Intervention Development Studies Research Articles

P93: Characteristics of complex, non-pharmacological cognitive stimulation interventions for people with dementia in nursing homes: systematic review

Objective:Several guidelines propose the use of cognitive stimulation (CS) in people with dementia. Multi-component CS interventions seem most effective in improving cognitive function, quality of life, and behavioral and psychological symptoms of dementia. For successful implementation, it is important to analyze CS interventions in detail in order to identify frequently used and potentially effective components. The aim of this systematic review is to identify, describe and summarise multicomponent CS interventions conducted in nursing homes aiming to improve cognitive function, quality of life, mood, and behavior of people with dementia in nursing homes.Methods:This review is based on established methodological frameworks for systematic evidence syntheses. We conducted a database search in February 2021, using PubMed, CENTRAL, PsycINFO, ALOIS and CINAHL. Two independent reviewers assessed all search results for eligible studies and assessed studies’ methodological quality using the Cochrane Risk of Bias tool for RCTs and the Joanna Briggs Institute checklist for quasi-experimental studies. Evaluation and intervention development studies of any design examining multicomponent interventions CS were included. Components of included intervention programs were analyzed using the TIDieR and CReDECI 2 criteria following a narrative analysis.Results:We identified 19,992 references and included 45 publications. We observed large heterogeneity regarding intervention components, delivery, materials, mode of delivery, intervention provider, and intervention duration. Intervention components included for example reminiscence therapy, activities of daily living, cognitive exercises or reality orientation. Risk of bias was generally low. Reporting of complex interventions was frequently insufficient. No study reported patient and public involvement (PPI) at any stage of the research process.Conclusion:This systematic review is the first to describe complex CS interventions conducted in nursing homes in detail. Results indicate the need for more detailed intervention description for future studies based on TIDieR and CReDECI2 guidelines to allow reliable replication of these interventions. Despite enormous research activities, many questions regarding the implementation and efficacy are still unanswered as process evaluations are lacking. In addition, reproducibility of interventions is hardly possible due to limited reporting. Future studies should use established frameworks for the development, evaluation and implementation of complex interventions and apply PPI concepts.

Advance care planning to patients with chronic kidney disease and their families: An intervention development study.

To develop an advance care planning intervention based on the needs of patients with chronic kidney disease, families and healthcare professionals. Patients with chronic kidney disease and their families request early advance care planning that continues throughout their illness trajectory. Healthcare professionals experience barriers to initiating advance care planning. Involvement of stakeholders in development of health interventions is important, to identify priorities, understand the problem and find solutions. The development was inspired by the Medical Research Council's framework, and codesign was applied. One future workshop and one design workshop were conducted with the consumers. The process was iterative, and data were analysed using the action research spiral. The Guidance for reporting intervention development studies in healthcare (GUIDED) was used. Five areas were considered significant to an advance care planning intervention; a biopsychosocial approach, early palliative care, a family-focused approach, early and continuous advance care planning and a consumer-centred approach. Based on these, a conversation process with healthcare professionals was designed to give patients and families the opportunity to share values, preferences and wishes for treatment and their family and everyday life. Codesign facilitated a collaborative process that allowed the consumers to have a significant impact on the design of an advance care planning intervention. A conversation process concerning everyday life, illness and treatment was designed for patients and families. The intervention included an advance care planning tool to guide the healthcare professionals. The intervention has the intention to improve the communication between healthcare professionals, patients and families. The study provides important knowledge about the significance of giving the patients and their families support in sharing their values, preferences and wishes for treatment and everyday life, thus, to improve care and treatment in their illness trajectory. What problem did the study address Patients with chronic kidney disease and their families strongly request early initiation of advance care planning that continues throughout the illness trajectory. Healthcare professionals experience barriers to the initiation of the advance care planning and request a more systematic approach. What were the main findings Development of a conversation process about everyday life, illness and treatment for patients diagnosed with chronic kidney disease and families, including an advance care planning tool to guide the healthcare professionals. Where and on whom will the research have an impact The study contributes an advance care planning intervention to patients in the early stages of chronic kidney disease and their families. We believe that the intervention could be included during consultations with healthcare professionals in other stages of chronic kidney disease as well as other chronic disease. To strengthen the reporting of the development of the advance care planning intervention, we used the Guidance for reporting intervention development studies in healthcare (GUIDED). The development of the intervention in this study was a collaborative process between patients, families, healthcare professionals and representatives from the Danish Kidney Association, the department's user council and the research team.

