Corrigendum: Usability, feasibility, and effect of a biocueing intervention in addition to a moderated digital social therapy-platform in young people with emerging mental health problems: a mixed-method approach.

[This corrects the article DOI: 10.3389/fpsyt.2022.871813.].

The Effects of a Digital, Transdiagnostic, Clinically and Peer-Moderated Treatment Platform for Young People With Emerging Mental Health Complaints: Repeated Measures Within-Subjects Study.

BACKGROUND: To address the growing prevalence of youth mental health problems, early intervention is crucial to minimize individual, societal, and economic impacts. Indicative prevention aims to target emerging mental health complaints before the onset of a full-blown disorder. When intervening at this early stage, individuals are more responsive to treatment, resulting in cost-effective outcomes. The Moderated Online Social Therapy platform, which was successfully implemented and proven effective in Australia, is a digital, peer- and clinically moderated treatment platform designed for young people. The Netherlands was the first country outside Australia to implement this platform, under the name Engage Young People Early (ENYOY). It has the potential to reduce the likelihood of young people developing serious mental health disorders. OBJECTIVE: This study aims to investigate the effects on young people using the ENYOY-platform in relation to psychological distress, psychosocial functioning, and positive health parameters. METHODS: Dutch-speaking young people with emerging mental health complaints (N=131) participated in the ENYOY-platform for 6 months in a repeated measures within-subjects study. Psychological distress, psychosocial functioning, and positive health parameters were assessed at baseline and 3, 6, and 12 months. Repeated measures ANOVA was conducted and adjusted for age, sex, therapy, and community activity. The Reliable Change Index and Clinically Significant Index were computed to compare the baseline with the 6- and 12-month measurements. The missing data rate was 22.54% and the dropout rate 62.6% (82/131). RESULTS: The primary analysis (77/131, 58.8%) showed that psychological distress decreased and psychosocial functioning improved over time with large effect sizes (P<.001 in both cases; ηp2=0.239 and 0.318, respectively) independent of age (P=.76 for psychological distress and P=.48 for psychosocial functioning), sex (P=.24 and P=.88, respectively), therapy activity (P=.49 and P=.80, respectively), or community activity (P=.59 and P=.48, respectively). Similarly, secondary analyses (51/131, 38.9%) showed significant effects of time on the quality of life, well-being, and meaningfulness positive health parameters (P<.05; ηp2=0.062, 0.140, and 0.121, respectively). Improvements in all outcome measures were found between baseline and 3 and 6 months (P≤.001-.01; d=0.23-0.62) and sustained at follow-up (P=.18-.97; d=0.01-0.16). The Reliable Change Index indicated psychological distress improvements in 38% (39/102) of cases, no change in 54.9% (56/102) of cases, and worsening in 5.9% (6/102) of cases. Regarding psychosocial functioning, the percentages were 50% (51/102), 43.1% (44/102), and 6.9% (7/102), respectively. The Clinically Significant Index demonstrated clinically significant changes in 75.5% (77/102) of cases for distress and 89.2% (91/102) for functioning. CONCLUSIONS: This trial demonstrated that the ENYOY-platform holds promise as a transdiagnostic intervention for addressing emerging mental health complaints among young people in the Netherlands and laid the groundwork for further clinical research. It would be of great relevance to expand the population on and service delivery of the platform. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12888-021-03315-x.

Expert appraisal and prioritization of barriers to mHealth use for older adults living with Alzheimer's disease and related Dementias: A Delphi study.

