Effectiveness of Digital Health Interventions Containing Game Components for the Self-management of Type 2 Diabetes: Systematic Review.

BACKGROUND: Games and game components have become a major trend in the realm of digital health research and practice as they are assumed to foster behavior change and thereby improve patient-reported and clinical outcomes for patients with type 2 diabetes. OBJECTIVE: The aim of this systematic review was to summarize and evaluate the current evidence on the effectiveness of digital health interventions containing game components on behavioral, patient-reported, and clinical outcomes for patients with type 2 diabetes. METHODS: An electronic search was conducted in MEDLINE and PsycINFO in April 2020; updated in April 2022; and supplemented by additional searches via Google Scholar, Web of Science (which was used for forward citation tracking), and within the references of the included records. Articles were identified using predefined inclusion and exclusion criteria. In total, 2 reviewers independently conducted title, abstract, and full-text screening and then individually performed a critical appraisal of all the included studies using the Cochrane risk-of-bias tool version 2. A consensus was reached through discussion. RESULTS: Of 2325 potentially relevant titles (duplicates excluded), 10 (0.43%) randomized controlled trials were included in this review. Quality assessment revealed a high risk of bias for all randomized controlled trials except for 10% (1/10), with performance bias due to the lack of blinding being the major source of bias. There is evidence suggesting that digital health interventions containing game components can substantially improve motivation for physical activity (1/1, 100% of the studies dealing with PA motivation), exercise intensity (3/5, 60%), dietary behavior (4/4, 100%), health literacy (1/3, 33%), mental quality of life (2/2, 100%), glycated hemoglobin level (2/6, 33%), BMI (1/3, 33%), fasting plasma glucose level (1/2, 50%), waist circumference (1/1, 100%), and aerobic capacity (1/1, 100%). CONCLUSIONS: Published studies indicated that digital health interventions containing game components might improve health behavior patterns, quality of life, and clinical outcomes in patients with type 2 diabetes. However, the intervention types and outcomes studied were heterogeneous, and study quality was mostly low, which translates to ambiguous results. Future research should focus on sound methodology and reporting as well as on identifying game components that contribute to significant positive effects. TRIAL REGISTRATION: PROSPERO CRD42020209706; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=209706.

[Development, Evaluation and Implementation of Digital Health Interventions (Part 1) - Discussion Paper of the Digital Health Working Group of the German Network for Health Services Research (DNVF)]. / Digitale Gesundheitsinterventionen entwickeln, evaluieren und implementieren (Teil I) ­ Diskussionspapier der Arbeitsgruppe Digital Health des Deutschen Netzwerk Versorgungsforschung (DNVF).

The development and application of digital interventions in health-related topics are gaining momentum in health service research. Digital interventions are often complex and need to be evaluated and implemented in complex settings. Due to their characteristics, this poses methodological challenges for health services research that have to be identified and addressed. Hence, the Working Group on Digital Health of the German Network for Health Services Research (DNVF) has prepared a discussion paper. This paper discusses methodological, practical and theoretical challenges associated with the development and evaluation of digital interventions from the perspective of health services research. Possible solutions are suggested and future research needs to address these methodological challenges are identified.

[Developing, Evaluating and Implementing Digital Health Interventions Part II - Discussion Paper of the Digital Health Working Group of the German Network for Health Services Research (DNVF)]. / Digitale Gesundheitsinterventionen entwickeln, evaluieren und implementieren Teil II ­ Diskussionspapier der Arbeitsgruppe Digital Health des Deutschen Netzwerk Versorgungsforschung (DNVF).

The methodological challenges of evaluating digital interventions (DI) for health services research are omnipresent. The Digital Health Working Group of the German Network for Health Services Research (DNVF) presented and discussed these challenges in a two-part discussion paper. The first part addressed challenges in definition, development and evaluation of DI. In this paper, which represents the second part, the definition of outcomes, reporting of results, synthesis of evidence, and implementation are addressed as methodological challenges of DI. Potential solutions are presented and the need to address these challenges in future research are discussed.

[Necessity and Ways to Develop Care Goals for the Health System in Germany - a Position Paper of the DNVF]. / Notwendigkeit und Wege zur Entwicklung von Versorgungszielen für das Gesundheitssystem in Deutschland ­ ein Positionspapier des DNVF.

