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P Fayers

Publications and source records attributed to P Fayers.

At least 19 recordsLinked to original sources
PubMed2006

The relationship between patient knowledge of hemoglobin levels and health-related quality of life.

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

Aged↗
PubMed2004

Use of item response theory to develop a shortened version of the EORTC QLQ-C30 emotional functioning scale.

BACKGROUND: As part of a larger study whose objective is to develop an abbreviated version of the EORTC QLQ-C30 suitable for research in palliative care, analyses were conducted to determine the feasibility of generating a shorter version of the 4-item emotional functioning (EF) scale that could be scored in the original metric. METHODS: We used data from 24 European cancer studies conducted in 10 different languages (n = 8242). Item selection was based on analyses by item response theory (IRT). Based on the IRT results, a simple scoring algorithm was developed to predict the original 4-item EF sum scale score from a reduced number of items. RESULTS: Both a 3-item and a 2-item version (item 21 'Did you feel tense?' and item 24 'Did you feel depressed?') predicted the total score with excellent agreement and very little bias. In group comparisons, the 2-item scale led to the same conclusions as those based on the original 4-item scale with little or no loss of measurement efficiency. CONCLUSION: Although these results are promising, confirmatory studies are needed based on independent samples. If such additional studies yield comparable results, incorporation of the 2-item EF scale in an abbreviated version of the QLQ-C30 for use in palliative care research settings would be justified. The analyses reported here demonstrate the usefulness of the IRT-based methodology for shortening questionnaire scales.

Adult↗
PubMed2004

Psychiatric symptoms and disorders in adolescents with low birth weight.

OBJECTIVE: To evaluate the prevalence of psychiatric symptoms and disorders associated with low birth weight.Design/study groups: A population based follow up study of 56 very low birthweight (VLBW: birth weight < or = 1500 g), 60 term small for gestational age (SGA: birth weight < 10th centile), and 83 term control (birth weight > or = 10th centile) children at 14 years of age. OUTCOME MEASURES: Schedule for affective disorders and schizophrenia for school aged children, attention deficit/hyperactivity disorder (ADHD) rating scale IV, autism spectrum screening questionnaire, and children's global assessment scale. RESULTS: VLBW adolescents had a higher prevalence of psychiatric symptoms (46%) than controls (13%) (odds ratio (OR) 5.7, 95% confidence interval (CI) 2.5 to 13.0) and more psychiatric disorders (25%) than controls (7%) (OR 4.3, 95%CI 1.5 to 12.0), especially anxiety disorders. Although 25% of the VLBW adolescents had attention problems, ADHD was diagnosed in only 7%. Four VLBW adolescents had symptoms of Asperger's disorder, and the VLBW group had a higher sum score than controls on the autism spectrum screening questionnaire. Although more SGA adolescents had psychiatric symptoms than controls (23% v 13%), the difference was not statistically significant. Results remained essentially the same when adolescents with low estimated intelligence quotient were excluded, and persisted after possible psychosocial confounders had been controlled for. CONCLUSION: VLBW, but not SGA adolescents, have a high risk of developing psychiatric symptoms and disorders by the age of 14, especially attention deficit, anxiety symptoms, and relational problems.

Adolescent↗
PubMed2003

Clinical and psychometric validation of an EORTC questionnaire module, the EORTC QLQ-OES18, to assess quality of life in patients with oesophageal cancer.

Quality of life (QOL) assessment requires clinically relevant questionnaires that yield accurate data. This study defined measurement properties and the clinical validity of the European Organisation for Research and Treatment of Cancer (EORTC) questionnaire module to assess QOL in oesophageal cancer. The oesophageal module the QLQ-OES24 and core questionnaire, the Quality of Life-Core 30 questionnaire (QLQ-C30) was administered patients undergoing treatment with curative (n=267) or palliative intent (n=224) and second assessments performed 3 months or 3 weeks later respectively. Psychometric tests examined scales and measurement properties of the module. Questionnaires were well accepted, compliance rates were high and less than 2% of items had missing data. Multi-trait scaling analyses and face validity refined the module to four scales and six single items (QLQ-OES18). Selective scales distinguished between clinically distinct groups of patients and demonstrated treatment-induced changes over time. The EORTC QLQ-OES18 demonstrates good psychometric and clinical validity. It is recommended for use with the core questionnaire, the QLQ-C30, to assess QOL in patients with oesophageal cancer.

