Medical Research Council Framework Research Articles

ReStOre@Home: Feasibility study of a virtually delivered 12-week multidisciplinary rehabilitation programme for survivors of upper gastrointestinal (UGI) cancer - study protocol

Background: Exercise rehabilitation programmes, traditionally involving supervised exercise sessions, have had to rapidly adapt to virtual delivery in response to the coronavirus disease 2019 (COVID-19) pandemic to minimise patient contacts. In the absence of an effective vaccine, the pandemic is likely to persist in the medium term and during this time it is important that the feasibility and effectiveness of remote solutions is considered. We have previously established the feasibility of the Rehabilitation Strategies following Oesophago-gastric Cancer (ReStOre) intervention - a face to face multidisciplinary rehabilitation programme for upper gastrointestinal (UGI) cancer survivors. This study will examine the feasibility of a virtually delivered 12-week multi-component ReStOre@Home programme. Methods: This single arm feasibility study will recruit 12 patients who have completed curative treatment for oesophago-gastric cancer. Participants will complete the 12-week ReStOre@Home programme consisting of exercise (aerobic and resistance training), 1:1 dietary counselling and group education sessions through virtual delivery. Underpinned by the Medical Research Council (MRC) Framework, feasibility will be determined by recruitment rates, adherence, retention, incidents, and acceptability. Acceptability will be assessed qualitatively through post-intervention interview and the Telehealth Usability Questionnaire. Secondary outcomes will be assessed pre and post-intervention and will include measures of physical performance (cardiopulmonary exercise test, short physical performance battery, hand grip strength, Godin Leisure Time Questionnaire, and body composition), health related quality of life (European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) and oesophago-gastric cancer specific subscale (EORTC-QLQ-OG25), fatigue (Multidimensional Fatigue Inventory (MFI-20), and venous blood samples will be collected for the UGI Cancer Survivorship Biobank. Discussion: The ReStOre@Home feasibility study will provide important data regarding the amenability of a multidisciplinary programme designed for UGI cancer survivors to virtual delivery. Trial registration: ClinicalTrials.gov NCT04603339 (26/10/2020)

Developing a complex intervention whilst considering implementation: the TANDEM (Tailored intervention for ANxiety and DEpression Management) intervention for patients with chronic obstructive pulmonary disease (COPD)

BackgroundGuidelines now call for a thorough and comprehensive description of the development of healthcare interventions to aid evaluation and understanding of the processes of change. This was the primary aim of this study but we also recognised that effective interventions are commonly not implemented in clinical practice. It is suggested that insufficient attention is given to the implementation process at the development phase of interventions. This study outlines the 5 step iterative process we adopted for considering both implementation and effectiveness issues from the outset of intervention development. We use the development of a complex intervention Tailored intervention for ANxiety and DEpression Management (TANDEM) in patients with chronic obstructive pulmonary disease to illustrate this process.MethodsIntervention development built upon the Medical Research Council framework for developing complex interventions and the person-based approach for development of behavioural interventions. Building an expert team, specifying theory, qualitative data collection and pre-piloting were all critical steps in our intervention development and are described here.ResultsContact with experts in the field, and explicitly building on previous work, ensured efficiency of design. Qualitative work suggested guiding principles for the intervention such as introducing mood in relation to breathlessness, and providing flexible tailoring to patients’ needs, whilst implementation principles focused on training selected respiratory professionals and requiring supervision to ensure standards of care. Subsequent steps of intervention development, pre-piloting and intervention refinement led to an intervention that was deemed acceptable and if successful will be ready for implementation.ConclusionsThe TANDEM study was developed efficiently by building on previous work and considering implementation issues from the outset, with the aim that if shown to be effective it will have more rapid translation in to the health care system with accelerated patient benefits.Trial registrationISRCTN ISRCTN59537391. Registered on 20 March 2017. Protocol version 6.0, 22 April 2018.

