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Evaluation of the Capillary Blood Glucose Self-monitoring Program

OBJECTIVE: to evaluate the structure, process and results of the Capillary Blood Glucose Self-monitoring Program in a Brazilian city. METHOD: epidemiological, cross-sectional study. The methodological framework of Donabedian was used to construct indicators of structure, process and outcome. A random sample (n = 288) of users enrolled and 96 health professionals who worked in the program was studied. Two questionnaires were used that were constructed for this study, one for professionals and one for users, both containing data for the evaluation of structure, process and outcome. Anthropometric measures and laboratory results were collected by consulting the patients' health records. The analysis involved descriptive statistics. RESULTS: most of the professionals were not qualified to work in the program and were not knowledgeable about the set of criteria for patient registration. None of the patients received complete and correct orientations about the program and the percentage with skills to perform conducts autonomously was 10%. As regards the result indicators, 86.4% of the patients and 81.3% of the professionals evaluated the program positively. CONCLUSION: the evaluation indicators designed revealed that one of the main objectives of the program, self-care skills, has not been achieved.


Introduction
The assessment of health services, technologies and programs has been greatly stimulated in Brazil, for monitoring health professionals' performance as well as for managers to make decisions about human resources and inputs in health, at the federal, state and municipal level.
The National Performance Assessment Policy of the Unified Health System (SUS) indicates that health assessment permits the adoption of intervention measures in response to possible distortions, contradictions and difficulties met in the health services (1) . Nevertheless, there are difficulties to established institutional evaluation processes in Brazil, due to the lack of tradition and understanding about the need for the professionals themselves to assess the service they are inserted in (1)(2) . In fact, the assessment of health services is a complex process that involves political, social, cultural, educational and financial aspects (3) . Mellitus patients on insulin therapy for the purpose of self-monitoring at home (4) .
Capillary glucose self-monitoring at home allows DM patients to develop skills with a view to autonomy and decision-making to achieve good glucose control measures, reduce acute and chronic complications and, consequently, improve their quality of life. This care technology is recommended as an essential part of the therapeutic strategies for adequate control of DM 1 (5)(6) .
Recently, its efficacy in DM 2 patients on insulin therapy has also been proven (7)(8) , when the capillary glucose measures are used for treatment adjustments. In Brazil, a clinical trial involving DM 1 patients evidenced improvements in metabolic control as a result of capillary glucose self-monitoring (9) .
Nevertheless, Brazilian literature about the assessment of the PAMGC is scarce (10) and the effectiveness of this Program and its benefits for the control of the disease are unknown. Thus, the objective in this study was to assess the structure, process and outcome of the Capillary Glucose Self-Monitoring Program in course in a medium-sized city in the interior of the State of São Paulo, Brazil. The intent is to offer support for the reorientation of the PAMGC proposed by the Ministry of Health, so as to improve the metabolic control of health service users.

Method
In this epidemiological and cross-sectional study, the PAMGC was assessed in a medium-sized city in the interior of the State of São Paulo in 2010. Therefore, Donabedian's methodological reference framework was used (2)(3) to construct the quality indicators of three components: structure, process and outcome.
In the structure assessment, the investigation of the training of the health professionals and patients enrolled in the PAMGC at the start of its implementation was privileged. In the process context, the intent was to assess whether the activities/actions the health professionals referred were those recommended by the technical and standards of the PAMGC and the frequency of the health service users self-monitoring.
As regards the outcome component, the proportion of health service users with self-care skills was selected as the main indicator, that is, who were capable of: analyzing the glucose levels, because they are familiar with the normal parameters; recognizing signs and symptoms of hyper and hypoglycemia and using these data for decision making, according to their knowledge level about the disease. In addition, the health service professionals and users' subjective perception was assessed about the benefits deriving from the Program as an outcome indicator.
The normative and technical frameworks used were: Federal Law 11.347 (2006), which established the compulsory supply of glucometers and inputs by the SUS (4) ; Decree 2.583 from 2007, which regulates how the inputs should be made available (11) ; the recommendations for care delivery to DM patients on insulin by the Ministry of Health (12) and the Brazilian Diabetes Society (6) . The city adopts these frameworks to direct care delivery to DM patients in the public primary  The sample included 288 DM 1 or DM 2 patients on insulin, with a 5% error and 95% reliability coefficient, in view of an unknown prevalence (50%) and study power corresponding to 80%.
The users were numbered at each health unit and randomly selected through a draft performed in statistical software. Considering possible losses due to deaths, incorrect addresses and refusals, the researchers decided to systematically replace any previously drafted user who could not be contacted by the immediately subsequent user.
To achieve the sample size (288), 326 individuals were drafted and contacted, making the replacements needed due to losses (ten deaths, 22 refusals to participate and six users who were not located).
As regards the professionals, no draft was used for sampling purposes. Instead, all of them were considered eligible for the study. Ninety-six out of 106 secondary and higher education professionals were investigated who worked with the health service users registered in the Program, including 49 nurse's aides and seven nursing technicians, 19 baccalaureate nurses and 21 physicians (general practitioners and general clinicians). The losses (N=10) were due to refusals and/or impossibility to contact the user after three attempts.
To collect the data, two instruments were

