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Objectives: To develop a value set reflecting the United States (US) general population's preferences for health states described by the Functional Assessment of Cancer Therapy (FACT) eight-dimensions preference-based multi-attribute utility instrument (FACT-8D), derived from the FACT-General cancer-specific health-related quality-of-life (HRQL) questionnaire. Methods: A US online panel was quota-sampled to achieve a general population sample representative by sex, age (≥ 18 years), race and ethnicity. A discrete choice experiment (DCE) was used to value health states. The valuation task involved choosing between pairs of health states (choice-sets) described by varying levels of the FACT-8D HRQL dimensions and survival (life-years). The DCE included 100 choice-sets; each respondent was randomly allocated 16 choice-sets. Data were analysed using conditional logit regression parameterized to fit the quality-adjusted life-year framework, weighted for sociodemographic variables that were non-representative of the US general population. Preference weights were calculated as the ratio of HRQL-level coefficients to the survival coefficient. Results: 2562 panel members opted in, 2462 (96%) completed at least one choice-set and 2357 (92%) completed 16 choice-sets. Pain and nausea were associated with the largest utility weights, work and sleep had more moderate utility weights, and sadness, worry and support had the smallest utility weights. Within dimensions, more severe HRQL levels were generally associated with larger weights. A preference-weighting algorithm to estimate US utilities from responses to the FACT-General questionnaire was generated. The worst health state's value was −0.33. Conclusions: This value set provides US population utilities for health states defined by the FACT-8D for use in evaluating oncology treatments. [ABSTRACT FROM AUTHOR]

Up to 50% of children and adolescents in the United States (U.S.) experience sleep problems. While existing research suggests that perceived stress in caregivers is associated with poorer sleep outcomes in children, research on this relationship is often limited to infant and early childhood populations; therefore, we investigated this association in school-age children and adolescents. We used cross-sectional caregiver-reported surveys and applied item response theory (IRT) followed by meta-analysis to assess the relationship between caregiver perceived stress and child sleep disturbance, and moderation of this relationship by child age and the presence of a child mental or physical health condition. We analyzed data from the National Institutes of Health (NIH) Environmental influences on Child Health Outcomes (ECHO) Program, a collaboration of existing pediatric longitudinal cohort studies that collectively contribute a diverse and large sample size ideal for addressing questions related to children's health and consolidating results across population studies. Participants included caregivers of children ages 8 to 16 years from four ECHO cohorts. Caregiver perceived stress was measured using the Perceived Stress Scale (PSS), and child sleep disturbance was assessed using five sleep-related items from the School-Age version of the Child Behavior Checklist (CBCL). Increases in caregiver perceived stress and child mental or physical health condition were independently associated with greater sleep disturbance among children. The findings reinforce the importance of accounting for, and potentially intervening on, the broader family context and children's mental and physical health in the interest of improving sleep health. Highlights: Existing research suggests caregiver perceived stress is associated with worse child sleep outcomes. Data from eight cohorts in the National Institutes of Health (NIH) Environmental influences on Child Health Outcomes (ECHO) program were used. We combined item-level analysis within each cohort with meta-analysis to aggregate results across cohorts. Higher caregiver perceived stress and child health conditions were independently associated with poorer child sleep. Study findings reinforce the importance of the broader family context in the interest of improving sleep health. [ABSTRACT FROM AUTHOR]

Purpose: To derive a health state classification system (HSCS) from the cancer-specific quality of life questionnaire, the EORTC QLQ-C30, as the basis for a multi-attribute utility instrument.Methods: The conceptual model for the HSCS was based on the established domain structure of the QLQ-C30. Several criteria were considered to select a subset of dimensions and items for the HSCS. Expert opinion and patient input informed a priori selection of key dimensions. Psychometric criteria were assessed via secondary analysis of a pooled dataset comprising HRQOL and clinical data from 2616 patients from eight countries and a range of primary cancer sites, disease stages, and treatments. We used confirmatory factor analysis (CFA) to assess the conceptual model's robustness and generalisability. We assessed item floor effects (>75 % observations at lowest score), disordered item response thresholds, coverage of the latent variable and differential item function using Rasch analysis. We calculated effect sizes for known group comparisons based on disease stage and responsiveness to change. Seventy-nine cancer patients assessed the relative importance of items within dimensions.Results: CFA supported the conceptual model and its generalisability across primary cancer sites. After considering all criteria, 12 items were selected representing 10 dimensions: physical functioning (mobility), role functioning, social functioning, emotional functioning, pain, fatigue, sleep, appetite, nausea, bowel problems.Conclusions: The HSCS created from QLQ-C30 items is known as the EORTC Quality of Life Utility Measure-Core 10 dimensions (QLU-C10D). The next phase of the QLU-C10D's development involves valuation studies, currently planned or being conducted across the globe. [ABSTRACT FROM AUTHOR]

Purpose: Huntington disease (HD) is an incurable terminal disease. Thus, end of life (EOL) concerns are common in these individuals. A quantitative measure of EOL concerns in HD would enable a better understanding of how these concerns impact health-related quality of life. Therefore, we developed new measures of EOL for use in HD.Methods: An EOL item pool of 45 items was field tested in 507 individuals with prodromal or manifest HD. Exploratory and confirmatory factor analyses (EFA and CFA, respectively) were conducted to establish unidimensional item pools. Item response theory (IRT) and differential item functioning analyses were applied to the identified unidimensional item pools to select the final items.Results: EFA and CFA supported two separate unidimensional sets of items: Concern with Death and Dying (16 items), and Meaning and Purpose (14 items). IRT and DIF supported the retention of 12 Concern with Death and Dying items and 4 Meaning and Purpose items. IRT data supported the development of both a computer adaptive test (CAT) and a 6-item, static short form for Concern with Death and Dying.Conclusion: The HDQLIFE Concern with Death and Dying CAT and corresponding 6-item short form, and the 4-item calibrated HDQLIFE Meaning and Purpose scale demonstrate excellent psychometric properties. These new measures have the potential to provide clinically meaningful information about end-of-life preferences and concerns to clinicians and researchers working with individuals with HD. In addition, these measures may also be relevant and useful for other terminal conditions. [ABSTRACT FROM AUTHOR]

Purpose: To assess the feasibility of using a discrete choice experiment (DCE) to value health states within the QLU-C10D, a utility instrument derived from the QLQ-C30, and to assess clarity, difficulty, and respondent preference between two presentation formats.Methods: We ran a DCE valuation task in an online panel (N = 430). Respondents answered 16 choice pairs; in half of these, differences between dimensions were highlighted, and in the remainder, common dimensions were described in text and differing attributes were tabulated. To simplify the cognitive task, only four of the QLU-C10D's ten dimensions differed per choice set. We assessed difficulty and clarity of the valuation task with Likert-type scales, and respondents were asked which format they preferred. We analysed the DCE data by format with a conditional logit model and used Chi-squared tests to compare other responses by format. Semi-structured telephone interviews (N = 8) explored respondents' cognitive approaches to the valuation task.Results: Four hundred and forty-nine individuals were recruited, 430 completed at least one choice set, and 422/449 (94 %) completed all 16 choice sets. Interviews revealed that respondents found ten domains difficult but manageable, many adopting simplifying heuristics. Results for clarity and difficulty were identical between formats, but the "highlight" format was preferred by 68 % of respondents. Conditional logit parameter estimates were monotonic within domains, suggesting respondents were able to complete the DCE sensibly, yielding valid results.Conclusion: A DCE valuation task in which only four of the QLU-C10D's ten dimensions differed in any choice set is feasible for deriving utility weights for the QLU-C10D. [ABSTRACT FROM AUTHOR]

