Medical Research Council Framework Research Articles

Implementation of the Practice Programme for Upright Positions in the Second Stage of Labour and the birth experience of Chinese women: A qualitative study

ObjectiveUpright positions in the second stage of labour are recommended by many international organizations. However, they have not been widely used worldwide, especially in China. One of the important factors is the absence of a practice programme based on the best available evidence. We thus developed a Practice Programme for Upright Positions in the Second Stage of Labour following the UK Medical Research Council framework. Under the guidance of the programme, whether the use of upright positions can improve the maternal birth experience is a question of great concern. This study aimed to explore the birth experience of Chinese women who adopted upright positions in the second stage of labour. DesignThis qualitative descriptive study was conducted as part of an implementation study that developed an evidence-based intervention and used strategies to integrate the evidence-based intervention into routine obstetric clinical practice. SettingThe maternity department of a tertiary comprehensive hospital in Hebei Province, China. ParticipantsSemi-structured interviews with twelve eligible women who adopted upright positions in the second stage of labour were conducted between March and April 2022. Qualitative data were analyzed by using conventional content analysis. FindingsThe average age of included women was 26.5 ± 3.5 years, and ten of them were primiparous women. Eight women adopted epidural analgesia during labour to relieve labour pain. All women gave birth in at least one type of upright position in the passive second stage of labour and adopted the semi-recumbent position in the active second stage of labour. Through conventional content analysis, we found that the use of upright positions in the second stage of labour could possibly promote an overall positive birth experience. Women giving birth in upright positions generally perceived they were more involved in their birthing process, and had greater physical and mental capacity to cope with childbirth. Key conclusionsWomen have a positive birth experience when using upright positions in the second stage of labour. Implications for practiceThis study suggests upright positions could improve women's birth experience and have the potential to be widely applied in clinical practice.

Strategies to preventing pressure injuries among intensive care unit patients mechanically ventilated in prone position: a systematic review and a Delphi study.

Although the incidence of pressure injury in the prone position is high for the mechanically ventilated patients in the intensive care unit, evidence-based strategies are still lacking. To conduct a systematic review of current evidence, and to propose a series of strategies to prevent pressure injuries among mechanically ventilated patients with prone position in the intensive care unit. The study was guided by the Medical Research Council framework. After a systematic review of current evidence of original articles, guidelines, expert consensus and theories, a strategy draft was developed. Then we invited 20 experts to modify and refine these strategies through two rounds of Delphi consensus method. After two rounds of Delphi process, the importance of coefficient of variation (Cv) and Kendall's coefficient of concordance in the strategies repository were 0.067 and 0.311, respectively. And the operability of Cv and Kendall's coefficient of concordance in the strategy draft was 0.055 and 0.294, respectively. Ultimately, we established 31 strategies for including 7 themes (assess risk factors, assess skin and tissue, body position management, skin care, nutrition, preventing medical device-related pressure injuries, education and supervision). In addition, we also developed a strategy framework to clarify our strategies. According to the Medical Research Council framework, we developed 7 themes and 31 strategies to prevention prone-position pressure injuries among the intensive care unit mechanically ventilated patients. This study was considered to improve the clinical management of pressure injuries among prone position patients in the intensive care unit settings.

Development and feasibility of a mHealth intervention to improve guardians' adherence to children's follow up care after treatment for acute lymphoblastic leukemia in Tanzania: An overview of the GuardiansCan project.

