Qualitative Process Evaluation Research Articles

Music and Movement for Health: Protocol for a pragmatic cluster-randomised feasibility pilot trial of an arts-based programme for the health and wellbeing of older adults.

Background: Arts-based health programmes (ABHP) can enhance the physical and psychosocial health and wellbeing of older people. However, the feasibility and usefulness of such programmes in Ireland are currently unknown. The primary aim of this study is to examine the feasibility of the study design, its application to a music and movement for health programme and associated costs. The secondary aim is to obtain preliminary effect estimates of an ABHP on health and wellbeing in older adults. Methods: This study is a pragmatic cluster-randomised controlled feasibility trial. Community-dwelling adults, aged 65 years or older will be recruited in the mid-west region of Ireland via methods including social prescription, traditional and social media. The clusters, based on geographical region, will be block randomised to either the ABHP or control using 1:1 allocation ratio. The programme will comprise a 1.5-hour music and dance session each week for 12-weeks together with a 1-hour home-based music and movement programme for 12-weeks. A qualitative and quantitative process evaluation of the arts-based health programme will be performed. Outcomes: Primary outcomes for feasibility include recruitment rates (the number of participants recruited per cluster per month); retention rate (the number of participants who complete measures at baseline and at follow up post intervention, and minimum average attendance. Secondary outcomes will include physical function, balance, physical activity, loneliness, social isolation, cognition, mood, as well as quality of life and cost. Conclusions: If this pioneering study finds evidence to support feasibility and acceptability, a future larger-scale definitive trial will be conducted to examine the effectiveness of an arts-based health programme for older adults. This research aims to strengthen collaborative efforts to implement effective, sustainable and cost-effective programmes for older adults to support community connection, enhancing health and wellbeing, in turn reducing demands on the healthcare system. ISRCTN registration: ISRCTN35313497 (18/02/2022).

A Qualitative Process Evaluation of Participant Experiences in a Feasibility Randomised Controlled Trial to Reduce Indulgent Foods and Beverages

There is a growing interest in the effects of ultra-processed/energy-dense nutrient-poor foods on health outcomes, and few interventions to reduce their consumption have been tested. We tested a simple intervention to help people reduce the indulgences they consume (energy-dense nutrient-poor (EDNP) foods). Herein, we report the qualitative findings to understand how participants reduced their consumption by exploring intervention fidelity and the factors affecting consumption. We conducted a qualitative descriptive study of 23 adults who had taken part in a feasibility randomised controlled trial that asked participants to say no to seven indulgences/week and record what they said no to. Data were collected using face-to-face semi-structured interviews and analysed thematically. A total of 23 adults with an average BMI of 30.8 kg/m2 took part. Participants liked the term indulgence, as they could apply it to their normal dietary intake and make small changes. They found self-monitoring what they said no to helpful and reported that emotional eating and habits affected consumption. They had difficulty overcoming these. As most people are consuming too many foods that are EDNP, this simple intervention of "Say No" seven times/week has the potential to be developed as a public health campaign.

Improving the Engagement of Underrepresented People in Health Research Through Equity-Centered Design Thinking: Qualitative Study and Process Evaluation for the Development of the Grounding Health Research in Design Toolkit.

