A Digital Platform (Telepalliation) for Patients in Palliative Care and Their Relatives: Protocol for a Multimethod Randomized Controlled Trial.

BACKGROUND: The World Health Organization defines end-of-life palliative care as "prevention and relief of suffering, by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual." Over 20 million people worldwide are in need of palliative care. In Denmark, palliative care is given at a general and a specialist level. The general level comprises health care professionals (HCPs) who do not perform palliative care full-time. The specialist level comprises specialized palliative care (SPC), where HCPs perform palliative care full-time. In total, 20%-30% of patients who need palliative care are referred to SPC. Challenges with SPC include a short time span from referral to end of life, patients who are very ill and may therefore find it hard to travel to an outpatient clinic, and the SPC unit having a relatively small staff. The need for SPC is expected to rise, as the number of patients dying from terminal diseases is increasing. Telehealth has been successfully implemented in different home care settings, including palliative care. OBJECTIVE: The aim of the study is to present the research design of the clinical testing of a telepalliation program by the use of a digital platform for patients in palliative care and their relatives. METHODS: The telepalliation program will be conducted as a multimethod randomized controlled trial. The intervention group will follow the telepalliation program, while the control group will follow the traditional standard of care program for palliative care. The primary outcome of the study is increased quality of life. Secondary outcomes include enhanced sense of security; reduced experience of pain; satisfactory experiences of patients and relatives with the TelePal platform and degree of satisfaction in being a part of the program; experiences with the use of the TelePal platform on the part of HCPs and the professionals' experiences of being a part of the program; the use of a cross-sector communication platform and the telepalliation program by patients, relatives, and HCPs; and the projected lower cost of health care services. These outcomes will be assessed using questionnaires, data generated by digital technologies, and semistructured interviews. RESULTS: The collection of data began in May 2021 and will be completed in August 2024. The results of the study will be published in peer-reviewed journals and presented at international conferences. Results from the telepalliation program are expected to be published by fall 2024. CONCLUSIONS: The expected outcomes of the study are increased quality of life and increased sense of security. We also expect that the study will have a clinical impact on future telepalliation for those patients who are referred to a palliative team. TRIAL REGISTRATION: ClinicalTrials.gov NCT04995848; https://clinicaltrials.gov/study/NCT04995848. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/49946.

Expectations and Experiences Among Clinical Staff Regarding Implementation of Digital Pathology: A Qualitative Study at Two Departments of Pathology.

The aim of this study was to assess and evaluate the individual expectations and experiences regarding the implementation of digital pathology (DIPA) among clinical staff in two of the pathology departments in the Region of Southern Denmark before and during the implementation in their department. Seventeen semi-structured interviews based upon McKinsey 7-S framework were held both prior to and during implementation with both managers and employees at the two pathology departments. The interviewees were pathologists, medical doctors in internship in pathology (interns), biomedical laboratory scientists (BLS), secretaries, and a project lead. Using deductive and inductive coding resulted in five overall themes and appertaining sub-themes. The findings pointed to an overall positive attitude towards DIPA from the beginning. The clinical staff perceived being rewarded already during implementation with benefits such as improved collaboration both inter- and intra-departmentally promoting better acceptance of DIPA. The clinical staff also experienced some challenges, e.g., increase in turnaround times, which affected and concerned staff on a personal level. Especially BLS expressed experiencing a demanding and stressful transition due to unexpected increase in workload as well as some barriers for a potentially better implementation process. The key findings of this study were a need for better preparation of staff through transparent communication of the upcoming challenges of the transition to DIPA, more system-specific training beforehand, more allocation of time and resources in the implementation process, and more focus on BLS' work tasks in the requirement specifications.

Developing a Program Costs Checklist of Digital Health Interventions: A Scoping Review and Empirical Case Study.

