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Randomized phase II study of two gemcitabine schedules for patients with impaired performance status (Karnofsky performance status </= 70) and advanced non-small-cell lung cancer.

PURPOSE: This randomized phase II study compared two treatment schedules of gemcitabine in patients with non-small-cell lung cancer (NSCLC) and impaired Karnofsky performance status (KP). Primary objectives were to record changes from baseline KP and to assess symptom palliation. Secondary objectives were overall survival, tumor response, and toxicity. PATIENTS AND METHODS: Patients with stage IIIb and IV NSCLC and KP </= 70 were randomly assigned to receive gemcitabine 1,000 mg/m(2) on days 1, 8, and 15 of each 28-day cycle (3w4) or gemcitabine 1,500 mg/m(2) on days 1 and 8 of each 21-day cycle (2w3), both for up to six cycles. KP, toxicity, and SS14 lung cancer specific questions were recorded before each cycle of treatment. Response was evaluated 4 weeks after the last cycle. RESULTS: One hundred seventy-four patients were enrolled. There was significant early attrition due to disease progression; only 61.5% of patients were alive at 2 months. There was a significant improvement in KP from baseline to pre-cycle 3 in both arms, with a trend in favor of the 3w4 regimen for duration and faster onset of improvement. Eight of the 17 quality-of-life (QOL) variables assessed showed an improvement of more than 10% between baseline and the start of the third cycle of treatment. Response rate, survival, and duration were similar in both arms. CONCLUSION: There was no significant difference between the two schedules examined in terms of improvement in KP or QOL, but there seemed to be a trend in favor of the 3w4 schedule.

Adult↗

Evaluation of patients with advanced cancer using the Karnofsky performance status.

The Karnofsky Performance Status Scale (KPS) was designed to measure the level of patient activity and medical care requirements. It is a general measure of patient independence and has been widely used as a general assessment of patient with cancer. Although there is a long history of use of the KPS for judging cancer patients, its reliability and validity have been assumed without formal investigation. The interrater reliability of the KPS was investigated in two ways, both of which gave evidence of moderately high reliability. The patients evaluated in their home were usually assigned a lower KPS score compared with a similar evaluation at the same time done in the outpatient clinic. Costruct validity of the KPS was demonstrated by strong correlation with several variables relating to physical function. On-study KPS score accurately predicted early death, but high initial KPS scores did not necessarily predict long survival. Patient deterioration with subsequent death within a few months could be predicted to a limited extent by a rapidly dropping KPS. These results suggest that the KPS has considerable validity as a global indicator of the functional status of patients with cancer and might be helpful for following other patients with chronic disease.

Adult↗

Performance status assessment in home hospice patients using a modified form of the Karnofsky Performance Status Scale.

The Karnofsky Performance Status (KPS) scale is considered to be the gold standard for quantifying the physical functioning of patients with cancer. However, problems have been identified with the scoring system when the scale is used in the home hospice setting. The goal of this study was to compare assessments of performance status using two instruments, the KPS and a modified version, the Thorne-KPS (TKPS). The TKPS avoids reference to location of care and has new descriptors for assessing the frequency of professional visits and the proportion of time spent in bed. Comparisons were made on a sample of 78 home-hospice patients in Perth, Western Australia. The median score for both scales was 60. The scales agreed in 56% of ratings overall but after correcting for chance, agreement was reduced to 47%. However, 91% of the 34 discrepancies occurred within one or two levels of the 11-point scale. TKPS scores were consistently lower than KPS scores and were spread over a wider range of the scale. The strongest agreement occurred at the higher levels of performance and the weakest agreement was within the middle levels of the scales. Further studies are required to determine which of the two scales more accurately reflects performance status and survival time. However, the results to date suggest that the TKPS may be a more objective and sensitive measure of functional performance in home hospice patients.

Journal Article↗

Karnofsky Performance Status Assessment: resident versus attending.

BACKGROUND: Karnofsky Performance Status (KPS) is a commonly used scale to assess a patient's functional status. METHODS: Between September 1999 and March 2000, 117 patients were independently evaluated and assigned KPS scores by both an attending physician and a resident physician at the time of radiation therapy simulation. RESULTS: Both attending and resident median assigned KPS score was 80. Attending and resident KPS scores were identical for 50 patients (43%). When KPS scores differed, this difference was of the smallest incremental value (10 points) in 50 patients (75%). The Pearson correlation coefficient is 0.85, significant at the 0.01 level. CONCLUSION: KPS scoring by radiation oncology attending physicians is similar to that by resident physicians.

