The influence of patients' nutritional risk, nutritional status, and energy density in MEDPass versus conventional administration of oral nutritional supplements - A secondary analysis of a randomized controlled trial.

OBJECTIVES The clinical influence of nutritional risk, nutritional status, and energy density of oral nutritional supplements (ONS) in MEDPass versus conventional administration of ONS is currently unknown. The aim of this analysis was to examine whether these variables have an impact on clinical outcomes. METHODS Secondary analysis of the intention to treat dataset of the randomized controlled MEDPass Trial in geriatric and medical inpatients. Patients in the intervention group received 4 × 50 ml ONS during the medication rounds (MEDPass mode), while those in the control group received ONS in a non-standardized manner. The examined endpoints included energy and protein coverage, ONS intake, handgrip strength (HGS), weight, appetite nausea and 30-day mortality. Three subgroup analyses for NRS 2002 total score (3, 4 or 5-7 points), NRS 2002 impaired nutritional status score (0, 1, 2 or 3 points) and energy density of the ONS (1.5 kcal/mL or 2 kcal/mL) were performed using linear and logistic regression with interaction and mixed effect models. RESULTS The data of 202 patients (103 women and 99 men) at nutritional risk (NRS total 2002 score ≥3), mean (SD) age 82.2 (6.5) years were included. There was no significant difference between the groups in the primary endpoint energy coverage in all three subgroup analyses. There were also no significant differences between the groups in the secondary endpoints of protein coverage, ONS intake, HGS, weight, appetite, nausea, and 30-day mortality. CONCLUSION The MEDPass mode of ONS administration was not superior to the conventional mode of administration in this study. ONS with high energy density (≥2 kcal/mL) should be offered since current evidence shows a tendency towards improved appetite, increased ONS and increased energy intake

Adaptive propensity score procedure improves matching in prospective observational trials

Background: Randomized controlled trials are the gold-standard for clinical trials. However, randomization is not always feasible. In this article we propose a prospective and adaptive matched case-control trial design assuming that a control group already exists. Methods: We propose and discuss an interim analysis step to estimate the matching rate using a resampling step followed by a sample size recalculation. The sample size recalculation is based on the observed mean resampling matching rate. We applied our approach in a simulation study and to a real data set to evaluate the characteristics of the proposed design and to compare the results to a naive approach. Results: The proposed design achieves at least 10% higher matching rate than the naive approach at final analysis, thus providing a better estimation of the true matching rate. A good choice for the interim analysis seems to be a fraction of around 1/2 to 2/3 of the control patients. Conclusion: The proposed resampling step in a prospective matched case-control trial design leads to an improved estimate of the final matching rate and, thus, to a gain in power of the approach due to sensible sample size recalculation

MEDPass versus conventional administration of oral nutritional supplements - A randomized controlled trial comparing coverage of energy and protein requirements.

BACKGROUND & AIMS The use of oral nutritional supplements (ONS) in the hospital setting is important to reach individual protein and energy goals in patients at risk for malnutrition. Compliance with ONS can be challenging but may be improved by prescribing ONS in smaller portions with medication rounds (MEDPass). We compared the likelihood of meeting energy and protein requirements in patients receiving ONS with MEDPass versus conventional ONS administration. METHODS The MEDPass Trial is a randomized, controlled, open-label superiority trial conducted on medical and geriatric wards in a University Hospital in Switzerland. The MEDPass group was allocated to receive 50 ml of ONS four times per day with the medication rounds. The control group received ONS per conventional care between the meals. The primary outcome was the percentage of energy in relation to the individual requirement. Secondary outcomes included the coverage of protein intake in relation to the individual requirement, the amount of daily consumed ONS, the course of handgrip strength (HGS), body weight appetite and nausea. Furthermore, we compared 30-day mortality and hospital length of stay (LOS) was studied in medical patients. RESULTS From November 22nd, 2018 until November 30th, 2021, 204 patients were included in the trial (MEDPass group n = 100, control group n = 104). A total of 203 patients at nutritional risk were analyzed in the intention-to-treat analysis (ITT). Regarding the primary endpoint, there was no difference in the coverage of energy requirement between the MEDPass and control group (82 vs. 85% (Δ -3%, 95%CI -11 to 4%), p = 0.38). Similarly, no differences were found for the secondary outcomes including coverage of protein requirement (101 vs. 104% (Δ -3%, 95% CI -12 -7%), p = 0.57, average daily intake of ONS (170 vs 173 ml (Δ - 3 ml, 95% CI -14 to 8 ml), p = 0.58) and 30-day mortality (3 vs. 8 patients, OR 0.4 (95% CI 0.1-1.4), p = 0.15). The course of HGS, body weight, appetite and nausea did not differ between the groups (p = 0.29, p = 0.14, p = 0.65 and p = 0.94, respectively). The per protocol analysis including 178 patients showed similar results. CONCLUSION Within this controlled trial setting, we found a high compliance for ONS intake and high coverage of protein requirements but no further improvement when ONS was administered using MEDPass compared to conventional care. MEDPass administration may provide an alternative that is easy to integrate into nursing routines, which may lead to lower workload with cost benefits and reduction of food waste. TRIAL REGISTRATION ClinicalTrials.gov: NCT03761680

Studienprotokoll: Register zur Prognose akut-symptomatischer Anfälle (PROSA-Register) – eine prospektive multizentrische Beobachtungsstudie

Background: Acute symptomatic epileptic seizures occur in close temporal relation to an acute disturbance of brain function. They are associated with a low risk of subsequent unprovoked seizures; thus, current guidelines recommend not to administer a long-term antiseizure medication; however, in clinical practice long-term secondary seizure prophylaxis is frequently initiated. The seizure prognosis after guideline-conform untreated or only briefly treated acute symptomatic seizures, is so far unknown. Hypothesis: Following an acute symptomatic first epileptic seizure of structural etiology, the 1-year risk of subsequent unprovoked seizures is not higher than 25%, even if antiseizure medication was not applied or for a short period only. Methods: The PROSE register is a single-arm, open, prospective, multicenter observational study. A total of 115 subjects aged 18 years or older with an acute symptomatic first epileptic seizure of structural etiology will be included if the seizure was not a status epilepticus. Intrahospital follow-up will be based on the hospital records. Telephone follow-up interviews will be conducted 3, 6, and 12 months after the acute symptomatic seizure. Discussion: The PROSE register will shed light on current treatment practice of acute symptomatic seizures and the actual seizure outcome within 1 year. The results are assumed to support the current evidence that giving antiseizure medication for a longer period of time exceeding the acute phase of the underlying condition is unnecessary

Decline in the number of patients with meningitis in German hospitals during the COVID-19 pandemic

BACKGROUND AND OBJECTIVES: In 2020, a wide range of hygiene measures was implemented to mitigate infections caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In consequence, pulmonary infections due to other respiratory pathogens also decreased. Here, we evaluated the number of bacterial and viral meningitis and encephalitis cases during the coronavirus disease 2019 (COVID-19) pandemic. METHODS: In a multicentre retrospective analysis of data from January 2016 until December 2020, numbers of patients diagnosed with bacterial meningitis and other types of CNS infections (such as viral meningitis and encephalitis) at 26 German hospitals were studied. Furthermore, the number of common meningitis-preceding ear-nose-throat infections (sinusitis, mastoiditis and otitis media) was evaluated. RESULTS: Compared to the previous years, the total number of patients diagnosed with pneumococcal meningitis was reduced (n = 64 patients/year in 2020 vs. n = 87 to 120 patients/year between 2016 and 2019, all p < 0.05). Additionally, the total number of patients diagnosed with otolaryngological infections was significantly lower (n = 1181 patients/year in 2020 vs. n = 1525 to 1754 patients/year between 2016 and 2019, all p < 0.001). We also observed a decline in viral meningitis and especially enterovirus meningitis (n = 25 patients/year in 2020 vs. n = 97 to 181 patients/year between 2016 and 2019, all p < 0.001). DISCUSSION: This multicentre retrospective analysis demonstrates a decline in the number of patients treated for viral and pneumococcal meningitis as well as otolaryngological infections in 2020 compared to previous years. Since the latter often precedes pneumococcal meningitis, this may point to the significance of the direct spread of pneumococci from an otolaryngological focus such as mastoiditis to the brain as one important pathophysiological route in the development of pneumococcal meningitis. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00415-022-11034-w

