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The German Innovation Fund has funded various studies on patient safety. Their thematic spectrum, methodological quality, results and recommendations of the Innovation committee were to be systematically investigated in order to derive proposals for optimizing transfer success. As part of a scoping review, all Innovation Fund projects funded in the period 2016-02/2023 with a focus on patient safety were analyzed. Each included study document was critically reviewed by two independent persons. The 16 included projects addressed a wide range of populations, indications and interventions. The study quality was mostly good. The results ranged from feasible indicator sets and the prevention of adverse drug reactions to the optimization of error management. For seven projects, the Innovation Committee recommended forwarding the results to healthcare institutions with the request that they take note and/or examine the feasibility of implementation in standard care. Implementation, however, has not yet taken place. In order to facilitate implementation, the joint development of an implementation strategy by the recipients of the Innovation Committee's recommendations is necessary.
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BACKGROUND: Recent analyses have shown that in health services research in Germany, healthcare organisations are often considered primarily as a study setting, without fully taking their complex organisational nature into account, neither theoretically nor methodologically. Therefore, an initiative was launched to analyse the state of Organisational Health Services Research (OHSR) in Germany and to develop a strategic framework and road map to guide future efforts in the field. This paper summarizes positions that have been jointly developed by consulting experts from the interdisciplinary and international scientific community. METHODS: In July 2023, a scoping workshop over the course of three days was held with 32 (inter)national experts from different research fields centred around OHSR topics using interactive workshop methods. Participants discussed their perspectives on OHSR, analysed current challenges in OHSR in Germany and developed key positions for the field's development. RESULTS: The seven agreed-upon key positions addressed conceptual and strategic aspects. There was consensus that the field required the development of a research agenda that can guide future efforts. On a conceptual level, the need to address challenges in terms of interdisciplinarity, terminology, organisation(s) as research subjects, international comparative research and utilisation of organisational theory was recognized. On a strategic level, requirements with regard to teaching, promotion of interdisciplinary and international collaboration, suitable funding opportunities and participatory research were identified. CONCLUSIONS: This position paper seeks to serve as a framework to support further development of OHSR in Germany and as a guide for researchers and funding organisations on how to move OHSR forward. Some of the challenges discussed for German OHSR are equally present in other countries. Thus, this position paper can be used to initiate fruitful discussions in other countries.
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INTRODUCTION: Since the beginning of the pandemic in spring 2020, inpatient healthcare has been under enormous burden, which is reflected especially in overworked staff, imprecise bed planning and/or data transfer. According to the recommendation of the Science Council, university clinics should play a controlling role in regional healthcare and act in conjunction with surrounding hospitals and practices. METHODS: In September 2021, 31 representatives from 18 university hospitals were invited to a hybrid Delphi study with a total of 4 survey rounds to discuss criteria for effective inpatient care in a pandemic situation, which were extracted from previous expert interviews. Criteria that were classified as very important/relevant by≥75% of the participants in the first round of the survey (consensus definition) were then further summarized in 4 different small groups. In a third Delphi round, all participants came together again to discuss the results of the small group discussions. Subsequently, these were prioritized as Optional ("can"), Desirable ("should") or Necessary ("must") recommendations. RESULTS: Of the invited clinical experts, 21 (67.7%) participated in at least one Delphi round. In an online survey (1st Delphi round), 233 criteria were agreed upon and reduced to 84 criteria for future pandemic management in four thematic small group discussions (2nd Delphi round) and divided into the small groups as follows: "Crisis Management and Crisis Plans" (n=20), "Human Resources Management and Internal Communication" (n=16), "Regional Integration and External Communication" (n=24) and "Capacity Management and Case & Care" (n=24). In the following group discussion (3rd Delphi round), the criteria were further modified and agreed upon by the experts, so that in the end result, there were 23 essential requirements and recommendations for effective inpatient care in a pandemic situation. CONCLUSION: The results draw attention to key demands of clinical representatives, for example, comprehensive digitization, standardization of processes and better (supra) regional networking in order to be able to guarantee needs-based care even under pandemic conditions. The present consensus recommendations can serve as guidelines for future pandemic management in the inpatient care sector.
