SARS-CoV-2 incidence in secondary schools; the role of national and school-initiated COVID-19 measures.

INTRODUCTION: Our aim was to gain insight into the effect of COVID-19 measures on SARS-CoV-2 incidence in secondary schools and the association with classroom CO2 concentration and airborne contamination. METHODS: Between October 2020-June 2021, 18 schools weekly reported SARS-CoV-2 incidence and completed surveys on school-initiated COVID-19 measures (e.g. improving hygiene or minimizing contacts). CO2 was measured in occupied classrooms twice, and SARS-CoV-2 air contamination longitudinally using electrostatic dust collectors (EDC) and analyzed using RT-qPCR. National COVID-19 policy measures varied during pre-lockdown, lockdown and post-lockdown periods. During the entire study, schools were recommended to improve ventilation. SARS-CoV-2 incidence rate ratios (IRR) were estimated by Generalized Estimating Equation (GEE) models. RESULTS: During 18 weeks follow-up (range: 10-22) SARS-CoV-2 school-incidence decreased during national lockdown (adjusted IRR: 0.41, 95%CI: 0.21-0.80) and post-lockdown (IRR: 0.60, 0.39-0.93) compared to pre-lockdown. School-initiated COVID-19 measures had no additional effect. Pre-lockdown, IRRs per 10% increase in time CO2 exceeded 400, 550 and 800 ppm above outdoor level respectively, were 1.08 (1.00-1.16), 1.10 (1.02-1.19), and 1.08 (0.95-1.22). Post-lockdown, CO2-concentrations were considerably lower and not associated with SARS-CoV-2 incidence. No SARS-CoV-2 RNA was detected in any of the EDC samples. CONCLUSION: During a period with low SARS-CoV-2 population immunity and increased attention to ventilation, with CO2 levels most of the time below acceptable thresholds, only the national policy during and post-lockdown of reduced class-occupancy, stringent quarantine, and contact testing reduced SARS-CoV-2 incidence in Dutch secondary schools. Widespread SARS-CoV-2 air contamination could not be demonstrated in schools under the prevailing conditions during the study.

Predictors and outcomes in primary depression care (POKAL) - a research training group develops an innovative approach to collaborative care.

BACKGROUND: The interdisciplinary research training group (POKAL) aims to improve care for patients with depression and multimorbidity in primary care. POKAL includes nine projects within the framework of the Chronic Care Model (CCM). In addition, POKAL will train young (mental) health professionals in research competences within primary care settings. POKAL will address specific challenges in diagnosis (reliability of diagnosis, ignoring suicidal risks), in treatment (insufficient patient involvement, highly fragmented care and inappropriate long-time anti-depressive medication) and in implementation of innovations (insufficient guideline adherence, use of irrelevant patient outcomes, ignoring relevant context factors) in primary depression care. METHODS: In 2021 POKAL started with a first group of 16 trainees in general practice (GPs), pharmacy, psychology, public health, informatics, etc. The program is scheduled for at least 6 years, so a second group of trainees starting in 2024 will also have three years of research-time. Experienced principal investigators (PIs) supervise all trainees in their specific projects. All projects refer to the CCM and focus on the diagnostic, therapeutic, and implementation challenges. RESULTS: The first cohort of the POKAL research training group will develop and test new depression-specific diagnostics (hermeneutical strategies, predicting models, screening for suicidal ideation), treatment (primary-care based psycho-education, modulating factors in depression monitoring, strategies of de-prescribing) and implementation in primary care (guideline implementation, use of patient-assessed data, identification of relevant context factors). Based on those results the second cohort of trainees and their PIs will run two major trials to proof innovations in primary care-based a) diagnostics and b) treatment for depression. CONCLUSION: The research and training programme POKAL aims to provide appropriate approaches for depression diagnosis and treatment in primary care.

Acupuncture in diabetic peripheral neuropathy-protocol for the randomized, multicenter ACUDPN trial.