Adenocarcinoma↗
PubMed2003

Influences on serum concentrations of morphine, M6G and M3G during routine clinical drug monitoring: a prospective survey in 300 adult cancer patients.

BACKGROUND: In order to make treatment decisions physicians should have knowledge about the relations between patient characteristics and drug disposition. Dose, route of administration, gender, age and renal function are reported to influence the serum concentrations of morphine, morphine-6-glucurnide (M6G) and morphine-3-glucuronide (M3G) during chronic treatment of cancer pain. These factors, however, are not evaluated in studies with a sample size sufficient to explore predictive factors. METHODS: Three hundred consecutive morphine users admitted because of a malignant disease were recruited. The relations of serum concentrations of morphine, M6G and M3G to patient characteristics (gender, age, weight, renal function, liver function, dose, route of administration) were explored, and regression analysis performed to investigate whether these characteristics predicted serum concentrations obtained during routine clinical drug monitoring. RESULTS: Morphine dose was associated with serum concentrations of morphine (r = 0.69), M6G (r = 0.76) and M3G (r = 0.76). Oral morphine resulted in higher dose-adjusted M6G and M3G serum concentrations compared with s.c. morphine. Creatinine serum concentrations correlated with serum concentrations of M6G and M3G. Dose and route of administration predicted morphine serum concentrations, while dose and renal function predicted M6G and M3G serum concentrations. Age was an additional factor predicting M3G concentrations. Dose was the only factor that explained a clinically significant part of the observed variability. CONCLUSION: Patient characteristics predict only minor parts of the variability of morphine, M3G and M6G serum concentrations observed during routine clinical drug-monitoring in cancer patients.

Adult↗
PubMed2002

Quality of life research within the EORTC-the EORTC QLQ-C30. European Organisation for Research and Treatment of Cancer.

In forming its Quality of Life Group, the EORTC created one of the earliest and largest of such groups in Europe. The EORTC QLQ-C30 which this group developed has become the most widely used questionnaire in Europe for cancer patients, and is extensively used around the world. The Quality of Life Group continues to build upon this success, both by refining the QLQ-C30, whilst developing a range of additional modules, and by initiating research projects that explore aspects of quality of life assessment, evaluation and interpretation. We review the progress to date and indicate directions of further research and development.

Clinical Trials as Topic↗
PubMed2001

Quality of life in advanced cancer patients: the impact of sociodemographic and medical characteristics.

Population-based surveys have shown that health-related quality of life (HRQL) is influenced by patients' characteristics such as age, gender, living situation and diagnoses. The present study explores the impact of such factors on the HRQL of severely ill cancer patients. The study sample included 395 cancer patients who participated in a cluster randomised trial of palliative care. Median survival was 13 weeks. HRQL assessments (using the EORTC QLQ-C30 questionnaire) were compared among subgroups of relevant patients' characteristics (ANOVA), and the significance of individual covariates was explored by multivariate linear regression. Most EORTC QLQ-C30 scores showed minor differences between genders. Higher age was associated with less sleeping disturbance, less pain and better emotional functioning. No positive impact of living with a partner was found. Performance status and/or time from assessment to death were significantly associated with most functioning and symptom scores. We concluded that although the overall impact of sociodemographic characteristics may seem less important to HRQL scores among advanced cancer patients than in general populations, age and gender should be allowed for. Performance status and closeness to death also need to be reported.

Adult↗
PubMed2001

Quality of life in palliative cancer care: results from a cluster randomized trial.

