Physical Well-being Scores Research Articles

Influence des troubles de la conscience sur l’auto-évaluation de la qualité de vie des patients souffrant de schizophrénie

Shizophrenia is a long-lasting condition with either episodic or continuous evolution that can result in physical, psychological, and social problems related to both the disease itself and the potential side-effects of treatments. These various aspects should be taken into account when assessing the outcome of medical management of patients suffering from schizophrenia. Subjective criteria, such as quality of life (QoL) measurements, should be considered an important focus for evaluation in this population. A major subgroup of patients with schizophrenia lacks insight of having a mental disorder or symptoms of a mental disorder. Studies on the relationship between insight and QoL have produced inconsistent results. While some studies found positive associations between insight and QoL, others found negative ones. Some possible explanations for the discrepancies between these findings can be expressed: differing patients' characteristics, heterogeneous insight or QoL measures, sample size and methodological differences. None of the previous research studies have looked at relationships between insight and QoL, as assessed respectively using the scale to assess unawareness of mental disorder (SUMD, a widely multidimensional insight questionnaire), and the S-QoL (a disease-specific patient-based instrument). The aim of this study was to assess the impact of insight into illness on the self-reported QoL as determined by schizophrenic patients, while taking into account the key confounding factors. This study incorporated a cross-sectional design and took place in the psychiatric department of a French public university teaching hospital (Marseille, France). The inclusion criteria were: diagnosis of schizophrenia or schizoaffective disorder (DSM-IV-R), age over 18, native French speaker, agreement to participate. The following data were recorded: sociodemographic parameters (age, gender, marital status, education level, occupational activity), clinical data (in- or out-patient, clinical form), and psychopathology (Positive And Negative Syndrome Scale, PANSS). Insight was assessed using the Scale to assess Unawareness of Mental Disorder (SUMD), a standardised expert-rating scale based on a patient interview describing nine domains. The S-QoL is a self-administered disease-specific instrument validated from patients' views that includes 41 items and describes eight dimensions (psychological well-being, self-esteem, family relationships, relationships with friends, resilience, physical well-being, autonomy, and sentimental life), and yielding a global index score. One hundred and fifty-three patients were enrolled (mean age 37.6, standard deviation 11.2). Patients with good insight generally reported a lower global QoL score, whatever the insight domains. Insight of mental disorder is the most important domain affecting QoL levels. Psychological well-being, self-esteem, physical well-being, and autonomy scores were significantly lower for subjects with good insight. Multivariate analysis showed that insight of mental disorder is the only parameter linked to the S-QoL index. No links were found between other insight domains and S-QoL index. Patients with good insight might realise consequences of their mental illness with restrictions in daily living and alteration of their QoL, while patients with poor insight might partially overrate their QoL and present themselves as more competent.

Quality‐of‐life and surgical treatments for rectal cancer—a longitudinal analysis using the California Cancer Registry

Heterogeneous results for research investigating health-related quality of life (HRQL) in patients undergoing sphincter-ablating procedures for rectal cancer are likely due to single institution experiences and measurement of HRQL. To address this heterogeneity, we evaluated HRQL in patients with rectal cancer by type of surgery, location of tumor, and receipt of adjuvant therapy using an HRQL instrument that has not been used to address rectal cancer patients in a population-based sample over time. The Functional Assessment of Cancer Therapy-Colorectal instrument was administered at 9 and 19 months after diagnosis to a consecutive sample of 160 patients in Northern California identified by the California Cancer Registry. A broad multidimensional interpretation of HRQL was used to examine the impact of tumor location and treatment status, stage of disease, age, and gender. In general, men had lower social well-being scores, and younger patients had lower physical and emotional well-being scores and colorectal concerns scores. We found no differences in HRQL by either tumor location or type of surgery, at either 9 or 19 months after diagnosis. Lower physical well-being and greater adverse colorectal concerns were reported at 9 months among patients who received adjuvant therapy; however, only adverse colorectal concerns persisted over time. This study provides additional evidence that sphincter-ablating procedures do not necessarily reduce quality of life in patients with rectal cancer. Distinctive features of this study include a broad multidimensional interpretation of HRQL, the 19 months of longitudinal follow-up, and a prospective population-based study design.

