Quality of life of the Canadian population using the VR-12: population norms for health utility values, summary component scores and domain scores.

OBJECTIVES: To estimate Canadian population norms (health utility values, summary component scores and domain scores) for the VR-12. METHODS: English and French speaking Canadians aged 18 and older completed an online survey that included sociodemographic questions and standardized health status instruments, including the VR-12. Responses to the VR-12 were summarized as: (i) a health utility value; (ii) mental and physical component summary scores (MCS and PCS, respectively), and (iii) eight domain scores. Norms were calculated for the full sample and by gender, age group, and province/territory (univariate), and for several multivariate stratifications (e.g., age group and gender). Results were summarized using descriptive statistics, including number of respondents, mean and standard deviation (SD), median and percentiles (25th and 75th), and minimum and maximum. RESULTS: A total of 6761 people who clicked on the survey link completed the survey (83.4% completion rate), of whom 6741 (99.7%) were included in the analysis. The mean health utility score was 0.698 (SD = 0.216). Mean health utility scores tended to be higher in older age groups, ranging from 0.661 (SD = 0.214) in those aged 18-29 to 0.728 (SD = 0.310) in those aged 80+. Average MCS scores were higher in older age groups, while PCS scores were lower. Females consistently reported lower mean health utility values, summary component scores and domain scores compared with males. CONCLUSIONS: This is the first study to present Canadian norms for the VR-12. Health utility norms can serve as a valuable input for Canadian economic models, while summary component and domain norms can help interpret routinely-collected data.

Bowel burdens: a systematic review and meta-analysis examining the relationships between bowel dysfunction and quality of life after spinal cord injury.

STUDY DESIGN: Systematic review and meta-analysis. OBJECTIVES: Many individuals with spinal cord injury (SCI) experience autonomic dysfunction, including profound impairments to bowel and cardiovascular function. Neurogenic bowel dysfunction (NBD) is emerging as a potential determinant of quality of life (QoL) after SCI. For individuals with high-level lesions ( > T6), bowel care-related autonomic dysreflexia (B-AD; profound episodic hypertension) further complicates bowel care. We aimed to evaluate the extent of bowel dysfunction after SCI, and the impact of bowel dysfunction on QoL after SCI. METHODS: We searched five databases to identify research assessing the influence of NBD or B-AD on QoL after SCI. Metrics of bowel dysfunction (fecal incontinence [FI], constipation, time to complete, and B-AD) and QoL data were extracted and synthesised. Where possible, meta-analyses were performed. RESULTS: Our search identified 2042 titles, of which 39 met our inclusion criteria. Individuals with SCI identified problems with NBD (74.7%), FI (56.9%), and constipation (54.6%), and 49.3% of individuals with SCI > T6 experienced B-AD. Additionally, 40.3% of individuals experienced prolonged defecation ( > 30 min). Moderate/severe deterioration in QoL due to NBD was reported by 55.5% of individuals with SCI, with negative impacts on physical, emotional, and social health-related QoL associated with inflexibility of bowel routines, fear of accidents, and loss of independence. CONCLUSION: Bowel dysfunction and bowel care challenges are prevalent and disabling for individuals with SCI, with a profoundly negative impact on QoL. Improving bowel management is a key target to improve QoL for those living with SCI.

What is measured by the composite, single-item pain/discomfort dimension of the EQ-5D-5L? An exploratory analysis.