Seronegative myasthenic crisis: a multicenter analysis

Myasthenic crisis (MC) is a life-threatening condition for patients with myasthenia gravis (MG). Seronegative patients represent around 10–15% of MG, but data on outcome of seronegative MCs are lacking. We performed a subgroup analysis of patients who presented with MC with either acetylcholine-receptor-antibody-positive MG (AChR-MG) or seronegative MG between 2006 and 2015 in a retrospective German multicenter study. We identified 15 seronegative MG patients with 17 MCs and 142 AChR-MG with 159 MCs. Seronegative MCs were younger (54.3 ± 14.5 vs 66.5 ± 16.3 years; p = 0.0037), had a higher rate of thymus hyperplasia (29.4% vs 3.1%; p = 0.0009), and were more likely to be female (58.8% vs 37.7%; p = 0.12) compared to AChR-MCs. Time between diagnosis of MG and MC was significantly longer in seronegative patients (8.2 ± 7.6 vs 3.1 ± 4.4 years; p < 0.0001). We found no differences in duration of mechanical ventilation (16.2 ± 15.8 vs 16.5 ± 15.9 days; p = 0.94) and length of stay at intensive care unit (17.6 ± 15.2 vs 17.8 ± 15.4 days; p = 0.96), or in-hospital mortality (11.8% vs. 10.1%; p = 0.69). We conclude that MC in seronegative MG affects younger patients after a longer period of disease, but that crisis treatment efficacy and outcome do not differ compared to AChR-MCs

Outcomes of cerebral venous thrombosis due to vaccine-induced immune thrombotic thrombocytopenia after the acute phase

© 2022 American Heart Association, Inc.Background: Cerebral venous thrombosis (CVT) due to vaccine-induced immune thrombotic thrombocytopenia (VITT) is a severe condition, with high in-hospital mortality rates. Here, we report clinical outcomes of patients with CVT-VITT after SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) vaccination who survived initial hospitalization. Methods: We used data from an international registry of patients who developed CVT within 28 days of SARS-CoV-2 vaccination, collected until February 10, 2022. VITT diagnosis was classified based on the Pavord criteria. Outcomes were mortality, functional independence (modified Rankin Scale score 0–2), VITT relapse, new thrombosis, and bleeding events (all after discharge from initial hospitalization). Results: Of 107 CVT-VITT cases, 43 (40%) died during initial hospitalization. Of the remaining 64 patients, follow-up data were available for 60 (94%) patients (37 definite VITT, 9 probable VITT, and 14 possible VITT). Median age was 40 years and 45/60 (75%) patients were women. Median follow-up time was 150 days (interquartile range, 94–194). Two patients died during follow-up (3% [95% CI, 1%–11%). Functional independence was achieved by 53/60 (88% [95% CI, 78%–94%]) patients. No new venous or arterial thrombotic events were reported. One patient developed a major bleeding during follow-up (fatal intracerebral bleed). Conclusions: In contrast to the high mortality of CVT-VITT in the acute phase, mortality among patients who survived the initial hospitalization was low, new thrombotic events did not occur, and bleeding events were rare. Approximately 9 out of 10 CVT-VITT patients who survived the acute phase were functionally independent at follow-up.This study was funded by the Netherlands Organisation for Health Research and Development (ZonMw, grant number 10430072110005), the Dr. C.J. Vaillant Foundation, and Hospital District of Helsinki and Uusimaa (grant TYH2022223).info:eu-repo/semantics/publishedVersio