Protective positive psychology factors and emotional distress after cardiac arrest

BackgroundThere is a critical need to identify factors that can prevent emotional distress post-cardiac arrest (CA). CA survivors have previously described benefitting from utilizing positive psychology constructs (mindfulness, existential well-being, resilient coping, social support) to cope with distress. Here, we explored associations between positive psychology factors and emotional distress post-CA. MethodsWe recruited CA survivors treated from 4/2021–9/2022 at a single academic medical center. We assessed positive psychology factors (mindfulness [Cognitive and Affective Mindfulness Scale-Revised], existential well-being [Meaning in Life Questionnaire Presence of Meaning subscale], resilient coping [Brief Resilient Coping Scale], perceived social support [ENRICHD Social Support Inventory]) and emotional distress (posttraumatic stress [Posttraumatic Stress Checklist-5], anxiety and depression symptoms [PROMIS Emotional Distress – Anxiety and Depression Short Forms 4a]) just before discharge from the index hospitalization. We selected covariates for inclusion in our multivariable models based on an association with any emotional distress factor (p < 0.10). For our final, multivariable regression models, we individually tested the independent association of each positive psychology factor and emotional distress factor. ResultsWe included 110 survivors (mean age 59 years, 64% male, 88% non-Hispanic White, 48% low income); 36.4% of survivors scored above the cut-off for at least one measure of emotional distress. In separate adjusted models, each positive psychology factor was independently associated with emotional distress (β: −0.20 to −0.42, all p < 0.05). ConclusionsHigher levels of mindfulness, existential well-being, resilient coping, and perceived social support were each associated with less emotional distress. Future intervention development studies should consider these factors as potential treatment targets.

Recruiting Socially Disconnected Latinos Caring for a Person with Alzheimer’s Disease and Related Dementias During the COVID-19 Pandemic: Lessons Learned

ABSTRACT Objectives The purpose of this article is to present conceptual and methodological challenges to recruitment strategies in enrolling socially disconnected middle-aged and older Latino caregivers of a loved one with Alzheimer’s disease and related dementias (ADRD). Methods Middle-aged and older Latino ADRD caregivers were recruited into two early stage, intervention development studies during the COVID-19 pandemic via online or in-person methods. Recruitment criteria included Latino ADRD caregivers over the age of 40 reporting elevated loneliness on the UCLA 3-item Loneliness Scale (LS) during screening. Results Middle-aged, Latino caregivers were recruited predominantly from online methods whereas older caregivers were mostly recruited from in-person methods. We report challenges identifying socially disconnected Latino caregivers using the UCLA 3-item LS. Conclusions Our findings support previously reported disparities in recruitment by age and language and suggest further methodological considerations to assess social disconnection among Latino caregivers. We discuss recommendations to overcome these challenges in future research. Clinical Implications Socially disconnected Latino ADRD caregivers have an elevated risk for poor mental health outcomes. Successful recruitment of this population in clinical research will ensure the development of targeted and culturally sensitive interventions to improve the mental health and overall well-being of this marginalized group.

Video-augmentation of the informed consent process in mental health research: An exploratory study from India.

