Effect of Ultrasonography-Guided Corticosteroid Injection vs Placebo Added to Exercise Therapy for Achilles Tendinopathy: A Randomized Clinical Trial.

Importance: Corticosteroid injections and exercise therapy are commonly used to treat chronic midportion Achilles tendinopathy, but the evidence for this combination is limited. Objective: To investigate the effect of corticosteroid injection and exercise therapy compared with placebo injection and exercise therapy for patients with Achilles tendinopathy. Design, Setting, and Participants: This was a participant-blinded, physician-blinded, and assessor-blinded randomized clinical trial of patients with Achilles tendinopathy verified by ultrasonography. Assessment of pain and function were conducted at baseline and at 1, 2, 3, 6, 12, and 24 months. Patients were recruited from a university medical clinic and a private rheumatology clinic in Denmark between April 2016 and September 2018. Data analysis was performed from June to September 2021. Interventions: Corticosteroid injection and placebo injection were performed with ultrasonography guidance. Exercise therapy was based on previous trials and consisted of 3 exercises done every second day. Main Outcomes and Measures: The primary outcome was the Victorian Institute of Sports Assessment-Achilles (VISA-A) score (range, 1-100, with 100 representing no symptoms) at 6 months. Secondary outcomes included pain measured using a 100-mm Visual Analog Scale for morning pain and pain during exercise (with higher scores indicating worse pain), global assessment (Likert scale), and tendon thickness. Results: A total of 100 patients were included, with 52 randomized to placebo (mean age, 46 years [95% CI, 44-48 years]; 32 men [62%]) and 48 randomized to corticosteroid injection (mean age, 47 years [95% CI, 45-49 years]; 28 men [58%]). Patients in the 2 groups had similar height (mean [SD], 177 [8] cm), weight (mean [SD], 79 [12] kg), and VISA-A score (mean [SD], 46 [18]) at baseline. The group receiving exercise therapy combined with corticosteroid injections had a 17.7-point (95% CI, 8.4-27.0 points; P < .001) larger improvement in VISA-A score compared with patients receiving exercise therapy combined with placebo injections at 6 months. No severe adverse events were observed in either group, and there was no deterioration in the long term (2-year follow-up). Conclusions and Relevance: Corticosteroid injections combined with exercise therapy were associated with better outcomes in the treatment of Achilles tendinopathy compared with placebo injections and exercise therapy. A combination of exercise therapy and corticosteroid injection should be considered in the management of long-standing Achilles tendinopathy. Trial Registration: ClinicalTrials.gov Identifier: NCT02580630.

Methotrexate and risk of interstitial lung disease and respiratory failure in rheumatoid arthritis: a nationwide population-based study.

OBJECTIVES: MTX is the most commonly recommended DMARD for first-line treatment of RA, however, it has been hypothesized to cause lung disease as an adverse effect. We investigated the risk of interstitial lung disease (ILD) and acute and chronic respiratory failure in persons with RA treated with MTX and other medications. METHODS: From the Danish National Patient Register (NPR) and the DANBIO register for rheumatic diseases, we retrieved data on 30 512 persons with RA registered in 1997-2015. Information on ILD and respiratory failure was obtained from the NPR. Information on age and sex for all Danish citizens was obtained from the Danish Civil Registration System. MTX and other medication purchases were retrieved from the Danish Prescription Registry. Associations between MTX and lung disease outcomes were analysed in Cox regression models with adjustment for age, calendar time, sex and other medications. Standardized incidence ratios (SIRs) of lung disease were calculated to compare the RA population with the general population. RESULTS: There was no increased risk of lung disease with MTX treatment [one or more purchases compared with no purchases; HR 1.00 (95% CI 0.78, 1.27) for ILD and 0.54 (95% CI 0.43, 0.67) for respiratory failure] at the 5 year follow-up. The SIR was three to four times higher for ILD in MTX-treated persons with RA, but similar to the whole RA population compared with the background population. CONCLUSION: Persons with RA had an increased risk of ILD compared with the general population, but there was no further increased risk associated with MTX treatment.

Home-based telehealth hospitalization for exacerbation of chronic obstructive pulmonary disease: findings from "the virtual hospital" trial.