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Pacientes Internados , Pandemias , Humanos , Técnica Delphi , Alemanha/epidemiologia , Inquéritos e QuestionáriosRESUMO
BACKGROUND: About 2% of the German population are affected by psoriasis. A growing number of cost-intensive systemic treatments are available. Surveys have shown high proportions of patients with moderate to severe psoriasis are not adequately treated despite a high disease burden. Digital therapy recommendation systems (TRS) may help implement guideline-based treatment. However, little is known about the acceptance of such clinical decision support systems (CDSSs). Therefore, the aim of the study was to access the acceptance of a prototypical TRS demonstrator. METHODS: Three scenarios (potential test patients with psoriasis but different sociodemographic and clinical characteristics, previous treatments, desire to have children, and multiple comorbidities) were designed in the demonstrator. The TRS demonstrator and test patients were presented to a random sample of 76 dermatologists attending a national dermatology conference in a cross-sectional face-to-face survey with case vignettes. The dermatologist were asked to rate the demonstrator by system usability scale (SUS), whether they would use it for certain patients populations and barriers of usage. Reasons for potential usage of the TRS demonstrator were tested via a Poisson regression with robust standard errors. RESULTS: Acceptance of the TRS was highest for patients eligible for systemic therapy (82%). 50% of participants accepted the system for patients with additional comorbidities and 43% for patients with special subtypes of psoriasis. Dermatologists in the outpatient sector or with many patients per week were less willing to use the TRS for patients with special psoriasis-subtypes. Dermatologists rated the demonstrator as acceptable with an mean SUS of 76.8. Participants whose SUS was 10 points above average were 27% more likely to use TRS for special psoriasis-subtypes. The main barrier in using the TRS was time demand (47.4%). Participants who perceived time as an obstacle were 22.3% less willing to use TRS with systemic therapy patients. 27.6% of physicians stated that they did not understand exactly how the recommendation was generated by the TRS, with no effect on the preparedness to use the system. CONCLUSION: The considerably high acceptance and the preparedness to use the psoriasis CDSS suggests that a TRS appears to be implementable in routine healthcare and may improve clinical care. Main barrier is the additional time demand posed on dermatologists in a busy clinical setting. Therefore, it will be a major challenge to identify a limited set of variables that still allows a valid recommendation with precise prediction of the patient-individual benefits and harms.
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Médicos , Psoríase , Criança , Humanos , Estudos Transversais , Psoríase/terapia , Atenção à Saúde , ComorbidadeRESUMO
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.
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With this discussion paper, the subgroup Mixed Methods of the working group Qualitative Research Methods in the non-profit organization German Network Health Services Research (DNVF) is taking up the topic of three previous discussion papers on the significance and potentials of qualitative research methods in health services research. Mixed methods are being increasingly used and demanded in health services research. However, there are also areas of conflict in the planning and implementation of mixed methods studies, and these are addressed in this paper from the perspective of qualitative research. Special attention is given to the aspect of integration as the fundamental signature of mixed methods research. With this discussion paper, our aim was to stimulate critical as well as constructive exchange of ideas on what constitutes high-quality health services research characterised by a diversity of methods and the framework conditions under which this can succeed.
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Pesquisa sobre Serviços de Saúde , Projetos de Pesquisa , Humanos , Alemanha , Pesquisadores , Pesquisa QualitativaRESUMO
To successfully scale-up telemedicine initiatives (TIs), communities play a crucial role. To empower communities fulfilling this role and increase end users' acceptance of TIs, support tools (from now on entitled artifacts) are needed that include specific measures to implement and scale up telemedicine. Addressing this need, the article introduces the Telemedicine Community Readiness Model (TCRM). The TCRM is designed to help decision-makers in communities to create a favorable environment that facilitates the implementation and scale-up of TIs. The TCRM is a practical tool to assess communities' readiness to implement TIs and identify aspects to improve this readiness. The development process follows a design-science procedure, which integrates literature reviews and semi-structured expert interviews to justify and evaluate design decisions and the final design. For researchers, the paper provides insights into factors that influence telemedicine implementation and scale-up (descriptive role of knowledge) on the community level. For practitioners, it provides a meaningful tool to support the implementation and scale-up of TIs (prescriptive role of knowledge). This should help to realize the potential of telemedicine solutions to increase access to healthcare services and their quality.
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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.
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Pesquisa sobre Serviços de Saúde , AlemanhaRESUMO
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.