PURPOSE: To assess the impact of comprehensive palliative care on patients' quality of life. The intervention was based on cooperation between a palliative medicine unit and the community service and was compared with conventional care. PATIENTS AND METHODS: A cluster randomized trial was carried out, with community health care districts defined as the clusters. Patients from these districts who had malignant disease and survival expectancy between 2 to 9 months were entered onto the trial. The main quality-of-life end points were physical and emotional functioning, pain, and psychologic distress assessed monthly by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) questionnaire and Impact of Event scale (IES). In total, 235 intervention patients and 199 controls were included. RESULTS: During the initial 4 months of follow-up, the compliance was good (72%) and comparable among treatment groups. No significant differences on any of the quality-of-life scores were found. At later assessments and for scores that were made within 3 months before death, there was also no consistent tendency in favor of any treatment group on the main outcomes or other EORTC QLQ-C30 scales/items. CONCLUSION: A general program of palliative care may be important to ensure flexibility and to meet the needs of terminally ill patients. However, to achieve improvements on a group level of the various dimensions of quality of life, specific interventions directed toward specific symptoms or problems may have to be defined, evaluated, and included in the program.

Adult↗
PubMed2001

Randomised, double-blind, placebo-controlled trial of corticosteroids for the treatment of hyperemesis gravidarum.

OBJECTIVE: To assess the efficacy of corticosteroids in the treatment of severe hyperemesis gravidarum refractory to conventional management. DESIGN: Multicentre, double-blind, randomised, placebo-controlled trial. SETTING: Inpatient gynaecology wards in eight collaborating centres. POPULATION: Twenty-five women with severe hyperemesis of which 24 completed the one- week study period. METHODS: Twenty-five women were randomised to receive either 40 mg prednisolone daily in two divided oral doses, or equivalent placebo tablets. If, after three days, a woman was still vomiting, medication was changed to the equivalent intravenous alternative (hydrocortisone 100 mg twice daily or normal saline injections) MAIN OUTCOME MEASURES: Frequency of vomiting and the dependence on intravenous fluid replacement therapy after one week of treatment. RESULTS: There was a non-significant trend towards improved nausea and vomiting and reduced dependence on intravenous fluids. However, steroid therapy led to an improved sense of wellbeing (P = 0.021), improved appetite (P = 0.039) and increased weight gain (P = 0.025) compared with placebo. There was no difference in pregnancy outcome between the treatment and placebo groups. CONCLUSIONS: This study supports a beneficial role for steroids in severe hyperemesis, but did not validate the hypothesis that they lead to rapid and complete remission of symptoms. The study was not large enough to demonstrate a significant improvement in the primary outcome measures.

Administration, Oral↗
PubMed2000

A palliative-care intervention and death at home: a cluster randomised trial.

BACKGROUND: The Palliative Medicine Unit at University Hospital of Trondheim, Norway, started an intervention programme that aims to enable patients to spend more time at home and die there if they prefer. Close cooperation was needed with the community health-care professionals, who acted as the principal formal caregivers, and a multidisciplinary consultant team coordinated the care. We did a cluster randomised trial to assess the intervention's effectiveness compared with conventional care METHODS: Community health-care districts in and around Trondheim, Norway, were defined as the clusters to be randomised. We enrolled 434 patients (235 assigned intervention and 199 conventional care [controls]) in these districts who had incurable malignant disease and an expected survival of 2-9 months. Main outcomes were place of death and time spent in institutions in the last month of life. FINDINGS: 395 patients died. Of these, more intervention patients than controls died at home (54 [25%] vs 26 [15%], p<0.05). The time spent at home was not significantly increased, although intervention patients spent a smaller proportion of time in nursing homes in the last month of life than did controls (7.2 vs 14.6%, p<0.05). Hospital use was similar in the two groups. INTERPRETATION: The palliative-care intervention enabled more patients to die at home. More resources for care in the home (palliative care training and staff) and an increased focus on use of nursing homes would be necessary, however, to increase time at home and reduce hospital admissions.

Adult↗
PubMed1999

Patient survival after D1 and D2 resections for gastric cancer: long-term results of the MRC randomized surgical trial. Surgical Co-operative Group.

