Complex Healthcare Interventions Research Articles

Feasibility of a new transmural care pathway for advance care planning for older persons: A qualitative study into community care registered nurses’ perspectives

BackgroundTransmural palliative care interventions aim to identify older persons with palliative care needs and timely provide advance care planning, symptom management, and coordination of care. Nurses can have an important role in these interventions; however, their expertise is currently underused. A new transmural care pathway with a central role for the community care registered nurse in advance care planning aims to contribute to the quality of palliative care for older persons. ObjectiveTo examine the perspectives of community nurses on the feasibility of a new transmural care pathway for advance care planning for older persons. DesignA qualitative study design using semi-structured interviews. Setting(s)Interviews were performed with community nurses of three participating homecare organizations in the Netherlands between March and May 2023. Participants19 community nurses. MethodsA topic guide was based on (1) challenges in advance care planning identified from the literature and (2) concepts that are important in assessing the feasibility of complex healthcare interventions provided by the Normalisation Process Theory framework. A combined inductive and deductive thematic analysis was performed. ResultsFour themes were identified: views on the transmural care pathway, community nurses’ needs to fulfil their role, key points regarding implementation, and evaluation of the new practice. In general, community nurses were positive about the feasibility of the new practice as it provided a more structured work process that could facilitate interprofessional collaboration and improve the quality of palliative care. Overall, the feasibility of the new practice, from community nurses perspective, was determined by (1) clear roles and responsibilities in the transmural care pathway, (2) standardized registration of advance care planning, and (3) close involvement of community nurses in the whole implementation process. ConclusionsWe highlighted important factors, from the perspectives of community nurses, that need to be considered in the implementation of a new transmural care pathway for advance care planning. A clear division of roles and responsibilities, standardized registration of advance care planning, and involvement of community nurses during the whole implementation process were mentioned as important enabling factors. This knowledge might contribute to successful implementation of a transmural care pathway that aims to enhance the quality of palliative care for older persons. Tweetable abstractCommunity nurses’ perspectives on the feasibility of a transmural care pathway for advance care planning for older persons.

A nurse-led multidisciplinary service for Nipple-Areola complex tattooing after breast cancer: reporting on a complex intervention with TIDieR analysis

BackgroundThe Nipple-Areola Complex (NAC) tattooing can restore physical and mental integrity after breast cancer, but it is not always easily accessible for women. This paper aims to report on the development of a multidisciplinary nurse-led service for NAC tattooing for women who underwent breast cancer surgery with NAC removal to allow its thorough review and replication.MethodsThe Medical Research Council’s framework for developing complex healthcare interventions was followed. According to the results of a literature review, and the context analysis, an initial intervention was planned. The Template for Intervention Description and Replication checklist was chosen to ensure the quality and completeness of the intervention description.ResultsThe Breast Unit and the Research departments were engaged; three nurse-tattooists were selected; the informative material was created and shared with patients, families and local associations, involving them actively. Finally, the setting and the materials were defined. A monthly schedule of activities was set: patients with the indication for NAC tattooing were contacted by the nurse case manager. Each treatment involves 3–4 sessions, 30–40 days apart, in an ambulatory setting. It consists of NAC shaping and tattooing with a dermographer and sterile needles.ConclusionImplementing freely and equally multidisciplinary nurse-led clinics might provide this treatment ensuring the patient’s quality of life and nurse competence. The NAC tattooing is a complex intervention that represents the final part of the breast cancer surgical care pathway.