Previous studies suggest switching from pamidronate to a more potent bone-targeted agent is associated with biomarker and palliative response in breast cancer patients with bone metastases. Until now, this has not been addressed in a double-blind, randomized trial. Breast cancer patients with high-risk bone metastases, despite >3 months of pamidronate, were randomized to either continue pamidronate or switch to zoledronic acid every 4 weeks for 12 weeks. Primary outcome was the proportion of patients achieving a fall in serum C-telopeptide (sCTx) at 12 weeks. Secondary outcomes included difference in mean sCTx, pain scores, quality of life, toxicity, and skeletal-related events (SREs). Seventy-three patients entered the study; median age 61 years (range 37-87). Proportion of patients achieving a fall in sCTx over the 12-week evaluation period was 26/32 (81 %) with zoledronic acid and 18/29 (62 %) with pamidronate ( p = 0.095). Mean decrease in sCTx (mean difference between groups = 50 ng/L, 95 % CI 18-84; p = 0.003) was significantly greater in patients who received zoledronic acid. Quality of life, pain scores, toxicity, and frequency of new SREs were comparable between the two arms. While a switch from pamidronate to zoledronic acid resulted in reduction in mean sCTx, there were no significant differences between the arms for proportion of patients achieving a reduction in sCTx, quality of life, pain scores, toxicity or SREs. Given the lack of palliative improvement, the current data do not support a switching strategy. [ABSTRACT FROM AUTHOR]

Introduction: The quality of life in neurological disorders (Neuro-QoL) measurement system is a 470-item compilation of health-related quality of life domains for adults and children with neurological disorders. It was developed and cognitively debriefed in English and Spanish, with general population and clinical samples in the USA. This paper describes the Spanish translation and linguistic validation process. Methods: The translation methodology combined forward and back-translations, multiple reviews, and cognitive debriefing with 30 adult and 30 pediatric Spanish-speaking respondents in the USA. The adult Fatigue bank was later also tested in Spain and Argentina. A universal approach to translation was adopted to produce a Spanish version that can be used in various countries. Translators from several countries were involved in the process. Results: Cognitive debriefing results indicated that most of the 470 Spanish items were well understood. Translations were revised as needed where difficulty was reported or where participants' comments revealed misunderstanding of an item's intended meaning. Additional testing of the universal Spanish adult Fatigue item bank in Spain and Argentina confirmed good understanding of the items and that no country-specific word changes were necessary. Conclusion: All the adult and pediatric Neuro-QoL measures have been linguistically validated with Spanish speakers in the USA. Instruments are available for use at . [ABSTRACT FROM AUTHOR]

The Functional Assessment of Human Immuno-deficiency Virus (HIV) Infection (FAHI) quality of life instrument was developed using a combination of conceptual and empirical strategies. The core, general health-related quality of life instrument is the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire. The FACT-G was selected to enable comparison of data across two similar, life-threatening conditions and because of its desirable psychometric properties. Initial data on both the relevance (applicability) of the FACT-G to the HIV population and the generation and testing of questions for an HIV-specific subscale were encouraging. Consequently, the FACT-G and a 9-item HIV-specific subscale were combined and tested in 196 patients in three categories: an English-speaking stress management sample from Chicago, illinois (n = 110); an English-speaking urban, mixed race sample from Chicago (n = 71); and a Spanish-speaking urban sample from Chicago and San Juan, Puerto Rico (n = 64). With the exception of the Social Well-being subscale, the subscales of the FACT-G demonstrated good internal consistency reliability across all three samples (alpha range = 0.72-0.88). Total FAHI scores produced consistently high alpha coefficients (0.89-0.91). Concurrent validity data included moderately strong associations with other measures of similar concepts and an ability to distinguish groups of patients by activity level and disease severity. Sensitivity to change in mood disturbance and responsiveness to a stress management intervention were also evident. The 9-item HIV-specific subscale demonstrated relatively low alpha coefficients (range = 0.53-0.71) and marginal sensitivity to change, leading to supplementation of content with an additional 11 items, creating a 20-item HIV-specific subscale that is currently being tested. Clinical trial and clinical practice investigators are encouraged to use the FACT-G in its current (version 3) form when evaluating group differences and within-group change over time. It should prove particularly useful when comparing clinical trial and clinical practice data for cancer vs. HIV-infected patients and in the evaluation of treatments for HIV disease and HIV-related malignancy. The supplemental 20 questions comprising the revised HIV-specific subscale are undergoing further testing, and may ultimately enhance the value of this measurement system. [ABSTRACT FROM AUTHOR]

There is need for multilingual cross-culturally valid quality of life (QOL) instrumentation to assess the QOL endpoint in international oncology clinical trials. We therefore initiated a multilingual translation of the Functional Assessment of Cancer Therapy (FACT) Quality of Life Measurement System (Version 3) into the following languages: Dutch, French, German, Italian, Norwegian and Swedish. Prior to this project, the FACT Measurement System was available in English, Spanish and Canadian French. The FACT is a self-report instrument which measures multidimensional QOL. The FACT (Version 3) evaluation system uses a 29-49 item compilation of a generic core (29 Likert-type items) and numerous subscales (9-20 items each) which reflect symptoms associated with different diseases, symptom complexes and treatments. The FACT-G (general version) and eight of 18 available cancer-related subscales were translated using an iterative forward-backward translation sequence. After subsequent review by 21 bilingual health professionals, all near final language versions underwent pretesting with a total of 95 patients in the native countries. Available results indicate good overall comprehensibility among native language-speakers. Equivalent foreign language versions of the FACT will permit QOL evaluation of people from diverse cultural backgrounds. [ABSTRACT FROM AUTHOR]

The purpose of this investigation is to examine methods of scoring the FACT-G when there is non-response to individual questions. Using completed questionnaires from 350 patients, random and non-random missing responses where simulated. Seven methods of scoring the FACT-G are compared on the basis of accuracy (bias and precision) of both population estimates and prediction of individual scores. Substituting the mean of the completed items in the subscale when more than 50% are completed is generally the most unbiased and precise approach. Case deletion is the worst approach and results in clinically significant bias when the missing responses were non-random and a lack of precision when the rate of non-response was high. [ABSTRACT FROM AUTHOR]

