Towards Global Consensus on Core Outcomes for Hidradenitis Suppurativa Research: An Update from the HISTORIC Consensus Meetings I and II

BACKGROUND: A core outcomes set (COS) is an agreed minimum set of outcomes that should be measured and reported in all clinical trials for a specific condition. Hidradenitis suppurativa (HS) has no agreed-upon COS. A central aspect in the COS development process is to identify a set of candidate outcome domains from a long list of items. Our long list had been developed from patient interviews, a systematic review of the literature and a healthcare professional survey, and initial votes had been cast in two e-Delphi surveys. In this manuscript, we describe two in-person consensus meetings of Delphi participants designed to ensure an inclusive approach to generation of domains from related items. OBJECTIVES: To consider which items from a long list of candidate items to exclude and which to cluster into outcome domains. METHODS: The study used an international and multistakeholder approach, involving patients, dermatologists, surgeons, the pharmaceutical industry and medical regulators. The study format was a combination of formal presentations, small group work based on nominal group theory and a subsequent online confirmation survey. RESULTS: Forty-one individuals from 13 countries and four continents participated. Nine items were excluded and there was consensus to propose seven domains: disease course, physical signs, HS-specific quality of life, satisfaction, symptoms, pain and global assessments. CONCLUSIONS: The HISTORIC consensus meetings I and II will be followed by further e-Delphi rounds to finalize the core domain set, building on the work of the in-person consensus meetings

Development and initial validation of the HS‐IGA: a novel hidradenitis suppurativa‐specific investigator global assessment for use in interventional trials

Abstract: Background: Few validated instruments exist for use in hidradenitis suppurativa (HS) trials. Objectives: To develop a novel HS Investigator Global Assessment (HS‐IGA) and to validate its psychometric properties. Methods: Development of HS‐IGA involved discussion among stakeholders, including patients, within HISTORIC. Data from replicate phase III randomized controlled trials evaluating HS treatment were utilized. Multivariate models identified lesion type and body region as variables of importance. Classification and regression trees for ordinal responses were built. Validation included assessment of test–retest reliability, predictive validity, responsiveness and clinical meaningfulness. Results: There were 3024 unique measurements available in PIONEER I. Mean and median lesion counts by region were largely <10 and were highest in axillary and inguinal regions. The mean and median number of regions involved were ≤ 3 for individual lesions and combinations. Regardless of lesion type, axillary and inguinal regions most influenced the HS‐IGA score. Accordingly, regions were combined into a six‐point IGA based on the maximum lesion number in either upper or lower body regions with a score of 0 (0–1 lesions), 1 (2–5), 2 (6–10), 3 (11–15), 4 (16–20) and 5 (≥ 20 lesions). The intraclass correlation coefficient for test–retest reliability was 0·91 (95% confidence interval 0·87–0·94). Spearman’s rank order correlations (SROCs) with HS‐PGA and Hidradenitis Suppurativa Clinical Response (HiSCR) were 0·73 and 0·51, respectively (P < 0·001 for both comparisons). SROCs with Dermatology Life Quality Index (DLQI), pain numerical rating scale and HS‐QoL were 0·42, 0·34 and –0·25, respectively (P < 0·001 for all comparisons). HS‐IGA was responsive at weeks 12 and 36. Predictive convergent validity was very good with HS‐PGA (area under the curve = 0·89) and with HiSCR (area under the curve = 0·82). Predictive divergent validity was low with DLQI and HS‐QoL. Conclusions: HS‐IGA has moderate‐to‐strong psychometric properties and is simple to calculate

How to Tackle Legal Barriers That Threaten A Successful Implementation of eHealth Technologies?

Background: Over the years, many eHealth technologies have been developed and implemented that support patients and healthcare professionals in addition to traditional treatment. Due to increased knowledge and technical options, the possibilities of (automation of) data exchange also increased, and more and more patient-doctor relationships are taking place via technology. We therefore see a transition from the development of eHealth tools for specific purposes, to the development of “Digital Health Environments”, which automatically connect the stakeholders and data involved. Within the eHealth Junior Consortium, we aim to develop such a digital health environment for chronical ill children. This environment will integrate several scientifically validated eHealth tools that provide personalized and transdiagnostic prevention. There are many possibilities and advantages offered by (automatic) sharing of data between eHealth tools, connected ICT systems (e.g., EPD), and the children, parents and other stakeholders involved. However, legal challenges also arise in the implementation of such environments with regard to guaranteeing privacy as well as medical ethical discussions. Goals: The aim of this workshop is to identify and validate barriers and success factors related to legal aspects of implementation of eHealth technologies, and to identify how we could overcome these legal barriers. We will discuss results from a previous literature review with the participants, exchange experiences in legal issues that occurred in participants’ own (clinical and scientific) field, and brainstorm about how we could tackle or prevent these issues. Content and (interactive) activities: In a previous literature review (included both peer reviewed as grey literature), we identified several barriers and success factors related to the legal aspects of implementation of eHealth. During the workshop, we will present the results of this review as input for a discussion on the findings that are uncertain or raise questions (e.g., issues in data privacy/transparency/responsibility). We will ask participants to share their opinions and experiences with these issues (or related ones) within their daily practice/research. We cooperate with the Stimulate Healthcare Technology Program and TechMed Centre, and we will invite legal experts from our consortium (eHealth Junior) to join the workshop and support us with their knowledge. The workshop will consist of a short presentation followed by an interactive group discussion and brainstorm session. We will create a mindmap during the workshop to provide an overview of all discussed legal topics, and how these relate to each other. Our target audience are researchers, healthcare professionals and policy makers, working with health technologies. Expertise of workshop leader(s): Our research team has a lot of expertise in organizing and conducting stakeholder workshops. The workshop will be moderated by two persons from our team and one person will keep track of the mentioned points in a mindmap, during the discussion/brainstorm session, to provide an overview. We will also strength forces by collaborating with the Stimulate Healthcare Technology Program, TechMed Centre, and experts from the legal field (partners from eHealth Junior Consortium), to support us during the brainstorm and discussion sessions. These experts also participated in earlier workshops of our consortium and bring valuable knowledge on the legal aspects of implementation of eHealth from own experiences