Health-related quality of life (HQOL) and early survival outcome of the randomized adjuvant dose-dense (dd) FEC75 versus FEC90 CECOG study.

e11058 Background: Adjuvant ddFEC75 and ddFEC90 chemotherapy regimens have been found feasible in operable breast cancer patients (Kahan et al, Breast Cancer Res Treat. 2008;112:557-563). A protocol-specified HQOL data obtained during chemotherapy, and the disease-free survival (DFS) 3 years after the randomisation of 51 patients were analyzed. Methods: The FACT-B HQOL questionnaires completed by the patients 2 weeks after each chemotherapy cycle were evaluated separately both in the whole study population and in the two treatment arms. DFS according to the treatment arm was analyzed by the Kaplan-Meier method and the Cox proportional hazards model. Results: A significant fall became apparent in the FACT-B outcome index after the third cycle of chemotherapy in the entire population, as a consequence of significant reduction of the Physical and Emotional Well-Being scores and the breast cancer subscales. No changes were detected in the scores of the Social/Family and the Functional Well-Being subscales. Th...

Placebo and nocebo effects in randomized double-blind clinical trials of agents for the therapy for fatigue in patients with advanced cancer.

A significant response to placebo in randomized controlled trials of treatments for cancer-related fatigue (CRF) had been reported. A retrospective study was conducted to determine the frequency and predictors of response to placebo effect and nocebo effects in patients with CRF treated in those trials. The records of 105 patients who received placebo in 2 previous randomized clinical trials conducted by this group were reviewed. The proportion of patients who demonstrated clinical response to fatigue, defined as an increase in Functional Assessment of Chronic Illness Therapy-Fatigue score of > or = 7 from baseline to Day 8, and the proportion of patients with a nocebo effect, defined as those reporting >2 side effects, were determined. Baseline patient characteristics and symptoms recorded using the Edmonton Symptom Assessment Scale (ESAS) were analyzed to determine their association with placebo and nocebo effects. Fifty-nine (56%) patients had a placebo response. Worse baseline anxiety and well-being subscale score (univariate) and well-being (multivariate) were significantly associated with placebo response. Commonly reported side effects were insomnia (79%), anorexia (53%), nausea (38%), and restlessness (34%). Multivariate analysis indicated that worse baseline (ESAS) sleep, appetite, and nausea were associated with increased reporting of the corresponding side effects. Greater than half of advanced cancer patients enrolled in CRF trials had a placebo response. Worse baseline physical well-being score was associated with placebo response. Patients experiencing specific symptoms at baseline were more likely to report these as side effects of the medication. These findings should be considered in the design of future CRF trials.

Psychological, Cognitive and Quality of Life Features in the Elderly with Chronic Headache

Chronic headache is common in the elderly, but there is little specific research on the impact on quality of life of headache and beliefs about pain in this age group. This study investigated the influence of headache type as well as headache frequency (≥15 headache days/month vs. <15 headache days/month) on quality of life and determined the relationships between elder’s well-being, pain beliefs and related headache features including commonly reported neck pain. 118 headache subjects and 44 non-headache controls, aged 60–75 years, were recruited from the community. Subjects completed a headache questionnaire for classification purposes, the SF-36, the Geriatric Depression Scale-short form (GDS-S), the Survey of Pain Attitudes (SOPA-35) and the Neck Disability Index (NDI). The results revealed that elders with headache compared to the control group scored lower on most SF-36 domains, higher on the GDS-S (p < 0.05) and comparably on the SOPA-35 (p > 0.05), noting that the GDS score was below the threshold value for depression. These measures were not different between the headache types but were influenced by headache frequency. Subjects with headaches ≥15 days/month scored lowest on SF-36 domains and highest on GDS-S questionnaire compared to those with headache <15 days/month and controls (all p < 0.05). The mean NDI score in the headache subjects indicated the presence of mild to moderate neck pain and disability. There were no strong relationships between well-being and headache frequency, intensity and length of headache history. The NDI score had the greatest influence on physical well-being and GDS-S score on mental well-being (p < 0.001). The results suggest that frequency of headache has an impact on health-related quality of life in elders. Notably, the level of neck pain and disability is an important factor influencing well-being and may warrant attention in the management of elders with chronic headache.