A brief visual analogue instrument was developed and tested in the context of a multicentre randomized double-blinded four-dose trial of megestrol acetate for the treatment of AIDS-related anorexia/cachexia. This nine-item instrument, the Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI), was administered every 4 weeks after initiation of study drug (placebo vs 100 mg, 400 mg or 800 mg of drug). The purpose of the instrument was to quantify patient perception of benefit in areas such as decreased concern over weight, decreased concern over appearance, increased pleasure in eating and increase in global perception of quality of life. Post-trial psychometric evaluation of the instrument strongly supported the use of a seven-item index of subjective recovery from symptoms of anorexia/cachexia (BACRI-7) and a single criterion item depicting patient perception of benefit (BACRI-1). The BACRI-7 and BACRI-1 scales showed significant improvement over 12 weeks in patients who received higher dose active drug (400 and 800 mg) compared with the placebo and 100 mg doses. Further differentiation of 400 vs 800 mg arms was seen in the BACRI-7 results, consistent with dose-response improvements in weight and lean body mass changes. Quadratic trends over time in lean body mass change and provider-rated appetite grade suggested peak therapeutic effect at 8 weeks for these endpoints, whereas the absence of these trends in overall weight and patient-reported BACRI scores suggested that these benefits are more persistent. Although subjective (patient-reported) benefit is strongly associated with objective indicators of improvement, there remains the possibility that there is some added, independent benefit of megestrol acetate to subjective well-being. [ABSTRACT FROM AUTHOR]

When planning to implement health-related quality of life (HRQL) assessment in a multinational clinical trial, there are at least four general considerations: the natural history of the disease or condition, the characteristics of the population, the treatment under consideration, and the structure and function of the clinical trial organization. Each of these considerations must be addressed simultaneously when planning, implementing and analysing a cross-national clinical trial. There are five relevant polar components of the natural history of a given disease or condition: (1) time frame (acute versus chronic); (2) life threat (yes versus no); (3) symptomatology (present versus absent); (4) symptom expression (episodic versus constant); and (5) functional impact (present versus absent). Differences in population characteristics, (e.g., age, conditions, co-morbidity), embedded within any cross-national trial, must be addressed conceptually prior to initiating the trial, methodologically when planning implementation, and statistically after the collection of the data. In terms of treatment, issues such as adverse and positive effects and timing of effects must be considered. The methods entailed in planning, implementing and analysing HRQL data will depend upon the degree of centralization of personnel and resources within any given clinical trial. The range of possibilities runs from complete centralization, in which all planning and coordination of data collection and transmittal is done by one office, to complete decentralization, in which the work is distributed to participating sites and interested investigators. Finally, successful implementation of HRQL data collection is enhanced by heightening awareness of the importance of, and value in, assessing HRQL in clinical trials.(ABSTRACT TRUNCATED AT 250 WORDS) [ABSTRACT FROM AUTHOR]

To promote the inclusion of quality of life (QOL) end-points in clinical research on cancer, the National Cancer Institute (USA) sponsored a workshop on QOL assessment in cancer clinical trials in July, 1990. Experts in clinical trials and QOL research formed four working groups to identify current areas of cancer treatment in which QOL end-points are most important; to discuss methodologic problems in QOL assessment; to address common problems in implementing clinical studies with QOL end-points; and to consider statistical issues in design, implementation, and data analysis. Recommendations made by the working groups are summarized in this paper. [ABSTRACT FROM AUTHOR]

Background: The Patient-Reported Outcomes Measurement Information System (PROMIS) is a new, state-of-the-art assessment system for measuring patient-reported health and well-being of adults and children that has the potential to be more valid, reliable and responsive than existing PROMs. The PROMIS items can be administered in short forms or, more efficiently, through computerized adaptive testing. This paper describes the translation of 563 items from 17 PROMIS item banks (domains) for adults from the English source into Dutch-Flemish. Methods: The translation was performed by FACITtrans using standardized methodology and approved by the PROMIS Statistical Center. The translation included four forward translations, two back-translations, three to five independent reviews (at least two Dutch, one Flemish) and pre-testing in 70 adults (age range 20-77) from the Netherlands and Flanders. Results: A small number of items required separate translations for Dutch and Flemish: physical function (five items), pain behaviour (two items), pain interference (one item), social isolation (one item) and global health (one item). Challenges faced in the translation process included: scarcity or overabundance of possible translations, unclear item descriptions, constructs broader/smaller in the target language, difficulties in rank ordering items, differences in unit of measurement, irrelevant items or differences in performance of activities. By addressing these challenges, acceptable translations were obtained for all items. Conclusion: The methodology used and experience gained in this study can be used as an example for researchers in other countries interested in translating PROMIS. The Dutch-Flemish PROMIS items are linguistically equivalent. Short forms will soon be available for use and entire item banks are ready for cross-cultural validation in the Netherlands and Flanders. [ABSTRACT FROM AUTHOR]

Background:Axitinib demonstrated greater progression-free survival vs sorafenib in a phase III study of previously treated patients with metastatic renal cell carcinoma. Here, we report patient-reported kidney-specific symptoms and health status, measured by the Functional Assessment of Cancer Therapy (FACT) Kidney Cancer Symptom Index (FKSI) and the European Quality of Life self-report questionnaire (EQ-5D).Methods:In all, 723 patients received axitinib (starting dose 5 mg twice daily (b.i.d.)) or sorafenib (400 mg b.i.d.). The FKSI-15, including the disease-related symptoms (FKSI-DRS) subscale, was administered on day 1 before dosing, every 4 weeks and at end of treatment (EOT)/withdrawal. Statistical methods included a mixed-effects repeated-measures model.Results:At baseline, patients in both arms had relatively high mean FSKI-15 and FKSI-DRS scores, comparable to the general US population. Subsequent on-treatment overall mean scores were similar between axitinib and sorafenib, and there was no substantial decline during treatment. Scores substantially worsened at EOT, mainly due to disease progression.Conclusion:Patient-reported outcomes were comparable for second-line axitinib and sorafenib and were maintained at relatively high levels while on treatment, but worsened at EOT. As duration of treatment was longer with axitinib than sorafenib, time to worsening of symptoms can be delayed longer with axitinib. [ABSTRACT FROM AUTHOR]

Background:In a randomized phase III trial of sunitinib vs interferon-alfa (IFN-α) in metastatic renal cell carcinoma (mRCC), better baseline quality of life (QoL) was predictive of longer survival. Using this dataset, we have developed a novel prognostic tool that establishes a relationship between baseline QoL scores and median survival time.Methods:Baseline QoL was assessed using the FACT-Kidney Symptom Index-15 item (FKSI-15), its disease-related symptoms (FKSI-DRS) subscale, and the Functional Assessment of Cancer Therapy-General (FACT-G) scale. Weibull models estimated median progression-free survival (mPFS) and overall survival (mOS) as a function of baseline QoL.Results:Longer PFS and OS were associated with higher baseline FKSI-15, FKSI-DRS, and FACT-G scores (P<0.05), and baseline FKSI-15 score was the best predictor of survival. For example, for a baseline FKSI-15 score of 60, the predicted mPFS was 67.9 weeks, and predicted mOS was 240.6 weeks. The magnitude of benefit was greater with sunitinib vs IFN-α for a given baseline QoL score.Conclusion:This novel tool indicates that baseline FKSI-15 scores were linked to mPFS and mOS in a clear and interpretable way. The results support evaluation of patient-reported QoL symptoms at baseline as a prognostic indicator of survival in clinical research and practice. [ABSTRACT FROM AUTHOR]