Implementation and User Evaluation of an eHealth Technology Platform Supporting Patients With Cardiovascular Disease in Managing Their Health After a Cardiac Event: Mixed Methods Study

Background: eHealth technology can help patients with cardiovascular disease adopt and maintain a healthy lifestyle by supporting self-management and offering guidance, coaching, and tailored information. However, to support patients over time, eHealth needs to blend in with their needs, treatment, and daily lives. Just as needs can differ between patients, needs can change within patients over time. To better adapt technology features to patients’ needs, it is necessary to account for these changes in needs and contexts of use. Objective: This study aimed to identify and monitor patients’ needs for support from a web-based health management platform and how these needs change over time. It aimed to answer the following research questions: “How do novice and more advanced users experience an online health management platform?” “What user expectations support or hinder the adoption of an online health management platform, from a user perspective?” and “How does actual usage relate to user experiences and adoption?” Methods: A mixed methods design was adopted. The first method involved 2 rounds of usability testing, followed by interviews, with 10 patients at 0 months (round 1) and 12 patients at 6 months (round 2). In the second method, log data were collected to describe the actual platform use. Results: After starting cardiac rehabilitation, the platform was used frequently. The patients mentioned that they need to have an incentive, set goals, self-monitor their health data, and feel empowered by the platform. However, soon after the rehabilitation program stopped, use of the platform declined or patients even quit because of the lack of continued tailored or personalized advice. The reward system motivated them to log data, but most participants indicated that being healthy should be the main focus, not receiving gifts. A web-based platform is flexible, accessible, and does not have any obligations; however, it should be implemented as an addition to regular care. Conclusions: Although use of the platform declined in the longer term, patients quitting the technology did not directly indicate that the technology was not functioning well or that patients no longer focused on achieving their values. The key to success should not be user adherence to a platform but adherence to healthy lifestyle habits. Therefore, the implementation of eHealth should include the transition to a stage where patients might no longer need support from a technology platform to be independently and sustainably adherent to their healthy lifestyle habits. This emphasizes the importance of conducting multi-iterative evaluations to continuously monitor whether and how patients’ needs and contexts of use change over time. Future research should focus on how this transition can be identified and monitored and how these insights can inform the design and implementation of the technology

The Dutch COVID-19 Contact Tracing App (the CoronaMelder): Usability Study

Background: Adoption and evaluation of contact tracing tools based on information and communications technology may expand the reach and efficacy of traditional contact tracing methods in fighting COVID-19. The Dutch Ministry of Health, Welfare and Sports initiated and developed CoronaMelder, a COVID-19 contact tracing app. This app is based on a Google/Apple Exposure Notification approach and aims to combat the spread of the coronavirus among individuals by notifying those who are at increased risk of infection due to proximity to someone who later tests positive for COVID-19. The app should support traditional contact tracing by faster tracing and greater reach compared to regular contact tracing procedures. Objective: The main goal of this study is to investigate whether the CoronaMelder is able to support traditional contact tracing employed by public health authorities. To achieve this, usability tests were conducted to answer the following question: is the CoronaMelder user-friendly, understandable, reliable and credible, and inclusive? Methods: Participants (N=44) of different backgrounds were recruited: youth with varying educational levels, youth with an intellectual disability, migrants, adults (aged 40-64 years), and older adults (aged >65 years) via convenience sampling in the region of Twente in the Netherlands. The app was evaluated with scenario-based, think-aloud usability tests and additional interviews. Findings were recorded via voice recordings, observation notes, and the Dutch User Experience Questionnaire, and some participants wore eye trackers to measure gaze behavior. Results: Our results showed that the app is easy to use, although problems occurred with understandability and accessibility. Older adults and youth with a lower education level did not understand why or under what circumstances they would receive notifications, why they must share their key (ie, their assigned identifier), and what happens after sharing. In particular, youth in the lower-education category did not trust or understand Bluetooth signals, or comprehend timing and follow-up activities after a risk exposure notification. Older adults had difficulties multitasking (speaking with a public health worker and simultaneously sharing the key in the app). Public health authorities appeared to be unprepared to receive support from the app during traditional contact tracing because their telephone conversation protocol lacks guidance, explanation, and empathy. Conclusions: The study indicated that the CoronaMelder app is easy to use, but participants experienced misunderstandings about its functioning. The perceived lack of clarity led to misconceptions about the app, mostly regarding its usefulness and privacy-preserving mechanisms. Tailored and targeted communication through, for example, public campaigns or social media, is necessary to provide correct information about the app to residents in the Netherlands. Additionally, the app should be presented as part of the national coronavirus measures instead of as a stand-alone app offered to the public. Public health workers should be trained to effectively and empathetically instruct users on how to use the CoronaMelder app

Evaluating patients' unmet needs in hidradenitis suppurativa: Results from the Global Survey Of Impact and Healthcare Needs (VOICE) Project

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Lecture 49 ISBN e-book : 9781615045754International audienc