The interpretation of scores from the EORTC quality of life questionnaire QLQ-C30

While quality of life (QOL) assessment is becoming more common, interpreting the results remains problematic. This paper demonstrates an approach to developing clinically-based interpretations for QOL outcomes, using the QLQ-C30 as an example. The results from 14 published QLQ-C30 studies which group patients by performance status, weight loss, toxicity, extent or severity of disease are collated. Groups with lower clinical status generally have worse QOL. The largest differences are between performance status groups, and the smallest differences are between groups of patients with local disease and those with metastases. The physical and role scores have the largest ranges of means across patient groups, and show the largest differences between clinical groups, while the cognitive and emotional scores have the smallest ranges of means and differences. Sicker groups have larger score standard deviations than healthier groups. Relatively large and small means and differences, and corresponding effect sizes, are presented. Collectively, the results provide a sense of the relative sizes of means and of differences, and of the types of clinical groups which give rise to them, thereby providing clinically-based benchmarks by which to interpret QLQ-C30 results.     

Suppression of crossing-over by DNA methylation in Ascobolus

Interpretation of health related quality of life (HRQOL) results in cancer patients is facilitated by knowledge of the levels of HRQOL in the general population. However, direct comparisons can be misleading unless age and gender are considered. We demonstrate the derivation of age- and gender-specific 'expected' values from population reference values by means of simple calculations. This survey included 3000 randomly selected Norwegians above 18 years of age who received the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30 (+3) by mail. 1965 responses from 2,892 eligible persons (68%) were received. The population was divided into six disease groups based on self-reported health problems. The observed mean scale scores of the different groups deviated greatly from those obtained in the general population. The score for physical function, for example, was 72 for cancer patients and ranged from 73.3 to 82.5 in other disease groups, as opposed to 89.9 in the general population and 98.9 in those with no health problems. The range for one of the quality of life (QOL) scales was 57.7 to 84.7 compared with 73.7 in the general population. Expected mean scores for the patient groups were computed from the reference values, based on the concept of equivalence of age and gender. The differences between the observed mean scores and the reference values were strongly mediated by this method. The expected scores for physical function then ranged from 83.3 to 93.1 and from 70.3 to 75 for the QOL scale. The impact of age and gender on the reference data from the EORTC QLQ-C30 (+3) obtained in a general population shows that these variables must be considered when interpreting data on HRQOL for cancer patients. The demonstration of how to generate mean values which are adjusted according to the age and gender distribution of a population should increase the usefulness of this questionnaire among clinicians.     

The assessment of functional status in rheumatoid arthritis: a cross cultural, longitudinal comparison of the Health Assessment Questionnaire and the Groningen Activity Restriction Scale

OBJECTIVE: To compare a disease specific measure of functional status, the Health Assessment Questionnaire (HAQ) with a generic measure of functional status, the Groningen Activity Restriction Scale (GARS) in a cross cultural and longitudinal setting. Besides the comparison of psychometric properties, sex differences were also studied. METHODS: In a sample of 634 patients with rheumatoid arthritis (RA) (290 from The Netherlands, 116 from France, 228 from Norway), the psychometric properties (Cronbach's alpha and rho) of the GARS and the HAQ were compared among countries. The sensitivity for change between T1 and T2 was tested by means of the standardized response mean for a one year followup; furthermore, the relative efficiency of both instruments was computed. A t test was used to trace sex differences. RESULTS: The psychometric properties of both the HAQ and the GARS were very good. Both form unidimensional scales of hierarchically ordered items; alpha and rho are > 0.91 for both instruments. For patients who improved between T1 and T2, measured by the Ritchie Articular Index, the standardized response mean of the HAQ and the GARS were moderate, whereas for patients who worsened, the standardized response means were small. The results based on the relative efficiency were ambiguous. Furthermore, the mean score for women on the HAQ was 0.25 higher in contrast to scores for men. The GARS did not yield different scores for women and men. CONCLUSION: The internal consistency of the GARS and the HAQ are comparable. The HAQ has yielded different results for women and men. Therefore, when the HAQ is used, sex differences should be taken into account. With respect to sensitivity to change, the GARS and the HAQ obtained much better results for patients who improved in contrast to patients who worsened. The GARS was found to be more sensitive to change for patients who improved.     

