BACKGROUND: The COVID-19 pandemic put unprecedented pressure on weight management services. These services were required to adapt to continue to provide care for people living with obesity. This study sought to develop consensus recommendations on the best practice solutions adopted by weight management services in the United Kingdom during the COVID-19 pandemic.
METHODS: This study utilised a semi-structured interview and a modified Delphi methodology to develop a consensus of best practice recommendations identified by specialist weight management services during the pandemic.
RESULTS: Twenty-three healthcare professionals working in weight management service across the United Kingdom participated in the study. Analysis of interview transcripts identified four key thematic domains: outpatient, patient education and support, perioperative care and team working. Of the initial 43 unique recommendations, 30 reached consensus agreement. Outpatient recommendations focused on communication strategies, patient self-monitoring and remote patient tracking. Patient education and support recommendations addressed the development of online educational resources and support groups. Perioperative care recommendations emphasised case prioritisation, waiting list support and postoperative care. Team working recommendations targeted the use of digital collaboration tools and strategies for effective teamwork.
CONCLUSIONS: Developing consensus recommendations on best practice is a critical step for weight management and outpatient services to achieve higher standards of care. These recommendations provide a springboard for departmental discussions, paving the way for improved experiences for individuals living with obesity as they progress along their weight management journey.

BACKGROUND: Digital approaches may be helpful in augmenting care to address unmet mental health needs, particularly for schizophrenia and severe mental illness (SMI).
OBJECTIVE: An international multidisciplinary group was convened to reach a consensus on the challenges and potential solutions regarding collecting data, delivering treatment, and the ethical challenges in digital mental health approaches for schizophrenia and SMI.
METHODS: The consensus development panel method was used, with an in-person meeting of 2 groups: the expert group and the panel. Membership was multidisciplinary including those with lived experience, with equal participation at all stages and coproduction of the consensus outputs and summary. Relevant literature was shared in advance of the meeting, and a systematic search of the recent literature on digital mental health interventions for schizophrenia and psychosis was completed to ensure that the panel was informed before the meeting with the expert group.
RESULTS: Four broad areas of challenge and proposed solutions were identified: (1) user involvement for real coproduction; (2) new approaches to methodology in digital mental health, including agreed standards, data sharing, measuring harms, prevention strategies, and mechanistic research; (3) regulation and funding issues; and (4) implementation in real-world settings (including multidisciplinary collaboration, training, augmenting existing service provision, and social and population-focused approaches). Examples are provided with more detail on human-centered research design, lived experience perspectives, and biomedical ethics in digital mental health approaches for SMI.
CONCLUSIONS: The group agreed by consensus on a number of recommendations: (1) a new and improved approach to digital mental health research (with agreed reporting standards, data sharing, and shared protocols), (2) equal emphasis on social and population research as well as biological and psychological approaches, (3) meaningful collaborations across varied disciplines that have previously not worked closely together, (4) increased focus on the business model and product with planning and new funding structures across the whole development pathway, (5) increased focus and reporting on ethical issues and potential harms, and (6) organizational changes to allow for true communication and coproduction with those with lived experience of SMI. This study approach, combining an international expert meeting with patient and public involvement and engagement throughout the process, consensus methodology, discussion, and publication, is a helpful way to identify directions for future research and clinical implementation in rapidly evolving areas and can be combined with measurements of real-world clinical impact over time. Similar initiatives will be helpful in other areas of digital mental health and similarly fast-evolving fields to focus research and organizational change and effect improved real-world clinical implementation.

BACKGROUND: Smoking tobacco implies significant health hazards. Digital cessation support can get more smokers in contact with guideline-based cessation. The objective was to test the efficacy of a guideline-based smoking cessation app (NichtraucherHelden®). The hypothesis was a significantly higher cessation rate in the intervention group.
METHODS: The study was a nationwide, multicentric, prospective, parallel, randomized controlled trial in Germany from November 2021 to March 2023. Recruitment took place in medical practices and by telephone via study centers. Eligible participants were adult tobacco-dependent smokers according to ICD-10 (F17.2). Randomization (1:1) was operated by a computer-generated stratified 1:1 block procedure. Intervention (IG; n = 336) and control group (CG; n = 325) were briefly advised with regard to stop smoking, IG was additionally treated with the cessation app. The primary endpoint was the self-reported 7-day-point abstinence after 6 months with an intention to treat analysis. Secondary endpoints comprised prolonged abstinence and biochemically verified abstinence. The study was registered at the German Registry of Clinical Trials (DRKS00025933, UTN U1111-1268-2181) and was approved by the competent ethics committees (leading ethic committee Berlin #Eth-52/20).
RESULTS: Three hundred thirty six participants (IG) and 325 (CG) were analyzed. Seven-day point prevalence was significantly higher in the app group (IG) (20% vs. 10%, OR 2.2 (1.4-3.4)). Additionally, the prolonged abstinence and the objective abstinence rates were significantly higher in the app group.
CONCLUSIONS: The NichtraucherHelden app doubles the abstinence rate. Apps can bridge the gap between the small number of therapeutic offers and the need for modern evidence-based cessation support.
CONCLUSIONS: The study is the first to provide evidence for the feasibility and efficacy of guideline-based digital smoking cessation provided by a smartphone app for the German statutory health insurance (SHI) system. Smoking cessation support by smartphone apps could be broadly distributed and thus bring more smokers in contact with guideline-based cessation support than to date and increase the number of successful quitters substantially.

