Preliminary Use and Outcome Data of a Digital Home Exercise Program for Back, Hip, and Knee Pain: Retrospective Observational Study With a Time Series and Matched Analysis

Background Musculoskeletal conditions are among the main contributors to the global burden of disease. International guidelines consider patient education and movement exercises as the preferred therapeutic option for unspecific and degenerative musculoskeletal conditions. Innovative and decentralized therapeutic means are required to provide access to and availability of such care to meet the increasing therapeutic demand for this spectrum of conditions. Objective This retrospective observational study of preliminary use and outcome data explores the clinical outcomes of Vivira (hereafter referred to as “program”), a smartphone-based program for unspecific and degenerative pain in the back, hip, and knee before it received regulatory approval for use in the German statutory health insurance system. Methods An incomplete matched block design was employed to assess pain score changes over the intended 12-week duration of the program. Post hoc analyses were performed. In addition, a matched comparison of self-reported functional scores and adherence rates is presented. Results A total of 2517 participants met the inclusion criteria and provided sufficient data to be included in the analyses. Overall, initial self-reported pain scores decreased significantly from an average of 5.19 out of 10 (SD 1.96) to an average of 3.35 out of 10 (SD 2.38) after 12 weeks. Post hoc analyses indicate a particularly emphasized pain score reduction over the early use phases. Additionally, participants with back pain showed significant improvements in strength and mobility scores, whereas participants with hip or knee pain demonstrated significant improvements in their coordination scores. Across all pain areas and pain durations, a high yet expected attrition rate could be observed. Conclusions This observational study provides the first insights into the clinical outcomes of an exercise program for unspecific and degenerative back, hip, and knee pain. Furthermore, it demonstrates a potential secondary benefit of improved functionality (ie, strength, mobility, coordination). However, as this study lacks confirmatory power, further research is required to substantiate the clinical outcomes of the program assessed. Trial Registration German Clinical Trials Register DRKS00021785; https://drks.de/search/en/trial/DRKS0002178

Postmarketing Follow-Up of a Digital Home Exercise Program for Back, Hip, and Knee Pain: Retrospective Observational Study With a Time-Series and Matched-Pair Analysis

Background: Musculoskeletal conditions are the main drivers of global disease burden and cause significant direct and indirect health care costs. Digital health applications improve the availability of and access to adequate care. The German health care system established a pathway for the approval of “Digitale Gesundheitsanwendungen” (DiGAs; Digital Health Applications) as collectively funded medical services through the “Digitale-Versorgung-Gesetz” (Digital Health Care Act) in 2019. Objective: This article presents real-world prescription data collected through the smartphone-based home exercise program “Vivira,” a fully approved DiGA, regarding its effect on self-reported pain intensity and physical inability in patients with unspecific and degenerative pain in the back, hip, and knee. Methods: This study included 3629 patients (71.8% [2607/3629] female; mean age 47 years, SD 14.2 years). The primary outcome was the self-reported pain score, which was assessed with a verbal numerical rating scale. The secondary outcomes were self-reported function scores. To analyze the primary outcome, we used a 2-sided Skillings-Mack test. For function scores, a time analysis was not feasible; therefore, we calculated matched pairs using the Wilcoxon signed-rank test. Results: Our results showed significant reductions in self-reported pain intensity after 2, 4, 8, and 12 weeks in the Skillings-Mack test (T3628=5308; P<.001). The changes were within the range of a clinically relevant improvement. Function scores showed a generally positive yet more variable response across the pain areas (back, hip, and knee). Conclusions: This study presents postmarketing observational data from one of the first DiGAs for unspecific and degenerative musculoskeletal pain. We noted significant improvements in self-reported pain intensity throughout the observation period of 12 weeks, which reached clinical relevance. Additionally, we identified a complex response pattern of the function scores assessed. Lastly, we highlighted the challenges of relevant attrition at follow-up and the potential opportunities for evaluating digital health applications. Although our findings do not have confirmatory power, they illustrate the potential benefits of digital health applications to improve the availability of and access to medical care

Advances in and the Applicability of Machine Learning-Based Screening and Early Detection Approaches for Cancer: A Primer

Despite the efforts of the past decades, cancer is still among the key drivers of global mortality. To increase the detection rates, screening programs and other efforts to improve early detection were initiated to cover the populations at a particular risk for developing a specific malignant condition. These diagnostic approaches have, so far, mostly relied on conventional diagnostic methods and have made little use of the vast amounts of clinical and diagnostic data that are routinely being collected along the diagnostic pathway. Practitioners have lacked the tools to handle this ever-increasing flood of data. Only recently, the clinical field has opened up more for the opportunities that come with the systematic utilisation of high-dimensional computational data analysis. We aim to introduce the reader to the theoretical background of machine learning (ML) and elaborate on the established and potential use cases of ML algorithms in screening and early detection. Furthermore, we assess and comment on the relevant challenges and misconceptions of the applicability of ML-based diagnostic approaches. Lastly, we emphasise the need for a clear regulatory framework to responsibly introduce ML-based diagnostics in clinical practice and routine care