The Inspired Life Program: Development of a multicomponent positive psychology intervention for rural adults in Ghana.

Although several theories and studies have explored human strengths and mental well-being at the global level, these insights are rarely tested and translated into practice in sub-Saharan Africa. This study aims to describe the development of a 10-session multicomponent positive psychology intervention, the Inspired Life Program (ILP), designed to promote mental health and reduce symptoms of depression and negative affect in rural adults in Ghana. Guided by the Medical Research Council's framework for developing complex interventions, a seven-step iterative community-based participatory research approach was adopted to develop the ILP, based on constructs and principles of positive psychology and cognitive-behavioral model. The final intervention components included a 10-session, two-hourly, once-weekly manualized program designed to promote meaningful and purposeful living, self-acceptance, personal growth, goal-setting and problem-solving skills, and positive thinking through group discussion and activity sessions. We describe the program theory and implementation strategy of the final intervention, and reflect on the challenges and lessons learned from applying this framework in the study context. The development of strengths-based interventions and practicality of methods to promote positive mental health in rural adults are feasible, and have important policy implications for mental health and social care in sub-Saharan Africa.

Understanding health-care outcomes of older people with cognitive impairment and/or dementia admitted to hospital: a mixed-methods study

Background Cognitive impairment is common in older people admitted to hospital, but previous research has focused on single conditions. Objective This project sits in phase 0/1 of the Medical Research Council Framework for the Development and Evaluation of Complex Interventions. It aims to develop an understanding of current health-care outcomes. This will be used in the future development of a multidomain intervention for people with confusion (dementia and cognitive impairment) in general hospitals. The research was conducted from January 2015 to June 2018 and used data from people admitted between 2012 and 2013. Design For the review of outcomes, the systematic review identified peer-reviewed quantitative epidemiology measuring prevalence and associations with outcomes. Screening for duplication and relevance was followed by full-text review, quality assessment and a narrative review (141 papers). A survey sought opinion on the key outcomes for people with dementia and/or confusion and their carers in the acute hospital (n = 78). For the analysis of outcomes including cost, the prospective cohort study was in a medical admissions unit in an acute hospital in one Scottish health board covering 10% of the Scottish population. The participants (n = 6724) were older people (aged ≥ 65 years) with or without a cognitive spectrum disorder who were admitted as medical emergencies between January 2012 and December 2013 and who underwent a structured nurse assessment. ‘Cognitive spectrum disorder’ was defined as any combination of delirium, known dementia or an Abbreviated Mental Test score of < 8 out of 10 points. The main outcome measures were living at home 30 days after discharge, mortality within 2 years of admission, length of stay, re-admission within 2 years of admission and cost. Data sources Scottish Morbidity Records 01 was linked to the Older Persons Routine Acute Assessment data set. Results In the systematic review, methodological heterogeneity, especially concerning diagnostic criteria, means that there is significant overlap in conditions of patients presenting to general hospitals with confusion. Patients and their families expect that patients are discharged in the same or a better condition than they were in on admission or, failing that, that they have a satisfactory experience of their admission. Cognitive spectrum disorders were present in more than one-third of patients aged ≥ 65 years, and in over half of those aged ≥ 85 years. Outcomes were worse in those patients with cognitive spectrum disorders than in those without: length of stay 25.0 vs. 11.8 days, 30-day mortality 13.6% vs. 9.0%, 1-year mortality 40.0% vs. 26.0%, 1-year mortality or re-admission 62.4% vs. 51.5%, respectively (all p < 0.01). There was relatively little difference by cognitive spectrum disorder type; for example, the presence of any cognitive spectrum disorder was associated with an increased mortality over the entire period of follow-up, but with different temporal patterns depending on the type of cognitive spectrum disorder. The cost of admission was higher for those with cognitive spectrum disorders, but the average daily cost was lower. Limitations A lack of diagnosis and/or standardisation of diagnosis for dementia and/or delirium was a limitation for the systematic review, the quantitative study and the economic study. The economic study was limited to in-hospital costs as data for social or informal care costs were unavailable. The survey was conducted online, limiting its reach to older carers and those people with cognitive spectrum disorders. Conclusions Cognitive spectrum disorders are common in older inpatients and are associated with considerably worse health-care outcomes, with significant overlap between individual cognitive spectrum disorders. This suggests the need for health-care systems to systematically identify and develop care pathways for older people with cognitive spectrum disorders, and avoid focusing on only condition-specific pathways. Future work Development and evaluation of a multidomain intervention for the management of patients with cognitive spectrum disorders in hospital. Study registration This study is registered as PROSPERO CRD42015024492. Funding This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 9, No. 8. See the NIHR Journals Library website for further project information.

