Jeanne A. Teresi

Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Scale Presentation and Clinimetric Testing Results

We present a clinimetric assessment of the Movement Disorder Society (MDS)‐sponsored revision of the Unified Parkinsons Disease Rating Scale (MDS‐UPDRS). The MDS‐UDPRS Task Force revised and expanded the UPDRS using recommendations from a published critique. The MDS‐UPDRS has four parts, namely, I: Non‐motor Experiences of Daily Living; II: Motor Experiences of Daily Living; III: Motor Examination; IV: Motor Complications. Twenty questions are completed by the patient/caregiver. Item‐specific instructions and an appendix of complementary additional scales are provided. Movement disorder specialists and study coordinators administered the UPDRS (55 items) and MDS‐UPDRS (65 items) to 877 English speaking (78% non‐Latino Caucasian) patients with Parkinsons disease from 39 sites. We compared the two scales using correlative techniques and factor analysis. The MDS‐UPDRS showed high internal consistency (Cronbachs alpha = 0.79–0.93 across parts) and correlated with the original UPDRS (ρ = 0.96). MDS‐UPDRS across‐part correlations ranged from 0.22 to 0.66. Reliable factor structures for each part were obtained (comparative fit index > 0.90 for each part), which support the use of sum scores for each part in preference to a total score of all parts. The combined clinimetric results of this study support the validity of the MDS‐UPDRS for rating PD.

Psychometric evaluation and calibration of health-related quality of life item banks: Plans for the Patient-Reported Outcomes Measurement Information System (PROMIS)

Background:The construction and evaluation of item banks to measure unidimensional constructs of health-related quality of life (HRQOL) is a fundamental objective of the Patient-Reported Outcomes Measurement Information System (PROMIS) project. Objectives:Item banks will be used as the foundation for developing short-form instruments and enabling computerized adaptive testing. The PROMIS Steering Committee selected 5 HRQOL domains for initial focus: physical functioning, fatigue, pain, emotional distress, and social role participation. This report provides an overview of the methods used in the PROMIS item analyses and proposed calibration of item banks. Analyses:Analyses include evaluation of data quality (eg, logic and range checking, spread of response distribution within an item), descriptive statistics (eg, frequencies, means), item response theory model assumptions (unidimensionality, local independence, monotonicity), model fit, differential item functioning, and item calibration for banking. Recommendations:Summarized are key analytic issues; recommendations are provided for future evaluations of item banks in HRQOL assessment.

The Daily Spiritual Experience Scale: Development, Theoretical Description, Reliability, Exploratory Factor Analysis, and Preliminary Construct Validity Using Health-Related Data

Spirituality and religiousness are gaining increasing attention as health research variables. However, the particular aspects examined vary from study to study, ranging from church attendance to religious coping to meaning in life. This frequently results in a lack of clarity regarding what is being measured, the meaning of the relationships between health variables and spirituality, and implications for action. This article describes the Daily Spiritual Experience Scale (DSES) and its development, reliability, exploratory factor analyses, and preliminary construct validity. Normative data from random samples and preliminary relationships of health-related data with the DSES also are included. Detailed data for the 16-item DSES are provided from two studies; a third study provided data on a subset of 6 items, and a fourth study was done on the interrater reliability of the item subset. A 6-item version was used in the General Social Survey because of the need to shorten the measure for the survey. A rationale for the conceptual underpinnings and item selection is provided, as are suggested pathways for linkages to health and well-being. This scale addresses reported ordinary experiences of spirituality such as awe, joy that lifts one out of the mundane, and a sense of deep inner peace. Studies using the DSES may identify ways in which this element of life may influence emotion, cognition and behavior, and health or ways in which this element may be treated as an outcome in itself, a particular component of well-being. The DSES evidenced good reliability across several studies with internal consistency estimates in the .90s. Preliminary evidence showed that daily spiritual experience is related to decreased total alcohol intake, improved quality of life, and positive psychosocial status.

Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Process, format, and clinimetric testing plan.

This article presents the revision process, major innovations, and clinimetric testing program for the Movement Disorder Society (MDS)–sponsored revision of the Unified Parkinsons Disease Rating Scale (UPDRS), known as the MDS‐UPDRS. The UPDRS is the most widely used scale for the clinical study of Parkinsons disease (PD). The MDS previously organized a critique of the UPDRS, which cited many strengths, but recommended revision of the scale to accommodate new advances and to resolve problematic areas. An MDS‐UPDRS committee prepared the revision using the recommendations of the published critique of the scale. Subcommittees developed new material that was reviewed by the entire committee. A 1‐day face‐to‐face committee meeting was organized to resolve areas of debate and to arrive at a working draft ready for clinimetric testing. The MDS‐UPDRS retains the UPDRS structure of four parts with a total summed score, but the parts have been modified to provide a section that integrates nonmotor elements of PD: I, Nonmotor Experiences of Daily Living; II, Motor Experiences of Daily Living; III, Motor Examination; and IV, Motor Complications. All items have five response options with uniform anchors of 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. Several questions in Part I and all of Part II are written as a patient/caregiver questionnaire, so that the total rater time should remain approximately 30 minutes. Detailed instructions for testing and data acquisition accompany the MDS‐UPDRS in order to increase uniform usage. Multiple language editions are planned. A three‐part clinimetric program will provide testing of reliability, validity, and responsiveness to interventions. Although the MDS‐UPDRS will not be published until it has successfully passed clinimetric testing, explanation of the process, key changes, and clinimetric programs allow clinicians and researchers to understand and participate in the revision process.