Simplification and First Validation of a Short Battery of Patient Questionnaires for Clinical Management of HIV-Infected Patients: The HIV-SQUAD (Symptom Quality of life Adherence) Questionnaire®

Purpose: Questionnaires assessing patient-reported outcomes in HIV are either too long or not HIV-specific. Our aim was to develop and validate a simplified HIV patient questionnaire. Method: 607 HIV patients treated with a combination of antiretroviral (ARV) drugs were enrolled in an observational, longitudinal study. Questionnaires covering health-related quality of life (HRQoL), satisfaction, tolerability, and adherence were administered at baseline (BL) and Month 3 (M3). The items were selected according to their content and discriminant properties. The simplified questionnaire was then administered at Month 12 (M12). Psychometric properties of physical wellbeing, psychological well-being, and global HRQoL scores were assessed. Results: The simplified questionnaire included 12 HRQoL items, 13 side-effects items, and one visual analog scale (VAS) measuring adherence. The principal component analysis (PCA) confirmed the validity of the global HRQoL score. The multivariate analysis showed acceptable-to-good internal consistency of the three scores. Convergent and discriminant validity were excellent for the physical score. The global score showed significant differences according to time since diagnosis, hepatitis coinfection, CD4 count, and viral load. Conclusion: This questionnaire deals with the major aspects of HIV patient perceptions. The global HRQoL score is well correlated to the surrogate markers of HIV. Such a questionnaire may represent a new tool for the therapeutic management of HIV-infected patients. Further steps are required to complete these results.

Health-related quality of life and pain assessment in 36 patients with resected pancreas adenocarcinoma: Preliminary analysis

e20692 Background: In order to begin to understand the effects of disease on the patient (pt) and possibly of the pt on the disease, we have begun a systematic psychological inventory of all our pts who have has a pancreatectomy for pancreas adenocarcinoma and have began to correlate this with disease extent, and later with survival. Methods: Prior to post-op discharge home, pts were invited to fill out a brief pain inventory (BPI-SF), BPI interference, emotional (EWB) and physical well-being score (Fact-Hep), as well as social/family and functional well-being (FWB) Fact-Hep. The data was entered into a database, together with pertinent lab results, tumor markers, and tumor characteristics from the pre-op CT scan and post-op pathology report. Data was analyzed by descriptive statistics, frequencies and Pearson Correlation (2-tailed sig). Results: Descriptive means (and ranges) were - tumor size 3.43 cm mean (2.0 min-5.2 max), bilirubin 1.26 (0.2–4.7), albumin 2.69 (1.5–3.6), Hb 10.3 (7.5–13.2), platelets 254K (109K-672K), CEA 4.7 (0.8–24), and Ca 19–9 was 987 (1.0–8127). Pain at presentation pre-op of moderate severity was present in 11% of pts and severe pain was present in 5.6% of pts (16.6% total). Pathologically, LNs were involved by cancer in 50% of pts, vascular invasion in 30%, neural invasion in 35% and any margin positive in 14%. 22% had metastases noted at surgery. Statistically significant correlations were found for tumor size and pain severity (p&lt;.035), platelets and FWB (p&lt;.022), albumin and Hb (p=.000), CA 19–9 and bilirubin (p&lt;.030 i.e. high CA 19–9 and high bilirubin). There was a negative correlation between CEA (but not CA 19–9) and both EWB (p&lt;.039) and FWB (p&lt;.035). Pain severity correlated with depressed mood (p&lt;.010), lower physical well-being (p&lt;.01) and interference with life activities (p&lt;.01). Conclusions: CEA, but not CA 19–9 correlated with both emotional and functional well-being. Baseline pain was present in only 16.6% of this cohort. We plan to follow up to examine how these parameters correlate with pt coping throughout therapy and survival. No significant financial relationships to disclose.