Health inequalities are rooted in historically unjust differences in economic opportunities, environment, access to health care services, and other social determinants. Owing to these health inequalities, the COVID-19 pandemic has disproportionately affected underserved populations, notably people of color, incarcerated and formerly incarcerated individuals, and those unable to physically distance themselves from others. However, people most strongly impacted by health disparities, and the pandemic, are not frequently engaged in research, either as researchers or as participants, resulting in slow progress toward improving health equity. Establishing ways to foster the engagement of historically excluded people is crucial to improving health equity through patient-centered health research. This study aimed to assess the use of equity-centered design thinking (EDT) for engaging community members in research prioritization related to COVID-19. The co-design methods and subsequent production of a toolkit that can be used for engagement were assessed through process evaluation and qualitative methods. Process evaluation and qualitative inquiry, using reflexive thematic analysis, were undertaken to examine the use of EDT. Patient community members and stakeholders remotely partnered with design and health researchers in a year-long digital process to cocreate capacity-building tools for setting agenda for research regarding the impact of COVID-19 on health outcomes. Through a series of 3 workshops, 5 community partners engaged in EDT activities to identify critical challenges for the health and well-being of their communities. The subsequent tools were tested with 10 health researchers who provided critical input over the course of 2 workshops. Interviews with co-designers, project materials, and feedback sessions were used in the process evaluation and finalization of an equity-centered toolkit for community engagement in research. Data from the co-design process, meetings, workshops, and interviews were analyzed using reflexive thematic analysis to identify salient themes. Process evaluation illustrated how the EDT co-design process offered an approach to engage patient partners and community stakeholders in health-related research around COVID-19. The participants expressed satisfaction with design thinking approaches, including creative activities and iterative co-design, as a means of working together. Thematic analysis identified 3 key themes: the value of authentic partnerships, building trust and empathy through design, and fostering candid dialogue around health and social issues impacting historically underrepresented and underinvested communities. The project addressed the need to test EDT strategies for fostering inclusive community engagement in health research agenda setting and provided an alternative to traditional top-down models. Despite the increasing use of human-centered design in health, few projects explicitly include equity in design thinking approaches. The use of methods and tools to intentionally engage underrepresented stakeholders in the process of research agenda setting and equitably sharing power between researchers and community members may improve health research, ultimately improving health equity.

A smoking cessation intervention for people with severe mental illness treated in ambulatory mental health care (KISMET): study protocol of a randomised controlled trial

BackgroundSmoking among people with severe mental illness (SMI) is highly prevalent and strongly associated with poor physical health. Currently, evidence-based smoking cessation interventions are scarce and need to be integrated into current mental health care treatment guidelines and clinical practice. Therefore, the present study aims to evaluate the implementation and effectiveness of a smoking cessation intervention in comparison with usual care in people with SMI treated by Flexible Assertive Community Treatment (FACT) teams in the Netherlands.MethodsA pragmatic, cluster-randomised controlled trial with embedded process evaluation will be conducted. Randomisation will be performed at the level of FACT teams, which will be assigned to the KISMET intervention or a control group (care as usual). The intervention will include pharmacological treatment combined with behavioural counselling and peer support provided by trained mental health care professionals. The intervention was developed using a Delphi study, through which a consensus was reached on the core elements of the intervention. We aim to include a total of 318 people with SMI (aged 18–65 years) who smoke and desire to quit smoking. The primary outcome is smoking status, as verified by carbon monoxide measurements and self-report. The secondary outcomes are depression and anxiety, psychotic symptoms, physical fitness, cardiovascular risks, substance use, quality of life, and health-related self-efficacy at 12 months. Alongside the trial, a qualitative process evaluation will be conducted to evaluate the barriers to and facilitators of its implementation as well as the satisfaction and experiences of both patients and mental health care professionals.DiscussionThe results of the KISMET trial will contribute to the evidence gap of effective smoking cessation interventions for people treated by FACT teams. Moreover, insights will be obtained regarding the implementation process of the intervention in current mental health care. The outcomes should advance the understanding of the interdependence of physical and mental health and the gradual integration of both within the mental health care system.Trial registrationNetherlands Trial Register, NTR9783. Registered on 18 October 2021.

IMplementing Predictive Analytics towards efficient COPD Treatments (IMPACT): protocol for a stepped-wedge cluster randomized impact study

