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Objective: To investigate the oncological safety and potential cost savings of selective histopathological examination after appendectomy. Background: The necessity of routine histopathological examination after appendectomy has been questioned, but prospective studies investigating the safety of a selective policy are lacking. Methods: In this multicenter, prospective, cross-sectional study, inspection and palpation of the (meso)appendix was performed by the surgeon in patients with suspected appendicitis. The surgeon's opinion on additional value of histopathological examination was reported before sending all specimens to the pathologist. Main outcomes were the number of hypothetically missed appendiceal neoplasms with clinical consequences benefiting the patient (upper limit two-sided 95% confidence interval below 3:1000 considered oncologically safe) and potential cost savings after selective histopathological examination. Results: Seven thousand three hundred thirty-nine patients were included. After a selective policy, 4966/7339 (67.7%) specimens would have been refrained from histopathological examination. Appendiceal neoplasms with clinical consequences would have been missed in 22/4966 patients. In 5/22, residual disease was completely resected during additional surgery. Hence, an appendiceal neoplasm with clinical consequences benefiting the patient would have been missed in 1.01:1000 patients (upper limit 95% confidence interval 1.61:1000). In contrast, twice as many patients (10/22) would not have been exposed to potential harm due to re-resections without clear benefit, whereas consequences were neither beneficial nor harmful in the remaining seven. Estimated cost savings established by replacing routine for selective histopathological examination were 725,400 per 10,000 patients. Conclusions: Selective histopathological examination after appendectomy for suspected appendicitis is oncologically safe and will likely result in a reduction of pathologists' workload, less costs, and fewer re-resections without clear benefit.

Zusammenfassung Einleitung Die freie Krankenhauswahl durch Patienten wird gesundheitspolitisch gefördert und soll durch die Qualitätsberichte der Krankenhäuser unterstützt werden. Doch wie entscheiden sich Patienten für ein Krankenhaus? Wie viele können selber entscheiden, wo informieren sie sich und was sind in der konkreten Situation ihre Entscheidungskriterien? Dies soll für stationäre Patienten der Inneren Medizin im Vergleich zu denen anderer Fachgebiete beantwortet werden. Methoden Die Daten entstammen einer Beobachtungsstudie. Die nach Fachgebieten und Krankenhausversorgungsstufen geschichtete Zufallsstichprobe wurde in 46 Fachabteilungen von 17 Krankenhäusern aus 15 Städten und Gemeinden Nordrhein-Westfalens erhoben. Die gewichtete Stichprobe wertet 758 Patienten der Inneren Medizin und 1168 Patienten anderer Fachgebiete deskriptiv und inferenzstatistisch aus. Ergebnisse Internistische Patienten sind älter, häufiger Männer, ohne Migrationshintergrund und chronisch krank, zudem öfter stationär vorbehandelt. Etwa die Hälfte entscheidet selbst über das Krankenhaus, wobei die eigene Kenntnis des Krankenhauses durch einen Voraufenthalt die wichtigste Informationsquelle darstellt und wichtige Entscheidungskriterien die eigene Vorerfahrung, der Ruf des Krankenhauses und die Empfehlung der ambulanten Behandler sind. Der kleine Anteil Patienten mit mehr Zeit vor der Aufnahme wählt das Krankenhaus aktiver. Diskussion In der Inneren Medizin können weniger Patienten selbst über das Krankenhaus bestimmen. Diese entscheiden dann überwiegend aufgrund ihrer Vorerfahrung mit dem Krankenhaus und setzen die erneute Behandlung im ihnen bekannten Krankenhaus, in dem auch sie bekannt sind, fort. Ein kleiner Anteil jüngerer, gebildeterer und weniger krankenhauserfahrener Patienten informiert sich aktiver vor elektiven Eingriffen. Die Behandlungserfahrungen der Patienten sind zentral bei der eigenen Krankenhauswahl und über den sozialen Austausch auch bei der ihrer Angehörigen.

Zusammenfassung Ziel Für die 10-Jahres-Evaluation der Integrierten Versorgung „Gesundes Kinzigtal“ (IVGK, Innovationsfonds-Projekt 01VSF16002) konsentierte eine multidisziplinäre Expertengruppe 101 Qualitätsindikatoren (QI), mit denen die Qualität der regional integrierten Versorgung mit ihrer Ausrichtung auf Gesundheits- und Präventionsprogramme evaluiert werden sollte. Ein Kriterium war, dass sich diese QI prinzipiell für eine Abbildung mittels Routinedaten eignen sollten. Ziel der Studie war es, zu prüfen, wie viele der und auf welche Weise die entwickelten QI in Deutschland tatsächlich mit Routinedaten abgebildet werden können und aus welchen Gründen eine Operationalisierung eingeschränkt oder nicht möglich war. Material und Methode Die Operationalisierung der QI erfolgte mittels pseudonymisierten Abrechnungsdaten der AOK Baden-Württemberg der Jahre 2006–2015, die das Wissenschaftliche Institut der AOK (WIdO) dem Evaluationsteam zur Verfügung stellte. Alle operationalisierten Indikatoren waren binär kodiert (Kriterium erfüllt ja/nein). Die in den Zähler- und Nennerdefinitionen benannten Diagnosen, Prozeduren oder Arzneimittel wurden über ICD-10-Kodes (Ein- und Ausschlussdiagnosen), EBM-Kennziffern, OPS-Schlüssel und ATC-Kodes operationalisiert. Indikatorprävalenzen wurden im zeitlichen Verlauf zur Prüfung von Auffälligkeiten als Hinweis auf mögliche Fehlkodierung untersucht. Ergebnisse 90 der 101 Indikatoren waren mit Routinedaten operationalisierbar. 14 der 90 Indikatoren konnten nur mit Einschränkungen operationalisiert werden, da entsprechende Leistungsziffern erst im Beobachtungszeitraum eingeführt oder bestehende Ziffern verändert wurden. 76 der 90 Indikatoren konnten uneingeschränkt operationalisiert werden, davon waren bei 15 Indikatoren Vor- und Nachbeobachtungszeiten notwendig, wodurch sie nicht für alle Jahre dargestellt werden konnten. 11 von 101 QI waren nicht operationalisierbar, da EBM-Ziffern erst nach 2015 eingeführt oder nicht als Einzelleistung für alle Arztgruppen erfasst wurden (z. B. Spirometrie und Langzeit-EKG). Auffällige Verläufe in den Indikatorprävalenzen waren erklärbar. Schlussfolgerung Routinedaten ermöglichen ein ressourcensparendes Qualitätsmonitoring. Eine Veränderung der Datengrundlage im Beobachtungszeitraum, wie etwa durch Neueinführung oder Streichung von Abrechnungsziffern, erschwert die longitudinale, routinedatenbasierte Qualitätsbewertung, ermöglicht aber ggfs. für spätere Zeiträume die Operationalisierung weiterer oder neuer Indikatoren.

Zusammenfassung Hintergrund Die freie Krankenhauswahl wird gesundheitspolitisch durch die öffentliche Qualitätsberichterstattung gefördert. Bisherige Studien zur Krankenhauswahl befragen zumeist Patienten zu spezifischen elektiven Eingriffen. Die vorliegende Studie untersucht alle vollstationären chirurgischen Patienten und vergleicht sie mit denen der anderen Fachgebiete. Fragestellungen sind: Wie viele Patienten entscheiden selber über das Krankenhaus? Wie viel Zeit steht ihnen vor Aufnahme zur Verfügung? Wo informieren sie sich und was sind ihre wichtigen Entscheidungskriterien? Material und Methoden Die vorliegende Untersuchung wertet querschnittlich per Fragebogen erhobene Primärdaten zur Krankenhauswahl von 1925 konsekutiv vollstationär aufgenommenen Patienten aus 11 medizinischen Fachgebieten und 3 Versorgungsstufen aus, darunter 438 chirurgische Patienten aus 6 allgemeinchirurgischen Fachabteilungen. Ergebnisse Drei Viertel der chirurgischen Patienten entscheiden selber über das Krankenhaus. Die eigene Vorerfahrung mit dem Krankenhaus ist für gut die Hälfte der Patienten wichtige Informationsquelle und Entscheidungskriterium, daneben Angehörige und die ambulanten Behandler sowie der Ruf des Krankenhauses. Schlussfolgerung Viele Patienten der Chirurgie entscheiden sich für ein Krankenhaus aufgrund des gewachsenen Vertrauens durch eine als zufrieden erlebte vorherige Behandlung in dem Krankenhaus. Die professionelle Behandlungsqualität ist damit der größte Wirkfaktor beim Patienten, dessen Angehörigen und den ambulanten Behandlern. Bedenkenswert ist ein aktives und gezieltes Ansprechen und Klären möglicher Unzufriedenheit auf Patientenseite vor der Entlassung.

