Access in all areas? A round up of developments in market access and HTA: part 5.

In this latest update, we explore the recent announcement by Canada's Drug Agency (CDA-AMC, formerly CADTH) on their pilot to include the societal perspective in the evaluation of certain new medicines; a recent Office of Health Economics (OHE) report on the evaluation of HTA agency methods over time; and publications examining the impact of Project Orbis on patient access to oncology treatments.

In Their Own Words: Patient Narratives of Breast Cancer Surgery and Reconstruction.

BACKGROUND: Breast cancer's global burden prompts a comprehensive understanding of patient experiences surrounding surgical interventions. Social media platforms serve as a new potential avenue for analysis, reflecting patients' coping mechanisms and support-seeking behaviors. OBJECTIVE: This study's objective is to further understand patient experiences regarding breast cancer interventions via social media to improve physician-patient dialogue. METHODS: A cross-sectional study was conducted of Instagram and TikTok posts surrounding breast cancer surgeries using procedure-related hashtags. Content was categorized to prevalent themes related to Breast-Q foci and was subsequently analyzed. RESULTS: Data from 1,028 individuals were analyzed. Posts encompassed double mastectomy (39%), single mastectomy (22%), and combined deep inferior epigastric perforator flap, latissimus dorsi flap, and transverse rectus abdominis muscle flap reconstruction (39%). Frequently identified themes included 'Raising Awareness' (86.87%), 'Spreading Positivity' (53.11%), 'Resiliency' (31.03%), 'Online Support' (24.61%), 'Update of Appearance' (20.82%), 'Recovery/Rehab' (19.94%), and 'Scientific Explanation' (19.75%). Instagram posts more likely encompassed positivity (p < 0.001), resiliency (p = 0.001), and mental health (p = 0.011). TikTok posts more likely (p = 0.001) discussed scientific explanations, decision-making, and symptoms (p < 0.001). Preoperative posts more likely (p < 0.001) surrounded scientific explanations, decision-making, and fear. Postoperative posts more likely (p < 0.001) highlighted appearance updates, recovery/rehab, and positivity (p = 0.012). Experiences with mastectomy and reconstruction differed: recovery/rehab (p < 0.001), scientific explanations (p = 0.015), treatment process (p = 0.003), range of motion (p < 0.001), self-esteem (p = 0.017), and wound management (p = 0.008). CONCLUSION: Concerns of patients online reflect Breast-Q measures. Understanding these nuanced patient discussions can provide novel insights for providers. Tailoring interactions through these insights may facilitate enhanced support, discussions, and experiences throughout the treatment journey. Main Points Social media offers a unique insight into personal patient experiences Online breast surgery patient perspectives reflect Breast-Q measures Outlooks from shared online posts may facilitate physician-patient dialogue LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Comparison of the Diagnosis and Management of Demodex Blepharitis Between Eye Care Practitioners in India and Australasia - A Survey-Based Comparison.

Aim: The primary aim of this study was to compare how eyecare professionals in disparate regions of the world diagnose and manage Demodex blepharitis. A secondary aim was to explore interprofessional differences in diagnostic and management practices. Methods: Ophthalmologists and optometrists from India and Australia/New Zealand, were invited to complete an online survey on Demodex blepharitis. Clinical practice patterns relating to patients with Demodex blepharitis, with details of how they investigate and manage Demodex blepharitis in clinical practice, were collected along with clinician demographics and general perceptions on eyelid health. Mann-Whitney U, and Fisher's exact tests were used for statistical analysis. Results: A total of 261 eyecare professionals completed the survey, comprising 207 from India (84% optometrists) and 54 from Australia and New Zealand (91% optometrists). Almost 70% of practitioners across the 3 countries recognized Demodex blepharitis as a cause of ocular discomfort, yet only 45% reported attempting to identify Demodex in their patients. There were significant differences noted in clinical practice between those in Australasia and India. Perceived prevalence of Demodex blepharitis also differed (60% in Australasia vs 27% in India; p<0.01), as well as, the choice of slit lamp magnification used to detect the mites (25x in Australasia vs 16x in India; p = 0.02), preferred treatment option to manage Demodex blepharitis (tea tree oil in Australasia vs Standard lid hygiene in India; p = 0.01), treatment duration (from 3-4 weeks to over 12 weeks in Australasia vs 3-4 weeks in India; p = 0.02) and treatment application frequency (once daily in Australasia vs twice daily in India; p = 0.01). Conclusions: This study highlights differences in clinical evaluation and treatment practices between eyecare professionals in India and Australasia. Overall, practitioners in Australia and New Zealand were more evidence-based in their investigation and management. However, in both regions, interprofessional differences in perceived optimal treatment duration and frequency were reported.