Strengthening and supporting nurses' communication with mechanically ventilated patients in the intensive care unit: Development of a communication intervention.

Nurse-patient communication in intensive care units is challenged by the fact that patients are voiceless due to intubation and mechanical ventilation. Difficult communication affects nurses negatively, and it requires knowledge and expertise to facilitate communication in this complex and technologically tense setting. Augmentative and alternative communication has been suggested as a way of optimising communication; several approaches can be combined in a multi-component intervention. Also, a communication algorithm has been proposed as a way of providing structure in patient communication. To enhance transparency and avoid poorly reported interventions, this paper describes the process, rationale and reflections behind developing a communication intervention called the ICU-COM. To present the development process of a communication intervention prototype that aims to support and strengthen nurses' communication with mechanically ventilated patients in an intensive care unit. The Medical Research Council's framework for developing complex interventions in health was applied. The approach was target-population centred. The intervention was developed and tailored to four intensive care unit departments at Aarhus University Hospital in Denmark. Intensive care nurses and various experts, namely, speech-language pathologists, graphic designers, a software company, the local Centre for E-learning and nurse specialists were involved in its development. An intervention consisting of: 1) a multi-component communication bundle, 2) delivery of the bundle via a teaching session and 3) initial implementation via nurse communication guides was developed. The communication bundle contained: 1) a communication strategy with a BASIS framework and algorithm, 2) a nurse education programme and 3) low-tech and high-tech communication tools. A systematic approach was applied in the development process. However, the acceptability and feasibility of the intervention is at present unknown.

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 Virtual Reality Exergame to Engage Adolescents in Physical Activity: Mixed Methods Study Describing the Formative Intervention Development Process

BackgroundEarly adolescence (13-17 years) is a critical developmental stage for physical activity promotion. Virtual reality (VR) exergaming is a promising intervention strategy to engage adolescents in physical activity.ObjectiveThe vEngage project aims to develop a physical activity intervention for adolescents using VR exergaming. Here, we describe the formative intervention development work and process of academic-industry collaboration.MethodsThe formative development was guided by the Medical Research Council framework and included recruiting an adolescent user group to provide iterative feedback, a literature review, a quantitative survey of adolescents, qualitative interviews with adolescents and parents, inductive thematic analysis of public reviews of VR exergames, a quantitative survey and qualitative interviews with users of the augmented reality running app Zombies, Run!, and building and testing a prototype with our adolescent user group.ResultsVR exergaming was appealing to adolescents and acceptable to parents. We identified behavior change techniques that users would engage with and features that should be incorporated into a VR exergame, including realistic body movements, accurate graphics, stepped levels of gameplay difficulty, new challenges, in-game rewards, multiplayer options, and the potential to link with real-world aspects such as physical activity trackers. We also identified some potential barriers to use, such as cost, perceived discomfort of VR headsets, and motion sickness concerns. A prototype game was developed and user-tested with generally positive feedback.ConclusionsThis is the first attempt to develop a VR exergame designed to engage adolescents in physical activity that has been developed within a public health intervention development framework. Our formative work suggests that this is a very promising avenue. The benefit of the design process was the collaborative parallel work between academics and game designers and the involvement of the target population in the game (intervention) design from the outset. Developing the game within an intervention framework allowed us to consider factors, such as parental support, that would be important for future implementation. This study also serves as a call to action for potential collaborators who may wish to join this endeavor for future phases and an example of how academic-industry collaboration can be successful and beneficial.

