronic care and to develop a framework for further research, we conducted a systematic literature review of IPT in chronic care for the years 2002-2014. Database searches yielded 3217 abstracts, 21 of which fulfilled inclusion criteria. We identified two more studies on the topic by scanning the reference lists of included articles, which resulted in a final total of 23 included studies. The key features identified in the articles (e.g., team member characteristics, common task, communication, cooperation, coordination, responsibility, participation, staff satisfaction, patient satisfaction, and efficiency) were structured in line with the input-process-output model, and evaluated interventions, such as tools, workshops, and changes in team structure, were added to the model. The most frequently evaluated team interventions were complex intervention programs. All but one of the 14 evaluation studies resulted in enhancement of teamwork and/or staff-related, patient-related, and organization-related outcome criteria. To date, there is no consensus about the main features of IPT and the most effective team interventions in chronic care. However, the findings may be used to standardize the implementation and evaluation of IPT and team interventions in practice and for further research.

The effect of a behaviour change intervention on the diets and physical activity levels of women attending Sure Start Children’s Centres: results from a complex public health intervention

PubMed Central

Baird, Janis; Jarman, Megan; Lawrence, Wendy; Black, Christina; Davies, Jenny; Tinati, Tannaze; Begum, Rufia; Mortimore, Andrew; Robinson, Sian; Margetts, Barrie; Cooper, Cyrus; Barker, Mary; Inskip, Hazel

2014-01-01

Objectives The UK government's response to the obesity epidemic calls for action in communities to improve people's health behaviour. This study evaluated the effects of a community intervention on dietary quality and levels of physical activity of women from disadvantaged backgrounds. Design Non-randomised controlled evaluation of a complex public health intervention. Participants 527 women attending Sure Start Children's Centres (SSCC) in Southampton (intervention) and 495 women attending SSCCs in Gosport and Havant (control). Intervention Training SSCC staff in behaviour change skills that would empower women to change their health behaviours. Outcomes Main outcomes dietary quality and physical activity. Intermediate outcomes self-efficacy and sense of control. Results 1-year post-training, intervention staff used skills to support behaviour change significantly more than control staff. There were statistically significant reductions of 0.1 SD in the dietary quality of all women between baseline and follow-up and reductions in self-efficacy and sense of control. The decline in self-efficacy and control was significantly smaller in women in the intervention group than in women in the control group (adjusted differences in self-efficacy and control, respectively, 0.26 (95% CI 0.001 to 0.50) and 0.35 (0.05 to 0.65)). A lower decline in control was associated with higher levels of exposure in women in the intervention group. There was a statistically significant improvement in physical activity in the intervention group, with 22.9% of women reporting the highest level of physical activity compared with 12.4% at baseline, and a smaller improvement in the control group. The difference in change in physical activity level between the groups was not statistically significant (adjusted difference 1.02 (0.74 to 1.41)). Conclusions While the intervention did not improve women's diets and physical activity levels, it had a protective effect on intermediate factors—control and self-efficacy—suggesting that a more prolonged exposure to the intervention might improve health behaviour. Further evaluation in a more controlled setting is justified. PMID:25031194

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.

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).

Space Fortress game training and executive control in older adults: A pilot intervention

PubMed Central

Stern, Yaakov; Blumen, Helena M.; Rich, Leigh W.; Richards, Alexis; Herzberg, Gray; Gopher, Daniel

2012-01-01

We investigated the feasibility of using the Space Fortress (SF) game, a complex video game originally developed to study complex skill acquisition in young adults, to improve executive control processes in cognitively healthy older adults. The study protocol consisted of 36 one-hour game play sessions over 3 months with cognitive evaluations before and after, and a follow-up evaluation at 6 months. Sixty participants were randomized to one of three conditions: Emphasis Change (EC) – elders were instructed to concentrate on playing the entire game but place particular emphasis on a specific aspect of game play in each particular game; Active Control (AC) – game play with standard instructions; Passive Control (PC) – evaluation sessions without game play. Primary outcome measures were obtained from five tasks, presumably tapping executive control processes. A total of 54 older adults completed the study protocol. One measure of executive control, WAIS-III letter–number sequencing, showed improvement in performance from pre- to post-evaluations in the EC condition, but not in the other two conditions. These initial findings are modest but encouraging. Future SF interventions need to carefully consider increasing the duration and or the intensity of the intervention by providing at-home game training, reducing the motor demands of the game, and selecting appropriate outcome measures. PMID:21988726

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.

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 .

Applying systems theory to the evaluation of a whole school approach to violence prevention.

PubMed

Kearney, Sarah; Leung, Loksee; Joyce, Andrew; Ollis, Debbie; Green, Celia

2016-02-01

Issue addressed Our Watch led a complex 12-month evaluation of a whole school approach to Respectful Relationships Education (RRE) implemented in 19 schools. RRE is an emerging field aimed at preventing gender-based violence. This paper will illustrate how from an implementation science perspective, the evaluation was a critical element in the change process at both a school and policy level. Methods Using several conceptual approaches from systems science, the evaluation sought to examine how the multiple systems layers - student, teacher, school, community and government - interacted and influenced each other. A distinguishing feature of the evaluation included 'feedback loops'; that is, evaluation data was provided to participants as it became available. Evaluation tools included a combination of standardised surveys (with pre- and post-intervention data provided to schools via individualised reports), reflection tools, regular reflection interviews and summative focus groups. Results Data was shared during implementation with project staff, department staff and schools to support continuous improvement at these multiple systems levels. In complex settings, implementation can vary according to context; and the impact of evaluation processes, tools and findings differed across the schools. Interviews and focus groups conducted at the end of the project illustrated which of these methods were instrumental in motivating change and engaging stakeholders at both a school and departmental level and why. Conclusion The evaluation methods were a critical component of the pilot's approach, helping to shape implementation through data feedback loops and reflective practice for ongoing, responsive and continuous improvement. Future health promotion research on complex interventions needs to examine how the evaluation itself is influencing implementation. So what? The pilot has demonstrated that the evaluation, including feedback loops to inform project activity, were an asset to implementation. This has implications for other health promotion activities, where evaluation tools could be utilised to enhance, rather than simply measure, an intervention. The findings are relevant to a range of health promotion research activities because they demonstrate the importance of meta-evaluation techniques that seek to understand how the evaluation itself was influencing implementation and outcomes.

[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.

Balancing Broad Ideas with Context: An Evaluation of Student Accuracy in Describing Ecosystem Processes after a System-Level Intervention

ERIC Educational Resources Information Center

Jordan, Rebecca C.; Brooks, Wesley R.; Hmelo-Silver, Cindy; Eberbach, Catherine; Sinha, Suparna

2014-01-01

Promoting student understanding of ecosystem processes is critical to biological education. Yet, teaching complex life systems can be difficult because systems are dynamic and often behave in a non-linear manner. In this paper, we discuss assessment results from a middle school classroom intervention in which a conceptual representation framework…

The Anger Management Project: A Group Intervention for Anger in People with Physical and Multiple Disabilities

ERIC Educational Resources Information Center

Hagiliassis, Nick; Gulbenkoglu, Hrepsime; Di Marco, Mark; Young, Suzanne; Hudson, Alan

2005-01-01

Background: This paper describes the evaluation of a group program designed specifically to meet the anger management needs of a group of individuals with various levels of intellectual disability and/or complex communication needs. Method: Twenty-nine individuals were randomly assigned to an intervention group or a waiting-list comparison group.…

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.

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.

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.

The Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE): method and design considerations.

PubMed

Boudreaux, Edwin D; Miller, Ivan; Goldstein, Amy B; Sullivan, Ashley F; Allen, Michael H; Manton, Anne P; Arias, Sarah A; Camargo, Carlos A

2013-09-01

Due to the concentration of individuals at-risk for suicide, an emergency department visit represents an opportune time for suicide risk screening and intervention. The Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) uses a quasi-experimental, interrupted time series design to evaluate whether (1) a practical approach to universally screening ED patients for suicide risk leads to improved detection of suicide risk and (2) a multi-component intervention delivered during and after the ED visit improves suicide-related outcomes. This paper summarizes the ED-SAFE's study design and methods within the context of considerations relevant to effectiveness research in suicide prevention and pertinent human participants concerns. 1440 suicidal individuals, from 8 general ED's nationally will be enrolled during three sequential phases of data collection (480 individuals/phase): (1) Treatment as Usual; (2) Universal Screening; and (3) Intervention. Data from the three phases will inform two separate evaluations: Screening Outcome (Phases 1 and 2) and Intervention (Phases 2 and 3). Individuals will be followed for 12 months. The primary study outcome is a composite reflecting completed suicide, attempted suicide, aborted or interrupted attempts, and implementation of rescue procedures during an outcome assessment. While 'classic' randomized control trials (RCT) are typically selected over quasi-experimental designs, ethical and methodological issues may make an RCT a poor fit for complex interventions in an applied setting, such as the ED. ED-SAFE represents an innovative approach to examining the complex public health issue of suicide prevention through a multi-phase, quasi-experimental design embedded in 'real world' clinical settings. Copyright © 2013 Elsevier Inc. All rights reserved.

A complex culturally targeted intervention to reduce Hispanic disparities in living kidney donor transplantation: an effectiveness-implementation hybrid study protocol.

PubMed

Gordon, Elisa J; Lee, Jungwha; Kang, Raymond H; Caicedo, Juan Carlos; Holl, Jane L; Ladner, Daniela P; Shumate, Michelle D

2018-05-16

The shortage of organs for kidney transplantation for patients with end-stage renal disease (ESRD) is magnified in Hispanics/Latin Americans in the United States. Living donor kidney transplantation (LDKT) is the treatment of choice for ESRD. However, compared to their representation on the transplant waitlist, fewer Hispanics receive a LDKT than non-Hispanic whites. Barriers to LDKT for Hispanics include: lack of knowledge, cultural concerns, and language barriers. Few interventions have been designed to reduce LDKT disparities. This study aims to reduce Hispanic disparities in LDKT through a culturally targeted intervention. Using a prospective effectiveness-implementation hybrid design involving pre-post intervention evaluation with matched controls, we will implement a complex culturally targeted intervention at two transplant centers in Dallas, TX and Phoenix, AZ. The goal of the study is to evaluate the effect of Northwestern Medicine's® Hispanic Kidney Transplant Program's (HKTP) key culturally targeted components (outreach, communication, education) on Hispanic LDKT rates over five years. The main hypothesis is that exposure to the HKTP will reduce disparities by increasing the ratio of Hispanic to non-Hispanic white LDKTs and the number of Hispanic LDKTs. We will also examine other process and outcome measures including: dialysis patient outreach, education session attendance, marketing efforts, Hispanic patients added to the waitlist, Hispanic potential donors per potential recipient, and satisfaction with culturally competent care. We will use mixed methods based on the Promoting Action on Research Implementation in Health Services (revised PARIHS) and the Consolidated Framework for Implementation Research (CFIR) frameworks to formatively evaluate the fidelity and innovative adaptations to HKTP's components at both study sites, to identify moderating factors that most affect implementation fidelity, and to identify adaptations that positively and negatively affect outcomes for patients. Our study will provide new knowledge about implementing culturally targeted interventions and their impact on reducing health disparities. Moreover, the study of a complex organizational-level intervention's implementation over five years is rare in implementation science; as such, this study is poised to contribute new knowledge to the factors influencing how organizational-level interventions are sustained over time. (ClinicalTrials.gov registration # NCT03276390 , date of registration: 9-7-17, retrospectively registered).

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.

Assessment and model guided cancer screening promotion by village doctors in China: a randomized controlled trial protocol.

PubMed

Feng, Rui; Shen, Xingrong; Chai, Jing; Chen, Penglai; Cheng, Jing; Liang, Han; Zhao, Ting; Sha, Rui; Li, Kaichun; Wang, Debin

2015-10-12

Proven cost-effectiveness contrasted by low uptake of cancer screening (CS) calls for new methodologies promoting the service. Contemporary interventions in this regard relies primarily on strategies targeting general or specific groups with limited attention being paid to individualized approaches. This trial tests a novel package promoting CS utilization via continuous and tailored counseling delivered by primary caregivers. It aims at demonstrating that high risk individuals in the intervention arm will, compared to those in the delayed intervention condition, show increased use of CS service. The trial adopts a quasi-randomized controlled trial design and involves 2160 high risk individuals selected, via rapid and detailed risk assessments, from about 72,000 farmers aged 35+ in 36 administrative villages randomized into equal intervention and delayed intervention arms. The CS intervention package uses: a) village doctors and village clinics to deliver personalized and thus relatively sophisticated CS counseling; b) two-stage risk assessment models in identifying high risk individuals to focus the intervention on the most needed; c) standardized operation procedures to guide conduct of counseling; d) real-time effectiveness and quality monitoring to leverage continuous improvement; e) web-based electronic system to enable prioritizing complex determinants of CS uptake and tailoring counseling sessions to the changing needs of individual farmers. The intervention arm receives baseline and semiannual follow up evaluations plus CS counseling for 5 years; while the delayed intervention arm, only the same baseline and follow-up evaluations for the first 5 years and CS counseling starting from the 6th year if the intervention proved effective. Evaluation measures include: CS uptake by high risk farmers and changes in their knowledge, perceptions and self-efficacy about CS. Given the complexity and heterogeneity in the determinant system of individual CS service seeking behavior, personalized interventions may prove to be an effective strategy. The current trial distinguishes itself from previous ones in that it not only adopts a personalized strategy but also introduces a package of pragmatic solutions based on proven theories for tackling potential barriers and incorporating key success factors in a synergetic way toward low cost, effective and sustainable CS promotion. ISRCTN33269053.

Challenges in evaluating surgical innovation.

PubMed

Ergina, Patrick L; Cook, Jonathan A; Blazeby, Jane M; Boutron, Isabelle; Clavien, Pierre-Alain; Reeves, Barnaby C; Seiler, Christoph M; Altman, Douglas G; Aronson, Jeffrey K; Barkun, Jeffrey S; Campbell, W Bruce; Cook, Jonathan A; Feldman, Liane S; Flum, David R; Glasziou, Paul; Maddern, Guy J; Marshall, John C; McCulloch, Peter; Nicholl, Jon; Strasberg, Steven M; Meakins, Jonathan L; Ashby, Deborah; Black, Nick; Bunker, John; Burton, Martin; Campbell, Marion; Chalkidou, Kalipso; Chalmers, Iain; de Leval, Marc; Deeks, Jon; Grant, Adrian; Gray, Muir; Greenhalgh, Roger; Jenicek, Milos; Kehoe, Sean; Lilford, Richard; Littlejohns, Peter; Loke, Yoon; Madhock, Rajan; McPherson, Kim; Rothwell, Peter; Summerskill, Bill; Taggart, David; Tekkis, Parris; Thompson, Matthew; Treasure, Tom; Trohler, Ulrich; Vandenbroucke, Jan

2009-09-26

Research on surgical interventions is associated with several methodological and practical challenges of which few, if any, apply only to surgery. However, surgical evaluation is especially demanding because many of these challenges coincide. In this report, the second of three on surgical innovation and evaluation, we discuss obstacles related to the study design of randomised controlled trials and non-randomised studies assessing surgical interventions. We also describe the issues related to the nature of surgical procedures-for example, their complexity, surgeon-related factors, and the range of outcomes. Although difficult, surgical evaluation is achievable and necessary. Solutions tailored to surgical research and a framework for generating evidence on which to base surgical practice are essential.

“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

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.

A systematic quality review of high-tech AAC interventions as an evidence-based practice.

PubMed

Morin, Kristi L; Ganz, Jennifer B; Gregori, Emily V; Foster, Margaret J; Gerow, Stephanie L; Genç-Tosun, Derya; Hong, Ee Rea

2018-06-01

Although high-tech augmentative and alternative communication (AAC) is commonly used to teach social-communication skills to people with autism spectrum disorder or intellectual disabilities who have complex communication needs, there is a critical need to evaluate the efficacy of this approach. The aim of this systematic review was to evaluate the quality of single-case experimental design research on the use of high-tech AAC to teach social-communication skills to individuals with autism spectrum disorder or intellectual disabilities who have complex communication needs, to determine if this intervention approach meets the criteria for evidence-based practices as outlined by the What Works Clearinghouse. Additionally, information on the following extended methodological standards is reported on all included studies: participant description, description of setting and materials, interventionist description, baseline and intervention description, maintenance, generalization, procedural integrity, and social validity. The results from 18 multiple-baseline or multiple-probe experiments across 17 studies indicate that using high-tech AAC to teach social-communication skills to individuals with autism spectrum disorder or intellectual disabilities and complex communication needs can be considered an evidence-based practice, although the review of comparison (i.e., alternating treatment) design studies did not indicate that high-tech AAC is significantly better than low-tech AAC.

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.

Examining the Effects of a National League for Nursing Core Competencies Workshop as an Intervention to Improve Nurse Faculty Practice

ERIC Educational Resources Information Center

VanBever Wilson, Robin R.

2010-01-01

Due to the complex challenges facing schools of nursing, a research study was implemented to introduce nurse faculty at one small rural northeastern Tennessee school of nursing to the NLN "Core Competencies for Nurse Educators". Utilizing Kalb's Nurse Faculty Self-Evaluation Tool as a pre- and post-intervention test, 30 nurse faculty…

[The evaluation of pharmacological drugs, medical devices, and non-pharmacological or public health interventions: Experimental design limitations. Moving towards new methods?

PubMed

Villeval, M; Carayol, M; Lamy, S; Lepage, B; Lang, T

2016-12-01

In the field of health, evidence-based medicine and associated methods like randomised controlled trials (RCTs) have become widely used. RCT has become the gold standard for evaluating causal links between interventions and health results. Originating in pharmacology, this method has been progressively expanded to medical devices, non-pharmacological individual interventions, as well as collective public health interventions. Its use in these domains has led to the formulation of several limits, and it has been called into question as an undisputed gold standard. Some of those limits (e.g. confounding biases and external validity) are common to these four different domains, while others are more specific. This paper describes the different limits, as well as several research avenues. Some are methodological reflections aiming at adapting RCT to the complexity of the tested interventions, and at overcoming some of its limits. Others are alternative methods. The objective is not to remove RCT from the range of evaluation methodologies, but to resituate it within this range. The aim is to encourage choosing between different methods according to the features and the level of the intervention to evaluate, thereby calling for methodological pluralism. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Evidence of a shared purpose, critical reflection, innovation and leadership in interprofessional healthcare teams: a realist synthesis.

PubMed

Sims, Sarah; Hewitt, Gillian; Harris, Ruth

2015-05-01

Realist synthesis is a theory-driven approach for evaluating complex interventions using empirical evidence, which seeks an explanatory analysis of who a complex intervention works for, how, why, and in what circumstances. Interprofessional teamworking in healthcare is one such complex intervention, as teams are influenced by social and organizational factors, which makes them highly variable and context dependent. This article concludes a series of four articles that report on a realist synthesis of interprofessional teamworking. The synthesis identified 13 mechanisms that are reported in the literature to be the underlying processes through which interprofessional teamworking produces its effects. This article explores four of these mechanisms: a shared purpose; critical reflection; innovation; and leadership. These mechanisms together explain how a team sets and maintains its focus and direction. This article highlights that whilst many assumptions are made within the healthcare literature about how these mechanisms operate within teams, these assumptions are not always founded upon strong empirical evidence.

Cost-effectiveness of a complex workplace dietary intervention: an economic evaluation of the Food Choice at Work study

PubMed Central

Fitzgerald, Sarah; Murphy, Aileen; Kirby, Ann; Geaney, Fiona; Perry, Ivan J

2018-01-01

Objective To evaluate the costs, benefits and cost-effectiveness of complex workplace dietary interventions, involving nutrition education and system-level dietary modification, from the perspective of healthcare providers and employers. Design Single-study economic evaluation of a cluster-controlled trial (Food Choice at Work (FCW) study) with 1-year follow-up. Setting Four multinational manufacturing workplaces in Cork, Ireland. Participants 517 randomly selected employees (18–65 years) from four workplaces. Interventions Cost data were obtained from the FCW study. Nutrition education included individual nutrition consultations, nutrition information (traffic light menu labelling, posters, leaflets and emails) and presentations. System-level dietary modification included menu modification (restriction of fat, sugar and salt), increase in fibre, fruit discounts, strategic positioning of healthier alternatives and portion size control. The combined intervention included nutrition education and system-level dietary modification. No intervention was implemented in the control. Outcomes The primary outcome was an improvement in health-related quality of life, measured using the EuroQoL 5 Dimensions 5 Levels questionnaire. The secondary outcome measure was reduction in absenteeism, which is measured in monetary amounts. Probabilistic sensitivity analysis (Monte Carlo simulation) assessed parameter uncertainty. Results The system-level intervention dominated the education and combined interventions. When compared with the control, the incremental cost-effectiveness ratio (€101.37/quality-adjusted life-year) is less than the nationally accepted ceiling ratio, so the system-level intervention can be considered cost-effective. The cost-effectiveness acceptability curve indicates there is some decision uncertainty surrounding this, arising from uncertainty surrounding the differences in effectiveness. These results are reiterated when the secondary outcome measure is considered in a cost–benefit analysis, whereby the system-level intervention yields the highest net benefit (€56.56 per employee). Conclusions System-level dietary modification alone offers the most value per improving employee health-related quality of life and generating net benefit for employers by reducing absenteeism. While system-level dietary modification strategies are potentially sustainable obesity prevention interventions, future research should include long-term outcomes to determine if improvements in outcomes persist. Trial registration number ISRCTN35108237; Post-results. PMID:29502090

Examining diffusion to understand the how of SASA!, a violence against women and HIV prevention intervention in Uganda.

PubMed

Starmann, Elizabeth; Heise, Lori; Kyegombe, Nambusi; Devries, Karen; Abramsky, Tanya; Michau, Lori; Musuya, Tina; Watts, Charlotte; Collumbien, Martine

2018-05-11

A growing number of complex public health interventions combine mass media with community-based "change agents" and/or mobilisation efforts acting at multiple levels. While impact evaluations are important, there is a paucity of research into the more nuanced roles intervention and social network factors may play in achieving intervention outcomes, making it difficult to understand how different aspects of the intervention worked (or did not). This study applied aspects of diffusion of innovations theory to explore how SASA!, a community mobilisation approach for preventing HIV and violence against women, diffused within intervention communities and the factors that influenced the uptake of new ideas and behaviours around intimate partner relationships and violence. This paper is based on a qualitative study of couples living in SASA communities and secondary analysis of endline quantitative data collected as part of a cluster randomised control trial designed to evaluate the impact of the SASA! The primary trial was conducted in eight communities in Kampala, Uganda between 2007 and 2012. The secondary analysis of follow up survey data used multivariate logistic regression to examine associations between intervention exposure and interpersonal communication, and relationship change (n = 928). The qualitative study used in-depth interviews (n = 20) and framework analysis methods to explore the intervention attributes that facilitated engagement with the intervention and uptake of new ideas and behaviours in intimate relationships. We found communication materials and mid media channels generated awareness and knowledge, while the concurrent influence from interpersonal communication with community-based change agents and social network members more frequently facilitated changes in behaviour. The results indicate combining community mobilisation components, programme content that reflects peoples' lives and direct support through local change agents can facilitate diffusion and powerful collective change processes in communities. This study makes clear the value of applying diffusion of innovations theory to illuminate how complex public health intervention evaluations effect change. It also contributes to our knowledge of partner violence prevention in a low-income, urban East African context. ClinicalTrials.gov # NCT00790959 . Registered 13th November 2008.

Application of Balanced Scorecard in the Evaluation of a Complex Health System Intervention: 12 Months Post Intervention Findings from the BHOMA Intervention: A Cluster Randomised Trial in Zambia

PubMed Central

Mutale, Wilbroad; Stringer, Jeffrey; Chintu, Namwinga; Chilengi, Roma; Mwanamwenge, Margaret Tembo; Kasese, Nkatya; Balabanova, Dina; Spicer, Neil; Lewis, James; Ayles, Helen

2014-01-01

Introduction In many low income countries, the delivery of quality health services is hampered by health system-wide barriers which are often interlinked, however empirical evidence on how to assess the level and scope of these barriers is scarce. A balanced scorecard is a tool that allows for wider analysis of domains that are deemed important in achieving the overall vision of the health system. We present the quantitative results of the 12 months follow-up study applying the balanced scorecard approach in the BHOMA intervention with the aim of demonstrating the utility of the balanced scorecard in evaluating multiple building blocks in a trial setting. Methods The BHOMA is a cluster randomised trial that aims to strengthen the health system in three rural districts in Zambia. The intervention aims to improve clinical care quality by implementing practical tools that establish clear clinical care standards through intensive clinic implementations. This paper reports the findings of the follow-up health facility survey that was conducted after 12 months of intervention implementation. Comparisons were made between those facilities in the intervention and control sites. STATA version 12 was used for analysis. Results The study found significant mean differences between intervention(I) and control (C) sites in the following domains: Training domain (Mean I:C; 87.5.vs 61.1, mean difference 23.3, p = 0.031), adult clinical observation domain (mean I:C; 73.3 vs.58.0, mean difference 10.9, p = 0.02 ) and health information domain (mean I:C; 63.6 vs.56.1, mean difference 6.8, p = 0.01. There was no gender differences in adult service satisfaction. Governance and motivation scores did not differ between control and intervention sites. Conclusion This study demonstrates the utility of the balanced scorecard in assessing multiple elements of the health system. Using system wide approaches and triangulating data collection methods seems to be key to successful evaluation of such complex health intervention. Trial number ClinicalTrials.gov NCT01942278 PMID:24751780

Application of balanced scorecard in the evaluation of a complex health system intervention: 12 months post intervention findings from the BHOMA intervention: a cluster randomised trial in Zambia.

PubMed

Mutale, Wilbroad; Stringer, Jeffrey; Chintu, Namwinga; Chilengi, Roma; Mwanamwenge, Margaret Tembo; Kasese, Nkatya; Balabanova, Dina; Spicer, Neil; Lewis, James; Ayles, Helen

2014-01-01

In many low income countries, the delivery of quality health services is hampered by health system-wide barriers which are often interlinked, however empirical evidence on how to assess the level and scope of these barriers is scarce. A balanced scorecard is a tool that allows for wider analysis of domains that are deemed important in achieving the overall vision of the health system. We present the quantitative results of the 12 months follow-up study applying the balanced scorecard approach in the BHOMA intervention with the aim of demonstrating the utility of the balanced scorecard in evaluating multiple building blocks in a trial setting. The BHOMA is a cluster randomised trial that aims to strengthen the health system in three rural districts in Zambia. The intervention aims to improve clinical care quality by implementing practical tools that establish clear clinical care standards through intensive clinic implementations. This paper reports the findings of the follow-up health facility survey that was conducted after 12 months of intervention implementation. Comparisons were made between those facilities in the intervention and control sites. STATA version 12 was used for analysis. The study found significant mean differences between intervention(I) and control (C) sites in the following domains: Training domain (Mean I:C; 87.5.vs 61.1, mean difference 23.3, p = 0.031), adult clinical observation domain (mean I:C; 73.3 vs.58.0, mean difference 10.9, p = 0.02 ) and health information domain (mean I:C; 63.6 vs.56.1, mean difference 6.8, p = 0.01. There was no gender differences in adult service satisfaction. Governance and motivation scores did not differ between control and intervention sites. This study demonstrates the utility of the balanced scorecard in assessing multiple elements of the health system. Using system wide approaches and triangulating data collection methods seems to be key to successful evaluation of such complex health intervention. ClinicalTrials.gov NCT01942278.

Evaluation of quality improvement programmes

PubMed Central

Ovretveit, J; Gustafson, D

2002-01-01



 In response to increasing concerns about quality, many countries are carrying out large scale programmes which include national quality strategies, hospital programmes, and quality accreditation, assessment and review processes. Increasing amounts of resources are being devoted to these interventions, but do they ensure or improve quality of care? There is little research evidence as to their effectiveness or the conditions for maximum effectiveness. Reasons for the lack of evaluation research include the methodological challenges of measuring outcomes and attributing causality to these complex, changing, long term social interventions to organisations or health systems, which themselves are complex and changing. However, methods are available which can be used to evaluate these programmes and which can provide decision makers with research based guidance on how to plan and implement them. This paper describes the research challenges, the methods which can be used, and gives examples and guidance for future research. It emphasises the important contribution which such research can make to improving the effectiveness of these programmes and to developing the science of quality improvement. PMID:12486994

A Realist Evaluation Approach to Unpacking the Impacts of the Sentencing Guidelines

ERIC Educational Resources Information Center

Hunt, Kim Steven; Sridharan, Sanjeev

2010-01-01

Evaluations of complex interventions such as sentencing guidelines provide an opportunity to understand the mechanisms by which policies and programs can impact intermediate and long-term outcomes. There is limited previous discussion of the underlying frameworks by which sentencing guidelines can impact outcomes such as crime rates. Guided by a…

Utilisation of three-dimensional printed heart models for operative planning of complex congenital heart defects.

PubMed

Olejník, Peter; Nosal, Matej; Havran, Tomas; Furdova, Adriana; Cizmar, Maros; Slabej, Michal; Thurzo, Andrej; Vitovic, Pavol; Klvac, Martin; Acel, Tibor; Masura, Jozef

2017-01-01

To evaluate the accuracy of the three-dimensional (3D) printing of cardiovascular structures. To explore whether utilisation of 3D printed heart replicas can improve surgical and catheter interventional planning in patients with complex congenital heart defects. Between December 2014 and November 2015 we fabricated eight cardiovascular models based on computed tomography data in patients with complex spatial anatomical relationships of cardiovascular structures. A Bland-Altman analysis was used to assess the accuracy of 3D printing by comparing dimension measurements at analogous anatomical locations between the printed models and digital imagery data, as well as between printed models and in vivo surgical findings. The contribution of 3D printed heart models for perioperative planning improvement was evaluated in the four most representative patients. Bland-Altman analysis confirmed the high accuracy of 3D cardiovascular printing. Each printed model offered an improved spatial anatomical orientation of cardiovascular structures. Current 3D printers can produce authentic copies of patients` cardiovascular systems from computed tomography data. The use of 3D printed models can facilitate surgical or catheter interventional procedures in patients with complex congenital heart defects due to better preoperative planning and intraoperative orientation.

[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.

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

Assessing health system interventions: key points when considering the value of randomization

PubMed Central

Schellenberg, Joanna; Todd, Jim

2011-01-01

Abstract Research is needed to help identify interventions that will improve the capacity or functioning of health systems and thereby contribute to achieving global health goals. Well conducted, randomized controlled trials (RCTs), insofar as they reduce bias and confounding, provide the strongest evidence for identifying which interventions delivered directly to individuals are safe and effective. When ethically feasible, they can also help reduce bias and confounding when assessing interventions targeting entire health systems. However, additional challenges emerge when research focuses on interventions that target the multiple units of organization found within health systems. Hence, one cannot complacently assume that randomization can reduce or eliminate bias and confounding to the same degree in every instance. While others have articulated arguments in favour of alternative designs, this paper is intended to help people understand why the potential value afforded by RCTs may be threatened. Specifically, it suggests six points to be borne in mind when exploring the challenges entailed in designing or evaluating RCTs on health system interventions: (i) the number of units available for randomization; (ii) the complexity of the organizational unit under study; (iii) the complexity of the intervention; (iv) the complexity of the cause–effect pathway, (v) contamination; and (vi) outcome heterogeneity. The authors suggest that the latter may be informative and that the reasons behind it should be explored and not ignored. Based on improved understanding of the value and possible limitations of RCTs on health system interventions, the authors show why we need broader platforms of research to complement RCTs. PMID:22271948

A Qualitative Approach: Evaluating the Childhood Health and Obesity Initiative Communities Empowered for Success (CHOICES) Pilot Study.

PubMed

Brown, Cynthia Williams; Alexander, Dayna S; Warren, Claudia A; Anderson-Booker, Marian

2017-08-01

Low-income and minority children are susceptible to obesity due to the social and environmental barriers that influence their health behaviors. Many programs and interventions fail to account for these aforementioned barriers among this population. Given what we know about the complexity of childhood obesity, low-income and minority children require innovative prevention strategies from those used in traditional childhood obesity interventions. The purpose of this study was to describe the evaluation of a 6-week summer childhood obesity pilot intervention designed for low-income and minority children. Focus groups and interviews (N = 29) were conducted among caregivers. Overall, caregivers indicated that the experience was mostly positive for their children who obtained small amounts of knowledge and behavioral changes. Caregivers also noted several perceived barriers for intervention completion. The CHOICES intervention is a promising approach that warrants attention in future childhood obesity intervention design. Interventions involving low-income and minority children should aim to help participants make healthier choices given the environmental and social barriers that cannot be overlooked or changed.

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.

Familiarity with current practices of granting and maintaining privileges in pediatric interventional radiology--a worldwide survey of the members of the Society for Pediatric Interventional Radiology (SPIR).

PubMed

Harned, Roger K

2012-11-01

Physician credentialing is a complex process driven by the demand for quality improvement in health care. In the U.S., the Joint Commission Standard of 2007 has tied hospital accreditation to credentialing through mandated use of the Focused Professional Practice Evaluation (FPPE) and Ongoing Professional Practice Evaluation (OPPE). To assess pediatric interventional radiologists' knowledge of how institutions grant them privileges. Members of the Society for Pediatric Interventional Radiology (SPIR) were sent a web-based survey regarding credentialing. Of 122 members from 19 countries, 81 (66%) responded, and of these 81, 59 (73%) were familiar with their hospital's privileging process. Of 49 U.S. respondents and 32 non-U.S. respondents, 37 (76%) and 17 (53%), respectively, stated that interventional radiology credentialing was different from diagnostic radiology credentialing. Of the 49 U.S. respondents, 24 (49%) reported an OPPE, and of the 32 non-U.S. respondents, 8 (25%) reported an ongoing evaluation. The U.S. OPPE is performed at shorter intervals than its international equivalent. Four years after the Joint Commission defined the FPPE and OPPE, separate credentialing of pediatric interventional radiology from pediatric diagnostic radiology is more likely in the U.S. than internationally, and U.S. pediatric interventional radiologists are more likely to have a defined ongoing professional evaluation and to be evaluated every 6 months or more frequently. There are many SPIR members who do not know how they obtain privileges and/or are not knowingly subject to an OPPE. This lack of knowledge may affect future education of interventional radiologists as well as the definition of pediatric interventional radiology practices within individual institutions.

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.

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.

Modeling the impact of simulated educational interventions on the use and abuse of pharmaceutical opioids in the United States: a report on initial efforts.

PubMed

Wakeland, Wayne; Nielsen, Alexandra; Schmidt, Teresa D; McCarty, Dennis; Webster, Lynn R; Fitzgerald, John; Haddox, J David

2013-10-01

Three educational interventions were simulated in a system dynamics model of the medical use, trafficking, and nonmedical use of pharmaceutical opioids. The study relied on secondary data obtained in the literature for the period of 1995 to 2008 as well as expert panel recommendations regarding model parameters and structure. The behavior of the resulting systems-level model was tested for fit against reference behavior data. After the base model was tested, logic to represent three educational interventions was added and the impact of each intervention on simulated overdose deaths was evaluated over a 7-year evaluation period, 2008 to 2015. Principal findings were that a prescriber education intervention not only reduced total overdose deaths in the model but also reduced the total number of persons who receive opioid analgesic therapy, medical user education not only reduced overdose deaths among medical users but also resulted in increased deaths from nonmedical use, and a "popularity" intervention sharply reduced overdose deaths among nonmedical users while having no effect on medical use. System dynamics modeling shows promise for evaluating potential interventions to ameliorate the adverse outcomes associated with the complex system surrounding the use of opioid analgesics to treat pain.

Multiple and mixed methods in formative evaluation: Is more better? Reflections from a South African study.

PubMed

Odendaal, Willem; Atkins, Salla; Lewin, Simon

2016-12-15

Formative programme evaluations assess intervention implementation processes, and are seen widely as a way of unlocking the 'black box' of any programme in order to explore and understand why a programme functions as it does. However, few critical assessments of the methods used in such evaluations are available, and there are especially few that reflect on how well the evaluation achieved its objectives. This paper describes a formative evaluation of a community-based lay health worker programme for TB and HIV/AIDS clients across three low-income communities in South Africa. It assesses each of the methods used in relation to the evaluation objectives, and offers suggestions on ways of optimising the use of multiple, mixed-methods within formative evaluations of complex health system interventions. The evaluation's qualitative methods comprised interviews, focus groups, observations and diary keeping. Quantitative methods included a time-and-motion study of the lay health workers' scope of practice and a client survey. The authors conceptualised and conducted the evaluation, and through iterative discussions, assessed the methods used and their results. Overall, the evaluation highlighted programme issues and insights beyond the reach of traditional single methods evaluations. The strengths of the multiple, mixed-methods in this evaluation included a detailed description and nuanced understanding of the programme and its implementation, and triangulation of the perspectives and experiences of clients, lay health workers, and programme managers. However, the use of multiple methods needs to be carefully planned and implemented as this approach can overstretch the logistic and analytic resources of an evaluation. For complex interventions, formative evaluation designs including multiple qualitative and quantitative methods hold distinct advantages over single method evaluations. However, their value is not in the number of methods used, but in how each method matches the evaluation questions and the scientific integrity with which the methods are selected and implemented.

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

Evaluation of alternative school feeding models on nutrition, education, agriculture and other social outcomes in Ghana: rationale, randomised design and baseline data.

PubMed

Gelli, Aulo; Masset, Edoardo; Folson, Gloria; Kusi, Anthoni; Arhinful, Daniel K; Asante, Felix; Ayi, Irene; Bosompem, Kwabena M; Watkins, Kristie; Abdul-Rahman, Lutuf; Agble, Rosanna; Ananse-Baden, Getrude; Mumuni, Daniel; Aurino, Elisabetta; Fernandes, Meena; Drake, Lesley

2016-01-20

'Home-grown' school feeding programmes are complex interventions with the potential to link the increased demand for school feeding goods and services to community-based stakeholders, including smallholder farmers and women's groups. There is limited rigorous evidence, however, that this is the case in practice. This evaluation will examine explicitly, and from a holistic perspective, the simultaneous impact of a national school meals programme on micronutrient status, alongside outcomes in nutrition, education and agriculture domains. The 3-year study involves a cluster-randomised control trial designed around the scale-up of the national school feeding programme, including 116 primary schools in 58 districts in Ghana. The randomly assigned interventions are: 1) a school feeding programme group, including schools and communities where the standard government programme is implemented; 2) 'home-grown' school feeding, including schools and communities where the standard programme is implemented alongside an innovative pilot project aimed at enhancing nutrition and agriculture; and 3) a control group, including schools and households from communities where the intervention will be delayed by at least 3 years, preferably without informing schools and households. Primary outcomes include child health and nutritional status, school participation and learning, and smallholder farmer income. Intermediate outcomes along the agriculture and nutrition pathways will also be measured. The evaluation will follow a mixed-method approach, including child-, household-, school- and community-level surveys as well as focus group discussions with project stakeholders. The baseline survey was completed in August 2013 and the endline survey is planned for November 2015. The tests of balance show significant differences in the means of a number of outcome and control variables across the intervention groups. Important differences across groups include marketed surplus, livestock income, per capita food consumption and intake, school attendance, and anthropometric status in the 2-5 and 5-15 years age groups. In addition, approximately 19 % of children in the target age group received some form of free school meals at baseline. Designing and implementing the evaluation of complex interventions is in itself a complex undertaking, involving a multi-disciplinary research team working in close collaboration with programme- and policy-level stakeholders. Managing the complexity from an analytical and operational perspective is an important challenge. The analysis of the baseline data indicates that the random allocation process did not achieve statistically comparable treatment groups. Differences in outcomes and control variables across groups will be controlled for when estimating treatment effects. ISRCTN66918874 (registered on 5 March 2015).

GoActive: a protocol for the mixed methods process evaluation of a school-based physical activity promotion programme for 13-14year old adolescents.

PubMed

Jong, Stephanie T; Brown, Helen Elizabeth; Croxson, Caroline H D; Wilkinson, Paul; Corder, Kirsten L; van Sluijs, Esther M F

2018-05-21

Process evaluations are critical for interpreting and understanding outcome trial results. By understanding how interventions function across different settings, process evaluations have the capacity to inform future dissemination of interventions. The complexity of Get others Active (GoActive), a 12-week, school-based physical activity intervention implemented in eight schools, highlights the need to investigate how implementation is achieved across a variety of school settings. This paper describes the mixed methods GoActive process evaluation protocol that is embedded within the outcome evaluation. In this detailed process evaluation protocol, we describe the flexible and pragmatic methods that will be used for capturing the process evaluation data. A mixed methods design will be used for the process evaluation, including quantitative data collected in both the control and intervention arms of the GoActive trial, and qualitative data collected in the intervention arm. Data collection methods will include purposively sampled, semi-structured interviews and focus group interviews, direct observation, and participant questionnaires (completed by students, teachers, older adolescent mentors, and local authority-funded facilitators). Data will be analysed thematically within and across datasets. Overall synthesis of findings will address the process of GoActive implementation, and through which this process affects outcomes, with careful attention to the context of the school environment. This process evaluation will explore the experience of participating in GoActive from the perspectives of key groups, providing a greater understanding of the acceptability and process of implementation of the intervention across the eight intervention schools. This will allow for appraisal of the intervention's conceptual base, inform potential dissemination, and help optimise post-trial sustainability. The process evaluation will also assist in contextualising the trial effectiveness results with respect to how the intervention may or may not have worked and, if it was found to be effective, what might be required for it to be sustained in the 'real world'. Furthermore, it will offer suggestions for the development and implementation of future initiatives to promote physical activity within schools. ISRCTN, ISRCTN31583496 . Registered on 18 February 2014.

Evaluation of community level interventions to address social and structural determinants of health: a cluster randomised controlled trial

PubMed Central

Wall, Martin; Hayes, Richard; Moore, Derek; Petticrew, Mark; Clow, Angela; Schmidt, Elena; Draper, Alizon; Lock, Karen; Lynch, Rebecca; Renton, Adrian

2009-01-01

Background In London and the rest of the UK, diseases associated with poor diet, inadequate physical activity and mental illness account for a large proportion of area based health inequality. There is a lack of evidence on interventions promoting healthier behaviours especially in marginalised populations, at a structural or ecological level and utilising a community development approach. The Well London project financed by the Big Lottery 'Wellbeing' Fund and implemented by a consortium of London based agencies led by the Greater London Authority and the London Health Commission is implementing a set of complex interventions across 20 deprived areas of London. The interventions focus on healthy eating, healthy physical activity and mental health and wellbeing and are designed and executed with community participation complementing existing facilities and services. Methods/Design The programme will be evaluated through a cluster randomised controlled trial. Forty areas across London were chosen based on deprivation scores. Areas were characterised by high proportion of Black and Minority Ethnic residents, worklessness, ill-health and poor physical environments. Twenty areas were randomly assigned to the intervention arm of Well London project and twenty 'matched' areas assigned as controls. Measures of physical activity, diet and mental health are collected at start and end of the project and compared to assess impact. The quantitative element will be complemented by a longitudinal qualitative study elucidating pathways of influence between intervention activities and health outcomes. A related element of the study investigates the health-related aspects of the structural and ecological characteristics of the project areas. The project 'process' will also be evaluated. Discussion The size of the project and the fact that the interventions are 'complex' in the sense that firstly, there are a number of interacting components with a wide range of groups and organisational levels targeted by the intervention, and secondly, a degree of flexibility or tailoring of the intervention, makes this trial potentially very useful in providing evidence of the types of activities that can be used to address chronic health problems in communities suffering from multiple deprivation. Trial Registration Current Controlled Trials ISRCTN68175121 PMID:19558712

Tools to overcome potential barriers to chlamydia screening in general practice: Qualitative evaluation of the implementation of a complex intervention.

PubMed

Ricketts, Ellie J; Francischetto, Elaine O'Connell; Wallace, Louise M; Hogan, Angela; McNulty, Cliodna A M

2016-03-22

Chlamydia trachomatis remains a significant public health problem. We used a complex intervention, with general practice staff, consisting of practice based workshops, posters, computer prompts and testing feedback and feedback to increase routine chlamydia screening tests in under 25 year olds in South West England. We aimed to evaluate how intervention components were received by staff and to understand what determined their implementation into ongoing practice. We used face-to-face and telephone individual interviews with 29 general practice staff analysed thematically within a Normalisation Process Theory Framework which explores: 1. Coherence (if participants understand the purpose of the intervention); 2. Cognitive participation (engagement with and implementation of the intervention); 3. Collective action (work actually undertaken that drives the intervention forwards); 4. Reflexive monitoring (assessment of the impact of the intervention). Our results showed coherence as all staff including receptionists understood the purpose of the training was to make them aware of the value of chlamydia screening tests and how to increase this in their general practice. The training was described by nearly all staff as being of high quality and responsible for creating a shared understanding between staff of how to undertake routine chlamydia screening. Cognitive participation in many general practice staff teams was demonstrated through their engagement by meeting after the training to discuss implementation, which confirmed the role of each staff member and the use of materials. However several participants still felt unable to discuss chlamydia in many consultations or described sexual health as low priority among colleagues. National targets were considered so high for some general practice staff that they didn't engage with the screening intervention. Collective action work undertaken to drive the intervention included use of computer prompts which helped staff remember to make the offer, testing rate feedback and having a designated lead. Ensuring patients collected samples when still in the general practice was not attained in most general practices. Reflexive monitoring showed positive feedback from patients and other staff about the value of screening, and feedback about the general practices testing rates helped sustain activity. A complex intervention including interactive workshops, materials to help implementation and feedback can help chlamydia screening testing increase in general practices.

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.

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

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.

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.

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.

A framework for learning about improvement: embedded implementation and evaluation design to optimize learning

PubMed Central

Barry, Danika; Kimble, Leighann E; Nambiar, Bejoy; Parry, Gareth; Jha, Ashish; Chattu, Vijay Kumar; Massoud, M Rashad; Goldmann, Don

2018-01-01

Abstract Improving health care involves many actors, often working in complex adaptive systems. Interventions tend to be multi-factorial, implementation activities diverse, and contexts dynamic and complicated. This makes improvement initiatives challenging to describe and evaluate as matching evaluation and program designs can be difficult, requiring collaboration, trust and transparency. Collaboration is required to address important epidemiological principles of bias and confounding. If this does not take place, results may lack credibility because the association between interventions implemented and outcomes achieved is obscure and attribution uncertain. Moreover, lack of clarity about what was implemented, how it was implemented, and the context in which it was implemented often lead to disappointment or outright failure of spread and scale-up efforts. The input of skilled evaluators into the design and conduct of improvement initiatives can be helpful in mitigating these potential problems. While evaluation must be rigorous, if it is too rigid necessary adaptation and learning may be compromised. This article provides a framework and guidance on how improvers and evaluators can work together to design, implement and learn about improvement interventions more effectively. PMID:29873794

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

Built environment interventions aimed at improving physical activity levels in rural Ontario health units: a descriptive qualitative study.