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Pesquisa sobre Serviços de Saúde , AlemanhaRESUMO
Aim: Telemedicine is a promising solution to extend traditional health care services. Even though mainly discussed during the past two decades, its roots go back into the past century and even further, considering the use of bonfires to warn other villages of diseases. Insights from historical cases can therefore be useful for the ongoing discussion regarding the successful implementation of telemedicine. Subject and Methods: We analyzed three historical telemedicine cases (varying regarding time and place) and extracted their success factors and barriers as well as assessed their maturity by using the Telemedicine Community Readiness Model (TCRM). Evidence-based categories of success factors and barriers as well as the TCRM's dimensions were used as deductive categories to analyze the study material's content. Results: The analysis showed that the readiness for telemedicine is higher when the technology is the only option to access health care services. In all three cases, core readiness played a central role. However, the health sector, existing technology, and finance were barriers present at all times, while during pandemics, some barriers are only temporarily removed, for example, by putting legal issues on hold. The analyzed cases were all on lower levels of maturity as they mainly represent pilot tests or exceptional circumstances. Conclusion: Results indicate the important core functions in telemedicine initiatives as well as the diversity of their circumstances. Insights from such historical meta-perspectives can, for example, help to strengthen the sustainability of the increased use of telemedicine during the COVID-19 pandemic and scale up current telemedicine projects.
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AIM: The purpose of this editorial is to provide guidance for the readers concerning the broad realm of approaches towards successful implementation of digital health applications into the health care system. Recent developments due to the challenges posed by the COVID-19 pandemic are used as a current angle. SUBJECT AND METHODS: All contributions within the special issue were scanned for their most decisive contribution to the special issue and the field of implementation science, with a focus on digital health. Micro, meso, and macro layers of implementation processes, as well as the technological perspective itself, are used as broad categories for sorting the contributions and structuring the special issue. RESULTS: The ten contributions to this special issue cover micro (n = 1), technology (n = 1), meso (n = 4) and macro (n = 2) perspectives on the implementation process of digital health applications. Two further contributions also tackle the issue from a wider perspective when aiming to structure telemedicine application types and barriers encountered when implementing digital health. CONCLUSION: Considering the wide array of research fields represented in this special issue, an emphasis is put on the importance of interdisciplinary work required for tackling the scale-up problem of digital health. As such, the special issue can assist in leveraging the full potential of digital health, not only when dealing with situations as out-of-the-ordinary as the current pandemic but also well beyond that, for example when dealing with the upcoming challenges of demographic change.
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As physical inactivity is one of the four leading risk factors for mortality, it should be intensively treated. Therefore, this one-year follow-up study aimed to evaluate the long-term effects of a preventive app to increase physical activity in German adults under real-life circumstances. Data collection took place from July 2019 to July 2021 and included six online questionnaires. Physical activity was studied as the primary outcome based on MET-minutes per week (metabolic equivalent). Secondary outcomes included health-related quality of life based on a mental (MCS) and physical health component summary score (PCS). At the time of publication, 46/65 participants completed the study (median 52 years, 81.5% women). A significant increase of physical activity was observed in people with a low/moderate baseline activity during the first four months of follow-up (median increase by 490 MET-minutes per week, p < 0.001, r = 0.649). Both MCS (median increase by 2.8, p = 0.006, r = 0.344) and PCS (median increase by 2.6, p < 0.001, r = 0.521) significantly increased during the first two months and the BMI significantly decreased during the first six months after the intervention (median decrease by 0.96 kg/m2, p < 0.001, r = 0.465). Thus, this study provides evidence for the medium-term impact of the app, since the effects decreased over time. However, due to the chosen study design and a sizeable loss to follow-up, the validity of these findings is limited.