INTRODUCTION: The rate of development and complexity of digital health interventions (DHIs) in recent years has to some extent outpaced the methodological development in economic evaluation and costing. Particularly, the choice of cost components included in intervention or program costs of DHIs have received scant attention. The aim of this study was to build a literature-informed checklist of program cost components of DHIs. The checklist was next tested by applying it to an empirical case, Mamma Mia, a DHI developed to prevent perinatal depression. METHOD: A scoping review with a structured literature search identified peer-reviewed literature from 2010 to 2022 that offers guidance on program costs of DHIs. Relevant guidance was summarized and extracted elements were organized into categories of main cost components and their associated activities following the standard three-step approach, that is, activities, resource use and unit costs. RESULTS: Of the 3448 records reviewed, 12 studies met the criteria for data extraction. The main cost categories identified were development, research, maintenance, implementation and health personnel involvement (HPI). Costs are largely considered to be context-specific, may decrease as the DHI matures and vary with number of users. The five categories and their associated activities constitute the checklist. This was applied to estimate program costs per user for Mamma Mia Self-Guided and Blended, the latter including additional guidance from public health nurses during standard maternal check-ups. Excluding research, the program cost per mother was more than double for Blended compared with Self-Guided (€140.5 versus €56.6, 2022 Euros) due to increased implementation and HPI costs. Including research increased the program costs to €190.8 and €106.9, respectively. One-way sensitivity analyses showed sensitivity to changes in number of users, lifespan of the app, salaries and license fee. CONCLUSION: The checklist can help increase transparency of cost calculation and improve future comparison across studies.

Estimating program or intervention costs of digital health interventions (DHIs) can be challenging without a checklist. We reviewed scientific literature to identify key cost categories of DHIs: development, research, maintenance, implementation and health personnel involvement. We also summarized relevant information regarding resource use and unit cost for each of the aforementioned categories. Applying this checklist to Mamma Mia, a DHI aimed at preventing perinatal depression, we find that the total cost per user for Mamma Mia Self-Guided is €106.9 and for Mamma Mia Blended is €190.8. Our checklist enhances visibility of DHI cost components and can aid analysts in better estimating costs for economic evaluations.

Cost-effectiveness of proactive health support-telephone-based self-management support compared with standard care for persons at risk of hospital admission.

BACKGROUND: A small share of patients account for a large proportion of costs to the healthcare system in Denmark as in many Western countries. A telephone-based self-management support, proactive health support (PaHS), was suggested for prevention of hospitalisations for persons at risk of hospital admission. These persons have chronic diseases, unplanned hospitalisations and age ≥ 65 years. However, evidence is limited on whether this type of intervention is cost-effective. AIM: The aim of this study was to assess the incremental cost-utility ratio (ICER) of PaHS, compared with standard care. METHODS: The economic evaluation was nested within a randomised controlled trial, and was based on a health system perspective, with follow-up and time horizon of 12 months. We measured incremental costs per quality-adjusted life years (QALY) gained. Total average costs per patient included PaHS programme costs, and costs in hospitals, primary care and municipalities. We analysed differences by generalised linear models with Gamma distribution for costs and mixed models for QALY. RESULTS: We analysed data on 6,139 patients, where 3,041 received PaHS and 3,098 received usual care. We found no difference in healthcare costs, and programme costs were on average €1,762 per patient, providing incremental costs of €2,075. Incremental effects on QALY were 0.007, resulting in an ICER of €296,389 per QALY gained. CONCLUSION: We found no evidence of PaHS being cost-effective in this study, but the results will be used to identify new ways to organise similar interventions and identify patients with the objective to reduce health system costs per patient.

Introduction of hospital-based health technology assessment in China: experiences from seven pilot hospitals.

OBJECTIVES: This study aimed to introduce a pilot program for hospital-based health technology assessment (HB-HTA) in China and present the participants' experiences based on seven case studies from seven tertiary hospitals. METHODS: One-year pilot projects were initiated at the beginning of 2018. Seven pilot hospitals were closely followed from the beginning until the completion of their pilot HTA project. Regular interviews were conducted with the hospital managers leading the HB-HTA projects and key members of the special HTA teams. Observations were made based on field trips and written HTA reports. RESULTS: Three pilot projects evaluated the use of medical consumables, three evaluated the use of surgical or medical interventions, and one evaluated an innovative management model for ventilators. Real-world data were collected from all the pilot projects to assist with the assessments. Most HB-HTA pilot projects achieved remarkable results such as improvements in economic efficiency; however, there were also obvious deficiencies such as the lack of a necessary cost-effectiveness analysis. CONCLUSIONS: The results varied among the seven HB-HTA pilot projects. The HB-HTA pilot program was implemented to promote the use of HB-HTA in hospital decision making in China. At the same time, HB-HTA in China faces challenges. We have made some policy recommendations based on the findings of the pilot projects.