Only around 50-75% of individuals fully understand the various aspects of informed consent in research. The aim of our study was to examine whether supplementing the conventional paper-based informed consent process with an audiovisual aid improves participants' understanding of the informed consent process and the information conveyed to them. Participants from two mental health/substance use intervention development studies were recruited for this study through consecutive sampling. They were then administered the traditional paper information and consenting process by itself or in combination with a video depicting the procedures of the study. Subsequently a bespoke questionnaire was administered to assess the participants' understanding of the information conveyed to them about the parent study. The various domains of the questionnaire were compared between those who were administered the two different consenting processes using the chi square test. 27 (58.7%) participants were administered the traditional consenting process and 19 were administered the video-supplemented consenting process. The video-supplemented consenting process was not superior to the traditional paper-based informed consent process on any of the domains examined. In settings with participants having a limited education, and in research involving people with mental health or substance use problems, further research is necessary to identify contextually relevant best practices for the informed consent process.

6.Q. Workshop: Developing interventions to improve health and wellbeing of sexual and gender minority populations

Abstract In recent years, public health research has increasingly focused on identifying various risk factors purportedly leading to poor social, mental, and physical health among sexual and gender minorities (SGM). There is however, still a great paucity of research focusing on facilitators, barriers, and characteristics that may help inform the creation and implementation of successful and affirming interventions aimed at improving health outcomes in these communities. Building upon knowledge of implementation science, this workshop will showcase important aspects that need to be weighed when designing interventions for these communities. The definite strength of this workshop is the focus on lessons learned from theory-driven and evidence-supported intervention development processes, as well as from evaluation of implemented interventions and research results which highlight the efficacy of such interventions. These lessons have a great potential for further implementation across social and cultural contexts and can shape the design of future interventions. The presentations in this workshop will feature results from high-quality international studies focusing on SGM communities in Europe and the USA. Moreover, the presentations take into consideration various points of view (both from SGM individuals but also stakeholders, policy makers, and health care workers) and show results from studies across various stages of implementation (from intervention development, feasibility and baseline cross-sectional studies to evaluated interventions). With this balance in mind as well as limiting the number of presentations, ample time will be reserved for meaningful discussions with the audience and experts to gain further insight. Radhika Seiler-Ramadas will present qualitative results of a multi-center European study focusing on facilitators and barriers in implementing anti-discrimination interventions at the workplace. The results will include insights from both SGM youth as well as relevant stakeholders. Lovro Markovic will present results on the patient-physician relationship in trans and non-binary people who are undergoing medical transitioning and how these may improve their experiences in the healthcare system. Continuing with the patient-healthcare system interaction and further connections to care and community, Arjan van der Star will present results of a feasibility study focusing on the implementation of the patient navigation model in SGM youth and young adults focusing on prevention of suicide. Subsequently, Stefanie Kirchner will present results of a randomized controlled trial to reduce suicidality in SGM youth using video messages containing narratives from SGM persons themselves. Key messages More work is needed to elucidate facilitators and barriers for successful design and implementation of interventions in sexual and gender minorities who are at greater risk for poor health. Understanding developments in implementation of public health interventions aiming at sexual and gender minorities is essential for reducing health inequities in this vulnerable population.

Conducting Digital Health Care Research: Document Analysis of Challenges Experienced During Intervention Development and Feasibility Study Setup of an Internet-Administered Intervention for Parents of Children Treated for Cancer.

BackgroundThe design and conduct of research to develop, test, and evaluate complex health care interventions is challenging. Although the existing literature describes key challenges associated with the design and conduct of definitive (evaluation) trials, there is a lack of information concerning specific challenges associated with the intervention development phase and setup of feasibility studies. In particular, the literature is scarce concerning the challenges associated with conducting digital health care research, such as research on internet-administered interventions and research using digital features to support the execution of study procedures (eg, recruitment, consent, retention, and data collection and management). This study is conducted in the context of the intervention development and feasibility study setup phases of an internet-administered, guided, low-intensity cognitive behavioral therapy–based intervention for parents of children previously treated for cancer.ObjectiveThe aim of this study is to explore the challenges experienced during the development phase of the internet-administered intervention and digital features to support the execution of the study procedures and a feasibility study setup.MethodsTo explore the key challenges experienced, we conducted a document analysis of written records from all study meetings held by the research team (meeting minutes) between June 7, 2018, and January 10, 2020, guided by a thematic analysis approach. Furthermore, discussion groups with members of the research team were held to develop a more detailed understanding of the key challenges experienced. Methods and results are reported in accordance with the relevant items from the Standards for Reporting Qualitative Research checklist.ResultsSix main themes were identified: decision-making and communication, expertise, external constraints, flexibility, planning and scheduling, and technical constraints.ConclusionsSignificant challenges were experienced during the intervention development and setup phases of the feasibility study. Implications are discussed to inform future design, conduct, and planning of internet-administered intervention development and feasibility studies, especially within the context of digital health care research.

