Clinical outcomes one year after a digital musculoskeletal (MSK) program: an observational, longitudinal study with nonparticipant comparison group.

BACKGROUND: The evidence base for the impact of digital health on musculoskeletal (MSK) outcomes is growing, but it is unclear how much digital MSK programs address pain and function in the intermediate and long term. METHODS: This observational study of digital MSK program participants versus nonparticipants (n = 2570) examined pain, function, depression, and anxiety at 3, 6, and 12 months, and health care use at 12 months. The intervention group engaged in a digital MSK program that included exercise, education, and coaching for at least 3 months. The nonparticipant group registered, but never started the program. We collected data in app or by emailed survey at 3, 6, and 12 months after registering for the program. We conducted descriptive analyses and unadjusted and adjusted regression modeling. RESULTS: The odds ratio of achieving a minimally clinically important difference (MCID) in pain improvement for the intervention versus the nonparticipant group was 1.97 (95% CI: 1.28, 3.02; p = .002) at 3 months, 1.44 (95% CI: 0.91, 2.25; p = .11) at 6 months, and 2.06 (95% CI: 1.38, 3.08; p = .004) at 12 months in adjusted models. The odds ratio of achieving a MCID in functional improvement for the intervention versus the nonparticipant group was 1.56 (95% CI: 1.03, 2.38; p = .01) at 3 months, 1.55 (95% CI: 1.02, 2.37; p = .04) at 6 months, and 1.35 (95% CI: 0.89, 2.06, p = 0.16) at 12 months in adjusted models. For those with moderate to severe depression or anxiety at baseline, we observed statistically significant lower odds of moderate to severe depression or anxiety at 3 months, 6 months, and 12 months for the intervention versus the nonparticipant group in adjusted models (p < .05). At 12 months, the percentage with invasive, imaging, and conservative services was higher for the nonparticipant versus intervention group by 5.7, 8.1, and 16.7 percentage points, respectively (p < 0.05). CONCLUSIONS: A digital MSK program may offer participants sustained improvement in pain, depression, and anxiety with concomitant decreases in health care use.

A real-world study of the longitudinal course of adult atopic dermatitis severity in clinical practice.

BACKGROUND: Little is known about the longitudinal course of adult atopic dermatitis (AD) lesional severity and extent in clinical practice. OBJECTIVE: To determine the longitudinal course of AD in clinical practice. METHODS: A prospective, dermatology practice-based study was performed (n = 400). Patients were assessed at baseline and approximately 6, 12, 18, and 24 months by eczema area and severity index (EASI) and objective-scoring atopic dermatitis (objective-SCORAD). Multivariable repeated measures linear regression models were constructed to evaluate AD severity over time. RESULTS: Overall, 36.2% and 18.2% of patients had moderate (6.0-22.9) or severe (23.0-72.0) EASI scores at any visit, respectively. Similarly, 29.0% and 26.4% of patients had moderate (24.0-37.9) or severe (38.0-83.0) objective-SCORAD scores at any visit, respectively. Among patients with baseline moderate (6.0-22.9) or severe (23.0-72.0) EASI scores, 25.0% and 18.6% continued to have moderate or severe scores at 1 or more follow-up visits, respectively. Similarly, among patients with baseline moderate (24.0-37.9) or severe (38.0-83.0) objective-SCORAD scores, 22.6% and 24.5% continued to have moderate or severe scores at 1 or more follow-up visits, respectively. In longitudinal regression models, EASI was significantly associated with body surface area (adjusted ß [95% confidence interval]: 0.16 [0.09-0.23]) and edema/papulation (2.31 [0.19-4.43]). In addition, objective-SCORAD was significantly associated with body surface area (0.12 [0.04-0.21]), edema/papulation (4.69 [2.05-7.32]), and scratch (3.34 [0.45-6.24]) over time. CONCLUSION: AD lesional severity has a heterogeneous longitudinal course. Many patients had fluctuating lesional severity scores over time. A minority of patients had persistently moderate or severe lesions over time. Most patients with moderate-severe disease at baseline were unable to achieve persistent lesional clearance.

Outcome in patients previously on antithrombotic therapy in the SAMMPRIS trial: subgroup analysis.

