Kathleen M. Bungay

The Work Limitations Questionnaire.

Objective.The objective of this work was to develop a psychometrically sound questionnaire for measuring the on-the-job impact of chronic health problems and/or treatment (“work limitations”). Research Design.Three pilot studies (focus groups, cognitive interviews, and an alternate forms test) generated candidate items, dimensions, and response scales. Two field trials tested the psychometric performance of the questionnaire (studies 1 and 2). To test recall error, study 1 subjects were randomly assigned to 2 different questionnaire groups, a questionnaire with a 4-week reporting period completed once or a 2-week version completed twice. Responses were compared with data from concurrent work limitation diaries (the gold standard). To test construct validity, we compared questionnaire scores of patients with those of healthy job-matched control subjects. Study 2 was a cross-sectional mail survey testing scale reliability and construct validity. Subjects.The study subjects were employed individuals (18–64 years of age) from several chronic condition groups (study 1, n = 48; study 2, n = 121) and, in study 1, 17 healthy matched control subjects. Measures.Study 1 included the assigned questionnaires and weekly diaries. Study 2 included the new questionnaire, SF-36, and work productivity loss items. Results.In study 1, questionnaire responses were consistent with diary data but were most highly correlated with the most recent week. Patients had significantly higher (worse) limitation scores than control subjects. In study 2, 4 scales from a 25-item questionnaire achieved Cronbach alphas of ≥0.90 and correlated with health status and self-reported work productivity in the hypothesized manner (P ≤0.05). Conclusions.With 25 items, 4 dimensions (limitations handling time, physical, mental-interpersonal, and output demands), and a 2-week reporting period, the Work Limitations Questionnaire demonstrated high reliability and validity.

International quality of life assessment (IQOLA) project

The International Quality of Life Assesment (IQOLA) Project is a 4-year project to translate and adapt the widely used MOS SF-36 Health Survey Questionnaire in up to 15 countries and validate, norm, and document the new translations as required for their use in international studies of health outcomes. In addition to the eight-scale SF-36 health profile, the project will also validate psychometrically based physical and mental health summary scores, as well as health utility indexes incorporating SF-36 scales for use in cost-utility studies.

A questionnaire to assess the generic and disease-specific health outcomes of patients with chronic hepatitis C

A 69-item questionnaire measuring generic functioning and well-being and disease-specific health outcomes was developed and tested using the pre-treatment data from patients with chronic hepatitis C (CHC) participating in two randomized trials of interferon α-2b (n = 157). The questionnaire included all eight scales from the SF-36 and measures of nine other generic and disease-specific health concepts. Psychometric tests confirmed the assumptions underlying the construction and scoring of all generic and disease-specific scales. Cross-sectional tests of ‘known groups’ validity showed that CHC patients scored worse on the generic scales than patients with other chronic conditions and worse than a healthy general population. The generic and disease-specific scale scores were lower in the presence of physical findings of CHC, as hypothesized, but only the physical functioning and bodily pain scales were linked to cirrhosis or extreme alanine aminotransferase (ALT) ratios. This instrument will be useful in studies of health outcome among patients with CHC, a condition whose health burden appears to have been underestimated in studies to date.

Antidepressant use: concordance between self-report and claims records.

Background. Researchers need valid methods to assess whether patients are taking their antidepressant medications. Two important sources of data on drug exposure are patients’ self-reports and pharmacy claims. Objective. To compare self-report and claims data for antidepressant exposure. Research Design. Cross-sectional analysis. Subjects. This study comprised 422 contemporaneous self-report and claims data points obtained from 164 unique patients in a longitudinal depression study in which patients completed up to five surveys during an 18-month period. Measures. For the self-report measure, the following question was asked: Do you now take any prescription medicines for depression? Using claims data, patients were considered to be using an antidepressant if they had filled at least one antidepressant prescription in the 90 days before survey dates. Results. Self-report and claims agreed in 85% (358/422) of cases, with a kappa of 0.69. Eighty-eight percent (56/64) of discrepant cases using other study data sources was resolved. Reasons for discrepancies included the use of medications for conditions other than depression (32/64), recent AD discontinuations (6/64), samples usage (3/64), and low-frequency/PRN use (7/64). Conclusions. Self-report and claims showed good concordance, but they reflect different truths. Self-report identifies medications intended primarily for the treatment of depressive disorders, whereas claims data identify use of medicines with antidepressant effects. Our assessment of discordant cases showed self-report to be more valid than claims to assess current antidepressant use for depression therapy.

