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.

The value of the GP's clinical judgement in predicting dementia: a multicentre prospective cohort study among patients in general practice.

BACKGROUND: Clinical judgement is intrinsic to diagnostic strategies in general practice; however, empirical evidence for its validity is sparse. AIM: To ascertain whether a GP's global clinical judgement of future cognitive status has an added value for predicting a patient's likelihood of experiencing dementia. DESIGN AND SETTING: Multicentre prospective cohort study among patients in German general practice that took place from January 2003 to October 2016. METHOD: Patients without baseline dementia were assessed with neuropsychological interviews over 12 years; 138 GPs rated the future cognitive decline of their participating patients. Associations of baseline predictors with follow-up incident dementia were analysed with mixed-effects logistic and Cox regression. RESULTS: A total of 3201 patients were analysed over the study period (mean age = 79.6 years, 65.3% females, 6.7% incident dementia in 3 years, 22.1% incident dementia in 12 years). Descriptive analyses and comparison with other cohorts identified the participants as having frequent and long-lasting doctor-patient relationships and being well known to their GPs. The GP baseline rating of future cognitive decline had significant value for 3-year dementia prediction, independent of cognitive test scores and patient's memory complaints (GP ratings of very mild (odds ratio [OR] 1.97, 95% confidence intervals [95% CI] = 1.28 to 3.04); mild (OR 3.00, 95% CI = 1.90 to 4.76); and moderate/severe decline (OR 5.66, 95% CI = 3.29 to 9.73)). GPs' baseline judgements were significantly associated with patients' 12-year dementia-free survival rates (Mantel-Cox log rank test P<0.001). CONCLUSION: In this sample of patients in familiar doctor-patient relationships, the GP's clinical judgement holds additional value for predicting dementia, complementing test performance and patients' self-reports. Existing and emerging primary care-based dementia risk models should consider the GP's judgement as one predictor. Results underline the importance of the GP-patient relationship.

Which patients with type 2 diabetes mellitus are perceived as 'difficult' by general practitioners?

AIMS: To find factors that are associated with a general practitioner's (GP's) subjective impression of a patient being 'difficult' within a sample of patients with type 2 diabetes mellitus (T2DM). METHODS: Secondary cross-sectional analysis of a cohort of GP patients with T2DM. GP questionnaire on clinical data and GPs' subjective ratings of patient attributes (including 'patient difficulty'). Patient questionnaire on sociodemographics and illness perceptions. Bivariate and multivariate analyses, adjusted for cluster-effect of GP practice. RESULTS: Data from 314 patients from 49 GPs could be analysed. Independent associations with higher GP-rated difficulty were found for (odds ratio; 95% confidence interval): male patients from male GPs (1.27; 1.06-1.53), unmarried men (1.25; 1.04-1.51), men with non-German nationality (1.80; 1.24-2.61), patients perceiving more problems with diabetes (1.17; 1.04-1.30), patients with higher BMI (1.01; 1.00-1.02) and HbA1c values (1.06; 1.02-1.10), patients being perceived by the GP as less adherent (1.34; 1.22-1.46) and less health-literate (1.19; 1.04-1.35). CONCLUSIONS: The impact of patients' gender and illness perception yield new insights into GP-perceived complexity of care. Culturally and gender-sensitive communication techniques for adapting health care goals to patients' problems (rather than norm values) may alleviate GPs' work.

General practitioners' attitudes towards patients with poorly controlled type 2 diabetes: a qualitative study.

BACKGROUND: Patients with type 2 diabetes mellitus (T2DM) with poor glycaemic control can represent a challenge from the perspective of the general practitioner (GP). Apart from patient-sided factors, the understanding of GPs' attitudes may provide ideas for improved management in these patients. The aim of this study is to reveal attitudes of GPs towards T2DM patients with poor metabolic control. METHODS: Qualitative research in German general practice; 20 GPs, randomly chosen from participants of a larger study; in-depth narrative interviews, audio-recorded and transcribed; inductive coding and categorisation in a multi-professional team; abstraction of major themes in terms of attitudinal responses. RESULTS: 1) Orientation on laboratory parameters: GPs see it as their medical responsibility to achieve targets, which instil a sense of security. 2) Resignation: GPs believe their efforts are in vain and see their role as being undermined. 3) Devaluation of the patient: GPs blame the "non-compliance" of the patients and experience care as a series of conflicts. 4) Fixed role structure: The expert GP on the one hand, the ignorant patient on the other. 5) Solidarity with the patient: GPs appreciate a doctor-patient relationship in terms of partnership. CONCLUSIONS: The conflict GPs experience between their sense of duty and feelings of futility may lead to perceptions such as personal defeat and insecurity. GPs (and patients) may benefit from adjusting the patient-doctor relationship with regard to shared definitions of realistic and authentic goals.

