360-degree Delphi: addressing sociotechnical challenges of healthcare IT.

BACKGROUND: IT systems in the healthcare field can have a marked sociotechnical impact: they modify communication habits, alter clinical processes and may have serious ethical implications. The introduction of such systems involves very different groups of stakeholders because of the inherent multi-professionalism in medicine and the role of patients and their relatives that are often underrepresented. Each group contributes distinct perspectives and particular needs, which create specific requirements for IT systems and may strongly influence their acceptance and success. In the past, needs analysis, challenges and requirements for medical IT systems have often been addressed using consensus techniques such as the Delphi technique. Facing the heterogeneous spectrum of stakeholders there is a need to develop these techniques further to control the (strong) influence of the composition of the expert panel on the outcome and to deal systematically with potentially incompatible needs of stakeholder groups. This approach uses the strong advantages a Delphi study has, identifies the disadvantages of traditional Delphi techniques and aims to introduce and evaluate a modified approach called 360-Degree Delphi. Key aspects of 360-Degree Delphi are tested by applying the approach to the needs and requirements analysis of a system for managing patients' advance directives and living wills. METHODS: 360-Degree Delphi (short 360°D), as a modified Delphi process, is specified as a structured workflow with the optional use of stakeholder groups. The approach redefines the composition of the expert panel by setting up groups of different stakeholders. Consensus is created within individual stakeholder groups, but is also communicated between groups, while the iterative structure of the Delphi process remains unchanged. We hypothesize that (1) 360-Degree Delphi yields complementary statements from different stakeholders, which would be lost in classical Delphi; while (2) the variation of statements within individual stakeholder groups is lower than within the total collective. A user study is performed that addresses five stakeholder groups (patients, relatives, medical doctors, nurses and software developers) on the topic of living will communication in an emergency context. Qualitative open questions are used in a Delphi round 0. Answer texts are coded by independent raters who carry out systematic bottom-up qualitative text analysis. Inter-rater reliability is calculated and the resulting codes are used to test the hypotheses. Qualitative results are transferred into quantitative questions and then surveyed in round 1. The study took place in Germany. RESULTS: About 25% of the invited experts (stakeholders) agreed to take part in the Delphi round 0 (three patients, two relatives, three medical doctors, two qualified nurses and three developers), forming a structured panel of the five stakeholder groups. Two raters created a bottom-up coding, and 238 thematic codes were identified by the qualitative text analysis. The inter-rater reliability showed that 44.95% of the codes were semantically similar and coded for the same parts of the raw textual replies. Based on a consented coding list, a quantitative online-questionnaire was developed and send to different stakeholder groups. With respect to the hypotheses, Delphi round 0 had the following results: (1) doctors had a completely different focus from all the other stakeholder groups on possible channels of communications with the patient; (2) the dispersion of codes within individual stakeholder groups and within the total collective - visualized by box plots - was approximately 28% higher in the total collective than in the sub-collectives, but without a marked effect size. With respect to the hypotheses, Delphi round 1 had the following results: different stakeholder groups had highly diverging opinions with respect to central questions on IT-development. For example, when asked to rate the importance of access control against high availability of data (likert scale, 1 meaning restrictive data access, 6 easy access to all data), patients (mean 4.862, Stdev +/- 1.866) and caregivers (mean 5.667, Stdev: +/- 0.816) highly favored data availability, while relatives would restrict data access (mean 2.778, stdev +/- 1.093). In comparison, the total group would not be representative of either of these individual stakeholder needs (mean 4.344, stdev +/- 1.870). CONCLUSION: 360-Degree Delphi is feasible and allows different stakeholder groups within an expert panel to reach agreement individually. Thus, it generates a more detailed consensus which pays more tribute to individual stakeholders needs. This has the potential to improve the time to consensus as well as to produce a more representative and precise needs and requirements analysis. However, the method may create new challenges for the IT development process, which will have to deal with complementary or even contradictory statements from different stakeholder groups.

Can commercially available wearable EEG devices be used for diagnostic purposes? An explorative pilot study.