PubMed

Coghill, Cara-Lee; Valaitis, Ruta K; Eyles, John D

2015-05-03

Few studies to date have explored the relationship between the built environment and physical activity specifically in rural settings. The Ontario Public Health Standards policies mandate that health units in Ontario address the built environment; however, it is unclear how public health practitioners are integrating the built environment into public health interventions aimed at improving physical activity in chronic disease prevention programs. This descriptive qualitative study explored interventions that have or are being implemented which address the built environment specifically related to physical activity in rural Ontario health units, and the impact of these interventions. Data were collected through twelve in-depth semi-structured interviews with rural public health practitioners and managers representing 12 of 13 health units serving rural communities. Key themes were identified using qualitative content analysis. Themes that emerged regarding the types of interventions that health units are employing included: Engagement with policy work at a municipal level; building and working with community partners, committees and coalitions; gathering and providing evidence; developing and implementing programs; and social marketing and awareness raising. Evaluation of interventions to date has been limited. Public health interventions, and their evaluations, are complex. Health units who serve large rural populations in Ontario are engaging in numerous activities to address physical activity levels. There is a need to further evaluate the impact of these interventions on population health.

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…

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…

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.

Evaluation of a family systems intervention for managing pediatric chronic illness: Mastering Each New Direction (MEND).

PubMed

Distelberg, Brian; Williams-Reade, Jackie; Tapanes, Daniel; Montgomery, Susanne; Pandit, Mayuri

2014-06-01

Family systems play a crucial, albeit complex, role in pediatric chronic illness. Unfortunately, very few psychosocial interventions are available to help these stressed families navigate the developmental steps of chronic illness. A new intervention (MEND) addresses the needs of these families and applies to a broad range of chronic illnesses. This article presents this family systems intervention as well as includes preliminary program evaluation data on 22 families that graduated from the program. Results show consistently strong effects across an array of psychosocial measures. Conclusions from this preliminary study suggest that families entering MEND present with high levels of stress due to the child's chronic illness, but after MEND, the level of stress and other functioning measures are comparable to those seen in healthy families, suggesting that the program offers a significant benefit to families with pediatric chronic illness. © 2014 FPI, Inc.

Evaluation of a family camp intervention for children with a heart transplant and their families.

PubMed

Nicholas, David B; Dodd, Bernadette; Urschel, Simon; Young, Amber; West, Lori J

2016-10-01

Given the arduous course of heart transplantation and follow-up care, recipients and their families face complex challenges and stressors warranting supportive interventions. This study explored the impact of a family camp as an intervention of education and social support for pediatric transplant recipients and their families. A total of 49 individuals participated in this evaluation, including eight children and nine youth with heart transplants, five siblings, 19 parents, and 13 health care providers. Participants ranked and described the 3-day family camp experience. Analysis of pre/post intervention measures on knowledge, social support, and coping revealed statistically significant improvements in knowledge, social support, self-esteem, and psychological stability. Satisfaction surveys revealed the camp to be an important resource for education, family fun, and peer support among transplant recipients, their families, and the health care team. Implications and recommendations are offered for clinical and community practice.

Evaluation of a Family Systems Intervention for Managing Pediatric Chronic Illness: Mastering Each New Direction (MEND)

PubMed Central

Distelberg, Brian; Williams-Reade, Jackie; Tapanes, Daniel; Montgomery, Susanne; Pandit, Mayuri

2015-01-01

Family systems play a crucial, albeit complex, role in pediatric chronic illness. Unfortunately, very few psychosocial interventions are available to help these stressed families navigate the developmental steps of chronic illness. A new intervention (MEND) addresses the needs of these families and applies to a broad range of chronic illnesses. This article presents this family systems intervention as well as includes preliminary program evaluation data on 22 families that graduated from the program. Results show consistently strong effects across an array of psychosocial measures. Conclusions from this preliminary study suggest that families entering MEND present with high levels of stress due to the child's chronic illness, but after MEND, the level of stress and other functioning measures are comparable to those seen in healthy families, suggesting that the program offers a significant benefit to families with pediatric chronic illness. PMID:24635346

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.

Measures of fidelity of delivery of, and engagement with, complex, face-to-face health behaviour change interventions: A systematic review of measure quality.

PubMed

Walton, Holly; Spector, Aimee; Tombor, Ildiko; Michie, Susan

2017-11-01

Understanding the effectiveness of complex, face-to-face health behaviour change interventions requires high-quality measures to assess fidelity of delivery and engagement. This systematic review aimed to (1) identify the types of measures used to monitor fidelity of delivery of, and engagement with, complex, face-to-face health behaviour change interventions and (2) describe the reporting of psychometric and implementation qualities. Electronic databases were searched, systematic reviews and reference lists were hand-searched, and 21 experts were contacted to identify articles. Studies that quantitatively measured fidelity of delivery of, and/or engagement with, a complex, face-to-face health behaviour change intervention for adults were included. Data on interventions, measures, and psychometric and implementation qualities were extracted and synthesized using narrative analysis. Sixty-six studies were included: 24 measured both fidelity of delivery and engagement, 20 measured fidelity of delivery, and 22 measured engagement. Measures of fidelity of delivery included observation (n = 17; 38.6%), self-report (n = 15; 34%), quantitatively rated qualitative interviews (n = 1; 2.3%), or multiple measures (n = 11; 25%). Measures of engagement included self-report (n = 18; 39.1%), intervention records (n = 11; 24%), or multiple measures (n = 17; 37%). Fifty-one studies (77%) reported at least one psychometric or implementation quality; 49 studies (74.2%) reported at least one psychometric quality, and 17 studies (25.8%) reported at least one implementation quality. Fewer than half of the reviewed studies measured both fidelity of delivery of, and engagement with complex, face-to-face health behaviour change interventions. More studies reported psychometric qualities than implementation qualities. Interpretation of intervention outcomes from fidelity of delivery and engagement measurements may be limited due to a lack of reporting of psychometric and implementation qualities. Statement of contribution What is already known on this subject? Evidence of fidelity and engagement is needed to understand effectiveness of complex interventions Evidence of fidelity and engagement are rarely reported High-quality measures are needed to measure fidelity and engagement What does this study add? Evidence that indicators of quality of measures are reported in some studies Evidence that psychometric qualities are reported more frequently than implementation qualities A recommendation for intervention evaluations to report indicators of quality of fidelity and engagement measures. © 2017 The Authors. British Journal of Health Psychology published by John Wiley & Sons Ltd on behalf of British Psychological Society.

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

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.

Systematic review of the economic evidence on home visitation programmes for vulnerable pregnant women.

PubMed

Stamuli, Eugena; Richardson, Gerry; Duffy, Steven; Robling, Michael; Hood, Kerry

2015-09-01

A systematic review of the economic evidence on home visitation programmes for young or vulnerable pregnant women was undertaken to provide a summary of the existing literature of these interventions. Relevant studies were identified from a number of sources including large databases, free text search on Google Scholar as well as hand-searching of the obtained references. The search yielded a large number of papers, of which 12 were considered appropriate to be included in the review. These were either full or partial economic evaluations: four studies were cost-benefit analyses, three were cost-effectiveness analyses and the remaining were costing studies. The review highlighted the paucity of good quality economic evaluations in the area of home visiting programmes for young or vulnerable pregnant women. Methods varied substantially between the studies spanning from differing data sources (e.g. single randomized trials or meta-analyses) to different perspectives taken, cost items and outcomes included in the analysis. It is difficult to establish a coherent body of economic evidence for these interventions and draw a firm conclusion on their value for money. Home visiting programmes are complex interventions, with impact on the lives of mothers and their children. The funding of such interventions should be based on rigorous effectiveness and economic evidence. There is a need for well-designed economic evaluations which will follow the appropriate methodological guidelines and also take into account the complexity of such interventions. These analyses should preferably consider multiple perspectives and allow for the fact that the majority of the benefits accrue in the long-term future. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Steps to Ensure a Successful Implementation of Occupational Health and Safety Interventions at an Organizational Level

PubMed Central

Herrera-Sánchez, Isabel M.; León-Pérez, José M.; León-Rubio, José M.

2017-01-01

There is increasing meta-analytic evidence that addresses the positive impact of evidence-based occupational health and safety interventions on employee health and well-being. However, such evidence is less clear when interventions are approached at an organizational level and are aimed at changing organizational policies and processes. Given that occupational health and safety interventions are usually tailored to specific organizational contexts, generalizing and transferring such interventions to other organizations is a complex endeavor. In response, several authors have argued that an evaluation of the implementation process is crucial for assessing the intervention’s effectiveness and for understanding how and why the intervention has been (un)successful. Thus, this paper focuses on the implementation process and attempts to move this field forward by identifying the main factors that contribute toward ensuring a greater success of occupational health and safety interventions conducted at the organizational level. In doing so, we propose some steps that can guide a successful implementation. These implementation steps are illustrated using examples of evidence-based best practices reported in the literature that have described and systematically evaluated the implementation process behind their interventions during the last decade. PMID:29375413

A systematic review of Markov models evaluating multicomponent disease management programs in diabetes.

PubMed

Kirsch, Florian

2015-01-01

Diabetes is the most expensive chronic disease; therefore, disease management programs (DMPs) were introduced. The aim of this review is to determine whether Markov models are adequate to evaluate the cost-effectiveness of complex interventions such as DMPs. Additionally, the quality of the models was evaluated using Philips and Caro quality appraisals. The five reviewed models incorporated the DMP into the model differently: two models integrated effectiveness rates derived from one clinical trial/meta-analysis and three models combined interventions from different sources into a DMP. The results range from cost savings and a QALY gain to costs of US$85,087 per QALY. The Spearman's rank coefficient assesses no correlation between the quality appraisals. With restrictions to the data selection process, Markov models are adequate to determine the cost-effectiveness of DMPs; however, to allow prioritization of medical services, more flexibility in the models is necessary to enable the evaluation of single additional interventions.

The effect of a behaviour change intervention on the diets and physical activity levels of women attending Sure Start Children's Centres: results from a complex public health intervention.

PubMed

Baird, Janis; Jarman, Megan; Lawrence, Wendy; Black, Christina; Davies, Jenny; Tinati, Tannaze; Begum, Rufia; Mortimore, Andrew; Robinson, Sian; Margetts, Barrie; Cooper, Cyrus; Barker, Mary; Inskip, Hazel

2014-07-15

The UK government's response to the obesity epidemic calls for action in communities to improve people's health behaviour. This study evaluated the effects of a community intervention on dietary quality and levels of physical activity of women from disadvantaged backgrounds. Non-randomised controlled evaluation of a complex public health intervention. 527 women attending Sure Start Children's Centres (SSCC) in Southampton (intervention) and 495 women attending SSCCs in Gosport and Havant (control). Training SSCC staff in behaviour change skills that would empower women to change their health behaviours. Main outcomes dietary quality and physical activity. Intermediate outcomes self-efficacy and sense of control. 1-year post-training, intervention staff used skills to support behaviour change significantly more than control staff. There were statistically significant reductions of 0.1 SD in the dietary quality of all women between baseline and follow-up and reductions in self-efficacy and sense of control. The decline in self-efficacy and control was significantly smaller in women in the intervention group than in women in the control group (adjusted differences in self-efficacy and control, respectively, 0.26 (95% CI 0.001 to 0.50) and 0.35 (0.05 to 0.65)). A lower decline in control was associated with higher levels of exposure in women in the intervention group. There was a statistically significant improvement in physical activity in the intervention group, with 22.9% of women reporting the highest level of physical activity compared with 12.4% at baseline, and a smaller improvement in the control group. The difference in change in physical activity level between the groups was not statistically significant (adjusted difference 1.02 (0.74 to 1.41)). While the intervention did not improve women's diets and physical activity levels, it had a protective effect on intermediate factors-control and self-efficacy-suggesting that a more prolonged exposure to the intervention might improve health behaviour. Further evaluation in a more controlled setting is justified. 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.

Economic Evaluation of Obesity Prevention in Early Childhood: Methods, Limitations and Recommendations.

PubMed

Döring, Nora; Mayer, Susanne; Rasmussen, Finn; Sonntag, Diana

2016-09-13

Despite methodological advances in the field of economic evaluations of interventions, economic evaluations of obesity prevention programmes in early childhood are seldom conducted. The aim of the present study was to explore existing methods and applications of economic evaluations, examining their limitations and making recommendations for future cost-effectiveness assessments. A systematic literature search was conducted using PubMed, Cochrane Library, the British National Health Service Economic Evaluation Databases and EconLit. Eligible studies included trial-based or simulation-based cost-effectiveness analyses of obesity prevention programmes targeting preschool children and/or their parents. The quality of included studies was assessed. Of the six studies included, five were intervention studies and one was based on a simulation approach conducted on secondary data. We identified three main conceptual and methodological limitations of their economic evaluations: Insufficient conceptual approach considering the complexity of childhood obesity, inadequate measurement of effects of interventions, and lack of valid instruments to measure child-related quality of life and costs. Despite the need for economic evaluations of obesity prevention programmes in early childhood, only a few studies of varying quality have been conducted. Moreover, due to methodological and conceptual weaknesses, they offer only limited information for policy makers and intervention providers. We elaborate reasons for the limitations of these studies and offer guidance for designing better economic evaluations of early obesity prevention.

Economic Evaluation of Obesity Prevention in Early Childhood: Methods, Limitations and Recommendations

PubMed Central

Döring, Nora; Mayer, Susanne; Rasmussen, Finn; Sonntag, Diana

2016-01-01

Despite methodological advances in the field of economic evaluations of interventions, economic evaluations of obesity prevention programmes in early childhood are seldom conducted. The aim of the present study was to explore existing methods and applications of economic evaluations, examining their limitations and making recommendations for future cost-effectiveness assessments. A systematic literature search was conducted using PubMed, Cochrane Library, the British National Health Service Economic Evaluation Databases and EconLit. Eligible studies included trial-based or simulation-based cost-effectiveness analyses of obesity prevention programmes targeting preschool children and/or their parents. The quality of included studies was assessed. Of the six studies included, five were intervention studies and one was based on a simulation approach conducted on secondary data. We identified three main conceptual and methodological limitations of their economic evaluations: Insufficient conceptual approach considering the complexity of childhood obesity, inadequate measurement of effects of interventions, and lack of valid instruments to measure child-related quality of life and costs. Despite the need for economic evaluations of obesity prevention programmes in early childhood, only a few studies of varying quality have been conducted. Moreover, due to methodological and conceptual weaknesses, they offer only limited information for policy makers and intervention providers. We elaborate reasons for the limitations of these studies and offer guidance for designing better economic evaluations of early obesity prevention. PMID:27649218

Time Together: A nursing intervention in psychiatric inpatient care: Feasibility and effects.

PubMed

Molin, Jenny; Lindgren, Britt-Marie; Graneheim, Ulla Hällgren; Ringnér, Anders

2018-04-25

The facilitation of quality time between patients and staff in psychiatric inpatient care is useful to promote recovery and reduce stress experienced by staff. However, interventions are reported to be complex to implement and are poorly described in the literature. This multisite study aimed to evaluate the feasibility and effects of the nursing intervention Time Together, using mixed methods. Data consisted of notes from participant observations and logs to evaluate feasibility, and questionnaires to evaluate effects. The primary outcome for patients was quality of interactions, and for staff, it was perceived stress. The secondary outcome for patients was anxiety and depression symptom levels, and for staff, it was stress of conscience. Data were analysed using visual analysis, percentage of nonoverlapping data, and qualitative content analysis. The results showed that Time Together was a feasible intervention, but measurements showed no effects on the two patient outcomes: quality of interactions and anxiety and depressive symptoms and, questionable effects on perceived stress and stress of conscience among staff. Shared responsibility, a friendly approach, and a predictable structure enabled Time Together, while a distant approach and an unpredictable structure hindered the intervention. In conclusion, the intervention proved to be feasible with potential to enable quality interactions between patients and staff using the enabling factors as supportive components. It also had some effects on perceived stress and stress of conscience among staff. Further evaluation is needed to build on the evidence for the intervention. © 2018 Australian College of Mental Health Nurses Inc.

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.

Evaluating a complex intervention with a single outcome may not be a good idea: an example from a randomised trial of stroke case management.

PubMed

Mayo, Nancy E; Scott, Susan

2011-11-01

to estimate the extent to which a case-management intervention for persons newly discharged into the community following an acute stroke effected a change in stroke outcome in comparison with usual care. a re-analysis of stratified, balanced, randomised clinical trial. five university-affiliated acute-care hospitals in Montreal, Quebec, Canada. a total of 190 persons (mean age 70 years) returning home directly from the acute-care hospital following a first or recurrent stroke with a need for health-care supervision post-discharge because of low function, co-morbidity or isolation. for 6 weeks following discharge a nurse case manager delivered, depending on need, over 50 different nursing interventions (range 2-15 per person), which targeted physical, emotional and psychological impairments, role participation restrictions and health perception. seven of the SF-36 subscales were used to measure the targeted constructs, at the post-intervention and 6 month evaluations. Seven binary response variables were created with a change of 10 points the criterion for individual response. Generalised estimating equations, equivalent to a logistic regression for multiple outcomes, were used. the odds of responding to one or more outcomes was 41% greater in the intervention group than in the control group [odds ratio (OR): 1.41; 95% confidence interval (CI): 1.11-1.79]. an analysis considering the complexity of the intervention and outcomes targeted indicated effectiveness of the nurse case-management post-stroke, whereas the traditional one outcome analysis did not.

Assessing the complexity of interventions within systematic reviews: development, content and use of a new tool (iCAT_SR).

PubMed

Lewin, Simon; Hendry, Maggie; Chandler, Jackie; Oxman, Andrew D; Michie, Susan; Shepperd, Sasha; Reeves, Barnaby C; Tugwell, Peter; Hannes, Karin; Rehfuess, Eva A; Welch, Vivien; Mckenzie, Joanne E; Burford, Belinda; Petkovic, Jennifer; Anderson, Laurie M; Harris, Janet; Noyes, Jane

2017-04-26

Health interventions fall along a spectrum from simple to more complex. There is wide interest in methods for reviewing 'complex interventions', but few transparent approaches for assessing intervention complexity in systematic reviews. Such assessments may assist review authors in, for example, systematically describing interventions and developing logic models. This paper describes the development and application of the intervention Complexity Assessment Tool for Systematic Reviews (iCAT_SR), a new tool to assess and categorise levels of intervention complexity in systematic reviews. We developed the iCAT_SR by adapting and extending an existing complexity assessment tool for randomized trials. We undertook this adaptation using a consensus approach in which possible complexity dimensions were circulated for feedback to a panel of methodologists with expertise in complex interventions and systematic reviews. Based on these inputs, we developed a draft version of the tool. We then invited a second round of feedback from the panel and a wider group of systematic reviewers. This informed further refinement of the tool. The tool comprises ten dimensions: (1) the number of active components in the intervention; (2) the number of behaviours of recipients to which the intervention is directed; (3) the range and number of organizational levels targeted by the intervention; (4) the degree of tailoring intended or flexibility permitted across sites or individuals in applying or implementing the intervention; (5) the level of skill required by those delivering the intervention; (6) the level of skill required by those receiving the intervention; (7) the degree of interaction between intervention components; (8) the degree to which the effects of the intervention are context dependent; (9) the degree to which the effects of the interventions are changed by recipient or provider factors; (10) and the nature of the causal pathway between intervention and outcome. Dimensions 1-6 are considered 'core' dimensions. Dimensions 7-10 are optional and may not be useful for all interventions. The iCAT_SR tool facilitates more in-depth, systematic assessment of the complexity of interventions in systematic reviews and can assist in undertaking reviews and interpreting review findings. Further testing of the tool is now needed.

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.

Patient-mediated knowledge translation (PKT) interventions for clinical encounters: a systematic review.

PubMed

Gagliardi, Anna R; Légaré, France; Brouwers, Melissa C; Webster, Fiona; Badley, Elizabeth; Straus, Sharon

2016-02-29

Patient-mediated knowledge translation (PKT) interventions engage patients in their own health care. Insight on which PKT interventions are effective is lacking. We sought to describe the type and impact of PKT interventions. We performed a systematic review of PKT interventions, defined as strategies that inform, educate and engage patients in their own health care. We searched MEDLINE, EMBASE and the Cochrane Library from 2005 to 2014 for English language studies that evaluated PKT interventions delivered immediately before, during or upon conclusion of clinical encounters to individual patients with arthritis or cancer. Data were extracted on study characteristics, PKT intervention (theory, content, delivery, duration, personnel, timing) and outcomes. Interventions were characterized by type of patient engagement (inform, activate, collaborate). We performed content analysis and reported summary statistics. Of 694 retrieved studies, 16 were deemed eligible (5 arthritis, 11 cancer; 12 RCTs, 4 cohort studies; 7 low, 3 uncertain, 6 high risk of bias). PKT interventions included print material in 10 studies (brochures, booklets, variety of print material, list of websites), electronic material in 10 studies (video, computer program, website) and counselling in 2 studies. They were offered before, during and after consultation in 4, 1 and 4 studies, respectively; as single or multifaceted interventions in 10 and 6 studies, respectively; and by clinicians, health educators, researchers or volunteers in 4, 3, 5 and 1 study, respectively. Most interventions informed or activated patients. All studies achieved positive impact in one or more measures of patient knowledge, decision-making, communication and behaviour. This was true regardless of condition, PKT intervention, timing, personnel, type of engagement or delivery (single or multifaceted). No studies assessed patient harms, or interventions for providers to support PKT intervention delivery. Two studies evaluated the impact on providers of PKT interventions aimed at patients. Single interventions involving print material achieved beneficial outcomes as did more complex interventions. Few studies were eligible, and no studies evaluated patient harms, or provider outcomes. Further research is warranted to evaluate these PKT interventions in more patients, or patients with different conditions; different types of PKT interventions for patients and for providers; and potential harms associated with interventions.

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.

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.

Continuity and change?: Exploring reactions to a guided self-management intervention in a randomised controlled trial for IBS with reference to prior experience of managing a long term condition

PubMed Central

Rogers, Anne; Lee, Victoria; Kennedy, Anne

2007-01-01

Self-care interventions are promoted as effective strategies for improving the quality of life and health outcomes for individuals with long-term health conditions. Outcome measures used in evaluations using Randomised Controlled Trials (RCTs) are not designed to consider patients' prior management strategies and experience of illness. Yet the experience of illness literature suggests that adjusting to living with chronic illness, together with broader contextual influences, are likely to be relevant to understanding responses to self-management initiatives. Using group and individual interview data we attempt to illuminate the transposition of IBS from a condition unsatisfactorily managed by medicine to one successfully managed within the life worlds of individuals. If routine embedding of complex interventions depends on the accomplishment of integration and workability in patients' everyday lives then the design and evaluation of such interventions should view participation as part of a process of continuity as well as change. Responses to formal self-management can be extended beyond psychological and other quantitatively measured outcomes. A useful addendum to trial outcomes for self-management education is an understanding of change as being inextricably linked to people's previous attempts to, and experience of, managing long-term conditions. We suggest that the benefits of understanding the prior experience of managing illness and contact with health services include the acceptability and workability of complex interventions in patients' everyday lives. PMID:17316438

A comprehensive grid to evaluate case management's expected effectiveness for community-dwelling frail older people: results from a multiple, embedded case study.

PubMed

Van Durme, Thérèse; Schmitz, Olivier; Cès, Sophie; Anthierens, Sibyl; Maggi, Patrick; Delye, Sam; De Almeida Mello, Johanna; Declercq, Anja; Macq, Jean; Remmen, Roy; Aujoulat, Isabelle

2015-06-18

Case management is a type of intervention expected to improve the quality of care and therefore the quality of life of frail, community-dwelling older people while delaying institutionalisation in nursing homes. However, the heterogeneity, multidimensionality and complexity of these interventions make their evaluation by the means of classical approaches inadequate. Our objective was twofold: (i) to propose a tool allowing for the identification of the key components that explain the success of case management for this population and (ii) to propose a typology based on the results of this tool. The process started with a multiple embedded case study design in order to identify the key components of case management. Based on the results of this first step, data were collected among 22 case management interventions, in order to evaluate their expected effectiveness. Finally, multiple correspondence analyses was conducted to propose a typology of case management. The overall approach was informed by Wagner's Chronic Care Model and the theory of complexity. The study identified a total of 23 interacting key components. Based on the clustering of response patterns of the 22 case management projects included in our study, three types of case management programmes were evidenced, situated on a continuum from a more "socially-oriented" type towards a more "clinically-oriented" type of case management. The type of feedback provided to the general practitioner about both the global geriatric assessment and the result of the intervention turned out to be the most discriminant component between the types. The study design allowed to produce a tool that can be used to distinguish between different types of case management interventions and further evaluate their effect on frail older people in terms of the delaying institutionalisation, functional and cognitive status, quality of life and societal costs.

Evaluation of a complex, population-based injury claims management intervention for improving injury outcomes: study protocol

PubMed Central

Collie, Alex; Gabbe, Belinda; Fitzharris, Michael

2015-01-01

Introduction Injuries resulting from road traffic crashes are a substantial cause of disability and death worldwide. Injured persons receiving compensation have poorer recovery and return to work than those with non-compensable injury. Case or claims management is a critical component of injury compensation systems, and there is now evidence that claims management can have powerful positive impacts on recovery, but can also impede recovery or exacerbate mental health concerns in some injured people. This study seeks to evaluate the impact of a population-based injury claims management intervention in the State of Victoria, Australia, on the health of those injured in motor vehicle crashes, their experience of the compensation process, and the financial viability of the compensation system. Methods and analysis Evaluation of this complex intervention involves a series of linked but stand-alone research projects to assess the anticipated process changes, impacts and outcomes of the intervention over a 5-year time frame. Linkage and analysis of routine administrative and health system data is supplemented with a series of primary studies collecting new information. Additionally, a series of ‘action’ research projects will be undertaken to inform the implementation of the intervention. A program logic model designed by the state government Transport Accident Commission in conjunction with the research team provides the evaluation framework. Ethics and dissemination Relatively few studies have comprehensively examined the impact of compensation system processes on the health of injured persons, their satisfaction with systems processes, and impacts on the financial performance of the compensation scheme itself. The wholesale, population-based transformation of an injury claims management model is a rare opportunity to document impacts of system-level policy change on outcomes of injured persons. Findings will contribute to the evidence base of information on the public health effects of injury claims management policy and practice. PMID:25967991

Evaluation of a complex, population-based injury claims management intervention for improving injury outcomes: study protocol.

PubMed

Collie, Alex; Gabbe, Belinda; Fitzharris, Michael

2015-05-12

Injuries resulting from road traffic crashes are a substantial cause of disability and death worldwide. Injured persons receiving compensation have poorer recovery and return to work than those with non-compensable injury. Case or claims management is a critical component of injury compensation systems, and there is now evidence that claims management can have powerful positive impacts on recovery, but can also impede recovery or exacerbate mental health concerns in some injured people. This study seeks to evaluate the impact of a population-based injury claims management intervention in the State of Victoria, Australia, on the health of those injured in motor vehicle crashes, their experience of the compensation process, and the financial viability of the compensation system. Evaluation of this complex intervention involves a series of linked but stand-alone research projects to assess the anticipated process changes, impacts and outcomes of the intervention over a 5-year time frame. Linkage and analysis of routine administrative and health system data is supplemented with a series of primary studies collecting new information. Additionally, a series of 'action' research projects will be undertaken to inform the implementation of the intervention. A program logic model designed by the state government Transport Accident Commission in conjunction with the research team provides the evaluation framework. Relatively few studies have comprehensively examined the impact of compensation system processes on the health of injured persons, their satisfaction with systems processes, and impacts on the financial performance of the compensation scheme itself. The wholesale, population-based transformation of an injury claims management model is a rare opportunity to document impacts of system-level policy change on outcomes of injured persons. Findings will contribute to the evidence base of information on the public health effects of injury claims management policy and practice. 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.

Patient and carer experience of hospital-based rehabilitation from intensive care to hospital discharge: mixed methods process evaluation of the RECOVER randomised clinical trial

PubMed Central

Ramsay, Pam; Huby, Guro; Merriweather, Judith; Salisbury, Lisa; Rattray, Janice; Griffith, David; Walsh, Timothy

2016-01-01

Objectives To explore and compare patient/carer experiences of rehabilitation in the intervention and usual care arms of the RECOVER trial (ISRCTN09412438); a randomised controlled trial of a complex intervention of post-intensive care unit (ICU) acute hospital-based rehabilitation following critical illness. Design Mixed methods process evaluation including comparison of patients' and carers' experience of usual care versus the complex intervention. We integrated and compared quantitative data from a patient experience questionnaire (PEQ) with qualitative data from focus groups with patients and carers. Setting Two university-affiliated hospitals in Scotland. Participants 240 patients discharged from ICU who required ≥48 hours of mechanical ventilation were randomised into the trial (120 per trial arm). Exclusion criteria comprised: primary neurologic diagnosis, palliative care, current/planned home ventilation and age <18 years. 182 patients completed the PEQ at 3 months postrandomisation. 22 participants (14 patients and 8 carers) took part in focus groups (2 per trial group) at >3 months postrandomisation. Interventions A complex intervention of post-ICU acute hospital rehabilitation, comprising enhanced physiotherapy, nutritional care and information provision, case-managed by dedicated rehabilitation assistants (RAs) working within existing ward-based clinical teams, delivered between ICU discharge and hospital discharge. Comparator was usual care. Outcome measures A novel PEQ capturing patient-reported aspects of quality care. Results The PEQ revealed statistically significant between-group differences across 4 key intervention components: physiotherapy (p=0.039), nutritional care (p=0.038), case management (p=0.045) and information provision (p<0.001), suggesting greater patient satisfaction in the intervention group. Focus group data strongly supported and helped explain these findings. Specifically, case management by dedicated RAs facilitated greater access to physiotherapy, nutritional care and information that cut across disciplinary boundaries and staffing constraints. Patients highly valued its individualisation according to their needs, abilities and preferences. Conclusions Case management by dedicated RAs improves patients' experiences of post-ICU hospital-based rehabilitation and increases perceived quality of care. Trial registration number ISRCTN09412438. PMID:27481624

Community and District Empowerment for Scale-up (CODES): a complex district-level management intervention to improve child survival in Uganda: study protocol for a randomized controlled trial.

PubMed

Waiswa, Peter; O'Connell, Thomas; Bagenda, Danstan; Mullachery, Pricila; Mpanga, Flavia; Henriksson, Dorcus Kiwanuka; Katahoire, Anne Ruhweza; Ssegujja, Eric; Mbonye, Anthony K; Peterson, Stefan Swartling

2016-03-11

Innovative and sustainable strategies to strengthen districts and other sub-national health systems and management are urgently required to reduce child mortality. Although highly effective evidence-based and affordable child survival interventions are well-known, at the district level, lack of data, motivation, analytic and planning capacity often impedes prioritization and management weaknesses impede implementation. The Community and District Empowerment for Scale-up (CODES) project is a complex management intervention designed to test whether districts when empowered with data and management tools can prioritize and implement evidence-based child survival interventions equitably. The CODES strategy combines management, diagnostic, and evaluation tools to identify and analyze the causes of bottlenecks to implementation, build capacity of district management teams to implement context-specific solutions, and to foster community monitoring and social accountability to increase demand for services. CODES combines UNICEF tools designed to systematize priority setting, allocation of resources and problem solving with Community dialogues based on Citizen Report Cards and U-Reports used to engage and empower communities in monitoring health service provision and to demand for quality services. Implementation and all data collection will be by the districts teams or local Community-based Organizations who will be supported by two local implementing partners. The study will be evaluated as a cluster randomized trial with eight intervention and eight comparison districts over a period of 3 years. Evaluation will focus on differences in uptake of child survival interventions and will follow an intention-to-treat analysis. We will also document and analyze experiences in implementation including changes in management practices. By increasing the District Health Management Teams' capacity to prioritize and implement context-specific solutions, and empowering communities to become active partners in service delivery, coverage of child survival interventions will increase. Lessons learned on strengthening district-level managerial capacities and mechanisms for community monitoring may have implications, not only in Uganda but also in other similar settings, especially with regard to accelerating effective coverage of key child survival interventions using locally available resources. ISRCTN15705788 , Date of registration; 24 July 2015.

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

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.

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.

Simplification and Saving

PubMed Central

Beshears, John; Choi, James J.; Laibson, David; Madrian, Brigitte C.

2012-01-01

The daunting complexity of important financial decisions can lead to procrastination. We evaluate a low-cost intervention that substantially simplifies the retirement savings plan participation decision. Individuals received an opportunity to enroll in a retirement savings plan at a pre-selected contribution rate and asset allocation, allowing them to collapse a multidimensional problem into a binary choice between the status quo and the pre-selected alternative. The intervention increases plan enrollment rates by 10 to 20 percentage points. We find that a similar intervention can be used to increase contribution rates among employees who are already participating in a savings plan. PMID:24443619

The use of schools for malaria surveillance and programme evaluation in Africa

PubMed Central

Brooker, Simon; Kolaczinski, Jan H; Gitonga, Carol W; Noor, Abdisalan M; Snow, Robert W

2009-01-01

Effective malaria control requires information on both the geographical distribution of malaria risk and the effectiveness of malaria interventions. The current standard for estimating malaria infection and impact indicators are household cluster surveys, but their complexity and expense preclude frequent and decentralized monitoring. This paper reviews the historical experience and current rationale for the use of schools and school children as a complementary, inexpensive framework for planning, monitoring and evaluating malaria control in Africa. Consideration is given to (i) the selection of schools; (ii) diagnosis of infection in schools; (iii) the representativeness of schools as a proxy of the communities they serve; and (iv) the increasing need to evaluate interventions delivered through schools. Finally, areas requiring further investigation are highlighted. PMID:19840372

Getting the best outcomes from epilepsy surgery

PubMed Central

Vakharia, Vejay N.; Witt, Juri‐Alexander; Elger, Christian E.; Staba, Richard; Engel, Jerome

2018-01-01

Neurosurgery is an underutilized treatment that can potentially cure drug‐refractory epilepsy. Careful, multidisciplinary presurgical evaluation is vital for selecting patients and to ensure optimal outcomes. Advances in neuroimaging have improved diagnosis and guided surgical intervention. Invasive electroencephalography allows the evaluation of complex patients who would otherwise not be candidates for neurosurgery. We review the current state of the assessment and selection of patients and consider established and novel surgical procedures and associated outcome data. We aim to dispel myths that may inhibit physicians from referring and patients from considering neurosurgical intervention for drug‐refractory focal epilepsies. Ann Neurol 2018;83:676–690 PMID:29534299

The impact of care pathways for exacerbation of Chronic Obstructive Pulmonary Disease: rationale and design of a cluster randomized controlled trial

PubMed Central

2010-01-01

Background Hospital treatment of chronic obstructive pulmonary disease (COPD) frequently does not follow published evidences. This lack of adherence can contribute to the high morbidity, mortality and readmissions rates. The European Quality of Care Pathway (EQCP) study on acute exacerbations of COPD (NTC00962468) is undertaken to determine how care pathways (CP) as complex intervention for hospital treatment of COPD affects care variability, adherence to evidence based key interventions and clinical outcomes. Methods An international cluster Randomized Controlled Trial (cRCT) will be performed in Belgium, Italy, Ireland and Portugal. Based on the power analysis, a sample of 40 hospital teams and 398 patients will be included in the study. In the control arm of the study, usual care will be provided. The experimental teams will implement a CP as complex intervention which will include three active components: a formative evaluation of the quality and organization of care, a set of evidence based key interventions, and support on the development and implementation of the CP. The main outcome will be six-month readmission rate. As a secondary endpoint a set of clinical outcome and performance indicators (including care process evaluation and team functioning indicators) will be measured in both groups. Discussion The EQCP study is the first international cRCT on care pathways. The design of the EQCP project is both a research study and a quality improvement project and will include a realistic evaluation framework including process analysis to further understand why and when CP can really work. Trial Registration number NCT00962468 PMID:21092098

Advancing the application of systems thinking in health: a realist evaluation of a capacity building programme for district managers in Tumkur, India.

PubMed

Prashanth, Nuggehalli Srinivas; Marchal, Bruno; Devadasan, Narayanan; Kegels, Guy; Criel, Bart

2014-08-26

Health systems interventions, such as capacity-building of health workers, are implemented across districts in order to improve performance of healthcare organisations. However, such interventions often work in some settings and not in others. Local health systems could be visualised as complex adaptive systems that respond variously to inputs of capacity building interventions, depending on their local conditions and several individual, institutional, and environmental factors. We aim at demonstrating how the realist evaluation approach advances complex systems thinking in healthcare evaluation by applying the approach to understand organisational change within local health systems in the Tumkur district of southern India. We collected data on several input, process, and outcome measures of performance of the talukas (administrative sub-units of the district) and explore the interplay between the individual, institutional, and contextual factors in contributing to the outcomes using qualitative data (interview transcripts and observation notes) and quantitative measures of commitment, self-efficacy, and supervision style. The talukas of Tumkur district responded differently to the intervention. Their responses can be explained by the interactions between several individual, institutional, and environmental factors. In a taluka with committed staff and a positive intention to make changes, the intervention worked through aligning with existing opportunities from the decentralisation process to improve performance. However, commitment towards the organisation was neither crucial nor sufficient. Committed staff in two other talukas were unable to actualise their intentions to improve organisational performance. In yet another taluka, the leadership was able to compensate for the lack of commitment. Capacity building of local health systems could work through aligning or countering existing relationships between internal (individual and organisational) and external (policy and socio-political environment) attributes of the organisation. At the design and implementation stage, intervention planners need to identify opportunities for such triggering alignments. Local health systems may differ in their internal configuration and hence capacity building programmes need to accommodate possibilities for change through different pathways. By a process of formulating and testing hypotheses, making critical comparisons, discovering empirical patterns, and monitoring their scope and extent, a realist evaluation enables a comprehensive assessment of system-wide change in health systems.

Prevention and treatment of long-term social disability amongst young people with emerging severe mental illness with social recovery therapy (The PRODIGY Trial): study protocol for a randomised controlled trial.

PubMed

Fowler, David; French, Paul; Banerjee, Robin; Barton, Garry; Berry, Clio; Byrne, Rory; Clarke, Timothy; Fraser, Rick; Gee, Brioney; Greenwood, Kathryn; Notley, Caitlin; Parker, Sophie; Shepstone, Lee; Wilson, Jon; Yung, Alison R; Hodgekins, Joanne

2017-07-11

Young people who have social disability associated with severe and complex mental health problems are an important group in need of early intervention. Their problems often date back to childhood and become chronic at an early age. Without intervention, the long-term prognosis is often poor and the economic costs very large. There is a major gap in the provision of evidence-based interventions for this group, and therefore new approaches to detection and intervention are needed. This trial provides a definitive evaluation of a new approach to early intervention with young people with social disability and severe and complex mental health problems using social recovery therapy (SRT) over a period of 9 months to improve mental health and social recovery outcomes. This is a pragmatic, multi-centre, single blind, superiority randomised controlled trial. It is conducted in three sites in the UK: Sussex, Manchester and East Anglia. Participants are aged 16 to 25 and have both persistent and severe social disability (defined as engaged in less than 30 hours per week of structured activity) and severe and complex mental health problems. The target sample size is 270 participants, providing 135 participants in each trial arm. Participants are randomised 1:1 using a web-based randomisation system and allocated to either SRT plus optimised treatment as usual (enhanced standard care) or enhanced standard care alone. The primary outcome is time use, namely hours spent in structured activity per week at 15 months post-randomisation. Secondary outcomes assess typical mental health problems of the group, including subthreshold psychotic symptoms, negative symptoms, depression and anxiety. Time use, secondary outcomes and health economic measures are assessed at 9, 15 and 24 months post-randomisation. This definitive trial will be the first to evaluate a novel psychological treatment for social disability and mental health problems in young people presenting with social disability and severe and complex non-psychotic mental health problems. The results will have important implications for policy and practice in the detection and early intervention for this group in mental health services. Trial Registry: International Standard Randomised Controlled Trial Number (ISRCTN) Registry. ISRCTN47998710 (registered 29/11/2012).

Hand-assisted Approach as a Model to Teach Complex Laparoscopic Hepatectomies: Preliminary Results.

PubMed

Makdissi, Fabio F; Jeismann, Vagner B; Kruger, Jaime A P; Coelho, Fabricio F; Ribeiro-Junior, Ulysses; Cecconello, Ivan; Herman, Paulo

2017-08-01

Currently, there are limited and scarce models to teach complex liver resections by laparoscopy. The aim of this study is to present a hand-assisted technique to teach complex laparoscopic hepatectomies for fellows in liver surgery. Laparoscopic hand-assisted approach for resections of liver lesions located in posterosuperior segments (7, 6/7, 7/8, 8) was performed by the trainees with guidance and intermittent intervention of a senior surgeon. Data as: (1) percentage of time that the senior surgeon takes the surgery as main surgeon, (2) need for the senior surgeon to finish the procedure, (3) necessity of conversion, (4) bleeding with hemodynamic instability, (5) need for transfusion, (6) oncological surgical margins, were evaluated. In total, 12 cases of complex laparoscopic liver resections were performed by the trainee. All cases included deep lesions situated on liver segments 7 or 8. The senior surgeon intervention occurred in a mean of 20% of the total surgical time (range, 0% to 50%). A senior intervention >20% was necessary in 2 cases. There was no need for conversion or reoperation. Neither major bleeding nor complications resulted from the teaching program. All surgical margins were clear. This preliminary report shows that hand-assistance is a safe way to teach complex liver resections without compromising patient safety or oncological results. More cases are still necessary to draw definitive conclusions about this teaching method.

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.

Evidence-based health promotion: applying it in practice.

PubMed

Wong, M L

2002-09-01

In health promotion, we should use interventions established by evidence to be effective in improving the health of the community. This paper reviews the concepts, evaluation and use of evidence in health promotion. A literature search of evidence-based health promotion and evaluation of health promotion was conducted using Medline, Social Science Citation Index (SSCI), PsycLIT and evidence-based web sites on health promotion, health education and community preventive services. Recent issues of key journals on health promotion, health education and public health were also hand-searched. The concept of evidence in health promotion interventions is complex due to its multidimensional nature. Evidence of effectiveness in health promotion is assessed by combining quantitative data on effect change in outcome measures and qualitative data on process evaluation of health promotion activities. Limitations to the use of randomised trials in community-based health promotion interventions include ethical and logistic problems in maintaining randomisation of subjects over long periods, absence of experimental conditions in the real-world setting, contamination of control subjects and the multidimensional nature of health promotion interventions. Randomised controlled trials should be used to evaluate the effectiveness of most health education and behavioural interventions in clinical settings. When such trials are not feasible as in community-based health promotion interventions, quasi-experimental designs provide strong evidence. Multiple methods are needed to assess evidence of effectiveness of health promotion programmes. Appropriate practice of evidence-based health promotion requires consideration of quality of available evidence, local values and prevailing resources.

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.

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 .

Community interventions providing care and support to orphans and vulnerable children: a review of evaluation evidence.

PubMed

Schenk, Katie D

2009-07-01

Children affected by HIV in their families and communities face multiple risks to their health, education and psychosocial wellbeing. Community interventions for children who have been orphaned or rendered vulnerable take many forms, including educational assistance, home-based care, legal protection and psychosocial support. Despite a recent influx of funding for programme implementation, there exists little evidence to inform policymakers about whether their investments are improving the lives of vulnerable children and meeting key benchmarks including the Millennium Development Goals. This paper reviews the current evidence base on evaluations of community interventions for orphans and vulnerable children (OVC) in high HIV-prevalence African settings, focusing on studies' methodologies. Sources reviewed include published research studies and evidence from the unpublished programmatic "grey literature" located through database and internet searches. A total of 21 studies, varying in scope and generalisability, were identified. Interventions reviewed address children's wellbeing through various strategies within their communities. Evaluation methodologies reflect quantitative and qualitative approaches, including surveys (with and without baseline or comparison data), costing studies, focus groups, interviews, case studies, and participatory review techniques. Varied study methodologies reflect diverse research questions, various intervention types, and the challenges associated with evaluating complex interventions; highlighting the need to broaden the research paradigm in order to build the evidence base by including quasi-experimental and process evaluation approaches, and seeking further insights through participatory qualitative methodologies and costing studies. Although findings overall indicate the value of community interventions in effecting measurable improvements in child and family wellbeing, the quality and rigour of evidence is varied. A strategic research agenda is urgently needed to inform resource allocation and programme management decisions. Immediate imperatives include building local technical capacity to conduct quantitative and qualitative evaluation research, and strengthening monitoring and evaluation systems to collect process and outcome data (including costing) on key support models. Donors and implementers must support the collection of sound empirical evidence to inform the development and scale-up of OVC programmes.

Selection and visualisation of outcome measures for complex post-acute acquired brain injury rehabilitation interventions

PubMed Central

Ford, Catherine Elaine Longworth; Malley, Donna; Bateman, Andrew; Clare, Isabel C.H.; Wagner, Adam P.; Gracey, Fergus

2016-01-01

Background Outcome measurement challenges rehabilitation services to select tools that promote stakeholder engagement in measuring complex interventions. Objectives To examine the suitability of outcome measures for complex post-acute acquired brain injury (ABI) rehabilitation interventions, report outcomes of a holistic, neuropsychological ABI rehabilitation program and propose a simple way of visualizing complex outcomes. Methods Patient/carer reported outcome measures (PROMS), experience measures (PREMS) and staff-rated measures were collected for consecutive admissions over 1 year to an 18-week holistic, neuropsychological rehabilitation programme at baseline, 18 weeks and 3- and 6-month follow-up. Results Engagement with outcome measurement was poorest for carers and at follow-up for all stakeholders. Dependence, abilities, adjustment, unmet needs, symptomatology including executive dysfunction, and self-reassurance showed improvements at 18 weeks. Adjustment, social participation, perceived health, symptomatology including dysexecutive difficulties, and anxiety were worse at baseline for those who did not complete rehabilitation, than those who did. A radar plot facilitated outcome visualization. Conclusions Engagement with outcome measurement was best when time and support were provided. Supplementing patient- with staff-rated and attendance measures may explain missing data and help quantify healthcare needs. The MPAI4, EBIQ and DEX-R appeared suitable measures to evaluate outcomes and distinguish those completing and not completing neuropsychological rehabilitation. PMID:27341362

Brief Report: The Effects of Equine-Assisted Activities on the Social Functioning in Children and Adolescents with Autism Spectrum Disorder.

