|
|
||||||||
Articles |
1 NOKLUS, Norwegian Center for External Quality Improvement of Primary Care Laboratories, Division of General Practice, Department of Public Health and Primary Care, Ulriksdal 8c, University of Bergen, N-5009 Bergen, Norway.
aAddress correspondence to this author at: Department of Medicine, Rogaland Central Hospital, PO Box 8100, 4068 Stavanger, Norway. Fax 47-51-51-99-06; e-mail svskeie{at}online.no
| Abstract |
|---|
|
|
|---|
Methods: We recruited 201 patients from a hospital outpatient clinic. A questionnaire was used to collect information on diabetes characteristics, perceived knowledge of HbA1c, last HbA1c value, HbA1c target value, and thresholds for action. Patients were asked to indicate the magnitude of change in HbA1c from 9.4% that they would consider to be a true (real) change; from their responses, we calculated patient-derived quality specifications for HbA1c.
Results: Fifty-eight percent of the patients felt they had "high" knowledge about HbA1c, and >80% of responders knew their last HbA1c value, their target HbA1c, and the threshold value of HbA1c for treatment intensification. The mean acceptable HbA1c value was 7.5%. Patients with lower values on their most recent tests reported lower target values for HbA1c and lower values for the upper HbA1c threshold for treatment intensification. An analytical CV (CVa) of 3.1% would be satisfactory for 75% of patients when HbA1c is increasing (80% confidence), and a CVa of 3.2% would be satisfactory for 75% when HbA1c is decreasing (95% confidence).
Conclusions: Type 1 patients perceived knowledge about HbA1c testing is high. They are well informed about their own personal results and about target values and the upper HbA1c threshold for action. The patient-derived analytical quality specification for imprecision (CV) is 3.1%.
| Introduction |
|---|
|
|
|---|
In a previous study, we examined the use and interpretation of results from glucose self-measurements among diabetic patients (9)(10). A similar study of HbA1c would be more complicated because the patients do not perform the analysis themselves. Nonetheless, because HbA1c has become the most important way of measuring long-term metabolic control, diabetes caregivers and patients need a similar understanding and interpretation of HbA1c values and what should be considered "real" changes in HbA1c. Today, patients knowledge about diabetes and HbA1c comes not only from caregivers, but increasingly from other sources such as diabetes associations, diabetes magazines, and sites on the World Wide Web. The use and interpretation of HbA1c results among physicians (11)(12) have been studied, but there is a lack of studies of patients views, knowledge, and understanding of HbA1c testing. Consequently, this study was designed to explore these aspects among type 1 diabetes patients and to use their statements concerning changes in HbA1c to define patient-derived analytical quality specifications for the HbA1c analysis.
| Materials and Methods |
|---|
|
|
|---|
The present study is based on self-reported data obtained with a questionnaire developed in cooperation with a diabetes specialist, diabetes nurses, and patients with type 1 diabetes. The questionnaire was evaluated by 10 type 1 patients in a pilot study before recruitment for the larger study was initiated, and only minimal changes were made. Assisting personnel handed the questionnaire to the patients when they arrived; patients answered the questions without assistance or professional influence before consultation with the nurse/doctor. Responders sealed their questionnaires in envelopes and placed them in a box, but because the questionnaires were anonymous, routines were established to ensure that no patient was included more than once.
In the general part of the questionnaire, patients stated their age, sex, and year that their diabetes was diagnosed as well as how long and how frequently they had performed SMBG. We then assessed patients perceived general knowledge about the HbA1c test, whether they knew their last HbA1c result, their target HbA1c value, and the upper and lower thresholds for treatment changes (Fig. 1
). The questionnaire included an opportunity to respond "Dont remember" or "Dont know" to these questions, which probably increased the likelihood of true and correct responses.
|
The two last questions assessed the magnitude of change in HbA1c from 9.4% necessary for patient to be certain that the change indicated a true (real) improvement or deterioration of their diabetes, i.e., the so-called critical difference (CD). The 9.4% value was chosen based on experience from a comparable study and our pilot test, both of which indicated that patients felt that they could foresee both improvement and deterioration of their metabolic control when this value was used as baseline (12).