An essay on measurement and factorial invariance.

Background:Analysis of subgroups such as different ethnic, language, or education groups selected from among a parent population is common in health disparities research. One goal of such analyses is to examine measurement equivalence, which includes both qualitative review of the meaning of items as well as quantitative examination of different levels of factorial invariance and differential item functioning. Objectives:The purpose of this essay is to review the definitions and assumptions associated with factorial invariance, placing this formulation in the context of bias, fairness, and equity. The connection between the concepts of factorial invariance and item bias (differential item functioning) using a variant of item response theory is discussed. The situations under which different forms of invariance (weak, strong, and strict) are required are discussed. Methods:Establishing factorial invariance involves a hierarchy of levels that include tests of weak, strong, and strict invariance. Pattern (metric or weak) factorial invariance implies that the regression slopes are invariant across groups. Pattern invariance requires only invariant factor loadings. Strong factorial invariance implies that the conditional expectation of the response, given the common and specific factors, is invariant across groups. Strong factorial invariance requires that specific factor means (represented as invariant intercepts) also be identical across groups. Strict factorial invariance implies that, in addition, the conditional variance of the response, given the common and specific factors, is invariant across groups. Strict factorial invariance requires that, in addition to equal factor loadings and intercepts, the residual (specific factor plus error variable) variances are equivalent across groups. The concept of measurement invariance that is most closely aligned to that of item response theory considers the latent variable as a common factor measured by manifest variables; the specific factors can be characterized as nuisance variables. Conclusions:Invariance of factor loadings across studied groups is required for valid comparisons of scale score or latent variable means. Strong and strict invariance may be less important in the context of basic research in which group differences in specific factors are indicative of individual differences that are important for scientific exploration. However, for most applications in which the aim is to ensure fairness and equity, strict factorial invariance is required. Health disparities research often focuses on self-reported clinical outcomes such as quality of life that are not observed directly. Latent variable models such as factor analyses are central to establishing valid assessment of such outcomes.

A Randomized Trial Comparing Telemedicine Case Management with Usual Care in Older, Ethnically Diverse, Medically Underserved Patients with Diabetes Mellitus

BACKGROUND Telemedicine is a promising but largely unproven technology for providing case management services to patients with chronic conditions who experience barriers to access to care or a high burden of illness. METHODS The authors conducted a randomized, controlled trial comparing telemedicine case management to usual care, with blinding of those obtaining outcome data, in 1,665 Medicare recipients with diabetes, aged 55 years or greater, and living in federally designated medically underserved areas of New York State. The primary endpoints were HgbA1c, blood pressure, and low-density lipoprotein (LDL) cholesterol levels. RESULTS In the intervention group (n = 844), mean HgbA1c improved over one year from 7.35% to 6.97% and from 8.35% to 7.42% in the subgroup with baseline HgbA1c > or =7% (n = 353). In the usual care group (n = 821) mean HgbA1c improved over one year from 7.42% to 7.17%. Adjusted net reductions (one-year minus baseline mean values in each group, compared between groups) favoring the intervention were as follows: HgbA1c, 0.18% (p = 0.006), systolic and diastolic blood pressure, 3.4 (p = 0.001) and 1.9 mm Hg (p < 0.001), and LDL cholesterol, 9.5 mg/dL (p < 0.001). In the subgroup with baseline HgbA1c > or =7%, net adjusted reduction in HgbA1c favoring the intervention group was 0.32% (p = 0.002). Mean LDL cholesterol level in the intervention group at one year was 95.7 mg/dL. The intervention effects were similar in magnitude in the subgroups living in New York City and upstate New York. CONCLUSION Telemedicine case management improved glycemic control, blood pressure levels, and total and LDL cholesterol levels at one year of follow-up.