Cancer is a leading cause of death during childhood and in low- and middle-income countries (LMICs) survival rates can be as low as 20%. A leading reason for low childhood cancer survival rates in LMICs such as Tanzania is treatment abandonment. Contributing factors include poor communication between healthcare providers and children's guardians (guardians), insufficient cancer knowledge, and psychological distress. Our aim is to respond to Tanzanian guardians' poor adherence to children's follow-up care after treatment for acute lymphoblastic leukemia with the help of mHealth technology. Our goal is to increase guardians' adherence to children's medications and follow-up visits; and secondly to decrease their psychological distress. Following the Medical Research Council (MRC) Framework for developing and evaluating complex interventions, we will undertake the GuardiansCan project in an iterative phased approach to develop an mHealth intervention for subsequent testing. Public contribution activities will be implemented throughout via a Guardians Advisory Board consisting of guardians of children with acute lymphoblastic leukemia. We will examine the acceptability, feasibility, and perceived impact of public contribution activities via an impact log and semi-structured interviews (Study I). In Phase One (intervention development) we will explore guardians' needs and preferences for the provision of follow-up care reminders, information, and emotional support using focus group discussions and photovoice (Study II). We will then co-design the mHealth intervention with guardians, healthcare professionals, and technology experts using participatory action research (Study III). In Phase Two (feasibility) we will examine clinical, methodological, and procedural uncertainties associated with the intervention and study methods in a single-arm pre-post mixed methods pragmatic feasibility study (Study IV). Data collection for the GuardiansCan project is anticipated to take three years. We plan to commence Study I by recruiting Guardians Advisory Board members in autumn 2023. By systematically following the intervention development and feasibility phases of the MRC Framework, and working alongside an advisory board of guardians, we intend to develop an acceptable, culturally appropriate, feasible, and relevant mHealth intervention with the potential to increase guardians' adherence to children's follow-up care after treatment of acute lymphoblastic leukemia, leading to a positive impact on children's health and chances to survive and reduced suffering for guardians. n/a.

Development of the HT&Me intervention to support women with breast cancer to adhere to adjuvant endocrine therapy and improve quality of life.

Breast cancer is the most common cancer in women worldwide. Approximately 80% of breast cancers are oestrogen receptor positive (ER+). Patients treated surgically are usually recommended adjuvant endocrine therapy (AET) for 5-10 years. AET significantly reduces recurrence, but up to 50% of women do not take it as prescribed. To co-design and develop an intervention to support AET adherence and improve health-related quality-of-life (QoL) in women with breast cancer. Design and development of the HT&Me intervention took a person-based approach and was guided by the Medical Research Council framework for complex interventions, based on evidence and underpinned by theory. Literature reviews, behavioural analysis, and extensive key stakeholder involvement informed 'guiding principles' and the intervention logic model. Using co-design principles, a prototype intervention was developed and refined. The blended tailored HT&Me intervention supports women to self-manage their AET. It comprises initial and follow-up consultations with a trained nurse, supported with an animation video, a web-app and ongoing motivational 'nudge' messages. It addresses perceptual (e.g. doubts about necessity, treatment concerns) and practical (e.g. forgetting) barriers to adherence and provides information, support and behaviour change techniques to improve QoL. Iterative patient feedback maximised feasibility, acceptability, and likelihood of maintaining adherence; health professional feedback maximised likelihood of scalability. HT&Me has been systematically and rigorously developed to promote AET adherence and improve QoL, and is complemented with a logic model documenting hypothesized mechanisms of action. An ongoing feasibility trial will inform a future randomised control trial of effectiveness and cost-effectiveness.

Implementation of dementia care management in routine care (RoutineDeCM): a study protocol for process evaluation

IntroductionDementia care management is a complex intervention intended to support persons with dementia and their (caring) relatives in home-based care arrangements. Dementia care management was developed in the federal state...

Development and content of a community-based reablement programme (I-MANAGE): a co-creation study

ObjectivesAs age increases, people generally start experiencing problems related to independent living, resulting in an increased need for long-term care services. Investing in sustainable solutions to promote independent living is...

Advance Care Planning Website for People With Dementia and Their Family Caregivers: Protocol for a Development and Usability Study.

