Scale-up of Digital Innovations in Health Care: Expert Commentary on Enablers and Barriers.

Health care delivery is undergoing a rapid change from traditional processes toward the use of digital health interventions and personalized medicine. This movement has been accelerated by the COVID-19 crisis as a response to the need to guarantee access to health care services while reducing the risk of contagion. Digital health scale-up is now also vital to achieve population-wide impact: it will only accomplish sustainable effects if and when deployed into regular health care delivery services. The question of how sustainable digital health scale-up can be successfully achieved has, however, not yet been sufficiently resolved. This paper identifies and discusses enablers and barriers for scaling up digital health innovations. The results discussed in this paper were gathered by scientists and representatives of public bodies as well as patient organizations at an international workshop on scaling up digital health innovations. Results are explored in the context of prior research and implications for future work in achieving large-scale implementations that will benefit the population as a whole.

Development and validation of a shoulder-specific body-perception questionnaire in people with persistent shoulder pain.

BACKGROUND: There is evidence that people with persistent shoulder pain exhibit findings consistent with the presence of sensorimotor dysfunction. Sensorimotor impairments can manifest in a variety of ways, and further developing our understanding of sensorimotor dysfunction in shoulder pain may improve current models of care. The Fremantle Back Awareness Questionnaire (FreBAQ) has been developed to assess disturbed body perception specific to the back. The purpose of the present study was to develop a shoulder-specific self-perception questionnaire and evaluate the questionnaire in people with persistent shoulder pain. METHODS: The Fremantle Shoulder Awareness Questionnaire (FreSHAQ-J) was developed by modifying the FreBAQ. One hundred and twelve consecutive people with persistent shoulder pain completed the FreSHAQ-J. Thirty participants completed the FreSHAQ-J again two-weeks later to assess test-retest reliability. Rasch analysis was used to assess the psychometric properties of the FreSHAQ-J. Associations between FreSHAQ-J total score and clinical status was explored using correlational analysis. RESULTS: The FreSHAQ-J has acceptable category order, unidimensionality, no misfitting items, and excellent test-retest reliability. The FreSHAQ-J was moderately correlated with disability and pain catastrophization. CONCLUSIONS: The FreSHAQ-J fits the Rasch measurement model well and is suitable for use with people with shoulder pain. Given the relationship between the FreSHAQ-J score and clinical status, change in body perception may be worth assessing when managing patients with shoulder pain.

[Comments on minimally invasive otoplasty (MIO)]. / Anmerkungen zur Minimal-invasiven Otoplastik (MIO).

According to our now quite large experience, minimally invasive otoplasty (MIO) is a reliable technique to correct protruding ears. With the correct indication its results are aesthetically pleasing, natural and lasting. The limitations of minimally invasive otoplasty techniques have though to be seen and respected. New instruments facilitate the procedure and reduce complication rates. Especially keloids and large hypertrophic scars due to extensive skin incisions and resections on the pinna backside are almost excluded with minimally invasive otoplasty. We present our concept that has grown over two decades.

Acupuncture applied as a sensory discrimination training tool decreases movement-related pain in patients with chronic low back pain more than acupuncture alone: a randomised cross-over experiment.

BACKGROUND: High-quality clinical evidence suggests that although acupuncture appears superior to usual care in the management of chronic low back pain, there is little meaningful difference between true and sham acupuncture. This suggests that the benefits of acupuncture are mediated by the placebo response. An alternative explanation is that sham acupuncture is an active treatment and shares a mechanism of action with traditionally applied acupuncture. One plausible candidate for this mechanism is improvement in self-perception mediated through the sensory discrimination-like qualities of acupuncture. We aimed to compare the effects of acupuncture with a sensory discrimination training component to acupuncture without. METHODS: 25 people with chronic low back pain were enroled in a randomised cross-over experiment. We compared the effect of acupuncture delivered when sensory discrimination is optimised to acupuncture delivered when it is not, on movement-related back pain immediately after each intervention. RESULTS: We found that the average pain intensity after participants had received acupuncture with sensory discrimination training (2.8±2.5) was less than when they received acupuncture without sensory discrimination training (3.6±2.0). This difference was statistically significant (after adjustment; mean difference=-0.8, 95% CI -1.4 to -0.3; p=0.011). CONCLUSIONS: Our findings are consistent with the idea that acupuncture may offer specific benefit that is not dependent on precisely where the needles are inserted so much as that the patient attends to where they are inserted. If so, the location of the needles might be better focused on the painful area and the need for penetration of the skin may be mitigated.

