Potential Overtreatment and Undertreatment of Diabetes in Different Patient Age Groups in Primary Care After the Introduction of Performance Measures

OBJECTIVETo assess whether after the introduction of diabetes performance measures decreases in undertreatment correspond with increases in overtreatment for blood pressure (BP) and glycemic control in different patient age groups.RESEARCH DESIGN AND METHODSWe conducted a cohort study using data from the Groningen Initiative to Analyse Type 2 Diabetes Treatment (GIANTT) database. General practices were included when data were available from 1 year before to at least 1 year after the introduction of diabetes performance measures. Included patients had a confirmed diagnosis of type 2 diabetes. Potential overtreatment was defined as prescribing maximum treatment or a treatment intensification to patients with a sustained low-risk factor level. Potential undertreatment was defined as a lack of treatment intensification in patients with a sustained high-risk factor level. Percentages of over- and undertreated patients at baseline were compared with those in subsequent years, and stratified analyses were performed for different patient age groups.RESULTSFor BP, undertreatment significantly decreased from 61 to 57% in the first year after the introduction of performance measures. In patients >75 years of age, undertreatment decreased from 65 to approximate to 61%. Overtreatment was relatively stable (approximate to 16%). For glycemic control, undertreatment significantly increased from 49 to 53%, and overtreatment remained relatively stable (approximate to 7%).CONCLUSIONSThe improvement of BP undertreatment after introduction of the performance measures did not correspond with an increase in overtreatment. The performance measures appeared to have little impact on improving glucose-regulating treatment. The trends did not differ among patient age groups

A review of methods used in assessing non-serious adverse drug events in observational studies among type 2 diabetes mellitus patients

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

Construct and concurrent validity of a patient-reported adverse drug event questionnaire:a cross-sectional study

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 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 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

Trends in hyperlipidemia and hypertension management in type 2 diabetes patients from 1998–2004: a longitudinal observational study

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 (>or= 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

Medication Adherence Affects Treatment Modifications in Patients With Type 2 Diabetes

Background: Low rates of treatment modification in patients with insufficiently controlled risk factors are common in type 2 diabetes. Although adherence problems are often mentioned in surveys as a reason for not intensifying treatment, observational studies have shown inconclusive results. Objective: To assess how medication adherence affects treatment modifications for hypertension and hyperglycemia in patients with type 2 diabetes. Methods: This was a cohort study of 11,268 primary care patients with type 2 diabetes in the Netherlands. Inclusion criteria were diagnosis before 2007, >= 1 prescription to antihypertensive or glucose-regulating medication in the preceding 6 months, and a systolic blood pressure level >= 140 mm Hg or glycosylated hemoglobin >= 7% in 2007. Patients on maximal treatment were excluded. Treatment modifications as observed from prescriptions were classified as none, dose increase, dose decrease, class switch, class addition, or class discontinuation. Refill adherence was assessed as medication possession ratio or length of last gap between refills. We performed multilevel multinomial regression analysis to test for associations. Results: We included 4980 diabetic patients with elevated blood pressure and 2945 diabetic patients with elevated glycosylated hemoglobin levels. Patients with lower adherence for antihypertensive drugs were more likely to have those medications discontinued (odds ratio [OR] for every 10% lower medication possession ratio =1.22; 95% CI, 1.11-1.33) or the dose decreased (OR = 1.14; CI 1.01-1.28). For glucose-regulating medication, dose increases (OR = 0.92; 95% CI, 0.85-0.98) and medication additions (OR = 0.90; 95% CI, 0.82-0.99) were less likely in patients with lower adherence levels. Conclusions: Low adherence inhibits the intensification of glucose-regulating but not antihypertensive medication in type 2 diabetic patients with insufficiently controlled risk factors in the Netherlands. Adherence problems may lead to diminished or even discontinued antihypertensive treatment. (Clin Ther. 2011;33:121-134) (c) 2011 Elsevier HS Journals, Inc

Healthcare professionals' self-reported experiences and preferences related to direct healthcare professional communications:a survey conducted in the Netherlands