The CD is conventionally defined as the difference needed between two consecutive test values to be certain (with a given probability) that the two results actually are different (i.e., that the change is not caused by analytical and biological variation). The formula used is: CD = bias + z value x
x
(15). We used z values for one-sided tests and 95% or 80% probabilities (z values of 1.64 and 0.84, respectively) to reflect the participants certainty before initiating an action. CVa is an estimate of the analytical imprecision (16), and CVi is the mean within-subject CV for HbA1c
(16). Calculations were performed using this formula with a CVi of 4% (17). Patients responses concerning the magnitude of change in HbA1c from 9.4% that they considered to be a true (real) change were taken as the CD. We then rearranged the formula to calculate the CVa, which can be considered the quality goal for imprecision, assuming the bias component to be zero (9)(12)(18).
The Student t-test or nonparametric tests were used when appropriate. Correlation coefficients were calculated using the Pearson method. Statistical significance was set at 5%.
| Results |
|---|
|
|
|---|
|
Question 1 assessed patients perceived knowledge about HbA1c testing (Fig. 1
). Fifty-eight percent responded that they had "high" knowledge of HbA1c testing [categories "very good" (18%) or "sufficient" (40%)], whereas 42% thought they had "low" knowledge [categories "some" (30%), "little" (10%), or "no" (2%)]. The two groups did not differ with regard to age, sex, or SMBG frequency. Patients in the high-knowledge group had a longer duration of diabetes (16.2 vs 12.7 years; P = 0.025) and had performed SMBG longer (10.8 vs 8.6 years; P = 0.012) than those in the low-knowledge group.
Questions 25 assessed personal HbA1c values, target values, and thresholds for action (Table 2
). Response rates were lower on these questions, varying from 70% on question 5 to 90% on question 3. Five percent of patients responded that they did not know their own HbA1c target (question 3), whereas 18% reported that they did not know their lower HbA1c threshold for action (question 5). Patients who had a low HbA1c value at their last visit also reported lower HbA1c satisfactory values (r = 0.436; P <0.01) and lower upper thresholds for treatment intensification (r = 0.631; P <0.01). There was no significant difference in responses concerning HbA1c values on these four questions between the two groups with different knowledge levels, but patients in the low-knowledge group had significantly lower response rates on these four questions compared with the high-knowledge group (mean, 72% vs 90%; P <0.05).
|
The magnitude of change in HbA1c from 9.4% that patients considered a true change reflects the difference a HbA1c method should be able to detect, and thus the patient-derived CD for HbA1c. The calculated CVa values based on these CDs at the 80% and 95% confidence levels are shown in Table 3
. The results show that the responders have higher quality expectations when HbA1c is increasing compared with decreasing from 9.4%. Approximately one-half of the patients indicated that for increasing HbA1c (80% confidence), the resulting CVa should be
3.1%, assuming a bias of 0%. The values were not significantly different for the two knowledge groups, but the response rates were significantly lower on questions 6 and 7 for the low-knowledge group compared with the high-knowledge group (67% and 58% vs 90% and 79%, respectively; P <0.01).
|
| Discussion |
|---|
|
|
|---|
More than 80% of the studied subjects knew their last HbA1c value, and 90% responded to the crucial question on what a satisfactory HbA1c value should be. The median HbA1c target value was 7.5%, and 75% of the patients declared their target to be
8%. This is in line with international recommendations giving a HbA1c target value of 7.07.5% (7)(13)(24). Thirteen of 181 patients (7%) gave target values of
9%, which may be reasonable for patients having difficulty in controlling their blood glucose.
At an HbA1c value of 10% (Table 2
, question 4), 25% of the patients still did not state that treatment intensification should occur. This might reflect that for some patients, the disease is more difficult to control and that targets, therefore, are individualized rather than based directly on recommended values. The fact that only 25% of patients felt that 6% HbA1c is too low (Table 2
, question 5), might indicate that many patients have not experienced or are unaware of the serious problems associated with the frequent and sometimes severe hypoglycemia that occurs when HbA1c decreases to this concentration (7). This is underscored by the finding that
25% of the patients indicated that therapeutic actions (less-intense therapy) can be postponed at a HbA1c value of 5.0%. The well-controlled patients set lower targets and adjusted their therapy on lower HbA1c concentrations.