IntroductionPersonalized disease management informed by quantitative risk prediction has the potential to improve patient care and outcomes. The integration of risk prediction into clinical workflow should be informed by the experiences and preferences of stakeholders, and the impact of such integration should be evaluated in prospective comparative studies.The objectives of the IMplementing Predictive Analytics towards efficient chronic obstructive pulmonary disease (COPD) treatments (IMPACT) study are to integrate an exacerbation risk prediction tool into routine care and to determine its impact on prescription appropriateness (primary outcome), medication adherence, quality of life, exacerbation rates, and sex and gender disparities in COPD care (secondary outcomes).MethodsIMPACT will be conducted in two phases. Phase 1 will include the systematic and user-centered development of two decision support tools: (1) a decision tool for pulmonologists called the ACCEPT decision intervention (ADI), which combines risk prediction from the previously developed Acute COPD Exacerbation Prediction Tool with treatment algorithms recommended by the Canadian Thoracic Society’s COPD pharmacotherapy guidelines, and (2) an information pamphlet for COPD patients (patient tool), tailored to their prescribed medication, clinical needs, and lung function. In phase 2, we will conduct a stepped-wedge cluster randomized controlled trial in two outpatient respiratory clinics to evaluate the impact of the decision support tools on quality of care and patient outcomes. Clusters will be practicing pulmonologists (n ≥ 24), who will progressively switch to the intervention over 18 months. At the end of the study, a qualitative process evaluation will be carried out to determine the barriers and enablers of uptake of the tools.DiscussionThe IMPACT study coincides with a planned harmonization of electronic health record systems across tertiary care centers in British Columbia, Canada. The harmonization of these systems combined with IMPACT’s implementation-oriented design and partnership with stakeholders will facilitate integration of the tools into routine care, if the results of the proposed study reveal positive association with improvement in the process and outcomes of clinical care. The process evaluation at the end of the trial will inform subsequent design iterations before largescale implementation.Trial registrationNCT05309356.

A Process Evaluation of the National Implementation of a Bundle for Central Venous Catheter Care for Hemodialysis.

Implementation of a care bundle standardising insertion, management and removal practices to reduce infection related to central venous catheters used for haemodialysis was evaluated in a stepped wedge, cluster randomised controlled trial conducted at 37 Australian hospitals providing kidney services, with no reduction in catheter related blood stream infection detected. This process evaluation explored the barriers, enablers and unintended consequences of the implementation to explain the trial outcomes. Qualitative process evaluation using pre post semi-structured interviews with 38 (19 nursing, 19 medical) and 44 (25 nursing, 19 medical) Australian health professionals involved in haemodialysis central venous catheter management. Analysis was guided by the process implementation domain of the Consolidated Framework for Implementation Research. Key influences on bundle uptake were that clinicians were open to change that was evidence-based and driven by guidelines and had a desire to improve practice and patient outcomes. However, resistance to change in environments of low infection, working in silos of practice, and a need for individualised delivery of patient education created barriers to uptake. Unintended impacts of increased costs and lack of interoperability of systems for data collection were reported. As the trial was in progress at the time of qualitative data collection, perceptions of the bundle may have been influenced by the fact that practices of participants were being observed as a part of the trial. This national process evaluation revealed that health professionals who reported experiencing a benefit viewed the bundle positively. Those that already provided most of the recommended care or perceived that their patient population was not included in the research evidence that underpinned the interventions, resisted the implementation of the bundle. Potentially, formal change management processes using facilitation may improve implementation of evidence-based practice.

A qualitative process evaluation of universal free school meal provision in two London secondary schools

BackgroundIn the UK, one in five households with children experienced food insecurity in 2022, defined as a household-level economic and social condition of limited or uncertain access to adequate food. Free school meals are a public health intervention aimed at reducing food insecurity amongst children. The provision of universal free school meals (UFSM) to secondary school-aged children is a novel and untested intervention in the UK. This study is a process evaluation of a pilot of UFSM in two secondary schools in England. The aim was to understand the feasibility, acceptability, cost implications and lessons for the implementation of UFSM.Methods20 parents, 28 students and 8 school staff from two intervention schools participated in online qualitative interviews, as well as 4 staff from non-intervention schools. The Framework Method of thematic analysis was applied. These data were supplemented with student-led observations of school meal times, and school lunch uptake-data and cost information provided by the local authority delivering the pilot.ResultsUFSM in secondary schools is a feasible and acceptable intervention, with coherent goals of increased access to a healthy meal, reduced food insecurity and better nutrition. All participants perceived these goals were met. Acceptability was further enhanced by the perception that UFSM were supporting a greater proportion of low-income families than the national, targeted Free School Meal scheme, as well as being easier to implement. Potential barriers to implementation include limited school kitchen and dining infrastructure, meal quality and choice, and increased queuing times. Participants’ concerns that UFSM may benefit middle- and high- income families not in need were not as prevalent as the perception that UFSM was an effective way to support all families with secondary-aged children experiencing food insecurity.ConclusionThis small-scale pilot study suggests that UFSM in secondary schools is feasible and acceptable, but more evidence is required from larger studies on the impact on long-term health, psychosocial and educational outcomes. Future, larger studies should also include detailed economic evaluations so this approach can be compared with other possible interventions.

