Biomedical subjects

Peter Fayers

Publications and source records attributed to Peter Fayers.

17 recordsLinked to original sources

PubMed2006

Health-related quality of life measurement in randomized clinical trials in surgical oncology.

PURPOSE: There is debate about the value of measuring health-related quality of life (HRQL) in clinical trials in oncology because of evidence suggesting that HRQL does not influence clinical decisions. Analysis of HRQL in surgical trials, however, may inform decision making because it provides detailed assessment of the immediate detrimental short-term impact of surgery on HRQL that needs to be considered against the long-term survival benefits and functional outcomes of surgery. This study evaluated whether HRQL in randomized trials in surgical oncology contributes to clinical decision making. METHODS: A systematic review identified randomized trials in surgical oncology with HRQL. Trials were evaluated independently by two reviewers and the value of HRQL in clinical decision making was categorized in three ways: whether trial investigators reported that HRQL influenced final treatment recommendations, whether trial investigators reported that HRQL would be useful for informed consent, and whether HRQL was assessed robustly according to predefined criteria. RESULTS: Thirty-three randomized trials with valid HRQL questionnaires were identified; 22 (67%) concluded that HRQL outcomes influenced treatment decisions or provided valuable data for informed consent, and seven of these trials had robust HRQL design. Another five trials had robust HRQL design but investigators reported that HRQL outcomes were not clinically important enough to influence treatment recommendations. CONCLUSION: In surgical trials in oncology, HRQL informed clinical decision making. It is recommended that HRQL be included in relevant surgical trials, and that information be used to inform clinicians and patients about the impact of surgery on short- and long-term HRQL.

Decision Making↗

PubMed2006

Prospective randomised multicenter trial on single fraction radiotherapy (8 Gy x 1) versus multiple fractions (3 Gy x 10) in the treatment of painful bone metastases.

BACKGROUND AND PURPOSE: To investigate whether single-fraction radiotherapy is equal to multiple fractions in the treatment of painful metastases. PATIENTS AND METHODS: The study planned to recruit 1000 patients with painful bone metastases from four Norwegian and six Swedish hospitals. Patients were randomized to single-fraction (8 Gy x 1) or multiple-fraction (3 Gy x 10) radiotherapy. The primary endpoint of the study was pain relief, with fatigue and global quality of life as the secondary endpoints. RESULTS: The data monitoring committee recommended closure of the study after 376 patients had been recruited because interim analyses indicated that, as in two other recently published trials, the treatment groups had similar outcomes. Both groups experienced similar pain relief within the first 4 months, and this was maintained throughout the 28-week follow-up. No differences were found for fatigue and global quality of life. Survival was similar in both groups, with median survival of 8-9 months. CONCLUSIONS: Single-fraction 8 Gy and multiple-fraction radiotherapy provide similar pain benefit. These results, confirming those of other studies, indicate that single-fraction 8 Gy should be standard management policy for these patients.

Aged↗

PubMed2006

Multidimensional computerized adaptive testing of the EORTC QLQ-C30: basic developments and evaluations.

OBJECTIVE: Self-report questionnaires are widely used to measure health-related quality of life (HRQOL). Ideally, such questionnaires should be adapted to the individual patient and at the same time scores should be directly comparable across patients. This may be achieved using computerized adaptive testing (CAT). Usually, CAT is carried out for a single domain at a time. However, many HRQOL domains are highly correlated. Multidimensional CAT may utilize these correlations to improve measurement efficiency. We investigated the possible advantages and difficulties of multidimensional CAT. STUDY DESIGN AND SETTING: We evaluated multidimensional CAT of three scales from the EORTC QLQ-C30: the physical functioning, emotional functioning, and fatigue scales. Analyses utilised a database with 2958 European cancer patients. RESULTS: It was possible to obtain scores for the three domains with five to seven items administered using multidimensional CAT that were very close to the scores obtained using all 12 items and with no or little loss of measurement precision. CONCLUSION: The findings suggest that multidimensional CAT may significantly improve measurement precision and efficiency and encourage further research into multidimensional CAT. Particularly, the estimation of the model underlying the multidimensional CAT and the conceptual aspects need further investigations.

