William H. Polonsky

Assessment of diabetes-related distress

OBJECTIVE To describe a new measure of psychosocial adjustment specific to diabetes, the Problem Areas in Diabetes Survey (PAID), and to present initial information on its reliability and validity. RESEARCH DESIGN AND METHODS Before their routine clinic appointments, 451 female patients with type I and type II diabetes, all of whom required insulin, completed a self-report survey. Included in the survey was the PAID, a 20-item questionnaire in which each item represents a unique area of diabetes-related psychosocial distress. Each item is rated on a six-point Likert scale, reflecting the degree to which the item is perceived as currently problematic. A total scale score, hypothesized to reflect the overall level of diabetes-related emotional distress, is computed by summing the total item responses. To examine the concurrent validity of the PAID, the survey also included a series of standardized questionnaires assessing psychosocial functioning (general emotional distress, fear of hypoglycemia, and disordered eating), attitudes toward diabetes, and self-care behaviors. All subjects were assessed for HbA1, within 30 days of survey completion and again ∼ 1–2 years later. Finally, long-term diabetic complications were determined through chart review. RESULTS Internal reliability of the PAID was high, with good item-to-total correlations. Approximately 60% of the subject sample reported at least one serious diabetes-related concern. As expected, the PAID was positively associated with relevant psychosocial measures of distress, including general emotional distress, disordered eating, and fear of hypoglycemia, short- and long-term diabetic complications, and HbA1, and negatively associated with reported self-care behaviors. The PAID accounted for ∼ 9% of the variance in HbA1. Diabetes-related emotional distress, as measured by the PAID, was found to be a unique contributor to adherence to self-care behaviors after adjustment for age, diabetes duration, and general emotional distress. In addition, the PAID was associated with HbA1 even after adjustment for age, diabetes duration, general emotional distress, and adherence to self-care behaviors. CONCLUSIONS These findings suggest that the PAID, a brief, easy-to-administer instrument, may be valuable in assessing psychosocial adjustment to diabetes. In addition to high internal reliability, the consistent pattern of correlational findings indicates that the PAID is tapping into relevant aspects of emotional distress and that its particular feature, the measurement of diabetes-related emotional distress, is uniquely associated with diabetes-relevant outcomes. These data are also consistent with the hypothesis that diabetes-related emotional distress, separate from general emotional distress, is an independent and major contributor to poor adherence. Given that the study was limited to female patients using insulin, further examination of the clinical usefulness of the PAID will need to focus on more heterogeneous samples.

The Problem Areas in Diabetes Scale: An evaluation of its clinical utility

OBJECTIVE To evaluate the reliability and concurrent and discriminant validity of the Problem Areas in Diabetes (PAID) scale, a new measure of emotional functioning in diabetes. RESEARCH DESIGN AND METHODS A battery of questionnaires, including the PAID, was completed by 256 volunteer diabetic outpatients. In our analyses, we examined the PAIDs internal structure and compared mean IDDM and NIDDM treatment group scores in regression analyses to explore its discriminant validity. We also evaluated concurrent validity from the correlations between the PAID and diabetes-specific measures of coping and health attitudes and HbA1c. RESULTS Principal component analyses identified a large emotional adjustment factor, supporting the use of the total score. Significant sizable correlations were found between the PAID and a range of selected health attitudinal measures. There were significant differences (with small-to-moderate effect sizes) in PAID scores between IDDM and NIDDM patients and between IDDM and NIDDM insulin- and tablet-treated subgroups; no differences were found between NIDDM insulin- and tablet-treated subgroups. CONCLUSIONS The study findings provided support for the construct validity of the PAID, including evidence for discriminant validity from its ability to detect differences between IDDM and NIDDM treatment groups expected to differ in the emotional impact of life with diabetes. Future studies should explore the PAIDs performance in nonspecialist treatment settings as well as its responsiveness to clinical change.

