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Modification of the EORTC QLQ-C30 (version 2.0) based on content validity and reliability testing in large samples of patients with cancer. The Study Group on Quality of Life of the EORTC and the Symptom Control and Quality of Life Committees of the NCI of Canada Clinical Trials Group.

A revision of the Quality of Life Questionnaire (QLQ-C30) of the European Organization for Research and Treatment of Cancer (EORTC) was undertaken to improve low internal consistency estimates (Cronbach's alpha) and content validity for the role functioning scale and a conceptual difficulty (undue emphasis on physical functioning) in the global quality of life (QOL) scale. The role functioning items were reworded and a four-category response format was substituted for the previous dichotomous format. A new item asking about 'overall health' was substituted for the 'overall physical condition' item in the global QOL domain. The original and new versions were tested at three time points in a total of 1,181 patients with cancer in Canada (n = 696) and the Netherlands (n = 485). In both samples there was a marked improvement in internal consistency for the role functioning scale (Cronbach's alpha s ranging from 0.78-0.88) in the new version. In the global QOL scale, the substitution of the new item for the previous one did not alter internal consistency (Cronbach's alpha's ranging from 0.81-0.92). The revised versions of the role functioning and global QOL domains have been incorporated into the QLQ-C30 (version 2.0).

Adult↗

Development and validation of an instrument to measure the effects of a mistletoe preparation on quality of life of cancer patients: the Life Quality Lectin-53 (LQL-53) Questionnaire.

Mistletoe preparations standardised to the content of mistletoe lectin are supposed to improve quality of life (QoL) in patients with cancer. To obtain a validated and sensitive research instrument, the Life Quality Lectin-53 (LQL-53) Questionnaire was developed in three phases: item generation via interviews with 42 patients, item selection by means of a study with 109 cancer patients, and psychometric testing. The LQL-53 includes 46 items assigned to the subscales 'General well-being', 'Emotional well-being', 'Vitality' 'Hope', 'Locus of control', Social relationships', and 'Physical complaints', plus seven items dealing with possible adverse effects of mistletoe treatment. Psychometric testing was carried out in a study with 112 patients with solid tumours who were treated with a mistletoe preparation standardised to mistletoe lectins for 12 weeks. Internal consistency (Cronbach's alpha) was between 0.72 and 0.94. Test-retest reliability was > or = r of 0.72. Subscales correlated highly with external criteria. Construct validity, as determined by Multitrait Scaling Analysis, resulted in an optimal assignment of items to subscales (scaling success) for four of the subscales. During the course of the therapy, significant improvement in QoL was found in all subscales. In two of the subscales, effect size was high (>0.80), and in five other subscales it varied between 0.53 and 0.78.

Adjuvants, Immunologic↗

A national study of the importance of oral health to life quality to inform scales of oral health related quality of life.

OBJECTIVES: To assess the content validity of traditional oral health status scales as measures of oral health related quality of life (OHQOL), based on a general public's perception of the most important ways in which oral health affects quality of life (QoL). METHODS: A nationwide United Kingdom study involving a random probability sample of 1778 adults. Data were collected by face-to-face interviews in participants homes. RESULTS: Most 75% (1332) perceived oral health as being important to QoL. Among them, 53% (699/1332) identified oral health's importance to QoL as being in a positive manner. Existing scales predominantly fail to include this dimension. The general public ranked oral health's importance to QoL through a range of physical, social and psychological domains. Most frequently though affecting eating or comfort; domains considered by all instruments. Other domains/ways are presented. It is apparent that even when some of the multidomain scales are employed, they frequently omit items that the public perceives as being most important to QoL. CONCLUSION: The study raises concerns about the appropriateness of utilising many of the existing oral health status scales as measures of OHQOL because the concepts do not appear to be interchangeable.

Adolescent↗

The first report from the patient outcomes registry for transplant effects on life (PORTEL): differences in side-effects and quality of life by organ type, time since transplant and immunosuppressive regimens.