People's judgments of humans and robots in a classic moral dilemma.

How do ordinary people evaluate robots that make morally significant decisions? Previous work has found both equal and different evaluations, and different ones in either direction. In 13 studies (N = 7670), we asked people to evaluate humans and robots that make decisions in norm conflicts (variants of the classic trolley dilemma). We examined several conditions that may influence whether moral evaluations of human and robot agents are the same or different: the type of moral judgment (norms vs. blame); the structure of the dilemma (side effect vs. means-end); salience of particular information (victim, outcome); culture (Japan vs. US); and encouraged empathy. Norms for humans and robots are broadly similar, but blame judgments show a robust asymmetry under one condition: Humans are blamed less than robots specifically for inaction decisions-here, refraining from sacrificing one person for the good of many. This asymmetry may emerge because people appreciate that the human faces an impossible decision and deserves mitigated blame for inaction; when evaluating a robot, such appreciation appears to be lacking. However, our evidence for this explanation is mixed. We discuss alternative explanations and offer methodological guidance for future work into people's moral judgment of robots and humans.

Psychological Aspects of Nerve Gap Reconstruction: Addressing Patient Perspectives and Expectations.

Purpose: Preoperative expectations play a major role in determining patient satisfaction after surgery. The aim of this study was to characterize patient's preoperative expectations and postoperative perceptions of nerve gap repair surgery. Methods: We conducted a search of Embase, Scopus, and Web of Science databases for peer-reviewed articles that studied patient expectations, perceptions, and impressions of nerve gap repair in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies related to lumbar plexus radiculopathy, reimplantation, or patient satisfaction scores without patient testimony were excluded. Primary and secondary outcomes were patient's preoperative expectations and postoperative perceptions of nerve gap repair surgery, respectively. Results: We included 11 studies evaluating a total of 462 patients. One study evaluated only patient expectations, six studies evaluated only patient perspectives, and four studies evaluated both. Patients were generally overly optimistic in their expectations of surgery. Postoperative satisfaction ranged from 82% to 86%, and 81% to 87% of patients would choose to undergo their surgery again knowing what they know now. Conclusions: Patient expectations in nerve gap repair are optimistic, and at times unrealistic. Patient satisfaction with nerve gap repair is high and subject to influence from preoperative education and postoperative outcomes of functional and sensory recovery. Clinical relevance: Surgeons should be aware that patient expectations of their postoperative outcomes can have substantial impacts on their perceived management and overall satisfaction. More emphasis should be placed on preoperative education and expectation management to optimize patient satisfaction.

Designing an Intervention to Improve Medication Safety for Nursing Home Residents Based on Experiential Knowledge Related to Patient Safety Culture at the Nursing Home Front Line: Cocreative Process Study.