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Exercício Físico/estatística & dados numéricos , Promoção da Saúde/métodos , Aplicativos Móveis , Índice de Massa Corporal , Feminino , Seguimentos , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Qualidade de Vida , Smartphone , Fatores de TempoRESUMO
INTRODUCTION: The complex and dynamic situation in the current pandemic requires a regionally coordinated and interconnected cooperation between the different stakeholders within the health care system, such as the inpatient sector or the public health service. The aim of this study is to analyze health care management during the COVID-19 pandemic in 2020 with a focus on regional networking and communication structures. METHODS: As part of the BMBF-funded project "egePan Unimed", an online questionnaire on pandemic management was sent to the boards of all 35 German university hospitals in November 2020. The questionnaire focused on the core topics of regional networking, crisis management, data exchange, and communication with political stakeholders. The questionnaire consisted of 37 closed and three open-ended questions. After piloting, the invitation to the survey was extended three times by mail and once by telephone. RESULTS: The results (n=25, response 71.4%) show that 68% of the clinics surveyed were connected to representatives from the inpatient sector and 86% to representatives from the public health service. Networking with representatives from the outpatient sector was less common (26%). Of the university hospitals surveyed, 84% had a leadership role in a regional COVID-19 pandemic management effort. Data exchange with regional hospitals in the course of pandemic management took place at 75% of the participating university hospitals and with supra-regional hospitals at 67% of the clinics surveyed. CONCLUSION: To manage regional medical care during the COVID-19 pandemic in 2020, university hospitals often assumed a coordinating role in the complex pandemic care process. There were often structured collaborations with regional clinics and health departments and comparatively few cooperations with the outpatient care sector. However, this cooperation has the potential to prevent overcrowding in hospitals.
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COVID-19 , Pandemias , Adaptação Psicológica , Atenção à Saúde , Alemanha , Hospitais Universitários , Humanos , SARS-CoV-2RESUMO
BACKGROUND: Model projects for flexible and integrated treatment (FIT) in Germany aim at advancing the quality of care for people with mental disorders. A new FIT model project was established in 2017 at the Department of child and adolescent psychiatry (KJP) of the University Hospital Tübingen (Universitätsklinikum Tübingen, UKT). The study design of EVA_TIBAS presented here describes the evaluation of the FIT model project at the KJP of the UKT. This evaluation aims at quantifying the anticipated FIT model project changes, which are to improve patients' cross-sectoral care at the same maximum cost as standard care. METHODS: EVA_TIBAS is a controlled cohort study using a mix of quantitative and qualitative methods. The FIT evaluation consists of three modules. In Module A, anonymized claims data of a statutory health insurance fund will be used to compare outcomes (duration of inpatient and day care psychiatric treatment, inpatient and day care psychiatric length of stay, outpatient psychiatric treatment in hospital, inpatient hospital readmission, emergency admission rate, direct medical costs) of patients treated in the model hospital with patients treated in structurally comparable control hospitals (estimated sample size = ca. 600 patients). In Module B, patient-reported outcomes (health related quality of life, symptom burden, return to psychosocial relationships (e.g. school, friends, hobbies), treatment satisfaction, societal costs) will be assessed quantitatively using validated questionnaires for the model and two control hospitals (estimated sample size = ca. 300 patients). A subsequent health economic evaluation will be based on cost-effectiveness analyses from both the insurance fund's and the societal perspective. In Module C, about 30 semi-structured interviews will examine the quality of offer, effects and benefits of the service offered by the social service of the AOK Baden-Württemberg (for stabilizing the overall situation of care in the family) in the model hospital. A focus group discussion will address the quality of cooperation between employees of the university hospital and the social services. DISCUSSION: The results of this evaluation will be used to inform policy makers whether this FIT model project or aspects of it should be implemented into standard care. TRIAL REGISTRATION: This study was registered at ClinicalTrials.gov PRS (ID: NCT04727359 , date: 27 January 2021).
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Psiquiatria do Adolescente , Qualidade de Vida , Adolescente , Criança , Humanos , Estudos de Coortes , AlemanhaRESUMO
Many telemedicine interventions fail to be implemented in medical care with non-use and discontinued use by patients being among the major reasons. The aim of this scoping review was to provide an overview of barriers associated with non-use and discontinued use of telemedicine. An electronic search was conducted in Pubmed in October 2019 and updated in November 2020, followed by a hand search in the beginning of 2021. All potential articles were screened by two independent reviewers based on predefined inclusion and exclusion criteria. A qualitative content analysis according to Mayring was carried out. The topics 'intervention', 'context of use' and 'user' were chosen as overarching themes. Out of 1377 potentially relevant articles, 73 were included. User-related barriers were mentioned in most of the analysed studies, followed by barriers related to the intervention. The analysis provides the basis for overcoming non-use issues in telemedicine.
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Telemedicina , Atenção à Saúde , HumanosRESUMO
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.