Showing papers in "Quality of Life Research in 1995"
TL;DR: The most problematic feature of the five surveys was their lack of precision for individual-patient applications, and across all scales, reliability standards for individual assessment and monitoring were not satisfied, and the 95% Cls were very wide.
Abstract: Interest has increased in recent years in incorporating health status measures into clinical practice for use at the individual-patient level. We propose six measurement standards for individual-patient applications: (1) practical features, (2) breadth of health measured, (3) depth of health measured, (4) precision for cross-sectional assessment, (5) precision for longitudinal monitoring and (6) validity. We evaluate five health status surveys (Functional Status Questionnaire, Dartmouth COOP Poster Charts, Nottingham Health Profile, Duke Health Profile, and SF-36 Health Survey) that have been proposed for use in clinical practice. We conducted an analytical literature review to evaluate the six measurement standards for individual-patient applications across the five surveys. The most problematic feature of the five surveys was their lack of precision for individual-patient applications. Across all scales, reliability standards for individual assessment and monitoring were not satisfied, and the 95% Cls were very wide. There was little evidence of the validity of the five surveys for screening, diagnosing, or monitoring individual patients. The health status surveys examined in this paper may not be suitable for monitoring the health and treatment status of individual patients. Clinical usefulness of existing measures might be demonstrated as clinical experience is broadened. At this time, however, it seems that new instruments, or adaptation of existing measures and scaling methods, are needed for individual-patient assessment and monitoring.
1,792 citations
TL;DR: A short 39 item Parkinson's Disease Questionnaire, referred to here as the PDQ-39, proved to have satisfactory internal and test-retest reliability, and construct validity in relation to other measures, reported by respondents with Parkinson's disease.
Abstract: Parkinson's disease is a common degenerative neurological condition. A number of general health status measures exist but these may not address areas salient to specific diseases. We report here the development and validation of a short 39 item health status questionnaire for use in Parkinson's disease. Questionnaire items, generated from in-depth interviews with people with Parkinson's disease, were developed into a 65 item questionnaire. Data from a postal survey using the 65 item questionnaire were statistically analysed to produce a shorter questionnaire with 39 items and eight scales addressing different dimensions of Parkinson's disease. A second postal survey was conducted in order to assess the reliability and validity of the new 39 item questionnaire. The final questionnaire, referred to here as the 39 item Parkinson's Disease Questionnaire (PDQ-39), proved to have satisfactory internal and test-retest reliability, and construct validity in relation to other measures, reported by respondents with Parkinson's disease.
993 citations
TL;DR: Construct validity was supported by significant associates between MSQOL-54 scales and degree of multiple sclerosis symptom severity in the prior year, level of ambulation, employment limitations due to health, admission to hospital in the previous year, and depressive symptoms.
Abstract: The need for measures of health-related quality of life (HRQOL) for clinical effectiveness research and for quality of care research, particularly for chronic diseases, is increasingly recognized. We assessed a measure of HRQOL for people with multiple sclerosis, a chronic neurological condition. We used the RAND 36-Item Health Survey 1.0 (aka SF-36) as a generic core measure, to enable comparisons of HRQOL of patients with multiple sclerosis to those of other patient populations and to the general population. To enhance comparisons within groups of multiple sclerosis patients, these items were supplemented with 18 additional items in the areas of health distress (four items), sexual function (four items), satisfaction with sexual function (one item), overall quality of life (two items), cognitive function (four items), energy (one item), pain (one item), and social function (one item). The final measure, the Multiple Sclerosis Quality of Life (MSQOL)-54 Instrument, contains 52 items distributed into 12 scales, and two single items. Internal consistency reliability estimates for the 12 multi-item scales ranged from 0.75 to 0.96 in a sample of 179 patients with multiple sclerosis. Test-retest intraclass correlation coefficients ranged from 0.66 to 0.96. Exploratory factor analysis confirmed two underlying dimensions of physical health and mental health. Construct validity was supported by significant associates between MSQOL-54 scales and degree of multiple sclerosis symptom severity in the prior year, level of ambulation, employment limitations due to health, admission to hospital in the previous year, and depressive symptoms.
923 citations
TL;DR: It is demonstrated that the QOL-CS and its subscales adequately measured QOL in this growing population of cancer survivors.
