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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.

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

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.

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.

Effectiveness of 1 dose of varicella vaccination was estimated to be 85-88% against clinical varicella of any severity in case-control studies in non-European countries, but lower effectiveness has been demonstrated in outbreaks.A prospective, age- and practice-matched case-control study was conducted in Germany to assess the effectiveness of 1 dose of OKA/GSK varicella vaccine (derived from the OKA strain, a Japanese clinical isolate) and of any varicella vaccine (including OKA/GSK, OKA/Merck and MMR-OKA/GSK) against polymerase chain reaction (PCR)-confirmed varicella under conditions of routine use.The cohort included 432 PCR-confirmed cases and 432 matched controls (1-7 years old). Varicella vaccination was reported for 13.2% (57/432) of cases and 45.1% (195/432) of controls. Median time since vaccination was 28 and 25 months, respectively. Vaccinated cases experienced milder disease (P0.0001) and shorter duration of disease (P = 0.004) compared with unvaccinated cases. After adjusting for gender and school/day-care attendance, vaccine effectiveness of 1 dose of OKA/GSK against PCR-confirmed varicella of any severity was 71.5% (95% confidence interval [CI]: 49.1-84.0) and 94.7% (95% CI: 77.8-98.7) against PCR-confirmed moderate or severe varicella. Adjusted effectiveness for any varicella vaccine was 86.4% (95% CI: 77.3-91.8) against any severity and 97.7% (95% CI: 90.5-99.4) against moderate or severe varicella.One dose of varicella vaccine provided high protection against moderate and severe varicella disease for a period of up to 5 years after vaccination. However, further effectiveness data are needed to assess long-term protection.

Since hepatitis A virus (HAV) infection during childhood is mostly asymptomatic, only seroprevalence studies can provide reliable information on incidence of HAV infection in children. The prevalence of anti-HAV antibodies was determined in sera taken in 2008 to 2010 from 1,645 children aged 0–17 years and in sera taken in 2010–2011 from 400 adult blood donors in Germany. For examination of trend over time, 715 sera collected between 1999 and 2006 from children at the age of 0–17 years within the federal state Thuringia were included. Antibody testing was carried out using the test kits ETI-AB-HAVK PLUS and ETI-HA-IGMK PLUS from DiaSorin. In children, the overall prevalence of antibodies was 10.8 %. After the seroprevalence declined from 8.8 % among the 0–2 year-olds to 2.4 % among the 3–4 year-olds, there was a significant increase to 20.5 % in the group of the 15–17 year-olds. Boys had with 12.7 % a significantly higher seroprevalence of anti-HAV antibodies compared to 8.8 % among girls. In adult blood donors, there was a HAV seroprevalence of 19.3 %. The likelihood of past infection or immunization within the age groups of children from 0 to 12 years differed significantly from that of adults. In conclusion, in Germany, only a small number of HAV infections occur in children, especially up to the age of 12 years. The proportion of susceptible children is greater than the proportion of susceptible adults. Thus, during outbreaks, the rate of infection among children would usually be higher than the rate among adults.

BACKGROUND Rotavirus (RV) vaccination with the first generation vaccine (Rotashield) has been associated with intussusception (IS). Reliable age specific baseline incidence data for children ≤6 months of age in particular is fundamental for further post marketing monitoring of potential effects of recently introduced new RV vaccines. METHODS IS incidence was estimated by a 2-source capture-recapture calculation (CRC) based on ESPED (German Paediatric Surveillance Unit) reports and on hospital discharge records for 2006 and 2007. ESPED as well as hospital records were validated according to the Brighton Collaboration's Group definition for definite IS. PATIENTS Children that have been treated for IS in a hospital in one of two states of Germany (North-Rhine Westphalia and Bavaria). RESULTS The annual IS incidence for infants

The primary objective of this epidemiological surveillance study was to estimate the incidence of intussusception (IS) associated with hospitalisation in children

