Development of Clinician-Reported Outcome (ClinRO) and Patient-Reported Outcome (PRO) Measures for Eyebrow, Eyelash and Nail Assessment in Alopecia Areata.

BACKGROUND: Eyebrow and eyelash hair loss and nail damage-in addition to scalp hair loss-are important signs/symptoms of alopecia areata (AA) to patients and deserve assessment in AA clinical trials. OBJECTIVES: Our objective was to develop clinician-reported outcome (ClinRO) and patient-reported outcome (PRO) measures and accompanying photoguides to aid in the assessment of AA-related eyebrow, eyelash and nail signs/symptoms. METHODS: Iterative rounds of qualitative, semi-structured interviews were conducted with US expert dermatologists and North American patients with AA. Patients with eyebrow, eyelash and nail involvement were purposefully sampled. Interview transcripts were qualitatively analyzed. RESULTS: Dermatologists (n = 10) described eyebrow and eyelash loss as concerning for affected patients and, along with nail appearance, as deserving assessment. Dermatologist data informed the development of single item, 4-point Likert-type ClinRO and PRO measures of current eyebrow loss, eyelash loss and nail appearance and a PRO measure of eye irritation. Patients (n = 45, age 15-72 years) confirmed the importance and relevance of these signs/symptoms. Interim revision resulted in measures that were understood by and relevant to patients. Dermatologists (n = 5) and patients (n = 10, age 21-54 years) participated in the development of the eyebrow, eyelash and nail photoguides and confirmed that they included photos that appropriately represented different severity levels and were helpful to derive and standardize ratings across raters. CONCLUSIONS: The ClinRO and PRO measures for eyebrow, eyelash and nail appearance, with their accompanying photoguides and the PRO Measure for Eye Irritation provide clear and meaningful assessments of outcomes important to patients with AA.

Exploring content and psychometric validity of newly developed assessment tools for itch and skin pain in atopic dermatitis.

BACKGROUND: Atopic dermatitis (AD) is a common skin disorder characterized by chronic inflammation, altered skin barrier function, and inflammatory cell skin infiltration that decreases health-related quality of life (HRQoL). The study objective was to understand the patient perspective of AD burden and determine suitable patient-reported outcome (PRO) measures. METHODS: This mixed methods study involved the collection of qualitative and quantitative information from adults (≥ 18 years old) and adolescents (12 - 17 years old) with clinician-confirmed AD regarding their experiences of AD symptoms and its impact on HRQoL. The first part of the study included three stages: in-person concept elicitation (CE) interviews, a 2-week daily electronic diary (eDiary) study, and in-person cognitive debriefing (CD) interviews. An Itch numeric rating scale (NRS) (v1.0) and a Skin Pain NRS (v1.0) evaluation during CD interviews required participants to think about their 'worst' itch and 'worst' skin pain in the past 24 h. Other PRO measures allowed for psychometric testing. The second part of the study involved telephone-depth interviews (TDIs) and qualitative feedback from participants who had not participated in the CD interviews. Qualitative data were thematically analyzed. Psychometric evaluation of NRS measures was performed using eDiary data. RESULTS: In the CE interviews, itch and/or itching and skin pain were the most prevalent symptoms consistently discussed by participants. Both NRS measures demonstrated strong psychometric reliability and were applicable across ages with suitable concurrent validity. During the CD interviews, some participants focused their answers on their 'average' itch/itching in the past 24 h, rather than their 'worst' itch. Some participants answered the Skin Pain NRS thinking about general pain or other types of pain, rather than skin pain specifically. Consequently, modifications to both measures addressed these issues and re-tested as paper-and-pen versions in subsequent TDIs. Itch NRS (v2.0) modifications helped participants focus on their worst itching. Most participants preferred Skin Pain NRS v2.0b, which included skin pain descriptors. CONCLUSIONS: Itching and skin pain are the most important and relevant AD symptoms. The Itch NRS (v2.0) and Skin Pain NRS (v2.0b) appear to be appropriate endpoints for the assessment of itching and skin pain severity for clinical trials with adults and adolescents with AD.

Global health resource utilization associated with pacemaker complications.

