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Biomedical subjects

D Revicki

Publications and source records attributed to D Revicki.

18 recordsLinked to original sources

Development and validation of a disease-specific treatment satisfaction questionnaire for gastro-oesophageal reflux disease.

BACKGROUND: Currently, no disease-specific, patient-based, treatment satisfaction instruments related to gastro-oesophageal reflux disease exist. AIM: To develop and validate a treatment satisfaction questionnaire for gastro-oesophageal reflux disease (TSQ-G). METHODS: A new questionnaire was developed from patient focus groups, clinician input and literature review. A validation study was conducted in treated gastro-oesophageal reflux disease patients. Ancillary measures included the Medical Outcomes Study Short Form-36, Quality of Life in Reflux and Dyspepsia, Gastrointestinal Symptom Rating Scale, Socially Desirable Response Scale, Patient Satisfaction Questionnaire-18 and physician and patient measures of symptoms and satisfaction. Statistical analyses included exploratory factor analysis, Cronbach's alpha, intra-class correlations, analyses of variance and t-tests. RESULTS: A total of 198 gastro-oesophageal reflux disease patients participated in the study, with a mean age of 50.7 years, 68% female and 84% Caucasian. The physician-rated severity of gastro-oesophageal reflux disease was mild (32%), moderate (50%) and severe (18%); 83% were on proton pump inhibitors. The final TSQ-G consisted of 28 items with seven sub-scales; Cronbach's alpha ranged from 0.58 to 0.94. Correlations with the expected sub-scales of the ancillary measures were moderate to strong. The TSQ-G sub-scales discriminated significantly between levels of physician-rated disease severity, symptom days and patient and physician ratings of satisfaction. CONCLUSIONS: The TSQ-G has excellent reliability and construct validity and appears to be a useful tool for the evaluation of treatment satisfaction in gastro-oesophageal reflux disease patients.

Female↗

Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: the OAB-q.

OBJECTIVE: Overactive bladder (OAB) is characterized by symptoms of urinary frequency and urgency, with and without incontinence, and has been shown to have significant impact on health-related quality of life (HRQL). Currently, no OAB-specific questionnaires exist to evaluate all symptoms of OAB; thus we sought to evaluate the psychometric properties of a newly developed OAB HRQL questionnaire. METHODS: The 33-item, self-administered OAB-q contains a symptom bother and HRQL scale. Both the OAB-q and SF-36 were completed by participants from two sources: (1) a community sample who screened positive for OAB in a random-digit dial telephone survey and participated in a clinical validation study (n = 254); and (2) a clinical study of patients' seeking treatment for OAB symptoms (baseline assessment) (n = 736). Item and exploratory factor analysis were performed to assess the subscale structure of the questionnaire. Psychometric evaluation was conducted to assess reliability and validity. RESULTS: Seventy-four percent of the sample were women with mean age of 58.5. Participants with continent and incontinent symptoms reported significantly greater symptom bother and HRQL impact than normal participants. Significant differences were present among all patient groups in all OAB-q subscales (p < 0.0001) except sleep where the impact of continent and incontinent OAB was similar, but significantly worse than normal participants (p < 0.0001). Internal consistency was high with the subscale Cronbach alpha-values ranging from 0.86 to 0.94. CONCLUSION: The OAB-q is a reliable and valid instrument that discriminates between normal and clinically diagnosed continent and incontinent OAB participants. The OAB-q demonstrates that both continent and incontinent OAB symptoms cause significant symptom bother and have a negative impact on HRQL.

Adaptation, Psychological↗

The impact of nocturnal symptoms associated with gastroesophageal reflux disease on health-related quality of life.

