Beyond effectiveness evaluation: Contributing to the discussion on complexity of digital health interventions with examples from cancer care

Digital health interventions (DHIs) have become essential complementary solutions in health care to enhance support and communication at a distance, with evidence of improving patient outcomes. Improving clinical outcomes is a major determinant of success in any health intervention, influencing its funding, development, adoption and implementation in real-world practice. In this article we explore our experiences of developing and testing DHIs to identify and discuss complexity challenges along their intervention research lifecycle. Informed by the case study research approach, we selected three individual DHIs aimed at satisfying the supportive and educational needs of people living with cancer. The Care Expert, the Digi-Do and the Gatapp were underpinned on different complexity frameworks i.e., the Medical Research Council framework and the Non-adoption, Abandonment, Scale-up, Spread and Sustainability framework. This variance on the methodological underpinning was expected to prompt a multifaceted discussion on the complexity dimensions endorsed by each of the frameworks. Our discussion endorses the adoption of mixed-methods research designs, to gather the perspectives of stakeholders and end-users, as well as pragmatic evaluation approaches that value effectiveness outcomes as much as process outcomes. Furthermore, the dissemination and sustainability agenda of DHIs needs to be considered from early-stage development with the inclusion of a business model. This business plan should be worked in partnership with healthcare services, regulatory bodies and industry, aiming to assure the management of the DHI throughout time

Föräldrars delaktighet i vård som genomförs enligt LVU

Denna uppsats behandlar gällande rätt vad avser tvångsvårdens genomförande när ett barn eller en ung person omhändertas för vård med stöd av lag (1990:52) med särskilda bestämmelser om vård av unga (LVU). Uppsatsen kommer att koncentreras kring vårdens utformning i förhållande till föräldrars möjlighet att medverka och bli delaktiga vid genomförandet av vården. Vid beskrivningen av föräldrars delaktighet har en distinktion gjorts mellan en förälder som är vårdnadshavare och en rättslig förälder som saknar vårdnadsansvar. Framställningens huvudsakliga syfte är att försöka klargöra på vilket sätt, en rättslig förälder som inte är vårdnadshavare, får medverka och bli delaktig i vården som verkställs med stöd av LVU. Ett annat syfte är att beskriva vilka skillnader i delaktighet som finns jämfört med den förälder som också är vårdnadshavare. Uppsatsen beskriver också till en del internationella aspekter av lagstiftningen på området för vård enligt LVU. Av särskild betydelse, för omhändertaganden med stöd av LVU och för den här framställningen, är artikel 8 i EKMR. Europadomstolen har vid flertalet tillfällen bedömt ifall tvångsvården är förenlig med rätten till familjeliv, vad avser föräldrars rätt att få vara delaktiga i vården. Uppsatsen syftar till att beskriva vad rätten till familjeliv enligt konventionen innebär. Särskilt vad gäller pågående vård med stöd av LVU och i förhållande till föräldrars rättigheter under tiden vården äger rum. I den här framställningen, har jag valt att utgå från min egen och för den här uppsatsen definition av delaktighet. Jag har valt se delaktigheten utifrån möjligheterna till att som förälder vara passivt eller aktivt delaktig. Med andra ord, rätten att få bli delaktig genom socialnämndens skyldighet att göra en förälder delaktig respektive en förälders egen möjlighet att begära att få vara delaktig. Detta begreppspar har sedan behandlats avseende rätten till information och rätten till umgänge med barnet. Uppsatsen besvarar hur och på vilket sätt en rättslig förälder som inte är vårdnadshavare görs delaktig och får medverka i vården. Samtidigt ges en tydlig bild av den civilrättsliga vårdnadens betydelse för möjligheten till delaktighet vid ett omhändertagande med stöd av LVU. Den förälder som också är vårdnadshavare får otvivelaktigt bättre förutsättningar till deltagande, framförallt vad gäller rätten till information om barnet. I uppsatsen konstateras även att den svenska lagstiftningen gällande en rättslig förälders utsikter att bli delaktig i tvångsvården överensstämmer med rätten till familjeliv i artikel 8 EKMR.This essay discusses the current law concerning the implementation of compulsory care when a child or young person is disposed of care under the Care of Young Persons Act (CYPA). The essay will focus on the implementation of compulsory care in relation to parents´ opportunity to participate and be involved in care of the child. In the description of parental participation a distinction has been made between a parent who has custody and a legal parent without responsibilities coming from custody. The main purpose is to try to clarify in which manner, a legal parent who does not have custody, can participate and become involved in care that is executed with support of CYPA. Another purpose is to describe which differences appear in participation compared to the parent who also is the legal guardian. The essay also describes international aspects of the legalization in the area of care according to the CYPA. Of particular importance, for disposal under the CYPA and for this petition is, Article 8 of the European Convention on Human Rights (ECHR). The European Court has on several occasions considered whether the compulsory care is compatible with the right to family life, as regards the right of parents to be involved in care of the child. The essay aims to describe what the right to family life under the Convention means. Especially in terms of ongoing care according to the CYPA and in relation to the rights of the parent while the care takes place. In this presentation, I have chosen to proceed from my own, and for this paper, the definition of participation. I have chosen to see the participation accordingly with the opportunities for parents to be passively or actively complicit. In other words, the right to get involved through the obligation of the socialcommittee to make a parent involved and a parent´s own ability to request to participate. This pair of concepts has been discussed concerning right to information and access to the child. The paper responds to how and in which way a legal parent who does not have custody can be involved and participate in care of the child. At the same time the essay gives a clear picture of the importance of civil law rights in terms of custody for the possibility to participate at a disposal under the CYPA. The parent who also is a legal guardian may undoubtedly get better conditions for participation, in particular as regards the right to information about the child. The essay also states that the Swedish legislation concerning the legal parent´s prospects of being involved in compulsory care consistent with the right to family life in Article 8 ECHR

