Measuring quality of life in clinical trials: a taxonomy and review.

Measurement of quality of life is becoming increasingly relevant to controlled clinical trials. Two basic types of instrument are available: generic instruments, which include health profiles and utility measurements based on the patient''s preferences in regard to treatment and outcome; and specific instruments, which focus on problems associated with individual diseases, patient groups or areas of function. The two approaches are not mutually exclusive; each has its strengths and weaknesses and may be suitable under different circumstances. We surveyed 75 randomized trials published in three medical journals in 1986 and categorized them according to the importance of quality of life as a measure of outcome and the extent to which quality of life was actually measured. Although a number of the investigators used quality-of-life instruments in a sophisticated manner, in only 10 of 55 trials in which the measurement had been judged to be crucial or important were instruments with established validity and responsiveness used. We conclude that although accurate measurement of quality of life in randomized trials is now feasible it is still not widely done. Using the framework we have outlined, investigators can choose generic or specific instruments according to the purpose and the focus of their trial.     

Development and Validation of the Keele Musculoskeletal Patient Reported Outcome Measure (MSK-PROM)

Objective

To develop and validate a patient report outcome measure (PROM) for clinical practice that can monitor health status of patients with a range of musculoskeletal (MSK) disorders.

Methods

Constructs for inclusion in the MSK-PROM were identified from a consensus process involving patients with musculoskeletal conditions, clinicians, purchasers of healthcare services, and primary care researchers. Psychometric properties of the brief tool, including face and construct validity, repeatability and responsiveness were assessed in a sample of patients with musculoskeletal pain consulting physiotherapy services in the United Kingdom (n=425).

Results

The consensus process identified 10 prioritised domains for monitoring musculoskeletal health status: pain intensity, quality of life, physical capacity, interference with social/leisure activities, emotional well-being, severity of most difficult thing, activities and roles, understanding independence, and overall impact. As the EuroQol (EQ-5D-5L) is a widely adopted PROMs tool and covers the first four domains listed, to reduce patient burden to a minimum the MSK-PROM was designed to capture the remaining six prioritised domains which are not measured by the EQ-5D-5L. The tool demonstrated excellent reliability, construct validity, responsiveness and acceptability to patients and clinicians for use in clinical practice.

Conclusion

We have validated a brief patient reported outcome measure (MSK-PROM) for use in clinical practice to measure musculoskeletal health status and monitor outcomes over time using domains that are meaningful to patients and sensitive to change. Further work will establish whether the MSK-PROM is useful in other musculoskeletal healthcare settings.     

Cognition after malignant media infarction and decompressive hemicraniectomy - a retrospective observational study

Background

The Multiple Sclerosis International Quality Of Life (MusiQoL) questionnaire, a 31-item, multidimensional, self-administrated questionnaire that is available in 14 languages including Spanish, has been validated using a large international sample. We investigated the validity and reliability of the Spanish version of MusiQoL in Spain.

Methods

Consecutive patients with different types and severities of multiple sclerosis (MS) were recruited from 22 centres across Spain. All patients completed the MusiQoL questionnaire, the 36-Item Short Form (SF-36) health survey, and a symptoms checklist at baseline and 21 days later. External validity, internal consistency, reliability and reproducibility were tested.

Results

A total of 224 Spanish patients were evaluated. Dimensions of MusiQoL generally demonstrated a high internal consistency (Cronbach's alpha: 0.70-0.92 for all but two MusiQoL domain scores). External validity testing revealed that the MusiQoL index score correlated significantly with all SF-36 dimension scores (Pearson's correlation: 0.46-0.76), reproducibility was satisfactory (intraclass correlation coefficient: 0.60-0.91), acceptability was high, and the time taken to complete the 31-item questionnaire was reasonable (mean [standard deviation]: 9.8 [11.8] minutes).

Conclusions

The Spanish version of the MusiQoL questionnaire appears to be a valid and reliable instrument for measuring quality of life in patients with MS in Spain and constitutes a useful instrument to measure health-related quality of life in the clinical setting.     

