Implicit self-comparisons against others could bias quality of life assessments

Objectives: To explore how patient-reported health related quality of life (HRQL) and global health status are affected by use of differing personal reference frames. We hypothesised that implicit comparisons against self at an earlier time, against healthy peers or against ill patients would greatly affect patients’ response values. Study design and setting: Patients in a randomised trial for treatment of Paget’s disease completed annual HRQL questionnaires. Supplementary questions were appended, asking the patients whether they were aware of having made implicit comparisons. Results: The majority of patients reported considering themselves a year ago (31% at baseline), themselves before becoming ill (23%) or other healthy people (24%), with similar proportions during follow up. Mean HRQL scores varied substantially according to the declared frame of reference, with differences as big as 19% of the scale score, or a standardised mean effect size of 0.74 standard deviations. Conclusion: Reported reference frames were associated with effects of similar magnitude to the differences in HRQL that are regarded as clinically important. This may be of particular concern in trials that andomise patients to management in different settings, such as treatment at home / in hospital, or surgery / chemotherapy, and might bias or obscure HRQL differences

Analysing randomised controlled trials with missing data : Choice of approach affects conclusions

Copyright © 2012 Elsevier Inc. All rights reserved. PMID: 22265924 [PubMed - indexed for MEDLINE]Peer reviewedPostprin

Using the literature to quantify the learning curve: a case study

Objective: To assess whether a literature review of a technology can allow a learning curve to be quantified. Methods: The literature for fibreoptic intubation was searched for studies reporting information relevant to the learning curve. The Cochrane Librar y, Medline, Embase and Science Citation index were searched. Studies that reported a procedure time were included. Data were abstracted on the three features of learning: initial level, rate of learning and asymptote level. Random effect meta-analysis was performed. Results: Only 21 studies gave explicit information concerning the previous experience of the operator(s). There were 32 different definitions of procedure time. From 4 studies of fibreoptic nasotracheal intubation, the mean starting level and time for the 10th procedure (95% confidence interval) was estimated to be 133s (113, 153) and 71s (62, 79) respectively. Conclusions: The review approach allowed learning to be quantified for our example technology. Poor and insufficient reporting constrained formal statistical estimation. Standardised reporting of non-drug techniques with adequate learning curve details is needed to inform trial design and costeffectiveness analysis

Alphas, betas and skewy distributions: two ways of getting the wrong answer

Although many parametric statistical tests are considered to be robust, as recently shown in Methodologist’s Corner, it still pays to be circumspect about the assumptions underlying statistical tests. In this paper I show that robustness mainly refers to α, the type-I error. If the underlying distribution of data is ignored there can be a major penalty in terms of the β, the type-II error, representing a large increase in false negative rate or, equivalently, a severe loss of power of the test

"It ain't over till the fat lady sings" : A response to Cameron N. McIntosh, improving the evaluation of model fit in confirmatory factor analysis

Peer reviewedPublisher PD

Predicting missing quality of life data that were later recovered : an empirical comparison of approaches

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Minimal important differences and response shift in health-related quality of life : a longitudinal study in patients with multiple myeloma

Acknowledgements This project has been financed with the aid of EXTRA funds from the Norwegian Foundation for Health and Rehabilitation. The authors thank health-care providers at the following hospitals for recruiting patients to this study: Akershus University Hospital; Diakonhjemmet Hospital; Lovisenberg Diaconal Hospital; Oslo University Hospital, Aker; Oslo University Hospital, Ulleval; Sorlandet Hospital, Arendal; Sykehuset in Vestfold, Tonsberg; Sykehuset Innlandet, division Gjovik, Hamar, Kongsvinger and Lillehammer; Sykehuset Ostfold, Fredrikstad; Telemark Hospital, Skien; Vestre Viken HF, division Asker and Baerum, Buskerud, Kongsberg and Ringerike. Preliminary results have been presented as a paper at the ISOQOL annual meeting, New Orleans, October 2009Peer reviewedPublisher PD