Electroencephalography (EEG) is a core element in the diagnosis of epilepsy syndromes and can help to monitor antiseizure treatment. Mobile EEG (mEEG) devices are increasingly available on the consumer market and may offer easier access to EEG recordings especially in rural or resource-poor areas. The usefulness of consumer-grade devices for clinical purposes is still underinvestigated. Here, we compared EEG traces of a commercially available mEEG device (Emotiv EPOC) to a simultaneously recorded clinical video EEG (vEEG). Twenty-two adult patients (11 female, mean age 40.2 years) undergoing noninvasive vEEG monitoring for clinical purposes were prospectively enrolled. The EEG recordings were evaluated by 10 independent raters with unmodifiable view settings. The individual evaluations were compared with respect to the presence of abnormal EEG findings (regional slowing, epileptiform potentials, seizure pattern). Video EEG yielded a sensitivity of 56% and specificity of 88% for abnormal EEG findings, whereas mEEG reached 39% and 85%, respectively. Interrater reliability coefficients were better in vEEG as compared to mEEG (ϰ = 0.50 vs. 0.30), corresponding to a moderate and fair agreement. Intrarater reliability between mEEG and vEEG evaluations of simultaneous recordings of a given participant was moderate (ϰ = 0.48). Given the limitations of our exploratory pilot study, our results suggest that vEEG is superior to mEEG, but that mEEG can be helpful for diagnostic purposes. We present the first quantitative comparison of simultaneously acquired clinical and mobile consumer-grade EEG for a clinical use-case.

Validation of an mHealth App for Depression Screening and Monitoring (Psychologist in a Pocket): Correlational Study and Concurrence Analysis.

BACKGROUND: Mobile health (mHealth) is a fast-growing professional sector. As of 2016, there were more than 259,000 mHealth apps available internationally. Although mHealth apps are growing in acceptance, relatively little attention and limited efforts have been invested to establish their scientific integrity through statistical validation. This paper presents the external validation of Psychologist in a Pocket (PiaP), an Android-based mental mHealth app which supports traditional approaches in depression screening and monitoring through the analysis of electronic text inputs in communication apps. OBJECTIVE: The main objectives of the study were (1) to externally validate the construct of the depression lexicon of PiaP with standardized psychological paper-and-pencil tools and (2) to determine the comparability of PiaP, a new depression measure, with a psychological gold standard in identifying depression. METHODS: College participants downloaded PiaP for a 2-week administration. Afterward, they were asked to complete 4 psychological depression instruments. Furthermore, 1-week and 2-week PiaP total scores (PTS) were correlated with (1) Beck Depression Index (BDI)-II and Center for Epidemiological Studies-Depression (CES-D) Scale for congruent construct validation, (2) Affect Balance Scale (ABS)-Negative Affect for convergent construct validation, and (3) Satisfaction With Life Scale (SWLS) and ABS-Positive Affect for divergent construct validation. In addition, concordance analysis between PiaP and BDI-II was performed. RESULTS: On the basis of the Pearson product-moment correlation, significant positive correlations exist between (1) 1-week PTS and CES-D Scale, (2) 2-week PTS and BDI-II, and (3) PiaP 2-week PTS and SWLS. Concordance analysis (Bland-Altman plot and analysis) suggested that PiaP's approach to depression screening is comparable with the gold standard (BDI-II). CONCLUSIONS: The evaluation of mental health has historically relied on subjective measurements. With the integration of novel approaches using mobile technology (and, by extension, mHealth apps) in mental health care, the validation process becomes more compelling to ensure their accuracy and credibility. This study suggests that PiaP's approach to depression screening by analyzing electronic data is comparable with traditional and well-established depression instruments and can be used to augment the process of measuring depression symptoms.

Psychologist in a Pocket: Lexicon Development and Content Validation of a Mobile-Based App for Depression Screening.

