Generalizability and reach of a randomized controlled trial to improve oral health among home care recipients: comparing participants and nonparticipants at baseline and during follow-up

Background The generalizability of randomized controlled trials (RCTs) with a low response can be limited by systematic differences between participants and nonparticipants. This participation bias, however, is rarely investigated because data on nonparticipants is usually not available. The purpose of this article is to compare all participants and nonparticipants of a RCT to improve oral health among home care recipients at baseline and during follow-up using claims data. Methods Seven German statutory health and long-term care insurance funds invited 9656 home care recipients to participate in the RCT MundPflege. Claims data for all participants (n = 527, 5.5% response) and nonparticipants (n = 9129) were analyzed. Associations between trial participation and sex, age, care dependency, number of Elixhauser diseases, and dementia, as well as nursing, medical, and dental care utilization at baseline, were investigated using multivariable logistic regression. Associations between trial participation and the probability of (a) moving into a nursing home, (b) being hospitalized, and (c) death during 1 year of follow-up were examined via Cox proportional hazards regressions, controlling for baseline variables. Results At baseline, trial participation was positively associated with male sex (odds ratio 1.29 [95% confidence interval 1.08–1.54]), high (vs. low 1.46 [1.15–1.86]) care dependency, receiving occasional in-kind benefits to relieve caring relatives (1.45 [1.15–1.84]), having a referral by a general practitioner to a medical specialist (1.62 [1.21–2.18]), and dental care utilization (2.02 [1.67–2.45]). It was negatively associated with being 75–84 (vs. < 60 0.67 [0.50–0.90]) and 85 + (0.50 [0.37–0.69]) years old. For morbidity, hospitalizations, and formal, respite, short-term, and day or night care, no associations were found. During follow-up, participants were less likely to move into a nursing home than nonparticipants (hazard ratio 0.50 [0.32–0.79]). For hospitalizations and mortality, no associations were found. Conclusions For half of the comparisons, differences between participants and nonparticipants were observed. The RCT’s generalizability is limited, but to a smaller extent than one would expect because of the low response. Routine data provide a valuable source for investigating potential differences between trial participants and nonparticipants, which might be used by future RCTs to evaluate the generalizability of their findings. Trial registrati German Clinical Trials Register DRKS00013517. Retrospectively registered on June 11, 2018

The impact of surgical delay on resectability of colorectal cancer: An international prospective cohort study

Aim: The SARS-CoV-2 pandemic has provided a unique opportunity to explore the impact of surgical delays on cancer resectability. This study aimed to compare resectability for colorectal cancer patients undergoing delayed versus non-delayed surgery. Methods: This was an international prospective cohort study of consecutive colorectal cancer patients with a decision for curative surgery (January–April 2020). Surgical delay was defined as an operation taking place more than 4 weeks after treatment decision, in a patient who did not receive neoadjuvant therapy. A subgroup analysis explored the effects of delay in elective patients only. The impact of longer delays was explored in a sensitivity analysis. The primary outcome was complete resection, defined as curative resection with an R0 margin. Results: Overall, 5453 patients from 304 hospitals in 47 countries were included, of whom 6.6% (358/5453) did not receive their planned operation. Of the 4304 operated patients without neoadjuvant therapy, 40.5% (1744/4304) were delayed beyond 4 weeks. Delayed patients were more likely to be older, men, more comorbid, have higher body mass index and have rectal cancer and early stage disease. Delayed patients had higher unadjusted rates of complete resection (93.7% vs. 91.9%, P = 0.032) and lower rates of emergency surgery (4.5% vs. 22.5%, P< 0.001). After adjustment, delay was not associated with a lower rate of complete resection (OR 1.18, 95% CI 0.90–1.55, P = 0.224), which was consistent in elective patients only (OR 0.94, 95% CI 0.69–1.27, P = 0.672). Longer delays were not associated with poorer outcomes. Conclusion: One in 15 colorectal cancer patients did not receive their planned operation during the first wave of COVID-19. Surgical delay did not appear to compromise resectability, raising the hypothesis that any reduction in long-term survival attributable to delays is likely to be due to micro-metastatic disease

Half-Year Longitudinal Seroprevalence of SARS-CoV-2-Antibodies and Rule Compliance in German Hospital Employees

COVID-19, which is caused by SARS-CoV-2, is an occupational health risk, especially for healthcare employees due to their higher exposure and consequently higher risk of symptomatic and asymptomatic infections. This study was designed to determine the longitudinal seroprevalence of specific immunoglobulin-G (IgG) antibodies in employees in a hospital setting. All employees in a secondary care hospital, including healthcare and non-healthcare workers, were invited to participate in this single-center study. After an initial screening, a 6-month follow-up was carried out, which included serological examination for SARS-CoV-2 IgG antibodies and a questionnaire for self-reported symptoms, self-perception, and thoughts about local and national hygiene and pandemic plans. The seroprevalence of SARS-CoV-2 IgG antibodies was 0.74% among 406 hospital employees (0.75% in healthcare workers, 0.72% in non-healthcare workers), initially recruited in April 2020, in their follow-up blood specimens in October 2020. In this study, 30.54% of the participants reported using the official German coronavirus mobile application and the majority were content with the local and national rules in relation to coronavirus-related restrictions. At the 6-month follow-up, the 0.74% seroprevalence was below the reported seroprevalence of 1.35% in the general German population. The prevalence in healthcare workers in direct patient care compared with that in workers without direct patient contact did not differ significantly. Further follow-up to monitor the seroprevalence in the high-risk healthcare sector during the ongoing global pandemic is essential