The PRIME-NL study: evaluating a complex healthcare intervention for people with Parkinson’s disease in a dynamic environment

BackgroundAn innovative, integrative care model for people with Parkinson (PRIME Parkinson) has gradually been implemented in a selected region of the Netherlands since 2021. A prospective evaluation of this model (PRIME-NL study) was initiated in parallel, spanning the year prior to implementation (baseline) and the implementation period. Following publication of the original study protocol, the COVID-19 crisis delayed implementation of the full PRIME Parkinson care model by two years and hampered the recruitment of study participants.ObjectiveTo describe which methodological adjustments were made to the study protocol because of these developments.MethodsWe compare various outcomes between a region where PRIME Parkinson care was implemented (innovation region) versus the rest of the Netherlands (usual care region). We use healthcare claims data of virtually all people with Parkinson in the Netherlands and annual questionnaires in a representative subsample of 984 people with Parkinson, 566 caregivers and 192 healthcare professionals. Four major methodological adjustments had to be made since publication of the original protocol. First, we extended the evaluation period by two years. Second, we incorporated annual process measures of the stage of implementation of the new care model. Third, we introduced a real-time iterative feedback loop of interim results to relevant stakeholders. Fourth, we updated the statistical analysis plan.DiscussionThis manuscript provides transparency in how the design and analyses of the evaluation study had to be adapted to control for external influences in a dynamic environment, including eruption of the COVID-19 crisis. Our solutions could serve as a template for evaluating other complex healthcare interventions in a dynamic environment.

Building a programme theory of a specialist paediatric palliative and hospice care programme: development process and methodological reflection

BackgroundPaediatric palliative and hospice care aims to improve the quality of life of children with life-limiting and life-threatening conditions and their families. The number of these patients has risen significantly in recent years, resulting in an increased need for palliative care for this population. Although the need for paediatric palliative and hospice care is growing, meaningful outcome evaluation to demonstrate its effectiveness as a complex healthcare intervention is in its early stages. For complex interventions (programmes), theory-based evaluations have grown in prominence in recent years. They seek to understand how and why an intervention works by uncovering its underlying mechanisms by means of programme theory. To support both outcome evaluation in paediatric palliative care and a reflective practice of programme theorizing, we aimed to describe the construction of a programme theory for a specialist paediatric palliative and hospice care programme in Austria and to offer a reflective account of its development process.MethodsWe drew on a combination of theory-based evaluation frameworks to construct a programme theory consisting of an action and a change component. Through multiple iterations, incorporating different stakeholders’ perspectives and drawing on different sources of knowledge and theory, we theorized how and why the programme likely achieves its intended outcomes.ResultsThe programme theory outlines the proposed chains of events, causal mechanisms and outcomes of a specialist paediatric palliative and hospice care programme for children and families in several areas corresponding to its main conceptual tenets. Through a range of activities and interventions, the programme triggers coping and adaptation mechanisms that ultimately contribute to family and child wellbeing in physical, psychological, social, and spiritual dimensions. Established trust and partnership between children/families and healthcare professionals as well as a person-centered and family-centered approach were identified as enabling factors.ConclusionsOur findings provide insights into how a specialized paediatric palliative and hospice care programme works to achieve its intended outcomes for children and families. This helps demonstrate its impact, contributing to meaningful outcome evaluation and service improvement.

Development and validation of the physical exercise program “Active Mums” for postpartum recovery: application of the CReDECI-2 guidelines

Postpartum physical activity is a public health issue. Reporting on the quality of exercise interventions designs must be ensured in view of the reproducibility and successful implementation of such studies. The objective was to develop and preliminary validate a physical exercise program for postpartum recovery, aiming to promote physical fitness and health of the new mothers. The study was carried out through the three stages of development, piloting, and evaluation. The Consensus on Exercise Reporting Template (CERT) was used to describe the postpartum exercise program. The Criteria for Reporting the Development and Evaluation of Complex Interventions in Healthcare (CReDECI2) was followed to develop and preliminary validate the program. A tailored postpartum exercise program was developed based on evidence-based international recommendations to be implemented by qualified exercise professionals. A pilot intervention of 16 weeks was carried out, engaging a group of postpartum women. The viability of the program was subsequently evaluated by all participants. The present work provided guidance to develop a study protocol with a larger sample in order to prove the effectiveness of a supervised postpartum exercise program on selected parameters of health.