AIM: To estimate health resource utilization (HRU) associated with the management of pacemaker complications in various healthcare systems. METHODS: Electrophysiologists (EPs) from four geographical regions (Western Europe, Australia, Japan, and North America) were invited to participate. Survey questions focused on HRU in the management of three chronic pacemaker complications (i.e. pacemaker infections requiring extraction, lead fractures/insulation breaches requiring replacement, and upper extremity deep venous thrombosis [DVT]). Panelists completed a maximum of two web-based surveys (iterative rounds). Mean, median values, and interquartile ranges were calculated and used to establish consensus. RESULTS: Overall, 32 and 29 panelists participated in the first and second rounds of the Delphi panel, respectively. Consensus was reached on treatment and HRU associated with a typical pacemaker implantation and complications. HRU was similar across regions, except for Japan, where panelists reported the longest duration of hospital stay in all scenarios. Infections were the most resource-intensive complications and were characterized by intravenous antibiotics days of 9.6?13.5 days and 21.3?29.2 days for pocket and lead infections respectively; laboratory and diagnostic tests, and system extraction and replacement procedures. DVT, on the other hand, was the least resource intensive complication. LIMITATIONS: The results of the panel represent the views of the respondents who participated and may not be generalizable outside of this panel. The surveys were limited in scope and, therefore, did not include questions on management of acute complications (e.g. hematoma, pneumothorax). CONCLUSIONS: The Delphi technique provided a reliable and efficient approach to estimating resource utilization associated with chronic pacemaker complications. Estimates from the Delphi panel can be used to generate costs of pacemaker complications in various regions.

Community-acquired pneumonia: symptoms and burden of illness at diagnosis among US adults aged 50 years and older.

PURPOSE: Community-acquired pneumonia (CAP) is a leading cause of morbidity and mortality in older adults, yet few studies have comprehensively measured the burden of CAP symptoms and their impact from the patient perspective. Our Web-survey used the newly developed CAP burden of illness questionnaire (CAP-BIQ) designed to assess the presence of key symptoms, comorbid conditions affected by CAP, psychosocial impacts, productivity, and CAP-associated physician visits in US adults aged 50 years and older. METHODS: The CAP-BIQ was developed from semi-structured one-on-one interviews and finalized after cognitive debriefings with recently diagnosed CAP patients. The CAP-BIQ was then administered to 500 survey participants with a CAP diagnosis within the past 120 days confirmed by chest imaging recruited from a Web-based panel. Analyses of survey results were weighted for national representativeness, and were compared between relevant age, hospitalization status, and pneumonia-risk subgroups. RESULTS: The survey participants' mean age was 62.4 years; 45 % were men; and 39.6 % were hospitalized due to CAP. On average, the surveys were completed 56.9 days after pneumonia diagnosis. Nearly all participants reported tiredness, cough, body aches, weakness, shortness of breath, wheezing, and a weak appetite at the time of diagnosis (99.0, 96.8, 96.9, 94.1, 89.1, 85.8, and 78.5 %, respectively). There was generally greater symptom prevalence at diagnosis in younger, nonhospitalized, or high-risk subgroups when compared to their respective older, hospitalized, or low-risk counterparts. Most participants reported at least one cough-related and weakness-related impact on their daily life and activities from CAP. Over three quarters of the respondents (77.4 %) needed assistance from a friend or family member during their bout with pneumonia and a majority of respondents (83.6 %) were satisfied with the care they received from their doctors across the course of their illness. CONCLUSIONS: This study systematically assessed CAP symptoms and their impacts using the CAP-BIQ, a questionnaire with established content validity. At CAP diagnosis, the range of patient-reported symptoms was broader than previous studies have reported. Additionally, the overwhelming need for caregiver assistance demonstrates the burden this illness places on older adults.

Are treatment benefits in neuropathic pain reflected in the Self Assessment of Treatment questionnaire?