Placebo and nocebo effects in randomized double-blind clinical trials for fatigue in advanced cancer patients

9640 Background: We have previously reported significant placebo response in randomized controlled treatment trials for cancer related fatigue (CRF). We conducted a retrospective study to determine the frequency and predictors of response to placebo and nocebo effect in patients with CRF. Methods: We reviewed patients that received placebo in two previous randomized clinical trials conducted by our group and determined the proportion of patients who demonstrated clinical response to fatigue using an increase (ΔFACIT-F score) &gt; 7 from baseline to day 8, and those with nocebo response as those who reported side effects. Baseline patient characteristics and symptoms recorded from the Edmonton Symptom Assessment Scale (ESAS) were analyzed to determine their association with placebo and nocebo effects. Results: A total of 105 advanced cancer patients received placebo. 59 (56%) patients responded to placebo (median Δ FACIT-F score of 22). Worse baseline anxiety and well-being subscale score (univariate) and well-being (multivariate, MR) were significantly associated with placebo response. Common side effects reported were insomnia (79%), anorexia (53%), nausea (38%) and restlessness (34%). MR analysis showed that worse baseline (ESAS) sleep, appetite, nausea, and restless are associated with increased reporting of these side effects ( Table ). Conclusions: Nearly half of advanced cancer patients enrolled in the fatigue trials responded to placebo. Worse physical well-being score was associated with placebo response. Patients experiencing specific symptoms at baseline were more likely to report these as side effects of the medication. These findings should be considered in fatigue clinical trial design. [Table: see text] No significant financial relationships to disclose.

Short‐term quality‐of‐life assessed after robot‐assisted radical cystectomy: a prospective analysis

To prospectively determine the effect of robot-assisted radical cystectomy (RARC) on quality of life (QoL) after surgery. In all, 34 patients who had RARC for bladder cancer between January 2006 and December 2007 at one institution were prospectively enrolled in a study of QoL. All patients had RARC with extracorporeal urinary diversion by one surgeon. As part of the routine follow-up, QoL was assessed at intervals. Functional Assessment of Cancer Therapy-Bladder (FACT-BL) questionnaires were administered before and then over a 6-month period after RARC. Patients undergoing chemotherapy were not excluded. Follow-up FACT-BL and individual domain scores for physical, social, emotional and functional well-being were compared with those obtained before RARC. The mean age of all patients was 65 years, 88% were men, and 13 (38%) had adjuvant chemotherapy. The mean time after RARC for the 1-, 3- and 6-month assessments was 29, 90 and 193 days, respectively; 19 patients completed three follow-up questionnaires. Initially, there were significant decreases in the physical and functional domains, with improvements in the emotional domain (P < 0.001). Total FACT-General and FACT-BL scores decreased in the initial period after RARC and then progressively improved. There was no statistically significant difference in total scores at 3 months after surgery; at the 6-month follow-up the total FACT-BL scores exceeded those before RARC (P = 0.048). QoL appears to return promptly to, or exceed, baseline levels by 6 months after RARC. The improvement in the short term might allow for more contented patients and quicker initiation of adjuvant chemotherapy.

Quality of life in low-grade glioma patients receiving temozolomide

The purpose of this study was to describe the quality of life (QOL) of low-grade glioma (LGG) patients at baseline prior to chemotherapy and through 12 cycles of temozolomide (TMZ) chemotherapy. Patients with histologically confirmed LGG with only prior surgery were given TMZ for 12 cycles. QOL assessments by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) were obtained at baseline prior to chemotherapy and at 2-month intervals while receiving TMZ. Patients with LGG at baseline prior to chemotherapy had higher reported social well-being scores (mean difference = 5.0; p < 0.01) but had lower reported emotional well-being scores (mean difference = 2.2; p < 0.01) compared to a normal population. Compared to patients with left hemisphere tumors, patients with right hemisphere tumors reported higher physical well-being scores (p = 0.01): 44% could not drive, 26% did not feel independent, and 26% were afraid of having a seizure. Difficulty with work was noted in 24%. Mean change scores at each chemotherapy cycle compared to baseline for all QOL subscales showed either no significant change or were significantly positive (p < 0.01). Patients with LGG on TMZ at baseline prior to chemotherapy reported QOL comparable to a normal population with the exception of social and emotional well-being, and those with right hemisphere tumors reported higher physical well-being scores compared to those with left hemisphere tumors. While remaining on therapy, LGG patients were able to maintain their QOL in all realms. LGG patients' QOL may be further improved by addressing their emotional well-being and their loss of independence in terms of driving or working.

