Prescribing Behavior and Reasonable Price for Mental Health DiGAs - Results of a Pilot Study.

BACKGROUND: Since the Digital Health Care Act came into force in 2020, mHealth services can be prescribed and reimbursed as DiGAs in Germany. The most reimbursable DiGAs can be found in the area of psychiatric diseases. Little is known about the prescribing behavior of medical and psychological psychotherapists and the price they considered reasonable. OBJECTIVES: To gather more detailed knowledge about the prescription behavior, appropriate diagnosis, reasonable price and importance of relevant characteristics. METHODS: Online survey of 38 medical and psychological psychotherapists working in central Hesse. RESULTS: Just under a third have prescribed DiGAs to date; suitable diagnoses include somatoform disorders, anxiety disorders and addictive disorders. Medical quality, user- friendliness and data protection are considered important. the reasonable price is below the current average market price. CONCLUSION: The DiGAs do not seem to be prescribed by psychotherapists on a broad scale yet, the suitable indications are in line with the market offer, although the prices seem to be too high from the prescribers' point of view.

Evaluation of a Regulatory Orientation Guide for Young Entrepreneurs in the Field of Digital Health.

BACKGROUND: The number of software products in the field of health and medicine increases excessively. Self-tracking, fitness, dose calculation, and analysis of physiological data - apps are popular and commonly used. For young entrepreneurs, it is difficult to recognize and understand the distinction between software as medical product and health software products. A product-related orientation guide was developed to help start-ups to understand the difference and to find the right strategy for placing their product on the market. OBJECTIVES: An initial evaluation of this orientation guide to improve the comprehensibility, the simplicity, and to validate the benefit. METHODS: The evaluation was performed using a questionnaire. In total, 15 employees from start-ups or those in foundation phase and in regulatory affairs positions or comparable were interviewed. RESULTS: the orientation guide was rated as very helpful and comprehensible. 80 % would highly recommend it to others. CONCLUSION: The orientation guide was positively evaluated and can be used in field. Nevertheless, further investigations must be performed, and a post-market surveillance will be necessary.

Comparison of Formative Evaluation Methods in the Usability Process on the Example of a Medical App.

BACKGROUND: The process of developing a medical device has become increasingly complex, not least because of the Medical Device Regulation. Some of the associated changes affect in particular the software development companies. One of the challenges to provide safe software products is the usability engineering process. Adequate methods must be identified to find severe usability issues effectively and efficiently. OBJECTIVES: The aim of this study was a comparison of normative recommended formative evaluation methods. METHODS: Two expert-based methods and two user-based methods were compared regarding effectiveness in finding issues, the level of detail and the temporal effort. RESULTS: The heuristics and the isometrics, both showed a significant advantage regarding the effectiveness and similarity in level of detail and temporal effort. CONCLUSION: Based on this paper, the heuristics and the isometrics, both can be recommended, but further studies are necessary to consolidate this statement. Also, further methods should be considered, and more test persons must be involved to give an overall comparison of formative evaluation methods in the usability process of medical apps.

Telemonitoring and medical care supporting of patients with chronic respiratory diseases.

Experts refer to innovative telemonitoring technologies to deal with chronic respiratory diseases, especially the chronic obstructive pulmonary disease - COPD. In chronic respiratory diseases, sudden acute exacerbations may occur that can be life-threatening in some cases. Telemonitoring solutions help to detect the beginning of an impaired medical condition and can induce an adequate countermeasure in time. As soon as individually determined parameters are passed, appropriate warning signs can be transmitted. As part of a project, a new monitoring device for the detection of COPD-typical parameters has been utilized and optimized. Furthermore, an innovative 3D-Video-System was used to enable the implementation of physical exercises in the domestic environment. The systems assists the patient during the entire training unit and creates a feedback based on the quality of his or her exercises.

A comparison of 3-day and daily follicle-stimulating hormone injections on stimulation days 1-6 in women undergoing controlled ovarian hyperstimulation.

OBJECTIVE: To evaluate the efficacy of ovarian hyperstimulation by intermittent doses of 450 IU of recombinant human (h)FSH compared with daily 150-IU doses of recombinant hFSH. DESIGN: A pilot, open, randomized, parallel-group study. SETTING: Center for Reproductive Medicine, Düsseldorf, Germany. PATIENT(S): Infertile women with indication for IVF/intracytoplasmic sperm injection after at least 1 year of unprotected intercourse. INTERVENTION(S): Recombinant hFSH was administered daily or intermittently (3-day intervals) from days 1 to 6 of stimulation and thereafter by daily injection. MAIN OUTCOME MEASURE(S): Number of preovulatory follicles, retrieved oocytes, two-pronuclei (2PN) zygotes, implantation, and pregnancy rates. RESULT(S): The number of oocytes in the daily-dose group was significantly greater. There were no significant differences in mean values for number of follicles > or =11 mm (except for day 7) and > or =14 mm, 2PN zygotes, and number of transferred embryos. Implantation and pregnancy rates per cycle were in favor of the intermittent 450-IU dose regimen; implantation rates were 17.0% and 9.8% in the 3-day-dose and daily-dose groups, respectively, and biochemical and clinical pregnancy rates were 33.3% and 15.7% and 25.5% and 13.7%, respectively. CONCLUSION(S): Intermittent administration of recombinant hFSH significantly reduces the total number of recombinant hFSH injections, compared with a conventional FSH regimen, without detrimental effects on implantation rate or pregnancy rate.