BACKGROUND: Telehealth interventions for patients with chronic obstructive pulmonary disease (COPD) have focused primarily on stable outpatients. Telehealth designed to handle the acute exacerbation that normally requires hospitalization could also be of interest. The aim of this study was to compare the effect of home-based telehealth hospitalization with conventional hospitalization for exacerbation in severe COPD. MATERIALS AND METHODS: A two-center, noninferiority, randomized, controlled effectiveness trial was conducted between June 2010 and December 2011. Patients with severe COPD admitted because of exacerbation were randomized 1:1 either to home-based telehealth hospitalization or to continue standard treatment and care at the hospital. The primary outcome was treatment failure defined as re-admission due to exacerbation in COPD within 30 days after initial discharge. The noninferiority margin was set at 20% of the control group's risk of re-admission. Secondary outcomes were mortality, need for manual or mechanical ventilation or noninvasive ventilation, length of hospitalization, physiological parameters, health-related quality of life, user satisfaction, healthcare costs, and adverse events. RESULTS: In total, 57 patients were randomized: 29 participants in the telehealth group and 28 participants in the control group. Testing the incidence of re-admission within 30 days after discharge could not confirm noninferiority (lower 95% confidence limit [CL], -24.8%; p=0.35). Results were also nonsignificant at 90 days (lower 95% CL, -16.2%; p=0.33) and 180 days (lower 95% CL, -16.6%; p =0.33) after discharge. Superiority testing on secondary outcomes showed nonsignificant differences between groups. Healthcare costs have not yet been evaluated. CONCLUSIONS: Whether home-based telehealth hospitalization is noninferior to conventional hospitalization requires further investigation. The results indicate that a subgroup of patients with severe COPD can be treated for acute exacerbation at home using telehealth, without the physical presence of health professionals and with a proper organizational "back-up."

Telemedicine-based treatment versus hospitalization in patients with severe chronic obstructive pulmonary disease and exacerbation: effect on cognitive function. A randomized clinical trial.

OBJECTIVES: Telemedicine is gaining ground in the treatment of patients with chronic obstructive pulmonary disease (COPD). Because telemedicine often requires both participation and engagement of the patients, it is important to take differences in cognitive ability into account, as there is evidence that cognitive dysfunction may be a limitation in patients with severe COPD. The aim of this study was to investigate whether cognitive performance is better after telemedicine-based treatment than after conventional hospitalization in patients with severe COPD and a mild to moderate exacerbation. MATERIALS AND METHODS: This randomized study was a substudy of the "Virtual Hospital," a multicenter, randomized controlled trial. The primary outcome in this substudy was cognitive function, evaluated 3 days and 6 weeks after discharge using a neuropsychological test battery comprising four tests and seven variables. RESULTS: We included 44 patients consecutively. Baseline characteristics were as follows: mean age, 70 (standard deviation [SD] 10) years; mean forced expiratory volume in 1 s, 1.0 (SD 0.55) L (42% of predicted); mean hemoglobin oxygen saturation, 95 (SD 2.0) percent; and mean Mini Mental State Examination score, 27.5 (SD 1.6) points. The performance in all seven neuropsychological test variables tended to be better in the group allocated to virtual admission 3 days and 6 weeks after discharge, but the difference was not significant after Bonferroni's correction for multiple comparisons. CONCLUSIONS: There were no significant differences in cognitive performance between the telemedicine-based group and the conventional hospital group. Patients with severe COPD suffering from mild to moderate exacerbations were able to manage the telemedicine-based treatment despite the reduced cognitive function often seen in COPD patients.

Hospital-admitted COPD patients treated at home using telemedicine technology in The Virtual Hospital Trial: methods of a randomized effectiveness trial.