Across two general population (total n=1,878) and two cancer (total n=3,140) samples, we evaluated the dimensionality of self-reported fatigue as measured by the Functional Assessment of Chronic Illness Therapy--Fatigue (FACIT-F) instrument. After evaluating dimensionality of the FACIT-F, we compared the conceptually distinct fatigue experience versus fatigue impact scores in each sample. Confirmatory factor analysis of the 13-item scale showed very good fit to a single dimension ("unidimensional") model for each sample (comparative fit index range=0.92-0.97). Using a bifactor model to compare the loading of each item with the general fatigue factor versus the identified sub-domain (experience or impact), we found the item-general loading to be higher than that of the item-sub-domain factor in 52 of 52 comparisons (13 items; four samples). When scored separately, experience and impact scores were correlated highly (range=0.80-0.88), yet their difference relative to one another was significant (p<0.001). Consistently across samples, experience scores were systematically higher (more endorsement) than impact scores, by a margin of 0.21-0.46 SD units. This suggests that the fatigue experience and the impact of fatigue upon function are reported along a single dimensional continuum, but that experience is more likely than impact upon function to be endorsed at lower levels of fatigue. Fatigue as an outcome or trial endpoint can be expressed as a single number, and the experience of the symptom is more likely to be endorsed at mild levels of fatigue, presumably before the symptom exerts an adverse impact upon function. [ABSTRACT FROM AUTHOR]

Purpose: Individuals diagnosed and treated for cancer often report high levels of distress, continuing even after successful treatment. Spiritual well-being (SpWB) has been identified as an important factor associated with positive health outcomes. This study had two aims: (1) examine the associations between SpWB (faith and meaning/peace) and health-related quality of life (HRQL) outcomes and (2) examine competing hypotheses of whether the relationship among distress, SpWB, and HRQL is better explained by a stress-buffering (i.e., interaction) or a direct (main effects) model.Methods: Study 1 consisted of 258 colorectal cancer survivors (57% men) recruited from comprehensive cancer centers in metropolitan areas (age, M=61; months post-diagnosis, M=17). Study 2 consisted of 568 colorectal cancer survivors (49% men) recruited from a regional cancer registry (age, M=67; months post-diagnosis, M=19). Participants completed measures of SpWB (functional assessment of chronic illness therapy-spiritual well-being (FACIT-Sp)) and HRQL (functional assessment of cancer therapy-colorectal) in both studies. Measures of general distress (profile of mood states-short form) and cancer-specific distress were also completed in study 1 and study 2, respectively.Results: After controlling for demographic and clinical variables, faith and meaning/peace were positively associated with HRQL. However, meaning/peace emerged as a more robust predictor of HRQL outcomes than faith. Planned analyses supported a direct rather than stress-buffering effect of meaning/peace.Conclusions: This study provides further evidence of the importance of SpWB, particularly meaning/peace, to HRQL for people with colorectal cancer. Future studies of SpWB and cancer should examine domains of the FACIT-Sp separately and explore the viability of meaning-based interventions for cancer survivors. [ABSTRACT FROM AUTHOR]

Background: We evaluated the reliability and validity of the Pediatric Functional Assessment of Cancer Therapy-Childhood Brain Tumor Survivor version 2.0 (pedsFACT-BrS; patient version for grade school children aged 7-12 years).Methods: After translating and cross-culturally adapting it into Korean, the psychometric properties of the pedsFACT-BrS were evaluated in 148 childhood brain tumor survivors (mean age, 9.67 years). Pre-testing was performed in 25 patients.Results: The pedsFACT-BrS showed good symptom coverage and overall user comprehension. Internal consistency was acceptable, with Cronbach's α coefficients ranging from 0.70 to 0.92. The pedsFACT-BrS also demonstrated good convergent and divergent validities when correlated with the Revised Children's Manifest Anxiety Scale and Kovacs' Children's Depression Scale. The pedsFACT-BrS showed good known-group validity and effectively differentiated between clinically distinct patient groups (patient vs. control groups, and among patients having different Karnofsky scores), but offered only partial discrimination of physical well-being (PWB) scores when patients were grouped by treatment type.Conclusions: Our results indicate that this instrument is reliable and valid and can be used to evaluate the quality of life of Korean childhood brain tumor survivors. [ABSTRACT FROM AUTHOR]

Background: In a randomised phase III trial, sunitinib significantly improved efficacy over interferon-alpha (IFN-alpha) as first-line therapy for metastatic renal cell carcinoma (mRCC). We report the final health-related quality of life (HRQoL) results.Methods: Patients (n=750) received oral sunitinib 50 mg per day in 6-week cycles (4 weeks on, 2 weeks off treatment) or subcutaneous IFN-alpha 9 million units three times weekly. Health-related quality of life was assessed with nine end points: the Functional Assessment of Cancer Therapy-General and its four subscales, FACT-Kidney Symptom Index (FKSI-15) and its Disease-Related Symptoms subscale (FKSI-DRS), and EQ-5D questionnaire's EQ-5D Index and visual analogue scale. Data were analysed using mixed-effects model (MM), supplemented with pattern-mixture models (PMM), for the total sample and the US and European Union (EU) subgroups.Results: Patients receiving sunitinib reported better scores in the primary end point, FKSI-DRS, across all patient populations (P<0.05), and in nine, five, and six end points in the total sample, in the US and EU groups respectively (P<0.05). There were no significant differences between the US and EU groups for all end points with the exception of the FKSI item 'I am bothered by side effects of treatment' (P=0.02). In general, MM and PMM results were similar.Conclusion: Patients treated with sunitinib in this study had improved HRQoL, compared with patients treated with IFN-alpha. Treatment differences within the US cohort did not differ from those within the EU cohort. [ABSTRACT FROM AUTHOR]

As part of a program to understand the genetics of Amazonian ornamental fish, classical cytogenetics was used to analyze Symphysodon aequifasciatus, S. discus and S. haraldi, popular and expensive aquarium fishes that are endemic to the Amazon basin. Mitotic analyses in Symphysodon have shown some odd patterns compared with other Neotropical cichlids. We have confirmed that Symphysodon species are characterized by chromosomal diversity and meiotic complexity despite the fact that species share the same diploid number 2n=60. An intriguing meiotic chromosomal chain, with up to 20 elements during diplotene/diakinesis, was observed in S. aequifasciatus and S. haraldi, whereas S. discus only contains typical bivalent chromosomes. Such chromosomal chains with a high number of elements have not been observed in any other vertebrates. We showed that the meiotic chromosomal chain was not sex related. This observation is unusual and we propose that the origin of meiotic multiples in males and females is based on a series of translocations that involved heterochromatic regions after hybridization of ancestor wild Discus species.Heredity (2009) 102, 435–441; doi:10.1038/hdy.2009.3; published online 25 February 2009 [ABSTRACT FROM AUTHOR]