BACKGROUND: Two types of reflux episodes have been identified: upright or daytime and supine or nocturnal. The population-based prevalence of symptoms of nocturnal gastroesophageal reflux disease (GERD) and the impact of those symptoms on health-related quality of life (HRQL) have not been established. METHODS: A national random-sample telephone survey was conducted to estimate the prevalence of frequent GERD and nocturnal GERD-like symptoms and to assess the relationship between HRQL, GERD, and nocturnal GERD symptoms. Respondents were classified as controls, subjects with symptomatic nonnocturnal GERD, and subjects with symptomatic nocturnal GERD. The HRQL was assessed using the Medical Outcomes Study Short-Form 36 Health Survey (SF-36). RESULTS: The prevalence of frequent GERD was 14%, with an overall prevalence of nocturnal GERD of 10%. Seventy-four percent of those with frequent GERD symptoms reported nocturnal GERD symptoms. Subjects with nonnocturnal GERD had significant decrements on the SF-36 physical and mental component summary scores compared with the US general population. Subjects reporting nocturnal GERD symptoms were significantly more impaired than subjects reporting nonnocturnal GERD symptoms on both the physical component summary (38.94 vs 41. 52; P<.001) and mental component summary (46.78 vs 49.51; P<.001) and all 8 subscales of the SF-36 (P<.001). Subjects with nocturnal GERD demonstrated considerable impairment compared with the US general population and chronic disease populations. Subjects with nocturnal GERD had significantly more pain than those with hypertension and diabetes (P<.001) and similar pain compared with those with angina and congestive heart failure. CONCLUSIONS: Nocturnal symptoms are commonly experienced by individuals who report frequent GERD symptoms. In addition, HRQL is significantly impaired in those persons who report frequent GERD symptoms, and HRQL impairment is exacerbated in those who report nocturnal GERD symptoms.

Adult↗

Psychometric evaluation of the fatigue severity scale for use in chronic hepatitis C.

Evidence exists demonstrating that infection with hepatitis C virus impairs health-related quality of life, but less is known about the effect of fatigue, a common symptom, on everyday life. The psychometric properties of the fatigue severity scale (FSS) were explored to determine suitability as an outcome measure in clinical trials. The FSS includes nine items developed to measure disabling fatigue and a visual analog scale (VAS) to measure overall fatigue. Using baseline data from three clinical trials (n = 1225) involving chronic hepatitis C patients, scaling and psychometric characteristics of the FSS were assessed. The SF-36 was also used in the trials. Item response theory analysis demonstrated that the FSS items can be placed along a single homogenous domain, fatigue. Internal consistency reliability was 0.94. Test-retest reliability was 0.82 for the total score and 0.80 for the VAS. The total score and the VAS were significantly correlated with the SF-36 vitality subscale (r = -0.76 and r = -0.76 respectively). Correlations with other SF-36 subscales were moderate (r = -0.46 to r = -0.67, all p < 0.0001). In summary, the FSS possesses good psychometric properties.

Adolescent↗

Olanzapine versus risperidone. A prospective comparison of clinical and economic outcomes in schizophrenia.

