Encouraging better evaluation in digital health: guidance, training and community development

Abstract Digital health have the potential to deliver effective interventions on a wide scale. However, digital health products and services need better evaluations. There are significant barriers to this. Public Health England wanted to understand and tackle pragmatically the problem of evaluating digital health. This is particularly important in the time of COVID-19, when a large number of digital interventions are being developed and introduced at pace. It assembled a multidisciplinary team including service designers, academics, and public health professionals. They employed user-centred design methods, including qualitative research, and engagement with end-users and stakeholders. They used the findings to identify opportunity areas, develop concepts, test prototypes, and plan service implementation. This work led to the Evaluating Digital Health Products resource on GOV.UK which includes practical guidance, a methods library with digital case studies, and workshop templates for teams. It is intended to help anyone developing or running a digital health intervention. This resource launched to the public in 2020 but the service is still being improved and developed. The aim of this presentation is to introduce the online resource, describe its comprehensive iterative development, and present the evaluation training models. We will also describe the immediate next steps, which include development of an evaluation community, user testing of new content, and plans for developing a sustainable workshop model. Funding: This project is funded by Public Health England

A Case Report of Primary Angiitis of the Central Nervous System

BACKGROUND AND OBJECTIVE: Primary angiitis of the central nervous system (PACNS) is an inflammatory vasculitis with very low frequency and prevalence. It is not clear why the inflammatory process of this disease is limited to cerebrovascular disease without systemic manifestations. A case of primary angiitis of the central nervous system with cerebrovascular manifestations is reported here. CASE REPORT: The patient is a 50-year-old woman with headache, nausea, vomiting, and visual symptoms without clear motor impairment. Normocytic normochromic anemias tests and function tests of kidney, liver and thyroid and serology of infectious diseases were reported to be normal. The patient underwent brain imaging, and due to multiple lesions in both cerebral hemispheres and cerebellum, she underwent biopsy with a probable diagnosis of cerebral vasculitis. After histopathologic confirmation, the patient was discharged with glucocorticoid and cyclophosphamide therapy, and the symptoms subsided after one year follow-up. CONCLUSION: Based on the results of this case report, some general and common symptoms of the primary angiitis of the central nervous system should also be considered

The Effectiveness of Cognitive – Behavioral Group Therapy On Pain Perception And Pain Severity Among Patients With Chronic Neuropathic Pain

BACKGROUND AND OBJECTIVE: The experience of pain consists of two sensory and emotional dimensions. The sensory dimension of pain indicates pain severity and the emotional dimension indicates pain perception. Since cognitive–behavioral therapy is an evidence-based treatment and emphasizes on the correction of dysfunctional thought processes and changing the maladaptive behaviors, this study was designed to investigate the effectiveness of cognitive – behavioral group therapy on pain perception and pain severity among patients with chronic neuropathic pain. METHODS: This quasi-randomized trial was performed among 30 patients with chronic neuropathy referring to Rouhani Hospital in Babol in two groups of case and control (15 patients in each group). Cognitive – behavioral group therapy was performed in ten 120-minute sessions, held once a week for the experimental group. Participants were examined before the experiment and 45 days after the sessions, and the perception of pain was evaluated by the components of belief in pain permanence, self-blame, belief in pain constancy, mysteriousness of pain, and pain severity. The attainable score in The Pain Beliefs and Perceptions Inventory was 30 to -30, and in The West Haven-Yale Multidimensional Pain Inventory was 0 to 6. FINDINGS: The results showed that there was a statistically significant difference between the two groups in the total score of pain perception (-8.87±7.40 vs. 1.6±93.30) (p=0.001), and the subscales of belief in pain permanence (-4.13±1.76 vs. 0.93±3.30) (p=0.04), belief in pain constancy (0.80±3.16 vs. -2.13±3.50) (p=0.04), mysteriousness of pain (-2.73±3.67 vs. 1.33±3.95) (p=0.003), and pain severity (2.19±1.28 vs. 3.64±1.27) (p=0.003). CONCLUSION: The present study showed that cognitive–behavioral group therapy could be an effective intervention for reducing the pain perception and pain severity in patients with chronic neuropathic pain

A922 Sequential measurement of 1 hour creatinine clearance (1-CRCL) in critically ill patients at risk of acute kidney injury (AKI)