Possible Paroxetine-Induced Bruxism

OBJECTIVE: To report the case of a patient with possible paroxetineinduced bruxism that was effectively treated with buspirone. CASE SUMMARY: A 20-year-old woman with no active medical conditions besides acne and no history of dental problems was seen in an outpatient psychiatry clinic for the evaluation of ongoing depression. The patient was prescribed paroxetine 10 mg every morning. After 5 days of therapy the patient reported no adverse effects, and the paroxetine dosage was increased to 20 mg every morning. Due to increased somnolence, the dosing schedule was subsequently changed to 20 mg hs. Two months later during a dental visit for a tooth extraction, the dentist noted that the patients teeth appeared damaged in what he believed to be a pattern consistent with the grinding and clenching of teeth. Prior to this time, dental examinations had not revealed any tooth damage. The patient was thought to have paroxetine-induced bruxism and, based on earlier case reports, was treated with buspirone 5 mg hs. On day 4 of buspirone therapy the patient reported a significant reduction in the extent of gritting, tooth pain, and jaw tenderness. DISCUSSION: The selective serotonin reuptake inhibitors (SSRIs) fluoxetine and sertraline have been associated with bruxism in previous reports. This case suggests paroxetine-induced bruxism. The exact mechanism of SSRI-induced bruxism remains unclear. Many theories have been proposed, including sleep disturbance, serotonergic-mediated inhibition of dopamine manifesting as akathisia, and SSRI-induced anxiety. According to published reports, SSRI-induced bruxism may respond to therapy with buspirone. Consistent with these reports, this patient responded favorably to buspirone therapy. CONCLUSIONS: Clinicians should be aware that the potential for paroxetine-induced bruxism exists and that buspirone may be an appropriate therapeutic intervention.

Assessing the performance of a new depression screener for primary care (PC-SAD©)

As many as 50% of patients with major depression seen in primary care settings are not diagnosed. To facilitate efficient identification of primary care patients with depression, we developed a new patient-administered depression screening instrument (PC-SAD) that produces a DSM-IV diagnosis, and compared its performance to other screeners that yield DSM-IV diagnoses. To assess validity, the diagnostic accuracy of the PC-SAD was compared with the Inventory to Diagnose Depression (IDD) and the PRIME-MD-PHQ (PHQ) in a convenience sample (N = 312) of health plan members, primary care outpatients, and psychiatric patients (with diagnoses). The screeners were compared with each other and with psychiatric diagnoses to assess their relative performance. Disagreement among the three screeners was formally tested using a triangulation approach that incorporates a statistical likelihood model. Of patients diagnosed as depressed using the IDD, 84.2% were also depressed by the PC-SAD (sensitivity). Of patients not diagnosed as depressed by the IDD, 94.7% were not depressed by the PC-SAD (specificity). Using the triangulation method the sensitivities were 87.2% (PC-SAD), 88.4% (IDD), and 60.7% (PHQ). The specificities were 95.0% (PC-SAD), 92.7% (IDD), and 98.3% (PHQ). The performance of the PC-SAD and the IDD was comparable. The PHQ was less sensitive than either of those. The PC-SAD respondent burden strikes a balance between the very short PHQ, and the longer IDD, and has the lowest (easiest) Flesch-Kincaid reading level. Investigators, clinicians, and health plans that want a DSM-IV-based depression screener can choose from among these three instruments, with known tradeoffs in sensitivity, respondent burden, and readability.