Minimally Invasive Otoplasty.

Minimally invasive otoplasty (MIO) is an elegant and well-proven technique for correcting protruding ears as the most frequent form of first-degree auricular dysplasia. It is well suited for the majority of patients with prominauris who regularly present to a facial plastic surgery practice. Although there are several variations of the MIO, all MIO techniques differ from traditional otoplasty techniques in that they avoid a large retroauricular skin incision and excision. This distinction considerably diminishes the risk of hypertrophic scars and keloids. The best elements of traditional otoplastic techniques can be utilized with much smaller incisions, respectively, even without incisions at all and with new surgical instruments to achieve an effective and precise surgical result. The MIO technique described herein enables all steps of cartilage work through the small retroauricular skin incision that Kaye already suggested in the very first publications of a closed otoplasty technique 1967.

The cross-cultural adaptation, validity, and reliability of the Spanish version of the Fremantle Back Awareness Questionnaire.

Introduction: In chronic low back pain (CLBP), disturbed body image has been highlighted as a contributor to the condition and a potential target for treatment. The Fremantle Back Awareness Questionnaire (FreBAQ) allows its assessment. Following international guidelines for the cross-cultural translation of questionnaires, we aimed to translate the FreBAQ into Spanish (FreBAQ-S) and validate the new questionnaire in a sample of Spanish-speaking people with CLBP. Methods: Two hundred and sixty-four adults with CLBP (91 males) and 128 healthy controls (34 males) completed an online form including the FreBAQ-S and questionnaires related to the pain experience. All participants were Spanish and no gender identities differing from biological sex were reported. A week later, 113 CLBP participants and 45 healthy controls (41 and 13 males, respectively), re-answered the FreBAQ-S to evaluate test-retest reliability. Confirmatory factor and multigroup analysis assessed the scale consistency on the patient sample. Discriminant and convergent validity were explored by between-group differences and the relationship with clinical characteristics. Reliability relied on Cronbach's alpha estimates and test-retest (intraclass correlation coefficient, standard error of measurement, minimal detectable change). Results and discussion: Confirmatory factor analysis showed a one-factor structure of the questionnaire, without supporting evidence for item deletion (CFI = 0.97; TLI = 0.96; RMSEA = 0.06; SRMR = 0.07; SRMRu = 0.064). Multigroup analyses do not support mean invariance between groups regarding health condition or sex. The FreBAQ-S demonstrated good discriminant and convergent validity, internal consistency (α = 0.82), and test-retest reliability (ICC = 0.78; SE = 3.41; MDC = 5.12). The FreBAQ-S is a valid and reliable tool to assess back awareness in clinical and non-clinical samples.

It's safe to move! A protocol for a randomised controlled trial investigating the effect of a video designed to increase people's confidence becoming more active despite back pain.

INTRODUCTION: Social media provide promising contemporary platforms for sharing public health information with a broad audience. Before implementation, testing social media campaigns that are intended to engage audiences and initiate behaviour change is necessary. This trial aims to investigate the effectiveness of a public health campaign to increase people's confidence in becoming more active despite low back pain in comparison with no intervention. METHODS AND ANALYSIS: This is an online randomised controlled trial with two intervention groups and one control group in a 1:1:1 allocation. People over 18 years of age and fluent in English will be recruited via social media advertising. We developed a social media-based public health campaign to support recommendations for managing low back pain. The interventions are two videos. Participants in the control group will be asked questions about low back pain but will not view either video intervention. The primary outcome will be item 10 of the Pain Self-Efficacy Questionnaire, which asks participants to rate how confident they would feel to gradually become more active despite pain ranging from 0 (not at all confident) to 6 (completely confident). This outcome will be measured immediately in all participant groups. We will compare group mean of the three arms of the trial using univariate analyses of variance. ETHICS AND DISSEMINATION: This trial has been prospectively registered with the Australian New Zealand Clinical Trials Registry. We obtained ethical approval from our institutions Human Research Ethics Committee before data collection. We will publish the results in a peer-reviewed medical journal and on institution websites. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12622000466741).

