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.

Herpes Simplex Virus 2 Meningitis in Adults: A Prospective, Nationwide, Population-Based Cohort Study.

BACKGROUND: Data on the clinical presentation are scarce and prognostic factors of herpes simplex virus type 2 (HSV-2) meningitis remain unknown. METHODS: Prospective, nationwide, population-based database identifying all adults treated for HSV-2 meningitis at departments of infectious diseases in Denmark from 2015 to 2020. Unfavorable outcome was defined as Glasgow Outcome Scale (GOS) scores of 1-4 and Extended GOS scores of 1-6. Modified Poisson regression was used to compute relative risks with 95% confidence intervals for unfavorable outcome. RESULTS: HSV-2 meningitis was diagnosed in 205 patients (76% female; median age [interquartile range (IQR)], 35 [27-49] years) yielding an incidence of 0.7/100 000 population/y. Common symptoms were headache (195 of 204 patients [95%]), photophobia or phonophobia (143 of 188 [76%]), and neck stiffness (106 of 196 [54%]). The median (IQR) time to lumbar puncture was 2.0 (1-4.8) hours, and the median cerebrospinal fluid (CSF) leukocyte count was 360 (166-670) × 10 × 6/L, with a mononuclear predominance of 97% (91%-99%). Lumbar puncture was preceded by brain imaging in 61 of 205 patients (30%). Acyclovir or valacyclovir was administered in 197 of 205 patients (96%) for a median (IQR) of 10 (7-14) days. Unfavorable outcome was observed in 64 of 205 patients (31%) at discharge and 19 of 181 (11%) after 6 months and was not associated with female sex (relative risk [95% confidence interval], 1.08 [.65-1.79]), age ≥35 years (1.28 [.83-1.97]), immunocompromise (1.07 [.57-2.03]), or CSF leukocyte count >1000 × 10 × 6/L (0.78 [.33-1.84]). CONCLUSIONS: HSV-2 meningitis often presented as meningeal symptoms in younger women. Unfavorable outcome at discharge was common and was not associated with sex, age, immunocompromise, or CSF leukocyte count. Sequelae persisted beyond 6 months in one-tenth of patients.

Description of content, structure and theoretical model of a group-based pain management programme in the treatment of patients with persistent non-specific low back pain and psychological risk factors in a secondary sector setting.

OBJECTIVE: To present the theoretical foundation and methodological considerations for a group-based pain management programme for patients with persistent non-specific low back pain and psychosocial risk factors. METHOD: The Template for Intervention Description and Replication (TIDieR) checklist was used as a framework for describing the content, structure and context of the program. The theoretical rationale underlying the pain management programme was described using the first three steps of the Intervention Mapping framework. The Fear-avoidance model and the Self-efficacy Theory were identified as the two main theories. These were used to establish specific factors addressed by the pain management programme as well as expected outcomes. INTERVENTION DESCRIPTION: A multidisciplinary, group-based programme using a cognitive-behavioural approach was developed. The programme consisting of six sessions of two hours duration, took place at a spine clinic at a regional hospital in Denmark. Psychoeducation and cognitive restructuring were specific strategies hypothesised to induce changes in outcome measures. The outcomes expected to change as a result of the intervention were disability, quality of life, sick leave and physical activity. A pilot study was performed, subsequent adjustments made and the final content and educational materials completed by January 2017. CONCLUSION: The theoretical foundation and underlying evidence for the hypothesised change mechanisms in the use of a cognitive-behavioural approach was presented. A theoretically sound and practically feasible intervention has been developed and its effectiveness is being determined in a randomised controlled trial, including 130 low back pain patients, which is currently underway.

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.

The impact of virtual admission on self-efficacy in patients with chronic obstructive pulmonary disease - a randomised clinical trial.