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The Effectiveness of Well-Being Therapy on Coping Strategies and Self-Efficacy of Patients with Chronic Neuropathic Pain

Background and Objective: Neuropathic diseases are neurodegenerative conditions and a wide and difficult group of peripheral nerve diseases in humans. Since well-being therapy emphasizes the high levels of six domains of psychological well-being, this study was conducted to investigate the effectiveness of well-being therapy on pain coping strategies and self-efficacy of patients with chronic neuropathic pain. Methods: This clinical trial was conducted on 30 chronic neuropathic patients referred to Ayatollah Rouhani hospital in Babol and a neurologist's private office in two groups of experimental and control (n=15). Well-being therapy was performed in 8 sessions of 120 minutes, once a week for the experimental group, while the control group received the routine treatment. After the follow-up period, the control group also underwent psychotherapy. Both groups completed questionnaires of pain coping strategies (Rosenstiel and Keefe, 1985) and pain self-efficacy (Nicholas, 1989) in the pre-test, post-test and follow-up (two months after the post-test) and were compared. Findings: The results showed that there was a statistically significant difference between the two experimental and control groups in the score of the subscales of pain coping strategies in distraction from pain (23.13±3.88 versus 11.47±7.34) (p<0.001), reinterpretation of pain (17.33±5.56 versus 13.0±8.65) (p=0.114), catastrophizing (10.0±6.24 versus 16.33±5.4) (p<0.001), ignoring pain (24.4±6.67 versus 12.6±5.11) (p<0.001), hoping/praying (29.13±9.97 versus 22.4±5.7) (p=0.031), self-talk (25±4.03 versus 21.2±4.79) (p=0.026), behavioral activation (20.47±4.43 versus 11.20±4.94) (p<0.001) and pain self-efficacy (43.2±9.45 versus 33.33±13.34) (p=0.027). These results were maintained in the follow-up period. Conclusion: The present study showed that wellness therapy can be an effective intervention in improving pain coping strategies and increasing pain self-efficacy in chronic neuropathic patients

Quantification of Collateral Supply with Local-AIF Dynamic Susceptibility Contrast MRI Predicts Infarct Growth

In ischemic stroke, leptomeningeal collaterals can provide compensatory blood flow to tissue at risk despite an occlusion, and impact treatment response and infarct growth. The purpose of this work is to test the hypothesis that local perfusion with an appropriate Local Arterial Input Function (AIF) is needed to quantify the degree of collateral blood supply in tissue distal to an occlusion. Seven experiments were conducted in a pre-clinical middle cerebral artery occlusion model. Magnetic resonance dynamic susceptibility contrast (DSC) was imaged and post-processed as cerebral blood flow maps with both a traditionally chosen single arterial input function (AIF) applied globally to the whole brain (i.e. "Global-AIF") and a novel automatic delay and dispersion corrected AIF (i.e. "Local AIF") that is sensitive to retrograde flow. Pial collateral recruitment was assessed from x-ray angiograms and infarct growth via serially acquired diffusion weighted MRI scans both blinded to DSC. The degree of collateralization at x-ray correlated strongly with quantitative perfusion determined using the Local AIF in the ischemic penumbra (R2=0.81) compared to a traditionally chosen Global-AIF (R2=0.05). Quantitative perfusion calculated using a Local-AIF was negatively correlated (less infarct progression as local perfusion increased) with infarct growth (R2 = 0.79) compared to Global-AIF (R2=0.02). Local DSC perfusion with a Local-AIF is more accurate for assessing tissue status and degree of leptomeningeal collateralization than traditionally chosen AIFs. These findings support use of a Local-AIF in determining quantitative tissue perfusion with collateral supply in occlusive disease.Comment: 13 pages, 5 figure

Evaluation of the effects of sodium valproate on plasma homocysteine, folate and vitamin B12 levels in epileptic patients