Web-based tools for people with dementia and their family caregivers have considerably increased over the years and offer promising solutions to several unmet needs such as supporting self-care in daily life, facilitating treatment delivery, or ensuring their ability to communicate. The use of web-based tools in the field of advance care planning (ACP) for people with dementia and their family caregivers has yet to be explored and requires careful consideration, given the sensitive topic and the specific needs of people with dementia and their families. This paper reports the protocol for a study aiming to develop and simultaneously test the usability of an ACP website designed for, and with, people with dementia and their families. The development of the website is based on a process map for the development of web-based decision support interventions and on the Medical Research Council framework for complex intervention development and evaluation. Additionally, we apply a user-centered approach in combination with patient and public involvement (PPI) throughout the development process. We describe our iterative development approach to the website. Participants and a PPI group give feedback on 4 prototypes of the ACP website. For each iteration, we aim to include 12 participants (3 people with dementia, 3 family caregivers, and 3 dyads) in usability testing. In the first 3 iterations, usability testing includes (1) a think-aloud exercise, (2) researcher observations, and (3) the System Usability Scale questionnaire. The last iteration of usability testing is composed of a semistructured interview assessing the layout, content, face validity, and readability of the website. Qualitative data from the think-aloud exercises and interviews are analyzed using thematic analysis. Mean scores are calculated for the System Usability Scale questionnaire. This study received approval from the Ethical Review Board of Brussels University Hospital of the Vrije Universiteit Brussel. Recruitment began in October 2021. The target date for paper submission of the results of the development and usability testing will be in 2023. The methods in this protocol describe a feasible and inclusive approach to the development of an ACP website together with people with dementia, their family caregivers, and other stakeholders. We provide a clear overview of how to combine PPI input and user-centered development methods, leading to a transparent and reliable development process. This protocol might stimulate the active participation of people with dementia, their caregivers, and regional stakeholders in future studies on web-based technologies. The results of this study will be used to refine the design and create a relevant and user-friendly ACP website that is ready to be tested in a larger evaluation study. DERR1-10.2196/46935.

Development of an online intervention for the Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) trial.

Up to half of people hospitalised with COVID-19 report diverse and persistent symptoms affecting quality of life for months and sometimes years after discharge (long-COVID). We describe the development of an online group exercise and behavioural support intervention for people who continue to experience such physical and/or emotional health problems more than three months after hospital discharge. Intervention development was informed by the Medical Research Council framework for complex interventions. Our multidisciplinary team of academics, clinicians, and people with long-COVID, had collective expertise in the development and testing of complex interventions. We integrated a bio-psycho-social model of care drawing on rehabilitation literature for long-term health conditions and experiences from our pre-pilot study. Multiple stakeholder meetings were held to refine the intervention which was designed to be deliverable within the UK National Health Service. We adhere to TIDieR guidance for transparent and explicit reporting of telehealth interventions. The final REGAIN online exercise and behavioural support intervention consisted of an initial 1:1 consultation with a trained practitioner, followed by eight online group exercise, and six group support, sessions delivered over eight weeks. Participants could also access an online library of on-demand exercise and support videos. The final REGAIN intervention, combining exercise and behavioural support, is fully manualised with clear pathways to delivery and implementation. It is currently being tested in a randomised controlled trial. The intervention, developed with extensive patient and stakeholder engagement, could be incorporated into existing NHS rehabilitation programmes, should it prove to be clinically and cost-effective for people with long-COVID. International Standard Randomised Controlled Trial Number (ISRCTN) 11466448: Rehabilitation exercise and psychological support after COVID-19 infection: REGAIN.

Development of theoretically informed audit and feedback: An exemplar from a complex implementation strategy to improve asthma self-management in UK primary care.

Audit and feedback is an evidence-based implementation strategy, but studies reporting the use of theory to guide design elements are limited. Within the context of a programme of research aiming to improve the implementation of supported asthma self-management in UK primary care (IMPlementing IMProved Asthma self-management as RouTine [IMP2 ART]), we aimed to design and develop theoretically-informed audit and feedback that highlighted supported asthma self-management provision and areas for improvement in primary care general practices. Aligned with the Medical Research Council (MRC) complex intervention framework, the audit and feedback was developed in three phases: (1) Development: literature and theory exploration, and prototype audit and feedback design; (2) Feasibility: eliciting feedback on the audit and feedback from general practice staff (n = 9); (3) Prepiloting: delivering the audit and feedback within the IMP2 ART implementation strategy (incorporating patient and professional resources and an asthma review template) and eliciting clinician feedback (n = 9). Audit and feedback design was guided by and mapped to existing literature suggestions and theory (e.g., Theoretical Domains Framework, Behaviour Change Technique Taxonomy). Feedback on the prototype audit and feedback confirmed feasibility but identified some refinements (a need to highlight supporting self-management and importance of asthma action plans). Prepiloting informed integration with other IMP2 ART programme strategies (e.g., patient resources and professional education). We conclude that a multistage development process including theory exploration and mapping, contributed to the design and delivery of the audit and feedback. Aligned with the MRC framework, the IMP2 ART strategy (incorporating the audit and feedback) is now being tested in a UK-wide cluster randomised controlled trial.