Goals: To examine the prevalence of chemotherapy-or radiotherapy-associated side effects and related treatment burden, and correlates of fatigue and missed work days among cancer patients.Materials and Methods: A cross-sectional survey was conducted using a dual sampling frame of 63,949 cancer patients (35,751 from an online panel and 28,198 from telephone listings) > or = 18 years receiving chemotherapy and/or radiotherapy at the time of the survey or during the previous 12 months. Data were collected on cancer type, time since diagnosis, treatment side effects, visits, caregiver burden, missed work days, and sociodemographic characteristics. Data are presented only for patients receiving cancer treatment at the time of the survey.Main Results: Of the 15,532 patients (24%) who responded to the screening questionnaire, 1,572 met the eligibility criteria and 1,569 completed the survey; 814 received chemotherapy and/or radiotherapy at the time of the survey. The most common side effects were fatigue (80%), pain (48%), and nausea/vomiting (48%). Patients spent 4.5 h, on average, per visit to treat side effects. Approximately 43% of the patients were employed; of these, 78% were actively working. Employed patients missed, on average, 18 work days annually for side effect treatment. Females, younger and unemployed patients, and those with higher levels of anxiety and depression experienced more fatigue; patients with a greater number of side effects endured more missed work days.Conclusions: In addition to the symptomatic experience of side effects, patients reported a considerable time burden for treatment. It is important to consider supportive care strategies that may effectively reduce side effects and their associated treatment burden. [ABSTRACT FROM AUTHOR]

Goals Of Work: Fatigue is the most common symptom associated with cancer and its treatment. The present study measured patient and provider perceptions of the feasibility and acceptability of conducting computerized fatigue assessments during routine follow-up outpatient clinic visits.Materials and Methods: A subset of 64 patients from a larger study, testing items for inclusion in a fatigue item bank, completed two computerized fatigue assessments at 2- to 3-month intervals. After the second assessment, patients completed a questionnaire about the usefulness of the assessments and the understandability of graphic reports depicting the fatigue scores. They were also asked about the optimal frequency for conducting fatigue assessments. Providers were asked similar feasibility questions.Main Results: Providers thought displays of fatigue scores would be more useful than patients did. Patients and providers also differed on the frequency with which fatigue assessments should be conducted. Interestingly, of the 37% of patients who reported that assessments should be conducted at a different frequency than the choices that were offered, 50% reported that the assessments should be conducted according to their treatment schedule. The majority of providers thought fatigue assessments should be administered at each MD visit.Conclusion: Patients and providers differed about the perceived usefulness of displaying fatigue scores and the frequency with which routine assessments should be conducted. However, both patients and providers appeared to endorse the notion that routine assessments would be beneficial. Integration of routine assessments of commonly experienced symptoms such as fatigue may have important implications for improving symptom management in the future, ultimately resulting in better overall patient care. [ABSTRACT FROM AUTHOR]

Goals Of Work: Fatigue, pain, and emotional distress are common symptoms among patients with cancer. We sought to learn about patient perceptions of these symptoms and their treatment.Materials and Methods: At a baseline assessment and two monthly follow-up assessments, we asked a diverse sample of patients with solid tumor or lymphoma (N = 99) about their fatigue, pain and distress, their treatment for these symptoms, and their satisfaction with treatment via standardized questionnaires and semistructured interviews.Main Results: In this observational study, patients reported fatigue, pain, emotional distress, and general quality of life at expected levels. Across all assessments, at least half of our sample experienced at least some fatigue, pain, or distress. On the whole, patients and providers do communicate about these concerns, and at least 75% of patients found these discussions helpful when they occurred.Conclusions: Improved symptom identification and communication may optimize the detection of those at risk of morbidity and decreased quality of life because of excess symptom burden. [ABSTRACT FROM AUTHOR]

Objective: The present study established the psychometric properties of the Functional Assessment of Cancer Therapy-Neutropenia (FACT-N), a self-report instrument to assess neutropenia-specific concerns and health-related quality of life (HRQL), in a sample of adults 65 years of age and older.Materials and Methods: Participants were undergoing chemotherapy for lung, breast, or ovarian cancer or non-Hodgkin's lymphoma (n = 852) and were randomly assigned to receive pegfilgrastim beginning with cycle 1 (primary prophylaxis) or pegfilgrastim subsequent to cycle 1 at their clinicians' discretion (usual care). Participants completed a self-report assessment on day 1 of each cycle (up to six cycles) and at the expected nadir of the white blood cell count of each cycle. Using factor analysis, three subscales were identified in the 19-item FACT-N subscale: Malaise, Worry, and Flu-like symptoms.Results and Discussions: The FACT-N and each of the subscales were sensitive to the presence of neutropenia although did not correlate with the absolute neutrophil count (ANC). While ANC is a marker of the impact of chemotherapy on the myeloid precursors of the bone marrow and is correlated with risk of febrile neutropenia, however the constellation of symptoms and patient experience vary throughout the period of neutropenia as the ANC first declines and then recovers. The 19-item neutropenia subscale can be used alone; however, evidence supporting reliability and validity was most robust for aggregate scores from the FACT-N and the Trial Outcome Index-Neutropenia (TOI-N).Conclusion: Understanding the impact of neutropenia on HRQL through the availability of a validated self-report measure will, ideally, lead to interventions to reduce the burden associated with cancer and its treatments. [ABSTRACT FROM AUTHOR]

Background: An anti-anemia drug may improve self-reported quality of life (QOL) partly because patients know their hemoglobin level is rising. In the absence of any published studies on this topic, the authors investigated the association between knowledge of hemoglobin levels and self-reported QOL.Methods: The study analyzed health-related QOL (HRQOL) data from five randomized clinical trials of erythropoietic therapy in patients with cancer-related anemia. Patients were asked whether they knew their hemoglobin level and, if so, to report its value. Patients (n=1007) were grouped into three categories depending on the extent and accuracy of hemoglobin level knowledge. HRQOL scale scores were compared between categories.Results: Only 23.2% of patients reported knowing their hemoglobin level at the end of the study; however, the value was accurate (within 1 g/dl) in 88.0% of these patients. On five of the 11 HRQOL scales studied, there was a significant association between knowledge of hemoglobin level and HRQOL score. However, the magnitude of the mean difference between those who knew vs. those who did not know their hemoglobin was generally below scale thresholds for minimally important differences.Conclusions: Patient knowledge of hemoglobin level has a modest association with some aspects of self-reported HRQOL. The magnitude of this association, where it exists, would be unlikely to explain large group differences in HRQOL reports over time, even for patients who know their hemoglobin level. [ABSTRACT FROM AUTHOR]