PubMed

Anderson, Sophie; Meints, Kerstin

2016-10-01

Equine-assisted activities and therapies are increasing in popularity for treatment of ASD symptoms. This research evaluated effects of a 5-week programme of therapeutic riding on social functioning of children/adolescents (N = 15) with ASD. The effectiveness of the programme was evaluated using the autism spectrum quotient, the Vineland Adaptive Behaviour Scale and the empathising and systemising quotient. Results established that the TR intervention increased empathising and reduced maladaptive behaviours. The findings also indicated that specific adaptive behaviours like socialization and communication were not affected by the intervention. Thus, a complex picture of the effects of this intervention emerges: while TR does not change all of the child's behaviour, it can improve specific aspects of social functioning and also reduce maladaptive ASD traits.

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.

Physical Activity and Exercise Interventions in the Workplace Impacting Work Outcomes: A Stakeholder-Centered Best Evidence Synthesis of Systematic Reviews.

PubMed

White, M I; Dionne, C E; Wärje, O; Koehoorn, M; Wagner, S L; Schultz, I Z; Koehn, C; Williams-Whitt, K; Harder, H G; Pasca, R; Hsu, V; McGuire, L; Schulz, W; Kube, D; Wright, M D

2016-04-01

The prevention of work disability is beneficial to employees and employers, and mitigates unnecessary societal costs associated with social welfare. Many service providers and employers have initiated workplace interventions designed to reduce unnecessary work disability. To conduct a best-evidence synthesis of systematic reviews on workplace interventions that address physical activities or exercise and their impact on workplace absence, work productivity or financial outcomes. Using a participatory research approach, academics and stakeholders identified inclusion and exclusion criteria, built an abstraction table, evaluated systematic review quality and relevance, and interpreted the combined findings. A minimum of two scientists participated in a methodological review of the literature followed by a consensus process. Stakeholders and researchers participated as a collaborative team. 3363 unique records were identified, 115 full text articles and 46 systematic reviews were included, 18 assessed the impact of physical fitness or exercise interventions. 11 focused on general workers rather than workers who were absent from work at baseline; 16 of the reviews assessed work absence, 4 assessed productivity and 6 assessed financial impacts. The strongest evidence supports the use of short, simple exercise or fitness programs for both workers at work and those absent from work at baseline. For workers at work, simple exercise programs (1-2 modal components) appear to provide similar benefits to those using more complex multimodal interventions. For workers off-work with subacute low back pain, there is evidence that some complex exercise programs may be more effective than simple exercise interventions, especially if they involve workplace stakeholder engagement, communication and coordination with employers and other stakeholders. The development and utilization of standardized definitions, methods and measures and blinded evaluation would improve research quality and strengthen stakeholder-centered guidance.

The Effect of Sex and Anthropometry on Clinical Outcomes in Patients Undergoing Percutaneous Coronary Intervention for Complex Coronary Lesions.

PubMed

Lee, Seung Yul; Shin, Dong Ho; Kim, Jung Sun; Kim, Byeong Keuk; Ko, Young Guk; Choi, Donghoon; Jang, Yangsoo; Hong, Myeong Ki

2017-03-01

To evaluate the effects of sex and anthropometry on clinical outcomes in patients who underwent percutaneous coronary intervention (PCI). From three randomized trials (REal Safety and Efficacy of 3-month dual antiplatelet Therapy following Endeavor zotarolimus-eluting stent implantation, Impact of intraVascular UltraSound guidance on outcomes of Xience Prime stents in Long lesions, Chronic Total Occlusion InterVention with drUg-eluting Stents), we compared 333 pairs of men and women matched by propensity scores, all of whom underwent intravascular ultrasound (IVUS)-guided PCI for complex lesions. For 12 months, the incidence of adverse cardiac events, defined as the composite of cardiac death, target lesion-related myocardial infarction, and target lesion revascularization, was not different between women and men (2.4% vs. 2.4%, p=0.939). Using multivariable Cox's regression analysis, post-intervention minimum lumen area [MLA; hazard ratio (HR)=0.620, 95% confidence interval (CI)=0.423-0.909, p=0.014] by IVUS was a predictor of adverse cardiac events. Height on anthropometry and lesions with chronic total occlusion were significantly related to post-intervention MLA. However, female sex was not independently associated with post-intervention MLA. In an age and sex-adjusted model, patients in the low tertile of height exhibited a greater risk for adverse cardiac events than those in the high tertile of height (HR=6.391, 95% CI=1.160-35.206, p=0.033). Sex does not affect clinical outcomes after PCI for complex lesions. PCI outcomes, however, may be adversely affected by height.

Prospective evaluation of a complex public health intervention: lessons from an initial and follow-up cross-sectional survey of the tuberculosis strain typing service in England.

PubMed

Mears, Jessica; Abubakar, Ibrahim; Crisp, Debbie; Maguire, Helen; Innes, John A; Lilley, Mike; Lord, Joanne; Cohen, Ted; Borgdorff, Martien W; Vynnycky, Emilia; McHugh, Timothy D; Sonnenberg, Pam

2014-10-02

The national tuberculosis strain typing service (TB-STS) was introduced in England in 2010. The TB-STS involves MIRU-VNTR typing of isolates from all TB patients for the prospective identification, reporting and investigation of TB strain typing clusters. As part of a mixed-method evaluation, we report on a repeated cross-sectional survey to illustrate the challenges surrounding the evaluation of a complex national public health intervention. An online initial and follow-up questionnaire survey assessed the knowledge, attitudes and practices of public health staff, physicians and nurses working in TB control in November 2010 and March 2012. It included questions on the implementation, experience and uptake of the TB-STS. Participants that responded to both surveys were included in the analysis. 248 participants responded to the initial survey and 137 of these responded to the follow-up survey (56% retention). Knowledge: A significant increase in knowledge was observed, including a rise in the proportion of respondents who had received training (28.6% to 67.9%, p = 0.003), and the self-rated knowledge of how to use strain typing had improved ('no knowledge' decreased from 43.2% to 27.4%). Attitudes: The majority of respondents found strain typing useful; the proportion that reported strain typing to be useful was similar across the two surveys (95.7% to 94.7%, p = 0.67). Practices: There were significant increases between the initial and follow-up surveys in the number of respondents who reported using strain typing (57.0% to 80.5%, p < 0.001) and the proportion of time health protection staff spent on investigating TB (2.74% to 7.08%, p = 0.04). Evaluation of a complex public health intervention is challenging. In this example, the immediate national roll-out of the TB-STS meant that a controlled survey design was not possible. This study informs the future development of the TB-STS by identifying the need for training to reach wider professional groups, and argues for its continuation based on service users' perception that it is useful. By highlighting the importance of a well-defined sampling frame, collecting baseline information, and including all stakeholders, it provides lessons for the implementation of similar services in other countries and future evaluations of public health interventions.

Alimentary habits, physical activity, and Framingham global risk score in metabolic syndrome.

PubMed

Soares, Thays Soliman; Piovesan, Carla Haas; Gustavo, Andréia da Silva; Macagnan, Fabrício Edler; Bodanese, Luiz Carlos; Feoli, Ana Maria Pandolfo

2014-04-01

Metabolic syndrome is a complex disorder represented by a set of cardiovascular risk factors. A healthy lifestyle is strongly related to improve Quality of Life and interfere positively in the control of risk factors presented in this condition. To evaluate the effect of a program of lifestyle modification on the Framingham General Cardiovascular Risk Profile in subjects diagnosed with metabolic syndrome. A sub-analysis study of a randomized clinical trial controlled blind that lasted three months. Participants were randomized into four groups: dietary intervention + placebo (DIP), dietary intervention + supplementation of omega 3 (fish oil 3 g/day) (DIS3), dietary intervention + placebo + physical activity (DIPE) and dietary intervention + physical activity + supplementation of omega 3 (DIS3PE). The general cardiovascular risk profile of each individual was calculated before and after the intervention. The study included 70 subjects. Evaluating the score between the pre and post intervention yielded a significant value (p < 0.001). We obtained a reduction for intermediate risk in 25.7% of subjects. After intervention, there was a significant reduction (p < 0.01) on cardiovascular age, this being more significant in groups DIP (5.2%) and DIPE (5.3%). Proposed interventions produced beneficial effects for reducing cardiovascular risk score. This study emphasizes the importance of lifestyle modification in the prevention and treatment of cardiovascular diseases.

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.

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.

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.

Measuring the Complexity of Treatment for Challenging Behavior using the Treatment Intensity Rating Form.

PubMed

Zarcone, Jennifer; Hagopian, Louis; Ninci, Jennifer; McKay, Chloe; Bonner, Andrew; Dillon, Christopher; Hausman, Nicole

2016-01-01

The goal of this study was to develop and evaluate a tool to measure the complexity and intensity of psychotropic medication interventions, behavioral interventions, and issues related to crisis management for challenging behavior using a standardized rating form. The Treatment Intensity Rating Form (TIRF) is a 10-item scale with three categories: pharmacological interventions, behavior supports, and protective equipment. In a retrospective review we examined the final treatment recommendations for 74 individuals with self-injurious behavior (SIB) based on psychiatric and behavioral notes and reports. We also compared whether TIRF scores differed across individuals for whom SIB was maintained by social reinforcement (e.g., to access attention or toys/activities, or escape from tasks) versus those for whom SIB was maintained by automatic reinforcement (e.g., occurs independent of social variables, and is presumed to be maintained by sensory reinforcement). The TIRF was demonstrated to have strong inter-rater reliability (98%) and appears to have good face validity. As hypothesized, individuals with SIB maintained by automatic reinforcement had significantly more medication trials (p=0.0005) and required more protective equipment than individuals with SIB maintained by social reinforcement (p=0.0002). Antidepressant medication was used more often with individuals with automatically reinforced SIB, although antipsychotics and anticonvulsants were also commonly used across both groups. Findings provide initial support for the TIRF's reliability, and face validity as a measure the level of complexity of medical and behavioral treatment plans - although additional research is needed to fully evaluate its psychometric properties.

HPV.edu study protocol: a cluster randomised controlled evaluation of education, decisional support and logistical strategies in school-based human papillomavirus (HPV) vaccination of adolescents.

PubMed

Skinner, S Rachel; Davies, Cristyn; Cooper, Spring; Stoney, Tanya; Marshall, Helen; Jones, Jane; Collins, Joanne; Hutton, Heidi; Parrella, Adriana; Zimet, Gregory; Regan, David G; Whyte, Patti; Brotherton, Julia M L; Richmond, Peter; McCaffrey, Kirsten; Garland, Suzanne M; Leask, Julie; Kang, Melissa; Braunack-Mayer, Annette; Kaldor, John; McGeechan, Kevin

2015-09-15

The National Human Papillomavirus (HPV) Vaccination Program in Australia commenced in 2007 for females and in 2013 for males, using the quadrivalent HPV vaccine (HPV 6,11,16,18). Thus far, we have demonstrated very substantial reductions in genital warts and in the prevalence of HPV among young Australian women, providing early evidence for the success of this public health initiative. Australia has a long history of school-based vaccination programs for adolescents, with comparatively high coverage. However, it is not clear what factors promote success in a school vaccination program. The HPV.edu study aims to examine: 1) student knowledge about HPV vaccination; 2) psycho-social outcomes and 3) vaccination uptake. HPV.edu is a cluster randomised trial of a complex intervention in schools aiming to recruit 40 schools with year-8 enrolments above 100 students (approximately 4400 students). The schools will be stratified by Government, Catholic, and Independent sectors and geographical location, with up to 20 schools recruited in each of two states, Western Australia (WA) and South Australia (SA), and randomly allocated to intervention or control (usual practice). Intervention schools will receive the complex intervention which includes an adolescent intervention (education and distraction); a decisional support tool for parents and adolescents and logistical strategies (consent form returns strategies, in-school mop-up vaccination and vaccination-day guidelines). Careful process evaluation including an embedded qualitative evaluation will be undertaken to explore in depth possible mechanisms for any observed effect of the intervention on primary and secondary outcomes. This study is the first to evaluate the relative effectiveness of various strategies to promote best practice in school-based vaccination against HPV. The study aims to improve vaccination-related psychosocial outcomes, including adolescent knowledge and attitudes, decision-making involvement, self-efficacy, and to reduce fear and anxiety. The study also aims to improve school vaccination program logistics including reduction in time spent vaccinating adolescents and increased number of consent forms returned (regardless of decision). Less anxiety in adolescents will likely promote more efficient vaccination, which will be more acceptable to teachers, nurses and parents. Through these interventions, it is hoped that vaccination uptake will be increased. Australian and New Zealand Clinical Trials Registry, ACTRN12614000404628 , 14.04.2014.

Cost-effectiveness of a complex workplace dietary intervention: an economic evaluation of the Food Choice at Work study.

PubMed

Fitzgerald, Sarah; Murphy, Aileen; Kirby, Ann; Geaney, Fiona; Perry, Ivan J

2018-03-03

To evaluate the costs, benefits and cost-effectiveness of complex workplace dietary interventions, involving nutrition education and system-level dietary modification, from the perspective of healthcare providers and employers. Single-study economic evaluation of a cluster-controlled trial (Food Choice at Work (FCW) study) with 1-year follow-up. Four multinational manufacturing workplaces in Cork, Ireland. 517 randomly selected employees (18-65 years) from four workplaces. Cost data were obtained from the FCW study. Nutrition education included individual nutrition consultations, nutrition information (traffic light menu labelling, posters, leaflets and emails) and presentations. System-level dietary modification included menu modification (restriction of fat, sugar and salt), increase in fibre, fruit discounts, strategic positioning of healthier alternatives and portion size control. The combined intervention included nutrition education and system-level dietary modification. No intervention was implemented in the control. The primary outcome was an improvement in health-related quality of life, measured using the EuroQoL 5 Dimensions 5 Levels questionnaire. The secondary outcome measure was reduction in absenteeism, which is measured in monetary amounts. Probabilistic sensitivity analysis (Monte Carlo simulation) assessed parameter uncertainty. The system-level intervention dominated the education and combined interventions. When compared with the control, the incremental cost-effectiveness ratio (€101.37/quality-adjusted life-year) is less than the nationally accepted ceiling ratio, so the system-level intervention can be considered cost-effective. The cost-effectiveness acceptability curve indicates there is some decision uncertainty surrounding this, arising from uncertainty surrounding the differences in effectiveness. These results are reiterated when the secondary outcome measure is considered in a cost-benefit analysis, whereby the system-level intervention yields the highest net benefit (€56.56 per employee). System-level dietary modification alone offers the most value per improving employee health-related quality of life and generating net benefit for employers by reducing absenteeism. While system-level dietary modification strategies are potentially sustainable obesity prevention interventions, future research should include long-term outcomes to determine if improvements in outcomes persist. ISRCTN35108237; Post-results. © 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.

Design of Economic Evaluations of Mindfulness-Based Interventions: Ten Methodological Questions of Which to Be Mindful.

PubMed

Edwards, Rhiannon Tudor; Bryning, Lucy; Crane, Rebecca

Mindfulness-based interventions (MBIs) are being increasingly applied in a variety of settings. A growing body of evidence to support the effectiveness of these interventions exists and there are a few published cost-effectiveness studies. With limited resources available within public sectors (health care, social care, and education), it is necessary to build in concurrent economic evaluations alongside trials in order to inform service commissioning and policy. If future research studies are well-designed, they have strong potential to investigate the economic impact of MBIs. The particular challenge to the health economist is how best to capture the ways that MBIs help people adjust to or build resilience to difficult life circumstances, and to disseminate effectively to enable policy makers to judge the value of the contribution that MBIs can make within the context of the limited resourcing of public services. In anticipation of more research worldwide evaluating MBIs in various settings, this article suggests ten health economics methodological design questions that researchers may want to consider prior to conducting MBI research. These questions draw on both published standards of good methodological practice in economic evaluation of medical interventions, and on the authors' knowledge and experience of mindfulness-based practice. We argue that it is helpful to view MBIs as both complex interventions and as public health prevention initiatives. Our suggestions for well-designed economic evaluations of MBIs in health and other settings, mirror current thinking on the challenges and opportunities of public health economics.

Study protocol: realist evaluation of effectiveness and sustainability of a community health workers programme in improving maternal and child health in Nigeria.

PubMed

Mirzoev, Tolib; Etiaba, Enyi; Ebenso, Bassey; Uzochukwu, Benjamin; Manzano, Ana; Onwujekwe, Obinna; Huss, Reinhard; Ezumah, Nkoli; Hicks, Joseph P; Newell, James; Ensor, Timothy

2016-06-07

Achievement of improved maternal and child health (MCH) outcomes continues to be an issue of international priority, particularly for sub-Saharan African countries such as Nigeria. Evidence suggests that the use of Community Health Workers (CHWs) can be effective in broadening access to, and coverage of, health services and improving MCH outcomes in such countries. In this paper, we report the methodology for a 5-year study which aims to evaluate the context, processes, outcomes and longer-term sustainability of a Nigerian CHW scheme. Evaluation of complex interventions requires a comprehensive understanding of intervention context, mechanisms and outcomes. The multidisciplinary and mixed-method realist approach will facilitate such evaluation. A favourable policy environment within which the study is conducted will ensure the successful uptake of results into policy and practice. A realist evaluation provides an overall methodological framework for this multidisciplinary and mixed methods research, which will be undertaken in Anambra state. The study will draw upon health economics, social sciences and statistics. The study comprises three steps: (1) initial theory development; (2) theory validation and (3) theory refinement and development of lessons learned. Specific methods for data collection will include in-depth interviews and focus group discussions with purposefully identified key stakeholders (managers, service providers and service users), document reviews, analyses of quantitative data from the CHW programme and health information system, and a small-scale survey. The impact of the programme on key output and outcome indicators will be assessed through an interrupted time-series analysis (ITS) of monthly quantitative data from health information system and programme reports. Ethics approvals for this study were obtained from the University of Leeds and the University of Nigeria. This study will provide a timely and important contribution to health systems strengthening specifically within Anambra state in southeast Nigeria but also more widely across Nigeria. This paper should be of interest to researchers who are interested in adapting and applying robust methodologies for assessing complex health system interventions. The paper will also be useful to policymakers and practitioners who are interested in commissioning and engaging in such complex evaluations to inform policies and practices.

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.

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

Teaching Algebra to Students With Learning Disabilities: Where Have We Come and Where Should We Go?

PubMed

Watt, Sarah J; Watkins, Jessie R; Abbitt, Jason

2016-07-01

This review investigates effective interventions for teaching algebra to students with learning disabilities and evaluates the complexity and alignment of skills with the Common Core State Standards in math. The review includes the results of 10 experimental and 5 single-subject designs (N = 15) producing a moderate overall effect size (g = 0.48). A total of five interventions were identified and analyzed across the studies using effect size data. © Hammill Institute on Disabilities 2014.

Why Early Prevention of Childhood Obesity Is More Than a Medical Concern: A Health Economic Approach.

PubMed

Sonntag, Diana

2017-01-01

Childhood overweight and obesity are a non-deniable health concern with increasing economic attention. International studies provide robust evidence about substantial lifetime excess costs due to childhood obesity, thereby underscoring the urgent need to implement potent obesity prevention programs in early childhood. Fortunately, this is happening more and more, as evidenced by the increase in well-conducted interventions. Nevertheless, an important piece of the puzzle is often missing, that is, health economic evaluations. There are 3 main reasons for this: an insufficient number of economic approaches which consider the complexity of childhood obesity, a lack of (significant) long-term effect sizes of an intervention, and inadequate planning of health economic evaluations in the design phase of an intervention. Key Messages: It is advisable to involve health economists during the design phase of an intervention. Equally necessary is the development of a tailored toolbox for efficient data acquisition. © 2017 S. Karger AG, Basel.

From Efficacy to Effectiveness and Beyond: What Next for Brief Interventions in Primary Care?

PubMed Central

O’Donnell, Amy; Wallace, Paul; Kaner, Eileen

2014-01-01

Background: Robust evidence supports the effectiveness of screening and brief alcohol interventions in primary healthcare. However, lack of understanding about their “active ingredients” and concerns over the extent to which current approaches remain faithful to their original theoretical roots has led some to demand a cautious approach to future roll-out pending further research. Against this background, this paper provides a timely overview of the development of the brief alcohol intervention evidence base to assess the extent to which it has achieved the four key levels of intervention research: efficacy, effectiveness, implementation, and demonstration. Methods: Narrative overview based on (1) the results of a review of systematic reviews and meta-analyses of the effectiveness of brief alcohol intervention in primary healthcare and (2) synthesis of the findings of key additional primary studies on the improvement and evaluation of brief alcohol intervention implementation in routine primary healthcare. Results: The brief intervention field seems to constitute an almost perfect example of the evaluation of a complex intervention. Early evaluations of screening and brief intervention approaches included more tightly controlled efficacy trials and have been followed by more pragmatic trials of effectiveness in routine clinical practice. Most recently, attention has shifted to dissemination, implementation, and wider-scale roll-out. However, delivery in routine primary health remains inconsistent, with an identified knowledge gap around how to successfully embed brief alcohol intervention approaches in mainstream care, and as yet unanswered questions concerning what specific intervention component prompt the positive changes in alcohol consumption. Conclusion: Both the efficacy and effectiveness of brief alcohol interventions have been comprehensively demonstrated, and intervention effects seem replicable and stable over time, and across different study contexts. Thus, while unanswered questions remain, given the positive evidence amassed to date, research efforts should maintain a continued focus on promoting sustained implementation of screening and brief alcohol intervention approaches in primary care to ensure that those who might benefit from screening and brief alcohol interventions actually receive such support. PMID:25221524

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

Understanding feedback report uptake: process evaluation findings from a 13-month feedback intervention in long-term care settings.

PubMed

Sales, Anne E; Fraser, Kimberly; Baylon, Melba Andrea B; O'Rourke, Hannah M; Gao, Gloria; Bucknall, Tracey; Maisey, Suzanne

2015-02-12

Long-term care settings provide care to a large proportion of predominantly older, highly disabled adults across the United States and Canada. Managing and improving quality of care is challenging, in part because staffing is highly dependent on relatively non-professional health care aides and resources are limited. Feedback interventions in these settings are relatively rare, and there has been little published information about the process of feedback intervention. Our objectives were to describe the key components of uptake of the feedback reports, as well as other indicators of participant response to the intervention. We conducted this project in nine long-term care units in four facilities in Edmonton, Canada. We used mixed methods, including observations during a 13-month feedback report intervention with nine post-feedback survey cycles, to conduct a process evaluation of a feedback report intervention in these units. We included all facility-based direct care providers (staff) in the feedback report distribution and survey administration. We conducted descriptive analyses of the data from observations and surveys, presenting this in tabular and graphic form. We constructed a short scale to measure uptake of the feedback reports. Our analysis evaluated feedback report uptake by provider type over the 13 months of the intervention. We received a total of 1,080 survey responses over the period of the intervention, which varied by type of provider, facility, and survey month. Total number of reports distributed ranged from 103 in cycle 12 to 229 in cycle 3, although the method of delivery varied widely across the period, from 12% to 65% delivered directly to individuals and 15% to 84% left for later distribution. The key elements of feedback uptake, including receiving, reading, understanding, discussing, and reporting a perception that the reports were useful, varied by survey cycle and provider type, as well as by facility. Uptake, as we measured it, was consistently high overall, but varied widely by provider type and time period. We report detailed process data describing the aspects of uptake of a feedback report during an intensive, longitudinal feedback intervention in long-term care facilities. Uptake is a complex process for which we used multiple measures. We demonstrate the feasibility of conducting a complex longitudinal feedback intervention in relatively resource-poor long-term care facilities to a wider range of provider types than have been included in prior feedback interventions.

[Complexity of care and organizational effectiveness: a survey among medical care units in nine Lombardy region hospitals].

PubMed

Pasquali, Sara; Capitoni, Enrica; Tiraboschi, Giuseppina; Alborghetti, Adriana; De Luca, Giuseppe; Di Mauro, Stefania

2017-01-01

Eleven medical care units of nine Lombardy Region hospitals organized by levels of care model or by the traditional departmental model have been analyzed, in order to evaluate if methods for complexity of patient-care evaluation represent an index factor of nursing organizational effectiveness. Survey with nine Nurses in managerial position was conducted between Nov. 2013-Jan. 2014. The following factors have been described: context and nursing care model, staffing, complexity evaluation, patient satisfaction, staff well-being. Data were processed through Microsoft Excel. Among Units analysed ,all Units in levels of care and one organized by the departmental model systematically evaluate nursing complexity. Registered Nurses (RN) and Health Care Assistants (HCA) are on average numerically higher in Units that measure complexity (0.55/ 0.49 RN, 0.38/0.23 HCA - ratio per bed). Adopted measures in relation to changes in complexity are:rewarding systems, supporting interventions, such as moving personnel within different Units or additional required working hours; reduction in number of beds is adopted when no other solution is available. Patient satisfaction is evaluated through Customer Satisfaction questionnaires. Turnover, stress and rate of absenteeism data are not available in all Units. Complexity evaluation through appropriate methods is carried out in all hospitals organized in levels of care with personalized nursing care models, though complexity is detected with different methods. No significant differences in applied managerial strategies are present. Patient's satisfaction is evaluated everywhere. Data on staffing wellbeing is scarcely available. Coordinated regional actions are recommended in order to gather comparable data for research, improve decision making and effectiveness of Nursing care.

Diagnosis and treatment of posterior sacroiliac complex pain: a systematic review with comprehensive analysis of the published data.

PubMed

King, Wade; Ahmed, Shihab U; Baisden, Jamie; Patel, Nileshkumar; Kennedy, David J; Duszynski, Belinda; MacVicar, John

2015-02-01

To assess the evidence on the validity of sacral lateral branch blocks and the effectiveness of sacral lateral branch thermal radiofrequency neurotomy in managing sacroiliac complex pain. Systematic review with comprehensive analysis of all published data. Six reviewers searched the literature on sacral lateral branch interventions. Each assessed the methodologies of studies found and the quality of the evidence presented. The outcomes assessed were diagnostic validity and effectiveness of treatment for sacroiliac complex pain. The evidence found was appraised in accordance with the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) system of evaluating scientific evidence. The searches yielded two primary publications on sacral lateral branch blocks and 15 studies of the effectiveness of sacral lateral branch thermal radiofrequency neurotomy. One study showed multisite, multidepth sacral lateral branch blocks can anesthetize the posterior sacroiliac ligaments. Therapeutic studies show sacral lateral branch thermal radiofrequency neurotomy can relieve sacroiliac complex pain to some extent. The evidence of the validity of these blocks and the effectiveness of this treatment were rated as moderate in accordance with the GRADE system. The literature on sacral lateral branch interventions is sparse. One study demonstrates the face validity of multisite, multidepth sacral lateral branch blocks for diagnosis of posterior sacroiliac complex pain. Some evidence of moderate quality exists on therapeutic procedures, but it is insufficient to determine the indications and effectiveness of sacral lateral branch thermal radiofrequency neurotomy, and more research is required. Wiley Periodicals, Inc.

Study Protocol: Evaluation of a DVD intervention designed to meet the informaton needs of patients with head and neck cancer and their partner, carer and families.

PubMed

Parker, Vicki; Bennett, Leearna; Bellamy, Douglas; Britton, Benjamin; Lambert, Sylvia

2016-11-22

Patients who undergo surgery for cancer of the head and neck and their families face complex and difficult challenges and are at risk of anxiety and depression and inability to cope with symptom and treatment burden. Information available to support them is not flexible enough to adjust to individual need. A randomised clinical trial pre and post intervention design, comparing the use of a tailored DVD intervention, provided preoperatively and used throughout the post- operative period, with usual treatment. One hundred fifty-six individuals or partner couples will be randomly recruited into either the intervention or control group. A survey will be administered at three time points, preoperatively, post operatively and 3 months post-surgery. Anxiety and empowerment are the primary outcome measures. Qualitative data about use of the resource will be gathered by phone interview. This is the first study to rigorously evaluate the impact of a DVD intervention for this group of patients and their family members. The study will help to understand the impact of information usage on patient and family well- being and test a means by which to evaluate information and education resources for this and other cancer patient groups. ACTRN12614001104640 . Date registered: 17/10/2014.

Integrating practice-based learning and improvement into medical student learning: evaluating complex curricular innovations.

PubMed

Ogrinc, Greg; West, Alan; Eliassen, M Scottie; Liuw, Stephen; Schiffman, Jennifer; Cochran, Nan

2007-01-01

Because practice-based learning and improvement (PBLI) is a core competency for residents, the fundamentals of PBLI should be developed in medical school. Evaluate the effects of a PBLI module for 1st-year students at Dartmouth Medical School in 2004-05. Design. Randomized two-group trial (early and late intervention). Intervention. One half of students received the standard curriculum--reviewing student-patient-preceptor reports with their small-group facilitator and student colleagues. The other half received the PBLI-DMEDS module--reviewing student-patient-preceptor reports and applying PBLI methods to history and physical exam skills. The module was assessed on (a) core learning of PBLI (pre- and postmodule); (b) student self-assessed proficiency in PBLI (pre- and postmodule); (c) student, faculty, and course leaders' satisfaction; and (d) time costs. Pretest PBLI knowledge scores were similar in both groups; intervention students scored significantly higher after the PBLI-DMEDS module. satisfaction of students, faculty, and course leaders was mixed. the time cost required to implement the module was excessive. The intervention effectively taught the basics of PBLI but did not integrate well into the core curriculum. Our multifaceted evaluation approach allowed us to amplify aspects of the intervention that worked well and discard those that did not.

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

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.

Image-based tracking of the suturing needle during laparoscopic interventions

NASA Astrophysics Data System (ADS)

Speidel, S.; Kroehnert, A.; Bodenstedt, S.; Kenngott, H.; Müller-Stich, B.; Dillmann, R.

2015-03-01

One of the most complex and difficult tasks for surgeons during minimally invasive interventions is suturing. A prerequisite to assist the suturing process is the tracking of the needle. The endoscopic images provide a rich source of information which can be used for needle tracking. In this paper, we present an image-based method for markerless needle tracking. The method uses a color-based and geometry-based segmentation to detect the needle. Once an initial needle detection is obtained, a region of interest enclosing the extracted needle contour is passed on to a reduced segmentation. It is evaluated with in vivo images from da Vinci interventions.

Multilevel Intervention Research: Lessons Learned and Pathways Forward

PubMed Central

Taplin, Stephen H.; Foster, Mary K.; Fagan, Pebbles; Kaluzny, Arnold D.

2012-01-01

This summary reflects on this monograph regarding multilevel intervention (MLI) research to 1) assess its added value; 2) discuss what has been learned to date about its challenges in cancer care delivery; and 3) identify specific ways to improve its scientific soundness, feasibility, policy relevance, and research agenda. The 12 submitted chapters, and discussion of them at the March 2011 multilevel meeting, were reviewed and discussed among the authors to elicit key findings and results addressing the questions raised at the outset of this effort. MLI research is underrepresented as an explicit focus in the cancer literature but may improve implementation of studies of cancer care delivery if they assess contextual, organizational, and environmental factors important to understanding behavioral and/or system-level interventions. The field lacks a single unifying theory, although several psychological or biological theories are useful, and an ecological model helps conceptualize and communicate interventions. MLI research designs are often complex, involving nonlinear and nonhierarchical relationships that may not be optimally studied in randomized designs. Simulation modeling and pilot studies may be necessary to evaluate MLI interventions. Measurement and evaluation of team and organizational interventions are especially needed in cancer care, as are attention to the context of health-care reform, eHealth technology, and genomics-based medicine. Future progress in MLI research requires greater attention to developing and supporting relevant metrics of level effects and interactions and evaluating MLI interventions. MLI research holds an unrealized promise for understanding how to improve cancer care delivery. PMID:22623606

News in early intervention in autism.

PubMed

Geoffray, Marie-Maude; Thevenet, Marion; Georgieff, Nicolas

2016-09-01

Autism Spectrum Disorder (ASD) is a complex neurodevelopmental trouble which prevents the child from socio-communicative interaction, and learning from his environment. Non-medical early intervention attempts to improve prognosis. We will review the main current hypothesis, intervention models and scientific supports about early intervention. We conducted a search of the literature published on Medline between 2010 and 2015 related to intervention models provided to children with ASD aged less than 3 years. Data were extracted from systematic reviews and recent randomized controlled trials with moderate to high GRADE quality of evidence. Early intervention refers to brain plasticity theory. With the epidemiological studies of infant "at risk" there is an attempt to intervene earlier before full syndrome is present. Interventions tend to follow more on a developmental hierarchy of socio-communicative skills and to focus on the dyadic relation between the child and the caregivers to improve the core autistic symptoms. Over the last 6 years, there's been news and fine-tuned ways about early intervention, and more and more systematic evaluation. However, there are only few interventions which were evaluated in trial with a strong GRADE recommendation and all of them have methodological concerns. It is important to be cautious in recommendations for mental health politic, even if it is important to improve access to services for all children and their families, hence finance and design rigorous project in research.

Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients (POPPI): protocol for a cluster-randomised clinical trial of a complex intervention

PubMed Central

Richards-Belle, Alvin; Mouncey, Paul R; Wade, Dorothy; Brewin, Chris R; Emerson, Lydia M; Grieve, Richard; Harrison, David A; Harvey, Sheila; Howell, David; Mythen, Monty; Sadique, Zia; Smyth, Deborah; Weinman, John; Welch, John; Rowan, Kathryn M

2018-01-01

Introduction Acute psychological stress, as well as unusual experiences including hallucinations and delusions, are common in critical care unit patients and have been linked to post-critical care psychological morbidity such as post-traumatic stress disorder (PTSD), depression and anxiety. Little high-quality research has been conducted to evaluate psychological interventions that could alleviate longer-term psychological morbidity in the critical care unit setting. Our research team developed and piloted a nurse-led psychological intervention, aimed at reducing patient-reported PTSD symptom severity and other adverse psychological outcomes at 6 months, for evaluation in the POPPI trial. Methods and analysis This is a multicentre, parallel group, cluster-randomised clinical trial with a staggered roll-out of the intervention. The trial is being carried out at 24 (12 intervention, 12 control) NHS adult, general, critical care units in the UK and is evaluating the clinical effectiveness and cost-effectiveness of a nurse-led preventative psychological intervention in reducing patient-reported PTSD symptom severity and other psychological morbidity at 6 months. All sites deliver usual care for 5 months (baseline period). Intervention group sites are then trained to carry out the POPPI intervention, and transition to delivering the intervention for the rest of the recruitment period. Control group sites deliver usual care for the duration of the recruitment period. The trial also includes a process evaluation conducted independently of the trial team. Ethics and dissemination This protocol was reviewed and approved by the National Research Ethics Service South Central - Oxford B Research Ethics Committee (reference: 15/SC/0287). The first patient was recruited in September 2015 and results will be disseminated in 2018. The results will be presented at national and international conferences and published in peer reviewed medical journals. Trial registration number ISRCTN53448131; Pre-results. PMID:29439083

Evaluation and validation of social and psychological markers in randomised trials of complex interventions in mental health: a methodological research programme.

PubMed

Dunn, Graham; Emsley, Richard; Liu, Hanhua; Landau, Sabine; Green, Jonathan; White, Ian; Pickles, Andrew

2015-11-01

The development of the capability and capacity to evaluate the outcomes of trials of complex interventions is a key priority of the National Institute for Health Research (NIHR) and the Medical Research Council (MRC). The evaluation of complex treatment programmes for mental illness (e.g. cognitive-behavioural therapy for depression or psychosis) not only is a vital component of this research in its own right but also provides a well-established model for the evaluation of complex interventions in other clinical areas. In the context of efficacy and mechanism evaluation (EME) there is a particular need for robust methods for making valid causal inference in explanatory analyses of the mechanisms of treatment-induced change in clinical outcomes in randomised clinical trials. The key objective was to produce statistical methods to enable trial investigators to make valid causal inferences about the mechanisms of treatment-induced change in these clinical outcomes. The primary objective of this report is to disseminate this methodology, aiming specifically at trial practitioners. The three components of the research were (1) the extension of instrumental variable (IV) methods to latent growth curve models and growth mixture models for repeated-measures data; (2) the development of designs and regression methods for parallel trials; and (3) the evaluation of the sensitivity/robustness of findings to the assumptions necessary for model identifiability. We illustrate our methods with applications from psychological and psychosocial intervention trials, keeping the technical details to a minimum, leaving the reporting of the more theoretical and mathematically demanding results for publication in appropriate specialist journals. We show how to estimate treatment effects and introduce methods for EME. We explain the use of IV methods and principal stratification to evaluate the role of putative treatment effect mediators and therapeutic process measures. These results are extended to the analysis of longitudinal data structures. We consider the design of EME trials. We focus on designs to create convincing IVs, bearing in mind assumptions needed to attain model identifiability. A key area of application that has become apparent during this work is the potential role of treatment moderators (predictive markers) in the evaluation of treatment effect mechanisms for personalised therapies (stratified medicine). We consider the role of targeted therapies and multiarm trials and the use of parallel trials to help elucidate the evaluation of mediators working in parallel. In order to demonstrate both efficacy and mechanism, it is necessary to (1) demonstrate a treatment effect on the primary (clinical) outcome, (2) demonstrate a treatment effect on the putative mediator (mechanism) and (3) demonstrate a causal effect from the mediator to the outcome. Appropriate regression models should be applied for (3) or alternative IV procedures, which account for unmeasured confounding, provided that a valid instrument can be identified. Stratified medicine may provide a setting where such instruments can be designed into the trial. This work could be extended by considering improved trial designs, sample size considerations and measurement properties. The project presents independent research funded under the MRC-NIHR Methodology Research Programme (grant reference G0900678).

Implementation of an audit with feedback knowledge translation intervention to promote medication error reporting in health care: a protocol.

PubMed

Hutchinson, Alison M; Sales, Anne E; Brotto, Vanessa; Bucknall, Tracey K

2015-05-19

Health professionals strive to deliver high-quality care in an inherently complex and error-prone environment. Underreporting of medical errors challenges attempts to understand causative factors and impedes efforts to implement preventive strategies. Audit with feedback is a knowledge translation strategy that has potential to modify health professionals' medical error reporting behaviour. However, evidence regarding which aspects of this complex, multi-dimensional intervention work best is lacking. The aims of the Safe Medication Audit Reporting Translation (SMART) study are to: 1. Implement and refine a reporting mechanism to feed audit data on medication errors back to nurses 2. Test the feedback reporting mechanism to determine its utility and effect 3. Identify characteristics of organisational context associated with error reporting in response to feedback A quasi-experimental design, incorporating two pairs of matched wards at an acute care hospital, is used. Randomisation occurs at the ward level; one ward from each pair is randomised to receive the intervention. A key stakeholder reference group informs the design and delivery of the feedback intervention. Nurses on the intervention wards receive the feedback intervention (feedback of analysed audit data) on a quarterly basis for 12 months. Data for the feedback intervention come from medication documentation point-prevalence audits and weekly reports on routinely collected medication error data. Weekly reports on these data are obtained for the control wards. A controlled interrupted time series analysis is used to evaluate the effect of the feedback intervention. Self-report data are also collected from nurses on all four wards at baseline and at completion of the intervention to elicit their perceptions of the work context. Additionally, following each feedback cycle, nurses on the intervention wards are invited to complete a survey to evaluate the feedback and to establish their intentions to change their reporting behaviour. To assess sustainability of the intervention, at 6 months following completion of the intervention a point-prevalence chart audit is undertaken and a report of routinely collected medication errors for the previous 6 months is obtained. This intervention will have wider application for delivery of feedback to promote behaviour change for other areas of preventable error and adverse events.

Implementing electronic clinical reminders for lipid management in patients with ischemic heart disease in the veterans health administration: QUERI Series

PubMed Central

Sales, Anne; Helfrich, Christian; Ho, P Michael; Hedeen, Ashley; Plomondon, Mary E; Li, Yu-Fang; Connors, Alison; Rumsfeld, John S

2008-01-01

Background Ischemic heart disease (IHD) affects at least 150,000 veterans annually in the United States. Lowering serum cholesterol has been shown to reduce coronary events, cardiac death, and total mortality among high risk patients. Electronic clinical reminders available at the point of care delivery have been developed to improve lipid measurement and management in the Veterans Health Administration (VHA). Our objective was to report on a hospital-level intervention to implement and encourage use of the electronic clinical reminders. Methods The implementation used a quasi-experimental design with a comparison group of hospitals. In the intervention hospitals (N = 3), we used a multi-faceted intervention to encourage use of the electronic clinical reminders. We evaluated the degree of reminder use and how patient-level outcomes varied at the intervention and comparison sites (N = 3), with and without adjusting for self-reported reminder use. Results The national electronic clinical reminders were implemented in all of the intervention sites during the intervention period. A total of 5,438 patients with prior diagnosis of ischemic heart disease received care in the six hospitals (3 intervention and 3 comparison) throughout the 12-month intervention. The process evaluation showed variation in use of reminders at each site. Without controlling for provider self-report of use of the reminders, there appeared to be a significant improvement in lipid measurement in the intervention sites (OR 1.96, 95% CI 1.34, 2.88). Controlling for use of reminders, the amount of improvement in lipid measurement in the intervention sites was even greater (OR 2.35, CI 1.96, 2.81). Adjusting for reminder use demonstrated that only one of the intervention hospitals had a significant effect of the intervention. There was no significant change in management of hyperlipidemia associated with the intervention. Conclusion There may be some benefit to focused effort to implement electronic clinical reminders, although reminders designed to improve relatively simple tasks, such as ordering tests, may be more beneficial than reminders designed to improve more complex tasks, such as initiating or titrating medications, because of the less complex nature of the task. There is value in monitoring the process, as well as outcome, of an implementation effort. PMID:18510748

EQUIP Healthcare: An overview of a multi-component intervention to enhance equity-oriented care in primary health care settings.

PubMed

Browne, Annette J; Varcoe, Colleen; Ford-Gilboe, Marilyn; Wathen, C Nadine

2015-12-14

The primary health care (PHC) sector is increasingly relevant as a site for population health interventions, particularly in relation to marginalized groups, where the greatest gains in health status can be achieved. The purpose of this paper is to provide an overview of an innovative multi-component, organizational-level intervention designed to enhance the capacity of PHC clinics to provide equity-oriented care, particularly for marginalized populations. The intervention, known as EQUIP, is being implemented in Canada in four diverse PHC clinics serving populations who are impacted by structural inequities. These PHC clinics serve as case studies for the implementation and evaluation of the EQUIP intervention. We discuss the evidence and theory that provide the basis for the intervention, describe the intervention components, and discuss the methods used to evaluate the implementation and impact of the intervention in diverse contexts. Research and theory related to equity-oriented care, and complexity theory, are central to the design of the EQUIP intervention. The intervention aims to enhance capacity for equity-oriented care at the staff level, and at the organizational level (i.e., policy and operations) and is novel in its dual focus on: (a) Staff education: using standardized educational models and integration strategies to enhance staff knowledge, attitudes and practices related to equity-oriented care in general, and cultural safety, and trauma- and violence-informed care in particular, and; (b) Organizational integration and tailoring: using a participatory approach, practice facilitation, and catalyst grants to foster shifts in organizational structures, practices and policies to enhance the capacity to deliver equity-oriented care, improve processes of care, and shift key client outcomes. Using a mixed methods, multiple case-study design, we are examining the impact of the intervention in enhancing staff knowledge, attitudes and practices; improving processes of care; shifting organizational policies and structures; and improving selected client outcomes. The multiple case study design provides an ideal opportunity to study the contextual factors shaping the implementation, uptake and impact of our tailored intervention within diverse PHC settings. The EQUIP intervention illustrates the complexities involved in enhancing the PHC sector's capacity to provide equity-oriented care in real world clinical contexts.

'Potentially inappropriate or specifically appropriate?' Qualitative evaluation of general practitioners views on prescribing, polypharmacy and potentially inappropriate prescribing in older people.

PubMed

Clyne, Barbara; Cooper, Janine A; Hughes, Carmel M; Fahey, Tom; Smith, Susan M

2016-08-11

Potentially inappropriate prescribing (PIP) is common in older people in primary care, as evidenced by a significant body of quantitative research. However, relatively few qualitative studies have investigated the phenomenon of PIP and its underlying processes from the perspective of general practitioners (GPs). The aim of this paper is to explore qualitatively, GP perspectives regarding prescribing and PIP in older primary care patients. Semi-structured qualitative interviews were conducted with GPs participating in a randomised controlled trial (RCT) of an intervention to decrease PIP in older patients (≥70 years) in Ireland. Interviews were conducted with GP participants (both intervention and control) from the OPTI-SCRIPT cluster RCT as part of the trial process evaluation between January and July 2013. Interviews were conducted by one interviewer and audio recorded. Interviews were transcribed verbatim and a thematic analysis was conducted. Seventeen semi-structured interviews were conducted (13 male; 4 female). Three main, inter-related themes emerged (complex prescribing environment, paternalistic doctor-patient relationship, and relevance of PIP concept). Patient complexity (e.g. polypharmacy, multimorbidity), as well as prescriber complexity (e.g. multiple prescribers, poor communication, restricted autonomy) were all identified as factors contributing to a complex prescribing environment where PIP could occur, as was a paternalistic-doctor patient relationship. The concept of PIP was perceived to be of variable usefulness to GPs and the criteria to measure it may be at odds with the complex processes of prescribing for this patient population. Several inter-related factors contributing to the occurrence of PIP were identified, some of which may be amenable to intervention. Improvement strategies focused on improved management of polypharmacy and multimorbidity, and communication across primary and secondary care could result in substantial improvements in PIP. Current controlled trials ISRCTN41694007.

A Bayesian Active Learning Experimental Design for Inferring Signaling Networks.