AIIMS ICU Rehabilitation (AIR): development and description of intervention for home rehabilitation of chronically ill tracheostomized patients using the TIDieR checklist

Background: The paucity of state-supported rehabilitation for chronically ill patients with long-term tracheostomies has ramifications of prolonged hospital-stay, increased burden on acute-care resources, and nosocomial infections. Few interventions describe home rehabilitation of adult tracheostomized patients. Almost none involve stakeholders. This paper describes the All-India Institute of Medical Sciences (AIIMS) ICU rehabilitation (AIR) healthcare intervention developed to facilitate home rehabilitation of chronically ill tracheostomized patients. Methods: The AIR intervention was developed in six stages using the experience-based codesign theory (EBCD). A core research-committee studied prevalent knowledge and gaps in the area. Patients-carer and health-care stakeholders’ experiences of barriers and facilitators to home care resulted in an intervention with interlinked components: family-carer training, equipment bank, m-health application, and follow-up, guided by the Medical Research Council (MRC) framework. Healthcare stakeholders (doctors, nurses, medical equipment vendors) and patient-carer dyads were engaged to gather experiences at various stages to form smaller codesign teams for each component. Multiple codesign meetings iteratively allowed refinement of the intervention over one year. The Template for Intervention Description and Replication (TIDieR) checklist was used to report the AIR intervention. Results: The first component comprised a minimum of three bedside hands-on training sessions for carers relating to tracheostomy suction, catheter care, monitoring oxygenation, enteral feeding, skincare, and physiotherapy, buttressed by pictorial-books and videos embedded in a mobile-application. The second was an equipment-bank involving a rental-retrieval model. The third component was a novel m-health tool for two-way communication with the core group and community of other patient-carers in the project for follow-up and troubleshooting. Home visits on days 7 and 21 post-discharge assessed patient hygiene, nutrition, physiotherapy, and established contact with the nearest primary healthcare facility for the future. Conclusions: Findings support the EBCD-based development using active feedback from stakeholders. Assessment of feasibility, process and effectiveness evaluation will follow.

Using multiple approaches to develop a physician-pharmacist collaborative care intervention to facilitate appropriate prescribing for older adults with multimorbidity

Background and objectivesThis article discusses the development process of an intervention to facilitate appropriate prescribing for older adults with multimorbidity at geriatric medicine outpatient clinics. Both effectiveness and implementability were key aims, which were achieved by a systematic combination of different approaches guided by published guidance. MethodsVarious frameworks and tools were used to guide the intervention development. They include The Medical Research Council Framework for complex health interventions as the overarching framework, supplemented by the Framework of Actions for Intervention Development and a taxonomy of intervention development approaches. ResultsA combination of theory and evidence-based-, implementation-based and partnership approaches were used to develop the intervention. The Behaviour Change Wheel and Theoretical Domains Framework were used for intervention design. Three scoping reviews and two modified Delphi studies were conducted to build an evidence base on prescribing-related barriers and existing interventions. The findings were synthesised, assessed for implementability, and culminated in a co-creation exercise with physicians and pharmacists. The final intervention aims to facilitate collaboration between physicians and pharmacists and to improve communication and documentation of prescribing decisions. ConclusionsMultiple approaches may be required when developing interventions that are effective and implementable. The study team's experiences in using published guidance, integrating different approaches, and co-creating the intervention with healthcare professionals provide a useful case study with lessons and insights for developers of complex interventions. Furthermore, systematic reporting of such research-based efforts would contribute to advancement of intervention development in healthcare and reducing research waste.

