Does the care dependency of nursing home residents influence their health-related quality of life?-A cross-sectional study.

BACKGROUND: Studies on health-related quality of life (HRQOL) are missing for nursing home residents independent from their health conditions or interventions after admission. Our aim was to analyse if the care dependency of nursing home residents influence their HRQOL and to describe HRQOL of nursing home residents at the time of admission. METHOD: Eleven German nursing homes were randomly selected for a cross-sectional multicentre study from April 2008 until December 2009. HRQOL was measured with the Nottingham Health Profile (NHP) in the six domains "Physical Mobility", "Energy", "Pain", "Social Isolation", "Emotional Reaction" and "Sleep". Domain scores range from zero (good subjective health status) to 100 (poor subjective health status). Care dependency was evaluated using the Care Dependency Scale, age, sex, cognitive status and diseases were documented by the research assistants. Multivariate regression analysis was performed to quantify the influence of care dependency on HRQOL. RESULTS: 120 residents were included in total. HRQOL was mostly reduced in the domains "Physical Mobility" and "Energy" (mean scores >43.0), while impairment differences in the domains "Pain", "Social Isolation", "Emotional Reaction" and "Sleep" were only moderate (≤25.0). HRQOL was not influenced by the age. Women (n = 85) had a significantly poorer HRQOL in the domain "Pain" than men (mean score women: 29.5 ± 31.5; males: 14.9 ± 17.2; p = 0.011). Care dependency had an influence on the domain "Sleep" (ß = -0.195, p = 0.031), while the other domains were not influenced by care dependency. Residents with a low care dependency scored significantly lower (better HRQOL) in the domain "Sleep" than residents with a high care dependency (mean score 15.3; SD ± 19.0 versus mean score 32.8 SD ± 33.2; p < 0.02). CONCLUSION: The level of care dependency has no influence on the HRQOL from the nursing home residents' perspective apart from the domain "Sleep". High care dependency residents have a lower HRQOL in the domain "Sleep" compared to moderate and low care dependency residents. We found a significantly lower HRQOL in women compared to men in the domain "Pain".

Adverse drug reactions for CAM and conventional drugs detected in a network of physicians certified to prescribe CAM drugs.

BACKGROUND: Within recent years, the increasing popularity of complementary and alternative medicine (CAM) has led health care authorities to focus on the safety of these drugs. One reason for the low awareness of adverse drug reactions (ADRs) associated with CAM might be that users and physicians believe that there are no risks associated with CAM drugs. Recent studies have shown that ADRs are under-reported and are considered a leading cause of morbidity and mortality. The Evaluation of Anthroposophical Medicine (EvaMed) Pharmacovigilance Network was formed in 2004 at the Havelhoehe Research Institute in Berlin and is composed of 38 CAM physicians located in 12 of the 16 federal states in Germany for the purpose of using EvaMed data to evaluate the prescribing patterns, effectiveness, and safety of CAM therapies. OBJECTIVE: To describe and quantify the volume and severity of ADRs for CAM and conventional (CON) drugs in a proprietary database created from prescriptions and patient data of primary care CAM physicians who participate in the EvaMed Network. METHODS: This was a prospective, multicenter, observational study based on the ADR reports and electronic prescription data of 38 individual physicians (21 general practitioners, 9 pediatricians, 4 internists, 2 gynecologists, 1 dermatologist, and 1 neurologist) participating in the EvaMed Network. In addition to standard medical education, all physicians had 5 years practical experience and an additional qualification for anthroposophic medicine, which is a subcategory of CAM. All 38 physicians documented ADRs deemed serious, defined as life threatening or resulting in death, disability/incapacity, or inpatient hospital days. Due to the time-consuming nature of documenting ADRs, only a subgroup of 7 physicians (4 in general practice and 1 each in internal medicine, pediatrics, and gynecology) agreed to report both nonserious and serious ADRs. Therefore, the incidence and frequency of ADRs were evaluated in this subgroup. The study period was January 2004 through June 2009. ADRs were documented by the physicians using an electronic case report form in the EvaMed software, which was linked to the physicians' existing electronic medical record (EMR) systems and incorporated into their daily routines to avoid missing data or double entries. The participating physicians were compensated €15 (approximately US$20) for each ADR report. All ADR reports were monitored at the Havelhoehe Research Institute by 2 physicians who evaluated patient characteristics, present visit diagnosis, target drugs, associated drug classes and type of drugs, type of ADR, actions taken for the ADR, and outcome of the ADR. RESULTS: There were 1,018,626 drugs (54.8% CAM) prescribed by the 38 physicians for 88,431 patients, and 412 ADRs reported for 389 patients; 124 (30.1%) ADRs were for CAM drugs. The majority were reported in children (69.2%, n = 285) and females (56.3%, n = 232). All serious ADRs (n = 14) were associated with CON drugs. In the subgroup of 7 physicians who agreed to report all ADRs, a total of 327 serious and nonserious ADRs were reported for 392,243 prescribed drugs (0.08%) and for 308 of 25,966 patients (1.2%). ADRs were reported for 241 of 16,032 children (aged 17 years or younger; 1.5%) versus 67 of 9,934 adults (0.7%). Of the 327 total ADRs, 10 (3.1%) were serious. There were 95 ADRs for 213,900 CAM prescriptions (4.4 per 10,000) versus 232 for 178,343 CON prescriptions (13.0 per 10,000). The CAM drug with the highest frequency of ADRs was Pelargonium sidoides root (0.21%, 4 of 1,940 prescriptions). The most frequently reported ingredient in CAM was ivy leaves with an ADR frequency of 0.17% (n = 11 of 6,575 prescriptions). The most reported drug connected with ADRs was amoxicillin (1.36%, n = 31 of 2,276 prescriptions). The most common ADR medical management was withdrawal of the drug (82.3% overall, 83.9% CAM, 81.6% CON). CONCLUSIONS: A sample of 38 CAM physicians reported the occurrence of at least 1 ADR for 0.4% of treated patients in a 5.5-year study period. There were no serious ADRs reported for CAM drugs. In a subsample of 7 physicians who agreed to report all nonserious and serious ADRs, 1.2% of patients experienced at least 1 ADR; rates of ADRs per 10,000 prescriptions were 4.4 for CAM drugs and 13.0 for CON drugs.

Depression, Comorbidities, and Prescriptions of Antidepressants in a German Network of GPs and Specialists with Subspecialisation in Anthroposophic Medicine: A Longitudinal Observational Study.

Background. Depression is a major reason for counselling in primary care. Our study aims at evaluating pharmacological treatment strategies among physicians specialised in anthroposophic medicine (AM). Methods. From 2004 to 2008, twenty-two German primary care AM-physicians participated in this prospective, multicentre observational study. Multiple logistic regression was used to determine factors associated with a prescription of any antidepressant medication. Results. A total of 2444 patients with depression were included (mean age: 49.1 years (SD: 15.4); 77.3% female). 2645 prescriptions of antidepressants for 833 patients were reported. Phytotherapeutic preparations from Hypericum perforatum were the most frequently prescribed antidepressants over all (44.6% of all antidepressants), followed by amitriptyline (16.1%). The likelihood of receiving an antidepressant medication did not depend on comorbidity after controlling for age, gender, physician specialisation, and type of depression (adjusted OR (AOR) = 1.01; CI: 0.81-1.26). Patients who had cancer were significantly less likely to be prescribed an antidepressant medication than those who had no cancer (AOR = 0.75; CI: 0.57-0.97). Conclusion. This study provides a comprehensive analysis of everyday practice for the treatment of depression in AM -physicians. Further analysis regarding the occurrence of critical combinations is of high interest to health services research.

The Nottingham Health Profile: a feasible questionnaire for nursing home residents?

BACKGROUND: The Nottingham Health Profile (NHP) assesses perceived emotional, social, and physical health problems and the extent to which such problems affect daily activities. The objective of our study was to determine the feasibility of the NHP for nursing home residents. METHODS: A prospective multicenter observational study was conducted in 11 nursing homes from April 2008 to December 2009 in which 286 newly admitted residents were included. Cognitive status was evaluated using the Mini-Mental State Examination (MMSE). The feasibility of the NHP was determined by administration rate, time and type of administration, and missing items. A cut-off point stating the MMSE score up to which the NHP can be applied was determined with receiver operating characteristics curves (ROC). Internal consistency (Cronbach's α) and test-retest reliability (intraclass correlation; ICC) were evaluated. RESULTS: Administration rate was 44.4% (n = 127) ranging from 76.1% for normal residents to 5.9% for residents with a severe cognitive impairment. An average of 12.6 (SD + 6.0) minutes was required for data collection and 92.1% (n = 117) of the questionnaires were completed during an interview. Frequently missing items were in the domain "Pain" (47.2). MMSE scores were significantly higher in the group with a completed NHP (P < 0.001) and analyses of ROC curves indicated a cut-off point of >16 on the MMSE score. Cronbach's α was >0.7 in four domains and >0.6 in two domains, while the ICC in all domains was >0.7. CONCLUSION: The NHP is a feasible questionnaire for residents with normal cognitive function and moderate cognitive impairment, and can be administered in nursing homes.