BackgroundInternet cognitive behavioural therapy (iCBT) is a viable delivery format of CBT for depression. However, iCBT programmes include training in a wide array of cognitive and behavioural skills via different delivery methods, and it remains unclear which of these components are more efficacious and for whom.MethodsWe did a systematic review and individual participant data component network meta-analysis (cNMA) of iCBT trials for depression. We searched PubMed, PsycINFO, Embase, and the Cochrane Library for randomised controlled trials (RCTs) published from database inception to Jan 1, 2019, that compared any form of iCBT against another or a control condition in the acute treatment of adults (aged ≥18 years) with depression. Studies with inpatients or patients with bipolar depression were excluded. We sought individual participant data from the original authors. When these data were unavailable, we used aggregate data. Two independent researchers identified the included components. The primary outcome was depression severity, expressed as incremental mean difference (iMD) in the Patient Health Questionnaire-9 (PHQ-9) scores when a component is added to a treatment. We developed a web app that estimates relative efficacies between any two combinations of components, given baseline patient characteristics. This study is registered in PROSPERO, CRD42018104683.FindingsWe identified 76 RCTs, including 48 trials contributing individual participant data (11 704 participants) and 28 trials with aggregate data (6474 participants). The participants' weighted mean age was 42·0 years and 12 406 (71%) of 17 521 reported were women. There was suggestive evidence that behavioural activation might be beneficial (iMD −1·83 [95% credible interval (CrI) −2·90 to −0·80]) and that relaxation might be harmful (1·20 [95% CrI 0·17 to 2·27]). Baseline severity emerged as the strongest prognostic factor for endpoint depression. Combining human and automated encouragement reduced dropouts from treatment (incremental odds ratio, 0·32 [95% CrI 0·13 to 0·93]). The risk of bias was low for the randomisation process, missing outcome data, or selection of reported results in most of the included studies, uncertain for deviation from intended interventions, and high for measurement of outcomes. There was moderate to high heterogeneity among the studies and their components.InterpretationThe individual patient data cNMA revealed potentially helpful, less helpful, or harmful components and delivery formats for iCBT packages. iCBT packages aiming to be effective and efficient might choose to include beneficial components and exclude ones that are potentially detrimental. Our web app can facilitate shared decision making by therapist and patient in choosing their preferred iCBT package.FundingJapan Society for the Promotion of Science.

Objective: The aims of the present study were to examine the impact of type 2 endoleaks (T2EL) on overall survival and to determine the need for secondary intervention after endovascular aneurysm repair (EVAR). Methods: A multicentre retrospective cohort study in the Netherlands was conducted among patients with an infrarenal abdominal aortic aneurysm (AAA) who underwent EVAR between 2007 and 2012. The primary endpoint was overall survival for patients with (T2EL+) or without (T2EL-) a T2EL. Secondary endpoints were sac growth, AAA rupture, and secondary intervention. Kaplan–Meier survival and multivariable Cox regression analysis were used. Results: A total of 2 018 patients were included. The median follow up was 62.1 (range 0.1 – 146.2) months. No difference in overall survival was found between T2EL+ (n = 388) and T2EL- patients (n = 1630) (p =.54). The overall survival estimates at five and 10 years were 73.3%/69.4% and 45.9%/44.1% for T2EL+/T2EL- patients, respectively. Eighty-five of 388 (21.9%) T2EL+ patients underwent a secondary intervention. There was no difference in overall survival between T2EL+ patients who underwent a secondary intervention and those who were treated conservatively (p =.081). Sac growth was observed in 89 T2EL+ patients and 44/89 patients (49.4%) underwent a secondary intervention. In 41/44 cases (93.1%), sac growth was still observed after the intervention, but was left untreated. Aneurysm rupture occurred in 4/388 T2EL patients. In Cox regression analysis, higher age, ASA classification, and maximum iliac diameter were significantly associated with worse overall survival. Conclusion: No difference in overall survival was found between T2EL+ and T2EL- patients. Also, patients who underwent a secondary intervention did not have better survival compared with those who did not undergo a secondary intervention. This study reinforces the need for conservative treatment of an isolated T2EL and the importance of a prospective study to determine possible advantages of the intervention.

ZusammenfassungDieses prospektiv registrierte Review charakterisiert 50 Interventionsstudien der ersten Welle des Innovationsfonds auf Grundlage von Studienprotokollen oder Originalartikeln. Die mehrheitlich (randomisierten) kontrollierten Interventionsstudien bezogen überwiegend Erwachsene bzw. Senioren in ambulanter Versorgung ohne regionalen Fokus ein und analysierten Behandlungsprozesse mit heterogenen klinischen und Patientenoutcomes als Zielgrößen. Die zu einem substantiellen Teil fehlenden Studienprotokolle und methodischen Details (u. a. Fallzahlplanung) zeigen (vermeidbare) methodische Probleme hinsichtlich der wissenschaftlichen Qualität der geförderten Studien auf.

Zusammenfassung Ziel der Studie Menschen mit geistiger Behinderung weisen eine geringere Lebenserwartung und häufigere Komorbidität als die Allgemeinbevölkerung sowie ungedeckte Gesundheitsbedarfe auf. Als ein Grund wird eine unzureichende medizinische Versorgung vermutet, wozu in Deutschland wenige Daten vorliegen. Die Studie widmet sich deshalb der Frage, wie Menschen mit geistiger Behinderung die medizinische Versorgung einschließlich Vorsorge und präventive Angebote in Anspruch nehmen. Methodik Querschnittstudie in 3 Werkstätten für Menschen mit geistiger Behinderung. Von Angehörigen wurde die Inanspruchnahme der Gesundheitsversorgung per Fragebogen erhoben. Die Auswertung erfolgte deskriptiv und inferenzstatistisch im Vergleich zur Allgemeinbevölkerung sowie innerhalb der Teilnehmenden auf soziodemografische Unterschiede. Ergebnisse Fast alle 181 Teilnehmer (Teilnahmequote 19,3%) haben einen Hausarzt. Im Vergleich zur Allgemeinbevölkerung nehmen die Teilnehmer die hausärztliche und die Versorgung durch zahlreiche andere Facharztgebiete häufiger in Anspruch. Die Krebsvorsorge für Dickdarm, Brust, Gebärmutterhals und Prostata nehmen sie seltener, für Haut und den Check-up öfter in Anspruch. Bei Zahnarztkontrollen und Maßnahmen der Gesundheitsförderung zeigt sich kein Unterschied. Teilnehmer aus Wohnheimen nehmen die Regelangebote mehr in Anspruch als die bei Angehörigen oder alleine Lebenden. Teilnehmer mit Migrationshintergrund kennen die Versorgungsangebote weniger gut. Schlussfolgerung Hinweise auf eine generelle gesundheitliche Unterversorgung zeigen die Ergebnisse nicht. Die Teilnahme an der Krebsvorsorge mit aufwändigeren Untersuchungen sollte gefördert werden, insbesondere für die allein oder bei Angehörigen lebenden Menschen mit geistiger Behinderung; Menschen mit Migrationshintergrund und ihre Angehörigen sollten gezielt informiert werden.

Costochondral separation is a rare phenomenon following blunt thoracic trauma that can also be associated with secondary injuries. We present a case with complete costochondral separation of the right second rib with concomitant mediastinal compression. Definitive treatment was provided through video-assisted thoracoscopic surgical plate osteosynthesis.

Zusammenfassung Hintergrund Die Epidemiologie patientensicherheitsrelevanter Probleme (PSP) im ambulanten Sektor Deutschlands ist weitgehend unbekannt. Bislang fehlen entsprechende Erfassungsinstrumente. Fragestellung Entwicklung und Anwendung eines Fragebogens (PSP-AMB), der in Form computergestutzter Telefoninterviews (CATI) an einer Bevolkerungsstichprobe ≥40-Jahriger die Epidemiologie von PSP im ambulanten Sektor aus der Patientenperspektive erfasst. Methoden Die Fragebogenitems wurden mittels Literaturrecherche und Leitfadeninterviews mit ambulanten Arzt*innen (N=10) und Patient*innen (N=20) entwickelt. Die Umsetzung in CATI und dessen Anwendung im Feld erfolgten durch ein Befragungsinstitut. Vor dem Feldeinsatz fanden qualitative (N=20) und quantitative (N=110) Pretests statt. Die Stichprobe wurde uber zufallig generierte Festnetz- und Mobilfunknummern gezogen. Ergebnisse PSP-AMB erhebt 32 PSP in sieben Bereichen der arztlichen Behandlung, von der Anamnese bis zur Praxisorganisation, und erfragt PSP der letzten 12 Monate (PSP-Ein-Jahres-Inzidenz), PSP mit Schaden seit dem 40. Lebensjahr (PSP-40+-Pravalenz) sowie PSP mit der Folge Tod oder Schwerstpflegebedurftigkeit per Proxy-Befragung der Teilnehmer*innen zu ihren Eltern und Kindern. Detailfragen erfassen Folgen und Umgang der Betroffenen mit PSP sowie die Soziodemografie. Zwischen Mai und Oktober 2018 konnten insgesamt 10.037 Burger (Teilnahmequote: 12,4%) befragt werden. Die Abbruchquote lag bei 8,3%. Die Stichprobe reprasentiert die deutsche Bevolkerung ≥40 Jahre. Diskussion PSP-AMB eignet sich dazu, aus Patientenperspektive PSP in der ambulanten Versorgung systematisch zu erfassen. Damit erfullt PSP-AMB die internationale Forderung, Patienten als wertvolle Informationsquelle zur Verbesserung der Patientensicherheit aktiv einzubeziehen.

