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Background Respiratory syncytial virus (RSV) is a leading cause of hospitalizations in children (≤5 years of age); limited data compare burden by age. Methods This single-center retrospective study included children (≤5 years of age) hospitalized for >24 hours with reverse-transcription polymerase chain reaction (RT-PCR)–confirmed RSV infection (2015–2018). Hospital length of stay (LOS), intensive care unit (ICU) admissions, ICU LOS, supplemental oxygen, and medication use were assessed. Multivariate logistic regression analyses identified predictors of hospital LOS >5 days. Results Three hundred twelve patients had RSV infection (ages 0 to Conclusions RSV causes substantial burden in hospitalized children (≤5 years), particularly preterm infants and those aged

Respiratory viruses were detected by multiplex-polymerase chain reaction from oropharyngeal swabs in 114/168 (67.9%) children with acute respiratory infection presenting to 5 pediatric practices in Germany between November 2020 and April 2021. In contrast to rhino- (48.8%), adeno- (14.3%) and endemic coronaviruses (14.9%), SARS-CoV-2 and influenza virus were detected only once; respiratory syncytial virus was not detected. This demonstrates differing impacts of pandemic infection control measures on the spread of respiratory viruses.

Vaccine 38(3), 570-577 (2020). doi:10.1016/j.vaccine.2019.10.056, Published by Elsevier, Amsterdam

Parapneumonic pleural effusion and pleural empyema (PPE/PE) are complications of community-acquired pneumonia. The objective of this study was to analyze prehospital antibiotic therapy (PH-ABT) of children with PPE/PE and investigate its effects on clinical outcome and pathogen detection.Prospective nationwide active surveillance in Germany between October 2010 and June 2018. Children and adolescents18 years of age with pneumonia-associated PE or PPE requiring drainage or with persistence of PPE/PE7 days were included.A total of 1724 children with PPE/PE were reported, of whom 556 children (32.3% of 1719 with available data) received PH-ABT. Children with PH-ABT had a shorter median hospital length of stay (15 vs. 18 days, P0.001), a longer time from onset of symptoms until hospital discharge (25 vs. 23 days, P = 0.002), a lower rate of intensive care unit admission (58.3% vs. 64.4%, P = 0.015) and fewer infectious complications (5.9% vs. 10.0%; P = 0.005). Bacterial pathogens in blood or pleural fluid culture were detected in 597 (34.5%) of 1513 children. Positive culture results were less frequent in children with than without PH-ABT (81/466 [17.4%] vs. 299/1005 [29.8%]; P0.001), whereas detection rates in pleural fluid samples by polymerase chain reaction were similar (91/181 [50.3%] vs. 220/398 [55.3%]; P = 0.263).In children with PPE/PE, PH-ABT significantly reduced the overall rate of bacterial pathogen detection by culture, but not by polymerase chain reaction. PH-ABT was associated with a lower rate of infectious complications but did not affect the overall duration of disease. We therefore speculate that the duration of PPE/PE is mainly a consequence of an infection-induced inflammatory process, which can only partially be influenced by antibiotic treatment.

Key Points Question Is continuous SARS-CoV-2 testing accepted by children, parents, and childcare workers and can it prevent viral spreading in day care centers? Findings In this nonrandomized controlled trial, surveillance testing for SARS-CoV-2 among 954 eligible individuals was well accepted by children, parents, and childcare workers if saliva sampling at home was used. Mathematical modeling based on study and literature data identified biweekly testing of at least 50% of children and childcare workers as minimal requirements to limit secondary infections. Meaning These findings suggest that SARS-CoV-2 surveillance testing is feasible and allows for continued day care attendance for children during the COVID-19 pandemic., This nonrandomized controlled trial investigates the feasibility of SARS-CoV-2 surveillance among children and childcare workers at day care centers in Germany and models the efficacy of surveillance for preventing viral spread., Importance Closure of day care centers has been implemented globally to contain the COVID-19 pandemic but has negative effects on children’s health and psychosocial well-being. Objective To investigate the feasibility of surveillance among children and childcare workers and to model the efficacy of surveillance on viral spread prevention. Design, Setting, and Participants This nonrandomized controlled trial was conducted at 9 day care centers in Wuerzburg, Germany, from October 2020 to March 2021. Participants included children attending day care, childcare workers, and household members. Participating day care centers were assigned to different surveillance modules in a nonrandomized feasibility study. A mathematical model for SARS-CoV-2 spread in day care centers was developed to identify optimal surveillance. Interventions Modules 1, 2, and 3 involved continuous surveillance of asymptomatic children and childcare workers by SARS-CoV-2 polymerase chain reaction testing of either midturbinate nasal swabs twice weekly (module 1) or once weekly (module 2) or self-sampled saliva samples twice weekly (module 3). Module 4 involved symptom-based, on-demand testing of children, childcare workers, and their household members by oropharyngeal swabs. All participants underwent SARS-CoV-2 antibody status testing before and after the sampling period. Questionnaires on attitudes and perception of the pandemic were administered in weeks 1, 6, and 12. Mathematical modeling was used to estimate SARS-CoV-2 spread in day care centers. Main Outcomes and Measures The primary outcomes were acceptance of the respective surveillance protocols (feasibility study) and the estimated number of secondary infections (mathematical modeling). Results Of 954 eligible individuals (772 children and 182 childcare workers), 592 (62%), including 442 children (median [IQR] age, 3 [2-4] years; 214 [48.6%] female) and 150 childcare workers (median [IQR] age, 29 [25-44] years; 129 [90.8%] female) participated in the surveillance. In total, 4755 tests for SARS-CoV-2 detected 2 infections (1 childcare worker and 1 adult household member). Acceptance for continuous surveillance was highest for biweekly saliva testing (150 of 221 eligible individuals [67.9%; 95% CI, 61.5%-73.7%]) compared with biweekly (51 of 117 individuals [43.6%; 95% CI, 35.0%-52.6%]) and weekly (44 of 128 individuals [34.4%; 95% CI, 26.7%-43.0%]) midturbinate swabbing (P

