Health-related Quality Of Life Information Research Articles

Interpreting the results of patient reported outcome measures in clinical trials: the clinician's perspective.

This article deals with the problem of interpreting health-related quality of life (HRQL) outcomes in clinical trials. First, we will briefly describe how dichotomization and item response theory can facilitate interpretation. Based on examples from the medical literature for the interpretation of HRQL scores we will show that dichotomies may help clinicians understand information provided by HRQL instruments in RCTs. They can choose thresholds to calculate proportions of patients benefiting based on absolute scores or change scores. For example, clinicians interpreting clinical trial results could consider the difference in the proportion of patients who achieve a mean score of 50 before and after an intervention on a scale from 1 to 100. For the change score approach, they could consider the proportion of patients who have changed by a score of 5 or more. Finally, they can calculate the proportion of patients benefiting and transform these numbers into a number needed to treat or natural frequencies. Second, we will describe in more detail an approach to the interpretation of HRQL scores based on the minimal important difference (MID) and proportions. The MID is the smallest difference in score in the outcome of interest that informed patients or informed proxies perceive as important, either beneficial or harmful, and that would lead the patient or clinician to consider a change in the management. Any change in management will depend on the downsides, including cost and inconvenience, associated with the intervention. Investigators can help with the interpretation of HRQL scores by determining the MID of an HRQL instrument and provide mean differences in relation to the MID. For instance, for an MID of 0.5 on a seven point scale investigators could provide the mean change on the instrument as well as the proportion of patients with scores greater than the MID. Thus, there are several steps investigators can take to facilitate this process to help bringing HRQL information closer to the bedside.

Improvements in measuring the health-related quality of life of cancer patients

There have been considerable improvements in the collection of health-related quality of life (HRQOL) data in oncology over the past 20 years. The facility with which HRQOL information can now be collected from patients has also been associated with an improved understanding of the meaning of HRQOL and the association between HRQOL and patients’ treatment and care plans. Therefore the role that HRQOL data can play in routine clinical practice is increasingly being recognized. The appearance of computer-adaptive tests will herald a new era in HRQOL where questionnaires will be individually tailored to each patient utilizing details unique to that person and linked to clinical management systems to allow a comprehensive assessment of HRQOL status.

COMPARISON OF PARENT AND YOUTH REPORTS OF HEALTH-RELATED QUALITY OF LIFE IN CEREBRAL PALSY

Purpose/Hypothesis: Cerebral palsy (CP) is associated with reduced health related quality of life (HRQL) secondary to neuromuscular impairments, activity restrictions, and participation limitations. HRQL measures are used to plan interventions and to evaluate treatment outcomes. Usually, HRQL information for youths with CP is obtained from parents. However, discrepancies between youth self-reports and parent proxy reports are well documented. The purpose of this study was to further examine the agreement between parent proxy and self-reports of HRQL in youths with CP. We hypothesized that agreement between parents and youths would be greatest for scales measuring observable (behavioral) areas of functioning and lowest for scales assessing subjective states. When discrepancies were found, and based on the findings from previous research, we hypothesized that parents would rate HRQL lower than youths. Number of Subjects: A convenience sample of 28 dyads of youths with CP and their parents were recruited through a tertiary care children's hospital and public postings. Participants were primarily male (n = 19) with a mean age of 14.1 years (range 8-20). Gross Motor Function Classification System levels were I = 8, II = 6, III = 6, IV = 4, and V = 4 and the topography of CP was spastic quadriplegia, (9) hemiplegia, (3) and diplegia, (16). Materials/Methods: The Child Health Questionnaire Parent Form (CHQ-PF-28) and Child Form (CHQ-CF-87) were administered as part of an ongoing study of pain in youth with disabilities. Parent and youth participants independently completed one-time interviews in-person or by telephone at home or at a university medical center. Independent samples paired t tests were used to compare parent and youth group mean subscale scores. Agreement in scores between parent and child dyads was examined across CHQ subscales using Pearson product moment correlations. Results: Parent and youth group mean scores differed significantly for Physical Functioning (t = -2.64, P = 0.01), Role/Social-Physical (t = -3.02, P = 0.004), Mental Health (t = -2.30, P = 0.03), Self Esteem (t = -2.07, P = 0.04), and Family Activities (t = -2.17, P = 0.04). In each case, parent scores were lower than youth scores. Correlations between scores for parent and child dyads were strong for Bodily Pain (r = 0.52, P = 0.01), Mental Health (r = 0.65, P = 0.001), and Self Esteem (r = 0.62, P = 0.001). The coefficients for the remaining CHQ scales were weak and most were positive. Conclusions: Parent and youth perceptions of HRQL in this group of children with CP were discordant in several domains. As predicted, when differences were found, parents' scores were lower than youths' scores. However, contrary to prediction, the associations between parent and youth scores were strongest for the more subjective CHQ scales. Also, while some of the associations were strong, the majority of associations were weak. Clinical Relevance: Parent and youth reports of youth HRQL appear to differ in many ways, suggesting that a thorough assessment of youth HRQL should include assessments from both sources.