Digi-Do: a digital information tool to support patients with breast cancer before, during, and after start of radiotherapy treatment: an RCT study protocol

Background: Radiation Therapy (RT) is a common treatment after breast cancer surgery and a complex process using high energy X-rays to eradicate cancer cells, important in reducing the risk of local recurrence. The high-tech environment and unfamiliar nature of RT can affect the patient\u27s experience of the treatment. Misconceptions or lack of knowledge about RT processes can increase levels of anxiety and enhance feelings of being unprepared at the beginning of treatment. Moreover, the waiting time is often quite long. The primary aim of this study will be to evaluate whether a digital information tool with VR-technology and preparatory information can decrease distress as well as enhance the self-efficacy and health literacy of patients affected by breast cancer before, during, and after RT. A secondary aim will be to explore whether the digital information tool increase patient flow while maintaining or increasing the quality of care. Method: The study is a prospective and longitudinal RCT study with an Action Research participatory design approach including mixed-methods data collection, i.e., standardised instruments, qualitative interviews (face-to-face and telephone) with a phenomenological hermeneutical approach, diaries, observations, and time measurements, and scheduled to take place from autumn 2020 to spring 2022. The intervention group (n=80), will receive standard care and information (oral and written) and the digital information tool; and the control group (n=80), will receive standard care and information (oral and written). Study recruitment and randomisation will be completed at two centres in the west of Sweden. Discussion: Research in this area is scarce and, to our knowledge, only few previous studies examine VR as a tool for increasing preparedness for patients with breast cancer about to undergo RT that also includes follow-ups six months after completed treatment. The participatory approach and design will safeguard the possibilities to capture the patient perspective throughout the development process, and the RCT design supports high research quality. Digitalisation brings new possibilities to provide safe, person-centred information that also displays a realistic picture of RT treatment and its contexts. The planned study will generate generalisable knowledge of relevance in similar health care contexts.Trial registration: ClinicalTrials.gov Identifier: NCT04394325. Registered May 19, 2020. Prospectively registered

Integrating perspectives of patients, healthcare professionals, system developers and academics in the co-design of a digital information tool

Background Patients diagnosed with cancer who are due to commence radiotherapy, often, despite the provision of a considerable amount of information, report a range of unmet information needs about the treatment process. Factors such as inadequate provision of information, or the stressful situation of having to deal with information about unfamiliar things, may influence the patient’s ability to comprehend the information. There is a need to further advance the format in which such information is presented. The composition of information should be tailored according to the patient’s individual needs and style of learning. Method and findings The PD methodology is frequently used when a technology designed artefact is the desired result of the process. This research is descriptive of its kind and provides a transparent description of the co-design process used to develop an innovative digital information tool employing PD methodology where several stakeholders participated as co-designers. Involving different stakeholders in the process in line with recommended PD activities enabled us to develop a digital information tool that has the potential to be relevant and user-friendly for the ultimate consumer. Conclusions Facilitating collaboration, structured PD activities can help researchers, healthcare professionals and patients to co-design patient information that meets the end users’ needs. Furthermore, it can enhance the rigor of the process, ensure the relevance of the information, and finally have a potential to employ a positive effect on the reach of the related digital information tool