Validation of a parent-proxy, obesity-specific quality-of-life measure: sizing them up

The aims of the present study were to develop and validate a new obesity-specific, parent-proxy measure of health-related quality of life (HRQOL), Sizing Them Up. Participants included 220 obese youth (M(age) = 11.6 years, 68% female, 53% African American, M(BMI) = 36.7) and their primary caregivers (88% mothers). Primary caregivers completed a demographics questionnaire and two HRQOL measures: Sizing Them Up (obesity-specific) and PedsQL (generic). Youth height and weight were measured. Psychometric evaluation of Sizing Them Up was completed by conducting a factor analysis and determining internal consistency coefficients, test-retest reliability, convergent and discriminant validity, predictive validity, responsiveness to change, and minimal clinically important difference (MCID) scores. Sizing Them Up is a 22-item measure with six scales (i.e., Emotional Functioning, Physical Functioning, Teasing/Marginalization, Positive Social Attributes, Mealtime Challenges, and School Functioning) that account for 66% of the variance. The measure also includes an Adolescent Developmental Adaptation module. Sizing Them Up had internal consistency coefficients ranging from 0.59 to 0.91 and test-retest reliabilities ranging from 0.57 to 0.80. Validity was demonstrated by significant relations between a majority of Sizing Them Up scales and BMI z-scores. Sizing Them Up also demonstrated good convergent validity with other HRQOL measures and responsiveness to change related to weight loss for adolescents who had undergone bariatric surgery. Overall, Sizing Them Up is a reliable and valid parent-proxy measure of obesity-specific HRQOL that can be used in both clinical and research settings.     

Predictive validity of the cognitive vs. somatic anxiety distinction

The purpose of this study was to test the predictive validity of an instrument, The Cognitive-Somatic Anxiety Questionnaire (CSAQ), which purports to measure separately cognitive and somatic anxiety. Twelve subjects with either predominantly cognitive or somatic anxiety received a treatment that matched their predominant anxiety mode ("matched"), and twelve received a treatment which addressed the secondary anxiety mode ("mismatched"). After five sessions, the "matched" subjects reported significantly fewer anxiety symptoms than the "mismatched" subjects. The results support the predictive validity of the CSAQ, and suggest that anxiety may not be a unidimensional phenomenon. The implications of these results for clinical practice are discussed.     

Patient-Reported Outcomes for Quality of Life Assessment in Atrial Fibrillation: A Systematic Review of Measurement Properties

BackgroundAtrial fibrillation is a large and growing burden across all types of healthcare. Both incidence and prevalence are expected to double in the next 20 years, with huge impact on hospital admissions, costs and patient quality of life. Patient wellbeing determines the management strategy for atrial fibrillation, including the use of rhythm control therapy and the clinical success of heart rate control. Hence, evaluation of quality of life is an emerging and important part of the assessment of patients with atrial fibrillation. Although a number of questionnaires to assess quality of life in atrial fibrillation are available, a comprehensive overview of their measurement properties is lacking.InterpretationGiven the low ratings for many measurement properties, no single questionnaire can be recommended, although AFEQT performed strongest. Further studies to robustly assess reliability, validity and responsiveness of AF-specific quality of life questionnaires are required. This review consolidates the current evidence for quality of life assessment in patients with atrial fibrillation and identifies priority areas for future research.     

Construct Validity of the Impact of Weight on Quality of Life Questionnaire

KOLOTKIN, RONETTE L, SUSAN HEAD, ALAN BROOKHART. Construct validity of the Impact of Weight on Quality of Life questionnaire. The Impact of Weight on Quality of Life questionnaire (IWQOL) is a 74-item self-report, condition-specific instrument that (1) assesses the effect of weight on quality of life in eight key areas, and (2) may be used as a treatment outcome measure and/or an evaluation tool for healthcare policy makers and third-party payers. This study explores IWQOL construct validity and provides new information on internal consistency, treatment effects, and differences between men and women. IWQOL total scores correlated highly with other measures of overall quality of life, and subscale scores correlated well with counterparts in the assessment battery. Internal consistency estimates for the IWQOL scales generally were high. For the women, 4-week participants, and the total sample, pretreatment-posttreatment differences were significant for all IWQOL scales and total score. For men, treatment differences were significant for the total score and all subscales except for Work and Mobility. Treatment differences for 2-week participants were significant for all scales except for Work. Consistent with previous IWQOL study results, the Comfort With Food scale scores reflected more discomfort at posttreatment as compared with pretreatment. The IWQOL, already translated into French and Italian, currently is demonstrating clinical and research utility as a quality-of-life outcome measure for clinical trials of antiobesity drugs and surgical treatments for patients with obesity.     