Structure
Having received preliminary training to work in the Program.
Knowing the criteria to enroll users in the Program.
Knowing the frequency of daily capillary glucose measuring recommended by the Program.
Having received orientations when included in the PAMGC.
Having received orientations on technical aspects of measures (calibrating, storage of strips, puncture site, amount of blood and use of substances that can interfere in the method), frequency and parameters of normal glucose (fasting, post-prandial and mean).

Process
Advising the patient to modify the insulin doses according to the glucose levels found Advising on behavioral changes related to diet, weight loss, physical exercise and smoking cessation. Requesting and using glucose controls during consultations and assessing them together with the beneficiaries Knowing and using glycated hemoglobin, fasting glucose, postprandial glucose and means for conducts Stimulate users' autonomy and self-care, training them to identify hypo/hyperglycemia and how to take the measures needed Develop educative activities for the users at the unit

Results
The patients studied were predominantly women (63.9%), white (88.2%), married (57.3%), over 60    Differences were found between the information referred by the professionals and that found in the health files with regard to the laboratory tests. Most of the health professionals (97.5%) indicated that they request at least one fasting glucose and HbA1C test for the health service users; 67% of them had no records of these tests in their files for the twelve months before the data collection.
Another process indicator highlighted is that 90.3% of the health service users indicated that they manipulate the glucometer and measure their glucose easily, although the Health services do not offer regular educative activities to train the patients for adherence to the monitoring process (data not shown in Table).
In Table 4, the results of the Program's structure, process and outcome assessment are summarized.
It is emphasized that 100% of the patients did not

Structure
Professionals who know the registration criteria and disease control parameters -

Process
Professionals who request capillary glucose levels during consultations, advise on diet, physical exercise and smoking cessation, when relevant, and request glycated hemoglobin, fast glucose and lipid profile, urea and creatinine tests.

2,5
Patients who follow recommendations on number of glucose measures 15,3 Patients with glycated hemoglobin, fasting glucose and lipid profile, urea and creatinine tests during 12 months before interview date.

18,0
Outcome Professionals who consider that the PAMGC improved the patients' disease control 81,3 Patients with skills to act on glucose levels 9,7 Patients who consider the inclusion in the PAMGC positive for their care and control 86,4

Discussion
The structure, process and outcome assessment of the PAMGC in the city of Botucatu evidenced weaknesses and contradictions. The analysis of the Program structure revealed that the professionals and patients are insufficiently trained to obtain the potential benefits of glucose self-monitoring. Glucose monitoring without a plan that implies the patients' involvement with the team or the underuse of the outcomes for the sake of therapeutic adequacy do not contribute to improve the glucose control, thus indicating that monitoring alone is not effective (13) . updates related to DM (4,10) .
In view of the public policies related to the adoption of healthy life habits (14) and their particular importance in share the decisions about the therapeutic plan with the users, favoring the right to know and decide on their own health (17)(18) . A study to assess the metabolic control of patients registered in the PAMGC, held in Ribeirão Preto-SP, showed that the metabolic control improved even without systematic monitoring by the multidisciplinary health team, characterized by the significant reduction of HbA1C (10) .
Based on the constructed structure, process and outcome indicators, it could be identified that one of the main objectives of the PAMGC, the joint construction of self-care skills (4,11,19) , has not been achieved in the condition (20) . Thus, access to equipment and inputs without any counterpart, i.e. as a right, may have been sufficient for the positive assessments. It is known that, in many chronic illness situations, like DM and cancer for example, access to medication and/or inputs needed for treatment has often depended on legal proceedings (21) .
The results of this assessment strongly suggest that