Adult↗

Effect of rest interval on tumor and normal tissue response--a report of phase III study of accelerated split course palliative radiation for advanced pelvic malignancies (RTOG-8502)

From August 1985 through September 1989, 284 patients with advanced pelvic malignancies were entered into a trial (RTOG 8502) of palliative split course radiation (4440 cGy in three courses of 1480 cGy/2 days/4 fractions with a rest of 2-4 weeks between courses). The initial 148 patients were part of a Phase II acceptable response rate and minimal acute or late toxicity (IJRBP 17:659-662, 1989). The present analysis is a report of the subsequent 136 patients randomized between rest intervals of 2 weeks versus 4 weeks to determine if length of rest would influence tumor response or patient toxicity. The patients were stratified for performance status (Karnofsky Performance Status) and histology. The patients were evenly matched for age and sex. There was a trend toward increased acute toxicity incidence in patients with shorter rest interval (5/68 versus 0/68; p = .07). Late toxicity was not significantly different between the two groups. Decreasing the interval between courses did not result in a significant improvement in tumor response (CR+PR = 34% vs. 26%, p = n.s.). More patients in the 2 week groups completed all three courses (72% vs. 63%). Not surprisingly, patients completing cell three courses had a significantly higher overall response rate than for patients completing less than three courses (42% vs. 5%) and higher complete response rate (17% vs. 1%). A multivariate analysis indicated performance status as the significant predictor for number of courses completed. For Karnofsky Performance Status greater than or equal to 80, the survival at 12 months was 40% for the 2 week interval and 25% for the 4 week interval. Performance status and histology were the only significant variables in a multivariate analysis of survival.

Adolescent↗

Validity of the Karnofsky Performance Status in an HIV-infected sample.

The Karnofsky Performance Status (KPS) is the most widely used health status measure in human immunodeficiency virus (HIV) medicine and research. Because there are limited data on KPS metric properties in this setting, we present evidence of the construct validity of the KPS in a sample of HIV-infected persons using data from the AIDS Time-Oriented Health Outcome Study (ATHOS). The sample consisted of 160 primarily white, homosexual/bisexual men with a mean age of 45 years and a mean KPS score of 82 (range, 40-100). Ninety percent were classified in Centers for Disease Control (CDC) clinical category B or C. Pearson's product-moment correlations were strong between the KPS and measures of global health status, physical disability, numbers of symptoms, CDC clinical category, social function, days off work, and energy/fatigue (r = 0.39-0.52, p < 0.0001). Correlations with measures of mental health and cognition were less impressive but statistically significant. Analysis of variance followed by Student Newman-Keuls test showed significant differences among three KPS groupings for global health status but not for physical disability. Regression analysis indicated three significant variables accounting for KPS variance: visual analogue global health status (27%), days off work (10%), and energy/fatigue (1.7%). We conclude that the upper range of the KPS reflects global health status better than physical performance and much better than psychosocial constructs, in persons with HIV infection. Further research examining the ability of the KPS to detect clinically significant change over time is needed.

Adult↗

Investigation of the Karnofsky Performance Status as a measure of quality of life.

The Karnofsky Performance Status appears to be the most widely used scale for objective assessment of medical patients' quality of life. Evidence for its reliability and validity is reviewed and new data presented. Tests of inter-rater reliability, concurrent validity, and discriminant validity indicate that, with standardized observational procedures based on a mental status exam, the Karnofsky scale is acceptably reliable and valid as a global measure but it does not adequately capture the conceptual domain of quality of life.

Aged↗

Estimating the quality of life in a clinical trial of patients with metastatic lung cancer using the Karnofsky performance status and the Functional Living Index--Cancer.

Serial assessments of Karnofsky performance status (KPS) and of the Functional Living Index--Cancer (FLIC) have been used to estimate the quality of life (QOL) of patients in a prospective, randomized trial of supportive care versus supportive care given with combination chemotherapy to patients with metastatic non-small cell lung cancer. There was a good correlation between KPS and FLIC scores at study entry, thus confirming results originally reported using the FLIC. However, a number of unexpected problems were encountered in data collection and quality control with this QOL assessment instrument. This made it impossible to look for differences in treatment effect on QOL in this clinical trial. It is believed that QOL assessment should be an integral part of cancer clinical trials; however, investigators must acknowledge the difficulties in collecting this type of data. The development of new instruments and the refinement of old ones will facilitate the collection of data for this important aspect of clinical trials research.

Aged↗

Long-term Karnofsky performance status and neurological outcome in patients with neurohypophyseal germinomas.