Developing a typology of interventions to support doctors’ mental health and wellbeing

BackgroundThe problem of mental ill-health in doctors is complex, accentuated by the COVID-19 pandemic, and impacts on healthcare provision and broader organisational performance. There are many interventions to address the problem but currently no systematic way to categorise them, which makes it hard to describe and compare interventions. As a result, implementation tends to be unfocussed and fall short of the standards developed for implementing complex healthcare interventions. This study aims to develop: 1) a conceptual typology of workplace mental health and wellbeing interventions and 2) a mapping tool to apply the typology within research and practice.MethodsTypology development was based on iterative cycles of analysis of published and in-practice interventions, incorporation of relevant theories and frameworks, and team and stakeholder group discussions.ResultsThe newly developed typology and mapping tool enable interventions to be conceptualised and/or mapped into different categories, for example whether they are designed to be largely preventative (by either improving the workplace or increasing personal resources) or to resolve problems after they have arisen. Interventions may be mapped across more than one category to reflect the nuance and complexity in many mental health and wellbeing interventions. Mapping of interventions indicated that most publications have not clarified their underlying assumptions about what causes outcomes or the theoretical basis for the intervention.ConclusionThe conceptual typology and mapping tool aims to raise the quality of future research and promote clear thinking about the nature and purpose of interventions, In doing so it aims to support future research and practice in planning interventions to improve the mental health and wellbeing of doctors.

Systematic review of applications and properties of the NoMAD instrument for assessing implementation outcomes: Study protocol.

Implementation outcomes measures can be used to assess the implementation of complex health and social care interventions, but evidence for the use of these measures, and their psychometric properties, remains limited. The NoMAD ( Normalisation Me asure Development) survey, based on Normalisation Process Theory, was developed to assess, monitor, or measure factors likely to affect normalisation of a new practice from the perspective of participants who are engaged in an implementation process. Since publication in 2015, NoMAD has been translated into several languages and is increasingly being used in health and care research. This systematic review will identify, appraise, and synthesise the existing literature on the use of NoMAD as an implementation outcome measure, focusing on use and application across different studies and settings, and on its properties as a measurement tool. We will systematically search the bibliographic databases Web of Science, Scopus and PubMed for articles reporting empirical data in peer-reviewed journals. A citation search will also be undertaken in Google Scholar for primary NoMAD publications. Studies will be eligible for inclusion if they: (a) specify using NoMAD as a method and report results from using it, and/or (b) report a translation and/or validation study of NoMAD's measurement properties. Screening of abstracts and full text articles will be done independently by two researchers. Data extraction will be structured to allow collection and descriptive synthesis of data on study characteristics, use of NoMAD, psychometric results, and authors' reflections and recommendations. This review will provide the first synthesis of how NoMAD has been applied in health and care research, and evidence on its properties as an outcome measure since its publication. This will be used to update existing freely accessible guidance for researchers and other users, and disseminated through peer-reviewed publications, and engagement activities with researchers and practitioners.

Evaluation of the telemedical health care network “SAFE BIRTH” for pregnant women at risk, premature and sick newborns and their families: study protocol of a cluster-randomized controlled stepped-wedge trial

