Standardized Quality Of Life Questionnaires Research Articles

Measuring the individual quality of life of patients with prostate cancer

Prostate cancer can have diverse effects on patients' quality of life (QoL). Standard QoL questionnaires do not address all of the concerns expressed by such patients. The primary purpose of this study was to identify those issues with the greatest influence on the QoL of patients with prostate cancer. A secondary aim was to compare the performance of the Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW) semi-structured interview with the Functional Assessment of Cancer Therapy-Prostate questionnaire (FACT-P). A mixed population of patients with prostate cancer (including those with localized and metastatic disease) completed the SEIQoL-DW and the FACT-P. The SEIQoL-DW was satisfactorily completed by 180 patients, including 93 patients with metastatic disease. Patients identified 144 separate QoL concerns, and these were then independently grouped by three of the authors into 13 distinct themes. The most frequently identified themes were 'leisure and hobbies', 'family' and 'health'. The themes that patients considered to be the most important were 'partner/spouse', 'family' and 'health'. Patients were most satisfied with their QoL in the domains of 'family', 'partner/spouse' and 'friends'. They were least satisfied with 'sexuality', 'mobility' and 'psychological factors'. Patients with metastatic disease rated their QoL significantly (P<0.0001) lower than other patients using the FACT-P, but not using the SEIQoL-DW (P=0.07). Patients with prostate cancer identified numerous QoL concerns that are not included (or are underrepresented) in standard health-related QoL questionnaires such as the FACT-P. Health-related QoL questionnaires may underestimate the QoL of patients with metastatic disease.

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To assess the effects of early intervention with suplatast tosilate (IPD® capsules, 100mg), a Th2 cytokine inhibitor, in patients with allergies to Japanese cedar and cypress pollen, we studied 93 patients with this type of allergy. Symptom, medication, and symptom medication scores were lower in patients who received early intervention with suplatast tosilate than in those who received suplatast during the pollen season. The results of a survey performed with the Japanese Allergic Rhinitis Standard Quality of Life Questionnaire also indicated that the early intervention group had good outcomes. Early intervention with suplatast was thus an effective treatment for patients with allergies to cedar and Japanese cypress pollen.We also surveyed the expectations of patients regarding drug treatment. We found that patients want to have drugs that exhibit a prolonged duration of action and are very effective without causing drowsiness.

Clinical and quality‐of‐life outcomes in women treated by the TVT‐O procedure

To objectively assess the success rate at 6 months after tension-free vaginal tape obturator (TVT-O) procedure. To assess subjective success rates, complications, patient satisfaction, and quality of life (QOL). A prospective observational study. A tertiary referral urogynaecology practice. A cohort of 100 consecutive women who underwent the TVT-O procedure between March and October 2004. The TVT-O technique was performed as described. Three standardised QOL questionnaires were completed preoperatively at 6 months and 12 months. At 6 months, a urogenital history, visual analogue scale score (VAS) for patient satisfaction, uroflow, and urinary stress test were performed. After 12 months, a urogenital history and patient satisfaction verbal analogue score (VeAS) were obtained by telephone interview. Objective success rate of the TVT-O procedure was measured by negative stress test. Secondary outcomes were subjective success rates at 6 and 12 months, pre- and postoperative comparison of urodynamic parameters, complications, postoperative symptomatology, QOL analysis, and patient satisfaction. Mean follow up was 18.5 months. Objective success rate was 95%. Subjective success rates were 92 and 84% at 6 and 12 months. Complications included recurrent urinary tract infection (six), voiding difficulty (two), persistent groin discomfort (three), haematoma (one), wound infection (one), vaginal tape erosion (one), and urethral irritation (one). Prevalence of de novo urge incontinence was 4.1 and 4.8% at 6 and 12 months. QOL analysis showed significant improvements in QOL scores postoperatively. Visual and verbal analogue scores indicated high patient satisfaction (VAS, VeAS >or= 80%) in 77 and 67% at 6 and 12 months. The TVT-O is a safe and effective treatment for female stress urinary incontinence.