Patient preference for self-collected cultures for group B streptococcus in pregnancy

The purpose of this study was to examine the factors which affect the level of fatigue among patients participating in clinical trials in which this symptom had been assessed with the EORTC QLQ-C30. Data were assembled from 2390 patients in ten clinical trials in which the QLQ-C30 had been used to assess baseline and on-study quality of life. The relationship between the level of fatigue reported by the patients on the fatigue scale of this questionnaire and patient and disease characteristics was assessed in univariate and multivariate cross-sectional analyses. In addition, changes in fatigue scores were compared in a longitudinal analysis among patients on two arms of an anti-emetic trial whose emesis control was markedly different. Baseline fatigue levels differed substantially among patients taking part in the different trials. Factors associated with greater fatigue severity on univariate analysis included: female gender, presence of metastatic disease, and poorer performance status. In addition, on multivariate analyses the oldest patients were found to have less fatigue, as were patients with breast cancer, while patients with ovarian and lung cancer experienced greater fatigue. Patients on the arm of the anti-emetic trial in which emesis was better controlled showed significantly less increase in fatigue after receiving chemotherapy. The fatigue scale of the QLQ-C30 appears to provide a useful approach to assessing this important symptom. The relationships found between fatigue and patient and disease characteristics need further exploration as does the degree to which the QLQ-C30 fully captures this dimension of quality of life.     

Stability of time-tradeoff utilities in survivors of myocardial infarction

To investigate whether time-tradeoff utilities of survivors of myocardial infarction change over time and whether changes in utilities correlate with changes in functional status, the authors conducted serial interviews using a time tradeoff and three measures of functional status in a cohort of 67 patients who had recently had myocardial infarction. The patients were also asked to rate their overall health on a rating scale and were asked about chest pain, exercise status, and employment status. Each patient was interviewed two to five times over one and a half years. The mean (95% CI) time-tradeoff score for all patients was 0.88 (0.84, 0.93). Over a mean interval of 8.4 months, 28 (42%) patients changed Karnofsky scores, 28 (42%) changed Specific Activity Scale classes, and 11 (16%) changed New York Heart Association classes, with most changes representing improvements in functional status. Scores on the rating scale improved by a mean (95% CI) of 0.06 [(0.03, 0.10); p < 0.002], but scores on the time tradeoff remained stable, with a mean (95% CI) change of 0.03 [(-0.02, 0.08); p = NS]. Changes in time-tradeoff scores did not correlate with changes in Specific Activity Scale classes (Kendall's tau = 0.21), New York Heart Association classes (tau = -0.02), or Karnofsky scores (tau = 0.14); with changes on the verbal rating scale (R = 0.20); with changes in chest pain status (tau = -0.05), exercise status (tau = 0.11), or employment status (tau = 0.11); or with interim hospitalizations (tau = 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)     