Framework for Implementing Individualised Dosing of Anti-Cancer Drugs in Routine Care: Overcoming the Logistical Challenges

Precision medicine in oncology involves identifying the ‘right drug’, at the ‘right dose’, for the right person. Currently, many orally administered anti-cancer drugs, particularly kinase inhibitors (KIs), are prescribed at a standard fixed dose. Identifying the right dose remains one of the biggest challenges to optimal patient care. Recently the Precision Dosing Group established the Accurate Dosing of Anti-cancer Patient-centred Therapies (ADAPT) Program to address individualised dosing; thus, use existing anti-cancer drugs more safely and efficiently. In this paper, we outline our framework, based on the Medical Research Council (MRC) framework, with a simple 6-step process and strategies which have led to the successful implementation of the ADAPT program in South Australia. Implementation strategies in our 6-step process involve: (1) Evaluate the evidence and identify the cancer drugs: Literature review, shadowing other experts, establishing academic partnerships, adaptability/flexibility; (2) Establishment of analytical equipment for drug assays for clinical purposes: assessment for readiness, accreditation, feasibility, obtaining formal commitments, quality assurance to all stakeholders; (3) Clinical preparation and education: educational material, conducted educational meetings, involve opinion leaders, use of mass media, promote network weaving, conduct ongoing training; (4) Blood collection, sample preparation and analyses: goods received procedures, critical control points (transport time); (5) Interpret and release results with recommendations: facilitate the relay of clinical data to providers; (6) Clinical application: providing ongoing consultation, identify early adopters, identify, and prepare champions. These strategies were selected from the 73 implementation strategies outlined in the Expert Recommendations for Implementing Change (ERIC) study. The ADAPT program currently provides routine plasma concentrations for patients on several orally administered drugs in South Australia and is currently in its evaluation phase soon to be published. Our newly established framework could provide great potential and opportunities to advance individualised dosing of oral anti-cancer drugs in routine clinical care.

Supporting SURgery with GEriatric Co-Management and AI (SURGE-Ahead): A study protocol for the development of a digital geriatrician.

Geriatric co-management is known to improve treatment of older adults in various clinical settings, however, widespread application of the concept is limited due to restricted resources. Digitalization may offer options to overcome these shortages by providing structured, relevant information and decision support tools for medical professionals. We present the SURGE-Ahead project (Supporting SURgery with GEriatric co-management and Artificial Intelligence) addressing this challenge. A digital application with a dashboard-style user interface will be developed, displaying 1) evidence-based recommendations for geriatric co-management and 2) artificial intelligence-enhanced suggestions for continuity of care (COC) decisions. The development and implementation of the SURGE-Ahead application (SAA) will follow the Medical research council framework for complex medical interventions. In the development phase a minimum geriatric data set (MGDS) will be defined that combines parametrized information from the hospital information system with a concise assessment battery and sensor data. Two literature reviews will be conducted to create an evidence base for co-management and COC suggestions that will be used to display guideline-compliant recommendations. Principles of machine learning will be used for further data processing and COC proposals for the postoperative course. In an observational and AI-development study, data will be collected in three surgical departments of a University Hospital (trauma surgery, general and visceral surgery, urology) for AI-training, feasibility testing of the MGDS and identification of co-management needs. Usability will be tested in a workshop with potential users. During a subsequent project phase, the SAA will be tested and evaluated in clinical routine, allowing its further improvement through an iterative process. The outline offers insights into a novel and comprehensive project that combines geriatric co-management with digital support tools to improve inpatient surgical care and continuity of care of older adults. German clinical trials registry (Deutsches Register für klinische Studien, DRKS00030684), registered on 21st November 2022.

Pilot study of a manualised mental health awareness and stigma reduction intervention for Black faith communities in the UK: ON TRAC project