Goals for health and health care are an indispensable basic requirement for a functioning health care system. The dilemma of the German health care system is that it has not been designed in a planned way, but that it has grown historically. In recent years, it has developed through the free play of forces into what it is today. The OECD characterizes the current state as follows: The costs of the German health system do not correspond to the often only average health outcomes for the population. To meet the legal requirements (especially SGB V §§ 12, 27 and 70), health care/the health system in Germany needs concrete goals. An orientation towards health care goals entails measures on all levels of health care: on the macro level (overall system/total population), on the meso level (subdivided according to regions, specific population groups, etc.) as well as on the micro level (patients and health care providers). Based on national and international experiences, this position paper of the DNVF e.V. (German Network for health services research) shows the potential of how operationalised health care targets can ensure effective, affordable and high-quality health care. The coalition agreement of the current government propagates a reorientation with patient-related health care goals. Now it is important to derive concrete and realisable goals from this declaration of intent and to involve all important groups in the process. In addition, values and ethical standards for implementation shall be agreed upon in this process. The Health Ministry (BMG) should facilitate and promote the process of societal will-building for the definition of national health care goals. This requires a clear political will. As a result, the National Health Care Goals are available at the end of the process, which are published and maintained together with evidence-based facts as well as valid and resilient data in a Manual "National Health Care Goals". The operational responsibility for implementation could lie with the newly to be founded Federal Institute of Public Health, as already announced in the agreement of the governing coalition. The DNVF is willing to actively participate in the development of health care targets.

Feasibility of a Multimodal Telemedical Intervention for Patients with Parkinson's Disease-A Pilot Study.

Symptoms of Parkinson's disease (PD) can be controlled well, but treatment often requires expert judgment. Telemedicine and sensor-based assessments can allow physicians to better observe the evolvement of symptoms over time, in particular with motor fluctuations. In addition, they potentially allow less frequent visits to the expert's office and facilitate care in rural areas. A variety of systems with different strengths and shortcomings has been investigated in recent years. We designed a multimodal telehealth intervention (TelePark) to mitigate the shortcomings of individual systems and assessed the feasibility of our approach in 12 patients with PD over 12 weeks in preparation for a larger randomized controlled trial. TelePark uses video visits, a smartphone app, a camera system, and wearable sensors. Structured training included setting up the equipment in patients' homes and group-based online training. Usability was assessed by questionnaires and semi-standardized telephone interviews. Overall, 11 out of 12 patients completed the trial (5 female, 6 male). Mean age was 65 years, mean disease duration 7 years, mean MoCA score 27. Adherence was stable throughout the study and 79% for a short questionnaire administered every second day, 62% for medication confirmation, and 33% for an electronic Hauser diary. Quality of life did not change in the course of the study, and a larger cohort will be required to determine the effect on motor symptoms. Interviews with trial participants identified motivations to use such systems and areas for improvements. These insights can be helpful in designing similar trials.

Use of Patient-Reported Outcome Measures and Patient-Reported Experience Measures Within Evaluation Studies of Telemedicine Applications: Systematic Review.