OBJECTIVE: To compare the clinical and economic outcomes associated with olanzapine and risperidone treatment for schizophrenia. DESIGN AND SETTING: An international, multicentre, double-blind, prospective study. To facilitate economic comparisons, our sample was restricted to patients enrolled in US sites. 150 patients with a Diagnostic and Statistical Manual of mental disorders, 4th edition (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder or schizophreniform disorder were randomised to therapy with either olanzapine 10 to 20 mg/day (n = 75) or risperidone 4 to 12 mg/day (n = 75) for a maximum of 28 weeks. In addition to tolerability and efficacy assessments, use of health services was assessed at baseline and prospectively, at 8-week intervals and at study completion. Clinically important response, defined as a 40% improvement in the Positive and Negative Syndrome Scale total score, maintenance of response and rates of treatment-emergent extrapyramidal symptoms were compared between groups. Direct medical costs were estimated by assigning standardised prices to resource units. Median total, inpatient/outpatient service and medication acquisition costs were compared between treatment groups. MAIN OUTCOME MEASURES AND RESULTS: The mean modal dosages for the olanzapine and risperidone treatment groups were 17.7 +/- 3.4 mg/day and 7.9 +/- 3.2 mg/day, respectively. Olanzapine-treated patients were more likely to maintain response compared with risperidone-treated patients (p = 0.048). In addition, a smaller proportion of olanzapine-treated patients required anticholinergic therapy compared with risperidone-treated patients (25.3 vs 45.3%; p = 0.016). Total per patient medical costs over the study interval were $US2843 (1997 values) [36%] lower in the olanzapine treatment group than in the risperidone treatment group (p = 0.342). Medication costs were significantly higher for olanzapine-treated patients ($US2513 vs $US1581; p < 0.001), but this difference was offset by a reduction of $US3774 (52%) in inpatient/outpatient service costs for olanzapine-treated patients in comparison with risperidone-treated patients ($US3516 vs $US7291, p = 0.083). Median cost findings were consistent with results observed using other robust measures of central tendency and provide conservative estimates of potential savings that may be obtained from olanzapine therapy. CONCLUSIONS: In this study, olanzapine-treated patients experienced clinical improvements that translated into savings in costs of care for both inpatient and outpatient services. These savings offset the difference in medication acquisition cost between olanzapine and risperidone.

Adult↗

Methodological and statistical issues of quality of life (QoL) and economic evaluation in cancer clinical trials: report of a workshop.

In recent years, quality of life (QoL) and economic evaluations have become increasingly important as additional outcome measures in cancer clinical trials. However, both fields of research are relatively new and in need of finding solutions to a substantial number of specific methodological problems. This paper reports on the proceedings of a symposium aimed at summarising and discussing some of the most contentious methodological and statistical issues in QoL and economic evaluations. In addition, possible solutions are indicated and the most pertinent areas of research are identified. Issues specific to QoL evaluations that are addressed include clinically meaningful changes in QoL scores; how to analyse QoL data and to handle missing and censored data and integration of length of life and QoL outcomes. Issues specific to economic evaluations are the advantages and disadvantages of various outcome measures; statistical methods to analyse economic data and choice of decision criteria and analytical perspective. How to perform QoL and economic evaluations in large and simple trials and whether the gap between QoL and utility measures can be bridged are also discussed.

Clinical Trials as Topic↗

Should anxiety and insomnia influence antidepressant selection: a randomized comparison of fluoxetine and imipramine.

BACKGROUND: The more sedating antidepressants are often recommended for patients presenting with anxiety or insomnia. We examine whether baseline anxiety or insomnia symptoms (1) show differential response to fluoxetine or imipramine or (2) predict differences between drugs in overall clinical response or likelihood of medication discontinuation. METHOD: 336 health maintenance organization primary care patients beginning antidepressant treatment for depression were randomly assigned to an initial prescription for fluoxetine or imipramine. All subsequent care (medication dosage, change, or discontinuation) was managed as usual by the primary care physician. The 17-item Hamilton Rating Scale for Depression (HAM-D) and the Hopkins Symptom Checklist (SCL) anxiety and depression subscales were administered prior to randomization and 1 month later. RESULTS: Rates of improvement in insomnia (HAM-D insomnia items), agitation (HAM-D agitation item), and anxiety (SCL anxiety subscale) were essentially identical in the two treatment groups. Baseline level of insomnia did not predict significant differences between randomization groups in improvement in overall HAM-D score (p = .44) or SCL depression subscale (p = .44). Similarly, baseline level of anxiety did not predict significant differences in improvement in HAM-D (p = .19) or SCL depression subscale (p = .31). Patients assigned to fluoxetine were significantly less likely to change or discontinue antidepressant medication during the first month, but this difference did not vary according to baseline level of insomnia (p = .68) or anxiety (p = .25). CONCLUSION: Among patients with moderate depression, baseline levels of insomnia or anxiety should not influence the choice of fluoxetine or imipramine as an initial antidepressant.

Adult↗

Psychometric considerations in evaluating health-related quality of life measures.

How does one determine if a measure of health-related quality of life (HRQL) is adequate for clinical trials? Psychometric methods are frequently used to answer this question. What is psychometrics all about? In this paper we address these questions, discussing common psychometric evaluation procedures applied to HRQL measures. Specifically, we discuss issues regarding the evaluation of reliability and validity (including responsiveness).

Cross-Cultural Comparison↗

Smoking status and the practice of other unhealthy behaviors.

This study examined the relationship between smoking behavior and other unhealthy practices in the US. Data from the 1979 National Survey of Personal Health Practices and Consequences were used to compare alcohol use, sleep behavior, overweight status, physical activity, and skipping breakfast with smoking status. Compared with nonsmokers, smokers were more likely to sleep fewer than six hours per night, skip breakfast, not actively exercise, and drink heavily. Smokers were less likely to be significantly overweight than former smokers or those who never smoked. These associations were present for both men and women for sleep behavior, skipping breakfast, overweight status, and alcohol use, but not for physical activity. These findings may assist physicians in understanding the association between smoking and other practices that influence morbidity and mortality.

Adult↗

A family medicine research library.

A family medicine research library can be a useful tool for conducting and teaching research methodology and data analysis. This paper lists 100 research books for family medicine collected from a questionnaire given to participants at the North American Primary Care Research Group (NAPCRG) annual meeting and a panel of experts in epidemiology and biostatistics. The areas (and number of books) include: general epidemiology (12), case control studies (3), clinical trials (3), experimental design (6), surveys (6), sampling and subject recruitment (5), measurement, scales and indices (10), family assessment and measurement (3), writing, publishing and presenting research (5), reading and reviewing the literature (5), statistics (19), coding and classification (5), and other books (18). Acquisition of a research library can facilitate family medicine research.

Bibliographies as Topic↗

Management of problem patients with multiple chronic diseases.

Residents in a university-based family medicine program perceived patients with diabetes mellitus, hypertension, and obesity as problem patients. The residents' perceptions of 166 patients were compared with information from a chart audit. A resident questionnaire outlined the goals, obstacles, and strategies pertaining to management of these patients as well as residents' perceptions of patient expectations. The results prompted a shift in focus from the problem patient to the problem patient-physician relationship and brought forth improved strategies that hold potential for making a difference in patient and physician satisfaction and outcome of care.

Attitude of Health Personnel↗

Sex differences in autism.

Comparisons were made between male and female children with autism, 384 boys and 91 girls, aged 3 years to 8 years, on nonverbal measures of intelligence, adaptive functioning, receptive vocabulary, perception, and eye-hand integration, and on ratings of affect, play, and relating and human interest. Males showed more advanced performances on eye-hand integration and perception skills on the Psychoeducational Profile (PEP) and had higher nonverbal IQs social quotients, and Peabody Picture Vocabulary Test (PPVT) IQs than females. When nonverbal IQ was controlled, the main effect of sex remained; however, sex differences on PPVT scores and on eye-hand integration and perception scale disappeared. Males showed more unusual visual responses and less appropriate, more stereotypic play than females. These results are discussed in terms of hypotheses concerning sex differences in genetic thresholds and in hemispheric lateralization.

Adaptation, Psychological↗

Long-term outcomes of initial antidepressant drug choice in a "real world" randomized trial.