Use of health-related quality of life information in managed care formulary decision-making

Background The extent to which the increased volume of available health-related quality of life (HRQOL) information and heightened education has increased the acceptance and use of HRQOL remains unclear. Likewise, the value of HRQOL information in the formulary decision-making process continues to be undefined. Objective To investigate the perceptions and use of HRQOL by managed care decision-makers in the formulary development process. Methods A mail survey was sent to a nationwide sample of 108 Academy of Managed Care Pharmacy (AMCP) members who were involved in formulary management. Survey candidates were identified according to their job titles listed in the 1999-2000 AMCP membership directory. The survey process began in May 2000 and ended in August 2000. The main outcome measures included ( a) managed care formulary decision-makers' assessment of HRQOL as a treatment outcome, ( b) the existing role and future use of HRQOL information in formulary decisions, and ( c) the level of understanding of HRQOL concepts and the benefits attributable to favorable HRQOL results. Results A response rate of 51.9% was obtained. Most of the respondents (>70%) believed that patients consider HRQOL as an important treatment outcome. Fewer respondents (43%) felt that payers view HRQOL outcomes as an important quality indicator. Most respondents (95%) considered HRQOL data in making formulary decisions, and many (73%) believe that HRQOL outcomes will play a more important role in future formulary decisions. Respondents indicated a better understanding of disease-specific and generic HRQOL measurements than utility measurement and interpretation of results. A minority of respondents (34%) would be willing to pay a higher price for a product with better HRQOL outcomes. When asked which factors would lead to increased use of HRQOL information, respondents indicated that health care cost savings and increased productivity were considered important (77% and 65%, respectively). Conclusions A drug product with better HRQOL outcomes alone will not command a favorable listing on managed care formularies. HRQOL information needs to be made more applicable to managed care decision-making. Future studies should focus on the link between positive HRQOL outcomes, health care cost savings, and increased productivity.

Communicating Quality of Life Information to Cancer Patients: A Study of Six Presentation Formats

To determine which formats for presenting health-related quality of life (HRQL) data are interpreted most accurately and are most preferred by cancer patients. Patients often want a great deal of information about cancer treatments, including information relevant to HRQL. Clinical trials provide methodologically sound HRQL data that may be useful to patients. In a multicenter study, 198 patients with previously treated cancer participated in a structured interview. Participants judged HRQL information presented in one textual and five graphical formats. Outcome measures included the accuracy of patients' interpretations and ease-of-use and helpfulness ratings for each format. Correct interpretations ranged from 85% to 98% across formats (F = 10.3, P < .0001) with line graphs of mean HRQL scores over time being interpreted correctly most often. Older patients and less-educated patients were less likely to interpret graphs accurately (F = 7.3, P = .008; and F = 10.6, P = .001, respectively), but all groups were most accurate on simple line graphs. Multivariate analysis revealed that format type, participant age and education were independent predictors of accuracy rates. Patients' ratings also varied across formats both for ease of understanding scores (F = 12.1, P < .0001) and for helpfulness scores (F = 13.2, P < .0001), with line graphs being rated highest on both outcomes. Patients generally prefer a simple linear representation of group mean HRQL scores, and can accurately interpret data presented in this format more than 98% of the time irrespective of their age group and educational level. The findings have important implications for the communication of clinical trial HRQL results.