Since 2004, general varicella vaccination has been recommended for all children 11-14 months of age in Germany. The objective of this study was to examine vaccination coverage in children and factors associated with parental acceptance during the first years after recommendation. In a regional surveillance area, cross-sectional parent surveys were conducted in 2006, 2007 and 2008 in random samples (n=600) of children aged 18-36 months; data were obtained for 372, 364 and 352 children, respectively. Parents were questioned on their child's varicella disease history, and on varicella vaccination status as recorded in the child's vaccination booklet. Overall coverage increased from 38% in 2006 to 51% in 2007 and stagnated at 53% in 2008; in susceptible children (without previous varicella disease until vaccination or time of survey) coverage was 42%, 61% and 59%, respectively. Recommendation by the paediatrician as reported by the parents increased from 48% (2006) to 57% (2007) and 60% (2008), and was the main independent factor associated with parental acceptance. In 32-35% of unvaccinated children parents had not yet decided whether to vaccinate against varicella. Additional programmes targeting paediatricians' and parents' acceptance of varicella vaccination are needed to achieve the WHO-defined goal of at least 85% coverage.

To investigate patient characteristics and outcomes after undergoing acupuncture treatment for chronic low back pain (cLBP) in Germany and to analyze chronification, pain grading, and depression as predictors for treatment outcomes.Patients with cLBP (ICD-10 diagnoses M54.4 or M54.5) who underwent acupuncture therapy (mean number of sessions 8.7+/-2.9) within the framework of a reimbursement and research program sponsored by German statutory sickness funds were included in an observational study. Patients were asked to complete detailed questionnaires that included questions on intensity and frequency of pain and instruments measuring functional ability, depression, and quality of life (SF-36) before and after treatment and 6 months after beginning acupuncture. Participating physicians assessed pain chronification in patients.A total of 2564 patients (mean age 57.7+/-14.0 y, 78.7% female), who were treated by 1607 physicians, were included in the main analysis. After 6 months (6-mo follow-up), 45.5% of patients demonstrated clinically significant improvements in their functional ability scores. The mean number of days with pain was decreased by half (from 21 to 10 d/mo). Employed patients (employed patient subgroup analysis) reported a 30% decrease from baseline in days of work lost. In all, 8.1% of patients reported adverse events, the majority of which were minor. Subgroup analyses focusing on pain severity, stage of chronification, and depression revealed statistically significant relationships both to baseline measures and to reduction of pain after acupuncture.Acupuncture treatment is associated with clinically relevant improvements in patients suffering from cLBP of varying degrees of chronification and/or severity.

BACKGROUND: Acupuncture is widely used by patients with low back pain, although its effectiveness is unclear. We investigated the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with chronic low back pain. METHODS: Patients were randomized to treatment with acupuncture, minimal acupuncture (superficial needling at nonacupuncture points), or a waiting list control. Acupuncture and minimal acupuncture were administered by specialized acupuncture physicians in 30 outpatient centers, and consisted of 12 sessions per patient over 8 weeks. Patients completed standardized questionnaires at baseline and at 8, 26, and 52 weeks after randomization. The primary outcome variable was the change in low back pain intensity from baseline to the end of week 8, as determined on a visual analog scale (range, 0-100 mm). RESULTS: A total of 298 patients (67.8% female; mean +/- SD age, 59 +/- 9 years) were included. Between baseline and week 8, pain intensity decreased by a mean +/- SD of 28.7 +/- 30.3 mm in the acupuncture group, 23.6 +/- 31.0 mm in the minimal acupuncture group, and 6.9 +/- 22.0 mm in the waiting list group. The difference for the acupuncture vs minimal acupuncture group was 5.1 mm (95% confidence interval, -3.7 to 13.9 mm; P = .26), and the difference for the acupuncture vs waiting list group was 21.7 mm (95% confidence interval, 13.9-30.0 mm; P

