The usage of over-the-counter products by private insured patients in Germany - a claims data analysis with focus on complementary medicine.

BACKGROUND: An important contribution to well-being of human beings can be observed by the use of self-medication products that is reflected in the constantly growing volume of over-the-counter (OTC) drugs. The aim of the current study was to extend the measurement concept for OTCs by exploring the relevance of the peripheral assortment provided by the widely accepted framework of the Anatomical Therapeutical and Chemical (ATC) classification of the WHO. METHODS: The focus was on the prescriptions and drug-related receipts submitted by privately insured persons to 18 private health insurers (PHIs) in Germany from the year 2016. The age- and gender-specific average claims amount per risks of outpatient drug expenditure were used as weights to scale up the relative distributions of the item amounts. The ATC-classification defines the commodity groups and discriminates between the main and the peripheral assortment. A descriptive analysis assessed the OTC frequencies and sum scores of the product groups within the main and peripheral assortment whereby the study group explored and assessed the relevance of each category independently according to the OTCs and integrative medicines. RESULTS: The analysis included 22.1 Mio. packages from the main assortment and examined 10.1 Mio. packages from the peripheral assortment. The latter was examined thoroughly and the commodity groups "Pharmaceutical food products", "Medicinal products for special therapy options" and particular "Hygiene and body care products" meet the defined requirements for OTCs relevant for integrative medicines. A high proportion of OTC products from the peripheral assortment was associated with the categories "medicinal products for special therapy options". Homeopathy and anthroposophy present two special therapy options, which are relevant for the extended OTC measurement. CONCLUSIONS: The analysis of OTC drugs is feasible when the main and the peripheral assortment is available and enable to integrate about 18% of all OTCs, which are neglected by the common ATC-based approach. The presented extended approach may help to identify potential users of OTCs or people in need of OTC use. In case of the highly disputed homeopathy and anthroposophy products, more research among interactions with prescriptions drugs (Rx), nutrition's and other potentially harmful exposures is recommended.

The adherence paradox: guideline deviations contribute to the increased 5-year survival of breast cancer patients.

BACKGROUND: In German breast cancer care, the S1-guidelines of the 1990s were substituted by national S3-guidelines in 2003. The application of guidelines became mandatory for certified breast cancer centers. The aim of the study was to assess guideline adherence according to time intervals and its impact on survival. METHODS: Women with primary breast cancer treated in three rural hospitals of one German geographical district were included. A cohort study design encompassed women from 1996-97 (N = 389) and from 2003-04 (N = 488). Quality indicators were defined along inpatient therapy sequences for each time interval and distinguished as guideline-adherent and guideline-divergent medical decisions. Based on all of the quality indicators, a binary overall adherence index was defined and served as a group indicator in multivariate Cox-regression models. A corrected group analysis estimated adjusted 5-year survival curves. RESULTS: From a total of 877 patients, 743 (85 %) and 504 (58 %) were included to assess 104 developed quality indicators and the resuming binary overall adherence index. The latter significantly increased from 13-15 % (1996-97) up to 33-35 % (2003-04). Within each time interval, no significant survival differences of guideline-adherent and -divergent treated patients were detected. Across time intervals and within the group of guideline-adherent treated patients only, survival increased but did not significantly differ between time intervals. Across time intervals and within the group of guideline-divergent treated patients only, survival increased and significantly differed between time intervals. CONCLUSIONS: Infrastructural efforts contributed to the increase of process quality of the examined certified breast cancer center. Paradoxically, a systematic impact on 5-year survival has been observed for patients treated divergently from the guideline recommendations. This is an indicator for the appropriate application of guidelines. A maximization of guideline-based decisions instead of the ubiquitous demand of guideline adherence maximization is advocated.

Exploring the heterogeneity in community pharmacist-led medication review studies - A systematic review.