Universal varicella vaccination for 1-year-old children was introduced in Germany in 2004. We investigated changes in the incidence and type of varicella-associated neurologic complications in children during the first 7 years after universal vaccination recommendation.A surveillance study was conducted based on patients17 years of age with an International Classification of Diseases (10th Revision) discharge diagnosis of varicella, annually reported by 22-29 pediatric hospitals in Bavaria, Germany, 2005 to 2011. Annual incidences were estimated and linear trend across years was assessed by Poisson regression models.Of a total of 1263 varicella-associated pediatric hospitalizations, 228 children (18.1%) had neurologic complications (median age 4 years, interquartile range 2-7; 56% male). The most frequent neurologic complications were febrile convulsion (32.0% of 228 children, median age 3.0 years), varicella encephalitis or meningitis (28.9%; median age 4.5 years), syncope (13.2%; median age 7.0 years) and cerebral convulsion (11.0%; median age 4.0 years). Other complications included ataxia (3.1%), facial nerve palsy (2.6%) and cerebral vasculitis/infarction (1.8%). Neurologic complications showed a continuous decrease between 2005 and 2011, from an incidence of 2.8 (95% confidence interval: 2.1-3.6) per 100,000 children17 years of age to 1.2 (95% confidence interval: 0.7-2.1; P0.001). In particular, a marked decline was observed among children up to 7 years of age, mainly because of a decrease in the number of febrile convulsions and encephalitis or meningitis.The incidence of varicella-associated neurologic complications in children decreased approximately by 60% during the first 7 years following the recommendation for universal vaccination.

Pediatric pulmonology 52(4), 540-547 (2017). doi:10.1002/ppul.23562, Published by Wiley-Liss, New York, NY [u.a.]

Background Rotavirus (RV)-associated infections account for high numbers of hospitalizations in neonates and young infants. Universal mass vaccination (UMV) has been shown to prevent the burden of disease in vaccinated children. Methods The present study investigated the long-term effects of UMV on RV-associated hospitalizations in children with particular focus on neonates and young infants (≤42 days old) not eligible for vaccination. Ten years of Austrian surveillance data were compared, including 10 960 laboratory-confirmed RV cases before (prevaccination period [PreVP]) and after (postvaccination period [PostVP]) introduction of UMV. Results A postvaccination decrease in hospitalized community-acquired RV infections by 89.3% was seen in all age groups, including unvaccinated neonates and young infants. Of the latter, 27.6% had a nosocomial RV infection in PreVP, and 19.3% in PostVP. Overall, the proportion of nosocomial RV infections increased from 5.5% in PreVP to 13.0% in PostVP. Breakthrough infections, usually after incomplete RV vaccination, could be identified in 6.2% of patients. Conclusions Unvaccinated neonates and infants ≤42 days old may indirectly benefit from UMV by reduction of RV infections. Breakthrough infections underline the importance of early and complete protection by the vaccine. In older patients, heightened awareness of nosocomial RV infections is warranted. Identification of RV reservoirs is also needed.

Parapneumonic pleural effusions/empyema (PPE/PE) are severe complications of community-acquired pneumonia. We investigated the bacterial aetiology and incidence of paediatric PPE/PE in Germany after the introduction of universal pneumococcal conjugate vaccine (PCV) immunization for infants.Children18 years of age hospitalized with pneumonia-associated PPE/PE necessitating pleural drainage or persisting7 days were reported to the German Surveillance Unit for Rare Diseases in Childhood between October 2010 and June 2017. All bacteria detected in blood or pleural fluid (by culture/PCR) were included, with serotyping for Streptococcus pneumoniae.The median age of all 1447 PPE/PE patients was 5 years (interquartile range 3-10). In 488 of the 1447 children with PPE/PE (34%), 541 bacteria (40 species) were detected. Aerobic gram-positive cocci accounted for 469 of 541 bacteria detected (87%); these were most frequently Streptococcus pneumoniae (41%), Streptococcus pyogenes (19%) and Staphylococcus aureus (6%). Serotype 3 accounted for 45% of 78 serotyped S. pneumoniae strains. Annual PPE/PE incidence varied between 14 (95%CI 12-16) and 18 (95%CI 16-21) PPE/PE per million children. Incidence of S. pneumoniae PPE/PE decreased from 3.5 (95%CI 2.5-4.6) per million children in 2010/11 to 1.5 (95%CI 0.9-2.4) in 2013/14 (p 0.002), followed by a re-increase to 2.2 (95%CI 1.5-3.2) by 2016/17 (p 0.205).In the era of widespread PCV immunization, cases of paediatric PPE/PE were still caused mainly by S. pneumoniae and, increasingly, by S. pyogenes. The re-increase in the incidence of PPE/PE overall and in S. pneumoniae-associated PPE/PE indicates ongoing changes in the bacterial aetiology and requires further surveillance.

