Fachkrankenhaus Hubertusburg

ObjectiveTo evaluate a nurse-led decision coaching programme aiming to redistribute health professionals’ tasks to support immunotherapy decision-making in people with multiple sclerosis (MS). MethodsCluster-randomised controlled trial with an accompanying mixed methods process evaluation (2014 - 2018). We planned to recruit 300 people with clinically isolated syndrome or relapsing-remitting MS facing immunotherapy decisions in 15 clusters across Germany. Participants in the intervention clusters received up to three decision coaching sessions by a trained nurse and access to an evidence-based online information platform. In the control clusters, participants also had access to the information platform. The primary outcome was informed choice after six months, defined as good risk knowledge and congruent attitude and uptake. ResultsTwelve nurses from eight clusters participated in the decision coaching training. Due to insufficient recruitment, the randomised controlled trial was terminated prematurely with 125 participants (n = 42 intervention clusters, n = 83 control clusters). We found a non-significant difference between groups for informed choice favouring decision coaching: odds ratio 1.64 (95% CI 0.49–5.53). ConclusionsResults indicate that decision coaching might facilitate informed decision-making in MS compared to providing patient information alone. Practice implicationsBarriers have to be overcome to achieve structural change and successful implementation.

Spondylodiscitis is asevere infectious disease of the spine that affects the intervertebral discs and adjacent vertebrae. It can lead to nonspecific pain, limited mobility, and destruction of spinal structures. Various pathogens, such as bacteria, fungi, or parasites, can trigger the disease. An early diagnosis and targeted treatment are crucial to reduce the risk of serious complications. Magnetic resonance imaging (MRI) with contrast agent and blood tests are essential for the diagnosis and assessing the course of the disease. The treatment includes conservative and surgical approaches. Conservative treatment consists of aminimum 6‑week antibiotic course and immobilization of the affected area. Surgical interventions, along with several weeks of antibiotic therapy, are indicated for instabilities or complications in order to eliminate the infection focus and to restore spinal stability.

Constipation is a common gastrointestinal disorder that may occur as occasional (acute) episodes, but can also persist over longer periods of time. Patients usually self-diagnose and self-manage constipation with over-the-counter (OTC) medications, so in terms of medical advice/consultation, the pharmacist is often the first point of contact. Patients’ self-management of constipation helps to free up primary care resources to focus on more complex conditions. However, there is no clear guidance on the appropriate, practice-oriented approach to, and the limitations of, self-management of constipation. The objective of this article is to provide up-to-date clinical practice guidance for healthcare professionals, particularly community pharmacists, to assist in the day-to-day management of patients who present with constipation. Here, we discuss typical clinical factors (e.g. symptom duration, warning symptoms and treatment response) that help to distinguish whether constipation can be self-managed or if further medical assessment is required. We have also developed screening questions and a patient management algorithm to help pharmacists and pharmacy technicians make appropriate decisions when a patient presents with symptoms of constipation or requests advice after initiation of OTC medications.

Background and ObjectivesMyasthenia gravis (MG) is an autoimmune disease characterized by dysfunction at the neuromuscular junction. Treatment frequently includes corticosteroids (CSs) and IV immunoglobulin (IVIG). This study was conducted to determine whether immune globulin (human), 10% caprylate/chromatography purified (IGIV-C) could facilitate CS dose reduction in CS-dependent patients with MG.MethodsIn this randomized double-blind placebo-controlled trial, CS-dependent patients with MG (Myasthenia Gravis Foundation of America Class II–Iva; AChR+) received a loading dose of 2 g/kg IGIV-C over 2 days (maximum 80 g/d) or placebo at week 0 (baseline). Maintenance doses (1 g/kg IGIV-C or placebo) were administered every 3 weeks through week 36. Tapering of CS was initiated at week 9 and continued through week 36 unless the patient worsened (quantitative MG score ≥4 points from baseline). CS doses were increased (based on the current CS dose) in patients who worsened. Patients were withdrawn if worsening failed to improve within 6 weeks or if a second CS increase was required. The primary efficacy end point (at week 39) was a ≥50% reduction in CS dose. Secondary and safety end points were assessed throughout the study and follow-up (weeks 42 and 45). The study results and full protocol are available at clinicaltrials.gov/ct2/show/NCT02473965.ResultsThe primary end point (≥50% reduction in CS dose) showed no significant difference between the IGIV-C treatment (60.0% of patients) and placebo (63.3%). There were no significant differences for secondary end points. Safety data indicated that IGIV-C was well tolerated.DiscussionIn this study, IGIV-C was not more effective than placebo in reducing daily CS dose. These results suggest that the effects of IGIV-C and CS are not synergistic and may be mechanistically different.Trial Registration InformationThe trial was registered on clinicaltrialsregister.eu (EudraCT #: 2013-005099-17) and clinicaltrials.gov (identifier NCT02473965).Classification of EvidenceThis study provides Class II evidence that IVIG infusions in adult patients with MG do not increase the percentage of patients achieving a ≥50% reduction in corticosteroid dose compared with placebo.

Abstract Background: There is need to focus on HIV prevention as the global number of people acquiring HIV has not declined enough to meet set targets. Painful sexual intercourse may be indicative of minor epithelial injury. Epithelial trauma signs are potential risk factors of HIV infection in men who have sex with men (MSM) and female sex workers (FSWs). The objective of the study was to establish whether there is a relationship between HIV serostatus and signs of epithelial disruption in two HIV key population samples. Methods: Participants were randomly selected from registers of two health facilities in Nairobi, namely Bar Hostess and Hoymas, which serve FSWs and MSM respectively. A questionnaire was administered to 322 FSWs and 231 MSM, who provided data on HIV infection status, sexual dysfunction, intercourse frequency and previous abstinence behaviour. Sexual dysfunction scores were created from items of the Female Sexual Function Index (FSFI-19). Additional questions addressed visual and sensory signs of epithelial trauma. Sexual dysfunction scores for MSM used an anal adaptation of questions from the FSFI-19 and additional trauma sign questions. Statistical tests included two-sample t-tests for abstinence gaps and intercourse frequencies, the number of sex partners, vaginal births, and age of sexual debut. Mann-Whitney U tests were used to compare HIV status and the ordinal variables of sexual behaviour, individual factors, dyspareunia and signs of trauma scores. Bivariate logistic regression was used to estimate the magnitude of difference for significant associations. Potential factors influencing the occurrence of sexual dysfunction were evaluated by FSWs, yielding percentages of the assessment options selected by FSWs out of the total sample. Results: Complaint levels for pain and discomfort from sexual intercourse in the previous four weeks were at least moderate for 60% of MSM and 74% of FSWs. Bleeding related to intercourse was reported at least sometimes by 57% of MSM and 51% of FSWs. For FSWs, living with HIV was 0.874 (0.814-0.939) (odds ratio (95% confidence interval)) times less likely with increased intervals (one day) between any instance of vaginal intercourse or comparable object insertion in the previous month. As the level of satisfaction with emotional closeness during sex decreased, the odds of living with HIV increased 1.479 (1.220-1.792) times. The odds of living without HIV decreased 0.807 (0.656-0.994) times with increasing satisfaction with overall sexual life. As the frequency level of pain and discomfort during or following vaginal penetration in the past four weeks increased, risk of living with HIV increased 1.757 (1.379-2.239) or 1.441 (1.125-1.845) times, respectively, while incrementing intensity of discomfort and pain increased the odds of living with HIV 1.398 (1.119-1.747) times. As the frequency level of bleeding signs during or after vaginal intercourse increased, the relative risk of living with HIV increased 1.737 (1.285-2.348) times, and noticing more vaginal itching, burning, or soreness increased the odds of living with HIV 2.145 (1.429-3.220) times. No significant association between self-reported HIV status and sexual dysfunction or sex frequency variables were found in the MSM sample. A majority of FSWs agreed that steady partnerships (81% agreement), regularity of intercourse (74%), foreplay (73%) and lubrication or artificial lubricants (65%) alleviate discomfort and painful vaginal intercourse. Conclusions: Dyspareunia and epithelial trauma signs were highly prevalent in FSWs and MSM. Complaint levels for pain and discomfort as well as bleeding and tenderness signs were associated with living with HIV, providing some evidence that reducing epithelial disruption may be a novel HIV prevention approach. Subjective factor assessments by FSWs may imply prevention methods for further study.