Understanding the cultural health belief model influencing health behaviors and health-related quality of life between Latina and Asian-American breast cancer survivors

The purpose of this study was to (1) describe health behaviors and health-related quality of life (HRQOL) of Latina and Asian-American breast cancer survivors (BCS), (2) estimate possible culturally driven predictors of health behaviors and HRQOL, and (3) compare pathways for predicting health behaviors and HRQOL between the two groups. Secondary data were used to investigate health behaviors and HRQOL among 183 Latina and 206 Asian Americans diagnosed with breast cancer. The study methodology was guided by the health belief model and the contextual model of HRQOL. Structural equation modeling was used to test cultural predictors on health behaviors of BCS. Asian Americans reported higher emotional and physical well-being scores than Latina-Americans. Confirmatory factor analyses demonstrated the adequacy of the two-factor model ("powerful others" and "sociocultural factors") in the cultural health belief construct for Latina and Asian-American BCS. In the structural model, Latinas and Asian Americans showed different pathways in the predicted relationships among the variables. For Latina-Americans, doctor-patient relationship was positively related to exercise, and in turn, influenced physical and emotional well-being. For Asian Americans, treatment decisions and the "sociocultural factor" were significantly related to stress management. This study adds to the existing literature in that no study has focused on cultural health beliefs and health behaviors between Latina and Asian-American BCS. Evidence that Latinas and Asian Americans varied in the patterns of cultural factors influencing health behaviors and HRQOL might lead to the development of culturally sensitive breast cancer interventions for promoting positive health behavior and ultimately increasing HRQOL.

Quality of Life in Men Treated With Carbon Ion Therapy for Prostate Cancer

To prospectively assess patient quality of life (QOL) after carbon ion radiotherapy (C-ion RT) for prostate cancer, using established questionnaires. The subjects were 150 patients who underwent C-ion RT. Of these, 25 patients with low-risk prostate cancer received C-ion RT alone, whereas the remaining 125 patients with a high-risk tumor also received androgen deprivation therapy. Quality of life was assessed using the self-administered Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire in all patients three times. In addition, the University of California-Los Angeles Prostate Cancer Index (UCLA-PCI) was conducted in the low-risk patients. The FACT-General (FACT-G) and FACT-P scores at 12 months after treatment averaged over all 150 patients showed no significant change compared with those before C-ion RT. In FACT-P subscales, emotional well-being increased significantly just after and 12 months after treatment. In contrast, physical well-being (PWB) and social/family well-being (S/FWB) decreased significantly at 12 months, whereas the prostate cancer subscale (PCS) decreased significantly just after treatment. Average scores for FACT-G, FACT-P, PWB, S/FWB, and PCS for the 125 patients receiving hormone therapy showed substantial detrimental changes at 12 months. In contrast, those of the 25 low-risk patients who had no hormone therapy showed no significant change. Similarly no significant change in the average of the UCLA-PCI scores in the low-risk patients was seen at 12 months. Average QOL parameters reported by patients with localized prostate cancer treated with C-ion RT, in the absence of hormone therapy, showed no significant decrease 12 months after C-ion RT.

Prospective assessment of the reliability, validity, and sensitivity to change of the Functional Assessment of Cancer Therapy-Melanoma questionnaire.

The authors previously developed a melanoma-specific module for the Functional Assessment of Cancer Therapy (FACT-Melanoma), a tool for the assessment of quality of life (QOL) in patients with melanoma. The reliability and validity of the FACT-Melanoma was examined in this study. Patients with melanoma (N = 273; stages I-IV) completed a battery of questionnaires at the time of enrollment. The validity of the instrument was examined by comparing FACT-Melanoma scores with performance status, disease stage, treatment status, and other scales, including the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Melanoma Module, the Profile of Mood States, and the Marlowe-Crowne Social Desirability Scale. Patients were assessed after 1 week to assess test-retest reliability and at 3 months to determine the sensitivity of the instrument to change in performance status. The internal consistency and test-retest reliability (r) of the melanoma subscale (Cronbach alpha = .85; r = .81) and the total FACT-Melanoma (alpha = .95; r = .90) were excellent. Overall, the scales were correlated with other measures, as anticipated. Total FACT-Melanoma scores, along with scores for physical well-being, emotional well-being, functional well-being, and melanoma-specific scales, were lower for patients with advanced (stage III/IV) melanoma, poor performance status, and patients who were receiving active treatment. The FACT-Melanoma total score and the score for physical well-being were sensitive to changes in performance status (P = .0012 and P = .004, respectively). The results of the current study indicated that the FACT-Melanoma questionnaire is a reliable and valid instrument for patients with melanoma that can be used for the assessment of QOL in clinical trials.