PURPOSE: This study examines the EQ-5D-5L pain/discomfort dimension by drawing comparisons with five other pain and discomfort items (pain severity, discomfort severity, pain frequency, discomfort frequency and pain interference) collected in the Australian psychometric study for the EQ Health and Wellbeing instrument. METHODS: Participants, recruited via a market research company, completed an online survey. Methods of analyses included the assessment of descriptive statistics, variation in reporting patterns using chi-square tests and cross-tabulations, correlation analyses, ordered univariate logistic regression, and discriminatory power analyses (Shannon index (H') and Shannon Evenness index (J')). RESULTS: Survey data from 514 participants were used. Compared with EQ-5D-5L pain/discomfort, there was a higher proportion of respondents reporting some level of impairment on at least one of the pain severity and discomfort severity items (74% versus 81%). Correlation with EQ-5D-5L pain/discomfort was strongest for pain severity (r = 0.83) and weakest for discomfort frequency (r = 0.41); the same inferences were drawn for predictive ability. Adding any additional pain or discomfort items to the EQ-5D-5L increased the absolute informativity (H') but not the relative informativity (J'). When replacing EQ-5D-5L pain/discomfort with separate pain and/or discomfort items - i.e., adding items to a modified 'EQ-4D-5L'-absolute informativity increased, while relative informativity increased only when pain interference and frequency-related items (independently or in combination) were added. CONCLUSION: The EQ-5D-5L pain/discomfort dimension captures aspects of pain more than aspects of discomfort. Potential reasons include the absence of descriptors or because pain is mentioned first in the composite item.

Sensitivity to change of generic preference-based instruments (EQ-5D-3L, EQ-5D-5L, and HUI3) in the context of treatment for people with prescription-type opioid use disorder in Canada.

PURPOSE: Using data from a randomized controlled trial for treatment of prescription-type opioid use disorder in Canada, this study examines sensitivity to change in three preference-based instruments [EQ-5D-3L, EQ-5D-5L, and the Health Utilities Index Mark 3 (HUI3)] and explores an oft-overlooked consideration when working with contemporaneous responses for similar questions-data quality. METHODS: Analyses focused on the relative abilities of three instruments to capture change in health status. Distributional methods were used to categorize individuals as 'improved' or 'not improved' for eight anchors (seven clinical, one generic). Sensitivity to change was assessed using area under the ROC (receiver operating characteristics) curve (AUC) analysis and comparisons of mean change scores for three time periods. A 'strict' data quality criteria, defined a priori, was applied. Analyses were replicated using 'soft' and 'no' criteria. RESULTS: Data from 160 individuals were used in the analysis; 30% had at least one data quality violation at baseline. Despite mean index scores being significantly lower for the HUI3 compared with EQ-5D instruments at each time point, the magnitudes of change scores were similar. No instrument demonstrated superior sensitivity to change. While six of the 10 highest AUC estimates were for the HUI3, 'moderate' classifications of discriminative ability were identified in 12 (of 22) analyses for each EQ-5D instrument, compared with eight for the HUI3. CONCLUSION: Negligible differences were observed between the EQ-5D-3L, EQ-5D-5L, and HUI3 regarding the ability to measure change. The prevalence of data quality violations-which differed by ethnicity-requires further investigation.

Generic preference-based health-related quality of life in children with neurodevelopmental disorders: a scoping review.

AIM: To describe how generic preference-based health-related quality of life (HRQoL) instruments have been used in research involving children with neurodevelopmental disorders (NDD). METHOD: A systematic search of nine databases identified studies that used generic preference-based HRQoL instruments in children with NDD. Data extracted following the Preferred Reporting Items for Systematic Review and Meta-Analyses extension for Scoping Review guidelines included type of NDD, instrument used, respondent type, justification, and critical appraisal for these selections. RESULTS: Thirty-six studies were identified: four cost-utility analyses; 15 HRQoL assessments; five economic burden studies; three intervention studies; and nine 'other'. The Health Utilities Index (Mark 2 and Mark 3) and EuroQoL 5D (EQ-5D; three-level EQ-5D, five-level EQ-5D, and the youth version of the EQ-5D) instruments were most frequently used (44% and 31% respectively). The relatively low use of these instruments overall may be due to a lack of psychometric evidence, inconsistency in justification for and lack of clarity on appropriate respondent type and age, and geographical challenges in applying preference weights. INTERPRETATION: This study highlights the dearth of studies using generic preference-based HRQoL instruments in children with NDD. The use of cost-utility analysis in this field is limited and validation of these instruments for children with NDD is needed. The quality of data should be considered before guiding policy and care decisions. WHAT THIS PAPER ADDS: Limited use of generic preference-based health-related quality of life (HRQoL) instruments in studies on children with neurodevelopmental disorders. Only 11% of studies were cost-utility analyses. Inconsistencies in justification for choosing generic preference-based HRQoL instruments and respondent types.