BackgroundThe Perinatal Center of the University Hospital Carl Gustav Carus Dresden has initiated the telemedical healthcare network “SAFE BIRTH” to coordinate and improve specialized care in non-metropolitan regions for pregnant women and newborns. The network incorporates five intervention bundles (IB): (1) Multi-professional, inter-disciplinary prenatal care plan; (2) Neonatal resuscitation; (3) Neonatal antibiotic stewardship; (4) Inter-facility transfer of premature and sick newborns; (5) Psycho-social support for parents. We evaluate if the network improves care close to home for pregnant women, premature and sick newborns.MethodsTo evaluate the complex healthcare intervention “SAFE BIRTH” we will conduct a cluster-randomized controlled stepped-wedge trial in five prenatal medical outpatient offices and eight non-metropolitan hospitals in Saxony, Germany. The offices and hospitals will be randomly allocated to five respectively eight sequential steps over a 30-month period to implement the telemedical IB. We define one specific primary process outcome for each IB (for instance IB#1: “Proportion of patients with inclusion criterion IB#1 who have a prenatal care plan and psychosocial counseling within one week”). We estimated a separate multilevel logistic regression model for each primary process outcome using the intervention status as a regressor (control or intervention group). Across all IB, a total of 1,541 and 1,417 pregnant women or newborns need to be included in the intervention and control group, respectively, for a power above 80% for small to medium intervention effects for all five hypothesis tests. Additionally, we will assess job satisfaction and sense of safety of health professionals caring for newborns (questionnaire survey) and we will assess families’ satisfaction, resilience, quality of life and depressive, anxiety and stress symptoms (questionnaire surveys). We will also evaluate the cost-effectiveness of ”SAFE BIRTH” (statutory health insurance routine data, process data) and barriers to its implementation (semi-structured interviews). We use multilevel regression models adjusting for relevant confounders (e.g. socioeconomic status, age, place of residence), as well as descriptive analyses and qualitative content analyses.DiscussionIf the telemedical healthcare network “SAFE BIRTH” proves to be effective and cost-efficient, strategies for its translation into routine care should be developed.Trial registrationGerman clinical trials register. DRKS-ID: DRKS00031482.

A Novel Methodology for Engaging Complex Therapeutic Landscapes and Health Care Performances: “Theatricality”

Complex health care interventions often consist of specific and non-specific effects and can present a methodological and intellectual challenge to researchers. This is especially the case in Complementary and Integrative Medicines (CIM), where research may inadequately capture the holistic nature of therapies, affecting the quality of outcomes and evidence reported. This article introduces a novel approach that advances methodology and helps researchers to “step inside” the therapeutic drama, to improve the quality of evidence produced. The method, termed Theatricality, was trialed in five complementary health centers across four European countries and provides a fresh view of therapy, where the interventions, practitioners, and researchers appear bound by their context and space, creating, or limiting the potential for these acts. Delivered as an adjunct to Ethnography, this approach offers a new way of conceiving, capturing, and communicating whole health care performances that may help to improve the quality of evidence in complex health care interventions.

Evaluating the implementation of a person-centred transition programme for adolescents and young adults with long-term conditions: the role of context and organisational behaviour

PurposeDrawing on the experiences of healthcare professionals in one paediatric hospital, this paper explores the influence of context and organisational behaviour on the implementation of a person-centred transition programme for adolescents and young adults (AYA) with long-term conditions.Design/methodology/approachA single embedded qualitative case study design informed by a realist evaluation framework, was used. Participants who had experience of implementing the transition programme were recruited from across seven individual services within the healthcare organisation. The data were gathered through semi-structured interviews (n = 20) and analysed using thematic analysis.FindingsImplementation of the transition programme was influenced by the complex interaction of macro, meso and micro processes and contexts. Features of organisational behaviour including routines and habits, culture, organisational readiness for change and professional relationships shaped professional decision-making around programme implementation.Originality/valueThere exists a significant body of research relating to the role of context and its influence on the successful implementation of complex healthcare interventions. However, within the area of healthcare transition there is little published evidence on the role that organisational behaviour and contextual factors play in influencing transition programme implementation. This paper provides an in-depth understanding of how organisational behaviour and contextual factors affect transition programme implementation.

Rapid implementation mapping to identify implementation determinants and strategies for cervical cancer control in Nigeria.