Sleep problems in Parkinson’s disease: a community-based study in Norway

Background

Neurogenic claudication (NC) is a common symptom in patients with lumbar spinal stenosis (LSS). The Neurogenic Claudication Outcome Score (NCOS) is a very short instrument for measuring functional status in these patients. This study aimed to translate and validate the NCOS in Iran.

Methods

This was a prospective clinical validation study. The 'forward-backward' procedure was applied to translate the NCOS from English into Persian (Iranian language). A total of 84 patients with NC were asked to respond to the questionnaire at two points in time: at preoperative and at postoperative (6 months follow-up) assessments. The Oswestry Disabiltiy Index (ODI) also was completed for patients. To test reliability, the internal consistency was assessed by Cronbach's alpha coefficient. Validity was evaluated using known groups comparison and criterion validity (convergent validity). Internal responsiveness of the NCOS to the clinical intervention (surgery) also was assessed comparing patients?? pre- and postoperative scores.

Results

The Cronbach??s alpha coefficients for the NCOS at preoperative and postoperative assessments were 0.77 and 0.91, respectively. Known groups analysis showed satisfactory results. The instrument discriminated well between sub-groups of patients who differed in claudication distance as measured by the Self-Paced Walking Test (SPWT). The change in the ODI after surgery was strongly correlated with change in the NCOS, lending support to its good convergent validity (r?=?0.81; P?<?0.001). Further analysis also indicated that the questionnaire was responsive to the clinical intervention (surgery) as expected (P?<?0.0001).

Conclusion

In general, the Iranian version of the NCOS performed well and the findings suggest that it is a reliable and valid measure of functionality in patients with lumbar spinal stenosis who are suffering from neurogenic claudication.     

Measuring Quality of Life in Owners of Companion Dogs: Development and Validation of a Dog Owner-specific Quality of Life Questionnaire

Numerous studies have examined the link between companiondog ownership and improved physical or psychological health outcomes; however, few have examined the association between dog ownership and owners’ overall wellbeing or quality of life (QOL). Moreover, the potential for dog ownership to adversely affect owner QOL has been largely ignored. In general, little is known regarding the specific aspects of QOL that are most affected by dog ownership, and there are no instruments specifically designed to assess the QOL of dog owners. If such a tool was available, these effects could be better quantified, understood, and potentially utilized to further improve owner QOL. The aim of the present study was to develop and validate a QOL questionnaire specifically suitable for use in dog owners. A literature review, focus-group activities, and expert content review were used to generate an item pool for the instrument. Both positive and negative effects of dog ownership on QOL were considered. Developmental and validation versions of a QOL instrument were tested using exploratory and confirmatory factor analysis, respectively. The validity and reliability of the QOL instrument were tested using goodness of fit indices and Cronbach’s alpha. The study produced the 10-item Dog Owner Quality Of Life Questionnaire (DOQOL) comprised of 3 different factors: emotional wellbeing, social and physical activities, and stress and responsibility of dog ownership. The factor structure had good fit and internal reliability. The DOQOL represents a suitable tool to measure QOL in dog owners, and future use could improve our understanding of the relationship between dog ownership and QOL.     

Development and Psychometric Evaluation of an Instrument to Assess Cross-Cultural Competence of Healthcare Professionals (CCCHP)

Background

Cultural competence of healthcare professionals (HCPs) is recognized as a strategy to reduce cultural disparities in healthcare. However, standardised, valid and reliable instruments to assess HCPs’ cultural competence are notably lacking. The present study aims to 1) identify the core components of cultural competence from a healthcare perspective, 2) to develop a self-report instrument to assess cultural competence of HCPs and 3) to evaluate the psychometric properties of the new instrument.