Changes in the Interstitial cells of Cajal in infantile hypertrophic pyloric stenosis

Einleitung und Fragestellung: Die Inzidenz der infantilen hypertrophischen Pylorusstenose (IHPS) nimmt in Deutschland, aber auch in anderen industriellen Staaten, seit einigen Jahren ab. Die Pathogenese dieser Erkrankung ist multifaktoriell und bis heute noch nicht vollständig geklärt. Insbesondere den Interstitiellen Zellen nach Cajal (ICC) kommt als funktionellem Bindeglied zwischen dem enterischen Nervensystem und der glatten Muskulatur mutmaßlich eine wesentliche Rolle bei der Entstehung der IHPS zu. Ziel der vorliegenden Untersuchungen war zu prüfen, ob die regrediente Inzidenzentwicklung auch im eigenen Zentrum (Studienzentrum) nachweisbar ist. Zur Pathogeneseforschung wurden immunhistochemische Vergleichsuntersuchungen des Verteilungsmusters der ICC in der Pylorusmuskulatur von Kindern mit IHPS und gesundem Kontrollmaterial aus Sektionspräparaten durchgeführt. Materialien und Methodik: Für die epidemiologischen Erhebungen wurden die bundesweiten Daten zur Diagnose Q40.0 und dem Geschlecht der Patienten vom Statistischen Bundesamt aus den Jahren 2000 bis 2013 ausgewertet. Am Studienzentrum wurden entsprechende Daten sowie das Alter bei der Operation für den Zeitraum 2005 bis 2014 erhoben. Für die prospektive Studie wurden von August 2013 bis August 2015 im Rahmen der Pyloromyotomien bei IHPS nach Aufklärung und schriftlicher Einverständniserklärung der Eltern entsprechende Gewebeproben entnommen. Als Kontrolle dienten Pylorusproben aus Sektionspräparaten verstorbener Neugeborener ohne Vorerkrankungen des Gastrointestinaltrakts. Daran schloss sich die Auszählung der im Paraffinschnitt CD117-positiven Zellen in jeweils 15 high-power fields (HPF) innerhalb der Muscularis an. Die univariate statistische Analyse erfolgte mittels des Man-Whitney- U-Tests (Signifikanzniveau p<0,05). Ergebnisse: Im Unterschied zur bundesweiten Verringerung im Untersuchungszeitraum von 3,67 auf 1,63 Fällen pro 1000 Lebendgeburten bei etwa gleichbleibender Geschlechterverteilung bestätigte sich im Studienzentrum dieses Phänomen nicht. Im Untersuchungszeitraum konnten vier männliche Patienten (n=4) mit IHPS in die Studie eingeschlossen werden. 14 Proben von Sektionspräparaten verstorbener Neugeborener bildeten die Kontrollgruppe. In den intraoperativ gewonnenen Proben fanden sich in 15 HPFs 194,5 ± 222,5 Zellen (Mittelwert ± Standardabweichung), während die Kontrollgruppe 635,8 ± 496,5 Zellen aufwies (p=0,034). Somit zeigten sich bei den Patienten mit Pylorusstenose im Vergleich zu den Proben aus gesundem Pylorus-Gewebe signifikant weniger Cajal-Zellen. Schlussfolgerung: Die epidemiologischen Ergebnisse verdeutlichen einen konsequenten Rückgang der IHPS im deutschlandweiten Vergleich. Die histologischen Untersuchungsergebnisse bestätigen die Hypothese der verminderten Anzahl von ICC als einen der wesentlichen pathophysiologischen Faktoren bei der Entstehung der IHPS.Introduction and aims: The incidence of infantile hypertrophic pyloric stenosis (IHPS) has been decreasing in Germany and in other industrialised countries for a number of years. The pathogenesis of this disease is multifaceted and currently not fully clear. Particularly, the Interstitial cells of Cajal (ICC) may play an essential role in the development of IHPS, as they form the functional link between the enteric nervous system and smooth muscle. The aim of this study was to verify whether this decreasing incidence could also be shown in our own institution (study centre). The immunhistochemical examination compared the ICC distribution patterns of pyloric biopsies from children with IHPS to healthy control tissue from section preparations. Materials and methods: For the epidemiological evaluation, nationwide data for diagnosis Q40.0 and gender from the Federal Statistics Office for the years 2000 to 2013 was evaluated. Equivalent data was collected at the study centre in addition to the age at the time of surgery during the years 2005 to 2014. For the prospective study we collected tissue samples at pyloromyotomies from August 2013 to August 2015 after obtaining informed written parental consent. Specimens of pyloric tissue from autopsies of infants without pre-existing gastrointestinal diseases served as a control. Subsequently, manual counting of the CD117-positive cells in paraffin sections in 15 high-power fields (HPF) in the lamina muscularis was performed. Univariate statistical analysis was performed using the Man- Whitney-U-test (significance level p<0.05). Results: The nationwide decreased from 3.67 to 1.63 cases of IHPS per 1000 live births with constant gender distribution could not be shown at the study centre. During the study period, four male patients with IHPS were included. The control group consisted of post- mortem specimens from 14 infants. The number of ICC counted in the intraoperatively obtained samples (n=4) in 15 HPFs showed 194.5 ± 222.5 cells (mean ± SD) in the muscularis while the control group showed 635.8 ± 496.5 cells (p=0.034). Thus significantly fewer ICC were seen in patients with pyloric stenosis compared to samples from healthy pyloric tissue. Conclusion: The epidemiological findings clearly show a consistent decline in IHPS cases in Germany. The histological findings support the hypothesis of the reduced number of ICC as one of the main pathophysiological factors in the development of IHPS