BACKGROUND AND PURPOSE: Stenting has been used as a rescue therapy in patients with intracranial arterial stenosis and a transient ischemic attack or stroke when on antithrombotic therapy (AT). We determined whether the stenting versus aggressive medical therapy for intracranial arterial stenosis (SAMMPRIS) trial supported this approach by comparing the treatments within subgroups of patients whose qualifying event (QE) occurred on versus off of AT. METHODS: The primary outcome, 30-day stroke and death and later strokes in the territory of the qualifying artery, was compared between (1) percutaneous transluminal angioplasty and stenting plus aggressive medical therapy (PTAS) versus aggressive medical management therapy alone (AMM) for patients whose QE occurred on versus off AT and between (2) patients whose QE occurred on versus off AT separately for the treatment groups. RESULTS: Among the 284/451 (63%) patients who had their QE on AT, the 2-year primary end point rates were 15.6% for those randomized to AMM (n=140) and 21.6% for PTAS (n=144; P=0.043, log-rank test). In the 167 patients not on AT, the 2-year primary end point rates were 11.6% for AMM (n=87) and 18.8% for PTAS (n=80; P=0.31, log-rank test). Within both treatment groups, there was no difference in the time to the primary end point between patients who were on or off AT (AMM, P=0.96; PTAS, P=0.52; log-rank test). CONCLUSIONS: SAMMPRIS results indicate that the benefit of AMM over PTAS is similar in patients on versus off AT at the QE and that failure of AT is not a predictor of increased risk of a primary end point. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00576693.

Effectiveness of Hybrid Form Impulse Therapy (HFIT) Compared to Traditional Transcutaneous Electronic Nerve Stimulation (TENS) in Patients with Chronic Low Back and Knee Pain: A Randomized Controlled Trial.

Purpose: Physical therapy (PT) and conservative care are recommended first-line treatments for musculoskeletal (MSK) pain. While essential to high-quality care, these solutions often do not provide immediate or sufficient pain relief. Traditional transcutaneous electronic nerve stimulation (TENS) devices are often recommended; however, there is mixed evidence behind their effectiveness. A novel approach called hybrid form impulse therapy (HFIT) incorporates a priming pulse with a traditional TENS pulse width and frequency. This randomized controlled trial (RCT) aimed to compare the effectiveness of HFIT versus traditional TENS versus usual care among members of a digital MSK program. Patients and Methods: A three-arm RCT comparing HFIT versus TENS versus usual care was conducted. A total of 325 people with chronic back or knee pain who were members of a digital MSK program consisting of PT-guided exercise therapy, education, and coaching were randomized. Outcomes including pain, function, anxiety, and depression were examined at 1, 2, and 4 weeks (primary endpoint). Engagement was measured through exercise therapy (ET) sessions completed. Unadjusted and adjusted logistic generalized estimating equations were conducted. Results: Adjusted per-protocol results at 4 weeks showed significantly lower odds of achieving pain improvement for both TENS (OR: 0.42, 95% CI: [0.19, 0.92]) and usual care (OR: 0.35, 95% CI: [0.17, 0.72]) groups, compared to HFIT group. Both HFIT and usual care users had significantly higher engagement than the TENS users (p=0.026 and p=0.002, respectively). No adverse events were reported throughout the study. Conclusion: More participants of a digital MSK program who were randomized to the HFIT group experienced meaningful pain improvement at 4 weeks than participants who used TENS and usual care. HFIT can be an effective, non-pharmaceutical solution for relief as a complement to first-line treatments for patients with chronic back and knee pain.

Effects of a Digital Musculoskeletal Acute Care Program on Chronic Pain Prevention: An Observational Study with Nonparticipant Comparison Group.

Background: There is limited research on whether digital interventions can prevent acute or subacute pain from developing into chronic pain. This observational study's primary objective examined whether chronic pain was more likely to be prevented in digital acute MSK program participants than nonparticipants. An exploratory objective was time to pain relief for program participants versus nonparticipants. Patients and Methods: The intervention group participants conducted video visits with physical therapists and were recommended exercise therapies and educational articles delivered through an app dedicated to addressing musculoskeletal (MSK) needs. This study used a multidimensional approach incorporating pain, function, depression, and anxiety scores to determine whether chronic pain prevention was achieved at 12 weeks. Descriptive analyses, unadjusted, and adjusted logistic regression were conducted. Time-to-event analysis was performed to compare the time to pain relief between groups. Results: A total of 171 participants (intervention: 75, nonparticipants: 96) with baseline and 3, 6, and 12 week follow-up data were included in the sample. Baseline mean (SD) age was 44.2 (11.8) years and mean VAS pain was 43.3 (22.9), out of 100. Results showed significantly higher odds of achieving chronic pain prevention at 12 weeks in the intervention participants versus nonparticipants. After adjusting for age, pain region, registration month, number of weeks of pain experienced, and healthcare service use at 12 weeks, 20.5% of the intervention group and 5.5% of the nonparticipant group achieved chronic pain prevention. At 91 days, the probability of developing chronic pain was 77.7% for nonparticipants and 46.5% for intervention participants (p<0.001; Log rank test). Conclusion: A digital acute MSK program may help to prevent chronic pain from developing among those with acute and subacute MSK needs. Study results also suggest that program participants achieve chronic pain relief sooner compared to nonparticipants.

