The Structured Delegation of Medical Care Services for Patients With Inflammatory Rheumatic Diseases.

BACKGROUND: In some areas of Germany, there is a shortage of specialist physicians for patients with inflammatory rheumatic diseases. Delegating certain medical care services to qualified, specialized rheumatological assistants (SRAs) might be an effective way to supplement the available capacity for specialized medical care. METHODS: Patients under stable treatment for rheumatoid arthritis (RA) or psoriatic arthritis (PsA) were included in this trial, which was designed to demonstrate, in a first step, the non-inferiority of a form of care involving delegation of physicians' tasks to SRAs (team-based care), in comparison to standard care, with respect to changes in disease activity at one year. "Non-inferiority," in this context, means either superiority or else an irrelevant extent of inferiority. In a second step, in case non-inferiority could be shown, the superiority of team-based care with respect to changes in patients' health-related quality of life would be tested as well. Disease activity was measured with the Disease Activity Score 28, and health-related quality of life with the EQ-5D-5L. This was a randomized, multicenter, rater-blinded trial with two treatment arms (team-based care and standard care). The statistical analysis was performed with mixed linear models (DRKS00015526). RESULTS: From September 2018 to June 2019, 601 patients from 14 rheumatological practices and 3 outpatient rheumatological clinics in the German states of North Rhine-Westphalia and Lower Saxony were randomized to either team-based or standard care. Team-based care was found to be non-inferior to standard care with respect to changes in disease activity (adjusted difference = -0.19; 95% confidence interval [-0.36; -0.02]; p <0.001 for non-inferiority). Superiority with respect to health-related quality of life was not demonstrated (adjusted difference = 0.02 [-0.02; 0.05], p = 0.285). CONCLUSION: Team-based care, with greater integration of SRAs, is just as good as standard care in important respects. Trained SRAs can effectively support rheumatologists in the care of stable patients with RA or PsA.

Subcutaneously administered methotrexate for rheumatoid arthritis, by prefilled syringes versus prefilled pens: patient preference and comparison of the self-injection experience.

PURPOSE: This multicenter, randomized, crossover study compared preference, ease of use, acceptability, satisfaction, and safety of repeated subcutaneous (SC) self-administrations with prefilled pens and prefilled syringes delivering methotrexate (MTX), in patients with rheumatoid arthritis (RA). PATIENTS AND METHODS: The study (ClinicalTrials.gov number NCT01793259) enrolled 120 patients requiring initiation or intensification of MTX therapy for RA. Patients were randomized to receive the test drug, a prefilled pen (Metex(®) PEN/Metoject(®) PEN), or the reference drug, a prefilled syringe (Metex(®)/Metoject(®)), at doses of 15, 17.5, or 20 mg MTX SC once a week for 3 weeks. This was followed by receipt of the reference drug (prefilled syringe) or the test drug (prefilled pen) in a crossover design, with each patient serving as his/her own control. Questionnaires regarding patient preference, the Self-Injection Assessment Questionnaire (SIAQ), and diaries regarding local tolerability were used to document outcomes. RESULTS: Overall patient preference for the MTX prefilled pen was 75% (P<0.0001). In a six-item questionnaire, 73% to 76% of the patients preferred the prefilled pen in relation to use, acceptability, and satisfaction, and 67% of the patients confirmed that it did not take much effort to overcome SC self-injection with the pen. The SIAQ showed no clinical differences, in any domain scores, between both devices. Overall patient attitude towards self-injection at baseline was positive, as was patient experience with both devices during the study. As well, 92% of physicians and study nurses indicated that they would recommend the MTX prefilled pen to patients for future MTX treatment. The formulations were generally well tolerated. CONCLUSION: SC self-injection of MTX with a prefilled pen was generally preferred, by patients with RA, over a prefilled syringe with regard to use, acceptability, and satisfaction. This is supported by the strong appreciation of their attending study nurses and physicians, for its convenience.

Radiotherapy in the treatment of postoperative chylothorax.

BACKGROUND: Chylothorax is characterized by the presence of chyle in the pleural cavity. The healing rate of non-operative treatment varies enormously; the maximum success rate in series is 70%. We investigate the efficacy and outcomes of radiotherapy for postoperative chylothorax. METHODS: Chylothorax was identified based on the quantity and quality of the drainage fluid. Radiation was indicated if the daily chyle flow exceeded 450 ml after complete cessation of oral intake. Radiotherapy consisted of opposed isocentric portals to the mediastinum using 15 MV photon beams from a linear accelerator, a single dose of 1-1.5 Gy, and a maximum of five fractions per week. The radiation target area was the anatomical region between TH3 and TH10 depending on the localization of the resected lobe. The mean doses of the ionizing energy was 8.5 Gy ± 3.5 Gy. RESULTS: The median start date of the radiation was the fourth day after chylothorax diagnosis. The patients' mediastinum was radiated an average of six times. Radiotherapy, in combination with dietary restrictions, was successful in all patients. The median time between the end of the radiation and the removal of the chest tube was one day. One patient underwent wound healing by secondary intention. The median time between the end of radiation and discharge was three days, and the overall hospital stay between the chylothorax diagnosis and discharge was 18 days (range: 11-30 days). After a follow-up of six months, no patient experienced chylothorax recurrence. CONCLUSIONS: Our results suggest that radiotherapy in combination with dietary restriction in the treatment of postoperative chylothorax is very safe, rapid and successful. This novel interventional procedure can obviate repeat major thoracic surgery and shorten hospital stays and could be the first choice in the treatment of postthoracotomy chylothorax.

Risk assessment of the application of a plasma jet in dermatology.

Regardless of the fact that several highly efficient antiseptics are commercially available, the antiseptic treatment of chronic wounds remains a problem. In the past, electrical plasma discharges have been frequently used in biometrical science for disinfection and sterilization of material surfaces. Plasma systems usually have a temperature of several hundred degrees. Recently, it was reported that "cold" plasma can be applied onto living tissue. In in vitro studies on cell culture, it could be demonstrated that this new plasma possesses excellent antiseptic properties. We perform a risk assessment concerning the in vivo application of a "cold" plasma jet on patients and volunteers. Two potential risk factors, UV radiation and temperature, are evaluated. We show that the UV radiation of the plasma in the used system is an order of magnitude lower than the minimal erythema dose, necessary to produce sunburn on the skin in vivo. Additionally, thermal damage of the tissue by the plasma can be excluded. The results of the risk assessment stimulate the in vivo application of the investigated plasma jet in the treatment of chronic wounds.