PubMed

Ness, Robert O; Sachs, Karen; Mallick, Parag; Vitek, Olga

2018-06-21

Machine learning methods for learning network structure are applied to quantitative proteomics experiments and reverse-engineer intracellular signal transduction networks. They provide insight into the rewiring of signaling within the context of a disease or a phenotype. To learn the causal patterns of influence between proteins in the network, the methods require experiments that include targeted interventions that fix the activity of specific proteins. However, the interventions are costly and add experimental complexity. We describe an active learning strategy for selecting optimal interventions. Our approach takes as inputs pathway databases and historic data sets, expresses them in form of prior probability distributions on network structures, and selects interventions that maximize their expected contribution to structure learning. Evaluations on simulated and real data show that the strategy reduces the detection error of validated edges as compared with an unguided choice of interventions and avoids redundant interventions, thereby increasing the effectiveness of the experiment.

Evaluation of a Specialized Yoga Program for Persons Admitted to a Complex Continuing Care Hospital: A Pilot Study

PubMed Central

Kuluski, Kerry; Bechsgaard, Gitte; Ridgway, Jennifer; Katz, Joel

2016-01-01

Introduction. The purpose of this study was to evaluate a specialized yoga intervention for inpatients in a rehabilitation and complex continuing care hospital. Design. Single-cohort repeated measures design. Methods. Participants (N = 10) admitted to a rehabilitation and complex continuing care hospital were recruited to participate in a 50–60 min Hatha Yoga class (modified for wheelchair users/seated position) once a week for eight weeks, with assigned homework practice. Questionnaires on pain (pain, pain interference, and pain catastrophizing), psychological variables (depression, anxiety, and experiences with injustice), mindfulness, self-compassion, and spiritual well-being were collected at three intervals: pre-, mid-, and post-intervention. Results. Repeated measures ANOVAs revealed a significant main effect of time indicating improvements over the course of the yoga program on the (1) anxiety subscale of the Hospital Anxiety and Depression Scale, F(2,18) = 4.74, p < .05, and η p 2 = .35, (2) Self-Compassion Scale-Short Form, F(2,18) = 3.71, p < .05, and η p 2 = .29, and (3) Magnification subscale of the Pain Catastrophizing Scale, F(2,18) = 3. 66, p < .05, and η p 2 = .29. Discussion. The results suggest that an 8-week Hatha Yoga program improves pain-related factors and psychological experiences in individuals admitted to a rehabilitation and complex continuing care hospital. PMID:28115969

Youth participatory research and evaluation to inform a Chagas disease prevention program in Ecuador.

PubMed

Marco-Crespo, Belén; Casapulla, Sharon; Nieto-Sanchez, Claudia; Urrego, J Guillermo Gómez; Grijalva, Mario J

2018-04-30

This qualitative study engaged a group of young people in participatory research and evaluation activities in order to study to what extent engaging youth in health interventions can inform research and evaluation processes. We applied a youth participatory research and evaluation approach (PRE) to inform research and evaluation on the impact of a Chagas disease control program in southern Ecuador. Our main interest was to examine the methodological contributions of PRE to knowledge sharing for health intervention planning in the context of global health and neglected tropical diseases. The results of this study suggest that by demystifying research and evaluation practices and rendering them accessible and relevant, marginalized youth can develop critical and reflexive thinking skills that could be useful for decision-making on health promotion. Our findings also reveal the potential of youth as active participants in project development in ways that enhance, validate, and improve health interventions. Young people are interested in learning about and sharing local knowledge that can benefit research and evaluation processes. Despite the numerous strengths demonstrated by PRE, the inherent complexities of international development, such as cultural differences, asymmetrical power relations, and the ongoing challenges of sustainability, remain. Copyright © 2018 Elsevier Ltd. All rights reserved.

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.

Developing a change model for peer worker interventions in mental health services: a qualitative research study.

PubMed

Gillard, S; Gibson, S L; Holley, J; Lucock, M

2015-10-01

A range of peer worker roles are being introduced into mental health services internationally. There is some evidence that attests to the benefits of peer workers for the people they support but formal trial evidence in inconclusive, in part because the change model underpinning peer support-based interventions is underdeveloped. Complex intervention evaluation guidance suggests that understandings of how an intervention is associated with change in outcomes should be modelled, theoretically and empirically, before the intervention can be robustly evaluated. This paper aims to model the change mechanisms underlying peer worker interventions. In a qualitative, comparative case study of ten peer worker initiatives in statutory and voluntary sector mental health services in England in-depth interviews were carried out with 71 peer workers, service users, staff and managers, exploring their experiences of peer working. Using a Grounded Theory approach we identified core processes within the peer worker role that were productive of change for service users supported by peer workers. Key change mechanisms were: (i) building trusting relationships based on shared lived experience; (ii) role-modelling individual recovery and living well with mental health problems; (iii) engaging service users with mental health services and the community. Mechanisms could be further explained by theoretical literature on role-modelling and relationship in mental health services. We were able to model process and downstream outcomes potentially associated with peer worker interventions. An empirically and theoretically grounded change model can be articulated that usefully informs the development, evaluation and planning of peer worker interventions.

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.

No longer lost in translation: the art and science of sports injury prevention implementation research.

PubMed

Finch, Caroline F

2011-12-01

It is now understood that sports injury interventions will not have significant public health impact if they are not widely accepted and adopted by target sports participants. Although there has been increasing recognition of the need for intervention studies conducted within the real-world context of sports delivery, very few studies have been conducted in this important area. A major reason for this is that there are significant challenges in conducting implementation research; the more traditional sports medicine approaches may not be fully appropriate and new ways of thinking about how to design, conduct and report such research is needed. Moreover, real-world implementation of sports injury interventions and evaluation of their effectiveness needs to start to take into account the broad ecological context in which they are introduced, as well as considering the best way to translate this knowledge to reach the audiences who most need to benefit from such research. This overview paper provides perspectives and guidance on the design, conduct and evaluation of sports injury intervention implementation studies, including better understanding of the complexity of the ecological settings for intervention delivery. Some conceptual approaches that could be adopted in future implementation studies are discussed; particular emphasis is given to intervention mapping as a tool to assist intervention development, diffusion of innovations theory to guide the planning of intervention strategies and the RE-AIM (reach, effectiveness, adoption, implementation and maintenance) framework for programme evaluation and programme design. Finally, a broad agenda for this emerging important field of sports medicine research is outlined.

A review of the methodological challenges in assessing the cost effectiveness of pharmacist interventions.

PubMed

Elliott, Rachel A; Putman, Koen; Davies, James; Annemans, Lieven

2014-12-01

Pharmacists' roles are shifting away from medicines supply and the provision of patient education involving acute medications towards consultation-type services for chronic medications. Determining the cost effectiveness of pharmacist interventions has been complicated by methodological challenges. A critique of 31 economic evaluations carried out alongside comparative studies of pharmacist interventions published between 2003 and 2013 (12 from the UK, six from the USA) found a range of disease-specific and cross-therapeutic interventions targeting both patients and prescribers in a range of settings evaluated through a variety of study designs. Only ten were full economic evaluations, five of which were based on randomized controlled trials (RCTs). The intervention was usually quite well described, but the comparator was not always clearly described, and some interventions are very context specific due to the variability in pharmacist services available in different countries and practice settings. Complex multidirectional aims of most pharmacist interventions have led to many process, intermediate and longer-term outcomes being included in any one study. Quality of resource use and cost data varied. Most incremental cost-effectiveness ratios (ICERs) were generated from process indicators such as errors and adherence, with only four studies reporting cost per quality-adjusted life-year (QALY). Very few studies examined the effect of uncertainty, and methods used were not very clear in some cases. The principal finding from our critique is that poor RCT study design or analysis precludes many studies from finding pharmacist interventions effective or cost effective. We conclude with a set of recommendations for future study design.

Treatment of severe tracheobronchomalacia: Ten-year experience.

PubMed

de Trey, Lorraine A; Dudley, Julia; Ismail-Koch, Hasnaa; Durward, Andrew; Bellsham-Revell, Hannah; Blaney, Sean; Hore, Ian; Austin, Conal B; Morrison, Gavin A

2016-04-01

Paediatric tracheobronchomalacia is a rare but potentially serious condition. Severe tracheobronchomalacia requires intervention or operation. This is an evaluation of a ten-year experience at an institution. In this retrospective study all patients were included that required an intervention for severe tracheobronchomalacia from 2003 to 2012. Symptoms, aetiology, comorbidities, localisation of the malacia, age at diagnosis, therapeutic measures and associated complications were evaluated. Forty-four patients with severe tracheobronchomalacia underwent intervention/operation. The predominant aetiology was vascular compression in 48%. The majority of patients had complex comorbidities, most importantly cardiac pathology in 66%. The median age at diagnosis was 3 months. A total of 17 aortopexies, 21 tracheostomies and 25 stent placements were performed. The mean follow-up was 2.6 years. Severe complications occurred in 12 patients. The most common complications were stent obstruction/fracture and tracheostomy tube obstruction. The management of severe tracheobronchomalacia is complex and the population of patients is very heterogeneous. Therefore the treatment has to be adapted for each patient individually. The decision strategies are discussed in this article. The surgical techniques for placement and safe removal of expandable bare metallic stents employed in our institution are presented. A multidisciplinary team of ENT surgeons, Intensivists, Cardiologists and Cardiac surgeons is of great importance. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Changing the individual to promote health-enhancing physical activity: the difficulties of producing evidence and translating it into practice.

PubMed

Blamey, Avril; Mutrie, Nanette

2004-08-01

This paper presents conclusions from recent systematic reviews and highlights individually targeted interventions that are effective at increasing physical activity. It discusses the limitations of currently available evidence, considers what factors lead to these limitations and what barriers exist in terms of implementing the evidence as part of local and national policy and practice. Barriers present themselves in terms of getting evidence into practice and in terms of ensuring that practice informs the evidence base. These barriers include difficulties in conducting systematic reviews, disaggregating knowledge from complex interventions, making local adaptations to existing evidence, the lack of an evaluation culture, ethical and pragmatic difficulties in designing interventions, selecting appropriate outcome measures, poor designs and implementation of evidence and, finally, a recognition that policy making is not only based on the available evidence. New and more integrated approaches to evaluation and to practice are needed.

Bioresorbable scaffolds: talking about a new interventional revolution [corrected].

PubMed

Hassell, M E C J; Grundeken, M J D; Delewi, R; Wykrzykowska, J J; Piek, J J

2013-04-01

After the introduction of coronary balloon angioplasty, bare-metal, and drug-eluting stents, fully bioresorbable scaffolds (BRS) could be the fourth revolution in interventional cardiology. The BRS technology shares the advantages of metallic stents regarding acute gain and prevention of acute vessel occlusion by providing transient scaffolding, while potentially overcoming many of the safety concerns of drug-eluting stents. Furthermore, without a permanent metallic cage, the vessel could remodel favourably and atherosclerotic plaques could regress in the long-term. This attracted increased interest and several BRS have been developed. In this review we will describe all BRS which are thus far clinically evaluated and provide an overview of ongoing clinical studies. Although the technology seems to be very promising, more studies including patients with more complex lesions are needed to evaluate whether the BRS can be used in daily clinical practice and if it is indeed becoming a new interventional revolution.

An innovative and comprehensive technique to evaluate different measures of medication adherence: The network meta-analysis.

PubMed

Tonin, Fernanda S; Wiecek, Elyssa; Torres-Robles, Andrea; Pontarolo, Roberto; Benrimoj, Shalom Charlie I; Fernandez-Llimos, Fernando; Garcia-Cardenas, Victoria

2018-05-19

Poor medication adherence is associated with adverse health outcomes and higher costs of care. However, inconsistencies in the assessment of adherence are found in the literature. To evaluate the effect of different measures of adherence in the comparative effectiveness of complex interventions to enhance patients' adherence to prescribed medications. A systematic review with network meta-analysis was performed. Electronic searches for relevant pairwise meta-analysis including trials of interventions that aimed to improve medication adherence were performed in PubMed. Data extraction was conducted with eligible trials evaluating short-period adherence follow-up (until 3 months) using any measure of adherence: self-report, pill count, or MEMS (medication event monitoring system). To standardize the results obtained with these different measures, an overall composite measure and an objective composite measure were also calculated. Network meta-analyses for each measure of adherence were built. Rank order and surface under the cumulative ranking curve analyses (SUCRA) were performed. Ninety-one trials were included in the network meta-analyses. The five network meta-analyses demonstrated robustness and reliability. Results obtained for all measures of adherence were similar across them and to both composite measures. For both composite measures, interventions comprising economic + technical components were the best option (90% of probability in SUCRA analysis) with statistical superiority against almost all other interventions and against standard care (odds ratio with 95% credibility interval ranging from 0.09 to 0.25 [0.02, 0.98]). The use of network meta-analysis was reliable to compare different measures of adherence of complex interventions in short-periods follow-up. Analyses with longer follow-up periods are needed to confirm these results. Different measures of adherence produced similar results. The use of composite measures revealed reliable alternatives to establish a broader and more detailed picture of adherence. Copyright © 2018 Elsevier Inc. All rights reserved.

Evaluating complex health financing interventions: using mixed methods to inform further implementation of a novel PBI intervention in rural Malawi.

PubMed

McMahon, Shannon A; Brenner, Stephan; Lohmann, Julia; Makwero, Christopher; Torbica, Aleksandra; Mathanga, Don P; Muula, Adamson S; De Allegri, Manuela

2016-08-19

Gaps remain in understanding how performance-based incentive (PBI) programs affect quality of care and service quantity, whether programs are cost effective and how programs could be tailored to meet client and provider needs while remaining operationally viable. In 2014, Malawi's Ministry of Health launched the Service Delivery Integration-PBI (SSDI-PBI) program. The program is unique in that no portion of performance bonuses are paid to individual health workers, and it shifts responsibility for infrastructure and equipment procurement from facility staff to implementing partners. This protocol outlines an approach that analyzes processes and outcomes, considers expected and unexpected consequences of the program and frames the program's outputs relative to its costs. Findings from this evaluation will inform the intended future scale-up of PBI in Malawi. This study employs a prospective controlled before-and-after triangulation design to assess effects of the PBI program by analyzing quantitative and qualitative data from intervention and control facilities. Guided by a theoretical framework, the evaluation consists of four main components: service provision, health worker motivation, implementation processes and costing. Quality and access outcomes are assessed along four dimensions: (1) structural elements (related to equipment, drugs, staff); (2) process elements (providers' compliance with standards); (3) outputs (service utilization); (4) experiential elements (experiences of service delivery). The costing component includes costs related to start-up, ongoing management, and the cost of incentives themselves. The cost analysis considers costs incurred within the Ministry of Health, funders, and the implementing agency. The evaluation relies on primary data (including interviews and surveys) and secondary data (including costing and health management information system data). Through the lens of a PBI program, we illustrate how complex interventions can be evaluated via not only primary, mixed-methods data collection, but also through a wealth of secondary data from program implementers (including monitoring, evaluation and financial data), and the health system (including service utilization and service readiness data). We also highlight the importance of crafting a theory and using theory to inform the nature of data collected. Finally, we highlight the need to be responsive to stakeholders in order to enhance a study's relevance.

Operational research as implementation science: definitions, challenges and research priorities.

PubMed

Monks, Thomas

2016-06-06

Operational research (OR) is the discipline of using models, either quantitative or qualitative, to aid decision-making in complex implementation problems. The methods of OR have been used in healthcare since the 1950s in diverse areas such as emergency medicine and the interface between acute and community care; hospital performance; scheduling and management of patient home visits; scheduling of patient appointments; and many other complex implementation problems of an operational or logistical nature. To date, there has been limited debate about the role that operational research should take within implementation science. I detail three such roles for OR all grounded in upfront system thinking: structuring implementation problems, prospective evaluation of improvement interventions, and strategic reconfiguration. Case studies from mental health, emergency medicine, and stroke care are used to illustrate each role. I then describe the challenges for applied OR within implementation science at the organisational, interventional, and disciplinary levels. Two key challenges include the difficulty faced in achieving a position of mutual understanding between implementation scientists and research users and a stark lack of evaluation of OR interventions. To address these challenges, I propose a research agenda to evaluate applied OR through the lens of implementation science, the liberation of OR from the specialist research and consultancy environment, and co-design of models with service users. Operational research is a mature discipline that has developed a significant volume of methodology to improve health services. OR offers implementation scientists the opportunity to do more upfront system thinking before committing resources or taking risks. OR has three roles within implementation science: structuring an implementation problem, prospective evaluation of implementation problems, and a tool for strategic reconfiguration of health services. Challenges facing OR as implementation science include limited evidence and evaluation of impact, limited service user involvement, a lack of managerial awareness, effective communication between research users and OR modellers, and availability of healthcare data. To progress the science, a focus is needed in three key areas: evaluation of OR interventions, embedding the knowledge of OR in health services, and educating OR modellers about the aims and benefits of service user involvement.

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.

Academic Detailing Interventions Improve Tobacco Use Treatment among Physicians Working in Underserved Communities.

PubMed

Leone, Frank T; Evers-Casey, Sarah; Graden, Sarah; Schnoll, Robert; Mallya, Giridhar

2015-06-01

Tobacco use disproportionately affects the poor, who are, in turn, least likely to receive cessation treatment from providers. Providers caring for low-income populations perform simple components of tobacco use treatment (e.g., assessing tobacco use) with reasonable frequency. However, performance of complex treatment behaviors, such as pharmacologic prescription and follow-up arrangement, remains suboptimal. Evaluate the influence of academic detailing (AD), a university-based, noncommercial, educational outreach intervention, on primary care physicians' complex treatment practice behaviors within an urban care setting. Trained academic detailers made in-person visits to targeted primary care practices, delivering verbal and written instruction emphasizing three key messages related to tobacco treatment. Physicians' self-reported frequency of simple and complex treatment behaviors were assessed using a seven-item questionnaire, before and 2 months after AD. Between May 2011 and March 2012, baseline AD visits were made to 217 physicians, 109 (50%) of whom also received follow-up AD. Mean frequency scores for complex behaviors increased significantly, from 2.63 to 2.92, corresponding to a clinically significant 30% increase in the number of respondents who endorsed "almost always" or "always" (P < 0.001). Improvement in mean simple behavior frequency scores was also noted (3.98 vs. 4.13; P = 0.035). Sex and practice type appear to influence reported complex behavior frequency at baseline, whereas only practice type influenced improvement in complex behavior scores at follow up. This study demonstrates the feasibility and potential effectiveness of a low-cost and highly disseminable intervention to improve clinician behavior in the context of treating nicotine dependence in underserved communities.

Social Validity: Perceptions of Check and Connect with Early Literacy Support

ERIC Educational Resources Information Center

Miltich Lyst, Aimee; Gabriel, Stacey; O'Shaughnessy, Tam E.; Meyers, Joel; Meyers, Barbara

2005-01-01

This article underscores the potential advantages of qualitative methods to illustrate the depth and complexity of social validity. This investigation evaluates the social validity of Check and Connect with Early Literacy Support (CCEL), through the perspectives of teachers and caregivers whose children participated in the intervention. Teachers…

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…

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.

Practice, progress and future directions for physical therapies in Huntingtons disease.

PubMed

Busse, Monica; Khalil, Hanan; Brooks, Simon; Quinn, Lori; Rosser, Anne

2012-01-01

Physical therapies and exercise may have potential as a disease modifying agent in Huntington's disease (HD) and in recent years, there have been several small scale feasibility studies that have shown benefit as a result of physical interventions. When evaluating complex physical interventions, a phased approach using mixed methodology designs that report specific intervention components, adherence, acceptability, adverse events and defined intervention protocols is important for replication and planning of future trials and to ensure potential for implementation in clinical practice. A narrative review of the available literature related to physical activity, physical therapy and exercise in people with HD was performed using a population, intervention, comparison and outcome (PICO) approach. Eight studies met specific inclusion criteria and were reviewed in terms of their systematic conduct and reporting standards. All of the studies (n = 8) provided details of intervention including location and duration. The majority of interventions included balance training activities in combination with other complex activities of daily living that required therapist supervision. Two of the interventions were home based, the remainder were facility or hospital based. None of the studies reported adverse events whilst only 3/8 reported adherence rates which were ranging from 60-80%. In general, limited detail was provided on the specific individual components of the interventions. This review of primary publications and conference proceedings, suggests that researchers working in the field need to focus on clearer reporting of intervention protocols so as to generate a clearer understanding of the impact of exercise and physical therapies on the symptoms of HD, as well as any potential synergistic role alongside the impending disease-modifying interventions.

Adaptive Flood Risk Management Under Climate Change Uncertainty Using Real Options and Optimization.

PubMed

Woodward, Michelle; Kapelan, Zoran; Gouldby, Ben

2014-01-01

It is well recognized that adaptive and flexible flood risk strategies are required to account for future uncertainties. Development of such strategies is, however, a challenge. Climate change alone is a significant complication, but, in addition, complexities exist trying to identify the most appropriate set of mitigation measures, or interventions. There are a range of economic and environmental performance measures that require consideration, and the spatial and temporal aspects of evaluating the performance of these is complex. All these elements pose severe difficulties to decisionmakers. This article describes a decision support methodology that has the capability to assess the most appropriate set of interventions to make in a flood system and the opportune time to make these interventions, given the future uncertainties. The flood risk strategies have been explicitly designed to allow for flexible adaptive measures by capturing the concepts of real options and multiobjective optimization to evaluate potential flood risk management opportunities. A state-of-the-art flood risk analysis tool is employed to evaluate the risk associated to each strategy over future points in time and a multiobjective genetic algorithm is utilized to search for the optimal adaptive strategies. The modeling system has been applied to a reach on the Thames Estuary (London, England), and initial results show the inclusion of flexibility is advantageous, while the outputs provide decisionmakers with supplementary knowledge that previously has not been considered. © 2013 HR Wallingford Ltd.

A dietary intervention to elicit rapid and complex dietary changes for studies investigating the effects of diet on tissues collected during invasive surgical procedures.

PubMed

Schenk, Jeannette M; Neuhouser, Marian L; Lin, Daniel W; Kristal, Alan R

2009-03-01

Nutrition intervention trials in patients undergoing surgical treatment for cancer offer a unique opportunity to study the mechanisms and pathways that underlie diet and cancer associations in target tissues. However, due to the short time period between diagnosis and treatment, traditional dietary intervention methods are not feasible. This report describes a novel dietary intervention program designed to elicit rapid and complex dietary change during a condensed study period. The intervention, based on Consumer Information Processing, used standardized menus and exchange lists to guide food choices, and was delivered using a single, in-person session followed by telephone-based counseling. This intervention program was used in a small pilot study evaluating the short-term effects of dietary change in men with newly diagnosed prostate cancer. Eight men were randomly assigned to either a low-fat/low-glycemic load or standard American diet during the 4 weeks preceding prostate surgery. Participants completed 24-hour dietary recalls each week, and were weighed at baseline and at surgery. Compared to men in the standard American arm (n=4), men in the low-fat/low-glycemic arm (n=4) reported consuming less total fat (51.0+/-36.0 vs 93.5+/-8.4 g/day, P=0.06), and had a lower glycemic load (134.8+/-6.0 vs 266.3+/-36.8 units/day, P<0.001). Men in the low-fat/low-glycemic arm lost a mean of 5.3+/-1.7 kg and men in the standard American arm gained 0.8+/-4.5 kg (P=0.04). Results of this small pilot study suggest that a relatively simple and minimally burdensome dietary intervention can elicit rapid and complex dietary changes that are maintained over a 4-week study period. Further studies in larger and more diverse populations are needed to fully understand the potential of this novel intervention approach.

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

Safety assessment for the postictal confusional phase following complex partial seizure.

PubMed

Tucker, C

1985-06-01

Misunderstanding of the postictal confusional state that follows the complex partial seizure has caused emotional and physical harm to patients. Concern about this phenomenon and its effects upon the patient prompted this study to explore, describe, and document one method of intervention to lessen these harmful effects. An evaluative descriptive research design was employed to assess patient safety during and after the postictal confusional phase following a complex partial seizure. A closed-structured questionnaire and participant observation were the methods used to collect data for this study. A Level of Safety Tool was specifically designed for this study.

Is scale-up of community mobilisation among sex workers really possible in complex urban environments? The case of Mumbai, India.

PubMed

Kongelf, Anine; Bandewar, Sunita V S; Bharat, Shalini; Collumbien, Martine

2015-01-01

In the last decade, community mobilisation (CM) interventions targeting female sex workers (FSWs) have been scaled-up in India's national response to the HIV epidemic. This included the Bill and Melinda Gates Foundation's Avahan programme which adopted a business approach to plan and manage implementation at scale. With the focus of evaluation efforts on measuring effectiveness and health impacts there has been little analysis thus far of the interaction of the CM interventions with the sex work industry in complex urban environments. Between March and July 2012 semi-structured, in-depth interviews and focus group discussions were conducted with 63 HIV intervention implementers, to explore challenges of HIV prevention among FSWs in Mumbai. A thematic analysis identified contextual factors that impact CM implementation. Large-scale interventions are not only impacted by, but were shown to shape the dynamic social context. Registration practices and programme monitoring were experienced as stigmatising, reflected in shifting client preferences towards women not disclosing as 'sex workers'. This combined with urban redevelopment and gentrification of traditional red light areas, forcing dispersal and more 'hidden' ways of solicitation, further challenging outreach and collectivisation. Participants reported that brothel owners and 'pimps' continued to restrict access to sex workers and the heterogeneous 'community' of FSWs remains fragmented with high levels of mobility. Stakeholder engagement was poor and mobilising around HIV prevention not compelling. Interventions largely failed to respond to community needs as strong target-orientation skewed activities towards those most easily measured and reported. Large-scale interventions have been impacted by and contributed to an increasingly complex sex work environment in Mumbai, challenging outreach and mobilisation efforts. Sex workers remain a vulnerable and disempowered group needing continued support and more comprehensive services.

The Effect of Sex and Anthropometry on Clinical Outcomes in Patients Undergoing Percutaneous Coronary Intervention for Complex Coronary Lesions

PubMed Central

Lee, Seung-Yul; Shin, Dong-Ho; Kim, Jung-Sun; Kim, Byeong-Keuk; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo

2017-01-01

Purpose To evaluate the effects of sex and anthropometry on clinical outcomes in patients who underwent percutaneous coronary intervention (PCI). Materials and Methods From three randomized trials (REal Safety and Efficacy of 3-month dual antiplatelet Therapy following Endeavor zotarolimus-eluting stent implantation, Impact of intraVascular UltraSound guidance on outcomes of Xience Prime stents in Long lesions, Chronic Total Occlusion InterVention with drUg-eluting Stents), we compared 333 pairs of men and women matched by propensity scores, all of whom underwent intravascular ultrasound (IVUS)-guided PCI for complex lesions. Results For 12 months, the incidence of adverse cardiac events, defined as the composite of cardiac death, target lesion–related myocardial infarction, and target lesion revascularization, was not different between women and men (2.4% vs. 2.4%, p=0.939). Using multivariable Cox's regression analysis, post-intervention minimum lumen area [MLA; hazard ratio (HR)=0.620, 95% confidence interval (CI)=0.423–0.909, p=0.014] by IVUS was a predictor of adverse cardiac events. Height on anthropometry and lesions with chronic total occlusion were significantly related to post-intervention MLA. However, female sex was not independently associated with post-intervention MLA. In an age and sex-adjusted model, patients in the low tertile of height exhibited a greater risk for adverse cardiac events than those in the high tertile of height (HR=6.391, 95% CI=1.160–35.206, p=0.033). Conclusion Sex does not affect clinical outcomes after PCI for complex lesions. PCI outcomes, however, may be adversely affected by height. PMID:28120559

The effects on student health of interventions modifying the school environment: systematic review.

PubMed

Bonell, C; Wells, H; Harden, A; Jamal, F; Fletcher, A; Thomas, J; Campbell, R; Petticrew, M; Whitehead, M; Murphy, S; Moore, L

2013-08-01

Owing to the limited effectiveness of traditional health education curricula in schools, there is increasing interest in interventions aiming to promote young people's health by modifying the school environment. Existing systematic reviews cannot determine whether environmental intervention is effective because they examine interventions combining environmental modifications and traditional health education. This gap is significant because school-environment interventions are complex to implement and may be sidelined in underfunded and attainment-focused school systems without evidence to support such an approach. This systematic review examined the effectiveness of school-environment interventions without health-education components on student health and inequalities. This was a systematic review of experimental/quasi-experimental studies of school-environment interventions. Sixteen databases were searched, eliciting 62 329 references which were screened, with included studies quality assessed, data extracted and narratively synthesised. Sixteen reports of 10 studies were included, all from the USA and the UK. Five evaluations of interventions aiming to develop a stronger sense of community and/or improve relationships between staff and students suggested potential benefits particularly regarding violence and aggression. Two trials of interventions enabling students to advocate for changes in school catering and physical activity reported benefits for physical activity but not diet. Three evaluations of improvements to school playgrounds offered weak evidence of effects on physical activity. School environment interventions show the potential to improve young people's health particularly regarding violence, aggression and physical activity. Further trials are required to provide a stronger and more generalisable evidence base.

Peer volunteer perspectives following a complex social cognitive intervention: a qualitative investigation.

PubMed

McHugh, J E; Lee, O; Aspell, N; Connolly, L; Lawlor, B A; Brennan, S

2016-09-01

Peer volunteers can be key to delivering effective social cognitive interventions due to increased potential for social modeling. We consulted peer volunteers who had just taken part in an 8-week social and nutritional mealtime intervention with older adults living alone, to seek their evaluation of the intervention. Semi-structured focus groups were used with a total of 21 volunteers (17 female) and two facilitators. Thematic analysis was used to interrogate the data. Six themes (16 sub-themes) are discussed. Peer volunteers described the importance of the socializing aspect of the intervention, of pairing considerations and compatibility in peer interventions, of considering the needs of the participant, of benefits to the volunteers, and of the practical considerations of conducting an intervention. Volunteers also discussed considerations for future research and services for older adults living alone. Volunteers found their involvement in the intervention to be personally beneficial, and revealed some valuable considerations for the researchers to take forward to future research. Results are pertinent to intervention design and could inform future social cognitive and other peer-oriented interventions for older adults living alone.

[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.

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.

Intervention complexity--a conceptual framework to inform priority-setting in health.

PubMed Central

Gericke, Christian A.; Kurowski, Christoph; Ranson, M. Kent; Mills, Anne

2005-01-01

Health interventions vary substantially in the degree of effort required to implement them. To some extent this is apparent in their financial cost, but the nature and availability of non-financial resources is often of similar importance. In particular, human resource requirements are frequently a major constraint. We propose a conceptual framework for the analysis of interventions according to their degree of technical complexity; this complements the notion of institutional capacity in considering the feasibility of implementing an intervention. Interventions are categorized into four dimensions: characteristics of the basic intervention; characteristics of delivery; requirements on government capacity; and usage characteristics. The analysis of intervention complexity should lead to a better understanding of supply- and demand-side constraints to scaling up, indicate priorities for further research and development, and can point to potential areas for improvement of specific aspects of each intervention to close the gap between the complexity of an intervention and the capacity to implement it. The framework is illustrated using the examples of scaling up condom social marketing programmes, and the DOTS strategy for tuberculosis control in highly resource-constrained countries. The framework could be used as a tool for policy-makers, planners and programme managers when considering the expansion of existing projects or the introduction of new interventions. Intervention complexity thus complements the considerations of burden of disease, cost-effectiveness, affordability and political feasibility in health policy decision-making. Reducing the technical complexity of interventions will be crucial to meeting the health-related Millennium Development Goals. PMID:15868020

Intervention complexity--a conceptual framework to inform priority-setting in health.

PubMed

Gericke, Christian A; Kurowski, Christoph; Ranson, M Kent; Mills, Anne

2005-04-01

Health interventions vary substantially in the degree of effort required to implement them. To some extent this is apparent in their financial cost, but the nature and availability of non-financial resources is often of similar importance. In particular, human resource requirements are frequently a major constraint. We propose a conceptual framework for the analysis of interventions according to their degree of technical complexity; this complements the notion of institutional capacity in considering the feasibility of implementing an intervention. Interventions are categorized into four dimensions: characteristics of the basic intervention; characteristics of delivery; requirements on government capacity; and usage characteristics. The analysis of intervention complexity should lead to a better understanding of supply- and demand-side constraints to scaling up, indicate priorities for further research and development, and can point to potential areas for improvement of specific aspects of each intervention to close the gap between the complexity of an intervention and the capacity to implement it. The framework is illustrated using the examples of scaling up condom social marketing programmes, and the DOTS strategy for tuberculosis control in highly resource-constrained countries. The framework could be used as a tool for policy-makers, planners and programme managers when considering the expansion of existing projects or the introduction of new interventions. Intervention complexity thus complements the considerations of burden of disease, cost-effectiveness, affordability and political feasibility in health policy decision-making. Reducing the technical complexity of interventions will be crucial to meeting the health-related Millennium Development Goals.

Process evaluation of a sport-for-health intervention to prevent smoking amongst primary school children: SmokeFree Sports.

PubMed

Trigwell, Joanne; McGee, Ciara E; Murphy, Rebecca C; Porcellato, Lorna A; Ussher, Michael; Garnham-Lee, Katy; Knowles, Zoe R; Foweather, Lawrence

2015-04-10

SmokeFree Sports (SFS) was a multi-component sport-for-health intervention aiming at preventing smoking among nine to ten year old primary school children from North West England. The purpose of this study was to evaluate the process and implementation of SFS, examining intervention reach, dose, fidelity, acceptability and sustainability, in order to understand the feasibility and challenges of delivering such interventions and inform interpretations of intervention effectiveness. Process measures included: booking logs, 18 focus groups with children (n = 95), semi-structured interviews with teachers (n = 20) and SFS coaches (n = 7), intervention evaluation questionnaires (completed by children, n = 1097; teachers, n = 50), as well direct observations (by researchers, n = 50 observations) and self-evaluations (completed by teachers, n = 125) of intervention delivery (e.g. length of sessions, implementation of activities as intended, children's engagement and barriers). Descriptive statistics and thematic analysis were applied to quantitative and qualitative data, respectively. Overall, SFS reached 30.8% of eligible schools, with 1073 children participating in the intervention (across 32 schools). Thirty-one schools completed the intervention in full. Thirty-three teachers (55% female) and 11 SFS coaches (82% male) attended a bespoke SFS training workshop. Disparities in intervention duration (range = 126 to 201 days), uptake (only 25% of classes received optional intervention components in full), and the extent to which core (mean fidelity score of coaching sessions = 58%) and optional components (no adaptions made = 51% of sessions) were delivered as intended, were apparent. Barriers to intervention delivery included the school setting and children's behaviour and knowledge. SFS was viewed positively (85% and 82% of children and teachers, respectively, rated SFS five out of five) and recommendations to increase school engagement were provided. SFS was considered acceptable to children, teachers and coaches. Nevertheless, efforts to enhance intervention reach (at the school level), teachers' engagement and sustainability must be considered. Variations in dose and fidelity likely reflect challenges associated with complex intervention delivery within school settings and thus a flexible design may be necessary. This study adds to the limited scientific evidence base surrounding sport-for-health interventions and their implementation, and suggests that such interventions offer a promising tool for engaging children in activities which promote their health.

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

PRIORITIES FOR HEALTH ECONOMIC METHODOLOGICAL RESEARCH: RESULTS OF AN EXPERT CONSULTATION.

PubMed

Tordrup, David; Chouaid, Christos; Cuijpers, Pim; Dab, William; van Dongen, Johanna Maria; Espin, Jaime; Jönsson, Bengt; Léonard, Christian; McDaid, David; McKee, Martin; Miguel, José Pereira; Patel, Anita; Reginster, Jean-Yves; Ricciardi, Walter; Rutten-van Molken, Maureen; Rupel, Valentina Prevolnik; Sach, Tracey; Sassi, Franco; Waugh, Norman; Bertollini, Roberto

2017-01-01

The importance of economic evaluation in decision making is growing with increasing budgetary pressures on health systems. Diverse economic evidence is available for a range of interventions across national contexts within Europe, but little attention has been given to identifying evidence gaps that, if filled, could contribute to more efficient allocation of resources. One objective of the Research Agenda for Health Economic Evaluation project is to determine the most important methodological evidence gaps for the ten highest burden conditions in the European Union (EU), and to suggest ways of filling these gaps. The highest burden conditions in the EU by Disability Adjusted Life Years were determined using the Global Burden of Disease study. Clinical interventions were identified for each condition based on published guidelines, and economic evaluations indexed in MEDLINE were mapped to each intervention. A panel of public health and health economics experts discussed the evidence during a workshop and identified evidence gaps. The literature analysis contributed to identifying cross-cutting methodological and technical issues, which were considered by the expert panel to derive methodological research priorities. The panel suggests a research agenda for health economics which incorporates the use of real-world evidence in the assessment of new and existing interventions; increased understanding of cost-effectiveness according to patient characteristics beyond the "-omics" approach to inform both investment and disinvestment decisions; methods for assessment of complex interventions; improved cross-talk between economic evaluations from health and other sectors; early health technology assessment; and standardized, transferable approaches to economic modeling.

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

Measuring the Complexity of Treatment for Challenging Behavior using the Treatment Intensity Rating Form

PubMed Central

Zarcone, Jennifer; Hagopian, Louis; Ninci, Jennifer; McKay, Chloe; Bonner, Andrew; Dillon, Christopher; Hausman, Nicole

2016-01-01

Objectives The goal of this study was to develop and evaluate a tool to measure the complexity and intensity of psychotropic medication interventions, behavioral interventions, and issues related to crisis management for challenging behavior using a standardized rating form. Method The Treatment Intensity Rating Form (TIRF) is a 10-item scale with three categories: pharmacological interventions, behavior supports, and protective equipment. In a retrospective review we examined the final treatment recommendations for 74 individuals with self-injurious behavior (SIB) based on psychiatric and behavioral notes and reports. We also compared whether TIRF scores differed across individuals for whom SIB was maintained by social reinforcement (e.g., to access attention or toys/activities, or escape from tasks) versus those for whom SIB was maintained by automatic reinforcement (e.g., occurs independent of social variables, and is presumed to be maintained by sensory reinforcement). Results The TIRF was demonstrated to have strong inter-rater reliability (98%) and appears to have good face validity. As hypothesized, individuals with SIB maintained by automatic reinforcement had significantly more medication trials (p=0.0005) and required more protective equipment than individuals with SIB maintained by social reinforcement (p=0.0002). Antidepressant medication was used more often with individuals with automatically reinforced SIB, although antipsychotics and anticonvulsants were also commonly used across both groups. Conclusion Findings provide initial support for the TIRF’s reliability, and face validity as a measure the level of complexity of medical and behavioral treatment plans - although additional research is needed to fully evaluate its psychometric properties. PMID:27917287

Using mixed methods to assess fidelity of delivery and its influencing factors in a complex self-management intervention for people with osteoarthritis and low back pain.

PubMed

Toomey, Elaine; Matthews, James; Hurley, Deirdre A

2017-08-04

Despite an increasing awareness of the importance of fidelity of delivery within complex behaviour change interventions, it is often poorly assessed. This mixed methods study aimed to establish the fidelity of delivery of a complex self-management intervention and explore the reasons for these findings using a convergent/triangulation design. Feasibility trial of the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) intervention (ISRCTN49875385), delivered in primary care physiotherapy. 60 SOLAS sessions were delivered across seven sites by nine physiotherapists. Fidelity of delivery of prespecified intervention components was evaluated using (1) audio-recordings (n=60), direct observations (n=24) and self-report checklists (n=60) and (2) individual interviews with physiotherapists (n=9). Quantitatively, fidelity scores were calculated using percentage means and SD of components delivered. Associations between fidelity scores and physiotherapist variables were analysed using Spearman's correlations. Interviews were analysed using thematic analysis to explore potential reasons for fidelity scores. Integration of quantitative and qualitative data occurred at an interpretation level using triangulation. Quantitatively, fidelity scores were high for all assessment methods; with self-report (92.7%) consistently higher than direct observations (82.7%) or audio-recordings (81.7%). There was significant variation between physiotherapists' individual scores (69.8% - 100%). Both qualitative and quantitative data (from physiotherapist variables) found that physiotherapists' knowledge (Spearman's association at p=0.003) and previous experience (p=0.008) were factors that influenced their fidelity. The qualitative data also postulated participant-level (eg, individual needs) and programme-level factors (eg, resources) as additional elements that influenced fidelity. The intervention was delivered with high fidelity. This study contributes to the limited evidence regarding fidelity assessment methods within complex behaviour change interventions. The findings suggest a combination of quantitative methods is suitable for the assessment of fidelity of delivery. A mixed methods approach provided a more insightful understanding of fidelity and its influencing factors. ISRCTN49875385; Pre-results. © 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.

Explicit Oral Narrative Intervention for Students with Williams Syndrome

PubMed Central

Diez-Itza, Eliseo; Martínez, Verónica; Pérez, Vanesa; Fernández-Urquiza, Maite

2018-01-01

Narrative skills play a crucial role in organizing experience, facilitating social interaction and building academic discourse and literacy. They are at the interface of cognitive, social, and linguistic abilities related to school engagement. Despite their relative strengths in social and grammatical skills, students with Williams syndrome (WS) do not show parallel cognitive and pragmatic performance in narrative generation tasks. The aim of the present study was to assess retelling of a TV cartoon tale and the effect of an individualized explicit instruction of the narrative structure. Participants included eight students with WS who attended different special education levels. Narratives were elicited in two sessions (pre and post intervention), and were transcribed, coded and analyzed using the tools of the CHILDES Project. Narratives were coded for productivity and complexity at the microstructure and macrostructure levels. Microstructure productivity (i.e., length of narratives) included number of utterances, clauses, and tokens. Microstructure complexity included mean length of utterances, lexical diversity and use of discourse markers as cohesive devices. Narrative macrostructure was assessed for textual coherence through the Pragmatic Evaluation Protocol for Speech Corpora (PREP-CORP). Macrostructure productivity and complexity included, respectively, the recall and sequential order of scenarios, episodes, events and characters. A total of four intervention sessions, lasting approximately 20 min, were delivered individually once a week. This brief intervention addressed explicit instruction about the narrative structure and the use of specific discourse markers to improve cohesion of story retellings. Intervention strategies included verbal scaffolding and modeling, conversational context for retelling the story and visual support with pictures printed from the cartoon. Results showed significant changes in WS students’ retelling of the story, both at macro- and microstructure levels, when assessed following a 2-week interval. Outcomes were better in microstructure than in macrostructure, where sequential order (i.e., complexity) did not show significant improvement. These findings are consistent with previous research supporting the use of explicit oral narrative intervention with participants who are at risk of school failure due to communication impairments. Discussion focuses on how assessment and explicit instruction of narrative skills might contribute to effective intervention programs enhancing school engagement in WS students. PMID:29379455

Using mixed methods to assess fidelity of delivery and its influencing factors in a complex self-management intervention for people with osteoarthritis and low back pain

PubMed Central

Toomey, Elaine; Matthews, James; Hurley, Deirdre A

2017-01-01

Objectives and design Despite an increasing awareness of the importance of fidelity of delivery within complex behaviour change interventions, it is often poorly assessed. This mixed methods study aimed to establish the fidelity of delivery of a complex self-management intervention and explore the reasons for these findings using a convergent/triangulation design. Setting Feasibility trial of the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) intervention (ISRCTN49875385), delivered in primary care physiotherapy. Methods and outcomes 60 SOLAS sessions were delivered across seven sites by nine physiotherapists. Fidelity of delivery of prespecified intervention components was evaluated using (1) audio-recordings (n=60), direct observations (n=24) and self-report checklists (n=60) and (2) individual interviews with physiotherapists (n=9). Quantitatively, fidelity scores were calculated using percentage means and SD of components delivered. Associations between fidelity scores and physiotherapist variables were analysed using Spearman’s correlations. Interviews were analysed using thematic analysis to explore potential reasons for fidelity scores. Integration of quantitative and qualitative data occurred at an interpretation level using triangulation. Results Quantitatively, fidelity scores were high for all assessment methods; with self-report (92.7%) consistently higher than direct observations (82.7%) or audio-recordings (81.7%). There was significant variation between physiotherapists’ individual scores (69.8% - 100%). Both qualitative and quantitative data (from physiotherapist variables) found that physiotherapists’ knowledge (Spearman’s association at p=0.003) and previous experience (p=0.008) were factors that influenced their fidelity. The qualitative data also postulated participant-level (eg, individual needs) and programme-level factors (eg, resources) as additional elements that influenced fidelity. Conclusion The intervention was delivered with high fidelity. This study contributes to the limited evidence regarding fidelity assessment methods within complex behaviour change interventions. The findings suggest a combination of quantitative methods is suitable for the assessment of fidelity of delivery. A mixed methods approach provided a more insightful understanding of fidelity and its influencing factors. Trial registration number ISRCTN49875385; Pre-results. PMID:28780544

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.

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.

Evaluation of community-level interventions to increase early initiation of antenatal care in pregnancy: protocol for the Community REACH study, a cluster randomised controlled trial with integrated process and economic evaluations.

PubMed

Sawtell, Mary; Sweeney, Lorna; Wiggins, Meg; Salisbury, Cathryn; Eldridge, Sandra; Greenberg, Lauren; Hunter, Rachael; Kaur, Inderjeet; McCourt, Christine; Hatherall, Bethan; Findlay, Gail; Morris, Joanne; Reading, Sandra; Renton, Adrian; Adekoya, Ruth; Green, Belinda; Harvey, Belinda; Latham, Sarah; Patel, Kanta; Vanlessen, Logan; Harden, Angela

2018-03-05

The provision of high-quality maternity services is a priority for reducing inequalities in health outcomes for mothers and infants. Best practice includes women having their initial antenatal appointment within the first trimester of pregnancy in order to provide screening and support for healthy lifestyles, well-being and self-care in pregnancy. Previous research has identified inequalities in access to antenatal care, yet there is little evidence on interventions to improve early initiation of antenatal care. The Community REACH trial will assess the effectiveness and cost-effectiveness of engaging communities in the co-production and delivery of an intervention that addresses this issue. The study design is a matched cluster randomised controlled trial with integrated process and economic evaluations. The unit of randomisation is electoral ward. The intervention will be delivered in 10 wards; 10 comparator wards will have normal practice. The primary outcome is the proportion of pregnant women attending their antenatal booking appointment by the 12th completed week of pregnancy. This and a number of secondary outcomes will be assessed for cohorts of women (n = approximately 1450 per arm) who give birth 2-7 and 8-13 months after intervention delivery completion in the included wards, using routinely collected maternity data. Eight hospitals commissioned to provide maternity services in six NHS trusts in north and east London and Essex have been recruited to the study. These trusts will provide anonymised routine data for randomisation and outcomes analysis. The process evaluation will examine intervention implementation, acceptability, reach and possible causal pathways. The economic evaluation will use a cost-consequences analysis and decision model to evaluate the intervention. Targeted community engagement in the research process was a priority. Community REACH aims to increase early initiation of antenatal care using an intervention that is co-produced and delivered by local communities. This pragmatic cluster randomised controlled trial, with integrated process and economic evaluation, aims to rigorously assess the effectiveness of this public health intervention, which is particularly complex due to the required combination of standardisation with local flexibility. It will also answer questions about scalability and generalisability. ISRCTN registry: registration number 63066975 . Registered on 18 August 2015.