AIMS AND OBJECTIVES: To investigate how virtual admission during acute exacerbation influences self-efficacy in patients with chronic obstructive pulmonary disease, compared with conventional hospital admission. BACKGROUND: Telemedicine solutions have been highlighted as a possible way to increase self-efficacy in patients with chronic diseases, such as chronic obstructive pulmonary disease. However, little is known about how telemedicine-based virtual admission as a replacement of hospital admission during acute exacerbation affects chronic obstructive pulmonary disease patients' self-efficacy. DESIGN: This study was a nonblinded, randomised clinical multicentre trial. The study was a substudy to The Virtual Hospital, investigating the feasibility and safety of telemedicine-based treatment at home for patients with acute exacerbation of chronic obstructive pulmonary disease. METHODS: Participants were consecutively randomised to virtual admission or conventional hospital admission. Data from 50 patients were analysed. Self-efficacy was assessed at baseline, three days after discharge, and also six weeks and three months after discharge, using the Danish version of 'The chronic obstructive pulmonary disease self-efficacy scale'. RESULTS: Intergroup comparison showed no significant differences between the two groups at baseline, three days after discharge, six weeks after discharge or three months after discharge. Furthermore, intragroup comparison did not reveal significant differences in the chronic obstructive pulmonary disease self-efficacy scale mean sum score within the two groups. CONCLUSIONS: The results of the study suggest that there is no difference between self-efficacy in chronic obstructive pulmonary disease patients undergoing virtual admission, compared with conventional hospital admission. However, the anticipated sample size could not be reached, which prompts caution regarding interpretation of the findings. RELEVANCE TO CLINICAL PRACTICE: This study provides new insight into how virtual admission affects chronic obstructive pulmonary disease patients' self-efficacy. Clinicians should consider the timing, duration and the content in the design of telemedical interventions directed at improving chronic obstructive pulmonary disease patients' self-efficacy, as telemedicine solutions alone may not be sufficient to enhance self-efficacy.

How virtual admission affects coping - telemedicine for patients with chronic obstructive pulmonary disease.

AIMS AND OBJECTIVES: To describe what characterises chronic obstructive pulmonary disease patients' coping of physical, emotional and social problems before, during and after virtual admission, in interaction with health professionals and relatives. BACKGROUND: Telemedicine for patients with chronic obstructive pulmonary disease is gaining ground. However, virtual admission using telemedicine in the patients' home as a replacement of hospital admission has received little attention. Furthermore, little is known about how telemedicine affects chronic obstructive pulmonary disease patients' coping. DESIGN: Grounded Theory study using semi-structured interviews. METHODS: The study was a part of The Virtual Hospital study, exploring virtual admission for patients with acute exacerbation of chronic obstructive pulmonary disease. During virtual admission, patients had access to medical equipment consisting of monitoring devices, medication, nebuliser and a touch screen with built-in videoconference system. Nine participants were interviewed after virtual admission. Open coding, axial coding and selective coding, using constant comparative analysis, were conducted. RESULTS: A substantive Grounded Theory was developed, containing the core category - struggling to be in control of life with chronic obstructive pulmonary disease - related to four categories: complete powerlessness, dependency, pursuit of regaining autonomy and efforts to remain in control of problems related to chronic obstructive pulmonary disease. Virtual admission supported participants' autonomy. The involvement of health professionals was reduced as participants used the medical equipment to cope with disease-related problems. Participants' coping was closely linked to the presence of the equipment, making it difficult for them to apply their experiences after discharge from virtual admission. CONCLUSIONS: Virtual admission may support chronic obstructive pulmonary disease patients' coping of physical and emotional problems. However, coping experiences made during virtual admission may not be directly applicable outside a telemedical setting. RELEVANCE TO CLINICAL PRACTICE: Telemedicine may result in different roles for patients, relatives and health professionals. Clinicians should consider how they can support chronic obstructive pulmonary disease patients' coping during telemedical interventions, focusing on how to ensure a sustained improvement that patients can benefit from outside the telemedical setting.

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.

Vitamin D status in Greenland--dermal and dietary donations.

BACKGROUND: Vitamin D status influences skeletal health, the risk of falls and fractures, and muscle health, and it has been associated with inflammatory, infectious, cardiovascular and metabolic disorders in addition to some cancers. Prevailing intracellular infections such as tuberculosis are speculated to relate to vitamin D status. The vitamin D sources are dietary and dermal, the latter depending on UVB radiation exposure from the sun. Life in the Arctic influences vitamin D status because of dietary peculiarities, the polar night, waning of the ozone layer and maybe ethnic differences between Inuit and non-Inuit. OBJECTIVE AND DESIGN: Data on vitamin D status as estimated by plasma 25OHD in Inuit and non-Inuit in Greenland are reviewed. RESULTS: Decreasing intake of vitamin D-rich local food items associated with decreasing plasma 25OHD levels and insufficient vitamin D status is seen with low intake of traditional Inuit foods. Plasma 25OHD levels increase markedly during spring and summer in parallel with the high influx of sunlight while plasma 25OHD is not influenced by obesity in Greenland Inuit and no clear-cut association is seen between plasma 25OHD and the risk of tuberculosis. CONCLUSION: The frequency of vitamin D deficiency in populations in Greenland rises with the dietary transition and diseases related to low vitamin D status should be monitored.