Developing a complex intervention targeting antipsychotic prescribing to nursing home residents with dementia

Background: Antipsychotics are commonly prescribed to people living with dementia in nursing home settings, despite strong guideline recommendations against their use except in limited circumstances. We aimed to transparently describe the development process for a complex intervention targeting appropriate requesting and prescribing of antipsychotics to nursing home residents with dementia in Ireland, by nurses and general practitioners (GPs) respectively. Methods: We report the development process for the ‘Rationalising Antipsychotic Prescribing in Dementia’ (RAPID) complex intervention, in accordance with the ‘Guidance for reporting intervention development studies in health research’ (GUIDED) checklist. The UK Medical Research Council framework for developing and evaluating complex interventions guided our overall approach, incorporating evidence and theory into the intervention development process. To unpack the intervention development process in greater detail, we followed the Behaviour Change Wheel approach. Guided by our stakeholders, we conducted three sequential studies (systematic review and qualitative evidence synthesis, primary qualitative study and expert consensus study), to inform the intervention development. Results: The RAPID complex intervention was developed in collaboration with a broad range of stakeholders, including people living with dementia and family carers, between 2015 and 2017. The finalised RAPID complex intervention was comprised of the following three components; 1) Education and training sessions with nursing home staff; 2) Academic detailing with GPs; 3) Introduction of an assessment tool to the nursing home. Conclusions: This paper describes the steps used by the researchers to develop a complex intervention targeting antipsychotic prescribing to nursing home residents with dementia in Ireland, according to the GUIDED checklist. We found that the GUIDED checklist provided a useful way of reporting all elements in a cohesive manner and complemented the other tools and frameworks used. Transparency in the intervention development processes can help in the translation of evidence into practice.

A Multi-Domain Group-Based Intervention to Promote Physical Activity, Healthy Nutrition, and Psychological Wellbeing in Older People with Losses in Intrinsic Capacity: AMICOPE Development Study.

The World Health Organization has developed the Integrated Care of Older People (ICOPE) strategy, a program based on the measurement of intrinsic capacity (IC) as “the composite of all physical and mental attributes on which an individual can draw”. Multicomponent interventions appear to be the most effective approach to enhance IC and to prevent frailty and disability since adapted physical activity is the preventive intervention that has shown the most evidence in the treatment of frailty and risk of falls. Our paper describes the development of a multi-domain group-based intervention addressed to older people living in the community, aimed at improving and/or maintaining intrinsic capacity by means of promoting physical activity, healthy nutrition, and psychological wellbeing in older people. The process of intervention development is described following the Guidance for reporting intervention development studies in health research (GUIDED). The result of this study is the AMICOPE intervention (Aptitude Multi-domain group-based intervention to improve and/or maintain IC in Older PEople) built upon the ICOPE framework and described following the Template for Intervention Description and Replication (TIDieR) guidelines. The intervention consists of 12 face-to-face sessions held weekly for 2.5 h over three months and facilitated by a pair of health and social care professionals. This study represents the first stage of the UK Medical Research Council framework for developing and evaluating a complex intervention. The next step should be carrying out a feasibility study for the AMICOPE intervention and, at a later stage, assessing the effectiveness in a randomized controlled trial.