Profiles of eHealth Adoption in Persons with Multiple Sclerosis and Their Caregivers.

(1) Background: Persons with multiple sclerosis (pwMS) are often characterized as ideal adopters of new digital healthcare trends, but it is worth thinking about whether and which pwMS will be targeted and served by a particular eHealth service like a patient portal. With our study, we wanted to explore needs and barriers for subgroups of pwMS and their caregivers when interacting with eHealth services in care and daily living. (2) Methods: This study comprises results from two surveys: one collecting data from pwMS and their relatives (as informal caregivers) and another one providing information on the opinions and attitudes of healthcare professionals (HCPs). Data were analyzed descriptively and via generalized linear models. (3) Results: 185 pwMS, 25 informal caregivers, and 24 HCPs in the field of MS participated. Nine out of ten pwMS used information technology on a daily base. Individual impairments like in vision and cognition resulted in individual needs like the desire to actively monitor their disease course or communicate with their physician in person. HCPs reported that a complete medication overview, additional medication information, overview of future visits and a reminder of medication intake would be very helpful eHealth features for pwMS, while they themselves preferred features organizing and enriching future visits. (4) Conclusions: A closer look at the various profiles of eHealth adoption in pwMS and their caregivers indicated that there is a broad and robust enthusiasm across several subgroups that does not exclude anyone in general, but constitutes specific areas of interest. For pwMS, the focus was on eHealth services that connect previously collected information and make them easily accessible and understandable.

Knee-related disability was largely influenced by cognitive factors and disturbed body perception in knee osteoarthritis.

The aim of this study was to explore the existence of subgroups in a cohort of people with knee osteoarthritis (OA) based upon data from multiple pain-related variables and to profile identified clusters according to levels of pain intensity and knee-related disability. Three hundred and three people with knee OA were recruited. Latent profile analysis was used to confirm the optimal number of knee OA subgroups. Body mass index, radiographic knee OA severity, pain catastrophizing, pain related self-efficacy, and knee specific self-perception, were incorporated into the model. Cluster, demographic and clinical variables were compared between the resulting classes. Four distinct classes were identified. Cluster 1 (28.7%) represented early radiographic OA, and moderate pain intensity, disability and cognitive and perceptual dysfunction. Cluster 2 (18.8%) showed advanced radiographic OA, and moderate pain intensity, disability and cognitive and perceptual dysfunction. Cluster 3 (34.3%) represented various levels of radiographic OA, and the lowest pain intensity, disability and cognitive and perceptual dysfunction. Cluster 4 (18.1%) represented various levels of radiographic OA, the highest disability and cognitive and perceptual dysfunction. Considering cognitive factors and disturbed body perception may help to explain the phenomenon of the discrepancy between the knee-related disability and the severity of radiographic knee OA.

Identifying participants with knee osteoarthritis likely to benefit from physical therapy education and exercise: A hypothesis-generating study.