The European Organisation for Research and Treatment of Cancer (EORTC) translation procedure for standardized quality of life questionnaires

16033 Background: The EORTC Quality of Life (QoL) Group has developed a modular approach to QoL measurement for use in clinical trials in cancer. Questionnaires are used in international trials and standardized translation procedures are therefore required. This report summarizes the EORTC translation procedure, its accomplishments and translation problems. Methods: Translations follow a forward-backward procedure, independently carried out by two native-speakers of the target language. Discrepancies are arbitrated by a third consultant, and solutions are reached by consensus. Translated questionnaires undergo pilot-testing. Suggestions (by patients and users) are incorporated into the final questionnaire version. Most translations are performed by professional translators. The translation procedure is managed and supervised by the Translation Committee within the EORTC QoL Group. Results: To date, the core EORTC QoL questionnaire, the QLQ-C30, has been translated and validated into 62 languages, with a further 12 translations in progress. Translations include all major Western languages, East European languages, Asian languages and also remote languages, such as Xhoza (Africa).The validated, condition-specific questionnaire modules have been translated in up to 37 languages. The following major translation problems were encountered: lack of expressions for specific symptoms in various languages, the quest for formal versus informal versions, recent spelling reforms in several European countries, and different weights of social issues between Western and Eastern cultures. The EORTC measurement system is now registered for use in over 9000 clinical studies in 80 countries worldwide. Conclusions: The EORTC provides a strong infrastructure and methodology to produce high quality translations of their QoL questionnaires for use in international clinical trials. Translation problems have been identified and it will be an important topic for future research to specify whether these problems arise out of procedural/methodological shortcomings or are due to subtle cross-cultural differences in concepts of health, illness and QoL. No significant financial relationships to disclose.

Development of a disease-specific quality of life questionnaire module for patients with gastrointestinal neuroendocrine tumours

Quality of life (QoL) measurements are increasingly being used as an end point in cancer clinical trials. Standard generic QoL questionnaires may not assess symptoms produced by neuroendocrine tumours. Here we report the development of a disease-specific quality of life score questionnaire for patients with neuroendocrine tumours of the gut to supplement the EORTC core cancer questionnaire, the QLQ-C30. Phases 1-3 of the EORTC quality of life group guidelines for module development were used to design the new questionnaire. Forty-one relevant issues (questions) were generated after an extensive literature search. Following interviews of 15 health care workers and 35 patients, a 35 question provisional questionnaire was constructed. This was translated into seven European languages and pre-tested in 180 patients resulting in a 21-item module that will be validated in an international clinical trial. The EORTC QLQ-NET21 provides a site-specific module to supplement the QLQ-C30 for patients with neuroendocrine tumours.

Impact of gefitinib (‘Iressa’) treatment on the quality of life of patients with advanced non-small-cell lung cancer

Patients with advanced non-small-cell lung cancer (NSCLC) have a short life expectancy; therefore, in addition to increasing their survival, improving their quality of life (QoL) is also an important treatment goal. We evaluated the QoL of patients with advanced NSCLC who were unfit to receive chemotherapy, failed to respond or progress following prior chemotherapy, who received subsequent treatment with gefitinib ('Iressa') on a compassionate use basis, using a standard QoL questionnaire, (EORTC) QLQ-C30 and the related lung cancer-specific module QLQ-LC13. Analysis of the functional scales showed a trend towards improvement for role, emotional and cognitive scales, while a substantial stability was seen for general QoL scale. Analysis of the symptoms scales of QLQ-C30, showed a trend towards improvement for fatigue, dyspnoea, insomnia, and constipation, after one month of therapy. Fifty-six of the 57 patients were considered evaluable for response. One patient evidenced a partial response (patient is still on response), 29 patients had stable disease for a median duration of 5 months (range 4-7 months), and 26 patients progressed. After treatment with Gefitinib, we observed maintenance of QoL in a group of patients with poor prognosis that would be expected to have a worsening QoL. Furthermore important symptoms like dyspnoea fatigue and pain in other parts, that usually afflict patients with NSCLC, showed a trend toward improvement after only one month of therapy.