Telemedicine and the assessment of clinician time: a scoping review.

OBJECTIVES: Telemedicine may improve healthcare access and efficiency if it demands less clinician time than usual care. We sought to describe the degree to which telemedicine trials assess the effect of telemedicine on clinicians' time and to discuss how including the time needed to treat (TNT) in health technology assessment (HTA) could affect the design of telemedicine services and studies. METHODS: We conducted a scoping review by searching clinicaltrials.gov using the search term "telemedicine" and limiting results to randomized trials or observational studies registered between January 2012 and October 2023. We then reviewed trial registration data to determine if any of the outcomes assessed in the trials measured effect on clinicians' time. RESULTS: We found 113 studies and of these 78 studies of telemedicine met the inclusion criteria and were included. Nine (12 percent) of the 78 studies had some measure of clinician time as a primary outcome, and 11 (14 percent) as a secondary outcome. Four studies compared direct measures of TNT with telemedicine versus usual care, but no statistically significant difference was found. Of the sixteen studies including indirect measures of clinician time, thirteen found no significant effects, two found a statistically significant reduction, and one found a statistically significant increase. CONCLUSIONS: This scoping review found that clinician time is not commonly measured in studies of telemedicine interventions. Attention to telemedicine's TNT in clinical studies and HTAs of telemedicine in practice may bring attention to the organization of clinical workflows and increase the value of telemedicine.

Nurses' perspectives on challenges and facilitators when implementing a self-management support intervention as an everyday healthcare practice: A qualitative study.

AIM: To explore registered nurses' perspectives on challenges and facilitators to implementing a telephone-based self-management support (SMS) intervention (Proactive Health Support) as an everyday healthcare practice, during the early stages of implementation. DESIGN: Data were collected using a qualitative research design involving focus-group interviews and participant observations. METHODS: We conducted participant observation following nine nurses and four focus group interviews with 14 nurses. Data were analysed using thematic analyses. RESULTS: Proactive Health Support was implemented in units organized independently of the existing organizational units within healthcare services. This independent organization, along with the intervention's generic (non-disease specific) design, empowered nurses to become autonomous practitioners capable of prioritizing the operationalization of SMS as an everyday healthcare practice. However, unlearning already embedded medical practices and establishing new nursing roles necessary to accommodate the intervention in practice was experienced a challenge. Education and supervision were identified as valuable tools for successful implementation. CONCLUSION: Our study highlights the significance of organizational context and autonomy in successful SMS implementation. Balancing external factors like organizational context, priority and time is vital, but navigating the internal shift in professional practice is equally crucial. Role transition processes can constitute challenges demanding accommodation. IMPLICATIONS FOR THE PROFESSION: From a nursing perspective, this study highlights that practising SMS requires substantial training and education. Generic SMS interventions can introduce higher levels of contingency due to their versatile nature. Thus, equipping nurses with competencies that enable them to navigate this unpredictability flexibly is crucial. IMPACT: Policymakers and administrators should allocate resources and support implementation processes in ways that accommodate both internal and external conditions to facilitate nurses in delivering effective SMS. REPORTING METHOD: This study adheres to the SRQR guideline. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.

Cost-effectiveness of 2-[18F]FDG-PET/CT versus CE-CT for response monitoring in patients with metastatic breast cancer: a register-based comparative study.

We evaluated the cost-effectiveness of 2-[18F]FDG-PET/CT compared to CE-CT for response monitoring in metastatic breast cancer (MBC) patients. The study included 300 biopsy-verified MBC patients treated at Odense University Hospital (Denmark). CE-CT was used in 144 patients, 83 patients underwent 2-[18F]FDG-PET/CT, and 73 patients received a combination of both. Hospital resource-based costs (2007-2019) were adjusted to the 2019 level. The incremental cost-effectiveness ratio (ICER) was calculated by comparing average costs per patient and gained survival with CE-CT. During a median follow-up of 33.0 months, patients in the 2-[18F]FDG-PET/CT group had more short admissions (median 6 vs. 2) and fewer overnight admissions (5 vs. 12) compared to the CE-CT group. The mean total cost per patient was €91,547 for CE-CT, €83,965 for 2-[18F]FDG-PET/CT, and €165,784 for the combined group. The ICER for 2-[18F]FDG-PET/CT compared to CE-CT was €-527/month, indicating gaining an extra month of survival at a lower cost (€527). 2-[18F]FDG-PET/CT was more cost-effective in patients with favorable prognostic factors (oligometastatic or estrogen receptor-positive disease), while CE-CT was more cost-effective in poor prognosis patients (liver/lung metastases or performance status ≥ 2 at baseline). In conclusion, our study suggests that 2-[18F]FDG-PET/CT is a cost-effective modality for response monitoring in metastatic breast cancer.