The effect of chronic luteinizing hormone treatment on adult rat Leydig cells

OBJECTIVES: In a preliminary pilot study of 30 treatments in 26 patients with osteonecrosis of the jaws and chronic disabling facial pain, our specific aim was to determine whether, to what degree, and how safely therapy of hypofibrinolysis and thrombophilia would ameliorate the chronic pain associated with osteonecrosis of the mandible and maxilla. STUDY DESIGN: Thrombophilia was treated with Coumadin (DuPont) in 10 patients; hypofibrinolysis was treated with Winstrol (Sanofi-Winthrop) in 20 patients, including 4 who had mixed thrombophilia and hypofibrinolysis and had previously been treated with Coumadin. The initial treatment period was targeted to be 4 months. Each patient was asked to keep a daily written pain-relief numeric rating score and side-effects diary and to provide a summary pain-relief numeric rating score and side effects compilation for the total treatment period. RESULTS: There were 4 men and 22 women in the study group; their mean age was 49 +/- 11 years. The mean onset of their osteonecrosis pain was at age 45 +/- 12 years, and the mean duration of their facial pain prior to therapy was 4.5 +/- 4.2 years. Ten patients had one or more thrombophilic traits (there were two patients with protein C deficiency, five with resistance to activated protein C and/or the mutant Factor V Leiden gene, and four with high anticardiolipin antibodies). The 10 patients who were thrombophilic were treated with Coumadin (the international normalized ratio was targeted to 2.5-3.0) for 22 +/- 9 weeks. By self-reported pain-relief numeric rating scores, 6 of the 10 patients with thrombophilia (60%) had > or = 40% pain relief, 2 (20%) had no change, and 2 (20%) had increased pain (30% and 80% worse). Nine of the 10 patients with thrombophilia (90%) had no Coumadin-related side effects; 1 patient (10%) stopped Coumadin therapy (after 28 weeks) because of nosebleeds. Winstrol (6 mg per day) was used for 16 +/- 9 weeks in 20 patients with hypofibrinolysis, some of whom had one or more hypofibrinolytic traits (10 had high levels of plasminogen activator/inhibitor activity, usually accompanied by low stimulated tissue plasminogen activator activity; 13 had high Lp[a] lipoprotein). Of these 20 patients with hypofibrinolysis, 9 patients (45%) had > or = 40% pain relief, 3 patients (15%) had 20% to 30% relief, 5 patients (25%) had no improvement, and 3 patients (15%) had increased pain (30% worse, 60% worse, and 70% worse). Six of the 20 patients with hypofibrinolysis (30%) had no Winstrol-related side effects, while 14 (70%) had side effects that could be attributed to Winstrol, including weight gain, peripheral edema, increased facial and body hair, and acne--all of which were reversed within 6 weeks of stopping Winstrol therapy. CONCLUSIONS: We postulate that thrombophilia and hypofibrinolysis lead to impaired venous circulation and venous hypertension of the mandible/maxilla with subsequent development of osteonecrosis and chronic facial pain. In many patients, facial pain can be ameliorated by treating the pathogenetic coagulation defects with Coumadin or Winstrol. Large, double-blind, placebo-controlled crossover studies will be required in the future to validate these preliminary results and to determine whether pain relief with Coumadin or Winstrol justifies the risks and side effects associated with these medications, especially for long-term use, in osteonecrosis of the jaws.     

Assessing social support: The Social Support Questionnaire.

Describes the Social Support Questionnaire (SSQ) and 4 empirical studies employing it. The SSQ yields scores for (a) perceived number of social supports and (b) satisfaction with social support that is available. Three studies (N?=?1,224 college students) dealt with the SSQ's psychometric properties, its correlations with measures of personality and adjustment, and the relation of the SSQ to positive and negative life changes. The 4th study (40 Ss) was an investigation of the relation between social support and persistence in working on a complex, frustrating task. The research reported suggests that the SSQ is a reliable instrument and that social support is (a) more strongly related to positive than negative life changes, (b) more related in a negative direction to psychological discomfort among women than men, and (c) an asset in enabling a person to persist at a task under frustrating conditions. Clinical implications are discussed. (47 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Change in MMPI scores from college to adulthood as a function of military service.

Examined changes in MMPI scores from adolescence to adulthood in a longitudinal study of 540 men who attended college during the Vietnam War. Using change scores that were adjusted for initial values, civilians were compared to veterans who were grouped according to combat exposure: none, peripheral, or direct. In cross-sectional analyses, the groups differed only as adults. Groups were similar in relative stability but differed by multivariate analysis in absolute change on the clinical scales. Only veterans with peripheral exposure differed from civilians in multivariate contrasts, even after controlling for premilitary variables. Effect sizes were small. Results suggest that combat exposure does not produce uniformly negative outcomes and may have positive effects in select populations. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Fat intake: implications of changes in distribution for setting dietary goals in the UK