Cervical cancer constitutes a huge burden among women in Nigeria, particularly HIV-infected women. However, the provision and uptake of cervical cancer screening and treatment is limited in Nigeria. Understanding implementation determinants is essential for the effective translation of such evidence-based interventions into practice, particularly in low-resource settings. COVID-19 pandemic necessitated online collaboration making implementation mapping challenging in some ways, while providing streamlining opportunities. In this study, we describe the use of a virtual online approach for implementation mapping (steps 1-3) to identify implementation determinants, mechanisms, and strategies to implement evidence-based cervical cancer screening and treatment in existing HIV infrastructure in Nigeria. This study used a mixed methods study design with a virtual modified nominal group technique (NGT) process aligning with Implementation Mapping steps 1-3. Eleven stakeholders (six program staff and five healthcare providers and administrators) participated in a virtual NGT process which occurred in two phases. The first phase utilized online surveys, and the second phase utilized an NGT and implementation mapping process. The Exploration, Preparation, Implementation and Sustainment (EPIS) framework was used to elicit discussion around determinants and strategies from the outer context (i.e., country and regions), inner organizational context of existing HIV infrastructure, bridging factors that relate to bi-directional influences, and the health innovation to be implemented (in this case cervical cancer screening and treatment). During the NGT, the group ranked implementation barriers and voted on implementation strategies using Mentimeter. Eighteen determinants to integrating cervical cancer screening and treatment into existing comprehensive HIV programs were related to human resources capacity, access to cervical cancer services, logistics management, clinic, and client-related factors. The top 3 determinants included gaps in human resources capacity, poor access to cervical cancer services, and lack of demand for services resulting from lack of awareness about the disease and servicesA set of six core implementation strategies and two enhanced implementation strategies were identified. Rapid Implementation Mapping is a feasible and acceptable approach for identifying and articulating implementation determinants, mechanisms, and strategies for complex healthcare interventions in LMICs.

A multi-facetted patient safety resource-A qualitative interview study on hospital managers' perception of the nurse-led Rapid Response Team.

To explore hospital managers' perceptions of the Rapid Response Team. An explorative qualitative study using semi-structured individual interviews. In September 2019, a qualitative interview study including nineteen hospital managers at three managerial levels in acute care hospitals was conducted. Interview transcripts were analysed with an inductive content analysis approach, involving researcher triangulation in data collection and analysis processes. One theme, 'A resource with untapped potential, enhancing patient safety, high-quality nursing, and organisational cohesion' was identified and underpinned by six categories and 30 sub-categories. The Rapid Response Team has an influence on the organization that goes beyond the team's original purpose. It strengthens the organization's dynamic cohesion by providing clinical support to nurses and facilitating learning, communication and collaboration across the hospital. Managers lack engagement in the team, including local key data to guide future quality improvement processes. For organizations, nursing, and patients to benefit from the team to its full potential, managerial engagement seems crucial. This study addressed possible challenges to using the Rapid Response Team optimally and found that hospital managers perceived this complex healthcare intervention as beneficial to patient safety and nursing quality, but lacked factual insight into the team's deliverances. The research impacts patient safety pointing at the need to re-organize managerial involvement in the function and development of the Rapid Response Team and System. We have adhered to the COREQ checklist when reporting this study. "No Patient or Public Contribution".

Development of an intravenous chemotherapy intervention for children and adolescents with cancer administered by their parents at home (INTACTatHome)

BackgroundFamilies of children and adolescents with cancer strive to maintain routines and normalcy during the child’s treatment trajectory that requires frequent hospital visits. Intravenous chemotherapy at home can reduce time spent on the frequent hospital visits and mitigate disruption in daily life. Studies on home chemotherapy for children and adolescents with cancer are limited, as is knowledge of family and health care professionals’ needs, and knowledge required to inform adaptation or replication of interventions in other settings. The aim of this study was to develop and describe an evidence-based home chemotherapy intervention that is feasible and safe for children and adolescents and suitable for future feasibility testing.MethodsThe Medical Research Council’s guidance for developing complex interventions in health care and the framework of action developed by O’Cathain et al. was used as theoretical frameworks to structure the development process. A literature search, an ethnographic study, and interviews with clinical nurse specialists from adult cancer departments formed the evidence base. Educational learning theory to support and understand the intervention was identified. Stakeholder perspectives were explored in workshops with health care professionals and parent-adolescent interviews. Reporting was qualified using the GUIDED checklist.ResultsA stepwise educational program to teach parents how to administer low-dose chemotherapy (Ara-C) to their child at home and a simple and safe administration procedure were developed. Key uncertainties were identified, including barriers and facilitators impacting future testing, evaluation, and implementation. Causal assumptions and reasoning for how the intervention leads to short-term outcomes and long-term impact were clarified in a logic model.ConclusionsThe iterative and flexible framework allowed for integration of existing evidence and new data and was successfully applied to the development process. The detailed report on the development process of the home chemotherapy intervention can enhance adaptation or replication of the intervention to other settings and thereby mitigate family disruption and stress of frequent hospital visits for these treatments. The study has informed the next phase of the research project that aims to test the home chemotherapy intervention in a prospective single-arm feasibility study.Trial registrationClinicalTrials.gov ID: NCT05372536.

