Theresa Coles

Psychometric evaluation of the Sheehan Disability Scale in adult patients with attention-deficit/hyperactivity disorder

Inattention and impulsivity symptoms are common among adults with attention-deficit/hyperactivity disorder (ADHD), which can lead to difficulty concentrating, restlessness, difficulty completing tasks, disorganization, impatience, and impulsiveness. Many adults with ADHD find it difficult to focus and prioritize. Resulting outcomes, such as missed deadlines and forgotten engagements, may ultimately impact the ability to function at work, school, home, or in a social environment. The European Medicines Agency guidelines for evaluating medicinal products for ADHD recommend inclusion of both functional outcomes, such as school, social, or work functioning, and outcomes related to symptoms of ADHD in clinical studies of novel medication primary efficacy endpoints. Due to its performance in other disease areas and the relevance of its items as evidenced by content validity analyses, the Sheehan Disability Scale (SDS) was chosen to assess functional impairment in ADHD. The aim of this study was to investigate the psychometric properties of the SDS, used as a brief measure of functional impairment in a number of psychiatric disorders, in adult patients with ADHD. To the authors’ knowledge, this is the first study to evaluate the reliability of the SDS (based on Cronbach’s coefficient alpha and test-retest reliability), its validity (construct and known-groups validity), and its ability to detect change in this patient population. This study also established a preliminary responder definition for the SDS in this study population to determine when change can be considered clinically beneficial in a clinical trial setting. The psychometric results support the use of the SDS subscales (items 1–3) and total score (sum of items 1–3) in an ADHD population. In addition, the evaluation provides evidence for a three-point preliminary responder definition for the SDS and further evidence of its responsiveness in adults with ADHD. Altogether, the results indicate that the SDS is a simple and easy-to-score scale that would have great utility in future clinical trials for monitoring functional impairment in adults with ADHD.

Sphygmomanometry-evoked allodynia in chronic pain patients with and without fibromyalgia

Background:Fibromyalgia is a chronic pain syndrome that affects about 2% of the U.S. general population, with greater prevalence among women (3.5%) than men (0.5%). Previous research results suggest that the experience of pain (allodynia) upon sphygmomanometry may indicate the presence of fibromyalgia. Objective:The aim of this study was to confirm these findings in patients with fibromyalgia and other chronic pain conditions and evaluate the use of sphygmomanometry as a potential screening tool for the identification of patients with fibromyalgia. Methods:A total of 150 people participated in this multicenter, cross-sectional observational study. The study included a physician-conducted evaluation to determine if the participant met the American College of Rheumatology (ACR) 1990 diagnostic criteria for fibromyalgia. The presence of sphygmomanometry-evoked allodynia was assessed during a seated cuff pressure inflation that was repeated three times on each arm. Each site was provided a sphygmomanometer to ensure standardization, and the pressure of the cuff at the moment of pain initiation was recorded. If the patient did not indicate pain prior to 180 mmHg, then the inflation was stopped, a notation of no pain was made, and a cuff pressure of 180 mmHg was recorded. The mean of the six cuff pressure measurements was used for the analyses. Logistic regression was performed to analyze the relationship between sphygmomanometry-evoked allodynia and fibromyalgia. Results:The evaluable sample was 148 (one participant had too large an arm circumference for the sphygmomanometer and another did not receive the clinician evaluation of ACR-determined fibromyalgia diagnosis). Over half of the participants were determined to have an ACR diagnosis of fibromyalgia. Of these, 71 (91%) were women and had an average age of 54 years. Of the 70 participants with no fibromyalgia diagnosis, 42 (60%) were women and also had an average age of 54 years. Sixty-one (78%) of the fibromyalgia participants, compared with 25 (36%) of those with no fibromyalgia diagnosis, reported sphygmomanometry-evoked allodynia. The participants with fibromyalgia reported pain ata lower cuff pressure compared with those without fibromyalgia (132 mmHg vs. 166 mmHg, p < .01). The logistic regression showed that sphygmomanometry-evoked allodynia predicted an ACR-determined FM diagnosis (&khgr;2 = 19.4, p < .01). Discussion:These findings support previous research suggesting that patients who report pain upon sphygmomanometry may warrant further evaluation for the presence of fibromyalgia.