Changes in quality of life among breast cancer patients three years post-diagnosis

To evaluate changes in quality of life (QOL) and identify medical and socio-demographic predictors of QOL among breast cancer survivors 3 years after diagnosis. Between April 2002 and March 2004 2,232 women with breast cancer were recruited into the Shanghai Breast Cancer Survival Study, a population-based cohort study, approximately 6 months after cancer diagnosis. QOL was evaluated at 6 and 36 months post-diagnosis using the General Quality of Life Inventory. Multiple linear regression models were used to evaluate changes in QOL and their associations with socio-demographic and medical factors. In general, breast cancer patients showed significant improvement over time in the physical, psychological, and social well-being domains, as well as overall QOL. However, QOL scores in several facets did not improve or even deteriorated, including increased negative feelings, reduced social support and interpersonal relationships, and worsened financial situation and living environment. Age at diagnosis was inversely associated with QOL changes in physical and psychological well-being and overall QOL scores. Compared with those who were disease-free, patients with a recurrence of disease had significantly poorer QOL scores across all well-being domains and almost all facets. Patients who received radiotherapy experienced significant improvements in physical and social well-being and overall QOL. Mixed ER/PR status was associated with improved scores in physical and psychological well-being and overall QOL. Education, body mass index, Charlson comorbidity score, TNM stage, type of surgery, chemotherapy, and immunotherapy were only associated with changes in certain well-being domains and/or facets, but not overall QOL. Tamoxifen use was not associated with changes in QOL outcomes. Our study provides valuable information for developing strategies/interventions for improving the QOL of breast cancer patients.

Use of the Short-Form-36 Health Survey to detect a subgroup of fibromyalgia patients with psychological dysfunction

The aim of the present study was to examine the in-depth application of the Short-Form-(SF)-36 Health Survey to score the general well-being in fibromyalgia syndrome (FS) patients. Quality of life was evaluated in 12 patients with FS. With respect to mental well-being (social functioning, role limitation due to emotional health problems, and mental health), two distinguished groups were found concerning psychological functioning. One group (n = 8) demonstrated psychological dysfunction, whereas the other (n = 4) showed normal psychological scores. Physical well-being scores (physical functioning, role limitation due to physical health problems, bodily pain, general health, and vitality) did not differ between FS patients but were altogether below the normal range. Regarding the psychological scores of the two groups of patients, SF-36 can be used to differentiate between patients with and without psychological dysfunction independent of pain. Therefore, we propose that the SF-36 could be of help to provide the most adequate therapy to achieve an optimal outcome in patients with FS and psychological disturbances.

The impact of follicular lymphoma on health-related quality of life

BackgroundThe purpose of this study was to determine whether there was a relationship between disease activity and health functioning, as measured by a range of patient-reported outcome (PRO) measures in patients with follicular lymphoma (FL). Patients and methodsA total of 222 patients with FL were recruited from eight sites across the UK and they completed a number of PRO measures. The participants were analyzed across five disease states: ‘active disease—newly diagnosed’, ‘active disease—relapsed’, ‘partial response’, ‘complete response’ and ‘disease free’. The relationship between these disease states and their level of health functioning was assessed as well as the relationship between being ‘on’ or ‘off’ chemotherapy and disease state. ResultsIn terms of health-related quality of life (HRQoL), participants in the relapsed category had the lowest mean physical well-being, emotional well-being, functional well-being and social well-being score. In a regression analysis, the ‘active disease–relapsed’ group acted as a significant predictor for each PRO variable. In addition, the remission group acted as a significant predictor of high anxiety scores as measured by the Hospital Anxiety and Depression Scale. ConclusionThe results of this study demonstrate that various aspects of patient-reported health outcomes differ according to disease state in patients with FL. For those patients who have relapsed, they are more likely to experience worse HRQoL and other patient-reported health outcomes than patients newly diagnosed, in partial or complete remission or when completely disease free.