BACKGROUND: The purpose of this investigation was to undertake a hypothesis-generating study to identify candidate variables that characterize people with knee osteoarthritis who are most likely to experience a positive response to exercise. METHODS: One hundred and fifty participants with knee osteoarthritis participated in this observational, longitudinal study. All participants received a standard exercise intervention that consisted of 20-min sessions two to three times a week for three months. The classification and regression tree methodology (CART) was used to develop prediction of positive clinical outcome. Positive pain and disability outcomes (dependent variables) were defined as an improvement in pain intensity by >50% or an improvement of five or more on the Oxford knee score, respectively. The predictor variables considered included age, sex, body mass index, knee osteoarthritis severity (Kellgren/Lawrence grade), pain duration, use of medication, range of knee motion, pain catastrophizing, self-efficacy and knee self-perception. RESULTS: Fifty-five participants (36.6%) were classified as responders for pain intensity and 36.6% were classified as responders for disability. The CART model identified impairments in knee self-perception and knee osteoarthritis severity as the discriminators for pain intensity reduction following exercise. No variables predicted reduction of disability level following exercise. CONCLUSIONS: Such findings suggest that both body perception and osteoarthritis severity may play a role in treatment outcome with exercise. It also raises the possibility that those with higher levels of disrupted body perception may need additional treatment targeted at restoring body perception prior to undertaking exercise. SIGNIFICANCE: Regardless age, sex, body mass index, pain duration, use of medication, knee range of motion, pain catastrophizing and self-efficacy, participants with knee osteoarthritis who report low levels of body perception disruption (a FreKAQ score ≦ 17) and minimal structural changes (KL grade I) demonstrate significantly better outcomes from exercise therapy than other participants.

Self-reported assessment of disability and performance-based assessment of disability are influenced by different patient characteristics in acute low back pain.

For an individual, the functional consequences of an episode of low back pain is a key measure of their clinical status. Self-reported disability measures are commonly used to capture this component of the back pain experience. In non-acute low back pain there is some uncertainty of the validity of this approach. It appears that self-reported assessment of disability and direct measurements of functional status are only moderately related. In this cross-sectional study, we investigated this relationship in a sample of 94 acute low back pain patients. Both self-reported disability and a performance-based assessment of disability were assessed, along with extensive profiling of patient characteristics. Scale consistency of the performance-based assessment was investigated using Cronbach's alpha, the relationship between self-reported and performance-based assessment of disability was investigated using Pearson's correlation. The relationship between clinical profile and each of the disability measures were examined using Pearson's correlations and multivariate linear regression. Our results demonstrate that the battery of tests used are internally reliable (Cronbach's alpha = 0.86). We found only moderate correlations between the two disability measures (r = 0.471, p < 0.001). Self-reported disability was significantly correlated with symptom distribution, medication use, physical well-being, pain intensity, depression, somatic distress and anxiety. The only significant correlations with the performance-based measure were symptom distribution, physical well-being and pain intensity. In the multivariate analyses no psychological measure made a significant unique contribution to the prediction of the performance-based measure, whereas depression made a unique contribution to the prediction of the self-reported measure. Our results suggest that self-reported and performance-based assessments of disability are influenced by different patient characteristics. In particular, it appears self-reported measures of disability are more influenced by the patient's psychological status than performance-based measures of disability.

A Digital Patient Portal for Patients With Multiple Sclerosis.

Background: Multiple Sclerosis is a chronic inflammatory disease of the central nervous system that requires a complex, differential, and lifelong treatment strategy, which involves high monitoring efforts and the accumulation of numerous medical data. A fast and broad availability of care, as well as patient-relevant data and a stronger integration of patients and participating care providers into the complex treatment process is desirable. The aim of the ERDF-funded project "Integrated Care Portal Multiple Sclerosis" (IBMS) was to develop a pathway-based care model and a corresponding patient portal for MS patients and health care professionals (HCPs) as a digital tool to deliver the care model. Methods: The patient portal was created according to a patient-centered design approach which involves both the patients' and the professionals' view. Buurmann's five iterative phases were integrated into a design science research process. A problem analysis focusing on functions and user interfaces was conducted through surveys and workshops with MS patients and HCPs. Based on this, the patient portal was refined and a prototype of the portal was implemented using an agile software development strategy. Results: HCPs and patients already use digital hardware and are open to new technologies. Nevertheless, they desire improved (digital) communication and coordination between care providers. Both groups require a number of functions for the patient portal, which were implemented in the prototype. Usability tests with patients and HCPs are planned to consider whether the portal is deemed as usable, acceptable as well as functional to prepare for any needed ameliorations. Discussion: After testing the patient portal for usability, acceptability, and functionality, it will most likely be a useful and high-quality electronic health (eHealth) tool for patient management from day care to telerehabilitation. It implements clinical pathways in a manner which is comprehensible for patients. Future developments of the patient portal modules could include additional diseases, the integration of quality management and privacy management tools, and the use of artificial intelligence to personalize treatment strategies.