BACKGROUND: With the rise of digital health technologies and telemedicine, the need for evidence-based evaluation is growing. Patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) are recommended as an essential part of the evaluation of telemedicine. For the first time, a systematic review has been conducted to investigate the use of PROMs and PREMs in the evaluation studies of telemedicine covering all application types and medical purposes. OBJECTIVE: This study investigates the following research questions: in which scenarios are PROMs and PREMs collected for evaluation purposes, which PROM and PREM outcome domains have been covered and how often, which outcome measurement instruments have been used and how often, does the selection and quantity of PROMs and PREMs differ between study types and application types, and has the use of PROMs and PREMs changed over time. METHODS: We conducted a systematic literature search of the MEDLINE and Embase databases and included studies published from inception until April 2, 2020. We included studies evaluating telemedicine with patients as the main users; these studies reported PROMs and PREMs within randomized controlled trials, controlled trials, noncontrolled trials, and feasibility trials in English and German. RESULTS: Of the identified 2671 studies, 303 (11.34%) were included; of the 303 studies, 67 (22.1%) were feasibility studies, 70 (23.1%) were noncontrolled trials, 20 (6.6%) were controlled trials, and 146 (48.2%) were randomized controlled trials. Health-related quality of life (n=310; mean 1.02, SD 1.05), emotional function (n=244; mean 0.81, SD 1.18), and adherence (n=103; mean 0.34, SD 0.53) were the most frequently assessed outcome domains. Self-developed PROMs were used in 21.4% (65/303) of the studies, and self-developed PREMs were used in 22.3% (68/303). PROMs (n=884) were assessed more frequently than PREMs (n=234). As the evidence level of the studies increased, the number of PROMs also increased (τ=-0.45), and the number of PREMs decreased (τ=0.35). Since 2000, not only has the number of studies using PROMs and PREMs increased, but the level of evidence and the number of outcome measurement instruments used have also increased, with the number of PREMs permanently remaining at a lower level. CONCLUSIONS: There have been increasingly more studies, particularly high-evidence studies, which use PROMs and PREMs to evaluate telemedicine. PROMs have been used more frequently than PREMs. With the increasing maturity stage of telemedicine applications and higher evidence level, the use of PROMs increased in line with the recommendations of evaluation guidelines. Health-related quality of life and emotional function were measured in almost all the studies. Simultaneously, health literacy as a precondition for using the application adequately, alongside proper training and guidance, has rarely been reported. Further efforts should be pursued to standardize PROM and PREM collection in evaluation studies of telemedicine.

Independent Use of a Home-Based Telemonitoring App by Older Patients With Multimorbidity and Mild Cognitive Impairment: Qualitative Study.

BACKGROUND: The management of multimorbidity is complex and patients have a high burden of disease. When symptoms of dementia also appear, it becomes even more difficult for patients to cope with their everyday lives and manage their diseases. Home-based telemonitoring may support older patients with multimorbidity and mild cognitive impairment (MCI) in their regular monitoring and self-management. However, to date, there has been no investigation into whether patients with MCI are able to operate a telemonitoring app independently to manage their own diseases. This question has become even more important during the current COVID-19 pandemic to maintain high-quality medical care for this patient group. OBJECTIVE: We examined the following research questions: (1) How do patients with MCI assess the usability of the telemonitoring app? (2) How do patients with MCI assess the range of functions offered by the telemonitoring app? (3) Was there an additional benefit for the patients with MCI in using the telemonitoring app? (4) Were patients with MCI able to use the telemonitoring app independently and without restrictions? (5) To what extent does previous experience with smartphones, tablets, or computers influence the perceived ease of use of the telemonitoring app? METHODS: We performed a formative evaluation of a telemonitoring app. Therefore, we carried out a qualitative study and conducted guided interviews. All interviews were audio-recorded, transcribed verbatim, and analyzed using the Mayring method of structured content analysis. RESULTS: Twelve patients (8 women, 4 men) were interviewed; they had an average age of 78.7 years (SD 5.6) and an average Mini-Mental State Examination score of 24.5 (SD 1.6). The interviews lasted between 17 and 75 minutes (mean 41.8 minutes, SD 19.4). Nine patients reported that the telemonitoring app was easy to use. All respondents assessed the range of functions as good or adequate. Desired functionalities mainly included more innovative and varied educational material, better fit of the telemonitoring app for specific needs of patients with MCI, and a more individually tailored content. Ten of the 12 patients stated that the telemonitoring app had an additional benefit for them. Most frequently reported benefits included increased feeling of security, appreciation of regular monitoring of vital parameters, and increased independence due to telemonitoring. Eight patients were able to operate the app independently. Participants found the app easy to use regardless of whether they had prior experience with smartphones, tablets, or computers. CONCLUSIONS: The majority of examined patients with MCI were capable of operating the telemonitoring app independently. Crucial components in attaining independent use were comprehensive personal support from the start of use and appropriate design features. This study provides initial evidence that patients with MCI could increasingly be considered as a relevant user group of telemonitoring apps.

Implementation of patient-reported outcome assessment in routine cancer care: A systematic review of multicentric programs in Europe.