BACKGROUND: Post-transplant patient quality of life (QOL) is affected by a number of different factors. A nationwide patient registry has been established to evaluate QOL and determine the effects of transplant and immunosuppressive regimens on patient outcomes. METHODS: Patients were contacted directly at national meetings, through transplant centers, and patient support groups and invited to participate in the registry. All transplant patients aged 16 and over were eligible to enroll. Patients completed a 100-item self-administered questionnaire consisting of questions about patient demographics, organ functioning, and other post-transplant outcomes. General QOL was measured by the Short form - 12 (SF-12). The Memphis Survey, an instrument developed and psychometrically validated at the University of Tennessee, was administered to patients to evaluate side-effects associated with immunosuppression. Data were analyzed from the first 722 patients who entered the registry. Side-effect profile and QOL outcomes were evaluated by organ type, time since transplant and immunosuppressive regimen. Multiple regression analyses were conducted to determine predictors of post-transplant QOL. RESULTS: When outcomes were analyzed by organ type, there were no differences in SF-12 or total weighted Memphis scores. Analysis by time since transplant demonstrated that side-effects in the mobility domain increased with patient age and time since transplant. Analysis by immunosuppressive regimen focused on cyclosporine and tacrolimus-based regimens congruent with similar classifications reported in previous studies (Pirsch JD et al. Transplantation 1997: 63: 977, Shield CF III et al. Transplantation 1997: 64: 1738). When analyzed by regimen, there were no differences between the groups in terms of patients reporting good to excellent organ function, treatment for rejection, infection, and over-immunosuppression. Statistically significant differences were observed when side-effect profile was analyzed by immunosuppressive regimen. Patients on cyclosporine-based regimens reported greater overall side-effect severity and more problems with mobility and life roles. Cyclosporine patients also reported more problems in the miscellaneous subscale, including high blood pressure, enlarged gums and hair growth, but less trouble with trembling hands. Multiple stepwise regression models identified several side-effect subscales as having profound effects on mental and physical QOL. CONCLUSION: Transplant recipients report good to excellent levels of QOL, however, side-effects associated with immunosuppressive regimens impair post-transplant QOL. Problems in certain domains, such as mobility, are found to increase with time since transplant. Tacrolimus-based regimens are associated with fewer and less severe side-effects than cyclosporine-based regimens in key domains that affect post-transplant QOL.

Activities of Daily Living↗

Quality of life in schizophrenia measured by the MOS SF-36 and the Lancashire Quality of Life Profile: a comparison.

OBJECTIVE: To compare two Quality of Life (QoL) instruments on reliability, feasibility and conceptual overlap in a group of schizophrenic out-patients. METHOD: The Lancashire Quality of Life Profile (LQoLP) and the MOS SF-36 were used to assess the QoL of 143 schizophrenic out-patients. RESULTS: Feasibility and reliability for both instruments were satisfying. Second order factor analysis on 10 LQoLP and eight MOS SF-36 scales resulted in three factors: one health related QoL factor and two general QoL factors; an internal and an external factor. CONCLUSION: QoL measures in schizophrenia studies are not exchangeable. Validity of a specific QoL instrument depends upon the purpose of the study. The LQoLP allows suggestions for specific improvements in mental health care for long-term psychiatric patients. The SF-36 is a good choice when comparison with other patient groups on health related QoL is relevant.

Adolescent↗

The intersection of life stage and social events: personality and life outcomes.

Two studies examined the intersection of life stage with the experience of social events. Study 1 tested whether social events coinciding with early adulthood are more meaningful to individuals than events during other life stages (K. Mannheim, 1972; A. J. Stewart & J. M. Healy, 1989). In 4 of 5 samples of college-educated women (3 age cohorts), the hypothesis was supported. Study 2 examined the impact of the women's movement on the personalities and careers of women who experienced the movement during early adulthood versus early middle adulthood. Women in both cohorts who found the movement meaningful attained higher education, work status, and income levels; were employed in upwardly mobile careers; and were more assertive and self-confident at midlife than women who found the movement less important. Consistent with hypotheses, finding the women's movement meaningful was associated with personality change in the older cohort.

Adult↗

Traumatic stress, perceived global stress, and life events: prospectively predicting quality of life in breast cancer patients.