The need for supportive mental wellbeing interventions in bladder cancer patients: A systematic review of the literature.

ObjectivesThere is an increased awareness of the effect of a bladder cancer diagnosis and its treatments on the mental wellbeing of patients. However, few studies have evaluated the efficacy, feasibility and acceptability of interventions to improve this mental wellbeing. This systematic review is the first phase of the Medical Research Council Framework for developing complex interventions and provides an overview of the published mental wellbeing interventions that could be used to design an intervention specific for BC patients.MethodsThis review was conducted in accordance with the PRISMA guidelines in January 2019 and studies were identified by conducting searches for Medline, the Cochrane Central Register of Controlled Trials and Ovid Gateway. All included studies met the following criteria: mental wellbeing interventions of adults with medically confirmed diagnosis of any type of urological cancer, reported outcomes for specific HRQoL domains including psychological factors. The quality of evidence was assessed according to Down and Black 27-item checklist.ResultsA total of 15,094 records were collected from the literature search and 10 studies matched the inclusion and exclusion criteria. Of these, nine interventions were for patients with prostate cancer and one for patients with kidney cancer. No studies were found for other urological cancers. Depression was the most commonly reported endpoint measured. Of the included studies with positive efficacy, three were group interventions and two were couple interventions. In the group interventions, all showed a reduction in depressive symptoms and in the couple interventions, there was a reduction in depressive symptoms and a favourable relationship cohesion. The couple interventions were the most feasible and acceptable, but further research was required for most of the studies.ConclusionWhile awareness of the importance of mental wellbeing in bladder cancer patients is growing, this systematic literature review highlights the gap of feasible and acceptable interventions for this patient population.

Impact of a multimedia website with patient experiences of multiple sclerosis (PExMS) on immunotherapy decision-making: study protocol for a pilot randomised controlled trial in a mixed-methods design

BackgroundA variety of management options (e.g. immunotherapies, lifestyle interventions, and rehabilitation) are available for people with relapsing-remitting multiple sclerosis (RRMS). Besides coping with the diagnosis, people with MS (pwMS) have to make complex decisions such as deciding about immunotherapies. In addition to factual information, reports of patient experiences (PEx) may support patients in decision-making. The added value of PEx in decision-making is not clear, and controlled studies are rare. Therefore, systematic methods are necessary to develop and analyse PEx. As there are no evaluated PEx for MS in Germany, we are currently creating a website presenting PEx structured according to topics and illustrated by video, audio, and text files. We aim to determine the feasibility of an intervention using PEx and evaluate whether PEx may help pwMS in their immunotherapy decision-making processes as a supplement to evidence-based information.MethodsThis project will follow the Medical Research Council framework for development and evaluation of complex interventions. After the development of a website with PEx, a randomised controlled pilot trial (pilot RCT) will be conducted in 2–3 MS centres, clinics, or rehabilitation centres including 55 pwMS and accompanied by a process evaluation. Patients with a RRMS diagnosis considering immunotherapy are eligible. The primary outcome is decision self-efficacy. Secondary outcomes include preparation for decision-making, decisional conflict, risk knowledge, confidence in active participation, affective forecasting, social support, and self-reported impact of eHealth on its users. Participants will be randomly assigned either to (i) an intervention group with 4 weeks access to an evidence-based patient information resource and the PExMS-website as an adjunct or to (ii) the control group with access to evidence-based information alone. A 6-member advisory panel involving representatives of pwMS, researchers, and neurologists, who accompany the whole project, will mentor this pilot RCT.DiscussionThe intervention was developed with systematic methods, created with active patient involvement and in critical appraisal by an expert advisory panel. The study is innovative as it contributes to the controversial evidence on the use of PEx in the context of evidence-based patient information.Trial registrationClinicalTrials.gov, NCT04236544

Development of an antimicrobial stewardship implementation model involving collaboration between general practitioners and pharmacists: GPPAS study in Australian primary care.