Non-specialist-delivered psychosocial intervention for prenatal anxiety in a tertiary care setting in Pakistan: a qualitative process evaluation

ObjectivesA manualised cognitive–behavioural therapy-based psychosocial intervention for prenatal anxiety called Happy Mother Healthy Baby is being tested for its effectiveness through a randomised control trial in Pakistan. The aim of...

Feasibility of randomized controlled trials and long-term implementation of interventions: Insights from a qualitative process evaluation of the PEDAL trial.

A multi-site randomized controlled trial was carried out between 2015 and 2019 to evaluate the impacts on quality of life of an intradialytic exercise programme for people living with chronic kidney disease. This included a qualitative process evaluation which gave valuable insights in relation to feasibility of the trial and of the intervention in the long-term. These can inform future clinical Trial design and evaluation studies. A constructivist phenomenological approach underpinned face-to-face, semi-structured interviews. Purposive recruitment ensured inclusion of participants in different arms of the PEDAL Trial, providers with different roles and trial team members from seven Renal Units in five study regions. Following ethical review, those willing took part in one interview in the Renal Unit. Audio-recorded interviews were transcribed (intelligent verbatim) and inductively thematically analyzed. Participants (n = 65) (Intervention arm: 26% completed; 13% who did not; Usual care arm: 13%; 46% women; 54% men; mean age 60 year) and providers (n = 39) were interviewed (23% PEDAL Trial team members). Three themes emerged: (1) Implementing the Intervention; (2) Implementing the trial; and (3) Engagement of the clinical team. Explanatory theory named "the Ideal Scenario" was developed, illustrating complex interactions between different aspects of intervention and trial implementation with the clinical context. This describes characteristics likely to optimize trial feasibility and intervention sustainability in the long-term. Key aspects of this relate to careful integration of the trial within the clinical context to optimize promotion of the trial in the short-term and engagement and ownership in the long-term. Strong leadership in both the clinical and trial teams is crucial to ensure a proactive and empowering culture. Novel explanatory theory is proposed with relevance for Implementation Science. The "Ideal Scenario" is provided to guide trialists in pre-emptive and ongoing risk analysis relating to trial feasibility and long-term intervention implementation. Alternative study designs should be explored to minimize the research-to-practice gap and optimize the likelihood of informative findings and long-term implementation. These might include Realist Randomized Controlled Trials and Hybrid Effectiveness-Implementation studies.

Methodological Insights, Advantages and Innovations Manuscript Title: Lessons Learned in Conducting Qualitative Healthcare Research Interviews in Malawi: A Qualitative Evaluation

With the growth of qualitative health research in low- and middle-income countries, local health professionals are increasingly involved in facilitating interviews with their fellow health workers. Understanding the methodological implications of such situations is required to ensure high-quality study findings and to build capacity and skills for interviewers with clinical backgrounds working with limited resources. This article reports a qualitative process evaluation of a study that assessed barriers and enablers of implementing bubble continuous positive airway pressure in Malawi. Findings were summarized through an iterative process of reflection on what worked, what did not work, areas for improvement, structural challenges, negotiating dual roles as nurses and researchers and the professional hierarchy within the health care system. Comprehensive practical training was critical to conducting qualitative research in a health setting. Interviewers were health workers themselves and required skills in reflexivity to effectively probe and navigate interviewing other health professionals, including senior staff. The main challenge in conducting interviews in a resource-limited healthcare setting was time constraints, which were compounded by staffing shortages. Lessons from this qualitative evaluation highlight the importance of training in reflexivity, engaging interviewers as collaborators and reserving adequate time to accommodate healthcare workers’ multiple roles and responsibilities.

Interdisciplinary interactions, social systems and technical infrastructure required for successful implementation of mobile stroke units: A qualitative process evaluation.