INTRODUCTION: Older adults living with Alzheimer's disease and related dementias (ADRD) can benefit from mHealth innovations in (daily) care. However, successful implementation and adoption of such innovations can be hindered by a lack of inclusive design. Inclusive design can be challenging, due to the variety of ADRD- and aging-related symptoms that can pose barriers to using mHealth. Previously, a literature-based model with 53 barriers to mHealth use for this population has been developed ("MHealth for OLder adults living with DEMentia - USability" or MOLDEM-US). In this study, we aim to prioritize these through a Delphi study with ADRD experts (case managers, informal caregivers, hospital healthcare professionals, district nurses, and researchers). METHODS: In the first round, participant characteristics and potentially new insights into barriers to mHealth use for older adults living with ADRD were gathered. The consensus questionnaire was submitted in the second round, containing barriers to mHealth use for this population (from MOLDEM-US) with questions inquiring its impact and frequency. In the third round, participants rejudged those barriers for which no consensus (<51 %) or minor consensus (51 % - 60 %) was reached. RESULTS: Thirty-seven participants completed the three rounds of the study. Consensus was reached for eleven barriers after the second round, all having major impact and frequency: integration of functions during daily activities, perceived complexity, efficiency in seeing benefits, trust in own ability, restlessness and agitation, computer literacy, self confidence in using wearables, learnability, working memory, and visual acuity. CONCLUSION: After round three, consensus was achieved for all 53 barriers. Twenty-six barriers are considered to majorly affect mHealth use, most of which relate to cognition and frame of mind. This study contributes to the development of mHealth design guidelines that take into account the progressive and diverse ADRD- and aging-related symptoms negatively affecting mHealth implementation and adoption.

Usability, Feasibility, and Effect of a Biocueing Intervention in Addition to a Moderated Digital Social Therapy-Platform in Young People With Emerging Mental Health Problems: A Mixed-Method Approach.

Introduction: To optimize treatment, it is of utmost importance to take into account the myriad of biological, social, and psychological changes that young people go through during adolescence which make them more vulnerable for developing mental health problems. Biocueing, a non-invasive method to transform physiological parameters into an observable signal, could strengthen stress- and emotion regulation by cueing physiologically unusual values in daily life. The aim of this study is to investigate the usability, feasibility, and exploratory effect of biocueing in addition to ENgage YOung people earlY (ENYOY), a moderated digital social therapy-platform, in young people with emerging mental health complaints. Methods: A user-centered mixed-method design was used. A focus group was conducted to optimize the ENYOY-platform and biocueing intervention. Biocueing was operationalized by a smartwatch and the Sense-IT app. A within-subjects design was used; 10 days for all participants 'biofeedback off' (control), followed by 10 days 'biofeedback on' (experimental). Emotional awareness and perceived stress were measured using ecological momentary assessment. Eight individuals participated. User-friendliness, usability, and acceptance were assessed using a qualitative design. Results: Findings from the focus group resulted in several adaptations of the biocueing intervention to the ENYOY-platform and vice versa. The average measurement compliance rate was 78.8%. Level-one findings showed different individual effects on perceived stress and emotional awareness. Level-two analyses showed no overall effects on perceived stress (B = -0.020, p = 0.562) and overall positive effects on emotional awareness (B = 0.030, p = 0.048) with small effect sizes (Improvement Rate Difference = 0.05-0.35). The intervention was found to be acceptable and showed moderate usability. Participants indicated they experienced improvements in reflection on feelings and changes in behavior, such as pausing and evaluating the situation. Conclusion: These preliminary results show that biocueing could be a promising addition to digital treatment platforms and help young people become more emotionally aware. Improvements should be made regarding the usability and acceptability of the smartwatch, as well as more extensive integration of the biocueing intervention with a digital treatment platform. It would be relevant to gain a better understanding of which individuals would benefit most from an additional biocueing intervention.

Late Mortality in Childhood Cancer Survivors according to Pediatric Cancer Diagnosis and Treatment Era in the Dutch LATER Cohort.

This multi-center cohort-study examined late mortality among 6,165 Dutch five-year childhood cancer survivors diagnosed 1963-2001. Clinical details and cause of death were based on medical records. Mortality was 12-fold that of the general population, with 51.3 additional deaths per 10,000 person-years (21.9 yrs median follow-up). Cumulative mortality 15 yrs post-diagnosis was 6.9%, predominantly from late recurrences; thereafter the absolute contribution of other health outcomes increased. Cumulative all-cause and recurrence-related mortality were highest for Central Nervous System and bone tumor survivors. All-cause, but not subsequent tumor and circulatory disease-related cumulative mortality, was highest for patients diagnosed 1963-1979 vs. later (p-trend <0.001).

Moderated digital social therapy for young people with emerging mental health problems: A user-centered mixed-method design and usability study.