Exploring the role of policy actors in the implementation of social distancing: a case of COVID-19 in Pakistan

PurposeAt the outbreak of the COVID-19 pandemic, the absence of pharmaceutical agents meant that policy institutions had to intervene by providing nonpharmaceutical interventions (NPIs). To satisfy this need, the World Health Organization (WHO) issued policy guidelines, such as NPIs, and the government of Pakistan released its own policy document that included social distancing (SD) as a containment measure. This study explores the policy actors and their role in implementing SD as an NPI in the context of the COVID-19 pandemic.Design/methodology/approachThe study adopted the constructs of Normalization Process Theory (NPT) to explore the implementation of SD as a complex and novel healthcare intervention under a qualitative study design. Data were collected through document analysis and interviews, and analysed under framework analysis protocols.FindingsThe intervention actors (IAs), including healthcare providers, district management agents, and staff from other departments, were active in implementation in the local context. It was observed that healthcare providers integrated SD into their professional lives through a higher level of collective action and reflexive monitoring. However, the results suggest that more coherence and cognitive participation are required for integration.Originality/valueThis novel research offers original and exclusive scenario narratives that satisfy the recent calls of the neo-implementation paradigm, and provides suggestions for managing the implementation impediments during the pandemic. The paper fills the implementation literature gap by exploring the normalisation process and designing a contextual framework for developing countries to implement guidelines for pandemics and healthcare crises.

Psychometric evaluation of the electronic faces thermometer scale for pain assessment in children 8-17 years old: A study protocol.

It is often a challenge for a child to communicate their pain, and their possibilities to do so should be strengthened in healthcare settings. Digital self-assessment provides a potential solution for person-centered care in pain management and promotes child participation when a child is ill. A child's perception of pain assessment differs when it is assessed using digital or analog formats. As we move into the digital era, there is an urgent need to validate digital pain assessment tools, including the newly developed electronic Faces Thermometer Scale (eFTS). This study protocol describes three studies with the overall aim to evaluate psychometric properties of the eFTS for assessing pain in children 8-17 years of age. A multi-site project design combining quantitative and qualitative methods will be used for three observational studies. Study 1: 100 Swedish-speaking children will report the level of anticipated pain from vignettes describing painful situations in four levels of pain and a think-aloud method will be used for data collection. Data will be analyzed with phenomenography as well as descriptive and comparative statistics. Study 2: 600 children aged 8-17 years at pediatric and dental settings in Sweden, Denmark, Iceland, and USA will be included. Children will assess their pain intensity due to medical or dental procedures, surgery, or acute pain using three different pain Scales for each time point; the eFTS, the Faces Pain Scale Revised, and the Coloured Analogue Scale. Descriptive and comparative statistics will be used, with subanalysis taking cultural context into consideration. Study 3: A subgroup of 20 children out of these 600 children will be purposely included in an interview to describe experiences of grading their own pain using the eFTS. Qualitative data will be analyzed with content analysis. Our pilot studies showed high level of adherence to the study procedure and rendered only a small revision of background questionnaires. Preliminary analysis indicated that the instruments are adequate to be used by children and that the analysis plan is feasible. A digital pain assessment tool contributes to an increase in pain assessment in pediatric care. The Medical Research Council framework for complex interventions in healthcare supports a thorough development of a new scale. By evaluating psychometric properties in several settings by both qualitative and quantitative methods, the eFTS will become a well-validated tool to strengthen the child's voice within healthcare.