Mobile stroke units (MSUs) are increasingly being implemented to provide acute stroke care in the prehospital environment, but a comprehensive implementation evaluation has not been undertaken. To identify successes and challenges in the pre- and initial operations of the first Australian MSU service from an interdisciplinary perspective. Process evaluation of the Melbourne MSU with a mixed-methods design. Purposive sampling targeted key stakeholder groups. Online surveys (administered June-September 2019) and semistructured interviews (October-November 2019) explored experiences. Directed content analysis (raters' agreement 85%) and thematic analysis results are presented using the Interactive Sociotechnical Analysis framework. Participants representing executive/program operations, MSU clinicians and hospital-based clinicians completed 135 surveys and 38 interviews. Results converged, with major themes addressing successes and challenges: stakeholders, vehicle, knowledge, training/education, communication, work processesand working relationships. Successes and challenges of establishing a new MSU service extend beyond technical, to include operational and social aspects across prehospital and hospital environments.

Fostering supportive interactions in the neighbourhood: Using visualized narratives

AbstractThe use of art (e.g. visualized narratives) in social work may stimulate dialogue between community members about family support in their neighbourhood. The Visualized Narratives on Parenting Interactions in the Neighbourhood (VN‐PIN) were developed in order to foster this dialogue. The aim of this study was to evaluate the implementation of the VN‐PIN in social work practice and to gain insight in mechanisms that stimulate dialogues supported by visualizations. A qualitative process evaluation was conducted to explore the use of the VN‐PIN in various urban settings. We observed meetings (N = 14) where the VN‐PIN was applied and interviewed professionals and community members (N = 81). The results of this study show that the VN‐PIN intervention gives parents a voice and allows them to recognize and reflect on their own parenting behaviour, thereby contributing to mutual exchanges in a supportive community. The conclusion of this study is that the VN‐PIN is a useful intervention that social work professionals can use to foster dialogues about parenting within diverse contexts in super‐diverse neighbourhoods. The intervention fosters a supportive structure to share experiences of various community members. Future research is needed to further evaluate the experiences and satisfaction of community members with the intervention.

Integrative approaches to methods training for early-career scientists: Rationale and process evaluation of the first cohort of the Michigan Integrative Well-Being and Inequality Training Program.

The Michigan Integrative Well-Being and Inequality (MIWI) Training Program aims to provide state-of-the-art, interdisciplinary training to enhance the methodological skills of early-career scientists interested in integrative approaches to understanding health disparities. The goals of this paper are to describe the scientific rationale and core design elements of MIWI, and to conduct a process evaluation of the first cohort of trainees (called "scholars") to complete this program. Mixed methods process evaluation of program components and assessment of trainee skills and network development of the first cohort (n = 15 scholars). The program drew 57 applicants from a wide range of disciplines. Of the 15 scholars in the first cohort, 53% (n = 8) identified as an underrepresented minority, 60% (n = 9) were within 2 years of completing their terminal degree, and most (n = 11, 73%) were from a social/behavioral science discipline (e.g., social work, public health). In the post-program evaluation, scholars rated their improvement in a variety of skills on a one (not at all) to five (greatly improved) scale. Areas of greatest growth included being an interdisciplinary researcher (mean = 4.47), developing new research collaborations (mean = 4.53), and designing a research study related to integrative health (mean = 4.27). The qualitative process evaluation indicated that scholars reported a strong sense of community and that the program broadened their research networks. These findings have implications for National Institutes of Health (NIH) efforts to train early-career scientists, particularly from underrepresented groups, working at the intersection of multiple disciplines and efforts to support the formation of research networks.

Understanding factors affecting implementation success and sustainability of a comprehensive prevention program for cardiovascular disease in primary health care: a qualitative process evaluation study combining RE-AIM and CFIR.