Methods

The conceptual model and initial item pool, which were applied to the cross-cultural competence instrument for the healthcare profession (CCCHP), were derived from an expert survey (n = 23), interviews with HCPs (n = 12), and a broad narrative review on assessment instruments and conceptual models of cultural competence. The item pool was reduced systematically, which resulted in a 59-item instrument. A sample of 336 psychologists, in advanced psychotherapeutic training, and 409 medical students participated, in order to evaluate the construct validity and reliability of the CCCHP.

Results

Construct validity was supported by principal component analysis, which led to a 32-item six-component solution with 50% of the total variance explained. The different dimensions of HCPs’ cultural competence are: Cross-Cultural Motivation/Curiosity, Cross-Cultural Attitudes, Cross-Cultural Skills, Cross-Cultural Knowledge/Awareness and Cross-Cultural Emotions/Empathy. For the total instrument, the internal consistency reliability was .87 and the dimension’s Cronbach’s α ranged from .54 to .84. The discriminating power of the CCCHP was indicated by statistically significant mean differences in CCCHP subscale scores between predefined groups.

Conclusions

The 32-item CCCHP exhibits acceptable psychometric properties, particularly content and construct validity to examine HCPs’ cultural competence. The CCCHP with its five dimensions offers a comprehensive assessment of HCPs’ cultural competence, and has the ability to distinguish between groups that are expected to differ in cultural competence. This instrument can foster professional development through systematic self-assessment and thus contributes to improve the quality of patient care.     

Cross-cultural adaptation of instruments assessing breastfeeding determinants: a multi-step approach

Background

Cross-cultural adaptation is a necessary process to effectively use existing instruments in other cultural and language settings. The process of cross-culturally adapting, including translation, of existing instruments is considered a critical set to establishing a meaningful instrument for use in another setting. Using a multi-step approach is considered best practice in achieving cultural and semantic equivalence of the adapted version. We aimed to ensure the content validity of our instruments in the cultural context of KwaZulu-Natal, South Africa.

Methods

The Iowa Infant Feeding Attitudes Scale, Breastfeeding Self-Efficacy Scale-Short Form and additional items comprise our consolidated instrument, which was cross-culturally adapted utilizing a multi-step approach during August 2012. Cross-cultural adaptation was achieved through steps to maintain content validity and attain semantic equivalence in the target version. Specifically, Lynn’s recommendation to apply an item-level content validity index score was followed. The revised instrument was translated and back-translated. To ensure semantic equivalence, Brislin’s back-translation approach was utilized followed by the committee review to address any discrepancies that emerged from translation.

Results

Our consolidated instrument was adapted to be culturally relevant and translated to yield more reliable and valid results for use in our larger research study to measure infant feeding determinants effectively in our target cultural context.

Conclusions

Undertaking rigorous steps to effectively ensure cross-cultural adaptation increases our confidence that the conclusions we make based on our self-report instrument(s) will be stronger. In this way, our aim to achieve strong cross-cultural adaptation of our consolidated instruments was achieved while also providing a clear framework for other researchers choosing to utilize existing instruments for work in other cultural, geographic and population settings.

     

Psychometric validation of the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) in Chinese patients with adolescent idiopathic scoliosis

Background

Scoliosis is a common spinal deformity that occurs often during adolescence. Previous studies suggested that adolescent idiopathic scoliosis (AIS) patients can have various aspects of their lives being affected, due to disease presentation and/or treatment received. It is important to define a reliable instrument based on which the affected patients’ health-related quality of life can be assessed. This study aims to assess the validity, reliability and sensitivity of the EuroQoL 5-dimension 5-level (EQ-5D-5L) in Chinese patients with AIS.