Application of the Blaivas–Groutz bladder outlet obstruction nomogram in women with urinary incontinence

To test the applicability of the Blaivas-Groutz nomogram for female bladder outlet obstruction in urinary incontinent women presenting in a general gynecologic practice and to determine how the nomogram results related to the presence of obstructive symptoms according to a standardized questionnaire. All women with complaints of urinary incontinence underwent multichannel urodynamic testing, free uroflowmetry and were asked to complete a standardized quality of life questionnaire consisting of the urogenital distress inventory (UDI). The patients were classified according to the Blaivas-Groutz nomogram. One hundred and nine patients were classified according to the nomogram. Thirty-three patients (30.3%) were classified as unobstructed, 63 patients (57.8%) as mildly, 12 patients (11%) as moderately, and 1 patient (0.9%) was classified as severely obstructed. Fifty patients correctly completed the UDI. There was no significant difference (P = 0.61) in the score on the domain UDI obstruction between, according to the nomogram, obstructed and unobstructed patients. Only 18% of the obstructed patients had isolated voiding symptoms suggestive of obstruction. Forty-nine percent of the obstructed patients had urgency-frequency symptoms as well as voiding symptoms suggestive of obstruction. There was no correlation (Pearson, r = -0.06, P = 0.61) between the severity of the symptoms (assessed by the UDI scale) and the degree of obstruction (the four nomogram zones). Application of the Blaivas-Groutz nomogram gave an unlikely high prevalence of obstruction in our patient group, which showed no correlation with symptoms when measured with the UDI.

Development, validation and clinical use of the FLQA-l, a disease-specific quality of life questionnaire for patients with lymphedema

It is known from clinical practice that lymphatic diseases can be associated with reductions of quality of life (QoL). Due to the lack of validated methods, only few studies however have systematically investigated the QoL in lymphedema. The aim of the study was 1) to develop a standardized QoL questionnaire specific for lymphedema and 2) to assess the QoL in these patients. We developed and tested the FLQA-l, a novel QoL questionnaire developed specific for use in lymphedema on the basis of the previously validated FLQA vein questionnaire. The questionnaire consists of 92 items that refer to the following scales: Physical status, everyday life, social life, emotional well-being, treatment, satisfaction and profession/household. 392 patients with primary (n = 246) and secondary (n = 146) lymphedema were included in the validation study. The FLQA-l showed good internal consistency; Cronbach's alpha was higher than 0.75 in all scales. There were no floor and ceiling effects and satisfactory item selectivity. The test-retest reliability, sensitivity to change and convergent validity with other psychometric instruments were satisfactory. Clinically, patients with lymphedema showed markedly impaired QoL in all fields, compared to persons with early stage venous insufficiency, and comparable reductions of QoL, compared to patients with venous leg ulcer. These data indicate that the FLQA-l is a reliable and valid questionnaire for the assessment of QoL in lymphedema. Since the QoL is impaired in many patients with lymphedema, QoL evaluation may be helpful for clinical diagnostics as well as for outcome measurement of specific edema therapy.

Xerostomia and effects on quality of life in long-term head and neck cancer survivors