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.

Clinical risk factors for osteoporosis are common among elderly people in Nuuk, Greenland.

BACKGROUND: Osteoporosis is a debilitating condition characterized by fractures, pain and premature death. Risk factors for osteoporosis predict the risk of fragility fractures. AIM: To describe the occurrence of risk factors for osteoporosis among populations in Nuuk, the capital of Greenland. METHODS: A random sample of women born in 1934-42, 1945-47, 1956, and men born in 1956 were selected from the national civil registry. A questionnaire was sent out in Greenlandic and Danish on risk factors for osteoporosis: family history, smoking habits, alcohol intake, presence of disease, sun exposure, intake of dairy products, age at menopause (women) and number of falls. Additional questions included the frequency of back pain, previous fractures, intake of vitamin D and calcium supplements, use of anti-osteoporotic drugs, steroids and other drugs. RESULTS: The questionnaire was sent to 317 subjects confirmed to be living at an address in Nuuk and 181 (57.1%) responded. More young women than older women were smokers (60.6% vs. 35.0%; p=0.022) while limited sun exposure was reported by more of the old women (37.2% vs. 5.6%; p=0.003). Family history of osteoporosis was reported by 15.0%, without difference between groups. Alcohol and milk intake did not differ between groups. Premature menopause was reported by 17.9% of the women. Falls within the last year were reported by 42.4% with fewer falls in the oldest age group (21.9% vs. 50.0%; p=0.005). Frequency of fragility fractures increased with age (5.7% vs. 24.3% vs. 30.4%; p=0.02) and the risk of a fragility fracture increased with age (p=0.004; OR, 95% CI: 4.5, 1.6-12.2, reference: below 70 years), when adjusted for smoking, gender and falls. The use of anti-osteoporotic drugs was low (3.4%) while 28.8% took calcium and vitamin D supplements. CONCLUSIONS: Age is a dominating risk factor for fragility fractures in Greenland. The use of anti-osteoporotic drugs is low in Greenland, even if osteoporotic fractures are common in old age.

Vitamin D status in North Greenland is influenced by diet and season: indicators of dermal 25-hydroxy vitamin D production north of the Arctic Circle.

Vitamin D status, as measured by serum 25-hydroxy vitamin D (s-25OHD), is important to human health. Dermal 25OHD production depends on UVB light that is influenced by latitude. We aimed to identify factors important to the production of s-25OHD in Arctic people and investigated subjects living in the town of Ilulissat and the settlement of Saqqaq in North Greenland (70°N) during the four seasons. Participants were enrolled with a balanced representation of non-Inuit and Inuit in Ilulissat and Inuit in Saqqaq, men and women, aged 30-39 and 40-49 years. Supplement use, hours spent outdoors and other lifestyle factors were determined by questionnaires. Scores of traditional Inuit food intake were computed from a FFQ at inclusion, and frequencies of intake were recorded at each visit. s-25OHD concentration was measured. There were sixty-four Inuit and thirty-three non-Inuit participants. Inuit food score < 40 % was found in 87, 64 and 48 % of non-Inuit, Inuit in Ilulissat and Inuit in Saqqaq participants, respectively (P= 0·009). Inuit diet associated positively with s-25OHD (P< 0·001). s-25OHD concentration was lower in non-Inuit than in Inuit participants (spring/summer/autumn/winter/average: 30·3 v. 36·8/43·2 v. 44·7/43·6 v. 48·6/32·8 v. 43·5/39·0 v. 44·6 nmol/l, P= 0·002/0·62/0·19/ < 0·001/0·011, respectively). s-25OHD levels differed with season (Inuit, P< 0·001; non-Inuit, P< 0·001) as did diet (Inuit, P< 0·001; non-Inuit, P< 0·001) and hours spent outdoors (Inuit, P< 0·001; non-Inuit, P= 0·012). s-25OHD level was influenced by diet (P< 0·001), season (P< 0·001), origin (P= 0·001), residence (P= 0·013) and sex (P= 0·026). We conclude that the season influenced vitamin D status in Arctic populations beyond diet, ethnicity and vitamin intake. This suggests dermal 25OHD production at a high latitude of 70°N.

[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.