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Background There is no widely accepted validated scale to assess the comprehensive symptom burden and severity of neurogenic orthostatic hypotension (NOH). The Orthostatic Hypotension Questionnaire (OHQ) was developed, with two components: the six-item symptoms assessment scale and a four-item daily activity scale to assess the burden of symptoms. Validation analyses were then performed on the two scales and a composite score of the OHQ. Methods The validation analyses of the OHQ were performed using data from patients with NOH participating in a phase IV, double blind, randomized, cross over, placebo-controlled trial of the alpha agonist midodrine. Convergent validity was assessed by correlating OHQ scores with clinician global impression scores of severity as well as with generic health questionnaire scores. Test–retest reliability was evaluated using intraclass correlation coefficients at baseline and crossover in a subgroup of patients who reported no change in symptoms across visits on a patient global impression scores of change. Responsiveness was examined by determining whether worsening or improvement in the patients’ underlying disease status produced an appropriate change in OHQ scores. Results Baseline data were collected in 137 enrolled patients, follow-up data were collected in 104 patients randomized to treatment arm. Analyses were conducted using all available data. The floor and ceiling effects were minimal. OHQ scores were highly correlated with other patient reported outcome measures, indicating excellent convergent validity. Test–retest reliability was good. OHQ scores could distinguish between patients with severe and patients with less severe symptoms and responded appropriately to midodrine, a pressor agent commonly used to treat NOH. Conclusion These findings provide empirical evidence that the OHQ can accurately evaluate the severity of symptoms and the functional impact of NOH as well as assess the efficacy of treatment.

Background: To evaluate the psychometric properties of the newly developed seven-item Irritable Bowel Syndrome – Diarrhea predominant (IBS-D) Daily Symptom Diary and four-item Event Log using phase II clinical trial safety and efficacy data in patients with IBS-D. This instrument measures diarrhea (stool frequency and stool consistency), abdominal pain related to IBS-D (stomach pain, abdominal pain, abdominal cramps), immediate need to have a bowel movement (immediate need and accident occurrence), bloating, pressure, gas, and incomplete evacuation. Methods: Psychometric properties and responsiveness of the instrument were evaluated in a clinical trial population [ClinicalTrials.gov identifier: NCT01494233]. Results: A total of 434 patients were included in the analyses. Significant differences were found among severity groups (p < 0.01) defined by IBS Patient Global Impression of Severity (PGI-S) and IBS Patient Global Impression of Change (PGI-C). Severity scores for each Diary and Event Log item score and five-item, four-item, and three-item summary scores were calculated. Between-group differences in changes over time were significant for all summary scores in groups stratified by changes in PGI-S (p < 0.05), two of six Diary items, and three of four Event Log items; a one-grade change in PGI-S was considered a meaningful difference with mean change scores on all Diary items −0.13 to −0.86 [standard deviation (SD) 0.79–1.39]. Similarly, for patients who reported being ‘slightly improved’ (considered a clinically meaningful difference) on the PGI-C, mean change scores on Diary items ranged from −0.45 to −1.55 (SD 0.69–1.39). All estimates of clinically important change for each item and all summary scores were small and should be considered preliminary. These results are aligned with the previous standalone psychometric study regarding reliability and validity tests. Conclusions: These analyses provide evidence of the psychometric properties of the IBS-D Daily Symptom Diary and Event Log in a clinical trial population.

Recently published articles have described criteria to assess qualitative research in the health field in general, but very few articles have delineated qualitative methods to be used in the development of Patient-Reported Outcomes (PROs). In fact, how PROs are developed with subject input through focus groups and interviews has been given relatively short shrift in the PRO literature when compared to the plethora of quantitative articles on the psychometric properties of PROs. If documented at all, most PRO validation articles give little for the reader to evaluate the content validity of the measures and the credibility and trustworthiness of the methods used to develop them. Increasingly, however, scientists and authorities want to be assured that PRO items and scales have meaning and relevance to subjects. This article was developed by an international, interdisciplinary group of psychologists, psychometricians, regulatory experts, a physician, and a sociologist. It presents rigorous and appropriate qualitative research methods for developing PROs with content validity. The approach described combines an overarching phenomenological theoretical framework with grounded theory data collection and analysis methods to yield PRO items and scales that have content validity.

