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Psychometric evaluation of the PROMIS® physical function short form 12a for use by adults with myalgic encephalomyelitis/chronic fatigue syndrome
Background
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a debilitating, long-term illness that significantly impairs physical functioning. Despite its impact, the use of modern generic instruments to assess physical function in this population remains underexplored. This study aims to assess the psychometric properties of the Patient-Reported Outcome Measurement Information System
®
(PROMIS) Physical Function Short Form (PF-SF) 12a for use in adults with ME/CFS.
Methods
This study included 334 participants (173 with ME/CFS and 161 healthy controls) who took part in a Cognitive and Exercise sub-study of the Multi-Site Clinical Assessment of ME/CFS study from six clinics across the US. Data was used to examine the ceiling/floor effects, internal consistency reliability, known-groups validity, and convergent validity of the PROMIS PF-SF.
Results
The mean T-score of the PROMIS PF-SF was 40.5 for participants with ME/CFS, about one standard deviation below the national norm (T-score = 50). The PROMIS PF-SF showed no substantial floor/ceiling effects and high internal consistency (standardized Cronbach’s α = 0.88 and ω = 0.92). In addition, this instrument showed good known-groups validity with medium-to-large effect sizes (η
2
= 0.08–0.35). A significant, monotonic increase of the physical function score was found across ME/CFS participant groups with low, medium, and high functional impairment as defined by four different measures. Participants with ME/CFS had significantly worse physical function scores than healthy controls (η
2
= 0.70). The PROMIS PF-SF also demonstrated good convergent validity with high correlations (magnitude of
r
= 0.47–0.55) with other relevant measures.
Conclusions
The PROMIS PF-SF 12a demonstrated satisfactory reliability and validity for use in ME/CFS research and clinical practice.
Journal Article
Signs and wonders : the photographs of John Beasley Greene
\"This book features the vintage archaeological photography of John Beasley Greene, one of the first photographers in Egypt and Algeria.\" --publisher's description, dust jacket.
Book
Sensitivity of alternative measures of functioning and wellbeing for adults with sickle cell disease: comparison of PROMIS® to ASCQ-Me
Background
Sickle Cell Disease (SCD) causes profound suffering and decrements in daily functioning. Demand is growing for valid and reliable measures to systematically document these effects, particularly in adults. The Adult Sickle Cell Quality of Life Measurement System, ASCQ-Me℠, was developed for this purpose. ASCQ-Me℠ is one of four measurement systems housed within the Person–Centered Assessment Resource (PCAR), funded by the National Institutes of Health, to support clinical research. To help users select the best of these measures for adults with SCD, we evaluated and compared two PCAR systems: one designed to be “universally applicable” (the Patient-Reported Outcome Measurement Information System, PROMIS®) and one designed specifically for SCD (ASCQ-Me℠).
Methods
Respondents to PROMIS and ASCQ-Me questions were 490 adults with SCD from seven geographically-disbursed clinics within the US. Data were collected for six ASCQ-Me measures (Emotional Impact, Sleep Impact, Social Impact, Stiffness Impact, Pain Impact, SCD Pain Episode Frequency and Severity) and ten PROMIS measures (Pain Impact, Pain Behavior, Physical Functioning, Anxiety, Depression, Fatigue, Satisfaction with Discretionary Social Activities, Satisfaction with Social Roles, Sleep Disturbance, and Sleep-Related Impairment). Statistical analyses, including analysis of variance and multiple linear regression, were conducted to determine the sensitivity of measures to SCD severity. SCD severity was assessed via a checklist of associated treatments and conditions.
Results
For those with the most severe SCD, PROMIS scores showed worse health compared to the general population for nine of ten health domains: the magnitude of the difference ranged 0.5 to 1.1 standard deviation units. The PROMIS domains most severely affected were Physical Functioning and Pain (Impact and Behavior). Significant differences by tertile of the SCD-MHC were shown for most PROMIS short forms and all ASCQ-Me short and fixed forms. In most models, ASCQ-Me measures explained statistically significant unique variance in SCD-MHC scores complementary to that explained by corresponding PROMIS measures.
Conclusions
Study results supported the validity of both PROMIS and ASCQ-Me measures for use in adults with SCD. Compared to comparable PROMIS scores, most ASCQ-Me scores were better predictors of SCD disease severity, as measured by a medical history checklist. The clinical implications of these results require further investigation.
Journal Article
Patient reports of health outcome for adults living with sickle cell disease: development and testing of the ASCQ-Me item banks
Background
Providers and patients have called for improved understanding of the health care requirements of adults with sickle cell disease (SCD) and have identified the need for a systematic, reliable and valid method to document the patient-reported outcomes (PRO) of adult SCD care. To address this need, the Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) was designed to complement the Patient Reported Outcome Measurement Information System (PROMIS®). Here we describe methods and results of the psychometric evaluation of ASCQ-Me item banks (IBs).