Problem: Few studies have evaluated the degree of xerostomia in long-term cancer survivors or its impact on quality of life (QOL). The purpose of this study was to objectively measure the degree of xerostomia and to determine the effect of xerostomia on the subjective quality of life of long-term survivors of head and neck cancer treated with external beam irradiation. Methods: A convenience sample of 5-year head and neck cancer survivors underwent the following battery of tests: (1) targeted head and neck exam, (2) OPSE (swallow evaluation), (3) measurements of stimulated and unstimulated saliva, and (4) standardized QOL questionnaires. Results: Eighty-six survivors were included in the study. The following associations were identified: (1) unstimulated weights were influenced by site ( P = 0.0096) and stage of cancer (and P = 0.047); (2) stimulated saliva weights were influenced by stage ( P = 0.0018); site ( P = 0.0002), particularly the larynx ( P = 0.0001); and treatment ( P = 0.0071); (3) unstimulated weight only correlated with one QOL measure (mouth is dry); (4) decreased stimulated saliva weight correlated with impaired swallowing ( P = 0.0043) and negatively impacted all but three QOL measures; and (5) subjective xerostomia correlated with impaired swallowing ( P = 0.046) as well as worse scores on about half of the QOL measures. Conclusion: This study shows that objective (stimulated saliva weight) and subjective (standardized QOL questionnaires) xerostomia persists in long-term head and neck cancer survivors. The xerostomia impairs swallowing and has a negative influence on many QOL measures. Laryngeal irradiation has little or no impact on subsequent xerostomia. Significance: Though many of the effects of radiation therapy resolve in the first 3 years, xerostomia may persist. This study demonstrates that subjective and objective indicators of xerostomia are present 5 years after treatment. The presence of chronic xerostomia continues to affect many areas of QOL in long-term head and neck cancer survivors, including though not limited to those related to the oral cavity. Support: None reported.

Questionnaires

In this issue of theCanadian Respiratory Journal, Bourbeau et al (pages 480-486) publish what could be loosely described as a validation of a French-Canadian translation of the Chronic Respiratory Questionnaire (CRQ) (1) and the St George's Respiratory Questionnaire (SGRQ) (2). They translated the questionnaires and went over them in detail until they were convinced that the questionnaires actually asked the questions that they were supposed to. They then administered them to two groups of chronic obstructive pulmonary disease (COPD) patients. One group had stable COPD and was tested twice with a two-week period between tests to examine test-retest reproducibility. The second group consisted of patients who either had an exacerbation of their COPD or who underwent rehabilitation for their disease. Both situations are associated with improvements in quality of life that should be detectable by the questionnaires. These results were compared with a third standard quality of life questionnaire. The results were very good. The questionnaire results met expectations: they were reproducible in stable patients and showed when patients improved. In psychometric terms, they were reliable and valid. I recommend the paper to people who are interested in developing and testing such instruments, both for the knowledge displayed by the authors and for the clarity of their presentation.

Effect of fexofenadine on the quality of life of Japanese cedar pollinosis patients

ABSTRACT Background The aim of the present survey was to investigate the changes associated with fexofenadine administration in the quality of life (QOL) of Japanese cedar pollinosis patients. Methods After obtaining informed consent, volunteers suffering from Japanese cedar pollinosis were divided into two groups: (i) the fexofenadine group (2 x 60 mg/day); and (ii) the placebo group. Changes in QOL were examined after administration for 14 days (randomized, double-blind comparison study). The study period was from 27 February to 13 March 2003. Subjects were recruited from the Tokyo metropolitan area; 104 were randomized to the fexofenadine group and 103 were randomized to the placebo group. The QOL was evaluated using the Japanese Allergic Rhinitis Standard QOL Questionnaire (JRQLQ no. 1). The JRQLQ is structured to evaluate six domains of usual daily activities, outdoor activities, social functioning, sleep problems, general physical problems and emotional function, as well as the overall QOL. Results On the 14th day after the start of fexofenadine or placebo administration, the QOL was improved in all domains of the JRQLQ in the fexofenadine group, whereas it had worsened in all domains, except outdoor activities, in the placebo group. The overall evaluation of QOL was significantly more favorable in the fexofenadine group on the 14th day after the start of administration. Conclusions The present study showed that fexofenadine administration suppressed the deterioration of overall QOL and alleviated the interference with daily life in patients suffering from Japanese cedar pollinosis.

Domains of health-related quality of life important to patients with giant cell arteritis.