Reduced Awareness of Hypoglycemia in Adults With IDDM: A prospective study of hypoglycemic frequency and associated symptoms

OBJECTIVE To prospectively evaluate the frequency and severity of hypoglycemic episodes in IDDM subjects who declare themselves to have reduced awareness of hypoglycemia, to validate their self-designations in their natural environment, and to determine objectively the presence or absence of autonomic and neuroglycopenic symptoms associated with their low blood glucose (BG) levels. RESEARCH DESIGN AND METHODS A total of 78 insulin-dependent diabetes mellitus (IDDM) subjects (mean age 38.3 ± 9.2 years; duration of diabetes 19.3 ± 10.4 years) completed two sets of assessments separated by 6 months. The assessments included reports of frequency and severity of low BG, symptoms associated with low BG, and a BG symptom/estimation trial using a hand-held computer (HHC). Diaries of hypoglycemic episodes were kept for the intervening 6 months. HbA1 levels were determined at each assessment. RESULTS Of the subjects, 39 declared themselves as having reduced awareness of hypoglycemia (reduced-awareness subjects). There were no differences between these reduced-awareness subjects and aware subjects with regard to age, sex, disease duration, insulin dose, or HbA1. During the HHC trials, reduced-awareness subjects were significantly less accurate in detecting BG < 3.9 mmol/l (33.2 ± 47 vs. 47.6 ± 50% detection, P = 0.001) and had significantly fewer autonomic (0.41 ± 0.82 vs. 1.08 ± 1.22, P = 0.006, reduced-awareness vs. aware) and neuroglycopenic (0.44 ± 0.85 vs. 1.18 ± 1.32, P = 0.004, reduced-awareness vs. aware) symptoms per subject. Prospective diary records revealed that reduced-awareness subjects experienced more moderate (351 vs. 238, P = 0.026) and severe (50 vs. 17, P = 0.0062) hypoglycemic events. The second assessment results were similar to the first and verified the reliability of the data. CONCLUSIONS IDDM subjects who believe they have reduced awareness of hypoglycemia are generally correct. They have a history of more moderate and severe hypoglycemia, are less accurate at detecting BG < 3.9 mmol/l, and prospectively experience more moderate and severe hypoglycemia than do aware subjects. Neither disease duration nor level of glucose control explains their reduced awareness of hypoglycemia. Reduced-awareness individuals may benefit from interventions designed to teach them to recognize all of their potential early warning symptoms.

Structured Self-Monitoring of Blood Glucose Significantly Reduces A1C Levels in Poorly Controlled, Noninsulin-Treated Type 2 Diabetes: Results from the Structured Testing Program study

OBJECTIVE To assess the effectiveness of structured blood glucose testing in poorly controlled, noninsulin-treated type 2 diabetes. RESEARCH DESIGN AND METHODS This 12-month, prospective, cluster-randomized, multicenter study recruited 483 poorly controlled (A1C ≥7.5%), insulin-naïve type 2 diabetic subjects from 34 primary care practices in the U.S. Practices were randomized to an active control group (ACG) with enhanced usual care or a structured testing group (STG) with enhanced usual care and at least quarterly use of structured self-monitoring of blood glucose (SMBG). STG patients and physicians were trained to use a paper tool to collect/interpret 7-point glucose profiles over 3 consecutive days. The primary end point was A1C level measured at 12 months. RESULTS The 12-month intent-to-treat analysis (ACG, n = 227; STG, n = 256) showed significantly greater reductions in mean (SE) A1C in the STG compared with the ACG: −1.2% (0.09) vs. −0.9% (0.10); Δ = −0.3%; P = 0.04. Per protocol analysis (ACG, n = 161; STG, n = 130) showed even greater mean (SE) A1C reductions in the STG compared with the ACG: −1.3% (0.11) vs. −0.8% (0.11); Δ = −0.5%; P < 0.003. Significantly more STG patients received a treatment change recommendation at the month 1 visit compared with ACG patients, regardless of the patient’s initial baseline A1C level: 179 (75.5%) vs. 61 (28.0%); <0.0001. Both STG and ACG patients displayed significant (P < 0.0001) improvements in general well-being (GWB). CONCLUSIONS Appropriate use of structured SMBG significantly improves glycemic control and facilitates more timely/aggressive treatment changes in noninsulin-treated type 2 diabetes without decreasing GWB.