Rising antimicrobial resistance (AMR) in primary care is a growing concern and a threat to community health. The rise of AMR can be slowed down if general practitioners (GPs) and community pharmacists (CPs) could work as a team to implement antimicrobial stewardship (AMS) programs for optimal use of antimicrobial(s). However, the evidence supporting a GP pharmacist collaborative AMS implementation model (GPPAS) in primary care remains limited. With an aim to design a GPPAS model in Australia, this paper outlines how this model will be developed. This exploratory study undertakes a systematic review, a scoping review, nationwide surveys, and qualitative interviews to design the model. Medical Research Council (MRC) framework and Normalization Process Theory are utilized as guides. Reviews will identify the list of effective GPPAS interventions. Two AMS surveys and paired interviews of GPs and CPs across Australia will explore their convergent and divergent views about the GPPAS interventions, attitudes towards collaboration in AMS and the perceived challenges of implementing GPPAS interventions. Systems Engineering Initiative for Patient Safety (SEIPS 2.0) model and factor analyses will guide the structure of GPPAS model through identifying the determinants of GPPAS uptake. The implementable GPPAS strategies will be selected based on empirical feasibility assessment by AMS stakeholders using the APEASE (Affordability, Practicability, Effectiveness and cost-effectiveness, Acceptability, Side-effects and safety, Equity) criteria. The GPPAS model might have potential implications to inform how to better involve GPs and CPs in AMS, and, to improve collaborative services to optimize antimicrobial use and reduce AMR in primary care.

Designing a Pragmatic Intervention to Help Improve the Bladder Cancer Patient Experience.

Bladder cancer (BC) is the 10th most common malignancy worldwide and the patient experience is found to be worse than that for patients diagnosed with other cancer types. We aimed to develop a wellbeing intervention to help improve the bladder cancer patient experience by ameliorating their health-related Quality of Life (HRQoL). We followed the 3 phases of the modified Medical Research Council (MRC) Framework for development of complex interventions. Following a systematic review of the literature on mental, sexual, and physical wellbeing, we conducted discussion groups with patients and healthcare professionals on these 3 themes. A consultation phase was then conducted with all relevant stakeholders to co-design a wellbeing intervention as part of a feasibility study. A pragmatic wellbeing feasibility trial was designed based on the hypothesis that a wellbeing program will increase patient awareness and attendance to services available to them and will better support their needs to improve HRQoL. The primary feasibility endpoints are patient attendance to the services offered and changes in HRQoL. The principle of patient centered care has strengthened the commitment to provide a holistic approach to support BC patients. In this study, we developed a wellbeing intervention in collaboration with patients and healthcare professionals to meet an unmet need in terms of the BC patient experience.

The DemWG study: reducing the risk of hospitalisation through a complex intervention for people with dementia and mild cognitive impairment (MCI) in German shared-housing arrangements: study protocol of a prospective, mixed-methods, multicentre, cluster-randomised controlled trial

IntroductionShared-housing arrangements (SHAs) are small, home-like care environments in Germany. Residents are predominantly people with dementia. The risk for all-cause hospitalisation is consistently higher for people with dementia compared with...

