Repeated Digitized Assessment of Risk and Symptom Profiles During Inpatient Treatment of Affective Disorder: Observational Study.

BACKGROUND: Predictive models have revealed promising results for the individual prognosis of treatment response and relapse risk as well as for differential diagnosis in affective disorders. Yet, in order to translate personalized predictive modeling from research contexts to psychiatric clinical routine, standardized collection of information of sufficient detail and temporal resolution in day-to-day clinical care is needed. Digital collection of self-report measures by patients is a time- and cost-efficient approach to gain such data throughout treatment. OBJECTIVE: The objective of this study was to investigate whether patients with severe affective disorders were willing and able to participate in such efforts, whether the feasibility of such systems might vary depending on individual patient characteristics, and if digitally acquired assessments were of sufficient diagnostic validity. METHODS: We implemented a system for longitudinal digital collection of risk and symptom profiles based on repeated self-reports via tablet computers throughout inpatient treatment of affective disorders at the Department of Psychiatry at the University of Münster. Tablet-handling competency and the speed of data entry were assessed. Depression severity was additionally assessed by a clinical interviewer at baseline and before discharge. RESULTS: Of 364 affective disorder patients who were approached, 242 (66.5%) participated in the study; 88.8% of participants (215/242) were diagnosed with major depressive disorder, and 27 (11.2%) had bipolar disorder. During the duration of inpatient treatment, 79% of expected assessments were completed, with an average of 4 completed assessments per participant; 4 participants (4/242, 1.6%) dropped out of the study prematurely. During data entry, 89.3% of participants (216/242) did not require additional support. Needing support with tablet handling and slower data entry pace were predicted by older age, whereas depression severity at baseline did not influence these measures. Patient self-reporting of depression severity showed high agreement with standardized external assessments by a clinical interviewer. CONCLUSIONS: Our results indicate that digital collection of self-report measures is a feasible, accessible, and valid method for longitudinal data collection in psychiatric routine, which will eventually facilitate the identification of individual risk and resilience factors for affective disorders and pave the way toward personalized psychiatric care.

Humanistic burden of chronic pruritus in patients with inflammatory dermatoses: Results of the European Academy of Dermatology and Venereology Network on Assessment of Severity and Burden of Pruritus (PruNet) cross-sectional trial.

BACKGROUND: Chronic pruritus is a multifactorial, challenging symptom of global relevance. OBJECTIVE: The European Academy of Dermatology and Venereology Network on Assessment of Severity and Burden of Pruritus (PruNet) investigation aimed to analyze the severity and humanistic burden of chronic pruritus in patients suffering from inflammatory dermatoses across Europe. METHODS: Prospectively collected routine data on 552 patients (with atopic dermatitis, contact dermatitis, prurigo nodularis, psoriasis vulgaris, lichen planus, or mycosis fungoides [pruritus numeric rating scale score ≥3]) from 9 European centers (in Austria, France, Germany, Italy, Poland, Russia, Spain, Switzerland, and Turkey) were analyzed by univariate and multivariate variance analyses of various itch characteristics and quality of life (as measured by the Dermatology Life Quality Index and the ItchyQoL). RESULTS: Duration, frequency, and intensity of pruritus (according to a numeric rating scale and visual analog scale) and related impairment of quality of life differed between European centers and dermatologic diagnoses (P < .05). The country in which the center was located had a greater impact on how patients evaluated pruritus intensity and quality of life than diagnosis did (P < .001). LIMITATIONS: One center per country was included. CONCLUSION: The humanistic burden of chronic pruritus in patients with inflammatory dermatoses is high. European cross-cultural factors may have a stronger influence than a specific dermatologic diagnosis on how patients rate intensity of pruritus and quality of life.

Does single-source create an added value? Evaluating the impact of introducing x4T into the clinical routine on workflow modifications, data quality and cost-benefit.