Self-reported quality of life of 8–12-year-old children with cerebral palsy: a cross-sectional European study

Little is known about the quality of life (QoL) of disabled children. We describe self-reported QoL of children with cerebral palsy, factors that influence it, and how it compares with QoL of the general population. 1174 children aged 8-12 years were randomly selected from eight population-based registers of children with cerebral palsy in six European countries and 743 (63%) agreed to participate; one further region recruited 75 children from multiple sources. Researchers visited these 818 children. 318 (39%) with severe intellectual impairment could not self-report; 500 (61%) reported their QoL using KIDSCREEN, an instrument with scores in ten domains, each with SD=10. Multivariable regression was used to relate QoL to impairments, pain, and sociodemographic characteristics. Comparisons were made with QoL data from the general population. Impairments were not significantly associated with six KIDSCREEN domains. Comparison of least and most able groups showed that severely limited self-mobility was significantly associated with reduced mean score for physical wellbeing (7.6, 95% CI 2.7-12.4); intellectual impairment with reduced mean for moods and emotions (3.7, 1.5-5.9) and autonomy (3.3, 0.9-5.7); and speech difficulties with reduced mean for relationships with parents (4.5, 1.9-7.1). Pain was common and associated with lower QoL on all domains. Impairments and pain explained up to 3% and 7%, respectively, of variation in QoL. Children with cerebral palsy had similar QoL to children in the general population in all domains except schooling, in which evidence was equivocal, and physical wellbeing, in which comparison was not possible. Parents can be reassured that most children aged 8-12 years with cerebral palsy will have similar QoL to other children. This finding should guide social and educational policy to ensure that disabled children participate fully in society. Because of its association with QoL, children's pain should be carefully assessed.

A Randomized Trial of the Effect of a Walking Regimen on the Functional Status of 100 Adult Allogeneic Donor Hematopoietic Cell Transplant Patients

To investigate the impact of exercise on adult allogeneic hematopoietic cell transplant recipients, we randomized 100 patients to either a structured walking regimen or to a control group with no formal exercise program. Starting on the day of admission for transplant, patients in the exercise arm were asked to walk on a treadmill twice a day for 15 minutes while in the hospital. After discharge, they were asked to walk once a day for 30 minutes. The effect of the exercise program was primarily measured by the change in the Karnofsky score (KPS) from transplant admission to day 100 posttransplant, which was scored by the attending physician who was blinded to the assigned exercise regimen. The decline in KPS was smaller in the exercise group than in the control group: 10 points versus 20 points. This difference was not statistically significant in the total study population ( P = .21) but was statistically significant among the subset of older and less fit patients receiving nonmyeloablative pretransplant conditioning ( P = .04). Sixty-four percent of patients on the exercise arm who had a baseline KPS <90 had a score ≥90 by day 100 compared to 18% of the control arm ( P = .03). Thirty-two percent of patients with a baseline score ≥90 had a score ≥90 by day 100 in both groups ( P = .99). Analyses of patients’ self reported scores at the time of discharge for physical and emotional well-being showed that the exercise arm had better scores for physical well-being ( P < .01). Among the subset of nonmyeloablative patients, scores for physical and emotional well-being were both higher in the exercise arm ( P = .02). Length of hospitalization and survival were not different between the 2 study arms. We conclude that assignment of a structured walking regimen to patients can lead to better physical performance during the recovery period and by patient assessment, a better perceived physical and emotional state. In addition, exercise has a greater impact among patients who are less fit coming into transplant. Structured exercise may have a positive impact on physical and emotional recovery following transplant therapy and may accelerate patients’ return to health and function.

A randomized comparison of darbepoetin alfa with epoetin for chemotherapy induced anemia in nonhematological tumors

