Platform trials.

Platform trials focus on the perpetual testing of many interventions in a disease or a setting. These trials have lasting organizational, administrative, data, analytic, and operational frameworks making them highly efficient. The use of adaptation often increases the probabilities of allocating participants to better interventions and obtaining conclusive results. The COVID-19 pandemic showed the potential of platform trials as a fast and valid way to improved treatments. This review gives an overview of key concepts and elements using the Intensive Care Platform Trial (INCEPT) as an example.

Organisational implementation climate in implementing internet-based cognitive behaviour therapy for depression.

BACKGROUND: Internet-based Cognitive Behaviour Therapy (iCBT) for depression have been implemented in routine care across Europe in varying ways, at various scales and with varying success. This study aimed to advance our understanding of organisational implementation climate from the perspectives of implementers and mental health service deliverers. METHODS: Qualitative and quantitative methods were combined to study the concept of organisational implementation climate in mental health care settings. Based on concept mapping, a qualitative workshop with implementers was used to conceptualise organisational implementation climate for optimizing iCBT use in routine practice. Service deliverers involved in the provision of iCBT were invited to participate in an explorative cross-sectional survey assessing levels of satisfaction and usability of iCBT, and organisational implementation climate in implementing iCBT. The two methods were applied independently to study viewpoints of implementers as well as service deliverers. Corresponding to the explorative nature of the study, inductive reasoning was applied to identify patterns and develop a reasonable explanation of the observations made. Correlative associations between satisfaction, usability and implementation climate were explored. RESULTS: Sixteen implementers representing fourteen service delivery organisations across Europe participated in the workshop. The top-three characteristics of a supportive organisational implementation climate included: (1) clear roles and skills of implementers, (2) feasible implementation targets, and (3) a dedicated implementation team. The top-three tools for creating a supportive implementation climate included: (1) feedback on job performance, (2) progress monitoring in achieving implementation targets, and (3) guidelines for assessing the impact of iCBT. The survey (n=111) indicated that service providers generally regarded their organisational implementation climate as supportive in implementing iCBT services. Organisational implementation climate was weakly associated with perceived usability and moderately with satisfaction with iCBT services. CONCLUSIONS: Organisational implementation climate is a relevant factor to implementers and service deliverers in implementing iCBT in routine care. It is not only an inherent characteristic of the context in which implementation takes place, it can also be shaped to improve implementation of iCBT services. Future research should further theorise organisational implementation climate and empirically validate the measurement instruments such as used in this study.

Transformations of practice in online exercise training for patients with COPD led by physiotherapists - a qualitative study.

PURPOSE: The aim of this study was to characterize the practice of telemediated training for patients with very severe Chronic Obstructive Pulmonary Disease (COPD) and to inform the development of clinical/professional practice. METHODS: Inspired by ethnographic methodology, participating observation, informal and formal interviews were conducted with patients (11), their partners (4), and physiotherapists (6) at sites where the telemediated training was practiced. Postphenomenology was used as theoretical and analytical framework. RESULTS: Telemediated training in the homes of the patients takes place where most daily activities happen, and together with activities in the rehabilitation units they are included in the training in a reduced or amplified version that may compromise the privacy of the patients. The mediated image and sound challenge the training and communication activities and the possibility for the physiotherapists to estimate the condition of the patients. Consequently, the physiotherapists lower how much they push the patients in the exercises. CONCLUSIONS: Making training accessible to very severely ill patients with COPD through homebased telemediation comes with several trade-offs. This study can be used to educate clinical practice before and during the practicing of telemediated services, which need to be organized in a way that allows continuous adjustment.IMPLICATIONS FOR PRACTICEThe technology itself is not a neutral device in online health care provision. Health professionals should therefore:Play an active role in structuring the content, communication, and inclusion of the patients' context during online health care provision.Receive training in how to spot ways in which online health care provision transforms traditional practice and to how to work around its limitations.Organize online health care practices in ways that allow for continuous adjustment (for which they need back up from management).

Tailored implementation of internet-based cognitive behavioural therapy in the multinational context of the ImpleMentAll project: a study protocol for a stepped wedge cluster randomized trial.