OBJECTIVES: The first objective of this study is to evaluate the impact of integrating a single-source system into the routine patient care documentation workflow with respect to process modifications, data quality and execution times in patient care as well as research documentation. The second one is to evaluate whether it is cost-efficient using a single-source system in terms of achieved savings in documentation expenditures. METHODS: We analyzed the documentation workflow of routine patient care and research documentation in the medical field of pruritus to identify redundant and error-prone process steps. Based on this, we established a novel documentation workflow including the x4T (exchange for Trials) system to connect hospital information systems with electronic data capture systems for the exchange of study data. To evaluate the workflow modifications, we performed a before/after analysis as well as a time-motion study. Data quality was assessed by measuring completeness, correctness and concordance of previously and newly collected data. A cost-benefit analysis was conducted to estimate the savings using x4T per collected data element and the additional costs for introducing x4T. RESULTS: The documentation workflow of patient care as well as clinical research was modified due to the introduction of the x4T system. After x4T implementation and workflow modifications, half of the redundant and error-prone process steps were eliminated. The generic x4T system allows direct transfer of routinely collected health care data into the x4T research database and avoids manual transcription steps. Since x4T has been introduced in March 2012, the number of included patients has increased by about 1000 per year. The average entire documentation time per patient visit has been significantly decreased by 70.1% (from 1116±185 to 334±83 s). After the introduction of the x4T system and associated workflow changes, the completeness of mandatory data elements raised from 82.2% to 100%. In case of the pruritus research study, the additional costs for introducing the x4T system are €434.01 and the savings are 0.48ct per collected data element. So, with the assumption of a 5-year runtime and 82 collected data elements per patient, the amount of documented patients has to be higher than 1102 to create a benefit. CONCLUSION: Introduction of the x4T system into the clinical and research documentation workflow can optimize the data collection workflow in both areas. Redundant and cumbersome process steps can be eliminated in the research documentation, with the result of reduced documentation times as well as increased data quality. The usage of the x4T system is especially worthwhile in a study with a large amount of collected data or a high number of included patients.

Analyses of medical data models - identifying common concepts and items in a repository of medical forms.

One year ago the portal of Medical Data Models (http://medical-data-models.org) was presented as a resource for the scientific community. As of November 2012 there are approximately 3,300 forms with 102,000 items available in the CDISC ODM format. First descriptive analyses regarding form metadata demonstrate the capability of such a repository to identify commonly used medical concepts. Most common items are administrative attributes which indicates that more clinical information are needed to increase the secondary use of data documented within these forms.

Integrative analyses for omics data: a Bayesian mixture model to assess the concordance of ChIP-chip and ChIP-seq measurements.

The analysis of different variations in genomics, transcriptomics, epigenomics, and proteomics has increased considerably in recent years. This is especially due to the success of microarray and, more recently, sequencing technology. Apart from understanding mechanisms of disease pathogenesis on a molecular basis, for example in cancer research, the challenge of analyzing such different data types in an integrated way has become increasingly important also for the validation of new sequencing technologies with maximum resolution. For this purpose, a methodological framework for their comparison with microarray techniques in the context of smallest sample sizes, which result from the high costs of experiments, is proposed in this contribution. Based on an adaptation of the externally centered correlation coefficient ( Schäfer et al. 2009 ), it is demonstrated how a Bayesian mixture model can be applied to compare and classify measurements of histone acetylation that stem from chromatin immunoprecipitation combined with either microarray (ChIP-chip) or sequencing techniques (ChIP-seq) for the identification of DNA fragments. Here, the murine hematopoietic cell line 32D, which was transduced with the oncogene BCR-ABL, the hallmark of chronic myeloid leukemia, was characterized. Cells were compared to mock-transduced cells as control. Activation or inhibition of other genes by histone modifications induced by the oncogene is considered critical in such a context for the understanding of the disease.

Qualitative and quantitative evaluation of EHR-integrated mobile patient questionnaires regarding usability and cost-efficiency.