Controversy still exists on the optimal surgical resection for potentially curable gastric cancer. Much better long-term survival has been reported in retrospective/non-randomized studies with D2 resections that involve a radical extended regional lymphadenectomy than with the standard D1 resections. In this paper we report the long-term survival of patients entered into a randomized study, with follow-up to death or 3 years in 96% of patients and a median follow-up of 6.5 years. In this prospective trial D1 resection (removal of regional perigastric nodes) was compared with D2 resection (extended lymphadenectomy to include level 1 and 2 regional nodes). Central randomization followed a staging laparotomy. Out of 737 patients with histologically proven gastric adenocarcinoma registered, 337 patients were ineligible by staging laparotomy because of advanced disease and 400 were randomized. The 5-year survival rates were 35% for D1 resection and 33% for D2 resection (difference -2%, 95% CI = -12%-8%). There was no difference in the overall 5-year survival between the two arms (HR = 1.10, 95% CI 0.87-1.39, where HR > 1 implies a survival benefit to D1 surgery). Survival based on death from gastric cancer as the event was similar in the D1 and D2 groups (HR = 1.05, 95% CI 0.79-1.39) as was recurrence-free survival (HR = 1.03, 95% CI 0.82-1.29). In a multivariate analysis, clinical stages II and III, old age, male sex and removal of spleen and pancreas were independently associated with poor survival. These findings indicate that the classical Japanese D2 resection offers no survival advantage over D1 surgery. However, the possibility that D2 resection without pancreatico-splenectomy may be better than standard D1 resection cannot be dismissed by the results of this trial.

Adenocarcinoma↗
PubMed1999

Do patients who are treated with stem cell transplantation have a health-related quality of life comparable to the general population after 1 year?

Health-related quality of life (HRQOL) in leukemia and lymphoma patients treated with high-dose chemotherapy followed by allogeneic (SCT) and autologous (ASCT) stem cell transplantation or receiving combination chemotherapy (CT) was prospectively assessed by the EORTC QLQ-C30 and compared with reference data from a general population sample. One year after transplant, the SCT group had functional scores which were close to population values except for lower social (P < 0.0001) and role function (P = 0.0004). More symptoms and problems were reported, especially appetite loss (P = 0. 001) and financial difficulties (P = 0.0001). The ASCT patients reported a less than optimal HRQOL relative to the population 1 year post transplant. Cognitive, physical, role, and social function, dyspnoea, financial difficulties and global quality of life were most impaired (P < 0.001). In the CT group, physical, role and social function, dyspnoea and financial difficulties were impaired 1 year after start of chemotherapy, compared with the general population (P < 0.001). The EORTC QLQ-C30 was supplemented by a high-dose chemotherapy module, the HDC-19, at the 1-year assessment, but no consistent differences were found across groups. Fifteen to 34% of the patients expressed fears of relapse and worries about future health, while 24-30% indicated no participation in sexual activities.

Adolescent↗
PubMed1999

Challenges in palliative care research; recruitment, attrition and compliance: experience from a randomized controlled trial.

Randomized controlled trials (RCTs) in palliative cancer care often experience methodological problems. In this paper we discuss issues of major concern, including recruitment, patient attrition and compliance, arising from an RCT that compared comprehensive palliative care to conventional care. The main criteria for trial entry were incurable malignant disease and a survival expectancy of between 2 and 9 months. Patients' health-related quality of life (HRQL), self-assessed by multi-item questionnaires, was a defined endpoint. The planned number of patients was successfully recruited, although the patients were referred late in the course of their disease so that follow-up tended to be short. Compliance in completing HRQL questionnaires was good up to 1 month before the patient's death; but in the final weeks it was found to drop substantially. Based on our experience, recommendations are given for those planning similar research. Procedures for improving patient recruitment are suggested, stressing the need for local data management, repeated information to referral sources, extensive screening for potentially eligible patients and simple referral routines. Precise inclusion criteria, including prognostic factors other than physicians' estimates of life expectancy, should be used to ensure a sufficient follow-up period. For HRQL assessment, multi-item questionnaires can achieve excellent compliance up to 1 month before patients' death, but in order to evaluate the very final weeks of life we recommend the use of simpler methods.