STUDY OBJECTIVE: To examine (a) changes in the shape of the distribution of dietary fat intake as the mean dietary fat intake of the population shifts and (b) implications for setting national dietary goals. DESIGN: Data on the percentage of energy from total fat, saturates, monounsaturates, polyunsaturates, and the P:S ratio were analysed for two dietary intervention trials and six cross sectional dietary surveys. The nutrient distributions from each study were described in terms of the mean, standard deviation (SD), coefficient of variation (CV), and skewness statistic. For the intervention trials statistical parameters were compared for groups who received and did not receive dietary advice. For the cross sectional studies, statistical parameters were compared across groups with different levels of mean fat intake. The implications of the results for setting dietary goals were considered using statistical models. MAIN RESULTS: For most fat fractions there was a positive association between the mean and the SD, and an inverse association between the mean and the CV, indicating that as the mean shifts upwards the SD increases but not in proportion to the mean. This is intermediate between a constant SD and a constant CV model. For a population nutrient goal of a maximum of 15% saturates, the estimated population mean for British women would be 8.4% using the constant SD model and 10.8% using the constant CV model. For saturates and the P:S ratio, a lower mean intake was associated with a greater positive skew in the distribution of reported intakes. For saturates, this is consistent with a group of high fat consumers who fail to reduce their intake as the population mean shifts downwards: a "rearguard effect". Findings for the P:S ratio are consistent with a group of consumers who produced a strong positive skew at low mean intakes, which reduced in size as the mean population intake increases: a "vanguard effect". CONCLUSIONS: These findings provide evidence that the distribution of fat intake may change with the mean to a degree that the setting and monitoring of nutritional goals may need to take account of changes in variance and shape of the intake distribution.     

Predictions of hospital mortality rates: a comparison of data sources

BACKGROUND: Complementary medicine is increasingly popular with patients and with GPs, although it still remains mainly in the private sector. Few data are available from the private sector about patient-consulting patterns and outcome. OBJECTIVES: We aimed to describe detailed consulting patterns, help-seeking behaviour and outcome of care for patients attending a group of private complementary practitioners in a single general practice surgery. METHOD: Prospective data on consulting patterns were collected from all 147 new patients attending complementary practitioners over a 12-month period. For the first 30 weeks of this period, additional information on help-seeking behaviour and outcome, as measured by the SF-36 health survey and Measure Yourself Medical Outcome Profile (MYMOP), was collected by questionnaires from 46 out of the 68 new patients. The same information was collected from a systematic one-in-seven sample of GP patients. RESULTS: Patients seen by complementary practitioners did not vary significantly in sex and age from GP patients, except in the low numbers of children. Almost half the patients had been symptomatic for over a year and musculoskeletal disorders accounted for 66% of problems; but there was much variation between the therapies. The average number of visits per patient was three for osteopathy and homeopathy but eight for acupuncture and reflexology. The change in MYMOP scores after four weeks showed a statistically significant improvement in both complementary and GP patients, which was to similar degrees except that the mean change in well-being was significantly greater for complementary patients. CONCLUSION: Prospective data collection in single settings adds valuable information to a little-researched area. This study illustrates how individual each complementary therapy is in its patient characteristics, problem category and length of treatment. The particular improvement in well-being with complementary therapy requires confirmation in other studies.     

Treatment of cervical dystonia: a comparison of measures for outcome assessment

There is little agreement on which outcome measures to use to express the efficacy of treatments for cervical dystonia. We analyzed change scores on various scales of 64 new patients with cervical dystonia before and after repeated injections with botulinum toxin. METHOD: The association between change in impairment (Tsui), and change in pain (TWSTRS-Pain) and functional health (TWSTRS-D, MOS-20) was expressed in percentages of variance explained. Effect sizes of the outcome measures from patients who continued botulinum treatment and dropouts were compared. Performance of outcome measures to distinguish patients who continued treatment and dropouts was analyzed with ROC curves and areas under the curve (AUC). Results: Impairments explained < or =7% of the score variance in functional health. There were no differences between the effect sizes of impairment and pain of patients who continued treatment and dropouts (p > 0.60). This suggests a poor reflection of the treatment efficacy by these outcome measures. Conversely, there were significant differences between the effect sizes of the functional status scales of the patients who continued treatment and the dropouts (p < or = 0.01). ROC curve analysis showed that the disability, handicap, and global disease burden scale accurately distinguished between the two groups (AUCs > 0.80). Impairments showed no discriminative accuracy (AUC = 0.46). CONCLUSION: Neurologic impairments have a small impact on the functional health of cervical dystonia patients. Disability, handicap, and a global measure of disease burden were the most suitable outcome parameters to express the clinical efficacy of botulinum therapy.     

Stability of new MMPI scales and statistical procedures for evaluating changes and differences in psychiatric patients.