Embodying the illusion of a strong, fit back in people with chronic low back pain. A pilot proof-of-concept study.

OBJECTIVE: This proof-of-concept pilot study aimed to investigate if a visual illusion that altered the size and muscularity of the back could be embodied and alter perception of the back. METHODS: The back visual illusions were created using the MIRAGE multisensory illusion system. Participants watched real-time footage of a modified version of their own back from behind. Participants undertook one experimental condition, in which the image portrayed a muscled, fit-looking back (Strong), and two control conditions (Reshaped and Normal) during a lifting task. Embodiment, back perception as well as pain intensity and beliefs about the back during lifting were assessed. RESULTS: Two participants with low back pain were recruited for this study: one with altered body perception and negative back beliefs (Participant A) and one with normal perception and beliefs (Participant B). Participant A embodied the Strong condition and pain and fear were less and both perceived strength and confidence were more than for the Normal or the Reshaped condition. Participant B did not embody the Strong condition and reported similar levels of pain, fear strength and confidence across all three conditions. DISCUSSION: An illusion that makes the back look strong successfully induced embodiment of a visually modified back during a lifting task in a low back pain patient with altered body perception. Both participants tolerated the illusion, there were no adverse effects, and we gained preliminary evidence that the approach may have therapeutic potential.

Chronic non-specific low back pain - sub-groups or a single mechanism?

BACKGROUND: Low back pain is a substantial health problem and has subsequently attracted a considerable amount of research. Clinical trials evaluating the efficacy of a variety of interventions for chronic non-specific low back pain indicate limited effectiveness for most commonly applied interventions and approaches. DISCUSSION: Many clinicians challenge the results of clinical trials as they feel that this lack of effectiveness is at odds with their clinical experience of managing patients with back pain. A common explanation for this discrepancy is the perceived heterogeneity of patients with chronic non-specific low back pain. It is felt that the effects of treatment may be diluted by the application of a single intervention to a complex, heterogeneous group with diverse treatment needs. This argument presupposes that current treatment is effective when applied to the correct patient. An alternative perspective is that the clinical trials are correct and current treatments have limited efficacy. Preoccupation with sub-grouping may stifle engagement with this view and it is important that the sub-grouping paradigm is closely examined. This paper argues that there are numerous problems with the sub-grouping approach and that it may not be an important reason for the disappointing results of clinical trials. We propose instead that current treatment may be ineffective because it has been misdirected. Recent evidence that demonstrates changes within the brain in chronic low back pain sufferers raises the possibility that persistent back pain may be a problem of cortical reorganisation and degeneration. This perspective offers interesting insights into the chronic low back pain experience and suggests alternative models of intervention. SUMMARY: The disappointing results of clinical research are commonly explained by the failure of researchers to adequately attend to sub-grouping of the chronic non-specific low back pain population. Alternatively, current approaches may be ineffective and clinicians and researchers may need to radically rethink the nature of the problem and how it should best be managed.

eHealth-Platforms - The Case of Europe.

Platform approaches to improve interorganisational integration and eHealth innovation have gained a lot of attention. A variety of platform projects have been established in Europe. However, a systematic view is missing. Based on a multiple source analysis, this paper collects existing European eHealth-platforms and systematizes them with regard to their functional adjustment. We contribute by proving a functional cluster of platforms. The paper describes classification dimensions and identifies two general classes of platforms in the healthcare sector.

