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Background: Routine primary care data are increasingly being used for evaluation and research purposes but there are concerns about the completeness and accuracy of diagnoses and events captured in such databases. We evaluated how well patients with major cardiovascular disease (CVD) can be identified using primary care morbidity data and drug prescriptions.Methods: The study was conducted using data from 17,230 diabetes patients of the GIANTT database and Dutch Hospital Data register. To estimate the accuracy of the different measures, we analyzed the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) relative to hospitalizations and/or records with a diagnosis indicating major CVD, including ischaemic heart diseases and cerebrovascular events.Results: Using primary care morbidity data, 43% of major CVD hospitalizations could be identified. Adding drug prescriptions to the search increased the sensitivity up to 94%. A proxy of at least one prescription of either a platelet aggregation inhibitor, vitamin k antagonist or nitrate could identify 85% of patients with a history of major CVD recorded in primary care, with an NPV of 97%. Using the same proxy, 57% of incident major CVD recorded in primary or hospital care could be identified, with an NPV of 99%.Conclusions: A substantial proportion of major CVD hospitalizations was not recorded in primary care morbidity data. Drug prescriptions can be used in addition to diagnosis codes to identify more patients with major CVD, and also to identify patients without a history of major CVD. [ABSTRACT FROM AUTHOR]

Background Direct patient-reported information about adverse drug events (ADEs) is important since it adds to healthcare professional-reported information about the safety of drugs. Previously, we developed an instrument to assess patient-reported ADEs in research settings. The aim of this study is to assess the construct and concurrent validity of the questionnaire. Methods Patients on at least an oral glucose-lowering drug completed the ADE questionnaire, the World Health Organization Quality of Life-BREF, and the Treatment Satisfaction Questionnaire for Medication (TSQM). The ADE questionnaire assesses ADEs for any drug that the patient uses. Construct validity was assessed by testing whether patients reporting an ADE had a lower general quality of life and physical health than those not reporting an ADE, using Mann-Whitney U-tests and t-tests (significance level <0.05). For concurrent validity, we tested whether ADEs that patients associate with particular drugs in the ADE questionnaire are documented in the Summary of Product Characteristics (SPC) of those drugs, and whether patients who report an ADE with the use of metformin on the TSQM, mention metformin as a drug associated with an ADE on the ADE questionnaire. Agreement of 70% with the SPC was considered satisfactory. Sensitivity and positive predictive value (PPV) were calculated for the comparison with the TSQM, where 70% was used as the cutoff level for sufficient concurrent validity. Results We included 135 patients (mean age 64 years, 35% women). Patients who reported an ADE (N = 37) had a lower general quality of life and physical health than those not reporting an ADE (P < 0.05). For 78 of the 146 reported ADEs (53%), patients mentioned at least 1 particular drug associated with the ADE. After clustering related ADEs, this resulted in 56 patient-reported ADE-drug associations. Of these, 41 (73%) were in agreement with information in the SPC. Finally, the questionnaire had a sensitivity of 38% and PPV of 79% for assessing ADEs associated with metformin. Conclusions The construct validity of the patient-reported ADE questionnaire was sufficient for reporting any versus no ADE, but the concurrent validity was only partly demonstrated. Therefore, the questionnaire needs to be adapted before it can be used. [ABSTRACT FROM AUTHOR]

Background: To improve risk factor management in diabetes, we need to support effective interactions between patients and healthcare providers. Our aim is to develop and evaluate a treatment decision aid that offers personalised information on treatment options and outcomes, and is intended to empower patients in taking a proactive role in their disease management. Important features are: (1) involving patients in setting goals together with their provider; (2) encourage them to prioritise on treatments that maximise relevant outcomes; and (3) integration of the decision aid in the practice setting and workflow. As secondary aim, we want to evaluate the impact of different presentation formats, and learn more from the experiences of the healthcare providers and patients with the decision aid. Methods and design: We will conduct a randomised trial comparing four formats of the decision aid in a 2×2 factorial design with a control group. Patients with type 2 diabetes managed in 18 to 20 primary care practices in The Netherlands will be recruited. Excluded are patients with a recent myocardial infarction, stroke, heart failure, angina pectoris, terminal illness, cognitive deficits, >65 years at diagnosis, or not able to read Dutch. The decision aid is offered to the patients immediately before their quarterly practice consultation. The same decision information will be available to the healthcare provider for use during consultation. In addition, the providers receive a set of treatment cards, which they can use to discuss the benefits and risks of different options. Patients in the control group will receive care as usual. We will measure the effect of the intervention on patient empowerment, satisfaction with care, beliefs about medication, negative emotions, health status, prescribed medication, and predicted cardiovascular risk. Data will be collected with questionnaires and automated extraction from medical records in 6 months before and after the intervention. Discussion: This decision aid is innovative in supporting patients and their healthcare providers to make shared decisions about multiple treatments, using the patient,s data from electronic medical records. The results can contribute to the further development and implementation of electronic decision support tools for the management of chronic diseases. [ABSTRACT FROM AUTHOR]