Zusammenfassung Hintergrund Empfehlungen aus S3-Leitlinien (S3-LL) stellen eine wichtige Grundlage fur die Entwicklung von Qualitatsindikatoren (QI) dar. Ein einheitliches methodisches Vorgehen zur Entwicklung von QI im Kontext von S3-LL existiert in Deutschland bisher nicht. Aus diesem Grund wurde ein methodischer Standard fur die leitlinienbasierte Entwicklung von QI (QI-Standard) anhand eines strukturierten Konsensprozesses unter Einbezug der relevanten Experten- und Interessengruppen erarbeitet. Methoden Die Inhalte des QI-Standards wurden evidenzgeleitet zusammengestellt, basierend auf den Ergebnissen von Ubersichtsarbeiten und qualitativen Studien sowie unter Berucksichtigung der bereits existierenden Manuale zur leitlinienbasierten QI-Entwicklung. Fur die Abstimmung des QI-Standards wurde ein multiperspektivisches Panel mit breiter Reprasentanz von Experten- und Interessengruppen aus dem deutschen Gesundheitssystem und Expertise in Leitlinienarbeit und/oder Qualitatsmanagement nominiert. Das iterative, strukturierte Konsensverfahren beinhaltete eine zweistufige Onlinebefragung angelehnt an das Delphi-Verfahren („vorlaufige Abstimmung“) sowie eine moderierte Abschlusskonferenz, bei der diejenigen Empfehlungen in den QI-Standard aufgenommen wurden, die eine Zustimmung von >75% (Konsens-Kriterium) des Expertenpanels erhielten. Ergebnisse Der erarbeitete QI-Standard sieht als QI-Entwicklungsschritte zuerst die kriteriengestutzte Auswahl „potenzieller QI“ vor, die nach ihrer Verabschiedung als „vorlaufige QI“ in der S3-LL veroffentlicht werden und schlieslich nach erfolgreicher Testung den Status „finale QI“ erlangen. Der QI-Standard setzt sich aus insgesamt 30 Empfehlungen zusammen, die sich auf sechs Bereiche verteilen: A) Vorbereitende Arbeitsschritte fur die leitlinienbasierte Empfehlung von QI, B) Zusammensetzung der QI-Entwicklergruppe und Zusammenarbeit mit der LL-Gruppe, C) Entwicklung der potenziellen QI, D) Bewertung der potenziellen QI, E) Verabschiedung und Publikation sowie F) Pilotierung/Testung der vorlaufigen und Uberfuhrung in finale QI. Diskussion Bevor der QI-Standard bei kunftigen S3-LL-Erstellungen oder Aktualisierungen zur Implementierung empfohlen werden kann, sollte dieser in ausgewahlten S3-Leitlinienprojekten erfolgreich erprobt worden sein. Neben methodischen Anforderungen an die QI-Entwicklung muss sichergestellt sein, dass den LL-Gruppen adaquate Ressourcen fur die Umsetzung des QI-Standards zur Verfugung stehen. Schlussfolgerung Vom Einsatz des QI-Standards durch Leitliniengruppen konnen wissenschaftlich fundierte und fur die Versorgung relevante QI erwartet werden.

Intersubject electroencephalogram (EEG) coherence of 11 couples was measured during an individual and joint practice of a guided mindful breathing exercise. Additionally, the relationship of personality dimensions of agreeableness and extraversion with intersubject coherence was examined. There were four male-male pairs, five female-female pairs, and two male-female pairs. The age of the participants ranged between 18 and 28 (M = 22.3, SD = 2.9). During the counterbalanced joint and individual conditions, the same mindfulness listening tape (3 min) was played, while during the individual task, a screen was placed between the two participants. Results showed an increase in intersubject coherence during joint practice compared to individual practice in frontal (F8) and temporal (T5 and T6) electrodes in the alpha band. With respect to personality characteristics, higher agreeableness of a dyad was associated with an increase in intersubject coherence in in temporal (T6) theta band. The increase in intersubject coherence in the theta band in high agreeableness subjects during joint practice might be associated with theory of mind activation. This study provides new insights concerning brain coherence in healthy people during joint mindful breathing, including the association with personality characteristics.

Aim of the study Patients with cancer might have an increased risk for severe outcome of coronavirus disease 2019 (COVID-19). To identify risk factors associated with a worse outcome of COVID-19, a nationwide registry was developed for patients with cancer and COVID-19. Methods This observational cohort study has been designed as a quality of care registry and is executed by the Dutch Oncology COVID-19 Consortium (DOCC), a nationwide collaboration of oncology physicians in the Netherlands. A questionnaire has been developed to collect pseudonymised patient data on patients’ characteristics, cancer diagnosis, and treatment. All patients with COVID-19 and a cancer diagnosis or treatment in the past 5 years are eligible. Results Between March 27th and May 4th, 442 patients were registered. For this first analysis, 351 patients were included of whom 114 patients died. In multivariable analyses, age ≥65 years (p, Highlights • Patients with cancer might have an increased risk for severe outcome of COVID-19. • This nationwide study investigated risk factors for fatal outcome of COVID-19. • Among 442 registered patients with cancer, 32.3% of patients died of COVID-19. • Haematological malignancy and lung cancer increased the risk of fatal outcome. • These results can guide treatment and vaccination decisions in patients with cancer.

Parkinson's disease (PD) diagnosis is based on clinical criteria, i.e., bradykinesia, rest tremor, rigidity, etc. Assessment of the severity of PD symptoms with clinical rating scales, however, is subject to inter-rater variability. In this paper, we propose a deep learning based automatic PD diagnosis method using videos to assist the diagnosis in clinical practices. We deploy a 3D Convolutional Neural Network (CNN) as the baseline approach for the PD severity classification and show the effectiveness. Due to the lack of data in clinical field, we explore the possibility of transfer learning from non-medical dataset and show that PD severity classification can benefit from it. To bridge the domain discrepancy between medical and non-medical datasets, we let the network focus more on the subtle temporal visual cues, i.e., the frequency of tremors, by designing a Temporal Self-Attention (TSA) mechanism. Seven tasks from the Movement Disorders Society - Unified PD rating scale (MDS-UPDRS) part III are investigated, which reveal the symptoms of bradykinesia and postural tremors. Furthermore, we propose a multi-domain learning method to predict the patient-level PD severity through task-assembling. We show the effectiveness of TSA and task-assembling method on our PD video dataset empirically. We achieve the best MCC of 0.55 on binary task-level and 0.39 on three-class patient-level classification.

Background/purpose: Among patients suspected of pectus excavatum, visual examination is a key aspect of diagnosis and, moreover, guides work-up and treatment strategy. This study evaluated the inter observer and intra-observer agreement of visual examination and diagnosis of pectus excavatum among experts. Methods: Three-dimensional surface images of consecutive patients suspected of pectus excavatum were reviewed in a multi-center setting. Interactive three-dimensional images were evaluated for the presence of pectus excavatum, asymmetry, flaring, depth of deformity, cranial onset, overall severity and morphological subtype through a questionnaire. Observers were blinded to all clinical patient information, completing the questionnaire twice per subject. Agreement was analyzed by kappa statistics. Results: Fifty-eight subjects with a median age of 15.5 years (interquartile range: 14.1-18.2) were evaluated by 5 (cardio)thoracic surgeons. Pectus excavatum was visually diagnosed in 55% to 95% of cases by different surgeons, revealing considerable inter-observer differences (kappa: 0.50; 95%-confidence interval [CI]: 0.41-0.58). All other items demonstrated inter-observer kappa's of 0.25-0.37. Intra-observer analyses evaluating the presence of pectus excavatum demonstrated a kappa of 0.81 (95%-CI: 0.72-0.91), while all other items showed intra-observer kappa's of 0.36-0.68. Conclusions: Visual examination and diagnosis of pectus excavatum yields considerable inter-observer and intra-observer disagreements. As this variation in judgement could impact work-up and treatment strategy, objective standardization is urged. Levels of evidence: III. (c) 2021 Elsevier Inc. All rights reserved.

Zusammenfassung Ziel der Studie Die starre Trennung von ambulanter und stationärer Versorgung im deutschen Gesundheitssystem verhindert eine Behandlungskontinuität, obwohl sie sich für psychiatrische Patienten als sehr wichtig erwiesen hat. Die vorliegende Studie analysiert die Behandlungskontinuität einer Modellklinik mit einem Gesamtbudget nach § 64b SGB V und konstantem Behandlungspersonal über alle Settings hinweg im Vergleich zu einer Kontrollklinik mit Regelfinanzierung ohne ein solches Team. Methodik In einer prospektiven Kohortenstudie mit einem Beobachtungszeitraum von 20 Monaten wurden Daten zur Behandlungskontinuität von 220 Patienten der Modellklinik und 215 Patienten der Kontrollklinik erhoben. Ergebnisse Die Modellklinik erreichte eine signifikant höhere Behandlungskontinuität als die Kontrollklinik, sowohl während der stationären Behandlung zum Zeitpunkt der Rekrutierung als auch in allen Settings während des Beobachtungszeitraums. Schlussfolgerung Ein Gesamtbudget kann die notwendigen Voraussetzungen für eine flexiblere psychiatrische Versorgung und eine bessere Umsetzung der Behandlungskontinuität schaffen.

Esophageal perforation after endoscopic ultrasound-guided fine-needle aspiration for mediastinal staging is a rare but severe complication. We report 2 cases of patients with esophageal perforation who were treated using video-assisted thoracoscopic surgery in combination with esophageal stenting. Through these cases, the feasibility of minimally invasive thoracic surgery was evaluated.