Postoperative Outcomes of a Digital Rehabilitation Program After Total Knee Arthroplasty: Retrospective, Observational Feasibility Study.

BACKGROUND: Surgery can sometimes be the best solution for chronic musculoskeletal pain, but presurgical preparation and postsurgical rehabilitation are often required to achieve the maximum benefits. A digital musculoskeletal surgical care program was developed to support the population of patients undergoing total knee arthroplasty. OBJECTIVE: We aimed to demonstrate safety, engagement, and acceptability and explore clinical outcomes, health care use, and satisfaction among participants of a digital musculoskeletal surgical care program who were undergoing total knee arthroplasty. METHODS: A retrospective, observational feasibility study comparing digital musculoskeletal surgical care program participants to a comparison group was conducted. The intervention group registered for a digital musculoskeletal surgical care program, which included health coaches, physical therapists, and tailored exercises and educational articles to provide preoperative and postoperative support to patients who had recently undergone total knee arthroplasty. Comparison group members received standard-of-care treatment. Engagement (number of exercise therapy sessions and educational articles accessed per week) and acceptability (Net Promoter Score) were examined among intervention group participants. Descriptive statistics for postoperative outcomes, including safety (postoperative complications), clinical improvement (pain, function, anxiety, and depression), and health care use and experiences (length of hospital stay, surgery satisfaction, and physical therapy adherence), were reported for both groups. Differences among postoperative results were compared by using the independent samples 2-tailed t test or Mann-Whitney test for continuous outcomes and the Fisher exact test or chi-square test for categorical outcomes. RESULTS: Of the 53 participants (intervention group: n=22; comparison group: n=31) who were included in this study, 35 (66%) were female and 25 (47%) were aged from 45 to 60 years. On average, the intervention group completed 23 exercise sessions, read 2.7 educational articles, sent 45.5 texts to their health coaches, and were actively engaged for 6 weeks after their operation. Among 21 participants, 14 (67%) self-reported as promoters on the Net Promoter Score scale. Intervention group members reported fewer postoperative complications (6/22, 27%) than the comparison group (15/31, 48%), and they experienced better outcomes with regard to function (Knee Injury and Osteoarthritis Outcome Score-Physical Function Short Form-intervention group: mean 23.0; comparison group: mean 32.5), depression (Patient Health Questionnaire 2-Item-intervention group: mean 0.4; comparison group: mean 1.6), anxiety (General Anxiety Disorder 2-Item-intervention group: mean 0.6; comparison group: mean 1.5), and impressions of change (Patient Global Impression of Change-intervention group: median 7.0; comparison group: median 6.0). Intervention group participants also reported less health care use, better adherence to their physical therapy exercises, and higher surgery satisfaction. CONCLUSIONS: Our digital musculoskeletal surgical care program shows promising levels of engagement and acceptability among those who recently underwent total knee arthroplasty. The surgical care program may also help with improving postsurgical complications and clinical outcomes and lowering health care use.

Clinical Outcomes After a Digital Musculoskeletal Program for Acute and Subacute Pain: Observational, Longitudinal Study With Comparison Group.