BACKGROUND/OBJECTIVE: The Self Assessment of Treatment (SAT) questionnaire was developed to reflect key patient reported outcomes of Neuropathic Pain (NP) treatments. This study aimed to understand how patients perceived the relevance and ease of understanding of the questions in the SAT and to recommend modifications based on patient and clinician interviews. METHODS: Semi-structured interviews were conducted with clinicians and NP patients to provide information regarding treatment attributes and the impact of pain. Patients were debriefed on the SAT, a 5-item scale evaluating pain, activity level, quality of life (QoL) and satisfaction with treatment (recommend treatment and undergo treatment again). The SAT has a recall period reflecting back to the start of treatment. The qualitative analysis software ATLAS.ti 5.0 was used to analyze patient transcripts. Changes to the SAT were integrated into the questionnaire for a second round of debriefing interviews. RESULTS: Three NP clinicians and 44 patients (20 painful diabetic neuropathy, 16 HIV-associated neuropathy and 8 post herpetic neuralgia) with a mean age of 60.3 (12.3) years and an even gender distribution were interviewed. Patient treatment experience included anticonvulsants (73%), antidepressants (34%), opioids (25%), and topical medications (41%). Pain descriptors and treatment attributes were similar across the three NP groups. Pain relief was judged the most important treatment attribute, followed by ability to undertake activities. Sleep improvement was another important attribute. Activity limitations and QOL were perceived as too broad and non-specific, and were split into 3 concepts each (activity limitations was split into self care, daily and physical activities and QOL was split into sleep, emotions, and social function). A 7-day recall period was introduced. The item stem and response options were made consistent, and a baseline and follow-up questionnaires were developed (except for the satisfaction items) to enable monitoring onset of treatment benefit and change over time. CONCLUSIONS: The content validity of the revised SAT was improved by the qualitative research, and NP treatment benefits are reflected in a more consistent fashion by the changes. Baseline and follow-up versions make it possible to perform assessments of change over time.

Validation of the Self-Assessment of Treatment Questionnaire among Patients with Postherpetic Neuralgia.

Introduction. A five-item Self-Assessment of Treatment (SAT) was developed to assess improvement and satisfaction with treatment associated with the application of a novel high concentration 8% capsaicin topical patch in clinical trials in patients with postherpetic neuralgia (PHN). This study evaluated the item performance and psychometric properties of the SAT. Methods. The SAT, Brief Pain Inventory, SF-36v2, Short-Form McGill Pain Questionnaire, and Patient and Clinician Global Impression of Change (PGIC; CGIC) scores were measured in two 12-week Phase 3 clinical trials. Factor analysis assessed the underlying factor structure, followed by examination of the reliability and validity of the multi-item domain. Results. Pooled data from 698 patients completing SAT after 12 weeks of treatment were analyzed. A one-factor model combining three of the five items emerged as the optimal solution. Internal consistency reliability of this treatment efficacy factor was high (Cronbach's alpha = 0.89). Construct validity was demonstrated by moderate to high correlations with change in other study endpoints. SAT mean scores consistently discriminated between patient change groups defined by PGIC and CGIC. Conclusions. The measurement properties of the three-item version of SAT are valid and reliable for assessment of treatment with a high concentration capsaicin patch among patients with PHN.

Humanistic and economic burden of generalized anxiety disorder in North America and Europe.

BACKGROUND: To review the humanistic and economic burden of generalized anxiety disorder (GAD). METHODS: MEDLINE, EMBASE and the Cochrane Library, limited to articles published in English, between 1987 and 2010, in North America, Europe and Australia. The key focus was humanistic or functional outcomes, cost of illness and economic outcomes. Ninety articles fitting criteria on (a) GAD study population, (b) United States, Europe or Australia, and (c) humanistic burden or economic burden were reviewed. Methods and findings were summarized by two researchers; inconsistencies were resolved by a third reviewer. RESULTS: GAD was associated with increased impairments in psychosocial functioning, role functioning, work productivity and health-related quality of life (HRQL). The HRQL impairments were comparable with those associated with depression or panic disorder. Patients with GAD and co-morbid depression reported significantly greater impairment in HRQL than did those with either disorder alone. GAD patients had significantly higher median medical costs than primary care patients without GAD (US $2375 versus $1448). The mean annual medical cost of GAD was $2138 higher than for other anxiety disorders (mean $6475). Finally, GAD was frequently under-recognized in primary care, and available studies reported that only 20% to 32% of patients were adequately treated. LIMITATIONS: The review was limited to pharmacologic treatments for GAD and to publications in English. CONCLUSIONS: GAD is associated with significant burden on patient functioning and well-being, leading to increased health care utilization and medical costs. Patients with GAD are often suboptimally treated, which adds to the HRQL burden of this disorder.