Usability evaluation both by experts and target users is an integral part of the process of developing and assessing digital solutions. Usability evaluation improves the probability of having digital solutions that are easier, safer, more efficient, and more pleasant to use. However, despite the widespread recognition of the importance of usability evaluation, there is a lack of research and consensus on related concepts and reporting standards.
The aim of the study is to generate consensus on terms and procedures that should be considered when planning and reporting a study on a usability evaluation of health-related digital solutions both by users and experts and provide a checklist that can easily be used by researchers when conducting their usability studies.
A Delphi study with 2 rounds was conducted with a panel of international participants experienced in usability evaluation. In the first round, they were asked to comment on definitions, rate the importance of preidentified methodological procedures using a 9-item Likert scale, and suggest additional procedures. In the second round, experienced participants were asked to reappraise the relevance of each procedure informed by round 1 results. Consensus on the relevance of each item was defined a priori when at least 70% or more experienced participants scored an item 7 to 9 and less than 15% of participants scored the same item 1 to 3.
A total of 30 participants (n=20 females) from 11 different countries entered the Delphi study with a mean age of 37.2 (SD 7.7) years. Agreement was achieved on the definitions for all usability evaluation-related terms proposed (usability assessment moderator, participant, usability evaluation method, usability evaluation technique, tasks, usability evaluation environment, usability evaluator, and domain evaluator). A total of 38 procedures related to usability evaluation planning and reporting were identified across rounds (28 were related to usability evaluation involving users and 10 related to usability evaluation involving experts). Consensus on the relevance was achieved for 23 (82%) of the procedures related to usability evaluation involving users and for 7 (70%) of the usability evaluation procedures involving experts. A checklist was proposed that can guide authors when designing and reporting usability studies.
This study proposes a set of terms and respective definitions as well as a checklist to guide the planning and reporting of usability evaluation studies, constituting an important step toward a more standardized approach in the field of usability evaluation that may contribute to enhancing the quality of planning and reporting usability studies. Future studies can contribute to further validating this study work by refining the definitions, assessing the practical applicability of the checklist, or assessing whether using this checklist results in higher-quality digital solutions.

Encounter decision aids (EDAs) are tools that can support shared decision making (SDM), up to the clinical encounter. However, adoption of these tools has been limited, as they are hard to produce, to keep up-to-date, and are not available for many decisions. The MAGIC Evidence Ecosystem Foundation has created a new generation of decision aids that are generically produced along digitally structured guidelines and evidence summaries, in an electronic authoring and publication platform (MAGICapp). We explored general practitioners\' (GPs) and patients\' experiences with five selected decision aids linked to BMJ Rapid Recommendations in primary care.
We applied a qualitative user testing design to evaluate user experiences for both GPs and patients. We translated five EDAs relevant to primary care, and observed the clinical encounters of 11 GPs when they used the EDA with their patients. We conducted a semi-structured interview with each patient after the consultation and a think-aloud interview with each GPs after multiple consultations. We used the Qualitative Analysis Guide (QUAGOL) for data analysis.
Direct observations and user testing analysis of 31 clinical encounters showed an overall positive experience. The EDAs created better involvement in decision making and resulted in meaningful insights for patients and clinicians. The design and its interactive, multilayered structure made the tool enjoyable and well-organized. Difficult terminology, scales and numbers hindered understanding of certain information, which was sometimes perceived as too specialized or even intimidating. GPs thought the EDA was not suitable for every patient. They perceived a learning curve was required and the need for time investment was a concern. The EDAs were considered trustworthy as they were provided by a credible source.
This study showed that EDAs can be useful tools in primary care by supporting actual shared decision making and enhancing patient involvement. The graphical approach and clear representation help patients better understand their options. To overcome barriers such as health literacy and GPs attitudes, effort is still needed to make the EDAs as accessible, intuitive and inclusive as possible through use of plain language, uniform design, rapid access and training.
The study protocol was approved by the The Research Ethics Committee UZ/KU Leuven (Belgium) on 31-10-2019 with reference number MP011977.

BACKGROUND: Patients presenting with acute shortness of breath and chest pain should be managed according to guideline recommendations. Serious games can be used to train clinical reasoning. However, only few studies have used outcomes beyond student satisfaction, and most of the published evidence is based on short-term follow-up. This study investigated the effectiveness of a digital simulation of an emergency ward regarding appropriate clinical decision-making.
METHODS: In this prospective trial that ran from summer 2017 to winter 2018/19 at Göttingen Medical University Centre, a total of 178 students enrolled in either the fourth or the fifth year of undergraduate medical education took six 90-min sessions of playing a serious game (\'training phase\') in which they managed virtual patients presenting with various conditions. Learning outcome was assessed by analysing log-files of in-game activity (including choice of diagnostic methods, differential diagnosis and treatment initiation) with regard to history taking and patient management in three virtual patient cases: Non-ST segment elevation myocardial infarction (NSTEMI), pulmonary embolism (PE) and hypertensive crisis. Fourth-year students were followed up for 1.5 years, and their final performance was compared to the performance of students who had never been exposed to the game but had otherwise taken the same five-year undergraduate course.
RESULTS: During the training phase, overall performance scores increased from 57.6 ± 1.1% to 65.5 ± 1.2% (p < 0.001; effect size 0.656). Performance remained stable over 1.5 years, and the final assessment revealed a strong impact of ever-exposure to the game on management scores (72.6 ± 1.2% vs. 63.5 ± 2.1%, p < 0.001; effect size 0.811). Pre-exposed students were more than twice as likely to correctly diagnose NSTEMI and PE and showed significantly greater adherence to guideline recommendations (e.g., troponin measurement and D-dimer testing in suspected PE).
CONCLUSIONS: The considerable difference observed between previously exposed and unexposed students suggests a long-term effect of using the game although retention of specific virtual patient cases rather than general principles might partially account for this effect. Thus, the game may foster the implementation of guideline recommendations.