PSYCHOSOCIAL FACTORS IN PATIENTS WITH CHRONIC KIDNEY DISEASE: Health‐Related Quality of Life in Nephrology Research and Clinical Practice

ABSTRACTPhysical, psychosocial, and lifestyle disturbances, along with physical and emotional symptoms, have been shown to impact the health‐related quality of life (HRQOL) of those dependent on renal replacement therapy. The value of HRQOL measurement as a tool to improve clinical care has been recognized by patients, clinical investigators, and health care providers. The potential importance of HRQOL assessment lies in the additional information it provides and the impact it has on the clinical decision‐making process between a patient and a physician. There remain a multitude of challenges facing renal providers who wish to incorporate HRQOL measurement to improve patient care. These challenges include the clinician's understanding of the conceptual model of HRQOL, the quality of the scientific process that contributed to the current literature on HRQOL, a willingness of the clinician to incorporate HRQOL information into clinical practice, and the logistic difficulties of collecting and applying HRQOL data in a busy practice setting. Arguably, optimizing HRQOL may be the most substantial impact the health care team will have on the person with kidney failure. In order to implement HRQOL assessment at the point of care, providers may consider using computer adaptive testing and scoring algorithms using item response theory, which will allow adequate reliability for interpretation of change among individuals. Moreover, the effective assessment and interpretation of HRQOL will be aided by continued publication of norms, outcomes of randomized controlled trials, and continued experience of investigators and clinicians.

The use of patient reported outcome measures in routine clinical practice: lack of impact or lack of theory?

This paper applies a theory-driven approach to explore why the use of patient-reported outcome (PRO) measures in clinical practice, in particular, health-related quality of life (HRQoL) instruments, has little or no apparent influence on clinical decision making. A theory-driven approach involves combining knowledge of whether and how an intervention works. It is argued that such an approach is currently lacking within the literature evaluating the effectiveness of feeding back HRQoL information to clinicians. The paper identifies a number of mechanisms that might give rise to the expected outcomes that are currently implicit within the design of the intervention and hypotheses specified within the trials evaluating the use of HRQoL measures in clinical practice. It then examines how far current clinical practice matches these mechanisms and in doing so, a number of possible explanations for the lack of impact of HRQoL on clinical decision making are reviewed. The influence of HRQoL information on clinical decision making depends on a large number of factors related to the design of the intervention, patients’ and clinicians’ desire to discuss HRQoL issues within the consultation and the legitimacy that clinicians give to HRQoL instruments. To date, knowledge of how the feedback of HRQoL information to clinicians might improve doctor-patient communication or clinical decision making has yet to sufficiently inform an assessment of whether these aspects of patient care are improved. The paper concludes by specifying how the feedback of HRQoL information to clinicians might be modified to maximise its impact on clinical decision making.

Cancer patients' preferences for communicating clinical trial quality of life information: a qualitative study.

Health-related quality of life (HRQL) is a prevalent outcome measure in clinical trials, but it is not known how best to communicate HRQL results to new patients with cancer. The purpose was to explore cancer patients' attitudes toward, and preferences for, 10 visual and written formats for communicating HRQL information. Using standardized qualitative methods, six focus groups were held (two groups in each of three cancer centres) with patients who had completed treatment for cancer at least 6 months earlier. Groups were stratified according to patients' education. To ensure consistency across centres, group moderators used the same detailed guide, training video, and props. Three investigators independently coded the resulting transcripts. Participants also rated each of the 10 presentation formats as to their perceived usefulness. Fourteen men and 19 women with a variety of cancer diagnoses participated; 13 (39%) participated in the three lower-education groups and 20 (61%) in the three higher-education groups. We found that simple formats (simple graphs or written text) were generally preferred to more complex graphical information, regardless of educational level. The same format was rated favourably by the highest proportion of participants in both the high (85%) and low (85%) education level groups. Individual patients, however, varied as to which visual format they most preferred. Patients did not wish to receive HRQL information out of context or without explanation. We conclude that cancer patients desire HRQL information, but vary in their preferences for its communication. Simple formats are generally preferred.