Abstract: A QOL instrument was developed to measure the specific concerns of long term cancer survivors. The QOL-CS is based on previous versions of the QOL instrument developed by researchers at the City of Hope National Medical Centre (Grant, Padilla, and Ferrell). This instrument was revised over a one year pilot by Hassey-Dow and Ferrell. The revised instrument included 41 items representing the four domains of quality of life incorporating physical, psychological, social, and spiritual well being. The present study was conducted as a mail survey to the membership (n = 1,200) of the National Coalition for Cancer Survivorship with 686 subjects responding to the survey. This survey included a Demographic tool, QOL-CS and the FACT-G tool developed by Cella. Psychometric analysis, performed on 686 respondents, included measures of reliability and validity. Two measures of reliability included test-retest and internal consistency. The overall QOL-CS tool test-retest reliability was 0.89 with subscales of Physical r = 0.88, Psychological r = 0.88, Social r = 0.81, and Spiritual, r = 0.90. The second measure of reliability was computation of internal consistency using Cronbach's alpha coefficient as a measure of agreement between items and subscales. Analysis revealed an overall r = 0.93. Subscale alphas average ranged from r = 0.71 for spiritual well being, r = 0.77 for physical, r = 0.81 for social, and r = 0.89 for psychological. Several measures of validity were used to determine the extent to which the instrument measured the concept of QOL in cancer survivors. The first method of content validity was based on a panel of QOL researchers and nurses with expertise in oncology. The second measure used stepwise multiple regression to determine factors most predictive of overall QOL in cancer survivors. Seventeen variables were found to be statistically significant accounting for 91% of the variance in overall QOL. The fourth measure of validity used Pearson's correlations to estimate the relationships between the subscales of QOL-CS and the subscales of the established FACT-G tool. There was moderate to strong correlation between associated subscales including QOL-CS physical to FACT physical (r = 0.74), QOL-CS Psych to FACT Emotional (r = 0.65), QOL Social to FACT Social (r = 0.44). The overall QOL-CS correlation with the FACT-G was 0.78. Additional measures of validity included correlations of individual items of the QOL-CS tool, factor analysis, and construct validity discriminating known groups of cancer survivors. Findings demonstrated that the QOL-CS and its subscales adequately measured QOL in this growing population of cancer survivors.
600 citations
TL;DR: The results indicate that the individual questions, attributes and provisional index scores generally provided reliable information on health status in the GSS.
Abstract: This study presents information on the test-retest reliability of the Health Utility Index—Mark III (HUI) system used in cycle 6 of the Canadian General Social Survey (GSS). The HUI system used in this reliability study consists of an eight-attribute health status classification system (HSCS) and a function for generating a summary score of health-related quality of life. To estimate test-retest reliability, a stratified random sample of individuals (n=506) completing GSS telephone interviews during August and September, 1991 were interviewed again 1 month later. Weighting adjustments based on the probability of selection were invoked during the analyses to provide unbiased estimates of testretest reliability for all GSS respondents in the August-September period. The results indicate that the individual questions, attributes and provisional index scores generally provided reliable information on health status in the GSS. The exceptions to this were limitations in speech and dexterity which were reported very infrequently. Kappa estimates of test-retest reliability for individual questions varied from 0.184 to 0.766. For the eight attributes, kappa estimates varied from 0.137 to 0.728. Using the provisional index scores to quantify health overall, a test-retest reliability of 0.767 was obtained (intra-class correlation coefficient).
178 citations
TL;DR: This study indicates that for group level comparisons, proxy respondents can be substituted for adults with epilepsy having low to moderate seizure frequency, however, for individual level assessments proxies should be used with caution.
Abstract: Agreement between self reports and proxy reports of quality of life was examined in a sample of 292 patients with epilepsy and their designated proxies. Patients and proxies completed an 89-item Quality of Life Inventory (QOLIE-89), with the items rephrased for the proxy. Results reveal moderate correlations (product-momentr ranging from 0.29 to 0.56 for 17 multi-item scales) between self reports and proxy reports. Agreement was good for measures of function that are directly observable and relatively poor for more subjective measures. Mean scale scores were significantly different between patients and proxies for only five of 17 multi-item scales. Proxy respondents systematically reported better functioning than did patients in three scales assessing cognitive functioning (allp<0.001). By contrast, patients reported more positive health perceptions and less seizure distress than proxies. Patient educational attainment correlated inversely with degree of disagreement between patient and proxy reports for six of the 17 QOL scales and for the overall score. In addition, proxy educational attainment correlated positively with agreement for four scales. This study indicates that for group level comparisons, proxy respondents can be substituted for adults with epilepsy having low to moderate seizure frequency. However, for individual level assessments proxies should be used with caution.
141 citations
TL;DR: It is shown that major benefits in completeness of data, speed of data flow, and data handling workload can be obtained from the use of pen-based electronic questionnaires.
Abstract: The use of pen-based electronic questionnaires and conventional paper questionnaires was compared in a randomized crossover study. Forty-six patients, aged 17-81 years, suffering from gastro-intestinal disorders, initially filled in a paper quality of life questionnaire for familiarization purposes, then on two subsequent visits completed electronic and paper questionnaires in randomized order. At the last visit they completed a preference survey. The results showed a high degree of acceptability of the electronic questionnaire, with 57% of patient preferring electronic and 13% preferring paper, while the remaining 30% expressed no preference. Neither age, gender nor familiarity with technology showed any marked association with patients' preferences. All patients found both paper and electronic questionnaires easy to use. Data were more complete on the electronic questionnaire (100%) than on the paper (99.1%). Data handling procedures were greatly simplified. These results show that major benefits in completeness of data, speed of data flow, and data handling workload can be obtained from the use of pen-based electronic questionnaires.
129 citations
TL;DR: A patient-administered questionnaire for menorrhagia based on the type of questions asked when taking a gynaecological history demonstrated a good level of reliability and the resulting patient scores correlated significantly with their scores on the scales making up the general health measure.