Motivational interviewing telephone counseling to increase postpartum maintenance of abstinence from tobacco

Although many women quit smoking while pregnant, rates of relapse after delivery are high. We examined the effectiveness of motivational interviewing (MI) in maintaining postpartum abstinence from smoking among pregnant women who recently quit smoking (N = 382), randomized to receive five brief MI phone counseling calls or to a prenatal and postpartum care as usual control condition. Relapse to smoking was assessed at 3, 6, and 12 months postpartum based on self-report and urine cotinine. Cox regressions compared conditions on relapse outcomes and hazard ratio of total number of MI calls was examined to probe dose-response effects. Results revealed no difference in the hazard ratio of relapse between treatment condition and no dose-response effect of total number of MI calls. Phone counseling in the prenatal and postpartum period did not facilitate maintenance of abstinence among new mothers. Considerations for future intervention development studies on relapse prevention during the postpartum period are discussed.

Developing a complex intervention targeting antipsychotic prescribing to nursing home residents with dementia.

Background: Antipsychotics are commonly prescribed to people living with dementia in nursing home settings, despite strong guideline recommendations against their use except in limited circumstances. We aimed to transparently describe the development process for a complex intervention targeting appropriate requesting and prescribing of antipsychotics to nursing home residents with dementia in Ireland, by nurses and general practitioners (GPs) respectively. Methods: We report the development process for the 'Rationalising Antipsychotic Prescribing in Dementia' (RAPID) complex intervention, in accordance with the 'Guidance for reporting intervention development studies in health research' (GUIDED) checklist. The UK Medical Research Council framework for developing and evaluating complex interventions guided our overall approach, incorporating evidence and theory into the intervention development process. To unpack the intervention development process in greater detail, we followed the Behaviour Change Wheel approach. Guided by our stakeholders, we conducted three sequential studies (systematic review and qualitative evidence synthesis, primary qualitative study and expert consensus study), to inform the intervention development. Results: The RAPID complex intervention was developed in collaboration with a broad range of stakeholders, including people living with dementia and family carers, between 2015 and 2017. The finalised RAPID complex intervention was comprised of the following three components; 1) Education and training sessions with nursing home staff; 2) Academic detailing with GPs; 3) Introduction of an assessment tool to the nursing home. Conclusions: This paper describes the steps used by the researchers to develop a complex intervention targeting antipsychotic prescribing to nursing home residents with dementia in Ireland, according to the GUIDED checklist. We found that the GUIDED checklist provided a useful way of reporting all elements in a cohesive manner and complemented the other tools and frameworks used. Transparency in the intervention development processes can help in the translation of evidence into practice.

Izbijanje epidemije COVID-19 virusa - kako mreža javnog zdravlja može funkcionisati bolje u prosleđivanju informacija i instrukcija za akcije - naučene lekcije

The priority for the period of COVID-19 outbreak was to provide fast, well-timed dissemination of information to the general population (especially vulnerable groups) as well to health professionals and professionals from other areas of public life (police, army, local governments, education, and the business sector) on behavior change and prevention measures, in terms of guidance for the current epidemiological situation. At the Public Health Institute Niš, Serbia, we directed activities relying primarily on formal intervention approaches, WHO guidance and on information and knowledge gained at the April 2019 WHO "Emergency Risk Communication training and plan-writing workshop" in Belgrade/Serbia. To define the advantages and disadvantages of the applied method for dissemination of information, we followed the reporting guidance contained in Duncan E and colleagues', Guidance for reporting intervention development studies in health research (GUIDED). Guidelines for treatment and recommendations were disseminated through standard communication channels. A local public health network with a large number of partners from the governmental and non-governmental sector, established in recent years, was a kind of channel for dissemination of materials. We realized that formal intervention approaches should be rapidly improved by better mapping of all population groups, by modern ways of communication, by urgent introduction of digital communication channels such as telemedicine, smart phone engagement and internet applications, in order to educate and exchange information more efficiently and quickly, especially in crisis situations such as COVID-19 epidemics/pandemics.

