Acceptance of an oncologic addendum for the application of the German Standardized Medication Plan in oral anticancer drug therapy

Background: The Federal Standardized Medication Plan (BMP) offers the possibility of providing patients with specific information on drug therapy. Cancer patients who are treated with oral anticancer drugs have a great need for information as they take the drugs independently in their home environment. Providing specific instructions for oral anticancer drugs may enhance the patient role and improve medi-cation safety.Methods: In a four-step process (needs assessment, compilation of the text modules, pilot and main phase), an oncologic addendum for the BMP was developed and subjected to an acceptance test. Also, a needs assessment was conducted with oncologists, pharmacists and patients to identify important information to be included in the oncologic addendum. Subsequently, the acceptability of the BMP including the addendum ('Onko-BMP') was tested among health care providers and patients in two study phases (pilot and main phase). Updates made to the Onko-BMP were documented at each follow-up visit. At the end of the observation period, discrepancies between a brown bag review and the latest Onko-BMP were identified to evaluate its completeness. In addition, acceptance of the Onko-BMP was analyzed using qualitative methods. At the end of the pilot phase the patients were interviewed and completed a questionnaire at the end of the main phase. Focus interviews and a focus group were conducted with the health care providers.Results: A total of 347 health care providers and cancer patients participated in the needs assessment, including 167 oncologists, 130 pharmacists, and 50 patients. Suggestions for additional information to be included in the oncologic addendum mainly included instructions for how to take the medication, therapy-limiting side effects as well as potentially relevant interactions with over-the-counter drugs. Ten patients participated in the pilot phase and 60 patients in the main phase of the project. The use of the Onko-BMP was positively evaluated by all participants. The majority of the 178 updates in the main phase were made by the patients themselves. Most frequently, missing items were added (62). After com-parison with the brown bag at the end of the observation period, 175 discrepancies for a total of 270 pro-ducts, including food supplements (mean 6.3 +/- 3.9), and 245 drugs (mean 5.7 +/- 3.1) taken by the patients were detected, 49 of which were due to missing drugs on the Onko-BMP, mainly on-demand medication (30). 82 documented discrepancies were for prescription drugs. In the qualitative surveys, health care providers indicated that there is a high need for the Onko-BMP. In particular, its use could strengthen the patient's role in therapy. The frequently missing or poor technical requirements for working with the BMP were perceived as limiting its widespread use. Assignment of clear responsibilities and remuneration of all professionals involved were identified as important influential factors for an efficient use of the Onko-BMP. Patients considered the added value of the Onko-BMP primarily to be in their being able to inform their treating physicians and pharmacists about their medication.Conclusions: The developed Onko-BMP gained a high level of acceptance among patients and health care providers. It can improve education about oral anticancer drugs and thereby strengthen the patient role. However, in order to ensure widespread use of the tool, the necessary conditions should be created on the part of the health care providers. In particular, the IT infrastructure for its use in daily routine needs to be improved in order to exploit its full potential and ensure its successful large-scale implemention

Identification of Novel Potential Type 2 Diabetes Genes Mediating β-Cell Loss and Hyperglycemia Using Positional Cloning

Type 2 diabetes (T2D) is a complex metabolic disease regulated by an interaction of genetic predisposition and environmental factors. To understand the genetic contribution in the development of diabetes, mice varying in their disease susceptibility were crossed with the obese and diabetes-prone New Zealand obese (NZO) mouse. Subsequent whole-genome sequence scans revealed one major quantitative trait loci (QTL), Nidd/DBA on chromosome 4, linked to elevated blood glucose and reduced plasma insulin and low levels of pancreatic insulin. Phenotypical characterization of congenic mice carrying 13.6 Mbp of the critical fragment of DBA mice displayed severe hyperglycemia and impaired glucose clearance at week 10, decreased glucose response in week 13, and loss of β-cells and pancreatic insulin in week 16. To identify the responsible gene variant(s), further congenic mice were generated and phenotyped, which resulted in a fragment of 3.3 Mbp that was sufficient to induce hyperglycemia. By combining transcriptome analysis and haplotype mapping, the number of putative responsible variant(s) was narrowed from initial 284 to 18 genes, including gene models and non-coding RNAs. Consideration of haplotype blocks reduced the number of candidate genes to four (Kti12, Osbpl9, Ttc39a, and Calr4) as potential T2D candidates as they display a differential expression in pancreatic islets and/or sequence variation. In conclusion, the integration of comparative analysis of multiple inbred populations such as haplotype mapping, transcriptomics, and sequence data substantially improved the mapping resolution of the diabetes QTL Nidd/DBA. Future studies are necessary to understand the exact role of the different candidates in β-cell function and their contribution in maintaining glycemic control