Methodological Frameworks and Dimensions to Be Considered in Digital Health Technology Assessment: Scoping Review and Thematic Analysis.

BACKGROUND: Digital health technologies (dHTs) offer a unique opportunity to address some of the major challenges facing health care systems worldwide. However, the implementation of dHTs raises some concerns, such as the limited understanding of their real impact on health systems and people's well-being or the potential risks derived from their use. In this context, health technology assessment (HTA) is 1 of the main tools that health systems can use to appraise evidence and determine the value of a given dHT. Nevertheless, due to the nature of dHTs, experts highlight the need to reconsider the frameworks used in traditional HTA. OBJECTIVE: This scoping review (ScR) aimed to identify the methodological frameworks used worldwide for digital health technology assessment (dHTA); determine what domains are being considered; and generate, through a thematic analysis, a proposal for a methodological framework based on the most frequently described domains in the literature. METHODS: The ScR was performed in accordance with the guidelines established in the PRISMA-ScR guidelines. We searched 7 databases for peer reviews and gray literature published between January 2011 and December 2021. The retrieved studies were screened using Rayyan in a single-blind manner by 2 independent authors, and data were extracted using ATLAS.ti software. The same software was used for thematic analysis. RESULTS: The systematic search retrieved 3061 studies (n=2238, 73.1%, unique), of which 26 (0.8%) studies were included. From these, we identified 102 methodological frameworks designed for dHTA. These frameworks revealed great heterogeneity between them due to their different structures, approaches, and items to be considered in dHTA. In addition, we identified different wording used to refer to similar concepts. Through thematic analysis, we reduced this heterogeneity. In the first phase of the analysis, 176 provisional codes related to different assessment items emerged. In the second phase, these codes were clustered into 86 descriptive themes, which, in turn, were grouped in the third phase into 61 analytical themes and organized through a vertical hierarchy of 3 levels: level 1 formed by 13 domains, level 2 formed by 38 dimensions, and level 3 formed by 11 subdimensions. From these 61 analytical themes, we developed a proposal for a methodological framework for dHTA. CONCLUSIONS: There is a need to adapt the existing frameworks used for dHTA or create new ones to more comprehensively assess different kinds of dHTs. Through this ScR, we identified 26 studies including 102 methodological frameworks and tools for dHTA. The thematic analysis of those 26 studies led to the definition of 12 domains, 38 dimensions, and 11 subdimensions that should be considered in dHTA.

Methodological Frameworks and Dimensions to Be Taken Into Consideration in Digital Health Technology Assessment: Protocol for a Scoping Review.

BACKGROUND: Health technology assessment (HTA) is one of the main tools that health systems have to appraise evidence and determine the value of a given health technology. Although the existing HTA frameworks are useful tools for the evaluation of a wide range of health technologies, more and more experts, organizations across the world, and HTA agencies are highlighting the need to update or develop specific methodological frameworks for the evaluation of digital health technologies in order to take into account additional domains that cover these technologies' intrinsic characteristics. OBJECTIVE: The purpose of our scoping review is to identify the methodological frameworks that are used worldwide for the assessment of digital health technologies; determine what dimensions and aspects are being considered; and generate, through a thematic analysis, a proposal for a methodological framework that is based on the most frequently described dimensions in the literature. METHODS: The scoping review will be performed in accordance with the guidelines established in the updated statement of the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews). We will search for peer-reviewed and grey literature published between 2011 and the date of the search execution. The retrieved references will be reviewed in a single-blind manner by 2 independent authors, and their quality will be assessed by using the Critical Appraisal Skills Program tool. The ATLAS.ti software (Scientific Software Development GmbH) will be used for data extraction and to perform the thematic analysis. RESULTS: The scoping review is currently (May 2022) in progress. It is expected to be completed in October 2022, and the final results of the research will be presented and published by November 2022. CONCLUSIONS: To our knowledge, no studies have been published to date that identify the existing methodological frameworks for digital HTA, determine which dimensions must be evaluated for correct decision-making, and serve as a basis for the development of a methodological framework of reference that health care systems can use to carry out this kind of assessment. This work is intended to address this knowledge gap of key relevance for the field of HTA. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39905.

An Educational and Exercise Mobile Phone-Based Intervention to Elicit Electrophysiological Changes and to Improve Psychological Functioning in Adults With Nonspecific Chronic Low Back Pain (BackFit App): Nonrandomized Clinical Trial.