Differences in smokers and nonsmokers' assessments of an educational campaign about tobacco use.

The authors surveyed 1,998 Missourians to evaluate (a) awareness and (b) understanding of messages about the impact of tobacco use in Missouri, (c) belief in the accuracy of the messages, and (d) intention to vote for a tobacco tax increase on the basis of the messages. Using structural equation modeling, the relationships among these four constructs were evaluated. A comparison of smokers and nonsmokers indicated that these two groups were influenced by the messages in different ways, χ(2)(8) = 20.89, p < .05, and should be modeled separately. The nonsmokers' model demonstrated significant (p < .05) relationships between understanding the messages and belief in message accuracy (b = .41; R (2) = .17) and between belief in message accuracy and intention to vote in favor of the tobacco tax (b = .54; R (2) = .29). In the smokers' model, understanding the messages was not a statistically significant predictor of belief in message accuracy. However, belief in message accuracy had a significant and positive relationship with intention to vote in favor of the tax (b = .45; R (2) = .21). These findings indicate that media campaigns about tobacco use should approach smokers and nonsmokers differently.

Assessment of quality of life enjoyment and satisfaction questionnaire-short form responder thresholds in generalized anxiety disorder and bipolar disorder studies.

Interpretation of change over time in patient-reported outcomes requires appropriate responder definitions. This study compares responder definitions for the short-form version of the Quality of Life Enjoyment and Satisfaction Questionnaire [Q-LES-Q(SF)] in populations with generalized anxiety disorder (GAD) and bipolar disorder. A review of the Q-LES-Q(SF) literature published in English from 1993 through May 2009 identified publications using the Q-LES-Q(SF) in GAD or bipolar disorder clinical trials. In six relevant articles reporting Q-LES-Q(SF) responder definitions in GAD or bipolar disorder, two methods for defining responders emerged: (i) return to a score within 10% of community norms for the Q-LES-Q(SF); and (ii) a change score at or greater than the condition-specific mean change achieved by patients with minimal improvement on the Clinical Global Impression-Improvement (CGI-I) at study endpoint or a 1-point decrease on the CGI-Severity scale between baseline and study endpoint. The magnitude of the CGI-I based responder thresholds differed across mental health conditions. Use of the Q-LES-Q(SF) community norms as a responder definition is discouraged. A responder definition needs to be investigated within each condition or disease using appropriate anchors, and may not be generalizable from one condition or disease to another.

Validation of the AQLQ12+ among adolescents and adults with persistent asthma.

BACKGROUND: To date, there is limited psychometric evidence on the Asthma Quality of Life Questionnaire (AQLQ12 +) among populations that include adolescents and adults. OBJECTIVE: To provide evidence of the psychometric properties of the AQLQ12+ as a measure of asthma-specific quality of life (QOL) in patients with persistent asthma treated with a combination of inhaled glucocorticoid and long-acting beta2-agonist, as well as explore the predictors of at least a minimally important AQLQ12+ improvement. METHODS: The psychometric properties of the AQLQ12+ were assessed through post hoc analysis of two large (n = 740 and 778) Phase III, randomized, double-blinded, placebo-controlled efficacy studies of mometasone furoate/formoterol fumarate (MF/F) combination compared with monotherapy in subjects with persistent asthma previously treated with either low-dose or medium-dose inhaled glucocorticoids. RESULTS: With 15% and 8% participation from 12- to 17-year olds, blinded trial data demonstrated excellent reproducibility (ICC range: 0.76-0.85) and moderate-to-strong construct validity with other measures of asthma health at baseline and over time for the AQLQ12 +. A greater percentage of the MF/F treatment group (44%) achieved an important change at 26 weeks on the AQLQ12+ compared with formoterol fumarate (F, 23%) and placebo (18%) treatment groups in the low-dose study (P < 0.001) and the medium-dose study (50% (MF/F) versus 34% (F) and 23% (placebo); P < 0.001). Pre-randomization nighttime awakenings and rescue medications use were significant predictors of AQLQ12+ improvement. CONCLUSIONS: These findings provide strong support for the measurement properties of the AQLQ12+ among patients with persistent asthma and confidence in the AQLQ12+ improvements demonstrated by the MF/F treatment group.