Prevalence of depression and depression recognition in nursing homes

Background The aim of this study was to estimate the prevalence of depression among nursing home residents, and the extent of depression recognition among nursing home staff. Random samples totaling 319 nursing home residents, drawn from a simple random sample of six downstate New York nursing homes were evaluated psychiatrically for depression. Samples of nurse aides, nurses and social workers also assessed the same residents for the presence of depressive symptomatology. Method Psychiatrists assessed residents using the Diagnostic and Statistical Manual of Mental Disorders (DSM-III-R) criteria. Depression measures used were the Cornell Scale for Depression in Dementia, the Feeling Tone Questionnaire, the Hamilton Depression Rating and the Structured Clinical Interview for DSM-III-R Personality Disorders Scale. Nursing and social services staff assessed residents using Depression Recognition Measures. Results Based on psychiatric evaluation, the prevalence estimate for probable and/or definite major depressive disorder among testable subjects was 14.4 % (95 % CI of 10.6 %–19.3 %); 15.4 % were not able to be assessed due to their refusal, impairment of consciousness, or severe physical illness. The estimate for minor depression was 16.8 % (95 % CI of 12.6 %–21.9 %). The prevalence of significant depressive symptomatology (including the category of possible depression) was 44.2 % (95 % CI of 38.2 %–50.3 %). The corresponding estimates of any depression were 19.7 % for social workers, 29 % for nurses and 32.1 % for nurse aides. Conclusions The prevalence of depressive disorders among nursing home residents is high; depression recognition is relatively low, with only 37 %–45 % of cases diagnosed by psychiatrists recognized as depressed by staff. A structured Depression Recognition Scale increased the rates of recognition (sensitivity of staff ratings) to 47 %–55 %, demonstrating the utility of the scale in increasing awareness of symptomatology.

A Randomized Trial Comparing Telemedicine Case Management with Usual Care in Older, Ethnically Diverse, Medically Underserved Patients with Diabetes Mellitus: 5 Year Results of the IDEATel Study

CONTEXT Telemedicine is a promising but largely unproven technology for providing case management services to patients with chronic conditions and lower access to care. OBJECTIVES To examine the effectiveness of a telemedicine intervention to achieve clinical management goals in older, ethnically diverse, medically underserved patients with diabetes. DESIGN, Setting, and Patients A randomized controlled trial was conducted, comparing telemedicine case management to usual care, with blinded outcome evaluation, in 1,665 Medicare recipients with diabetes, aged >/= 55 years, residing in federally designated medically underserved areas of New York State. Interventions Home telemedicine unit with nurse case management versus usual care. Main Outcome Measures The primary endpoints assessed over 5 years of follow-up were hemoglobin A1c (HgbA1c), low density lipoprotein (LDL) cholesterol, and blood pressure levels. RESULTS Intention-to-treat mixed models showed that telemedicine achieved net overall reductions over five years of follow-up in the primary endpoints (HgbA1c, p = 0.001; LDL, p < 0.001; systolic and diastolic blood pressure, p = 0.024; p < 0.001). Estimated differences (95% CI) in year 5 were 0.29 (0.12, 0.46)% for HgbA1c, 3.84 (-0.08, 7.77) mg/dL for LDL cholesterol, and 4.32 (1.93, 6.72) mm Hg for systolic and 2.64 (1.53, 3.74) mm Hg for diastolic blood pressure. There were 176 deaths in the intervention group and 169 in the usual care group (hazard ratio 1.01 [0.82, 1.24]). CONCLUSIONS Telemedicine case management resulted in net improvements in HgbA1c, LDL-cholesterol and blood pressure levels over 5 years in medically underserved Medicare beneficiaries. Mortality was not different between the groups, although power was limited. Trial Registration http://clinicaltrials.gov Identifier: NCT00271739.

Differential item functioning and health assessment

Establishing measurement equivalence is important because inaccurate assessment may lead to incorrect estimates of effects in research, and to suboptimal decisions at the individual, clinical level. Examination of differential item functioning (DIF) is a method for studying measurement equivalence. An item (i.e., one question in a longer scale) exhibits DIF if the item response differs across groups (e.g., gender, race), controlling for an estimate of the construct being measured. A distinction between applications in health, as contrasted with other settings such as educational and aptitude testing, is that there are many health-related constructs and multiple measures of each, few of which have received much critical evaluation. Discussed in this article are several methods for detection of differential item functioning (DIF), including non-parametric and parametric methods such as logistic regression, and those based on item response theory. Basic definitions and criteria for DIF detection are provided, as are steps in performing the analyses. Recommendations are presented and future directions discussed.

Columbia University's Informatics for Diabetes Education and Telemedicine (IDEATel) Project: rationale and design.

The Columbia University Informatics for Diabetes Education and Telemedicine (IDEATel) Project is a four-year demonstration project funded by the Centers for Medicare and Medicaid Services with the overall goals of evaluating the feasibility, acceptability, effectiveness, and cost-effectiveness of telemedicine in the management of older patients with diabetes. The study is designed as a randomized controlled trial and is being conducted by a state-wide consortium in New York. Eligibility requires that participants have diabetes, are Medicare beneficiaries, and reside in federally designated medically underserved areas. A total of 1,500 participants will be randomized, half in New York City and half in other areas of the state. Intervention participants receive a home telemedicine unit that provides synchronous videoconferencing with a project-based nurse, electronic transmission of home fingerstick glucose and blood pressure data, and Web access to a project Web site. End points include glycosylated hemoglobin, blood pressure, and lipid levels; patient satisfaction; health care service utilization; and costs. The project is intended to provide data to help inform regulatory and reimbursement policies for electronically delivered health care services.