Abstract: A patient-administered questionnaire for menorrhagia based on the type of questions asked when taking a gynaecological history was developed and tested using the following steps: literature reviews, devising the questions, testing responses for internal consistency and test-retest reliability and validating the questionnaire by comparing patient's scores with their responses to the SF-36 general health measure, and with family practitioner perceptions of severity The main sample consisted of 351 women with menorrhagia, 246 referred to gynaecology ambulatory clinics and 105 from four large training practices in North-east Scotland Following testing, two questions were discarded from the questionnaire The final questionnaire demonstrated a good level of reliability and the resulting patient scores correlated significantly with their scores on the scales making up the general health measure The questions asked in taking a clinical history from a woman with menorrhagia can be used to construct a valid and reliable measure of health status This clinical measure may be a useful guide in selection for treatment and in the assessment of patient outcome following treatment
123 citations
TL;DR: Transplant recipients reported better HRQOL than dialysis patients, they reported fewer problems with physical mobility, self-care, social and personal relationships and usual activities, and these differences remained after controlling for age and comorbidity.
Abstract: The objective of this study was to describe the health-related quality of life (HRQOL) of patients on different forms of treatment for endstage renal failure in such a way that the data could be used in a cost-utility analysis of renal failure treatment in Britain. Twenty-four British renal units participated in this study. 997 adult dialysis and transplant patients were randomly selected from these units using the European Dialysis and Transplant (EDTA) Registry Database. The Health Measurement Questionnaire was completed by 705 of the 900 patients who were alive at the time of the survey (response rate of 78%). The HRQOL data were linked with comorbidity data and with clinical data from the EDTA Registry. Compared to the general population, patients with endstage renal failure experienced a lower quality of life. Many factors contributed to this, but uncertainty about the future and lack of energy emerged as key components. Transplant recipients reported better HRQOL than dialysis patients, they reported fewer problems with physical mobility, self-care, social and personal relationships and usual activities. They also experienced significantly less distress, while dialysis patients reported problems with depression, anxiety, pain and uncertainty about the future. These differences remained after controlling for age and comorbidity.
119 citations
TL;DR: In this article, the authors present baseline values for three questionnaires measuring psychological Wellbeing, Treatment Statisfaction and General Health among a representative sample of adult people with diabetes in Sweden consisting of 423 individuals of which 153 were insulin treated and 270 were diet/tablet-treated.
Abstract: In order to implement the St Vincent Declaration programme, instruments for quality assurance of medical outcomes as well as measures of psychological outcomes of diabetes care had to be developed. This paper presents baseline values for three questionnaires measuring psychological Wellbeing, Treatment Statisfaction and General Health among a representative sample of adult people with diabetes in Sweden consisting of 423 individuals of which 153 were insulin treated and 270 were diet/tablet-treated. Cronbach's α indicated that each of the Well-being and Treatment Satisfaction subscales was internally reliable, alphas ranging from 0.66–0.88. Factor analysis resulted in identification of five subscales (depression, anxiety, positive well-being, treatment satisfaction and metabolic control). There was no relation between any of the quality of life subscales with HbA1c, BMI, duration of diabetes, frequency of blood glucose tests per day, insulin regimens or diabetic complications. Females reported a more negative impact of diabetes on daily life compared with males (p<0.001). In conclusion, the Well-being and Treatment Satisfaction scales are reliable for quality assurance purposes in diabetes while the briefer general health instrument provides a useful assessment of the global impact of a chronic disease.
107 citations
TL;DR: It is concluded that the disease-specific CSS was more sensitive to change than the SF-36 survey in patients following ethmoid sinus surgery.
Abstract: The utility of reliable health measures for longitudinal studies in chronic sinusitis depends on their ability to detect clinically relevant change. Sixty-three patients with chronic sinusitis were evaluated before and three months after ethmoid sinus surgery using the Chronic Sinusitis Survey (CSS) and the generic Short-Form 36-Item Health Survey (SF-36). Statistically significant improvement was found for several SF-36 subscales including physical functioning, role functioning-physical, bodily pain, vitality and all CSS subscales. However, the differences between the instruments in longitudinal sensitivity to change as measured by standardized response means (SRM) and effect sizes (ES) were large. For the SF-36, sensitivity to change ranged from minimal to small (SRM: 0.01-0.43; ES: 0.01-0.52) with bodily pain and role functioning-physical scores most sensitive. For the CSS, sensitivity to change ranged from moderate to large (SRM: 0.56-0.82; ES: 0.48-1.12) with symptom-based and total index scores most sensitive. Despite this, the SF-36 yielded useful information concerning the relative burden of chronic sinusitis and failure of these patients to achieve normal levels of general health 3 months after sinus surgery. We conclude that the disease-specific CSS was more sensitive to change than the SF-36 survey in patients following ethmoid sinus surgery.
TL;DR: Generic measures, especially measures of social and role functioning and mental health, were best at differentiating groups of patients differenting in symptom impact, while the epilepsy-specific Mastery, Impact, Experience, Worry, Distress and Agitation scales were among the 10 best measures in discriminating among groups differing in disease severity.