Two-way Automated Text Messaging Support From Community Pharmacies for Medication Taking in Multiple Long-term Conditions: Human-Centered Design With Nominal Group Technique Development Study

Reviews of digital communication technologies suggest that they can be effective in supporting medication use; however, their use alongside nondigital components is unclear. We also explored the delivery of a digital communication intervention in a relatively novel setting of community pharmacies and how such an intervention might be delivered to patients with multiple long-term conditions. This meant that despite the large number of intervention examples available in the literature, design questions remained, which we wanted to explore with key stakeholders. Examples of how to involve stakeholders in the design of complex health care interventions are lacking; however, human-centered design (HCD) has been suggested as a potential approach. This study aimed to design a new community pharmacy text messaging intervention to support medication use for multiple long-term conditions, with patient and health care professional stakeholders in primary care. HCD was used to map the intervention "journey" and identify design questions to explore with patients and health care professionals. Six prototypes were developed to communicate the intervention concept, and a modified version of the Nominal Group Technique was used to gather feedback. Nominal group meetings generated qualitative data using questions about the aspects that participants liked for each prototype and any suggested changes. The discussion was analyzed using a framework approach to transform feedback into statements. These statements were then ranked using a web-based questionnaire to establish a consensus about what elements of the design were valued by stakeholders and what changes to the design were most important. A total of 30 participants provided feedback on the intervention design concept over 5 nominal group meetings (21 health care professionals and 9 patients) with a 57% (17/30) response rate to the ranking questionnaire. Furthermore, 51 proposed changes in the intervention were generated from the framework analysis. Of these 51 changes, 27 (53%) were incorporated into the next design stage, focusing on changes that were ranked highest. These included suggestions for how text message content might be tailored, patient information materials, and the structure for pharmacist consultation. All aspects that the participants liked were retained in the future design and provided evidence that the proposed intervention concept had good acceptability. HCD incorporating the Nominal Group Technique is an appropriate and successful approach for obtaining feedback from key stakeholders as part of an iterative design process. This was particularly helpful for our intervention, which combined digital and nondigital components for delivery in the novel setting of a community pharmacy. This approach enabled the collection and prioritization of useful multiperspective feedback to inform further development and testing of our intervention. This model has the potential to minimize research waste by gathering feedback early in the complex intervention design process.

Development of a Psychological Intervention to Improve Depressive Symptoms and Enhance Adherence to Antiretroviral Therapy among Adolescents and Young People Living with HIV in Dar es Salaam Tanzania.

Background: Interventions that simultaneously target depression and antiretroviral therapy (ART) medication adherence are recommended for improving HIV treatment outcomes and quality of life for adolescents living with HIV. However, evidence is scarce on culturally feasible and acceptable interventions that can be implemented for HIV-positive adolescents in Tanzania. We, therefore, developed a manualized brief psychological intervention that utilizes evidence-based strategies to address depression and ART adherence in adolescents living with HIV in Tanzania. Methods: We used the Theory of Change Enhanced Medical Research Council framework (TOCMRC) for developing complex interventions in health care to develop the intervention in five phases. First, the literature was reviewed to identify potential intervention components. Second, we conducted a situational analysis using qualitative interviews with adolescents living with HIV, health care providers, and caregivers. Third, we conducted a mental health expert workshop; and fourth, theory of change workshops with representatives from the Ministry of Health, mental health professionals, HIV implementing partners, adolescents, and healthcare providers. Lastly, we synthesized results to finalize the intervention and a theory of change map showing the causal pathway for how we expect the developed intervention to achieve its impact. Results: Adolescents living with HIV in Tanzania experience several unmet mental health needs ranging from overwhelming depressive symptoms to not feeling understood by healthcare providers who lack mental health knowledge. Participants perceived psychological intervention that utilizes a task-shifting approach to be acceptable and beneficial to addressing those problems. The novel components of the NITUE intervention included incorporating evidence-based intervention components, namely, cognitive-behavioral therapy, motivational interviewing, and problem solving. In addition, caregiver inclusion in the treatment was essential to ensure access to care, compliance, and improved outcomes. Conclusions: A culturally appropriate brief psychological intervention that utilizes a task-shifting approach to address depression and medication adherence for adolescents living with HIV in Dar es Salaam, Tanzania, was developed. The intervention will be piloted for appropriateness, feasibility, and acceptability and will provide material for a future trial to determine its effectiveness.

