General Population Norms for the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale

Background

The Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale is an internationally used validated measure. General population–based age- and sex-specific percentile norms are, however, not published to date, although these are needed as reference for the interpretation of clinical research data.

β-Thromboglobulin, Platelet Production Time and Platelet Function in Vascular Disease

Plasma beta-thromboglobulin (beta TG) levels were measured in 103 healthy controls and 112 patients suffering from either peripheral vascular disease (PVD), or cerebrovascular disease (CVD) or deep vein thrombosis (DVT). Plasma beta TG was significantly elevated in 46 PVD patients and 24 recent DVT patients compared to controls, but did not differ significantly in 18 chronic DVT and 24 old CVD patients. In addition, heparin neutralizing activity (HNA) and platelet aggregation induced by adenosine diphosphate, 1-epinephrine and thrombin were compared in 33 out of the 46 PVD patients to 33 controls. The mean HNA was significantly shorter in the PVD patients than in controls. The rate and extent of platelet aggregation were increased in PVD patients compared to controls, but the difference was not statistically significant. Platelet production time (PPT) was measured in 20 controls, 35 PVD patients, nine chronic DVT and 12 chronic CVD patients; significantly shorter PPT was only observed in 14 patients with advanced PVD compared to controls, suggesting increased platelet consumption in these patients. All four assays (plasma beta TG, HNA, platelet aggregation and PPT) were performed in 25 patients; no correlation between the four tests was found in these patients suggesting that the tests were measuring various aspects of platelet function. These results suggest that in vivo platelet consumption as well as platelet aggregation and 'release reaction' are presumably enhanced in PVD and recent DVT patients and that plasma beta TG and PPT assays may be better and more specific indicators of in vivo platelet activation than in vitro platelet aggregation test.     

Heart rate variability and left ventricular diastolic function in patients with borderline hypertension with and without left ventricular hypertrophy

The relationships between heart rate variability (HRV), left ventricular mass and diastolic function in borderline hypertensive patients (BHT) were evaluated. 24 h Holter electrocardiogram (ECG) and blood pressure (BP) monitoring, M and 2 D echocardiogram and Doppler analysis in 42 BHT with and without left ventricular hypertrophy (LVH) and in 20 normotensive controls were assessed. From 24-h ECG, time domain indexes of HRV were calculated. Standard Deviation of all Cycles (SDNN) and Standard Deviation of the means of heart periods over five-minute intervals (SDANN) were significantly reduced in BHT with LVH but not in BHT without LVH. No significant differences of short-term variability measures were detectable, although a progressive decrease among control subjects and BHT with and without LVH was observed. Diastolic left ventricular compliance evaluated by early to late transmitral flow velocity ratio (E/A ratio) significantly declined from normotensive subjects to BHT with LVH. There was a significant positive correlation between E/A and SDNN and SDANN throughout all studied groups. This indicates that BHT with LVH has a reduced HRV compared to other groups. This impairment is probably related to left ventricular mass and left ventricular filling abnormalities.     

Setting standards for severity of common symptoms in oncology using the PROMIS item banks and expert judgment

Background

Although the use of patient-reported outcome measures (PROs) has increased markedly, clinical interpretation of scores remains lacking. We developed a method to identify clinical severity thresholds for pain, fatigue, depression, and anxiety in people with cancer.

Methods

Using available Patient-Reported Outcomes Measurement Information System (PROMIS) item bank response data collected on 840 cancer patients, symptom vignettes across a range of symptom severity were developed and placed on index cards. Cards represented symptom severity at five-point intervals differences on the T score metric [mean = 50; standard deviation (SD) = 10]. Symptom vignettes for each symptom were anchored on these standardized scores at 0.5 SD increments across the full range of severity. Clinical experts, blind to the PROMIS score associated with each vignette, rank-ordered the vignettes by severity, then arrived at consensus regarding which two vignettes were at the upper and lower boundaries of normal and mildly symptomatic for each symptom. The procedure was repeated to identify cut scores separating mildly from moderately symptomatic, and moderately from severely symptomatic scores. Clinician severity rankings were then compared to the T scores upon which the vignettes were based.