Slowing gait during turning: how volition of modifying walking speed affects the gait pattern in healthy adults

BackgroundTurning during walking and volitionally modulating walking speed introduces complexity to gait and has been minimally explored.Research questionHow do the spatiotemporal parameters vary between young adults walking at a normal speed and a slower speed while making 90°, 180°, and 360° turns?MethodsIn a laboratory setting, the spatiotemporal parameters of 10 young adults were documented as they made turns at 90°, 180°, and 360°. A generalized linear model was utilized to determine the effect of both walking speed and turning amplitude.ResultsYoung adults volitionally reducing their walking speed while turning at different turning amplitudes significantly decreased their cadence and spatial parameters while increasing their temporal parameters. In conditions of slower movement, the variability of certain spatial parameters decreased, while the variability of some temporal parameters increased.SignificanceThis research broadens the understanding of turning biomechanics in relation to volitionally reducing walking speed. Cadence might be a pace gait constant synchronizing the rhythmic integration of several inputs to coordinate an ordered gait pattern output. Volition might up-regulate or down-regulate this pace gait constant (i.e., cadence) which creates the feeling of modulating walking speed

Postmarketing Follow-Up of a Digital Home Exercise Program for Back, Hip, and Knee Pain: Retrospective Observational Study With a Time-Series and Matched-Pair Analysis

Background: Musculoskeletal conditions are the main drivers of global disease burden and cause significant direct and indirect health care costs. Digital health applications improve the availability of and access to adequate care. The German health care system established a pathway for the approval of “Digitale Gesundheitsanwendungen” (DiGAs; Digital Health Applications) as collectively funded medical services through the “Digitale-Versorgung-Gesetz” (Digital Health Care Act) in 2019. Objective: This article presents real-world prescription data collected through the smartphone-based home exercise program “Vivira,” a fully approved DiGA, regarding its effect on self-reported pain intensity and physical inability in patients with unspecific and degenerative pain in the back, hip, and knee. Methods: This study included 3629 patients (71.8% [2607/3629] female; mean age 47 years, SD 14.2 years). The primary outcome was the self-reported pain score, which was assessed with a verbal numerical rating scale. The secondary outcomes were self-reported function scores. To analyze the primary outcome, we used a 2-sided Skillings-Mack test. For function scores, a time analysis was not feasible; therefore, we calculated matched pairs using the Wilcoxon signed-rank test. Results: Our results showed significant reductions in self-reported pain intensity after 2, 4, 8, and 12 weeks in the Skillings-Mack test (T3628=5308; P<.001). The changes were within the range of a clinically relevant improvement. Function scores showed a generally positive yet more variable response across the pain areas (back, hip, and knee). Conclusions: This study presents postmarketing observational data from one of the first DiGAs for unspecific and degenerative musculoskeletal pain. We noted significant improvements in self-reported pain intensity throughout the observation period of 12 weeks, which reached clinical relevance. Additionally, we identified a complex response pattern of the function scores assessed. Lastly, we highlighted the challenges of relevant attrition at follow-up and the potential opportunities for evaluating digital health applications. Although our findings do not have confirmatory power, they illustrate the potential benefits of digital health applications to improve the availability of and access to medical care.ISSN:1438-887

Preliminary Use and Outcome Data of a Digital Home Exercise Program for Back, Hip, and Knee Pain: Retrospective Observational Study With a Time Series and Matched Analysis

BackgroundMusculoskeletal conditions are among the main contributors to the global burden of disease. International guidelines consider patient education and movement exercises as the preferred therapeutic option for unspecific and degenerative musculoskeletal conditions. Innovative and decentralized therapeutic means are required to provide access to and availability of such care to meet the increasing therapeutic demand for this spectrum of conditions. ObjectiveThis retrospective observational study of preliminary use and outcome data explores the clinical outcomes of Vivira (hereafter referred to as “program”), a smartphone-based program for unspecific and degenerative pain in the back, hip, and knee before it received regulatory approval for use in the German statutory health insurance system. MethodsAn incomplete matched block design was employed to assess pain score changes over the intended 12-week duration of the program. Post hoc analyses were performed. In addition, a matched comparison of self-reported functional scores and adherence rates is presented. ResultsA total of 2517 participants met the inclusion criteria and provided sufficient data to be included in the analyses. Overall, initial self-reported pain scores decreased significantly from an average of 5.19 out of 10 (SD 1.96) to an average of 3.35 out of 10 (SD 2.38) after 12 weeks. Post hoc analyses indicate a particularly emphasized pain score reduction over the early use phases. Additionally, participants with back pain showed significant improvements in strength and mobility scores, whereas participants with hip or knee pain demonstrated significant improvements in their coordination scores. Across all pain areas and pain durations, a high yet expected attrition rate could be observed. ConclusionsThis observational study provides the first insights into the clinical outcomes of an exercise program for unspecific and degenerative back, hip, and knee pain. Furthermore, it demonstrates a potential secondary benefit of improved functionality (ie, strength, mobility, coordination). However, as this study lacks confirmatory power, further research is required to substantiate the clinical outcomes of the program assessed. Trial RegistrationGerman Clinical Trials Register DRKS00021785; https://drks.de/search/en/trial/DRKS0002178