To determine aspects of quality of life (QOL) important to people with giant cell arteritis (GCA). We explored the domains of QOL affected by GCA in audiotaped focus groups. We then created an Importance Rating Questionnaire (IRQ) by constructing questions related to the domains most frequently mentioned. Of 214 GCA patients to whom the IRQ was sent, 145 (68%) responded. We calculated frequencies of responses and then ranked items by the proportion selecting the top category of importance and also according to a mean item rank. We compared the domains of QOL covered by the IRQ with those in the Short Form 12 (SF-12). The highest rated QOL item was "losing sight in both eyes permanently." Of the top 20 items, 12 were in domains not covered directly by the SF-12. We have identified aspects of QOL important to GCA patients. Assessment of QOL in GCA should include vision and other domains that are not included in standard QOL questionnaires.

Quality of life profile: from measurement to clinical application

Quality of life (QoL) can be assessed in an accurate, valid and reliable way by means of standardized QoL questionnaires and is an important endpoint in clinical trials today. The aim of this study is to implement quality of life as a diagnostic tool for problem-oriented follow-up care of cancer patients. This is done in the framework of an intervention study in the area of regional health care research using qualitative analysis and the methodological concept of barrier analysis. We developed the diagnostic tool by generating individual, graphic QoL profiles based on patients' responses to the EORTC QLQ-C30 and the corresponding disease-specific modules BR23 for breast cancer and CR38 for rectal cancer. The clinical application is investigated by assessing physicians' responses. The QoL profile is judged as a useful diagnostic tool by all participating physicians. It enables physicians to assess the QoL of the patient and incorporate the knowledge they gain in their daily practice. Especially in breast cancer follow-up care QoL profiles give added value to both patients and doctors. The next implementation steps have to extend the concept of QoL to larger groups of patients and physicians by overcoming the restraining factors as identified in the barrier analysis.

Major bile duct injuries associated with laparoscopic cholecystectomy: effect of surgical repair on quality of life.

To assess the quality of life (QOL) of patients after surgical reconstruction of a major bile duct injury from laparoscopic cholecystectomy (LC). The incidence of bile duct injuries has increased dramatically since the introduction and widespread use of LC. Previous reports show that at long-term follow-up, most patients surgically repaired will have a successful outcome as measured by standard clinical parameters. However, there is a general impression that these patients have an impaired QOL. Data addressing QOL of these patients are limited. A standard QOL questionnaire was sent to 89 patients after successful surgical repair of a major bile duct injury from a LC treated at the Johns Hopkins Hospital between 1990 and 2000. The instrument consisted of 30 items on a visual analog scale categorized into physical (15 items), psychological (10 items), and social (5 items) domains. The same questionnaire was sent to age- and sex-matched healthy controls (n = 100) and to patients who underwent uncomplicated LC (n = 100). An additional portion of the questionnaire inquired about outcome measures and legal action undertaken by patients. Overall QOL scores for bile duct injury patients in the three domains (physical, psychological, and social) were 76%, 77%, and 75%, respectively. QOL scores were comparable to those of patients undergoing uncomplicated LC and healthy controls in the physical and social domains but were significantly different in the psychological domain. Presenting symptoms, prior repair, level of injury, number of stents, length of postoperative stenting, and length of follow-up did not influence QOL scores. Repaired patients reported similar rates of abdominal pain, change in bowel habits, use of pain medications, and recent symptoms of fever or chills as LC controls. Thirty-one percent of responding bile duct injury patients reported having sought legal recourse for their injury. All QOL domain scores were significantly lower in the patients who pursued a lawsuit versus those who did not. This study provides formal data evaluating QOL after surgical repair of major bile duct injuries from LC. Although there was a significant difference in the QOL as evaluated from a psychological dimension, bile duct injury patients reported QOL scores in the physical and social domains comparable to those of control patients. The decreased QOL assessment in the psychological dimension may be attributable to the prolonged, complicated, and unexpected nature of these injuries. The presence of a lawsuit appears to be associated with a poorer QOL assessment.