Being pragmatic about healthcare complexity: our experiences applying complexity theory and pragmatism to health services research.

PubMed

Long, Katrina M; McDermott, Fiona; Meadows, Graham N

2018-06-20

The healthcare system has proved a challenging environment for innovation, especially in the area of health services management and research. This is often attributed to the complexity of the healthcare sector, characterized by intersecting biological, social and political systems spread across geographically disparate areas. To help make sense of this complexity, researchers are turning towards new methods and frameworks, including simulation modeling and complexity theory. Herein, we describe our experiences implementing and evaluating a health services innovation in the form of simulation modeling. We explore the strengths and limitations of complexity theory in evaluating health service interventions, using our experiences as examples. We then argue for the potential of pragmatism as an epistemic foundation for the methodological pluralism currently found in complexity research. We discuss the similarities between complexity theory and pragmatism, and close by revisiting our experiences putting pragmatic complexity theory into practice. We found the commonalities between pragmatism and complexity theory to be striking. These included a sensitivity to research context, a focus on applied research, and the valuing of different forms of knowledge. We found that, in practice, a pragmatic complexity theory approach provided more flexibility to respond to the rapidly changing context of health services implementation and evaluation. However, this approach requires a redefinition of implementation success, away from pre-determined outcomes and process fidelity, to one that embraces the continual learning, evolution, and emergence that characterized our project.

Implementation of a two-part unit-based multiple intervention: moving evidence-based practice into action.

PubMed

Rashotte, Judy; Thomas, Margot; Grégoire, Diane; Ledoux, Sheila

2008-06-01

This study examined the impact of a 2-part unit-based multiple intervention on the use by pediatric critical care nurses of best practice guidelines for pressure-ulcer prevention. A total of 23 nurses participated in a repeated-measures design pre- and post-intervention to address 2 questions: Is there a difference in nurses' evidence-based practices following implementation of an educational intervention only versus implementation of both an educational and an innovative intervention? Are the changes sustained 6 months after completion of the intervention? A significant change occurred in the implementation of 2 of 11 recommended practices following both interventions: assessment of risk of pressure ulcers using an age-appropriate tool (p < or = 0.001), and the documentation of same (p < or = 0.001). These changes may have been sustained. The findings bring to light the real challenges encountered when attempting to implement and evaluate multiple knowledge translation strategies associated with complex best practice guidelines in clinical practice.

Real-time three dimensional CT and MRI to guide interventions for congenital heart disease and acquired pulmonary vein stenosis.

PubMed

Suntharos, Patcharapong; Setser, Randolph M; Bradley-Skelton, Sharon; Prieto, Lourdes R

2017-10-01

To validate the feasibility and spatial accuracy of pre-procedural 3D images to 3D rotational fluoroscopy registration to guide interventional procedures in patients with congenital heart disease and acquired pulmonary vein stenosis. Cardiac interventions in patients with congenital and structural heart disease require complex catheter manipulation. Current technology allows registration of the anatomy obtained from 3D CT and/or MRI to be overlaid onto fluoroscopy. Thirty patients scheduled for interventional procedures from 12/2012 to 8/2015 were prospectively recruited. A C-arm CT using a biplane C-arm system (Artis zee, VC14H, Siemens Healthcare) was acquired to enable 3D3D registration with pre-procedural images. Following successful image fusion, the anatomic landmarks marked in pre-procedural images were overlaid on live fluoroscopy. The accuracy of image registration was determined by measuring the distance between overlay markers and a reference point in the image. The clinical utility of the registration was evaluated as either "High", "Medium" or "None". Seventeen patients with congenital heart disease and 13 with acquired pulmonary vein stenosis were enrolled. Accuracy and benefit of registration were not evaluated in two patients due to suboptimal images. The distance between the marker and the actual anatomical location was 0-2 mm in 18 (64%), 2-4 mm in 3 (11%) and >4 mm in 7 (25%) patients. 3D3D registration was highly beneficial in 18 (64%), intermediate in 3 (11%), and not beneficial in 7 (25%) patients. 3D3D registration can facilitate complex congenital and structural interventions. It may reduce procedure time, radiation and contrast dose.

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

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.

A systematic review of interventions to enhance access to best practice primary health care for chronic disease management, prevention and episodic care.

PubMed

Comino, Elizabeth Jean; Davies, Gawaine Powell; Krastev, Yordanka; Haas, Marion; Christl, Bettina; Furler, John; Raymont, Anthony; Harris, Mark F

2012-11-21

Although primary health care (PHC) is a key component of all health care systems, services are not always readily available, accessible or affordable. This systematic review examines effective strategies to enhance access to best practice processes of PHC in three domains: chronic disease management, prevention and episodic care. An extensive search of bibliographic data bases to identify peer and non-peer reviewed literature was undertaken. Identified papers were screened to identify and classify intervention studies that measured the impact of strategies (singly or in combination) on change in use or the reach of services in defined population groups (evaluated interventions). The search identified 3,148 citations of which 121 were intervention studies and 75 were evaluated interventions. Evaluated interventions were found in all three domains: prevention (n = 45), episodic care (n = 19), and chronic disease management (n = 11). They were undertaken in a number of countries including Australia (n = 25), USA (n = 25), and UK (n = 15). Study quality was ranked as high (31% of studies), medium (61%) and low (8%). The 75 evaluated interventions tested a range of strategies either singly (n = 46 studies) or as a combination of two (n = 20) or more strategies (n = 9). Strategies targeted both health providers and patients and were categorised to five groups: practice re-organisation (n = 43 studies), patient support (n = 29), provision of new services (n = 19), workforce development (n = 11), and financial incentives (n = 9). Strategies varied by domain, reflecting the complexity of care needs and processes. Of the 75 evaluated interventions, 55 reported positive findings with interventions using a combination of strategies more likely to report positive results. This review suggests that multiple, linked strategies targeting different levels of the health care system are most likely to improve access to best practice PHC. The proposed changes in the structure of PHC in Australia may provide opportunities to investigate the factors that influence access to best practice PHC and to develop and implement effective, evidence based strategies to address these.

Examining effectiveness of tailorable computer-assisted therapy programmes for substance misuse: Programme usage and clinical outcomes data from Breaking Free Online.

PubMed

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

2017-11-01

When evaluating complex, tailorable digital behavioural interventions, additional approaches may be required alongside established methodologies such as randomised controlled trials (RCTs). Research evaluating a computer-assisted therapy (CAT) programme for substance misuse, Breaking Free Online (BFO), is informed by Medical Research Council (MRC) guidance recommending examination of 'mechanisms of action' of individual intervention strategies, which is relevant when evaluating digital interventions with content that may evolve over time. To report findings from examination of mechanisms of action of tailoring advice within the BFO programme and outcomes from specific intervention strategies. Analysis of covariance and linear regressions were used to assess intervention completion data, and psychometric and clinical outcomes, for 2311 service users accessing drug and alcohol treatment services across the UK. Tailoring advice provided to users appeared to prompt them to prioritise completion of intervention strategies associated with their areas of highest biopsychosocial impairment. Completion of specific intervention strategies within BFO were associated with specific clinical outcomes, with a dose response also being found. Mechanisms of action analyses revealed the primacy of cognitions, with cognitive restructuring strategies being associated with improvements in mental health, severity of substance dependence, quality of life and global biopsychosocial functioning. The MRC framework provides an evolved research paradigm within the field of digital behavioural change. By assessing baseline profiles of need, BFO can target the most appropriate clinical content for individual users. Mechanisms of action research can be used to inform modifications to BFO to continually update clinical content and the technology platform. Copyright © 2017 Elsevier Ltd. All rights reserved.

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.

An Applied Ecological Framework for Evaluating Infrastructure to Promote Walking and Cycling: The iConnect Study

PubMed Central

Bull, Fiona; Powell, Jane; Cooper, Ashley R.; Brand, Christian; Mutrie, Nanette; Preston, John; Rutter, Harry

2011-01-01

Improving infrastructure for walking and cycling is increasingly recommended as a means to promote physical activity, prevent obesity, and reduce traffic congestion and carbon emissions. However, limited evidence from intervention studies exists to support this approach. Drawing on classic epidemiological methods, psychological and ecological models of behavior change, and the principles of realistic evaluation, we have developed an applied ecological framework by which current theories about the behavioral effects of environmental change may be tested in heterogeneous and complex intervention settings. Our framework guides study design and analysis by specifying the most important data to be collected and relations to be tested to confirm or refute specific hypotheses and thereby refine the underlying theories. PMID:21233429

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.

Physical activity and the environment: conceptual review and framework for intervention research.

PubMed

Panter, Jenna; Guell, Cornelia; Prins, Rick; Ogilvie, David

2017-11-15

Changing the physical environment is one way to promote physical activity and improve health, but evidence on intervention effectiveness is mixed. The theoretical perspectives and conceptual issues discussed or used in evaluative studies and related literature may contribute to these inconsistencies. We aimed to advance the intervention research agenda by systematically searching for and synthesising the literature pertaining to these wider conceptual issues. We searched for editorials, commentaries, reviews, or primary qualitative or quantitative studies in multiple disciplines by electronic searches of key databases (MEDLINE and MEDLINE In-Process, Web of Science, Cochrane Reviews, ProQuest for dissertations, Health Evidence, EPPI-Centre, TRID and NICE) and snowballing. We extracted theoretical and conceptual material and used thematic analysis in an in-depth, configurative narrative approach to synthesis. Our initial searches identified 2760 potential sources from fields including public health, sociology, behavioural science and transport, of which 104 were included. By first separating out and then drawing together this material, we produced a synthesis that identified five high-level conceptual themes: one concerning outcomes (physical activity as a behaviour and a socially embedded practice), one concerning exposures (environmental interventions as structural changes) and three concerning how interventions bring about their effects (the importance of social and physical context; (un) observable mechanisms linking interventions and changes in physical activity; and interventions as events in complex systems). These themes are inter-related but have rarely been considered together in the disparate literatures. Drawing on these insights, we present a more generalisable way of thinking about how environmental interventions work which could be used in future evaluation studies. Environmental and policy interventions are socially embedded and operate within a system. Evaluators should acknowledge this, and the philosophical perspective taken in their evaluation. Across disciplinary fields, future studies should seek to understand how interventions work through considering these systems, the context in which interventions take place, and the (un) observable mechanisms that may operate. This will help ensure that findings can be more easily interpreted and widely applied by policymakers. We hope that highlighting these conceptual issues will help others to interpret and improve upon a somewhat contested evidence base.

Guidelines for reporting evaluations based on observational methodology.

PubMed

Portell, Mariona; Anguera, M Teresa; Chacón-Moscoso, Salvador; Sanduvete-Chaves, Susana

2015-01-01

Observational methodology is one of the most suitable research designs for evaluating fidelity of implementation, especially in complex interventions. However, the conduct and reporting of observational studies is hampered by the absence of specific guidelines, such as those that exist for other evaluation designs. This lack of specific guidance poses a threat to the quality and transparency of these studies and also constitutes a considerable publication hurdle. The aim of this study thus was to draw up a set of proposed guidelines for reporting evaluations based on observational methodology. The guidelines were developed by triangulating three sources of information: observational studies performed in different fields by experts in observational methodology, reporting guidelines for general studies and studies with similar designs to observational studies, and proposals from experts in observational methodology at scientific meetings. We produced a list of guidelines grouped into three domains: intervention and expected outcomes, methods, and results. The result is a useful, carefully crafted set of simple guidelines for conducting and reporting observational studies in the field of program evaluation.

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 effectiveness and experience of self-management following acute coronary syndrome: A review of the literature.

PubMed

Guo, Ping; Harris, Ruth

2016-09-01

To evaluate the effectiveness of interventions used to support self-management, and to explore patients' experiences after acute coronary syndrome in relation to self-management. Scoping review. Keyword search of CINAHL Plus, Medline, the Cochrane Library, and PsycINFO databases for studies conducted with adult population and published in English between 1993 and 2014. From title and abstract review, duplicated articles and obviously irrelevant studies were removed. The full texts of the remaining articles were assessed against the selection criteria. Studies were included if they were original research on: (1) effectiveness of self-management interventions among individuals following acute coronary syndrome; or (2) patients' experience of self-managing recovery from acute coronary syndrome. 44 articles (19 quantitative and 25 qualitative) were included. Most studies were conducted in western countries and quantitative studies were UK centric. Self-management interventions tended to be complex and include several components, including education and counselling, goal setting and problem solving skills which were mainly professional-led rather than patient-led. The review demonstrated variation in the effectiveness of self-management interventions in main outcomes assessed - anxiety and depression, quality of life and health behavioural outcomes. For most participants in the qualitative studies, acute coronary syndrome was unexpected and the recovery trajectory was a complex process. Experiences of making adjustment and adopting lifestyle changes following acute coronary syndrome were influenced by subjective life experiences and individual, sociocultural and environmental contexts. Participants' misunderstandings, misconceptions and confusion about disease processes and management were another influential factor. They emphasised a need for ongoing input and continued support from health professionals in their self-management of rehabilitation and recovery, particularly during the initial recovery period following hospital discharge. Evidence of the effectiveness of self-management interventions among people with acute coronary syndrome remains inconclusive. Findings from the patients' experiences in relation to self-management following acute coronary syndrome provided important insights into what problems patients might have encountered during self-managing recovery and what support they might need, which can be used to inform the development of self-management interventions. Theoretical or conceptual frameworks have been minimally employed in these studies and should be incorporated in future development and evaluation of self-management interventions as a way of ensuring clarity and consistency related to how interventions are conceptualised, operationalised and empirically studied. Further research is needed to evaluate self-management interventions among people following acute coronary syndrome for sustained effect and within different health care contexts. Copyright © 2016 Elsevier Ltd. All rights reserved.

CT-Guided Interventions Using a Free-Hand, Optical Tracking System: Initial Clinical Experience

DOE Office of Scientific and Technical Information (OSTI.GOV)

Schubert, Tilman, E-mail: TSchubert@uhbs.ch; Jacob, Augustinus L.; Pansini, Michele

2013-08-01

PurposeThe present study was designed to evaluate the geometrical accuracy and clinical applicability of a new, free-hand, CT-guided, optical navigation system.MethodsFifteen procedures in 14 consecutive patients were retrospectively analyzed. The navigation system was applied for interventional procedures on small target lesions, in cases with long needle paths, narrow access windows, or when an out-of-plane access was expected. Mean lesion volume was 27.9 ml, and mean distance to target measured was 107.5 mm. Eleven of 15 needle trajectories were planned as out-of-plane approaches regarding the axial CT plane.ResultsNinety-one percent of the biopsies were diagnostic. All therapeutic interventions were technically successful. Targetingmore » precision was high with a mean distance of the needle tip from planned target of 1.98 mm. Mean intervention time was 1:12 h. A statistically significant correlation between angular needle deviation and intervention time (p = 0.007), respiratory movement of the target (p = 0.008), and body mass index (p = 0.02) was detected. None of the evaluated parameters correlated significantly with the distance from the needle tip to the planned target.ConclusionsThe application of a navigation system for complex CT-guided procedures provided safe and effective targeting within a reasonable intervention time in our series.« less

Adapting realist synthesis methodology: The case of workplace harassment interventions.

PubMed

Carr, Tracey; Quinlan, Elizabeth; Robertson, Susan; Gerrard, Angie

2017-12-01

Realist synthesis techniques can be used to assess complex interventions by extracting and synthesizing configurations of contexts, mechanisms, and outcomes found in the literature. Our novel and multi-pronged approach to the realist synthesis of workplace harassment interventions describes our pursuit of theory to link macro and program level theories. After discovering the limitations of a dogmatic approach to realist synthesis, we adapted our search strategy and focused our analysis on a subset of data. We tailored our realist synthesis to understand how, why, and under what circumstances workplace harassment interventions are effective. The result was a conceptual framework to test our theory-based interventions and provide the basis for subsequent realist evaluation. Our experience documented in this article contributes to an understanding of how, under what circumstances, and with what consequences realist synthesis principles can be customized. Copyright © 2017 John Wiley & Sons, Ltd.

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...

Understanding Variation in Treatment Effects in Education Impact Evaluations: An Overview of Quantitative Methods. NCEE 2014-4017

ERIC Educational Resources Information Center

Schochet, Peter Z.; Puma, Mike; Deke, John

2014-01-01

This report summarizes the complex research literature on quantitative methods for assessing how impacts of educational interventions on instructional practices and student learning differ across students, educators, and schools. It also provides technical guidance about the use and interpretation of these methods. The research topics addressed…

Evaluation of a Computer-Based Revision Prompting Intervention for Undergraduate Writers with Acquired Brain Injury

ERIC Educational Resources Information Center

Ledbetter, Alexander K.

2017-01-01

People with acquired brain injury (ABI) present with impairments in working memory and executive functions, and these cognitive deficits contribute to difficulty self-regulating the production of expository writing. Cognitive processes involved in carrying out complex writing tasks include planning, generating text, and reviewing or revising text…

Improving contraceptive choice: fidelity of implementation and the gap between effectiveness and efficacy.

PubMed

Garbers, Samantha; Flandrick, Kathleen; Bermudez, Dayana; Meserve, Allison; Chiasson, Mary Ann

2014-11-01

Interventions to reduce unintended pregnancy through improved contraceptive use are a public health priority. A comprehensive process evaluation of a contraceptive assessment module intervention with demonstrated efficacy was undertaken. The 12-month process evaluation goal was to describe the extent to which the intervention was implemented as intended over time, and to identify programmatic adjustments to improve implementation fidelity. Quantitative and qualitative methods included staff surveys, electronic health record data, usage monitoring, and observations. Fidelity of implementation was low overall (<10% of eligible patients completed the entire module [dose received]). Although a midcourse correction making the module available in clinical areas led to increased dose delivered (23% vs. 30%, chi-square test p = .006), dose received did not increase significantly after this adjustment. Contextual factors including competing organizational and staff priorities and staff buy-in limited the level of implementation and precluded adoption of some strategies such as adjusting patient flow. Using a process evaluation framework enabled the research team to identify and address complexities inherent in effectiveness studies and facilitated the alignment of program and context. © 2014 Society for Public Health Education.

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

Evaluation of a large scale implementation of disease management programmes in various Dutch regions: a study protocol

PubMed Central

2011-01-01

Background Disease management programmes (DMPs) have been developed to improve effectiveness and economic efficiency within chronic care delivery by combining patient-related, professional-directed, and organisational interventions. The benefits of DMPs within different settings, patient groups, and versions remain unclear. In this article we propose a protocol to evaluate a range of current DMPs by capturing them in a single conceptual framework, employing comparable structure, process, and outcome measures, and combining qualitative and quantitative research methods. Methods To assess DMP effectiveness a practical clinical trial will be conducted. Twenty-two disease management experiments will be studied in various Dutch regions consisting of a variety of collaborations between organisations and/or professionals. Patient cohorts include those with cardiovascular diseases, chronic obstructive pulmonary disease, diabetes, stroke, depression, psychotic diseases, and eating disorders. Our methodological approach combines qualitative and quantitative research methods to enable a comprehensive evaluation of complex programmes. Process indicators will be collected from health care providers' data registries and measured via physician and staff questionnaires. Patient questionnaires include health care experiences, health care utilisation, and quality of life. Qualitative data will be gathered by means of interviews and document analysis for an in depth description of project interventions and the contexts in which DMPs are embedded, and an ethnographic process evaluation in five DMPs. Such a design will provide insight into ongoing DMPs and demonstrate which elements of the intervention are potentially (cost)-effective for which patient populations. It will also enable sound comparison of the results of the different programmes. Discussion The study will lead to a better understanding of (1) the mechanisms of disease management, (2) the feasibility, and cost-effectiveness of a disease management approach to improving health care, and (3) the factors that determine success and failure of DMPs. Our study results will be relevant to decision makers and managers who confront the challenge of implementing and integrating DMPs into the health care system. Moreover, it will contribute to the search for methods to evaluate complex healthcare interventions. PMID:21219620

Evaluation of a large scale implementation of disease management programmes in various Dutch regions: a study protocol.

PubMed

Lemmens, Karin M M; Rutten-Van Mölken, Maureen P M H; Cramm, Jane M; Huijsman, Robbert; Bal, Roland A; Nieboer, Anna P

2011-01-10

Disease management programmes (DMPs) have been developed to improve effectiveness and economic efficiency within chronic care delivery by combining patient-related, professional-directed, and organisational interventions. The benefits of DMPs within different settings, patient groups, and versions remain unclear. In this article we propose a protocol to evaluate a range of current DMPs by capturing them in a single conceptual framework, employing comparable structure, process, and outcome measures, and combining qualitative and quantitative research methods. To assess DMP effectiveness a practical clinical trial will be conducted. Twenty-two disease management experiments will be studied in various Dutch regions consisting of a variety of collaborations between organisations and/or professionals. Patient cohorts include those with cardiovascular diseases, chronic obstructive pulmonary disease, diabetes, stroke, depression, psychotic diseases, and eating disorders. Our methodological approach combines qualitative and quantitative research methods to enable a comprehensive evaluation of complex programmes. Process indicators will be collected from health care providers' data registries and measured via physician and staff questionnaires. Patient questionnaires include health care experiences, health care utilisation, and quality of life. Qualitative data will be gathered by means of interviews and document analysis for an in depth description of project interventions and the contexts in which DMPs are embedded, and an ethnographic process evaluation in five DMPs. Such a design will provide insight into ongoing DMPs and demonstrate which elements of the intervention are potentially (cost)-effective for which patient populations. It will also enable sound comparison of the results of the different programmes. The study will lead to a better understanding of (1) the mechanisms of disease management, (2) the feasibility, and cost-effectiveness of a disease management approach to improving health care, and (3) the factors that determine success and failure of DMPs. Our study results will be relevant to decision makers and managers who confront the challenge of implementing and integrating DMPs into the health care system. Moreover, it will contribute to the search for methods to evaluate complex healthcare interventions.

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.

A multi-level intervention in subsidized housing sites to increase fruit and vegetable access and intake: Rationale, design and methods of the 'Live Well, Viva Bien' cluster randomized trial.

PubMed

Gans, Kim M; Gorham, Gemma; Risica, Patricia M; Dulin-Keita, Akilah; Dionne, Laura; Gao, Tina; Peters, Sarah; Principato, Ludovica

2016-06-28

Adequate fruit and vegetable (F&V) intake is important for disease prevention. Yet, most Americans, especially low-income and racial/ethnic minorities, do not eat adequate amounts. These disparities are partly attributable to food environments in low-income neighborhoods where residents often have limited access to affordable, healthful food and easy access to inexpensive, unhealthful foods. Increasing access to affordable healthful food in underserved neighborhoods through mobile markets is a promising, year-round strategy for improving dietary behaviors and reducing F&V intake disparities. However, to date, there have been no randomized controlled trials studying their effectiveness. The objective of the 'Live Well, Viva Bien' (LWVB) cluster randomized controlled trial is to evaluate the efficacy of a multicomponent mobile market intervention at increasing F&V intake among residents of subsidized housing complexes. One housing complex served as a pilot site for the intervention group and the remaining 14 demographically-matched sites were randomized into either the intervention or control group. The intervention group received bimonthly, discount, mobile, fresh F&V markets in conjunction with a nutrition education intervention (two F&V campaigns, newsletters, DVDs and cooking demonstrations) for 12 months. The control group received physical activity and stress reduction interventions. Outcome measures include F&V intake (measured by two validated F&V screeners at baseline, six-month and twelve-months) along with potential psychosocial mediating variables. Extensive quantitative and qualitative process evaluation was also conducted throughout the study. Modifying neighborhood food environments in ways that increase access to affordable, healthful food is a promising strategy for improving dietary behaviors among low-income, racial and ethnic minority groups at increased risk for obesity and other food-related chronic diseases. Discount, mobile F&V markets address all the major barriers to eating more F&V (high cost, poor quality, limited access and limited time to shop and cook) and provide a year-round solution to limited access to healthful food in low-income neighborhoods. LWVB is the first randomized controlled trial evaluating the effectiveness of mobile markets at increasing F&V intake. If proven efficacious at increasing F&V consumption, LWVB could be disseminated widely to neighborhoods that have low access to fresh F&V. Clinicatrials.gov registration number: NCT02669472 First Received: January 19, 2016.

From hypertension control to global cardiovascular risk management: an educational intervention in a cluster-randomised controlled trial.

PubMed

Mortsiefer, Achim; Meysen, Tobias; Schumacher, Martin; Abholz, Heinz-Harald; Wegscheider, Karl; In der Schmitten, Jürgen

2015-05-07

Guidelines on hypertension management recommend adjusting therapeutic efforts in accordance with global cardiovascular risk (CVR) rather than by blood pressure levels alone. However, this paradigm change has not yet arrived in German General Practice. We have evaluated the effect of an educational outreach visit with general practitioners (GPs), encouraging them to consider CVR in treatment decisions for patients with hypertension. Prospective cluster-randomised trial comprising 3443 patients with known hypertension treated by 87 GPs. Practices were randomly assigned to complex (A) or simple (B) intervention. Both groups received a guideline by mail; group A also received complex peer intervention promoting the concept of global CVR. Clinical data were collected at baseline and 6-9 months after intervention. Main outcome was improvement of calculated CVR in the predefined subpopulation of patients with a high CVR (10-year mortality ≥5%), but no manifest cardiovascular disease. Adjusted for baseline the follow-up CVR were 13.1% (95% CI 12.6%-13.6%) (A) and 12.6% (95% CI 12.2%-13.1%) (B) with a group difference (A vs. B) of 0.5% (-0.2%-1.1%), p = 0.179. The group difference was -0.05% in patients of GPs familiar with global CVR and 1.1% in patients of GPs not familiar with with global CVR. However, this effect modification was not significant (p = 0.165). Pooled over groups, the absolute CVR reduction from baseline was 1.0%, p < 0.001. The ICC was 0.026 (p = 0.002). Hypertension control (BP <140/90 mmHg) improved in the same subpopulation from 38.1 to 45.9% in the complex intervention group, and from 35.6 to 46.5% in the simple intervention group, with adjusted follow-up control rates of 46.7% (95% CI 40.4%-53.1%) (A) and 46.9% (95% CI 40.3%-53.5% (B) and an adjusted odds ratio (A vs B) of 0.99 (95% CI 0.68-1.45), p = 0.966. Our complex educational intervention, including a clinical outreach visit, had no significant effect on CVR of patients with known hypertension at high risk compared to a simple postal intervention. ISRCTN44478543 .

Academic Detailing Interventions Improve Tobacco Use Treatment among Physicians Working in Underserved Communities

PubMed Central

Evers-Casey, Sarah; Graden, Sarah; Schnoll, Robert; Mallya, Giridhar

2015-01-01

Rationale: Tobacco use disproportionately affects the poor, who are, in turn, least likely to receive cessation treatment from providers. Providers caring for low-income populations perform simple components of tobacco use treatment (e.g., assessing tobacco use) with reasonable frequency. However, performance of complex treatment behaviors, such as pharmacologic prescription and follow-up arrangement, remains suboptimal. Objectives: Evaluate the influence of academic detailing (AD), a university-based, noncommercial, educational outreach intervention, on primary care physicians’ complex treatment practice behaviors within an urban care setting. Methods: Trained academic detailers made in-person visits to targeted primary care practices, delivering verbal and written instruction emphasizing three key messages related to tobacco treatment. Physicians’ self-reported frequency of simple and complex treatment behaviors were assessed using a seven-item questionnaire, before and 2 months after AD. Results: Between May 2011 and March 2012, baseline AD visits were made to 217 physicians, 109 (50%) of whom also received follow-up AD. Mean frequency scores for complex behaviors increased significantly, from 2.63 to 2.92, corresponding to a clinically significant 30% increase in the number of respondents who endorsed “almost always” or “always” (P < 0.001). Improvement in mean simple behavior frequency scores was also noted (3.98 vs. 4.13; P = 0.035). Sex and practice type appear to influence reported complex behavior frequency at baseline, whereas only practice type influenced improvement in complex behavior scores at follow up. Conclusions: This study demonstrates the feasibility and potential effectiveness of a low-cost and highly disseminable intervention to improve clinician behavior in the context of treating nicotine dependence in underserved communities. PMID:25867533

Feasibility, appropriateness, meaningfulness and effectiveness of patient participation at bedside shift reporting: mixed-method research protocol.

PubMed

Malfait, Simon; Eeckloo, Kristof; Lust, Elisa; Van Biesen, Wim; Van Hecke, Ann

2017-02-01

To evaluate the feasibility, appropriateness, meaningfulness and effectiveness of bedside shift reporting in a minimum of five interventions and five control wards. Hospitals continually improve their quality of care. Next to improvements in clinical performance, more patient participation is stimulated through different methods. Methods to enhance patient participation such as bedside shift reporting lack rigorously performed research to determine their feasibility, appropriateness, meaningfulness and effectiveness. Small-scale research and a previous pilot study indicate that bedside shift reporting improves patient participation, nurse-nurse communication and nurse-patient communication. The development, implementation and evaluation of bedside shift report are based on the Medical Research Council framework for complex interventions in health care. A matched, controlled, mixed-method, longitudinal study design will be used. The Feasibility-Appropriateness-Meaningfulness-Effectiveness framework will be applied for the quantitative and qualitative evaluation of bedside shift report. A tailored intervention and implementation process for bedside shift report will be developed using diagnostic interviews, co-design and acceptability testing. The intervention will be evaluated before implementation and three times after implementation. Individual and focus group interviews will be performed. Questionnaires, observations and analysis of the medical records and administrative databases will be completed. This study was funded in October 2015. Research Ethics Committee approval was granted in March 2016. There is a pressing need for rigorous research into the effects of interventions for improving patient participation. This study addresses the significance of bedside shift report as an intervention to improve quality of care, communication and patient participation within a large-scale, matched, controlled research design. © 2016 John Wiley & Sons Ltd.

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.

Mediation and moderation of treatment effects in randomised controlled trials of complex interventions.

PubMed

Emsley, Richard; Dunn, Graham; White, Ian R

2010-06-01

Complex intervention trials should be able to answer both pragmatic and explanatory questions in order to test the theories motivating the intervention and help understand the underlying nature of the clinical problem being tested. Key to this is the estimation of direct effects of treatment and indirect effects acting through intermediate variables which are measured post-randomisation. Using psychological treatment trials as an example of complex interventions, we review statistical methods which crucially evaluate both direct and indirect effects in the presence of hidden confounding between mediator and outcome. We review the historical literature on mediation and moderation of treatment effects. We introduce two methods from within the existing causal inference literature, principal stratification and structural mean models, and demonstrate how these can be applied in a mediation context before discussing approaches and assumptions necessary for attaining identifiability of key parameters of the basic causal model. Assuming that there is modification by baseline covariates of the effect of treatment (i.e. randomisation) on the mediator (i.e. covariate by treatment interactions), but no direct effect on the outcome of these treatment by covariate interactions leads to the use of instrumental variable methods. We describe how moderation can occur through post-randomisation variables, and extend the principal stratification approach to multiple group methods with explanatory models nested within the principal strata. We illustrate the new methodology with motivating examples of randomised trials from the mental health literature.

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.

Will X-ray Safety Glasses Become Mandatory for Radiological Vascular Interventions?

PubMed

Thomas, Rohit Philip; Grau, Mathias; Eldergash, Osama; Kowald, Tobias; Schnabel, Johannes; Szczechowicz, Marcin; Chavan, Ajay

2018-07-01

The annual permissible radiation ocular lens dose has been reduced to 20 millisieverts (mSv) in the current European directive 2013/59/Euratom. The aim of this study was to evaluate the personal radiation dose for vascular interventions with special focus on ocular lens dose. From May 2016 to October 2016, the personal radiation doses of two interventionists and four technicians were prospectively recorded during 206 vascular interventions. The position of personnel, intervention type and fluoroscopy time were recorded. Parameters evaluated were total body dose measured by film dosimeter, hand dose measured by ring thermoluminescent dosimeter (TLD) and ocular lens dose measured by TLD placed in front of the safety glasses. Linear regression analysis was used to estimate the dose at 2 and 5 years. The ocular lens dose, hand and total body dose of the two interventionists were 11/5, 56/47 and 0.6 mSv each, respectively. The estimated 5-year ocular dose was 113.08 mSv (95% CI 38.2-187.97)/40.95 (95% CI 16.9-64.7). Similarly, hand dose was 608.4 mSv (95% CI 442.78-774.38)/514.47 (95% CI 329.83-699.10) and body dose 6.07 mSv (95% CI 4.70-8.22)/5.12 (95% CI 3.65-6.59), respectively. Amongst four technicians, only the first assistant showed recordings of 0.3 mSv body dose, 2 mSv ocular lens dose and 5 mSv hand dose. The yearly ocular lens dose, particularly for interventionists dealing with complex interventions, could cross the permitted yearly limit set by the new Euratom directive. Therefore, X-ray safety glasses would become mandatory for complex radiological vascular interventions. Level III, non-randomized controlled cohort/follow-up study.

Effects of a Telehealth Care Coordination Intervention on Perceptions of Health Care by Caregivers of Children With Medical Complexity: A Randomized Controlled Trial.

PubMed

Looman, Wendy S; Antolick, Megan; Cady, Rhonda G; Lunos, Scott A; Garwick, Ann E; Finkelstein, Stanley M

2015-01-01

The purpose of this study was to evaluate the effect of advanced practice registered nurse (APRN) telehealth care coordination for children with medical complexity (CMC) on family caregiver perceptions of health care. Families with CMC ages 2 to 15 years (N = 148) were enrolled in a three-armed, 30-month randomized controlled trial to test the effects of adding an APRN telehealth care coordination intervention to an existing specialized medical home for CMC. Satisfaction with health care was measured using items from the Consumer Assessment of Healthcare Providers and Systems survey at baseline and after 1 and 2 years. The intervention was associated with higher ratings on measures of the child's provider, provider communication, overall health care, and care coordination adequacy, compared with control subjects. Higher levels of condition complexity were associated with higher ratings of overall health care in some analyses. APRN telehealth care coordination for CMC was effective in improving ratings of caregiver experiences with health care and providers. Additional research with CMC is needed to determine which children benefit most from high-intensity care coordination. Copyright © 2015 National Association of Pediatric Nurse Practitioners. Published by Elsevier Inc. All rights reserved.

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.

Improving the well-being of children and youths: a randomized multicomponent, school-based, physical activity intervention.

PubMed

Smedegaard, Søren; Christiansen, Lars Breum; Lund-Cramer, Pernille; Bredahl, Thomas; Skovgaard, Thomas

2016-10-28

The benefits of physical activity for the mental health and well-being of children and young people are well-established. Increased physical activity during school hours is associated with better physical, psychological and social health and well-being. Unfortunately many children and young people exercise insufficiently to benefit from positive factors like well-being. The main aim of this study is to develop, implement and evaluate a multi-component, school-based, physical activity intervention to improve psychosocial well-being among school-aged children and youths from the 4 th to the 6 th grade (10-13 years). A four-phased intervention - design, pilot, RCT, evaluation - is carried out for the development, implementation and evaluation of the intervention which are guided by The Medical Research Council framework for the development of complex interventions. 24 schools have been randomized and the total study population consists of 3124 children (baseline), who are followed over a period of 9 months. Outcome measure data at the pupil level are collected using an online questionnaire at baseline and at follow-up, 9 months later with instruments for measuring primary (general physical self-worth) and secondary outcomes (self-perceived sport competences, body attractiveness, scholastic competences, social competences and global self-worth; enjoyment of PA; self-efficacy; and general well-being) that are both valid and manageable in setting-based research. The RE-AIM framework is applied as an overall instrument to guide the evaluation. The intervention focuses on the mental benefits of physical activity at school, which has been a rather neglected theme in health promotion research during recent decades. This is unfortunate as mental health has been proclaimed as one of the most important health concerns of the 21 st century. Applying a cluster RCT study design, evaluating the real-world effectiveness of the intervention, this study is one of the largest physical activity intervention projects promoting psychosocial well-being among children and youths. Through a comprehensive effectiveness evaluation and a similar substantial process evaluation, this study is designed to gain knowledge on a broad variety of implementation issues and give detailed information on project delivery and challenges at the school level - among other things to better inform future practice. Date of registration: 24 April 2015 retrospectively registered at Current Controlled Trials with study ID ISRCTN12496336.

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

An empirical assessment of implementation, adaptation, and tailoring: the evaluation of CDC's National Diffusion of VOICES/VOCES.

PubMed

Harshbarger, Camilla; Simmons, Gretchen; Coelho, Helen; Sloop, Kira; Collins, Charles

2006-08-01

The Centers for Disease Control and Prevention (CDC), through its Diffusion of Effective Behavioral Interventions (DEBI) program, trained over 260 agencies on VOICES/VOCES between August 2003 and April 2005. ORC Macro conducted interviews with agency staff 3 months after receiving VOICES/VOCES training. This article discusses the diffusion of VOICES/VOCES; agencies' adoption, adaptation, and implementation of this intervention; and needs for ongoing proactive technical assistance (TA) for agencies to successfully integrate behavioral interventions into their programs. The vastmajority of agencies implemented VOICES/VOCES with fidelity to the core elements, and agencies successfully adapted the intervention to make it more appealing to target populations. TA is needed for interventions to be successfully adapted and implemented with fidelity to the core elements, and to ensure program sustainability. More effective interventions of short duration and minimum complexity to easily match with existing resources and conditions of agency capacity among HIV prevention providers in the community are needed.

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.

Economic Evaluation of Childhood Obesity Interventions: Reflections and Suggestions.

PubMed

Frew, Emma

2016-08-01

Rising levels of childhood obesity present a serious global public health problem amounting to 7 % of GDP in developed countries and affecting 14 % of children. As such, many countries are investing increasingly large quantities of resource towards treatment and prevention. Whilst it is important to demonstrate the clinical effectiveness of any intervention, it is equally as important to demonstrate cost effectiveness as policy makers strive to get the best value for money from increasingly limited public resources. Economic evaluation assists with making these investment decisions and whilst it can offer considerable support in many healthcare contexts, applying it to a childhood obesity context is not straightforward. Childhood obesity is a complex disease with interventions being multi-component in nature. Furthermore, the interventions are implemented in a variety of settings such as schools, the community, and the home, and have costs and benefits that fall outside the health sector. This paper provides a reflection from a UK perspective on the application of the conventional approach to economic evaluation to childhood obesity. It offers suggestions for how evaluations should be designed to fit better within this context, and to meet the needs of local decision makers. An excellent example is the need to report costs using a micro-costing format and for benefit measurement to go beyond a health focus. This is critical as the organisation and commissioning of childhood obesity services is done from a Local Authority setting and this presents further challenges for what is the most appropriate economic evaluation approach to use. Given that adult obesity is now of epidemic proportions, the accurate assessment of childhood obesity interventions to support public health decision making is critical.

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

Process evaluation of the data-driven quality improvement in primary care (DQIP) trial: active and less active ingredients of a multi-component complex intervention to reduce high-risk primary care prescribing.

PubMed

Grant, Aileen; Dreischulte, Tobias; Guthrie, Bruce

2017-01-07

Two to 4% of emergency hospital admissions are caused by preventable adverse drug events. The estimated costs of such avoidable admissions in England were £530 million in 2015. The data-driven quality improvement in primary care (DQIP) intervention was designed to prompt review of patients vulnerable from currently prescribed non-steroidal anti-inflammatory drugs (NSAIDs) and anti-platelets and was found to be effective at reducing this prescribing. A process evaluation was conducted parallel to the trial, and this paper reports the analysis which aimed to explore response to the intervention delivered to clusters in relation to participants' perceptions about which intervention elements were active in changing their practice. Data generation was by in-depth interview with key staff exploring participant's perceptions of the intervention components. Analysis was iterative using the framework technique and drawing on normalisation process theory. All the primary components of the intervention were perceived as active, but at different stages of implementation: financial incentives primarily supported recruitment; education motivated the GPs to initiate implementation; the informatics tool facilitated sustained implementation. Participants perceived the primary components as interdependent. Intervention subcomponents also varied in whether and when they were active. For example, run charts providing feedback of change in prescribing over time were ignored in the informatics tool, but were motivating in some practices in the regular e-mailed newsletter. The high-risk NSAID and anti-platelet prescribing targeted was accepted as important by all interviewees, and this shared understanding was a key wider context underlying intervention effectiveness. This was a novel use of process evaluation data which examined whether and how the individual intervention components were effective from the perspective of the professionals delivering changed care to patients. These findings are important for reproducibility and roll-out of the intervention. ClinicalTrials.gov, NCT01425502 .

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.

Why performance-based contracting failed in Uganda--an "open-box" evaluation of a complex health system intervention.

PubMed

Ssengooba, Freddie; McPake, Barbara; Palmer, Natasha

2012-07-01

Performance-based contracting (PBC) is a tool that links rewards to attainment of measurable performance targets. Significant problems remain in the methods used to evaluate this tool. The primary focus of evaluations on the effects of PBC (black-box) and less attention to how these effects arise (open-box) generates suboptimal policy learning. A black-box impact evaluation of PBC pilot by the Development Research Group of the World Bank (DRG) and the Ministry of Health (MOH) concluded that PBC was ineffective. This paper reports a theory-based case study intended to clarify how and why PBC failed to achieve its objectives. To explain the observed PBC implementation and responses of participants, this case study employed two related theories i.e. complex adaptive system and expectancy theory respectively. A prospective study trailed the implementation of PBC (2003-2006) while collecting experiences of participants at district and hospital levels. Significant problems were encountered in the implementation of PBC that reflected its inadequate design. As problems were encountered, hasty adaptations resulted in a de facto intervention distinct from the one implied at the design stage. For example, inadequate time was allowed for the selection of service targets by the health centres yet they got 'locked-in' to these poor choices. The learning curve and workload among performance auditors weakened the validity of audit results. Above all, financial shortfalls led to delays, short-cuts and uncertainty about the size and payment of bonuses. The lesson for those intending to implement similar interventions is that PBC should not be attempted 'on the cheap'. It requires a plan to boost local institutional and technical capacities of implementers. It also requires careful consideration of the responses of multiple actors - both insiders and outsiders to the intended change process. Given the costs and complexity of PBC implementation, strengthening conventional approaches that are better attuned to low income contexts (financing resource inputs and systems management) remains a viable policy option towards improving health service delivery. Copyright © 2012 Elsevier Ltd. All rights reserved.

[Position Paper of The AG Digital Health DNVF on Digital Health Applications: Framework Conditions For Use in Health Care, Structural Development and Science].

PubMed

Vollmar, Horst Christian; Kramer, Ursula; Müller, Hardy; Griemmert, Maria; Noelle, Guido; Schrappe, Matthias

2017-12-01

The term "digital health" is currently the most comprehensive term that includes all information and communication technologies in healthcare, including e-health, mobile health, telemedicine, big data, health apps and others. Digital health can be seen as a good example of the use of the concept and methodology of health services research in the interaction between complex interventions and complex contexts. The position paper deals with 1) digital health as the subject of health services research; 2) digital health as a methodological and ethical challenge for health services research. The often-postulated benefits of digital health interventions should be demonstrated with good studies. First systematic evaluations of apps for "treatment support" show that risks are higher than benefits. The need for a rigorous proof applies even more to big data-assisted interventions that support decision-making in the treatment process with the support of artificial intelligence. Of course, from the point of view of health services research, it is worth participating as much as possible in data access available through digital health and "big data". However, there is the risk that a noncritical application of digital health and big data will lead to a return to a linear understanding of biomedical research, which, at best, accepts complex conditions assuming multivariate models but does not take complex facts into account. It is not just a matter of scientific ethical requirements in health services care research, for instance, better research instead of unnecessary research ("reducing waste"), but it is primarily a matter of anticipating the social consequences (system level) of scientific analysis and evaluation. This is both a challenge and an attractive option for health services research to present itself as a mature and responsible scientific discipline. © Georg Thieme Verlag KG Stuttgart · New York.

Preventing type 2 diabetes: systematic review of studies of cost-effectiveness of lifestyle programmes and metformin, with and without screening, for pre-diabetes

PubMed Central

Roberts, Samantha; Barry, Eleanor; Craig, Dawn; Airoldi, Mara; Bevan, Gwyn; Greenhalgh, Trisha

2017-01-01

Objective Explore the cost-effectiveness of lifestyle interventions and metformin in reducing subsequent incidence of type 2 diabetes, both alone and in combination with a screening programme to identify high-risk individuals. Design Systematic review of economic evaluations. Data sources and eligibility criteria Database searches (Embase, Medline, PreMedline, NHS EED) and citation tracking identified economic evaluations of lifestyle interventions or metformin alone or in combination with screening programmes in people at high risk of developing diabetes. The International Society for Pharmaco-economics and Outcomes Research’s Questionnaire to Assess Relevance and Credibility of Modelling Studies for Informing Healthcare Decision Making was used to assess study quality. Results 27 studies were included; all had evaluated lifestyle interventions and 12 also evaluated metformin. Primary studies exhibited considerable heterogeneity in definitions of pre-diabetes and intensity and duration of lifestyle programmes. Lifestyle programmes and metformin appeared to be cost effective in preventing diabetes in high-risk individuals (median incremental cost-effectiveness ratios of £7490/quality-adjusted life-year (QALY) and £8428/QALY, respectively) but economic estimates varied widely between studies. Intervention-only programmes were in general more cost effective than programmes that also included a screening component. The longer the period evaluated, the more cost-effective interventions appeared. In the few studies that evaluated other economic considerations, budget impact of prevention programmes was moderate (0.13%–0.2% of total healthcare budget), financial payoffs were delayed (by 9–14 years) and impact on incident cases of diabetes was limited (0.1%–1.6% reduction). There was insufficient evidence to answer the question of (1) whether lifestyle programmes are more cost effective than metformin or (2) whether low-intensity lifestyle interventions are more cost effective than the more intensive lifestyle programmes that were tested in trials. Conclusions The economics of preventing diabetes are complex. There is some evidence that diabetes prevention programmes are cost effective, but the evidence base to date provides few clear answers regarding design of prevention programmes because of differences in denominator populations, definitions, interventions and modelling assumptions. PMID:29146638

TESTING AN INTEGRATED MODEL OF PROGRAM IMPLEMENTATION: THE FOOD, HEALTH & CHOICES SCHOOL-BASED CHILDHOOD OBESITY PREVENTION INTERVENTION PROCESS EVALUATION

PubMed Central

Gray, Heewon Lee; Tipton, Elizabeth; Contento, Isobel; Koch, Pamela

2016-01-01

Childhood obesity is a complex, worldwide problem. Significant resources are invested in its prevention, and high-quality evaluations of these efforts are important. Conducting trials in school settings is complicated, making process evaluations useful for explaining results. Intervention fidelity has been demonstrated to influence outcomes, but others have suggested that other aspects of implementation, including participant responsiveness, should be examined more systematically. During Food, Health & Choices (FHC), a school-based childhood obesity prevention trial designed to test a curriculum and wellness policy taught by trained FHC instructors to fifth grade students in 20 schools during 2012–2013, we assessed relationships among facilitator behaviors (i.e., fidelity and teacher interest), participant behaviors (i.e., student satisfaction and recall), and program outcomes (i.e., energy balance-related behaviors) using hierarchical linear models, controlling for student, class, and school characteristics. We found positive relationships between student satisfaction and recall and program outcomes, but not fidelity and program outcomes. We also found relationships between teacher interest and fidelity when teachers participated in implementation. Finally, we found a significant interaction between fidelity and satisfaction on behavioral outcomes. These findings suggest that individual students in the same class responded differently to the same intervention. They also suggest the importance of teacher buy-in for successful intervention implementation. Future studies should examine how facilitator and participant behaviors together are related to both outcomes and implementation. Assessing multiple aspects of implementation using models that account for contextual influences on behavioral outcomes is an important step forward for prevention intervention process evaluations. PMID:27921200

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.