BackgroundBuilding partnerships between mental health services and Black faith communities to co-produce culturally tailored interventions is an essential step towards improving access to services and reducing stigma among the Black population. Given that Black faith organisations are considered a primary source of emotional and psychological support they are well positioned as ‘gatekeepers’ for services, to overcome barriers to engagement and build trusting relationships with the Black community. The aim of this paper is to pilot a manualised mental health awareness and stigma reduction intervention for Black faith communities in the UK, and to make an initial assessment of feasibility, acceptability and outcomes.MethodsThis study employed a mixed methods pre–post-design, based upon the Medical Research Council Framework (MRC) for complex interventions, and the Implementation Science Research Development.ResultsThe qualitative assessments indicate that the intervention was found overall to be acceptable and feasible to the Black faith community population. This pilot study did not find statistically significant changes for the Mental Health Knowledge schedule (MAKS), Reported and Intended Behaviour Scale (RIBS), intended help-seeking or willingness to disclose (Attitudes to Mental Illness Survey) measures. However, the direction of all the non-significant changes in these measures suggests positive changes in mental health knowledge, a reduction in participants’ desire for social distance, and greater willingness to disclose personal experiences of mental health problems. A statistically significant improvement in the Community Attitudes towards Mental Illness (CAMI) scale results indicated a lower level of stigmatising attitudes towards people with lived experience of mental health conditions (PWLE), and an increase in tolerance and support towards PWLE after the intervention. Significant improvement in the willingness to disclose measure suggests increased preparedness to seek help amongst participants, a lesser desire for social distance, and greater willingness to engage with PWLE after the intervention. Three key themes, including 9 subthemes were identified from the qualitative data analysis: (i) initial implementation and intention to adopt; (ii) perceived suitability and usefulness of intervention to address cultural issues relating to mental health in the Black community; and (iii) strengthening the capacity of faith leaders.ConclusionsThis ON TRAC pilot study shows that the intervention was feasible and acceptable, and that it has promising positive impacts and next requires larger scale evaluation. These results demonstrate that the intervention was a culturally acceptable way to potentially increase mental health awareness and reduce stigma in Black faith communities.Trial registrationISRCTN12253092.

Incentives for physical activity in cardiac patients in Germany: pre-trial health economic modelling

Abstract Funding Acknowledgements Type of funding sources: Public hospital(s). Main funding source(s): University Hospital Düsseldorf Cardiovascular disease (CVD) is the most prevalent non-communicable disease and the leading cause of death globally. Evidence suggests that exercise-based interventions in secondary prevention can mitigate adverse health events. Implementing incentive schemes for patients to engage in physical activity (PA) might be a promising approach to improve adherence. The INPHY trial, a complex intervention that is currently being developed at the University Hospital Düsseldorf, aims at improving PA in people with coronary heart disease (CHD) using monetary and social incentives. The UK Medical Research Council (MRC) framework for the development and evaluation of complex interventions recommends pre-trial health economic modelling to inform the design of the trial. A decision-analytic Markov model was developed to evaluate the costs and benefits of exercise-based, incentivized secondary prevention interventions from a health services provider. A cohort of individuals with a history of myocardial infarction was followed in the model from age 65 years through a total of 25 1-year Markov cycles. Primary outcomes included costs, quality-adjusted life-years (QALY) gained and incremental cost-effectiveness ratios (ICERs). Sensitivity and scenario analyses were performed to reflect parameter and model uncertainty. In the base-case, the incremental QALYs gained from the monetary and social incentives, relative to control, were respectively estimated at 0.01 [95% CI 0.00-0.01] and 0.03 [95% CI 0.02-0.05]. In comparison to control, the implementation of the monetary and social incentive interventions increased the costs by 795€ [95% CI 697-884] and 831€ [95% CI 593-1,191], respectively. ICERs were 24,473€ [95% CI 15,871-38,868] and 112,015€ [95% CI 81,140-169,888] per QALY gained for the social and monetary incentive interventions, respectively. At a per-capita gross domestic product threshold (GDP) of 43,000€/QALY for Germany, the probability that the social and monetary incentive intervention would be seen as cost effective was 100% and 0%, respectively. Exercise-based secondary prevention using incentivized reinforcement schemes might offer a cost-effective strategy to reduce the burden of CHD, offering good value for money in preventing a significant non-communicable disease. Translation of these findings into policy and practice alongside rigorous monitoring and evaluation is important. More epidemiological research from Germany is recommended to reduce the remaining model uncertainty surrounding this decision.

Implementation of a salt substitute intervention using social marketing in resourced-limited communities in Peru: a process evaluation study.