Is progression-free survival associated with a better health-related quality of life in patients with lung cancer? : Evidence from two randomised trials with afatinib

Acknowledgements Medical writing assistance, supported financially by Boehringer Ingelheim, was provided by Suzanne Patel during the preparation of this article. Funding This study was supported by Boehringer Ingelheim.Peer reviewedPublisher PD

Meaning behind measurement : self-comparisons affect responses to health related quality of life questionnaires

Purpose The subjective nature of quality of life is particularly pertinent to the domain of health-related quality of life (HRQOL) research. The extent to which participants’ responses are affected by subjective information and personal reference frames is unknown. This study investigated how an elderly population living with a chronic metabolic bone disorder evaluated self-reported quality of life. Methods Participants (n = 1,331) in a multi-centre randomised controlled trial for the treatment of Paget’s disease completed annual HRQOL questionnaires, including the SF-36, EQ-5D and HAQ. Supplementary questions were added to reveal implicit reference frames used when making HRQOL evaluations. Twenty-one participants (11 male, 10 female, aged 59–91 years) were interviewed retrospectively about their responses to the supplementary questions, using cognitive interviewing techniques and semi-structured topic guides. Results The interviews revealed that participants used complex and interconnected reference frames to promote response shift when making quality of life evaluations. The choice of reference frame often reflected external factors unrelated to individual health. Many participants also stated that they were unclear whether to report general or disease-related HRQOL. Conclusions It is important, especially in clinical trials, to provide instructions clarifying whether ‘quality of life’ refers to disease-related HRQOL. Information on selfcomparison reference frames is necessary for the interpretation of responses to questions about HRQOL.The Chief Scientist Office of the Scottish Government Health Directorates, The PRISM funding bodies (the Arthritis Research Campaign, the National Association for the Relief of Paget’s disease and the Alliance for Better Bone Health)Peer reviewedAuthor final versio

Deriving a preference-based measure for cancer using the EORTC QLQ-C30 : a confirmatory versus exploratory approach

Background: To derive preference-based measures from various condition-specific descriptive health-related quality of life (HRQOL) measures. A general 2-stage method is evolved: 1) an item from each domain of the HRQOL measure is selected to form a health state classification system (HSCS); 2) a sample of health states is valued and an algorithm derived for estimating the utility of all possible health states. The aim of this analysis was to determine whether confirmatory or exploratory factor analysis (CFA, EFA) should be used to derive a cancer-specific utility measure from the EORTC QLQ-C30. Methods: Data were collected with the QLQ-C30v3 from 356 patients receiving palliative radiotherapy for recurrent or metastatic cancer (various primary sites). The dimensional structure of the QLQ-C30 was tested with EFA and CFA, the latter based on a conceptual model (the established domain structure of the QLQ-C30: physical, role, emotional, social and cognitive functioning, plus several symptoms) and clinical considerations (views of both patients and clinicians about issues relevant to HRQOL in cancer). The dimensions determined by each method were then subjected to item response theory, including Rasch analysis. Results: CFA results generally supported the proposed conceptual model, with residual correlations requiring only minor adjustments (namely, introduction of two cross-loadings) to improve model fit (increment χ2(2) = 77.78, p 75% observation at lowest score), 6 exhibited misfit to the Rasch model (fit residual > 2.5), none exhibited disordered item response thresholds, 4 exhibited DIF by gender or cancer site. Upon inspection of the remaining items, three were considered relatively less clinically important than the remaining nine. Conclusions: CFA appears more appropriate than EFA, given the well-established structure of the QLQ-C30 and its clinical relevance. Further, the confirmatory approach produced more interpretable results than the exploratory approach. Other aspects of the general method remain largely the same. The revised method will be applied to a large number of data sets as part of the international and interdisciplinary project to develop a multi-attribute utility instrument for cancer (MAUCa)