Insulin Omission in Women With IDDM

OBJECTIVE To describe the extent of intentional insulin omission in an outpatient population of women with insulin-dependent diabetes mellitus (IDDM) and examine its relationship to disordered eating, attitudes toward diabetes, other psychosocial factors, long-term complications, and glycemic control. RESEARCH DESIGN AND METHODS Before their routinely scheduled clinic appointments, female IDDM patients who were 13–60 years of age completed a self-report survey (final n = 341). The survey included standardized questionnaires assessing disordered eating attitudes and behaviors, psychological functioning (general distress, diabetes-specific distress, and hypoglycemic fear), attitudes toward diabetes, and self-care behaviors. All subjects were assessed for glycosylated hemoglobin within 30 days of survey completion. Long-term complications were determined through chart review. RESULTS Approximately 31% of the subject sample, representing women of all ages, reported intentional insulin omission, but only 8.8% reported frequent omission. Compared with non-omitters, omitters reported more disordered eating, greater psychological distress (general and diabetes-specific), more hypoglycemic fear, poorer regimen adherence, and greater fears concerning improved diabetes management (which may lead to weight gain). Omitters evidenced poorer glycemic control, more diabetes-related hospitalizations, and higher rates of retinopathy and neuropathy. Multivariate examination revealed only two variables that independently predicted omission: diabetes-specific distress and fear of improved glycemic control (“because I will gain weight”). Of the omitters, approximately half reported omitting insulin for weight-management purposes (weight-related omitters). These subjects evidenced significantly greater psychological distress, poorer regimen adherence (including more frequent omission), poorer glycemic control, and higher rates of complications than did non-weight-related omitters as well as non-omitters. Non-weight-related omitters tended to fall between weight-related omitters and non-omitters on most measures of psychological functioning, adherence, and glycemic control. CONCLUSIONS These findings suggest that insulin omission is common, that it is not limited to younger women, and that the medical consequences of omission, especially frequent omission, may be severe. Although a strong association between omission and disordered eating was observed, these data suggest that this link may be complicated by important diabetes-specific factors. Patients preoccupied with eating and weight concerns may also become emotionally overwhelmed by diabetes and/or fearful of normoglycemia (and the associated weight-related consequences), thus reinforcing the desire to omit insulin and maintain elevated blood glucose levels.

Responsiveness of the Problem Areas In Diabetes (PAID) questionnaire

Aim Responsiveness (sensitivity to change over time) is a key psychometric quality for an outcome measure. We examined the responsiveness of the Problem Areas In Diabetes (PAID) questionnaire, a measure of diabetes‐specific emotional distress.

Development of a Brief Diabetes Distress Screening Instrument

PURPOSE Previous research has documented that diabetes distress, defined as patient concerns about disease management, support, emotional burden, and access to care, is an important condition distinct from depression. We wanted to develop a brief diabetes distress screen instrument for use in clinical settings. METHODS We assessed 496 community-based patients with type 2 diabetes on the previously validated, 17-item Diabetes Distress Scale (DDS17) and 6 biobehavioral measures: glycated hemoglobin (HbA1c); non–high-density-lipoprotein (non-HDL) cholesterol; kilocalories, percentage of calories from fat, and number of fruit and vegetable servings consumed per day; and physical activity as measured by the International Physical Activity Questionnaire. RESULTS An average item score of ≥3 (moderate distress) discriminated high- from low-distressed subgroups. The 4 DDS17 items with the highest correlations with the DDS17 total (r = .56–.61) were selected. Composites, comprised of 2, 3, and 4 of these items (DDS2, DDS3, DDS4), yielded higher correlations (r=.69–.71). The sensitivity and specificity of the composites were .95 and .85, .93 and .87, and .97 and .86, respectively. The DDS3 had a lower sensitivity and higher percentages of false-negative and false-positive results. All 3 composites significantly discriminated subgroups on HbA1c, non-HDL cholesterol, and kilocalories consumed per day; none discriminated subgroups on fruit and vegetable servings consumed per day; and only the DDS3 yielded significant results on the International Physical Activity Questionnaire. Because of its psychometric properties and brevity, the DDS2 was selected as a screening instrument. CONCLUSIONS The DDS2 is a 2-item diabetes distress screening instrument asking respondents to rate on a 6-point scale the degree to which the following items caused distress: (1) feeling overwhelmed by the demands of living with diabetes, and (2) feeling that I am often failing with my diabetes regimen. The DDS17 can be administered to those who have positive findings on the DDS2 to define the content of distress and to direct intervention.