Introduction: Over 25% of Dutch young people are psychologically unhealthy. Individual and societal consequences that follow from having mental health complaints at this age are substantial. Young people need care which is often unavailable. ENgage YOung people earlY (ENYOY) is a moderated digital social therapy-platform that aims to help youngsters with emerging mental health complaints. Comprehensive research is being conducted into the effects and to optimize and implement the ENYOY-platform throughout the Netherlands. The aim of this study is to explore the usability and user experience of the ENYOY-platform. Methods: A user-centered mixed-method design was chosen. 26 young people aged 16-25 with emerging mental health complaints participated. Semi-structured interviews were conducted to explore usability, user-friendliness, impact, accessibility, inclusivity, and connection (Phase 1). Phase 2 assessed usability problems using the concurrent and retrospective Think Aloud-method. User experience and perceived helpfulness were assessed using a 10-point rating scale and semi-structured interviews (Phase 3). The Health Information Technology Usability Evaluation Scale (Health-ITUES; Phase 1) and System Usability Scale (SUS; Phase 2 and 3) were administered. Qualitative data was analyzed using thematic analysis. Task completion rate and time were tracked and usability problems were categorized using the Nielsen's rating scale (Phase 2). Results: Adequate to high usability was found (Phase 1 Health-ITUES 4.0(0.34); Phase 2 SUS 69,5(13,70); Phase 3 SUS 71,6(5,63)). Findings from Phase 1 (N = 10) indicated that users viewed ENYOY as a user-friendly, safe, accessible, and inclusive initiative which helped them reduce their mental health complaints and improve quality of life. Phase 2 (N = 10) uncovered 18 usability problems of which 5 of major severity (e.g. troubles accessing the platform). Findings from Phase 3 (N = 6) suggested that users perceived the coaching calls the most helpful [9(0.71)] followed by the therapy content [6.25(1.41)]. Users liked the social networking aspect but rated it least helpful [6(2.1)] due to inactivity. Conclusion: The ENYOY-platform has been found to have adequate to high usability and positive user experiences were reported. All findings will be transferred to the developmental team to improve the platform. Other evaluation methods and paring these with quantitative outcomes could provide additional insight in future research.

Erratum: Barsasella et al. Sleep Quality among Breast and Prostate Cancer Patients: A Comparison between Subjective and Objective Measurements. Healthcare 2021, 9, 785.

The authors wish to make the following erratum to this paper [...].

Sleep Quality among Breast and Prostate Cancer Patients: A Comparison between Subjective and Objective Measurements.

Breast and prostate cancer patients may experience physical and psychological distress, and a possible decrease in sleep quality. Subjective and objective methods measure different aspects of sleep quality. Our study attempted to determine differences between objective and subjective measurements of sleep quality using bivariate and Pearson's correlation data analysis. Forty breast (n = 20) and prostate (n = 20) cancer patients were recruited in this observational study. Participants were given an actigraphy device (ACT) and asked to continuously wear it for seven consecutive days, for objective data collection. Following this period, they filled out the Pittsburgh Sleep Quality Index Questionnaire (PSQI) to collect subjective data on sleep quality. The correlation results showed that, for breast cancer patients, PSQI sleep duration was moderately correlated with ACT total sleeping time (TST) (r = -0.534, p < 0.05), and PSQI daytime dysfunction was related to ACT efficiency (r = 0.521, p < 0.05). For prostate cancer patients, PSQI sleep disturbances were related to ACT TST (r = 0.626, p < 0.05). Both objective and subjective measurements are important in validating and determining details of sleep quality, with combined results being more insightful, and can also help in personalized care to further improve quality of life among cancer patients.

Online Indicated Preventive Mental Health Interventions for Youth: A Scoping Review.