Methods
At seven geographically-disbursed clinics within the US, 556 patients responded to questions generated to assess cognitive, emotional, physical and social impacts of SCD. We evaluated the construct validity of the hypothesized domains using exploratory factor analysis (EFA), parallel analysis (PA), and bi-factor analysis (Item Response Theory Graded Response Model, IRT-GRM). We used IRT-GRM and the Wald method to identify bias in responses across gender and age. We used IRT and Cronbach’s alpha coefficient to evaluate the reliability of the IBs and then tested the ability of summary scores based on IRT calibrations to discriminate among tertiles of respondents defined by SCD severity.
Results
Of the original 140 questions tested, we eliminated 48 that either did not form clean factors or provided biased measurement across subgroups defined by age and gender. Via EFA and PA, we identified three subfactors within physical impact: sleep, pain and stiffness impacts. Analysis of the resulting six item sets (sleep, pain, stiffness, cognitive, emotional and social impacts of SCD) supported their essential unidimensionality. With the exception of the cognitive impact IB, these item sets also were highly reliable across a broad range of values and highly significantly related to SCD disease severity.
Conclusion
ASCQ-Me pain, sleep, stiffness, emotional and social SCD impact IBs demonstrated exceptional measurement properties using modern and classical psychometric methods of evaluation. Further development of the cognitive impact IB is required to improve its sensitivity to differences in SCD disease severity. Future research will evaluate the sensitivity of the ASCQ-Me IBs to change in SCD disease severity over time due to health interventions.
Journal Article
Comparison of two rating scales with the orofacial esthetic scale and practical recommendations for its application
Purpose
We compared measurement properties of 5-point and 11-point response formats for the orofacial esthetic scale (OES) items to determine whether collapsing the format would degrade OES score precision.
Methods
Data were collected from a consecutive sample of adult dental patients from HealthPartners dental clinics in Minnesota (N = 2,078). We fitted an Item Response Theory (IRT) model to the 11-point response format and the six derived 5-point response formats. We compared all response formats using test (or scale) information, correlation between the IRT scores, Cronbach’s alpha estimates for each scaling format, correlations based on the observed scores for the seven OES items and the eighth global item, and the relationship of observed and IRT scores to an external criterion using orofacial appearance (OA) indicators from the Oral Health Impact Profile (OHIP).
Results
The correlations among scores based on the different response formats were uniformly high for observed (0.97–0.99) and IRT scores (0.96–0.99); as were correlations of both observed and IRT scores and the OHIP measure of OA (0.66–0.68). Cronbach’s alpha based on any of the 5-point formats (α = 0.95) was nearly the same as that based on the 11-point format (α = 0.96). The weighted total information area for five of six derived 5-point response formats was 98% of that for the 11-point response format.
Conclusions
Our results support the use of scores based on a 5-point response format for the OES items. The measurement properties of scores based on a 5-point response format are comparable to those of scores based on the 11-point response format.
Journal Article
Should the frequency, severity, or both response scales be used for multi-item dental patient-reported outcome measures?
The Oral Impacts on Daily Performances (OIDP) index asks the respondents to indicate both, the frequency and severity of the impact. However, it is not clear if the two scaling methods are correlated, and if using one scale is sufficient. The purpose of the study was to investigate the correlation between frequency and severity rating scales of the OIDP instrument, and whether only one of the rating scales can be used instead of both.
A battery of patient-reported outcome questionnaires were administered to a consecutive sample of adult dental patients from HealthPartners dental clinics in Minnesota (
= 2,115). Only those who responded to any of the OIDP items were included in the analysis for this study (
= 873). We assessed correlations between the frequency and severity scales for all OIDP items, and for the summary scores of the two OIDP response scales. We additionally fit a categorical structural equation model (SEM) (or an item factor analysis model) and examined the correlation between two latent variables (Frequency and Severity).
The correlation estimates for all OIDP items were greater than 0.50, indicating large correlations between the frequency and severity scores for each OIDP item. The correlation estimate between the two summary scores was 0.85 (95% CI [0.82-0.86]). When we calculated the correlation coefficient using a latent variable model, the value increased to 0.96 (95% CI [0.93-1.00]).
Our study findings show that OIDP frequency and severity scores are highly correlated, which indicates the use of one scale only. Based on previous evidence, we recommend applying the frequency rating scale only in research and clinical settings.