Adult↗

PubMed2006

Randomised trial of in-hospital geriatric intervention: impact on function and morale.

BACKGROUND: In two previous publications, we have shown that treatment of acutely sick, frail elderly patients in a Geriatric Evaluation and Management Unit (GEMU) compared to treatment in the general Medical Wards (MW) reduced mortality and improved the chances of living at home in contrast to living in nursing homes or being dead. OBJECTIVE: The aim of this presentation was to study the impact on function, symptoms of depression and general well-being of treatment in the GEMU as compared to treatment in MW. METHODS: Acutely sick, frail patients aged >or=75 years, admitted as emergencies to the Department of Internal Medicine, were randomised either to treatment in the GEMU (n = 127) or the MW (n = 127). In the GEMU the treatment strategy emphasised comprehensive interdisciplinary assessment of all relevant disorders, prevention of complications and iatrogenic conditions, early mobilisation, rehabilitation and discharge planning. The control group received treatment as usual from the Department of Internal Medicine. After discharge neither group received specific follow-up. Activities of daily living (ADL), instrumental ADL, cognitive function, symptoms of depression and general well-being were assessed 3, 6 and 12 months after discharge from hospital. RESULTS: There was no difference in function, depression or general well-being in the GEMU as compared to the MW group. If the dead were included in the analysis at the highest ADL dependency level, there was better function in the GEMU group at 3 months (p = 0.03). CONCLUSION: Treatment in the GEMU had no measurable beneficial impact on function, morale or symptoms of depression. Taken the previously shown mortality reduction into consideration an additional effect on function was less likely and the overall treatment effect was considered to be positive.

Activities of Daily Living↗

PubMed2005

Patterns of drug prescription in a geriatric evaluation and management unit as compared with the general medical wards: a randomised study.

OBJECTIVE: This study's objective was to determine whether patients treated in a geriatric evaluation and management unit (GEMU) had a more appropriate drug profile than patients treated in the general medical wards (MW). METHODS: Frail elderly patients admitted as emergencies to the medical department were randomised to treatment in the GEMU (n=127) or MW (n=127). Drugs used at inclusion and discharge were registered retrospectively and analysed with regard to polypharmacy, number of drugs withdrawn or started, potential drug-drug interactions (DDIs), number of anticholinergic drugs prescribed, and the number of inappropriate drug prescriptions according to Beers' criteria. Utilisation of psychotropic and cardiovascular drugs was compared in detail according to prespecified hypotheses. RESULTS: The number of patients with polypharmacy did not differ significantly between the GEMU and MW. The median number of scheduled drugs withdrawn per patient was higher in the GEMU than in the MW (p=0.005). Drugs with anticholinergic effects (p=0.003); cardiovascular drugs (p<0.001), particularly digitalis glycosides (p<0.001); and antipsychotic drugs (p=0.009) were withdrawn more often in the GEMU. The median number of scheduled drugs started was higher in the GEMU than in the MW (p=0.03). In particular, antidepressants (p<0.001) and estriol (p=0.001) were started more often in the GEMU than in the MW. Fewer GEMU than MW patients had potential DDIs at discharge (p=0.009). CONCLUSION: Drug treatment in the GEMU as compared with the MW was more appropriate in terms of prescription of fewer drugs with anticholinergic effects and fewer potential DDIs. There were distinct differences in treatment patterns of cardiovascular and psychotropic drugs.

Aged↗

PubMed2005

Item response theory was used to shorten EORTC QLQ-C30 scales for use in palliative care.