Abstract: We studied 31 previously validated and newly developed generic and epilepsy-specific scales to evaluate their usefulness for assessing the impact of epilepsy and anti-epileptic drug (AED) therapy on health-related quality of life (HRQOL). Included were the MOS SF-36 Health Survey, additional measures of mental health, cognition, epilepsy-specific perception of control, behavioural problems, distress, worries and experiences, the Liverpool Epilepsy Impact and Seizure Severity scales, and a patient-completed symptom checklist. Questionnaires were completed twice by 136 patients on AED therapy in a multicentre study in the UK. Validity was assessed in relation to disease severity, defined as time since last seizure, and to patient-reported symptoms. Statistical analyses to estimate the contribution of HRQOL information of each scale relative to that of others were conducted. The 171-item questionnaire could be completed by out-patients with epilepsy with good data quality. With few exceptions, generic and epilepsy-specific measures satisfied psychometric tests of hypothesized item groupings and scale score reliability (internal consistency and test-retest reliability) and differentiated well between groups of patients differing in time since last seizure and in symptom impact, regardless of time since last seizure. However, scales differed widely in their validity in discriminating between groups of patients known to differ clinically. The SF-36 Role Physical scale best discriminated among groups differing in disease severity. The epilepsy-specific Mastery, Impact, Experience, Worry, Distress, and Agitation scales were among the 10 best measures in discriminating among groups differing in disease severity. Generic measures, especially measures of social and role functioning and mental health, were best at differentiating groups of patients differenting in symptom impact. Recommendations are offered for concepts and specific scales most likely to be useful in future studies of the HRQOL burden of epilepsy and the HRQOL benefits of AED therapy.
TL;DR: Both the SF-36 and the COOP charts may prove suitable for the assessment of health perception outcomes in surgical clinical trials and the importance of checking item content to determine the suitability of any particular measure for a given study is highlighted.
Abstract: This study compared the sensitivity to change of comparable dimensions of a multi-item multi-dimensional health status measure (the SF-36) with the equivalent single item domains on the Dartmouth COOP charts. One hundred and twenty nine patients were randomized to either day case laparoscopic surgery (n=60) or open inguinal hernia repair (n=69). Respondents completed the SF-36 and COOP charts at baseline (prior to surgery) and at follow up at 10 days and 6 weeks. Equivalent dimensions of physical functioning, mental health/emotional condition, social activities, pain and overall condition/general health on the two questionnaires were compared. Despite slightly different pictures of change provided by the physical functioning and ‘overall condition/general health’ dimensions the general picture of change provided by the two instruments was similar. At 10 days, patients who underwent open surgery reported far greater levels of dysfunction than those who underwent laparoscopic surgery on both questionnaires. At 6 weeks the pain dimension of both questionnaires indicated a large improvement from baseline, whilst no other domain on either questionnaire for either group indicated such improvement. The general picture of change provided by the two measures was similar. The results suggest that both the SF-36 and the COOP charts may prove suitable for the assessment of health perception outcomes in surgical clinical trials. Differences on certain domains were caused in large measure by the nature of the questions posed. The study once again highlights the importance of checking item content to determine the suitability of any particular measure for a given study.
TL;DR: The results of three HRQOL questionnaires used to measure health change in 332 patients referred for MRI of the knee are presented and some evidence is provided to suggest that the EurolQol© may be less responsive in assessing change in health status than the SF-36.
Abstract: Evidence suggests that magnetic resonance imaging (MRI) allows accurate diagnosis of meniscal and ligamentous injuries of the knee. However the link between improved diagnosis through MRI and improved patient quality of life (QOL) has yet to be shown. Previous studies almed at establishing this link have found no significant improvements in health related quality of life (HRQOL) as measured by the Rosser classification and index. This paper presents the results of three HRQOL questionnaires (SF-36, Rosser and EuroQol©) used to measure health change in 332 patients referred for MRI of the knee. Before imaging, patients reported poorer HRQOL than the general population on two of the three questionnaires (SF-36 and EuroQol©). The same two questionnaires recorded significant improvements in patient health at six months, although patients' health had not yet reached that experienced in the general population. There was evidence to suggest that the index values attached to the Rosser classification made it unresponsive in this group of patients, which may have predisposed the null results of previous studies of the influence of MRI on HRQOL. Some evidence is provided to suggest that the EurolQol© may be less responsive in assessing change in health status than the SF-36.
TL;DR: The Brief Pain Inventory was used to follow the daily and weekly amount of pain reported by 50 patients with herpes zoster and the area under the curve (AUC) for each patient was derived from the pain reported on sequential administrations of the BPI.
Abstract: Herpes zoster manifests as a characteristic painful rash that resolves within 2 months of initial presentation in 90% of patients. As pain is a hallmark of the disease, the severity of an episode can be described by the magnitude and duration of pain. The Brief Pain Inventory (BPI) was used to follow the daily and weekly amount of pain reported by 50 patients with herpes zoster. Results demonstrate that the BPI is a reproducible, responsive and valid measure of pain due to herpes zoster. From the individual responses on the BPI, the area under the curve (AUC) for each patient was derived from the pain reported on sequential administrations of the BPI. This metric was simple to calculate, easy to explain and captured two dimensions of this episodic disease (magnitude and duration of pain) in a single continuous measure. AUC could prove useful in the application of patient response data to intervention trials in diseases that are of an episodic nature.