Results

For each of the targeted PROs, the severity rankings reached by clinician consensus perfectly matched the numerical rankings of their associated T scores. Across all symptoms, the thresholds (cut scores) identified to differentiate normal from mildly symptomatic were near a T score of 50. Cut scores differentiating mildly from moderately symptomatic were at or near 60, and those separating moderately from severely symptomatic were at or near 70.

Conclusions

The study results provide empirically generated PROMIS T score thresholds that differentiate levels of symptom severity for pain interference, fatigue, anxiety, and depression. The convergence of clinical judgment with self-reported patient severity scores supports the validity of this methodology to derive clinically relevant symptom severity levels for PROMIS symptom measures in other settings.     

Concept Analysis of the Patient Reported Outcomes Measurement Information System (PROMIS®) and the International Classification of Functioning,Disability and Health (ICF)

Purpose

The Patient Reported Outcomes Measurement Information System (PROMIS ^® ) is a US National Institutes of Health initiative that has produced self-report outcome measures, using a framework of physical, mental, and social health defined by the World Health Organization in 1948 (WHO, in Preamble to the Constitution of the World Health Organization as adopted by the International Health Conference, New York, 1948). The World Health Organization’s International Classification of Functioning, Disability and Health (ICF) is a comprehensive classification system of health and health-related domains that was put forward in 2001. The purpose of this report is to compare and contrast PROMIS and ICF conceptual frameworks to support mapping of PROMIS instruments to the ICF classification system .

Methods

We assessed the objectives and the classification schema of the PROMIS and ICF frameworks, followed by content analysis to determine whether PROMIS domain and sub-domain level health concepts can be linked to the ICF classification.

Results

Both PROMIS and ICF are relevant to all individuals, irrespective of the presence of health conditions, person characteristics, or environmental factors in which persons live. PROMIS measures are intended to assess a person’s experiences of his or her health, functional status, and well-being in multiple domains across physical, mental, and social dimensions. The ICF comprehensively describes human functioning from a biological, individual, and social perspective. The ICF supports classification of health and health-related states such as functioning, but is not a specific measure or assessment of health, per se. PROMIS domains and sub-domain concepts can be meaningfully mapped to ICF concepts.

Conclusions

Theoretical and conceptual similarities support the use of PROMIS instruments to operationalize self-reported measurement for many body function, activity and participation ICF concepts, as well as several environmental factor concepts. Differences observed in PROMIS and ICF conceptual frameworks provide a stimulus for future research and development.     

Psychometric properties of a brief,clinically relevant measure of pain in patients with hepatocellular carcinoma

Purpose

Due to diagnosis at advanced stages, comorbidities, and the impact of treatment, patients with hepatocellular carcinoma (HCC) may experience pain. The purpose of this study was to evaluate the psychometric properties of a brief, clinically relevant measure of pain in HCC.

Methods

We conducted a secondary data analysis from four longitudinal studies of patients with HCC (total n = 304). All patients completed the FACT-Hepatobiliary (FACT-Hep) questionnaire, and 49 patients completed the Brief Pain Inventory (BPI) Interference scale. We conducted confirmatory factor analysis (CFA), Rasch modeling, and correlational analysis to assess the psychometrics of the three items on the FACT-Hep that assess HCC-relevant pain scale.

Results

Patients had an average age of 63.5 (±12.2) and were mostly male (76 %). The mean three-item pain subscale score was 8.5 ± 3.0. Seventy-four (24.3 %) patients reported no pain (score = 12). Results of a one-factor CFA supported unidimensionality of the items, and all items fit the Rasch model. An item-person map demonstrated that the three items covered all patients with non-extreme scores. Pain scores were significantly associated with baseline general health-related quality of life (FACT-General, r = 0.60, p < 0.001) and pain interference (BPI, r = ?0.63, p < 0.001).

Conclusions

The three FACT-Hep pain items are unidimensional, cover the range of pain experienced by most patients with HCC, and demonstrate convergent validity. This pain subscale is, if future research demonstrates its sensitivity to change, potentially useful for HCC clinical trials.