Background: In Europe, Direct Healthcare Professional Communications (DHPCs) are important tools to inform healthcare professionals of serious, new drug safety issues. However, this tool has not always been successful in effectively communicating the desired actions to healthcare professionals. Objective: The aim of this study was to explore healthcare providers' experiences and their preferences for improvement of risk communication, comparing views of general practitioners (GPs), internists, community pharmacists and hospital pharmacists. Methods: A questionnaire was developed and pilot tested to assess experiences and preferences of Dutch healthcare professionals with DHPCs. The questionnaire and two reminders were sent to a random sample of 3488 GPs, internists and community and hospital pharmacists in the Netherlands. Descriptive statistics were used to describe demographic characteristics of the respondents. Chi squares, ANOVAs and the Wilcoxon signed rank test were used, when appropriate, to compare healthcare professional groups. Results: The overall response rate was 34% (N=1141, ranging from 24% for internists to 46% for community pharmacists). Healthcare providers trusted safety information more when provided by the Dutch Medicines Evaluation Board (MEB) than by the pharmaceutical industry. This was more the case for GPs than for the other healthcare professionals. Respondents preferred safety information to be issued by the MEB, the Dutch Pharmacovigilance Center or their own professional associations. The preferred alternative channels of drug safety information were e-mail, medical journals and electronic prescribing systems. Conclusions: Safety information of drugs does not always reach healthcare professionals through DHPCs. To improve current risk communication of drug safety issues, alternative and/or additional methods of risk communication should be developed using electronic methods and medical journals. Moreover, (additional) risk communication coming from an independent source such as the MEB should be considered. Special effort is needed to reach GPs

Hypertension treatment practices and its determinants among ambulatory patients:Retrospective cohort study in Ethiopia

Objectives We examined determinants of achieving blood pressure control in patients with hypertension and of treatment intensification in patients with uncontrolled blood pressure (BP).Design A retrospective cohort study in six public hospitals, Ethiopia.Participants Adult ambulatory patients with hypertension and with at least one previously prescribed antihypertensive medication in the study hospital.Outcome Controlled BP (&lt;140/90 mm Hg) and treatment intensification of patients with uncontrolled BP.Results The study population comprised 897 patients. Their mean age was 57 (SD 14) years, 63% were females, and 35% had one or more cardiometabolic comorbidities mainly diabetes mellitus. BP was controlled in 37% of patients. Treatment was intensified for 23% patients with uncontrolled BP. In multivariable (logistic regression) analysis, determinants positively associated with controlled BP were treatment at general hospitals (OR 1.89, 95% CI 1.26 to 2.83) compared with specialised hospitals and longer treatment duration (OR 1.04, 95% CI 1.01 to 1.06). Negatively associated determinants were previously uncontrolled BP (OR 0.30, 95% CI 0.21 to 0.43), treatment regimens with diuretics (OR 0.68, 95% CI 0.50 to 0.94) and age (OR 0.99, 95% CI 0.98 to 1.00). The only significant-positive-determinant for treatment intensification was duration of therapy (OR 1.05, 95% CI 1.02 to 1.09).Conclusions The level of controlled BP and treatment intensification practice in this study was low. The findings suggest the need for in-depth understanding and interventions of the identified determinants such as uncontrolled BP on consecutive visits, older age and type of hospital.</p

Views of general practice staff about the use of a patient-oriented treatment decision aid in shared decision making for patients with type 2 diabetes:A mixed-methods study

BACKGROUND: Decision aids can be used to support shared decision making (SDM). A patient-oriented treatment decision aid (DA) was developed for type 2 diabetes but its use by general practice staff appeared to be limited. OBJECTIVES: To explore views of practice staff towards SDM and the DA. DESIGN: A mixed-methods study within the Dutch PORTDA-diab trial. SETTING AND PARTICIPANTS: Included were 17 practices with staff members who were responsible for routine diabetes care and had worked with the DA, and 209 of their patients. METHODS: Interviews were conducted focusing on applicability, usefulness and feasibility of the DA. Interviews were tape-recorded, transcribed verbatim and subjected to content analysis for identifying and classifying views. Patient-reported data about the use of the DA were collected. Associations between specific views and use of the DA were tested using Pearson point-biserial correlation. RESULTS: The majority of practice staff expressed positive views towards SDM, which was associated with making more use of the DA. Most of the staff expressed that the DA stimulated a two-way conversation. By using the DA, several became aware of their paternalistic approach. Some staff experienced a conflict with the content of the DA, which was associated with making less use of the DA. CONCLUSIONS: The DA was considered useful by practice staff to support SDM. A positive view towards SDM was a facilitator, whereas experiencing a conflict with the content of the DA was a barrier for making use of the DA