BACKGROUND: Findings on the effectiveness of medication reviews led by community pharmacists (CPs) are often inconclusive. It has been hypothesized that studies are not sufficiently standardized, and thus, it is difficult to draw conclusions. OBJECTIVE(S): To examine differences in the way CP-led medication review studies are set up. This was accomplished by investigating (1) patient selection criteria, (2) components of the medication review interventions, (3) types of outcomes, and (4) measurement instruments used. METHODS: A systematic literature search of randomized controlled trials of CP-led medication reviews was carried out in PubMed and Cochrane Library. Information on patient selection, intervention components, and outcome measurements was extracted, and frequencies were analyzed. Where possible, outcomes were mapped to the Core Outcome Set (COS) for medication review studies. Finally, a network analysis was conducted to explore the influence of individual factors on outcome effects. RESULTS: In total, 30 articles (26 studies) were included. Most articles had a drug class-specific or disease-specific patient selection criterion (n = 19). Half of the articles included patients aged ≥60 years (n = 15), and in 40% (n = 12/30) patients taking 4 drugs or more. In 24 of 30 articles, a medication review was comprised with additional interventions, such as distribution of educational material and training or follow-up visits. About 40 different outcomes were extracted. Within specific outcomes, the measurement instruments varied, and COS was rarely represented. CONCLUSION: The revealed differences in patient selection, intervention delivery, and outcome assessment highlight the need for more standardization in research on CP-led medication reviews. While intervention delivery should be more precisely described to capture potential differences between interventions, outcome assessment should be standardized in terms of outcome selection by application of the COS, and with regard to the selected core outcome measurement instruments to enable comparison of the results.

Using relative survival measures for cross-sectional and longitudinal benchmarks of countries, states, and districts: the BenchRelSurv- and BenchRelSurvPlot-macros.

BACKGROUND: The objective of screening programs is to discover life threatening diseases in as many patients as early as possible and to increase the chance of survival. To be able to compare aspects of health care quality, methods are needed for benchmarking that allow comparisons on various health care levels (regional, national, and international). OBJECTIVES: Applications and extensions of algorithms can be used to link the information on disease phases with relative survival rates and to consolidate them in composite measures. The application of the developed SAS-macros will give results for benchmarking of health care quality. Data examples for breast cancer care are given. METHODS: A reference scale (expected, E) must be defined at a time point at which all benchmark objects (observed, O) are measured. All indices are defined as O/E, whereby the extended standardized screening-index (eSSI), the standardized case-mix-index (SCI), the work-up-index (SWI), and the treatment-index (STI) address different health care aspects. The composite measures called overall-performance evaluation (OPE) and relative overall performance indices (ROPI) link the individual indices differently for cross-sectional or longitudinal analyses. RESULTS: Algorithms allow a time point and a time interval associated comparison of the benchmark objects in the indices eSSI, SCI, SWI, STI, OPE, and ROPI. Comparisons between countries, states and districts are possible. Exemplarily comparisons between two countries are made. The success of early detection and screening programs as well as clinical health care quality for breast cancer can be demonstrated while the population's background mortality is concerned. CONCLUSIONS: If external quality assurance programs and benchmark objects are based on population-based and corresponding demographic data, information of disease phase and relative survival rates can be combined to indices which offer approaches for comparative analyses between benchmark objects. Conclusions on screening programs and health care quality are possible. The macros can be transferred to other diseases if a disease-specific phase scale of prognostic value (e.g. stage) exists.

Prognostic relevance of the loss of stromal CD34 positive fibroblasts in invasive lobular carcinoma of the breast.

CD34+ fibroblasts are constitutive stromal components of virtually all organs, including the mammary stroma, being involved in matrix synthesis, antigen presentation, and tumor-associated stromal remodeling. The most common subtype of invasive breast carcinoma, invasive carcinoma of no special type (IBC-NST), is known for its stromal loss of CD34+ fibroblasts while acquiring alpha smooth muscle actin-positive (α-SMA+) myofibroblasts, i.e., cancer-associated fibroblasts (CAF), whereas invasive lobular carcinoma (ILC) displays partial preservation of CD34+ fibroblasts. The aim of this study was to evaluate the prognostic relevance of stromal CD34+ fibroblasts and α-SMA+ myofibroblasts in an extended collection of ILC. A total of 133 cases of ILC, primarily resected between 1996 and 2004 at University Hospital Marburg, were examined semiquantitatively for stromal content of CD34+ fibroblasts and α-SMA+ myofibroblasts. Partial preservation of CD34+ fibroblasts in the tumor stroma of ILC was confirmed. Absence of CD34+ fibroblasts in the tumor stroma significantly correlated with the presence of α-SMA+ myofibroblasts (p = 0.010), positive lymph node status (p = 0.004), and pN stage (p = 0.006). Stromal loss of CD34+ fibroblasts was significantly associated with lower overall and disease-free survival rates (p = 0.012 and 0.013, respectively). Multivariate analysis adjusted for pT and pN stage revealed stromal loss of CD34+ fibroblasts as independent prognostic parameter (p = 0.05). To our knowledge, this is the first report defining prognostically relevant stromal subtypes of ILC with long-term follow-up. Future research targeting the potential diagnostic and therapeutic implications of CD34+ fibroblasts and CAF in breast cancer, especially ILC, is a promising field of interest.