Fatigue is the most prevalent cancer-related symptom and has a significant adverse impact on patients' functional ability and quality of life. Hypotheses regarding the aetiology of cancer-related fatigue are discussed, and clinical practice guidelines for the evaluation and management of oncology patients with fatigue are reviewed. Both nonpharmacologic and pharmacologic strategies for the management of fatigue are summarised. [ABSTRACT FROM AUTHOR]

Purpose: This paper reports on the development and validation of two biologic response modifier (BRM) subscales for use with the Functional Assessment of Cancer Therapy-General (FACT-G) quality of life (QOL) questionnaire.Methods: Using the FACT-G as a base, 17 additional questions related to symptoms common to interferon and retinoid therapy were developed. Data collected at baseline (n = 191) and week 2 (n = 168) in a randomized trial of interferon +/- 13-cis-retinoic acid in advanced renal cell carcinoma patients were used to validate this measure.Results: Using a combined empirical and conceptual approach, the 17 questions were reduced to 13 questions consisting of two subscales: 'BRM-physical' (7 items; baseline coefficient alpha(alpha) = 0.70; week-2 alpha = 0.75) and 'BRM-mental' (6 items; baseline alpha = 0.79; week-2 alpha = 0.78). Internal consistency of the trial outcome index (TOI) combining physical well-being, functional well-being and the BRM subscales, was 0.91 for baseline assessments and 0.92 for week 2. Discriminant validity was demonstrated for the TOI by its ability to differentiate among prognostic risk groups, and for the total FACT-G, TOI and total FACT-BRM scores by their ability to distinguish between groups differing in performance, response and toxicity status.Conclusions: The 'BRM-physical' and 'BRM-mental' subscales can be combined with the FACT-G to form the 'FACT BRM' scale, useful for measuring QOL in cancer patients who are receiving treatment with biologic response modifiers. [ABSTRACT FROM AUTHOR]

Patients managed in European or North American cancer centres have a variety of ethnic backgrounds and primary languages. To gain insight into the impact of ethnic origin, we have investigated understanding of disease status and quality of life (QoL) for 202 patients. Patients completed questionnaires in their first language (52 English, 50 Chinese, 50 Italian, 50 Spanish or Portuguese), including the Functional Assessment of Cancer Therapy - General (FACT-G) QoL instrument, questions about disease status, expectations of cure and the language and/or type of interpretation used at initial consultation. Physicians also evaluated their status of disease and expectation of cure, and performance status was estimated by a trained health professional. The initial consultation was usually provided in English (except for 32% of Chinese-speaking patients); interpretation was provided by a family member for 34% of patients with limited English proficiency (LEP) and by a bilingual member of staff for 21%. Patients underestimated their extent of disease and overestimated their probability of cure (P=0.001 and <0.0001, respectively). Estimates of probability of cure by the English speakers were closer to those of their physicians than the other groups (P=0.02). English-speaking patients reported better and Italian-speaking patients poorer overall QoL (P<0.001 for Italian vs other groups). Performance status was correlated with QoL and most closely related with the extent of disease. Understanding of cultural differences is important for optimal management of patients with cancer.British Journal of Cancer (2003) 89, 641-647. doi:10.1038/sj.bjc.6601159 www.bjcancer.com [ABSTRACT FROM AUTHOR]

Cancer-related anaemia is associated with a wide spectrum of symptoms that can negatively affect quality of life. Because epoetin alfa has demonstrated efficacy in correcting cancer-related anaemia, the impact of this treatment on quality of life was evaluated in a multinational, randomised, double-blind, placebo-controlled trial in 375 anaemic cancer patients receiving non-platinum-based chemotherapy. The cancer-specific measures of quality of life included the general scale (FACT-G Total) and fatigue subscale (FACT-An Fatigue subscale) of the Functional Assessment of Cancer Therapy-Anaemia and the Cancer Linear Analogue Scales measuring energy, ability to do daily activities, and overall quality of life. These measures were also used to examine the relationship between haemoglobin levels and quality of life. Both univariate and multiple linear regression analyses of quality of life data were performed. Results of the univariate analysis have been reported previously. The a priori-planned multiple linear regression analysis, which accounted for the effects of disease progression and several other possibly confounding variables on quality of life, showed a significant advantage for epoetin alfa over placebo for the five scales (all, P<0.05), and confirmed the results of the univariate analysis. For cancer-specific measures, significant correlations were demonstrated between baseline haemoglobin and quality of life (r, range: 0.14-0.26, all P<0.05) and between change in haemoglobin and change in quality of life (r, range: 0.26-0.34, all P<0.01). These findings provide evidence that increasing haemoglobin levels by epoetin alfa administration can significantly improve cancer patients' quality of life. [ABSTRACT FROM AUTHOR]

Summary. To investigate vertical transmission of TT virus, TTV-DNA was looked for in serum samples taken from 22 mothers and their 22 infants at birth and during nine months of follow-up. Sixteen mothers at delivery and six infants within nine months of age had TTV-DNA detected by the amplification of the non coding (NC) region. Two of these newborns had positive viremia at birth. Sequence analysis of the NC region of five mother-infant pairs revealed that the TTV strains detected at three and six months of age in two of the infants were closely related to that of their mothers, whereas two that became TTV-DNA positive at three moths had a different nucleotide sequence from that of their mothers. One of the two infants with detectable viremia at birth also had a different nucleotide sequence from her mother. These findings suggest that both in utero and perinatal transmission of TT virus may occur, and that the strain detected in the infants was not invariably dominant in the mothers at delivery. [ABSTRACT FROM AUTHOR]

Objective: Assess impact of a computer-based patient support system on quality of life in younger women with breast cancer, with particular emphasis on assisting the underserved.Design: Randomized controlled trial conducted between 1995 and 1998.Setting: Five sites: two teaching hospitals (Madison, Wis, and Chicago, Ill), two nonteaching hospitals (Chicago), and a cancer resource center (Indianapolis, Ill). The latter three sites treat many underserved patients.Participants: Newly diagnosed breast cancer patients (N = 246) under age 60.Interventions: Experimental group received Comprehensive Health Enhancement Support System (CHESS), a home-based computer system providing information, decision-making, and emotional support.Measurements and Main Results: Pretest and two post-test surveys (at two- and five-month follow-up) measured aspects of participation in care, social/information support, and quality of life. At two-month follow-up, the CHESS group was significantly more competent at seeking information, more comfortable participating in care, and had greater confidence in doctor(s). At five-month follow-up, the CHESS group had significantly better social support and also greater information competence. In addition, experimental assignment interacted with several indicators of medical underservice (race, education, and lack of insurance), such that CHESS benefits were greater for the disadvantaged than the advantaged group.Conclusions: Computer-based patient support systems such as CHESS may benefit patients by providing information and social support, and increasing their participation in health care. These benefits may be largest for currently underserved populations. [ABSTRACT FROM AUTHOR]