Disability discrimination and misdirected criticism of the quality-adjusted life year framework.

Whose values should count - those of patients or the general public - when adopting the quality-adjusted life year (QALY) framework for healthcare decision making is a long-standing debate. Specific disciplines, such as economics, are not wedded to a particular side of the debate, and arguments for and against the use of patient values have been discussed at length in the literature. In 2012, Sinclair proposed an approach, grounded within patient preference theory, which sought to avoid a perceived unfair discrimination against people with disabilities when using values from the general public. Key assumptions about general public values that beget this line of thinking were that 'disabled states always tally with lower quality of life', and the use of standardised instruments means that 'you are forced into a fixed view of disability as a lower value state' (Sinclair, 2012). Drawing on recent contributions to the health economics literature, we contend that such assumptions are not inherent to the incorporation of general public values for the estimation of QALYs. In practice, whether health states of people with disabilities are of 'lower value' is, to some extent, a reflection of the health state descriptions that members of the public are asked to value.

Prevalence of chronic pain among individuals with neurological conditions.

BACKGROUND: The prevalence of pain among people with a variety of individual neurological conditions has been estimated. However, information is limited about chronic pain among people with neurological conditions overall, and about the conditions for which chronic pain is most prevalent. To fill these information gaps, a common method of pain assessment is required. DATA AND METHODS: The data are from the Survey on Living with Neurological Conditions in Canada, a cross-sectional national survey. Based on self-reports, chronic pain was assessed for 16 neurological conditions. Multivariable logistic regression was used to produce odds ratios and 95% confidence intervals (CIs). RESULTS: Close to 1.5 million individuals aged 15 or older who lived in private households reported having been diagnosed with a neurological condition. The overall prevalence of chronic pain for the 16 neurological conditions combined was 36% (95% CI: 31% to 42%). The odds of chronic pain were significantly elevated among individuals with spinal cord trauma. DISCUSSION: Chronic pain is highly prevalent among people with neurological conditions, particularly those with spinal cord trauma. These results suggest a need to target health services and direct research to improved pain management, and thereby reduce the burden of neurological disease.

Framing of mobility items: a source of poor agreement between preference-based health-related quality of life instruments in a population of individuals receiving assisted ventilation.

PURPOSE: To explore the influence of descriptive differences in items evaluating mobility on index scores generated from two generic preference-based health-related quality of life (HRQoL) instruments. METHODS: The study examined cross-sectional data from a postal survey of individuals receiving assisted ventilation in two state/province-wide home mechanical ventilation services, one in British Columbia, Canada and the other in Victoria, Australia. The Assessment of Quality of Life 8-dimension (AQoL-8D) and the EQ-5D-5L were included in the data collection. Graphical illustrations, descriptive statistics, and measures of agreement [intraclass correlation coefficients (ICCs) and Bland-Altman plots] were examined using index scores derived from both instruments. Analyses were performed on the full sample as well as subgroups defined according to respondents' self-reported ability to walk. RESULTS: Of 868 individuals receiving assisted ventilation, 481 (55.4%) completed the questionnaire. Mean index scores were 0.581 (AQoL-8D) and 0.566 (EQ-5D-5L) with 'moderate' agreement demonstrated between the two instruments (ICC = 0.642). One hundred fifty-nine (33.1%) reported level 5 ('I am unable to walk about') on the EQ-5D-5L Mobility item. The walking status of respondents had a marked influence on the comparability of index scores, with a larger mean difference (0.206) and 'slight' agreement (ICC = 0.386) observed when the non-ambulant subgroup was evaluated separately. CONCLUSIONS: This study provides further evidence that between-measure discrepancies between preference-based HRQoL instruments are related in part to the framing of mobility-related items. Longitudinal studies are necessary to determine the responsiveness of preference-based HRQoL instruments in cohorts that include non-ambulant individuals.

Health state descriptions, valuations and individuals' capacity to walk: a comparative evaluation of preference-based instruments in the context of spinal cord injury.