Testing an Integrated Model of Program Implementation: the Food, Health & Choices School-Based Childhood Obesity Prevention Intervention Process Evaluation.

PubMed

Burgermaster, Marissa; Gray, Heewon Lee; Tipton, Elizabeth; Contento, Isobel; Koch, Pamela

2017-01-01

Childhood obesity is a complex, worldwide problem. Significant resources are invested in its prevention, and high-quality evaluations of these efforts are important. Conducting trials in school settings is complicated, making process evaluations useful for explaining results. Intervention fidelity has been demonstrated to influence outcomes, but others have suggested that other aspects of implementation, including participant responsiveness, should be examined more systematically. During Food, Health & Choices (FHC), a school-based childhood obesity prevention trial designed to test a curriculum and wellness policy taught by trained FHC instructors to fifth grade students in 20 schools during 2012-2013, we assessed relationships among facilitator behaviors (i.e., fidelity and teacher interest); participant behaviors (i.e., student satisfaction and recall); and program outcomes (i.e., energy balance-related behaviors) using hierarchical linear models, controlling for student, class, and school characteristics. We found positive relationships between student satisfaction and recall and program outcomes, but not fidelity and program outcomes. We also found relationships between teacher interest and fidelity when teachers participated in implementation. Finally, we found a significant interaction between fidelity and satisfaction on behavioral outcomes. These findings suggest that individual students in the same class responded differently to the same intervention. They also suggest the importance of teacher buy-in for successful intervention implementation. Future studies should examine how facilitator and participant behaviors together are related to both outcomes and implementation. Assessing multiple aspects of implementation using models that account for contextual influences on behavioral outcomes is an important step forward for prevention intervention process evaluations.

Evaluating the impact of a disease management program for chronic complex conditions at two large northeast health plans using a control group methodology.

PubMed

Schwerner, Henry; Mellody, Timothy; Goldstein, Allan B; Wansink, Daryl; Sullivan, Virginia; Yelenik, Stephan N; Charlton, Warwick; Lloyd, Kelley; Courtemanche, Ted

2006-02-01

The objective of this study was to observe trends in payer expenditures for plan members with one of 14 chronic, complex conditions comparing one group with a disease management program specific to their condition (the intervention group) and the other with no specific disease management program (the control group) for these conditions. The authors used payer claims and membership data to identify members eligible for the program in a 12-month baseline year (October 2001 to September 2002) and a subsequent 12-month program year (October 2002 to September 2003). Two payers were analyzed: one health plan with members primarily in New Jersey (AmeriHealth New Jersey [AHNJ]), where the disease management program was offered, and one affiliated large plan with members primarily in the metro Philadelphia area, where the program was not offered. The claims payment policy for both plans is identical. Intervention and control groups were analyzed for equivalence. The analysis was conducted in both groups over identical time periods. The intervention group showed statistically significant (p < 0.01) differences in total paid claims trend and expenditures when compared to the control group. Intervention group members showed a reduction in expenditures of -8%, while control group members showed an increase of +10% over identical time periods. Subsequent analyses controlling for outliers and product lines served to confirm the overall results. The disease management program is likely responsible for the observed difference between the intervention and control group results. A well-designed, targeted disease management program offered by a motivated, supportive health plan can play an important role in cost improvement strategies for members with complex, chronic conditions.

Enhanced implementation of low back pain guidelines in general practice: study protocol of a cluster randomised controlled trial.

PubMed

Riis, Allan; Jensen, Cathrine Elgaard; Bro, Flemming; Maindal, Helle Terkildsen; Petersen, Karin Dam; Jensen, Martin Bach

2013-10-20

Evidence-based clinical practice guidelines may improve treatment quality, but the uptake of guideline recommendations is often incomplete and slow. Recently new low back pain guidelines are being launched in Denmark. The guidelines are considered to reduce personal and public costs. The aim of this study is to evaluate whether a complex, multifaceted implementation strategy of the low back pain guidelines will reduce secondary care referral and improve patient outcomes compared to the usual simple implementation strategy. In a two-armed cluster randomised trial, 100 general practices (clusters) and 2,700 patients aged 18 to 65 years from the North Denmark region will be included. Practices are randomly allocated 1:1 to a simple or a complex implementation strategy. Intervention practices will receive a complex implementation strategy, including guideline facilitator visits, stratification tools, and quality reports on low back pain treatment. Primary outcome is referral to secondary care. Secondary outcomes are pain, physical function, health-related quality of life, patient satisfaction with care and treatment outcome, employment status, and sick leave. Primary and secondary outcomes pertain to the patient level. Assessments of outcomes are blinded and follow the intention-to-treat principle. Additionally, a process assessment will evaluate the degree to which the intervention elements will be delivered as planned, as well as measure changes in beliefs and behaviours among general practitioners and patients. This study provides knowledge concerning the process and effect of an intervention to implement low back pain guidelines in general practice, and will provide insight on essential elements to include in future implementation strategies in general practice. Registered as NCT01699256 on ClinicalTrials.gov.

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).

The Clinical Aspects of Mirror Therapy in Rehabilitation: A Systematic Review of the Literature

ERIC Educational Resources Information Center

Rothgangel, Andreas Stefan; Braun, Susy M.; Beurskens, Anna J.; Seitz, Rudiger J.; Wade, Derick T.

2011-01-01

The objective of this study was to evaluate the clinical aspects of mirror therapy (MT) interventions after stroke, phantom limb pain and complex regional pain syndrome. A systematic literature search of the Cochrane Database of controlled trials, PubMed/MEDLINE, CINAHL, EMBASE, PsycINFO, PEDro, RehabTrials and Rehadat, was made by two…

Networks and landscapes: a framework for setting goals and evaluating performance at the large landscape scale

Treesearch

R Patrick Bixler; Shawn Johnson; Kirk Emerson; Tina Nabatchi; Melly Reuling; Charles Curtin; Michele Romolini; Morgan Grove

2016-01-01

The objective of large landscape conser vation is to mitigate complex ecological problems through interventions at multiple and overlapping scales. Implementation requires coordination among a diverse network of individuals and organizations to integrate local-scale conservation activities with broad-scale goals. This requires an understanding of the governance options...

An Evaluation of a School-Based Teenage Pregnancy Prevention Program Using a Logic Model Framework

ERIC Educational Resources Information Center

Hulton, Linda J.

2007-01-01

Teenage pregnancy and the subsequent social morbidities associated with unintended pregnancies are complex issues facing school nurses in their daily work. In contemporary practice, school nurses are being held to higher standards of accountability and being asked to demonstrate the effective outcomes of their interventions. The purpose of this…

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…

Stroke Units: The Implementation of a Complex Intervention

ERIC Educational Resources Information Center

Kilbride, Cherry; Meyer, Julienne; Flatley, Mary; Perry, Lin

2005-01-01

This article reports on selected findings from an action research study that looked at the lessons learnt from setting up a new in-patient stroke service in a London teaching hospital. Key participants in the design and evaluation of this 2-year study included members of the multi-professional stroke team and support staff within the unit, the…

The Southampton Initiative for Health: a complex intervention to improve the diets and increase the physical activity levels of women and children from disadvantaged communities

PubMed Central

Barker, Mary; Lawrence, Wendy; Baird, Janis; Jarman, Megan; Black, Christina; Barnard, Katharine; Cradock, Sue; Davies, Jenny; Margetts, Barrie; Inskip, Hazel; Cooper, Cyrus

2013-01-01

The ‘Southampton Initiative for Health’ (SIH) is a training intervention with Sure Start Children’s Centre staff designed to improve the diets and physical activity levels of women of child-bearing age. Training aims to help staff to support women in making changes to their lifestyles by improving three skills: reflection on current practice; asking ‘open discovery’ questions; and goal setting. The impact of the training on staff practice is being assessed. A before and after non-randomised controlled trial is being used to evaluate the effectiveness and cost-effectiveness of the intervention in improving women’s diets and increasing their physical activity levels. PMID:20709878

Factors affecting adoption, implementation fidelity, and sustainability of the Redesigned Community Health Fund in Tanzania: a mixed methods protocol for process evaluation in the Dodoma region

PubMed Central

Kalolo, Albino; Radermacher, Ralf; Stoermer, Manfred; Meshack, Menoris; De Allegri, Manuela

2015-01-01

Background Despite the implementation of various initiatives to address low enrollment in voluntary micro health insurance (MHI) schemes in sub-Saharan Africa, the problem of low enrollment remains unresolved. The lack of process evaluations of such interventions makes it difficult to ascertain whether their poor results are because of design failures or implementation weaknesses. Objective In this paper, we describe a process evaluation protocol aimed at opening the ‘black box’ to evaluate the implementation processes of the Redesigned Community Health Fund (CHF) program in the Dodoma region of Tanzania. Design The study employs a cross-sectional mixed methods design and is being carried out 3 years after the launch of the Redesigned CHF program. The study is grounded in a conceptual framework which rests on the Diffusion of Innovation Theory and the Implementation Fidelity Framework. The study utilizes a mixture of quantitative and qualitative data collection tools (questionnaires, focus group discussions, in-depth interviews, and document review), and aligns the evaluation to the Theory of Intervention developed by our team. Quantitative data will be used to measure program adoption, implementation fidelity, and their moderating factors. Qualitative data will be used to explore the responses of stakeholders to the intervention, contextual factors, and moderators of adoption, implementation fidelity, and sustainability. Discussion This protocol describes a systematic process evaluation in relation to the implementation of a reformed MHI. We trust that the theoretical approaches and methodologies described in our protocol may be useful to inform the design of future process evaluations focused on the assessment of complex interventions, such as MHI schemes. PMID:26679408

Increasing the rate of return of resident rotation evaluations by their attending physicians in an in-patient psychiatric facility.

PubMed

Shah, Nurun; Thompson, Britta; Averill, Patricia; Searle, Nancy

2007-01-01

Psychiatrist's evaluations of residents are the primary means of determining whether the residents are ready to be promoted. However, the return rate for evaluations is quite low. The purpose of this study was to increase the return rates. Feedback from two surveys and open discussion was utilized to develop and implement a system for increasing completion rates. Completion rates before and after the intervention were compared. The survey revealed that the initial evaluation form was too complex and not readily available. In addition, participants indicated that reminders would be helpful for increasing compliance. Completion rates were 48% and 80% for the 4 months prior and after the intervention, respectively. Addressing the problem and implementing suggested strategies increased completion rates significantly. However, it is unclear which strategy was most associated with the change. Future directions will focus on determining whether gains will be maintained and what would be necessary to obtain 100% compliance rates.

Formalizing the Role of Agent-Based Modeling in Causal Inference and Epidemiology

PubMed Central

Marshall, Brandon D. L.; Galea, Sandro

2015-01-01

Calls for the adoption of complex systems approaches, including agent-based modeling, in the field of epidemiology have largely centered on the potential for such methods to examine complex disease etiologies, which are characterized by feedback behavior, interference, threshold dynamics, and multiple interacting causal effects. However, considerable theoretical and practical issues impede the capacity of agent-based methods to examine and evaluate causal effects and thus illuminate new areas for intervention. We build on this work by describing how agent-based models can be used to simulate counterfactual outcomes in the presence of complexity. We show that these models are of particular utility when the hypothesized causal mechanisms exhibit a high degree of interdependence between multiple causal effects and when interference (i.e., one person's exposure affects the outcome of others) is present and of intrinsic scientific interest. Although not without challenges, agent-based modeling (and complex systems methods broadly) represent a promising novel approach to identify and evaluate complex causal effects, and they are thus well suited to complement other modern epidemiologic methods of etiologic inquiry. PMID:25480821

Methodology used in comparative studies assessing programmes of transition from paediatrics to adult care programmes: a systematic review

PubMed Central

Le Roux, E; Mellerio, H; Guilmin-Crépon, S; Gottot, S; Jacquin, P; Boulkedid, R; Alberti, C

2017-01-01

Objective To explore the methodologies employed in studies assessing transition of care interventions, with the aim of defining goals for the improvement of future studies. Design Systematic review of comparative studies assessing transition to adult care interventions for young people with chronic conditions. Data sources MEDLINE, EMBASE, ClinicalTrial.gov. Eligibility criteria for selecting studies 2 reviewers screened comparative studies with experimental and quasi-experimental designs, published or registered before July 2015. Eligible studies evaluate transition interventions at least in part after transfer to adult care of young people with chronic conditions with at least one outcome assessed quantitatively. Results 39 studies were reviewed, 26/39 (67%) published their final results and 13/39 (33%) were in progress. In 9 studies (9/39, 23%) comparisons were made between preintervention and postintervention in a single group. Randomised control groups were used in 9/39 (23%) studies. 2 (2/39, 5%) reported blinding strategies. Use of validated questionnaires was reported in 28% (11/39) of studies. In terms of reporting in published studies 15/26 (58%) did not report age at transfer, and 6/26 (23%) did not report the time of collection of each outcome. Conclusions Few evaluative studies exist and their level of methodological quality is variable. The complexity of interventions, multiplicity of outcomes, difficulty of blinding and the small groups of patients have consequences on concluding on the effectiveness of interventions. The evaluation of the transition interventions requires an appropriate and common methodology which will provide access to a better level of evidence. We identified areas for improvement in terms of randomisation, recruitment and external validity, blinding, measurement validity, standardised assessment and reporting. Improvements will increase our capacity to determine effective interventions for transition care. PMID:28131998

The effectiveness of interventions to reduce the household economic burden of illness and injury: a systematic review

PubMed Central

Kimman, Merel; Svenstrup, Nina; Lindevig Kjoege, Katharina; Lea Laba, Tracey; Hackett, Maree L; Jan, Stephen

2015-01-01

Abstract Objective To determine the nature, scope and effectiveness of interventions to reduce the household economic burden of illness or injury. Methods We systematically reviewed reports published on or before 31 January 2014 that we found in the CENTRAL, CINAHL, Econlit, Embase, MEDLINE, PreMEDLINE and PsycINFO databases. We extracted data from prospective controlled trials and assessed the risk of bias. We narratively synthesized evidence. Findings Nine of the 4330 studies checked met our inclusion criteria – seven had evaluated changes to existing health-insurance programmes and two had evaluated different modes of delivering information. The only interventions found to reduce out-of-pocket expenditure significantly were those that eliminated or substantially reduced co-payments for a given patient population. However, the reductions only represented marginal changes in the total expenditures of patients. We found no studies that had been effective in addressing broader household economic impacts – such as catastrophic health expenditure – in the disease populations investigated. Conclusion In general, interventions designed to reduce the complex household economic burden of illness and injury appear to have had little impact on household economies. We only found a few relevant studies using rigorous study designs that were conducted in defined patient populations. The studies were limited in the range of interventions tested and they evaluated only a narrow range of household economic outcomes. There is a need for method development to advance the measurement of the household economic consequences of illness and injury and facilitate the development of innovative interventions to supplement the strategies based on health insurance. PMID:25883403

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 .

Developing and Modeling Complex Social Interventions: Introducing the Connecting People Intervention

ERIC Educational Resources Information Center

Webber, Martin; Reidy, Hannah; Ansari, David; Stevens, Martin; Morris, David

2016-01-01

Objectives: Modeling the processes involved in complex social interventions is important in social work practice, as it facilitates their implementation and translation into different contexts. This article reports the process of developing and modeling the connecting people intervention (CPI), a model of practice that supports people with mental…

Training pharmacists to deliver a complex information technology intervention (PINCER) using the principles of educational outreach and root cause analysis.

PubMed

Sadler, Stacey; Rodgers, Sarah; Howard, Rachel; Morris, Caroline J; Avery, Anthony J

2014-02-01

To describe the training undertaken by pharmacists employed in a pharmacist-led information technology-based intervention study to reduce medication errors in primary care (PINCER Trial), evaluate pharmacists' assessment of the training, and the time implications of undertaking the training. Six pharmacists received training, which included training on root cause analysis and educational outreach, to enable them to deliver the PINCER Trial intervention. This was evaluated using self-report questionnaires at the end of each training session. The time taken to complete each session was recorded. Data from the evaluation forms were entered onto a Microsoft Excel spreadsheet, independently checked and the summary of results further verified. Frequencies were calculated for responses to the three-point Likert scale questions. Free-text comments from the evaluation forms and pharmacists' diaries were analysed thematically. All six pharmacists received 22 h of training over five sessions. In four out of the five sessions, the pharmacists who completed an evaluation form (27 out of 30 were completed) stated they were satisfied or very satisfied with the various elements of the training package. Analysis of free-text comments and the pharmacists' diaries showed that the principles of root cause analysis and educational outreach were viewed as useful tools to help pharmacists conduct pharmaceutical interventions in both the study and other pharmacy roles that they undertook. The opportunity to undertake role play was a valuable part of the training received. Findings presented in this paper suggest that providing the PINCER pharmacists with training in root cause analysis and educational outreach contributed to the successful delivery of PINCER interventions and could potentially be utilised by other pharmacists based in general practice to deliver pharmaceutical interventions to improve patient safety. © 2013 The Authors. IJPP © 2013 Royal Pharmaceutical Society.

Implementation of a Manualized Communication Intervention for School-Aged Children with Pragmatic and Social Communication Needs in a Randomized Controlled Trial: The Social Communication Intervention Project

ERIC Educational Resources Information Center

Adams, Catherine; Lockton, Elaine; Gaile, Jacqueline; Earl, Gillian; Freed, Jenny

2012-01-01

Background: Speech-language interventions are often complex in nature, involving multiple observations, variable outcomes and individualization in treatment delivery. The accepted procedure associated with randomized controlled trials (RCT) of such complex interventions is to develop and implement a manual of intervention in order that reliable…

Feasibility of Applied Gaming During Interdisciplinary Rehabilitation for Patients With Complex Chronic Pain and Fatigue Complaints: A Mixed-Methods Study.

PubMed

Vugts, Miel A P; Joosen, Margot C W; van Bergen, Alfonsus H M M; Vrijhoef, Hubertus J M

2016-04-01

Applied gaming holds potential as a convenient and engaging means for the delivery of behavioral interventions. For developing and evaluating feasible computer-based interventions, policy makers and designers rely on limited knowledge about what causes variation in usage. In this study, we looked closely at why and by whom an applied game (LAKA) is demanded and whether it is feasible (with respect to acceptability, demand, practicality, implementation, and efficacy) and devised a complementary intervention during an interdisciplinary rehabilitation program (IRP) for patients with complex chronic pain and fatigue complaints. A mixed-methods design was used. Quantitative process analyses and assessments of feasibility were carried out with patients of a Dutch rehabilitation center who received access to LAKA without professional support during a 16-week interdisciplinary outpatient program. The quantitative data included records of routinely collected baseline variables (t0), additional surveys to measure technology acceptance before (t1) and after 8 weeks of access to LAKA (t2), and automatic log files of usage behavior (frequency, length, and progress). Subsequently, semistructured interviews were held with purposively selected patients. Interview codes triangulated and illustrated explanations of usage and supplemented quantitative findings on other feasibility domains. Of the 410 eligible patients who started an IRP during the study period, 116 patients participated in additional data collections (108 with problematic fatigue and 47 with moderate or severe pain). Qualitative data verified that hedonic motivation was the most important factor for behavioral intentions to use LAKA (P<.001). Moreover, quotes illustrated a positive association between usage intentions (t1) and baseline level (t0) coping by active engagement (Spearman ρ=0.25; P=.008) and why patients who often respond by seeking social support were represented in a group of 71 patients who accessed the game (P=.034). The median behavioral intention to use LAKA was moderately positive and declined over time. Twenty patients played the game from start to finish. Behavioral change content was recognized and seen as potentially helpful by interview respondents who exposed themselves to the content of LAKA. Variation in the demand for applied gaming is generally explained by perceived enjoyment and effort and by individual differences in coping resources. An applied game can be offered as a feasible complementary intervention for more patients with complex chronic pain or fatigue complaints by embedding and delivering in alignment with patient experiences. Feasibility, effectiveness, and cost-effectiveness can be evaluated in a full-scale evaluation. New observations elicit areas of further research on the usage of computer-based interventions.

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

Developing and Evaluating Digital Interventions to Promote Behavior Change in Health and Health Care: Recommendations Resulting From an International Workshop

PubMed Central

Yardley, Lucy; West, Robert; Patrick, Kevin; Greaves, Felix

2017-01-01

Devices and programs using digital technology to foster or support behavior change (digital interventions) are increasingly ubiquitous, being adopted for use in patient diagnosis and treatment, self-management of chronic diseases, and in primary prevention. They have been heralded as potentially revolutionizing the ways in which individuals can monitor and improve their health behaviors and health care by improving outcomes, reducing costs, and improving the patient experience. However, we are still mainly in the age of promise rather than delivery. Developing and evaluating these digital interventions presents new challenges and new versions of old challenges that require use of improved and perhaps entirely new methods for research and evaluation. This article discusses these challenges and provides recommendations aimed at accelerating the rate of progress in digital behavior intervention research and practice. Areas addressed include intervention development in a rapidly changing technological landscape, promoting user engagement, advancing the underpinning science and theory, evaluating effectiveness and cost-effectiveness, and addressing issues of regulatory, ethical, and information governance. This article is the result of a two-day international workshop on how to create, evaluate, and implement effective digital interventions in relation to health behaviors. It was held in London in September 2015 and was supported by the United Kingdom’s Medical Research Council (MRC), the National Institute for Health Research (NIHR), the Methodology Research Programme (PI Susan Michie), and the Robert Wood Johnson Foundation of the United States (PI Kevin Patrick). Important recommendations to manage the rapid pace of change include considering using emerging techniques from data science, machine learning, and Bayesian approaches and learning from other disciplines including computer science and engineering. With regard to assessing and promoting engagement, a key conclusion was that sustained engagement is not always required and that for each intervention it is useful to establish what constitutes “effective engagement,” that is, sufficient engagement to achieve the intended outcomes. The potential of digital interventions for testing and advancing theories of behavior change by generating ecologically valid, real-time objective data was recognized. Evaluations should include all phases of the development cycle, designed for generalizability, and consider new experimental designs to make the best use of rich data streams. Future health economics analyses need to recognize and model the complex and potentially far-reaching costs and benefits of digital interventions. In terms of governance, developers of digital behavior interventions should comply with existing regulatory frameworks, but with consideration for emerging standards around information governance, ethics, and interoperability. PMID:28663162

Promoting psychosocial well-being following stroke: study protocol for a randomized, controlled trial.

PubMed

Kirkevold, Marit; Kildal Bragstad, Line; Bronken, Berit A; Kvigne, Kari; Martinsen, Randi; Gabrielsen Hjelle, Ellen; Kitzmüller, Gabriele; Mangset, Margrete; Angel, Sanne; Aadal, Lena; Eriksen, Siren; Wyller, Torgeir B; Sveen, Unni

2018-04-03

Stroke is a major public health threat globally. Psychosocial well-being may be affected following stroke. Depressive symptoms, anxiety, general psychological distress and social isolation are prevalent. Approximately one third report depressive symptoms and 20% report anxiety during the first months or years after the stroke. Psychosocial difficulties may impact significantly on long-term functioning and quality of life, reduce the effects of rehabilitation services and lead to higher mortality rates. The aim of the study is to evaluate the effect of a previously developed and feasibility tested dialogue-based psychosocial intervention aimed at promoting psychosocial well-being and coping following stroke among stroke survivors with and without aphasia. The study will be conducted as a multicenter, randomized, single blind controlled trial with one intervention and one control arm. It will include a total of 330 stroke survivors randomly allocated into either an intervention group (dialogue-based intervention to promote psychosocial well-being) or a control group (usual care). Participants in the intervention group will receive eight individual sessions of supported dialogues in their homes during the first six months following an acute stroke. The primary outcome measure will be psychosocial well-being measured by the General Health Questionnaire (GHQ). Secondary outcome measures will be quality of life (SAQoL), sense of coherence (SOC), and depression (Yale). Process evaluation will be conducted in a longitudinal mixed methods study by individual qualitative interviews with 15-20 participants in the intervention and control groups, focus group interviews with the intervention personnel and data collectors, and a comprehensive analysis of implementation fidelity. The intervention described in this study protocol is based on thorough development and feasibility work, guided by the UK medical research council framework for developing and testing complex interventions. It combines classical effectiveness evaluation with a thorough process evaluation. The results from this study may inform the development of further trials aimed at promoting psychosocial well-being following stroke as well as inform the psychosocial follow up of stroke patients living at home. NCT02338869 ; registered 10/04/2014 (On-going trial).

Process evaluations of task sharing interventions for perinatal depression in low and middle income countries (LMIC): a systematic review and qualitative meta-synthesis.

PubMed

Munodawafa, Memory; Mall, Sumaya; Lund, Crick; Schneider, Marguerite

2018-03-23

Perinatal depression is common in low and middle income countries (LAMICs). Task sharing interventions have been implemented to treat perinatal depression in these settings, as a way of dealing with staff shortages. Task sharing allows lay health workers to provide services for less complex cases while being trained and supervised by specialists. Randomized controlled trials suggest that these interventions can be effective but there is limited qualitative information exploring barriers and facilitators to their implementation. This systematic review aims to systematically review current qualitative evidence of process evaluations of task sharing interventions for perinatal depression in LAMICs in relation to the United Kingdom (UK) Medical Research Council (MRC) framework for conducting process evaluations. We searched Medline/ PubMed, PsycINFO, Scopus, Cochrane Library and Web of science for studies from LAMICS using search terms under the broad categories of: (a) "maternal depression'" (b) "intervention" (c) "lay counsellor" OR "community health worker" OR "non-specialist" and (d) "LAMICs". Abstracts were independently reviewed for inclusion by two authors. Full text articles were screened and data for included articles were extracted using a standard data extraction sheet. Qualitative synthesis of qualitative evidence was conducted. 8420 articles were identified from initial searches. Of these, 26 full text articles were screened for eligibility with only three studies meeting the inclusion criteria. Main findings revealed that participants identified the following crucial factors: contextual factors included physical location, accessibility and cultural norms. Implementation factors included acceptability of the intervention and characteristics of the personnel. Mechanisms included counsellor factors such as motivating and facilitating trust; intervention factors such as use of stories and visual aids, and understandability of the content; and participant factors such as shared experience, meeting learning needs, and meeting expectations. While task sharing has been suggested as an effective way of filling the treatment gap for perinatal depression, there is a paucity of qualitative research exploring barriers and facilitators to implementing these interventions. Qualitative process evaluations are crucial for the development of culturally relevant interventions.

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.

Interaction of mathematical modeling and social and behavioral HIV/AIDS research.

PubMed

Cassels, Susan; Goodreau, Steven M

2011-03-01

HIV is transmitted within complex biobehavioral systems. Mathematical modeling can provide insight to complex population-level outcomes of various behaviors measured at an individual level. HIV models in the social and behavioral sciences can be categorized in a number of ways; here, we consider two classes of applications common in the field generally, and in the past year in particular: those models that explore significant behavioral determinants of HIV disparities within and between populations; and those models that seek to evaluate the potential impact of specific social and behavioral interventions. We discuss two overarching issues we see in the field: the need to further systematize effectiveness models of behavioral interventions, and the need for increasing investigation of the use of behavioral data in epidemic models. We believe that a recent initiative by the National Institutes of Health will qualitatively change the relationships between epidemic modeling and sociobehavioral prevention research in the coming years.

Challenging logics of complex intervention trials: community perspectives of a health care improvement intervention in rural Uganda.

PubMed

Okwaro, Ferdinand M; Chandler, Clare I R; Hutchinson, Eleanor; Nabirye, Christine; Taaka, Lilian; Kayendeke, Miriam; Nayiga, Susan; Staedke, Sarah G

2015-04-01

Health systems in many African countries are failing to provide populations with access to good quality health care. Morbidity and mortality from curable diseases such as malaria remain high. The PRIME trial in Tororo, rural Uganda, designed and tested an intervention to improve care at health centres, with the aim of reducing ill-health due to malaria in surrounding communities. This paper presents the impact and context of this trial from the perspective of community members in the study area. Fieldwork was carried out for a year from the start of the intervention in June 2011, and involved informal observation and discussions as well as 13 focus group discussions with community members, 10 in-depth interviews with local stakeholders, and 162 context descriptions recorded through quarterly interviews with community members, health workers and district officials. Community members observed a small improvement in quality of care at most, but not all, intervention health centres. However, this was diluted by other shortfalls in health services beyond the scope of the intervention. Patients continued to seek care at health centres they considered inadequate as well as positioning themselves and their children to access care through other sources such as research and nongovernmental organization (NGO) projects. These findings point to challenges of designing and delivering interventions within a paradigm that requires factorial (reduced to predictable factors) problem definition with easily actionable and evaluable solutions by small-scale projects. Such requirements mean that interventions often work on the periphery of a health system rather than tackling the murky political and economic realities that shape access to care but are harder to change or evaluate with randomized controlled trials. Highly projectified settings further reduce the ability to genuinely 'control' for different health care access scenarios. We argue for a raised consciousness of how evaluation paradigms impact on intervention choices. Copyright © 2015 Elsevier Ltd. 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.

Public health evaluation in the twenty-first century: time to see the wood as well as the trees.

PubMed

Smith, Richard D; Petticrew, Mark

2010-03-01

This paper argues that concepts, methodologies and practices within public health need further development if they are to be sufficient to allow us to develop, undertake and evaluate interventions in the twenty-first century. The public health profession, and the disciplines that contribute to it, maintains the historical focus upon detailed micro analysis (individual and health sector) and not broader macro analysis (societal and system). This brief paper suggests why this is and outlines three challenges it poses: specifying and evaluating outcomes; specifying and understanding complex causal pathways in social interventions and the development of multisector evaluation, to meet information demands from multiple stakeholders. While there is general agreement that public health evaluation needs development, this paper argues that the focus needs to be more upon a broader evaluative space than is currently practiced. There is a need to move beyond primary and secondary health-related effects upon individuals, and focus more on evaluation of the wider range and distribution of direct and indirect effects upon individuals, communities and populations. That is, those involved in public health evaluation need to step back and first consider the wood before focusing in on specific trees.

3.2 million stillbirths: epidemiology and overview of the evidence review

PubMed Central

Lawn, Joy E; Yakoob, Mohammad Yawar; Haws, Rachel A; Soomro, Tanya; Darmstadt, Gary L; Bhutta, Zulfiqar A

2009-01-01

More than 3.2 million stillbirths occur globally each year, yet stillbirths are largely invisible in global data tracking, policy dialogue and programme implementation. This mismatch of burden to action is due to a number of factors that keep stillbirths hidden, notably a lack of data and a lack of consensus on priority interventions, but also to social taboos that reduce the visibility of stillbirths and the associated family mourning. Whilst there are estimates of the numbers of stillbirths, to date there has been no systematic global analysis of the causes of stillbirths. The multiple classifications systems in use are often complex and are primarily focused on high-income countries. We review available data and propose a programmatic classification that is feasible and comparable across settings. We undertook a comprehensive global review of available information on stillbirths in order to 1) identify studies that evaluated risk factors and interventions to reduce stillbirths, 2) evaluate the level of evidence for interventions, 3) place the available evidence for interventions in a health systems context to guide programme implementation, and 4) elucidate key implementation, monitoring, and research gaps. This first paper in the series outlines issues in stillbirth data availability and quality, the global epidemiology of stillbirths, and describes the methodology and framework used for the review of interventions and strategies. PMID:19426465

Economic evaluation of integrated new technologies for health and social care: Suggestions for policy makers, users and evaluators.

PubMed

Wildman, John; McMeekin, Peter; Grieve, Eleanor; Briggs, Andrew

2016-11-01

With an ageing population there is a move towards the use of assisted living technologies (ALTs) to provide social care and health care services, and to improve service processes. These technologies are at the forefront of the integration of health and social care. However, economic evaluations of ALTs, and indeed economic evaluations of any interventions providing both health benefits and benefits beyond health are complex. This paper considers the challenges faced by evaluators and presents a method of economic evaluation for use with interventions where traditional methods may not be suitable for informing funders and decision makers. We propose a method, combining economic evaluation techniques, that can accommodate health outcomes and outcomes beyond health through the use of a common numeraire. Such economic evaluations can benefit both the public and private sector, firstly by ensuring the efficient allocation of resources. And secondly, by providing information for individuals who, in the market for ALTs, face consumption decisions that are infrequent and for which there may be no other sources of information. We consider these issues in the welfarist, extra-welfarist and capabilities frameworks, which we link to attributes in an individual production model. This approach allows for the valuation of the health component of any such intervention and the valuation of key social care attributes and processes. Finally, we present a set of considerations for evaluators highlighting the key issues that need to be considered in this type of economic evaluation. Crown Copyright © 2016. Published by Elsevier Ltd. All rights reserved.

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.

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 economic evaluation of a complex intervention to improve the mental health of maltreated infants and children in foster care in the UK (The BeST? services trial)

PubMed Central

Boyd, Kathleen Anne; Minnis, Helen; Donaldson, Julia; Brown, Kevin; Boyer, Nicole R S; McIntosh, Emma

2018-01-01

Introduction Children who have experienced abuse and neglect are at increased risk of mental and physical health problems throughout life. This places an enormous burden on individuals, families and society in terms of health services, education, social care and judiciary sectors. Evidence suggests that early intervention can mitigate the negative consequences of child maltreatment, exerting long-term positive effects on the health of maltreated children entering foster care. However, evidence on cost-effectiveness of such complex interventions is limited. This protocol describes the first economic evaluation of its kind in the UK. Methods and analysis An economic evaluation alongside the Best Services Trial (BeST?) has been prospectively designed to identify, measure and value key resource and outcome impacts arising from the New Orleans intervention model (NIM) (an infant mental health service) compared with case management (CM) (enhanced social work services as usual). A within-trial economic evaluation and long-term model from a National Health Service/Personal Social Service and a broader societal perspective will be undertaken alongside the National Institute for Health Research (NIHR)–Public Health Research Unit (PHRU)-funded randomised multicentre BeST?. BeST? aims to evaluate NIM compared with CM for maltreated children entering foster care in a UK context. Collection of Paediatric Quality of Life Inventory (PedsQL) and the recent mapping of PedsQL to EuroQol-5-Dimensions (EQ-5D) will facilitate the estimation of quality-adjusted life years specific to the infant population for a cost–utility analysis. Other effectiveness outcomes will be incorporated into a cost-effectiveness analysis (CEA) and cost-consequences analysis (CCA). A long-term economic model and multiple economic evaluation frameworks will provide decision-makers with a comprehensive, multiperspective guide regarding cost-effectiveness of NIM. The long-term population health economic model will be developed to synthesise trial data with routine linked data and key government sector parameters informed by literature. Methods guidance for population health economic evaluation will be adopted (lifetime horizon, 1.5% discount rate for costs and benefits, CCA framework, multisector perspective). Ethics and dissemination Ethics approval was obtained by the West of Scotland Ethics Committee. Results of the main trial and economic evaluation will be submitted for publication in a peer-reviewed journal as well as published in the peer-reviewed NIHR journals library (Public Health Research Programme). Trial registration number NCT02653716; Pre-results. PMID:29540420

Is Scale-Up of Community Mobilisation among Sex Workers Really Possible in Complex Urban Environments? The Case of Mumbai, India

PubMed Central

Kongelf, Anine; Bandewar, Sunita V. S.; Bharat, Shalini; Collumbien, Martine

2015-01-01

Background In the last decade, community mobilisation (CM) interventions targeting female sex workers (FSWs) have been scaled-up in India’s national response to the HIV epidemic. This included the Bill and Melinda Gates Foundation’s Avahan programme which adopted a business approach to plan and manage implementation at scale. With the focus of evaluation efforts on measuring effectiveness and health impacts there has been little analysis thus far of the interaction of the CM interventions with the sex work industry in complex urban environments. Methods and Findings Between March and July 2012 semi-structured, in-depth interviews and focus group discussions were conducted with 63 HIV intervention implementers, to explore challenges of HIV prevention among FSWs in Mumbai. A thematic analysis identified contextual factors that impact CM implementation. Large-scale interventions are not only impacted by, but were shown to shape the dynamic social context. Registration practices and programme monitoring were experienced as stigmatising, reflected in shifting client preferences towards women not disclosing as ‘sex workers’. This combined with urban redevelopment and gentrification of traditional red light areas, forcing dispersal and more ‘hidden’ ways of solicitation, further challenging outreach and collectivisation. Participants reported that brothel owners and ‘pimps’ continued to restrict access to sex workers and the heterogeneous ‘community’ of FSWs remains fragmented with high levels of mobility. Stakeholder engagement was poor and mobilising around HIV prevention not compelling. Interventions largely failed to respond to community needs as strong target-orientation skewed activities towards those most easily measured and reported. Conclusion Large-scale interventions have been impacted by and contributed to an increasingly complex sex work environment in Mumbai, challenging outreach and mobilisation efforts. Sex workers remain a vulnerable and disempowered group needing continued support and more comprehensive services. PMID:25811484

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.

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.

Outcomes in Economic Evaluations of Public Health Interventions in Low‐ and Middle‐Income Countries: Health, Capabilities and Subjective Wellbeing

PubMed Central

Lorgelly, Paula; Yamabhai, Inthira

2016-01-01

Abstract Public health programmes tend to be complex and may combine social strategies with aspects of empowerment, capacity building and knowledge across sectors. The nature of the programmes means that some effects are likely to occur outside the healthcare sector; this breadth impacts on the choice of health and non‐health outcomes to measure and value in an economic evaluation. Employing conventional outcome measures in evaluations of public health has been questioned. There are concerns that such measures are too narrow, overlook important dimensions of programme effect and, thus, lead to such interventions being undervalued. This issue is of particular importance for low‐income and middle‐income countries, which face considerable budget constraints, yet deliver a large proportion of health activities within public health programmes. The need to develop outcome measures, which include broader measures of quality of life, has given impetus to the development of a variety of new, holistic approaches, including Sen's capability framework and measures of subjective wellbeing. Despite their promise, these approaches have not yet been widely applied, perhaps because they present significant methodological challenges. This paper outlines the methodological challenges for the identification and measurement of broader outcomes of public health interventions in economic evaluation in low‐income and middle‐income countries. PMID:26804360

Additional considerations are required when preparing a protocol for a systematic review with multiple interventions.

PubMed

Chaimani, Anna; Caldwell, Deborah M; Li, Tianjing; Higgins, Julian P T; Salanti, Georgia

2017-03-01

The number of systematic reviews that aim to compare multiple interventions using network meta-analysis is increasing. In this study, we highlight aspects of a standard systematic review protocol that may need modification when multiple interventions are to be compared. We take the protocol format suggested by Cochrane for a standard systematic review as our reference and compare the considerations for a pairwise review with those required for a valid comparison of multiple interventions. We suggest new sections for protocols of systematic reviews including network meta-analyses with a focus on how to evaluate their assumptions. We provide example text from published protocols to exemplify the considerations. Standard systematic review protocols for pairwise meta-analyses need extensions to accommodate the increased complexity of network meta-analysis. Our suggested modifications are widely applicable to both Cochrane and non-Cochrane systematic reviews involving network meta-analyses. Copyright © 2017 Elsevier Inc. All rights reserved.

How to use concept mapping to identify barriers and facilitators of an electronic quality improvement intervention.

PubMed

van Engen-Verheul, Mariëtte; Peek, Niels; Vromen, Tom; Jaspers, Monique; de Keizer, Nicolette

2015-01-01

Systematic quality improvement (QI) interventions are increasingly used to change complex health care systems. Results of randomized clinical trials can provide quantitative evidence whether QI interventions were effective but they do not teach us why and how QI was (not) achieved. Qualitative research methods can answer these questions but typically involve only a small group of respondents against high resources. Concept mapping methodology overcomes these drawbacks by integrating results from qualitative group sessions with multivariate statistical analysis to represent ideas of diverse stakeholders visually on maps in an efficient way. This paper aims to describe how to use concept mapping to qualitatively gain insight into barriers and facilitators of an electronic QI intervention and presents experiences with the method from an ongoing case study to evaluate a QI system in the field of cardiac rehabilitation in the Netherlands.

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

Interrupted time series regression for the evaluation of public health interventions: a tutorial.

PubMed

Bernal, James Lopez; Cummins, Steven; Gasparrini, Antonio

2017-02-01

Interrupted time series (ITS) analysis is a valuable study design for evaluating the effectiveness of population-level health interventions that have been implemented at a clearly defined point in time. It is increasingly being used to evaluate the effectiveness of interventions ranging from clinical therapy to national public health legislation. Whereas the design shares many properties of regression-based approaches in other epidemiological studies, there are a range of unique features of time series data that require additional methodological considerations. In this tutorial we use a worked example to demonstrate a robust approach to ITS analysis using segmented regression. We begin by describing the design and considering when ITS is an appropriate design choice. We then discuss the essential, yet often omitted, step of proposing the impact model a priori. Subsequently, we demonstrate the approach to statistical analysis including the main segmented regression model. Finally we describe the main methodological issues associated with ITS analysis: over-dispersion of time series data, autocorrelation, adjusting for seasonal trends and controlling for time-varying confounders, and we also outline some of the more complex design adaptations that can be used to strengthen the basic ITS design.

Conditions, components and outcomes of Integrative Validation Therapy in a long-term care facility for people with dementia. A qualitative evaluation study.

PubMed

Erdmann, Anke; Schnepp, Wilfried

2016-09-01

In this study, the practical application of Integrative Validation Therapy (IVA) in a nursing home for people with dementia was investigated and evaluated from the perspectives of professionals and relatives by using Fourth Generation Evaluation. IVA, a complex intervention frequently applied in Germany's long-term care settings, is a modification of Feil's Validation Therapy and contains a specific attitude and several components of action. The findings demonstrate that professionals as well as relatives of nursing home residents gave the intervention a positive rating. From the perspective of the participating professionals, the application of IVA results in less agitated residents which also has an influence on the consumption of benzodiazepine and neuroleptics. The authors conclude that IVA is a beneficial nursing intervention helping to facilitate the illness-related transition process of people with dementia. IVA is able to support them to cope with emotional distress during transition (e.g. irritability, anxiety, depression, changes in self-esteem). Another conclusion is that IVA supports person-centred care because, with IVA, professionals react to typical needs people with dementia have: comfort, inclusion, attachment and identity (Kitwood, 2012). © The Author(s) 2014.

Interrupted time series regression for the evaluation of public health interventions: a tutorial

PubMed Central

Bernal, James Lopez; Cummins, Steven; Gasparrini, Antonio

2017-01-01

Abstract Interrupted time series (ITS) analysis is a valuable study design for evaluating the effectiveness of population-level health interventions that have been implemented at a clearly defined point in time. It is increasingly being used to evaluate the effectiveness of interventions ranging from clinical therapy to national public health legislation. Whereas the design shares many properties of regression-based approaches in other epidemiological studies, there are a range of unique features of time series data that require additional methodological considerations. In this tutorial we use a worked example to demonstrate a robust approach to ITS analysis using segmented regression. We begin by describing the design and considering when ITS is an appropriate design choice. We then discuss the essential, yet often omitted, step of proposing the impact model a priori. Subsequently, we demonstrate the approach to statistical analysis including the main segmented regression model. Finally we describe the main methodological issues associated with ITS analysis: over-dispersion of time series data, autocorrelation, adjusting for seasonal trends and controlling for time-varying confounders, and we also outline some of the more complex design adaptations that can be used to strengthen the basic ITS design. PMID:27283160

Economic evaluation of health promotion for older people-methodological problems and challenges.

PubMed

Huter, Kai; Kocot, Ewa; Kissimova-Skarbek, Katarzyna; Dubas-Jakóbczyk, Katarzyna; Rothgang, Heinz

2016-09-05

The support of health promotion activities for older people gains societal relevance in terms of enhancing the health and well-being of older people with a view to the efficient use of financial resources in the healthcare sector. Health economic evaluations have become an important instrument to support decision-making processes in many countries. Sound evidence on the cost-effectiveness of health promotion activities would encourage support for the implementation of health promotion activities for older people. This debate article discusses to what extent economic evaluation techniques are appropriate to support decision makers in the allocation of resources regarding health promotion activities for older people. We address the problem that the economic evaluation of these interventions is hampered by methodological obstacles that limit comparability, e.g. with economic evaluations of curative measures. Our central objective is to describe and discuss the specific problems and challenges entailed in the economic evaluation of health promotion activities especially for older people with regard to their usefulness for informing decision making processes. Beyond general problems concerning the economic evaluation of health promotion, our discussion focusses on problems that pertain to the analysis of cost and outcomes of health promotion interventions for older people. With regard to costs these are general problems of economic evaluations, namely the actual implementation of a societal perspective, the appropriate measurement and valuation of informal caregiver time, the measurement and valuation of productivity costs and costs incurred in added years of life. The main problems concerning the identification and measurement of outcomes are related to the identification of outcome parameters that, firstly, adequately reflect the broad effects of health promotion interventions, especially social benefits that gain importance for older people, and secondly, ensure a comparability of effects across different age groups. In particular, the limitations of the widely used QALY for older people are discussed and recently developed alternatives are presented. The key conclusion of the article is that a comparison of the effects of different health promotion initiatives between different age groups by means of economic evaluation is not recommendable. Taking into account the complex outcomes of health promotion interventions it has to be accepted that the outcomes of these interventions will often not be comparable with clinical interventions and have to be assessed differently.