BACKGROUND: Acupuncture is used to treat patients with diabetic peripheral neuropathy; however, the evidence is unclear. We present the design and methodology of the ACUDPN (ACUpuncture in Diabetic Peripheral Neuropathy) trial, which investigates the effectiveness of acupuncture for the treatment of diabetic peripheral neuropathy (DPN) symptoms. The aim of this study is to investigate whether acupuncture is effective for the treatment of DPN symptoms. METHODS: This study is a two-armed, randomized, controlled, parallel group, open-label, confirmatory, multicenter trial (8-week intervention period plus 16 weeks of follow-up). Physicians in outpatient units in Germany who specialize in acupuncture treatment will treat 110 diabetes type II patients with clinical symptoms of peripheral neuropathy in the feet and legs with signs of neuropathy according to nerve conduction testing. The patients will be randomized in a 1:1 ratio to one of the following two groups: (a) semi-standardized acupuncture plus routine care or (b) routine care alone. Acupuncture will consist of 12 treatments per patient over 8 weeks. The primary outcome will be the overall DPN-related complaints in the extremities after 8 weeks as measured by the Visual Analog Scale (VAS). Further outcome measures will include DPN-related pain, the Neuropathic Pain Symptom Inventory (NPSI), Diabetic Peripheral Neuropathic Pain Impact (DPNPI) scores, and nerve conduction parameters of the sural nerve at weeks 8, 16, and 24. DISCUSSION: The results of this trial will be available in 2021 and will help clarify whether acupuncture can be considered effective for the treatment of DPN with regard to the subdimensions of the neuropathic clinical picture. TRIAL REGISTRATION: ClinicalTrials.gov NCT03755960 . Registered on 11 August 2018.

[The Motivation for Physicians in Training as Specialists in General Medicine to Open their Own Surgery]. / Niederlassungsmotive ­ Die Bereitschaft zur Niederlassung in eigener Praxis von Ärztinnen und Ärzten in Weiterbildung zum Facharzt für Allgemeinmedizin.

Our mixed methods (narrative interviews; group discussions; quantitative online survey) study examines the motivation of physicians in training as specialists in general practice to open their own practice. In addition, we wondered how motivations change during the vocational training. In a synchronic perspective motivations are highly differentiated on the one hand, on the other hand they are clearly gender-specific. In a diachronic perspective, the decision for or against their own GP surgery is uncertain for a long time during vocational training.

The persistence of the effects of acupuncture after a course of treatment: a meta-analysis of patients with chronic pain.

There is uncertainty regarding how long the effects of acupuncture treatment persist after a course of treatment. We aimed to determine the trajectory of pain scores over time after acupuncture, using a large individual patient data set from high-quality randomized trials of acupuncture for chronic pain. The available individual patient data set included 29 trials and 17,922 patients. The chronic pain conditions included musculoskeletal pain (low back, neck, and shoulder), osteoarthritis of the knee, and headache/migraine. We used meta-analytic techniques to determine the trajectory of posttreatment pain scores. Data on longer term follow-up were available for 20 trials, including 6376 patients. In trials comparing acupuncture to no acupuncture control (wait-list, usual care, etc), effect sizes diminished by a nonsignificant 0.011 SD per 3 months (95% confidence interval: -0.014 to 0.037, P = 0.4) after treatment ended. The central estimate suggests that approximately 90% of the benefit of acupuncture relative to controls would be sustained at 12 months. For trials comparing acupuncture to sham, we observed a reduction in effect size of 0.025 SD per 3 months (95% confidence interval: 0.000-0.050, P = 0.050), suggesting approximately a 50% diminution at 12 months. The effects of a course of acupuncture treatment for patients with chronic pain do not seem to decrease importantly over 12 months. Patients can generally be reassured that treatment effects persist. Studies of the cost-effectiveness of acupuncture should take our findings into account when considering the time horizon of acupuncture effects. Further research should measure longer term outcomes of acupuncture.

[What are the Prerequisites for a Successful Cooperation between Nursing Homes and Physicians? - Results of a Mixed-methods Cross-Sectional Study in Bavarian Nursing Homes]. / Was sind die Voraussetzungen für eine erfolgreiche Zusammenarbeit zwischen Pflegeeinrichtung und Ärzten? ­ Ergebnisse einer Mixed Methods Querschnittserhebung in bayerischen Pflegeeinrichtungen.