Developing a complex intervention to support pregnant women with mild to moderate anxiety: application of the Medical Research Council framework

BackgroundTo design and develop an intervention to support women with symptoms of mild to moderate anxiety in pregnancy.MethodsThe development followed the MRC framework for complex interventions, utilising psychological theory, review level evidence and professional and public involvement. Two systematic reviews were completed which helped identify potentially beneficial intervention components. The theory underpinning the components was explored to consider the potential benefit for women with mild to moderate anxiety symptoms in pregnancy. Methods of delivering the intervention within maternity services were explored. The intervention comprised: group discussions, one to one support and assisted self-help resources. Midwives were identified as ideally placed to facilitate the intervention supported by midwifery support workers. A bespoke training package was provided by subject experts to prepare the facilitators.ResultsThe absence of established interventions and a paucity of evidence based approaches for pregnant women with symptoms of mild to moderate anxiety indicated the need for a rigorous and systematic approach to the intervention design. This approach led to the development of an intervention feasible for implementation in maternity care systems tailored to the needs of pregnant women. The involvement of a multi-professional advisory team and active engagement of service users helped to consider the acceptability of the intervention for women and the feasibility of delivering the intervention in the context of maternity care.ConclusionThe MRC Framework provided useful overarching guidance to develop a midwife facilitated intervention for women with symptoms of anxiety in pregnancy. The framework assisted the development of a robust rationale for each intervention component and considered the processes of evaluation and implementation into maternity care systems.

Development and validation of a Tai chi intervention protocol for managing the fatigue-sleep disturbance-depression symptom cluster in female breast cancer patients

ObjectiveTo develop an evidence-based tai chi intervention protocol for managing the fatigue-sleep disturbance-depression symptom cluster (FSDSC) in breast cancer (BC) patients. MethodsThe Medical Research Council (MRC) Framework for Developing and Evaluating Complex Interventions (the MRC framework) was utilized to guide the study design. This study focused on Phase І of the MRC framework—the development of the intervention—to develop an evidence-based tai chi intervention protocol for managing the FSDSC in BC patients based on existing research evidence, theories, practice standards/guidelines, and experts’ consensus. An extensive literature search was performed to identify current systematic reviews, theories, and practice standards/guidelines that can be utilized to inform the intervention dosage and techniques of tai chi and practice instructions. Content validity assessment was also conducted to assess the content validity of the tai chi protocol through expert panel consensus. The content validity index (CVI) was calculated to identify whether the intervention required further refinement. ResultsThe components of the tai chi protocol were identified by current research evidence and relevant practice standards/guidelines, including the selection of an appropriate tai chi modality and intensity and the duration of the intervention. The Easy 8 form Yang-style tai chi was selected based on the guidelines of the National Comprehensive Cancer Network, the American College of Sports Medicine, and China’s State Commission for Physical Culture and Sports. The intensity and duration of the tai chi intervention were scheduled, respectively, twice per week, with each session lasting about one hour, for eight weeks based on the current systematic review evidence on traditional Chinese exercise for the alleviation of cancer-related symptoms. The practise techniques of tai chi were identified from practise standards released by the State Sport General Administration of China. All the items in the tai chi protocol were determined to be content valid after the first round of rating, with all item-level CVIs at 1.00. The scale-level CVI for the tai chi protocol was also identified as excellent, at 1.00. ConclusionAn evidence-based tai chi program for managing the FSDSC in BC patients was developed by following the MRC framework. The results provided a clear specification of the tai chi intervention protocol for healthcare professionals and researchers in the next phase of the study—pilot testing the tai chi intervention protocol for FSDSC management through a preliminary randomized controlled trial.

The elephant in the room: an exploratory study of hypertensive disorders of pregnancy (HDP) management in Indonesian primary care settings