Methods

Adolescent idiopathic scoliosis patients of Chinese descent were prospectively recruited to complete both the traditional Chinese versions of the EQ-5D-5L and the refined Scoliosis Research Society-22 (SRS-22r) questionnaires. Patients’ demographic profiles and corresponding clinical parameters including treatment modalities, spinal curve pattern and magnitude, and duration of bracing were recorded. Telephone interviews were then conducted at least two weeks later for the assessment of test-retest reliability. Statistical analysis was performed: construct validity of the EQ-5D-5L domains were assessed using Spearman’s correlation test against the SRS-22r; whereas intra-class correlation coefficient (ICC) was used to assess the test-retest reliability, and agreement over the test-retest period was expressed in percentages. Also, the sensitivity of the EQ-5D-5L in differentiating various clinical known groups was determined by effect size, independent t-test and analysis of variance.

Results

A total of 227 AIS patients were recruited. Scores of domains of the EQ-5D-5L correlated significantly (r: 0.57-0.74) with the scores of the SRS-22r domains that were intended to measure similar constructs, supporting construct validity. The EQ-5D-5L domain responses and utility scores showed good test-retest reliability (ICC: 0.777; agreement: 76.4?-98.1 %). Internal consistency was good (Cronbach’s α: 0.78) for the EQ-5D-5L utility score. The EQ-5D-5L utility score was sensitive in detecting differences between subjects who had different treatment modalities and bracing duration, but not for curve pattern and its magnitude.

Conclusions

The EQ-5D-5L is found to be a valid, reliable and sensitive measure to assess the health-related quality of life in Chinese AIS patients. This potentiates the possibility of utilizing the EQ-5D-5L to estimate AIS patients’ health-related quality of life, based on which the outcome of various treatment options can eventually be evaluated.

     

Adaptation and validation of the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) for the Netherlands

Background

The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) is the first disease-specific instrument for pulmonary arterial hypertension (PAH) to assess patient-perceived symptoms, activity limitations and quality of life. To be able to use this questionnaire in the Netherlands, the aim of the study was to translate and validate this instrument for the Dutch-speaking population.

Methods

First the CAMPHOR was translated into Dutch (by means of a bilingual and a lay panel) and field-tested by means of cognitive debriefing interviews with ten PAH patients. For psychometric evaluation, 80 patients with PAH or chronic thromboembolic pulmonary hypertension (CTEPH) were asked to complete the CAMPHOR twice over a two-week period. To test for construct validity, participants also completed the Nottingham Health Profile (NHP).

Results

The Dutch version of the CAMPHOR showed high internal consistency for all scales (Cronbach’s alpha 0.89–0.91) and excellent reproducibility over two weeks (reliability coefficients 0.87–0.91). Concurrent validity showed that the CAMPHOR scales correlated as expected with the NHP scales. The CAMPHOR was able to distinguish between patient groups based on self-reported general health status, disease severity and NYHA classification demonstrating evidence of known group validity. The CAMPHOR activity limitations scale correlated moderately with the distance walked during the 6?minute walk test (r = ?0.47, p < 0.01) and the symptoms scale with the Borg dyspnoea score (r = 0.51, p < 0.01).

Conclusion

The Dutch version of the CAMPHOR is a reliable and valid measure of quality of life and health status in patients with PAH and CTEPH is recommended for use in routine care and in clinical research.

     

Assessing weight-related quality of life in adolescents

Objective : The development of a new weight‐related measure to assess quality of life in adolescents [Impact of Weight on Quality of Life (IWQOL)‐Kids] is described. Research Methods and Procedures : Using a literature search, clinical experience, and consultation with pediatric clinicians, 73 items were developed, pilot tested, and administered to 642 participants, 11 to 19 years old, recruited from weight loss programs/studies and community samples (mean z‐BMI, 1.5; range, ?1.2 to 3.4; mean age, 14.0; 60% female; 56% white). Participants completed the 73 items and the Pediatric Quality of Life Inventory and were weighed and measured. Results : Four factors (27 items) were identified (physical comfort, body esteem, social life, and family relations), accounting for 71% of the variance. The IWQOL‐Kids demonstrated excellent psychometric properties. Internal consistency coefficients ranged from 0.88 to 0.95 for scales and equaled 0.96 for total score. Convergent validity was demonstrated with strong correlations between IWQOL‐Kids total score and the Pediatric Quality of Life Inventory (r = 0.76, p < 0.0001). Significant differences were found across BMI groups and between clinical and community samples, supporting the sensitivity of this measure. Participants in a weight loss camp demonstrated improved IWQOL‐Kids scores, suggesting responsiveness of the IWQOL‐Kids to weight loss/social support intervention. Discussion : The present study provides preliminary evidence regarding the psychometric properties of the IWQOL‐Kids, a weight‐related quality of life measure for adolescents. Given the rise of obesity in youth, the development of a reliable and valid weight‐related measure of quality of life is timely.     