Objective: to investigate the effects of sodium valproate on plasma concentrations of homocysteine, folate and vitamin B12 levels in epileptic patients with long-standing tonic-clonic seizures compared to newly diagnosed epileptic patients and healthy controls.Material and methods. The study included 90 participants (mean age 36.30±12.83 years, the majority (58.89%) were males) divided into three groups: 30 non-epileptic people (control Group 1), 30 newly diagnosed epileptic patients (Group 2), and 30 patients with long-term tonic-clonic seizures epilepsy (Group 3). In Group 3, patients received sodium valproate therapy. All subjects underwent clinical and neurological examinations. Differences in plasma levels of homocysteine, folic acid and vitamin B12 in three groups were investigated after 6 months of follow-up.Results. Homocysteine level in Groups 2 and 3 was increased; for Group 2 it was significantly higher than for Groups 3 and 1 (p=0.001). Plasma folate level in Groups 2 and 3 was decreased; for Group 3 it was significantly higher than for Group 2 and lower than for Group 1 (p=0.001). Vitamin B12 level in Groups 2 and 3 was decreased, but the difference was not significant (p=0.090). In Groups 1 and 2, a significant correlation was observed between the indicators.Conclusion. Sodium valproate аdministration might disrupt the homeostatic level of homocysteine, folate and vitamin B12 and cause irregularity of their plasma contents in epileptic patients with long-standing tonic-clonic seizures

Effectiveness and safety of non-steroidal anti-inflammatory drugs and opioid treatment for knee and hip osteoarthritis: network meta-analysis

OBJECTIVE: To assess the effectiveness and safety of different preparations and doses of non-steroidal anti-inflammatory drugs (NSAIDs), opioids, and paracetamol for knee and hip osteoarthritis pain and physical function to enable effective and safe use of these drugs at their lowest possible dose. DESIGN: Systematic review and network meta-analysis of randomised trials. DATA SOURCES: Cochrane Central Register of Controlled Trials (CENTRAL), Medline, Embase, regulatory agency websites, and ClinicalTrials.gov from inception to 28 June 2021. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised trials published in English with ≥100 patients per group that evaluated NSAIDs, opioids, or paracetamol (acetaminophen) to treat osteoarthritis. OUTCOMES AND MEASURES: The prespecified primary outcome was pain. Physical function and safety outcomes were also assessed. REVIEW METHODS: Two reviewers independently extracted outcomes data and evaluated the risk of bias of included trials. Bayesian random effects models were used for network meta-analysis of all analyses. Effect estimates are comparisons between active treatments and oral placebo. RESULTS: 192 trials comprising 102 829 participants examined 90 different active preparations or doses (68 for NSAIDs, 19 for opioids, and three for paracetamol). Five oral preparations (diclofenac 150 mg/day, etoricoxib 60 and 90 mg/day, and rofecoxib 25 and 50 mg/day) had ≥99% probability of more pronounced treatment effects than the minimal clinically relevant reduction in pain. Topical diclofenac (70-81 and 140-160 mg/day) had ≥92.3% probability, and all opioids had ≤53% probability of more pronounced treatment effects than the minimal clinically relevant reduction in pain. 18.5%, 0%, and 83.3% of the oral NSAIDs, topical NSAIDs, and opioids, respectively, had an increased risk of dropouts due to adverse events. 29.8%, 0%, and 89.5% of oral NSAIDs, topical NSAIDs, and opioids, respectively, had an increased risk of any adverse event. Oxymorphone 80 mg/day had the highest risk of dropouts due to adverse events (51%) and any adverse event (88%). CONCLUSIONS: Etoricoxib 60 mg/day and diclofenac 150 mg/day seem to be the most effective oral NSAIDs for pain and function in patients with osteoarthritis. However, these treatments are probably not appropriate for patients with comorbidities or for long term use because of the slight increase in the risk of adverse events. Additionally, an increased risk of dropping out due to adverse events was found for diclofenac 150 mg/day. Topical diclofenac 70-81 mg/day seems to be effective and generally safer because of reduced systemic exposure and lower dose, and should be considered as first line pharmacological treatment for knee osteoarthritis. The clinical benefit of opioid treatment, regardless of preparation or dose, does not outweigh the harm it might cause in patients with osteoarthritis. SYSTEMATIC REVIEW REGISTRATION: PROSPERO number CRD42020213656

Incidence of self-reported interpersonal violence related physical injury in Iran