INTRODUCTION: To give an overview of patient-reported outcome measures (PROMs) programs in routine cancer care that allow for both major purposes of PROM assessment: 1) monitoring of an individual patient's outcome to assist treatment decision making, and 2) use in quality improvement initiatives including the benchmarking of providers. We synthesize information on program elements like the mode of assessment and questionnaire used, as well as information relevant for adaptation following a PDCA scheme. METHOD: We carried out a systematic literature research in the databases PubMed and EMBASE using MeSH terms and keywords related to PROM assessment in routine cancer care to identify eligible studies published between January 2003 and November 2018 (PROSPERO reg. no. CRD42019141402). We included studies in which PROM assessment programs had been reported as being implemented in clinical practice as well as collected multicentrically with at least one site in Europe and in which PROMs had been collected before and at least once after intervention. Study authors were queried to verify or correct the program elements extracted and merged during the review. Study quality assessment was not done, since it is not expedient for the objective of this review. RESULTS: Overall, 5,545 unique references were identified, 5,416 of which were excluded after the screening of titles and abstracts. Of the 29 references assessed, five programs were identified and included in the synthesis. The programs included those from Germany, Austria, Denmark, the Netherlands and the UK, and patients with different cancer types and tumor stages, which used paper-based or purely electronic PROM assessment. DISCUSSION AND CONCLUSION: Few reports have so far been published on PROM programs that allow for both the monitoring of an individual patient's outcome and use in quality improvement initiatives. The studies revealed relevant information on existing PROM programs and gave valuable insight into issues that need to be considered when setting up such an infrastructure. Some critical issues, however, were hardly addressed, among them costs, staff resources and methods of reporting and responding.

Theories Predicting End-User Acceptance of Telemedicine Use: Systematic Review.

BACKGROUND: Only a few telemedicine applications have made their way into regular care. One reason is the lack of acceptance of telemedicine by potential end users. OBJECTIVE: The aim of this systematic review was to identify theoretical predictors that influence the acceptance of telemedicine. METHODS: An electronic search was conducted in PubMed and PsycINFO in June 2018 and supplemented by a hand search. Articles were identified using predefined inclusion and exclusion criteria. In total, two reviewers independently assessed the title, abstract, and full-text screening and then individually performed a quality assessment of all included studies. RESULTS: Out of 5917 potentially relevant titles (duplicates excluded), 24 studies were included. The Axis Tool for quality assessment of cross-sectional studies revealed a high risk of bias for all studies except for one study. The most commonly used models were the Technology Acceptance Model (n=11) and the Unified Theory of Acceptance and Use of Technology (n=9). The main significant predictors of acceptance were perceived usefulness (n=11), social influences (n=6), and attitude (n=6). The results show a superiority of technology acceptance versus original behavioral models. CONCLUSIONS: The main finding of this review is the applicability of technology acceptance models and theories on telemedicine adoption. Characteristics of the technology, such as its usefulness, as well as attributes of the individual, such as his or her need for social support, inform end-user acceptance. Therefore, in the future, requirements of the target group and the group's social environment should already be taken into account when planning telemedicine applications. The results support the importance of theory-guided user-centered design approaches to telemedicine development.

[Reasons for non-acceptance and non-use of a home telemonitoring application by multimorbid patients aged 65 years and over]. / Motive für die Nichtakzeptanz und Nichtnutzung einer Telemonitoring-Anwendung im häuslichen Umfeld durch multimorbide Patienten über 65 Jahre.