This article reviews the genetic testing of infertility disorders. Genetic abnormalities can lead to disturbances of sexual development and hamper reproduction by influencing gamete production and maturation, fertilization, and embryonic development. Until now, the vast majority of detectable genetic abnormalities causing infertility were chromosomal abnormalities in both males and females. However, the number of monogenetic disorders, which play a role in disturbing fertility, such as single gene defects or complex disorders involving multiple genes in combination with environmental factors, is increasing. The common genetic causes of infertility in males are sex chromosomal abnormalities, Robertsonian translocations, cystic fibrosis transmembrane conductance regulator (CFTR) mutations, and Y chromosome microdeletions. In females, Turner syndrome, genetic causes of premature ovarian failure, such as fra(X) and complex disorders like polycystic ovary syndrome (PCOS), and endometriosis are the most prevailing. However, insight into the total impact of genetic abnormalities is increasing. This is because a growing number of mutations are detected among subfertile patients with an unknown etiology. Genetics is one of the most important yet under-emphasized causes of subfertility. Improved understanding of the genetics of infertility holds promise to define the etiology and counsel cases that were previously diagnosed with idiopathic infertility.

Objective This study determined if partial sick leave was associated with a shorter duration of sick leave due to musculoskeletal disorders (MSD) based on routinely collected health data in Dutch sick-listed employees. Furthermore, the effect of timing of partial sick leave on sick leave duration was determined. Methods This cohort study consisted of 771 employees with partial sick leave and 198 employees with full-time sick leave who participated in an occupational health check, and had sick leave due to MSD for minimally 4 weeks and were diagnosed by an occupational physician. Multivariable linear regression models were performed to determine the effects of partial sick leave (unadjusted and adjusted for confounders and MSD diagnosis) and Kaplan–Meier curves were presented for visualization of return to work for different timings of starting partial sick leave. Furthermore, linear regression analysis were done in subsets of employees with different minimal durations of sick leave to estimate the effects of timing of partial sick leave. Results Initial results suggest that partial sick leave was associated with longer sick leave duration, also when adjusted for confounders and sick leave diagnosis. Secondary results which accounted for the timing of partial sick leave suggest that partial sick leave had no effect on the duration of sick leave. Conclusion Partial sick leave does not influence MSD sick leave duration in this study when accounting for the timing of partial sick leave.

Zusammenfassung Hintergrund Der Innovationsausschuss beim Gemeinsamen Bundesausschuss (G-BA) fordert das Projekt „INTEGRAL–10-Jahres-Evaluation der populationsbezogenen Integrierten Versorgung Gesundes Kinzigtal“ (IVGK) (Forderkennzeichen 01VSF16002). Basis der Evaluation soll ein mit Routinedaten erfassbares Indikatorenset sein, mit dem zum einen die programmspezifischen, auf Pravention und Disease Management ausgerichteten IVGK-Programme beurteilt werden konnen. Zum anderen sollen mogliche negative Begleiterscheinungen der als „Shared-Savings-Vertrag“ angelegten IVGK uberpruft werden, indem auch nicht vom IV-Vertrag erfasste Versorgungsbedarfe beobachtet werden. Da ein konsentiertes Indikatorenset fur regionale Programme der integrierten Versorgung (IV) bisher nicht verfugbar ist, sollte ein geeignetes Indikatorenset entwickelt werden. Methoden 1. Festlegung eines methodologischen Rahmens der Indikatorenentwicklung auf der Basis von Konzepten aus der Literatur. 2. Recherche potenzieller Qualitatsindikatoren (QI) in a) Literatur- (PubMed, Web of Science, Cochrane, Embase) und b) Indikatorendatenbanken. 3. Dokumentenanalyse der IVGK-Programme. 4. Durchfuhrung von Fokusgruppen mit Patient*innen, Arzt*innen und Akteuren der IVGK. 5. Zusammenfuhrung der QI aus den verschiedenen Quellen, Entfernung von Dopplungen, Abgleich der Indikatoren mit der Datengrundlage GKV-Routinedaten. 6. Inhaltliche Zuordnung der Indikatoren zu Krankheitskategorien, Versorgungsbedarfen und Qualitatsdimensionen nach OECD und Donabedian. 7. Bewertung und Konsentierung der Indikatoren durch eine multidisziplinare Expertengruppe mithilfe der modifizierten RAND-UCLA-Appropriateness-Method (RAM) anhand der Relevanz und Machbarkeit der Indikatoren. Ergebnisse Das Rahmenkonzept verknupft das OECD-Konzept zur Qualitatsbewertung von Gesundheitssystemen mit der Tracer-Methodik nach Kessner. Als Tracer wurden Krankheitsgruppen mit hoher Pravalenz („Volkskrankheiten“), Praventionspotenzial und Verbesserungspotenzial durch eine IV ausgewahlt. Die Literaturrecherche ergab 239 QI und die QI-Datenbankrecherche 293 QI, die durch 21 QI aus den Fokusgruppen erganzt wurden. Von den insgesamt 553 QI verblieben nach Entfernung von Dopplungen und Abgleich mit der Datengrundlage 251 QI. Die Konsentierung reduzierte dieses vorlaufige QI-Set auf 101 QI. Zudem wurden 48 QI der Gesundheitsberichterstattung erganzt, die der Einordnung der regionalen Qualitatsergebnisse dienen. Das finale QI-Set bildet folgende 19 Krankheitskategorien/Tracer ab: Herzinsuffizienz (16 QI), Myokardinfarkt (4 QI), KHK (10 QI), Schlaganfall (6 QI), Metabolisches Syndrom (7 QI, davon 5 Diabetes-QI), COPD (6 QI), Asthma (3 QI), Chronischer Schmerz (5 QI), Ruckenschmerz (3 QI), Geriatrie (7 QI), Demenz (8 QI), Osteoporose (3 QI), Rheuma (3 QI), Multiple Sklerose (2 QI), Depression (4 QI), Antibiotikatherapie (3 QI), Arzneimittelsicherheit (1 QI), Kindervorsorge (5 QI), Fruherkennung/ Pravention (5 QI). Darunter widmen sich 33 QI funf Tracern, die nicht explizit Programme der IVGK sind. Die meisten QI bewerten Aspekte der Effektivitat der Versorgung chronisch Kranker und messen die Prozessqualitat. Diskussion Das Indikatorenset ermoglicht zunachst die Qualitatsbewertung der regionalen, indikationsubergreifenden Versorgungsqualitat im Integrierten Versorgungsmodell ‚Gesundes Kinzigtal‘ auf der Basis von Routinedaten. Zwar fokussiert das QI-Set die Effektivitat und Prozessqualitat, jedoch existieren daneben auch QI zur praventiven- und Akutversorgung, zur Versorgungskoordination, Patientenorientierung und Patientensicherheit sowie Ergebnisqualitat. Im Unterschied zu anderen QI-Sets werden sowohl die allgemeinmedizinische als auch die spezialisiert facharztliche Gesundheitsversorgung und integrierte, sektoren- und Berufsgruppen-ubergreifende Versorgungsaspekte betrachtet. Der Nutzen des QI-Sets fur einen regionalen Qualitatsvergleich und die Evaluation verschiedener IV-Programme bleibt zu testen. Schlussfolgerung Auf der Basis eines breit angelegten Recherche- und partizipativen Entwicklungsprozesses konnte ein Indikatorenset entwickelt werden, das eine umfassende Evaluation der regionalen Versorgungsqualitat indikationsubergreifender, auf Volkskrankheiten fokussierter, integrierter Versorgungsmodelle ermoglicht. Um in Zukunft vermehrt auch Aspekte der Versorgungskoordination und Patientenorientierung, der Gesundheitsforderung sowie der pflegerischen- und palliativen- sowie Notfallversorgung bewerten zu konnen, mussten auch in diesen Bereichen Routinedaten erhoben beziehungsweise erschlossen werden.

IntroductionStrict imaging surveillance protocols to detect complications following endovascular aneurysm repair (EVAR) are common practice. However, controversy exists as to whether all EVAR patients need intense surveillance. The 2019 European Society for Vascular Surgery guidelines for management of abdominal aortic aneurysm (AAA) suggest that patients may be considered for limited follow-up with imaging if classified as ‘low risk’ for complications based on their initial postoperative imaging. The current study aims to investigate the intervention-free survival and overall survival stratified for patients with and without yearly imaging surveillance.Methods and analysisThe Observing a Decade of Yearly Standardised Surveillance in EVAR patients with Ultrasound or CT Scan study comprises a national multicentre retrospective cohort study in 17 medical centres. Consecutive patients with an asymptomatic or symptomatic infrarenal AAA who underwent EVAR between January 2007 and January 2012 will be included in this study with follow-up until December 2018. Clinical variables and all follow-up information will be retrieved in extensive data collection from the patient’s medical records. In addition, an e-survey was sent to vascular surgeons at the 17 participating centres to gauge their opinions regarding the possibility of safely reducing the frequency of imaging surveillance. Primary endpoints are intervention after EVAR and aneurysm-related mortality. The initial estimated sample size is 1997 patients.Ethics and disseminationThe study has been approved by the Medical Ethics Review Committee of the Amsterdam UMC, location Academic Medical Centre, Amsterdam, the Netherlands. Study findings will be disseminated via presentations at conferences and publications in peer-reviewed journal.Trial registration numberThe Netherlands Trial Registry, NL6953 (old: NTR28773).