The authors investigated the relationship between stress at initial cancer diagnosis and treatment and subsequent quality of life (QoL). Women (n = 112) randomized to the assessment-only arm of a clinical trial were initially assessed after breast cancer diagnosis and surgery and then reassessed at 4 months (during adjuvant treatment) and 12 months (postadjuvant treatment). There were 3 types of stress measured: number of stressful life events (K. A. Matthews et al., 1997), cancer-related traumatic stress symptoms (M. J. Horowitz, N. Wilner, & W. Alvarez, 1979), and perceived global stress (S. Cohen, T. Kamarck, & R. Mermelstein, 1983). Using hierarchical multiple regressions, the authors found that stress predicted both psychological and physical QoL (J. E. Ware, K. K. Snow, & M. Kosinski, 2000) at the follow-ups (all ps < .03). These findings substantiate the relationship between initial stress and later QoL and underscore the need for timely psychological intervention.

Adult↗

Quality of Sexual Life Questionnaire (QVS): a reliable, sensitive and reproducible instrument to assess quality of life in subjects with erectile dysfunction.

A French quality of life questionnaire specific to erectile dysfunction (ED), 'QVS' for 'Questionnaire de Vie Sexuelle', has been developed. This paper describes its validation: item reduction and reliability (internal consistency and reproducibility), construct validity and criterion validity (clinical, discriminant and concurrent). The initial 40-item questionnaire was administered once to 316 ED and 117 control subjects, and twice (D0 and D7) to 104 ED and 29 control subjects. Item reduction gave a 27-item questionnaire with three scales (Sexual Life, Skills and Psychosocial Well-being) and four scores (one score for each scale and a Global Index). Psychometric analyses demonstrated the reliability and the validity of the QVS. The questionnaire was able to discriminate patients according to the presence or severity of ED. The Skills scale was the least sensitive. Analysis of responsiveness to change over time still needs to be addressed to consider the questionnaire as a fully validated instrument.

Adult↗

Acromegaly Quality of Life Questionnaire (ACROQOL) a new health-related quality of life questionnaire for patients with acromegaly: development and psychometric properties.

OBJECTIVE: To develop a disease-specific questionnaire suitable to measure health-related quality of life (HRQOL) in acromegaly (ACROQOL). DESIGN, PATIENTS AND MEASUREMENTS: For the development of the ACROQOL questionnaire different sources of information were used: First, a literature search was performed to identify relevant papers describing the impact of acromegaly in HRQOL. Second, 10 endocrinologists identified the main domains of impact on HRQOL in patients with acromegaly. Third, 10 in-depth, semistructured interviews were conducted in acromegalic patients to identify domains and items related to the self-perceived impact of acromegaly in patients' life. Qualitative analyses of the information were performed identifying domains and items to be included in the questionnaire. Those items considered ambiguous, complicated to read, double-barrelled, with jargon terms, too long, or negatively worded were excluded. Each remaining item was subsequently rated by the same panel of endocrinologists and experts in HRQOL evaluation, and assessed according to clarity of wording, frequency of occurrence and importance among patients with acromegaly. Analysis of internal consistency of the questionnaire was evaluated with a Cronbach's Alpha. A preliminary questionnaire was administered to 72 patients with acromegaly. Rasch analysis (dichotomous logistic response model) of the answers given by these patients allowed parameter estimates and model data fit indices to be computed and misfitting items deleted. Frequency of occurrence and degree of agreement with the statements were selected as response choices in a 5-point Likert type scale. RESULTS: The following domains related to HRQOL in acromegaly were identified: physical and psychological functions, social, daily activities, symptoms, cognition, general health perception, sleep, sexual function, pain, energy and body image. An initial set of 204 expressions were identified from the initial transcripts of the patient interviews. After elimination of ambiguous or unclear expressions, 142 items remained drafted in question form. From the quantitative analysis of the item rank position within each of the three areas of clarity, frequency and importance, the 38-item questionnaire was produced, with satisfactory internal consistency (Cronbach's Alpha 0.94). Rasch analysis produced a further reduction to the final 22-item questionnaire (Cronbach's Alpha 0.91) containing two scales that evaluate physical (eight questions) and psychological aspects related to appearance and personal relations (seven items each). The evaluation of the item parameters confirmed the construct validity of the new instrument. The substantial reliability of the questionnaire suggested the sample was well targeted by the questionnaire. The initial Spanish version was translated into English and presented to five English-speaking Australian patients with acromegaly to assess and correct for comprehension, clarity, cultural relevance and suitable wording. CONCLUSIONS: We present the ACROQOL questionnaire, developed and preliminarily validated to specifically assess HRQOL in patients with acromegaly.