When Is Diabetes Distress Clinically Meaningful? Establishing cut points for the Diabetes Distress Scale

OBJECTIVE To identify the pattern of relationships between the 17-item Diabetes Distress Scale (DDS17) and diabetes variables to establish scale cut points for high distress among patients with type 2 diabetes. RESEARCH DESIGN AND METHODS Recruited were 506 study 1 and 392 study 2 adults with type 2 diabetes from community medical groups. Multiple regression equations associated the DDS17, a 17-item scale that yields a mean-item score, with HbA1c, diabetes self-efficacy, diet, and physical activity. Associations also were undertaken for the two-item DDS (DDS2) screener. Analyses included control variables, linear, and quadratic (curvilinear) DDS terms. RESULTS Significant quadratic effects occurred between the DDS17 and each diabetes variable, with increases in distress associated with poorer outcomes: study 1 HbA1c (P < 0.02), self-efficacy (P < 0.001), diet (P < 0.001), physical activity (P < 0.04); study 2 HbA1c (P < 0.03), self-efficacy (P < 0.004), diet (P < 0.04), physical activity (P = NS). Substantive curvilinear associations with all four variables in both studies began at unexpectedly low levels of DDS17: the slope increased linearly between scores 1 and 2, was more muted between 2 and 3, and reached a maximum between 3 and 4. This suggested three patient subgroups: little or no distress, <2.0; moderate distress, 2.0–2.9; high distress, ≥3.0. Parallel findings occurred for the DDS2. CONCLUSIONS In two samples of type 2 diabetic patients we found a consistent pattern of curvilinear relationships between the DDS and HbA1c, diabetes self-efficacy, diet, and physical activity. The shape of these relationships suggests cut points for three patient groups: little or no, moderate, and high distress.

The confusing tale of depression and distress in patients with diabetes: a call for greater clarity and precision.

Studies have identified significant linkages between depression and diabetes, with depression associated with poor self‐management behaviour, poor clinical outcomes and high rates of mortality. However, findings are not consistent across studies, yielding confusing and contradictory results about these relationships. We suggest that there has been a failure to define and measure ‘depression’ in a consistent manner. Because the diagnosis of depression is symptom‐based only, without reference to source or content, the context of diabetes is not considered when addressing the emotional distress experienced by individuals struggling with diabetes. To reduce this confusion, we suggest that an underlying construct of ‘emotional distress’ be considered as a core construct to link diabetes‐related distress, subclinical depression, elevated depression symptoms and major depressive disorder (MDD). We view emotional distress as a single, continuous dimension that has two primary characteristics: content and severity; that the primary content of emotional distress among these individuals include diabetes and its management, other life stresses and other contributors; and that both the content and severity of distress be addressed directly in clinical care. We suggest further that all patients, even those whose emotional distress rises to the level of MDD or anxiety disorders, can benefit from consideration of the content of distress to direct care effectively, and we suggest strategies for integrating the emotional side of diabetes into regular diabetes care. This approach can reduce confusion between depression and distress so that appropriate and targeted patient‐centred interventions can occur.

Depression in Diabetes: Have We Been Missing Something Important?

An extensive literature has developed to suggest that depression is more common in patients with diabetes than in the general population (1) and is associated with chronic hyperglycemia (2), risk for diabetes complications (3), and mortality (4). Although the causal linkages among these relationships have not been demonstrated, their consistency has led to calls for intensive efforts to identify and treat clinical depression in patients with diabetes, with the reasonable presumption that this will contribute to better diabetes outcomes. Recent studies, however, suggest a more complicated picture and cast doubt on this presumption. Although research has suggested that the prevalence of clinical depression, or major depressive disorder (MDD), among adults with diabetes may be two to three times greater than among community adults (1), recent studies—which have used structured clinical interviews, the gold standard in the diagnosis of MDD—suggest that it is only about 60% more common (5). More importantly, diabetes-related distress, or significant negative emotional reactions to the diagnosis of diabetes, threat of complications, self-management demands, unresponsive providers, and/or unsupportive interpersonal relationships, has been found to be far more common, more chronic, and more closely related to diabetes self-care and glycemic control than MDD (5–7). Symptoms of depression, such as depressed mood, diminished interest, loss of energy, and concentration difficulties, that are elevated but do not meet severity criteria for MDD (referred to here as depressive symptoms) are also quite common among patients with diabetes and are associated with poor self-care (8). Furthermore, increased risk of complications and early mortality is not limited to those with MDD but also extends to those with elevated depressive symptoms, even when these elevations are quite modest (4). This suggests an incremental relationship between the severity of depressive symptoms and poorer diabetes outcomes rather than an effect of MDD per …