Long-term posttreatment Karnofsky Performance Status (KPS) and neurological status of 16 patients with neurohypophyseal (NH) germinomas were retrospectively analysed, in order to deduce the best treatment modality to achieve a good outcome. The average age at treatment was 15.5 years (rouge 6-26) and they were followed up for 107.3 months (26-209). The KPS averaged 81.5 (0-100). Three patients were below 60 in the KPS. The first one had hemiparesis due to a delayed cerebrovascular accident (CVA), and the second became indifferent and inactive with recent memory loss. The third died from marginal recurrence of tumour and subsequent systemic metastasis. The low scores were all more or less attributable to complications related to irradiation: delayed CVA, diffuse cortical atrophy and inappropriate selection of irradiation field, respectively. The second case had the tumour origin at the hypothalamus, which indicates intraparenchymal tumour location as another factor to worsen the quality of life (QOL). Visual field and acuity, and EOM impairment were observed in eight and five patients, respectively. It improved in all patients but one. The visual and EOM dysfunction recovered satisfactorily and was not a disabling factor. The intraparenchymal lesion resulting in hemiparesis and higher cortical dysfunction due to either irradiation-related complications or tumour invasion is a major determining factor of lower KPS. Irradiation related complications are considered to be avoidable by reducing radiation dosage with appropriate chemotherapy and/or proper selection of irradiation field. Patients with smaller tumour size of less than 20 mm had higher KPS. Accordingly, repeated studies of tumour markers and neuroimages are required in patients with idiopathic diabetes insipidis, in order to detect the tumour, if present, at the small-sized and early stage.

Adolescent↗

An exploratory study of frequent pain measurement in a cancer clinical trial.

The ideal methodology for quality of life (QOL) measurement in cancer clinical trials matches the evaluation to the anticipated outcomes, thereby increasing the likelihood that clinically relevant changes are captured. The present study explored the importance of such methodological 'tailoring' in a phase II trial of paclitaxel and recombinant human granulocyte-colony stimulating factor (rhG-CSF) for metastatic breast cancer. Prior to the trial, clinical observation suggested that frequent short-lived episodes of pain might occur during this treatment regimen. Twenty-one patients provided longitudinal data for at least three cycles of chemotherapy. To assess transient pain, a routine QOL assessment at baseline and every third cycle was supplemented with pain measurements twice weekly. The interval assessment included a multidimensional QOL instrument (Functional Living Index-Cancer) and measures of psychological state (Rand Mental Health Inventory), symptom distress (Memorial Symptom Assessment Scale), and performance status (Karnofsky Performance Status Score). The frequent pain measurements were acquired using visual analogue and categorical scales for pain intensity (Memorial Pain Assessment Card). From baseline to the end of cycle three, global pain scores declined and the results on other QOL measures were variable. The data obtained using these measures did not reveal the existence of episodic pains. In contrast, the twice weekly pain measurements clearly demonstrated transient severe pains in approximately half the patients. These data highlight the importance of specific measurement of troubling symptoms or other relevant QOL concerns at clinically appropriate intervals during the routine QOL assessment of clinical trials. The additional burden involved in these assessments is warranted if the information derived is highly relevant, would not be adequately captured otherwise and could improve therapy.

Adult↗

Emergency drainage for urosepsis associated with upper urinary tract calculi.

PURPOSE: We examined the characteristics of patients with urosepsis associated with upper urinary tract calculi requiring emergency drainage. MATERIALS AND METHODS: From January 1994 to December 2003, 424 patients were admitted to our urological department a total of 473 times for treatment of upper urinary tract calculi, of whom 53 required a total of 59 emergency drainage procedures for urosepsis. We summarized the characteristics of these patients and events, and determined risk factors for emergency drainage using logistic regression analysis. RESULTS: In 14 events (24%) intensive management, such as the use of vasopressors and anticoagulants, was performed. Transient thrombocytopenia less than 100,000/mm occurred in 18 events (31%). Hyperbilirubinemia occurred in 8 of 38 events (16%) without prior antibiotic therapy. One patient (2%) died of urosepsis. Patients with calculi who underwent emergency drainage required a longer hospital stay than those without emergency drainage (25.2 vs 14.8 days, p <0.001). Of the variables analyzed poor performance status (Karnofsky performance status 70% or less, OR 2.9, p = 0.003), age 75 years or older (OR 2.1, p = 0.038) and female sex (OR 1.8, p = 0.046) were risk factors on multivariate analysis. CONCLUSIONS: Our findings suggest that the frequency of emergency drainage in elderly patients with poor performance status has increased in recent years, at least in our rural area of Japan. Preventing calculous formation and urinary tract infection in individuals with poor performance status will be of considerable importance in the future.