BACKGROUND: User acceptance is a key indicator and driver for the use and implementation of telemonitoring applications (TMA) in healthcare. Despite various positive effects that previous studies have revealed for users of TMA, there are always patients who discontinue their participation in a telemedicine study or even decline participation. There is little evidence for the reasons for non-acceptance and non-use of TMA, especially in multimorbid patients at the age of 65 and over in their home environment. To close this research gap, this sub-study focuses on patient-reported reasons for non-acceptance and non-use of TMA in the home environment. METHODS: This study follows a mixed-method approach and focuses on patients' perspective. Quantitative data collection took place via computer-assisted telephone interviews among all drop-outs and non-participants. Qualitative data were collected via semi-structured interviews with drop-out patients and non-users. Eligible patients were recruited consecutively by general practitioners, informed and included in the study according to the inclusion criteria. Amongst others, patients measured their vital signs (blood pressure, heart frequency, oxygen saturation, weight) via telemedical measures and sent them via tablet to a Care Coordination Center to ascertain the need for intervention. Collected data on non-acceptance and non-use of TMA were analyzed quantitatively and qualitatively. RESULTS: Nine general practices in two German cities included a total of 177 patients according to the inclusion criteria. During the study, 61 study participants (34.5 %) dropped out, 80 patients (31.1 %) declined participation in the study. Drop-outs and non-participants were significantly older than active participants (p=.004 and p=.001, respectively). Predominant reasons for drop-out were the lack of the perceived added value and the content-related variety of the program on the patient's tablet, the missing interest/need for telemedical monitoring as well as the time spent participating in the study. Patients living alone, single and widowed patients reported significantly more difficulties in handling the hardware (tablet) (p=.040) and the program (Motiva) (p=.013) than married and cohabiting patients. These reasons were also reported mainly by female patients, patients aged 75 years and over, and those with a low level of education. CONCLUSION: In order to increase the acceptance and the added value of TMA for patients, the individual needs of the future target group should be analyzed at the beginning of the development. To ensure maximum user centricity, individual development steps should be continuously evaluated by the target group. TMA should be adapted to the functional abilities of elderly, multimorbid patients through, e. g., an appropriate design of the content, which is tailored to patients' individual needs. TMA should be used to an appropriate degree to avoid overburdening and should fit unobtrusively into patients' usual daily routine. For patient-specific acceptance of TMA, easy handling of the telemedical measuring and input devices is as important as the variety of offers on the platform and personal contact for technical queries. Special attention should be paid to patients who live alone, women, elderly patients over 75 years of age, and poorly educated patients in order to ensure full and easy access to technology-based telemonitoring for their own healthcare.

[Principles for the evaluation of telemedicine applications: Results of a systematic review and consensus process]. / Grundsätze für die Evaluation telemedizinischer Anwendungen ­ Ergebnisse eines systematischen Reviews und Konsens-Verfahrens.

BACKGROUND: The limited number of telemedicine applications being transferred to standard medical care in Germany may to some extent be explained by deficits in the current evaluation practice. Effectiveness and cost effectiveness can only be demonstrated to decision makers and potential users with methodologically sound and fully published evaluations. There is a lack of well-founded and mandatory standards for adequate, comparable evaluations of telemedicine applications. METHODS: As part of the project CCS Telehealth Eastern Saxony (CCS THOS), a systematic review on evaluation concepts for telemedicine applications (search period until September 2014, databases Medline, Embase, HTA-Database, DARE, NHS EED) as well as an additional selective literature search were conducted. Suggestions for evaluation fundamentals were derived from the results. These suggestions were subjected to a formal consensus process (nominal group process) with relevant stakeholder groups (healthcare payers, healthcare providers, health policy representatives, researchers). RESULTS: 19 papers were included in the systematic review. In accordance with the predefined inclusion criteria, each presented an evaluation concept for telemedicine applications that was based upon a systematic review and/or a consensus process. Via a formal consensus process, the suggestions for evaluation principles derived from the review and the selective literature search (23 papers) resulted in ten agreed evaluation principles. Eight of them were unanimously agreed upon, two were arrived at with one abstention each. The principles enclose criteria for the planning, conduct and reporting of telemedicine evaluations. Adherence to them is obligatory for users of the telemedical infrastructure provided by CCS THOS. Furthermore, right from the beginning the intention was very much for these principles to be seized upon by other projects and initiatives. CONCLUSIONS: The agreed evaluation principles for telemedicine applications are the first in Germany to be based both upon evidence and consensus. Due to the methodology of development, they have a strong scientific and health policy legitimation. Therefore, and because of their general applicability, adherence to these principles beyond the context of the telemedicine platform developed within CCS THOS is recommended, namely throughout the German telemedicine scene.

Safety and efficacy of thrombolysis in telestroke: A systematic review and meta-analysis.

