Qualitative and quantitative validation of the FACIT-fatigue scale in iron deficiency anemia.

BACKGROUND: Fatigue is a burdensome symptom in iron deficiency anemia (IDA). To capture the severity and impact of fatigue appropriately it must be measured using validated scales. This study evaluated the content validity and psychometric validity of the Functional Assessment of Chronic Illness Therapy - fatigue scale (FACIT-fatigue) in IDA patients. METHODS: Qualitative patient interviews were conducted in the United States to evaluate content validity. The psychometric properties of the FACIT-fatigue scale were investigated using data from a phase 3 clinical trial assessing ferumoxytol in patients with a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used. The statistical analysis assessed the acceptability, reliability, validity and responsiveness of the FACIT-fatigue scale. RESULTS: Qualitative interviews showed that fatigue is a central concern to IDA patients and that the FACIT-fatigue scale sufficiently assessed this construct. Psychometric assessment demonstrated that the FACIT-fatigue scale was stable over time (ICC = 0.87) and internally consistent (α = 0.93). The scale demonstrated convergence with other conceptually relevant scales such as SF-36 Vitality (r = 0.74), and distinguished between known groups [i.e., treatment arms (mean difference (95 % CI) = 3.56 (1.68, 5.43), p <0.001) and high vs. low hemoglobin groups (mean difference (95 % CI) = 5.51 (8.59, 2.44) p <0.001)]. Responsiveness was also demonstrated; significant improvements in FACIT-fatigue scale scores corresponded with significant differences between minimal, moderate, and much improved vitality cohorts (p < 0.05). CONCLUSIONS: This research demonstrated that the FACIT-fatigue scale has sound measurement properties and is an appropriate and interpretable assessment of fatigue among IDA patients with various underlying conditions.

An examination of drug craving over time in abstinent methamphetamine users.

Craving for addictive drugs may predict relapse in abstinent addicts. To assess relationships between craving and use, we examined changes in craving for methamphetamine (MA) in a sample of 865 outpatients in a multisite 16-week MA-treatment study. Craving was assessed on a 0-100 scale, and MA use was assessed by self-report and confirmed by urinalysis. We hypothesized that the magnitude of craving would decline (decay) with increased time of abstinence, and that decay would be greater for more frequent MA users, and greater for intravenous (IV) users and smokers as compared to those who used MA intranasally. Craving declined significantly as the number of weeks of consecutive abstinence increased. Rate of decay was greater for IV users and smokers as compared to both intranasal users and oral users, but not for more frequent users of MA. Rate of decay was independent of age, gender, and race/ethnicity. The trajectory to 0 (no) craving was 1 week shorter for females than males because females had significantly lower pretreatment craving scores compared to males. This study confirms that the sooner MA-dependent people are able to quit using and the longer that they are able to stay abstinent, the more likely it is that their craving for MA will decrease over time.

The costs and benefits of writing, talking, and thinking about life's triumphs and defeats.

Three studies considered the consequences of writing, talking, and thinking about significant events. In Studies 1 and 2, students wrote, talked into a tape recorder, or thought privately about their worst (N = 96) or happiest experience (N = 111) for 15 min each during 3 consecutive days. In Study 3 (N = 112), students wrote or thought about their happiest day; half systematically analyzed, and half repetitively replayed this day. Well-being and health measures were administered before each study's manipulation and 4 weeks after. As predicted, in Study 1, participants who processed a negative experience through writing or talking reported improved life satisfaction and enhanced mental and physical health relative to those who thought about it. The reverse effect for life satisfaction was observed in Study 2, which focused on positive experiences. Study 3 examined possible mechanisms underlying these effects. Students who wrote about their happiest moments--especially when analyzing them--experienced reduced well-being and physical health relative to those who replayed these moments. Results are discussed in light of current understanding of the effects of processing life events.

Becoming happier takes both a will and a proper way: an experimental longitudinal intervention to boost well-being.

An 8-month-long experimental study examined the immediate and longer term effects of regularly practicing two assigned positive activities (expressing optimism and gratitude) on well-being. More important, this intervention allowed us to explore the impact of two metafactors that are likely to influence the success of any positive activity: whether one self-selects into the study knowing that it is about increasing happiness and whether one invests effort into the activity over time. Our results indicate that initial self-selection makes a difference, but only in the two positive activity conditions, not the control, and that continued effort also makes a difference, but, again, only in the treatment conditions. We conclude that happiness interventions are more than just placebos, but that they are most successful when participants know about, endorse, and commit to the intervention.

Modified Severity of Dyspepsia Assessment pain scale: a new tool for measuring upper abdominal pain in osteoarthritis patients taking NSAIDs.

BACKGROUND: This study evaluated the electronically administered modified Severity of Dyspepsia Assessment (mSODA) pain scale, a six-item measure of upper abdominal pain intensity, for daily use in osteoarthritis patients taking nonsteroidal anti-inflammatory drugs. METHODS: Once the mSODA pain scale was isolated, cognitive debriefing interviews (n = 30) were used to examine its appropriateness in the target population. Following administration of the instrument in two Phase III pivotal trials, the data were analyzed to examine reliability, validity, responsiveness, and the minimal important difference. RESULTS: Using a subset of trial data (n = 90 patients), the mSODA pain scale proved to be a unidimensional, highly internally consistent instrument (α = 0.93) with good test-retest reliability (intraclass correlation coefficient 0.77). Construct validity was established via moderate correlations with other similar patient-reported outcomes. Additionally, known-groups validity demonstrated that the mSODA pain scale could distinguish between subjects who did and did not report gastrointestinal symptoms and antacid use (both P values ≤ 0.05). The mSODA pain scale was also responsive to change in heartburn at weeks 6 and 12 (Guyatt's statistic = 1.7 and 2.6, respectively), and the minimal important difference obtained via ½ SD was 5.7 (range 2-47). CONCLUSION: This research suggests that the mSODA pain scale is both feasible and valid for assessing dyspepsia in patients taking nonsteroidal anti-inflammatory drugs for relief of symptoms of osteoarthritis.