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ORIGINAL INVESTIGATION Role of Organizational Factors in Poor Blood Pressure Control in Patients With Type 2 Diabetes The QuED Study Group—Quality of Care and Outcomes in Type 2 Diabetes Fabio Pellegrini, MS; Maurizio Belfiglio, MD; Giorgia De Berardis, MScPharmChem; Monica Franciosi, MScBiolS; Barbara Di Nardo, HSDip; Sheldon Greenfield, MD; Sherrie H. Kaplan, PhD, MPH; Michele Sacco, MD; Gianni Tognoni, MD; Miriam Valentini, MD; Donatella Corrado, BioTech; Antonio D’Ettorre, MScEngen; Antonio Nicolucci, MD; for the QuED Study Group Background: A large body of evidence supports the need Results: Only 16% of GPs and 14% of DOC physicians for reducing the cardiovascular burden of diabetes. Only targeted BP values of less than 130/85 mm Hg. At study indirect and occasional data describe the adequacy of rou- entry, 6% of the patients had values below 130/85 mm Hg, tine management of hypertension in patients with dia- whereas 52% showed values of 160/90 mm Hg or greater. betes. The aim of this study was to explore the interplay Only 12% of subjects were treated with more than 2 drugs of some potential key determinants of quality of antihy- at study entry, compared with 16% at the 1-year fol- pertensive care, including the settings, physicians’ be- low-up (P=.001). Multilevel analysis showed that pa- liefs about blood pressure (BP) control, and patient- tients attending DOCs had a more than 2-fold increased related factors. risk for inadequate BP control, compared with those treated by GPs. The risk for poor BP control was 2 times Methods: We evaluated physicians’ beliefs about BP con- higher for patients treated by male physicians com- trol using questionnaire responses at study entry. A sample pared with those treated by female physicians, and it was of 3449 patients with type 2 diabetes mellitus, of whom halved when the physician responsible for the diabetes 1782 (52%) were considered to have hypertension, was care specialized in diabetology or endocrinology. recruited by 212 physicians practicing in 125 diabetes outpatients clinics (DOCs) and 106 general practition- Conclusion: In a model situation of comorbidity, the ers (GPs). We evaluated the type and number of antihy- overall quality of care depends on structural and orga- pertensive agents used and the BP values at study entry nizational factors, which are likely to be more influen- and after 1 year of follow-up. We used multilevel analy- tial than existing guidelines. sis to investigate correlates of poor BP control (Ն160/90 mm Hg). Arch Intern Med. 2003;163:473-480 URING THE PAST several The QuED Project is a nationwide ini- years, compelling evi- tiative aimed at assessing the relation- dence from recent clini- ship between the quality of health care de- cal trials1,2 has increas- livered to patients with type 2 diabetes and ingly underlined the fact their outcomes.9-11 The context of this Dthat 2 important variables in medicine and project provided the opportunity to ad- health care, cardiovascular risk and dia- dress the issue of the quality of health care From the Department of betes mellitus, cannot be separated in strat- of diabetic patients with hypertension. In Clinical Pharmacology and egies aimed at reducing the cardiovascu- particular, we explored the interplay of Epidemiology, Istituto di some of the potential key determinants of Ricerche Farmacologiche Mario lar burden of disease. Only indirect and Negri, Consorzio Mario Negri occasional data describe whether pa- quality of care, including the contexts and Sud, S Maria Imbaro, Italy tients and populations with both clinical providers of care (general practitioners (Mssrs Pellegrini and D’Ettorre, conditions undergo adequate treatment [GPs] and physicians in diabetes outpa- Drs Belfiglio, Sacco, Tognoni, during routine health care. In particular, tient clinics [DOCs]), the subjective be- Valentini, and Nicolucci, and appropriate care for patients with type 2 liefs of physicians about blood pressure Mss De Berardis, Franciosi, diabetes requires a multidisciplinary and (BP) control, and patient-related factors. Di Nardo, and Corrado); and patient-tailored approach, which is not the Primary Care Outcomes readily available. Despite the prolifera- Research Institute, Tufts 3-5 METHODS University School of Medicine, tion of several guidelines, independent Boston, Mass (Drs Greenfield reports document that even the best The study design has already been described and Kaplan). A complete list of known and most traditional risk condi- in detail elsewhere.10,11 investigators of the QuED Study tion, essential hypertension, is inad- Briefly, physicians were identified in all Group appears on page 479. equately managed.6-8 regions of Italy and selected according to their (REPRINTED) ARCH INTERN MED/ VOL 163, FEB 24, 2003 WWW.ARCHINTERNMED.COM 473 ©2003 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/27/2021 willingness to participate in the project. Overall, 212 diabe- To account for the multilevel nature of the data (patients