Narrative medicine-based intervention in primary care to reduce polypharmacy: results from the cluster-randomised controlled trial MultiCare AGENDA.

OBJECTIVES: To determine if patient-centred communication leads to a reduction of the number of medications taken without reducing health-related quality of life. DESIGN: Two-arm cluster-randomised controlled trial. SETTING: 55 primary care practices in Hamburg, Düsseldorf and Rostock, Germany. PARTICIPANTS: 604 patients 65 to 84 years of age with at least three chronic conditions. INTERVENTIONS: Within the 12-month intervention, general practitioners (GPs) had three 30 min talks with each of their patients in addition to routine consultations. The first talk aimed at identifying treatment targets and priorities of the patient. During the second talk, the medication taken by the patient was discussed based on a 'brown bag' review of all the medications the patient had at home. The third talk served to discuss goal attainment and future treatment targets. GPs in the control group performed care as usual. PRIMARY OUTCOME MEASURES: We assumed that the number of medications taken by the patient would be reduced by 1.5 substances in the intervention group and that the change in the intervention group's health-related quality of life would not be statistically significantly inferior to the control group. RESULTS: The patients took a mean of 7.0±3.5 medications at baseline and 6.8±3.5 medications at follow-up. There was no difference between treatment and control group in the change of the number of medications taken (0.43; 95% CI -0.07 to 0.93; P=0.094) and no difference in health-related quality of life (0.03; -0.02 to 0.08; P=0.207). The likelihood of receiving a new prescription for analgesics was twice as high in the intervention group compared with the control group (risk ratio, 2.043; P=0.019), but the days spent in hospital were reduced by the intervention (-3.07; -5.25 to -0.89; P=0.006). CONCLUSIONS: Intensifying the doctor-patient dialogue and discussing the patient's agenda and personal needs did not lead to a reduction of medication intake and did not alter health-related quality of life. TRIAL REGISTRATION NUMBER: ISRCTN46272088; Pre-results.

The Prevention and Treatment of Retinal Complications in Diabetes.

BACKGROUND: Microvascular complications of diabetes mellitus can cause retino pathy and maculopathy, which can irreversibly damage vision and lead to blindness. The prevalence of retinopathy is 9-16% in patients with type 2 diabetes and 24-27% in patients with type 1 diabetes. 0.2-0.5% of diabetics are blind. METHODS: The National Disease Management Guideline on the prevention and treatment of retinal complications in diabetes was updated according to recommendations developed by seven scientific medical societies and organizations and by patient representatives and then approved in a formal consensus process. These recommendations are based on international guidelines and systematic reviews of the literature. RESULTS: Regular ophthalmological examinations enable the detection of retinopathy in early, better treatable stages. The control intervals should be based on the individual risk profile: 2 years for low-risk patients and 1 year for others, or even shorter depending on the severity of retinopathy. General risk factors for retinopathy include the duration of diabetes, the degree of hyperglycemia, hypertension, and diabetic nephropathy. The general, individually adapted treatment strategies are aimed at improving the risk profile. The most important specifically ophthalmological treatment recommendations are for panretinal laser coagulation in proliferative diabetic retinopathy and, in case of clinically significant diabetic macular edema with foveal involvement, for the intravitreal application of medications (mainly, vascular endothelial growth factor [VEGF] inhibitors), if an improvement of vision with this treatment is thought to be possible. CONCLUSION: Regular, risk-adapted ophthalmological examinations, with standardized documentation of the findings for communication between ophthalmologists and the patients' treating primary care physicians/diabetologists, is essential for the prevention of diabetic retinal complications, and for their optimal treatment if they are already present.

From hypertension control to global cardiovascular risk management: an educational intervention in a cluster-randomised controlled trial.

BACKGROUND: Guidelines on hypertension management recommend adjusting therapeutic efforts in accordance with global cardiovascular risk (CVR) rather than by blood pressure levels alone. However, this paradigm change has not yet arrived in German General Practice. We have evaluated the effect of an educational outreach visit with general practitioners (GPs), encouraging them to consider CVR in treatment decisions for patients with hypertension. METHODS: Prospective cluster-randomised trial comprising 3443 patients with known hypertension treated by 87 GPs. Practices were randomly assigned to complex (A) or simple (B) intervention. Both groups received a guideline by mail; group A also received complex peer intervention promoting the concept of global CVR. Clinical data were collected at baseline and 6-9 months after intervention. Main outcome was improvement of calculated CVR in the predefined subpopulation of patients with a high CVR (10-year mortality ≥5%), but no manifest cardiovascular disease. RESULTS: Adjusted for baseline the follow-up CVR were 13.1% (95% CI 12.6%-13.6%) (A) and 12.6% (95% CI 12.2%-13.1%) (B) with a group difference (A vs. B) of 0.5% (-0.2%-1.1%), p = 0.179. The group difference was -0.05% in patients of GPs familiar with global CVR and 1.1% in patients of GPs not familiar with with global CVR. However, this effect modification was not significant (p = 0.165). Pooled over groups, the absolute CVR reduction from baseline was 1.0%, p < 0.001. The ICC was 0.026 (p = 0.002). Hypertension control (BP <140/90 mmHg) improved in the same subpopulation from 38.1 to 45.9% in the complex intervention group, and from 35.6 to 46.5% in the simple intervention group, with adjusted follow-up control rates of 46.7% (95% CI 40.4%-53.1%) (A) and 46.9% (95% CI 40.3%-53.5% (B) and an adjusted odds ratio (A vs B) of 0.99 (95% CI 0.68-1.45), p = 0.966. CONCLUSIONS: Our complex educational intervention, including a clinical outreach visit, had no significant effect on CVR of patients with known hypertension at high risk compared to a simple postal intervention. TRIAL REGISTRATION: ISRCTN44478543 .