BACKGROUND: Telerehabilitation for musculoskeletal (MSK) conditions may produce similar or better outcomes than usual care, but most telerehabilitation studies address only chronic or postsurgical pain. OBJECTIVE: We aimed to examine pain and function at 3, 6, and 12 weeks for individuals with acute and subacute MSK pain who took part in a digital MSK program versus a nonparticipant comparison group. METHODS: We conducted an observational, longitudinal study with a nonparticipant comparison group. The intervention group had video visits with physical therapists who recommended exercise therapies and educational articles delivered via an app. Nonparticipants were those who were registered but unable to participate because their benefit coverage had not yet begun. We collected pain and function outcomes through surveys delivered at 3-, 6-, and 12-week follow-ups. We conducted descriptive analyses, unadjusted regression, and mixed effects regression adjusting for baseline characteristics, time as fixed effects, and a time*group interaction term. RESULTS: The analysis included data from 675 nonparticipants and 262 intervention group participants. Compared to baseline, the intervention group showed significantly more pain improvement at 3, 6, and 12 weeks versus nonparticipants after adjusting for baseline factors. Specifically, the intervention group's pain scores decreased by 55.8% at 3 weeks versus baseline, 69.1% at 6 weeks, and 73% at 12 weeks. The intervention group's adjusted pain scores decreased from 43.7 (95% CI 41.1-46.2) at baseline to 19.3 (95% CI 16.8-21.8) at 3 weeks to 13.5 (95% CI 10.8-16.2) at 6 weeks to 11.8 (95% CI 9-14.6) at 12 weeks. In contrast, nonparticipants' pain scores decreased by 30.8% at 3 weeks versus baseline, 45.8% at 6 weeks, and 46.7% at 12 weeks. Nonparticipants' adjusted pain scores decreased from 43.8 (95% CI 42-45.5) at baseline to 30.3 (95% CI 27.1-33.5) at 3 weeks to 23.7 (95% CI 20-27.5) at 6 weeks to 23.3 (95% CI 19.6-27) at 12 weeks. After adjustments, the percentage of participants reporting that pain was better or much better at follow-up was significantly higher by 40.6% at 3 weeks, 31.4% at 6 weeks, and 31.2% at 12 weeks for intervention group participants versus nonparticipants. After adjustments, the percentage of participants with meaningful functional improvement at follow-up was significantly higher by 15.2% at 3 weeks and 24.6% at 12 weeks for intervention group participants versus nonparticipants. CONCLUSIONS: A digital MSK program may help to improve pain and function in the short term among those with acute and subacute MSK pain.

A real-world study of the longitudinal course of itch severity and frequency in adults with atopic dermatitis.

Itch is a complex symptom that is both common and burdensome in atopic dermatitis (AD). Yet, little is known about the longitudinal course of itch in AD. A prospective, dermatology practice-based study was performed of adults with AD (n = 463). Patients were assessed at baseline and approximately 6, 12, 18 and 24 months. Itch was assessed using Numeric Rating Scale (NRS) average and worst-itch scores, and frequency of itch in the past week. Repeated-measures regression models were constructed to examine itch over time. Overall, 31.5% and 22.5% had moderate (4-6) or severe (7-10) NRS average-itch scores; 27.4% and 36.4% had moderate (4-6) or severe (7-10) NRS worst-itch scores; 12.7% and 62.0% had itch from eczema 3-4 and ≥ 5 days in the past week; 27.4% and 45.1% reported sometimes and often/almost always having itch, respectively. Among patients with baseline moderate (4-6) or severe (7-10) NRS average-itch scores, 21.2% and 16.3% continued to have moderate or severe scores at ≥ 1 follow-up visits. In repeated-measures regression models, persistent NRS average-itch scores were associated with baseline NRS average-itch [adjusted ß (95% CI): 0.75 (0.68, 0.82)] and food allergy [- 0.45 (- 0.84, - 0.07)]. Persistent NRS worst-itch was associated with baseline worst-itch NRS [0.73 (0.66, 0.80)] and Medicaid insurance [1.06 (0.17, 1.94)]. AD patients had a heterogeneous longitudinal course with fluctuating and complex overlapping patterns of average- and worst-itch intensity, and frequency.

Outcomes of Open, Laparoscopic, and Percutaneous Drainage of Infected Walled-Off Pancreatic Necrosis: A Nationwide Inpatient Sample Study.

Background Walled-off pancreatic necrosis (WOPN) represents an encapsulated collection of necrotic pancreatic or peripancreatic tissue that tends to develop four weeks after the onset of acute necrotizing pancreatitis. When infected, it is managed initially by antibiotic therapy before drainage by endoscopic, percutaneous, or surgical means. This study aims to describe the morbidity, mortality, length of stay (LOS), and cost of care associated with open surgical, laparoscopic, and radiology-guided percutaneous drainage in adult patients with infected WOPN. Methods Using the Nationwide Inpatient Sample (NIS), patients aged 18 years and older discharged with the diagnosis of WOPN between January 1, 2016 and December 31, 2016 who underwent open, laparoscopic, or percutaneous drainage were included. Patients' characteristics including age, gender, and body mass index were reported. The primary endpoints were the mortality rate as well as length and cost of stay in each group. The secondary endpoint was the rate of procedural complications in each arm. Endpoints were reported and compared with studies assessing similar outcomes. Statistical Analysis System (SAS) statistical software (SAS Institute Inc., Cary, NC, USA) was used to perform the analysis. Results A total of 229 patients with the diagnosis of acute pancreatitis with infected necrosis were identified. Of these 229 patients, 27, 15, and 20 underwent open, laparoscopic, and percutaneous drainage, respectively. A total of eight studies were used for comparison of outcome variables. Mortality rate was found to be similar among comparison studies. LOS and costs varied widely among studies. There were significantly fewer pancreatic fistula and significantly more multi-organ failure complications as a result of open necrosectomy in the NIS study sample. Conclusion Overall, in analyzing the outcomes of patients undergoing intervention for infected WOPN through the 2016 NIS database, it appears that the database is representative of the majority of outcomes seen in similar clinical trials.