Health related quality of life in pregeriatric patients with chronic diseases at urban, public supported clinics

BackgroundUnderstanding health-related quality of life (HRQOL) leads to more effective and focused healthcare. America's growing health disparities makes it is increasingly necessary to understand the HRQOL of pregeriatric individuals who are now 55–64 years old, i.e. before they are eligible for federally mandated health care at age 65. Our study measured the self-perceived HRQOL of pregeriatric, poor patients with multiple chronic diseases treated at 2 public clinics.MethodsConsecutive patients aged 55–64 years, many with multiple chronic diseases, responded in an interview to the 36-Item Short-Form Health Survey (SF–36) as a general measure of HRQOL during a regular visit to one of two university-staffed urban public clinics.ResultsThe perceived physical and mental functioning of 316 pregeriatric patients was tabulated from SF–36 scores to yield their HRQOL. Their scores were statistically significantly lower than those of the general US pregeriatric population and lower than averages for US patients with multiple chronic diseases. All eight subscale scores of SF–36 were 16% to 36% lower compared with the averages of the general US pregeriatric population. Further, as the number of chronic diseases increased, the lower was the HRQOL. Lower physical and mental scores were associated with a lower income, unemployment, and higher numbers of multiple chronic diseases.ConclusionChronic diseases have a powerful negative impact on perceived mental and physical functioning in pregeriatric patients. HRQOL information can assist health care providers to gain a more complete picture of their pregeriatric patients' health.

Regulatory Issues for Health-Related Quality of Life— PhRMA Health Outcomes Committee Workshop, 1999

Introduction Health-related quality-of-life (HRQL) can be defined as the impact of disease and treatment across the physical, psychological, social and somatic domains of functioning and well-being. Health-related quality-of-life measures are included in clinical trials of drug treatment to assess the impact of therapy on the patient's functioning. HRQL guidance could allow for use of this data in drug labeling and promotion. Objectives The aim of our study was to provide recommendations with respect to regulatory issues important to the development of guidelines for HRQL research. Methods The HRQL workshop was planned jointly by members of the Pharmaceutical Research and Manufacturers of America Health Outcomes Committee and the Division of Drug Marketing, Advertising, and Communications of the Food and Drug Administration. The workshop was limited to six regulatory issues related to HRQL research in clinical trials of pharmaceutical therapies. These six issues were: instrument selection and validation, study design, data analysis, HRQL and safety, clinical meaning, and promotional use. Before the meeting, a consensus was reached that HRQL does not measure, nor should it be used to measure, safety. Therefore, five work groups discussed HRQL issues and made recommendations. Results Overall, the workshop recommended that HRQL measures be treated as any other clinical end point. The workshop recognized that research in HRQL methods is ongoing and that any guidance should be flexible to allow for changes in this developing research area. Conclusions HRQL provides a patient perspective on the impact of disease and therapy on patients' daily life and functioning. Including HRQL information in promotion could be beneficial to decision making on the use of therapies. HRQL is a measure of effectiveness, not safety, and should be treated as any other clinical end point.