Objective: What are the cost per live birth and the incremental cost of preventing a miscarriage with preimplantation genetic testing for aneuploidy (PGT-A) by polar body biopsy and array-based comprehensive genome hybridisation (aCGH) versus regular IVF/ICSI without PGT-A for infertility treatment in women 36–40 years of age?. Design: Decision tree model. Population: A randomised clinical trial on PGT-A (ESTEEM study). Methods: Two treatment strategies were compared: one cycle of IVF/ICSI with or without PGT-A. Costs and effects were analysed with this model for four different cost scenarios: high-, higher medium, lower medium and low-cost. Base case, sensitivity, threshold, and probabilistic sensitivity analyses were used to examine the cost-effectiveness implications of PGT-A. Results: PGT-A increased the cost per live birth by approximately 15% in the high-cost scenario to approximately 285% in the low-cost scenario. Threshold analysis revealed that PGT-A would need to be associated with an absolute increase in pregnancy rate by 6% to >39% or, alternatively, would need to be US$2,969 (high-cost scenario) to US$4,888 (low-cost scenario) cheaper. The incremental cost to prevent one miscarriage by PGT-A using the base case assumptions was calculated to be US$34,427 (high-cost scenario) to US$51,146 (low-cost scenario). A probabilistic sensitivity analysis showed cost-effectiveness for PGT-A from 1.9% (high-cost scenario) to 0.0% (low-cost scenario) of calculated samples. Conclusions: While avoiding unnecessary embryo transfers and miscarriages are important goals, patients and doctors need to be aware of the high-cost implications of applying PGT-A using aCGH on polar bodies. Tweetable abstract: PGT-A by polar body biopsy and comprehensive genome hybridisation increases cost per live birth and requires high financial spending per miscarriage averted.

Aim of the study: The coronavirus disease 2019 (COVID-19) pandemic significantly impacted cancer care. In this study, clinical patient characteristics related to COVID-19 outcomes and advanced care planning, in terms of non-oncological treatment restrictions (e.g. do not-resuscitate codes), were studied in patients with cancer and COVID-19. Methods: The Dutch Oncology COVID-19 Consortium registry was launched in March 2020 in 45 hospitals in the Netherlands, primarily to identify risk factors of a severe COVID-19 outcome in patients with cancer. Here, an updated analysis of the registry was performed, and treatment restrictions (e.g. do-not-intubate codes) were studied in relation to COVID19 outcomes in patients with cancer. Oncological treatment restrictions were not taken into account. Results: Between 27th March 2020 and 4th February 2021, 1360 patients with cancer and COVID-19 were registered. Follow-up data of 830 patients could be validated for this analysis. Overall, 230 of 830 (27.7%) patients died of COVID-19, and 60% of the remaining 600 patients with resolved COVID-19 were admitted to the hospital. Patients with haematological malignancies or lung cancer had a higher risk of a fatal outcome than other solid tumours. No correlation between anticancer therapies and the risk of a fatal COVID-19 outcome was found. In terms of end-of-life communication, 50% of all patients had restrictions regarding life prolonging treatment (e.g. do-not-intubate codes). Most identified patients with treatment restrictions had risk factors associated with fatal COVID-19 outcome. Conclusion: There was no evidence of a negative impact of anticancer therapies on COVID-19 outcomes. Timely end-of-life communication as part of advanced care planning could save patients from prolonged suffering and decrease burden in intensive care units. Early discussion of treatment restrictions should therefore be part of routine oncological care, especially during the COVID-19 pandemic. 2021 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

Objectives Our objective was to evaluate the role of potential predictors in explaining spatial variation among diabetes hospitalization rates in Germany. Study design This was an ecological analysis using hospital routine data. Methods County-level hospitalization rates (n = 402) in 2015 were calculated based on the German Diagnosis Related Groups database. We used a funnel plot to identify counties with high hospitalization rates. To examine the impact of predictors such as socio-economic status or structure of primary care, we performed linear and logistic regression analyses. Results The crude hospitalization rate was 262 admissions per 100,000 population. In multivariable logistic models, we found the percentage of employees with academic degree (odds ratio [OR]: 0.72, 95% confidence interval [CI]: 0.56–0.91), high hospital bed rate (4th quartile vs 1st quartile; OR: 2.73, CI: 1.03–7.24), and diabetes prevalence (OR: 1.49, CI: 1.17–1.90) to be significant predictors for high hospitalization rates. In multivariable linear models, the percentage of unemployed (regression coefficient b: 4.79, CI: 0.81–8.78) and rurality (b: 0.52, CI: 0.19–0.85) explained the variation in addition to predictors from logistic regression. Primary care structure was not a significant predictor in multivariable models. Conclusions The non-significant impact of primary care in adjusted models casts the use of diabetes hospitalizations as indicators for access and quality of primary care into doubt. Diabetes hospitalizations may rather reflect demand for care.

OBJECTIVE: The aim of this study was to develop a prediction model for the prognosis of sick leave due to low back pain (LBP). METHODS: This is a cohort study with 103 employees sick-listed due to non-specific LBP and spinal disc herniation. A prediction model was developed based on questionnaire data and registered sick leave data with follow up of 180 days. RESULTS: At follow up 31 (30.1%) employees were still sick-listed due to LBP. Forward selection procedure resulted in a model with: catastrophizing, musculoskeletal work load, and disability. The explained variance was 27.3%, calibration was adequate and discrimination was fair with area under the ROC-curve (AUC) = 0.761 (interquartile range [IQR]: 0.755-0.770). CONCLUSION: The prediction model of this study can adequately predict LBP sick leave after 180 days and could be used for employees sick listed due LBP.

BACKGROUND: Quality assurance for acute in-hospital care in Germany is based on compulsory comparisons between institutions, so-called external quality assurance (EQA). The effectiveness of EQA has not yet been adequately studied. The purpose of the QUASCH project, which is supported by the Innovation Fund of the Federal Joint Committee, is to investigate the association between EQA and health care outcomes, specifically with respect to stroke. METHODS: The analyses were based on data from 379 825 patients insured by the AOK health insurance fund who were acutely admitted to a hospital because of stroke over the period 2007–2017. Data on 47 659 patients were derived from EQA documentation in the state of Hesse, in which stroke EQA had already been introduced in 2003; data on the remaining 332 166 patients were from other federal states, where 117 734 of these patients had been treated under EQA conditions. The association of EQA with mortality over the period of observation was analyzed by multivariate Cox regression, with the following covariates: age, sex, comorbidities, time period of occurrence, nursing care level, type of stroke, socio-economic deprivation in the region of origin, and treatment in a stroke unit. RESULTS: Compared to treatment without EQA, mortality risk under EQA in the state of Hesse was significantly lower (hazard ratio [HR]: 0.93; 95% confidence interval: [0.92; 0.95]). The reduction in mortality risk with EQA was somewhat lower in the other federal states (HR: 0.96 [0.95; 0.97]). Treatment in a stroke unit was associated with a mortality risk that was lower still (HR: 0.86 [0.85; 0.87]). Mortality risk rose with age, comorbidities, and need for nursing care; it was lower in women and in persons whose stroke occurred in a later period. CONCLUSION: Quality assurance measures are associated with lower mortality risk after stroke. The concentration of care in specially qualified institutions is associated with stronger effects than EQA alone.

Purpose: Lifelong follow-up after endovascular abdominal aortic aneurysm repair (EVAR) is recommended due to a continued risk of complications, especially if the first postoperative imaging shows abnormal findings. We studied the long-term outcomes in patients with abnormalities on the first postoperative computed tomography angiography (CTA) following EVAR. Materials and Methods: This is a retrospective study of all consecutive patients who underwent elective EVAR for nonruptured abdominal aortic aneurysm (AAA) between January 2007 and January 2012 in 16 Dutch hospitals with follow-up until December 2018. Patients were included if the first postoperative CTA showed one of the following abnormal findings: endoleak type I–IV, endograft kinking, infection, or limb occlusion. AAA diameter, complications, and secondary interventions during follow-up were registered. Primary endpoint was overall survival, and other endpoints were secondary interventions and intervention-free survival. Kaplan-Meier analyses were used to estimate overall and intervention-free survival. Cox regression analyses were used to identify the association of independent determinants with survival and secondary interventions. Results: A total of 502 patients had abnormal findings on the first postoperative CTA after EVAR and had a median follow-up (interquartile range IQR) of 83.0 months (59.0). The estimated overall survival rate at 1, 5, and 10 years was 84.7%, 51.0%, and 30.8%, respectively. Age [hazard ratio (HR) 1.06, 95% confidence interval (CI) 1.05 to 1.10] and American Society of Anesthesiologists (ASA) classification (ASA IV HR 3.20, 95% CI 1.99 to 5.15) were significantly associated with all-cause mortality. Overall, 167 of the 502 patients (33.3%) underwent 238 secondary interventions in total. Fifty-eight patients (12%) underwent an intervention based on a finding on the first postoperative CTA. Overall survival was 38.4% for patients with secondary interventions and 44.5% for patients without (log rank; p=0.166). The intervention-free survival rate at 1, 5, and 10 years was 82.9%, 61.3%, and 45.6%, respectively. Conclusions: Patients with abnormalities on the first postoperative CTA after elective EVAR for infrarenal AAA cannot be discharged from regular imaging follow-up due to a high risk of secondary interventions. Patients who had a secondary intervention had similar overall survival as those without secondary interventions.