Objective: Between the ages of 12 and 25 the onset of mental disorders typically occurs, and the burden of mental health problems is greatest for this group. Indicated preventive interventions to target individuals with subclinical symptoms to prevent the transition to clinical levels of disorders have gained considerable traction. However, the threshold to seek help appears to be high even when help is needed. Online interventions could offer a solution, especially during the COVID-19 pandemic. This scoping review will present an overview of the recent research of indicated online preventive interventions for youth (12-25 years) experiencing the early stages of mental health complaints with the aim of identifying the nature and extent of the research evidence. Methods: The 5-stage framework by Arksey and O'Malley was used. Academic literature published from 2013 onwards in printed or electronic format was included from Scopus, PsychINFO, and Ovid MEDLINE(R) ALL. Results: The search yielded 11,122 results, with the final selection resulting in inclusion of 30 articles for this review. In total, the articles included 4,950 participants. 26.7% of the selected articles focused on youth between 12 and 25 years. Of the articles 60% did not screen for, nor exclude participants with clinical levels of symptoms. Most studies used a common evidence-based therapy for the disorder-category targeted. More than half of the online interventions included some form of human support. Adherence levels ranged between 27.9 and 98%. The results indicate general effectiveness, usability and acceptability of online indicated preventive interventions. The most commonly used approach was CBT (n = 12 studies). Studies varied in their size, rigor of study, effectiveness and outcome measures. Online interventions with a combination of clinical and peer moderation (n = 3 studies) appear to result in the most stable and highest effect sizes. Conclusion: Online indicated preventive mental health interventions for youth with emerging mental health issues show promise in reducing various mental health complaints, and increasing positive mental health indicators such as well-being and resilience. Additionally, high levels of usability and acceptability were found. However, the included studies show important methodological shortcomings. Also, the research has mainly focused on specific diagnostic categories, meaning there is a lack of transdiagnostic approaches. Finally, clear definitions of- as well as instruments to measure- emerging or subclinical mental health symptoms in youth remain are missing.

Considerate mHealth design for older adults with Alzheimer's disease and related dementias (ADRD): A scoping review on usability barriers and design suggestions.

BACKGROUND: The number of older adults with Alzheimer's disease and related dementias (ADRD) is increasing worldwide. This offers ample opportunities for mobile health (mHealth) apps, for example to support them in performing daily activities or monitoring their health status. However, how to design these apps taking into consideration ADRD related barriers remains a challenge. OBJECTIVE: To provide a synthesis of mHealth usability barriers of older adults with ADRD and design suggestions to enhance user-friendliness of mHealth apps. METHODS: We performed a scoping review of mHealth studies focused on older adults with ADRD and: (1) usability barriers experienced, and/or (2) implementation or design suggestions. PubMed, Medline, EMBASE, PsycINFO, and Web of Science were searched. Clinical and grey literature on ADRD diminishments was explored to identify potential barriers to using mHealth. Detected usability barriers caused by ADRD impairments were mapped onto the MOLD-US framework through validation, calibration, and adaption. MOLD-US was initially developed to provide an overview of barriers influencing mHealth usability for the general aging population. RESULTS: Title and abstract of 792 unique citations were scanned of which 69 were included for full text review. Fifteen studies matched inclusion criteria. In total 42 barriers were identified to influence mobile health use for older adults with ADRD. Twenty design suggestions were extracted from the studies. CONCLUSIONS: The identified usability barriers were classified in five categories: cognition, perception, physical ability, frame of mind, and speech- and language. In addition, the design suggestions were categorized as evidence- or expert-based. Evidence-based design suggestions include showing limited information, repeating instructions multiple times and breaking instructions into simple steps given one at a time. This research provides a first step for further collaboration between ADRD experts and designers to support the development of effective mHealth apps with high user-friendliness.

Smoking cessation among disadvantaged young women during and after pregnancy: Exploring the role of social networks.

OBJECTIVE: Smoking prevalence during and after pregnancy remains high among socioeconomically disadvantaged, European women. This research aims to gain insight into the role of social networks on smoking cessation among disadvantaged young women during and after pregnancy. DESIGN: Qualitative interview study. SETTING: Dutch preventive care program (VoorZorg). PARTICIPANTS: Disadvantaged young women during and after pregnancy (n = 17) who participated in a Dutch preventive care program, and members in their social networks (n = 4). METHODS: All qualitative interviews were recorded, transcribed, and analyzed by iterative coding processes. FINDINGS: Many women were not intrinsically motivated to quit smoking due to, amongst other factors, difficulties in their lives (e.g. domestic violence, psychosocial problems), limited supportive social networks, and a strong dependence on relatives who smoked. Women seemed to be prompted to smoke by smoking cues in their social networks, while distancing from smokers would lead to feelings of social exclusion. When attempting to stop smoking, women experienced little encouragement from their social networks, which instead often undermined their smoking cessation efforts. KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: The social networks of disadvantaged young women mostly had a negative role on their smoking cessation efforts. Our results emphasize the need to look at interventions that involve women's social networks, and explore novel opportunities, such as eHealth and mHealth applications so that these women can build supportive new social networks.