Prescribing patterns in dementia: a multicentre observational study in a German network of CAM physicians.

BACKGROUND: Dementia is a major and increasing health problem worldwide. This study aims to investigate dementia treatment strategies among physicians specialised in complementary and alternative medicine (CAM) by analysing prescribing patterns and comparing them to current treatment guidelines in Germany. METHODS: Twenty-two primary care physicians in Germany participated in this prospective, multicentre observational study. Prescriptions and diagnoses were reported for each consecutive patient. Data were included if patients had at least one diagnosis of dementia according to the 10th revision of the International Classification of Diseases during the study period. Multiple logistic regression was used to determine factors associated with a prescription of any anti-dementia drug including Ginkgo biloba. RESULTS: During the 5-year study period (2004-2008), 577 patients with dementia were included (median age: 81 years (IQR: 74-87); 69% female). Dementia was classified as unspecified dementia (57.2%), vascular dementia (25.1%), dementia in Alzheimer's disease (10.4%), and dementia in Parkinson's disease (7.3%). The prevalence of anti-dementia drugs was 25.6%. The phytopharmaceutical Ginkgo biloba was the most frequently prescribed anti-dementia drug overall (67.6% of all) followed by cholinesterase inhibitors (17.6%). The adjusted odds ratio (AOR) for receiving any anti-dementia drug was greater than 1 for neurologists (AOR = 2.34; CI: 1.59-3.47), the diagnosis of Alzheimer's disease (AOR = 3.28; CI: 1.96-5.50), neuroleptic therapy (AOR = 1.87; CI: 1.22-2.88), co-morbidities hypertension (AOR = 2.03; CI: 1.41-2.90), and heart failure (AOR = 4.85; CI: 3.42-6.88). The chance for a prescription of any anti-dementia drug decreased with the diagnosis of vascular dementia (AOR = 0.64; CI: 0.43-0.95) and diabetes mellitus (AOR = 0.55; CI: 0.36-0.86). The prescription of Ginkgo biloba was associated with sex (female: AOR = 0.41; CI: 0.19-0.89), patient age (AOR = 1.06; CI: 1.02-1.10), treatment by a neurologist (AOR = 0.09; CI: 0.03-0.23), and the diagnosis of Alzheimer's disease (AOR = 0.07; CI: 0.04-0.16). CONCLUSIONS: This study provides a comprehensive analysis of everyday practice for treatment of dementia in primary care in physicians with a focus on CAM. The prescribing frequency for anti-dementia drugs is equivalent to those found in other German studies, while the administration of Ginkgo biloba is significantly higher.

Anthroposophic medicine in pediatric primary care: a prospective, multicenter observational study on prescribing patterns.