Fourteen years of quality improvement education in healthcare: a utilisation-focused evaluation using concept mapping

Background: The need for training in quality improvement for healthcare staff is well acknowledged, but long-term outcomes of such training are hard to evaluate. Behaviour change, improved organisational performance and results are sought for, but these variables are complex, multifactorial and difficult to assess. Aim: The purpose of this article is to explore the personal and organisational outcomes identified by participants over 14 years of university-led QI courses for healthcare professionals. Method: Inspired by the Kirkpatrick model for evaluation, we used concept mapping, a structured mixed method that allows for richness of data to be captured and visualised by inviting stakeholders throughout the process. In total, 331 previous course participants were included in the study by responding to two prompts, and 19 stakeholders taking part in the analysis process by doing the sorting. Result: Two maps, one for personal outcomes and one for organisational outcomes, show clusters of the responses from previous course participants and how the outcomes relate to each other in meta-clusters. Both maps show possible long-term outcomes described by the previous course participants. Conclusion: The results of this study indicate that it is possible that training in quality improvement with a strong experiential pedagogical approach fosters a long-term improvement capability for the course participants and, even more important, a long-term improvement capability (and increased improvement skill) in their respective organisations

Exploring power shifts as an enabler for a strengthened patient role in quality improvements: A Swedish survey study

Objectives This study examined the relationship between professionals\u27 perceptions of a strengthened role for the patient and of patient involvement in quality improvement (QI) and whether professionals\u27 experiences in improvement science were a moderator on such a relationship. Design From a predominantly close-ended, 44-item questionnaire, 4 questions specifically concerning professionals′ perception on patient involvement in QI were analysed. Setting Three Swedish regions. Participants 155 healthcare professionals who had previously participated in courses in improvement science. Results The covariate patient involvement was significantly related to a perceived strengthened patient role. There was also a significant interaction effect between degree of patient involvement and professionals\u27 experience in the area of improvement science on a strengthened patient role. The result shows that there is a relationship between the perceived level of patient involvement in improvements and professionals\u27 perceptions of a strengthened patient role. In this study, the covariate, perceived patient involvement, was significantly related to experiences of more equal relationships between patients and healthcare professionals. There was also a significant interaction effect between the degree of patient involvement and professionals\u27 experience in the area of improvement science, for a more equal relationship between patients and healthcare professionals. Conclusion Increased patient involvement in QI is a means of strengthening the patient role and supporting a more equal relation between patients and healthcare professionals. Furthermore, empirical evidence shows that the healthcare professionals\u27 experiences in the area of improvement science support a strengthened patient role and a more equal power relationship, but for this to happen, the mindset of professionals is key. Future research is needed to capture and investigate the experiences from patients and relatives about being involved in QI in healthcare, and to study the effects on quality in care processes

Client predictors of therapy dropout in a primary care setting: a prospective cohort study

Background Therapy dropout poses a major challenge. Considerable research has been conducted on predictors of dropout, however none in the context of primary mental health services in Norway. The purpose of this study was to investigate which client characteristics can predict dropout from the service Prompt Mental Health Care (PMHC). Methods We performed a secondary analysis of a Randomized Controlled Trial (RCT). Our sample consisted of 526 adult participants receiving PMHC-treatment in the municipalities of Sandnes and Kristiansand, between November 2015 to August 2017. Using logistic regression, we investigated the association between nine client characteristics and dropout. Results The dropout rate was 25.3%. The adjusted analysis indicated that older clients had a lower odds ratio (OR) of dropping out compared to younger clients (OR = 0.43, [95% CI = 0.26, 0.71]). Moreover, clients with higher education had a lower odds ratio of dropping out compared to clients with lower levels of education (OR = 00.55, 95% CI [0.34, 0.88]), while clients who were unemployed were more likely to drop-out as compared the regularly employed (OR = 2.30, [95% CI = 1.18, 4.48]). Finally, clients experiencing poor social support had a higher odds ratio of dropping out compared to clients who reported good social support (OR = 1.81, [95% CI = 1.14, 2.87]). Sex, immigrant background, daily functioning, symptom severity and duration of problems did not predict dropout. Conclusion The predictors found in this prospective study might help PMHC-therapists identify clients at risk of dropout. Strategies for preventing dropout are discussed.publishedVersio