Punching Below its Weight? The European Union @ the United Nations General Assembly

The thesis explores and analyses the behaviour of the European Union vis-à-vis the promotion and protection of human rights within the United Nations General Assembly (UNGA). It furthermore examines whether the theory of ‘normative power Europe’ is an appropriate theory in characterizing the external action of the EU at the UNGA. Drawing on seven interviews with EU and non-EU officials in both New York and Brussels, and through the method of discourse analysis, the thesis identifies four ‘core’ elements i.e. a) the structure of the UNGA, b) the intergovernmental nature of the EU (and the UNGA), c) the necessity for UN legitimacy in EU action and d) the norms and mechanisms, that ultimately determine the behaviour of the EU at the UNGA. The thesis additionally argues that, while the EU ideally would like to behave like a normative actor, its behaviour is prescribed by a number of limitations and inconsistencies, which ultimately hamper its effectiveness and credibility. Consequently the EU acts like a contradictory actor. In conclusion it is contended that the EU is an actor punching below its weight, as it, given its expanded membership and cooperation with like-minded states, should be able to be more effective, have more impact, and exercise more control than it currently does

The Question about Humanitarian Intervention in Darfur

The question about humanitarian intervention in Darfur poses many great obstacles. The essay explores the various factors, such as the legal, moral and political aspects of humanitarian intervention. The main purpose of the study is not to understand the current conflict in Darfur but to explain and comprehend why no state action has been taken towards the government of Sudan to stop a humanitarian crises that combines the worst of everything and most likely a case of genocide. The most complex issue in this essay is the fact that states most often do states have theopportunity to reduce the massive suffering among foreigners at comparatively low cost to their own citizens but most often they fail to do so, mainly often due to their lack of interest in a certain conflict. Therefore I will also examine a variety of political and legal theories and furthermore analyse various Security Council Resolutions and verbatim records thereby creating an in-depth and clear understanding of the complexity of the subject

Verbesserung der Mundgesundheit bei Pflegebedürftigen in häuslicher Pflege: Welche weiteren Schritte sind notwendig

Trotz vieler gesetzlicher Maßnahmen erscheint die Mundgesundheit Pflegebedürftiger in häuslicher Pflege immer noch unbefriedigend. In dem vom Innovationsfonds geförderten Projekt „Mundgesundheit bei Pflegebedürftigen“ wird untersucht, inwieweit eine Verbesserung der Mundgesundheit erreicht werden kann, wenn Krankenkassen proaktiv einen Zahnarztbesuch initiieren. Der Beitrag skizziert das Projekt und stellt Ergebnisse der Prozessevaluation dar. Wie sich zeigt, ist das größte Problem dieses zugehenden und aufsuchenden Ansatzes, dass es nicht gelingt, die Zielgruppe zielgenau und umfassend anzusprechen

Effectiveness of a Dental Intervention to Improve Oral Health among Home Care Recipients: A Randomized Controlled Trial

We quantified the effectiveness of an oral health intervention among home care recipients. Seven German insurance funds invited home care recipients to participate in a two-arm randomized controlled trial. At t0, the treatment group (TG) received an intervention comprising an oral health assessment, dental treatment recommendations and oral health education. The control group (CG) received usual care. At t1, blinded observers assessed objective (Oral Health Assessment Tool (OHAT)) and subjective (Oral Health Impact Profile (OHIP)) oral health and the objective periodontal situation (Periodontal Screening Index (PSI)). Of 9656 invited individuals, 527 (5.5%) participated. In the TG, 164 of 259 (63.3%) participants received the intervention and 112 (43.2%) received an outcome assessment. In the CG, 137 of 268 (51.1%) participants received an outcome assessment. The OHAT mean score (2.83 vs. 3.31, p = 0.0665) and the OHIP mean score (8.92 vs. 7.99, p = 0.1884) did not differ significantly. The prevalence of any periodontal problems (77.1% vs. 92.0%, p = 0.0027) was significantly lower in the TG than in the CG, but the prevalence of periodontitis was not (35.4% vs. 44.6%, p = 0.1764). Future studies should investigate whether other recruitment strategies and a more comprehensive intervention might be more successful in improving oral health among home care recipients