Our aim was to evaluate the implementation process of a comprehensive cardiovascular disease prevention program in general practice, to enhance understanding of influencing factors to implementation success and sustainability, and to learn how to overcome barriers. Cardiovascular disease and its risk factors are the world's leading cause of mortality, yet can be prevented by addressing unhealthy lifestyle behavior. Nevertheless, the transition toward a prevention-oriented primary health care remains limited. A better understanding of factors facilitating or hindering implementation success and sustainability of prevention programs, and how barriers may be addressed, is needed. This work is part of Horizon 2020 project 'SPICES', which aims to implement validated preventive interventions in vulnerable populations. We conducted a qualitative process evaluation with participatory action research approach of implementation in five general practices. Data were collected through 38 semi-structured individual and small group interviews with seven physicians, 11 nurses, one manager and one nursing assistant, conducted before, during, and after the implementation period. We applied adaptive framework analysis guided by RE-AIM Qualitative Evaluation for Systematic Translation (RE-AIM QuEST) and Consolidated Framework for Implementation Research (CFIR). Multiple facilitators and barriers affected reach of vulnerable target populations: adoption by primary health care providers, implementation and fidelity and intention to maintain the program into routine practice. In addition, our study revealed concrete actions, linked to implementation strategies, that can be undertaken to address identified barriers. Prioritization of prevention in general practice vision, ownership, and shared responsibility of all team members, compatibility with existing work processes and systems, expanding nurse's roles and upskilling competence profiles, supportive financial and regulatory frameworks, and a strong community - health care link are crucial to increase implementation success and long-term maintenance of prevention programs. COVID-19 was a major barrier to the implementation. RE-AIM QuEST, CFIR, and participatory strategies are useful to guide implementation of prevention programs in primary health care.

Tackling the COVID-19 infodemic among Syrian refugees in Lebanon: Development and evaluation of the "Wikaytek" tool.

The COVID-19 infodemic has been a global public health challenge, especially affecting vulnerable populations such as Syrian refugees with limited internet access and functional, health, digital, and media literacies. To address this problem, we developed Wikaytek, a software to diffuse reliable COVID-19 information using WhatsApp, the preferred communication channel among Syrian refugees. In this paper, we describe the systematic development of the tool. We undertook a pilot study guided by the Humanitarian Engineering Initiative (HEI)'s user-centered design framework, comprising five stages: (a) user research, including needs assessment and desk review of interventions with target users; (b) concept design based on platform and source selection, message format, concept testing, and architecture design; (c) prototyping and implementation, encompassing software development and system operation; (d) user testing (alpha and beta); and (e) evaluation through software analytics and user interviews. We reported a qualitative process evaluation. Wikaytek scrapes validated and reliable COVID-19-related information from reputable sources on Twitter, automatically translates it into Arabic, attaches relevant media (images/video), and generates an audio format using Google text-to-speech. Then, messages are broadcast to WhatsApp. Our evaluation shows that users appreciate receiving "push" information from reliable sources they can trust and prefer the audio format over text. Wikaytek is a useful and well-received software for diffusing credible information on COVID-19 among Syrian refugees with limited literacy, as it complements the texts with audio messages. The tool can be adapted to diffuse messages about other public health issues among vulnerable communities, extending its scope and reach in humanitarian settings.

A kind reminder-A qualitative process evaluation of women's perspectives on receiving a reminder of type 2 diabetes follow-up screening after gestational diabetes.

Women with previous gestational diabetesmellitus(GDM) are more than eight times more likely to develop type 2 diabetes (T2DM) compared to women without GDM. Annual follow-up T2DM-screening is recommended, but participation rates decrease rapidly after the first year. In the North Denmark Region, an electronic reminder has been tested with the aim of improving follow-up care for women with prior GDM. The aim of this study was to explore women's perspectives on receiving an electronic reminder, and the role of reminders in both women's decision-making and informed choice regarding participation in follow-up screening. A qualitative process evaluation informed by a critical realistic perspective. Data consisted of 20 semi-structured interviews with women previously diagnosed with GDM who had received the reminder. Interviews were analyzed using reflexive thematic analysis. The reminder affected women's decision-making and informed choices through a range of mechanisms. Its personalized design prompted feelings of co-responsibility and care from the healthcare system, supported continuity in women's care pathways, and helped women bridge the gap between healthcare sectors. Women's perception of diabetes risk and the importance of follow-up influenced their decision-making. Participation in follow-up screening was influenced by several contextual factors, as women's everyday life impeded their prioritizing follow-up screening. Women who experienced being met by their general practitioner (GP) with acknowledgement rather than stigmatization and received supportive information tailored to their life situation were more motivated to participate in future follow-up screenings. The reminder indicated both concern and co-responsibility for women's follow-up care after GDM and was well received by the women. It supported participation in follow-up screening through an emphasis on shared decision-making and informed choice. Women's interaction with their GP played a significant role.