BACKGROUND Limited data on the influenza burden in pediatric outpatients are available, especially regarding direct comparison of the cocirculating (sub)types A(H1N1)pdm09, A(H3N2) and B. METHODS Children 1-5 years of age, unvaccinated against influenza and presenting with febrile acute respiratory infections (ARIs), were enrolled in 33 pediatric practices in Germany from 2013 to 2015 (January-May). Influenza was confirmed by multiplex polymerase chain reaction from pharyngeal swabs and (sub)typed. RESULTS In 805 children with ARI, influenza was the most frequently detected respiratory virus (n = 305; 37.9%). Of 217 influenza patients included, 122 (56.2%) were infected with A(H3N2), 56 (25.8%) with A(H1N1)pdm09 and 39 (18.0%) with B. Median age was 3.7 years [interquartile range (IQR), 2.1-4.8]; 11% had underlying conditions. Median fever duration was 4 days (IQR, 3-5), and the disease duration was 9 days (IQR, 7-12). Most frequent diagnoses were pharyngitis (26%), bronchitis (18%) and acute otitis media (10%). Children received mainly antipyretics (86%) and adrenergic nasal drops/spray (53%); 9% received antibiotics and 3% oseltamivir. Thirty-six percent required at least 1 additional practice visit; 1% was hospitalized. Median absences from childcare were 5 days (IQR, 3-7); parents lost 4 workdays (IQR, 2-6). Symptoms, severity and impact on the family were largely unrelated to (sub)type. However, patients with A(H1N1)pdm09 had fewer underlying conditions (P = 0.017), whereas patients with B more often had pharyngitis (P = 0.022), acute otitis media (P = 0.012) and stenosing laryngotracheitis (P = 0.007). CONCLUSIONS Influenza was the most frequently detected viral pathogen in outpatient children with febrile, mostly uncomplicated ARI. In this setting, clinical manifestations and severity were similar across the (sub)types prevalent during the postpandemic seasons.

Germany introduced routine varicella (V) vaccination in 2004. Due to a slightly increased risk of febrile convulsions after first-dose application of combined measles-mumps-rubella-varicella (MMRV) vaccine separate first-dose vaccinations with MMR and monovalent V vaccine were recommended in September 2011.We compared V and MMR vaccinations in paediatric practices from two surveillance regions (Munich and Würzburg) one year before and after the change in the recommendation.A total of 1405/326 monthly reports were provided by a monthly average of 79/14 practices participating in Munich/Würzburg. V first-dose vaccinations (monovalent V or MMRV vaccine) declined by 12% in Munich (from 10.1 to 8.9 vaccinations per month and practice; p0.005) and by 4% in Würzburg (from 9.9 to 9.5; p=0.620), respectively. First-dose vaccinations for MMR (MMR or MMRV vaccine) did not change significantly in both regions.Acceptance of V vaccination depends in part on the use of combination vaccine.

Varicella in oncology patients can result in serious complications. We analyzed trends in hospitalization rates and characteristics of pediatric oncology and non-oncology patients hospitalized with varicella during the first 7 years after introduction of routine varicella vaccination. Our data included children

In the freshwater planarian Dugesia polychroa (Tricladida, Paludicola), both animals fulfil the male and female role simultaneously in any given copulation. This study presents the first detailed account of the copulatory behaviour, timing and frequency in this species. We also describe an experimental set-up that enables continuous, undisturbed observation of large numbers of animals. D. polychroa pairs copulate repeatedly in the lab (up to eight times in 5 d). Animals that were kept in isolation for longer, were more likely to copulate. The mating behaviour lacks a behaviourally recognizable precopulatory courtship sequence, suggesting that precopulatory assessment is absent or only marginally important. Copulation duration ranged from a few minutes to 2.5 h and showed a distinct bimodal distribution. Two copulation types were recognized: short (

In an introductory discussion it is argued why a topographical ‘pattern map’ based on a familiar visual landscape should come into conflict with an angular shift of the sun compass, whereas a ‘point map’ based on atmospheric odours is expected to be freely rotatable by compass shifts. To test whether these predictions are met, releases were conducted in a familiar area with pigeons whose circadian clock was shifted 6 h forward. Half of the pigeons were prevented from smelling natural airborne odours by air filtration before release and nasal anaesthesia upon release. Analysis of initial bearings, also including earlier releases in unfamiliar areas, led to the following results. (1) Unfamiliar area, olfaction unimpaired (only assumed point map applicable): full deflection of bearings according to the amount of sun-compass shift. (2) Familiar area, olfaction unimpaired (both point map and pattern map applicable): average deflection of bearings somewhat smaller than compass shift. (3) Familiar area, no olfactory access to natural air (only assumed pattern map applicable): average deflection of bearings only about half compass shift; increased variability. Corresponding non-shifted controls were always homeward orientated. Results support the hypothesis that pigeons in a familiar area, if relying exclusively on non-olfactory spatial information, utilize the visible landscape to find the way home. Certainly they also do so under normal conditions when additionally available airborne odours co-determine behaviour, so that the investigator is unable to separate the roles of vision and olfaction. This most plausible and parsimonious hypothesis should be falsified before consideration of alternative hypotheses suggesting there are some mysterious unknown factors at work. How pigeons may view and evaluate the landscape for orientation over longer distances is briefly discussed.