Willingness to participate in mammography screening: a randomized controlled questionnaire study of responses to two patient information leaflets with different factual content.

BACKGROUND: From 2010 onward, a new leaflet about mammography screening for breast cancer, more informative than the preceding version, has been sent to women in Germany aged 50 to 69 with the invitation to undergo screening. The purpose of this study was to determine the effect of different informational content on the decision whether or not to be screened. METHODS: In a randomized and blinded design, 792 women aged 48 to 49 were sent either the old or the new leaflet. Questionnaires were sent together with the leaflets in order to assess the following: willingness to undergo mammography screening, knowledge, decisional confidence, personal experiences of breast cancer, and demographic data. RESULTS: 370 (46.7%) of the questionnaires were returned, and 353 were evaluable. The two groups did not differ significantly in their willingness to be screened: 81.5% (95% confidence interval [CI] 75.8%-87.2%) versus 88.6% (95% CI 83.9%-91.3%, p = 0.060). A post-hoc analysis showed that women who reported having had personal experience of breast cancer (18.7%) were more willing to be screened if they were given the new leaflet, rather than the old one (interaction p = 0.014). The two groups did not differ in their knowledge about screening (p = 0.260). Women who received the old leaflet reported a higher decisional confidence (p = 0.017). The most commonly mentioned factors affecting the decision were experience of breast cancer in relatives and close acquaintances (26.5% of mentions) and a doctor's recommendation (48.2%). Leaflets (3.6%) and all other factors played only a secondary role. CONCLUSION: The greater or lesser informativeness of the leaflet affected neither the participants' knowledge of mammography screening nor their willingness to undergo it. The leaflet was not seen as an aid to decision-making. The best way to assure an informed decision about screening may be for the patient to discuss the matter personally with a qualified professional.

Management of low back pain in general practice - is it of acceptable quality: an observational study among 25 general practices in South Tyrol (Italy).

BACKGROUND: There are several guidelines dealing with the management of low back pain (LBP), but only few studies on the quality of care provided within General Practices as judged against those guidelines.The objective of this study is to analyse the management of LBP in Italian General Practice and compare it with guideline recommendations. METHODS: In this observational study, all patients visiting their General Practitioners (GPs) for treatment of LBP within a 8-week period were monitored for at least four weeks with regard to symptoms and diagnostic and therapeutic interventions. Management of LBP was judged by pre-defined quality indicators based on guideline recommendations. RESULTS: Twenty-five of 114 eligible GPs participated in the study, representing a total of 43,012 registered patients. Of the 475 patients complaining of LBP and monitored for four weeks, 55.8% were diagnosed as having acute lumbar pain, 13.5% chronic lumbar pain, 17.1% acute sciatica, and 12.6% chronic sciatica; 76.0% underwent no technical investigations, 21.7% underwent x-rays, 5.5% MRI and 4% CT scans; 20.4% were referred to secondary care; 93.3% of all patients received some medication. In those receiving a medication, in 88.3% it was an NSAID, in 6.3% Paracetamol, in 10.4% Paracetamol combined with Codeine, and in 9% a muscle relaxants. When physiotherapy was prescribed (17,1%), it was mostly massage. Hardly more than 50% of GPs (partially) followed locally established guidelines, while the remainder seemed not to follow guidelines at all. CONCLUSIONS: Our study reveals gross deviations of GP management of LBP from current guidelines and points to two different types of deviators: those who partially follow guidelines, and those who do not follow them at all. Further research should evaluate whether these two types of deviation are best addressed by different foci of education, i.e. on knowledge versus attitudes, respectively.

Effects of different information brochures on women's decision-making regarding mammography screening: study protocol for a randomized controlled questionnaire study.