BACKGROUND: Although the treatment of children has been a core domain ofanthroposophic medicine since its inception, a systematic analysis of anthroposophic therapies in pediatric primary care is still lacking. This study describes the spectrum of diagnoses and therapies observed in children treated in everyday anthroposophic practice. METHODS: Thirty-eight primary care physicians in Germany participated in this prospective, multicenter observational study on prescribing patterns. Prescriptions and diagnoses were reported for each consecutive patient. Multiple logistic regression analysis was used to determine factors associated with anthroposophic prescriptions. RESULTS: In 2005, a total of 57 893 prescriptions for 18 440 children under 12 years of age (48.1% female) were issued. In total, 50.3% of the prescriptions were classified as CAM remedies alone, 22.6% as conventional pharmaceuticals alone, and 27.1% as a combination of both. Anthroposophic remedies accounted for 41.8% of all medications prescribed. The odds ratio (OR) for receiving an anthroposophic remedy was significantly higher for the first consultation (OR= 1.19; confidence interval [CI]: 1.16-1.23). Anthroposophic remedies were prescribed most frequently for disorders of the conjunctiva (OR = 2.47; CI: 2.27-2.70), otitis media (OR = 1.50; CI: 1.43-1.59), acute upper respiratory tract infections (OR= 1.28; CI: 1.23-1.33), other respiratory diseases (OR= 1.15; CI: 1.07-1.24), digestive system and abdominal symptoms (OR= 1.39; CI: 1.28-1.51), general symptoms and signs (OR= 1.25; CI: 1.16-1.36), .and pneumonia (OR= 1.36; CI: 1.25-1.49). The likelihood of being prescribed an anthroposophic remedy decreased with patient age (OR= 0.96; CI: 0.95-0.96) and was lower in patients treated by a pediatrician (OR= 0.43; CI: 0.42-0.44). Of the 2475 therapeutic procedures prescribed (29% anthroposophic), the most frequent were physiotherapy, speech therapy, ergotherapy, and logopedics. CONCLUSION: The present study is the first to provide a systematic overview of everyday anthroposophic medical practice in primary care for children. The findings show that practitioners of anthroposophic medicine take an integrative approach by combining conventional and anthroposophic treatments.

Pharmacotherapy of elderly patients in everyday anthroposophic medical practice: a prospective, multicenter observational study.

BACKGROUND: Pharmacotherapy in the older adult is a complex field involving several different medical professionals. The evidence base for pharmacotherapy in elderly patients in primary care relies on only a few clinical trials, thus documentation must be improved, particularly in the field of complementary and alternative medicine (CAM) like phytotherapy, homoeopathy, and anthroposophic medicine. This study describes diagnoses and therapies observed in elderly patients treated with anthroposophic medicine in usual care. METHODS: Twenty-nine primary care physicians in Germany participated in this prospective, multicenter observational study on prescribing patterns. Prescriptions and diagnoses were reported for each consecutive patient. Data were included if patients were at least 60 years of age. Multiple logistic regression analysis was used to determine factors associated with anthroposophic prescriptions. RESULTS: In 2005, a total of 12 314 prescriptions for 3076 patients (68.1% female) were included. The most frequent diagnoses were hypertension (11.1%), breast cancer (3.5%), and heart failure (3.0%). In total, 30.5% of the prescriptions were classified as CAM remedies alone, 54.4% as conventional pharmaceuticals alone, and 15.1% as a combination of both. CAM remedies accounted for 41.7% of all medications prescribed (35.5% anthroposophic). The adjusted odds ratio (AOR) for receiving an anthroposophic remedy was significantly higher for the first consultation (AOR = 1.65; CI: 1.52-1.79), treatment by an internist (AOR = 1.49; CI: 1.40-1.58), female patients (AOR = 1.35; CI: 1.27-1.43), cancer (AOR = 4.54; CI: 4.12-4.99), arthropathies (AOR = 1.36; CI: 1.19-1.55), or dorsopathies (AOR = 1.34; CI: 1.16-1.55) and it decreased with patient age (AOR = 0.97; CI: 0.97-0.98). The likelihood of being prescribed an anthroposophic remedy was especially low for patients with hypertensive diseases (AOR = 0.36; CI: 0.32-0.39), diabetes mellitus (AOR = 0.17; CI: 0.14-0.22), or metabolic disorders (AOR = 0.17; CI: 0.13-0.22). CONCLUSION: The present study is the first to provide a systematic overview of everyday anthroposophic medical practice in primary care for elderly patients. Practitioners of anthroposophic medicine prescribe both conventional and complementary treatments. Our study may facilitate further CAM-research on indications of, for example, dementia or adverse drug reactions in the elderly.

Diagnostic profiles and prescribing patterns in everyday anthroposophic medical practice--a prospective multi-centre study.