18554 Background: Although once weekly (QW) Darbepoetin is nowadays used for chemotherapy induced anemia by many oncologists, a head to head comparison with thrice weekly (TIW) Epoetin regimen has not been published so far. Methods: We randomly compared QW Darbepoetin alfa with TIW Epoetin in 110 cancer patients with chemotherapy induced anemia (Hb ≤ 11 gr%). Epoetin was administered at 10.000 U TIW (20.000 U in nonresponders after 4 weeks, Group A). Darbepoetin was administered at 150 mcg QW (300 mcg as above, Group B). Evaluation was performed on week 4 and 8 including QoL assessment using FACT- An scale. Results: In group A, Hb increased from 10.11 ± 0.94 at baseline to 11.02 ± 1.39 at 4 weeks (p = .000) and to 12.09 ± 1.78 at 8 weeks (p = .000). It also increased between week 4 and 8 (p = .000). In group B, Hb increased from 10.26 ± 0.81 at baseline to 10.91 ± 1.89 at 4 weeks (p = .003) and to 11.66 ± 2.25 at 8 weeks (p = .000). It also increased between week 4 and 8 (p = .001). In all 110 patients, Hb increased from 10.2 ± 0.87 at baseline to 10.95 ± 1.71 at 4 weeks (p= .000) and to 11.82 ± 2.08 at 8 weeks (p = .000). It also increased between week 4 and 8 (p = .000). Fifteen of 27 (55.6%) responding patients in group A had to double Epoetin dose versus 18 of 39 (46.2%) in group B (P = .61). Three patients in group A required transfusions compared with 9 in group B (p= .35). On an intent to treat analysis, RR, at 4 weeks, was 46.7% for Epoetin versus 40% for Darbepoetin (p =.56). At 8 weeks, it was 55.6% and 56.9%, respectively (p = NS). QoL analysis showed that mean physical, social, functional and emotional well-being scores as well as mean fatigue and non-fatigue subscale scores were not significantly different between the two groups. Conclusions: Once weekly Darbepoetin is equally effective and more convenient therapy than thrice weekly Epoetin. No significant financial relationships to disclose.

A Quality of Life Assessment of Ablative Allogeneic Bone Marrow Transplant (BMT) Recipients One and Twelve Months after Transplant.

Quality of life (QOL) data concerning allogeneic BMT recipients is relatively sparse. We surveyed allogeneic BMT recipients at baseline, one month post-transplant, and one year from transplant attempting to determine fluctuations in QOL over time. We used the FACT-BMT tool, which consists of five component scores, including physical well-being (PWB), social well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and additional concerns (AC). PWB, SWB, and FWB uses a 0–28 point scale while EWB ranges from 0–24. Fifty-three patients were initially entered into this analysis, all of whom received ablative allogeneic transplants from 6/2003 to 6/2005. Median age was 46 years; the majority (57%) were female; underlying diagnoses included AML (42%), ALL (23%), MDS (13%), and other (22%). Median time from diagnosis to transplant was rapid, at 5.2 months. Fifty-one percent had a matched related donor, and 49% had a matched unrelated donor. As of August 2005, 70% of these 53 patients are alive. This analysis compares scores obtained one month from transplant and one year from transplant to baseline values. The average hospital length of stay for this ablative transplant was 29 days. One month after transplant, 21% of patients had grade 2–4 acute GVHD. The median WBC was 4.4 K/μL and the median platelet count was 51 K/μL. When surveyed one month post-transplant, not surprisingly, patients had a significant deterioration of physical well-being and functional well-being scores as shown in the table below. However, this was coupled by a significant increase in emotional well-being:FACT-BMT SCORES: median (range)ComponentBaseline (n = 53)1-month post-transplant BMT (n = 53)1-month p-value compared to baseline12-months post-BMT (n = 23)12-month p-value compared to baselinePWB21 (6–28)18 (2–26)p < 0.00121 (3–28)0.82FWB17 (0–27)13 (4–23)p = 0.00617 (6–27)0.46EWB17 (3–24)19 (1–24)p < 0.00119 (5–24)0.015The decrease in PWB and FWB was expected given the rigors of an ablative allogeneic transplant, but the significant rise in EWB was surprising. This may reflect a sense of accomplishment, relief, and optimism among patients concerning their underlying diagnosis and treatment. Twenty-three patients were available to complete the survey tool 12 months after transplant. This was a favorable cohort of patients with continued remissions. Fifty-two percent of these 23 patients, however, did have some degree of chronic graft-versus-host disease. The PWB and SWB scores returned to baseline, and the enhanced EWB scores persisted. Thus, the negative impact of the BMT on PWB and SWB was self-limited. The underlying mechanisms of the sustained EWB improvement one year post-transplant may reflect the fact that these patients were doing well clinically. Further analysis of the early rise in emotional well-being after ablative allogeneic BMT would be of interest.