BACKGROUND: Concomitant psychological and cognitive impairments modulate nociceptive processing and contribute to chronic low back pain (CLBP) maintenance, poorly correlated with radiological findings. Clinical practice guidelines recommend self-management and multidisciplinary educational and exercise-based interventions. However, these recommendations are based on self-reported measurements, which lack evidence of related electrophysiological changes. Furthermore, current mobile health (mHealth) tools for self-management are of low quality and scarce evidence. Thus, it is necessary to increase knowledge on mHealth and electrophysiological changes elicited by current evidence-based interventions. OBJECTIVE: The aim of this study is to investigate changes elicited by a self-managed educational and exercise-based 4-week mHealth intervention (BackFit app) in electroencephalographic and electrocardiographic activity, pressure pain thresholds (PPTs), pain, disability, and psychological and cognitive functioning in CLBP versus the same intervention in a face-to-face modality. METHODS: A 2-arm parallel nonrandomized clinical trial was conducted at the University of the Balearic Islands (Palma, Spain). A total of 50 patients with nonspecific CLBP were assigned to a self-managed group (23/50, 46%; mean age 45.00, SD 9.13 years; 10/23, 43% men) or a face-to-face group (27/50, 54%; mean age 48.63, SD 7.54 years; 7/27, 26% men). The primary outcomes were electroencephalographic activity (at rest and during a modified version of the Eriksen flanker task) and heart rate variability (at rest), PPTs, and pressure pain intensity ratings. The secondary outcomes were pain, disability, psychological functioning (mood, anxiety, kinesiophobia, pain catastrophizing, and fear-avoidance beliefs), and cognitive performance (percentage of hits and reaction times). RESULTS: After the intervention, frequency analysis of electroencephalographic resting-state data showed increased beta-2 (16-23 Hz; 0.0020 vs 0.0024; P=.02) and beta-3 (23-30 Hz; 0.0013 vs 0.0018; P=.03) activity. In addition, source analyses revealed higher power density of beta (16-30 Hz) at the anterior cingulate cortex and alpha (8-12 Hz) at the postcentral gyrus and lower power density of delta (2-4 Hz) at the cuneus and precuneus. Both groups also improved depression (7.74 vs 5.15; P=.01), kinesiophobia (22.91 vs 20.87; P=.002), activity avoidance (14.49 vs 12.86; P<.001), helplessness (6.38 vs 4.74; P=.02), fear-avoidance beliefs (35 vs 29.11; P=.03), and avoidance of physical activity (12.07 vs 9.28; P=.01) scores, but there was an increase in the disability score (6.08 vs 7.5; P=.01). No significant differences between the groups or sessions were found in heart rate variability resting-state data, electroencephalographic data from the Eriksen flanker task, PPTs, subjective ratings, or cognitive performance. CONCLUSIONS: Both intervention modalities increased mainly beta activity at rest and improved psychological functioning. Given the limitations of our study, conclusions must be drawn carefully and further research will be needed. Nevertheless, to the best of our knowledge, this is the first study reporting electroencephalographic changes in patients with CLBP after an mHealth intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT04576611; https://clinicaltrials.gov/ct2/show/NCT04576611.

Acute Effects of a Brief Physical Exercise Intervention on Somatosensory Perception, Lumbar Strength, and Flexibility in Patients with Nonspecific Chronic Low-Back Pain.

BACKGROUND: Evidence-based clinical guidelines consider physical exercise one of the best nonpharmacological interventions for low-back pain (LBP), but it is necessary to clarify the exercise-induced hypoalgesia effect of different modalities of exercise in chronic pain populations. PURPOSE: This study focused on exploring acute changes in tactile and pressure-pain perception and lumbar strength and flexibility in patients with nonspecific chronic LBP (NSCLBP) after performing one of three 20-minute physical exercise modalities. METHODS: A total of 81 patients with NSCLBP were pseudorandomly distributed into three groups of 20-minute physical exercise - 1) aerobic (n=21, mean age 42±9.72 years, nine men), 2) stretching (n=21, mean age 40±11.37 years, ten men), and 3) strengthening (n=20, mean age 35.80±11.56 years, ten men) - and 4) a control group (n=19, mean age 38.64±10.24 years, eight men), and completed self-reported questionnaires during the same period. Tactile and pressure-pain thresholds and isometric lumbar muscle endurance and flexibility were assessed before and after this brief exercise-based intervention. RESULTS: All groups were comparable in terms of sociodemographic and clinical data, cardiovascular capacity, and self-reported data onphysical disability, mood, motivation, psychological response to stimulus properties of physical exercise, and physical activity enjoyment. Our analyses revealed higher tactile sensitivity (p<0.001) and pressure-pain thresholds (p<0.001) at the forefinger than other body locations. We also found lower pain sensitivity (p=0.010) and pressure pain-intensity ratings (p=0.001) and higher lumbar flexibility (p<0.001) after intervention. After calculation of absolute pre-post differences, higher tactile sensitivity was observed at the gluteus medius muscle than the erector spinal muscle only after aerobic intervention (p=0.046). CONCLUSION: These results add some evidence about different modalities of exercise-induced hypoalgesia in NSCLBP. However, the fact that we also found improvements in the control group limits our conclusions.