Journal Article
Giving Voice to the Vulnerable: The Development of a CAHPS Nursing Home Survey Measuring Family Members' Experiences
Background: To complement a nursing home resident survey, the team developed a survey asking family members about their experiences with nursing homes. Although a family member does not receive care directly from a nursing home, their experiences at the nursing home and with staff can contribute to understanding nursing home quality. Objectives: To describe how the nursing home family member instrument was developed, refined, tested, and finalized. Research Design: The team developed a draft survey using information from a literature review, 12 focus groups with family members involved in choosing a nursing home for someone, review of nursing home surveys, and expert/stakeholder input. The survey went through 2 rounds of cognitive interviews (n= 54) and revisions and was fielded in 15 nursing homes. Data from the pilot survey (n = 885) were subjected to psychometric analyses to evaluate the measurement properties of items as well as the reliability and validity of the resulting composites. On the basis of these analyses and input from experts, the survey was finalized. Results: Focus groups and experts provided input into discerning important indicators of quality, although in some cases family members were not the best sources of information. Cognitive testing refined the survey and eliminated some of the proxy items. The field test analysis and input from experts eliminated 10 items. The final survey included 21 items organized into 4 composites. Conclusions: This survey measures family members' experiences of nursing home care, and the results contribute to the understanding of quality of care in nursing homes.
Journal Article
Sleep Problems, Health-Related Quality of Life, Work Functioning and Health Care Utilization among the Chronically Ill
Objectives: To provide a comprehensive assessment of whether sleep problems among the chronically ill are associated with decrements in functional health and well-being, decreases in work functioning and increases in the use of health care services. Design: Cross-sectional survey of patients from the Medical Outcomes Study (MOS), an observational study of functional health and well-being. Chronically ill patients (n = 3484) were sampled from health maintenance organizations, large multi-specialty groups, and solo or single-specialty group practices in Boston, Los Angeles, and Chicago. Chronic illness subgroups include: clinical depression (n = 527), congestive heart failure (229), diabetes (n = 577), recent myocardial infarction (n = 170), hypertension (n = 2206), asthma (n = 84), back problems (n = 771), and arthritis (n = 672). ANCOVA analyses of the relationship between sleep problems and SF-36 scales and summaries were performed. In addition, a 'relative impact' analysis determined what scales or summaries were most associated with sleep problems. Main outcome measures: Eight scales and two summary measures from the SF-36 Health Survey, work productivity and work quality measures and self-reports of health care utilization. Results: Comparing chronically ill patients with no sleep problems to those with mild, moderate, or severe sleep problems revealed a direct association between sleep problems and decrements in health-related quality of life (HRQOL) as measured by SF-36 scales and summaries (MANOVA F 24.1; d.f. 24; p ≤ 0.0001). In addition, significant differences in HRQOL were found when comparing patients with and without sleep problems within most of the disease groups studied. The relative impact analysis revealed that measures of mental health and the mental health summary were most associated with sleep problem severity in the total sample and chronic disease subsets, in comparison with measures of physical health. In addition, monotonic relationships were found between severity of sleep problems and decreases in work productivity and increases in health care utilization, as expected. Conclusions: The analyses revealed that sleep problems go hand in hand with poorer mental health, diminished work productivity and work quality and greater use of health care services. Sleep problems, therefore, may be a significant confounding factor in the interpretation of health outcomes among patients with chronic diseases.
Journal Article
Assessing sleep and pain among adults with myalgic encephalomyelitis/chronic fatigue syndrome
Purpose
To evaluate the psychometric properties of the patient-reported outcome measurement information system® (PROMIS) short forms for assessing sleep disturbance, sleep-related impairment, pain interference, and pain behavior, among adults with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
Methods
Data came from the Multi-Site ME/CFS study conducted between 2012 and 2020 at seven ME/CFS specialty clinics across the USA. Baseline and follow-up data from ME/CFS and healthy control (HC) groups were used to examine ceiling/floor effects, internal consistency reliability, differential item functioning (DIF), known-groups validity, and responsiveness.
Results
A total of 945 participants completed the baseline assessment (602 ME/CFS and 338 HC) and 441 ME/CFS also completed the follow-up. The baseline mean T-scores of PROMIS sleep and pain measures ranged from 57.68 to 62.40, about one standard deviation above the national norm (T-score = 50). All four measures showed high internal consistency (
ω
= 0.92 to 0.97) and no substantial floor/ceiling effects. No DIF was detected by age or sex. Known-groups comparisons among ME/CFS groups with low, medium, and high functional impairment showed significant small-sized differences in scores (
η
2
= 0.01 to 0.05) for the two sleep measures and small-to-medium-sized differences (
η
2
= 0.01 to 0.15) for the two pain measures. ME/CFS participants had significantly worse scores than HC (
η
2
= 0.35 to 0.45) for all four measures. Given the non-interventional nature of the study, responsiveness was evaluated as sensitivity to change over time and the pain interference measure showed an acceptable sensitivity.
Conclusion
The PROMIS sleep and pain measures demonstrated satisfactory psychometric properties supporting their use in ME/CFS research and clinical practice.
Journal Article