Background: Violence is the cause of death for 1.5 million people in a year. Objectives: Our study aimed to estimate the incidence rate of self-reported interpersonal violence related physical injury (VRPI) and its associated factors in Iran. Patients and Methods: The sample included people ranged from 15 to 64 years old who were residing in Iran. A total of 1525 clusters were selected from the whole country. Six families were selected from each cluster via a systematic random sampling method. Then, the residential units were identified and the interviewers contacted the inhabitants. In the next step, one of the family members was selected by using Kish grid method. The instrument was a researcher-made questionnaire and consisted of two sections; demographics and project related data. Face validity and content validity of our questionnaire were investigated based on expert opinions and the reliability was confirmed by a pilot study, as well. The inclusion criteria were considered for choosing the interviewers. An interviewer was assigned for each 42 participants (7 clusters). An educational seminar was held for the administrative managers (54 persons) and interviewers (230 persons) for a week. The field work was distributed among all 46 Medical Sciences universities in Iran. In each university, administrative issues were related to an executive director. Mann-Whitney U test and odds ratio were used to analyze the data with 95 confidence interval. α value was considered less than 5. Results: The frequency of VRPI among 7886 participants was 24 during the last three months. The incidence rate of interpersonal VRPI was estimated at 3.04 per 1000 population (95 CI: 2.66-3.42) during a three-month interval in Iran. The incidence was 4.72 per 1000 population (95 CI: 4.01-5.43) for males and 1.78 per 1000 population (95 CI: 1.39-2.17) for females during a three-month interval. The mean (SD) of age of the participants with and without a history of VRPI were 26.5 (7.21) and 33.05 (12.05) years, respectively (P = 0.008). Considering the participants� gender, 66.7 were males (OR = 2.66, 95 CI: 1.14-6.23). Khuzestan Province had the most VRPIs (25 of all VRPIs). Streets and roads were the places with the highest frequency of injury (50). The most frequent injured organ was the upper limb (54.17). The most prevalent type of injury was a superficial wound (50). Finally, the most common place of treatment was home (45.83). Conclusions: We determined the incidence rate of self-reported interpersonal VRPI for the first time in Iran based on a national survey. The injuries were more common among young men. We suggest consecutive national surveys with different data gathering methods and more sample sizes. © 2015, Iranian Red Crescent Medical Journal

Impaired Striatal Akt Signaling Disrupts Dopamine Homeostasis and Increases Feeding

DOI is broken and has been reportedThe prevalence of obesity has increased dramatically worldwide. The obesity epidemic begs for novel concepts and therapeutic targets that cohesively address “food-abuse” disorders. We demonstrate a molecular link between impairment of a central kinase (Akt) involved in insulin signaling induced by exposure to a high-fat (HF) diet and dysregulation of higher order circuitry involved in feeding. Dopamine (DA) rich brain structures, such as striatum, provide motivation stimuli for feeding. In these central circuitries, DA dysfunction is posited to contribute to obesity pathogenesis. We identified a mechanistic link between metabolic dysregulation and the maladaptive behaviors that potentiate weight gain. Insulin, a hormone in the periphery, also acts centrally to regulate both homeostatic and reward-based HF feeding. It regulates DA homeostasis, in part, by controlling a key element in DA clearance, the DA transporter (DAT). Upon HF feeding, nigro-striatal neurons rapidly develop insulin signaling deficiencies, causing increased HF calorie intake. Methodology/Principal Findings We show that consumption of fat-rich food impairs striatal activation of the insulin-activated signaling kinase, Akt. HF-induced Akt impairment, in turn, reduces DAT cell surface expression and function, thereby decreasing DA homeostasis and amphetamine (AMPH)-induced DA efflux. In addition, HF-mediated dysregulation of Akt signaling impairs DA-related behaviors such as (AMPH)-induced locomotion and increased caloric intake. We restored nigro-striatal Akt phosphorylation using recombinant viral vector expression technology. We observed a rescue of DAT expression in HF fed rats, which was associated with a return of locomotor responses to AMPH and normalization of HF diet-induced hyperphagia. Conclusions/Significance Acquired disruption of brain insulin action may confer risk for and/or underlie “food-abuse” disorders and the recalcitrance of obesity. This molecular model, thus, explains how even short-term exposure to “the fast food lifestyle” creates a cycle of disordered eating that cements pathological changes in DA signaling leading to weight gain and obesity.National Institutes of Health (U.S.) (grant DA14684)National Institutes of Health (U.S.) (grant DK085712