Background: Information on prescribing quality of diabetes care is required by health care providers, insurance companies, policy makers, and the public. Knowledge regarding the opinions and preferences of all involved parties regarding prescribing quality information is important for effective use of prescribing quality indicators. Methods: Between June and December 2009 we conducted semi structured interviews with 16 key-informants representing eight different organizations in the Netherlands involved in healthcare quality measurement and improvement. The interview guide included topics on participants' opinions and preferences regarding existing types of prescribing quality indicators in relation to their aim of using quality information. Content analysis methods were used to process the resulting transcripts following the framework of predetermined themes. Results: Findings from this qualitative study of stakeholder preferences showed that indicators focusing on undertreatment are found important by all participants. Furthermore, health care providers and policy makers valued prescribing safety indicators, insurance companies prioritized indicators focusing on prescribing costs, and patients' organization representatives valued indicators focusing on interpersonal side of prescribing. Representatives of all stakeholders preferred positive formulation of the indicators to motivate health care providers to participate in health improvement programs. A composite score was found to be most useful by all participants as a starting point of prescribing quality assessment. Lack of information on reasons for deviating from guidelines recommendations appeared to be the most important barrier for using prescribing quality indicators. According to the health care providers, there are many legitimate reasons for not prescribing the recommended treatment and these reasons are not always taken into account by external evaluators. The latter may cause mistrust of health care providers towards external stakeholders and limit the use of PQI in external quality improvement programs. Conclusion: Prescribing quality indicators are considered to be an important tool for assessing quality of provided diabetes care by all participants, although the preferences for specific types of indicators may differ by stakeholder depending on their user aim. Introduction of information systems to register the reasons for deviating from the recommended drug treatment may contribute to a more widespread use of PQI for assessment of provided health care quality to diabetic patents. This study identified the potential preferences regarding quality indicators for diabetes care, and this could be used for development of questionnaires to conduct a survey among a larger group of participants. [ABSTRACT FROM AUTHOR]

Background: Information on prescribing quality is increasingly used by policy makers, insurance companies and health care providers. For reliable assessment of prescribing quality it is important to correctly identify the patients eligible for recommended treatment. Often either diagnostic codes or clinical measurements are used to identify such patients. We compared these two approaches regarding the outcome of the prescribing quality assessment and their ability to identify treated and undertreated patients. Methods: The approaches were compared using electronic health records for 3214 diabetes patients from 70 general practitioners. We selected three existing prescribing quality indicators (PQI) assessing different aspects of treatment in patients with hypertension or who were overweight. We compared population level prescribing quality scores and proportions of identified patients using definitions of hypertension or being overweight based on diagnostic codes, clinical measurements or both. Results: The prescribing quality score for prescribing any antihypertensive treatment was 93% (95% confidence interval 90-95%) using the diagnostic code-based approach, and 81% (78-83%) using the measurement-based approach. Patients receiving antihypertensive treatment had a better registration of their diagnosis compared to hypertensive patients in whom such treatment was not initiated. Scores on the other two PQI were similar for the different approaches, ranging from 64 to 66%. For all PQI, the clinical measurement -based approach identified higher proportions of both well treated and undertreated patients compared to the diagnostic code -based approach. Conclusions: The use of clinical measurements is recommended when PQI are used to identify undertreated patients. Using diagnostic codes or clinical measurement values has little impact on the outcomes of proportion-based PQI when both numerator and denominator are equally affected. In situations when a diagnosis is better registered for treated than untreated patients, as we observed for hypertension, the diagnostic code-based approach results in overestimation of provided treatment. [ABSTRACT FROM AUTHOR]