PURPOSE: This study explores variation in health state descriptions and valuations derived from preference-based health-related quality of life instruments in the context of spinal cord injury (SCI). METHODS: Individuals living with SCI were invited to complete a web-based, cross-sectional survey. The survey comprised questions regarding demographics, SCI classifications and characteristics, secondary health complications and conditions, quality of life and SCI-specific functioning in activities of daily living. Four preference-based health status classification systems were included; Assessment of Quality of Life 8-dimension questionnaire (AQoL-8D), EQ-5D-5L, Health Utilities Index (HUI) and SF-6D (derived from the SF-36v2). In addition to descriptive comparisons of index scores and item/dimension responses, analyses explored dimension-level correlation and absolute agreement (intraclass correlation coefficient (ICC)). Subgroup analyses examined the influence of individuals' self-reported ability to walk. RESULTS: Of 609 invitations, 364 (60 %) individuals completed the survey. Across instruments, convergent validity was seen between pain and mental health dimensions, while sizeable variation pertaining to issues of mobility was observed. Mean index scores were 0.248 (HUI-3), 0.492 (EQ-5D-5L), 0.573 (AQoL-8D) and 0.605 (SF-6D). Agreement ranged from 'slight' (HUI-3 and SF-6D; ICC = 0.124) to 'moderate' (AQoL-8D and SF-6D; ICC = 0.634). Walking status had a markedly different impact on health state valuations across instruments. CONCLUSIONS: Variation in the way that individuals are able to describe their health state across instruments is not unique to SCI. Further research is necessary to understand the significant differences in index scores and, in particular, the implications of framing mobility-related questions in the context of respondents' ability to walk.

Joint protection and hand exercises for hand osteoarthritis: an economic evaluation comparing methods for the analysis of factorial trials.

OBJECTIVES: Evidence regarding the cost-effectiveness of joint protection and hand exercises for the management of hand OA is not well established. The primary aim of this study is to assess the cost-effectiveness (cost-utility) of these management options. In addition, given the absence of consensus regarding the conduct of economic evaluation alongside factorial trials, we compare different analytical methodologies. METHODS: A trial-based economic evaluation to assess the cost-utility of joint protection only, hand exercises only and joint protection plus hand exercises compared with leaflet and advice was undertaken over a 12 month period from a UK National Health Service perspective. Patient-level mean costs and mean quality-adjusted life years (QALYs) were calculated for each trial arm. Incremental cost-effectiveness ratios (ICERs) were estimated and cost-effectiveness acceptability curves were constructed. The base case analysis used a within-the-table analysis methodology. Two further methods were explored: the at-the-margins approach and a regression-based approach with or without an interaction term. RESULTS: Mean costs (QALYs) were £58.46 (s.d. 0.662) for leaflet and advice, £92.12 (s.d. 0.659) for joint protection, £64.51 (s.d. 0.681) for hand exercises and £112.38 (s.d. 0.658) for joint protection plus hand exercises. In the base case, hand exercises were the cost-effective option, with an ICER of £318 per QALY gained. Hand exercises remained the most cost-effective management strategy when adopting alternative methodological approaches. CONCLUSION: This is the first trial evaluating the cost-effectiveness of occupational therapy-supported approaches to self-management for hand OA. Our findings showed that hand exercises were the most cost-effective option.

Examining the relationship between health-related quality of life and increasing numbers of diagnoses.