BACKGROUND: Recent reviews suggest that telemedicine solutions for patients with chronic obstructive pulmonary disease (COPD) may prevent hospital readmissions and emergency room visits and improve health-related quality of life. However, the studies are few and only involve COPD patients who are in a stable phase or in-patients who are ready for discharge. COPD patients hospitalized with an acute exacerbation may also benefit from telemedicine solutions. The overall aim is to investigate a telemedicine-based treatment solution for patients with acute exacerbation of COPD at home as compared to conventional hospital treatment measured according to first treatment failure, which is defined as readmission due to COPD within 30 days after discharge. METHODS: COPD patients with acute exacerbation who fulfilled the eligibility criteria and were from two university hospitals in Denmark were randomized (1:1) by computer-generated tables that allocated treatments in blocks of four to receive either standard treatment at the hospital or the same standard treatment at home using telemedicine technology (that is, a video conference system with a touch screen and webcam and monitoring equipment (spirometer, thermometer, and pulse oximeter)). Patients treated in the telemedicine group were backed up by an organizational setting securing 24/7/365 online access to the hospital, as well as access to oxygen, nebulizer therapy, oral medical therapy and surveillance of vital parameters from home monitoring devices. Patients in both groups were discharged when clinically stable and when fulfilling five pre-specified discharge criteria. Follow-up was performed at 1, 3 and 6 months after discharge. RESULTS: Enrollment of patients started in June 2010 and ended in December 2011. Follow-up ended in May 2012. Results were analyzed in 2013. CONCLUSIONS: The results may have implications on future hospital treatment modalities for patients with severe exacerbations in COPD where telemedicine may be used as an alternative to conventional admission. TRIAL REGISTRATION: Clinical Trials NCT01155856.

A randomised trial of telemedicine-based treatment versus conventional hospitalisation in patients with severe COPD and exacerbation - effect on self-reported outcome.

We investigated self-reported outcome in patients with COPD and exacerbation. Consecutive patients were randomised to an intervention group with home telemedicine and a control group who had conventional hospital admission. We assessed Health-Related Quality of Life (HRQoL) using the St George's Respiratory Questionnaire, daily activity using Instrumental Activity of Daily Living, anxiety and depression using the Hospital Anxiety and Depression Scale, and self-assessed cognitive decline using Subjective Cognitive Functioning. Data were collected at 3 days, 6 weeks and 3 months after discharge. There were 22 patients in each group. Their baseline characteristics were similar: a mean age of 70 years, FEV1 42% predicted and oxygen saturation 95%. After 6 weeks, FEV1 had improved in both groups, to 1.2 L in the intervention group and 1.0 L in the control group. Oxygen saturation had improved in the intervention group from 94% to 96%. Regarding HRQoL, there was a non-significant (P = 0.05) improvement in the symptom score in favour of the control group, but the improvement was not maintained after three months. However, there were no significant differences in self-reported outcomes in COPD patients with exacerbation treated at home via telemedicine versus conventionally in hospital.

[Varying effect of telemedicine in the treatment of chronic obstructive pulmonary disease--a systematic review]. / Vekslende effekt af telemedicin ved behandling af kronisk obstruktiv lungesygdom.

A systematic review of existing evidence on the efficiency of telemedicine solutions for patients with chronic obstructive pulmonary disease (COPD) was performed. A systematic literature search was conducted in five relevant databases followed by evaluation of methodology and results in selected studies. Nine RCT trials of varying quality were identified. The selected studies were mostly multimodal with telemedicine as part of a more complex intervention. Benefits of using telemedicine solutions for patients with COPD are not yet clear, but in some multimodal studies with telemedicine as part of the solution a positive effect on hospital admissions, emergency room visits and contacts to primary care may be seen. Larger studies are needed.

[Acute Addisonian crisis in a patient with systemic lupus erythematosus and secondary antiphospholipid syndrome]. / Akut Addisonkrise hos en patient med systemisk lupus erythematosus og sekundaert antifosfolipidsyndrom.

This article describes a 57-year-old woman with SLE and positive antiphospholipid and lupus anticoagulant antibodies (Ig type M) who developed an acute Addisonian crisis due to bilateral adrenal haemorrhage. It is important to recognise that bilateral adrenal haemorrhage can be part of the thrombo-embolic complications that are seen in both the primary and the secondary APS. Since there have been a number of similar cases, we suggest that APS with adrenal haemorrhage should be taken into consideration in SLE patients with abdominal pain, fever, nausea, hypotension and hyponatremia.