Screening for Depressive Disorders in Patients with Skin Diseases: A Comparison of Three Screeners

Despite being common, depression often goes undetected in patients with skin diseases. Our aim was to examine and compare the performance of three depression screeners. We studied dermatological inpatients aged 18-65 years. They completed the questionnaires Primary Care Screener for Affective Disorders (PC-SAD), Patient Health Questionnaire (PHQ) and General Health Questionnaire (GHQ-12) and were administered a standardized psychiatric interview (SCID-I) by a mental health professional, who was unaware of the questionnaire answers. The analysis was performed on 141 patients with complete data (79% of all eligible patients, 89% of all patients who agreed to participate). The prevalence of the main forms of depression, major depressive disorder and dysthymic disorder, was 8.4% and 6.3%, respectively. For major depressive disorder, the sensitivity and specificity of the questionnaires were as follows: PC-SAD, 73% and 88%; PHQ, 55% and 91%; GHQ-12, 73% and 78%. For dysthymic disorder, the sensitivity and specificity were as follows: PC-SAD, 56% and 95%; PHQ, 44% and 90%; GHQ-12, 56% and 76%. The small sample size suggests caution in drawing conclusions about the relative merits of these screeners. Although both the GHQ and the PHQ are short and easily hand scored, the first is a generic screener for psychiatric morbidity that is not specific for depression, while the second displayed modest sensitivity. The PC-SAD, with short average administration time, acceptable sensitivity and high specificity, might be particularly useful in settings where the technology for computer automated scoring is available. Although screening programmes might be useful, they should be supplemented by quality improvement programmes and by the development of consultation-liaison services.

The health status of adults with epilepsy compared with that of people without chronic conditions

Study Objectives. To examine the feasibility of administering and the psychometric properties of a general health status questionnaire in adults with epilepsy, and to assess the health status of these patients.

Depression, Antidepressants, and Plasma Amyloid β (Beta) Peptides in Those Elderly Who Do Not Have Cardiovascular Disease

BACKGROUND Low plasma amyloid-beta peptide 42 (Abeta42) is associated with depressive symptoms independently of cardiovascular disease (CVD) in the elderly. It is critical to investigate whether antidepressants modify this relationship. METHODS We evaluated 324 elders without CVD in a cross-sectional study. Depression was evaluated with the Center for Epidemiological Studies Depression (CES-D) scale. Antidepressants were documented. Plasma Abeta40 and Abeta42 were measured. RESULTS In the absence of CVD, those with depression had lower plasma Abeta42 (median: 13.7 vs. 18.8 pg/mL, p = .003) than those without. Depressed subjects on antidepressant treatment had a lower concentration of plasma Abeta40 (median: 97.8 vs. 133.5 pg/mL, p = .008), but not Abeta42, than those without the treatment. Multivariate logistic regression showed that antidepressant use did not influence the relationship between depression and low plasma Abeta42 (odds ratio = .55; 95% CI = .33, .90; p = .02) after adjusting for confounders, but its use interacted with plasma Abeta40 in the model. CONCLUSIONS Lower concentration of plasma Abeta42 is associated with depression in the absence of CVD that is not related to the antidepressant use by those subjects. Prospective studies are needed to determine whether depression associated with low plasma Abeta42 predicts the onset of Alzheimers disease.

Responsiveness and calibration of the general well-being adjustment scale in patients with hypertension

We examined the discriminant ability and responsiveness of the General Well-Being Adjustment Scale in patients enrolled in a randomized clinical trial of antihypertensive therapy. We also tried to translate the effects of physical symptoms on general well-being. This secondary analysis used demographic, clinical, physical symptom, and general well-being data for 545 white, male hypertensive patients. General well-being was measured by the General Well-Being Adjustment Scale (GWB) collected on 2 occasions over 8 weeks of treatment. Patients with any one of 14 physical symptoms or problems, compared to those without symptoms, had lower GWB scores (p < 0.003 to p < 0.0001). Decreases of 2.83-8.76 points in GWB scores were observed in patients developing physical symptoms over the 8 week study period (p < 0.05 to p < 0.0001). These effects were demonstrated in patients developing cold sensitivity, sexual problems, chest pain, shortness of breath, loss of taste, nausea, hot or cold spells, numbness and tingling, dry mouth, blurred vision, and dizziness. We conclude that the GWB is responsive to clinically meaningful changes in symptoms and may provide a more complete evaluation of the effects of medical treatment. The GWB is a valid and responsive measure of health status outcomes in the evaluation of antihypertensive treatment.