BackgroundIndonesia has the highest maternal mortality rate in South East Asia, that a third of the mortality is caused by hypertensive disorders of pregnancy (HDP), including preeclampsia and eclampsia. Research suggests that maternal deaths from HDP are avoidable with appropriate initial management in primary care. However, little is known regarding the exact way HDP management is conducted in Indonesian primary care. This research aims to explore the way HDP management is provided, including its barriers and facilitators in Indonesian primary care settings.MethodsThis research applied a practical qualitative methodology using interviews with a topic guide. It is guided by the implementation science framework of the Medical Research Council (MRC) framework and Practical Robust Implementation and Sustainability Model (PRISM) to design and evaluate complex healthcare interventions. Primary care key stakeholders from Yogyakarta province were recruited from May–December 2018. The interviews were conducted in face-to-face, telephone, and teleconference interviews. Data from the interviews were analysed thematically using a mix of inductive and deductive approaches.ResultsA total of 24 participants were interviewed, consisting of four general practitioners, five midwives, three nurses, three obstetricians, a cardiologist, five policymakers and three women with a previous history of HDP. Referrals are the usual management performed for HDP women in primary care and the primary care providers’ practice is challenged by three identified themes: (i) providers’ limited confidence to perform HDP management, (ii) fragmented continuity of care, and (iii) community beliefs. Many participants also desired to have more focused guidance to improve HDP management in primary care practice.ConclusionEven though Indonesian antenatal care and referrals are generally accessible, there are many challenges and fragmentation of HDP management. The most prominent challenge is the primary care providers’ lack of confidence in performing the management and the ‘elephant’ of an urgent need of practice guidelines in primary care that has never been appropriately described in the literature. Further development of an evidence-based primary care-focused guidance will potentially improve primary care providers’ skills to perform optimal HDP management and provide appropriate education to their patients.

ReStOre@Home: Feasibility study of a virtually delivered 12-week multidisciplinary rehabilitation programme for survivors of upper gastrointestinal (UGI) cancer - study protocol

Background: Exercise rehabilitation programmes, traditionally involving supervised exercise sessions, have had to rapidly adapt to virtual delivery in response to the coronavirus disease 2019 (COVID-19) pandemic to minimise patient contacts. In the absence of an effective vaccine, the pandemic is likely to persist in the medium term and during this time it is important that the feasibility and effectiveness of remote solutions is considered. We have previously established the feasibility of the Rehabilitation Strategies following Oesophago-gastric Cancer (ReStOre) intervention - a face to face multidisciplinary rehabilitation programme for upper gastrointestinal (UGI) cancer survivors. This study will examine the feasibility of a virtually delivered 12-week multi-component ReStOre@Home programme. Methods: This single arm feasibility study will recruit 12 patients who have completed curative treatment for oesophago-gastric cancer. Participants will complete the 12-week ReStOre@Home programme consisting of exercise (aerobic and resistance training), 1:1 dietary counselling and group education sessions through virtual delivery. Underpinned by the Medical Research Council (MRC) Framework, feasibility will be determined by recruitment rates, adherence, retention, incidents, and acceptability. Acceptability will be assessed qualitatively through post-intervention interview and the Telehealth Usability Questionnaire. Secondary outcomes will be assessed pre and post-intervention and will include measures of physical performance (cardiopulmonary exercise test, short physical performance battery, hand grip strength, Godin Leisure Time Questionnaire, and body composition), health related quality of life (European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) and oesophago-gastric cancer specific subscale (EORTC-QLQ-OG25), fatigue (Multidimensional Fatigue Inventory (MFI-20), and venous blood samples will be collected for the UGI Cancer Survivorship Biobank. Discussion: The ReStOre@Home feasibility study will provide important data regarding the amenability of a multidisciplinary programme designed for UGI cancer survivors to virtual delivery. Trial registration: ClinicalTrials.gov NCT04603339 (26/10/2020).

An Individual Cognitive Stimulation Therapy App for People With Dementia: Development and Usability Study of Thinkability.