Best Practices for Designing Discrete Choice Experiments and the Use for Older Adults with Cognitive Impairment.

OBJECTIVE: the aim of this scoping review is to 1) identify guidelines, frameworks, issues, and recommendations regarding the development of a discrete choice experiment (DCE), 2) look at potential design considerations regarding the development of a DCE for older adults with dementia, and 3) summarize knowledge about the current inclusion of and experiences with older adults with cognitive impairment in DCE studies. METHODS: Two literature searches divided into two topics were performed in PubMed, CINAHL, and PsycINFO. RESULTS: Topic 1 found 19 articles regarding frameworks, guidelines and design considerations for DCEs in healthcare. Topic 2 found eight articles regarding the effect of cognitive impairment on DCE results and/or discussing the inclusion of cognitive impaired older adults in these DCE studies. CONCLUSION: There is minimal literature available regarding the effect of cognitive impairment on DCE results. In future studies we will explore if DCEs can be used to involve older adults with dementia in decisions regarding transitions in care.

The Value of Teledermoscopy to the Expertise of General Practitioners Diagnosing Skin Disorders Based on ICD-10 Coding.

Early recognition of skin cancer is vital to enhance patient outcomes. Teledermoscopy (TDsc), a telemedicine service, supports general practitioners (GPs) in gaining fast access to dermatologists' feedback to detect skin cancer. This study aimed to assess if GPs gain expertise in diagnosing skin disorders after continued use of TDsc, based on diagnosis classification by the International Statistical Classification of Diseases and Related Health Problems (ICD-10). A retrospective study was conducted on TDsc consultations sent by GPs to teledermatologists in the Netherlands (July 2015 - June 2018). GP sensitivity and confirmed cases in diagnosing skin disorders slightly increased over time. However, the total positive predictive value showed a decrease. In three years, 43 melanomas were diagnosed by the TD for which the GP did not provide a (correct) pre-diagnose. Though GPs appear to improve their expertise in skin disorder detection after continued TDsc use, TDsc remains imperative to early melanoma detection.

Barriers experienced by nurses providing smoking cessation support to disadvantaged, young women during and after pregnancy.

In Europe, smoking during and after pregnancy is still highly prevalent among socioeconomically disadvantaged women. Nurses caring for these women can play a key role in smoking cessation, but encounter many problems when providing support. This research aims to identify barriers in providing smoking cessation support, experienced by nurses working within a Dutch preventive care programme for disadvantaged young women (VoorZorg), and to understand the underlying reasons of these barriers. Sixteen semi-structured interviews with nurses were performed. All interviews were recorded, transcribed and analysed deductively and inductively. We found that the VoorZorg programme provided nurses with training, resources and time to deliver smoking cessation support. Yet, nurses experienced important barriers, such as unmotivated clients and support methods that do not fit clients' needs. Underlying reasons are competing care demands, unsatisfactory training for cessation support, lack of self-efficacy in attending their clients, and conflicts with own professional attitudes. The results emphasise that nurses' ability to provide smoking cessation support could be improved by proper training in interventions that fit their clients' needs, and by time schedules and task definitions that help them to prioritise smoking cessation support over other matters.

Is Teledermoscopy Improving General Practitioner Skin Cancer Care?

Skin cancer incidences have tripled in the Netherlands for the last twenty years and are expected to increase even more in the coming years. Teledermoscopy (TDsc) is implemented in Dutch practice to support and enhance early skin cancer detection by general practitioners (GPs) through remote consultation with dermatologists. This study assesses the effect of TDsc consultation on the quality and efficiency of skin cancer care in the primary setting by analyzing 10,184 TDsc consultations.

Obstacles to Successful Implementation of eHealth Applications into Clinical Practice.

eHealth can improve healthcare worldwide, and scientific research should provide evidence on the efficacy, safety and added value of such interventions. For successful implementation of eHealth interventions into clinical practice, barriers need to be anticipated. We identified seven barriers by interviewing health professionals in the Dutch healthcare system. These barriers covered three topics: financing, human factors and organizational factors. This paper discusses their potential impact on eHealth uptake. Bridging the gap between studies to assess effective eHealth interventions and their value-based implementation in healthcare is much needed.