Factors associated with older patients’ satisfaction with care in an inner-city emergency department

Study Objectives: We sought to assess older patients’ satisfaction with care in the emergency department and to identify factors associated with global satisfaction with care. Methods: We performed a prospective cohort study of 778 patients 65 years of age and older presenting to an urban academic ED between 1995 and 1996, of whom 79% were black and 63% were female. A baseline survey at presentation to the ED asked for demographic information, medical history, and health-related quality of life information. A follow-up satisfaction survey asked patients to rate the care they received in the ED on a 5-point Likert scale (1=excellent, 5=poor). Overall satisfaction with care, dichotomized into responses of “excellent” versus all others, was the primary dependent variable in our bivariate analyses. Results: Of respondents, 40% rated their ED care as “excellent.” Variables significantly correlated with high satisfaction include having the perception of time spent in the ED as not “too long,” having the emergency physicians and nurses clearly answer patients’ questions, having a relationship of trust with an ED staff member, being told why tests were done, feeling involved in decisions about care as much as they wanted, having pain addressed fully, having a perception of greater health status, and having fewer comorbid conditions at the time of the ED visit. Results may be applicable only to urban academic EDs and may be limited by time elapsed between ED visits and follow-up surveys. Conclusion: To improve quality of care for older adults in the ED, physicians should be more attentive to older patients’ concerns and questions, recognize and aggressively treat pain, and reduce the patients’ perception of a long waiting time. [Nerney MP, Chin MH, Jin L, Karrison TG, Walter J, Mulliken R, Miller A, Hayley DC, Friedmann PD. Factors associated with older patients’ satisfaction with care in an inner-city emergency department. Ann Emerg Med. August 2001;38:140-145.]

What has been learned from measuring health-related quality of life in clinical oncology

The measurement of health-related quality of life (HRQL) in oncology clinical trials has come of age. Most cooperative clinical trials groups as well as individual institutions have either been measuring, or are starting to measure, HRQL. Over the past decade, much has been learned about how to incorporate HRQL components into multicentre, randomised controlled (phase III) trials and how to collect the data with reasonably low levels of missing information. A selective review, focused primarily on phase III studies, shows that HRQL data are useful for deciding which treatment is preferable when survival rates are similar and for determining whether changes in HRQL, as compared with baseline levels, are related to a treatment or intervention. HRQL information is improving our knowledge of the effects of diseases and their treatments on the patient’s ability to function and sense of well-being, and HRQL status is proving to be a more accurate predictor of survival than is performance status. Much more remains to be done, but it is apparent that the inclusion of HRQL in clinical trials has been informative and useful. The increasing frequency of HRQL assessment in clinical trials is evidence of the emergence of a patient-centred philosophy in clinical medicine which, in time, will modify the disease-oriented paradigm under which medical professionals have functioned for the past century.

Defining an international research agenda for quality of life in men with prostate cancer

While the traditional goal in the management of patients with prostate cancer has been to maximize survival, the recent advent of the medical outcomes movement has underscored the importance of patient-centered issues, such as health-related quality of life (HRQOL). In this paper we present a comprehensive approach to the study of HRQOL in men with prostate cancer. We begin by defining HRQOL in general, discussing its measurement, and placing it in the context of prostate cancer. We then describe the primary goals of HRQOL research and present examples of validated instruments. We finish by proposing a quality of life research agenda for the next two decades. Contemporary perspectives on HRQOL are based on the World Health Organization's definition of health as not merely the absence of disease, but as a state of physical, emotional, and social well-being. HRQOL measurement must adhere to the strict methodological principles of survey psychometrics and is best accomplished with any of several validated instruments. Once collected, HRQOL information is useful for prostate cancer patients facing difficult treatment decisions. A solid foundation for HRQOL research has been built in early- and late-stage prostate cancer. It includes the development of new instruments and the establishment of descriptive data. This groundwork will allow investigators to address more complex research issues, such as interpreting interactions among HRQOL domains, presenting HRQOL data to future patients, optimally timing HRQOL data collection, uncovering innate and alterable factors that influence HRQOL, and exploring the intercultural nuances of HRQOL assessment.

Quality of life assessment by community pharmacists: an exploratory study.