Convergence with SEER database achieved by a breast cancer network: a longitudinal benchmark of 5-year relative survival.

PURPOSE: To benchmark outcomes of a German breast cancer network with the Surveillance Epidemiology and End Results programme (SEER) of the USA from a longitudinal point of view. METHODS: All women receiving primary breast cancer therapy of three hospitals in a rural district of Marburg-Biedenkopf (Germany) of time intervals 1996-1997 and 2003-2004 were used to define local benchmark objects. Data from SEER-programme contributed longitudinal benchmark objects from national level (1988-2004). All benchmark objects were compared with the time-fixed benchmark reference of SEER (2004). Stage distributions and 5-year relative survival ratios were combined to estimate standardized screening-, case-mix-, work-up-, treatment- and relative overall performance index. RESULTS: From the entry cohort of 877 German women, 97.7 % of the patients accounted for the institutional sample (N = 857) and 65.8 % accounted for the regional sample (N = 577). Stage distributions, relative survival ratios and indices of the German breast cancer network improved over time. Developed indices converged with SEER (2004). CONCLUSIONS: Effectiveness gap between one exemplary German breast cancer network and international benchmark defined by SEER has been closed. Reasons are manifold, and further research is recommended.

Practice network-based care management for patients with type 2 diabetes and multiple comorbidities (GEDIMAplus): study protocol for a randomized controlled trial.

BACKGROUND: Care management interventions in the German health-care system have been evaluated with promising results, but further research is necessary to explore their full potential in the context of multi-morbidity. Our aim in this trial is to assess the efficacy of a primary care practice network-based care management intervention in improving self-care behaviour among patients with type 2 diabetes mellitus and multiple co-occurring chronic conditions. METHODS/DESIGN: The study is designed as a prospective, 18-month, multicentre, investigator-blinded, two-arm, open-label, individual-level, randomized parallel-group superiority trial. We will enrol 582 patients with type 2 diabetes mellitus and at least two severe chronic conditions and one informal caregiver per patient. Data will be collected at baseline (T0), at the primary endpoint after 9 months (T1) and at follow-up after 18 months (T2). The primary outcome will be the differences between the intervention and control groups in changes of diabetes-related self-care behaviours from baseline to T1 using a German version of the revised Summary of Diabetes Self-Care Activities (SDSCA-G). The secondary outcomes will be the differences between the intervention and control groups in: changes in scores on the SDSCA-G subscales, glycosylated haemoglobin A level, health-related quality of life, self-efficacy, differences in (severe) symptomatic hypoglycaemia, cost-effectiveness and financial family burden. The intervention will be delivered by trained health-care assistants as an add-on to usual care and will consist of three main elements: (1) three home visits, including structured assessment of medical and social needs; (2) 24 structured telephone monitoring contacts; and (3) self-monitoring of blood glucose levels after T1 in 3-month intervals. The control group will receive usual care. The confirmatory primary analysis will be performed following the intention-to-treat (ITT) principle. The efficacy of the intervention will be quantified using two-level linear regression stratified by type of medical treatment adjusted for baseline values on the SDSCA-G. Secondary analyses will be performed according to the ITT principle. In health economic evaluations, we will estimate the incremental cost-effectiveness ratios. DISCUSSION: We hope that the results of this study will provide insights into the efficacy of practice network-based care management among patients with complex health-care needs. TRIAL REGISTRATION: Current Controlled Trials ISRCTN 83908315 (ISRCTN assigned 25 February 2014).

Service provision for mentally disordered homeless people.

PURPOSE OF REVIEW: Mentally ill homeless persons are among the most neglected or marginalized patient groups. Their needs for mental healthcare are widely unmet. The current economic crisis probably accelerates the social decline and deterioration of physical and mental health in high-risk groups worldwide and increases the need for appropriate treatments, services, and prevention strategies. RECENT FINDINGS: Research on service provision for mentally disordered homeless people (from 2010 to 2012) covers the following issues: epidemiology of mental ill health among homeless persons, service delivery and healthcare utilization, specific treatments, specific high-risk groups among homeless persons, and subjective experience with mental health service provision. SUMMARY: The number of studies published on these issues between 2010 and 2012 may suggest an awareness for the need for adequate service provision of this marginalized clientele. Research evidence is still not sufficient. The majority of studies are from the United States. The methodological quality of the studies is still moderate, being descriptive in nature or applying qualitative approaches to small samples. Included are usually easy to access patients from inner-city regions. There is an encouraging trend to focus on younger age groups that supports the focus on primary or secondary prevention strategies for homelessness and mental disorders.