BACKGROUND AND OBJECTIVE: The goal was to develop a shortened version of the EORTC QLQ-C30 for use in palliative care. We wanted to keep as few items as possible in each scale while still being able to compare results with studies using the original scales. We examined the possibilities of shortening the physical functioning, cognitive functioning, fatigue, and nausea and vomiting scales. STUDY DESIGN AND SETTING: The shortening was based on 2,366 (physical functioning) and 10,815 (three other scales) observations, respectively. We used item response theory to construct scoring algorithms for predicting scores on the original scales. RESULTS: Evaluations showed that a three-item physical scale, a two-item fatigue scale, and a one-item nausea or vomiting scale predicted the scores on the original scales with excellent agreement and had measurement abilities similar to the original scales with no loss or only a little loss in power to detect group differences. The results of the cognitive functioning scale indicated problems when predicting scores from a shortened version. CONCLUSION: Given the favorable results for the physical functioning, fatigue, and nausea or vomiting scales we expect that the shortened versions of these scales will be included in the abbreviated version of the EORTC QLQ-C30 for palliative care.

Cognition↗

PubMed2005

Scoring based on item response theory did not alter the measurement ability of EORTC QLQ-C30 scales.

BACKGROUND AND OBJECTIVES: Most health-related quality-of-life questionnaires include multi-item scales. Scale scores are usually estimated as simple sums of the item scores. However, scoring procedures utilizing more information from the items might improve measurement abilities, and thereby reduce the needed sample sizes. We investigated whether item response theory (IRT)-based scoring improved the measurement abilities of the EORTC QLQ-C30 physical functioning, emotional functioning, and fatigue scales. METHODS: Using a database of 13,010 subjects we estimated the relative validities of IRT scoring compared to sum scoring of the scales. RESULTS: The mean relative validities were 1.04 (physical), 1.03 (emotional), and 0.97 (fatigue). None of these were significantly larger than 1. Thus, no gain in measurement abilities using IRT scoring was found for these scales. Possible explanations include that the items in the scales are not constructed for IRT scoring and that the scales are relatively short. CONCLUSION: IRT scoring of the three longest EORTC QLQ-C30 scales did not improve measurement abilities compared to the traditional sum scoring of the scales.

Adult↗

PubMed2005

Quality of life may be affected more by disease parameters and response to therapy than by haemoglobin changes.

Earlier studies showing a negative impact of anaemia on quality of life (QOL) lack adequate adjustment for confounding factors such as disease stage and tumour response. We examined the impact of haemoglobin concentration on QOL scores of 745 multiple myeloma patients followed from diagnosis, adjusting for objective disease parameters. Data from two Nordic studies with the EORTC QLQ-C30 questionnaire were analysed using linear regression analysis. Haemoglobin was independently related only to fatigue at baseline (P = 0.001) and at 12 months (P = 0.010). In multivariate analysis, extent of skeletal disease was at least as strong a predictor for fatigue at diagnosis as haemoglobin and was also related to other important QOL scores such as physical functioning, role functioning, global QOL and pain (P < 0.001). At 12 months' follow-up, response to therapy was related to physical functioning (P < 0.001) and pain (P = 0.001). In conclusion, haemoglobin and extent of skeletal disease were both predictors for fatigue in patients with newly diagnosed multiple myeloma, but extent of skeletal disease was also associated with other important QOL scores. During follow-up, response to therapy emerged as an important predictor variable. When examining the effect of haemoglobin on QOL, it is essential to adjust for disease parameters and response to therapy in order not to overestimate the impact of haemoglobin on QOL. Our findings imply that uncontrolled studies on the effect of erythropoietin (EPO) in cancer patients may be making exaggerated claims for the effect of EPO on QOL.

Adult↗

PubMed2004

Acute geriatric intervention increases the number of patients able to live at home. A prospective randomized study.