Preliminary Use and Outcome Data of a Digital Home Exercise Program for Back, Hip, and Knee Pain: Retrospective Observational Study With a Time Series and Matched Analysis

Background: Musculoskeletal conditions are among the main contributors to the global burden of disease. International guidelines consider patient education and movement exercises as the preferred therapeutic option for unspecific and degenerative musculoskeletal conditions. Innovative and decentralized therapeutic means are required to provide access to and availability of such care to meet the increasing therapeutic demand for this spectrum of conditions. Objective: This retrospective observational study of preliminary use and outcome data explores the clinical outcomes of Vivira (hereafter referred to as “program”), a smartphone-based program for unspecific and degenerative pain in the back, hip, and knee before it received regulatory approval for use in the German statutory health insurance system. Methods: An incomplete matched block design was employed to assess pain score changes over the intended 12-week duration of the program. Post hoc analyses were performed. In addition, a matched comparison of self-reported functional scores and adherence rates is presented. Results: A total of 2517 participants met the inclusion criteria and provided sufficient data to be included in the analyses. Overall, initial self-reported pain scores decreased significantly from an average of 5.19 out of 10 (SD 1.96) to an average of 3.35 out of 10 (SD 2.38) after 12 weeks. Post hoc analyses indicate a particularly emphasized pain score reduction over the early use phases. Additionally, participants with back pain showed significant improvements in strength and mobility scores, whereas participants with hip or knee pain demonstrated significant improvements in their coordination scores. Across all pain areas and pain durations, a high yet expected attrition rate could be observed. Conclusions: This observational study provides the first insights into the clinical outcomes of an exercise program for unspecific and degenerative back, hip, and knee pain. Furthermore, it demonstrates a potential secondary benefit of improved functionality (ie, strength, mobility, coordination). However, as this study lacks confirmatory power, further research is required to substantiate the clinical outcomes of the program assessed.ISSN:2291-522

Balancing adaptability and standardisation: insights from 27 routinely implemented ICHOM standard sets

Abstract Background Healthcare systems around the world experience increasing pressure to control future growth of healthcare expenditures. Among other initiatives, quality and value-based benchmarking has become an important field to inform clinical evaluation and reimbursement questions. The International Consortium for Health Outcomes Measurement (ICHOM) has become one of the driving forces to translate scientific evidence into standardized assessments that are routinely applicable in day-to-day care settings. These aim to provide a benchmarking tool that allows the comparison and competition of health care delivery on the basis of value-based health care principles. Methods This work focuses on the consolidation of the ICHOM methodology and presents insights from 27 routinely implemented Standard Sets. The analysis is based on a literature review of the ICHOM literature repository, a process document review and key informant interviews with ICHOM’s outcomes research and development team. Results Key findings are that the scope of ICHOM Standard Sets shifted from a more static focus on burden of disease and poorly standardized care pathways to a more dynamic approach that also takes into account questions about the setting of care, feasibility of implementing a benchmarking tool and compatibility of different Standard Sets. Although certain overlaps exist with other initiatives in the field of patient reported outcomes (PRO), their scopes differ significantly and they hence rather complement each other. ICHOM pursues a pragmatic approach to enable the benchmarking and the analysis of healthcare delivery following the principles of value-based healthcare. Conclusion The ICHOM Standard Sets complement other initiatives in the field of patient-reported outcomes (PRO) and functional reporting by placing a particular focus on healthcare delivery, while other initiatives primarily focus on evaluation of academic endpoints. Although ICHOM promotes a pragmatic approach towards developing and devising its Standard Sets, the definition of standardized decision making processes emerged as one of the key challenges. Furthermore, the consolidation of core metrics across number of disease areas to enable the parallel implementation of different Standard Sets in the same care setting is an important goal that will enable the widespread implementation of patient-reported outcome measures (PROM)

The Effect of an App-Based Home Exercise Program on Self-reported Pain Intensity in Unspecific and Degenerative Back Pain: Pragmatic Open-label Randomized Controlled Trial