tologists practicing in 125 DOCs and 106 GPs participated in clustered within physician or practice) and to control simul- the study. taneously for the possible confounding effects of the different All patients with type 2 diabetes mellitus were consid- variables, we used multilevel logistic regression models (ie, ran- ered eligible for the project, irrespective of age, diabetes dura- dom intercept models)12,13 to investigate correlates of BP val- tion, or treatment. In the DOCs, patients were sampled by means ues of 160/90 mm Hg or greater. These models allow us to take of random lists, stratified by patient age (Ͻ65 or Ն65 years). into account the separated contribution to the total variance Each center was asked to recruit at least 30 patients, whereas given by patient- and physician-related characteristics, thus mini- GPs enrolled only those patients for whom they were primar- mizing the risk for false-positive results. We used the devi- ily responsible for diabetes care. ance test with a ␹2 distribution to assess whether the propor- General medical history and diabetes-specific data were tion of variance at the physicians’ level significantly differed collected at 6-month intervals by the patients’ physicians us- from 0, ie, whether the multilevel structure of the data needed ing forms specifically developed for the project by the scien- to be taken into account. The setting of care and physician char- tific committee. acteristics were considered level 2 variables, whereas level 1 Patients were asked to fill in a questionnaire investigat- variables consisted of all patient characteristics. In particular, ing different aspects of diabetes management and health care we considered the following patient characteristics (for cat- resource utilization. For this analysis, we asked the number of egorical variables, the first class represents the reference cat- times each patient had seen the physician responsible for their egory): age (tested as a continuous variable), sex (male vs fe- diabetes care in the past 6 months. This information was avail- male), duration of diabetes (Յ10, 11-20, or Ͼ20 years), duration able for 1330 patients (response rate, 75%). of hypertension (Ͻ5, 5-9, or Ն10 years), number of diabetes Patients were defined as having hypertension according complications (none, 1, 2, 3, or more), body mass index (BMI, to the physicians’ judgment. Patterns of care at study entry calculated as weight in kilograms divided by the square of height Ͻ Ͼ Ͻ (March 1 through October 31, 1998) were compared with those in meters) (men, 25, 25-27, or 27; women, 24, 24-26, or Ͼ at the 1-year follow-up. The analyses focused on antihyperten- 26), diabetes treatment (diet only, oral agents, or insulin with sive treatment (ie, the type and number of drugs) and the out- or without oral agents), cardiac-cerebrovascular disease (yes come in terms of BP control. vs no), number of antihypertensive drugs (1, 2, 3, or more), and number of visits in the previous 6 months (Ͼ3vsՅ3). QUESTIONNAIRE Level 2 variables tested included physician age and sex, physician specialty (diabetologist, endocrinologist, or other or The physicians’ survey was conducted in 1999 by means of a no further training), health care setting (DOC vs general prac- questionnaire that included the following questions: “For tice), and diabetes care modalities (single vs multiple physicians). the average type 2 diabetic patient, which are the threshold To investigate the role of physicians’ beliefs, we ran a sepa- values for the initiation of antihypertensive treatment?” and rate multilevel model including only patients treated by those “For the average type 2 diabetic patient with hypertension, physicians who filled in the questionnaire. Declared target val- what do you use as target diastolic and systolic BP levels?” ues of systolic and diastolic BP were included in this model as We did not define the average patient, because the physi- level 2 covariates and tested as continuous variables. cians’ opinions are influenced by the real patients they see in The values for all the covariates refer to the information their practice and can therefore vary according to patient collected at baseline. case-mix. We also collected information on the sociodemographic RESULTS characteristics of the physicians (age, sex, and specialty). The questionnaire was sent by mail to all the physicians participat- ing in the project. Two additional recall mailings were sent to PHYSICIAN BELIEFS initial nonrespondents. Of the 318 physicians, 182 (57%) returned the question- SETTING naire investigating their beliefs about BP control. The re- sponse rate was 61% (65 physicians) for GPs and 55% All Italian citizens are covered by government health insur- (117 physicians) for DOC physicians. Sixty-seven per- ance and are registered with a GP. An average of 1000 patients cent of the respondents were male; the median age was (range, 500-1500) are registered with each GP, of whom 15 to 45 years (range, 28-70 years).

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