BACKGROUND AND AIMS: In a previous publication, we showed that treatment of acutely sick, frail elderly patients in a Geriatric Evaluation and Management Unit (GEMU) reduced mortality considerably when compared with the general Medical Wards (MW). The aim of this presentation was to study the impact of treatment in a GEMU on health care utilization. METHODS: Acutely sick, frail patients, 75 years or older, who had been admitted as emergencies to the Department of Internal Medicine were randomized either to treatment in the GEMU (n=127) or to continued treatment in the MW (n=127). While usual treatment was given in the MW, the GEMU emphasized interdisciplinary and comprehensive assessment of all relevant disorders, early mobilization/rehabilitation, and discharge planning. After discharge from hospital, no specific follow-up was offered to any of the groups. RESULTS: Of all subjects, 101 (80%) GEMU and 79 (64%) MW patients were still living in their own homes at three months (p=0.005); at six months the number was 91 (72%) and 74 (60%) (p=0.04) respectively. Median length of index stay was 19 days in the GEMU and 13 days in the MW group (p<0.001). After the initial stay, there were no statistically significant differences in admissions to or time spent in institutions. CONCLUSIONS: The results indicate the overall positive treatment effect of acutely sick, frail elderly in a GEMU, i.e. patients treated in the GEMU had increased possibilities of living in their own homes, an effect that was mainly related to considerably reduced mortality in the GEMU group.

Aged↗

PubMed2004

Place of death: hospital-based advanced home care versus conventional care. A prospective study in palliative cancer care.

The purpose of this prospective nonrandomized study was to evaluate time spent at home, place of death and differences in sociodemographic and medical characteristics of patients, with cancer in palliative stage, receiving either hospital-based advanced home care (AHC), including 24-hour service by a multidisciplinary palliative care team or conventional hospital care (CC). Recruitment to the AHC group and to the study was a two-step procedure. The patients were assigned to either hospital-based AHC or CC according to their preferences. Following this, the patients were asked to participate in the study. Patients were eligible for the study if they had malignant disease, were older than 18 years and had a survival expectancy of 2-12 months. A total of 297 patients entered the study and 280 died during the study period of two and a half years, 117 in the AHC group and 163 in the CC group. Significantly more patients died at home in the AHC group (45%) compared with the CC group (10%). Preference for and referral to hospital-based AHC were not related to sociodemographic or medical characteristics. However, death at home was associated with living together with someone. Advanced hospital-based home care targeting seriously ill cancer patients with a wish to remain at home enable a substantial number of patients to die in the place they desire.

Adult↗

PubMed2004

Statistical evaluation of learning curve effects in surgical trials.

Randomized controlled trials (RCTs) in surgery have been impeded by concerns that improvements in the technical performance of a new technique over time (a "learning curve") may distort comparisons. The statistical assessment of learning curves in trials has received little attention. In this paper, we discuss what a learning curve effect is, the factors which effect it, how to display it, and how to incorporate the learning effect into the trial analysis. Bayesian hierarchical models are proposed to adjust the trial results for the existence of a learning curve effect. The implications for trial evaluation and data collection are considered.

Bayes Theorem↗

PubMed2003

The relationship between psychologic distress and cancer-related fatigue.

BACKGROUND: The authors examined the relationship between changes in depression and anxiety levels with changes in fatigue levels among anemic patients with lung cancer who participated in a randomized, double-blind, placebo-controlled clinical trial of darbepoetin alfa for the treatment of anemia. METHODS: Patients completed the Brief Symptom Inventory (BSI) Depression and Anxiety subscales and the Functional Assessment of Cancer Therapy (FACT) Fatigue subscale during the trial. Pearson correlation coefficients were used to compare changes in the BSI scores with changes in the FACT Fatigue scores. Multiple regression models were used to explore sociodemographic and clinical explanatory variables. RESULTS: At baseline, 25% and 35% of 250 patients reported high levels (normed BSI scores >or= 65) of anxiety and depression, respectively. Correlations of changes in normed BSI Anxiety and Depression subscale scores with changes in FACT Fatigue scores had coefficients of -0.45 (P < 0.001) and -0.44 (P < 0.001), respectively. In the multiple regression models, change in the FACT Fatigue score was the only significant explanatory variable (P < 0.001). For every unit improvement in FACT Fatigue score, there was a corresponding improvement of 0.7 points and 0.8 points in anxiety and depression levels, respectively. CONCLUSIONS: Improvements in fatigue were associated significantly with reductions in anxiety and depression. For patients with anemia, fatigue can be improved or reversed with darbepoetin alfa therapy. Thus, less fatigued patients also may benefit from reduced levels of anxiety and depression.