Varicella is an acute febrile, highly infectious disease. We describe the incidence and types of neurologic complications in children up to 16 years old. Hospitalized varicella cases were prospectively captured by active nationwide surveillance through the German Pediatric Surveillance Unit for Rare Diseases from January 2003 to December 2004. Neurologic complications occurred in 232 (25.4%) of 918 hospitalized children with varicella, and were the most frequent reason for hospitalization. The median age was 4.2 years (interquartile range 2.5-5.9). The median duration of hospital stay was 6 days (interquartile range 3-11). Neurologic complications were more frequent (P=0.054) in immunocompetent (32%) than immunocompromised (4%) children. The most frequent diagnoses comprised acute cerebellar ataxia in 72 (31.0%), febrile convulsion in 69 (29.7%), meningoencephalitis in 52 (22.4%), cerebral convulsions in 21 (9.1%), syncope in 9 (3.9%), and cerebral vasculitis/infarction in 6 (2.6%) of all children with neurologic complications. Twenty-eight (12%) demonstrated sequelae (18 with ataxia, four with epilepsy, two with hemiparesis, three with cerebral nerve palsy, and one with dysesthesia). Three patients died. The yearly incidence of neurologic varicella-associated hospitalizations was estimated at 2.4 neurologic complications per 100,000 children, corresponding to about one neurologic complication in 2000 varicella cases.

Resumen Antecedentes y objetivo Dentro de los proyectos piloto de la Seguridad Social alemana se estudiaron la eficacia y la tolerabilidad de la acupuntura para el tratamiento de pacientes con dolores cronicos. En el presente trabajo se refieren los resultados del extenso estudio observacional sobre seguridad y tolerabilidad realizado con estos proyectos piloto. Metodos Los aspectos sobre seguridad y tolerabilidad se analizaron de 3 formas diferentes: para todos los 503.397 casos clinicos documentados entre julio de 2001 y junio de 2003, los medicos debian emitir una valoracion global sobre la tolerabilidad del tratamiento y citar los efectos adversos aparecidos. Los efectos adversos graves debian comunicarse antes de finales de 2004 al centro investigador asociado. Ademas, se pregunto directamente a 6.140 pacientes acerca de los posibles efectos secundarios experimentados. Resultados Los medicos refirieron efectos adversos en el 7,8% de los casos, siendo el dolor de la puntura el efecto mencionado con mas frecuencia. Se comunicaron un total de 17 casos de efectos adversos graves, y el acontecimiento citado con mas frecuencia fue el neumotorax (5 casos). El 9,3% de los pacientes respondieron afirmativamente a la pregunta de si habian experimentado efectos secundarios. En una cuarta parte de los casos estos efectos se consideraron muy negativos. Los efectos secundarios citados con mas frecuencia por los pacientes fueron dolores, fatiga y molestias circulatorias. Conclusiones Los efectos adversos graves del tratamiento de acupuntura son muy raros. En cambio, los pacientes indicaron a menudo efectos secundarios mas leves. En conjunto, la acupuntura aplicada por medicos debe contemplarse como un metodo terapeutico comparativamente seguro.

Zusammenfassung Hintergrund und Ziel Im Rahmen des Modellvorhabens der Ersatzkassen wurden Wirksamkeit und Vertraglichkeit der Akupunktur bei der Behandlung von Patienten mit chronischen Schmerzen untersucht. In der vorliegenden Arbeit berichten wir uber die Ergebnisse einer grosen Beobachtungsstudie im Rahmen des Modellvorhabens zur Sicherheit und Vertraglichkeit. Methoden Aspekte der Sicherheit und Vertraglichkeit wurden auf dreierlei Weise untersucht: Bei allen 503.397 zwischen Juli 2001 und Juni 2003 dokumentierten Behandlungsfallen sollten die Arzte eine globale Vertraglichkeitsbewertung abgeben und aufgetretene unerwunschte Wirkungen benennen. Schwerwiegende unerwunschte Wirkungen sollten bis Ende 2004 der begleitenden Forschungseinrichtung gemeldet werden. Auserdem wurden 6.140 Patienten direkt zu Nebenwirkungen befragt. Ergebnisse Die Arzte berichteten in 7,8% der Falle uber unerwunschte Wirkungen; die am haufigsten genannte unerwunschte Wirkung war Nadelungsschmerz. Insgesamt 17 Falle von schwerwiegenden unerwunschten Wirkungen wurden gemeldet; das am haufigsten genannte Ereignis war hierbei ein Pneumothorax (5 Falle). 9,3% der Patienten bejahten die Frage nach Nebenwirkungen; in einem Viertel der Falle wurden diese als stark beeintrachtigend bewertet. Die von Patienten am haufigsten genannten Nebenwirkungen waren Schmerzen, Mudigkeit und Kreislaufbeschwerden. Schlussfolgerung Schwerwiegende unerwunschte Wirkungen der Akupunktur sind sehr selten, leichtere Nebenwirkungen werden dagegen haufig von Patienten angegeben. Insgesamt ist Akupunktur bei arztlicher Anwendung als vergleichsweise sichere Methode anzusehen.