An assessment of change in asthma control among adolescents and adults with persistent asthma in mometasone furoate/formoterol fumarate clinical trials.

OBJECTIVE: This article provides evidence on the psychometric properties of the Asthma Control Questionnaire (ACQ) in adolescent and adult patients with persistent asthma treated with a combination of inhaled glucocorticoid and long-acting beta2-agonist (LABAs), and explores the factors associated with important improvements in asthma control. METHODS: Data from patients in two large (n = 737 and 772) Phase III, randomized, double-blind, parallel-group, multi-center, placebo-controlled studies of mometasone furoate/formoterol fumarate (MF/F) combination formulation compared with monotherapies in subjects with persistent asthma previously treated with either low- or medium-dose inhaled glucocorticoids were used to evaluate the ACQ psychometric properties and predictors of important ACQ improvement, defined as an ACQ score decline from baseline of 0.5 or more at the end of treatment. RESULTS: With 15% and 8% participation from adolescents in the low- and medium-dose studies, the ACQ yielded acceptable reliability (intraclass correlation coefficient ≥ 0.75), and baseline and change scores demonstrated moderate to strong correlations with other baseline measures and change scores in other measures of asthma-related health, including the Asthma Quality of Life Questionnaire (AQLQ12+) domains and total scores. More MF/F treatment group patients (48%) achieved an important ACQ change at 26 weeks compared with MF (32%), F (26%), and placebo (18%) treatment groups (p < .001). Use of rescue medications before randomization was a significant predictor of important ACQ improvement in both studies. CONCLUSIONS: These findings support the psychometric properties of the ACQ to measure asthma control among persistent asthma patients and provide confidence in the significant improvements in asthma control demonstrated by the MF/F treatment group.

Reliability and validity of the SF-12v2 in the medical expenditure panel survey.

OBJECTIVE: Evaluate the reliability and validity of the Medical Outcomes Study Short-Form version 2 (SF-12v2) in the 2003-2004 Medical Expenditure Panel Survey (MEPS). RESEARCH DESIGN: Data were collected in the self-administered mail-out questionnaire and face-to-face interviews of the MEPS (n = 20,661). Internal consistency and test-retest reliability and construct, discriminate, predictive and concurrent validity were tested. The EQ-5D, perceived health and mental health questions were used to test construct and discriminate validity. Self-reported work, physical and cognitive limits tested predictive validity and number of chronic conditions assessed concurrent validity. RESULTS: Both Mental Component Summary Scores (MCS) and Physical Component Summary Scores (PCS) were shown to have high internal consistency reliability (alpha > .80). PCS showed high test-retest reliability (ICC = .78) while MCS demonstrated moderate reliability (ICC = .60). PCS had high convergent validity for EQ-5D items (except self-care) and physical health status (r > .56). MCS demonstrated moderate convergent validity on EQ-5D and mental health items (r > .38). PCS distinguish between groups with different physical and work limitations. Similarly, MCS distinguished between groups with and without cognitive limitations. The MCS and PCS showed perfect dose response when variations in scores were examined by participant's chronic condition status. CONCLUSIONS: Both component scores showed adequate reliability and validity with the 2003-2004 MEPS and should be suitable for use in a variety of proposes within this database.

Validity of patient-reported health-related quality of life global ratings of change using structural equation modeling.