Guidance for reporting intervention development studies in health research (GUIDED): an evidence-based consensus study

ObjectiveTo improve the quality and consistency of intervention development reporting in health research.DesignThis was a consensus exercise consisting of two simultaneous and identical three-round e-Delphi studies (one with experts in...

Communication strategies for designing Facebook advertising campaigns to recruit rural participants to develop healthcare delivery interventions.

Little is known about designing research recruitment campaigns that connect with underserved, geographically isolated rural populations. A theoretically informed process is needed to assist research teams and practitioners in their evaluation of Facebook's feasibility as a recruitment tool and development of online materials for recruiting rural adults into healthcare delivery intervention development studies. We drew from research and theory in communication and incorporated process analysis techniques to develop replicable procedures for designing and evaluating Facebook campaigns for rural recruitment. We describe our process and illustrate using two case studies. Campaigns received approximately 1000 link clicks from the target rural demographic and successfully enrolled participants using Facebook as a primary method of recruitment. The rural tobacco intervention development study received a total of 477 link clicks, cost only $155.80, and enrolled three (23%) of its 13 participants from Facebook. The rural mental health intervention development study received a total of 518 link clicks, cost only $233.28, and enrolled 178 participants. Our process yielded two successful recruitment campaigns. Facebook was an affordable and efficacious strategy for enrolling adults in behavioral research studies on tobacco and mental health. Future work should apply these theoretical techniques to additional study topics and evaluate specific message features associated with recruitment.

Using a Social Support Framework to Understand How HIV Positive Kenyan Men Engage in PMTCT/EID Care: Qualitative Insights From Male Partners.

Greater male partner involvement in Prevention of Mother to Child Transmission (PMTCT) and Early Infant Diagnosis (EID) is associated with improved outcomes. Perceived low social support for the mother can negatively impact the uptake of PMTCT/EID services. Most research relies on women's reports of the types and quality of male partner support received versus what is desired. This qualitative study examines Kenyan male partners'reported social support provision pre- and post-partum from their own perspective. The study was embedded within intervention development studies in Kenya designed to develop and pilot a PMTCT module of a web based system to improve EID. Focus groups were conducted with male partners of pregnant women with HIV and elicited feedback on male partner involvement in maternal and child care and factors affecting participation. Interviews were analyzed within a theoretical social support framework. Participants described providing tangible support (financial resources), informational support (appointment reminders) and emotional support (stress alleviation in the face of HIV-related adversity). African conceptualizations of masculinity and gender norms influenced the types of support provided. Challenges included economic hardship; insufficient social support from providers, peers and bosses; and HIV stigma. Collaboration among providers, mothers and partners; a community-based social support system; and recasting notions of traditional masculinity were identified as ways to foster male partner support.

Mobilising knowledge between practitioners and researchers to iteratively refine a complex intervention (DAFNEplus) pre-trial: protocol for a structured, collaborative working group process

BackgroundRandomised controlled trials (RCTs) of complex interventions often begin with a pilot phase to test the proposed methods and refine the intervention before it is trialled. Although the Medical Research Council (MRC) recommends regular communication between the practitioners delivering the intervention and the researchers evaluating it during the pilot phase, there is a lack of practical guidance about how to undertake this aspect of pre-trial work. This paper describes a novel structured process for collaborative working, which we developed to iteratively refine a complex intervention prior to an RCT. We also describe an in-built qualitative study to learn lessons about how this approach could be used by future study teams.MethodsThis work forms part of a broader research programme to develop and trial a complex intervention for people with type 1 diabetes, called DAFNEplus. The intervention is being piloted in three National Health Service (NHS) diabetes centres in two waves, with refinements being incrementally implemented between each wave in response to real-time, collective learning (combining practitioner experience, process evaluation data and patient and public involvement via an advisory group). A structured ‘Collaborative Working Group’ (CWG) process, comprising monthly teleconferences and four strategically timed face-to-face meetings, is being used to identify and respond systematically to emerging implementation challenges and research findings. The group involves 25 members of the study team, including the multi-disciplinary practitioners delivering the intervention, the research teams conducting the process evaluation, the study manager and Chief Investigator. An in-built qualitative study comprising documentary analysis of meeting materials, discourse analysis of meeting transcripts, reflexive note taking, and thematic analysis of focus groups and interviews with CWG members is being undertaken to explore how the CWG works and how its processes and procedures might be improved.DiscussionThe CWG process offers a potential model for collaborative working in future pre-trial pilot phases and intervention development studies that operationalises MRC guidance to progressively develop a complex intervention and foster shared ownership through genuine collaboration. The findings from the qualitative study will provide insight into how to best support collaborative working to achieve optimal intervention design.