Summary Objectives To investigate which patients receive acupuncture in the framework of statutory health insurance in Germany, how treatment was carried out, and what results were achieved. Design Basic documentation (carried out by physician) within a prospective observational study. Setting 454,920 patients with at least one of the three chronic pain conditions including headache, low back pain and osteoarthritis treated by 8727 medical acupuncturists (panel doctors) within the scope of a reimbursement program. Results Fifty-three percent of the patients were treated by general practitioners, 19% by orthopaedists and 9% by internists. Eighty percent of patients were female, mean age was 53.6 (S.D. = 15.7) years. Primary indication for acupuncture was low back pain (45%), headache (36%), and osteoarthritis (12%). Median time since the initial diagnosis was 3 years. 8.4 (S.D. = 3.0) acupuncture sessions (body acupuncture) were administered on average. In 28% a concomitant treatment was reported. Effectiveness of acupuncture was rated by physicians in 22% of the patients as marked, in 54% as moderate, in 16% as minimal and in 4% as poor (unchanged). In 8% of the patients mild adverse reactions were reported, severe side effects occurred in 13 patients (0.003%). Orthopaedists rated the effectiveness of acupuncture lower, showing shortest time for face-to-face contact with the patient. More acupuncture training did not correspond to better therapeutic effect assessed by physicians. Conclusions Acupuncture proved a highly demanded treatment option for chronic pain conditions within the German research program. Results indicate that acupuncture provided by qualified therapists is safe, and patients benefited from the treatment.

Summary Objective The aim of this paper is to describe the treatment and physician characteristics in a randomised trial of acupuncture for osteoarthritis of the knee. Design Three-armed, randomised, controlled multicentre trial with 1-year follow-up. Setting Twenty-eight outpatient centres in Germany. Interventions A total of 294 patients with osteoarthritis of the knee were randomised to 12 sessions of semi-standardised acupuncture (at least 6 local and 2 distant points needled per affected knee from a selection of predefined points, but individual choice of additional body or ear acupuncture points possible), 12 sessions of minimal acupuncture (superficial needling of at least 8 of 10 predefined, bilateral, distant non-acupuncture points) or a waiting list control (2 months no acupuncture). Outcome Participating trial physicians and interventions. Results Forty-seven physicians specialised in acupuncture (mean age 43 ± 8 years, 26 females) provided study interventions in 28 outpatient centres in Germany. The median duration of acupuncture training completed by participating physicians was 350 h (range 140–2508). The total number of needles used was 17.4 ± 4.8 in the acupuncture group compared to 12.9 ± 3.3 in the minimal acupuncture group. In total, 39 physicians (83%) stated that they would have treated patients in either a similar or in exactly the same way outside of the trial, whereas 7 (15%) stated that they would have treated patients differently (1 missing). Conclusions Our documentation of the trial interventions shows that semi-standardised acupuncture strategy represents an acceptable compromise for efficacy studies. However, a substantial minority of participating trial physicians stated that they would have treated patients differently outside of the trial.

In a pooled analysis of four randomized controlled trials of acupuncture in patients with migraine, tension-type headache, chronic low back pain, and osteoarthritis of the knee we investigated the influence of expectations on clinical outcome. The 864 patients included in the analysis received either 12 sessions of acupuncture or minimal (i.e. sham) acupuncture (superficial needling of non-acupuncture points) over an 8 week period. Patients were asked at baseline whether they considered acupuncture to be an effective therapy in general and what they personally expected from the treatment. After three acupuncture sessions patients were asked how confident they were that they would benefit from the treatment strategy they were receiving. Patients were classified as responders if the respective main outcome measure improved by at least fifty percent. Both univariate and multivariate analyses adjusted for potential confounders (such as condition, intervention group, age, sex, duration of complaints, etc.) consistently showed a significant influence of attitudes and expectations on outcome. After completion of treatment, the odds ratio for response between patients considering acupuncture an effective or highly effective therapy and patients who were more sceptical was 1.67 (95% confidence interval 1.20-2.32). For personal expectations and confidence after the third session, odds ratios were 2.03 (1.26-3.26) and 2.35 (1.68-3.30), respectively. Results from the 6-month follow-up were similar. In conclusion, in our trials a significant association was shown between better improvement and higher outcome expectations.