ObjectivesPatients in German ambulatory care frequently report patient safety problems (PSP). It is unclear whether patients report PSP back to their general practitioner (GP) or specialist in charge. This study reports on how patients respond to experienced PSP.DesignRetrospective cross-sectional study.SettingComputer-assisted telephone interviews (CATI) with randomly recruited citizens aged ≥40 years in Germany.Participants10 037 citizens ≥40 years. About 52% of the interviewees were female, 38% were between 60 and 79 years old and about 47% reported that they were chronically ill. A total of 2589 PSPs was reported.Primary and secondary measures/ResultsAccording to the respondents (n=1422, 77%, 95% CI: 74.7 to 79.1), 72% (95% CI: 70.2 to 73.7) of PSP were reported back to the GP in charge or to another GP/specialist. Further reactions were taken by 65% (95% CI: 62.5 to 67.5) of the interviewees: around 63% (95% CI: 62.5 to 66.2) of the reported PSP led to a loss of faith in the physician or to complaints. χ2 and binary logistic regression analyses show significant associations between the (a) reporting and (b) reaction behaviour and determinants like ‘medical treatment area’ ((a) χ2=17.13, p=0.009/(b) χ2=97.58, p=0.000), ‘PSP with/without harm’ ((a) χ2=111.84, p=0.000/(b) χ2=265.39, p=0.000) and sociodemographic characteristics when respondents are aged between 40 and 59 years ((a) OR 2.57/(b) OR 2.60) or have chronic illnesses ((a) OR 2.16/(b) OR 2.14).ConclusionThe data suggest that PSPs are frequently reported back to the GP or specialist in charge and have a significant serious impact on the physician–patient relationship. Much could be learnt from the patient reporting and reacting behaviour to prevent PSPs in ambulatory care.

Objective To assess the care for hypertension in Sierra Leone, by the use of a cascade-of-care approach, to identify where the need for healthcare system interventions is greatest. Methods Using data from a nationwide household survey on surgical conditions undertaken in 1.956 participants ≥18 years from October 2019 till March 2020, a cascade of care for hypertension consisting of four categories - hypertensive population, those diagnosed, those treated and those controlled - was constructed. Hypertension was defined as having a blood pressure ≥140/90mmHg, or self-reported use of antihypertensive medication. Logistic regression analysis was used to investigate factors associated with undiagnosed hypertension. Results The prevalence of hypertension was 22%. Male sex, age 18-34 years and living in a rural location were significantly associated with the odds of undiagnosed hypertension. Among those with hypertension, 23% were diagnosed, 11% were treated, and 5% had controlled blood pressure. The largest loss to care (77%) was between being hypertensive and receiving a diagnosis. There was no significant difference between men and women in the number of patients with controlled blood pressure. Adults aged 40 or older were observed to be better retained in care compared to those younger than 40 years of age. Conclusion There is a significant loss to care in the care cascade of hypertension in Sierra Leone. Our results suggests that increasing awareness of cardiovascular risk and risk factor screening for early diagnosis might have a large impact on hypertension care.

IntroductionThe quality of healthcare in childhood and adolescence is of key importance, in order to foster a healthy development and to avoid chronic health problems. Yet, data for Germany regarding the quality of healthcare for this patient group are lacking. The QualiPäd research project aims to estimate the quality of outpatient healthcare for children and adolescents in Germany, focusing on common psychiatric and physical disorders.Methods and analysisQuality indicators for seven common physical and mental childhood and adolescent clinical conditions (attention deficit/hyperactivity disorder, asthma, atopic dermatitis, depression, otitis media, conduct disorder/oppositional defiant disorder, tonsillitis) will be developed and ratified by experts, using the RAND/UCLA Appropriateness Method.Initially, 1400 medical records of children and adolescents with one of the aforementioned clinical conditions will then be randomly drawn from 40 outpatient practices in the German federal state of Hessen. The records will then be assessed regarding their adherence to the respective quality indicators. Based on this, the percentage of appropriate and inappropriate (eg, wasteful) healthcare of all clinical conditions (primary endpoint) will be estimated. Additionally, possible factors influencing the quality of care (eg, patient characteristics, type of condition, type of practice) will be identified using generalised estimation equation models.Ethics and disseminationThis study will show for which of the studied clinical conditions and/or patients improvement of quality of care is necessary within the German health system. Also, the quality indicators designed for the study can afterwards be implemented in regular care and thus enable regular reporting of the outpatient care of this target group. The authors plan to disseminate their findings through international, peer-reviewed scientific publications, and through presentations at national and international paediatric and child psychiatric conferences.Trial registration numberDRKS00022408., publishedVersion

STUDY QUESTION Is fatigue a frequent symptom of endometriosis? SUMMARY ANSWER Fatigue is an underestimated symptom of endometriosis as it affects the majority of women with endometriosis, but it is not widely discussed in literature. WHAT IS KNOWN ALREADY Fatigue can be a symptom of endometriosis causing major distress impacting the daily activities and quality of life of women with endometriosis. However, few studies with large sample sizes have investigated fatigue as a symptom of endometriosis. STUDY DESIGN, SIZE, DURATION The study was designed as a multi-center matched case-control study. Recruitment took place at hospitals and private practices in Switzerland, Germany and Austria between 2010 and 2016. Data was collected from 1120 women, 560 of them with endometriosis. The women with endometriosis were matched to 560 control women in regard to age ±3 years and ethnic background. PARTICIPANTS/MATERIALS, SETTING, METHODS Diagnosis of women with endometriosis had to be surgically and histologically confirmed. Surgical exclusion or absence of any endometriosis-identifying symptoms was required for control subjects. Materials included surgical and histological reports as well as data retrieved from a self-administered questionnaire. This study focused on the symptom fatigue in endometriosis. Relationships of variables were established by regression analysis and associations were quantified as odds ratios. MAIN RESULTS AND THE ROLE OF CHANCE Frequent fatigue was experienced by a majority of women diagnosed with endometriosis (50.7% versus 22.4% in control women, P < 0.001). Fatigue in endometriosis was associated with insomnia (OR: 7.31, CI: 4.62-11.56, P < 0.001), depression (OR: 4.45, CI: 2.76-7.19, P < 0.001), pain (OR: 2.22, CI: 1.52-3.23, P < 0.001), and occupational stress (OR: 1.45, CI: 1.02-2.07, P = 0.037), but was independent of age, time since first diagnosis and stage of the disease. LIMITATIONS, REASONS FOR CAUTION Women with asymptomatic endometriosis cannot be excluded in the control group which would lead to underestimation of our results. The study's design allows no evaluation of causal effects. WIDER IMPLICATIONS OF THE FINDINGS As fatigue is experienced by numerous women with endometriosis, it needs to be addressed in the discussion of management and treatment of the disease. In addition to treating endometriosis, it would be beneficial to reduce insomnia, depression, pain and occupational stress in order to better manage fatigue. STUDY FUNDING/COMPETING INTEREST(s) There was no additional funding received for this study and no conflict of interest. TRIAL REGISTRATION NUMBER ClinicalTrials.gov, NCT 02511626.

Background The sharp decrease in open surgical repair (OSR) for abdominal aortic aneurysm (AAA) has raised concerns about contemporary postoperative outcomes. The study was designed to analyse the impact of complications on clinical outcomes within 30 days following OSR. Methods Patients who underwent OSR for intact AAA registered prospectively between 2016 and 2019 in the Dutch Surgical Aneurysm Audit were included. Complications and outcomes (death, secondary interventions, prolonged hospitalization) were evaluated. The adjusted relative risk (aRr) and 95 per cent confidence intervals were computed using Poisson regression. Subsequently, the population-attributable fraction (PAF) was calculated. The PAF reflects the expected percentage reduction of an outcome if a complication were to be completely prevented. Results A total of 1657 patients were analysed. Bowel ischaemia and renal complications had the largest impact on death (aRr 12·44 (95 per cent c.i. 7·95 to 19·84) at PAF 20 (95 per cent c.i. 8·4 to 31·5) per cent and aRr 5·07 (95 per cent c.i. 3·18 to 8.07) at PAF 14 (95 per cent c.i. 0·7 to 27·0) per cent, respectively). Arterial occlusion had the greatest impact on secondary interventions (aRr 11·28 (95 per cent c.i. 8·90 to 14·30) at PAF 21 (95 per cent c.i. 14·7 to 28·1) per cent), and pneumonia (aRr 2·52 (95 per cent c.i. 2·04 to 3·10) at PAF 13 (95 per cent c.i. 8·3 to 17·8) per cent) on prolonged hospitalization. Small effects were observed on outcomes for other complications. Conclusion The greatest clinical impact following OSR can be made by focusing on measures to reduce the occurrence of bowel ischaemia, arterial occlusion and pneumonia.

Background The population-based integrated health care system called "Gesundes Kinzigtal" (Integrierte Versorgung Gesundes Kinzigtal, IVGK) was initiated more than 10 years ago in the Kinzig River Valley region, which is located in the Black Forest in the German state of Baden-Wurttemberg. IVGK is intended to optimize health care while maximizing cost-effectiveness. It consists of programs for promoting health and for enabling cooperation among service providers, as well as of a shared-savings contract that has enabled resources to be saved every year. The goal of the present study was to investigate trends in the quality of care provided by IVGK over the past ten years in comparison to conventional care. Methods This is a non-randomized observational study with a control-group design (Kinzig River Valley versus 13 structurally comparable control regions), employing data collected by AOK, a large statutory health-insurance provider in Germany, over the period 2006-2015. Quality assessment was conducted with the aid of a set of indicators, developed by the authors, that was based exclusively on claims data. The statistical analysis of the trends in these indicators over time was conducted with preset criteria for the relevance of any observed changes, as well as preset mechanisms of controlling for confounding factors. Results For 88 of the 101 evaluable indicators, no relevant difference was seen between the trend over time in the region of the intervention and the average trend in the control regions. Relevant differences in favor of the IVGK were observed for six indicators, and negatively divergent trends compared to the controls were observed for seven indicators. In the main summarizing statistical analysis, no positive or negative difference was found between the Kinzig River Valley and the other regions with respect to trends in the health-care indicators over time. Conclusion An evaluation based on 101 indicators derived from health-insurance data did not reveal any improvement of the quality of care by IVGK and the totality of the programs that were implemented under it. However, under the conditions of the shared-savings contract, no relevant diminution in the quality of care was observed over a period of 10 years either, compared with structurally similar control regions without an integrated care model.