Purpose: The original Functional Assessment of Anorexia/Cachexia Therapy (FAACT) was designed to measure general aspects of quality of life (QOL) as well as specific anorexia/cachexia-related concerns. Our primary purpose was to reduce the number of anorexia/cachexia subscale items in a manner that either retains or improves reliability, validity and precision.Methods: The FAACT was administered using an interactive computer program that allowed immediate entry of the data. A total of 213 patients were recruited.Results: A combined empirical and conceptual approach led to the reduction of the anorexia/cachexia subscale (A/CS) from 18 to 12 items. A 26-item trial outcome index (TOI) combining physical well-being (PWB), functional well-being (FWB), and the A/CS-12 was highly reliable and sensitive to change in performance status rating (PSR). We found that PWB, FWB, and A/CS-12 subscales performed differently. Specifically, PWB and FWB scores decreased in patients whose (PSR) worsened. However, although A/CS-12 scores were responsive to change in PSR over time, average A/CS-12 scores of all patients, even those whose PSR worsened, improved over the course of treatment.Conclusions: Elimination of six items from the anorexia/cachexia subscale of the FAACT was accomplished without loss of internal consistency or sensitivity to change in performance status. The A/CS-12 subscale provides unique, important information not captured by a generic chronic illness questionnaire. [ABSTRACT FROM AUTHOR]

Background: Co-operative groups have played an important role in the advance of health-related quality of life (HRQL) research. However, definitions of the concept, criteria for selection of existing instruments and methods for data collection and interpretation remain poorly defined in the literature. A survey was conducted amongst the major cancer co-operative groups in order to gain a better understanding of their current policy and processes to ensure optimal HRQL data collection within cancer clinical trials. The topic of health economics was similarly addressed.Methods: A written questionnaire was addressed to 16 major European and North American cancer co-operative groups. Eleven groups responded (response rate: 69%). however, one group could not provide information for the survey, thus ten questionnaires were available for analysis.Results: The results from this survey among co-operative groups show that HRQL (more than health economics) is recognized as an important, although usually secondary, outcome measure in oncology trials. On the whole, co-operative groups have a rather flexible policy towards the inclusion of HRQL (and HE) into their clinical trials, and practice is very much on a case-by-case basis, but use standard practice guidelines and internal procedures is to ensure well-defined study protocols and enhance good quality studies. [ABSTRACT FROM AUTHOR]

Background : Co-operative groups have played an important role in the advance of health-related quality of life (HRQL) research. However, definitions of the concept, criteria for selection of existing instruments and methods for data collection and interpretation remain poorly defined in the literature. A survey was conducted amongst the major cancer co-operative groups in order to gain a better understanding of their current policy and processes to ensure optimal HRQL data collection within cancer clinical trials. The topic of health economics was similarly addressed. Methods : A written questionnaire was addressed to 16 major European and North American cancer co-operative groups. Eleven groups responded (response rate: 69%), however, one group could not provide information for the survey, thus ten questionnaires were available for analysis. Results : The results from this survey among co-operative groups show that HRQL (more than health economics) is recognized as an important, although usually secondary, outcome measure in oncology trials. On the whole, co-operative groups have a rather flexible policy towards the inclusion of HRQL (and HE) into their clinical trials, and practice is very much on a case-by-case basis, but use standard practice guidelines and internal procedures is to ensure well-defined study protocols and enhance good quality studies. [ABSTRACT FROM AUTHOR]

This pilot study investigated the feasibility of translating a quality of life instrument, the Functional Assessment of Cancer Therapy--General version (FACT-G) and the breast cancer version (FACT-B), which consists of the FACT-G plus 10 additional items, into three South African languages (Pedi, Tswana, and Zulu). The international, interdisciplinary research team hypothesized that we could develop reliable and valid translations, and that valuable information could be gleaned from the responses of the three groups of traditional African people, which could inform the Western-trained medical profession. Understanding of cross-cultural views of cancer including its diagnosis and treatment could lead to better communication between the two cultures (Western and Traditional) resulting in increased utilization of Western medical treatment and increased treatment compliance by three of the underserved black populations. A total of 167 respondents completed one of three translated questionnaires, which assessed the patients' quality of life in 5 domains: Physical Well-Being, Social and Family Well-Being, Relationship with Doctor, Emotional Well-Being, and Functional Well-Being, plus for breast cancer patients the additional items on the FACT-B. However, only the items from the FACT-G (the 'core' of the FACT-B) were statistically analyzed for this pilot project. Results showed that it was possible to develop a reliable instrument in the three languages by modifying the standard translation methodology. Translation of physical and functional concepts was most straightforward. Translation of emotional items posed some difficulty. As expected, based upon observations about cultural differences in social values and functioning, the Social/Family Well-Being subscale was problematic. Analysis of this subscale provides information on cultural differences which may be important to physicians desiring to effectively treat this population with sensitivity and dignity. Methodology may be generalizable to other third world patient populations in translation of existing health status questionnaires. [ABSTRACT FROM AUTHOR]

Purpose: The objective was to compare health related quality of life (QOL) in hormone receptor negative, node-positive breast cancer patients receiving adjuvant chemotherapy to determine whether a more intensive chemotherapy regimen has an adverse effect upon QOL that is not balanced by improvements in disease control or survival. Increased physical symptoms, including fatigue and the inconvenience of the dose intensive 16-week regimen, were expected to have a negative impact on QOL.Design: QOL was measured in 163 patients, randomized to either a standard cyclophosphamide, doxorubicin and 5-flurouracil (CAF) or a 16-week multidrug regimen, using the Breast Chemotherapy Questionnaire (BCQ). The 30 item BCQ was self-administered prior to therapy, during therapy, and 4 months post treatment.Results: BCQ scores decreased (worsened) more during therapy on the 16-week regimen, median change -1.4, than on CAF, median change -0.8 (p < 0.001). By 4 months post treatment, BCQ scores were higher than pre-treatment and equal in the two arms (CAF: 8.1 and 16 weeks: 8.2, p = 0.6). Over a period of 48 months, patients on the 16-week regimen averaged 1.4 fewer months of treatment with toxicity, 4.0 more months without symptoms and 0.7 fewer months post recurrence compared to patients on the CAF regimen. Given typical values for these health states, the gain in Q-TWiST observed for the CAF regimen during treatment shifted to the 16-week regimen after 1 year, with a gain of 2.0 to 2.4 months after 4 years.Conclusions: The hypothesized negative impact of the dose intensive 16-week regimen was confirmed by the BCQ assessments. However, Q-TWiST analysis suggests a small gain for the 16-week regimen. The later results should be interpreted with caution with the limited follow-up of 4 years. [ABSTRACT FROM AUTHOR]