Aim: This mixed-methods cross-sectional study examined the cooperation between nursing home staff and physicians in Bavarian nursing homes in order to understand which organisational and communication measures are resulting in satisfying teamwork among professional groups in nursing homes. Methods: In 3 interview rounds nursing home staff, general practitioners, medical specialists, dentists, nursing home residents, and relatives in 52 nursing homes were interviewed using a questionnaire that was enhanced after every round. Additionally, focus group interviews have been performed in 2 nursing homes. Results: 443 persons involved in patient care, 50 residents and 47 relatives participated in the structured interviews. 22 persons attended the focus group interviews. 65% of the nursing homes required regular visits of general practitioners and 36% or, respectively, 27% required regular or on demand visits of specialists. 47% of the nursing home staff that was asked about this issue stated that it would make their work easier if only a small number of physicians were in charge of their institution. Measures for improvement of medical care in nursing homes most frequently suggested by interview partners responsible for patient care were: better communication (9%), better remuneration of physicians' nursing home visits (7%, nurses and physicians) and less bureaucracy and regular physicians' visits (5% in each question). Conclusion: Because of the composition of our study sample it cannot be assumed that the results are representative for all Bavarian nursing homes. Confidence in one another, low number of persons in charge, binding agreements and regular physicians' nursing home visits are essential for a successful cooperation between providing physicians and nursing home staff.

Endoscopic mucosal resection of large rectal adenomas in the era of centralization: Results of a multicenter collaboration.

BACKGROUND AND OBJECTIVE: Endoscopic mucosal resection (EMR) of large rectal adenomas is largely being centralized. We assessed the safety and effectiveness of EMR in the rectum in a collaboration of 15 Dutch hospitals. METHODS: Prospective, observational study of patients with rectal adenomas >3 cm, resected by piecemeal EMR. Endoscopic treatment of adenoma remnants at 3 months was considered part of the intervention strategy. Outcomes included recurrence after 6, 12 and 24 months and morbidity. RESULTS: Sixty-four patients (50% male, age 69 ± 11, 96% ASA 1/2) presented with 65 adenomas (diameter 46 ± 17 mm, distance ab ano 4.5 cm (IQR 1-8), 6% recurrent lesion). Sixty-two procedures (97%) were technically successful. Histopathology revealed invasive carcinoma in three patients (5%), who were excluded from effectiveness analyses. At 3 months' follow-up, 10 patients showed adenoma remnants. Recurrence was diagnosed in 16 patients during follow-up (recurrence rate 25%). Fifteen of 64 patients (23%) experienced 17 postprocedural complications. CONCLUSION: In a multicenter collaboration, EMR was feasible in 97% of patients. Recurrence and postprocedural morbidity rates were 25% and 23%. Our results demonstrate the outcomes of EMR in the absence of tertiary referral centers.

[Secondary data analysis of the prevalence of alcohol dependence (F10.2) in Germany]. / Sekundärdatenanalyse der Prävalenz der Alkoholabhängigkeit (F10.2) in Deutschland.