BackgroundThe recommended first-line treatment for unspecific and degenerative back pain consists of movement exercises and patient education. ObjectiveUsing a pragmatic, randomized controlled trial, we evaluated the effectiveness of a digital home exercise program on self-reported pain intensity compared with the standard of care for physiotherapy. MethodsParticipant recruitment was based on newspaper advertisements and a consecutive on-site assessment for eligibility and enrollment. Participants with unspecific and degenerative back pain aged ≥18 years were randomly assigned in a 1:1 ratio to receive a 12-week stand-alone digital home exercise program or physiotherapy. The digital home exercise program included 4 exercises daily, while physiotherapy included 6 to 12 sessions, depending on the severity of symptoms. The primary outcome was pain, which was assessed using a verbal numerical rating scale. The clinical relevance of pain reduction was assessed using the following thresholds: improvement of at least 1.4 points on the verbal numerical rating scale and a pain reduction of at least 30%. ResultsDuring the study period, 108 participants were assigned to the intervention group and 105 participants to the control group. The mean difference in pain scores between the 2 groups at 12 weeks was −2.44 (95% CI −2.92 to −1.95; P<.01) in favor of the intervention group. The group receiving the digital therapeutic achieved a clinically relevant reduction in pain over the course of the study (baseline vs 12 weeks), with a mean change of −3.35 (SD 2.05) score points or −53.1% (SD 29.5). By contrast, this change did not reach clinical relevance in the control group (mean −0.91, SD 1.5; −14.6%, SD 25.3). Retention rates of 89.9% in the intervention group and 97.3% in the control group were maintained throughout the study. ConclusionsThe use of the app-based home exercise program led to a significant and clinically relevant reduction in pain intensity throughout the 12-week duration of the program. The intervention studied showed superior improvement in self-reported pain intensity when compared with the standard of care. Given the great demand for standard physiotherapy for unspecific and degenerative back pain, digital therapeutics are evolving into a suitable therapeutic option that can overcome the limitations of access and availability of conventional modes of health care delivery into this spectrum of indications. However, further independent evaluations are required to support the growing body of evidence on the effectiveness of digital therapeutics in real-world care settings. Trial RegistrationGerman Clinical Trials Register DRKS00022781; https://tinyurl.com/hpdraa8

Factors influencing the occurrence of ambulatory care sensitive conditions in the emergency department - a single-center cross-sectional study

Background and importanceThe differentiation between patients who require urgent care and those who could receive adequate care through ambulatory services remains a challenge in managing patient volumes in emergency departments (ED). Different approaches were pursued to characterize patients that could safely divert to ambulatory care. However, this characterization remains challenging as the urgency upon presentation is assessed based on immediately available characteristics of the patients rather than on subsequent diagnoses. This work employs a core set of Ambulatory Care Sensitive Conditions (core-ACSCs) in an ED to describe conditions that do not require inpatient care if treated adequately in the ambulatory care sector. It subsequently analyzes the corresponding triage levels and admission status to determine whether core-ACSCs relevantly contribute to patient volumes in an ED.Settings and participantsSingle center cross-sectional analysis of routine data of a tertiary ED in 2019.Outcome measures and analysisThe proportion of core-ACSCs among all presentations was assessed. Triage levels were binarily classified as “urgent” and “non-urgent,” and the distribution of core-ACSCs in both categories was studied. Additionally, the patients presenting with core-ACSCs requiring inpatient care were assessed based on adjusted residuals and logistic regression. The proportion being discharged home underwent further investigation.Main resultsThis study analyzed 43,382 cases of which 10.79% (n = 4,683) fell under the definition of core-ACSC categories. 65.2% of all core-ACSCs were urgent and received inpatient care in 62.8% of the urgent cases. 34.8% of the core-ACSCs were categorized as non-urgent, 92.4% of wich were discharged home. Age, triage level and sex significantly affected the odds of requiring hospital admission after presenting with core-ACSCs. The two core-ACSCs that mainly contributed to non-urgent cases discharged home after the presentation were “back pain” and “soft tissue disorders.”DiscussionCore-ACSCs contribute relevantly to overall ED patient volume but cannot be considered the primary drivers of crowding. However, once patients presented to the ED with what was later confirmed as a core-ACSC, they required urgent care in 65.2%. This finding highlights the importance of effective ambulatory care to avoid emergency presentations. Additionally, the core-ACSC categories “back pain” and “soft tissue disorders” were often found to be non-urgent and discharged home. Although further research is required, these core-ACSCs could be considered potentially avoidable ED presentations.Clinical trial registrationThe study was registered in the German trials register (DRKS-ID: DRKS00029751) on 2022-07-22