OBJECTIVES: The objective of this evaluation study is to assess a web-based application, currently available on iPad, to document questionnaires regarding patient reported outcomes such as quality of life. Based on the single source approach, the results of these questionnaires are available in the electronic health record to be used for treatment and research purposes. The assessment focuses on the usability and efficiency of the system. METHODS: The system usability scale questionnaire with seven additional items was used to rate the usability by the patients. It was formally validated by a Cronbach Alpha test. In addition, semi-structured interviews were conducted with patients and medical staff. Time and cost measures, based on official tables of costs, were taken through workflow observations. This study was conducted in the department of dermatology at the University Hospital of Münster, Germany from April to June 2011. RESULTS: Using the web-based application questionnaire, results about patient reported outcomes like quality of life are immediately available in the electronic health record and can be used for treatment or research purposes. 118 patients and four staff members participated in the study. The usability score reached 80 from 100 points and patients as well as medical staff stated in the interviews that the usability of the web-based system was high, and they preferred it to the previously used paper-based questionnaires. In the setting of our pilot department the mobile devices amortized their costs after 6.7 months. In general, depending on the professional group who are going to post process the paper-based forms, the earliest break-even point to use mobile questionnaires is at 1737 paper sheets per year. CONCLUSION: The mobile patient questionnaires, integrated into the electronic health record, were well accepted in our pilot setting with high usability scores from patients and medical staff alike. The system has also proved to be cost-efficient compared to the paper-based workflow, given that a certain number of questionnaires is used per year.

[Psychooncological interventions - what do cancer patients aged 60 years or older wish for?]. / Psychoonkologische Angebote - was wunschen uber 60-jahrige Krebspatienten?

OBJECTIVES: To determine the acceptance of psychooncological interventions and predictors of subjective needs in cancer patients over 60 years of age. METHODS: We examined 292 in- and outpatients (51% female, 51.7% aged over 60 years) from the Interdisciplinary Cancer Center of the University Hospital of Münster with a questionnaire designed to assess their wish to participate in various psychooncological interventions (FIPA) and with the Hospital Anxiety and Depression Scale (HADS-D). RESULTS: 73.5 % of those over 60 years and 87.9 % of those under 60 years professed a wish for at least one specific psychooncological intervention. Higher age, lower levels of anxiety and cancer relapse were negative predictors of the readiness to attend psychooncological interventions (9 % variance explained). As to specific interventions, those aged 60 years or older showed lower acceptance only for relaxation techniques. CONCLUSIONS: Readiness to attend psychooncological interventions was high with only marginal differences between the age groups. Because objective features of the patient and the disease resulted only in a low predictability of the subjective need for psychooncological interventions, routine screening of cancer patients seems an important issue.

Integrated analysis of copy number alterations and gene expression: a bivariate assessment of equally directed abnormalities.

MOTIVATION: The analysis of a number of different genetic features like copy number (CN) variation, gene expression (GE) or loss of heterocygosity has considerably increased in recent years, as well as the number of available datasets. This is particularly due to the success of microarray technology. Thus, to understand mechanisms of disease pathogenesis on a molecular basis, e.g. in cancer research, the challenge of analyzing such different data types in an integrated way has become increasingly important. In order to tackle this problem, we propose a new procedure for an integrated analysis of two different data types that searches for genes and genetic regions which for both inputs display strong equally directed deviations from the reference median. We employ this approach, based on a modified correlation coefficient and an explorative Wilcoxon test, to find DNA regions of such abnormalities in GE and CN (e.g. underexpressed genes accompanied by a loss of DNA material). RESULTS: In an application to acute myeloid leukemia, our procedure is able to identify various regions on different chromosomes with characteristic abnormalities in GE and CN data and shows a higher sensitivity to differences in abnormalities than standard approaches. While the results support various findings of previous studies, some new interesting DNA regions can be identified. In a simulation study, our procedure also shows more reliable results than standard approaches. AVAILABILITY: Code and data available as R packages edira and ediraAMLdata from http://www.statistik.tu-dortmund.de/~schaefer/ CONTACT: martin.schaefer@udo.edu SUPPLEMENTARY INFORMATION: Supplementary data are available at Bioinformatics online.