Effect of single versus multiple prophylactic antibiotic doses on prosthetic joint infections following primary total hip arthroplasty in patients with osteoarthritis at public and private hospitals in Denmark: protocol for a nationwide cross-over, cluster randomised, non-inferiority trial [The Pro-Hip-Quality Trial].

INTRODUCTION: A feared complication after total hip arthroplasty (THA) is prosthetic joint infection (PJI), associated with high morbidity and mortality. Prophylactic antibiotics can reduce the risk of PJI. However, there is no consensus on the dosages and current recommendations are based on a low evidence level. The objective is to compare the effect of a single versus multiple doses of prophylactic antibiotics administered within 24 hours on PJI. METHODS AND ANALYSIS: The study is designed as a cross-over, cluster randomised, non-inferiority trial. All clinical centres use both antibiotic practices (1 year of each intervention). All Danish orthopaedic surgery departments will be involved: Based on quality databases, 2-year cohorts of approximately 20 000 primary THAs conducted at 39 public and private hospitals, will be included. INCLUSION CRITERIA: age ≥18 years, all indications for THA except patients operated due to acute or sequelae from proximal femoral or pelvic fractures or bone tumour or metastasis. The primary outcome is PJI within 90 days after primary THA. Secondary outcomes include (1) serious adverse events, (2) potential PJI, (3) length of hospitalisation stay, (4) cardiovascular events, (5) hospital-treated infections, (6) community-based antibiotic use, (7) opioid use and (8) use of acetaminophen and non-steroidal anti-inflammatory drugs. All outcome measures will be extracted from national databases. Analyses will be based on the intention-to-treat population. Non-inferiority will be shown if the upper limit of the two-sided 95% CI for the OR is less than 1.32 for the single dose as compared with multiple doses. The results will establish best practice on antibiotic prophylaxis dosages in the future. ETHICS AND DISSEMINATION: This study has been approved by Committees on Health Research Ethics for The Capital Region of Denmark (21069108) and The Danish Medicines Agency (2021091723). All results will be presented in peer-reviewed medical journals and international conferences. TRIAL REGISTRATION NUMBER: NCT05530551.

Who benefits from self-management support? Results from a randomized controlled trial.

Background: Self-management support models adapted to accommodate the needs of each patient are complex interventions that should be evaluated for intervention mechanisms. In a national randomized controlled trial (RCT), we evaluated the efficacy of telephone-based self-management support that demonstrated improved health-related quality of life (HRQoL), no reduction in hospital admissions, and an unexpected increase in primary healthcare services. Objective: The objective of this study is to identify RCT impact mechanisms and explore which participants could benefit the most from the PaHS intervention. Methods: This study evaluates intervention mechanisms through interaction analyses of predefined intervention moderators (sex, age, education, chronic disease, risk of hospital admissions, and coping) and post-hoc intervention mediators (contacts in primary care and anxiety medication). The one co-primary outcome HRQoL was assessed with SF26v2 and analyzed with generalized linear mixed models and the other co-primary hospital admissions was analyzed with poisson regression. Results: PaHS interacted with diabetes, multimorbidity, coping, and anxiety medication on the outcome hospital admissions. PaHS led to a significant reduction in hospital admissions in participants with diabetes or multimorbidity and an increase in hospital admissions in participants with higher baseline coping and participants using anxiety medication. The interaction analyses revealed significant intervention mediation in the outcome HRQoL by sex and diabetes. Conclusions: Participants with diabetes, multimorbidity, and women could benefit the most from telephone-based self-management support, but the intervention involves the risk of over-treatment.