A standardized measurement instrument was recommended for evaluating operator experience in complex healthcare interventions

ObjectiveDuring development of complex surgical innovations, modifications occur to optimize safety and efficacy. Operators' experiences (how professionals feel undertaking the innovation) drive this process but comprehensive overviews of measures of this concept are lacking. This study identified and appraised measures to assess operators’ experience of surgical innovation. Study Design and SettingThere were three phases: (1) Literature reviews identified measures of operators’ experience and concepts measured were extracted and grouped into domains. (2) Quality appraisal was conducted to assess content validity of identified instruments and was supported by COnsensus-based Standards for the selection of health Measurement Instruments methodology. Self-reported measurement instruments that had underdone formal development were eligible. Content validity was assessed using COnsensus-based Standards for the selection of health Measurement Instruments criteria for good content validity (rated sufficient/insufficient/indeterminate/inconsistent), informed by standards for measurement development and domains identified in phase 1. (3) Instruments determined suitable and of sufficient quality underwent supplemental appraisal in interviews with international multidisciplinary professionals and a focus group. ResultsLiterature reviews identified 16 measurement instruments from 243 studies. Most assessed ‘psychological’ experiences and ‘usability’. No instrument was specifically validated for innovative surgery. Three instruments were rated ‘sufficient’ (Surgery Task Load Index [SURG-TLX]) or ‘indeterminate’ (Spielberger State-Trait Anxiety Inventory, Imperial Stress Assessment Tool). Twenty professionals were interviewed (seven female; 15 specialties; six countries) and the focus group included 10 participants (four professionals, six researchers). The SURG-TLX was considered the most relevant, comprehensive, and comprehensible instrument. ConclusionThe SURG-TLX is preliminarily recommended to measure operators’ experiences of innovation. Further work exploring its role and impact on surgical innovation is required.

Prioritization of implementation barriers related to integrated care models in Central and Eastern European countries

The importance of integrated care will increase in future health systems due to aging populations and patients with chronic multimorbidity, however, such complex healthcare interventions are often developed and implemented in higher income countries. For Central and Eastern European (CEE) countries it is important to investigate which integrated care models are transferable to their setting and facilitate the implementation of relevant models by identifying barriers to their implementation. This study investigates the relative importance of integrated care models and the most critical barriers for their implementation in CEE countries. Experts from Croatia, Hungary, Poland, Romania and Serbia were invited to complete an online survey within the SELFIE H2020 project. 81 respondents completed the survey. Although experts indicated that some integrated care models were already being implemented in CEE countries, the survey revealed a great need for further improvement in the integration of care, especially the managed care of oncology patients, coordinated palliative care of terminally ill patients, and nursing care of elderly with multimorbidity. Lack of long-term financial sustainability as well as of dedicated financing schemes were seen the most critical implementation barriers, followed by the lack of integration between health and social care providers and insufficient availability of human resources. These insights can guide future policy making on integrated care in CEE countries.

Justification, rationale and methodological approaches to realist reviews.

Realist reviews offer a method to understand why an intervention is successful or not. Many factors influence how complex healthcare interventions are delivered and this makes understanding what works difficult. Effectiveness depends on delivery context, and success in one setting does not guarantee the same result in alternate settings. How an intervention works (the underlying mechanisms) in a particular setting for one population group, may not work in the same way for a different group. A realist review provides an iterative theory-driven approach to help understand how and for whom and under what conditions an intervention works.