This study aimed to conduct a process evaluation of a salt substitute trial conducted in Peru. Through semi-structured interviews of intervention participants, we documented and analyzed process evaluation variables as defined by the Medical Research Council Framework. This study was a stepped wedge trial conducted in Tumbes, Peru in 2014. The intervention was a community-wide replacement of regular salt (100% sodium) with "Salt Liz" (75% sodium and 25% potassium) using social marketing strategies to promote the adoption and continued use of the salt substitute in daily life. The components of the social marketing campaign included entertainment educational activities and local product promoters ("Amigas de Liz"). Another component of the intervention was the Salt Liz spoon to help guide the amount of salt that families should consume. The process evaluation variables measured were the context, mechanism of action, and implementation outcomes (acceptability, fidelity and adoption, perceptions, and feedback). In total, 60 women were interviewed, 20 with hypertension and 40 without hypertension. Regarding context, common characteristics across the four villages included residents who primarily ate their meals at home and women who were responsible for household food preparation. As the mechanism of action, most participants did not notice a difference in the flavor between regular salt and Salt Liz; those that did notice a difference took around 2 weeks to become accustomed to the taste of the salt substitute. In terms of implementation outcomes, the Salt Liz was accepted by villagers and factors explaining this acceptability included that it was perceived as a "high quality" salt and as having a positive effect on one's health. Participants recognized that the Salt Liz is healthier than regular salt and that it can help prevent or control hypertension. However, most participants could not accurately recall how the compositions of the Salt Liz and regular salt differed and the role they play in hypertension. Although the use of the Salt Liz was far-reaching at the community level, the use of the Salt Liz spoon was poor. Educational entertainment activities were well-received, and most participants enjoyed them despite not always being active participants but rather sideline observers. This process evaluation identifies key intervention components that enabled a successful trial. Seeking and incorporating feedback from the target population helps deepen the understanding of contextual factors that influence an intervention's success. Furthermore, feedback received can aid the development of the intervention product. Some factors that can be improved for future interventions are acknowledged. NCT01960972.

Theory-guided process evaluation of a multicomponent, technology-based 'SMART Eating' trial among Indian adults: an embedded mixed-methods study.

We report process evaluation findings from the 'SMART Eating' intervention trial, which significantly improved fat, sugar and salt (FSS), and fruits and vegetables (FVs) intake among adults. Intervention used information technology [short message service (SMS), WhatsApp and website] and interpersonal communication (distribution of SMART Eating kit) and pamphlet for comparison group. Guided by UK Medical Research Council's framework, using embedded mixed-methods design, continuous process evaluation documented fidelity, dose, reach, acceptability and mechanisms. Intervention was implemented as intended, with high reach (91%) in both groups: 'comparison group' (n = 366): inadequate use of pamphlets (46%); 'intervention group' (n = 366): with timely remedial measures to remove implementation/usage barriers, dose of SMS (93%), WhatsApp (89%) and 'SMART Eating' kit (100%) was adequate, but website usage was low (50%); compliance was evident from participants' interactions with the implementor and observations on kit usage. All these might have improved attitude, social influence, self-efficacy and household behaviours, which, in turn, mediated intervention's effect on improving FSS and FV intake. Among poor performers, lack of effect on FV intake was perceived to be related to high cost/pesticides use and FSS intake was related to lack of family support. Low website usage, challenges with WhatsApp messaging and contextual factors (cost, pesticides abuse and family support) need to be considered while designing similar future interventions.

Concept and study protocol of the process evaluation of a pragmatic randomized controlled trial to promote physical activity in outpatients with heterogeneous mental disorders—the ImPuls study

BackgroundEvidence suggests that patients suffering from different mental disorders benefit from exercise programs combined with behavior change techniques. Based on this evidence, we have developed an exercise program (ImPuls) specifically designed to provide an additional treatment option in the outpatient mental health care system. The implementation of such complex programs into the outpatient context requires research that goes beyond the evaluation of effectiveness, and includes process evaluation. So far, process evaluation related to exercise interventions has rarely been conducted. As part of a current pragmatic randomized controlled trial evaluating ImPuls treatment effects, we are therefore carrying out comprehensive process evaluation according to the Medical Research Council (MRC) framework. The central aim of our process evaluation is to support the findings of the ongoing randomized controlled trial.MethodsThe process evaluation follows a mixed-methods approach. We collect quantitative data via online-questionnaires from patients, exercise therapists, referring healthcare professionals and managers of outpatient rehabilitative and medical care facilities before, during, and after the intervention. In addition, documentation data as well as data from the ImPuls smartphone application are collected. Quantitative data is complemented by qualitative interviews with exercise therapists as well as a focus-group interview with managers. Treatment fidelity will be assessed through the rating of video-recorded sessions. Quantitative data analysis includes descriptive as well as mediation and moderation analyses. Qualitative data will be analyzed via qualitative content analysis.DiscussionThe results of our process evaluation will complement the evaluation of effectiveness and cost-effectiveness and will, for example, provide important information about mechanisms of impact, structural prerequisites, or provider qualification that may support the decision-making process of health policy stakeholders. It might contribute to paving the way for exercise programs like ImPuls to be made successively available for patients with heterogeneous mental disorders in the German outpatient mental health care system.Trial registrationThe parent clinical study was registered in the German Clinical Trials Register (ID: DRKS00024152, registered 05/02/2021, https://drks.de/search/en/trial/DRKS00024152).