OBJECTIVE: The aim of this systematic review and meta-analysis was to evaluate the safety and efficacy of IV thrombolysis (IVT) with tissue plasminogen activator (tPA) delivered through telestroke networks in patients with acute ischemic stroke. METHODS: We conducted a systematic review and meta-analysis according to PRISMA guidelines. Literature searches on MEDLINE, Embase, and CENTRAL databases covered prospective randomized controlled and nonrandomized studies comparing telemedicine-guided IVT to IVT administered at stroke centers and were published from the earliest date available until April 1, 2015. Outcomes of interest were symptomatic intracerebral hemorrhage, mortality, and functional independence (modified Rankin Scale scores 0-1) at 3 months. Random-effects meta-analysis was used to compute pooled effect estimates and the I(2) statistic to assess heterogeneity. RESULTS: Of 529 records identified, 7 studies totaling 1,863 patients fulfilled our eligibility criteria. Among these, thrombolysis was largely restricted to the 3-hour time window. Symptomatic intracerebral hemorrhage rates were similar between patients subjected to telemedicine-guided IVT and those receiving tPA at stroke centers (risk ratio [RR] = 1.01, 95% confidence interval [CI] 0.37-2.80; p = 0.978) with low evidence of heterogeneity (I(2) = 37%; p = 0.189). There was no difference in mortality (RR = 1.04, 95% CI 0.74-1.48; p = 0.806) or in functional independence (RR = 1.11, 95% CI 0.78-1.57; p = 0.565) at 3 months between telemedicine-guided and stroke center thrombolysis. No heterogeneity was identified (I(2) = 0%, p = 0.964 and I(2) = 52%, p = 0.123, respectively). CONCLUSIONS: Our findings indicate that IV tPA delivery through telestroke networks is safe and effective in the 3-hour time window. Lack of prospective trials, however, emphasizes the need to further substantiate these findings in the 3- to 4.5-hour time window. PROSPERO REGISTRATION INFORMATION: URL: http://www.crd.york.ac.uk/PROSPERO. Unique identifier: CRD42015017232.

Acceptance factors of mobile apps for diabetes by patients aged 50 or older: a qualitative study.

BACKGROUND: Mobile apps for people with diabetes offer great potential to support therapy management, increase therapy adherence, and reduce the probability of the occurrence of accompanying and secondary diseases. However, they are rarely used by elderly patients due to a lack of acceptance. OBJECTIVE: We investigated the question "Which factors influence the acceptance of diabetes apps among patients aged 50 or older?" Particular emphasis was placed on the current use of mobile devices/apps, acceptance-promoting/-inhibiting factors, features of a helpful diabetes app, and contact persons for technical questions. This qualitative study was the third of three substudies investigating factors influencing acceptance of diabetes apps among patients aged 50 or older. METHODS: Guided interviews were chosen in order to get a comprehensive insight into the subjective perspective of elderly diabetes patients. At the end of each interview, the patients tested two existing diabetes apps to reveal obstacles in (first) use. RESULTS: Altogether, 32 patients with diabetes were interviewed. The mean age was 68.8 years (SD 8.2). Of 32 participants, 15 (47%) knew apps, however only 2 (6%) had already used a diabetes app within their therapy. The reasons reported for being against the use of apps were a lack of additional benefits (4/8, 50%) compared to current therapy management, a lack of interoperability with other devices/apps (1/8, 12%), and no joy of use (1/8, 12%). The app test revealed the following main difficulties in use: nonintuitive understanding of the functionality of the apps (26/29, 90%), nonintuitive understanding of the menu navigation/labeling (19/29, 66%), font sizes and representations that were too small (14/29, 48%), and difficulties in recognizing and pressing touch-sensitive areas (14/29, 48%). Furthermore, the patients felt the apps lacked individually important functions (11/29, 38%), or felt the functions that were offered were unnecessary for their own therapy needs (10/29, 34%). The most important contents of a helpful diabetes app were reported as the ability to add remarks to measured values (9/28, 32%), the definition of thresholds for blood glucose values and highlighting deviating values (7/28, 25%), and a reminder feature for measurement/medication (7/28, 25%). The most important contact persons for technical questions were family members (19/31, 61%). CONCLUSIONS: A lack of additional benefits and ease of use emerged as the key factors for the acceptance of diabetes apps among patients aged 50 or older. Furthermore, it has been shown that the needs of the investigated target group are highly heterogeneous due to varying previous knowledge, age, type of diabetes, and therapy. Therefore, a helpful diabetes app should be individually adaptable. Personal contact persons, especially during the initial phase of use, are of utmost importance to reduce the fear of data loss or erroneous data input, and to raise acceptance among this target group.