Structured decision support to prevent hospitalisations of community-dwelling older adults in Denmark (PATINA): an open-label, stepped-wedge, cluster-randomised controlled trial.

BACKGROUND: Ageing populations and health-care staff shortages encourage efforts in primary care to recognise and prevent health deterioration and acute hospitalisation in community-dwelling older adults. The PATINA algorithm and decision-support tool alerts home-based-care nurses to older adults at risk of hospitalisation. The study aim was to test whether use of the PATINA tool was associated with changes in health-care use. METHODS: An open-label, stepped-wedge, cluster-randomised controlled trial was done in three Danish municipalities, covering 20 area teams providing home-based care to around 7000 recipients. During a period of 12 months, area teams were randomly assigned to an intervention crossover for older adults (aged 65 years or older) who received care at home. The primary outcome was hospitalisation within 30 days of identification by the algorithm as being at risk of hospitalisation. Secondary outcomes were hospital readmission and other hospital contacts, outpatient contacts, contact with primary care physicians (PCPs), temporary care, and death, within 30 days of identification. This study was registered at ClinicalTrials.gov (NTC04398797). FINDINGS: In total, 2464 older adults participated in the study: 1216 (49·4%) in the control phase and 1248 (50·6%) in the intervention phase. In the control phase, 102 individuals were hospitalised within 30 days during 33 943 days of risk (incidence 0·09 per 30 days), compared with 118 individuals within 34 843 days of risk (0·10 per 30 days) during the intervention phase. The intervention was not associated with a reduction in the number of first hospitalisations within 30 days (incidence rate ratio [IRR] 1·10 [90% CI 0·90-1·40]; p=0·28). Furthermore it was not associated with reduced rates of other hospital contacts (IRR 1·10 [95% CI 0·90-1·40]; p=0·28), outpatient contacts (1·10 [0·88-1·40]; p=0·42), or mortality (0·82 [0·58-1·20]; p=0·25). The intervention was associated with a 59% reduction in readmissions within 30 days of hospital discharge (IRR 0·41 [95% CI 0·24-0·68]; p=0·0007), a 140% increase in contacts with PCPs (2·40 [1·18-3·20]; p<0·0001), and a 150% increase in use of temporary care (2·50 [1·40-4·70]; p=0·0027). INTERPRETATION: Despite having no effect on the primary outcome, the PATINA tool showed other benefits for older adults receiving home-based care. Such algorithms have the potential to shift health-care use from secondary to primary care but need to be tested in other home-based care settings. Implementation of algorithms in clinical practice should be informed by analysis of cost-effectiveness and potential harms as well as the benefits. FUNDING: Innovation Fund Denmark and Region of Southern Denmark. TRANSLATIONS: For the Danish, French and German translations of the abstract see Supplementary Materials section.

Value assessment of artificial intelligence in medical imaging: a scoping review.

BACKGROUND: Artificial intelligence (AI) is seen as one of the major disrupting forces in the future healthcare system. However, the assessment of the value of these new technologies is still unclear, and no agreed international health technology assessment-based guideline exists. This study provides an overview of the available literature in the value assessment of AI in the field of medical imaging. METHODS: We performed a systematic scoping review of published studies between January 2016 and September 2020 using 10 databases (Medline, Scopus, ProQuest, Google Scholar, and six related databases of grey literature). Information about the context (country, clinical area, and type of study) and mentioned domains with specific outcomes and items were extracted. An existing domain classification, from a European assessment framework, was used as a point of departure, and extracted data were grouped into domains and content analysis of data was performed covering predetermined themes. RESULTS: Seventy-nine studies were included out of 5890 identified articles. An additional seven studies were identified by searching reference lists, and the analysis was performed on 86 included studies. Eleven domains were identified: (1) health problem and current use of technology, (2) technology aspects, (3) safety assessment, (4) clinical effectiveness, (5) economics, (6) ethical analysis, (7) organisational aspects, (8) patients and social aspects, (9) legal aspects, (10) development of AI algorithm, performance metrics and validation, and (11) other aspects. The frequency of mentioning a domain varied from 20 to 78% within the included papers. Only 15/86 studies were actual assessments of AI technologies. The majority of data were statements from reviews or papers voicing future needs or challenges of AI research, i.e. not actual outcomes of evaluations. CONCLUSIONS: This review regarding value assessment of AI in medical imaging yielded 86 studies including 11 identified domains. The domain classification based on European assessment framework proved useful and current analysis added one new domain. Included studies had a broad range of essential domains about addressing AI technologies highlighting the importance of domains related to legal and ethical aspects.