PURPOSE: Little is known about estimating utilities for comorbid (or 'joint') health states. Several joint health state prediction models have been suggested (for example, additive, multiplicative, best-of-pair, worst-of-pair, etc.), but no general consensus has been reached. The purpose of the study is to explore the relationship between health-related quality of life (HRQoL) and increasing numbers of diagnoses. METHODS: We analyzed a large dataset containing respondents' ICD-9 diagnoses and preference-based HRQoL (EQ-5D and SF-6D). Data were stratified by the number of diagnoses, and mean HRQoL values were estimated. Several adjustments, accounting for the respondents' age, sex, and the severity of the diagnoses, were carried out. Our analysis fitted additive and multiplicative models to the data and assessed model fit using multiple standard model selection methods. RESULTS: A total of 39,817 respondents were included in the analyses. Average HRQoL values were represented well by both linear and multiplicative models. Although results across all analyses were similar, adjusting for severity of diagnoses, age, and sex strengthened the linear model's performance measures relative to the multiplicative model. Adjusted R (2) values were above 0.99 for all analyses (i.e., all adjusted analyses, for both HRQoL instruments), indicating a robust result. CONCLUSIONS: Additive and multiplicative models perform equally well within our analyses. A practical implication of our findings, based on the presumption that a linear model is simpler than an additive model, is that an additive model should be preferred unless there is compelling evidence to the contrary.

Pain location matters: the impact of leg pain on health care use, work disability and quality of life in patients with low back pain.

PURPOSE: In low back pain (LBP) patients, those with radiating leg pain or sciatica have poorer pain and disability outcomes. Few studies have assessed the effect of leg pain on health care use and quality of life. METHODS: Prospective cohort study of 1,581 UK LBP primary care consulters. Back pain, employment, health care utilisation, and quality of life (EQ-5D) data were collected at baseline, 6 and 12 months. At baseline, patients were classified as reporting (1) LBP only, (2) LBP and leg pain above the knee only (LBP + AK) or (3) LBP and leg pain extending below the knee (LBP + BK). RESULTS: Self-reported leg pain was common; at baseline 645 (41 %) reported LBP only, 392 (25 %) reported LBP + AK and 544 (34 %) reported LBP + BK. Patients with LBP + BK, compared to those with LBP only, were significantly more likely to be unemployed, take time off work, consult their family doctor, receive physical therapy, or be referred to other health care practitioners. There were statistically significant decrements in EQ-5D scores for LBP + AK compared to LBP only, and for LBP + BK compared to LBP + AK (p ≤ 0.05 for all comparisons). CONCLUSIONS: Patients with self-reported leg pain below the knee utilise more health care are more likely to be unemployed and have poorer quality of life than those with LBP only 12 months following primary care consultation. The presence of leg pain warrants early identification in primary care to explore if targeted interventions can reduce the impact and consequences of leg pain.

Comparison of contemporaneous EQ-5D and SF-6D responses using scoring algorithms derived from similar valuation exercises.

OBJECTIVES: Poor agreement between preference-based health-related quality-of-life instruments has been widely reported across patient and community-based samples. This study compares index scores generated from contemporaneous EQ-5D (3-level version) and SF-6D (SF-36 version) responses using scoring algorithms derived from independently-conducted Australian population-representative discrete choice experiments (DCEs), providing the first comparative analysis of health state valuations using the same method of valuation across the full value sets. METHODS: EQ-5D and SF-6D responses from seven patient data sets were transformed into health state valuations using published DCE-derived scoring algorithms. The empirical comparative evaluation consisted of graphical illustration of the location and spread of index scores, reporting of basic descriptive statistics, exploration of between-measure differences in mean index scores, and analysis of agreement. RESULTS: Compared with previously published findings regarding the comparability of "conventional" EQ-5D and SF-6D index scores, health state valuations from the DCE-derived scoring procedures showed that agreement between scores remained "fair" (intraclass correlation coefficient values across the seven data sets ranged from 0.375 to 0.615). Mean SF-6D scores were significantly lower than the respective mean EQ-5D score across all patient groups (mean difference for the whole sample = 0.253). CONCLUSIONS: The magnitude of disagreement previously reported between EQ-5D and SF-6D index scores is not ameliorated through the application of DCE-derived value sets; sizeable discrepancies remain. These findings suggest that differences between EQ-5D and SF-6D index scores persist because of their respective descriptive systems. Further research is required to explore the implications of variations in the descriptive systems of preference-based instruments.

Effect of stratified care for low back pain in family practice (IMPaCT Back): a prospective population-based sequential comparison.