Development of "LvL UP 1.0": a smartphone-based, conversational agent-delivered holistic lifestyle intervention for the prevention of non-communicable diseases and common mental disorders.

Non-communicable diseases (NCDs) and common mental disorders (CMDs) are the leading causes of death and disability worldwide. Lifestyle interventions via mobile apps and conversational agents present themselves as low-cost, scalable solutions to prevent these conditions. This paper describes the rationale for, and development of, "LvL UP 1.0″, a smartphone-based lifestyle intervention aimed at preventing NCDs and CMDs. A multidisciplinary team led the intervention design process of LvL UP 1.0, involving four phases: (i) preliminary research (stakeholder consultations, systematic market reviews), (ii) selecting intervention components and developing the conceptual model, (iii) whiteboarding and prototype design, and (iv) testing and refinement. The Multiphase Optimization Strategy and the UK Medical Research Council framework for developing and evaluating complex interventions were used to guide the intervention development. Preliminary research highlighted the importance of targeting holistic wellbeing (i.e., both physical and mental health). Accordingly, the first version of LvL UP features a scalable, smartphone-based, and conversational agent-delivered holistic lifestyle intervention built around three pillars: Move More (physical activity), Eat Well (nutrition and healthy eating), and Stress Less (emotional regulation and wellbeing). Intervention components include health literacy and psychoeducational coaching sessions, daily "Life Hacks" (healthy activity suggestions), breathing exercises, and journaling. In addition to the intervention components, formative research also stressed the need to introduce engagement-specific components to maximise uptake and long-term use. LvL UP includes a motivational interviewing and storytelling approach to deliver the coaching sessions, as well as progress feedback and gamification. Offline materials are also offered to allow users access to essential intervention content without needing a mobile device. The development process of LvL UP 1.0 led to an evidence-based and user-informed smartphone-based intervention aimed at preventing NCDs and CMDs. LvL UP is designed to be a scalable, engaging, prevention-oriented, holistic intervention for adults at risk of NCDs and CMDs. A feasibility study, and subsequent optimisation and randomised-controlled trials are planned to further refine the intervention and establish effectiveness. The development process described here may prove helpful to other intervention developers.

A self-management intervention for people with multiple sclerosis: The development of a programme theory in the field of rehabilitation nursing

BackgroundPeople with multiple sclerosis (PwMS) have recurrent stays in rehabilitation clinics because of progressive disease. Nurses are key players in supporting PwMS through self-management interventions. However, little is known about the effectiveness, or sustainability of nursing interventions. The aim of this study was to develop a nurse-led self-management intervention and its programme theory for PwMS in one Swiss rehabilitation clinic. MethodsOn the basis of the Medical Research Council framework, we developed a theory-based programme for a nurse-led intervention. As key element of the intervention, we created a consulting guidance. ResultsAs part of the programme theory, we created a systematic plan (action model) to illustrate how contextual resources (e.g., skills of the MS nurse and responsibilities of the multidisciplinary team) need to be coordinated. The change model shows how changes in the intervention lead to the achievement of outcomes (e.g., increased self-efficacy). The consulting guidance was refined by PwMS and four Swiss MS experts. ConclusionsAn initial programme theory is a solid foundation for the next phases of the theory-based evaluations to refine the programme theory and sustainable implementation of the intervention.