High-Frequency Impulse Therapy for Treatment of Chronic Back Pain: A Multicenter Randomized Controlled Pilot Study.

PURPOSE: This study aims to examine high-frequency impulse therapy (HFIT) impact on pain and function among patients undergoing care for chronic low back pain (CLBP). METHODS: A pilot randomized-controlled trial of HFIT system versus sham was conducted across 5 orthopedic and pain center sites in California, USA. Thirty-six patients seeking clinical care for CLBP were randomized. Primary outcome was function measured by the Six Minute Walk Test (6MWT). Secondary outcomes were function (Timed Up and Go [TUG] and Oswestry Disability Index [ODI]), pain (Numerical Rating Scale [NRS]), quality of life (Patient Global Impression of Change [PGIC]), and device use. Patients were assessed at baseline and every week for 4 weeks of follow-up. Mann-Whitney U-test was used to analyze changes in each outcome. Repeated measures ANOVA was used to assess the effect of treatment over time. RESULTS: The average age of subjects was 53.9 ± 15.7 (mean ± SD) years, with 12.1 ± 8.8 years of chronic low back pain. Patients who received an HFIT device had a significantly higher 6MWT score at weeks 2 [Cohen's d (95% CI): 0.33 (0.02, 0.61)], 3 [0.32 (0.01, 0.59)] and 4 [0.31 (0.01, 0.60)], respectively, as compared to their baseline scores (p < 0.05). Patients in the treatment group had significantly lower TUG scores at week 3 [0.30 (0.04, 0.57)] and significantly lower NRS scores at weeks 2 [0.34 (0.02, 0.58)] and 4 [0.41 (0.10, 0.67)] (p < 0.05). CONCLUSION: A larger-scale RCT can build on the findings of this study to test whether HFIT is effective in reducing pain and improving function in CLBP patients. This study shows encouraging evidence of functional improvement and reduction in pain in subjects who used HFIT. The efficacy and minimally invasive nature of HFIT is anticipated to substantially improve the management of CLBP patients.

Reliability and Longitudinal Course of Itch/Scratch Severity in Adults With Atopic Dermatitis.

BACKGROUND: Itch is a complex and burdensome symptom in atopic dermatitis (AD). Severity of scratching/excoriation (SCORAD-scratch) has been found to be a valid measure of itch in AD. However, little is known about the longitudinal course of scratching/excoriations in AD. METHODS: A prospective, dermatology practice-based study was performed of adults with AD (N = 399). The patients were assessed at baseline and approximately 6, 12, 18, and 24 months. RESULTS: Severity of excoriations correlated best with the Numerical Rating Scale-worst itch (Spearman correlation, ρ = 0.50), followed by a Patient-Reported Outcome Measurement Information System Itch Questionnaire-scratching behavior T score (ρ = 0.48), Numerical Rating Scale-average itch (ρ = 0.41), relative frequency of itch (ρ = 0.36), and frequency of itch from eczema (ρ = 0.29, all P < 0.0001). Scratching severity showed good reliability (intraclass correlation coefficient range = 0.62-0.69). Overall, 30.6% and 5.5% had moderate (2) or severe (3) SCORAD-scratch scores. Among patients with baseline moderate (2) or severe (3) SCORAD-scratch scores, 18.9% and 13.6% continued to have moderate or severe scores at 1 or more follow-up visits. In repeated-measures regression models, persistent SCORAD-scratch scores were associated with baseline severity of excoriations (adjusted ß [95% confidence interval] = 0.51 [0.37 to 0.65]), Medicaid insurance (-0.35 [-0.65 to -0.04]), and Eczema Area and Severity Index scores (0.03 [0.02 to 0.04]). CONCLUSIONS: Adult AD patients had a heterogeneous longitudinal course with fluctuating severity of excoriations.