BACKGROUND: Internet-based Cognitive Behavioural Therapy (iCBT) is found effective in treating common mental disorders. However, the use of these interventions in routine care is limited. The international ImpleMentAll study is funded by the European Union's Horizon 2020 programme. It is concerned with studying and improving methods for implementing evidence-based iCBT services for common mental disorders in routine mental health care. A digitally accessible implementation toolkit (ItFits-toolkit) will be introduced to mental health care organizations with the aim to facilitate the ongoing implementation of iCBT services within local contexts. This study investigates the effectiveness of the ItFits-toolkit by comparing it to implementation-as-usual activities. METHODS: A stepped wedge cluster randomized controlled trial (SWT) design will be applied. Over a trial period of 30 months, the ItFits-toolkit will be introduced sequentially in twelve routine mental health care organizations in primary and specialist care across nine countries in Europe and Australia. Repeated measures are applied to assess change over time in the outcome variables. The effectiveness of the ItFits-toolkit will be assessed in terms of the degree of normalization of the use of the iCBT services. Several exploratory outcomes including uptake of the iCBT services will be measured to feed the interpretation of the primary outcome. Data will be collected via a centralized data collection system and analysed using generalized linear mixed modelling. A qualitative process evaluation of routine implementation activities and the use of the ItFits-toolkit will be conducted within this study. DISCUSSION: The ImpleMentAll study is a large-scale international research project designed to study the effectiveness of tailored implementation. Using a SWT design that allows to examine change over time, this study will investigate the effect of tailored implementation on the normalization of the use of iCBT services and their uptake. It will provide a better understanding of the process and methods of tailoring implementation strategies. If found effective, the ItFits-toolkit will be made accessible for mental health care service providers, to help them overcome their context-specific implementation challenges. TRIAL REGISTRATION: ClinicalTrials.gov NCT03652883 . Retrospectively registered on 29 August 2018.

Telemediated Training in the Home as a Part of the Everyday Life and Practice With Very Severe Chronic Obstructive Pulmonary Disease.

Patients with very severe chronic obstructive pulmonary disease (COPD) conduct their everyday lives under shortness of breath. The aim of this study was to explore telemediated exercise training to patients at home, with the conduct of everyday life as a theoretical framework. Based on ethnographic fieldwork involving a hospital, two municipalities, and homes of 11 patients from 2013 to 2017, this article shows how telemediated training became part of patients' and partners' everyday lives and the prioritization of time and resources for basic activities. Most of the patients found telemediated training meaningful, that it can work as an agent of hope in holding on to essential everyday life activities, but also that it may be experienced as burdensome and disciplining. The physiotherapists' understanding of the patients' circumstances and needs for rehabilitation changed. The article argues that telemediated training should be offered as part of a palliative approach for those severely affected by COPD.

Impact Assessment of an Innovative Integrated Care Model for Older Complex Patients with Multimorbidity: The CareWell Project.

OBJECTIVES: To evaluate the impact in terms of use of health services, clinical outcomes, functional status, and patient's satisfaction of an integrated care program, the CareWell program, for complex patients with multimorbidity, supported by information and communication technology platforms in six European regions. DATA SOURCES: Primary data were used and the follow-up period ranged between 8 and 12 months. STUDY DESIGN: A quasi-experimental study, targeting chronic patients aged 65 or older, with 2 or more conditions - one of them necessarily being diabetes, congestive heart failure or congestive obstructive pulmonary disease. The intervention group received the integrated care program and the control group received usual care. Generalized mixed regression models were used. DATA COLLECTION: Data were obtained from individual interviews and electronic clinical records. PRINCIPAL FINDINGS: Overall, 856 patients were recruited (475 intervention and 381 control). In the intervention group, the number of visits to emergency rooms was significantly lower, and the number of visits to the general practitioners and primary care nurses was higher than in the control group. CONCLUSION: The CareWell program resulted in improvements in the use of health services, strengthening the role of PC as the cornerstone of care provision for complex patients with multimorbidity.

Informed Choice for Participation in Down Syndrome Screening: Development and Content of a Web-Based Decision Aid.

BACKGROUND: In Denmark, all pregnant women are offered screening in early pregnancy to estimate the risk of having a fetus with Down syndrome. Pregnant women participating in the screening program should be provided with information and support to allow them to make an informed choice. There is increasing interest in the use of Web-based technology to provide information and digital solutions for the delivery of health care. OBJECTIVE: The aim of this study was to develop an eHealth tool that contained accurate and relevant information to allow pregnant women to make an informed choice about whether to accept or reject participation in screening for Down syndrome. METHODS: The development of the eHealth tool involved the cooperation of researchers, technology experts, clinicians, and users. The underlying theoretical framework was based on participatory design, the International Patient Decision Aid Standards (IPDAS) Collaboration guide to develop a patient decision aid, and the roadmap for developing eHealth technologies from the Center for eHealth Research and Disease Management (CeHRes). The methods employed were a systematic literature search, focus group interviews with 3 care providers and 14 pregnant women, and 2 weeks of field observations. A qualitative descriptive approach was used in this study. RESULTS: Relevant themes from pregnant women and care providers with respect to information about Down syndrome screening were identified. Based on formalized processes for developing patient decision aids and eHealth technologies, an interactive website containing information about Down syndrome, methods of screening, and consequences of the test was developed. The intervention was based on user requests and needs, and reflected the current hospital practice and national guidelines. CONCLUSIONS: This paper describes the development and content of an interactive website to support pregnant women in making informed choices about Down syndrome screening. To develop the website, we used a well-structured process based on scientific evidence and involved pregnant women, care providers, and technology experts as stakeholders. To our knowledge, there has been no research on the combination of IPDAS standards and the CeHRes roadmap to develop an eHealth tool to target information about screening for Down syndrome.