On questions 6 and 7, we asked for CDs set by the patients when estimating true changes in HbA1c from 9.4%. The 2030% who did not respond to these questions probably were unable to judge this issue of CD. The responding patients set lower CDs when HbA1c increased than when it decreased (medians, 0.6% vs 1.4%). In a similar study, general practitioners gave corresponding median CDs of 0.6% and 1.0%, respectively, when asked which changes in HbA1c that they considered true in response to a case history (12). General practitioners overall seemed to have higher quality expectations for the HbA1c analysis compared with the type 1 diabetes patients. This similarity in response patterns from 407 general practitioners and 201 type 1 patients, i.e., higher CDs when HbA1c increases than when it decreases, is shown in Fig. 2
. The same response pattern was found in a study involving family practitioners, internists, and endocrinologists (11). We believe that this finding is attributable to the adverse effect of poorer metabolic control compared with an improvement; consequently, both doctors and patients want to detect smaller "increases" than "decreases" when judging HbA1c results, probably to initiate therapeutic actions. This might imply that both patients and doctors will intensify treatment with <95% confidence that the increase in HbA1c is true, but want to be more confident that a decrease in HbA1c in fact has occurred before making treatment changes. To reflect the optimum quality (18) stated by the patients in this study, a CVa of 3.1% would be satisfactory for 75% of patients when HbA1c is increasing (80% confidence), whereas a CVa of 3.2% would be satisfactory for 75% when HbA1c is decreasing (95% confidence; Table 3
).
|
Similarly, to establish analytical quality specifications for HbA1c, Larsen (25) stated that the test should be able to detect a true change in HbA1c of >1% (e.g., change in HbA1c from 7% to 8%). In this example, bias should be negligible, specificity should exclude other minor hemoglobins, and the test should be able to measure the lowest occurring HbA1c in healthy individuals. This approach thus would establish CVa goals of 24%. This method was described as a way of defining analytical goals for clinical practice but could also be applicable to patients who have agreed on their treatment goals and targets with their doctors. Kolatkar et al. (11) examined changes in HbA1c interpreted by family practitioners, internists, and endocrinologists and found an optimum CV for HbA1c of 24%, not taking bias into account.
From the literature and external national quality-control surveys, we know that the most common analytical methods for HbA1c have a CVa of
3% (12)(26)(27)(28). In the setting of diabetes follow-up, testing of HbA1c typically takes place at intervals of at least 2 or more months. Bias (systematic error of measurement) is a more important part of total analytical error when the time interval between tests is long or different laboratories or lot numbers of reagents are used (16)(29). Including a bias component will put higher demands on patient-derived analytical quality specifications for imprecision (CV) in this setting. When patients and their caregivers set clinical treatment goals, including HbA1c targets, knowledge about analytical quality can be crucial (29)(30), and analytical imprecision will probably be considered most important in the monitoring situation (16).
In conclusion, most of the studied type 1 diabetes patients were aware of their last HbA1c result, and they had relatively high perceived knowledge about HbA1c testing. Well-controlled patients seem to have higher ambitions and therefore set lower targets and act on lower thresholds. Patients apparently act on smaller increases in HbA1c than decreases. These findings correspond with the patterns found for doctors use and interpretation of HbA1c values. The patient-derived quality specification for imprecision (CV) is
3%.
| Footnotes |
|---|
| References |
|---|
|
|
|---|
The following articles in journals at HighWire Press have cited this article:
![]() |
A. M. Delamater Clinical Use of Hemoglobin A1c to Improve Diabetes Management Clin. Diabetes, January 1, 2006; 24(1): 6 - 8. [Full Text] [PDF] |
||||
![]() |
S. Skeie, C. Perich, C. Ricos, A. Araczki, A. R. Horvath, W. P. Oosterhuis, T. Bubner, G. Nordin, R. Delport, G. Thue, et al. Postanalytical External Quality Assessment of Blood Glucose and Hemoglobin A1c: An International Survey Clin. Chem., July 1, 2005; 51(7): 1145 - 1153. [Abstract] [Full Text] [PDF] |
||||
![]() |
P. Luraschi, S. Brambilla, R. Mozzi, G. Cattozzo, and C. Franzini Monitoring Analytical Quality in Routine Glycohemoglobin Measurements Clin. Chem., September 1, 2002; 48(9): 1594 - 1597. [Full Text] [PDF] |
||||
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |