Patient experience in systemic lupus erythematosus: development of novel patient-reported symptom and patient-reported impact measures.

BACKGROUND: Comprehensive assessment of systemic lupus erythematosus (SLE) and its treatment requires patient-reported outcome (PRO) measures to capture impacts and fluctuating symptoms. The objective of this study was to develop PROs, in accordance with the Food and Drug Administration (FDA) PRO Guidance, to assess fluctuations in SLE symptoms and its impact. METHODS: Following independent review board approval, six US rheumatology practices recruited patients with SLE to participate in concept elicitation (CE) interviews, in order to identify important SLE symptoms and their impacts. The SLE Symptom Severity Diary (SSD) and SLE Impact Questionnaire (SIQ) were drafted based on CE interview results and clinician input. The PROs were revised based on patient feedback from cognitive debriefing (CD) interviews, clinician feedback, and a translatability assessment. RESULTS: Forty-one patients completed CE interviews. Commonly-reported symptoms included fatigue (98%), joint pain (93%), and rash (88%). The most frequently reported impact was difficulty with chores/housework (61%). Eighteen patients completed CD interviews. The PROs were considered comprehensive, clear, and relevant.The SSD contains 17 items assessing energy/vitality, joint and muscle pain/stiffness/swelling, flu-like symptoms, cognition, numbness/tingling, skin symptoms and hair loss using an 11-point numeric response scale and a 24-h recall period (with the exception of hair loss). It also evaluates steroid status and dose. The SIQ contains 50 items, uses a 5-point Likert scale and a 7-day recall period, to assess disease impacts including patients' ability to make plans, work, and physical/social/emotional functioning. CONCLUSION: The SSD and SIQ are comprehensive SLE-specific PROs developed in accordance with the FDA PRO Guidance. Following assessment of their measurement properties, they may be useful in clinical studies and clinical practice to measure fluctuations in, and the impact of, symptoms in patients with SLE.

Reliability and validity of the Advanced Basal Cell Carcinoma Index (aBCCdex).

BACKGROUND: Patient-reported outcome (PRO) questionnaires were recently developed specifically for use with patients with advanced basal cell carcinoma (aBCC) and basal cell carcinoma naevus syndrome (BCCNS). OBJECTIVES: To evaluate the measurement properties of PRO questionnaires for use in patients with aBCC or BCCNS. METHODS: In total 129 patients from 10 clinical sites in the U.S.A. and the BCCNS Support Network completed the two newly developed questionnaires multiple times over 3 months. Patients also completed the Skindex-16 and the 12-Item Short-Form Health Survey as collateral measures. Psychometric properties of the questionnaires were evaluated, including internal consistency and test-retest reliability, construct and known-groups validity, and responsiveness. RESULTS: Based on the results of exploratory factor analysis and clinical input, the two newly developed questionnaires were combined into a single questionnaire, called the aBCCdex, which is relevant for patients with both aBCC and BCCNS. The internal consistency reliability was acceptable, and all aBCCdex scale scores correlated significantly with conceptually similar scales. When divided into groups that differed based on scores from collateral measures, aBCCdex scale scores differentiated between groups (known-groups validity) and were responsive to change. CONCLUSIONS: The aBCCdex is a brief and comprehensive questionnaire appropriate for use with patients with aBCC and BCCNS. Its reliability and validity have been confirmed. Further research is necessary to estimate the minimally important difference in a larger patient population.

Relationships between symptoms, symptom bother, and health-related quality of life in patients with overactive bladder taking solifenacin or placebo in the VIBRANT study.

AIMS: Studies of antimuscarinics for overactive bladder (OAB) typically use objective and subjective measures to assess efficacy, as each provides unique information about patient outcome. We evaluated the relationships between changes in diary-documented OAB symptoms and other patient-reported outcome (PRO) measures. METHODS: In VIBRANT, OAB patients received solifenacin (5/10 mg) or placebo for 12 weeks. During the study, patients completed 3-day bladder diaries and other generic and disease-specific PRO measures. Data from both treatment groups were combined (n=738). Categorical changes in diary variables were compared with changes in PRO measures. Partial correlations controlling for treatment and Spearman correlations were also calculated. RESULTS: Categorical improvements in diary variables were significantly associated with greater improvements in PRO measures. Pair-wise comparisons showed that patients with major symptomatic improvements had significantly greater improvements on PROs vs. those with some or no improvement. Odds ratios ranged from 1.52 to 4.09 (p≤0.002). Linear relationships between changes in PRO measures and diary variables were low to moderate but statistically significant (p<0.001). Partial correlations were highest for diary variables and OAB-Questionnaire Symptom Bother. Spearman correlations ranged from 0.170 to 0.450 (p<0.001). CONCLUSIONS: In patients with OAB, changes in objectively measured symptoms of urgency, incontinence and frequency showed low-to-moderate correlations to changes in PRO measures. While providing evidence for similar change patterns in symptoms and patient perceptions, correlations were not high, lending support to the concept that in OAB clinical trials, both bladder diaries and PRO measures are important independent measures of efficacy.

The ORTHO BC-SAT--a satisfaction questionnaire for women using hormonal contraceptives.

OBJECTIVE: To assess the reliability and validity of the ORTHO Birth Control Satisfaction Assessment Tool (ORTHO BC-SAT). DESIGN: 339 women using 1 of 4 hormonal birth control methods (oral contraceptives, transdermal patch, vaginal ring, injections), completed the questionnaire 1-2 times. MATERIALS AND METHODS: The questionnaire was developed based on findings from the literature, focus groups, and interviews. Internal consistency reliability, test-retest reliability, construct validity, and known groups validity were evaluated. RESULTS: Based on variable clustering, 8 domains were identified (Ease of Use/Convenience, Compliance, Lifestyle Impact, Symptom/Side Effect Bother, Menstrual Impact, Future Fertility Concerns, Assurance/Confidence, Overall Satisfaction). Internal consistency reliability was demonstrated with Cronbach's alpha values ranging from 0.70 to 0.89. All multi-item scales reported acceptable test-retest reliability (0.79-0.87). Construct validity was demonstrated by support of a hypothesized pattern of correlations. Known groups validity was confirmed by examining scale scores of women categorized by levels of symptom bother. As expected, women with the least amount of bother reported higher scores on all satisfaction scales than those with higher bother (p < 0.0001), except on Future Fertility Concerns (p = 0.27). CONCLUSION: Our results support the reliability and validity of the ORTHO BC-SAT. It may be used in future studies to evaluate satisfaction among hormonal contraceptive users.

Gout Assessment Questionnaire: Initial results of reliability, validity and responsiveness.

We evaluated the psychometric properties of a new gout-specific patient reported outcomes questionnaire. The Gout Assessment Questionnaire (GAQ) and the SF-36 were administered to 126 subjects in a multicenter Phase II program of febuxostat, an investigational treatment for hyperuricemia (serum uric acid >8.0 mg/dl) in patients with chronic gout. The questionnaire was administered at baseline and 1, 6 and 12 months later. The majority of subjects, mean age 54 years, were male, Caucasian and had experienced a gout flare within the last year. Seven domains were identified, all met criteria for reliability and validity. Cronbach's alpha ranged from 0.78 to 0.97. Pearson correlations between GAQ and SF-36 scales were generally low to moderate, with the highest correlation between Gout Pain and Severity and SF-36 Bodily Pain, r = 0.45. Guyatt's statistic (measure of responsiveness) ranged from 0.24 to 1.00 at 12 months. Minimal clinically important differences ranged from 2 (Gout Concern) to 10 points (Productivity). The GAQ has acceptable psychometric properties. Further research is required to confirm results, which may provide more information to improve the GAQ for use in clinical trials.

Health-Related quality-of-life and quality-days incrementally gained in symptomatic nonerosive GERD patients treated with lansoprazole or ranitidine.

Eight-hundred forty-nine patients with symptomatic nonerosive GERD from two clinical trials of lansoprazole 15 mg daily (LAN 15) and lansoprazole 30 mg daily (LAN 30) vs ranitidine 150 mg twice a day (RAN 150) completed a health-related quality-of-life (HRQoL) questionnaire at baseline and four and eight weeks after treatment. The questionnaire included the Short-Form 12, GERD symptoms, eating symptoms, social restrictions, problems with sleep, work disability, treatment satisfaction, and associated importance weights items. Both LAN groups reported greater, although not significant, improvement from baseline to week 8 versus RAN 150 in the majority of HRQoL scales. Treatment satisfaction was significantly higher at week 8 in both LAN groups. Quality-days incrementally gained analysis showed that both LAN groups gained significantly more quality days than RAN 150. Patients taking lansoprazole 15 or 30 mg daily reported better outcomes than those receiving ranitidine 150 twice a day over the eight-week study.

Health-related quality of life in venous leg ulcer patients successfully treated with Apligraf: a pilot study.

Apligraf (Graftskin) is a bilayered, living human skin construct that is indicated for use with standard therapeutic compression for the treatment of noninfected partial- and full-thickness skin ulcers due to venous insufficiency of greater than 1-month duration that have not adequately responded to conventional ulcer therapy. A pilot study was conducted to assess the health-related quality of life impact of patients with venous leg ulcers treated with Apligraf. A 2-part questionnaire was administered over the telephone to patients treated with Apligraf whose ulcers had healed within the past 12 weeks. The patients were asked to respond to questions when thinking about the past week and when thinking about the time immediately prior to treatment. A total of 14 participants completed the questionnaire. All patients reported improvement in health-related quality of life after successful treatment of Apligraf. Compared with the time before treatment, 79% of respondents said their health was "much better" now. The greatest improvement was reported in pain and in other physical health dimensions. Despite the small sample size and cross-sectional design of the study, statistically significant differences were observed on a number of scales.

An instrument to measure patient satisfaction with healthcare in an observational database: results of a validation study using data from CaPSURE.

OBJECTIVE: To validate a satisfaction measure for use in longitudinal, prospective studies of patient care. STUDY DESIGN: Patients with biopsy-confirmed prostate cancer (n = 228) who were enrolled in CaPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor) completed a self-administered questionnaire that included a health-related quality-of-life and satisfaction measure. A subset of patients completed the questionnaire again within 30 days. METHODS: The satisfaction measure contained 6 individual subscales: overall satisfaction with care, contact with providers, confidence in providers, communication skills, humaneness, and a summary scale. Six items surveyed patients' willingness to participate in decision making (participatory style), and these were averaged into a single score. Variability, reliability, stability, and validity were evaluated. RESULTS: Responses to the items varied substantially. The overall satisfaction scale demonstrated good internal consistency reliability (Cronbach alpha = 0.82) and moderate test-retest reliability (0.62), and it could discriminate between groups of individuals expected to differ with regard to satisfaction (by age and disease stage). Subscale internal consistency reliability (0.37-0.54) and stability (0.38-0.63) were weaker, suggesting that only a single scale should be reported. The participatory scale performed poorly and could not be recommended for future use. CONCLUSION: The overall satisfaction measure developed for this study demonstrated good reliability and validity and should be useful in other population-based studies in conjunction with other outcome measures.

Catheter-directed thrombolysis for iliofemoral deep venous thrombosis improves health-related quality of life.

PURPOSE: Treatment designed to eliminate thrombus in patients with iliofemoral deep venous thrombosis (DVT) is theoretically attractive; however, its benefits, compared with those of anticoagulation, have not been definitively demonstrated. Although not previously analyzed, an effective measure of treatment success is likely to be the assessment of health-related quality of life (HRQOL). This study evaluated whether catheter-directed thrombolysis for iliofemoral DVT is associated with improved HRQOL, compared with standard anticoagulation, and whether HRQOL outcome in the thrombolysis group is related to lytic success. METHODS: An 80-item self-administered HRQOL questionnaire was developed. It contained the Health Utilities Index, Short Form-12, and disease-targeted scales, including health distress, stigma, health interference, physical functioning, and symptoms (eg, leg swelling, pain, ulcers). The HRQOL questionnaire was confirmed to be reliable and valid by means of psychometric testing. Questionnaires were administered to 98 retrospectively identified patients who had had iliofemoral DVT treated at least 6 months earlier. Sixty-eight patients who were identified through a DVT registry were treated with catheter-directed thrombolysis with urokinase (UK), and 30 patients who were identified by means of a medical record review were treated with anticoagulation alone. The treatment decision was made by the attending physician, and all patients were candidates for both thrombolysis and anticoagulation. RESULTS: Most patients were women (61%), white (95%), married (65%), and had a mean interval since initial DVT of 16 months. The group treated with UK was younger (53 +/- 17 years) than the group treated with heparin (61 +/- 6 years; P =.039). After treatment, patients treated with UK reported better overall physical functioning (P =.046), less stigma (P =.033), less health distress (P =.022), and fewer post-thrombotic symptoms (P =. 006), compared with the patients treated with anticoagulation alone. Within the UK group, phlebographically successful lysis correlated with improved HRQOL (P =.038). Patients classified as lytic failures had similar outcomes to patients treated with heparin. CONCLUSION: Patients with iliofemoral DVT treated with catheter-directed thrombolysis have better functioning and well-being, compared with patients treated with anticoagulation alone. Successful lysis was directly correlated with improved HRQOL, with patients who were classified as lytic failures having similar outcomes to patients treated with heparin. These data support the need for a future randomized trial, which should include an HRQOL measure as part of the outcome analysis.

Health-related quality of life and functional status of patients with rheumatoid arthritis randomly assigned to receive etanercept or placebo.

OBJECTIVE: To compare the functional status and well-being of patients with rheumatoid arthritis (RA) who were randomly assigned to receive placebo, etanercept 10 mg, or etanercept 25 mg during a 26-week, phase III, double-blind clinical trial. BACKGROUND: No single indicator of disease activity, severity, or therapeutic efficacy has been established for RA. During the past decade, health-related quality of life, a multidimensional way to assess physical, emotional, and social aspects of a disease or its treatment, has become an important outcome in RA studies and in assessments of RA drug therapies. METHODS: A total of 234 patients completed the Health Assessment Questionnaire (HAQ), the Short-Form 36 (SF-36) (n = 48 patients), items assessing energy and mental health from the Medical Outcomes Study (MOS), and a single-item rating scale assessing current health (feeling thermometer) at baseline and several times during 6 months. RESULTS: Significant improvements from baseline to last assessment were reported with etanercept versus placebo and in the HAQ Disability Index score (ie, the total HAQ score) and all 8 HAQ categories (P < 0.05), with the exception of grip. Significant improvements with etanercept in the MOS energy and mental health subscales, current health (from the feeling thermometer), and mental and physical function components of the SF-36 were reported (P < 0.05). CONCLUSIONS: Patients receiving 10- or 25-mg doses of etanercept reported significantly better functional status and well-being than did patients receiving placebo.

A new treatment satisfaction measure for asthmatics: a validation study.

The Patient Satisfaction with Asthma Medication (PSAM) questionnaire was developed because no treatment satisfaction questionnaire could be identified that was comprehensive yet brief enough for use in clinical trials. Adult moderate asthmatics residing in Canada using an inhaled medication (either salmeterol, formoterol, or albuterol) self-administered the questionnaire, which also included the Asthma Quality of Life Questionnaire (AQLQ). A total of 53 asthmatics (70% female, 45% married, mean age: 47 years) completed the questionnaire. Using variable clustering, four PSAM scales were identified: Inhaler Properties, Comparison with Other Medications, Overall Perception of Medication, and Relief. Internal-consistency reliability provided evidence of reliability and lack of redundancy (Cronbach's Alpha: 0.82-0.88). Test-retest reliability was acceptable (ICC values at or near 0.70). As expected, interscale PSAM correlations were moderate to high; correlations between the PSAM and the AQLQ were low to moderate. To assess known groups validity, respondents were categorized by self-reported degree of asthma control: 'very well controlled', 'somewhat controlled', and 'not well controlled'. Significant between-groups differences were found on all PSAM scales except Inhaler Properties. Patients categorized as 'very well controlled' tended to report highest PSAM scale scores. The PSAM questionnaire demonstrated reliability and validity in moderate asthmatics. Responsiveness should be assessed in future, prospective studies.

Uterine fibroid embolization: measurement of health-related quality of life before and after therapy.

OBJECTIVE: To determine the change in health-related quality of life associated with uterine fibroid embolization (UFE). MATERIALS AND METHODS: A health-related quality-of-life questionnaire was administered before and after therapy. The questionnaire contained validated scales from the Medical Outcomes Study, with additional domains and symptom items specific to fibroids. Patients treated with UFE for symptomatic uterine leiomyomata completed a health-related quality of life questionnaire before therapy. A follow-up quality of life questionnaire and an additional brief questionnaire to assess symptom improvement were completed 3 and 6 months postprocedure. Confirmatory reliability and validity testing was also conducted. Mean scores for each scale on the quality of life questionnaire were calculated and change scores were computed. RESULTS: Fifty women were enrolled in the study and completed the baseline assessment. Health-related quality of life scores improved in all instances at follow-up. Mean change scores were statistically significant for all domains between baseline and month 3 (P < .01) and between baseline and month 6 (P < .05) except backache (P = .12). CONCLUSION: Patients undergoing UFE report significant improvements in health-related quality of life and fibroid-specific symptoms. These findings suggest that the measurement of health-related quality of life may be an effective means of comparing the outcome of UFE with other fibroid therapies.

A comparison of patient and partner responses to a brief sexual function questionnaire.

PURPOSE: Patient self-administered questionnaires have recently been developed to assess sexual function in men with erectile dysfunction. However, it may also be important to assess satisfaction with and any improvements in sexual function from the perspective of the female partner. We report the results of a brief 3-item questionnaire developed for the female partner and its association with an 11-item questionnaire developed for men with erectile dysfunction. MATERIALS AND METHODS: Men and their female partners each self-administered a brief sexual function questionnaire several times during a clinical trial of an experimental treatment for erectile dysfunction. Items addressed the frequency and firmness of erection, and satisfaction with sex life on a 5-point Likert scale with responses ranging from 0 to 4. We compared mean values of the 3 items common to each questionnaire by respondent, and also analyzed item and scale correlations using weighted kappa statistics and/or the Pearson correlation coefficient. RESULTS: Data from 389 pairs were available. Generally patient results were fairly consistent with those of partners. Men reported slightly more frequent erection (1.6 versus 1.5), identical firmness of erection (1.2) and less satisfaction (1.2 versus 1.4) than partners. Weighted kappas of the 3 items ranged from 0.47 to 0.61, representing good agreement. The Pearson correlations were slightly higher. Internal consistency reliability using Cronbach's alpha of the 3-item scale was 0.69 (0.77 for patient and 0.81 for partner). CONCLUSIONS: These data support the use of patient and partner assessments of sexual function in clinical trials of erectile dysfunction.

Development of a health-related quality-of-life questionnaire for individuals with gastroesophageal reflux disease: a validation study.

This study was conducted to test the psychometric properties of a newly developed health-related quality-of-life (HRQoL) questionnaire. A total of 172 symptomatic GERD patients completed a 57-item questionnaire (containing the SF-12; symptom frequency/bothersomeness; problems related to activities, sleep, work disability; overall HRQoL; and treatment satisfaction) at baseline, week 1 [retest (N = 25)], and week 4 [follow-up (N = 100)]. Internal-consistency reliability was acceptable for most scales (range: 0.74-0.92). Test-retest reliability was acceptable for most scales (ICC: 0.74-0.85). Construct validity was demonstrated based on observed correlations. Known-groups validity was upheld, as patients who experienced more symptom days and patients who reported higher pain reported worse HRQoL than those with less symptoms or less severe pain. When categorized according to change in pain severity, Guyatt's statistic for the "improved" and "worse" groups demonstrated responsiveness, although many of the scales for the "stable" group were also responsive. In conclusion, the HRQoL questionnaire was found to be reliable, valid, and responsive.

A comparison of two approaches for assessing patient importance weights to conduct an Extended Q-TWiST analysis.

OBJECTIVE: Patient-centered methods for evaluating treatments require validated preference-elicitation techniques. We describe the validation of two preference-elicitation approaches for use in an Extended Q-TWiST treatment evaluation. The first method was an "idiographic" approach, which attempts to capture intra-individual differences in the degree to which each domain distracted from and interfered with life activities. The second method, a Likert-scaled approach, asks patients to evaluate the importance of each quality-of-life (QOL) domain. METHODS: Patient-reported QOL and preferences were assessed in participants with gastroesophageal reflux disease at baseline (n = 172), one week (n = 25), and 4 weeks after baseline (n = 100). RESULTS: Both approaches demonstrated high internal consistency and the ability to discriminate known groups based on reported pain and number of days with symptoms. The idiographic approach exhibited responsiveness, although it was more highly correlated with QOL than the Likert-scaled approach. The Likert-scaled approach had good face validity but demonstrated low reliability compared to the idiographic approach. CONCLUSIONS: Both preference-elicitation methods exhibited promise as well as limitations. Future research should focus on increasing the reliability of the Likert-scaled approach, reducing the overlap between the idiographic approach and QOL, and examining the relationship between reliability and responsiveness for a range of illness trajectories.

Development and validation of the Diabetes Quality of Life Clinical Trial Questionnaire.

OBJECTIVE: The objective of this study was to develop a valid and reliable health-related quality of life (HRQOL) questionnaire for use in multinational clinical trials of patients with type I and type II diabetes. METHODS: Through patient focus groups and expert clinician panels in the United States (US) and France, relevant HRQOL domains for patients with type I and type II diabetes were identified. A draft questionnaire was developed by including validated, widely used generic and diabetes-specific domains and by developing original questions as required. A pilot study (n = 123) was conducted to evaluate the psychometric properties of the draft questionnaire with revisions being subsequently made. Data collected from two multinational clinical trials of patients with type I and type II diabetes were used to further validate and enhance the questionnaire (DQLCTQ). RESULTS: A total of 942 patients were recruited in the clinical trials from Canada, France, Germany, and the United States. The mean age was 33.8 years for patients with type I diabetes (n = 468) and 58.2 years for patients with type II diabetes (n = 474). The mean HbAlc level at baseline was 8.6. The revised version of the questionnaire (DQLCTQ-R) contains a total of 57 questions comprising 8 generic and disease-specific domains, as follows: Physical Function; Energy/Fatigue; Health Distress; Mental Health; Satisfaction; Treatment Satisfaction; Treatment Flexibility; and Frequency of Symptoms. Intraclass correlation coefficients range from 0.74 to 0.90 and Cronbach's alphas range from 0.77 to 0.90. With very few exceptions, all eight domains were able to discriminate between type I and type II diabetes, tight and poor metabolic control, male and female, and good and poor self perceived control of diabetes. Four domains (Treatment Satisfaction, Health/Distress, Mental Health, and Satisfaction) were responsive to clinical change in metabolic control. CONCLUSION: The DQLCTQ-R is a reliable, valid, and comprehensive HRQOL instrument. It is suitable in multinational clinical trials to evaluate new or alternative treatments for patients with type I and type II diabetes.

A health-related quality-of-life instrument for symptomatic patients with endometriosis: a validation study.

OBJECTIVE: This study was designed to evaluate the reliability, validity, and responsiveness of a newly developed, health-related quality-of-life measure. STUDY DESIGN: A total of 137 women (122 from a Phase III clinical trial and 15 from a private practice setting) with endometriosis completed the questionnaire several times. RESULTS: Reproducibility and internal-consistency reliability were acceptable with intraclass correlation coefficients ranging from 0.94 to 1.00 and Cronbach's alpha coefficients ranging from 0.84 to 0.97. Construct validity was demonstrated on the basis of correlations between items and scales. Health-related quality of life varied in a consistent manner according to clinician-rated measures of pelvic pain and dysmenorrhea and patient-reported levels of endometriosis pain, but no relationship emerged according to the revised American Fertility Society classification. In general, the questionnaire was moderately to highly responsive to change. CONCLUSION: This is the first comprehensive health-related quality-of-life questionnaire available for use with endometriosis patients that has demonstrated reliability, validity, and responsiveness.

Health state preferences of persons with anxiety.

We compared patient ratings of the desirability of anxiety health states with measures of psychological distress and functional status and investigated how these ratings predicted treatment by primary care and mental health clinicians. As expected, associations between desirability ratings and psychological and physical health status were low to moderate. Persons who rated their current anxiety health state as more desirable received fewer mental health referrals and were statistically more likely to receive a prescription for psychotropic medication. Simple ratings of health state desirability may help clinicians evaluate patients' views of their health status and discuss potential treatment options.

Quality of life and cancer pain: satisfaction and side effects with transdermal fentanyl versus oral morphine.

PURPOSE: To compare pain-related treatment satisfaction, patient-perceived side effects, functioning, and well-being in patients with advanced cancer who were receiving either transdermal fentanyl (Duragesic, Janssen Pharmaceuticals, Titusville, NJ) or sustained-release oral forms of morphine (MS Contin, Perdue Frederick Co, Norwalk, CT, or Oramorph SR, Roxanne Laboratories, Columbus, OH). PATIENTS AND METHODS: A total of 504 assessable cancer patients participated in this cross-sectional, quality-of-life study. Relevant elements of four validated scales were used--the Functional Assessment of Cancer Therapy-General (FACT-G) scale, the Brief Pain Inventory (BPI), the Medical Outcomes Study (MOS) questionnaire, and the Memorial Symptom Assessment Scale (MSAS)--as well as original scales that were developed and validated for this study. RESULTS: The majority of patients in both treatment groups had late-stage (IV/D) cancer. Patients who received transdermal fentanyl were more satisfied overall with their pain medication than those who received sustained-release oral forms of morphine (P = .035). Fentanyl patients also experienced a significantly lower frequency (P < .002) and impact (P < .001) of pain medication side effects. These results occurred despite the fact that cancer patients who received fentanyl were significantly older (P < .001) and had significantly lower functioning and well-being scores (P = .001). Measures of pain intensity, sleep adequacy, and symptoms demonstrated no significant differences between treatment groups. CONCLUSION: These data suggest that patients are more satisfied with transdermal fentanyl compared with sustained-release oral forms of morphine. A lower frequency and reduced impact of side effects with transdermal fentanyl may be one reason cancer patients who receive fentanyl are more satisfied with their pain management.

Quality of life, health care utilization, and costs among women undergoing hysterectomy in a managed-care setting.

OBJECTIVE: We compared quality of life, utilization, and costs for women undergoing elective abdominal, laparoscopically assisted vaginal, or vaginal hysterectomy within a managed-care organization. STUDY DESIGN: A prospective study of 287 women who underwent an elective hysterectomy was performed. RESULTS: Patients undergoing a vaginal hysterectomy reported returning to normal activity levels sooner and had more favorable quality-of-life scores than did those undergoing laparoscopically assisted vaginal hysterectomy or abdominal hysterectomy. Laparoscopically assisted vaginal hysterectomy was often nearly as favorable as vaginal hysterectomy, particularly at 28 days after the operation, whereas the abdominal hysterectomy group consistently reported the poorest postoperative quality-of-life scores. No significant differences were noted in utilization or costs in the 60-day preoperative period, whereas hospitalization and postoperative costs were highest among the abdominal hysterectomy group and lowest for those undergoing a vaginal hysterectomy. CONCLUSIONS: Vaginal hysterectomy resulted in better quality-of-life outcomes and lower utilization and costs compared with laparoscopically assisted vaginal or abdominal hysterectomy.