Background: This paper aims to describe the characteristics of physicians and interventions of a large, multicenter randomized trial of acupuncture for migraine (ART Migraine) in order to enable acupuncturists to assess the study interventions. Patients and Methods: 302 patients suffering from migraine were randomized to 12 sessions of semi-standardized acupuncture (6 predefined basic points, recommendations for optional individual choice of additional points given), standardized minimal acupuncture (superficial needling of at least 5 of 10 predefined, distant non-acupuncture points) or a waiting list. 30 physicians trained and experienced in acupuncture from 18 centers in Germany participated in the trial. Results: The median duration of acupuncture training of trial physicians was 500 h (range 140-1350). Physicians had acupuncture experience for 10 (1000) patients with acupuncture in the year preceding trial participation. The 6 basic points were needled in 76-93% of sessions. Compliance with treatment instructions varied considerably among centers in the acupuncture group. In contrast, compliance with the minimal acupuncture protocol was very good. 6 of the 30 physicians stated that they would have treated patients somewhat differently outside the trial, 1 completely differently. The trial found a significant effect of those treated with acupuncture compared to those on the waiting list for treatment, but minimal acupuncture was as effective as acupuncture. Conclusions: The treatment protocols for acupuncture and minimal acupuncture in ART Migraine appeared an adequate compromise in the specific situation and for the predefined purposes. However, a relevant minority of participating physicians would have treated patients differently outside the trial.

Objective To investigate the effectiveness of acupuncture compared with minimal acupuncture and with no acupuncture in patients with tension-type headache. Design Three armed randomised controlled multicentre trial. Setting 28 outpatient centres in Germany. Participants 270 patients (74% women, mean age 43 (SD 13) years) with episodic or chronic tension-type headache. Interventions Acupuncture, minimal acupuncture (superficial needling at non-acupuncture points), or waiting list control. Acupuncture and minimal acupuncture were administered by specialised physicians and consisted of 12 sessions per patient over eight weeks. Main outcome measure Difference in numbers of days with headache between the four weeks before randomisation and weeks 9-12 after randomisation, as recorded by participants in headache diaries. Results The number of days with headache decreased by 7.2 (SD 6.5) days in the acupuncture group compared with 6.6 (SD 6.0) days in the minimal acupuncture group and 1.5 (SD 3.7) days in the waiting list group (difference: acupuncture v minimal acupuncture, 0.6 days, 95% confidence interval -1.5 to 2.6 days, P = 0.58; acupuncture v waiting list, 5.7 days, 3.9 to 7.5 days, P < 0.001). The proportion of responders (at least 50% reduction in days with headache) was 46% in the acupuncture group, 35% in the minimal acupuncture group, and 4% in the waiting list group. Conclusions The acupuncture intervention investigated in this trial was more effective than no treatment but not significantly more effective than minimal acupuncture for the treatment of tension-type headache. Trial registration number ISRCTN9737659.

Acupuncture is widely used by patients with chronic pain although there is little evidence of its effectiveness. We investigated the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with osteoarthritis of the knee.Patients with chronic osteoarthritis of the knee (Kellgren gradeor =2) were randomly assigned to acupuncture (n=150), minimal acupuncture (superficial needling at non-acupuncture points; n=76), or a waiting list control (n=74). Specialised physicians, in 28 outpatient centres, administered acupuncture and minimal acupuncture in 12 sessions over 8 weeks. Patients completed standard questionnaires at baseline and after 8 weeks, 26 weeks, and 52 weeks. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index at the end of week 8 (adjusted for baseline score). All main analyses were by intention to treat.294 patients were enrolled from March 6, 2002, to January 17, 2003; eight patients were lost to follow-up after randomisation, but were included in the final analysis. The mean baseline-adjusted WOMAC index at week 8 was 26.9 (SE 1.4) in the acupuncture group, 35.8 (1.9) in the minimal acupuncture group, and 49.6 (2.0) in the waiting list group (treatment difference acupuncture vs minimal acupuncture -8.8, [95% CI -13.5 to -4.2], p=0.0002; acupuncture vs waiting list -22.7 [-27.5 to -17.9], p0.0001). After 52 weeks the difference between the acupuncture and minimal acupuncture groups was no longer significant (p=0.08).After 8 weeks of treatment, pain and joint function are improved more with acupuncture than with minimal acupuncture or no acupuncture in patients with osteoarthritis of the knee. However, this benefit decreases over time.