Model for ASsessing the value of Artificial Intelligence in medical imaging (MAS-AI).

OBJECTIVES: Artificial intelligence (AI) is seen as a major disrupting force in the future healthcare system. However, the assessment of the value of AI technologies is still unclear. Therefore, a multidisciplinary group of experts and patients developed a Model for ASsessing the value of AI (MAS-AI) in medical imaging. Medical imaging is chosen due to the maturity of AI in this area, ensuring a robust evidence-based model. METHODS: MAS-AI was developed in three phases. First, a literature review of existing guides, evaluations, and assessments of the value of AI in the field of medical imaging. Next, we interviewed leading researchers in AI in Denmark. The third phase consisted of two workshops where decision makers, patient organizations, and researchers discussed crucial topics for evaluating AI. The multidisciplinary team revised the model between workshops according to comments. RESULTS: The MAS-AI guideline consists of two steps covering nine domains and five process factors supporting the assessment. Step 1 contains a description of patients, how the AI model was developed, and initial ethical and legal considerations. In step 2, a multidisciplinary assessment of outcomes of the AI application is done for the five remaining domains: safety, clinical aspects, economics, organizational aspects, and patient aspects. CONCLUSIONS: We have developed an health technology assessment-based framework to support the introduction of AI technologies into healthcare in medical imaging. It is essential to ensure informed and valid decisions regarding the adoption of AI with a structured process and tool. MAS-AI can help support decision making and provide greater transparency for all parties.

Proactive Health Support: a randomised controlled trial of telephone-based self-management support for persons at risk of hospital admission.

BACKGROUND: Persons with frequent hospital admissions have a disease burden that may exceed their self-management skills. The evidence base of telephone-based interventions to support self-management is poor with mixed results. The aim of this study is to evaluate the effect of Proactive Health Support (PaHS): telephone-based self-management support for persons with risk of hospitalizations. METHODS: This study is a national randomised controlled trial of PaHS versus usual universal tax-funded healthcare. Participants were persons at risk of emergency hospital admissions. The intervention began with a physical start-up session followed by telephone sessions of self-management support. The two co-primary outcomes were Health-Related Quality of Life (HRQoL) (Mental Health Component Summary Score of SF36v2) analysed with mixed models and hospital admissions analysed with Poisson regression at 6 months. Secondary outcomes were at 3- and 12-month follow-up and disease subgroup analyses. RESULTS: During the study period, 6,402 persons were randomised (3,190 intervention, 3,212 control). HRQoL was significantly improved at 6 months (Est. 1.4992, P = <0.0001) and at 3 and 12 months on all 10 scales. There was no overall effect on hospital admissions at 6 months with an adjusted estimate of 0.0074 (P = 0.8691). Persons with diabetes had significant improvement of HRQoL and reduced hospital admissions. CONCLUSIONS: The PaHS intervention improved HRQoL for all participants and reduced hospital admissions for persons with diabetes only.

mHealth education for patients with chronic kidney disease: protocol for a scoping review.

INTRODUCTION: More than 10% of the population worldwide is affected by chronic kidney disease (CKD). Despite many promising indications regarding the use of mHealth education for patients with CKD, there is still little evidence regarding the feasibility, effectiveness outcomes and outcome measures. Therefore, we will conduct a scoping review to examine the currently available evidence on mHealth education for patients with CKD and, thus, explore the existing evidence regarding feasibility, effectiveness outcomes and outcome measures, patient and/or provider perception and implementation challenges. METHODS AND ANALYSIS: A scoping review will be conducted in accordance with Joanna Briggs Institute Manual for Evidence Synthesis chapter on scoping reviews.MEDLINE, Embase, CINAHL and PsycINFO will be searched. The search strategy will consist of blocks, which have been adopted and modified from former Cochrane reviews. Two independent reviewers will screen studies. Characteristics of the included studies, both quantitative and qualitative, will be reported using quantitative descriptive statistics. Quantitative results will be grouped by objectives (feasibility, effectiveness outcomes and outcome measures, patient perception and implementation challenges), types of intervention and characteristics of participants. Qualitative results will be organised into categories using an iterative process, as suggested by Pollock et al. ETHICS AND DISSEMINATION: As this scoping review does not involve primary data collection, ethical permission is unnecessary. Results of the scoping review will be published in an international peer-reviewed scientific journal. TRIAL REGISTRATION NUMBER: Open Science Framework (https://osf.io/gxkeh/).