Entropy-based cluster validation and estimation of the number of clusters in gene expression data

Many external and internal validity measures have been proposed in order to estimate the number of clusters in gene expression data but as a rule they do not consider the analysis of the stability of the groupings produced by a clustering algorithm. Based on the approach assessing the predictive power or stability of a partitioning, we propose the new measure of cluster validation and the selection procedure to determine the suitable number of clusters. The validity measure is based on the estimation of the "clearness" of the consensus matrix, which is the result of a resampling clustering scheme or consensus clustering. According to the proposed selection procedure the stable clustering result is determined with the reference to the validity measure for the null hypothesis encoding for the absence of clusters. The final number of clusters is selected by analyzing the distance between the validity plots for initial and permutated data sets. We applied the selection procedure to estimate the clustering results on several datasets. As a result the proposed procedure produced an accurate and robust estimate of the number of clusters, which are in agreement with the biological knowledge and gold standards of cluster quality.     

Cross-Cultural Adaptation and Validation of the Dutch Version of the Hip and Groin Outcome Score (HAGOS-NL)

Background

Valid and reliable questionnaires to assess hip and groin pain are lacking. The Hip and Groin Outcome Score (HAGOS) is a valid and reliable self-reported measure to assess symptoms, activity limitations, participation restrictions and quality of life of persons with hip and/or groin complaints. The purpose of this study was to translate and cross-culturally adapt the HAGOS into Dutch (HAGOS-NL), and to evaluate its internal consistency, validity and reliability.

Methods

Translation and cross-cultural adaption of the Dutch version of the HAGOS (HAGOS-NL) was performed according to international guidelines. The study population consisted of 178 adult patients who had undergone groin hernia repair surgery in the previous year. All respondents filled in the HAGOS-NL, the SF-36, and the SMFA-NL for determining construct validity of the HAGOS-NL. To determine reliability, 81 respondents filled in the HAGOS-NL after a time interval of two weeks.

Results

Factor analysis confirmed the original six-factor solution of the HAGOS. Internal consistency was good for all the subscales of the HAGOS-NL. High correlations were observed between the HAGOS-NL and the SF-36 and SMFA-NL, indicating good construct validity. The HAGOS-NL showed high reliability, except for the subscale Participation in Physical Activities which was moderate.

Conclusions

The HAGOS was successfully translated and cross-culturally adapted from English into Dutch (HAGOS-NL). This study shows that the HAGOS-NL is a valid and reliable instrument for the assessment of functional status and health-related quality of life in patients with groin complaints.     

A new short form individual quality of life measure (SEIQoL-DW): application in a cohort of individuals with HIV/AIDS.

Quality of life is an increasingly important outcome measure in medicine and health care. Many measures of quality of life present patients with predetermined lists of questions that may or may not be relevant to the individual patient. This paper describes a brief measure, the SEIQoL-DW, which is derived from the schedule for evaluation of individual quality of life (SEIQoL). The measure allows respondents to nominate the areas of life which are most important, rate their level of functioning or satisfaction with each, and indicate the relative importance of each to their overall quality of life. Given its practicality and brevity, the measure should prove particularly useful in clinical situations where patient generated data on quality of life is important. This article describes the first clinical application of the measure, assessing the quality of life of a cohort of patients with HIV/AIDS managed in general practice.     

Measuring outcomes in primary care: a patient generated measure,MYMOP, compared with the SF-36 health survey.