Test-retest data are reported for 66 MMPI scales and utilized to illustrate some statistical procedures for answering 5 common questions in clinical practice and research: (1) Does an individual patient's specific retest score on a given scale represent a reliable change? (2) Are the scores of 2 patients significantly different? (3) How accurate is a patient's score? (4) For a patient with a score on each of 2 scales, how reliable is the difference? (5) For scores of a group of patients obtained before and after (or during) some experimental or therapeutic experience, what is the significance of a specific net change? These statistical procedures may be applied to continuous scores from a variety of tests. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Stability of expressed emotion in relatives of those with schizophrenia and its relationship with burden of care and perception of patients' social functioning

BACKGROUND: There is evidence that high expressed emotion (EE) in relatives of patients with schizophrenia is associated with higher levels of burden of care, and with worse perception of patient's social functioning. However, it is not clear whether changes in EE levels over time are associated with changes in relatives' burden of care and their perception of patients' social functioning. METHODS: Fifty patients with a diagnosis of schizophrenia and 50 relatives were included in the study soon after patients' admission to hospital. Thirty-six relatives and 31 patients were re-assessed 9 months after patients' discharge. Both assessments included patients' symptomatology and relatives' EE levels, burden of care, and perception of patients' social functioning. RESULTS: Twenty-three relatives (64%) had the same EE level in both assessments, nine (25%) had changed from high to low EE, and four (11%) from low to high EE. Improvement in burden and perception of patients' social role performance were significantly more accentuated among relatives who changed from high to low EE than among relatives who had a stable EE level. Variables that best predicted changes in EE levels were changes in burden scores and number of hours of contact between patients and relatives at follow-up. CONCLUSIONS: Change in EE is associated with change in circumstances and burden. Findings support the idea that EE is better understood in an integrative model.     

Chronic melatonin treatment counteracts glucocorticoid-induced dysregulation of the hypothalamic-pituitary-adrenal axis in the rat

The aromatherapy service at the Cancer Support and Information Centre (CSIC) of this regional Cancer Centre has been continually assessed since its inception in 1993. New methods of assessing complementary therapies, based on the 'therapy-as-practised', have been explored. The present study evaluates the service following changes made after an initial pilot. The professional aromatherapist developed an evaluation tool, and formal questionnaires were limited to the Hospital Anxiety and Depression Scale (HADS). HADS was completed before and after a course of six aromatherapy sessions. Of 89 patients referred, 58 patients completed the six sessions. Referrals were made by health professionals working in the Cancer Centre and in the CSIC. The majority of patients were female with breast cancer and were receiving radical oncological treatment. Tension, stress and anxiety/fear were the most common reasons for referral, and this was reflected in high initial HADS scores. There were significant improvements in HADS scores in the 58 patients completing the course (mean anxiety, depression, and combined scores dropped from 8.9 to 6.2 6.1 to 4.0 and 15.0 to 10.2, respectively, P < 0.001). Fifty per cent or more of the sample reported a significant improvement in the eight most commonly assessed symptoms. The therapist was initially cautious about using questionnaires, but she gained confidence in using HADS as an assessment tool. The areas covered by her own evaluation tools were broadly comparable to established instruments such as the EORTC QLQ-C30. We conclude that aromatherapy massage has a role in reducing psychological distress, and improving symptom control in cancer patients. Further service evaluation is needed to promote appropriate referral and effective planning of treatment, and to justify cost. Given the multifaceted nature of complementary therapies, the need to develop new research methodologies is acknowledged.     

Delayed neuropsychologic sequelae after carbon monoxide poisoning: prevention by treatment with hyperbaric oxygen

STUDY OBJECTIVE: Carbon monoxide (CO) poisoning is a major clinical problem. The risk of morbidity and the most effective treatment have not been clearly established. We measured the incidence of delayed neurologic sequelae (DNS) in a group of patients acutely poisoned with CO and tested the null hypothesis that the incidence would not be affected by treatment with hyperbaric oxygen (HBO). DESIGN: We conducted a prospective, randomized study in patients with mild to moderate CO poisoning who presented within 6 hours. Patients had no history of loss of consciousness or cardiac instability. INTERVENTIONS: The incidence of DNS was compared between groups treated with ambient pressure 100% oxygen or HBO (2.8 ATA for 30 minutes followed by 2.0 ATA oxygen for 90 minutes). DNS were defined as development of new symptoms after oxygen treatment plus deterioration on one or more subtests of a standardized neuropsychologic screening battery. RESULTS: In 7 of 30 patients (23%), DNS developed after treatment with ambient-pressure oxygen, whereas no sequelae developed in 30 patients after HBO treatment (P < .05). DNS occurred 6 +/- 1 (mean +/- SE) days after poisoning and persisted 41 +/- 8 days. At follow-up 4 weeks after poisoning, patients who had been treated with ambient pressure oxygen and had not sustained DNS exhibited a worse mean score on one subtest, Trail Making, compared with the group treated with HBO and with a control group matched according to age and education level. There were no differences in scores between the control group and the hyperbaric oxygen group. CONCLUSION: DNS after CO poisoning cannot be predicted on the basis of a patient's clinical history or CO level. HBO treatment decreased the incidence of DNS after CO poisoning.     