PURPOSE: We aimed to determine the effects of implementing risk-stratified care for low back pain in family practice on physician's clinical behavior, patient outcomes, and costs. METHODS: The IMPaCT Back Study (IMplementation to improve Patient Care through Targeted treatment) prospectively compared separate patient cohorts in a preintervention phase (6 months of usual care) and a postintervention phase (12 months of stratified care) in family practice, involving 64 family physicians and linked physical therapy services. A total of 1,647 adults with low back pain were invited to participate. Stratified care entailed use of a risk stratification tool to classify patients into groups at low, medium, or high risk for persistent disability and provision of risk-matched treatment. The primary outcome was 6-month change in disability as assessed with the Roland-Morris Disability Questionnaire. Process outcomes captured physician behavior change in risk-appropriate referral to physical therapy, diagnostic tests, medication prescriptions, and sickness certifications. A cost-utility analysis estimated incremental quality-adjusted life-years and back-related health care costs. Analysis was by intention to treat. RESULTS: The 922 patients studied (368 in the preintervention phase and 554 in the postintervention phase) had comparable baseline characteristics. At 6 months follow-up, stratified care had a small but significant benefit relative to usual care as seen from a mean difference in Roland-Morris Disability Questionnaire scores of 0.7 (95% CI, 0.1-1.4), with a large, clinically important difference in the high risk group of 2.3 (95% CI, 0.8-3.9). Mean time off work was 50% shorter (4 vs 8 days, P = .03) and the proportion of patients given sickness certifications was 30% lower (9% vs 15%, P = .03) in the postintervention cohort. Health care cost savings were also observed. CONCLUSIONS: Stratified care for back pain implemented in family practice leads to significant improvements in patient disability outcomes and a halving in time off work, without increasing health care costs. Wider implementation is recommended.

Perceptions of individuals living with spinal cord injury toward preference-based quality of life instruments: a qualitative exploration.

BACKGROUND: Generic preference-based health-related quality of life instruments are widely used to measure health benefit within economic evaluation. The availability of multiple instruments raises questions about their relative merits and recent studies have highlighted the paucity of evidence regarding measurement properties in the context of spinal cord injury (SCI). This qualitative study explores the views of individuals living with SCI towards six established instruments with the objective of identifying 'preferred' outcome measures (from the perspective of the study participants). METHODS: Individuals living with SCI were invited to participate in one of three focus groups. Eligible participants were identified from Vancouver General Hospital's Spine Program database; purposive sampling was used to ensure representation of different demographics and injury characteristics. Perceptions and opinions were solicited on the following questionnaires: 15D, Assessment of Quality of Life 8-dimension (AQoL-8D), EQ-5D-5L, Health Utilities Index (HUI), Quality of Well-Being Scale Self-Administered (QWB-SA), and the SF-36v2. Framework analysis was used to analyse the qualitative information gathered during discussion. Strengths and limitations of each questionnaire were thematically identified and managed using NVivo 9 software. RESULTS: Major emergent themes were (i) general perceptions, (ii) comprehensiveness, (iii) content, (iv) wording and (v) features. Two sub-themes pertinent to content were also identified; 'questions' and 'options'. All focus group participants (n = 15) perceived the AQoL-8D to be the most relevant instrument to administer within the SCI population. This measure was considered to be comprehensive, with relevant content (i.e. wheelchair inclusive) and applicable items. Participants had mixed perceptions about the other questionnaires, albeit to varying degrees. CONCLUSIONS: Despite a strong theoretical underpinning, the AQoL-8D (and other AQoL instruments) is infrequently used outside its country of origin (Australia). Empirical comparative analyses of the favoured instruments identified in this qualitative study are necessary within the context of spinal cord injury.

Exploring psychometric properties of the SF-6D, a preference-based health-related quality of life measure, in the context of spinal cord injury.