OBJECTIVE--To assess the sensitivity to within person change over time of an outcome measure for practitioners in primary care that is applicable to a wide range of illness. DESIGN--Comparison of a new patient generated instrument, the measure yourself medical outcome profile (MYMOP), with the SF-36 health profile and a five point change score; all scales were completed during the consultation with'' practitioners and repeated after four weeks. 103 patients were followed up for 16 weeks and their results charted; seven practitioners were interviewed. SETTING--Established practice of the four NHS general practitioners and four of the private complementary practitioners working in one medical centre. SUBJECTS--Systematic sample of 218 patients from general practice and all 47 patients of complementary practitioners; patients had had symptoms for more than seven days. OUTCOME MEASURES--Standardised response mean and index of responsiveness; view of practitioners. RESULTS--The index of responsiveness, relating to the minimal clinically important difference, was high for MYMOP: 1.4 for the first symptom, 1.33 for activity, and 0.85 for the profile compared with < 0.45 for SF-36. MYMOP''s validity was supported by significant correlation between the change score and the change in the MYMOP score and the ability of this instrument to detect more improvement in acute than in chronic conditions. Practitioners found that MYMOP was practical and applicable to all patients with symptoms and that its use increased their awareness of patients'' priorities. CONCLUSION--MYMOP shows promise as an outcome measure for primary care and for complementary treatment. It is more sensitive to change than the SF-36 and has the added bonus of improving patient-practitioner communication.     

Preliminary Development and Validation of a New End-of-Life Patient-Reported Outcome Measure Assessing the Ability of Patients to Finalise Their Affairs at the End of Life

Introduction

The ability of patients to finalise their affairs at the end of life is an often neglected aspect of quality of life (QOL) measurement in palliative care effectiveness research despite compelling evidence of the high value patients place on this domain.

Objective

This paper describes the preliminary development and evaluation of a new, single-item, end-of-life patient-reported outcome measure (EOLPRO) designed to capture changes in the ability of patients to finalise their affairs at the end of life.

Methods

Cognitive interviews with purposively sampled Australian palliative care patients (N = 9) were analysed thematically to explore content validity. Simultaneously, secondary analysis of data from a randomised controlled trial comparing ketamine and placebo for the management of cancer pain (N = 185) evaluated: construct validity; test-retest reliability; and responsiveness.

Results

Preliminary findings suggest patients interpret the new measure consistently. The EOLPRO captures the ability to complete physical tasks and finalise practical matters although it is unclear whether emotional tasks or resolution of relationship issues are considered. Personal and financial affairs should be separated to allow for differences in ability for these two types of affairs. The significant correlation between performance status and EOLPRO scores (r = 0.41, p<0.01, n = 137) and expected relationships between EOLPRO and proximity to death and constipation demonstrated construct validity. Pre- and post-treatment EOLPRO scores moderately agreed (n = 14, κ = 0.52 [95% CI 0.19, 0.84]) supporting reliability. The measure’s apparent lack of sensitivity to discriminate between treatment responders and non-responders may be confounded.

Conclusion

Based on the preliminary findings, the EOLPRO should be separated into ‘personal’ and ‘financial’ affairs with further testing suggested, particularly to verify coverage and responsiveness. Initial evaluation suggests that the single-item EOLPRO is a useful addition to QOL outcome measurement in palliative care effectiveness research because common palliative care specific QOL questionnaires do not include or explicitly capture this domain.     

Quality-of-life measurements: origin and pathogenesis

Despite extensive growth in recent years, the field of "quality-of-life" appraisal still evokes debate about basic perception of the concept and is accompanied by a plethora of indexes for measurement. One prime reason for the problems is that the measurements have been transferred from two separate sources - medical health status indexes and social-science population indexes - neither of which was designed for appraising the particular personal distinctions of the way people feel about their own quality of life. When regulatory and commercial incentives were offered for measuring patients' quality of life, it became appraised with the indexes available from the medical and psychosocial sources, even though neither set of indexes was specifically intended for that purpose. They are not developed from the basic principle that a person's "quality of life" is a state of mind, not a state of health, which is uniquely perceived by that person, and which will not be appropriately appraised unless the most cogent personal components are allowed suitable expressions. An approach that lets patients state their own opinions directly can offer the "face validity" or "common sense" that now seems absent from the generally applied measurements.