Usability of a diabetes and cardiovascular disease education module in an African American, diabetic sample with physical, visual, and cognitive impairment.

Objective: Develop an accessible education module and test whether presence of diabetes complications and functional impairments differentially impacted intervention usability. Method: 30 African Americans with type 2 diabetes completed 1 of 4 (90-min) group education classes. Preintervention measures included medical history, Medical Outcomes Study Short Form-8, Telephone Interview for Cognitive Status, and Diabetes and Cardiovascular Disease Knowledge Test. For outcomes comparisons, patients were categorized according to functional impairment (physical; physical + cognitive or physical + visual; physical + cognitive + visual) and number of diabetes complications (0-1, 2-3, 4-6). Outcome measures were knowledge test change scores and patient ratings of satisfaction and accessibility of class and materials. Results: Education resulted in increased mean knowledge scores, from 6.6 to 11.3 (p     

Pharmacology and function of imidazole 4-acetic acid in brain

OBJECTIVE: A significant amount of evidence indicates that some antidepressants have an analgesic effect. We wished to determine whether this analgesic effect could be demonstrated in studies that had used antidepressants for the treatment of pain in patients diagnosed with psychogenic pain or somatoform pain disorder. Meta-analysis was used for this purpose. METHODS: All randomized, placebo-controlled antidepressant treatment studies of patients diagnosed with psychogenic pain disorder or somatoform pain disorder were isolated. These studies were reviewed and relevant statistics were coded. For each study, a single p value for the drug/placebo comparison was found or calculated for pain change scores from pretreatment to completion of treatment. The z scores and effect sizes were calculated for each study, followed by a calculation of an overall z score and effect size. RESULTS: Eleven studies fulfilled the inclusion and exclusion criteria for this meta-analysis. The combined difference showed that antidepressants decreased pain intensity in patients with psychogenic pain or somatoform pain disorder significantly more than placebo (z = 5.71, p<.0001). The overall effect size was large (mean = 0.48) and ranged from 0 to 0.91. CONCLUSIONS: The results indicate that, in patients diagnosed with psychogenic pain or somatoform pain disorder, antidepressant treatment resulted in a reduction in pain that was significantly greater than that of placebo. Possible explanations for these results are discussed.     

Regulation of cGMP-dependent current in On bipolar cells by calcium/calmodulin-dependent kinase