Implicit in the evolving role of pharmacy is that its practitioners embrace the concept of quality of life (QoL). In recent years there has been an increased interest in incorporating health-related quality of life (HRQoL) measures into clinical practice, primarily focusing on the physician as the user of this information. Pharmacists may be able to use these instruments in their practices to provide better pharmaceutical care. To explore the feasibility of such an undertaking, questionnaires were mailed to a national sample of community pharmacies. In addition to the questionnaire, the respondents were provided with examples of two instruments: the Duke Health Profile and the QOLIE-10. A definition of HRQoL was provided to the respondents. After two mailings and a reminder postcard, a usable response rate of 27.2% was achieved. The results revealed that over 80% of the respondents currently discuss HRQoL issues with their patients. In addition, 66% reported that they attempt to assess the HRQoL of their patients, albeit usually on a subjective, informal basis. After viewing examples of HRQoL instruments, over three-quarters of the respondents reported a willingness to use HRQoL assessment tools in their practices. However, only 53.7% of the respondents were familiar with the concept of HRQoL. Less than 5% reported familiarity with formal instruments. The self-reported knowledge of pharmacists concerning HRQoL was low and the respondents recognized a significant gap between their current knowledge and the level of knowledge needed to assess the HRQoL of their patients formally. The results suggest a possible role for the pharmacist in HRQoL assessment. However, the use of HRQoL instruments in community pharmacies will require further training and education on the part of pharmacists concerning the concept of HRQoL, the issues involved in its measurement and how they can use HRQoL information in their practices. In addition, a number of unanswered questions must be addressed through the research process in order for HRQoL questionnaires to become clinical tools in the practice of pharmacy.

The usefulness of the Functional Status Questionnaire and Medical Outcomes Study Short Form in Parkinson's disease research.

Parkinson's disease (PD) has no cure and is a progressive neurological disorder with treatment aimed at the maintenance of function and limitation of the symptoms. No extensive studies of the disease's impact on health-related quality of life (HRQoL) have been conducted. The purpose of this study was to assess the potential usefulness of the Medical Outcomes Study Short Form (SF-36) and the Functional Status Questionnaire (FSQ) in Parkinson's disease research. This cross-sectional study of 193 PD patients who visited two hospital-based neurology clinics used self-administered in-clinic and take-home questionnaires to ascertain the demographic and environmental characteristics of the subjects and to gain health profile measures from the SF-36 and the FSQ. The two health profiles provide important HRQoL information supplementary to the traditional signs and symptoms evaluated by the Unified Parkinson's Disease Rating Scale (UPDRS). Many of the HRQoL measures discriminate progressive stages of disease in this study group and distinguish those with complications of therapy from subjects without complications.

Are proxy assessments of health status after stroke with the EuroQol questionnaire feasible, accurate, and unbiased?

It is often difficult to determine the health-related quality of life (HRQoL) of stroke patients because physical and cognitive problems limit their ability to complete complex questionnaires. A proxy, such as a family member or caregiver, may be able to give an estimate of the patients' health status. We therefore examined the agreement between the HRQoL as assessed by a series of patients and that assessed by their proxies. We studied the validity of the EuroQol in a series of 152 patients from our prospective registry of patients with first (or recurrent) stroke. We asked patients to ensure that a friend or relative (a proxy) who knew them well was available at the time of the interview. We asked each proxy to complete a EuroQol questionnaire independently on behalf of the patient. Proxies completed forms for 130 patients (86%). Agreement between responses from the patients and those from their proxies was better for patients who were able to self-complete the EuroQol than for patients who required the EuroQol to be administered by interview. For both groups, agreement was best for the self-care domain and worst for the domain that assessed psychological outcome. For the more severely affected patients, agreement was only fair for the pain and social functioning domains and no better than chance alone for the psychological functioning domain (kappa = 0.05, 95% confidence interval, 0 to 0.43). Patients tended to rate their own health status as better than their proxies did (P < .05). We found moderate agreement between responses from patients and those from their proxies for the more directly observable domains of the EuroQol. Proxy agreement was less good for the more subjective domains. In health surveys, allowing responses by a proxy increases response rate. However, the disadvantages inherent in the use of proxy responses must be considered carefully. In general, some domains of HRQoL information obtained from a proxy may be sufficiently valid and unbiased to be useable in most types of trials and surveys.