BACKGROUND: Despite years of attention, avoiding medication-related harm remains a global challenge. Nursing homes provide essential health care for frail older individuals, who often experience multiple chronic diseases and polypharmacy, increasing their risk of medication errors. Evidence of effective interventions to improve medication safety in these settings is inconclusive. Focusing on patient safety culture is a potential key to intervention development as it forms the foundation for overall patient safety and is associated with medication errors. OBJECTIVE: This study aims to develop an intervention to improve medication safety for nursing home residents through a cocreative process guided by integrated knowledge translation and experience-based codesign. METHODS: This study used a cocreative process guided by integrated knowledge translation and experience-based co-design principles. Evidence on patient safety culture was used as an inspirational source for exploration of medication safety. Data collection involved semistructured focus groups to generate experiential knowledge (stage 1) to inform intervention design in a multidisciplinary workshop (stage 2). Research validation engaging different types of research expertise and municipal managerial representatives in finalizing the intervention design was essential. Acceptance of the final intervention for evaluation was aimed for through contextualization focused on partnership with a municipal advisory board. An abductive, rapid qualitative analytical approach to data analysis was chosen using elements from analyzing in the present, addressing the time-dependent, context-bound aspects of the cocreative process. RESULTS: Experiential knowledge was represented by three main themes: (1) closed systems and gaps between functions, (2) resource interpretation and untapped potential, and (3) community of medication safety and surveillance. The main themes informed the design of preliminary intervention components in a multidisciplinary workshop. An intervention design process focused on research validation in addition to contextualization resulted in the Safe Medication in Nursing Home Residents (SAME) intervention covering (1) campaign material visualizing key roles and responsibilities regarding medication for nursing home residents and (2) "Medication safety reflexive spaces" focused on social and health care assistants. CONCLUSIONS: The cocreative process successfully resulted in the multifaceted SAME intervention, grounded in lived experiences shared by some of the most important (but often underrepresented in research) stakeholders: frontline health care professionals and representatives of nursing home residents. This study brought attention toward closed systems related to functions in medication management and surveillance, not only informing the SAME intervention design but as opportunities for further exploration in future research. Evaluation of the intervention is an important next step. Overall, this study represents an important contribution to the complex field of medication safety. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/43538.

Systematic literature review of asthma biologic self-administration enhanced by a patient perspective.

Background: Several biologics for the treatment of severe asthma are available as self-administration devices. Objective: We performed a systematic literature review to understand the use, benefits, and challenges of these self-administration devices. Methods: Electronic databases and conference proceedings were searched using terms for asthma, biologic treatment, and at-home/self-administration (GSK study 213094). Publications were scanned for relevance using prespecified Population, Intervention, Comparison, Outcomes, Study Design (PICOS) criteria. Data on efficacy, safety, patient experience, and economic outcomes were extracted; study quality was assessed. A firsthand patient perspective was obtained. Results: Thirty-five of 504 records met the inclusion criteria. Across four phase 3 studies, ≥95% of biologic self-administrations were successful on the basis of predefined criteria. At-home self-administration was preferred over in-clinic administration by 43-96% of patients across 5 studies. Most patients (≥89%) in two phase 3 studies reported completing self-administration easily without repeated reference to instructions; high proportions of patients (≥98%) were confident in their ability to self-administer their biologic, and ≥96% rated it as extremely, very or moderately easy to self-administer. Across 16 studies reporting efficacy data, there was evidence of reduced blood eosinophil counts and improved asthma control with biologic self-administration, with improved health-related quality of life shown across 6 studies. Economic outcomes data were limited. From a patient perspective, autonomy is the major benefit of self-administration. Conclusion: Although more evidence is needed, this systematic literature review provides consistent evidence of high injection success rates and, supported by a patient perspective, preference for self-administration of biologics among patients with severe asthma.

Mnemonically modulated perceptual processing to represent allocentric space in macaque inferotemporal cortex.

To encode allocentric space information of a viewing object, it is important to relate perceptual information in the first-person perspective to the representation of an entire scene which would be constructed before. A substantial number of studies investigated the constructed scene information (e.g., cognitive map). However, only few studies have focused on its influence on perceptual processing. Therefore, we designed a visually guided saccade task requiring monkeys to gaze at objects in different locations on different backgrounds clipped from large self-designed mosaic pictures (parental pictures). In each trial, we presented moving backgrounds prior to object presentations, indicating a frame position of the background image on a parental picture. We recorded single-unit activities from 377 neurons in the posterior inferotemporal (PIT) cortex of two macaques. Equivalent numbers of neurons showed space-related (119 of 377) and object-related (125 of 377) information. The space-related neurons coded the gaze locations and background images jointly rather than separately. These results suggest that PIT neurons represent a particular location within a particular background image. Interestingly, frame positions of background images on parental pictures modulated the space-related responses dependently on parental pictures. As the frame positions could be acquired by only preceding visual experiences, the present results may provide neuronal evidence of a mnemonic effect on current perception, which might represent allocentric object location in a scene beyond the current view.