Aged↗

Correlation between Karnofsky Performance Status Scale and Short-Form Health Survey in patients on maintenance hemodialysis.

BACKGROUND: Assessment of quality of life is vital inmonitoring response to various treatment measures. Various instruments, which include both generic and disease-specific instruments, are used in the assessment of health-related quality of life (HRQOL). In this study, we compare two commonly used generic instruments. OBJECTIVES: The objective of this study was to compare two generic instruments, the Karnofsky Performance Status Scale and the SF-36 Health Survey in hemodialysis (HD) patients. The study also aims to find out the association (if any) between HRQOL scores using these two scales and various clinical and biochemical parameters. MATERIALS AND METHODS: Sixty-two maintenance HD patients were recruited after informed consents were obtained. Detailed sociodemographic data was obtained. They were assessed during their regular HD sessions. Serum chemistry (which included serum urea, creatinine, Na+, K+, HCO3-, Ca2+, Po4(2-)), albumin, globulin, total protein and hemoglobin (g/dl) were assessed in all the patients. Adequacy of HD was assessed using second-generation Daugirdais formula. HRQOL was assessed using the Karnofsky and SSF-36 instruments and the scores collated and compared. Data was analyzed using SPSS version 10. RESULTS: Fifty-five patients completed the study (27 males and 28 females, mean age 40.76 +/- 11.05 years and age range of 20-65 years). There was a significant positive correlation between Karnofsky scores and all eight SF-36 domains, but only physical functioning, social functioning and role limitation due to emotional problems maintained the significance on multiple regression analysis. The serum creatinine and hemoglobin postively correlated with physical function, bodily pain, social functioning and Karnofsky scores. Age of the patients correlated negatively with two SF-36 dimensions (physical functioning and role limitation due to physical fitness) and Karnofsky scores. CONCLUSION: This study revealed a good correlation between Karnofsky performance status scale and the short-form (SF36) health survey in this Egyptian population. Age, serum creatinine and hemoglobin significantly influence quality of life in this HD patient population.

Adult↗

The Karnofsky Performance Status Scale. An examination of its reliability and validity in a research setting.

The Karnofsky Performance Status Scale (KPS) is widely used to quantify the functional status of cancer patients. However, limited data exist documenting its reliability and validity. The KPS is used in the National Hospice Study (NHS) as both a study eligibility criterion and an outcome measure. As part of intensive training, interviewers were instructed in and tested on guidelines for determining the KPS levels of patients. After 4 months of field experience, interviewers were again tested based on narrative patient descriptions. The interrator reliability of 47 NHS interviewers was found to be 0.97. The construct validity of the KPS was analyzed, and the KPS was found to be strongly related (P less than 0.001) to two other independent measures of patient functioning. Finally, the relationship of the KPS to longevity (r = 0.30) in a population of terminal cancer patients documents its predictive validity. These findings suggest the utility of the KPS as a valuable research tool when employed by trained observers.

Activities of Daily Living↗

The Karnofsky Performance Status Scale re-examined: a cross-validation with the EORTC-C30.

A cross-validation of the Karnofsky Performance Status (KPS) and quality of life (QOL) as measured by item 30 of the quality of life questionnaire developed by the European Organization for Research and Treatment of Cancer Study Group (EORTC QLQ-C30) was conducted using ordered logit analysis and prospective data from a continuous sample of 139 lung cancer patients. The QOL is found to be a much broader concept than the KPS, since it likely captures not only physical functioning but also functioning in the non-physical dimensions of social, emotional, and possibly cognitive well-being as well as the level of distress in the physical dimensions of pain, breathing and fatigue. These results suggest that the palliative treatment of advanced cancer and the terminally ill should be guided by a broad concept of well-being that goes beyond one based only on physical functioning.

Humans↗

The Australia-modified Karnofsky Performance Status (AKPS) scale: a revised scale for contemporary palliative care clinical practice [ISRCTN81117481].