Prior to Implementation of Digital Pathology-Assessment of Expectations among Staff by Means of Normalization Process Theory.

The Region of Southern Denmark is the first in Denmark to implement digital pathology (DIPA), starting at the end of 2020. The DIPA process involves changes in workflow, and the pathologist will have to diagnose based on digital whole slide imaging instead of through the traditional use of the conventional light microscope and glass slides. In addition, in the laboratory, the employees will have to implement one more step to their workflow-scanning of tissue. The aim of our study was to assess the expectations and readiness among employees and management towards the implementation of DIPA, including their thoughts and motivations for starting to use DIPA. We used a mixed-method approach. Based on the findings derived from 18 semi-structured interviews with employees from the region's departments of pathology, we designed a questionnaire, including questions from the normalization measure development tool. The questionnaires were e-mailed to 181 employees. Of these employees, 131 responded to the survey. Overall, they reported feeling sufficiently tech-savvy to be able to use DIPA, and they had high expectations as well as motivation and readiness for the upcoming changes. However, the employees were skeptical regarding the allocation of resources, and few were aware of reports about the effects of DIPA. Based on the findings, it seems to be important to provide not only a thorough introduction to the new intervention and the changes it will entail, but also to continue to ensure that the staff know how it works and why it is necessary to implement.

Effectiveness of video consultations in type 1 diabetes patients treated with insulin pumps in the outpatient clinic: protocol for a randomised controlled trial.

INTRODUCTION: The purpose of the study is to assess the effectiveness of video consultations in patients with type 1 diabetes mellitus (DM) treated with insulin pumps in the outpatient clinic. METHODS AND ANALYSIS: A 52 weeks' duration, open-label, randomised controlled trial will be conducted, enrolling 100 patients with type 1 DM currently treated with insulin pump.Patients will be recruited from the diabetes outpatient clinic at Hospital of Southern Jutland, Department of internal medicine, Sønderborg. Participants will be randomised to either video consultations (experimental intervention) or standard care (control comparator). Participants in the video consultation group will follow their standard care treatment but will have all of their scheduled and non-scheduled appointments by video consultation. The control group will follow their standard care treatment as usual, having all their appointments at the outpatient centre. Primary outcome will be change from baseline of time in range (3.9-10.0 mmol/L). ETHICS AND DISSEMINATION: The study has been approved by the Regional Committe on Health Research Ethics for Southern Denmark, S-20200039G Acadre 20/12922. We will present the results of the trial at international conferences as well as publish the results of the trial in (a) peer-reviewed scientific journal(s). TRIAL REGISTRATION NUMBER: NCT04612933.

A cost-minimization analysis comparing teledermoscopy and face-to-face evaluations of suspicious skin lesions in Southern Denmark.

INTRODUCTION: Skin cancers are common in European populations and generate considerable costs. In Denmark, patients with suspicious skin lesions will usually consult their general practitioner who may refer the patient to a dermatologist or plastic surgeon if necessary. However, it is also possible for the general practitioner to take and send dermoscopic and macroscopic photographs of the suspicious skin lesion for evaluation by a dermatologist, so-called teledermoscopy. This study aims to calculate and compare costs of teledermoscopy and standard care in the form of face-to-face evaluation by a dermatologist of suspicious skin lesions referred by general practitioners in the Region of Southern Denmark. METHODS: A cost-minimization study was performed. Investment costs, costs in general practice, hospital-associated costs and patient costs were included to calculate the average cost per patient episode. RESULTS: The overall cost of teledermoscopy was €17.2-€23.1 higher than that of standard care. However, hospital-associated costs and patient costs were reduced. DISCUSSION: The total cost of teledermoscopy was slightly higher than the cost of standard care. Sensitivity analyses indicated that the number of preventable face-to-face evaluations and the distance to the dermatologist were the two factors that influenced costs the most.