Social perspective-taking influences on metacognition.

We often effortlessly take the perceptual perspective of others: we represent some aspect of the environment that others currently perceive. However, taking someone's perspective can interfere with one's perceptual processing: another person's gaze can spontaneously affect our ability to detect stimuli in a scene. But it is still unclear whether our cognitive evaluation of those judgements is also affected. In this study, we investigated whether social perspective-taking can influence participants' metacognitive judgements about their perceptual responses. Participants performed a contrast detection task with a task-irrelevant avatar oriented either congruently or incongruently to the stimulus location. By "blindfolding" the avatar, we tested the influence of social perspective-taking versus domain-general directional orienting. Participants had higher accuracy and perceptual sensitivity with a congruent avatar regardless of the blindfold, suggesting a directional cueing effect. However, their metacognitive efficiency was modulated only by the congruency of a seeing avatar. These results suggest that perceptual metacognitive ability can be socially enhanced by sharing perception of the same objects with others.

Benefits beyond health in the willingness to pay for a quality-adjusted life-year.

Adopting a societal perspective in cost-effectiveness analysis (CEA) requires including all societal costs and benefits even if they fall outside of the realm of health and healthcare. While some benefits are not explicitly included, they might be implicitly included when people value quality-adjusted life-years (QALYs) in monetary terms. An example is utility of consumption (UoC) which has played a crucial role in discussions regarding the welfare economic underpinnings of CEA. This study investigates whether people consider elements beyond health when valuing QALYs monetarily and the influence of inclusion on this value. A Willingness to Pay (WTP) experiment was administered among the general public in which people were asked to assign monetary values to QALYs. Our results show that (stated) UoC increases with quality of life but that instructing people to consider UoC does not impact their monetary valuation of the QALY. Furthermore, many respondents consider elements beyond health when valuing QALYs but the impact on the monetary value of a QALY is limited. These findings suggest that these elements are currently not (adequately) captured in CEA. Findings also illustrate that it is difficult to isolate health from non-health benefits and to consistently capture these in CEA. With that, reconciling CEA with welfare economics remains challenging.

A new perspective on tumor progression: Evolution via selection for function.

Tumorigenesis is commonly attributed to Darwinian processes involving natural selection among cells and groups of cells. However, progressing tumors are those that also achieve an appropriate group phenotypic composition (GPC). Yet, the selective processes acting on tumor GPCs are distinct from that associated with classical Darwinian evolution (i.e. natural selection based on differential reproductive success) as tumors are not genuine evolutionary individuals and do not exhibit heritable variation in fitness. This complex evolutionary scenario is analogous to the recently proposed concept of 'selection for function' invoked for the evolution of both living and non-living systems. Therefore, we argue that it is inaccurate to assert that Darwinian processes alone account for all the aspects characterizing tumorigenesis and cancer progression; rather, by producing the genetic and phenotypic diversity required for creating novel GPCs, these processes fuel the evolutionary success of tumors that is dependent on selection for function at the tumor level.

In vivo Multi-perspective 3D + t Ultrasound Imaging and Motion Estimation of Abdominal Aortic Aneurysms.