Objective To compare patient characteristics and outcomes between a randomized controlled trial (RCT) and an observational study (OS) of acupuncture treatment in patients with migraine. Study Design and Setting Within the framework of a research program for acupuncture for chronic pain, both an RCT and an OS of routine care were performed in patients with migraine. One hundred forty-five patients received acupuncture in the RCT and 732 in the OS. All patients completed a pain questionnaire, including instruments evaluating disability, quality of life, and depression, at baseline and at 6-month follow-up. Results At baseline, patients participating in the RCT had a significantly longer history of complaints and more headache days but better quality of life and fewer depressive symptoms than patients participating in the OS. In unadjusted analyses, improvements after 6 months were more pronounced in the OS than in the RCT. After adjustment for potential confounders, the differences decreased but were still significant for several outcomes. Conclusion Participants of the RCT were probably not representative of migraine patients undergoing acupuncture treatment in routine care under current regulations in Germany. However, changes after treatment were similar in the RCT and the OS of routine care.

OBJECTIVE: Descriptions of the interventions used in acupuncture studies are often incomplete. The aim of this paper is to describe participating trial physicians and interventions in a randomised trial of acupuncture for low back pain. DESIGN: Three-armed, randomized, controlled multicenter trial with 1-year follow-up. A total of 301 patients with low-back pain were randomized to 12 sessions of semistandardized acupuncture (at least six local and two distant points needled bilaterally from a selection of predefined points, but individual choice of additional body or ear acupuncture points possible), minimal acupuncture (superficial needling of at least 6 of 10 predefined, bilateral, distant nonacupuncture points), or a waiting list control (2 months no acupuncture followed by semistandardised acupuncture described above). OUTCOME MEASURES: Participating trial physicians and interventions. RESULTS: Forty-five (45) physicians specializing in acupuncture (mean age 44 +/- 7.8 years, 23 (51%) female) in 30 outpatient centers in Germany provided the interventions. The median duration of acupuncture training of trial physicians was 350 hours (range 140-2508). The most frequently reported Chinese diagnosis was Kidney deficiency (39%), followed by qi and Blood stagnation (24%), and bi syndrome (20%). The total number of needles used was 17.3 +/- 4.2 in the acupuncture group compared to 12.3 +/- 1.2 in the minimal acupuncture group. In total, 40 physicians (89%) stated that they would have treated patients similarly or in exactly the same way outside of the trial, whereas 5 (11%) stated that they would have treated patients differently. CONCLUSIONS: For most trial physicians, the semistandardized acupuncture strategy used in this trial was an acceptable compromise for an efficacy study. However, a relevant minority of participating trial physicians stated that they would have treated patients differently outside of the trial.

Zusammenfassung Ziel Beschreibung der am Modellvorhaben Akupunktur der Ersatzkassen teilnehmenden Arzte bzw. Arztpraxen hinsichtlich Merkmalen zur Struktur- und allgemeinen Prozessqualitat. Methodik Schriftliche Befragung der Arzte sechs Monate nach dem Start des Modellvorhabens mit Erfassung von demographischen Daten, Niederlassungsdauer, Praxisgrose, Akupunkturqualifikation und Indikations- und Methodenschwerpunkten im Zeitraum eines Jahres vor der Befragung. Die Daten wurden fur das Gesamtkollektiv und stratifiziert nach Akupunkturqualifikation (A- bzw. B-Diplom) und Facharztgruppe (Allgemein-/Praktische Arzte, Orthopaden, Sonstige) analysiert. Ergebnisse 5.217 (57 %) von 9.182 Arzten beantworteten den Fragebogen (Alter im Median 46 Jahre; 64 % mannlich; 28 % mit B-Diplom). Der Anteil von Allgemein-/Praktischen Arzten lag bei 51 %, der von Orthopaden bei 18 %. Akupunktur wurde im Median seit sieben Jahren eingesetzt, bei im Durchschnitt 5 % aller Praxis-Patienten; dafur wurde 10 % der Zeit der therapeutischen Tatigkeit aufgewendet. 87 % der Arzte nutzten auch Mikrosystemverfahren. B-Diplom-Trager setzten eine grosere Vielfalt an Akupunkturverfahren und haufiger auch klassische Naturheilverfahren, Homoopathie und chinesische Phytotherapie ein. Orthopaden unterschieden sich bezuglich der Qualifikation nicht von den anderen Facharztgruppen, verwendeten aber eine geringere Vielfalt an Akupunkturmethoden. Schlussfolgerung Die Stratifizierungen nach Akupunkturqualifikation bzw. Facharztgruppe zeigten erhebliche Unterschiede in Struktur- und Prozessmerkmalen.

OBJECTIVE: To investigate characteristics and outcomes of patients undergoing acupuncture treatment for osteoarthritic pain under conditions of routine care in the framework of statutory health insurance in Germany. METHODS: Patients with chronic pain due to osteoarthritis (ICD-10 diagnoses M15 to M19) treated with acupuncture as the leading form of therapy were included in an observational study. Detailed questionnaires including instruments to measure pain intensity (numerical rating scales from 0 to 10), disability (Pain Disability Index) and quality of life (SF-36) were filled in before treatment, after treatment and at 6 months. Patients suffering from osteoarthritis of the knee and hip also filled in the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index questionnaire. RESULTS: A total of 736 patients were included in the main analysis. Seventy (10%) patients and 278 (38%) patients, respectively, suffered exclusively from primary osteoarthritis of the hip or knee, 239 (33%) from another type of osteoarthritis and 149 (20%) had more than one affected joint. On average, patients received 8.7 +/- 3.1 acupuncture treatments. Statistically significant and clinically relevant improvements were seen in all subgroups both after treatment and at 6 months in all major outcome measures. In patients with osteoarthritis of the hip, the WOMAC sum score was 47.9 +/- 20.7 at baseline, 34.8 +/- 20.0 after treatment and 33.1 +/- 22.2 at 6 months. The respective values in patients with osteoarthritis of the knee were 51.7 +/- 20.9, 34.1 +/- 23.3 and 34.6 +/- 25.1. CONCLUSIONS: In this study, patients with chronic pain due to osteoarthritis reported clinically relevant improvements after acupuncture treatment. Due to the uncontrolled design and the high proportion of patients lost to follow-up, the study findings must be interpreted cautiously.

