HbA1c as a shared treatment goal in type 2 diabetes? A secondary analysis of the DEBATE trial.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is a major health problem in the western world. Despite a widespread implementation of integrated care programs there are still patients with poorly controlled T2DM. Shared goal setting within the process of Shared Decision Making (SDM) may increase patient's compliance and adherence to treatment regimen. In our secondary analysis of the cluster-randomized controlled DEBATE trial, we investigated if patients with shared vs. non-shared HbA1c treatment goal, achieve their glycemic goals. METHODS: In a German primary care setting, we collected data before intervention at baseline, 6, 12 and 24 months. Patients with T2DM with an HbA1c ≥ 8.0% (64 mmol/mol) at the time of recruitment and complete data at baseline and after 24 months were eligible for the presented analyses. Using a generalized estimating equation analysis, we analysed the association between the achievement of HbA1c goals at 24 months based on their shared vs. non-shared status, age, sex, education, partner status, controlled for baseline HbA1c and insulin therapy. RESULTS: From N = 833 recruited patients at baseline, n = 547 (65.7%) from 105 General Practitioners (GPs) were analysed. 53.4% patients were male, 33.1% without a partner, 64.4% had a low educational level, mean age was 64.6 (SD 10.6), 60.7% took insulin at baseline, mean baseline HbA1c was 9.1 (SD 1.0). For 287 patients (52.5%), the GPs reported to use HbA1c as a shared goal, for 260 patients (47.5%) as a non-shared goal. 235 patients (43.0%) reached the HbA1c goal after two years, 312 patients (57.0%) missed it. Multivariable analysis shows that shared vs. non-shared HbA1c goal setting, age, sex, and education are not associated with the achievement of the HbA1c goal. However, patients living without a partner show a higher risk of missing the goal (p = .003; OR 1.89; 95% CI 1.25-2.86). CONCLUSIONS: Shared goal setting with T2DM patients targeting on HbA1c-levels had no significant impact on goal achievement. It may be assumed, that shared goal setting on patient-related clinical outcomes within the process of SDM has not been fully captured yet. TRIAL REGISTRATION: The trial was registered at ISRCTN registry under the reference ISRCTN70713571.

Shared decision making and patient-centeredness for patients with poorly controlled type 2 diabetes mellitus in primary care-results of the cluster-randomised controlled DEBATE trial.

BACKGROUND: We investigate whether an educational intervention of GPs increases patient-centeredness and perceived shared decision making in the treatment of patients with poorly controlled type 2 diabetes mellitus? METHODS: We performed a cluster-randomized controlled trial in German primary care. Patients with type 2 diabetes mellitus defined as HbA1c levels ≥ 8.0% (64 mmol/mol) at the time of recruitment (n = 833) from general practitioners (n = 108) were included. Outcome measures included subjective shared decision making (SDM-Q-9; scale from 0 to 45 (high)) and patient-centeredness (PACIC-D; scale from 1 to 5 (high)) as secondary outcomes. Data collection was performed before intervention (baseline, T0), at 6 months (T1), at 12 months (T2), at 18 months (T3), and at 24 months (T4) after baseline. RESULTS: Subjective shared decision making decreased in both groups during the course of the study (intervention group: -3.17 between T0 and T4 (95% CI: -4.66, -1.69; p < 0.0001) control group: -2.80 (95% CI: -4.30, -1.30; p = 0.0003)). There were no significant differences between the two groups (-0.37; 95% CI: -2.20, 1.45; p = 0.6847). The intervention's impact on patient-centeredness was minor. Values increased in both groups, but the increase was not statistically significant, nor was the difference between the groups. CONCLUSIONS: The intervention did not increase patient perceived subjective shared decision making and patient-centeredness in the intervention group as compared to the control group. Effects in both groups might be partially attributed to the Hawthorne-effect. Future trials should focus on patient-based intervention elements to investigate effects on shared decision making and patient-centeredness. TRIAL REGISTRATION: The trial was registered on March 10th, 2011 at ISRCTN registry under the reference ISRCTN70713571 .