Early telemedicine training and counselling after hospitalization in patients with severe chronic obstructive pulmonary disease: a feasibility study.

BACKGROUND: An essential element in the treatment of patients with chronic obstructive pulmonary disease (COPD) is rehabilitation, of which supervised training is an important part. However, not all individuals with severe COPD can participate in the rehabilitation provided by hospitals and municipal training centres due to distance to the training venues and transportation difficulties. The aim of the study was to assess the feasibility of an individualized home-based training and counselling programme via video conference to patients with severe COPD after hospitalization including assessment of safety, clinical outcomes, patients' perceptions, organisational aspects and economic aspects. METHODS: The design was a pre- and post-test intervention study. Fifty patients with severe COPD were included. The telemedicine training and counselling included three weekly supervised exercise sessions by a physiotherapist and up to two supervised counselling and training sessions in energy conservation techniques by an occupational therapist. The telemedicine videoconferencing equipment was a computer containing a screen, a microphone, an on/off switch and a volume control. RESULTS: Thirty seven (74%) participants completed the programme, with improvements in health status assessed by the Clinical COPD Questionnaire and physical performance assessed by a sit-to-stand test and a timed-up-and-go test. There were no cases of patient fall or emergency contact with a general practitioner during the telemedicine training sessions. The study participants believed the telemedicine training and counselling was essential for getting started with being physically active in a secure manner. The business case showed that under the current financing system, the reimbursement to the hospital was slightly higher than the hospital expenditures. Thus, the business case for the hospital was positive. The organizational analysis indicated that the perceptions of the staff were that the telemedicine service had improved the continuity of the rehabilitation programme for the patients and enabled the patients' everyday lives to be included in the treatment. CONCLUSIONS: This study showed that home-based supervised training and counselling via video conference is safe and feasible and that telemedicine can help to ensure more equitable access to supervised training in patients with severe COPD. TRIAL REGISTRATION: Clinical Trials NCT02085187 (Date of registration 10.03.2014).

A model for assessment of telemedicine applications: mast.

OBJECTIVES: Telemedicine applications could potentially solve many of the challenges faced by the healthcare sectors in Europe. However, a framework for assessment of these technologies is need by decision makers to assist them in choosing the most efficient and cost-effective technologies. Therefore in 2009 the European Commission initiated the development of a framework for assessing telemedicine applications, based on the users' need for information for decision making. This article presents the Model for ASsessment of Telemedicine applications (MAST) developed in this study. METHODS: MAST was developed through workshops with users and stakeholders of telemedicine. RESULTS: Based on the workshops and using the EUnetHTA Core HTA Model as a starting point a three-element model was developed, including: (i) preceding considerations, (ii) multidisciplinary assessment, and (iii) transferability assessment. In the multidisciplinary assessment, the outcomes of telemedicine applications comprise seven domains, based on the domains in the EUnetHTA model. CONCLUSIONS: MAST provides a structure for future assessment of telemedicine applications. MAST will be tested during 2010-13 in twenty studies of telemedicine applications in nine European countries in the EC project Renewing Health.

The Story of MedCom.

This chapter describes the development of the electronic communication in Denmark and the background behind the Danish project organisation MedCom. Since 1996, there has been an IT-strategy in the healthcare sector by the Danish government, which has been under constant development. These strategies have laid the foundation for MedCom, which was established in 1994 in order to build a Danish Healthcare Data Network. Today, the Healthcare Data Network forms an integral part of the everyday work of the Danish healthcare sector, since the dissemination and use of it has risen sharply since it was established.

The cost benefit of electronic patient referrals in Denmark: summary report.

This summary report is written by ACCA and MedCom in collaboration with the European Commission Information Society Directorate-General.