Purpose Diarrhea-predominant irritable bowel syndrome (IBS-D) can considerably impact patients' lives. Patient-reported symptoms are crucial in understanding the diagnosis and progression of IBS-D. This study psychometrically evaluates the newly developed IBS-D Daily Symptom Diary and Symptom Event Log (hereafter, \"Event Log\") according to US regulatory recommendations. Methods A US-based observational field study was conducted to understand cross-sectional psychometric properties of the IBS-D Daily Symptom Diary and Event Log. Analyses included item descriptive statistics, item-to-item correlations, reliability, and construct validity. Results The IBS-D Daily Symptom Diary and Event Log had no items with excessive missing data. With the exception of two items (\"frequency of gas\" and \"accidents\"), moderate to high inter-item correlations were observed among all items of the IBS-D Daily Symptom Diary and Event Log (day 1 range 0.67-0.90). Item scores demonstrated reliability, with the exception of the \"frequency of gas\" and \"accidents\" items of the Diary and \"incomplete evacuation\" item of the Event Log. The pattern of correlations of the IBS-D Daily Symptom Diary and Event Log item scores with generic and disease-specific measures was as expected, moderate for similar constructs and low for dissimilar constructs, supporting construct validity. Known-groups methods showed statistically significant differences and monotonie trends in each of the IBS-D Daily Symptom Diary item scores among groups defined by patients' IBS-D severity ratings (\"none\"/\"mild,\" \"moderate,\" or \"severe'/\"very severe\"), supporting construct validity. Conclusions Initial psychometric results support the reliability and validity of the items of the IBS-D Daily Symptom Diary and Event Log.

Background Fatigue is a common symptom of chronic hepatitis C virus (cHCV) infection and a common side effect of interferon-based treatment for cHCV. This study provides confirmatory evidence of the reliability and validity of the Fatigue Severity Scale (FSS) to document fatigue in cHCV research and identifies values that indicate clinically important differences in FSS to aid in interpreting fatigue in cHCV clinical trials. Methods The study used data from two double-blind, randomized, placebo-controlled, Phase IIb trials evaluating the efficacy and safety of simeprevir plus peginterferon-α/ribavirin in treatment-naïve (PILLAR, n = 386) and treatment-experienced patients (ASPIRE, n = 462) with cHCV infection. Patients completed the FSS and EuroQoL 5 dimension questionnaire (EQ-5D) at baseline and at regular intervals throughout both trials. Reliability was assessed using Cronbach’s coefficient α at Week 24 (internal consistency reliability) and intraclass correlation (ICC) between FSS at Weeks 12 and 24 in stable patients (<0.5 g/dL hemoglobin [Hb] change between Weeks 12/24). Correlation with the EQ-5D visual analog scale (VAS) and “Usual Activity” domain score was used to assess concurrent validity. Clinical validity was evaluated using a case-control method to link spontaneously reported fatigue and anemia adverse events (AEs) during the study to FSS scores. Results FSS total scores demonstrated good reliability (Cronbach’s α: 0.95, 0.96; ICC: 0.74, 0.86 for PILLAR and ASPIRE, respectively) and concurrent validity (correlation with EQ-5D VAS: -0.63, -0.66) with a monotonic relationship between the EQ-5D “Usual Activities” item response and FSS. Clinical validity was confirmed by a significant difference between cases and controls for fatigue AEs (p < 0.05); however, anemia defined by AE or Hb abnormalities was only weakly related to FSS score. Analyses indicate that a change of 0.33–0.82 in mean FSS scores represents a meaningful improvement in fatigue, and a one-point change is a conservative indicator of an important change in individual FSS scores. Conclusion A difference of ≥0.7 in mean FSS scores can be considered a clinically important difference within groups over time or between groups. A one-point change or less in individual FSS scores indicates a clinically relevant change in fatigue.

Background Fatigue is a common symptom of chronic hepatitis C virus (HCV) infection and a frequent side-effect of peginterferon/ribavirin (PR) therapy for HCV. This study evaluated the impact of adding the oral HCV NS3/4A protease inhibitor simeprevir to PR on patient-reported fatigue and health status among patients with chronic HCV genotype 1 infection enrolled in the Phase IIb PILLAR and ASPIRE trials [NCT00882908; NCT00980330]. Methods Treatment-naïve patients (PILLAR, n = 386) and treatment-experienced patients (ASPIRE, n = 462) were randomized to simeprevir plus PR (simeprevir/PR) or placebo plus PR (placebo/PR). In PILLAR, duration of PR treatment in the simeprevir/PR groups was determined using response-guided therapy (RGT) criteria. PR could be terminated at Week 24, instead of Week 48, if HCV RNA was <25 IU/mL by Week 4 and then undetectable at Weeks 12, 16, and 20. In both studies, patients completed the Fatigue Severity Scale (FSS) and EQ-5D quality-of-life questionnaire in their native language at baseline and throughout the studies up until Week 72. Results During the first 24 weeks of treatment, mean FSS total score was increased to a similar degree compared with baseline among patients receiving simeprevir/PR or placebo/PR in both studies indicating increased fatigue severity. Mean FSS scores returned to values comparable with baseline among patients receiving simeprevir/PR after Week 24 in PILLAR (after treatment completion for the majority of patients) and in ASPIRE (after Week 48), consistent with RGT enabling early termination of all treatment at Week 24 in 82.2% of simeprevir/PR-treated patients in the PILLAR study. Similar results were observed for EQ-5D, with simeprevir/PR-treated patients experiencing less time with worse health problems according to EQ-5D scores compared with placebo/PR groups in both studies, and more rapid improvement in health status associated with shorter treatment duration in the PILLAR study. Conclusions Combination of simeprevir with PR did not increase patient-reported fatigue severity or health status impairments beyond that reported by patients treated with PR alone. Many patients treated with simeprevir/PR returned to pretreatment fatigue and health status levels sooner due to increased treatment efficacy that enabled shorter duration of all therapy, compared with PR alone.