BACKGROUND: Patient-perceived global ratings of change are often used as anchors of health-related quality of life (HRQoL) since they are easy for clinicians to interpret and incorporate the patient's perception of change as a means to capture clinical significance. Although this approach may be preferred, the validity of the anchor-based approach is currently under scrutiny. OBJECTIVE: To estimate the explained variation in single-item domain-specific global ratings of change (GRCs) that is accounted for by time 1 (T1) and time 2 (T2) domain-specific summary change scores from the Short-Form 36, V2 (SF-36) Health Survey in asthma primary care patients. METHODS: The baseline and first follow-up enrollment data to be evaluated in this investigation were part of a larger longitudinal HRQoL study conducted from August 2000-December 2002, in which the 356 asthma patients from Midwestern primary care facilities completed telephone interviews for every two consecutive months for a year on multiple HRQoL measures, including the SF-36 and domain-specific GRCs. A structural equation modeling technique was employed to ascertain the explained variability in patient-reported GRCs for each SF-36 domain that is accounted for by the summary change scores at the two time-points for four SF-36 domains (bodily pain, general health perception, mental health, and physical functioning). The model was estimated by the maximum likelihood method with the Satorra-Bentler correction for ordinal variables using equal threshold asymptotic covariance matrices. RESULTS: Multicollinearity between T1 and T2 latent constructs clouded interpretation of the standardized structural coefficients leading to GRCs. Correlations, however, revealed that all four domain-specific GRCs were more strongly related to T2- than T1-domain summary scores, indicating that patients were not equally relying on T1 and T2 to generate the GRCs. Furthermore, T1-domain summary scores were not of equal magnitude and opposite sign as compared to T2 scores. CONCLUSIONS: In this study, there is insufficient evidence to establish SF-36 domain-specific GRC validity in asthma primary care patients. Therefore, it is recommended to reassess validity before using domain-specific SF-36 GRCs to classify clinically important change over time.

Measuring patient and clinician perspectives to evaluate change in health-related quality of life among patients with chronic obstructive pulmonary disease.

CONTEXT: Many treatments aim to improve patients' health-related quality of life (HRQoL), and many care guidelines suggest assessing symptoms and their impact on HRQoL. However, there is a lack of consensus regarding which HRQoL outcome measures are appropriate to assess, and how much change on those measures depict significant HRQoL improvement. OBJECTIVE: We used triangulation methods to identify and understand clinically important differences (CIDs) for the amount of change in HRQoL that reflects both health professionals and patients' values, among patients with chronic obstructive pulmonary disease (COPD). DESIGN, SETTING, AND PARTICIPANTS: We incorporated three perspectives: (1) an expert panel of physicians familiar with the measurement of HRQoL in COPD patients; (2) 610 primary care COPD outpatients who completed baseline and bimonthly follow-up HRQoL interviews over the 12-month study; and (3) the primary care physicians (PCPs; n = 43) of these outpatients who assessed their patients' disease at baseline and at subsequent PCP visits during the year long study. MEASUREMENTS: The Chronic Respiratory Disease Questionnaire (CRQ), the Medical Outcomes Study Short Form 36-item survey (SF-36, version 2.0), and global assessments of change from each of the three perspectives for all HRQoL domains. RESULTS: With few exceptions, the CRQ was able to detect small changes at levels reported by the patients (1-2 points) and their PCPs (1-5 points). These results confirm minimal important difference standards developed in 1989 by Jaeschke et al. anchored on patient-perceived changes in HRQoL. In general, the expert panel and PCP CIDs were larger than the patient CIDs. CONCLUSION: This triangulation methodology yielded improved interpretation, understanding, and insights on stakeholder perspectives of CIDs for patient-reported outcomes.

Assessing fatigue in persons with cancer: further validation of the Wu Cancer Fatigue Scale.

Cancer-related fatigue (CRF) is a significant clinical symptom. Effective assessment of CRF attributes from the patients' perspective is essential. This study tested the psychometric properties of the Wu Cancer Fatigue Scale (WCFS). A total of 172 outpatients with breast cancer, who were at various stages and on various chemotherapy regimens, and were undergoing treatment at one of three cancer clinics in a Midwest metropolitan area, participated in this study. The participants were instructed to complete four instruments in the following order: the 16-item WCFS, Schwartz Cancer Fatigue Scale (SCFS), Geriatric Depression Scale (GDS), and Cancer-Related Fatigue Distress Scale (CRFDS). Structural equation modeling (LISREL 8.54) supported the one-factor measurement model with nine items remaining. Nonsignificant Satorra-Bentler Scaled Chi-square (27)=32.52, P=0.21, standardized root mean square residual=0.032, nonnormal fit index=0.97, comparative fit index=0.98, and incremental fit index=0.98 indicated a good model fit. Convergent validity with the SCFS was 0.78, concurrent validity with the GDS was 0.60, and predictive validity with the CRFDS was 0.73. Internal consistency reliability was alpha=0.91 for the nine-item scale. The revised WCFS is a reliable and valid instrument that aims to measure the subjective characteristics of CRF from the patients' perspective. It may prove useful in both clinical and research settings.