Long-Term Risk of Subsequent Malignant Neoplasms After Treatment of Childhood Cancer in the DCOG LATER Study Cohort: Role of Chemotherapy.

Purpose Childhood cancer survivors (CCSs) are at increased risk for subsequent malignant neoplasms (SMNs). We evaluated the long-term risk of SMNs in a well-characterized cohort of 5-year CCSs, with a particular focus on individual chemotherapeutic agents and solid cancer risk. Methods The Dutch Childhood Cancer Oncology Group-Long-Term Effects After Childhood Cancer cohort includes 6,165 5-year CCSs diagnosed between 1963 and 2001 in the Netherlands. SMNs were identified by linkages with the Netherlands Cancer Registry, the Dutch Pathology Registry, and medical chart review. We calculated standardized incidence ratios, excess absolute risks, and cumulative incidences. Multivariable Cox proportional hazard regression analyses were used to evaluate treatment-associated risks for breast cancer, sarcoma, and all solid cancers. Results After a median follow-up of 20.7 years (range, 5.0 to 49.8 years) since first diagnosis, 291 SMNs were ascertained in 261 CCSs (standardized incidence ratio, 5.2; 95% CI, 4.6 to 5.8; excess absolute risk, 20.3/10,000 person-years). Cumulative SMN incidence at 25 years after first diagnosis was 3.9% (95% CI, 3.4% to 4.6%) and did not change noticeably among CCSs treated in the 1990s compared with those treated earlier. We found dose-dependent doxorubicin-related increased risks of all solid cancers ( Ptrend < .001) and breast cancer ( Ptrend < .001). The doxorubicin-breast cancer dose response was stronger in survivors of Li-Fraumeni syndrome-associated childhood cancers (leukemia, CNS, and non-Ewing sarcoma) versus survivors of other cancers ( Pdifference = .008). In addition, cyclophosphamide was found to increase sarcoma risk in a dose-dependent manner ( Ptrend = .01). Conclusion The results strongly suggest that doxorubicin exposure in CCSs increases the risk of subsequent solid cancers and breast cancer, whereas cyclophosphamide exposure increases the risk of subsequent sarcomas. These results may inform future childhood cancer treatment protocols and SMN surveillance guidelines for CCSs.

What is needed to implement a web-based audit and feedback intervention with outreach visits to improve care quality: A concept mapping study among cardiac rehabilitation teams.

INTRODUCTION: Evidence on successful quality improvement (QI) in health care requires quantitative information from randomized clinical trials (RCTs) on the effectiveness of QI interventions, but also qualitative information from professionals to understand factors influencing QI implementation. OBJECTIVE: Using a structured qualitative approach, concept mapping, this study determines factors identified by cardiac rehabilitation (CR) teams on what is needed to successfully implement a web-based audit and feedback (A&F) intervention with outreach visits to improve the quality of CR care. METHODS: Participants included 49 CR professionals from 18 Dutch CR centres who had worked with the A&F system during a RCT. In three focus group sessions participants formulated statements on factors needed to implement QI successfully. Subsequently, participants rated all statements for importance and feasibility and grouped them thematically. Multi dimensional scaling was used to produce a final concept map. RESULTS: Forty-two unique statements were formulated and grouped into five thematic clusters in the concept map. The cluster with the highest importance was QI team commitment, followed by organisational readiness, presence of an adequate A&F system, access to an external quality assessor, and future use and functionalities of the A&F system. CONCLUSION: Concept mapping appeared efficient and useful to understand contextual factors influencing QI implementation as perceived by healthcare teams. While presence of a web-based A&F system and external quality assessor were seen as instrumental for gaining insight into performance and formulating QI actions, QI team commitment and organisational readiness were perceived as essential to actually implement and carry out these actions. These two sociotechnical factors should be taken into account when implementing and evaluating the success of QI implementations in future research.

Effect of a web-based audit and feedback intervention with outreach visits on the clinical performance of multidisciplinary teams: a cluster-randomized trial in cardiac rehabilitation.