PURPOSE: The validity of the SF-6D, a preference-based measure of health-related quality of life, is not well explored in the context of spinal cord injury (SCI). The aim of this analysis was to assess appropriate measurement properties of the SF-6D in a sample of individuals living with SCI. METHODS: Longitudinal data from the Rick Hansen Spinal Cord Injury Registry were used. Responses to the 36-item short-form health survey were transformed into SF-6D utility scores. We investigated practicality, floor and ceiling effects, and responsiveness to change. Responsiveness to change was explored using three different anchors that reflected changes in self-reported health, functional independence, and life satisfaction. Discriminative validity was assessed by ten a priori defined hypotheses, with a distinction made between 'strong' and 'weak' hypotheses. RESULTS: Three hundred and fifty-eight individuals with SCI were included in this analysis. Practicality was deemed acceptable based on a completion rate of 94%. The SF-6D showed low responsiveness to detect important health changes over time, and differences in responsiveness were found between individuals with paraplegia and tetraplegia. All five strong hypotheses and three weak hypotheses were confirmed. CONCLUSION: The SF-6D demonstrated good practicality and discriminative validity in this sample. The failure to detect self-reported and clinically important health changes requires further consideration. Comparative performance of the SF-6D (i.e., how the SF-6D performs against other preference-based measures) is unknown in the SCI context and requires further research.

Short Form health surveys and related variants in spinal cord injury research: a systematic review.

CONTEXT: 'Short Form' health surveys - such as the SF-36 and SF-12 - are widely used in medical research. Spinal cord injury (SCI) is no exception, despite oft-cited concerns regarding measurement properties for populations with physical impairment. OBJECTIVE: To provide a comprehensive overview of the use of Short Form health surveys and their variants within the SCI literature. METHODS: Papers published between database inception and September 2012 were identified from 11 electronic databases; a supplementary reference list search was also conducted. Data extraction focused on details regarding the range of different Short Form surveys and variants used in SCI research, the respective frequency of use, the nature of reporting (complete versus partial reporting) and the method of survey administration. RESULTS: One hundred seventy-four papers were identified. Thirty-six-item Short Form health surveys were frequently administered as complete instruments (n = 82); in 69 of these 82 studies (84%), it was not clearly stated which 36-item version had been used (e.g. SF-36v1, SF-36v2, RAND-36). Data for individual items and domains were often reported (29% of identified studies), indicating significant partial use of standardized measures. Modified variants of standardized health surveys were administered in 12 studies. CONCLUSION: Although standardized Short Form health surveys are common within SCI research, attempts to add, delete, or modify items have resulted in a number of variants, often with minimal supportive psychometric evidence. Using established, generic outcome measures is appealing for a number of reasons. However, validity is paramount and requires further explicit consideration within the SCI research community.

Impact of secondary health conditions on the quality of life and wellbeing of Canadians living with spinal cord injury: A comparison of preference-weighted index scores derived from generic standardized instruments.

CONTEXT/OBJECTIVES: To compare the assessment of the impact of secondary health conditions (SHCs) on the quality of life and wellbeing of Canadians living with spinal cord injury (SCI) using four preference-based outcome measures. DESIGN: Secondary analysis of data from a cross-sectional, online survey. SETTING: Community. PARTICIPANTS: Community-dwelling adults (n = 364) living with traumatic or non-traumatic spinal cord injury at least one year post-injury (70% at least 10 years post-injury). OUTCOME MEASURES: A modified version of the Spinal Cord Injury Secondary Conditions Scale (SCI-SCS); three health-related instruments (EQ-5D-5L, Health Utilities Index Mark 3 (HUI3), and the Assessment of Quality of Life 8-dimension questionnaire (AQoL-8D)) and a capability wellbeing instrument (ICEpop CAPability measure for Adults (ICECAP-A)). RESULTS: Across unadjusted and controlled analyses (i.e. controlling for associations between index scores and sociodemographic and impairment characteristics), trends were observed that identified lower levels of quality of life/wellbeing with higher problem ratings for each of the SHCs. Despite the trends, there was considerable variation in mean index scores across instruments, with HUI3 scores the lowest of the health-related instruments and ICECAP-A scores the highest overall. Respiratory problems, depression/mood problems, pressure sores, and autonomic dysreflexia were associated with the lowest levels of quality of life and wellbeing. CONCLUSIONS: Higher problem ratings for SHCs are negatively associated with scores derived from preference-based quality of life and wellbeing instruments. Variation in index scores across instruments - including across the health-related instruments alone - highlights the critical importance of assessing the relative merits of preference-based instruments when using (or considering using) these instruments/estimates in comparative effectiveness research and economic evaluation.