BACKGROUND AND AIM: Compared to other European countries, alcohol consumption and abuse in Germany is on a high level. Even in smaller quantities, frequent alcohol consumption can generate organic damages and thus lead to secondary diseases that have a significant societal relevance regarding direct and indirect costs for the healthcare system. After several publications have already addressed the prevalence of acute alcohol intoxication and alcohol abuse in adolescents, the question arises how the prevalence of alcohol abuse develops on the basis of the accounting data of outpatient and inpatient care providers in the population of adults aged 18 and over and what tendency can be observed within a multi-year period. Within this study, the coding of alcohol abuse (F10.2 diagnosis) was analyzed separately for outpatient and inpatient sector in the insured population ≥ 18 years and presented over time. PATIENTS AND METHODS: The development of the prevalence of alcohol abuse was analyzed on the basis of secondary random sample data from one nation-wide working statutory health insurance with a total population of more than 3 million insurants in the 5-year period from 2006 to 2010. For the presentation of the prevalences, insurant numbers were used. For the identification of the relevant insurants, only confirmed outpatient F10.2 diagnoses or inpatient F10.2 diagnoses were used. The age and sex distributions of the dataset were adjusted to the distribution in the statutory health insurance to ensure representativeness. The analyses of each single year only allude to insured persons aged ≥ 18 years. With the help of the statistics of the insured of statutory health insurance, for each calendar year, projections of the detected prevalence rates were determined to estimate the number of cases on the statutory health insurance level and their development over time. RESULTS: The results show a tendency of slightly increasing prevalence of alcohol dependence from 2006 to 2010. For insured persons with at least one inpatient or outpatient F10.2 diagnosis, the prevalence continuously rises from 1,04% in 2006 to 1.14% in 2010; the prevalence of insured persons who received an alcohol dependence diagnosis only in the outpatient sector, increased from 0,67% to 0,79% in that time scale. In all analyzes, there was a ratio of 30% affected women to 70% affected men. From 2006 to 2010, the proportion of insured persons with hospitalization caused by alcohol dependence decreased steadily from 14,51% to 12,24%. CONCLUSION: For the analyzed group of persons aged ≥ 18 years, the present analysis results show a tendency of slightly increasing prevalences of alcohol abuse, however at the same time combined with a decreasing proportion of hospitalized patients. Similar nationwide studies from 2010 on the basis of secondary data of a health insurance company and inclusion of outpatient and inpatient diagnoses also indicate prevalences of alcohol dependence of about 1.18%, but they base on the age range of 15- to 64-year-old insurants.

Over-the-counter-drugs for the treatment of mood and anxiety disorders--the views of German pharmacists.

INTRODUCTION: Depression, anxiety, agitation and sleep disorders are highly prevalent in the general population, but few persons receive psychiatric care. METHODS: Our aim was to study the views of 690 German pharmacists on "over-the counter" (OTC) drugs for these indications. RESULTS: They reported dispensing OTC medication to an average of 12 customers per day, and this corresponded to almost one quarter of the medications provided for these indications. Herbal drugs and complex homeopathic formulations were used most frequently. Patients preferring OTC substances were described as being younger, with shorter durations of illness and less severe symptoms, and more skeptical regarding psychopharmacology. While genuine pharmacological effects were considered as most relevant, pharmacists were highly aware of placebo and interpersonal factors. Symptoms, comorbidity and advice on drug intake were prominent topics during pharmacy consultations. CONCLUSION: German pharmacists report dispensing large amounts of OTC drugs for anxiety, agitation, sleep disturbances or depression. It is unclear whether this constitutes a rational and cost effective method to deal with mild courses of high prevalence diseases or must be seen critically.

The use of placebo interventions in clinical practice.

Although a considerable number of mostly quantitative surveys have investigated the frequency and circumstances of the use of placebo interventions in clinical practice, it remains rather unclear what role placebo interventions really have outside clinical and laboratory research and why they are used. In this article I discuss two aspects which have to be taken into account when future research aims to provide further insights: (1) the different perspectives of patients, providers and scientists when it comes to decide whether a treatment is a placebo or not and (2) the fact that applying placebos intentionally is not only an ethical but also a professional problem.

[Challenges for medical staff and local authorities in an aging population in a German rural area]. / Medizinische und kommunale Herausforderungen einer alternden Gesellschaft im ländlichen Bereich.

OBJECTIVE: The aim of this survey is the assessment of health and social situation of elderly persons in rural regions as well as their requests and needs concerning accommodation and medical care in the old age. METHODS: In a cross-sectional survey, inhabitants of the rural commune Markt Heiligenstadt, Upper Franconia, aged over 50 years were interviewed. Sixty-eight questions were asked regarding wishes and needs concerning accommodation and living in the old age. RESULTS: 513 (39%) inhabitants participated. Their mean age was 66 years (± 11 years) and 53% were female. 49% are suffering from hypertension and 17% from diabetes mellitus. Reduced autonomy in everyday life is predominantly caused by diseases of the musculoskeletal system. 40% of the respondents aged over 70 years reported hearing and visual impairments. Most of the participants are living in their privately owned home (81%) despite their comparatively low income and express their wish to live and be cared for in their own home in old age (90%). 75% of the respondents are married or living in a partnership. 90% have children and in 55% the children are living in the same house or in the commune. There are 2 local family doctors' practices, but no specialists' practices and no hospitals in the commune. Almost all the respondents (98%) have a regular family doctor. 17% of the participants would relocate if there was no family doctor nearby, 6% if there was no specialist and 4% if there was no hospital nearby. CONCLUSION: Health problems and functional limitations among the inhabitants of Markt Heiligenstadt are similar to those reported in German nationwide surveys. Medical care is strongly depending on general practitioners. The strong social networks of the participants and the predominant presence of residential property are important resources needed to accomplish the preference for home care in old age. This implies increasing challenges for the primary care providers. In future, the general practitioner will be a central coordinator of medical care and professional nursing together with the care by family members.