Patterns and Facilitators for the Promotion of Glaucoma Medication Adherence-A Qualitative Study.

Primary open-angle glaucoma (POAG) is a chronic optic neuropathy causing irreversible nerve fiber damage. Initially asymptomatic, it progresses slowly without any notable sign of vision loss, thus early detection and treatment is essential. The standard treatment being non-invasive topical administration of eye drops harbors the problem of patients not being adherent. This study aimed to explore the experiences and thoughts of glaucoma patients about their medication management to improve our knowledge on how adherence works for the individual patient. Narrative interviews were conducted with 21 glaucoma patients. Data were analyzed using inductive content analysis and the documentary method. Different patterns of adherence were identified which depended on personal biographies, living conditions, or the patient's knowledge about the disease. Interpreting eye drop medication as a ritual, a task, or routine was helpful for some patients, whereas other patients, who were aware of the consequences of not taking the drops, were motivated by intrinsic or extrinsic factors. The patterns identified here represent strategies for managing and adhering to daily glaucoma medication at an individual level. Linking daily drop application or medication intake to these patterns may help to promote correct medication management of patients with chronic diseases who lack a regular medication regimen.

Treatment Complexity in Primary Open-Angle Glaucoma (POAG): Perspectives on Patient Selection in Micro-Invasive Glaucoma Surgery (MIGS) Using Stents. / Versorgungskomplexität beim primären Offenwinkelglaukom (POWG): Perspektiven zur Patientenauswahl in der mikroinvasiven Glaukomchirurgie (MIGS) mit Stents.

BACKGROUND: Primary open-angle glaucoma (POAG) is still one of the most common causes of impaired vision worldwide, despite the further development of therapy options, and can lead to blindness. Micro-invasive glaucoma surgery (MIGS) using stents aims at reducing intraocular pressure (IOP), as it is the main risk factor. With regard to adherence and adverse drug reactions it also aims at reducing the drug burden on patients. The study investigates under everyday conditions the criteria according to which ophthalmologists in Germany select patients for MIGS using stents. In addition, it will be investigated which patients (could) benefit most from the therapy. MATERIAL AND METHODS: In this qualitative study, 11 narrative interviews were conducted between May 2017 and July 2018 with ophthalmologists working in the hospital or in a private practice. They were interviewed on their experiences in the treatment of POAG with microstents. The interviews were analysed by an interdisciplinary team using the qualitative content analysis. RESULTS: The stages of therapy escalation form the frame of reference for patient selection in MIGS using stents. Only if the IOP cannot be sufficiently reduced by drop therapy or when this causes drug-related side effects that are intolerable for the patients, stents are apparently used as the next higher escalation stage. The intensive post-operative medication and the frequent check-up appointments are perceived as barriers by the interviewees, especially for people with or without disabilities, who are dependent on external help and/or those living in rural areas. The active cooperation of the patients in the demanding aftercare seems to be indispensable for the ophthalmologists. In addition, necessary revisions are sometimes stressful for patients (physical/psychological) and doctors (work organisation/therapy). Against the background of the organisational and economic challenges in the outpatient spectrum of tasks, especially physicians in private practice seem to weigh up carefully for which patients microstent therapy would be reasonable. CONCLUSION: In view of the therapeutic requirements, the current microstent therapy seems to be used in a selected, adherent patient group. Further qualitative and quantitative studies (in other health care regions and structures) are necessary to verify and extend the available results.

Hospitalization for Acute Respiratory Tract Infection in a Low-Antibiotic-Prescribing Setting: Cross-Sectional Data from General Practice.