A qualitative process evaluation of social recovery therapy for enhancement of social recovery in first-episode psychosis (SUPEREDEN3)

Many individuals with first-episode psychosis experience severe and persistent social disability despite receiving specialist early intervention. The SUPEREDEN3 trial assessed whether augmenting early intervention in psychosis services with Social Recovery Therapy (SRT) would lead to better social recovery. A qualitative process evaluation was conducted to explore implementation and mechanisms of SRT impact from the perspective of SUPEREDEN3 participants. A subsample of SUPEREDEN3 trial participants (n = 19) took part in semi-structured interviews, which were transcribed verbatim and analysed thematically. Trial participants were early intervention service users aged 16-35 years with severe and persistent social disability. Both SRT plus early intervention and early intervention alone arm participants were interviewed to facilitate better understanding of the context in which SRT was delivered and to aid identification of mechanisms specific to SRT. The six themes identified were used to generate an explanatory model of SRT's enhancement of social recovery. Participant experiences highlight the importance of the therapist cultivating increased self-understanding and assertively encouraging clients to face feared situations in a way that is perceived as supportive, while managing ongoing symptoms. The sense of achievement generated by reaching targets linked to personally meaningful goals promotes increased self-agency, and generates hope and optimism. The findings suggest potentially important processes through which social recovery was enhanced in this trial, which will be valuable in ensuring the benefits observed can be replicated. Participant accounts provide hope that, with the right support, even clients who have persistent symptoms and the most severe disability can make a good social recovery.

'Eczema shouldn't control you; you should control eczema': qualitative process evaluation of online behavioural interventions to support young people and parents/carers of children with eczema.

There is a lack of well-conducted randomized controlled trials evaluating the effectiveness of theory-based online interventions for eczema. To address these deficiencies, we previously developed and demonstrated the effectiveness of two online behavioural interventions: Eczema Care Online for parents/carers of children with eczema, and Eczema Care Online for young people with eczema. To explore the views and experiences of people who have used the Eczema Care Online interventions to provide insights into how the interventions worked and identify contextual factors that may impede users' engagement with the interventions. Qualitative semistructured interviews were conducted with 17 parents/carers of children with eczema and 17 young people with eczema. Participants were purposively sampled from two randomized controlled trials of the interventions and recruited from GP surgeries in England. Transcripts were analysed using inductive thematic analysis, and intervention modifications were identified using the person-based approach table of changes method. Both young people and parents/carers found the interventions easy to use, relatable and trustworthy, and perceived that they helped them to manage their eczema, thus suggesting that Eczema Care Online may be acceptable to its target groups. Our analysis suggested that the interventions may reduce eczema severity by facilitating empowerment among its users, specifically through improved understanding of, and confidence in, eczema management, reduced treatment concerns, and improved treatment adherence and management of irritants/triggers. Reading about the experiences of others with eczema helped people to feel 'normal' and less alone. Some (mainly young people) expressed firmly held negative beliefs about topical corticosteroids, views that were not influenced by the intervention. Minor improvements to the design and navigation of the Eczema Care Online interventions and content changes were identified and made, ready for wider implementation. People with eczema and their families can benefit from reliable information, specifically information on the best and safest ways to use their eczema treatments early in their eczema journey. Together, our findings from this study and the corresponding trials suggest wider implementation of Eczema Care Online (EczemaCareOnline.org.uk) is justified.

Women living with HIV, diabetes and/or hypertension multi-morbidity in Uganda: a qualitative exploration of experiences accessing an integrated care service