BACKGROUND: Although anthroposophic medicine has been used for more than 80 years and global interest in complementary treatments is increasing, a comprehensive and long-term description of everyday anthroposophic care is still lacking. Our study aims to evaluate how anthroposophic medicine is practised under everyday conditions. METHODS: A total of 38 primary-care physicians in Germany participated in this prospective, multi-centre observational study. Prescriptions, diagnoses, and non-pharmacological therapies were reported for each consecutive patient. RESULTS: In 2005, 95,116 prescriptions for 32,839 patients (56.2% children, 57.3% female) were recorded. The median duration of consultation depended on physician specialization (general practitioners: 9.5 min; paediatricians: 8.1 min). The most frequent single diagnoses were acute upper respiratory tract infections (URTI), otitis media, and bronchitis in children; hypertension, breast cancer, and depressive episodes in adult females; and hypertension, URTI, and asthma in adult males. Anthroposophic remedies accounted for 41.8% of all drugs prescribed. The odds ratio (OR) for receiving an anthroposophic remedy was very high for cancer (OR = 4.5; 95% CI: 4.2-4.8) and >1 for dorsopathies (OR = 1.5; CI: 1.3-1.6), otitis media (OR = 1.3; CI: 1.2-1.3), and URTI (OR = 1.1; CI: 1.1-1.2). Of the 5,289 therapeutic procedures prescribed, 27% were anthroposophic. CONCLUSION: A broad range of anthroposophic remedies and non-pharmacological therapies are prescribed for a specific set of diseases in everyday anthroposophic practice. Particularly, patients <60 years received anthroposophic care. Our findings will help in the planning and implementation of further studies.

Educational intervention to improve physician reporting of adverse drug reactions (ADRs) in a primary care setting in complementary and alternative medicine.

BACKGROUND: Recent studies have shown that adverse drug reactions (ADRs) are underreported. This may be particularly true of ADRs associated with complementary and alternative medicine (CAM). Data on CAM-related ADRs, however, are sparse.Objective was to evaluate the impact of an educational intervention and monitoring programme designed to improve physician reporting of ADRs in a primary care setting. METHODS: A prospective multicentre study with 38 primary care practitioners specialized in CAM was conducted from January 2004 through June 2007. After 21 month all physicians received an educational intervention in terms of face-to-face training to assist them in classifying and reporting ADRs. The study centre monitored the quantity and quality of ADR reports and analysed the results.To measure changes in the ADR reporting rate, the median number of ADR reports and interquartile range (IQR) were calculated before and after the educational intervention. The pre-intervention and post-intervention quality of the reports was assessed in terms of changes in the completeness of data provided for obligatory items. Interrater reliability between the physicians and the study centre was calculated using Cohen's kappa with a 95% confidence interval (CI). We used Mann Whitney U-test for testing continuous data and chi-square test was used for categorical data. The level of statistical significance was set at P < 0.05. RESULTS: A total of 404 ADRs were reported during the complete study period. An initial 148% increase (P = 0.001) in the number of ADR reports was observed after the educational intervention. Compared to baseline the postinterventional number of ADR reportings was statistically significant higher (P < 0.005) through the first 16 months after the intervention but not significant in the last 4-month period (median: 8.00 (IQR [2.75; 8.75]; P = 0.605). The completeness of the ADR reports increased from 80.3% before to 90.7% after the intervention. The completeness of the item for classifying ADRs as serious or non-serious increased significantly (P < 0.001) after the educational intervention. The quality of ADR reports increased from kappa 0.15 (95% CI: 0.08; 0.29) before to 0.43 (95% CI: 0.23; 0.63) after the intervention. CONCLUSION: The results of the present study demonstrate that an educational intervention can increase physician awareness of ADRs. Participating physicians were able to incorporate the knowledge they had gained from face-to-face training into their daily clinical practice. However, the effects of the intervention were temporary.

Remedies containing Asteraceae extracts: a prospective observational study of prescribing patterns and adverse drug reactions in German primary care.