IntroductionPrevious studies showed insufficient control of cardiovascular risk factors (CVRF) and high stroke recurrence rates among ischemic stroke patients in Germany. Currently, no structured secondary prevention program exists in clinical routine. We present the trial design and pilot phase results of a complex intervention to improve stroke care after hospital discharge in Germany.Patients and methodsSANO is a cluster-randomized trial with 30 participating regions across Germany aiming to enrol 2,790 patients (drks.de, DRKS00015322). Study intervention combines both structural and patient-centred elements. Study development was based on the Medical Research Council framework for complex interventions. In 15 intervention regions, a cross-sectoral multidisciplinary network is established to enhance CVRF control as well as detection and treatment of post-stroke complications. Recommendations on CVRF are based on high-quality secondary prevention guidelines. Study physicians use motivational interviewing and agree with patients on therapeutic targets. While hospitalised, patients also receive dietary counselling and a health-passport to track their progress. During regular visits, CVRF management and potential complications are monitored. The intervention is compared to 15 regions providing usual care. The primary endpoint is the combination of recurrent stroke, myocardial infarction and death assessed 12 months after enrolment and adjudicated in a blinded manner.ResultsEighteen patients were enrolled in a pilot phase that demonstrated feasibility of patient recruitment and study procedures.ConclusionSANO is investigating a program to reduce outcome events after ischemic stroke by implementing a complex intervention. If successful, the program may be implemented in routine care on national level in Germany.

The association of surgical hematoma evacuation with clinical outcomes in patients with cerebellar intracerebral hemorrhage (ICH) has not been established. To determine the association of surgical hematoma evacuation with clinical outcomes in cerebellar ICH. Individual participant data (IPD) meta-analysis of 4 observational ICH studies incorporating 6580 patients treated at 64 hospitals across the United States and Germany (2006-2015). Surgical hematoma evacuation vs conservative treatment. The primary outcome was functional disability evaluated by the modified Rankin Scale ([mRS] score range: 0, no functional deficit to 6, death) at 3 months; favorable (mRS, 0-3) vs unfavorable (mRS, 4-6). Secondary outcomes included survival at 3 months and at 12 months. Analyses included propensity score matching and covariate adjustment, and predicted probabilities were used to identify treatment-related cutoff values for cerebellar ICH. Among 578 patients with cerebellar ICH, propensity score-matched groups included 152 patients with surgical hematoma evacuation vs 152 patients with conservative treatment (age, 68.9 vs 69.2 years; men, 55.9% vs 51.3%; prior anticoagulation, 60.5% vs 63.8%; and median ICH volume, 20.5 cm3 vs 18.8 cm3). After adjustment, surgical hematoma evacuation vs conservative treatment was not significantly associated with likelihood of better functional disability at 3 months (30.9% vs 35.5%; adjusted odds ratio [AOR], 0.94 [95% CI, 0.81 to 1.09], P = .43; adjusted risk difference [ARD], -3.7% [95% CI, -8.7% to 1.2%]) but was significantly associated with greater probability of survival at 3 months (78.3% vs 61.2%; AOR, 1.25 [95% CI, 1.07 to 1.45], P = .005; ARD, 18.5% [95% CI, 13.8% to 23.2%]) and at 12 months (71.7% vs 57.2%; AOR, 1.21 [95% CI, 1.03 to 1.42], P = .02; ARD, 17.0% [95% CI, 11.5% to 22.6%]). A volume range of 12 to 15 cm3 was identified; below this level, surgical hematoma evacuation was associated with lower likelihood of favorable functional outcome (volume ≤12 cm3, 30.6% vs 62.3% [P = .003]; ARD, -34.7% [-38.8% to -30.6%]; P value for interaction, .01), and above, it was associated with greater likelihood of survival (volume ≥15 cm3, 74.5% vs 45.1% [P < .001]; ARD, 28.2% [95% CI, 24.6% to 31.8%]; P value for interaction, .02). Among patients with cerebellar ICH, surgical hematoma evacuation, compared with conservative treatment, was not associated with improved functional outcome. Given the null primary outcome, investigation is necessary to establish whether there are differing associations based on hematoma volume.

Facilitated temporal summation is one component of central sensitization. The aim of this exploratory study was to classify pro-, eu- and antinociceptive subgroups based on wind-up ratio cut-off scores in patients with knee osteoarthritis (OA). A total of56patients with knee OA met the inclusion criteria. Temporal summation was measured and wind-up ratio was calculated. Reference values of 180 healthy subjects were used to define wind-up ratio cut-off scores. Twenty-seven percent of patients showed a pro-nociceptive pain profile. Sixteen percent of patients showed an anti-nociceptive pain profile. A eu-nociceptive pain profile was present in 57% of patients. Central pain sensitization was present in approximately a third of knee OA patients. The results should be confirmed in larger studies.

To compare the pattern of cognitive deficits, information processing capacity and associated MRI changes at different stages of MS.