TL;DR: The development, content and translation of this survey instrument are described and its reliability and validity in six countries are reported on based on data collected for the first 487 patients to complete questionnaires at study entry.
Abstract: To explore the value of antiandrogen therapy for advanced prostate cancer, two clinical trials of similar design were recently conducted in six countries throughout Europe. A total of 550 patients with previously untreated metastatic prostate cancer were randomized either to treatment with an antiandrogen or castration. While time to treatment failure, objective tumour response and survival were expected to be similar between study treatments, their effects on health-related quality of life (HRQOL) were expected to differ and were therefore a focus of concern in this trial. To assess these effects, we developed a brief self-administered patient questionnaire covering 10 domains of HRQOL (general health perceptions, pain, emotional well-being, vitality, social functioning, physical capacity, sexual interest, sexual functioning, activity limitation and bed disability), which we translated from English into several other languages. In this paper, we describe the development, content and translation of this survey instrument and report on its reliability and validity in six countries based on data collected for the first 487 patients to complete questionnaires at study entry.
TL;DR: This study develops a Spanish translation of the CAncer Rehabilitation Evaluation System (CARES) and performs content and construct validation of the Spanish CARES in Spanish-speaking and bilingual patients with cancer, and provides descriptive data on the rehabilitation needs and quality of life of these patients.
Abstract: The increasing diversity of the US population has drawn attention to the need for the development of quality of life tools that are appropriate for special populations, including Hispanic Americans, Asian Pacific Islanders, and Native Americans. The Hispanics are one of the fastest growing of these special populations, and this group includes persons who have lived in the USA for many generations, as well as recent immigrants. Both language and culture are important to consider when developing a quality of life tool for Hispanics. The initial aims of this study were to develop a Spanish translation of the CAncer Rehabilitation Evaluation System (CARES), perform content and construct validation of the Spanish CARES in Spanish-speaking and bilingual patients with cancer, and provide descriptive data on the rehabilitation needs and quality of life of these patients. However, in performing this study we encountered a number of methodological problems that had not been previously described in the literature, including the need for idiomatic translations, lack of familiarity with questionnaires, low acculturation and low literacy rates among Hispanic cancer patients in the southwestern USA. We suggest a number of practical considerations for future investigators planning to develop quality of life tools for this special population.
TL;DR: This update of the Quality of L$?
Abstract: We are pleased to offer the sixth installment of the Quality of L$? Bibliography and indexes (Berzon et al., 1994; Berzon et aZ., 1993; Spilker et al., 1992a; Spilker et al, 1992b; Spilker et al, 1990). This update includes articles published in the latter half of 1993 and throughout 1994, as well as several from prior periods called to our attention in the interim. This year marks our second appearance in Quality of Life Research. The bibliography is arranged alphabetically by author. In addition three indexes are included: (1) Index to HRQL papers by instrument; (2) Index to HRQL papers by therapeutic category; and (3) Cumulative Index of HRQL instruments by therapeutic category Of these, the third index includes the only cumulative listing of instruments from prior bibliographies as well as current citations. As is our custom, we have highlighted with ‘**’ those measures under the Cumulative Index that appeared in 1994 so as to provide investigators with a clear picture of current trends and instrument usages in HRQL research. The references chosen for inclusion in this update focus primarily on the use of HRQL instruments in comparative clinical studies and discuss results from the use of newly available and older established measures. Articles which are primarily philosophical commentary or reviews are included if they report new primary data or if new issues raised are especially thoughtful and/or provocative. Consistent with earlier installments of this bibliography, only articles which appear in English are included. Given the prodigious number of HRQL references that now appear in the literature, we have attempted to focus the bibliography upon actual research applications. To be included an article must: (1) provide a theoretical explanation of the HRQL concept being applied, either from a health profile (descriptive) or patient preference (utility) perspective; (2) rationalize instrument selection within the context of use; and (3) offer some evidence, either primary or by citation, of the measure’s psychometric properties
TL;DR: The fifth instalment of the ‘Quality of Life Bibliography and Indexes’ includes articles published in the latter half of 1992 and throughout 1993, as well as several from prior periods called to the authors' attention in the interim.