OBJECTIVE: To compare the long-term clinical, quality-of-life, and economic outcomes after an initial prescription for fluoxetine, imipramine hydrochloride, or desipramine hydrochloride. DESIGN: Randomized, controlled trial. SETTING: Primary care clinics of a staff-model health maintenance organization in the Seattle, Wash, area. PATIENTS: Four hundred seventy-one adults beginning antidepressant drug treatment for depression. INTERVENTION: Random assignment of initial medication (desipramine, fluoxetine, or imipramine), with treatment (dosing, medication changes or discontinuation, and follow-up visits) managed by a primary care physician. MEASUREMENTS: Interviews at baseline and at 6, 9, 12, 18, and 24 months examined medication use, clinical outcomes (Hamilton Depression Rating Scale and depression subscale of the Hopkins Symptom Checklist), and quality of life (Medical Outcomes Study SF-36 Health Survey). Medical costs were assessed using the health maintenance organization's accounting data. RESULTS: Patients assigned to fluoxetine therapy were significantly more likely to continue taking the initial antidepressant but no more likely to continue any antidepressant therapy. The fluoxetine group did not differ significantly from either tricyclic drug group on any measure of depression severity or quality of life. For 24 months, antidepressant drug costs were approximately $250 higher for patients assigned to fluoxetine therapy, but total medical costs were essentially identical. CONCLUSIONS: Initial selection of fluoxetine or a tricyclic antidepressant drug should lead to similar clinical outcomes, functional outcomes, and overall costs. Differences in antidepressant prescription costs are blunted by the large minority of tricyclic-treated patients who switch to use of more expensive medications. Restrictions on first-line use of fluoxetine in primary care will probably not reduce overall treatment costs.

Adrenergic Uptake Inhibitors↗

Telephone assessment of depression severity.

This report describes the adaptation of three common measures of depression severity, the Hamilton Depression Rating Scale, the Structured Clinical Interview for DSM-III-R, and selected items of the Symptom Checklist-90 for follow-up assessment by telephone. In a sample of 30 patients beginning antidepressant treatment, telephone and in-person assessment of current symptom severity produced nearly identical results for all three instruments.

Adult↗

Recovery from depression, work productivity, and health care costs among primary care patients.

We describe a secondary analysis of data from a randomized trial conducted at seven primary care clinics of a Seattle area HMO. Adults with major depression (n=290) beginning antidepressant treatment completed structured interviews at baseline, 1, 3, 6, 9, 12, 18, and 24 months. Interviews examined clinical outcomes (Hamilton Depression Rating Scale and depression module of the Structured Clinical Interview for DSM-IIIR), employment status, and work days missed due to illness. Medical comorbidity was assessed using computerized pharmacy data, and medical costs were assessed using the HMO's computerized accounting data. Using data from the 12-month assessment, patients were classified as remitted (41%), improved but not remitted (47%), and persistently depressed (12%). After adjustment for depression severity and medical comorbidity at baseline, patients with greater clinical improvement were more likely to maintain paid employment (P=.007) and reported fewer days missed from work due to illness (P<.001). Patients with better 12-month clinical outcomes had marginally lower health care costs during the second year of follow-up (P=.06). We conclude that recovery from depression is associated with significant reductions in work disability and possible reductions in health care costs. Although observational data cannot definitively prove any causal relationships, these longitudinal results strengthen previous findings regarding the economic burden of depression on employers and health insurers.

Adolescent↗

Patterns of interrelations among health-promotion behaviors.

We examined the interrelationships among 36 health behaviors for men and 38 for women in a telephone survey of a national sample of 3,025 adults. Wide variations existed in the frequency of respondents engaging in healthy practices, ranging from 9% to 96%. Men practiced an average of 17, and women 19, healthy behaviors. Correlations between health behaviors were weak, with an absolute value averaging r = .07, ranging from r = .00 to r = .71. Factor analysis revealed 10 underlying dimensions among the behaviors, which we interpreted for men as: (1) health care use, (2) exercise and recreation activity, (3) alcohol use, (4) smoking, (5) physical activity, (6) dental care, (7) nutrition, (8) sleep, (9) beverage use, and (10) breakfast. Women had the same 10 factors as men, except for a women's health screening factor instead of a beverage use factor. These findings suggest that engaging in one health behavior is not necessarily associated with practicing others, and that public health and individual counseling efforts to encourage healthy behaviors should be multifaceted and behavior-specific.

Data Collection↗