This manuscript describes the validation of the Premature Ejaculation Questionnaire (PEQ), a self-report instrument designed to assess the effects of premature ejaculation on an individual. The PEQ is intended to be used as a diagnostic assessment, as well as to measure response to drug intervention for use in clinical trials designed to test the efficacy of drug therapy for premature ejaculation. Data from clinical studies and control studies were used in these analyses. Exploratory and confirmatory analyses suggested that the PEQ measures a unidimensional construct but that latency, control, and sexual satisfaction items all contribute significantly to the measure of PE. Twelve items were retained on the final measure, which is called the PEQ-12. The PEQ-12 demonstrated high test-retest reliability in a control study (r = .91) and high internal consistency (r = .95). The PEQ-12 also showed moderate correlations with the stopwatch latency (r = .36), and change from baseline scores on the PEQ-12 showed higher correlations with change from baseline latency ( r = .67), and Global Satisfaction Evaluation (r = .65) in the homogeneous clinical sample. The PEQ-12 showed moderate correlation (r = .45) with the Subject Severity Impression in the homogeneous clinical sample, and a high correlation (r = .92) with the Subject Severity Impression in the heterogeneous combination of the clinical and control groups. These results demonstrated the concurrent validity of the PEQ-12. Receiver Operating Characteristic curves and logistic regression were used to establish cutoff scores for diagnostic criteria. The selected cutoff score of 30 or less had a specificity of .94 and a sensitivity of .97. Cutoff scores for therapeutic improvement were also evaluated. An increase of at least six points over baseline measure was selected as criteria for clinically significant improvement. A six point or greater increase from baseline criteria had an associated sensitivity of .88 and specificity of .69. The PEQ-12 is a psychometrically sound measure of premature ejaculation with desirable diagnostic properties. Further development of the PEQ and research in the field of sexual dysfunction is encouraged.

On May 29, 1865, President Andrew Johnson issued a Proclamation of Pardon and Amnesty and outlined the manner in which the provisional government of North Carolina would be organized. While the President's proclamation of amnesty absolved the majority of Confederates for their activities against the United States, fourteen classes, such as minor Confederate office holders, high-ranking Confederate civil and military officials, men indicted for treason and those owning more than $20,000 worth of property in 1860, had to compose a pardon petition, swear an oath of allegiance, and forward the documents to their respective state governors who sent the documents to Washington. This study is the first to mine and analyze the 850 pardon petitions filed by men in Tennessee and Western North Carolina in order to understand the factors which motivated men of varying social, educational, and economic backgrounds to link their futures with the Confederacy. Furthermore, these pardon petitions offer an immediate commentary on the mood of defeated Southerners and their anxieties as: they waited for the terms of peace from the North. An analysis of the pardon documents explores the process of Reconstruction on a state and local level and emphasizes the role state governors played in executing the Presidents policy. In addition, the dissertation offers a corrective to those historians who have concentrated on the wealthy and elite southerners who applied for pardon, while ignoring a substantial number of number of men who aided the Confederacy by holding office, donating goods to the Rebel army, or who required pardon to escape a trial for treason. President Johnson pardoned the overwhelming majority of ex-Confederates who applied, much to the chagrin of Congress. As Southerners exercised their right to vote and hold office, many elected ex-Rebels to local, state, and national offices. Alarmed at the defiance and recalcitrance, Congress decided that the President's plan was a failure and that a different program had to be instituted.

Data from the North Carolina End-of-Grade test of eighth-grade mathematics are used to estimate the achievement results on the scale of the National Assessment of Educational Progress (NAEP) Trial State Assessment. Linear regression models are used to develop projection equations to predict state NAEP results in the future, and the results of such predictions are compared with those obtained in the 1996 administration of NAEP. Standard errors of the parameter estimates are obtained using a bootstrap resampling technique.