Abstract: In the late 1980s Bert Spilker in collaboration with two of us (RLS and HHT) first began to identify, collect, and categorize publications which had, as a significant focus, the use of health-related quality of life (HRQL) measures. In 1990 we decided to make this compilation available to our colleagues through publication. In keeping with that tradition, we are pleased to offer the fifth instalment of the ‘Quality of Life Bibliography and Indexes’.*-4 This update includes articles published in the latter half of 1992 and throughout 1993, as well as several from prior periods called to our attention in the interim. This year marks our first appearance in Quality of Life Research. Over the past 5 years, many methodological and theoretical developments have taken place in the HRQL research field, including a more precise understanding of the construct. Given the state of the art and the mission of Qttality of Life Research, we believe that this journal is currently the most appropriate home for the bibliography. We would like to thank the editors of Medical Care and, more recently, the journal of Clinical Research and Drug Development (formerly the Journal of Clinical Research and Pharmacoepidemiology) for their past assistance in these efforts. The references chosen for inclusion in this update focus primarily on the use of HRQL instruments in comparative clinical studies; discuss results from the use of newly available and older established measures; and include broadened criteria of what constitutes a quality of life instrument. Articles which are primarily philosophical commentary or reviews are included if they report new primary data or if new issues raised are especially thoughtful and/or provocative. Consistent with earlier installments of this bibliography, only articles which appear in English are included. Given the prodigious number of HRQL references that now appear in the literature, we have attempted to focus the bibliography upon actual research applications. To be included an article must: (I) provide a theoretical explanation of the HRQL concept being
TL;DR: The psychometric properties of the French version of the APQLQ (Angina Pectoris Quality of Life Questionnaire), that is to say, scaling assumptions, reliability and validity, are described, to be used as an index rather than as a profile.
Abstract: This paper describes the psychometric properties of the French version of the APQLQ (Angina Pectoris Quality of Life Questionnaire), that is to say, scaling assumptions, reliability and validity. This disease-specific Swedish questionnaire provides a global score as well as four subscores measuring physical activities, somatic symptoms, emotional distress, and life satisfaction. The French version was produced according to the forward-backward translation methodology. In a cross-sectional study, 183 coronary patients filled out the APQLQ and the MOS (Medical Outcomes Study) SF-36; 170 sent it back; the rate of missing data was low (1.3%). The factorial structure and the high level of inter-scale correlations (> 0.60) suggested that the APQLQ measured one global concept rather than separate domains. The multitrait analysis identified one problematic item correlated strongly with all domains. The internal consistency was good (α Cronbach > 0.70). The correlations with the SF-36 scales were consistent with what was expected. The distribution of the scores of the APQLQ according to the clinical severity of Angina Pectoris (AP) was as hypothesized: the more severe the AP, the more impaired the Quality of Life. The score significantly discriminated between symptomatic (n=110) and asymptomatic patients (n=60) except for the emotional distress scale (p=0.14). We recommend to analyze the French APQLQ as an index rather than as a profile. Its reliability, concurrent and clinical validity allowed its use in clinical trials.
TL;DR: HRQOL questionnaires have the potential to become a new clinical tool which could enhance the quality of care physicians are able to provide for their patients with epilepsy, but are not routinely used in epilepsy patients' care.
Abstract: Reliable and valid patient-completed questionnaires to assess the health related quality of life (HRQOL) of people with epilepsy are becoming increasingly available. At present, however, they are not routinely used in epilepsy patients' care. The use of HRQOL measurement in clinical practice settings may improve the quality of care for people with epilepsy through (1) increasing the detection of patients' problems with daily functioning and well-being: (2) guiding therapeutic management; and (3) leading to improvements in patients' HRQOL and satisfaction with care. To realize the potential benefits of HRQOL assessment in the care of people with epilepsy, research into the feasibility of the office-based use of HRQOL questionnaires, measurement quality, and the impact of routine HRQOL assessment on the quality of epilepsy patients' care needs to be undertaken. The transfer of HRQOL questionnaires from research tools into clinical tools requires the collaboration of social scientists, health services researchers, and clinicians. HRQOL questionnaires have the potential to become a new clinical tool which could enhance the quality of care physicians are able to provide for their patients with epilepsy.
TL;DR: Concern regarding the impact and consequences of epilepsy is not a new development, but has evolved over the years, resulting in new models and methods of assessment of disease impact on well-being and functional status.
Abstract: The purpose of this article is to review the ways in which quality of life has been assessed in patients with epilepsy. It is specifically proposed that there have been three phases or types of studies examining the effects of epilepsy on cognitive, behavioural, social and physical function. The first and oldest phase was characterized by the use of traditional forms of clinical evaluation and available generic measures of cognitive, behavioural and psychosocial function to study the general effects of epilepsy, effects of epilepsy-specific clinical variables (e.g. seizure type, age at onset), and the consequences of treatment with antiepileptic medications on patients' lives. The second phase of research was characterized by the development of epilepsyspecific measures of cognitive ability, psychological status and psychosocial status, which were designed to meet the special research and clinical needs not provided by previous generic measures (e.g. Washington Psychosocial Seizure Inventory, Fear of Seizures Scale). The third and most recent phase is characterized by the use of models, techniques, and measures developed from the health services research field to assess formally contemporary definitions of health-related quality of life (HRQOL) (e.g. ESI-55, QOLIE-89, Seizure Severity Scale) and develop models of the effects of epilepsy on HRQOL. Thus, concern regarding the impact and consequences of epilepsy is not a new development, but has evolved over the years, resulting in new models and methods of assessment of disease impact on well-being and functional status.
TL;DR: Education late effects in long-term survivors of child- hood acute lymphocytic leukemia Pediatrics 1988; 81: 127-133 and BMT and quality of life Appendix 1: Parents' questionnaire.