Adult↗

PubMed2003

Use of differential item functioning analysis to assess the equivalence of translations of a questionnaire.

In cross-national comparisons based on questionnaires, accurate translations are necessary to obtain valid results. Differential item functioning (DIF) analysis can be used to test whether translations of items in multi-item scales are equivalent to the original. In data from 10,815 respondents representing 10 European languages we tested for DIF in the nine translations of the EORTC QLQ-C30 emotional function scale when compared to the original English version. We tested for DIF using two different methods in parallel, a contingency table method and logistic regression. The DIF results obtained with the two methods were similar. We found indications of DIF in seven of the nine translations. At least two of the DIF findings seem to reflect linguistic problems in the translation. 'Imperfect' translations can affect conclusions drawn from cross-national comparisons. Given that translations can never be identical to the original we discuss how findings of DIF can be interpreted and discuss the difference between linguistic DIF and DIF caused by confounding, cross-cultural differences, or DIF in other items in the scale. We conclude that testing for DIF is a useful way to validate questionnaire translations.

Adult↗

PubMed2003

Which cancer patients die in nursing homes? Quality of life, medical and sociodemographic characteristics.

In this study, cancer patients' characteristics associated with death in nursing homes were explored. The study sample included 395 cancer patients who had participated in a trial of palliative care, 260 (66%) patients died in hospital, 80 (20%) at home and 55 (14%) in nursing homes. Health-related quality of life was prospectively recorded using the EORTC QLQ-C30 questionnaire. Death in nursing home was associated with greater age, not living with spouse and poor performance status. Patients dying in nursing homes reported severe functioning impairments and more fatigue and appetite loss compared with those dying elsewhere. The association between death in nursing homes and poor physical, role, cognitive and social functioning remained significant when sociodemographic and medical differences were taken into account. Further research on frail elderly cancer patients is warranted to improve their care, to evaluate the appropriateness of nursing home placement and for future planning of palliative care services.

Adult↗

PubMed2003

Routine drug monitoring of serum concentrations of morphine, morphine-3-glucuronide and morphine-6-glucuronide do not predict clinical observations in cancer patients.

The clinical importance of routine drug monitoring of serum concentrations of morphine, morphine-6-glucuronide (M6G) and morphine-3-glucuronide (M3G) during chronic morphine therapy is not established. We measured morphine, M6G and M3G serum concentrations in cancer pain patients receiving oral (n = 263, median dose 80 mg/24 hours) or subcutaneous (sc) (n = 35, median dose 110 mg/24 hours) morphine. Regression analyses were performed to investigate if serum concentrations of morphine, M3G and M6G predicted pain intensity (Brief Pain Inventory), health-related quality-of-life variables (EORTC QLQ-C30) and cognitive function (Mini-Mental Score). Serum concentrations were also compared in patients categorized as morphine 'treatment successes' and 'treatment failures'. We observed that serum concentrations of morphine, M6G or M3G did not predict pain intensity, cognitive function, nausea or tiredness. 'Treatment failures' caused by nausea, tiredness, cognitive failure or constipation did not have statistically significant different morphine, M6G and M3G serum concentrations than patients classified as 'treatment successes'. In conclusion, this study did not observe any concentration-effect relationships of morphine, M3G or M6G with pain intensity, nausea, constipation, tiredness or cognitive failure in blood samples obtained during routine clinical drug monitoring in cancer patients. This result suggests that therapeutic drug monitoring as a routine tool during chronic morphine treatment has limited value for clinical decision making.