Acromegaly↗

Pain and health-related quality of life among cancer patients in final stage of life: a comparison between two palliative care teams.

A two-centred descriptive study was performed in order to describe and compare pain and health-related quality of life (HRQOL) among cancer patients, in their final stage of life. The patients were cared for by either a nurse-led palliative care team I (PCT I) or a physician-led palliative care team II (PCT II). Forty-six consecutive, stratified patients (PCT I, n = 21 and PCT II, n = 25) participated. The medical outcomes study short form 36 (SF-36) was used for evaluating HRQOL and the Pain-O-Meter for assessing pain. Patients' pain intensity, pain quality and HRQOL showed no significant difference between the two groups PCT I and PCT II. The patients from PCT I had significantly longer survival time (P = 0.017) than those from PCT II. The different composition of the teams being led by nurses or physicians is worth further research; both from the patient's and staff's viewpoint, there may also be cost-benefits worth examining.

Aged↗

[Quality of life assessment in Inflammatory Bowel Disease (IBD): German version of the Inflammatory Bowel Disease Questionnaire (IBDQ-D; disease-specific instrument for quality of life assessment) -- first application and comparison with international investigations].

BACKGROUND: Health-related quality of life (HRQOL) is an important outcome-parameter in health research and care. The aim of the working group Quality of Life in the Competence Network Inflammatory Bowel Disease (IBD; in the original German: "Kompetenznetz chronisch entzündliche Darmerkrankungen") is to generate instruments for assessment of HRQOL and its implementation as standards in clinical trials, health care and research in IBD. METHODS: The Inflammatory Bowel Disease Questionnaire (IBDQ) is an international validated disease specific instrument for HRQOL-assessment. A German version of the IBDQ was elaborated and tested in 415 outpatients with Crohn's disease (CD, n = 306) and ulcerative colitis (UC, n = 109). The aim of the study was to compare the results of HRQOL-assessment (IBDQ-D) with international investigations, to correlate HRQOL results with disease activity and to preform a pretest of psychometric properties. RESULTS: International data suggest that the IBDQ-D is a suitable instrument for HRQOL-assessment in CD and UC. For both disease a statistically significant negative correlation with disease activity was found. Tested psychometric properties do not suggest that a revision of the IBDQ-D is required. The IBDQ-D offers the HRQOL-assessment as an primary or secondary outcome in clinical trials in IBD in Germany.

Adult↗

Impact of the Duett sealing device on quality of life and hospitalization costs for coronary diagnostic and interventional procedures: Results from the Study of Economic and Quality of Life substudy of the SEAL trial.

BACKGROUND: The Simple and Effective Arterial Closure (SEAL) trial examined the safety and effectiveness of the Duett vascular sealing device (Vascular Solutions, Minneapolis, Minn) versus manual compression after diagnostic and interventional coronary procedures. We compared quality of life and initial hospitalization costs among patients treated with the Duett device versus manual compression. METHODS: Functional status was assessed with the Duke Activity Status Index (DASI) at 7 and 30 days after intervention. General health status was assessed with the Short Form (SF-36) at 30 days after intervention. Hospitalization costs were derived from the UB92 formulation of the hospital bill. RESULTS: There was a strong trend toward higher functional status in patients receiving treatment with the Duett device at 7 days both before (P =.04) and after (P =.08) adjustment for significant covariates. This difference was significant in the diagnostic group but not in the interventional group. No significant differences in quality of life between the Duett device and manual compression at 30 days were found. There was no significant difference in total hospitalization costs between treatment arms (P =.91). For interventional patients, mean total in-hospital costs were $10,167 in the Duett group and $10,225 in the manual compression group (P =.82). For diagnostic patients, mean hospitalization costs were $7784 and $7996 for the Duett device and manual compression groups, respectively (P =.72). Trends toward reduced recovery/observation room costs with the Duett device (P =.06) were found; this difference was significant in the diagnostic group ($198 vs $279, P =.02). CONCLUSIONS: The Duett sealing device was associated with significantly higher functional status at 7 days after the procedure in addition to shortened time to hemostasis and ambulation, with no associated increase in cost.