Reporting experiments in homeopathic basic research-description of the checklist development.

The objective of this study was to develop a criteria catalogue serving as a guideline for authors to improve quality of reporting experiments in basic research in homeopathy. A Delphi Process was initiated including three rounds of adjusting and phrasing plus two consensus conferences. European researchers who published experimental work within the last 5 years were involved. A checklist for authors provide a catalogue with 23 criteria. The "Introduction" should focus on underlying hypotheses, the homeopathic principle investigated and state if experiments are exploratory or confirmatory. "Materials and methods" should comprise information on object of investigation, experimental setup, parameters, intervention and statistical methods. A more detailed description on the homeopathic substances, for example, manufacture, dilution method, starting point of dilution is required. A further result of the Delphi process is to raise scientists' awareness of reporting blinding, allocation, replication, quality control and system performance controls. The part "Results" should provide the exact number of treated units per setting which were included in each analysis and state missing samples and drop outs. Results presented in tables and figures are as important as appropriate measures of effect size, uncertainty and probability. "Discussion" in a report should depict more than a general interpretation of results in the context of current evidence but also limitations and an appraisal of aptitude for the chosen experimental model. Authors of homeopathic basic research publications are encouraged to apply our checklist when preparing their manuscripts. Feedback is encouraged on applicability, strength and limitations of the list to enable future revisions.

Esophageal perforation due to removal of partially covered self-expanding metal stents placed for a benign perforation or leak.

Benign esophageal perforations and anastomotic leaks can be effectively managed by stent placement. However, when partially covered self-expanding metal stents (SEMS) are used, safe removal may be complicated. In this case series, we evaluated the complicated removal of SEMS placed for a benign esophageal perforation or leak in four patients. In all patients a partially covered SEMS was placed. After a median stent time of 29 days (range 21 - 30), the SEMS were found to have become embedded in the esophageal wall. Endoscopic removal resulted in perforation in all patients. All patients recovered uneventfully, although one patient underwent esophagectomy. If uncovered SEMS ends become embedded, removal of the stent may cause major damage to the esophageal wall. It is therefore recommended to remove embedded partially covered SEMS only after first placing a fully covered SEMS or self-expanding plastic stent inside this stent to necrotize the ingrown tissue at the uncovered stent ends.

[Validity of clinical trials: are there differences between conventional and complementary alternative medicine?]. / Studienvalidität: Gibt es Unterschiede zwischen Schul- und Komplementärmedizin?

So far there has been no consensus on the criteria which confirm the validity of scientific contributions in conventional medicine (CM) and complementary/ alternative medicine (CAM). An interdisciplinary group of experts from various disciplines within each of the areas of medicine held six well-documented sessions in an effort to reach a consensus. The group agreed that the methods to confirm the validity of clinical trials are identical in CM and CAM. There are differences in research strategies and there may also be differences in interpreting the results, depending on the concept of medicine.

Reporting experiments in homeopathic basic research (REHBaR)--a detailed guideline for authors.