BACKGROUND: The use of complementary therapies by patients has increased over the past 20 years, both in terms of self-medication and physician prescriptions. Among herbal medicines, those containing extracts of Asteraceae (Compositae), such as Echinacea spp., Arnica montana, Matricaria recutita and Calendula officinalis, are especially popular in the primary-care setting. However, there remains a gap between the growing acceptance of these remedies and the lack of data on their safety. OBJECTIVE: The aim of this study was to analyse prescribing patterns and adverse drug reactions (ADRs) for Asteraceae-containing remedies in Germany. METHODS: Primary-care physicians, all of whom were members of the German National Association of Anthroposophic Physicians were invited to participate in this prospective, multicentre, observational study. During the study period (September 2004 to September 2006), all prescriptions and suspected ADRs for both conventional and complementary therapies were documented using a web-based system. The study centre monitored all ADR reports and conducted a causality assessment according to Uppsala Monitoring Centre guidelines. Relative risks (RRs) and proportional reporting ratios (PRRs) were calculated. RESULTS: Thirty-eight physicians, 55% of whom were general practitioners and 45% were specialists, fulfilled the technical requirements and were included in the investigation. Because documenting all ADRs (i.e. serious and nonserious) was time consuming, only a subgroup consisting of seven physicians agreed to report nonserious in addition to serious ADRs. During the study period, a total of 50 115 patients were evaluated and 344 ADRs for conventional and complementary remedies were reported. Altogether, 18 830 patients (58.0% female, 60.3% children) received 42 378 Asteraceae-containing remedies. The most frequently prescribed Asteraceae was Matricaria recutita (23%), followed by Calendula officinalis (20%) and Arnica montana (20%). No serious ADRs for Asteraceae-containing remedies were reported. In the analysis of the subgroup of seven physicians who also documented nonserious ADRs, 11 nonserious ADRs for Asteraceae-containing remedies occurred in 6961 patients, resulting in an RR of 0.13 (95% CI 0.07, 0.23). The majority of reported ADRs for Asteraceae-containing remedies were classified as uncommon. A subgroup analysis comparing phytotherapeutic and homoeopathic preparations did not reveal any relevant differences. The PRR for Asteraceae-containing remedies with respect to all other prescriptions was 1.7 (95% CI 1.0, 2.0) for the system organ class 'skin and subcutaneous tissue disorders' (six ADRs) and 1.0 (95% CI 0.3, 3.6) for 'gastrointestinal disorders' (three ADRs). Neither result was significant according to the PRR criteria developed by Evans et al. CONCLUSION: This is the first study to provide a systematic overview of prescribing patterns and ADRs for Asteraceae-containing remedies in the German primary-care sector. Asteraceae-containing remedies were used frequently in this context, especially among children. Our results indicate that treatment with Asteraceae-containing remedies is not associated with a high risk of ADRs.

[Prescribing practices in the treatment of upper respiratory tract infections in anthroposophic medicine]. / Verordnungsverhalten anthroposophisch orientierter ärzte bei akuten Infektionen der oberen Atemwege.

BACKGROUND: Upper respiratory tract infections (URTI) are among the leading reasons for doctor consultations. This study investigates the prescribing practices of medical doctors specialized in anthroposophic medicine in the treatment of URTI with a special focus on the prescription of antibiotics, complications, recurrence rates and costs. MATERIALS AND METHODS: Starting in May 2004 all prescriptions within a 1-year period by 35 primary care practitioners in Germany were analysed. Data were extracted from practice software with special interfaces with additional linking of medications and diagnoses by practitioners. RESULTS: 21,818 prescriptions for 12,081 patients (73.7%children) with 19,050 cases of URTI were analysed. The most common diagnosis was common cold (63.3%), followed by acute tonsillitis (12.9%). 63.0% were treated purely with complementary medicine. Antibiotics were given in 6.3% of cases (minimum: common cold 1.9%, maximum: tonsillitis 24.3%). Predictive factors for antibiotic prescribing were the diagnoses tonsillitis (odds ratio [OR]: 6.7; 95% confidence interval [CI]:4.5-9.9) and sinusitis (OR: 1.9; 95% CI: 1.1-3.1), concomitant disease (OR: 1.2; 95% CI: 1.0-1.4), complications (OR: 7.2; 95% CI:5.5-9.4) and the specialty paediatrics (OR: 2.1; 95% CI: 1.7-2.6). In cases that were initially treated with only complementary medicine, antibiotics were eventually prescribed in 0.7%. Overall complication rates were 2.9% and follow-up visits occurred in 6.3%. Patients had an average of 2.4 URTI/year (adults 1.7,children 2.7). Treatment costs did not differ between complementary care and antibiotics. CONCLUSION: Prescription practices in the treatment of URTI by anthroposophic practitioners were documented through the processing of routine medical data with minimal additional data. The therapy was found to be in accordance with the guidelines, however, the prescription rate for antibiotics was well below the German average.