This paper describes the concept and realization of a nation-wide observational study which is part of the patient care evaluation programme on acupuncture as part of a model project of German statutory insurance bodies. The study aimed describing medical care with acupuncture to estimate the incidence of adverse reactions as well as the treatment effects of acupuncture in chronically ill patients with headache, low back pain or osteoarthritic pain. It was also intended to analyse relations between treatment effects and specialties of the treating acupuncturists. During the two-year period of report 9,918 acupuncturists took part in the study documenting 503,397 cases. A more comprehensive documentation is available for a sample of 10,366 patients with complete longitudinal data of 6,140 patients. The difficulties with data management and sampling technique are presented with reference to restricted capacities for monitoring. Furthermore the question of generalising of the results is discussed. There were differences in some respects (for example, frequencies of different indications) between the patient sample and the population of all patients included in the project. Patients also differed slightly with respect to the completeness of the longitudinal documentation. The results indicated that we cannot claim global representativeness for the sample-based findings, but there is no reason to assume a "positive" selection.

Background: We report on the study design and protocols of two randomized controlled trials (Acupuncture Randomized Trials = ART) that investigate the efficacy of acupuncture in the treatment of chronic low back pain and osteoarthritis of the knee, respectively. Objective: To investigate whether acupuncture is more efficacious than (a) no treatment or (b) minimal acupuncture in the treatment of low back pain and osteoarthritis. Design: Two randomized, controlled, multicenter trials with three treatment arms and a total follow-up time of 52 weeks. Setting: 30 practitioners and outpatient units in Germany specialized in acupuncture treatment. Patients: 300 patients will be included in each study. In the low back pain trial, patients will be included according to clinical diagnosis. In the osteoarthritis pain trial, patients will be included according to the American College of Rheumatology criteria. Interventions: Patients are randomly assigned to receive either (1) semi-standardized acupuncture (150 patients), (2) minimal acupuncture at non-acupuncture points (75 patients), or (3) no treatment for two months followed by semi-standardized acupuncture (75 patients, waiting list control). Acupuncture treatment consists of 12 sessions per patient over a period of 8 weeks. Main Outcome Measure: The main outcome measure is the difference between baseline and the end of the 8-week treatment period in the following parameters: pain intensity as measured by a visual analogue scale (VAS; 0–100 mm) in the low back pain trial and by the Western Ontario and McMaster Universities Osteoarthritis Score (WOMAC) in the osteoarthritis trial. Outlook: The results of these two studies (available in 2004) will provide health care providers and policy makers with the information needed to make scientifically sound assessments of acupuncture therapy.

Background and Objective: We report the design and essentials of the protocols of two Acupuncture Randomized Trials (ART) investigating whether acupuncture is more efficacious than no treatment and minimal acupuncture in the interval treatment of migraine and tension-type headache. Design: Randomized controlled multicenter trials with three treatment arms and a total observation period of 28 weeks. Setting: 30 practitioners and outpatient units in Germany specialized in acupuncture treatment. Patients: Per study 300 patients with migraine and episodic or chronic tension-type headache, respectively (diagnosis according to the criteria of the International Headache Society). Interventions: Patients are randomly assigned to receive either (1) semi-standardized acupuncture (150 patients), (2) standardized minimal acupuncture (75 patients), or (3) no interval treatment for 12 weeks followed by semi-standardized acupuncture (75 patients, waiting list control). Acupuncture treatment consists of 12 sessions per patient over a period of 8 weeks. Main Outcome Measure: Main outcome measure in the migraine trial is the difference between the number of days with headache of moderate or severe intensity during the 4 weeks before randomization and weeks 9 to 12 after randomization. In the study on tension-type headache the main outcome measure is similar to that described above, but for the number of headache days regardless of intensity. Outlook: The results of these two studies (available in 2004) will provide health care providers and policy makers with the information needed to make scientifically sound assessments of acupuncture therapy.