Commercial Tanning Bed Treatment Is an Effective Psoriasis Treatment: Results from an Uncontrolled Clinical Trial

Phototherapy is highly effective in the therapy of psoriasis, but patient access to phototherapeutic facilities is not universal. Commercial tanning facilities are universal, but their efficacy in psoriasis treatment is unestablished. Our purpose was to conduct a study to assess the effect of a commercial tanning unit outfitted with nonprescription lamps on psoriasis. We conducted a 6-wk open study of 20 adult patients with stable psoriasis vulgaris. Clinical response was defined as a decrease in the Psoriasis Area Severity Index (PASI) or the Self-Administered PASI (SAPASI) by > or = 10%. There were 16 men and 4 women who participated with a mean (+/-SD) age of 43.0 +/- 14.8 y. Initial and final health-related quality of life information collected included the following instruments: the Brief Symptom Inventory (BSI), the Psoriasis-Related Stressor Scale (PRSS), and the Psoriasis Disability Scale (PDS). Side effects of tanning therapy were closely monitored. Fifteen subjects completed the entire 6-wk trial, and exit data on all subjects were used for analysis. The mean number of tanning sessions was 19 +/- 7.6 with a median of 19 and range of 3 to 29. Analysis of all 20 enrolled subjects found that 16 (80%) showed clinical response as measured by PASI, whereas 17 (85%) showed SAPASI response. Initial and final PASI scores decreased (p = 0.0001) from 7.96 +/- 1.77 to 5.04 +/- 2.5, and SAPASI scores also decreased (p = 0.02) from 11.8 +/- 4.4 to 7.9 +/- 7.7. When controlled for age and sex, a dose-response relationship was demonstrated with the PASI and SAPASI (p < 0.02). Decreases in the mean BSI and PRSS scales were demonstrated (p < 0.02), confirming the clinical significance of the reductions in disease severity scores. Episodes of mild burning occurred in 7 of 20 (35%) participants. Three subjects reported itching after one or two tanning sessions. This study showed that a tested commercial nonprescription tanning unit improved both psoriasis severity and health-related quality of life. Commercial tanning bed treatments may be a useful approach in patients unable to obtain office-based ultraviolet treatments.

Assessment of Health-related Quality of Life After Corneal Transplantation

To determine the extent to which commonly used clinical measures of corneal transplantation outcome are related to aspects of visual function and health-related quality of life. In a cross-sectional validation study, ophthalmic examination information was collected by chart review of, and health-related quality of life information was collected by telephone contact with, patients (n = 77) undergoing routine follow-up examinations at least 1 year after corneal transplantation. A questionnaire that included the VF-14 and SF-36 instruments was completed for each participant. Associations between clinical and questionnaire outcomes were evaluated using analysis of variance and regression analyses. When the best-corrected visual acuity of both eyes was evaluated, there was a positive association (P < .0001) of visual acuity with the VF-14 score and with the following SF-36 scales: role limitations because of emotional problems (P = .04), emotional well-being (P = .08), and social functioning (P = .02). Those with a high degree of keratometric astigmatism showed an impact on social functioning (P = .005). Upon regression analysis, the single most important factor associated with the patients' reported visual function was their visual acuity in the better eye, followed by the extent of keratometric astigmatism. These findings demonstrate a high degree of criterion validity in using the VF-14 instrument to assess the outcome of corneal transplantation. Application of the more generic SF-36 measure shows effects of visual disability on other aspects of corneal transplant patients' health status, including their emotional and social functioning.

Health-related quality of life as an outcome for patients with heart failure.

The Agency for Health Care Policy and Research Clinical Practice Guidelines on heart failure recommends that providers assess patients' health-related quality of life (HRQOL) and recommends using HRQOL information to modify treatment and guide patient and family teaching to facilitate adaptation to heart failure. This research column reviews eight studies that measured HRQOL as an outcome for patients with medically managed heart failure.

Advances in methods for assessing the impact of epilepsy and antiepileptic drug therapy on patients' health-related quality of life.

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 differing 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.