Adult↗

Developing the Vascular Quality of Life Questionnaire: a new disease-specific quality of life measure for use in lower limb ischemia.

AIMS: The purpose of this study was to develop and validate an easily used disease-specific quality of life (QOL) measure for patients with chronic lower limb ischemia and to design an evaluative instrument, responsive to within-subject change, that adds to clinical measures of outcome when comparing treatment options in the management of lower limb ischemia. METHODS: The first phase consisted of item generation, item reduction, formulating, and pretesting in patients with ischemia. The proportion of patients who selected an item as troublesome and the mean importance they attached to it were combined to give a clinical impact factor. Items with the highest clinical impact factor were used to formulate a new 25-item questionnaire that was then pretested in 20 patients with lower limb ischemia. In the second phase, reliability, validity, and responsiveness of the new questionnaire were assessed in 39 patients with lower limb ischemia who were tested at 0 and 4 weeks. The King's College Hospital's Vascular Quality of Life Questionnaire and the Short-Form 36 were administered at each visit, and treadmill walking distance and ankle/brachial pressure indices were recorded. The new questionnaire's reliability, internal consistency, responsiveness, and validity were determined. RESULTS: Areas of QOL impairment were consistent through the ranges of disease severity and age, with no apparent differences between the men and women. Therefore, a single questionnaire is applicable to all patients with chronic lower limb ischemia. In stable patients test-retest scores demonstrated a reliability of r more than 0.90. Each item had internal consistency (item-domain Cronbach alpha =.7-.9). The questionnaire was responsive to change, with correlation between change in the questionnaire's total score and both global and clinical indicators of change (P <.001). The questionnaire showed face and construct validity. CONCLUSIONS: This disease-specific questionnaire is reliable, responsive, valid, and ready for use as an outcome measure in clinical trials. It is sensitive to the concerns of patients with lower limb ischemia, offering a simple method to measure the effect of interventions on their QOL.

Adult↗

Quality of life assessment in the collaborative ocular melanoma study: design and methods. COMS-QOLS Report No. 1. COMS Quality of Life Study Group.

The Collaborative Ocular Melanoma Study (COMS) is a set of randomized clinical trials sponsored by the National Eye Institute of the National Institutes of Health. The COMS is being conducted to evaluate the role of radiotherapy in the treatment of patients with choroidal melanoma. Primary choroidal melanoma can enlarge or metastasize and eventually cause death in a significant percentage of cases. The primary COMS trial is designed to determine whether enucleation (removal of the eye) or radiotherapy without removal of the eye provides the patient with the longest remaining lifespan. More than 40 clinical centers in the United States and Canada are participating in the COMS. The objective of the COMS is to assess the effect of treatment upon 5-year and 10-year survival and the reduction or elimination of the disease process in patients randomly assigned to receive either radiation or enucleation. An ancillary component of the COMS, referred to as the COMS-QOLS, was designed to measure the impact of disease and its treatment on quality of life. The two treatment approaches being investigated, enucleation and radiation therapy, are likely to have different psychological and physiological effects on the patients receiving them. The COMS-QOLS assessments include the SF-36 Health Survey, the Activities of Daily Vision Scale (ADVS), the Visual Functioning Questionnaire (VFQ), and the Hospital Anxiety and Depression Scale (HADS). Patients are interviewed at selected intervals during follow-up; in addition, 200 patients will be interviewed before randomization and have repeat interviews at six months and annually after randomization. The patient's quality of life after treatment will become an important consideration in determining the best form of therapy, particularly in the event that no survival difference between treatment groups is found.

Activities of Daily Living↗

Pain and the barriers to its relief at the end of life: a lesson for improving end of life health care.