Unravelling the Self-Report Versus Proxy-Report Conundrum for Older Aged Care Residents: Findings from a Mixed-Methods Study.

OBJECTIVES: No guidance currently exists as to the cognition threshold beyond which self-reported quality of life for older people with cognitive impairment and dementia is unreliable. METHODS: Older aged care residents (≥ 65 years) were randomly assigned to complete the EQ-5D-5L in computer-based (eye movements were tracked) or hard copy (participants were encouraged to 'think aloud') format. Cognition was assessed using the Mini-Mental State Examination (MMSE). Think aloud and eye tracking data were analysed by two raters, blinded to MMSE scores. At the participant level, predefined criteria were used to assign traffic light grades (green, amber, red). These grades indicate the extent to which extracted data elements provided evidence of self-report reliability. The MMSE-defined cognition threshold was determined following review of the distributions of assigned traffic light grades. RESULTS: Eighty-one residents participated and provided complete data (38 eye tracking, 43 think aloud). In the think aloud cohort, all participants with an MMSE score ≤ 23 (n = 10) received an amber or red grade, while 64% of participants with an MMSE score ≥ 24 (21 of 33) received green grades. In the eye tracking cohort, 68% of participants with an MMSE score ≥ 24 (15 of 22) received green grades. Of the 16 eye tracking participants with an MMSE score ≤ 23, 14 (88%) received an amber or red grade. CONCLUSIONS: Most older residents with an MMSE score ≥ 24 have sufficient cognitive capacity to self-complete the EQ-5D-5L. More research is needed to better understand self-completion reliability for other quality-of-life instruments in cognitively impaired populations.

Exploring the Use of Pictorial Approaches in the Development of Paediatric Patient-Reported Outcome Instruments: A Systematic Review.

INTRODUCTION: Children may find self-reporting health-related quality of life (HRQoL) using patient-reported outcome measures (PROMs) presented in text-based formats difficult, particularly younger children and children with developmental delays or chronic illness. In such cases, pictorial PROMs (where pictorial representations are used alongside or to replace text) may offer a valid alternative. AIM: This systematic literature review focused on identifying and describing paediatric PROMs that incorporate pictorial approaches, providing children with more effective means to express their HRQoL. METHODS: Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed. Seven electronic databases were searched from inception to 1 March 2022. There were no country restrictions applied to the search; all English-language studies were considered for inclusion in the review. Characteristics and development methods of the identified pictorial PROMs were evaluated against context-specific good practice guidelines published by The Professional Society for Health Economics and Outcomes Research (ISPOR). RESULTS: A total of 22 paediatric pictorial PROMs, comprising 28 unique versions, were identified. These PROMs were predominantly developed in the USA and the UK, targeting children aged 3-18 years. Likert scales with pictorial anchors, particularly happy-sad faces, were commonly used for response options, appearing in 15 (54%) of the PROMs. Various graphic methods, such as happy-sad faces, cartoons, and thermometers, were adapted to specific content domains. These PROMs covered a wide range of domains, including physical and emotional health and social functioning. Emphasis was placed on content validity, including active child participation in developing pictorial elements. Notably, children's participation was sought during the development of the pictorial elements for 13 (46%) of the PROMs. Various development methods were employed, with 43% of paediatric PROMs using literature reviews, 43% using focus groups, and 32% involving expert consultation. Interviews emerged as the primary method, being employed in 61% of the studies. Additionally, three measures specifically addressed cross-cultural considerations. CONCLUSION: Paediatric pictorial PROMs offer child-friendly tools for assessing HRQoL for application with children who find reading and understanding text-based PROMs challenging. There is some evidence that pictorial PROMs facilitate self-report in this population and improve measurement properties compared to text-only PROMs. Further research is needed to develop, validate, and test paediatric pictorial PROMs, with an emphasis on including children from the inception in the co-design process.