BACKGROUND: In order to give informed consent for mammography screening, women need to be told the relevant facts; however, screening information often remains vague because of the worry that detailed information might deter women from participating in recommended screening programs. Since September 2010, German women aged 50 to 69 invited for mammography screening have received a new, comprehensive information brochure that frankly discusses the potential benefit and harm of mammography screening. In contrast, the brochure that was in use before September 2010 contained little relevant information.The aim of this study is to compare the impact of the two different brochures on the intention of women to undergo mammography screening, and to broaden our understanding of the effect that factual information has on the women's decision-making. METHODS: This is a controlled questionnaire study comparing knowledge, views and hypothetical preferences of women aged 48-49 years after receiving the old versus the new information brochure. German GP's in the region of North Rhine-Westfalia will be asked by mail and telephone to participate in the study. Eligible women will be recruited via their general practitioners (GPs) and randomized to groups A ('new brochure') and B ('old brochure'), with an intended recruitment of 173 participants per group. The study is powered to detect a 15% higher or lower intention to undergo mammography screening in women informed by the new brochure. DISCUSSION: This study will contribute to our understanding of the decision-making of women invited to mammography screening. From both ethical and public health perspectives, it is important to know whether frank, factual information leads to a change in the intention of women to participate in a recommended breast cancer screening program. TRIAL REGISTRATION: DRKS00004271.

Risk-adjusted versus overall blood pressure control rate for identifying the need for intensified cardiovascular risk reduction: lessons from a cross-sectional study.

OBJECTIVE: To compare a cardiovascular risk (CVR)-adjusted with the traditional blood pressure (BP) control rate for assessing BP control and consequent target populations for intensified treatment. METHODS: Model calculation using cross-sectional data retrieved from 89 German general practices; a random sample of 3355 patients with known hypertension was consecutively enrolled by their general practitioners. Cardiovascular history and risk factors were documented. In addition to the traditional control rate (fixed BP target <140/90), we calculated CVR-adjusted control rates, stratifying analyses according to three CVR categories and their corresponding BP targets on the basis of the European Cardiovascular Society's SCORE tables: (1) very high CVR, owing to manifest cardiovascular disease (CVD), BP target <130/80; (2) high CVR, BP target <140/90; and (3) low CVR, BP target <160/100 mmHg. RESULTS: Traditional vs. CVR-adjusted BP control rates were 55.1 vs. 14.9% (manifest CVD, kappa 0.27), 36.7 vs. 35.8% (high CVR, kappa 0.98), 52.6 vs. 88.5% (low CVR, kappa 0.25), and 45.8 vs. 46.5% (overall, kappa 0.61). Among the study patients, 19.2% switched from 'controlled' to 'uncontrolled' or vice versa depending on the criterion applied. CONCLUSIONS: Compared with the traditional BP control rate, the CVR-adjusted approach identifies a substantially different - although overall similarly large - target group for intensified cardiovascular risk reduction. Using CVR-adjusted BP control rates in surveys describing hypertension management could help to focus attention and resources on reducing CVR in patients who are likely to benefit from additional treatment efforts.

Accuracy in diagnosing deep and pelvic vein thrombosis in primary care: an analysis of 395 cases seen by 58 primary care physicians.

BACKGROUND: Ruling out a deep vein thrombosis (DVT) is difficult in general practice because the clinical manifestations of DVT are nonspecific and more often due to other diseases. The aim of diagnostic screening in primary care must be to rule out a DVT with high accuracy in most patients, so that only those who are likely to have a DVT will undergo further testing. In this study, we tested the accuracy of exclusion of DVT by the combination of a clinical score (the Wells score) with either a bedside D-dimer test or selective compression sonography. METHOD: This cohort study included all patients who presented to the participating primary care physicians and were suspected of having a DVT on the basis of pre-defined inclusion criteria. To rule out DVT, a Wells score was determined for all patients, and all patients additionally underwent either a D-dimer test or selective compression sonography as required by the clinical algorithm. Patients were seen six weeks later in follow-up to determine whether they had actually had a DVT (gold standard). The negative predictive value (NPV) for the exclusion of DVT in this way was determined, as was the NPV of clinical judgment alone, without knowledge of Wells score or D-dimer results. RESULTS: 395 patients were evaluated by 58 primary care physicians for suspected DVT; 59 were ultimately found to have had a definite DVT, and 9 a probable DVT. Exclusion of DVT with the study protocol had an NPV of 99.0% (95% CI, 96.3 to 99.8)-i.e. only one case of DVT in 100 patients was missed (maximum: 4, minimum: 0)-while clinical judgment alone had an NPV of 95.0% (95% CI, 90.7 to 97.7). CONCLUSION: We recommend the Wells score combined with either a D-dimer test or selective compression sonography according to the algorithm used in this study for use in primary care to rule out DVT. Clinical judgment alone is less effective.