BACKGROUND: The Karnofsky Performance Status (KPS) is a gold standard scale. The Thorne-modified KPS (TKPS) focuses on community-based care and has been shown to be more relevant to palliative care settings than the original KPS. The Australia-modified KPS (AKPS) blends KPS and TKPS to accommodate any setting of care. METHODS: Performance status was measured using all three scales for palliative care patients enrolled in a randomized controlled trial in South Australia. Care occurred in a range of settings. Survival was defined from enrollment to death. RESULTS: Ratings were collected at 1600 timepoints for 306 participants. The median score on all scales was 60. KPS and AKPS agreed in 87% of ratings; 79% of disagreements occurred within 1 level on the 11-level scales. KPS and TKPS agreed in 76% of ratings; 85% of disagreements occurred within one level. AKPS and TKPS agreed in 85% of ratings; 87% of disagreements were within one level. Strongest agreement occurred at the highest levels (70-90), with greatest disagreement at lower levels (< or =40). Kappa coefficients for agreement were KPS-TKPS 0.71, KPS-AKPS 0.84, and AKPS-TKPS 0.82 (all p < 0.001). Spearman correlations with survival were KPS 0.26, TKPS 0.27 and AKPS 0.26 (all p < 0.001). AKPS was most predictive of survival at the lower range of the scale. All had longitudinal test-retest validity. Face validity was greatest for the AKPS. CONCLUSION: The AKPS is a useful modification of the KPS that is more appropriate for clinical settings that include multiple venues of care such as palliative care.

Journal Article↗

Karnofsky performance status revisited: reliability, validity, and guidelines.

Little research has been conducted documenting the reliability and validity of the Karnofsky Performance Status (KPS) scale, and guidelines based on empirical data do not exist to govern its use. Two hundred ninety-three cancer patients completed a questionnaire that assesses their physical and psychosocial difficulties. Physicians rated patients on the KPS and a subsample of 75 patients was used to evaluate interrater reliability. Analyses were conducted to evaluate the interrater reliability and construct validity of the KPS. The KPS was shown to have good reliability and validity. Detailed examination of the reliability data suggested areas in which physicians err in their judgments. Multiple regression techniques were used to empirically identify seven behaviorally based questions that would be helpful in predicting KPS scores. The seven variables included weight loss, weight gain, reduced energy, difficulty walking, driving, grooming, and working part time. An interview approach with behaviorally based guidelines is presented using these variables to obtain relevant data and make more accurate KPS ratings. With the approach suggested and the guidelines presented, oncologists may train themselves to use the KPS in a standard way, which should increase reliability and validity of the KPS and has implications for patients and research studies that use KPS as a stratifying variable.

Activities of Daily Living↗

Clinical prediction of survival is more accurate than the Karnofsky performance status in estimating life span of terminally ill cancer patients.

Predicting the survival of terminally ill cancer patients can help in informing patients and their families, in programming therapy and assistance models, and in utilising existing resources correctly. Clinical prediction of survival (CPS) and Karnofsky performance status (KPS) are two factors which have already been described in the literature. The aim of our study was to verify their respective predictive value with regard to actual survival. In our study of 100 consecutive patients, the CPS obtained a higher prediction accuracy than that reported previously (correlation coefficient with actual survival = 0.51) and than that obtained with KPS alone (correlation coefficient = 0.37). The median difference between predicted and expected survival was only 1 week. The resultant predictivity could be further improved by integrating other prognostic factors studied in larger prospective, multicentric studies.

Adolescent↗

Prognostic significance of the Karnofsky Performance Status score in patients with acute myocardial infarction: comparison with the left ventricular ejection fraction and the exercise treadmill test performance. The MILIS Study Group.

The prognostic significance of functional status has not been previously studied in the setting of acute myocardial infarction. We assessed the Karnofsky Performance Status (KPS) score, a simple functional status scale that is commonly used to categorize physical ability, in 849 patients with acute myocardial infarction who were enrolled in the Multicenter Investigation of the Limitation of Infarct Size (MILIS) study. We then compared the KPS score with other predictors of prognosis in these patients. In patients who presented with acute myocardial infarction, a lower KPS score (less than 8 on a scale of 1 to 10) 3 weeks before the index infarction was associated with a higher incidence of congestive heart failure, in-hospital cardiac arrest, and mortality during hospitalization, as compared with patients with KPS scores greater than or equal to 8 (each p less than 0.001). Cumulative 1-year and 4-year mortality rates were significantly higher in patients with KPS scores less than 8, as compared with patients with KPS scores greater than or equal to 8 (42.5% vs. 12.6% at 1 year and 61.6% vs 25.1% at 4 years, respectively; both p less than 0.001). The left ventricular ejection fraction on admission was significantly lower in patients with KPS scores less than 8, as compared with those with KPS scores greater than or equal to 8 (p less than 0.019). The cumulative mortality rate was equally well predicted by low KPS score and by left ventricular ejection fraction (both p less than 0.0001).(ABSTRACT TRUNCATED AT 250 WORDS)

Disability Evaluation↗