Background: Lack of treatment initiation or intensification might explain why some patients with type 2 diabetes do not reach target goals. The objective is to assess trends in risk factor treatment, and identify determinants for medication adjustments in patients with uncontrolled hypertension and/or hyperlipidemia. Methods: We conducted a cohort study using data from the Zwolle Outpatient Diabetes project Integrated Available Care (ZODIAC)-study in The Netherlands. Management of hypertension and hyperlipidemia was assessed yearly from 1998-2004 by measuring the percentage of patients receiving a treatment initiation or intensification among all patients with elevated risk factor levels. Generalized estimating equation analyses were performed. Results: During the study period, the percentage of patients with an elevated total cholesterol/ high-density lipoproteins ratio (>6) decreased considerably (from 29% to 4%) whereas the percentage of hypertensive patients decreased only slightly (≥ 150/85 mmHg; from 58% to 51%). Initiation of lipid-lowering therapy and intensification of antihypertensive therapy was higher in more recent years. However, still two-third of patients with insufficiently controlled blood pressure in 2003 did not receive an initiation or intensification of antihypertensive treatment in the following year. Treatment changes were mainly determined by elevated levels of the corresponding risk factor. We did not observe increased initiation rates for lipid-lowering therapy in patients with both hypertension and hyperlipidemia. Conclusion: Hypertension and hyperlipidemia management in type 2 diabetes patients has improved in the past decade but further improvement is possible. Greater effort is needed to stimulate medication adjustments in patients with insufficiently controlled hypertension and combined risk factors. [ABSTRACT FROM AUTHOR]

Background: The aim of this study is to determine to what extent barriers perceived by general practitioners (GPs) for prescribing angiotensin-converting enzyme inhibitors (ACE-I) in chronic heart failure (CHF) patients are related to underuse and underdosing of these drugs in actual practice. Methods: Barriers were assessed with a semi-structured questionnaire. Prescribing data were extracted from GPs' computerised medical records for a random sample of their CHF patients. Relations between barriers and prescribing behaviour were assessed by means of Spearman rank correlation and multivariate regression modelling. Results: GPs prescribed ACE-I to 45% of their patients and had previously initiated such treatment in an additional 3.5%, in an average standardised dose of 13.5 mg. They perceived a median of four barriers in prescribing ACE-I or optimising ACE-I dose. Many GPs found it difficult to change treatment initiated by a cardiologist. Furthermore, initiating ACE-I in patients already using a diuretic or stable on their current medication was perceived as barrier. Titrating the ACE-I dose was seen as difficult by more than half of the GPs. No significant relationships could be found between the barriers perceived and actual ACE-I prescribing. Regarding ACE-I dosing, the few GPs who did not agree that the ACE-I should be as high as possible prescribed higher ACE-I doses. Conclusion: Variation between GPs in prescribing ACE-I for CHF cannot be explained by differences in the barriers they perceive. Tailor-made interventions targeting only those doctors that perceive a specific barrier will therefore not be an efficient approach to improve quality of care. [ABSTRACT FROM AUTHOR]

Clinical drug trials are often conducted in selective patient populations, with relatively small numbers of patients, and a short duration of follow-up. Observational studies are therefore important for collecting additional information on adverse drug events (ADEs). Currently, there is no guidance regarding the methodology for measuring ADEs in such studies. Our aim was to evaluate whether the methodology used to assess non-serious ADEs in observational studies is adequate for detecting these ADEs, and for addressing limitations from clinical trials in patients with type 2 diabetes mellitus. We systematically searched MEDLINE and EMBASE for observational studies reporting non-serious ADEs (1999-2008). Methods to assess ADEs were classified as: 1) medical record review; 2) surveillance by health care professionals (HCP); 3) patient survey; 4) administrative data; 5) laboratory/clinical values; 6) not specified. We compared the range of ADEs identified, number and selection of patients included, and duration of follow-up. Out of 10,125 publications, 68 studies met our inclusion criteria. The most common methods were based on laboratory/clinical values (n = 25) and medical record review (n = 18). Solicited surveillance by HCP (n = 17) revealed the largest diversity of ADEs. Patient surveys (n = 15) focused mostly on hypoglycaemia and gastrointestinal ADEs, laboratory values based studies on hepatic and metabolic ADEs, and administrative database studies (n = 5) on cardiovascular ADEs. Four studies presented ADEs that were identified with the use of more than one method. The patient population was restricted to a lower risk population in 19% of the studies. Less than one third of the studies exceeded pre-approval regulatory requirements for sample size and duration of follow-up. We conclude that the current assessment of ADEs is hampered by the choice of methods. Many observational studies rely on methods that are inadequate for identifying all possible ADEs. Patient-reported outcomes and combinations of methods are underutilized. Furthermore, while observational studies often include unselective patient populations, many do not adequately address other limitations of pre-approval trials. This implies that these studies will not provide sufficient information about ADEs to clinicians and patients. Better protocols are needed on how to assess adverse drug events not only in clinical trials but also in observational studies. [ABSTRACT FROM AUTHOR]