Time-resolved three-dimensional ultrasound (3D + t US) is a promising imaging modality for monitoring abdominal aortic aneurysms (AAAs), providing their 3D geometry and motion. The lateral contrast of US is poor, a well-documented drawback which multi-perspective (MP) imaging could resolve. This study aims to show the feasibility of in vivo multi-perspective 3D + t ultrasound imaging of AAAs for improving the image contrast and displacement accuracy. To achieve this, single-perspective (SP) aortic ultrasound images from three different angles were spatiotemporally registered and fused, and the displacements were compounded. The fused MP had a significantly higher wall-lumen contrast than the SP images, for both patients and volunteers (P < .001). MP radial displacements patterns are smoother than SP patterns in 67% of volunteers and 92% of patients. The MP images from three angles have a decreased tracking error (P < .001 for all participants), and an improved SNRe compared to two out of three SP images (P < .05). This study has shown the added value of MP 3D + t US, improving both image contrast and displacement accuracy in AAA imaging. This is a step toward using multiple or large transducers in the clinic to capture the 3D geometry and strain more accurately, for patient-specific characterization of AAAs.

Comparing self-other distinction across motor, cognitive and affective domains.

The self-other distinction (SOD) is a process by which humans disentangle self from other-related mental representations. This online study investigated two unresolved questions: (i) whether partially the same processes underpin SOD for motor, cognitive and affective representations, and (ii) whether SOD overlaps with domain-general cognitive control processes. Participants (N = 243) performed three SOD tasks (motor: automatic imitation inhibition (AIT); cognitive: visual perspective-taking (VPT); affective: emotional egocentricity bias (av-EEB) tasks) and two cognitive control tasks (Stroop and stop-signal reaction time (SSRT) tasks). Correlation analyses showed no associations among the motor, cognitive and affective SOD indexes. Similarly, distinct SOD clusters emerged in the hierarchical clustering dendrogram, indicating clear separations among SODs. However, the results of multidimensional scaling suggested a tendency towards two clusters, as evidenced by the proximity of AIT and VPT indexes in relation to EEB indexes. AIT spatial laterality and Stroop domain-general cognitive control confounded AIT and VPT indexes, albeit slightly differently depending on the analysis method used. SSRT showed neither associations with SODs nor with other domain-general indexes. These findings underscore the complexity of SOD processes and have notable implications for basic and applied research, e.g. in the domain of clinical disorders affected by deficiencies in SOD.

The dorsomedial prefrontal cortex promotes self-control by inhibiting the egocentric perspective.

The dorsomedial prefrontal cortex (dmPFC) plays a crucial role in social cognitive functions, including perspective-taking. Although perspective-taking has been linked to self-control, the mechanism by which the dmPFC might facilitate self-control remains unclear. Using the multimodal neuroimaging dataset from the Human Connectome Project (Study 1, N =978 adults), we established a reliable association between the dmPFC and self-control, as measured by discounting rate-the tendency to prefer smaller, immediate rewards over larger, delayed ones. Experiments (Study 2, N = 36 adults) involving high-definition transcranial direct current stimulation showed that anodal stimulation of the dmPFC reduces the discounting of delayed rewards and decreases the congruency effect in egocentric but not allocentric perspective in the visual perspective-taking tasks. These findings suggest that the dmPFC promotes self-control by inhibiting the egocentric perspective, offering new insights into the neural underpinnings of self-control and perspective-taking, and opening new avenues for interventions targeting disorders characterized by impaired self-regulation.

Provider costs of treating opioid dependence with extended-release buprenorphine in Australia.

INTRODUCTION: The costs of providing medication-assisted treatment for opioid dependence can determine its scale of provision. To provide estimates of the costs of extended-release buprenorphine (BUP-XR), we performed a bottom-up costing analysis of provider operational treatment costs. METHODS: Data were collected in a single-arm open label trial of BUP-XR injections conducted in specialist public drug treatment services and primary care private practices in three Australian states (the CoLAB study). The unit costs of resources used for each activity were combined with quantities used at each participating facility to arrive at the average annual cost per client. RESULTS: One hundred participants across the six health facility sites received monthly subcutaneous BUP-XR injections administered by a health-care practitioner. The average cost of providing 1 year of treatment per participant was $6656 ($6026-$8326). Screening cost (initial assessment and medical history) was $282 while monthly follow-up appointments cost $531 per client. The main cost driver was the monthly treatment costs accounting for 79% of the average annual client cost, with medication costs comprising 95% of this cost. DISCUSSION AND CONCLUSION: With medication costs making up the largest proportion of treatment costs, treatment using BUP-XR has the potential to free up other health system resources, for example, staff time. The costs reported in this study can be used in an economic evaluation to estimate the net benefit or cost-effectiveness of BUP-XR especially when compared to other opioid agonist treatments.