BACKGROUND: The objective of this study was to assess the effect of a web-based audit and feedback (A&F) intervention with outreach visits to support decision-making by multidisciplinary teams. METHODS: We performed a multicentre cluster-randomized trial within the field of comprehensive cardiac rehabilitation (CR) in the Netherlands. Our participants were multidisciplinary teams in Dutch CR centres who were enrolled in the study between July 2012 and December 2013 and received the intervention for at least 1 year. The intervention included web-based A&F with feedback on clinical performance, facilities for goal setting and action planning, and educational outreach visits. Teams were randomized either to receive feedback that was limited to psychosocial rehabilitation (study group A) or to physical rehabilitation (study group B). The main outcome measure was the difference in performance between study groups in 11 care processes and six patient outcomes, measured at patient level. Secondary outcomes included effects on guideline concordance for the four main CR therapies. RESULTS: Data from 18 centres (14,847 patients) were analysed, of which 12 centres (9353 patients) were assigned to group A and six (5494 patients) to group B. During the intervention, a total of 233 quality improvement goals was identified by participating teams, of which 49 (21%) were achieved during the study period. Except for a modest improvement in data completeness (4.5% improvement per year; 95% CI 0.65 to 8.36), we found no effect of our intervention on any of our primary or secondary outcome measures. CONCLUSIONS: Within a multidisciplinary setting, our web-based A&F intervention engaged teams to define local performance improvement goals but failed to support them in actually completing the improvement actions that were needed to achieve those goals. Future research should focus on improving the actionability of feedback on clinical performance and on addressing the socio-technical perspective of the implementation process. TRIAL REGISTRATION: NTR3251.

Optimizing the user interface of a data entry module for an electronic patient record for cardiac rehabilitation: A mixed method usability approach.

INTRODUCTION: Cumbersome electronic patient record (EPR) interfaces may complicate data-entry in clinical practice. Completeness of data entered in the EPR determines, among other things, the value of computerized clinical decision support (CCDS). Quantitative usability evaluations can provide insight into mismatches between the system design model of data entry and users' data entry behavior, but not into the underlying causes for these mismatches. Mixed method usability evaluation studies may provide these insights, and thus support generating redesign recommendations for improving an EPR system's data entry interface. AIM: To improve the usability of the data entry interface of an EPR system with CCDS in the field of cardiac rehabilitation (CR), and additionally, to assess the value of a mixed method usability approach in this context. METHODS: Seven CR professionals performed a think-aloud usability evaluation both before (beta-version) and after the redesign of the system. Observed usability problems from both evaluations were analyzed and categorized using Zhang et al.'s heuristic principles of good interface design. We combined the think-aloud usability evaluation of the system's beta-version with the measurement of a new usability construct: users' deviations in action sequence from the system's predefined data entry order sequence. Recommendations for redesign were implemented. We assessed whether the redesign improved CR professionals' (1) task efficacy (with respect to the completeness of data they collected), and (2) task efficiency (with respect to the average number of mouse clicks they needed to complete data entry subtasks). RESULTS: With the system's beta version, 40% of health care professionals' navigation actions through the system deviated from the predefined next system action. The causes for these deviations as revealed by the think-aloud method mostly concerned mismatches between the system design model for data entry action sequences and users expectations of these action sequences, based on their paper-based daily routines. This caused non completion of data entry tasks (31% of main tasks completed), and more navigation actions than minimally required (146% of the minimum required). In the redesigned system the data entry navigational structure was organized in a flexible way around an overview screen to better mimic users' paper-based daily routines of collecting patient data. This redesign resulted in an increased number of completed main tasks (70%) and a decrease in navigation actions (133% of the minimum required). The think-aloud usability evaluation of the redesigned system showed that remaining problems concerned flexibility (e.g., lack of customization options) and consistency (mainly with layout and position of items on the screen). CONCLUSION: The mixed method usability evaluation was supportive in revealing the magnitude and causes of mismatches between the system design model of data-entry with users' data entry behavior. However, as both task efficacy and efficiency were still not optimal with the redesigned EPR, we advise to perform a cognitive analysis on end users' mental processes and behavior patterns in daily work processes specifically during the requirements analysis phase of development of interactive healthcare information systems.