Safety and feasibility of transcranial direct current stimulation (tDCS) combined with sensorimotor retraining in chronic low back pain: a protocol for a pilot randomised controlled trial.

INTRODUCTION: Chronic low back pain (LBP) is a common and costly health problem yet current treatments demonstrate at best, small effects. The concurrent application of treatments with synergistic clinical and mechanistic effects may improve outcomes in chronic LBP. This pilot trial aims to (1) determine the feasibility, safety and perceived patient response to a combined transcranial direct current stimulation (tDCS) and sensorimotor retraining intervention in chronic LBP and (2) provide data to support a sample size calculation for a fully powered trial should trends of effectiveness be present. METHODS AND ANALYSIS: A pilot randomised, assessor and participant-blind, sham-controlled trial will be conducted. Eighty participants with chronic LBP will be randomly allocated to receive either (1) active tDCS + sensorimotor retraining or (2) sham tDCS + sensorimotor retraining. tDCS (active or sham) will be applied to the primary motor cortex for 20 min immediately prior to 60 min of supervised sensorimotor retraining twice per week for 10 weeks. Participants in both groups will complete home exercises three times per week. Feasibility, safety, pain, disability and pain system function will be assessed immediately before and after the 10-week intervention. Analysis of feasibility and safety will be performed using descriptive statistics. Statistical analyses will be conducted based on intention-to-treat and per protocol and will be used to determine trends for effectiveness. ETHICS AND DISSEMINATION: Ethical approval has been gained from the institutional human research ethics committee (H10184). Written informed consent will be provided by all participants. Results from this pilot study will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ACTRN12616000624482.

CDA Templates - Utilizing the MediCUBE.

The specification and customization of clinical document types are tasks that need a strong collaboration between domain experts and IT specialists. However, these collaborators are often faced with difficulties due to different interpretation of domain knowledge. Therefore, an adequate method for sharing domain knowledge about documents is necessary. Even though there are some tools that help to define medical document types, there is a lack of approaches that focus on the understandability of the specification for the domain experts. This paper proposes a modeling approach based on the Clinical Document Architecture to address this gap.

Disturbed body perception, reduced sleep, and kinesiophobia in subjects with pregnancy-related persistent lumbopelvic pain and moderate levels of disability: An exploratory study.

BACKGROUND: For a small but significant group, pregnancy-related lumbopelvic pain may become persistent. While multiple factors may contribute to disability in this group, previous studies have not investigated sleep impairments, body perception or mindfulness as potential factors associated with disability post-partum. OBJECTIVES: To compare women experiencing no pain post-pregnancy with those experiencing pregnancy-related persistent lumbopelvic pain (either low- or high-level disability) across multiple biopsychosocial domains. DESIGN: Cross-sectional. METHODS: Participants completed questionnaires for thorough profiling of factors thought to be important in pregnancy-related lumbopelvic pain. Specific measures were the Urinary Distress Inventory, Medical Outcomes Study Sleep Scale, Back Beliefs Questionnaire, Tampa Scale for Kinesiophobia, Depression Anxiety Stress Scale, Coping Strategies Questionnaire, Pain Catastrophising Scale, The Fremantle Back Awareness Questionnaire and the Mindful Attention Awareness Scale. Women where categorised into three groups; pain free (n = 26), mild disability (n = 12) and moderate disability (n = 12) (based on Oswestry Disability Index scores). Non-parametric group comparisons were used to compare groups across the profiling variables. RESULTS: Differences were identified for kinesiophobia (p = 0.03), body perception (p = 0.02), sleep quantity (p < 0.01) and sleep adequacy (p = 0.02). Generally subjects in the moderate disability group had more negative findings for these variables. CONCLUSION: Disturbances in body-perception, sleep and elevated kinesiophobia were found in pregnancy-related lumbopelvic pain subjects with moderate disability, factors previously linked to persistent low back pain. The cross-sectional nature of this study does not allow for identification of directional pathways between factors. The results support the consideration of these factors in the assessment and management of pregnancy-related lumbopelvic pain.