Pain among cancer patients is a common distressing symptom that frequently affects physical functioning, social interaction, psychological status, and quality of life. Despite the extensive body of knowledge available regarding cancer pain assessment and management, it often remains untreated, thereby diminishing the quality of patient care at the end of life. Recommendations on how to remove these barriers, as well as to improve care of the dying in general, need to be implemented by the U.S. government.

Activities of Daily Living↗

Quality of life in childhood asthma: use of the Paediatric Asthma Quality of Life Questionnaire in a Swedish sample of children 7 to 9 years old.

To validate a Swedish translation of the Paediatric Asthma Quality of Life Questionnaire (PAQLQ) and to study determinants of asthmatic children's quality of life, seventy-one 7-9-y-old children and their families were approached. Sixty-one children (86%) participated, 36 boys and 25 girls: 11 children with mild, 40 with moderate and 10 with severe asthma. The mean age was 8.7 y. Most commonly restricted activities during the week preceding the investigation were running (74%), gymnastics (30%), walking uphill (26%), playing football (20%) and shouting (13%). Parental rating of symptoms (Spearman's rho = -0.40, p = 0.001), percentage of expected peak flow rate (PEFR) (rho = 0.30, p = 0.009) and physicians' grading (mild, moderate and severe asthma, p = 0.047) all correlated significantly with PAQLQ scores. Younger children reported more impairment of QoL, as did children of parents not sharing household. Sex or presence of eczema or rhinoconjunctivitis did not significantly affect the scores. Children suffering from food allergy scored less impairment of QoL. The instrument was easy to administer, was well accepted by the children and had acceptable internal consistency.

Asthma↗

Can basic life support personnel safely determine that advanced life support is not needed?

OBJECTIVE: To determine whether firefighter/emergency medical technicians-basic (FF/EMT-Bs) staffing basic life support (BLS) ambulances in a two-tiered emergency medical services (EMS) system can safely determine when advanced life support (ALS) is not needed. METHODS: This was a prospective, observational study conducted in two academic emergency departments (EDs) receiving patients from a large urban fire-based EMS system. Runs were studied to which ALS and BLS ambulances were simultaneously dispatched, with the patient transported by the BLS unit. Prospectively established criteria for potential need for ALS were used to determine whether the FF/EMT-B's decision to cancel the ALS unit was safe, and simple outcomes (admission rate, length of stay, mortality) were examined. In the system studied, BLS crews may cancel responding ALS units at their discretion; there are no protocols or medical criteria for cancellation. RESULTS: A convenience sample of 69 cases was collected. In 52 cases (75%), the BLS providers indicated that they cancelled the responding ALS unit because they did not feel ALS was needed. Of these, 40 (77%) met study criteria for ALS: 39 had potentially serious chief complaints, nine had abnormal vital signs, and ten had physical exam findings that warranted ALS. Forty-five (87%) received an intervention immediately upon ED arrival that could have been provided in the field by an ALS unit, and 16 (31%) were admitted, with a median length of stay of 3.3 days (range 1.1-73.4 days). One patient died. CONCLUSION: Firefighter/EMT-Bs, working without protocols or medical criteria, cannot always safely determine which patients may require ALS intervention.

Academic Medical Centers↗

Quality of life after stroke: well-being, life satisfaction, and subjective aspects of work.

Stroke incidence in those of working age has been reported to be increasing significantly, implying strong incentives for research concerning working ability after stroke. This study focused on differences in subjective aspects of work and dimensions of quality of life after having experienced stroke. Sixty-five persons answered a postal questionnaire. The median age at the time of the stroke was 54 years, (Q3 -Q1 = 8 years). "Financial aspects" and "intrinsic aspects" of work were rated as the most important by 37% and 36% of the respondents, respectively. Fewer respondents ranked "social aspects" as most important. In total, 23 persons had returned to work, but no difference in the ratings of the most important aspects of work between those who had returned to work and those who had not was found. Persons who rated "intrinsic aspects" of work as the most important were more satisfied with the subjective dimensions of quality of life "vocational situation" (p = 0.020) and "work" (p = 0.015) than the others. In conclusion, subjective aspects of work need to be explored and discussed thoroughly in rehabilitation of younger stroke patients.

Employment↗