Exploring the phase for highest impact on radicality: a cross-sectional study of patient involvement in quality improvement in Swedish healthcare

Objectives Involving patients in quality improvement is often suggested as a critical step for improving healthcare processes. However, this comes with challenges related to resources, tokenism, validity and competence. Therefore, to optimise the use of available resources, there is a need to understand at what stage in the improvement cycle patient involvement is most beneficial. Thus, the purpose of this study was to identify the phase of an improvement cycle in which patient involvement had the highest impact on radicality of improvement.Design An exploratory cross-sectional survey was used.Setting and methods A questionnaire was completed by 155 Swedish healthcare professionals (response rate 34%) who had trained and had experience in patient involvement in quality improvement. Based on their replies, the impact of patient involvement on radicality in various phases of the improvement cycle was modelled using the partial least squares method.Results Patient involvement in quality improvement might help to identify and realise innovative solutions; however, there is variation in the impact of patient involvement on perceived radicality depending on the phase in which patients become involved. The highest impact on radicality was observed in the phases of capture experiences and taking action, while a moderate impact was observed in the evaluate phase. The lowest impact was observed in the identify and prioritise phase.Conclusions Involving patients in improvement projects can enhance the quality of care and help to identify radically new ways of delivering care. This study shows that it is possible to suggest at what point in an improvement cycle patient involvement has the highest impact, which will enable more efficient use of the resources available for patient involvement

Exploring the meaning, role and experiences of a patient-led social innovation for people affected by cancer: a new collaborative care model complementing traditional cancer rehabilitation in Sweden

Objective Kraftens Hus is the first support centre in Sweden designed by and for people affected by cancer, including patients, family, friends, staff members and local community representatives (collectively \u27stakeholders\u27). The purpose of this study was to explore the meaning, role and experiences of Kraftens Hus stakeholders using a patient and public involved methodology. Methods To understand and map the experiences of visitors to Kraftens Hus, we applied concept mapping (CM), a mixed methods approach where data are collected and analysed in four structured steps designed to capture the diverse perspectives of multiple stakeholders. Qualitative interviews with relevant stakeholders supplemented the CM findings. Results The final concept map contained six clusters of ideas. Within the clusters, there was a recurring theme that cancer-affected people value accessible and long-term psychosocial support (PSS). The intended emotional, social and practical needs identified in a previous design process seem to have been addressed and appreciated by Kraftens Hus visitors. Conclusion Kraftens Hus is an example of a new patient-led social innovation based on a life-event perspective and integration of resources from different sectors in society. By focusing on life, not the disease, the care continuum expands, and long-term PSS is provided alongside cancer treatment. The evaluation confirms that PSS should focus on health and well-being in the broadest sense

Determinants of intima-media thickness in the young: the ALSPAC Study

Objectives: This study characterized the determinants of carotid intima-media thickness (cIMT) in a large (n > 4,000) longitudinal cohort of healthy young people age 9 to 21 years. Background: Greater cIMT is commonly used in the young as a marker of subclinical atherosclerosis, but its evolution at this age is still poorly understood. Methods: Associations between cardiovascular risk factors and cIMT were investigated in both longitudinal (ages 9 to 17 years) and cross-sectional (ages 17 and 21 years) analyses, with the latter also related to other measures of carotid structure and stress. Additional use of ultra-high frequency ultrasound in the radial artery at age 21 years allowed investigation of the distinct layers (i.e., intima or media) that may underlie observed differences. Results: Fat-free mass (FFM) and systolic blood pressure were the only modifiable risk factors positively associated with cIMT (e.g., mean difference in cIMT per 1-SD increase in FFM at age 17: 0.007 mm: 95% confidence interval [CI]: 0.004 to 0.010; p < 0.001), whereas fat mass was negatively associated with cIMT (difference: −0.0032; 95% CI: 0.004 to −0.001; p = 0.001). Similar results were obtained when investigating cumulative exposure to these factors throughout adolescence. An increase in cIMT maintained circumferential wall stress in the face of increased mean arterial pressure when increases in body mass were attributable to increased FFM, but not fat mass. Risk factor−associated differences in the radial artery occurred in the media alone, and there was little evidence of a relationship between intimal thickness and any risk factor. Conclusions: Subtle changes in cIMT in the young may predominantly involve the media and represent physiological adaptations as opposed to subclinical atherosclerosis. Other vascular measures might be more appropriate for the identification of arterial disease before adulthood