The Cue-Response Mental Link: Its Critical Role in the Downregulation of Disgust by Perspective Taking Implementation Intention.

Implementation intentions are if-then plans that create a mental link between a situational cue and a goal-directed response that people can form to help them achieve emotion regulation goals more effectively. The main goal of this study was to determine if forming the goal intention to not get disgusted together with a perspective taking implementation intention is more effective than forming the goal intention to not get disgusted that spells out the same perspective taking strategy but without linking it to the cue. Eighty-six female participants viewed disgusting, neutral, and pleasant pictures under four instructions: no emotion regulation instructions (CG), the goal intention to not get disgusted (GI), this goal intention furnished with the perspective taking regulation strategy (GI-PT), and this goal intention in tandem with the perspective taking implementation intention (PT-II). Compared with CG, GI, and GI-PT participants, PT-II participants showed a significantly larger decrease in disgust when seeing the disgusting pictures. This effect remained constant across repeated exposure to the critical contents and was larger among individuals who did not consciously try to reappraise the disgusting pictures than among individuals who consciously tried to reappraise them. Valence rating, arousal rating, and sympathetic activity did not significantly differ between conditions. We conclude that it is the if(situational cue)-then(goal-directed response) link created by forming the perspective taking implementation intention that accounts for the positive effect on disgust and not simply the information about the perspective taking behavior to adopt.

Between Public Guidelines for User Involvement and Ideals About Free Research: Using Collaborative Autoethnography to Explore Researcher Experiences From a User Involvement Process.

BACKGROUND AND AIM: User participation is a prerequisite for receiving research funding in healthcare in Norway. Despite many positive benefits, studies report challenges from users' and researchers' perspectives. Limited knowledge exists concerning researchers' experiences in scenarios where the users are professionals within healthcare and research. The aim of this retrospective study was to explore and reflect on personal experiences as researchers from a process of planning and developing research questions for a PhD project, following the James Lind Alliance guidelines, which were a requirement for funding. We focused on how the process of collaboration with a specific group of users influenced the researchers' sense of selves. DESIGN AND METHOD: We used a qualitative design based on collaborative autoethnography, exploring personal experiences from a sociocultural point of view. Two of the three researchers in the team recollected their experiences from the user involvement process while applying the James Lind Alliance guidelines. We used different data sources to develop two autoethnographic narratives. The narratives were analysed using thematic analysis. RESULTS: The autoethnographic narratives demonstrate the complexity of user involvement from the researchers' perspectives. We identified four themes in the analysis: intrinsic and extrinsic motivation, competing paradigms, hierarchy and dual roles. The accounts illustrated the researchers' ambivalence within the process, indicating that they feared a loss of control over the direction of the research project. The narratives visualised a struggle to appear as credible researchers, illustrating how the involvement of a specific group of users and adherence to a specific guideline for user involvement influenced the researchers' experiences of their roles and identities in the collaboration. CONCLUSION: The results point to the relevance of the sociocultural backdrop; researchers might become frontline providers of policy implementation in research, balancing tensions between regulatory constraints, user involvement and researchers' professional identity and research ideals, when a specific, detailed procedure for user involvement is required. PATIENT OR PUBLIC CONTRIBUTION: Two user panels comprising participants from clinical practice, education and research, along with a service user, collaborated in the planning and development of research questions for a PhD project. This autoethnographic study elaborates this process.

mHealth Apps for Hypertension Self-Management: Interview Study Among Patient-Users.