PurposeWomen experience a triple burden of ill-health spanning non-communicable diseases (NCDs), reproductive and maternal health conditions and human immunodeficiency virus (HIV) in sub-Saharan Africa. Whilst there is research on integrated service experiences of women living with HIV (WLHIV) and cancer, little is known regarding those of WLHIV, diabetes and/or hypertension when accessing integrated care. Our research responds to this gap.Design/methodology/approachThe INTE-AFRICA project conducted a pragmatic parallel arm cluster randomised trial to scale up and evaluate “one-stop” integrated care clinics for HIV-infection, diabetes and hypertension at selected primary care centres in Uganda. A qualitative process evaluation explored and documented patient experiences of integrated care for HIV, diabetes and/or hypertension. In-depth interviews were conducted using a phenomenological approach with six WLHIV with diabetes and/or hypertension accessing a “one stop” clinic. Thematic analysis of narratives revealed five themes: lay health knowledge and alternative medicine, community stigma, experiences of integrated care, navigating personal challenges and health service constraints.FindingsWLHIV described patient pathways navigating HIV and diabetes/hypertension, with caregiving responsibilities, poverty, travel time and cost and personal ill health impacting on their ability to adhere to multi-morbid integrated treatment. Health service barriers to optimal integrated care included unreliable drug supply for diabetes/hypertension and HIV linked stigma. Comprehensive integrated care is recommended to further consider gender sensitive aspects of care.Originality/valueThis study whilst small scale, provides a unique insight into the lived experience of WLHIV navigating care for HIV and diabetes and/or hypertension, and how a “one stop” integrated care clinic can support them (and their children) in their treatment journeys.

Photobiomodulation in the management of oral mucositis for adult head and neck cancer patients receiving irradiation: the LiTEFORM RCT.

Oral mucositis is a debilitating and painful complication of head and neck cancer irradiation that is characterised by inflammation of the mucous membranes, erythema and ulceration. Oral mucositis affects 6000 head and neck cancer patients per year in England and Wales. Current treatments have not proven to be effective. International studies suggest that low-level laser therapy may be an effective treatment. To assess the clinical effectiveness and cost-effectiveness of low-level laser therapy in the management of oral mucositis in head and neck cancer irradiation. To identify barriers to and facilitators of implementing low-level laser therapy in routine care. Placebo-controlled, individually randomised, multicentre Phase III superiority trial, with an internal pilot and health economic and qualitative process evaluations. The participants, outcome assessors and therapists were blinded. Nine NHS head and neck cancer sites in England and Wales. A total of 87 out of 380 participants were recruited who were aged ≥ 18 years and were undergoing head and neck cancer irradiation with ≥ 60 Gy. Random allocation (1 : 1 ratio) to either low-level laser therapy or sham low-level laser therapy three times per week for the duration of irradiation. The diode laser had the following specifications: wavelength 660 nm, power output 75 mW, beam area 1.5 cm2, irradiance 50 mW/cm2, exposure time 60 seconds and fluence 3 J/cm2. There were 20-30 spots per session. Sham low-level laser therapy was delivered in an identical manner. The mean Oral Mucositis Weekly Questionnaire-Head and Neck Cancer score at 6 weeks following the start of irradiation. Higher scores indicate a worse outcome. A total of 231 patients were screened and, of these, 87 were randomised (low-level laser therapy arm, n = 44; sham arm, n = 43). The mean age was 59.4 years (standard deviation 8.8 years) and 69 participants (79%) were male. The mean Oral Mucositis Weekly Questionnaire-Head and Neck Cancer score at 6 weeks was 33.2 (standard deviation 10) in the low-level laser therapy arm and 27.4 (standard deviation 13.8) in the sham arm. The trial lacked statistical power because it did not meet the recruitment target. Staff and patients willingly participated in the trial and worked hard to make the LiTEFORM trial succeed. However, the task of introducing, embedding and sustaining new low-level laser therapy services into a complex care pathway proved challenging. Sites could deliver low-level laser therapy to only a small number of patients at a time. The administration of low-level laser therapy was viewed as straightforward, but also time-consuming and sometimes uncomfortable for both patients and staff, particularly those staff who were not used to working in a patient's mouth. This trial had a robust design but lacked power to be definitive. Low-level laser therapy is relatively inexpensive. In contrast with previous trials, some patients found low-level laser therapy sessions to be difficult. The duration of low-level laser therapy sessions is, therefore, an important consideration. Clinicians experienced in oral cavity work most readily adapt to delivering low-level laser therapy, although other allied health professionals can be trained. Blinding the clinicians delivering low-level laser therapy is feasible. There are important human resource, real estate and logistical considerations for those setting up low-level laser therapy services. Further well-designed randomised controlled trials investigating low-level laser therapy in head and neck cancer irradiation are needed, with similar powered recruitment targets but addressing the recruitment challenges and logistical findings from this research. This trial is registered as ISRCTN14224600. This project was funded by the National Institute for Health and Care Research ( NIHR ) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 46. See the NIHR Journals Library website for further project information.