Administration, Oral↗

PubMed2003

The validity of EORTC QLQ-C30 fatigue scale in advanced cancer patients and cancer survivors.

Fatigue is a major complaint among advanced cancer patients. Several instruments are available for measuring fatigue. The EORTC QLQ-C30 is one of the most frequently used health-related quality of life (HRQOL) instruments, and it includes a three-item fatigue subscale. Limited knowledge exists about the validity, performance and sensitivity of EORTC QLQ-C30 fatigue scale as compared with a fatigue-specific instrument. The aim of the present study was to validate the EORTC QLQ-C30 fatigue scale (FA) against the Fatigue Questionnaire (FQ). The FQ is frequently used and was developed to measure fatigue in both cancer and noncancer populations. The FQ measures physical (PF, seven items) and mental fatigue (MF, four items). The study population included two different cohorts: A) patients with advanced metastatic cancer included in a prospective randomized study of palliative radiotherapy (n = 238); B) patients with leukaemia and malignant lymphoma curatively treated with stem-cell transplantation and high-dose chemotherapy (n = 128). The analysis demonstrated that the FA correlated higher with the PF scale (r = 0.67-0.75) as compared with the MF scale (r = 0.49-0.61). The item scale correlations between FA items and the PF scale were consistently higher than between FA items and the MF scale. A factor analysis including all the items within the FA and the FQ identified two factors. All FA items loaded on a PF factor (0.70-0.85). A floor/ ceiling effect, indicating a high number of respondents with lowest, respectively, highest scores was observed more frequently in the FA as compared with the FQ. The PF discriminated better between diagnostic groups with different levels of fatigue than the FA did. In conclusion, the EORTC QLQ-C30 fatigue scale is measuring physical fatigue. A floor/ ceiling effect seems to appear for the EORTC QLQ-C30 fatigue scale. The validity of the EORTC QLQ-C30 fatigue scale is to be questioned for use in palliative care patients. In studies with fatigue as a defined end point, a domain-specific instrument should, therefore, be added.

Adult↗

PubMed2002

Reduced mortality in treating acutely sick, frail older patients in a geriatric evaluation and management unit. A prospective randomized trial.

OBJECTIVES: Documentation of treatment effects in acutely sick frail older patients in geriatric evaluation and management units (GEMUs) is scarce. The present study evaluated whether treatment in a GEMU would reduce mortality as compared to traditional treatment delivered in the Department of Internal Medicine. DESIGN: Prospective randomized trial. SETTING: GEMU or general medical ward. PARTICIPANTS: Acutely sick frail patients aged 75 and older who had been admitted to the Department of Internal Medicine were randomly assigned to treatment in the GEMU (n = 127) or to the general medical wards (n = 127). The following inclusion criteria were used to target frail patients: chronic disability, acute impairment of single activity of daily living, mild/moderate dementia, confusion, depression, imbalance/dizziness, falls, impaired mobility, urinary incontinence, malnutrition, polypharmacy, vision or hearing impairment, social problems, or prolonged bedrest. INTERVENTION: In the GEMU, the treatment strategy emphasized interdisciplinary assessment of all relevant disorders, prevention of complications and iatrogenic conditions, early mobilization/rehabilitation, and comprehensive discharge planning. The control group received treatment as usual from the Department of Internal Medicine. After discharge neither group received specific follow-up. MEASUREMENTS: Mortality and causes of death. RESULTS: Mortality in the intervention and control groups, respectively, was 12% and 27% at 3 months (P =.004), 16% and 29% (P =.02) at 6 months, and 28% and 34% (P =.06) at 12 months. The hazard ratio was 0.39 (95% confidence interval = 0.21-0.72) at 3 months. The main cause of death was cardiovascular disease. CONCLUSION: Treatment of acutely sick, frail, older patients in a GEMU substantially reduced mortality.

Activities of Daily Living↗