Background: This paper describes the development of the Functional Assessment of Cancer Therapy-Colorectal (FACT-C)--a questionnaire assessing quality of life concerns pertinent to colorectal cancer patients. This self-report instrument combines specific concerns related to colorectal cancer with concerns that are common to all cancer patients as assessed with the FACT-General (FACT-G).Method: Three separate and distinct validation samples were used with different ethnic and stage of disease compositions.Results: Results suggest that the FACT-C is a reliable and valid measure in both its English and Spanish language versions. Specifically, the FACT-C evidenced good internal consistency reliability and concurrent validity, as well as an ability to distinguish between groups based on functional status and extent of disease. The FACT-C was also found to be sensitive to changes in functional status. Colorectal cancer-specific items form the Colorectal Cancer Subscale (CCS) which was found to have adequate convergent and divergent validity. Internal consistency was adequate in most samples. In addition, the CCS was able to distinguish among groups that differed in functional status and was sensitive to change in functional status.Conclusion: It is recommended that the entire FACT-C (rather than simply the CCS) be used when studying patients with colorectal cancer in order to provide a comprehensive assessment of quality of life. Recommendations are offered concerning the appropriate use of these measures in clinical research and directions for future research with colorectal cancer patients. [ABSTRACT FROM AUTHOR]

Health status assessment is frequently used to evaluate the combined impact of human immunodeficiency virus (HIV) disease and its treatment on functioning and well-being from the patient's perspective. No single health status measure can efficiently cover the range of problems in functioning and well-being experienced across HIV disease stages. Item response theory (IRT), item banking and computer adaptive testing (CAT) provide a solution to measuring health-related quality of life (HRQoL) across different stages of HIV disease. IRT allows us to examine the response characteristics of individual items and the relationship between responses to individual items and the responses to each other item in a domain. With information on the response characteristics of a large number of items covering a HRQoL domain (e.g. physical function, and psychological well-being), and information on the interrelationships between all pairs of these items and the total scale, we can construct more efficient scales. Item banks consist of large sets of questions representing various levels of a HRQoL domain that can be used to develop brief, efficient scales for measuring the domain. CAT is the application of IRT and item banks to the tailored assessment of HRQoL domains specific to individual patients. Given the results of IRT analyses and computer-assisted test administration, more efficient and brief scales can be used to measure multiple domains of HRQoL for clinical trials and longitudinal observational studies. [ABSTRACT FROM AUTHOR]

The revised Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) quality of life (QoL) instrument has been updated and expanded to provide more complete and accurate coverage of human immune deficiency virus/ acquired immune deficiency syndrome (HIV/AIDS)-related QoL. Factor analysis and the Rasch measurement model were used to determine a new subscale structure for the FAHI. The content of these subscales, including physical well-being (ten items, α = 0.91), function and global well-being (13 items, α = 0.86), emotional well-being/living with HIV (10 items, α = 0.82), social well-being (eight items, α = 0.73), and cognitive functioning (three items; α = 0.75), reflect both general illness- and HIV/AIDS-specific QoL concerns: a total QoL score can also be calculated for the FAHI (44 items, α =0.91). Psychometric evaluation revealed good internal consistency reliability for the FAHI and its subscales. In addition, construct validity, known groups validity and sensitivity to change were demonstrated by significant associations between the FAHI and additional indicators of functional status, psychological symptoms, stress and illness severity. In summary, the FAHI is a psychometrically sound instrument that captures multiple important dimensions of HIV/AIDS-related QoL. It is brief, easy to administer and score, has been translated into nine languages other than English and is appropriate for use in clinical trials and clinical practice. [ABSTRACT FROM AUTHOR]

We developed a 12-item bone marrow transplant subscale (BMTS) for the general Functional Assessment of Cancer Therapy (FACT) measure. The subscale combined with the FACT, (FACT-BMT) is a 47-item, valid and reliable measure of five dimensions of quality of life in bone marrow transplant patients. The three-step validation process involved the generation and selection of BMT-specific items and the testing of the overall measure. Items were selected from a list produced by seven oncology experts and 15 patients and were designed to assess content not represented in the general FACT items. A total of 182 patients completed the FACT-BMT at baseline, prior to BMT. An analysis measuring sensitivity to change was performed with 74 patients after transplantation and 60 patients over the three time-points of baseline, hospital discharge and 100 days. The FACT-BMT and all subscales were correlated, sensitivity to change was measured, and the internal consistency for each scale was calculated. Coefficients of reliability and validity ranged from 0.86 to 0.89 for the entire FACT-BMT and 0.54 to 0.63 for the BMTS. The BMTS was able to discriminate patients on the basis of performance status rating and also demonstrated sensitivity to change over time. The FACT-BMT has good psychometric properties for use in assessing quality of life in bone marrow transplant patients. The addition of the bone marrow transplant subscale to the general FACT measure makes it an excellent choice for use in BMT clinical trials. [ABSTRACT FROM AUTHOR]

In this paper, methodologies which have been used in the pharmaceutical industry to demonstrate the equivalence of drug preparations, are applied to the measurement of quality of life (QOL). This approach is feasible when the generated data are measured on the same scale. Data from the quality of life instruments are transformed into interval scales by means of an appropriate scaling procedure. It is demonstrated that equivalence of QOL instruments is linked by a linear relationship between the QOL instruments Functional Assessment of Cancer Therapy (FACT) and the Functional Living Index-Cancer (FLIC). The linear relationship is derived using orthogonal least squares regression which takes into account that both measures are subject to error. [ABSTRACT FROM AUTHOR]

In the age of increased international collaboration in medical research, the necessity of having at hand cross-culturally applicable instruments for the assessment of health-related quality of life (HRQL) in clinical trials has been voiced. Several important theoretical bases leading to cultural bias in HRQL measurement include differences in definitions of HRQL across national and cultural contexts, levels of observation relied upon to indicate HRQL states, and the significance or weight placed upon the various HRQL states or dimensions measured. Despite a growing literature on the development and evaluation of existing HRQL measures in other cultures, comprehensive sets of procedures or requirements for the international part of development and evaluation are lacking. This paper reviews major approaches to developing international HRQL measures, and discusses various methods and criteria that have been recommended for evaluating measurement equivalence in comparisons of research across national and cultural contexts. A summary of recent trends and advances in international HRQL assessment is presented. [ABSTRACT FROM AUTHOR]

The US health-care transition demands increased accountability for medical care. This has contributed to increased interest in documenting valued medical outcomes, including improvements in health-related quality of life and treatment satisfaction. These data can only be obtained validly by asking patients directly about their current health state, perception of well-being, and satisfaction with care. A core set of well-validated instruments have been developed to measure health-related quality of life in patients with cancer. As these are employed with increasing frequency, rigorous quality assurance of data collection is critical. Because of the necessity of quality control, patient-reported data collection can be labor-intensive and prohibitively costly. However, time and cost-saving methods, such as centralized telephone survey methods or on-site direct data entry via interactive computer, can guarantee high-quality data while minimizing costs. Justification of the need for these methods and a brief description are provided. [ABSTRACT FROM AUTHOR]