Individual, social environmental, and physical environmental influences on physical activity among black and white adults: a structural equation analysis.

BACKGROUND: Social ecological models suggest that conditions in the social and physical environment, in addition to individual factors, play important roles in health behavior change. Using structural equation modeling, this study tested a theoretically and empirically based explanatory model of physical activity to examine theorized direct and indirect effects of individual (e.g., motivation and self-efficacy), social environmental (e.g., social support), and physical environmental factors (e.g., neighborhood quality and availability of facilities). METHOD: A community-based sample of adults (N = 910) was recruited from 2 public health centers (67% female, 43% African American, 43% < $20,000/year, M age = 33 years) and completed a self-administered survey assessing their current physical activity level, intrinsic and extrinsic motivation for physical activity, perceived social support, self-efficacy, and perceptions of the physical environment. RESULTS: Results indicated that (a) perceptions of the physical environment had direct effects on physical activity, (b) both the social and physical environments had indirect effects on physical activity through motivation and self-efficacy, and (c) social support influenced physical activity indirectly through intrinsic and extrinsic motivation. For all forms of activity, self-efficacy was the strongest direct correlate of physical activity, and evidence of a positive dose-response relation emerged between self-efficacy and intensity of physical activity. CONCLUSIONS: Findings from this research highlight the interactive role of individual and environmental influences on physical activity.

Clinically important differences in health status for patients with heart disease: an expert consensus panel report.

BACKGROUND: The purpose of the study was to develop clinically important difference (CID) standards for patients with coronary artery disease and congestive heart failure that identify small, moderate, and large intraindividual changes with time in a modified version of the Chronic Heart Failure Questionnaire (CHQ) and the Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36, version 2). Prior work in ascertaining important difference standards for the CHQ have centered on patient-perceived changes. No important difference standards for the SF-36 have been published for patients with heart disease. This development of CIDs would facilitate the use of health status measures in daily clinical decision-making. METHODS: We used a modification of the RAND Appropriateness Method to assemble and guide a 9-member consensus panel of physicians with substantial experience in using the CHQ or the SF-36 among patients with heart disease. RESULTS: On the basis of their own experience using these measures and an extensive review of articles describing the development and use of these instruments, the expert panel achieved consensus on small, medium, and large clinically relevant changes in scores for the CHQ and SF-36. The CID standards established by this panel were slightly higher than the minimal important difference standards previously established for the CHQ using patient-perceived changes. CONCLUSIONS: The CID standards established by this expert panel provide an important and useful tool for determining whether routine clinical health status assessments will benefit patients and enhance physicians' decision-making capacity in clinical settings.

Minimal important difference thresholds and the standard error of measurement: is there a connection?

Several recently published investigations have examined the relationship between the magnitude of the standard error of measurement (SEM) and established thresholds for a minimal clinically important difference (MCID) or a minimal important difference (MID) for change scores on health-related quality of life (HRQOL) or health status measures. These investigations, however, have resulted in differing SEM criteria for the MCID or MID. This study reviews and compares two sets of studies: (1) three investigations using a disease-specific HRQOL measure among patient samples with the chronic disease (heart disease, chronic obstructive pulmonary disease, or asthma) that have consistently demonstrated a 1 SEM correspondence with the established MCIDs or MIDs and (2) three investigations among patients referred to physical therapists with back, lower extremity, and neck pain showing that approximately 2.3 SEMs estimated the established MCID standards for three different measures of health status. Chronic disease patients were classified to have a MCID or MID if their global change ratings for the better or the worse were 1, 2, or 3 on a Likert scale ranging from 1 (almost the same, hardly any better, or worse at all) to 7 (a very great deal better or worse). Back pain patients, however, needed average global transition scores of 5, 6, or 7 (a good, a great, or a very great deal better) on the same 7-point Likert scale in order to experience an MCID in their condition. Charting these change levels against their respective SEM-MID criteria provides insight and promise for linking SEM-based criteria to MCID standards for other HRQOL and health status measures.