Objectives To gain first insight into the effectiveness of a home-based exercise programme for pre-frail older adults with independent use of novel ICT technology. Methods A pilot study. Forty pre-frail older adults joined a six-month home-based exercise programme using a tablet PC for exercise administration and feedback, and a necklace-worn motion sensor for daily physical activity registration. Participants received weekly telephone supervision during the first 3 months and exercised independently without supervision from a coach during the last 3 months. Functional performance and daily physical activity were assessed at baseline, after three and 6 months. Results Twenty-one participants completed the programme. Overall, functional performance showed positive results varying from (very) small to large effects (Cohen’s d 0.04–0.81), mainly during the supervised part of the intervention. Regarding daily physical activity, a slight improvement with (very) small effects (Cohen’s d 0.07–0.38), was observed for both self-reported and objectively measured physical activity during the supervised period. However, during the unsupervised period this pattern only continued for self-reported physical activity. Conclusion This pilot study showed positive results varying from (very) small to large effects in levels and maintenance of functional performance and daily physical activity, especially during the supervised first 3 months. Remote supervision seems to importantly affect effectiveness of a home-based exercise programme. Effectiveness of the programme and the exact contribution of its components should be further quantified in a randomized controlled trial. Practice implications Home-based exercising using novel technology may be promising for functional performance and physical activity improvement in (pre-frail) older adults. Trial registration Netherlands Trial Register (NTR); trial number NL4049. The study was prospectively registered (registration date 14/11/2013).

Background Subthalamic deep brain stimulation (STN DBS) may relieve refractory motor complications in Parkinson's disease (PD) patients. Despite careful screening, it remains difficult to determine severity of alpha-synucleinopathy involvement which influences the risk of postoperative complications including cognitive deterioration. Quantitative electroencephalography (qEEG) reflects cognitive dysfunction in PD and may provide biomarkers of postoperative cognitive decline. Objective To develop an automated machine learning model based on preoperative EEG data to predict cognitive deterioration 1 year after STN DBS. Methods Sixty DBS candidates were included; 42 patients had available preoperative EEGs to compute a fully automated machine learning model. Movement Disorder Society criteria classified patients as cognitively stable or deteriorated at 1-year follow-up. A total of 16,674 EEG-features were extracted per patient; a Boruta algorithm selected EEG-features to reflect representative neurophysiological signatures for each class. A random forest classifier with 10-fold cross-validation with Bayesian optimization provided class-differentiation. Results Tweny-five patients were classified as cognitively stable and 17 patients demonstrated cognitive decline. The model differentiated classes with a mean (SD) accuracy of 0.88 (0.05), with a positive predictive value of 91.4% (95% CI 82.9, 95.9) and negative predictive value of 85.0% (95% CI 81.9, 91.4). Predicted probabilities between classes were highly differential (hazard ratio 11.14 [95% CI 7.25, 17.12]); the risk of cognitive decline in patients with high probabilities of being prognosticated as cognitively stable (>0.5) was very limited. Conclusions Preoperative EEGs can predict cognitive deterioration after STN DBS with high accuracy. Cortical neurophysiological alterations may indicate future cognitive decline and can be used as biomarkers during the DBS screening. © 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

Background The Framingham score is commonly used to estimate the risk of cardiovascular disease (CVD). This study investigated whether work-related variables improve Framingham score predictions of sickness absence due to CVD. Methods Eleven occupational health survey variables (descent, marital status, education, work type, work pace, cognitive demands, supervisor support, co-worker support, commitment to work, intrinsic work motivation and distress) and the Framingham Point Score (FPS) were combined into a multi-variable logistic regression model for CVD sickness absence during 1-year follow-up of 19 707 survey participants. The Net Reclassification Index (NRI) was used to investigate the added value of work-related variables to the FPS risk classification. Discrimination between participants with and without CVD sickness absence during follow-up was investigated by the area under the receiver operating characteristic curve (AUC). Results A total of 129 (0.7%) occupational health survey participants had CVD sickness absence during 1-year follow-up. Manual work and high cognitive demands, but not the other work-related variables contributed to the FPS predictions of CVD sickness absence. However, work type and cognitive demands did not improve the FPS classification for risk of CVD sickness absence [NRI = 2.3%; 95% confidence interval (CI) −2.7 to 9.5%; P = 0.629]. The FPS discriminated well between participants with and without CVD sickness absence (AUC = 0.759; 95% CI 0.724–0.794). Conclusion Work-related variables did not improve predictions of CVD sickness absence by the FPS. The non-laboratory Framingham score can be used to identify health survey participants at risk of CVD sickness absence.

Parkinson's disease (PD) is accompanied by functional changes throughout the brain, including changes in the electromagnetic activity recorded with magnetoencephalography (MEG). An integrated overview of these changes, its relationship with clinical symptoms, and the influence of treatment is currently missing. Therefore, we systematically reviewed the MEG studies that have examined oscillatory activity and functional connectivity in the PD‐affected brain. The available articles could be separated into motor network‐focused and whole‐brain focused studies. Motor network studies revealed PD‐related changes in beta band (13–30 Hz) neurophysiological activity within and between several of its components, although it remains elusive to what extent these changes underlie clinical motor symptoms. In whole‐brain studies PD‐related oscillatory slowing and decrease in functional connectivity correlated with cognitive decline and less strongly with other markers of disease progression. Both approaches offer a different perspective on PD‐specific disease mechanisms and could therefore complement each other. Combining the merits of both approaches will improve the setup and interpretation of future studies, which is essential for a better understanding of the disease process itself and the pathophysiological mechanisms underlying specific PD symptoms, as well as for the potential to use MEG in clinical care.

Purpose: To study the effects of imaging surveillance after endovascular aortic repair (EVAR) on reintervention and mortality. Materials and Methods: A systematic review was conducted comparing complication rates in EVAR patients compliant with the imaging surveillance protocol vs partially or noncompliant patients. Two authors independently selected articles and performed quality assessment and data extraction. Risk differences for reintervention and mortality between compliant and partially/noncompliant patients were meta-analyzed. The pooled risk difference (RD) is reported with the 95% confidence interval (CI). The review protocol is registered at Prospero (CRD42017080494). Results: A total of 11 cohort studies involving 21,838 patients were included. Studies differed in imaging, their surveillance protocols, and definitions of compliance subgroups. Median follow-up was 31.7 months (interquartile range 29.8, 49.3). The overall reintervention rate was 5%, while the overall mortality was 31%. The RD for the reintervention rate was 4% (95% CI 1% to 7%) in favor of partial/noncompliance [number needed to harm 25 (95% CI 14 to 100)], while mortality showed a nonsignificant RD of 12% (95% CI −2% to 26%) in favor of partial/noncompliance. Two studies reported that 41% to 53% of reinterventions were performed for complications detected through imaging surveillance; the other events were detected through patient symptoms. Conclusion: Patients who are compliant with imaging surveillance appear to undergo more reinterventions than those who are partially or noncompliant. However, imaging surveillance does not seem to protect against mortality. This suggests that the recommended yearly imaging surveillance may not be beneficial for all EVAR patients.

There is a need to measure and improve the quality of paediatric primary care in Europe where major differences in the delivery and outcomes of child health care exist. A collaborative panel of paediatric senior experts developed a Core Set of Indicators for Paediatric Primary Care in Europe by compiling 42 quality indicators in a modified consensus process following the RAND/UCLA appropriateness method. The aim of this study was to explore the feasibility of the quality indicator set in European paediatric primary care practices. Seventy-nine practices from eight countries participated in a detailed online interview. The practices rated the applicability, relevance, reliability and acceptance of the 42 quality indicator as well as the availability, technical feasibility and effort to retrieve the needed data from their medical records. Most quality indicators were considered applicable, available, reliable, acceptable and relevant for monitoring quality of care in paediatric primary care. Respondents rated feasibility and effort to retrieve the data lowest because of difficulties collecting the data from the medical records.Conclusion: European paediatric primary care practices generally agree with the proposed quality indicator set. They document most of the parameters. However, the collection of specific needed values from available routine patient-data is considered technically difficult and time-consuming. What is Known? • Paediatric primary care systems in Europe show striking differences in their performance. Pre-existing sets of quality indicators are predominantly limited to national populations, specific diseases and hospital care. • A Core Set of 42 quality indicators for paediatric primary care in Europe was developed by European paediatricians using a systematic literature review and a consensus process following a modified RAND/UCLA appropriateness method. What is New? • Paediatric primary care providers in Europe agree with the idea to use COSI-PPC-EU to monitor and improve the quality of care. The set was considered applicable, available, reliable, acceptable, and relevant for quality improvement. • The score for feasibility and effort to retrieve the data was low, because of technical reasons; the electronical or paper-based medical documentation in most cases does not allow convenient access to all necessary data.