ContextAcupuncture is widely used to prevent migraine attacks, but the available evidence of its benefit is scarce.ObjectiveTo investigate the effectiveness of acupuncture compared with sham acupuncture and with no acupuncture in patients with migraine.Design, Setting, and PatientsThree-group, randomized, controlled trial (April 2002-January 2003) involving 302 patients (88% women), mean (SD) age of 43 (11) years, with migraine headaches, based on International Headache Society criteria. Patients were treated at 18 outpatient centers in Germany.InterventionsAcupuncture, sham acupuncture, or waiting list control. Acupuncture and sham acupuncture were administered by specialized physicians and consisted of 12 sessions per patient over 8 weeks. Patients completed headache diaries from 4 weeks before to 12 weeks after randomization and from week 21 to 24 after randomization.Main Outcome MeasuresDifference in headache days of moderate or severe intensity between the 4 weeks before and weeks 9 to 12 after randomization.ResultsBetween baseline and weeks 9 to 12, the mean (SD) number of days with headache of moderate or severe intensity decreased by 2.2 (2.7) days from a baseline of 5.2 (2.5) days in the acupuncture group compared with a decrease to 2.2 (2.7) days from a baseline of 5.0 (2.4) days in the sham acupuncture group, and by 0.8 (2.0) days from a baseline if 5.4 (3.0) days in the waiting list group. No difference was detected between the acupuncture and the sham acupuncture groups (0.0 days, 95% confidence interval, −0.7 to 0.7 days; P = .96) while there was a difference between the acupuncture group compared with the waiting list group (1.4 days; 95% confidence interval; 0.8-2.1 days; P

Objective The goal of this paper is to describe the characteristics of physicians and their interventions in a large, multicentre randomised trial of acupuncture for tension-type headache known as ARTTTH, in order to enable acupuncturists to assess the study interventions. Methods Participating physicians were recruited whose qualifications met or surpassed those of physicians currently accredited for providing acupuncture by state health funding agencies in Germany. Semi-standardised treatment strategies for acupuncture and minimal acupuncture were developed in a consensus process with acupuncture experts. A total of 270 patients suffering from episodic or chronic tension-type headache were randomised to 12 sessions of semi-standardised acupuncture (three predefined ‘basic’ points, recommendations for additional points given, but individual choice of additional points possible), standardised minimal acupuncture (superficial needling of at least 5 of 10 predefined, bilateral, distant non-acupuncture points) or a waiting list. Forty two physicians, trained and experienced in acupuncture, from 28 centres in Germany participated in the trial. Results The median duration of acupuncture training of trial physicians was 500 hours (range 140 to 1350 hours). Physicians had 10 (Conclusions In general, trial physicians complied well with the predefined interventions. A relevant minority of participating trial physicians stated that they would have treated patients differently outside the trial.

Objective The aim of the Programme for the Evaluation of Patient care with Acupuncture (PEP-Ac) was to investigate the efficacy, effectiveness and safety of acupuncture in patients with the following three indications: chronic headache, chronic low back pain and chronic osteoarthritic pain. This article provides an overview of the results of the whole programme. Methods The programme included five randomised trials, a large observational study, a survey of physicians providing acupuncture, and three systematic reviews. Results The results show that, for all three indications, acupuncture, when compared to no treatment, produces a clear benefit that lasts for at least several months. However the effects of point-specific acupuncture only offered a significant advantage over minimal acupuncture in the treatment of OA knee. Conclusions The evidence from these trials – on the one hand, a clear overall effect of acupuncture and on the other hand, the lack of evidence supporting its superiority over sham acupuncture for all indications except osteoarthritis of the knee – leaves a considerable amount of room for interpretation.