High uterosacral vaginal vault suspension with fascial reconstruction for vaginal repair of enterocele and vaginal vault prolapse

Objective: The purpose of this study was to review retrospectively the functional and anatomic outcomes of women who underwent vaginal repair of enterocele and vault prolapse with the use of an intraperitoneal suspension of the vaginal vault to the uterosacral ligaments in conjunction with fascial reconstruction of the anterior and posterior vaginal wall. Study Design: Two hundred two women with advanced symptomatic uterovaginal prolapse or posthysterectomy vault prolapse underwent a standard transvaginal procedure to correct their prolapse between January 1997 and June 2000. Anatomic results were assessed by standardized examination from 6 months to 3 years after the operation. Functional results were assessed subjectively and with standard quality of life questionnaires. The average age of the women was 60.3 years. Follow-up data were available for 168 of the 202 women. Fifty-three percent of the women had their uterus in place and underwent a vaginal hysterectomy. The prolapse repair was a primary procedure in 45.2% of the women and was performed for a recurrence or persistence in 54.8% of the women. Sixty percent and 78.6% of women underwent anterior and posterior repair, respectively. Thirty-five percent of the women underwent an anti-incontinence procedure. Results: Eighty-nine percent of the women expressed satisfaction with the results of the procedure. Ten women (5.5%) underwent a repeat operation (by the authors) for recurrence of prolapse in one or more segments of the pelvic floor. Quality of life assessment revealed a significant reduction in all aspects of daily living, when the short forms of the incontinence impact questionnaire and urogenital distress inventory were evaluated before and after the operation. Major intraoperative complications included 5 cases (2.4%) of ureteral injury, 1 case of a small bowel injury, and 1 case of a pelvic abscess that required abdominal exploratory operation and diversion of the colon. Conclusion: High uterosacral ligament vaginal vault suspension with fascial reconstruction would seem to provide a durable anatomic repair with good functional improvement in patients with significant complex uterine or vaginal vault prolapse. (Am J Obstet Gynecol 2001;185:1339-43.)

Anatomic and functional outcome of vaginal paravaginal repair in the correction of anterior vaginal wall prolapse.

Over a 2-year period 45 patients with bilateral paravaginal support defects underwent vaginal paravaginal repair. Postoperative evaluations were conducted and anatomic outcome was determined by vaginal examination, with grading of vaginal wall support. Functional outcome was assessed by a standardized quality of life questionnaire, voiding dairy and standing stress test with a full bladder. Thirty-five patients had long-term follow-up with a mean of 1.6 years (range 1-85). The recurrence rates for displacement cystocele, enterocele and rectocele were 3% (1/35), 20% (7/35) and 14% (5/35), respectively. In no patients did vault prolapse develop or recur. Subjective or objective evidence of persistent stress urinary incontinence was found in 57% of patients (12/21). Vaginal paravaginal repair is a safe and effective technique for the surgical correction of anterior vaginal wall prolapse but has limited applicability in the surgical correction of genuine stress incontinence.

Quality of life influenced by primary surgical treatment for stage I–III breast cancer - long-term follow-up of a matched-pair analysis

Background: Breast-conserving therapy has been demonstrated to be just as safe and a less disruptive experience compared with mastectomy for surgically manageable breast cancer. There is, however, no agreement in the literature about the impact of these procedures on several important aspects of quality of life (QOL). The purpose of the present study is to compare the long-term impact of these two surgical approaches on QOL in patients with identical tumor stages and to suggest possible shortcomings of the standard QOL questionnaires.

Acute leukaemia or highly malignant lymphoma patients' quality of life over two years: a pilot study.

The aim of this study was, first, to investigate the quality of life and sense of coherence for acute leukaemia and malignant lymphoma patients at the start of treatment and over 2 years. A second aim was to compare questionnaire responses with patients' statements in open-ended interviews. A consecutive sample of 16 patients responded to the Quality of Life Questionnaire (QLQ-C30), Lund Gerontological Centre questionnaire and the Sense of Coherence Scale at the start of treatment and after 12 and 24 months. The QLQ-C30 questionnaire was administered also after 4, 8, 16 and 20 months. Tape-recorded open-ended interviews were conducted every 4 months before the patients responded to the questionnaires. Quality of life (QoL) and sense of coherence were scored more highly at the beginning of treatment for patients who did not relapse, than for those who relapsed. This difference remained throughout the study period. There was no correspondence in responses between questionnaire and personal interviews, although the results from the interviews, in some aspects, validated the result from the QLQ-C30. Those patients who relapsed may have had different prerequisites or been in a worse position at the onset of the disease and, reasonably, they needed more compensatory nursing care. More knowledge about the correspondence between a person's perceived QoL when discussed in personal interviews compared with responses given in standardised QoL questionnaires is needed before any assumption about clinical relevance can be made.