RLIM, also known as RNF12, is an X-linked E3 ubiquitin ligase acting as a negative regulator of LIM-domain containing transcription factors and participates in X-chromosome inactivation (XCI) in mice. We report the genetic and clinical findings of 84 individuals from nine unrelated families, eight of whom who have pathogenic variants in RLIM (RING finger LIM domain-interacting protein). A total of 40 affected males have X-linked intellectual disability (XLID) and variable behavioral anomalies with or without congenital malformations. In contrast, 44 heterozygous female carriers have normal cognition and behavior, but eight showed mild physical features. All RLIM variants identified are missense changes co-segregating with the phenotype and predicted to affect protein function. Eight of the nine altered amino acids are conserved and lie either within a domain essential for binding interacting proteins or in the C-terminal RING finger catalytic domain. In vitro experiments revealed that these amino acid changes in the RLIM RING finger impaired RLIM ubiquitin ligase activity. In vivo experiments in rlim mutant zebrafish showed that wild type RLIM rescued the zebrafish rlim phenotype, whereas the patient-specific missense RLIM variants failed to rescue the phenotype and thus represent likely severe loss-of-function mutations. In summary, we identified a spectrum of RLIM missense variants causing syndromic XLID and affecting the ubiquitin ligase activity of RLIM, suggesting that enzymatic activity of RLIM is required for normal development, cognition and behavior.

Objective: A downside of Deep Brain Stimulation (DBS) for Parkinson's Disease (PD) is that cognitive function may deteriorate postoperatively. Electroencephalography (EEG) was explored as biomarker of cognition using a Machine Learning (ML) pipeline.Methods: A fully automated ML pipeline was applied to 112 PD patients, taking EEG time-series as input and predicted class-labels as output. The most extreme cognitive scores were selected for class differentiation, i.e. best vs. worst cognitive performance (n = 20 per group). 16,674 features were extracted per patient; feature-selection was performed using a Boruta algorithm. A random forest classifier was modelled; 10-fold cross-validation with Bayesian optimization was performed to ensure generalizability. The predicted class-probabilities of the entire cohort were compared to actual cognitive performance.Results: Both groups were differentiated with a mean accuracy of 0.92; using only occipital peak frequency yielded an accuracy of 0.67. Class-probabilities and actual cognitive performance were negatively linearly correlated (b =-0.23 (95% confidence interval (-0.29,-0.18))).Conclusions: Particularly high accuracies were achieved using a compound of automatically extracted EEG biomarkers to classify PD patients according to cognition, rather than a single spectral EEG feature.Significance: Automated EEG assessment may have utility for cognitive profiling of PD patients during the DBS screening. (c) 2021 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

Background Early morbidity and mortality are low after endovascular abdominal aneurysm repair (EVAR), but secondary interventions and late complications are common. The aim of the present multicenter cohort study is to detail the frequency and indication for interventions after EVAR and the impact on long-term survival. Methods A retrospective multicenter cohort study of secondary interventions after elective EVAR for an infrarenal abdominal aortic aneurysm was conducted. Consecutive patients (n = 349) undergoing EVAR between January 2007 and January 2012 were analyzed, with long-term follow-up until December 2018. Those requiring intervention were classified in accordance with the indications and specific nature of the intervention and treatment. The primary study end point was overall survival classified for patients with and without intervention. Kaplan-Meier analysis was used to estimate overall survival for those who did and who did not undergo secondary interventions. Univariable and multivariable Cox regression were performed to identify independent variables associated with mortality. Results Some 56 patients (16%) underwent 72 secondary interventions after EVAR during a median (interquartile range) follow-up period of 53.2 months (60.1). Some 45 patients (80.4%) underwent one intervention. Indications for intervention included mainly endograft kinking/outflow obstruction and type II endoleak. An endovascular technique was used in 40.3% of interventions. Median time to secondary intervention was 24.1 months. In 93 patients with abnormalities on imaging, no intervention was performed mainly because the abnormality had disappeared on follow-up imaging (43%). Kaplan-Meier curves showed no difference in survival for patients with and without secondary interventions (P = 0.153). Age (hazard ratio [HR]: 1.089, 95% confidence interval [CI]: 1.063–1.116), ASA classification (ASA III, IV HR: 1.517, 95% CI: 1.056–2.178) were significantly related to mortality. Conclusions Secondary intervention rates are still considerable after EVAR. Endograft kinking/outflow obstruction and endoleak type II are the most common indications for a secondary intervention. Secondary interventions did not adversely affect long-term overall survival after EVAR.

Huntington’s disease (HD) is an autosomal dominant disease that immensely impacts the affected families. However, the transmission of the disease from carriers to their offspring could be prevented. Prenatal diagnosis (PND) and preimplantation genetic diagnosis (PGD) are the only two available reproductive options for the carriers at risk to have disease-free children. PND for HD could be done through two kinds of genetic testing: direct and indirect. The same approaches are available for preimplantation genetic testing. In addition, a third alternative is nondisclosure testing, which is only available in the case of PGD. The pros and cons of different approaches are discussed. However, only a relatively few at-risk parents opt for PND and PGD. Furthermore, compared to PND, PGD is even more seldom opted for as a reproductive option.

Importance: Personalized treatment choices would increase the effectiveness of internet-based cognitive behavioral therapy (iCBT) for depression to the extent that patients differ in interventions that better suit them.Objective: To provide personalized estimates of short-term and long-term relative efficacy of guided and unguided iCBT for depression using patient-level information.Data Sources: We searched PubMed, Embase, PsycInfo, and Cochrane Library to identify randomized clinical trials (RCTs) published up to January 1, 2019.Study Selection: Eligible RCTs were those comparing guided or unguided iCBT against each other or against any control intervention in individuals with depression. Available individual patient data (IPD) was collected from all eligible studies. Depression symptom severity was assessed after treatment, 6 months, and 12 months after randomization.Data Extraction and Synthesis: We conducted a systematic review and IPD network meta-analysis and estimated relative treatment effect sizes across different patient characteristics through IPD network meta-regression.Main Outcomes and Measures: Patient Health Questionnaire-9 (PHQ-9) scores.Results: Of 42 eligible RCTs, 39 studies comprising 9751 participants with depression contributed IPD to the IPD network meta-analysis, of which 8107 IPD were synthesized. Overall, both guided and unguided iCBT were associated with more effectiveness as measured by PHQ-0 scores than control treatments over the short term and the long term. Guided iCBT was associated with more effectiveness than unguided iCBT (mean difference [MD] in posttreatment PHQ-9 scores, -0.8; 95% CI, -1.4 to -0.2), but we found no evidence of a difference at 6 or 12 months following randomization. Baseline depression was found to be the most important modifier of the relative association for efficacy of guided vs unguided iCBT. Differences between unguided and guided iCBT in people with baseline symptoms of subthreshold depression (PHQ-9 scores 5-9) were small, while guided iCBT was associated with overall better outcomes in patients with baseline PHQ-9 greater than 9.Conclusions and Relevance: In this network meta-analysis with IPD, guided iCBT was associated with more effectiveness than unguided iCBT for individuals with depression, benefits were more substantial in individuals with moderate to severe depression. Unguided iCBT was associated with similar effectiveness among individuals with symptoms of mild/subthreshold depression. Personalized treatment selection is entirely possible and necessary to ensure the best allocation of treatment resources for depression.

BackgroundIn contrast with the setting of acute myocardial infarction, there are limited data regarding the impact of diabetes mellitus on clinical outcomes in contemporary cohorts of patients with chronic coronary syndromes. We aimed to investigate the prevalence and prognostic impact of diabetes according to geographical regions and ethnicity.Methods and resultsCLARIFY is an observational registry of patients with chronic coronary syndromes, enrolled across 45 countries in Europe, Asia, America, Middle East, Australia, and Africa in 2009–2010, and followed up yearly for 5 years. Chronic coronary syndromes were defined by ≥1 of the following criteria: prior myocardial infarction, evidence of coronary stenosis >50%, proven symptomatic myocardial ischaemia, or prior revascularization procedure.Among 32 694 patients, 9502 (29%) had diabetes, with a regional prevalence ranging from below 20% in Northern Europe to ∼60% in the Gulf countries. In a multivariable-adjusted Cox proportional hazards model, diabetes was associated with increased risks for the primary outcome (cardiovascular death, myocardial infarction, or stroke) with an adjusted hazard ratio of 1.28 (95% confidence interval 1.18, 1.39) and for all secondary outcomes (all-cause and cardiovascular mortality, myocardial infarction, stroke, heart failure, and coronary revascularization). Differences on outcomes according to geography and ethnicity were modest.ConclusionIn patients with chronic coronary syndromes, diabetes is independently associated with mortality and cardiovascular events, including heart failure, which is not accounted by demographics, prior medical history, left ventricular ejection fraction, or use of secondary prevention medication. This is observed across multiple geographic regions and ethnicities, despite marked disparities in the prevalence of diabetes.ClinicalTrials identifierISRCTN43070564

Supplemental material, sj-pdf-1-jet-10.1177_15266028211030539 for Analysis of Outcomes After Endovascular Abdominal Aortic Aneurysm Repair in Patients With Abnormal Findings on the First Postoperative Computed Tomography Angiography by Anna C. M. Geraedts, Sana Mulay, Susan van Dieren, Mark J. W. Koelemay and Ron Balm in Journal of Endovascular Therapy