Abstract: s of the 3rd International Syrnposium on Therapy of Acute Leukemias, Rome, 1982; 265. 18. Koocher GT, O'Malley JE, Gogan JL, Foster DJ. Psycho- logical adjustment among pediatric cancer survivors. 1 Child Psychol Psychiatry 1980; 21: 163-173. 19. Slavin LA, O'Malley JE, Koocher GP, Foster DJ. Commu- nication of the cancer diagnosis to pediatric patients: impact on long-term adjustment. Amer] Psychiatry 1982; 139: 179-183. 20. Peckham VC, Meadows AT, Bartel N, Marrero 0. Educational late effects in long-term survivors of child- hood acute lymphocytic leukemia Pediatrics 1988; 81: 127-133. 21. Spinetta JJ. The sibling of the child with cancer. In: Spinetta JJ, Spinetta D, eds. Living with childhood cancer. St Louis, Mosby 1981: 133-142. (Received 16 August 1994; accepted 13 April 1995) 238 Quality of Life Research. Vol 4 1995 This content downloaded from 157.55.39.116 on Sun, 18 Sep 2016 06:11:54 UTC All use subject to http://about.jstor.org/terms BMT and quality of life Appendix 1: Parents' questionnaire
TL;DR: Results generally support the validity of all three measures in assessing the aspects of QOL they were designed to address, and the ESI-55 and SIP are preferred over the WPSI in studies of the broad impact of epilepsy on quality of life.
Abstract: Understanding how epilepsy affects an individual's quality of life (QOL) requires reliable and valid QOL measures. Analyses of reliability and validity rarely examine measures obtained in the same sample, making comparisons among measures difficult. We report analyses of internal consistency reliability, face, content, construct and criterion validity for the Epilepsy Surgery Inventory-55 (ESI-55, a measure based on the SF-36 Health Survey), the Sickness Impact Profile (SIP) and the Washington Psychosocial Seizure Inventory (WPSI) administered concurrently in the same sample of intractable epilepsy patients. Results generally support the validity of all three measures in assessing the aspects of QOL they were designed to address. The ESI-55 and SIP assess a broad, multi-dimensional construct of QOL in epilepsy, compared with the more specific focus of the WPSI on psychological and social adjustment. Judged by objective psychometric criteria, the ESI-55 and SIP are preferred over the WPSI in studies of the broad impact of epilepsy on quality of life.
TL;DR: Analysis of variance revealed that visual acuity (both best and worst eye) was statistically related only to the physical function scale; no other exam measure was related to any other SF-36 scale score.
Abstract: Given the enormous recent interest in functional capabilities related to vision, the goal of this study was to examine the relationship of standard clinicial measures of vision (e.g. Snellen acuity) to functioning and well-being. The association between Snellen visual acuity, Amsler grid distortion and presence of diabetic retinopathy with self-reported functioning and well-being (SF-36) were examined in a sample of 327 diabetics from the Medical Outcomes Study (MOS). There was little or no correlation between Snellen visual acuity, Amsler grid distortion or diabetic retinopathy and functioning and well-being (i.e. SF-36 scales). Maximum product-moment correlation was 0.15 with worst eye visual aculty, 0.13 with best eye visual acuity, 0.08 with presence of retinopathy, and 0.10 with Amsler grid distortion. Analysis of variance revealed that visual acuity (both best and worst eye) was statistically related only to the physical function scale; no other exam measure was related to any other SF-36 scale score. Snellen visual acuity, Amsler distortion and diabetic retinopathy correlate weakly with patient self-reported functioning and well-being. Thus, the information provided by functioning and well-being measures is complementary to that of standard clinical measures of visual ability.
TL;DR: It is suggested that simple measures of pain are sensitive to change and are worthwhile indicators of the impact of an intervention upon acute pain, although some care is needed in interpreting results from such instruments.
Abstract: Our objective was to assess the sensitivity to change over time of three methods of assessing pain. We conducted a comparison of the sensitivity to change of three pain assessment measures in a double blind, double dummy parallel group study evaluating the efficacy of one of two doses of oral bromfenac and one of two doses of sublingual buprenorphine. Our subject pool consisted of 75 patients following general surgical and orthopaedic procedures. Pain intensity was measured by the affective, sensory and evaluative dimensions of the McGill Pain Questionnaire together with total score and word score, a 10 cm Visual Analogue Scale and by a four word scale. Effect size calculations indicated considerable variation in the sensitivity of the instruments to change. However, despite variation in the size of effect indicated by different measures, there was consistent agreement as to the most effective treatment regimen. This study suggests that simple measures of pain are sensitive to change and are worthwhile indicators of the impact of an intervention upon acute pain, although some care is needed in interpreting results from such instruments. More complex forms of assessment, such as the calculation of the MPQ sub-scales may not add anything to such data.
TL;DR: A possible application of the proposed Q-TWiST method is demonstrated with a hypothetical example comparing surgeryvs antiepileptic medication management alone for seizure control, along with patient importance weightings regarding various dimensions of quality of life.