Willingness-To-Pay and Time-Trade-Off: Useful Utilities in Patients with Psoriasis vulgaris?

Background: For cost-utility-analyses in pharmaco-economic research, it is necessary to additionally assess quality-of-life (QoL) parameters for content validation of the utilities. Utilities such as ‘willingness-to-pay’ and ‘time-trade-off’ bear several advantages in comparison to questionnaires of QoL: utilities are more practicable and provide data that are easier to use for pharmaco-economic evaluations. Objective: Development of suitable questions for assessing both ‘willingness-to-pay’ and ‘time-trade-off’ and evaluation of correlation with a standardized QoL questionnaire. Methods: Both assessments were employed in a survey on patients suffering from psoriasis vulgaris pre and post treatment with synchronous balneo-phototherapy. Simultaneously the Psoriasis Disability Index (PDI) for evaluation of quality-of-life was used. Results: Data of 105 patients could be annualized. Com-pared to the assessments pre treatment, mean reduction of PDI was 25.5% (29 pre treatment, 21.6 post treatment), mean reduction in willingness-to-pay was 22.5% (proportion of monthly income in %: 16 pre to 12.4 post treatment) and mean reduction in time-trade-off 1% (percentage of hours per day: 3.4 pre to 3.3 post treatment). While willing-ness- to-pay is highly correlated with the PDI (p < 0.05), time-trade- off does not seem to be a valid parameter for assessment of utilities over time in this target population. Conclusion: The results indicate that the principle of willingness- to-pay bears high potential for use in dermatological indications, especially in pharmaco-economic evaluations.

Quality of life and outcomes after pancreaticoduodenectomy.

To assess the quality of life (QOL) and functional outcome of patients after pancreaticoduodenectomy. Pancreaticoduodenectomy is gaining acceptance and is being performed in increasing numbers for various malignant and benign diseases of the pancreas and periampullary region. There is a general impression that pancreaticoduodenectomy can severely impair QOL and alter normal activities. Only a few small studies have evaluated QOL after pancreaticoduodenectomy. A standard QOL questionnaire was sent to 323 patients surviving pancreaticoduodenectomy who had undergone surgery at The Johns Hopkins Hospital between 1981 and 1997. Thirty items on a visual analog scale were categorized into three domains: physical (15 items), psychological (10 items), and social (5 items). Scores are reported as a percentile, with 100% being the highest possible score. The same QOL questionnaire was also sent to laparoscopic cholecystectomy patients and healthy controls. A separate component of the questionnaire asked about functional outcomes and disabilities. Overall QOL scores for the 192 responding pancreaticoduodenectomy patients in the three domains (physical, psychological, social) were 78%, 79%, and 81%, respectively. These QOL scores were comparable to those of the 37 laparoscopic cholecystectomy patients and the 31 healthy controls. The pancreaticoduodenectomy patients were subgrouped into chronic pancreatitis, other benign disease, pancreatic adenocarcinoma, and other cancers. Patients who underwent resection for chronic pancreatitis and pancreatic adenocarcinoma had significantly lower QOL scores in the physical and psychological domains compared with the laparoscopic cholecystectomy patients and the healthy controls. Common problems after pancreaticoduodenectomy were weight loss, abdominal pain, fatigue, foul stools, and diabetes. This is the largest single-institution experience assessing QOL after pancreaticoduodenectomy. These data demonstrate that as a group, patients who survive pancreaticoduodenectomy have near-normal QOL scores. Many patients report weight loss and symptoms consistent with pancreatic exocrine and endocrine insufficiency. Most patients have QOL scores comparable to those of control patients and can function independently in daily activities.