Adult↗
PubMed1998

Double data entry: what value, what price?

We challenge the notion that double data entry is either sufficient or necessary to ensure good-quality data in clinical trials. Although we do not completely reject that notion, we quantify some of the effects that poor quality data have on final study results in terms of estimation, significance testing, and power. By introducing digit errors into simulated blood pressure measurements we demonstrate that simple range checks allow us to detect (and therefore correct) the main errors that impact the final study results and conclusions. The errors that cannot easily be detected by such range checks, although possibly numerous, are shown to be of little importance in drawing the correct conclusions from the statistical analysis of data. Exploratory data analysis cannot identify all errors that a second data entry would detect, but on the other hand, not all errors that are found by exploratory data analysis are detectable by double data entry. Double data entry is concerned solely with ensuring, to a high degree of certainty, that what is recorded on the case record form is transcribed into the database. Exploratory data analysis looks beyond the case record form to challenge the plausibility of the written data. In this sense, the second entering of data has some benefit, but the use of exploratory data analysis methods, either as data entry is ongoing or at the end of data entry and as the first stage in an analysis strategy, should always be mandatory.

Algorithms↗
PubMed1998

Methodological and statistical issues of quality of life (QoL) and economic evaluation in cancer clinical trials: report of a workshop.

In recent years, quality of life (QoL) and economic evaluations have become increasingly important as additional outcome measures in cancer clinical trials. However, both fields of research are relatively new and in need of finding solutions to a substantial number of specific methodological problems. This paper reports on the proceedings of a symposium aimed at summarising and discussing some of the most contentious methodological and statistical issues in QoL and economic evaluations. In addition, possible solutions are indicated and the most pertinent areas of research are identified. Issues specific to QoL evaluations that are addressed include clinically meaningful changes in QoL scores; how to analyse QoL data and to handle missing and censored data and integration of length of life and QoL outcomes. Issues specific to economic evaluations are the advantages and disadvantages of various outcome measures; statistical methods to analyse economic data and choice of decision criteria and analytical perspective. How to perform QoL and economic evaluations in large and simple trials and whether the gap between QoL and utility measures can be bridged are also discussed.

Clinical Trials as Topic↗
PubMed1996

Postoperative morbidity and mortality after D1 and D2 resections for gastric cancer: preliminary results of the MRC randomised controlled surgical trial. The Surgical Cooperative Group.

BACKGROUND: In Japan the surgical approach to treatment of potentially curable gastric cancer, including extended lymphadenectomy, seems in retrospective surveys to give better results than the less radical procedures favoured in Western countries. There has, however, been no evidence from randomised trials that extended lymphadenectomy (D2 gastric resection) confers a survival advantage. This question was addressed in a trial involving thirty-two surgeons in Europe. METHODS: In a prospective randomised controlled trial, D1 resection (level 1 lymphadenectomy) was compared with D2 resection (levels 1 and 2 lymphadenectomy). Central randomisation (200 patients in each arm) followed a staging laparotomy. FINDINGS: The D2 group had greater postoperative hospital mortality (13% vs 6.5%; p=0.04 [95% Cl 9-18% for D2, 4-11% for D1] and higher overall postoperative morbidity (46% vs 28%; p<0.001); their postoperative stay was also longer. The excess postoperative morbidity and mortality in the D2 group was accounted for by distal pancreaticosplenectomy and splenectomy. In the whole group (400 patients), survival beyond three years was 30% in patients whose gastrectomy included en-bloc pancreatico-splenic resection versus 50% in the remainder. INTERPRETATION: D2 gastric resections are followed by higher morbidity and mortality than D1 resections. These disadvantages are consequent upon additional pancreatectomies and distal splenectomies, and in long-term follow-up the higher mortality when the pancreas and spleen are resected may prove to nullify any survival benefit from D2 procedures.

Adenocarcinoma↗