BACKGROUND: Language reflects the state of one's mental health and personal characteristics. It also reveals preoccupations with a particular schema, thus possibly providing insights into psychological conditions. Using text or lexical analysis in exploring depression, negative schemas and self-focusing tendencies may be depicted. As mobile technology has become highly integrated in daily routine, mobile devices have the capacity for ecological momentary assessment (EMA), specifically the experience sampling method (ESM), where behavior is captured in real-time or closer in time to experience in one's natural environment. Extending mobile technology to psychological health could augment initial clinical assessment, particularly of mood disturbances, such as depression and analyze daily activities, such as language use in communication. Here, we present the process of lexicon generation and development and the initial validation of Psychologist in a Pocket (PiaP), a mobile app designed to screen signs of depression through text analysis. OBJECTIVE: The main objectives of the study are (1) to generate and develop a depressive lexicon that can be used for screening text-input in mobile apps to be used in the PiaP; and (2) to conduct content validation as initial validation. METHODS: The first phase of our research focused on lexicon development. Words related to depression and its symptoms based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and in the ICD-10 Classification of Mental and Behavioural Disorders: Clinical Descriptions and Diagnostic Guidelines classification systems were gathered from focus group discussions with Filipino college students, interviews with mental health professionals, and the review of established scales for depression and other related constructs. RESULTS: The lexicon development phase yielded a database consisting of 13 categories based on the criteria depressive symptoms in the DSM-5 and ICD-10. For the draft of the depression lexicon for PiaP, we were able to gather 1762 main keywords and 9655 derivatives of main keywords. In addition, we compiled 823,869 spelling variations. Keywords included negatively-valenced words like "sad", "unworthy", or "tired" which are almost always accompanied by personal pronouns, such as "I", "I'm" or "my" and in Filipino, "ako" or "ko". For the content validation, only keywords with CVR equal to or more than 0.75 were included in the depression lexicon test-run version. The mean of all CVRs yielded a high overall CVI of 0.90. A total of 1498 main keywords, 8911 derivatives of main keywords, and 783,140 spelling variations, with a total of 793, 553 keywords now comprise the test-run version. CONCLUSIONS: The generation of the depression lexicon is relatively exhaustive. The breadth of keywords used in text analysis incorporates the characteristic expressions of depression and its related constructs by a particular culture and age group. A content-validated mobile health app, PiaP may help augment a more effective and early detection of depressive symptoms.

Smartphone-based diagnostic for preeclampsia: an mHealth solution for administering the Congo Red Dot (CRD) test in settings with limited resources.

OBJECTIVE: Morbidity and mortality due to preeclampsia in settings with limited resources often results from delayed diagnosis. The Congo Red Dot (CRD) test, a simple modality to assess the presence of misfolded proteins in urine, shows promise as a diagnostic and prognostic tool for preeclampsia. We propose an innovative mobile health (mHealth) solution that enables the quantification of the CRD test as a batch laboratory test, with minimal cost and equipment. METHODS: A smartphone application that guides the user through seven easy steps, and that can be used successfully by non-specialized personnel, was developed. After image acquisition, a robust analysis runs on a smartphone, quantifying the CRD test response without the need for an internet connection or additional hardware. In the first stage, the basic image processing algorithms and supporting test standardizations were developed using urine samples from 218 patients. In the second stage, the standardized procedure was evaluated on 328 urine specimens from 273 women. In the third stage, the application was tested for robustness using four different operators and 94 altered samples. RESULTS: In the first stage, the image processing chain was set up with high correlation to manual analysis (z-test P < 0.001). In the second stage, a high agreement between manual and automated processing was calculated (Lin's concordance coefficient ρc = 0.968). In the last stage, sources of error were identified and remedies were developed accordingly. Altered samples resulted in an acceptable concordance with the manual gold-standard (Lin's ρc = 0.914). CONCLUSION: Combining smartphone-based image analysis with molecular-specific disease features represents a cost-effective application of mHealth that has the potential to fill gaps in access to health care solutions that are critical to reducing adverse events in resource-poor settings.

Advanced modular automated calculation of the morpho-histological parameters in myocardial infarction.

Myocardial infarction represents the most investigated pathology. Heart tissues are histologically assayed on a routine base in clinical laboratories. However, the lack of a standard operation procedure for e.g. calculating the size of the infarcted area of myocardium, may lead to an increased errors' interval, with little correlation between results of a same tissue and/or with other pathophysiological parameters. This creates a clear barrier for further development of novel therapeutic strategies. In the present study, we present the robust applicability of a novel methodology such as: advanced modular automated calculation of (i) the size of infarcted heart of mice, (ii) the net collagen content present in the scar, and (iii) the interstitial fibrosis in remote, which are simultaneously performed. The new approach of defining the infarct size, one of the important predictor of every cardiac therapeutic intervention, will create a positive impact in the research accuracy. Additionally, it will be expected that the readily assembled reports of simultaneously computed parameters and its user-friendly operation allow an efficient and effective estimation of measurements.