A Network Analysis Perspective to Implementation: The Example of Health Links to Promote Coordinated Care.

PubMed

Yousefi Nooraie, Reza; Khan, Sobia; Gutberg, Jennifer; Baker, G Ross

2018-01-01

Although implementation models broadly recognize the importance of social relationships, our knowledge about applying social network analysis (SNA) to formative, process, and outcome evaluations of health system interventions is limited. We explored applications of adopting an SNA lens to inform implementation planning, engagement and execution, and evaluation. We used Health Links, a province-wide program in Canada aiming to improve care coordination among multiple providers of high-needs patients, as an example of a health system intervention. At the planning phase, an SNA can depict the structure, network influencers, and composition of clusters at various levels. It can inform the engagement and execution by identifying potential targets (e.g., opinion leaders) and by revealing structural gaps and clusters. It can also be used to assess the outcomes of the intervention, such as its success in increasing network connectivity; changing the position of certain actors; and bridging across specialties, organizations, and sectors. We provided an overview of how an SNA lens can shed light on the complexity of implementation along the entire implementation pathway, by revealing the relational barriers and facilitators, the application of network-informed and network-altering interventions, and testing hypotheses on network consequences of the implementation.

Exploratory studies to decide whether and how to proceed with full-scale evaluations of public health interventions: a systematic review of guidance.

PubMed

Hallingberg, Britt; Turley, Ruth; Segrott, Jeremy; Wight, Daniel; Craig, Peter; Moore, Laurence; Murphy, Simon; Robling, Michael; Simpson, Sharon Anne; Moore, Graham

2018-01-01

Evaluations of complex interventions in public health are frequently undermined by problems that can be identified before the effectiveness study stage. Exploratory studies, often termed pilot and feasibility studies, are a key step in assessing the feasibility and value of progressing to an effectiveness study. Such studies can provide vital information to support more robust evaluations, thereby reducing costs and minimising potential harms of the intervention. This systematic review forms the first phase of a wider project to address the need for stand-alone guidance for public health researchers on designing and conducting exploratory studies. The review objectives were to identify and examine existing recommendations concerning when such studies should be undertaken, questions they should answer, suitable methods, criteria for deciding whether to progress to an effectiveness study and appropriate reporting. We searched for published and unpublished guidance reported between January 2000 and November 2016 via bibliographic databases, websites, citation tracking and expert recommendations. Included papers were thematically synthesized. The search retrieved 4095 unique records. Thirty papers were included, representing 25 unique sources of guidance/recommendations. Eight themes were identified: pre-requisites for conducting an exploratory study, nomenclature, guidance for intervention assessment, guidance surrounding any future evaluation study design, flexible versus fixed design, progression criteria to a future evaluation study, stakeholder involvement and reporting of exploratory studies. Exploratory studies were described as being concerned with the intervention content, the future evaluation design or both. However, the nomenclature and endorsed methods underpinning these aims were inconsistent across papers. There was little guidance on what should precede or follow an exploratory study and decision-making surrounding this. Existing recommendations are inconsistent concerning the aims, designs and conduct of exploratory studies, and guidance is lacking on the evidence needed to inform when to proceed to an effectiveness study. PROSPERO 2016, CRD42016047843.

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.

Barriers and facilitators of interventions for improving antiretroviral therapy adherence: a systematic review of global qualitative evidence.

PubMed

Ma, Qingyan; Tso, Lai Sze; Rich, Zachary C; Hall, Brian J; Beanland, Rachel; Li, Haochu; Lackey, Mellanye; Hu, Fengyu; Cai, Weiping; Doherty, Meg; Tucker, Joseph D

2016-01-01

Qualitative research on antiretroviral therapy (ART) adherence interventions can provide a deeper understanding of intervention facilitators and barriers. This systematic review aims to synthesize qualitative evidence of interventions for improving ART adherence and to inform patient-centred policymaking. We searched 19 databases to identify studies presenting primary qualitative data on the experiences, attitudes and acceptability of interventions to improve ART adherence among PLHIV and treatment providers. We used thematic synthesis to synthesize qualitative evidence and the CERQual (Confidence in the Evidence from Reviews of Qualitative Research) approach to assess the confidence of review findings. Of 2982 references identified, a total of 31 studies from 17 countries were included. Twelve studies were conducted in high-income countries, 13 in middle-income countries and six in low-income countries. Study populations focused on adults living with HIV (21 studies, n =1025), children living with HIV (two studies, n =46), adolescents living with HIV (four studies, n =70) and pregnant women living with HIV (one study, n =79). Twenty-three studies examined PLHIV perspectives and 13 studies examined healthcare provider perspectives. We identified six themes related to types of interventions, including task shifting, education, mobile phone text messaging, directly observed therapy, medical professional outreach and complex interventions. We also identified five cross-cutting themes, including strengthening social relationships, ensuring confidentiality, empowerment of PLHIV, compensation and integrating religious beliefs into interventions. Our qualitative evidence suggests that strengthening PLHIV social relationships, PLHIV empowerment and developing culturally appropriate interventions may facilitate adherence interventions. Our study indicates that potential barriers are inadequate training and compensation for lay health workers and inadvertent disclosure of serostatus by participating in the intervention. Our study evaluated adherence interventions based on qualitative data from PLHIV and health providers. The study underlines the importance of incorporating social and cultural factors into the design and implementation of interventions. Further qualitative research is needed to evaluate ART adherence interventions.

Diabetes in adolescence: effects of multifamily group intervention and parent simulation of diabetes.

PubMed

Satin, W; La Greca, A M; Zigo, M A; Skyler, J S

1989-06-01

Insulin-dependent diabetes mellitus (IDDM) is a complex, chronic disease that is difficult to control during adolescence. This study evaluated the effects of a 6-week, family-oriented, group intervention on adolescents' metabolic control and psychosocial and family functioning. Thirty-two families were randomly assigned to one of three groups: multifamily (MF), multifamily plus parent simulation of diabetes (MF + S), and control (C). Outcome measures included glycosylated hemoglobin (Hb Al); perceptions of diabetes; estimates of youngsters' self-care; and family functioning. Adolescents in the MF + S group displayed significant decrements in Hb Al, and adolescents in both intervention groups reported more positive perceptions of a "teen-ager with diabetes" at posttreatment, relative to controls. Adolescents participating in smaller family groups demonstrated clinically significant improvements in Hb Al that were maintained at 6-month follow-up. Parent reports suggested that adolescents in the intervention groups improved their diabetes care. Findings support the use of multifamily groups plus parent simulation of diabetes as an intervention strategy for adolescents with IDDM.

Promoting Student Teachers' Content Related Knowledge in Teaching Systems Thinking: Measuring Effects of an Intervention through Evaluating a Videotaped Lesson

ERIC Educational Resources Information Center

Rosenkränzer, Frank; Kramer, Tim; Hörsch, Christian; Schuler, Stephan; Rieß, Werner

2016-01-01

The understanding of complex, dynamic and animate systems has a special standing in education for sustainable development and biology. Thus one important role of science teacher education is to promote student teachers' Content Related Knowledge (CRK) for teaching systems thinking, consisting of extensive Content Knowledge (CK) and well formed…

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.

A simulation model of building intervention impacts on indoor environmental quality, pediatric asthma, and costs

PubMed Central

Fabian, Maria Patricia; Adamkiewicz, Gary; Stout, Natasha Kay; Sandel, Megan; Levy, Jonathan Ian

2013-01-01

Background Although indoor environmental conditions can affect pediatric asthmatics, few studies have characterized the impact of building interventions on asthma-related outcomes. Simulation models can evaluate such complex systems but have not been applied in this context. Objective To evaluate the impacts of building interventions on indoor environmental quality and pediatric asthma healthcare utilization, and to conduct cost comparisons between intervention and healthcare costs, and energy savings. Methods We applied our previously developed discrete event simulation model (DEM) to simulate the effect of environmental factors, medication compliance, seasonality, and medical history on: 1) pollutant concentrations indoors, and 2) asthma outcomes in low-income multi-family housing. We estimated healthcare utilization and costs at baseline and subsequent to interventions, and then compared healthcare costs to energy savings and intervention costs. Results Interventions such as integrated pest management and repairing kitchen exhaust fans led to 7–12% reductions in serious asthma events with 1–3 year payback periods. Weatherization efforts targeted solely towards tightening a building envelope led to 20% more serious asthma events, but bundling with repairing kitchen exhaust fans and eliminating indoor sources (e.g. gas stoves or smokers) mitigated this impact. Conclusion Our pediatric asthma model provides a tool to prioritize individual and bundled building interventions based on their impact on health and cost, and highlighting the tradeoffs between weatherization, indoor air quality, and health. Our work bridges the gap between clinical and environmental health sciences by increasing physicians’ understanding of the impact that home environmental changes can have on their patients’ asthma. PMID:23910689

Using self-determination theory to promote adolescent girls' physical activity: Exploring the theoretical fidelity of the Bristol Girls Dance Project.

PubMed

Sebire, Simon J; Kesten, Joanna M; Edwards, Mark J; May, Thomas; Banfield, Kathryn; Tomkinson, Keeley; Blair, Peter S; Bird, Emma L; Powell, Jane E; Jago, Russell

2016-05-01

To report the theory-based process evaluation of the Bristol Girls' Dance Project, a cluster-randomised controlled trial to increase adolescent girls' physical activity. A mixed-method process evaluation of the intervention's self-determination theory components comprising lesson observations, post-intervention interviews and focus groups. Four intervention dance lessons per dance instructor were observed, audio recorded and rated to estimate the use of need-supportive teaching strategies. Intervention participants (n = 281) reported their dance instructors' provision of autonomy-support. Semi-structured interviews with the dance instructors (n = 10) explored fidelity to the theory and focus groups were conducted with participants (n = 59) in each school to explore their receipt of the intervention and views on the dance instructors' motivating style. Although instructors accepted the theory-based approach, intervention fidelity was variable. Relatedness support was the most commonly observed need-supportive teaching behaviour, provision of structure was moderate and autonomy-support was comparatively low. The qualitative findings identified how instructors supported competence and developed trusting relationships with participants. Fidelity was challenged where autonomy provision was limited to option choices rather than input into the pace or direction of lessons and where controlling teaching styles were adopted, often to manage disruptive behaviour. The successes and challenges to achieving theoretical fidelity in the Bristol Girls' Dance Project may help explain the intervention effects and can more broadly inform the design of theory-based complex interventions aimed at increasing young people's physical activity in after-school settings.

Using self-determination theory to promote adolescent girls' physical activity: Exploring the theoretical fidelity of the Bristol Girls Dance Project

PubMed Central

Sebire, Simon J.; Kesten, Joanna M.; Edwards, Mark J.; May, Thomas; Banfield, Kathryn; Tomkinson, Keeley; Blair, Peter S.; Bird, Emma L.; Powell, Jane E.; Jago, Russell

2016-01-01

Objectives To report the theory-based process evaluation of the Bristol Girls' Dance Project, a cluster-randomised controlled trial to increase adolescent girls' physical activity. Design A mixed-method process evaluation of the intervention's self-determination theory components comprising lesson observations, post-intervention interviews and focus groups. Method Four intervention dance lessons per dance instructor were observed, audio recorded and rated to estimate the use of need-supportive teaching strategies. Intervention participants (n = 281) reported their dance instructors' provision of autonomy-support. Semi-structured interviews with the dance instructors (n = 10) explored fidelity to the theory and focus groups were conducted with participants (n = 59) in each school to explore their receipt of the intervention and views on the dance instructors' motivating style. Results Although instructors accepted the theory-based approach, intervention fidelity was variable. Relatedness support was the most commonly observed need-supportive teaching behaviour, provision of structure was moderate and autonomy-support was comparatively low. The qualitative findings identified how instructors supported competence and developed trusting relationships with participants. Fidelity was challenged where autonomy provision was limited to option choices rather than input into the pace or direction of lessons and where controlling teaching styles were adopted, often to manage disruptive behaviour. Conclusion The successes and challenges to achieving theoretical fidelity in the Bristol Girls' Dance Project may help explain the intervention effects and can more broadly inform the design of theory-based complex interventions aimed at increasing young people's physical activity in after-school settings. PMID:27175102

Efficient physics-based tracking of heart surface motion for beating heart surgery robotic systems.

PubMed

Bogatyrenko, Evgeniya; Pompey, Pascal; Hanebeck, Uwe D

2011-05-01

Tracking of beating heart motion in a robotic surgery system is required for complex cardiovascular interventions. A heart surface motion tracking method is developed, including a stochastic physics-based heart surface model and an efficient reconstruction algorithm. The algorithm uses the constraints provided by the model that exploits the physical characteristics of the heart. The main advantage of the model is that it is more realistic than most standard heart models. Additionally, no explicit matching between the measurements and the model is required. The application of meshless methods significantly reduces the complexity of physics-based tracking. Based on the stochastic physical model of the heart surface, this approach considers the motion of the intervention area and is robust to occlusions and reflections. The tracking algorithm is evaluated in simulations and experiments on an artificial heart. Providing higher accuracy than the standard model-based methods, it successfully copes with occlusions and provides high performance even when all measurements are not available. Combining the physical and stochastic description of the heart surface motion ensures physically correct and accurate prediction. Automatic initialization of the physics-based cardiac motion tracking enables system evaluation in a clinical environment.

Importance of baseline specification in evaluating conservation interventions and achieving no net loss of biodiversity.

PubMed

Bull, J W; Gordon, A; Law, E A; Suttle, K B; Milner-Gulland, E J

2014-06-01

There is an urgent need to improve the evaluation of conservation interventions. This requires specifying an objective and a frame of reference from which to measure performance. Reference frames can be baselines (i.e., known biodiversity at a fixed point in history) or counterfactuals (i.e., a scenario that would have occurred without the intervention). Biodiversity offsets are interventions with the objective of no net loss of biodiversity (NNL). We used biodiversity offsets to analyze the effects of the choice of reference frame on whether interventions met stated objectives. We developed 2 models to investigate the implications of setting different frames of reference in regions subject to various biodiversity trends and anthropogenic impacts. First, a general analytic model evaluated offsets against a range of baseline and counterfactual specifications. Second, a simulation model then replicated these results with a complex real world case study: native grassland offsets in Melbourne, Australia. Both models showed that achieving NNL depended upon the interaction between reference frame and background biodiversity trends. With a baseline, offsets were less likely to achieve NNL where biodiversity was decreasing than where biodiversity was stable or increasing. With a no-development counterfactual, however, NNL was achievable only where biodiversity was declining. Otherwise, preventing development was better for biodiversity. Uncertainty about compliance was a stronger determinant of success than uncertainty in underlying biodiversity trends. When only development and offset locations were considered, offsets sometimes resulted in NNL, but not across an entire region. Choice of reference frame determined feasibility and effort required to attain objectives when designing and evaluating biodiversity offset schemes. We argue the choice is thus of fundamental importance for conservation policy. Our results shed light on situations in which biodiversity offsets may be an inappropriate policy instrument.

The E Sibling Project – exploratory randomised controlled trial of an online multi-component psychoeducational intervention for siblings of individuals with first episode psychosis

PubMed Central

2013-01-01

Background Siblings of individuals with first episode psychosis are natural partners to promote service users’ recovery and are themselves vulnerable to mental ill health due to the negative impact of psychosis within the family. This study aims to develop and undertake a preliminary evaluation of the efficacy of an online multi-component psychoeducational intervention for siblings of individuals with first episode psychosis. The impetus for the intervention arose from siblings' expressed needs for peer support and information on psychosis, coping and management strategies for common symptoms and ways to promote recovery. Methods/Design The project design draws on the Medical Research Council framework for the design and evaluation of complex interventions. Mixed methods comprising collection of qualitative focus group data, systematic review and expert advisory group consultation are used to develop the theoretical basis for and design of the intervention. This protocol focuses on the modelling and piloting phase which uses a randomised controlled trial with factorial design to test the efficacy of the intervention. Outcome data on participants’ mental wellbeing, knowledge, perceived self-efficacy and experiences of caregiving will be assessed at baseline, at end of the intervention (10 weeks later) and at 10 week follow-up. In addition, a post-intervention semi-structured interview with 20% of the participants will explore their experiences and acceptability of the intervention. Discussion This multi-component online psychoeducational intervention aims to enhance siblings' knowledge about psychosis and their coping capacity, thus potentially improving their own mental wellbeing and promoting their contribution to service users’ recovery. The factorial design randomised controlled trial with a supplementary process evaluation using semi-structured interviews and usage-monitoring will collect preliminary evidence of efficacy, feasibility and acceptability, as well as feedback about the barriers and strategies to using such an innovative resource. The RCT will provide data for estimating the likely effect size of the intervention on outcomes for siblings and inform the development of a definitive future trial. Trial registration Trial registration: ISRCTN01416694 PMID:23622123

Policymakers' experience of a capacity-building intervention designed to increase their use of research: a realist process evaluation.

PubMed

Haynes, Abby; Brennan, Sue; Redman, Sally; Williamson, Anna; Makkar, Steve R; Gallego, Gisselle; Butow, Phyllis

2017-11-23

An intervention's success depends on how participants interact with it in local settings. Process evaluation examines these interactions, indicating why an intervention was or was not effective, and how it (and similar interventions) can be improved for better contextual fit. This is particularly important for innovative trials like Supporting Policy In health with Research: an Intervention Trial (SPIRIT), where causal mechanisms are poorly understood. SPIRIT was testing a multi-component intervention designed to increase the capacity of health policymakers to use research. Our mixed-methods process evaluation sought to explain variation in observed process effects across the six agencies that participated in SPIRIT. Data collection included observations of intervention workshops (n = 59), purposively sampled interviews (n = 76) and participant feedback forms (n = 553). Using a realist approach, data was coded for context-mechanism-process effect configurations (retroductive analysis) by two authors. Intervention workshops were very well received. There was greater variation of views regarding other aspects of SPIRIT such as data collection, communication and the intervention's overall value. We identified nine inter-related mechanisms that were crucial for engaging participants in these policy settings: (1) Accepting the premise (agreeing with the study's assumptions); (2) Self-determination (participative choice); (3) The Value Proposition (seeing potential gain); (4) 'Getting good stuff' (identifying useful ideas, resources or connections); (5) Self-efficacy (believing 'we can do this!'); (6) Respect (feeling that SPIRIT understands and values one's work); (7) Confidence (believing in the study's integrity and validity); (8) Persuasive leadership (authentic and compelling advocacy from leaders); and (9) Strategic insider facilitation (local translation and mediation). These findings were used to develop tentative explanatory propositions and to revise the programme theory. This paper describes how SPIRIT functioned in six policy agencies, including why strategies that worked well in one site were less effective in others. Findings indicate a complex interaction between participants' perception of the intervention, shifting contextual factors, and the form that the intervention took in each site. Our propositions provide transferable lessons about contextualised areas of strength and weakness that may be useful in the development and implementation of similar studies.

The E Sibling Project - exploratory randomised controlled trial of an online multi-component psychoeducational intervention for siblings of individuals with first episode psychosis.

PubMed

Sin, Jacqueline; Henderson, Claire; Pinfold, Vanessa; Norman, Ian

2013-04-26

Siblings of individuals with first episode psychosis are natural partners to promote service users' recovery and are themselves vulnerable to mental ill health due to the negative impact of psychosis within the family. This study aims to develop and undertake a preliminary evaluation of the efficacy of an online multi-component psychoeducational intervention for siblings of individuals with first episode psychosis. The impetus for the intervention arose from siblings' expressed needs for peer support and information on psychosis, coping and management strategies for common symptoms and ways to promote recovery. The project design draws on the Medical Research Council framework for the design and evaluation of complex interventions. Mixed methods comprising collection of qualitative focus group data, systematic review and expert advisory group consultation are used to develop the theoretical basis for and design of the intervention. This protocol focuses on the modelling and piloting phase which uses a randomised controlled trial with factorial design to test the efficacy of the intervention. Outcome data on participants' mental wellbeing, knowledge, perceived self-efficacy and experiences of caregiving will be assessed at baseline, at end of the intervention (10 weeks later) and at 10 week follow-up. In addition, a post-intervention semi-structured interview with 20% of the participants will explore their experiences and acceptability of the intervention. This multi-component online psychoeducational intervention aims to enhance siblings' knowledge about psychosis and their coping capacity, thus potentially improving their own mental wellbeing and promoting their contribution to service users' recovery. The factorial design randomised controlled trial with a supplementary process evaluation using semi-structured interviews and usage-monitoring will collect preliminary evidence of efficacy, feasibility and acceptability, as well as feedback about the barriers and strategies to using such an innovative resource. The RCT will provide data for estimating the likely effect size of the intervention on outcomes for siblings and inform the development of a definitive future trial. Trial registration: ISRCTN01416694.

The effect of a complex training program on skating abilities in ice hockey players.

PubMed

Lee, Changyoung; Lee, Sookyung; Yoo, Jaehyun

2014-04-01

[Purpose] Little data exist on systemic training programs to improve skating abilities in ice hockey players. The purpose of this study was to evaluate the effectiveness of a complex training program on skating abilities in ice hockey players. [Methods] Ten male ice hockey players (training group) that engaged in 12 weeks of complex training and skating training and ten male players (control group) that only participated in 12 weeks of skating training completed on-ice skating tests including a 5 time 18 meters shuttle, t-test, Rink dash 5 times, and line drill before, during, and the training. [Results] Significant group-by-time interactions were found in all skating ability tests. [Conclusion] The complex training program intervention for 12 weeks improved their skating abilities of the ice hockey players.

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.

Dietary Interventions and Blood Pressure in Latin America - Systematic Review and Meta-Analysis

PubMed Central

Mazzaro, Caroline Cantalejo; Klostermann, Flávia Caroline; Erbano, Bruna Olandoski; Schio, Nicolle Amboni; Guarita-Souza, Luiz César; Olandoski, Marcia; Faria-Neto, José Rocha; Baena, Cristina Pellegrino

2014-01-01

Background High blood pressure is the major risk factor for cardiovascular disease. Low blood pressure control rates in Latin American populations emphasize the need for gathering evidence on effective therapies. Objective To evaluate the effects of dietary interventions on blood pressure in Latin American populations. Methods Systematic review. Electronic databases (MEDLINE/PubMed, Embase, Cochrane Library, CINAHL, Web of Science, Scopus, SciELO, LILACS and VHL) were searched and manual search for studies published up to April 2013 was performed. Parallel studies about dietary interventions in Latin American adult populations assessing arterial blood pressure (mm Hg) before and after intervention were included. Results Of the 405 studies identified, 10 randomized controlled trials were included and divided into 3 subgroups according to the proposed dietary intervention. There was a non-significant reduction in systolic blood pressure in the subgroups of mineral replacement (-4.82; 95% CI: -11.36 to 1.73) and complex pattern diets (-3.17; 95% CI: -7.62 to 1.28). Regarding diastolic blood pressure, except for the hyperproteic diet subgroup, all subgroups showed a significant reduction in blood pressure: -4.66 mmHg (95% CI: -9.21 to -0.12) and -4.55 mmHg (95% CI: -7.04 to -2.06) for mineral replacement and complex pattern diets, respectively. Conclusion Available evidence on the effects of dietary changes on blood pressure in Latin American populations indicates a homogeneous effect of those interventions, although not significant for systolic blood pressure. Samples were small and the quality of the studies was generally low. Larger studies are required to build robust evidence. PMID:24676220

Dietary interventions and blood pressure in Latin America - systematic review and meta-analysis.

PubMed

Mazzaro, Caroline Cantalejo; Klostermann, Flávia Caroline; Erbano, Bruna Olandoski; Schio, Nicolle Amboni; Guarita-Souza, Luiz César; Olandoski, Marcia; Faria-Neto, José Rocha; Baena, Cristina Pellegrino

2014-04-01

High blood pressure is the major risk factor for cardiovascular disease. Low blood pressure control rates in Latin American populations emphasize the need for gathering evidence on effective therapies. To evaluate the effects of dietary interventions on blood pressure in Latin American populations. Systematic review. Electronic databases (MEDLINE/PubMed, Embase, Cochrane Library, CINAHL, Web of Science, Scopus, SciELO, LILACS and VHL) were searched and manual search for studies published up to April 2013 was performed. Parallel studies about dietary interventions in Latin American adult populations assessing arterial blood pressure (mm Hg) before and after intervention were included. Of the 405 studies identified, 10 randomized controlled trials were included and divided into 3 subgroups according to the proposed dietary intervention. There was a non-significant reduction in systolic blood pressure in the subgroups of mineral replacement (-4.82; 95% CI: -11.36 to 1.73) and complex pattern diets (-3.17; 95% CI: -7.62 to 1.28). Regarding diastolic blood pressure, except for the hyperproteic diet subgroup, all subgroups showed a significant reduction in blood pressure: -4.66 mmHg (95% CI: -9.21 to -0.12) and -4.55 mmHg (95% CI: -7.04 to -2.06) for mineral replacement and complex pattern diets, respectively. Available evidence on the effects of dietary changes on blood pressure in Latin American populations indicates a homogeneous effect of those interventions, although not significant for systolic blood pressure. Samples were small and the quality of the studies was generally low. Larger studies are required to build robust evidence.

Cost-effectiveness of interventions for increasing the possession of functioning smoke alarms in households with pre-school children: a modelling study.

PubMed

Saramago, Pedro; Cooper, Nicola J; Sutton, Alex J; Hayes, Mike; Dunn, Ken; Manca, Andrea; Kendrick, Denise

2014-05-16

The UK has one of the highest rates for deaths from fire and flames in children aged 0-14 years compared to other high income countries. Evidence shows that smoke alarms can reduce the risk of fire-related injury but little exists on their cost-effectiveness. We aimed to compare the cost effectiveness of different interventions for the uptake of 'functioning' smoke alarms and consequently for the prevention of fire-related injuries in children in the UK. We carried out a decision model-based probabilistic cost-effectiveness analysis. We used a hypothetical population of newborns and evaluated the impact of living in a household with or without a functioning smoke alarm during the first 5 years of their life on overall lifetime costs and quality of life from a public health perspective. We compared seven interventions, ranging from usual care to more complex interventions comprising of education, free/low cost equipment giveaway, equipment fitting and/or home safety inspection. Education and free/low cost equipment was the most cost-effective intervention with an estimated incremental cost-effectiveness ratio of £34,200 per QALY gained compared to usual care. This was reduced to approximately £4,500 per QALY gained when 1.8 children under the age of 5 were assumed per household. Assessing cost-effectiveness, as well as effectiveness, is important in a public sector system operating under a fixed budget restraint. As highlighted in this study, the more effective interventions (in this case the more complex interventions) may not necessarily be the ones considered the most cost-effective.

A randomised controlled trial evaluating a rehabilitation complex intervention for patients following intensive care discharge: the RECOVER study

PubMed Central

Salisbury, Lisa G; Boyd, Julia; Ramsay, Pamela; Merriweather, Judith; Huby, Guro; Forbes, John; Rattray, Janice Z; Griffith, David M; Mackenzie, Simon J; Hull, Alastair; Lewis, Steff; Murray, Gordon D

2012-01-01

Introduction Patients who survive an intensive care unit admission frequently suffer physical and psychological morbidity for many months after discharge. Current rehabilitation pathways are often fragmented and little is known about the optimum method of promoting recovery. Many patients suffer reduced quality of life. Methods and analysis The authors plan a multicentre randomised parallel group complex intervention trial with concealment of group allocation from outcome assessors. Patients who required more than 48 h of mechanical ventilation and are deemed fit for intensive care unit discharge will be eligible. Patients with primary neurological diagnoses will be excluded. Participants will be randomised into one of the two groups: the intervention group will receive standard ward-based care delivered by the NHS service with additional treatment by a specifically trained generic rehabilitation assistant during ward stay and via telephone contact after hospital discharge and the control group will receive standard ward-based care delivered by the current NHS service. The intervention group will also receive additional information about their critical illness and access to a critical care physician. The total duration of the intervention will be from randomisation to 3 months postrandomisation. The total duration of follow-up will be 12 months from randomisation for both groups. The primary outcome will be the Rivermead Mobility Index at 3 months. Secondary outcomes will include measures of physical and psychological morbidity and function, quality of life and survival over a 12-month period. A health economic evaluation will also be undertaken. Groups will be compared in relation to primary and secondary outcomes; quantitative analyses will be supplemented by focus groups with patients, carers and healthcare workers. Ethics and dissemination Consent will be obtained from patients and relatives according to patient capacity. Data will be analysed according to a predefined analysis plan. Trial registration The trial is registered as ISRCTN09412438 and funded by the Chief Scientist Office, Scotland. PMID:22761291

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

PubMed Central

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

2015-01-01

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. PMID:24876076

[Individual, community, regulatory, and systemic approaches to tobacco control interventions].

PubMed

Gorini, Giuseppe

2011-01-01

During the 60s and the 70s strategies for decreasing initiation or quitting have been developed, in order to find those with high success rates. Unfortunately, interventions with an individual approach involved few smokers, so their impact in decreasing smoking prevalence was limited. The socio-ecological model offers a theoretical framework to community interventions for smoking cessation developed during the 80s, in which smoking was considered not only an individual, but also a social problem. In the 80s and the 90s smoking cessation community trials were developed, such as the Community Intervention Trial for Smoking Cessation (COMMIT). Afterwards, policy interventions (price policy; smoking bans in public places; advertising bans; bans of sales to minors) were developed, such as the American Stop Smoking Intervention Study for Cancer Prevention (ASSIST). California has been the first State all over the world to develop a comprehensive Tobacco Control Program in 1988, becoming the place for an ever-conducted natural experiment. All policy interventions in tobacco control have been finally grouped together in the World Health Organization - Framework Convention on Tobacco Control (WHO-FCTC), the first Public Health Treaty. Study designs have changed, according to the individual, community, or regulatory approaches: the classical randomized controlled trials (RCTs), in which the sampling unit is the individual, have been carried out for the evaluation of smoking cessation treatments, whereas cluster RCTs, in which the sampling unit is the community, have been conducted for evaluating community interventions, such as COMMIT. Finally, quasi-experimental studies (before/after study; prospective cohorts, both with a control group), in which the observational unit is a State, have been used for evaluating tobacco control policies, such as ASSIST and the International Tobacco Control Policy Evaluation Project. Although the successes of the last 20 years, tobacco control is at a critical point: in a reductionist approach, we tried to study its parts, but few efforts have been done to consider tobacco control as a complex network that needs an alternative approach to be understood, the systems thinking approach. New attempts of understanding and solving contradictions within tobacco control using a systems thinking approach are presented.

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.

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.

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.

QUARITE (quality of care, risk management and technology in obstetrics): a cluster-randomized trial of a multifaceted intervention to improve emergency obstetric care in Senegal and Mali.

PubMed

Dumont, Alexandre; Fournier, Pierre; Fraser, William; Haddad, Slim; Traore, Mamadou; Diop, Idrissa; Gueye, Mouhamadou; Gaye, Alioune; Couturier, François; Pasquier, Jean-Charles; Beaudoin, François; Lalonde, André; Hatem, Marie; Abrahamowicz, Michal

2009-09-18

Maternal and perinatal mortality are major problems for which progress in sub-Saharan Africa has been inadequate, even though childbirth services are available, even in the poorest countries. Reducing them is the aim of two of the main Millennium Development Goals. Many initiatives have been undertaken to remedy this situation, such as the Advances in Labour and Risk Management (ALARM) International Program, whose purpose is to improve the quality of obstetric services in low-income countries. However, few interventions have been evaluated, in this context, using rigorous methods for analyzing effectiveness in terms of health outcomes. The objective of this trial is to evaluate the effectiveness of the ALARM International Program (AIP) in reducing maternal mortality in referral hospitals in Senegal and Mali. Secondary goals include evaluation of the relationships between effectiveness and resource availability, service organization, medical practices, and satisfaction among health personnel. This is an international, multi-centre, controlled cluster-randomized trial of a complex intervention. The intervention is based on the concept of evidence-based practice and on a combination of two approaches aimed at improving the performance of health personnel: 1) Educational outreach visits; and 2) the implementation of facility-based maternal death reviews. The unit of intervention is the public health facility equipped with a functional operating room. On the basis of consent provided by hospital authorities, 46 centres out of 49 eligible were selected in Mali and Senegal. Using randomization stratified by country and by level of care, 23 centres will be allocated to the intervention group and 23 to the control group. The intervention will last two years. It will be preceded by a pre-intervention one-year period for baseline data collection. A continuous clinical data collection system has been set up in all participating centres. This, along with the inventory of resources and the satisfaction surveys administered to the health personnel, will allow us to measure results before, during, and after the intervention. The overall rate of maternal mortality measured in hospitals during the post-intervention period (Year 4) is the primary outcome. The evaluation will also include cost-effectiveness.

Disentangling the effects of a multiple behaviour change intervention for diarrhoea control in Zambia: a theory-based process evaluation.

PubMed

Greenland, Katie; Chipungu, Jenala; Chilekwa, Joyce; Chilengi, Roma; Curtis, Val

2017-10-17

Diarrhoea is a leading cause of child death in Zambia. As elsewhere, the disease burden could be greatly reduced through caregiver uptake of existing prevention and treatment strategies. We recently reported the results of the Komboni Housewives intervention which tested a novel strategy employing motives including affiliation and disgust to improve caregiver practice of four diarrhoea control behaviours: exclusive breastfeeding; handwashing with soap; and correct preparation and use of oral rehydration salts (ORS) and zinc. The intervention was delivered via community events (women's forums and road shows), at health clinics (group session) and via radio. A cluster randomised trial revealed that the intervention resulted in a small improvement in exclusive breastfeeding practices, but was only associated with small changes in the other behaviours in areas with greater intervention exposure. This paper reports the findings of the process evaluation that was conducted alongside the trial to investigate how factors associated with intervention delivery and receipt influenced caregiver uptake of the target behaviours. Process data were collected from the eight peri-urban and rural intervention areas throughout the six-month implementation period and in all 16 clusters 4-6 weeks afterwards. Intervention implementation (fidelity, reach, dose delivered and recruitment strategies) and receipt (participant engagement and responses, and mediators) were explored through review of intervention activity logs, unannounced observation of intervention events, semi-structured interviews, focus groups with implementers and intervention recipients, and household surveys. Evaluation methods and analyses were guided by the intervention's theory of change and the evaluation framework of Linnan and Steckler. Intervention reach was lower than intended: 39% of the surveyed population reported attending one or more face-to-face intervention event, of whom only 11% attended two or more intervention events. The intervention was not equally feasible to deliver in all settings: fewer events took place in remote rural areas, and the intervention did not adequately penetrate communities in several peri-urban sites where the population density was high, the population was slightly higher socio-economic status, recruitment was challenging, and numerous alternative sources of entertainment existed. Adaptations made by the implementers affected the fidelity of implementation of messages for all target behaviours. Incorrect messages were consequently recalled by intervention recipients. Participants were most receptive to the novel disgust and skills-based interactive demonstrations targeting exclusive breastfeeding and ORS preparation respectively. However, initial disgust elicitation was not followed by a change in associated psychological mediators, and social norms were not measurably changed. The lack of measured behaviour change was likely due to issues with both the intervention's content and its delivery. Achieving high reach and intensity in community interventions delivered in diverse settings is challenging. Achieving high fidelity is also challenging when multiple behaviours are targeted for change. Further work using improved tools is needed to explore the use of subconscious motives in behaviour change interventions. To better uncover how and why interventions achieve their measured effects, process evaluations of complex interventions should develop and employ frameworks for investigation and interpretation that are structured around the intervention's theory of change and the local context. The study was registered as part of the larger trial on 5 March 2014 with ClinicalTrials.gov: NCT02081521 .

A review of economic evaluations of behavior change interventions: setting an agenda for research methods and practice.

PubMed

Alayli-Goebbels, Adrienne F G; Evers, Silvia M A A; Alexeeva, Daria; Ament, André J H A; de Vries, Nanne K; Tilly, Jan C; Severens, Johan L

2014-06-01

The objective of this study was to review methodological quality of economic evaluations of lifestyle behavior change interventions (LBCIs) and to examine how they address methodological challenges for public health economic evaluation identified in the literature. Pubmed and the NHS economic evaluation database were searched for published studies in six key areas for behavior change: smoking, physical activity, dietary behavior, (illegal) drug use, alcohol use and sexual behavior. From included studies (n = 142), we extracted data on general study characteristics, characteristics of the LBCIs, methodological quality and handling of methodological challenges. Economic evaluation evidence for LBCIs showed a number of weaknesses: methods, study design and characteristics of evaluated interventions were not well reported; methodological quality showed several shortcomings and progress with addressing methodological challenges remained limited. Based on the findings of this review we propose an agenda for improving future evidence to support decision-making. Recommendations for practice include improving reporting of essential study details and increasing adherence with good practice standards. Recommendations for research methods focus on mapping out complex causal pathways for modeling, developing measures to capture broader domains of wellbeing and community outcomes, testing methods for considering equity, identifying relevant non-health sector costs and advancing methods for evidence synthesis. © 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.

Multilevel Interventions Targeting Obesity: Research Recommendations for Vulnerable Populations.

PubMed

Stevens, June; Pratt, Charlotte; Boyington, Josephine; Nelson, Cheryl; Truesdale, Kimberly P; Ward, Dianne S; Lytle, Leslie; Sherwood, Nancy E; Robinson, Thomas N; Moore, Shirley; Barkin, Shari; Cheung, Ying Kuen; Murray, David M

2017-01-01

The origins of obesity are complex and multifaceted. To be successful, an intervention aiming to prevent or treat obesity may need to address multiple layers of biological, social, and environmental influences. NIH recognizes the importance of identifying effective strategies to combat obesity, particularly in high-risk and disadvantaged populations with heightened susceptibility to obesity and subsequent metabolic sequelae. To move this work forward, the National Heart, Lung, and Blood Institute, in collaboration with the NIH Office of Behavioral and Social Science Research and NIH Office of Disease Prevention convened a working group to inform research on multilevel obesity interventions in vulnerable populations. The working group reviewed relevant aspects of intervention planning, recruitment, retention, implementation, evaluation, and analysis, and then made recommendations. Recruitment and retention techniques used in multilevel research must be culturally appropriate and suited to both individuals and organizations. Adequate time and resources for preliminary work are essential. Collaborative projects can benefit from complementary areas of expertise and shared investigations rigorously pretesting specific aspects of approaches. Study designs need to accommodate the social and environmental levels under study, and include appropriate attention given to statistical power. Projects should monitor implementation in the multiple venues and include a priori estimation of the magnitude of change expected within and across levels. The complexity and challenges of delivering interventions at several levels of the social-ecologic model require careful planning and implementation, but hold promise for successful reduction of obesity in vulnerable populations. Copyright © 2016. Published by Elsevier Inc.

The effectiveness of a life style modification and peer support home blood pressure monitoring in control of hypertension: protocol for a cluster randomized controlled trial.

PubMed

Su, Tin Tin; Majid, Hazreen Abdul; Nahar, Azmi Mohamed; Azizan, Nurul Ain; Hairi, Farizah Mohd; Thangiah, Nithiah; Dahlui, Maznah; Bulgiba, Awang; Murray, Liam J

2014-01-01

Death rates due to hypertension in low and middle income countries are higher compared to high income countries. The present study is designed to combine life style modification and home blood pressure monitoring for control of hypertension in the context of low and middle income countries. The study is a two armed, parallel group, un-blinded, cluster randomized controlled trial undertaken within lower income areas in Kuala Lumpur. Two housing complexes will be assigned to the intervention group and the other two housing complexes will be allocated in the control group. Based on power analysis, 320 participants will be recruited. The participants in the intervention group (n = 160) will undergo three main components in the intervention which are the peer support for home blood pressure monitoring, face to face health coaching on healthy diet and demonstration and training for indoor home based exercise activities while the control group will receive a pamphlet containing information on hypertension. The primary outcomes are systolic and diastolic blood pressure. Secondary outcome measures include practice of self-blood pressure monitoring, dietary intake, level of physical activity and physical fitness. The present study will evaluate the effect of lifestyle modification and peer support home blood pressure monitoring on blood pressure control, during a 6 month intervention period. Moreover, the study aims to assess whether these effects can be sustainable more than six months after the intervention has ended.

Multilevel Interventions Targeting Obesity: Research Recommendations for Vulnerable Populations

PubMed Central

Stevens, June; Pratt, Charlotte; Boyington, Josephine; Nelson, Cheryl; Truesdale, Kimberly P.; Ward, Dianne S.; Lytle, Leslie; Sherwood, Nancy E.; Robinson, Thomas N.; Moore, Shirley; Barkin, Shari; Cheung, Ying Kuen; Murray, David M.

2017-01-01

Introduction The origins of obesity are complex and multifaceted. To be successful, an intervention aiming to prevent or treat obesity may need to address multiple layers of biological, social, and environmental influences. Methods NIH recognizes the importance of identifying effective strategies to combat obesity, particularly in high-risk and disadvantaged populations with heightened susceptibility to obesity and subsequent metabolic sequelae. To move this work forward, the National Heart, Lung, and Blood Institute, in collaboration with the NIH Office of Behavioral and Social Science Research and NIH Office of Disease Prevention convened a working group to inform research on multilevel obesity interventions in vulnerable populations. The working group reviewed relevant aspects of intervention planning, recruitment, retention, implementation, evaluation, and analysis, and then made recommendations. Results Recruitment and retention techniques used in multilevel research must be culturally appropriate and suited to both individuals and organizations. Adequate time and resources for preliminary work are essential. Collaborative projects can benefit from complementary areas of expertise and shared investigations rigorously pretesting specific aspects of approaches. Study designs need to accommodate the social and environmental levels under study, and include appropriate attention given to statistical power. Projects should monitor implementation in the multiple venues and include a priori estimation of the magnitude of change expected within and across levels. Conclusions The complexity and challenges of delivering interventions at several levels of the social—ecologic model require careful planning and implementation, but hold promise for successful reduction of obesity in vulnerable populations. PMID:28340973

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.

Resolving Complex Research Data Management Issues in Biomedical Laboratories: Qualitative Study of an Industry-Academia Collaboration

PubMed Central

Myneni, Sahiti; Patel, Vimla L.; Bova, G. Steven; Wang, Jian; Ackerman, Christopher F.; Berlinicke, Cynthia A.; Chen, Steve H.; Lindvall, Mikael; Zack, Donald J.

2016-01-01

This paper describes a distributed collaborative effort between industry and academia to systematize data management in an academic biomedical laboratory. Heterogeneous and voluminous nature of research data created in biomedical laboratories make information management difficult and research unproductive. One such collaborative effort was evaluated over a period of four years using data collection methods including ethnographic observations, semi-structured interviews, web-based surveys, progress reports, conference call summaries, and face-to-face group discussions. Data were analyzed using qualitative methods of data analysis to 1) characterize specific problems faced by biomedical researchers with traditional information management practices, 2) identify intervention areas to introduce a new research information management system called Labmatrix, and finally to 3) evaluate and delineate important general collaboration (intervention) characteristics that can optimize outcomes of an implementation process in biomedical laboratories. Results emphasize the importance of end user perseverance, human-centric interoperability evaluation, and demonstration of return on investment of effort and time of laboratory members and industry personnel for success of implementation process. In addition, there is an intrinsic learning component associated with the implementation process of an information management system. Technology transfer experience in a complex environment such as the biomedical laboratory can be eased with use of information systems that support human and cognitive interoperability. Such informatics features can also contribute to successful collaboration and hopefully to scientific productivity. PMID:26652980

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,…

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 Hybrid Process Fidelity Assessment in a Home-based Randomized Clinical Trial

PubMed Central

WILDE, MARY H.; LIEBEL, DIANNE; FAIRBANKS, EILEEN; WILSON, PAULA; LASH, MARGARET; SHAH, SHIVANI; McDONALD, MARGARET V.; BRASCH, JUDITH; ZHANG, FENG; SCHEID, EILEEN; McMAHON, JAMES M.

2016-01-01

A process fidelity assessment was conducted as a nested study within a home-based randomized clinical trial teaching self-management to 101 long-term indwelling urinary catheter users in the treatment group. Our hybrid model combined external assessments (outside observations and tape recordings) with internal evaluation methods (through study nurse forms and notes) for a comprehensive process fidelity assessment. Barriers, patient-related issues, and nurse perspectives were identified demonstrating the complexity in home care intervention research. The complementary and synergistic approaches provided in depth information about the context of the delivery and the impact of the intervention on study outcomes. PMID:25894688

Neurobiology of food addiction and adolescent obesity prevention in low- and middle-income countries.

PubMed

Lee, Albert; Gibbs, Susannah E

2013-02-01

Adolescent obesity has become an increasingly urgent issue in low- and middle-income countries. Recent relevant advances include the application of the neurobiology of addiction to food addiction and obesity. The biochemistry of the etiology of obesity indicates the need for multilevel interventions that go beyond simple behavioral approaches. Additional research on the neurobiology of food addiction and adolescent obesity in low- and middle-income countries, as well as program evaluations that examine the biochemical effects of complex interventions, is urgently needed. Copyright © 2013 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

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.

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.

A Classification System to Guide Physical Therapy Management in Huntington Disease: A Case Series.

PubMed

Fritz, Nora E; Busse, Monica; Jones, Karen; Khalil, Hanan; Quinn, Lori

2017-07-01

Individuals with Huntington disease (HD), a rare neurological disease, experience impairments in mobility and cognition throughout their disease course. The Medical Research Council framework provides a schema that can be applied to the development and evaluation of complex interventions, such as those provided by physical therapists. Treatment-based classifications, based on expert consensus and available literature, are helpful in guiding physical therapy management across the stages of HD. Such classifications also contribute to the development and further evaluation of well-defined complex interventions in this highly variable and complex neurodegenerative disease. The purpose of this case series was to illustrate the use of these classifications in the management of 2 individuals with late-stage HD. Two females, 40 and 55 years of age, with late-stage HD participated in this case series. Both experienced progressive declines in ambulatory function and balance as well as falls or fear of falling. Both individuals received daily care in the home for activities of daily living. Physical therapy Treatment-Based Classifications for HD guided the interventions and outcomes. Eight weeks of in-home balance training, strength training, task-specific practice of functional activities including transfers and walking tasks, and family/carer education were provided. Both individuals demonstrated improvements that met or exceeded the established minimal detectible change values for gait speed and Timed Up and Go performance. Both also demonstrated improvements on Berg Balance Scale and Physical Performance Test performance, with 1 of the 2 individuals exceeding the established minimal detectible changes for both tests. Reductions in fall risk were evident in both cases. These cases provide proof-of-principle to support use of treatment-based classifications for physical therapy management in individuals with HD. Traditional classification of early-, mid-, and late-stage disease progression may not reflect patients' true capabilities; those with late-stage HD may be as responsive to interventions as those at an earlier disease stage.Video Abstract available for additional insights from the authors (see Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A172).