BACKGROUND: Hypertension is a major risk factor for cardiovascular disease, affecting over a billion people worldwide. Mobile health (mHealth) apps have emerged as effective tools for managing hypertension, offering capabilities for monitoring blood pressure, fostering lifestyle changes, and improving treatment adherence. OBJECTIVE: This study aimed to explore patient-users' perspectives on the hypertension care mHealth app Hypertension.APP, focusing on its accessibility, expected benefits, potential risks, and role in hypertension management in Germany. METHODS: A qualitative study was conducted involving semistructured interviews with 20 patient-users of a hypertension care mHealth app, Hypertension.APP. Participants were recruited between January and June 2023 using purposive sampling. Verbatim transcripts were analyzed using qualitative content analysis. RESULTS: Participants primarily discovered the app independently, driven by recent hypertension diagnoses and insufficient information from health care professionals regarding effective self-management strategies for their blood pressure. They valued the app for its continuous monitoring and feedback capabilities, aiding in understanding their condition and making lifestyle adjustments. Risks were perceived as minimal, mainly concerning data privacy and potential overreliance on the app. The app became integral to patient-users' hypertension management by offering consistent information and support. The integration into formal health care was limited, as patient-users felt that health care professionals did not accept the use of the technology or might have even felt intimidated to use it. CONCLUSIONS: Among the sample studied, mHealth apps like Hypertension.APP were valued for their continuous monitoring and educational content, aiding in hypertension management. The findings suggest potential benefits of mHealth apps for effective hypertension care among patients who are health- and digitally literate as well as self-effective. There is a critical need for better integration of these apps into routine health care practices, as perceived by the app users. Given the small and specific sample of this qualitative study, further quantitative research with a broader and more varied participant group is necessary to validate these findings. TRIAL REGISTRATION: Deutsches Register Klinischer Studien DRKS00029761; https://tinyurl.com/r33ru22s.

User Requirements for an Electronic Patient Recruitment System: Semistructured Interview Analysis After First Implementation in 3 German University Hospitals.

BACKGROUND: Clinical trials are essential for medical research and medical progress. Nevertheless, trials often fail to reach their recruitment goals. Patient recruitment systems aim to support clinical trials by providing an automated search for eligible patients in the databases of health care institutions like university hospitals. To integrate patient recruitment systems into existing workflows, previous works have assessed user requirements for these tools. In this study, we tested patient recruitment systems KAS+ and recruIT as part of the MIRACUM (Medical Informatics in Research and Care in University Medicine) project. OBJECTIVE: Our goal was to investigate whether and to what extent the 2 different evaluated tools can meet the requirements resulting from the first requirements analysis, which was performed in 2018-2019. A user survey was conducted to determine whether the tools are usable in practice and helpful for the trial staff. Furthermore, we investigated whether the test phase revealed further requirements for recruitment tools that were not considered in the first place. METHODS: We performed semistructured interviews with 10 participants in 3 German university hospitals who used the patient recruitment tools KAS+ or recruIT for at least 1 month with currently recruiting trials. Thereafter, the interviews were transcribed and analyzed by Meyring method. The identified statements of the interviewees were categorized into 5 groups of requirements and sorted by their frequency. RESULTS: The evaluated recruIT and KAS+ tools fulfilled 7 and 11 requirements of the 12 previously identified requirements, respectively. The interviewed participants mentioned the need for different notification schedules, integration into their workflow, different patient characteristics, and pseudonymized screening lists. This resulted in a list of new requirements for the implementation or enhancement of patient recruitment systems. CONCLUSIONS: Trial staff report a huge need of support for the identification of eligible trial participants. Moreover, the workflows in patient recruitment differ across trials. For better suitability of the recruitment systems in the workflow of different kinds of trials, we recommend the implementation of an adjustable notification schedule for screening lists, a detailed workflow analysis, broad patient filtering options, and the display of all information needed to identify the persons on the list. Despite criticisms, all participants confirmed to use the patient recruitment systems again.