PURPOSE/OBJECTIVE: A review of available head and neck quality of life (QOL) instruments reveals them to inadequately address important radiation related side effects, or to be too cumbersome for routine use. The purpose of this study was to develop a head and neck disease specific module as a companion to the previously developed quality of life - radiation therapy instrument (QOL-RTI). The goal was to create a more complete, yet concise, head and neck site-specific module geared toward patients receiving radiation therapy for head and neck cancer. METHODS AND MATERIALS: This exploratory study included 34 consecutive patients undergoing definitive radiotherapy over a 6-7 week course (60-79.8 Gy). We developed and administered a 14-item questionnaire to all eligible patients treated with radiotherapy for head and neck cancer who were not already registered in another research study assessing quality of life (e.g., RTOG). During the treatment period, the QOL-RTI general tool and the head and neck (H&N) module were administered as follows: at baseline, at week four (for test-retest), and at the end of the treatment period. For validation purposes the QOL-RTI/H&N was compared to the functional assessment cancer tool head and neck (FACT-H&N) questionnaire. The FACT-H&N was administered one time at week 4, on the same day as the QOL-RTI/H&N. This report includes the treatment phase of the study (during the course of radiation). RESULTS: Mean age was 62 years (range 40-75). Internal consistency of the module was satisfactory (Chronbach's alpha = 0.85). Test-retest yielded a correlation coefficient of 0.90 (p < 0.001). Concurrent validity, established by comparing the module to the FACT/H&N , yielded a correlation coefficient of 0.85. Significant changes in quality of life scores during a course of radiation was noted for both general quality of life tool and the site specific module. For the head and neck module, the difference in the mean baseline (7.17) and end of treatment scores (4.20) was 2.94, or 42% change (p < 0.0001). A smaller, yet still significant, difference in scores was seen in the general QOL tool (22 % change, p = 0.001). Item analysis of the module revealed statistically significant (p < 0.05) worsening in quality of life scores in the following areas: pain in throat, swallowing difficulty (meat/bread and liquids), changes in mucous and saliva, changes in taste, difficulty chewing, trouble with coughing, and speech difficulties. Items that were not significant were pain in the mouth, and appearance. CONCLUSION: These initial results suggest that the H&N companion module to the QOL-RTI is a valid and reliable tool that is responsive to changes in QOL during a course of H&N radiation therapy. This tool differs from existing H&N tools by including specific assessments of mucous, saliva, taste, cough, and local pain in a concise format. Significant changes in QOL scores were noted in all of these items. Evaluation of the tool in the post-treatment period (follow-up) is ongoing.     

A multivariate model for predicting respiratory status in patients with chronic obstructive pulmonary disease

OBJECTIVE: To develop and validate a multivariate model for predicting respiratory status in patients with advanced chronic obstructive pulmonary disease (COPD). DESIGN: Prospective, double-blind study of peak flow monitoring. SETTING: Albuquerque Veterans Affairs Medical Center. PATIENTS: Male veterans with an irreversible component of airflow obstruction on baseline pulmonary function tests. MEASUREMENTS: This study was conducted between January 1995 and May 1996. At entry, subjects were instructed in the use of the modified Medical Research Council Dyspnea Scale and a mini-Wright peak flow meter equipped with electronic storage. For the next 6 months, they recorded their dyspnea scores once daily and peak expiratory flow rates twice daily, before and after the use of bronchodilators. Patients were blinded to their peak expiratory flow rates, and medical care was provided in the customary manner. Readings were aggregated into 7-day sampling intervals, and interval means were calculated for dyspnea score and peak expiratory flow rate parameters. Intervals from all subjects were then pooled and randomized to separate groups for model development (training set) and validation (test set). In the training set, logistic regression was used to identify variables that predicted future respiratory status. The dependent variable was the log odds that the subject would attain his highest level of dyspnea in the next 7 days. The final model was used to stratify the test set into "high-risk" and "low-risk" categories. The analysis was repeated for 3-day intervals. MAIN RESULTS: Of the 40 patients considered eligible for study, 8 declined to participate, 4 could not master the technique of peak flow monitoring, and 6 had no fluctuations in their dyspnea level. The remaining 22 subjects form the basis of this report. Fourteen (64%) of the latter completed the 6-month protocol. Data from the 8 who were dropped or died were included up to the point of withdrawal. For 7-day forecasts, mean dyspnea score and mean daily prebronchodilator peak expiratory flow rate were identified as predictor variables. The adjusted odds ratio (OR) for mean dyspnea score was 2.71 (95% confidence interval [CI] 1.79, 4.12) per unit. For mean prebronchodilator peak expiratory flow rate, it was 1.05 (95% CI 1.01, 1.09) per percentage predicted. For 3-day forecasts, the model was composed of mean dyspnea score and mean daily bronchodilator response. The ORs for these terms were 2.66 (95% CI 2.06, 3.44) per unit and 0.980 (95% CI 0.962, 0.998) per percentage of improvement over baseline, respectively. For a given level of dyspnea, higher pre-bronchodilator peak expiratory flow rate and lower bronchodilator response were poor prognostic findings. When the models were applied to the test sets, "high-risk" intervals were 4 times more likely to be followed by maximal symptoms than "low-risk" intervals. CONCLUSIONS: Dyspnea scores and certain peak expiratory flow rate parameters are independent predictors of respiratory status in patients with COPD. However, our results suggest that monitoring is of little benefit except in patients with the most advanced form of this disease, and its contribution to their management is modest at best.