Improving decision making in multidisciplinary tumor boards: prospective longitudinal evaluation of a multicomponent intervention for 1,421 patients.

PubMed

Lamb, Benjamin W; Green, James S A; Benn, Jonathan; Brown, Katrina F; Vincent, Charles A; Sevdalis, Nick

2013-09-01

Due to its complexity, cancer care is increasingly being delivered by multidisciplinary tumor boards (MTBs). Few studies have investigated how best to organize and run MTBs to optimize clinical decision making. We developed and evaluated a multicomponent intervention designed to improve the MTB's ability to reach treatment decisions. We conducted a prospective longitudinal study during 16 months that evaluated MTB decision making for urological cancer patients at a university hospital in London, UK. After a baseline period, MTB improvement interventions (eg, MTBs checklist, MTB team training, and written guidance) were delivered sequentially. Outcomes measures were the MTB's ability to reach a decision, the quality of information presentation, and the quality of teamwork (as assessed by trained assessors using a previously validated observational assessment tool). The efficacy of the intervention was evaluated using multivariate analyses. There were 1,421 patients studied between December 2009 and April 2, 2011. All outcomes improved considerably between baseline and intervention implementation: the MTB's ability to reach a decision rose from 82.2% to 92.7%, quality of information presentation rose from 29.6% to 38.3%, and quality of teamwork rose from 37.8% to 43.0%. The MTB's ability to reach a treatment decision was related to the quality of available information (r = 0.298; p < 0.05) and quality of teamwork within the MTB (r = 0.348; p < 0.05). The most common barriers to reaching clinical decisions were inadequate radiologic information (n = 77), inadequate pathologic information (n = 51), and inappropriate patient referrals (n = 21). Multidisciplinary tumor board-delivered treatment is becoming the standard for cancer care worldwide. Our intervention is efficacious and applicable to MTBs and can improve decision making and expedite cancer care. Copyright © 2013 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Understanding User Reactions and Interactions With an Internet-Based Intervention for Tinnitus Self-Management: Mixed-Methods Process Evaluation Protocol

PubMed Central

Sereda, Magdalena; Coulson, Neil; Hoare, Derek J

2016-01-01

Background Tinnitus is a common medical symptom that can affect an individual’s emotional and functional quality of life. Psychological therapies are acknowledged as beneficial to people with tinnitus; however, such therapies are not always readily accessible. With their global reach, automated Internet-based interventions have the potential to reduce the disparity in access to psychological support that people with tinnitus currently experience. However, the evidence on the acceptability and efficacy of these interventions is lacking. Process evaluations that develop an in-depth understanding of how users experience these interventions provide an essential first step when evaluating complex psychological interventions. Objective To describe the protocol for a study that will explore past, current, and new users’ reactions to and interactions with the Tinnitus E-Programme, an Internet-based intervention for the self-management of tinnitus. Methods Two parallel mixed-methods studies will be carried out with 2 different populations. Study 1 will use an online survey to gather past and current users’ views of the program. Study 2 will recruit new program users to take part in an interview and complete a relaxation log to explore how well they were able to implement the skills they learned during the program in their everyday lives. The findings from both studies will be triangulated to develop an in-depth understanding of the program’s mechanisms of impact and identify any implementation or contextual factors that strengthen or impede its delivery and functioning. Results Study 1 is open for recruitment with a projected completion in June 2016 and Study 2 was completed November 2015. At the time of submission, 36 participants have been recruited to Study 1 and 12 participants have taken part in Study 2. Conclusions Findings will inform the optimization of the Tinnitus E-Programme and guide future evaluation work to assess the program’s effectiveness as a therapy for people with tinnitus. PMID:27009548

An application of Extended Normalisation Process Theory in a randomised controlled trial of a complex social intervention: Process evaluation of the Strengthening Families Programme (10-14) in Wales, UK.

PubMed

Segrott, Jeremy; Murphy, Simon; Rothwell, Heather; Scourfield, Jonathan; Foxcroft, David; Gillespie, David; Holliday, Jo; Hood, Kerenza; Hurlow, Claire; Morgan-Trimmer, Sarah; Phillips, Ceri; Reed, Hayley; Roberts, Zoe; Moore, Laurence

2017-12-01

Process evaluations generate important data on the extent to which interventions are delivered as intended. However, the tendency to focus only on assessment of pre-specified structural aspects of fidelity has been criticised for paying insufficient attention to implementation processes and how intervention-context interactions influence programme delivery. This paper reports findings from a process evaluation nested within a randomised controlled trial of the Strengthening Families Programme 10-14 (SFP 10-14) in Wales, UK. It uses Extended Normalisation Process Theory to theorise how interaction between SFP 10-14 and local delivery systems - particularly practitioner commitment/capability and organisational capacity - influenced delivery of intended programme activities: fidelity (adherence to SFP 10-14 content and implementation requirements); dose delivered; dose received (participant engagement); participant recruitment and reach (intervention attendance). A mixed methods design was utilised. Fidelity assessment sheets (completed by practitioners), structured observation by researchers, and routine data were used to assess: adherence to programme content; staffing numbers and consistency; recruitment/retention; and group size and composition. Interviews with practitioners explored implementation processes and context. Adherence to programme content was high - with some variation, linked to practitioner commitment to, and understanding of, the intervention's content and mechanisms. Variation in adherence rates was associated with the extent to which multi-agency delivery team planning meetings were held. Recruitment challenges meant that targets for group size/composition were not always met, but did not affect adherence levels or family engagement. Targets for staffing numbers and consistency were achieved, though capacity within multi-agency networks reduced over time. Extended Normalisation Process Theory provided a useful framework for assessing implementation and explaining variation by examining intervention-context interactions. Findings highlight the need for process evaluations to consider both the structural and process components of implementation to explain whether programme activities are delivered as intended and why.

Developing a holistic policy and intervention framework for global mental health.

PubMed

Khenti, Akwatu; Fréel, Stéfanie; Trainor, Ruth; Mohamoud, Sirad; Diaz, Pablo; Suh, Erica; Bobbili, Sireesha J; Sapag, Jaime C

2016-02-01

There are significant gaps in the accessibility and quality of mental health services around the globe. A wide range of institutions are addressing the challenges, but there is limited reflection and evaluation on the various approaches, how they compare with each other, and conclusions regarding the most effective approach for particular settings. This article presents a framework for global mental health capacity building that could potentially serve as a promising or best practice in the field. The framework is the outcome of a decade of collaborative global health work at the Centre for Addiction and Mental Health (CAMH) (Ontario, Canada). The framework is grounded in scientific evidence, relevant learning and behavioural theories and the underlying principles of health equity and human rights. Grounded in CAMH's research, programme evaluation and practical experience in developing and implementing mental health capacity building interventions, this article presents the iterative learning process and impetus that formed the basis of the framework. A developmental evaluation (Patton M.2010. Developmental Evaluation: Applying Complexity Concepts to Enhance Innovation and Use. New York: Guilford Press.) approach was used to build the framework, as global mental health collaboration occurs in complex or uncertain environments and evolving learning systems. A multilevel framework consists of five central components: (1) holistic health, (2) cultural and socioeconomic relevance, (3) partnerships, (4) collaborative action-based education and learning and (5) sustainability. The framework's practical application is illustrated through the presentation of three international case studies and four policy implications. Lessons learned, limitations and future opportunities are also discussed. The holistic policy and intervention framework for global mental health reflects an iterative learning process that can be applied and scaled up across different settings through appropriate modifications. © The Author 2015. Published by Oxford University Press in association with The London School of Hygiene and Tropical Medicine.

WELLFOCUS PPT – modified positive psychotherapy to improve well-being in psychosis: study protocol for a pilot randomised controlled trial

PubMed Central

2014-01-01

Background The promotion of well-being is an important goal of recovery oriented mental health services. No structured, evidence-based intervention exists that aims to increase the well-being in people with severe mental illness such as psychosis. Positive psychotherapy (PPT) is a promising intervention for this goal. Standard PPT was adapted for use with people with psychosis in the UK following the Medical Research Council framework for developing and testing complex interventions, resulting in the WELLFOCUS Model describing the intended impact of WELLFOCUS PPT. This study aims to test the WELLFOCUS Model, by piloting the intervention, trial processes, and evaluation strategy. Methods/Design This study is a non-blinded pragmatic pilot RCT comparing WELLFOCUS PPT provided as an 11-session group therapy in addition to treatment as usual to treatment as usual alone. Inclusion criteria are adults (aged 18–65 years) with a main diagnosis of psychosis who use mental health services. A target sample of 80 service users with psychosis are recruited from mental health services across the South London and Maudsley NHS Foundation Trust. Participants are randomised in blocks to the intervention and control group. WELLFOCUS PPT is provided to groups by specifically trained and supervised local therapists and members of the research team. Assessments are conducted before randomisation and after the group intervention. The primary outcome measure is well-being assessed by the Warwick-Edinburgh Mental Well-being Scale. Secondary outcomes include good feelings, symptom relief, connectedness, hope, self-worth, empowerment, and meaning. Process evaluation using data collected during the group intervention, post-intervention individual interviews and focus groups with participants, and interviews with trial therapists will complement quantitative outcome data. Discussion This study will provide data on the feasibility of the intervention and identify necessary adaptations. It will allow optimisation of trial processes and inform the evaluation strategy, including sample size calculation, for a future definitive RCT. Trial registration Current Controlled Trials ISRCTN04199273 – WELLFOCUS study: an intervention to improve well-being in people with psychosis, Date registered: 27 March 2013, first participant randomised on 26 April 2013. PMID:24888479

WELLFOCUS PPT - modified positive psychotherapy to improve well-being in psychosis: study protocol for a pilot randomised controlled trial.

PubMed

Schrank, Beate; Riches, Simon; Coggins, Tony; Rashid, Tayyab; Tylee, Andre; Slade, Mike

2014-06-03

The promotion of well-being is an important goal of recovery oriented mental health services. No structured, evidence-based intervention exists that aims to increase the well-being in people with severe mental illness such as psychosis. Positive psychotherapy (PPT) is a promising intervention for this goal. Standard PPT was adapted for use with people with psychosis in the UK following the Medical Research Council framework for developing and testing complex interventions, resulting in the WELLFOCUS Model describing the intended impact of WELLFOCUS PPT. This study aims to test the WELLFOCUS Model, by piloting the intervention, trial processes, and evaluation strategy. This study is a non-blinded pragmatic pilot RCT comparing WELLFOCUS PPT provided as an 11-session group therapy in addition to treatment as usual to treatment as usual alone. Inclusion criteria are adults (aged 18-65 years) with a main diagnosis of psychosis who use mental health services. A target sample of 80 service users with psychosis are recruited from mental health services across the South London and Maudsley NHS Foundation Trust. Participants are randomised in blocks to the intervention and control group. WELLFOCUS PPT is provided to groups by specifically trained and supervised local therapists and members of the research team. Assessments are conducted before randomisation and after the group intervention. The primary outcome measure is well-being assessed by the Warwick-Edinburgh Mental Well-being Scale. Secondary outcomes include good feelings, symptom relief, connectedness, hope, self-worth, empowerment, and meaning. Process evaluation using data collected during the group intervention, post-intervention individual interviews and focus groups with participants, and interviews with trial therapists will complement quantitative outcome data. This study will provide data on the feasibility of the intervention and identify necessary adaptations. It will allow optimisation of trial processes and inform the evaluation strategy, including sample size calculation, for a future definitive RCT. Current Controlled Trials ISRCTN04199273 - WELLFOCUS study: an intervention to improve well-being in people with psychosis, Date registered: 27 March 2013, first participant randomised on 26 April 2013.

Psychosocial interventions for pregnant women in outpatient illicit drug treatment programs compared to other interventions.

PubMed

Terplan, M; Lui, S

2007-10-17

Illicit drug use in pregnancy is a complex social and public health problem. It is important to develop and evaluate effective treatments. There is evidence for the effectiveness of psychosocial in this population; however, to our knowledge, no systematic review on the subject has been undertaken. To evaluate the effectiveness of psychosocial interventions in pregnant women enrolled in illicit drug treatment programs on birth and neonatal outcomes, on attendance and retention in treatment, as well as on maternal and neonatal drug abstinence. In short, do psychosocial interventions translate into less illicit drug use, greater abstinence, better birth outcomes, or greater clinic attendance.? We searched the Cochrane Drugs and Alcohol Group's trial register (May 2006), the Cochrane Central Register of Trials (Central- The Cochrane Library, Issue 3, 2005); MEDLINE (1.1996-8.2006); EMBASE (1.1996-8.2006); CINAHL (1.1982-8.2006), and reference lists of articles. Randomised studies comparing any psychosocial intervention versus pharmacological interventions or placebo or non-intervention or another psychosocial intervention for treating illicit drug use in pregnancy. Two reviewers independently assessed trial quality and extracted data. Nine trials involving 546 pregnant women were included. Five studies considered contingency management (CM), and four studies considered manual based interventions such as motivational interviewing (MI). The main finding was that contingency management led to better study retention. There was only minimal effect of CM on illicit drug abstinence. In contrast, motivational interviewing led towards poorer study retention, although this did not approach statistical significance. For both, no difference in birth or neonatal outcomes was found, but this was an outcome rarely captured in the studies. The present evidence suggests that CM strategies are effective in improving retention of pregnant women in illicit drug treatment programs as well as in transiently reducing illicit drug use. There is insufficient evidence to support the use of MI. Overall the available evidence has low numbers and, therefore, it is impossible to accurately assess the effect of psychosocial interventions on obstetrical and neonatal outcomes. It is important to develop a better evidence base to evaluate psychosocial modalities of treatment in this important population.

Using the iPad to facilitate interaction between preschool children who use AAC and their peers.

PubMed

Therrien, Michelle C S; Light, Janice

2016-09-01

Social interaction is one of the key components of education, yet children with complex communication needs often face social isolation in the classroom, rarely interacting with same-age peers. This study investigated the impact of the provision of an iPad(®) (1) with an AAC app with visual scene displays and a dyadic turn taking training on the number of communicative turns taken by children with complex communication needs in interaction with same-age peers. Two preschool children with complex communication needs and six peers without disabilities participated in this research. A single-subject, multiple probe across partners design with one replication was used to evaluate the effectiveness of the intervention on the frequency of communicative turns expressed by the children with complex communication needs. Parents, teachers, speech-language pathologists, and the children participated in social validation measures. As a result of intervention, Participant 1 showed immediate gains in the frequency of symbolic communicative turns after the first training session across all three partners (average gains of 30-46 symbolic communicative turns per 10-min session across peer partners). Participant 2 showed some initial gains, but they were not maintained over time (average gains of 11-24 turns across partners). Classroom implications and future research directions are discussed.

An individually randomized controlled trial to determine the effectiveness of the Women for Women International Programme in reducing intimate partner violence and strengthening livelihoods amongst women in Afghanistan: trial design, methods and baseline findings.

PubMed

Gibbs, Andrew; Corboz, Julienne; Shafiq, Mohammed; Marofi, Frozan; Mecagni, Anna; Mann, Carron; Karim, Fazal; Chirwa, Esnat; Maxwell-Jones, Charlotte; Jewkes, Rachel

2018-01-22

Intimate Partner Violence (IPV) is the most common form of violence in conflict and post-conflict settings, but there are few evaluations of interventions to prevent IPV in such settings. The Women for Women International (WfWI) intervention is a year-long combined economic and social empowerment intervention for marginalized women survivors of conflict. Primarily, it seeks to support women to achieve four key outcomes: women earn and save money; women improve their health and well-being; women influence decisions in their homes and communities; women connect to networks for support. The organization recognizes Violence Against Women and Girls (VAWG) as a significant barrier to women's empowerment and expects to see reduction in VAWG, and specifically IPV, as part of building women's social and economic empowerment. This program is being quantitatively evaluated through an individually randomized control trial amongst women in Afghanistan, with a 24-month follow up. A comparison of baseline characteristics of participants is also included as well as a discussion of implementation of the baseline research. There is a high demand amongst Afghan women for such interventions, and this posed challenges in completing the randomization and baseline. In addition, the complex security situation in Afghanistan also posed challenges. However, despite these issues, recruitment was successfully achieved and the arms were balanced on socio-demographic measures. The evaluation will contribute to the limited evidence base on interventions to prevent IPV in conflict-affected settings. NCT03236948 . Registered 28 July 2017, retrospectively registered.

Cognitive-Based Interventions to Improve Mobility: A Systematic Review and Meta-analysis.

PubMed

Marusic, Uros; Verghese, Joe; Mahoney, Jeannette R

2018-06-01

A strong relation between cognition and mobility has been identified in aging, supporting a role for enhancement mobility through cognitive-based interventions. However, a critical evaluation of the consistency of treatment effects of cognitive-based interventions is currently lacking. The objective of this study was 2-fold: (1) to review the existing literature on cognitive-based interventions aimed at improving mobility in older adults and (2) to assess the clinical effectiveness of cognitive interventions on gait performance. A systematic review of randomized controlled trials (RCT) of cognitive training interventions for improving simple (normal walking) and complex (dual task walking) gait was conducted in February 2018. Older adults without major cognitive, psychiatric, neurologic, and/or sensory impairments were included. Random effect meta-analyses and a subsequent meta-regression were performed to generate overall cognitive intervention effects on single- and dual-task walking conditions. Ten RCTs met inclusion criteria, with a total of 351 participants included in this meta-analysis. Cognitive training interventions revealed a small effect of intervention on complex gait [effect size (ES) = 0.47, 95% confidence interval (CI) 0.13 to 0.81, P = .007, I 2  = 15.85%], but not simple gait (ES = 0.35, 95% CI -0.01 to 0.71, P = .057, I 2  = 57.32%). Moreover, a meta-regression analysis revealed that intervention duration, training frequency, total number of sessions, and total minutes spent in intervention were not significant predictors of improvement in dual-task walking speed, though there was a suggestive trend toward a negative association between dual-task walking speed improvements and individual training session duration (P = .067). This meta-analysis provides support for the fact that cognitive training interventions can improve mobility-related outcomes, especially during challenging walking conditions requiring higher-order executive functions. Additional evidence from well-designed large-scale randomized clinical trials is warranted to confirm the observed effects. Copyright © 2018 AMDA – The Society for Post-Acute and Long-Term Care Medicine. All rights reserved.

LAHYSTOTRAIN development and evaluation of a complex training system for hysteroscopy.

PubMed

Müller-Wittig, W K; Bisler, A; Bockholt, U; Los Arcos, J L; Oppelt, P; Stähler, J; Voss, G

2001-01-01

Hysteroscopy has already become an irreplaceable method in gynaecoloic diagnosis and therapy. In the diagnostic case the hysteroscope with a 30 degrees optic is insert transvaginally, in the therapeutic case the resectoscope with a 12 degrees optic is used. The endoscopic intervention requires special surgical skills for endoscope handling and remote instrument control. To acquire these skills currently hands-on training in clinical praxis has become standard, which is linked with higher danger for the women. To overcome current drawbacks of traditional training methods the European project LAHYSTOTRAIN was set up, that tries to combine Virtual Reality (VR), Multimedia (MM) technology, and Intelligent Tutoring Systems (ITS) to develop an alternative training system for hysteroscopic interventions. The first prototype of the LAHYSTOTRAIN demonstrator has been shown on several European conferences. An evaluation of the system was performed, with the idea, to collect feedback and impressions, that should be considered in further developments. This paper presents the LAHYSTOTRAIN prototype and the results of these evaluations.

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.

Internet-Delivered Dialectical Behavioral Therapy Skills Training for Suicidal and Heavy Episodic Drinkers: Protocol and Preliminary Results of a Randomized Controlled Trial.

PubMed

Wilks, Chelsey; Yin, Qingqing; Ang, Sin Yee; Matsumiya, Brandon; Lungu, Anita; Linehan, Marsha

2017-10-25

The need to develop effective and accessible interventions for suicidal individuals engaging in heavy episodic drinking (HED) cannot be understated. While the link between alcohol use and suicidality is a complex one that remains to be elucidated, emotion dysregulation may play a key role in alcohol-related suicide risk in these individuals. In the current study, an 8-week Internet-delivered dialectical behavior therapy (DBT) skills training intervention was developed and preliminarily evaluated for suicidal individuals who engage in HED to regulate emotions. The aim of the study is to evaluate the feasibility and effectiveness of the therapist-assisted and Internet-delivered intervention, and to inform the design of a subsequent full-scale study. The study was a pilot randomized controlled trial comparing participants receiving immediate-treatment (n=30) to waitlist controls (n=29) over a period of 16 weeks. Intervention effects will be assessed longitudinally using hierarchical linear modeling and generalized estimating equations, along with analyses of effect sizes and clinically significant change. The primary outcomes are suicidal ideation, alcohol problems, and emotion dysregulation. Secondary outcomes include alcohol-related consequences, reasons for living, skills use, and depression. The trial is ongoing. A total of 60 individuals returned their informed consent and were randomized, of whom 59 individuals were intended to treat. A total of 50 participants in the study were retained through the 16-week enrollment. There is a dearth of evidence-based treatment for individuals presenting with high risk and complex behaviors. Furthermore, computerized interventions may provide a beneficial alternative to traditional therapies. The particular clinical features and treatment needs of suicidal individuals who also engage in HED constitute key domains for further investigation that are needed to consolidate the design of appropriate interventions for this high-risk population. Clinicaltrials.gov NCT02932241; https://clinicaltrials.gov/ct2/show/NCT02932241 (Archived by WebCite at http://www.webcitation.org/6uJHdQsC2). ©Chelsey Wilks, Qingqing Yin, Sin Yee Ang, Brandon Matsumiya, Anita Lungu, Marsha Linehan. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 25.10.2017.

Complementary and alternative medicine whole systems research: beyond identification of inadequacies of the RCT.

PubMed

Verhoef, Marja J; Lewith, George; Ritenbaugh, Cheryl; Boon, Heather; Fleishman, Susan; Leis, Anne

2005-09-01

Complementary and alternative medicine (CAM) often consists of whole systems of care (such as naturopathic medicine or traditional Chinese medicine (TCM)) that combine a wide range of modalities to provide individualised treatment. The complexity of these interventions and their potential synergistic effect requires innovative evaluative approaches. Model validity, which encompasses the need for research to adequately address the unique healing theory and therapeutic context of the intervention, is central to whole systems research (WSR). Classical randomised controlled trials (RCTs) are limited in their ability to address this need. Therefore, we propose a mixed methods approach that includes a range of relevant and holistic outcome measures. As the individual components of most whole systems are inseparable, complementary and synergistic, WSR must not focus only on the "active" ingredients of a system. An emerging WSR framework must be non-hierarchical, cyclical, flexible and adaptive, as knowledge creation is continuous, evolutionary and necessitates a continuous interplay between research methods and "phases" of knowledge. Finally, WSR must hold qualitative and quantitative research methods in equal esteem to realize their unique research contribution. Whole systems are complex and therefore no one method can adequately capture the meaning, process and outcomes of these interventions.

The Impact of Telehealth and Care Coordination on the Number and Type of Clinical Visits for Children With Medical Complexity.

PubMed

McKissick, Holly D; Cady, Rhonda G; Looman, Wendy S; Finkelstein, Stanley M

The purpose of this analysis was to evaluate the effects of an advanced practice nurse-delivered telehealth intervention on health care use by children with medical complexity (CMC). Because CMC account for a large share of health care use costs, finding effective ways to care for them is an important challenge requiring exploration. This was a secondary analysis of data from a randomized clinical trial with a control group and two intervention groups. The focus of the analysis was planned and unplanned clinical and therapy visits by CMC over a 30-month data collection period. Nonparametric tests were used to compare visit counts among and within the three groups. The number of unplanned visits decreased over time across all groups, with the greatest decrease in the video telehealth intervention group. Planned visits were higher in the video telehealth group across all time periods. Advanced practice registered nurse-delivered telehealth care coordination may support a shift from unplanned to planned health care service use among CMC. Copyright © 2016 National Association of Pediatric Nurse Practitioners. Published by Elsevier Inc. All rights reserved.

An integrative literature review on nursing interventions aimed at increasing self-care among heart failure patients 1

PubMed Central

Boisvert, Sophie; Proulx-Belhumeur, Alexandra; Gonçalves, Natalia; Doré, Michel; Francoeur, Julie; Gallani, Maria Cecilia

2015-01-01

Abstract Objective: to analyze and summarize knowledge concerning critical components of interventions that have been proposed and implemented by nurses with the aim of optimizing self-care by heart failure patients. Methods: PubMed and CINAHL were the electronic databases used to search full peer-reviewed papers, presenting descriptions of nursing interventions directed to patients or to patients and their families and designed to optimize self-care. Forty-two studies were included in the final sample (n=4,799 patients). Results: this review pointed to a variety and complexity of nursing interventions. As self-care encompasses several behaviors, interventions targeted an average of 3.6 behaviors. Educational/counselling activities were combined or not with cognitive behavioral strategies, but only about half of the studies used a theoretical background to guide interventions. Clinical assessment and management were frequently associated with self-care interventions, which varied in number of sessions (1 to 30); length of follow-up (2 weeks to 12 months) and endpoints. Conclusions: these findings may be useful to inform nurses about further research in self-care interventions in order to propose the comparison of different modalities of intervention, the use of theoretical background and the establishment of endpoints to evaluate their effectiveness. PMID:26444179

Multilevel Interventions: Study Design and Analysis Issues

PubMed Central

Gross, Cary P.; Zaslavsky, Alan M.; Taplin, Stephen H.

2012-01-01

Multilevel interventions, implemented at the individual, physician, clinic, health-care organization, and/or community level, increasingly are proposed and used in the belief that they will lead to more substantial and sustained changes in behaviors related to cancer prevention, detection, and treatment than would single-level interventions. It is important to understand how intervention components are related to patient outcomes and identify barriers to implementation. Designs that permit such assessments are uncommon, however. Thus, an important way of expanding our knowledge about multilevel interventions would be to assess the impact of interventions at different levels on patients as well as the independent and synergistic effects of influences from different levels. It also would be useful to assess the impact of interventions on outcomes at different levels. Multilevel interventions are much more expensive and complicated to implement and evaluate than are single-level interventions. Given how little evidence there is about the value of multilevel interventions, however, it is incumbent upon those arguing for this approach to do multilevel research that explicates the contributions that interventions at different levels make to the desired outcomes. Only then will we know whether multilevel interventions are better than more focused interventions and gain greater insights into the kinds of interventions that can be implemented effectively and efficiently to improve health and health care for individuals with cancer. This chapter reviews designs for assessing multilevel interventions and analytic ways of controlling for potentially confounding variables that can account for the complex structure of multilevel data. PMID:22623596

A Human Systems Integration Perspective to Evaluating Naval Aviation Mishaps and Developing Intervention Strategies

DTIC Science & Technology

2009-12-01

SWISS CHEESE ” MODEL........................................... 16 1. Errors and Violations...16 Figure 5. Reason’s Swiss Cheese Model (After: Reason, 1990, p. 208) ........... 20 Figure 6. The HFACS Swiss Cheese Model of...become more complex. E. REASON’S “ SWISS CHEESE ” MODEL Reason’s (1990) book, Human Error, is generally regarded as the seminal work on the subject

Developing and Evaluating Digital Interventions to Promote Behavior Change in Health and Health Care: Recommendations Resulting From an International Workshop.

PubMed

Michie, Susan; Yardley, Lucy; West, Robert; Patrick, Kevin; Greaves, Felix

2017-06-29

Devices and programs using digital technology to foster or support behavior change (digital interventions) are increasingly ubiquitous, being adopted for use in patient diagnosis and treatment, self-management of chronic diseases, and in primary prevention. They have been heralded as potentially revolutionizing the ways in which individuals can monitor and improve their health behaviors and health care by improving outcomes, reducing costs, and improving the patient experience. However, we are still mainly in the age of promise rather than delivery. Developing and evaluating these digital interventions presents new challenges and new versions of old challenges that require use of improved and perhaps entirely new methods for research and evaluation. This article discusses these challenges and provides recommendations aimed at accelerating the rate of progress in digital behavior intervention research and practice. Areas addressed include intervention development in a rapidly changing technological landscape, promoting user engagement, advancing the underpinning science and theory, evaluating effectiveness and cost-effectiveness, and addressing issues of regulatory, ethical, and information governance. This article is the result of a two-day international workshop on how to create, evaluate, and implement effective digital interventions in relation to health behaviors. It was held in London in September 2015 and was supported by the United Kingdom's Medical Research Council (MRC), the National Institute for Health Research (NIHR), the Methodology Research Programme (PI Susan Michie), and the Robert Wood Johnson Foundation of the United States (PI Kevin Patrick). Important recommendations to manage the rapid pace of change include considering using emerging techniques from data science, machine learning, and Bayesian approaches and learning from other disciplines including computer science and engineering. With regard to assessing and promoting engagement, a key conclusion was that sustained engagement is not always required and that for each intervention it is useful to establish what constitutes "effective engagement," that is, sufficient engagement to achieve the intended outcomes. The potential of digital interventions for testing and advancing theories of behavior change by generating ecologically valid, real-time objective data was recognized. Evaluations should include all phases of the development cycle, designed for generalizability, and consider new experimental designs to make the best use of rich data streams. Future health economics analyses need to recognize and model the complex and potentially far-reaching costs and benefits of digital interventions. In terms of governance, developers of digital behavior interventions should comply with existing regulatory frameworks, but with consideration for emerging standards around information governance, ethics, and interoperability. ©Susan Michie, Lucy Yardley, Robert West, Kevin Patrick, Felix Greaves. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 29.06.2017.

Interventions to reduce discrimination and stigma: the state of the art.

PubMed

Gronholm, Petra C; Henderson, Claire; Deb, Tanya; Thornicroft, Graham

2017-03-01

There is a rich literature on the nature of mental health-related stigma and the processes by which it severely affects the life chances of people with mental health problems. However, applying this knowledge to deliver and evaluate interventions to reduce discrimination and stigma in a lasting way is a complex and long-term challenge. We conducted a narrative synthesis of systematic reviews published since 2012, and supplemented this with papers published subsequently as examples of more recent work. There is evidence for small to moderate positive impacts of both mass media campaigns and interventions for target groups in terms of stigma-related knowledge, attitudes, and intended behaviour in terms of desire for contact. However, the limited evidence from longer follow-up times suggests that it is not clear whether short-term contact interventions have a lasting impact. The risk that short-term interventions may only have a short-term impact suggests a need to study longer term interventions and to use interim process and outcome data to improve interventions along the way. There is scope for more thorough application of intergroup contact theory whenever contact is used and of evidence-based teaching and assessment methods when skills training is used for target groups.

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.

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

Accounting for the impact of conservation on human well-being.

PubMed

Milner-Gulland, E J; McGregor, J A; Agarwala, M; Atkinson, G; Bevan, P; Clements, T; Daw, T; Homewood, K; Kumpel, N; Lewis, J; Mourato, S; Palmer Fry, B; Redshaw, M; Rowcliffe, J M; Suon, S; Wallace, G; Washington, H; Wilkie, D

2014-10-01

Conservationists are increasingly engaging with the concept of human well-being to improve the design and evaluation of their interventions. Since the convening of the influential Sarkozy Commission in 2009, development researchers have been refining conceptualizations and frameworks to understand and measure human well-being and are starting to converge on a common understanding of how best to do this. In conservation, the term human well-being is in widespread use, but there is a need for guidance on operationalizing it to measure the impacts of conservation interventions on people. We present a framework for understanding human well-being, which could be particularly useful in conservation. The framework includes 3 conditions; meeting needs, pursuing goals, and experiencing a satisfactory quality of life. We outline some of the complexities involved in evaluating the well-being effects of conservation interventions, with the understanding that well-being varies between people and over time and with the priorities of the evaluator. Key challenges for research into the well-being impacts of conservation interventions include the need to build up a collection of case studies so as to draw out generalizable lessons; harness the potential of modern technology to support well-being research; and contextualize evaluations of conservation impacts on well-being spatially and temporally within the wider landscape of social change. Pathways through the smog of confusion around the term well-being exist, and existing frameworks such as the Well-being in Developing Countries approach can help conservationists negotiate the challenges of operationalizing the concept. Conservationists have the opportunity to benefit from the recent flurry of research in the development field so as to carry out more nuanced and locally relevant evaluations of the effects of their interventions on human well-being. © 2014 The Authors. Conservation Biology published by Wiley Periodicals, Inc., on behalf of the Society for Conservation Biology.

Risk and protective factors for sexual risk taking among adolescents involved in Prime Time.

PubMed

Garwick, Ann; Nerdahl, Peggy; Banken, Rachel; Muenzenberger-Bretl, Lynn; Sieving, Renee

2004-10-01

This article describes a preliminary qualitative evaluation of risk and protective factors associated with consistent contraceptive use and healthy sexual decision-making among ten of the first participants in the Prime Time intervention study. Prime Time is an 18-month intervention including one-on-one case management and peer educator training targeting sexually active 13-17-year-old girls who are recruited from health care clinics. Using an approach grounded in findings from previous research, social cognitive theory, and the social development model, Prime Time aims to improve participants' contraceptive use consistency, reduce number of sexual partners, and reduce unwanted sexual activity. Findings from this preliminary evaluation alert health care providers to the complex and dynamic nature of adolescent girls' sexual behaviors and to a broad range of risk and protective factors within individuals and their environments that may influence adolescent girls' sexual behaviors and contraceptive use. Findings suggest that an ongoing, supportive relationship with a case manager who is able to pace and tailor an intervention to the individual young person can have positive effects on adolescent girls' sexual behaviors and contraceptive use.

Clinical effectiveness of knee rehabilitation techniques and implications for a self-care treatment model.

PubMed

Button, Kate; Iqbal, Arshi S; Letchford, Robert H; van Deursen, Robert W M

2012-12-01

Physiotherapy is a complex intervention frequently recommended for knee conditions. The International Classification of Functioning and Disability (ICF) can be used as a framework to evaluate evidence to develop care models and clinical guidelines. To evaluate the clinical effectiveness of knee rehabilitation modalities categorised according to the ICF domains. A keyword search of Medline, Cinahl, Amed, Embase and Cochrane databases from 1996 to 2010 using terms related to the knee joint and physiotherapeutic interventions. Reviewer assessment using inclusion/exclusion criteria and a quality assessment tool compiled from the Critical Appraisal Skills Programme Tool, Consort and Cochrane Bone Joint and Muscle Trauma Groups. Information about the research design, intervention and subjects was extracted. Outcome measures and findings were categorised according to ICF domains. The majority of studies evaluated exercise. Findings were supportive but specific recommendations were limited due to variations in content and application. There was limited quality research to support the theory that manual therapy, electrotherapy or taping in isolation contributes to recovery. Multimodality physiotherapy programmes were found to be beneficial and to reflect clinical practice, but the effectiveness of each component is unknown. Outcome measures from the participation domain of the ICF were used least frequently and were not generally true measures of participation. Development of participation outcome measures is required to evaluate the long-term benefits of interventions. Rehabilitation should be based around delivery of effective exercise programmes incorporating participation outcomes to provide feedback and complement self-care for knee conditions. Copyright © 2011 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Meta-analysis of the effectiveness of nursing discharge planning interventions for older inpatients discharged home.

PubMed

Mabire, Cédric; Dwyer, Andrew; Garnier, Antoine; Pellet, Joanie

2018-04-01

To determine the effectiveness of nursing discharge planning interventions on health-related outcomes for older inpatients discharged home. Inadequate discharge planning for the ageing population poses significant challenges for health services. Effective discharge planning interventions have been examined in several studies, but little information is available on nursing interventions for older people. Despite the research published on the importance of discharge planning, the impact on patient's health outcomes still needs to be evaluated in practice. Systematic review and meta-analysis. A systematic search was undertaken across 13 databases to retrieve published and unpublished studies in English between 2000-2015. Critical appraisal, data extraction and meta-analysis followed the methodology of the Joanna Briggs Institute. Thirteen studies were included in the review, 2 of 13 were pilot studies and one had a pre-post design. Included studies involved 3,964 participants with a median age of 77 years. Nurse discharge planning did not significantly reduce hospital readmission or quality of life, except readmission was lower across studies conducted in the USA. The overall effect score for nurse discharge planning on length of stay was statistically significant and positive. Nursing discharge planning is a complex intervention and difficult to evaluate. Findings suggest that nursing discharge planning for older inpatients discharged home increases the length of stay yet neither reduces readmission rate nor improves quality of life. © 2017 John Wiley & Sons Ltd.

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…

Physical activity and the rejuvenation of Connswater (PARC study): protocol for a natural experiment investigating the impact of urban regeneration on public health

PubMed Central

2013-01-01

Background There is a dearth of evidence regarding the impact of urban regeneration projects on public health, particularly the nature and degree to which urban regeneration impacts upon health-related behaviour change. Natural experiment methodology enables comprehensive large-scale evaluations of such interventions. The Connswater Community Greenway in Belfast is a major urban regeneration project involving the development of a 9 km linear park, including the provision of new cycle paths and walkways. In addition to the environmental improvements, this complex intervention involves a number of programmes to promote physical activity in the regenerated area. The project affords a unique opportunity to investigate the public health impact of urban regeneration. Methods/Design The evaluation framework was informed by the socio-ecological model and guided by the RE-AIM Framework. Key components include: (1) a quasi-experimental before-and-after survey of the Greenway population (repeated cross-sectional design), in tandem with data from a parallel Northern Ireland-wide survey for comparison; (2) an assessment of changes in the local built environment and of walkability using geographic information systems; (3) semi-structured interviews with a purposive sample of survey respondents, and a range of community stakeholders, before and after the regeneration project; and (4) a cost-effectiveness analysis. The primary outcome is change in proportion of individuals identified as being regularly physically active, according to the current UK recommendations. The RE-AIM Framework will be used to make an overall assessment of the impact of the Greenway on the physical activity behaviour of local residents. Discussion The Connswater Community Greenway provides a significant opportunity to achieve long-term, population level behaviour change. We argue that urban regeneration may be conceptualised meaningfully as a complex intervention comprising multiple components with the potential, individually and interactively, to affect the behaviour of a diverse population. The development and implementation of our comprehensive evaluation framework reflects this complexity and illuminates an approach to the empirical, rigorous evaluation of urban regeneration. More specifically, this study will add to the much needed evidence-base about the impact of urban regeneration on public health as well as having important implications for the development of natural experiment methodology. PMID:24103381

Physical activity and the rejuvenation of Connswater (PARC study): protocol for a natural experiment investigating the impact of urban regeneration on public health.

PubMed

Tully, Mark A; Hunter, Ruth F; McAneney, Helen; Cupples, Margaret E; Donnelly, Michael; Ellis, Geraint; Hutchinson, George; Prior, Lindsay; Stevenson, Michael; Kee, Frank

2013-08-23

There is a dearth of evidence regarding the impact of urban regeneration projects on public health, particularly the nature and degree to which urban regeneration impacts upon health-related behaviour change. Natural experiment methodology enables comprehensive large-scale evaluations of such interventions. The Connswater Community Greenway in Belfast is a major urban regeneration project involving the development of a 9 km linear park, including the provision of new cycle paths and walkways. In addition to the environmental improvements, this complex intervention involves a number of programmes to promote physical activity in the regenerated area. The project affords a unique opportunity to investigate the public health impact of urban regeneration. The evaluation framework was informed by the socio-ecological model and guided by the RE-AIM Framework. Key components include: (1) a quasi-experimental before-and-after survey of the Greenway population (repeated cross-sectional design), in tandem with data from a parallel Northern Ireland-wide survey for comparison; (2) an assessment of changes in the local built environment and of walkability using geographic information systems; (3) semi-structured interviews with a purposive sample of survey respondents, and a range of community stakeholders, before and after the regeneration project; and (4) a cost-effectiveness analysis. The primary outcome is change in proportion of individuals identified as being regularly physically active, according to the current UK recommendations. The RE-AIM Framework will be used to make an overall assessment of the impact of the Greenway on the physical activity behaviour of local residents. The Connswater Community Greenway provides a significant opportunity to achieve long-term, population level behaviour change. We argue that urban regeneration may be conceptualised meaningfully as a complex intervention comprising multiple components with the potential, individually and interactively, to affect the behaviour of a diverse population. The development and implementation of our comprehensive evaluation framework reflects this complexity and illuminates an approach to the empirical, rigorous evaluation of urban regeneration. More specifically, this study will add to the much needed evidence-base about the impact of urban regeneration on public health as well as having important implications for the development of natural experiment methodology.

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.

Public health economics: a systematic review of guidance for the economic evaluation of public health interventions and discussion of key methodological issues

PubMed Central

2013-01-01

Background If Public Health is the science and art of how society collectively aims to improve health, and reduce inequalities in health, then Public Health Economics is the science and art of supporting decision making as to how society can use its available resources to best meet these objectives and minimise opportunity cost. A systematic review of published guidance for the economic evaluation of public health interventions within this broad public policy paradigm was conducted. Methods Electronic databases and organisation websites were searched using a 22 year time horizon (1990–2012). References of papers were hand searched for additional papers for inclusion. Government reports or peer-reviewed published papers were included if they; referred to the methods of economic evaluation of public health interventions, identified key challenges of conducting economic evaluations of public health interventions or made recommendations for conducting economic evaluations of public health interventions. Guidance was divided into three categories UK guidance, international guidance and observations or guidance provided by individual commentators in the field of public health economics. An assessment of the theoretical frameworks underpinning the guidance was made and served as a rationale for categorising the papers. Results We identified 5 international guidance documents, 7 UK guidance documents and 4 documents by individual commentators. The papers reviewed identify the main methodological challenges that face analysts when conducting such evaluations. There is a consensus within the guidance that wider social and environmental costs and benefits should be looked at due to the complex nature of public health. This was reflected in the theoretical underpinning as the majority of guidance was categorised as extra-welfarist. Conclusions In this novel review we argue that health economics may have come full circle from its roots in broad public policy economics. We may find it useful to think in this broader paradigm with respect to public health economics. We offer a 12 point checklist to support government, NHS commissioners and individual health economists in their consideration of economic evaluation methodology with respect to the additional challenges of applying health economics to public health. PMID:24153037

The Human Behaviour-Change Project: harnessing the power of artificial intelligence and machine learning for evidence synthesis and interpretation.

PubMed

Michie, Susan; Thomas, James; Johnston, Marie; Aonghusa, Pol Mac; Shawe-Taylor, John; Kelly, Michael P; Deleris, Léa A; Finnerty, Ailbhe N; Marques, Marta M; Norris, Emma; O'Mara-Eves, Alison; West, Robert

2017-10-18

Behaviour change is key to addressing both the challenges facing human health and wellbeing and to promoting the uptake of research findings in health policy and practice. We need to make better use of the vast amount of accumulating evidence from behaviour change intervention (BCI) evaluations and promote the uptake of that evidence into a wide range of contexts. The scale and complexity of the task of synthesising and interpreting this evidence, and increasing evidence timeliness and accessibility, will require increased computer support. The Human Behaviour-Change Project (HBCP) will use Artificial Intelligence and Machine Learning to (i) develop and evaluate a 'Knowledge System' that automatically extracts, synthesises and interprets findings from BCI evaluation reports to generate new insights about behaviour change and improve prediction of intervention effectiveness and (ii) allow users, such as practitioners, policy makers and researchers, to easily and efficiently query the system to get answers to variants of the question 'What works, compared with what, how well, with what exposure, with what behaviours (for how long), for whom, in what settings and why?'. The HBCP will: a) develop an ontology of BCI evaluations and their reports linking effect sizes for given target behaviours with intervention content and delivery and mechanisms of action, as moderated by exposure, populations and settings; b) develop and train an automated feature extraction system to annotate BCI evaluation reports using this ontology; c) develop and train machine learning and reasoning algorithms to use the annotated BCI evaluation reports to predict effect sizes for particular combinations of behaviours, interventions, populations and settings; d) build user and machine interfaces for interrogating and updating the knowledge base; and e) evaluate all the above in terms of performance and utility. The HBCP aims to revolutionise our ability to synthesise, interpret and deliver evidence on behaviour change interventions that is up-to-date and tailored to user need and context. This will enhance the usefulness, and support the implementation of, that evidence.

Public health economics: a systematic review of guidance for the economic evaluation of public health interventions and discussion of key methodological issues.

PubMed

Edwards, Rhiannon Tudor; Charles, Joanna Mary; Lloyd-Williams, Huw

2013-10-24

If Public Health is the science and art of how society collectively aims to improve health, and reduce inequalities in health, then Public Health Economics is the science and art of supporting decision making as to how society can use its available resources to best meet these objectives and minimise opportunity cost. A systematic review of published guidance for the economic evaluation of public health interventions within this broad public policy paradigm was conducted. Electronic databases and organisation websites were searched using a 22 year time horizon (1990-2012). References of papers were hand searched for additional papers for inclusion. Government reports or peer-reviewed published papers were included if they; referred to the methods of economic evaluation of public health interventions, identified key challenges of conducting economic evaluations of public health interventions or made recommendations for conducting economic evaluations of public health interventions. Guidance was divided into three categories UK guidance, international guidance and observations or guidance provided by individual commentators in the field of public health economics. An assessment of the theoretical frameworks underpinning the guidance was made and served as a rationale for categorising the papers. We identified 5 international guidance documents, 7 UK guidance documents and 4 documents by individual commentators. The papers reviewed identify the main methodological challenges that face analysts when conducting such evaluations. There is a consensus within the guidance that wider social and environmental costs and benefits should be looked at due to the complex nature of public health. This was reflected in the theoretical underpinning as the majority of guidance was categorised as extra-welfarist. In this novel review we argue that health economics may have come full circle from its roots in broad public policy economics. We may find it useful to think in this broader paradigm with respect to public health economics. We offer a 12 point checklist to support government, NHS commissioners and individual health economists in their consideration of economic evaluation methodology with respect to the additional challenges of applying health economics to public health.