BACKGROUND: Acute respiratory tract infections (ARTI) are the main cause of inappropriate antibiotic prescribing. To date, there is limited evidence concerning whether low levels of antibiotic prescribing may impact patient safety. We investigate whether antibiotic prescribing for patients seeking primary care for ARTI correlates with the odds for hospitalization. METHODS: Analysis of patient baseline data (n = 3669) within a cluster-randomized controlled trial. Adult patients suffering from ARTI in German primary care are included. The main outcome measure is acute hospitalization for respiratory infection and for any acute disease from 0 to 42 days after initial consultation. RESULTS: Neither the antibiotic status of individual patients (OR 0.91; 95% CI: 0.49 to 1.69; p-value = 0.769) nor the physician-specific antibiotic prescription rates for ARTI (OR 1.22; 95% CI: 1.00 to 1.49; p-value = 0.054) had a significant effect on hospitalization. The following factors increased the odds for hospitalization: patient's age, the ARTI being defined as lower respiratory tract infections (such as bronchitis) by the physician, the physician's perception of disease severity, and being cared for within group practices (versus treated in single-handed practices). CONCLUSIONS: In a low-antibiotic-prescribing primary care setting such as Germany, lack of treatment with antibiotics for ARTI did not result in higher odds for hospitalization in an adult population.

Patient-centered communication and shared decision making to reduce HbA1c levels of patients with poorly controlled type 2 diabetes mellitus - results of the cluster-randomized controlled DEBATE trial.

BACKGROUND: Does an intervention designed to foster patient-centered communication and shared decision making among GPs and their patients with poorly controlled type 2 diabetes mellitus reduce the level of HbA1c. METHODS: The DEBATE trial is a cluster-randomized controlled trial conducted in German primary care and including patients with type 2 diabetes mellitus having an HbA1c level of 8.0% (64 mmol/mol) or above at the time of recruitment. Data was measured before intervention (baseline, T0), 6-8 months (T1), 12-14 months (T2), 18-20 months (T3), and 24-26 months (T4) after baseline. Main outcome measure is the level of HbA1c. RESULTS: In both, the intervention and the control group the decline of the HbA1c level from T0 to T4 was statistically significant (- 0.67% (95% CI: - 0.80,-0.54%; p < 0.0001) and - 0.64% (95% CI: - 0.78, - 0.51%; p < 0.0001), respectively). However, there was no statistically significant difference between both groups. CONCLUSIONS: Although the DEBATE trial was not able to confirm effectiveness of the intervention tested compared to care as usual, the results suggest that patients with poorly controlled type 2 diabetes are able to improve their blood glucose levels. This finding may encourage physicians to stay on task to regularly approach this cohort of patients. TRIAL REGISTRATION: The trial was registered at ISRCTN registry under the reference ISRCTN70713571 .

Partial rescue of NT-3 null mutant phenotype by a PDGF-ß regulated transgene.

The phenotype of neurotrophin-3 (NT-3) null mutant mice is characterized by sensory ataxia and early postnatal death. Previous analysis revealed a severe depletion of peripheral sensory, sympathetic and parasympathetic neurons. Most of the deficits are established early during embryonic development. Whereas absence of proprioceptive afferents can explain the sensory ataxia, the reasons for early postnatal death are unclear. To circumvent the limitations imposed by early mortality of null mutants we generated mouse line expressing NT-3 transgenes driven by the platelet-derived growth factor ß-chain (PDGF-ß) promoter, which is known to be active in neurons and mesenchyme derivatives. Mice carrying one or two PDGF-NT3 transgenes on a background null for wildtype NT-3 were generated by crossing with an NT-3 null strain. Although still ataxic, mice from this cross could survive for periods longer than a year. Histological analysis revealed a limited rescue of muscle spindles and parvalbumin immunoreactive sensory neurons.

An organometallic chimie douce approach to new Re(x)W(1-x)O3 phases.

Re(x)W(1-x)O3.H2O and Re(x)W(1-x)O3 phases are prepared by a new organometallic chimie douce concept employing the organometallic precursor methyltrioxorhenium.