BackgroundThere is a lack of technological resources for the mental stimulation and communication of people with dementia, which can be helpful in improving cognition and quality of life. Paper-based individual cognitive stimulation therapy (iCST) for people with dementia has the potential to be adapted to a touchscreen format. This can improve accessibility and provide mental stimulation using interactive features. There is a need for a rigorous and systematic approach toward development, leading to improved suitability and implementation of the intervention, so that more people can benefit from its use.ObjectiveThis study aims to develop and investigate the usability of Thinkability, an iCST app that can be used by people with dementia and carers on touchscreen tablets.MethodsThe Medical Research Council framework for evaluating complex interventions and the Centre for eHealth Research roadmap served as frameworks for the stages of intervention and technology development. The development of the iCST app itself adopted an agile approach with elements from action research. Hence, it was developed in 3 successive sprints and was evaluated by relevant stakeholders at each sprint. Sprint 1 included 2 patient and public involvement (PPI) consultation meetings, sprint 2 included 1 PPI consultation meeting, and 4 focus groups and 10 individual interviews were organized in sprint 3. A feasibility trial is currently underway.ResultsThe findings from each sprint were used to inform the development. Sprint 1 helped to identify the relevant evidence base and explored the attitudes of people with dementia and carers toward a potential iCST app. In sprint 2, an initial prototype was evaluated in a small PPI consultation meeting. In sprint 3, feedback was gathered through a qualitative study on the quality and perceived effectiveness of the iCST app. It was well received by people with dementia and carers. A need for more updated and personalized content was highlighted.ConclusionsThis study proves that an agile approach toward technology development involving all relevant stakeholders is effective in creating suitable technology. Adding to our previous knowledge of noncomputerized cognitive stimulation therapy, the release of the iCST app will make this psychosocial intervention accessible to more users worldwide.

A novel ACT-based video game to support mental health through embedded learning: a mixed-methods feasibility study protocol

IntroductionIn recent years, serious video games have been used to promote emotional regulation in individuals with mental health issues. Although these therapeutic strategies are innovative, they are limited with respect...

Development and preliminary evaluation of a communication skills training programme for hospital physicians by a specialized palliative care service: the \u2018Teach to Talk\u2019 programme

BackgroundThere is widespread agreement about the importance of communication skills training (CST) for healthcare professionals caring for cancer patients. Communication can be effectively learned and improved through specific CST. Existing CSTs have some limitations with regard to transferring the learning to the workplace. The aim of the study is developing, piloting, and preliminarily assessing a CST programme for hospital physicians caring for advanced cancer patients to improve communication competences.MethodsThis is a Phase 0-I study that follows the Medical Research Council framework; this paper describes the following sections: a literature review on CST, the development of the Teach to Talk training programme (TtT), the development of a procedure for assessing the quality of the implementation process and assessing the feasibility of the implementation process, and the pilot programme. The study was performed at a 900-bed public hospital. The programme was implemented by the Specialized Palliative Care Service. The programme was proposed to 19 physicians from 2 departments.ResultsThe different components of the training course were identified, and a set of quality indicators was developed. The TtT programme was implemented; all the physicians attended the lesson, videos, and role-playing sessions. Only 25% of the physicians participated in the bedside training. It was more challenging to involve Haematology physicians in the programme.ConclusionsThe programme was completed as established for one of the two departments in which it was piloted. Thus, in spite of the good feedback from the trainees, a re-piloting of a different training program will be developed, considering in particular the bed side component.The program should be tailored on specific communication attitude and believes, probably different between different specialties.

Using the Medical Research Council framework for developing a logic model to support children with visual impairments in their learning environments

Interventions can be designed to support the interactions of children with visual impairments with their learning environments. However, there is a need to develop systematic and theory‐based interventions for supporting children with visual impairments and additional disabilities in their learning environments. This exploratory qualitative study aims to develop a logic model for parents/guardians teachers, and children with visual impairments who attend preschool or primary school by using the Medical Research Council framework for complex interventions. The data were collected in two stages using qualitative data collection methods and in total 27 participants took part. Analysis of the collected data revealed that complex factors can impact on children's interactions with their learning environments. Subsequently, a logic model was developed based on the findings which indicates the importance of a holistic approach through partnership to address the needs of this population.