BACKGROUND: Reporting experiments in basic research in homeopathy is an important issue as comprehensive description of what exactly was done is required. So far, there is no guideline for authors available, unlike criteria catalogues common in clinical research. METHODS: A Delphi Process was conducted, including a total of five rounds, three rounds of adjusting and phrasing plus two consensus conferences. European researchers who published experimental work within the last five years were involved. RESULTS: A checklist of 23 items was obtained and supplemented with detailed examples emphasizing what each item implies. Background, objectives and possible hypotheses should be given in the part 'introduction'. Special emphasis is put on the 'materials and methods' section, where a detailed description of chosen controls, object of investigation, experimental setup, replication, parameters, intervention, allocation, blinding, and statistical methods is required. The section 'results' should present sufficient details on analysed data, descriptive as well as inferential. Authors should discuss their results and give an interpretation in the context of current evidence. CONCLUSION: A guideline for Reporting Experiments in Homeopathic Basic Research (REHBaR) was compiled to be applied by authors when preparing their manuscripts, and to be used by scientific journals in the reviewing process. Furthermore the guideline is a commitment to a certain minimum quality level needed in basic research, e.g. blinding and randomisation. Feedback is encouraged on applicability, strength and limitations of the list to enable future revisions.

Mistletoe therapy in oncology.

BACKGROUND: Mistletoe extracts are commonly used in cancer patients. It is claimed that they improve survival and quality of life (QOL) in cancer patients. OBJECTIVES: To determine the effectiveness, tolerability and safety of mistletoe extracts given either as monotherapy or adjunct therapy for patients with cancer. SEARCH STRATEGY: Search sources included the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 3, 2007) Cochrane Complementary Medicine Field Registry of randomized clinical trials (RCTs) and controlled clinical trials, MEDLINE, EMBASE, HEALTHSTAR, INT. HEALTH TECHNOLOGY ASSESSMENT, SOMED, AMED, BIOETHICSLINE, BIOSIS, CancerLit, CATLINE, CISCOM (August 2007). For the search the Standard Operating Procedures of the Information System in Health Economics at the German Institute for Medical Documentation and Information (DIMDI) were utilized. Reference lists of relevant articles and authors extensive files were searched for additional studies. Manufacturers of mistletoe preparations were contacted. SELECTION CRITERIA: We included RCTs of adults with cancer of any type. The interventions were mistletoe extracts as sole treatments or given concomitantly with chemo- or radiotherapy. The outcome measures were survival times, tumor response, QOL, psychological distress, adverse effects from antineoplastic treatment and safety of mistletoe extracts. DATA COLLECTION AND ANALYSIS: Three review authors independently assessed trials for inclusion in the review. All review authors independently took part in the extraction of data and assessment of study quality and clinical relevance. Disagreements were resolved by consensus. Study authors were contacted where information was unclear. Methodological quality was narratively described and additionally assessed with the Delphi list and the Jadad score. High methodological quality was defined if six out of nine Delphi criteria, or four out of five Jadad criteria were fulfilled. Results were presented qualitatively. MAIN RESULTS: Eighty studies were identified. Fifty-eight were excluded for various reasons, usually as there was no prospective trial design with randomised treatment allocation. Of the 21 included studies 13 provided data on survival, 7 on tumour response, 16 on measures of QOL or psychological outcomes, or prevalence of chemotherapy-related adverse effects and 12 on side effects of mistletoe treatment; overall comprising 3484 randomised cancer patients. Interventions evaluated were 5 preparations of mistletoe extracts from 5 manufacturers and one commercially not available preparation. The general reporting of RCTs was poor. Of the 13 trials investigating survival, 6 showed some evidence of a benefit, but none of them was of high methodological quality. The results of two trials in patients with melanoma and head and neck cancer gave some evidence that the used mistletoe extracts are not effective for improving survival. Of the 16 trials investigating the efficacy of mistletoe extracts for either improving QOL, psychological measures, performance index, symptom scales or the reduction of adverse effects of chemotherapy, 14 showed some evidence of a benefit, but only 2 of them including breast cancer patients during chemotherapy were of higher methodological quality. Data on side effects indicated that, depending on the dose, mistletoe extracts were usually well tolerated and had few side effects. AUTHORS' CONCLUSIONS: The evidence from RCTs to support the view that the application of mistletoe extracts has impact on survival or leads to an improved ability to fight cancer or to withstand anticancer treatments is weak. Nevertheless, there is some evidence that mistletoe extracts may offer benefits on measures of QOL during chemotherapy for breast cancer, but these results need replication. Overall, more high quality, independent clinical research is needed to truly assess the safety and effectiveness of mistletoe extracts. Patients receiving mistletoe therapy should be encouraged to take part in future trails.