Einleitung: Es werden erste Zwischenergebnisse aus der Basisdokumentation einer Beobachtungsstudie zur Akupunktur bei chronischem Kopfschmerz, chronischen LWS-Beschwerden und chronischem Osteoarthroseschmerz berichtet. Die Studie ist eine Teilkomponente des wissenschaftlichen Begleitprogramms des Modellvorhabens der Ersatzkassen zur Akupunktur. Zielsetzung: Beschreibung der Versorgungspraxis mit Akupunktur bei den definierten Indikationen, durchgefuhrt von qualifizierten arztlichen Akupunkteuren im niedergelassenen Bereich; Abschatzung der Inzidenz von unerwunschten Ereignissen und Beschreibung der Behandlungseffekte der Akupunktur. Methodik: Offene, prospektive, multizentrische Beobachtungsstudie mit einer fur alle Patienten des Modellvorhabens verbindlichen Basisdokumentation durch den Arzt. Neben den allgemeinen Rahmenbedingungen des Modellvorhabens gibt es keine weiteren Vorgaben hinsichtlich der durchgefuhrten Akupunktur. Ergebnisse: Zum Stichtag 25.3.2002 steht die Basisdokumentation von 97 733 Fallen (80,5 % weiblich, Alter 55,1 ± 15,5 Jahre), behandelt von 7050 Akupunkteuren, zur Verfugung. Haufigste Indikation fur die Akupunktur sind LWS-Beschwerden (45,7 %). 35,2 % der Falle werden wegen chronischer Kopfschmerzen und 12,1 % wegen Arthroseschmerz behandelt. In 7 % liegen mehrere Indikationen gleichzeitig vor. Die Diagnose ist im Median seit 3 Jahren bekannt und meist facharztlich gesichert. 70,8 % der Patienten erhielten bislang noch keine Akupunktur. Pro Patient wurden durchschnittlich 7,9 Akupunktursitzungen dokumentiert. 34,3 % erhielten eine Begleitbehandlung. Die therapeutische Wirksamkeit wird von den Arzten abschliesend in 21,6 % der Falle als sehr gut, in 55,1 % als gut und in 16,8 % als gering beurteilt. 3,6 % der Falle werden als unverandert oder verschlechtert eingestuft. Eine unerwunschte Wirkung wurde in 7,1 % der Falle berichtet. Schwerwiegende Ereignisse wurden in 6 Fallen mitgeteilt, ihre Haufigkeit liegt unter 0,01 %. Ausblick: Fur die laufende Studie werden bis etwa 500 000 Behandlungsfalle erwartet. Derzeit werden die an einer Patientenstichprobe zusatzlich eingesetzten Patientenfragebogen ausgewertet. Eine elektronische Form der Dokumentation wird derzeit erprobt. Introduction: The German Social Law allows the health insurance companies to perform so called „Modellvorhaben” (trial phases) in order to investigate effectiveness and efficiency of health care interventions under real life conditions. We report preliminary results of a study representing one component of the concomitant research strategy of a Modellvorhaben on acupuncture by a group of German social health insurance companies. Objective: Description of the usage of acupuncture in routine care of out-patients, estimation of the incidence of adverse effects, description of the therapeutic effects of acupuncture. Methods: Open prospective multicenter observational study of patients suffering from chronic headache, low back pain and osteoarthritic pain. Acupuncture is performed by registered medical acupuncturists with at least 140 hours of acupuncture training. Results: By March, 25, 2002 data from 97 733 patients (80.5 % female; mean age 55.1 ± 15.5 yrs) treated by 7050 acupuncturists were available for analysis. The most frequent indication for acupuncture was low back pain (45.7 %). The relative frequency of chronic headache was 35.2 % and 12.1 % for osteoarthritic pain, respectively. Multiple indications were reported in 7 % of the patients. The median duration of complaints was 3 years. 70.8 % of the patients were treated with acupuncture for the first time. 7.9 acupuncture sessions were reported per patient on average. 34.3 % of the patients received concomitant treatment. The therapeutic effectiveness was judged by the physicians as very good in 21.6 % of the patients, as good in 55.1 %, and as minimal in 16.8 %. In 3.6 % complaints were rated as unchanged or worse. Adverse effects were reported in 7.1 % of all patients, whereas severe adverse effects were documented in 6 cases meaning a frequency of below 0.01 %. Outlook: About 500 000 patients are expected for this ongoing study. An electronic version of the documentation is currently being tested. At present, more detailed patient-based data obtained in a random sample of patients are analyzed.

Many simultaneously hermaphroditic animals cross-inseminate when copulating, even though unilateral sperm exchange is functionally possible. The question is why reciprocity is the rule. This study addresses sperm exchange in a hermaphroditic planarian flatworm, Dugesia polychroa, in which self-fertilisation does not occur. We investigated the availability of self sperm for inseminating a partner, how self sperm affects the likelihood of sperm donation, and whether sperm donation depends on reciprocation by the partner. The amount of self sperm depended on body size, duration of isolation and experimental date, and animals that had more self sperm were more likely to mate. Depletion of allosperm (sperm received from partners) played only an indirect role, suggesting that animals copulate more to donate sperm rather than to replenish allosperm reserves. Among 60 copulating pairs, reciprocal insemination was more common (63.3%) than unilateral transfer (18.3%). A surprising 18.3% did not exchange sperm in either direction. Individuals were more likely to behave like their partners, resulting in more symmetrical matings (either reciprocity or no sperm exchange) than asymmetrical matings (unilateral sperm donation). The amount of self sperm donated during a copulation depended mainly on the amount available before the copulation and not on the amount received from the partner. The results suggest that conditional sperm exchange, or sperm trading, takes place in D. polychroa.