Abstract: We propose to develop a methodology for evaluating clinical interventions for epilepsy in terms of their effects on disease-related outcomes, social cost and quality of life, while incorporating patient preference. The technique represents an extension of the ‘quality-adjusted time without symptoms and toxicities’ (Q-TWiST) method, which has been previously used to evaluate treatments for cancer and AIDS with respect to their costs in terms of toxicities, and benefits in terms of improved progression-free and overall survival. The extensions we propose to develop allow additional dimensions of quality of life relevant to epilepsy to be included in the analysis. We demonstrate a possible application of the proposed Q-TWiST method with a hypothetical example comparing surgeryvs antiepileptic medication management alone for seizure control. The trade-offs between these alternative treatments are highlighted, along with patient importance weightings regarding various dimensions of quality of life. We describe further research needed to develop the methodology fully and comment on its potential usefulness.
TL;DR: In patients with refractory epilepsy, seizure severity may be a more important determinant of psychosocial well-being than seizure frequency, while for those patients with mild seizure disorders the diagnostic label itself may have the greatest impact.
Abstract: Although the overall prognosis of epilepsy is favourable,' 25-30% of patients continue to have disabling seizures despite optimal treatment, and the need for more efficacious, less toxic new antiepileptic drugs (AEDs) is well recognized2 Potential new AEDs must be shown, in controlled clinical trials, to be safe and effective3 Trials using seizure frequency as the only measure of efficacy possess limited sensitivity because potentially useful treatment effects are disregarded, and the need for complimentary outcome measures is also well recognized4 This is especially relevant in refractory patients in whom complete remission of seizures is unlikely and where reduced seizure severity or increased psychological well-being, with a consequent improvement in quality of life (QOL), are equally valuable therapeutic aims Selected patients are rendered seizure-free by resective surgery and this is directly related to psychosocial outcome5 However, in 30-40% of cases surgery is only partially successful, and there is no clear relationship between post-operative seizure number and wellbeing Indeed there is evidence that, in these patients, seizure type is a better indicator of outcome6 Patients with epilepsy usually appear physically well but often suffer social and psychological handicaps which impair their QOL The physical symptoms which contribute to these handicaps include the frequency and severity of their seizures and the sideeffects of AEDs Unfortunately there is no simple relationship between seizure number and the consequences of epilepsy Indeed, in patients with refractory epilepsy, seizure severity may be a more important determinant of psychosocial well-being than seizure frequency7 while for those patients with mild seizure disorders the diagnostic label itself may have the greatest impact8 Thus a valid measure of seizure severity has two potential applications, first as a
TL;DR: Results from a series of clinical trials confirm that the Daily Diary Card appears to be a valid, reliable and sensitive instrument which is able to detect the transient changes in health and QOL which occur on a day to day basis during therapy for cancer.
Abstract: The UK Medical Research Council (MRC) Daily Diary Card for quality of life (QOL) assessment was first designed over ten years ago, and since then has been in continuous use in cancer clinical trials organized by the MRC Cancer Trials Office. However, clinical trials using this technique have only reached maturity since 1989 and later. Thus it is timely to review the experiences gained by use of this method of assessing QOL. Results from a series of clinical trials confirm that the Daily Diary Card appears to be a valid, reliable and sensitive instrument which is able to detect the transient changes in health and QOL which occur on a day to day basis during therapy for cancer. However, in early studies we also encountered a number of problems which were addressed during later MRC trials; we belleve that many of these are of general importance to any investigation of QOL in patients, many of the issues raised remain controversial, and the practical lessons learned from applying the Diary Card will be of relevance to those planning future studies of QOL assessment.
TL;DR: Although subjective (patient-reported) benefit is strongly associated with objective indicators of improvement, there remains the possibility that there is some added, independent benefit of megestrol acetate to subjective well-being.
Abstract: A brief visual analogue instrument was developed and tested in the context of a multicentre randomized double-blinded four-dose trial of megestrol acetate for the treatment of AIDS-related anorexia/cachexia This nine-item instrument, the Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI), was administered every 4 weeks after initiation of study drug (placebovs 100 mg, 400 mg or 800 mg of drug) The purpose of the instrument was to quantify patient perception of benefit in areas such as decreased concern over weight, decreased concern over appearance, increased pleasure in eating and increase in global perception of quality of life Post-trial psychometric evaluation of the instrument strongly supported the use of a seven-item index of subjective recovery from symptoms of anorexia/cachexia (BACRI-7) and a single criterion item depicting patient perception of benefit (BACRI-1) The BACRI-7 and BACRI-1 scales showed significant improvement over 12 weeks in patients who received higher dose active drug (400 and 800 mg) compared with the placebo and 100 mg doses Further differentiation of 400vs 800 mg arms was seen in the BACRI-7 results, consistent with dose-response improvements in weight and lean body mass changes Quadratic trends over time in lean body mass change and provider-rated appetite grade suggested peak therapeutic effect at 8 weeks for these endpoints, whereas the absence of these trends in overall weight and patient-reported BACRI scores suggested that these benefits are more persistent Although subjective (patient-reported) benefit is strongly associated with objective indicators of improvement, there remains the possibility that there is some added, independent benefit of megestrol acetate to subjective well-being