Equality in sexual health promotion: a systematic review of effective interventions for black and minority ethnic men who have sex with men.

BackgroundOver the past decade, new diagnoses of HIV have increased eightfold among men who have sex with men (MSM) of other or of mixed ethnicity in the UK. Yet there is little intervention research on HIV among black and minority ethnic (BME) MSM. This article aimed to identify effective HIV and sexual health prevention strategies for BME MSM.MethodsWe searched three databases PubMed, Scopus and PsychInfo using a combination of search terms: MSM or men who have sex with men and women (MSMW); Black and Minority Ethnic; HIV or sexual health; and evaluation, intervention, program* or implementation. We identified a total of 19 studies to include in the review including those which used randomised control, pre/post-test and cross-sectional design; in addition, we included intervention development studies.ResultsA total of 12 studies reported statistically significant results in at least one of the behavioural outcomes assessed; one study reported significant increases in HIV knowledge and changes in safer sex practices. In 10 studies, reductions were reported in unprotected anal intercourse (UAI), number of sexual partners, or in both of these measures. Six out of the 13 studies reported reductions in UAI; while seven reported reductions in number of sexual partners. Seven were intervention development studies.ConclusionsResearch into the mechanisms and underpinnings of future sexual health interventions is urgently needed in order to reduce HIV and other sexually transmitted infection (STI) among UK BME MSM. The design of interventions should be informed by the members of these groups for whom they are targeted to ensure the cultural and linguistic sensitivity of the tools and approaches generated.

Realist complex intervention science: Applying realist principles across all phases of the Medical Research Council framework for developing and evaluating complex interventions.

The integration of realist evaluation principles within randomised controlled trials (‘realist RCTs’) enables evaluations of complex interventions to answer questions about what works, for whom and under what circumstances. This allows evaluators to better develop and refine mid-level programme theories. However, this is only one phase in the process of developing and evaluating complex interventions. We describe and exemplify how social scientists can integrate realist principles across all phases of the Medical Research Council framework. Intervention development, modelling, and feasibility and pilot studies need to theorise the contextual conditions necessary for intervention mechanisms to be activated. Where interventions are scaled up and translated into routine practice, realist principles also have much to offer in facilitating knowledge about longer-term sustainability, benefits and harms. Integrating a realist approach across all phases of complex intervention science is vital for considering the feasibility and likely effects of interventions for different localities and population subgroups.

Enrollment and Retention Challenges in Early-Phase Intervention Development Studies: The Obesity-Related Behavioral Intervention Trials (ORBIT)

Recent gains in life expectancy in the United States are threatened by high rates of obesity. Substandard diets and low levels of physical activity have been identified as key determinants of overweight, obesity, and many other chronic conditions. Fundamental to preventing and treating obesity and its concomitant conditions is the adoption and maintenance of healthful dietary and physical activity habits.

4155 Using the Patient Generated Index (PGI) to elicit quality of life priorities in patients following curative treatment for colorectal cancer: experience from two lifestyle intervention development studies

4155 Using the Patient Generated Index (PGI) to elicit quality of life priorities in patients following curative treatment for colorectal cancer: experience from two lifestyle intervention development studies