Elementary School–Located Influenza Vaccine Programs: Key Stakeholder Experiences From Initiation to Continuation

This study examined the initiation and logistics, funding, perceived barriers and benefits, and disruption of school activities by school-located influenza vaccination (SLIV) programs conducted during the 2008–2009 influenza season. Seventy-two interviews using a structured protocol were conducted with 26 teachers, 16 school administrators, and 30 health care professionals from 34 schools in 8 school districts. SLIV programs used a variety of locations, scheduling and staffing options, and methods for receiving parental consent and screening children. Health care professionals were primarily responsible for implementing SLIV programs, and most administrators and health care professionals considered programs easy to initiate. Health care professionals identified successful programs as requiring adequate planning/coordination, a dedicated program coordinator, and a consistent funding source. Most respondents (96%) reported minimal school-day disruptions. The perception of most stakeholders is that SLIV programs can be relatively easy to initiate, minimally disruptive and can become more efficient with experience, especially with feedback from all stakeholders.

Psychometric validation of a patient-reported measure of physical functioning in sporadic inclusion body myositis

Introduction: To assess self‐reported physical functioning in patients with sporadic inclusion body myositis (sIBM), the sIBM Physical Functioning Assessment (sIFA) was developed. This research establishes the validity, reliability, and responsiveness of the sIFA in patients with sIBM. Methods: Data from 3 small, noninterventional, observational studies were analyzed. Several measures of physical function were included to assess validity. Reliability (Cronbach alpha, test–retest intraclass correlations), construct validity (correlations, analyses of variance), and responsiveness (effect size estimates) were evaluated. Results: Cronbach alphas (range = 0.86–0.91) and test–retest reliability (0.91) were highly satisfactory. Correlations with other measures provided evidence of convergent validity. sIBM patients able to walk without assistive devices scored significantly better on the sIFA (means = 36.0–47.05) than those who required power mobility or wheelchairs (means = 54.9–71.5), demonstrating the discriminating ability of the sIFA. Effect size estimates of responsiveness suggested mild functional progression. Conclusions: Psychometric analyses of the sIFA demonstrate satisfactory reliability, validity, and responsiveness. Muscle Nerve 54: 658–665, 2016

Adding bevacizumab to single agent chemotherapy for the treatment of platinum-resistant recurrent ovarian cancer: A cost effectiveness analysis of the AURELIA trial

OBJECTIVE AURELIA, a randomized phase III trial of adding bevacizumab (B) to single agent chemotherapy (CT) for the treatment of platinum-resistant recurrent ovarian cancer, demonstrated improved progression free survival (PFS) in the B+CT arm compared to CT alone. We aimed to evaluate the cost effectiveness of adding B to CT in the treatment of platinum-resistant recurrent ovarian cancer. METHODS A decision tree model was constructed to evaluate the cost effectiveness of adding bevacizumab (B) to single agent chemotherapy (CT) based on the arms of the AURELIA trial. Costs, quality-adjusted life years (QALYs), and progression free survival (PFS) were modeled over fifteen months. Model inputs were extracted from published literature and public sources. Incremental cost effectiveness ratios (ICERs) per QALY gained and ICERs per progression free life year saved (PF-LYS) were calculated. One-way sensitivity analyses were performed to evaluate the robustness of results. RESULTS The ICER associated with B+CT is

RASCH FIRST? FACTOR FIRST?

410,455 per QALY gained and

Psychometric Evaluation of the Patient’s Knee Implant Performance Questionnaire

217,080 per PF-LYS. At a willingness to pay (WTP) threshold of

Sleep quality in individuals diagnosed with colorectal cancer: Factors associated with sleep disturbance as patients transition off treatment

50,000/QALY, adding B to single agent CT is not cost effective for this patient population. Even at a WTP threshold of

Psychometric Evaluation Of The Patient's Knee Implant Performance (PKIP) Questionnaire For The Assessment Of Primary Total Knee Arthroplasty.

100,000/QALY, B+CT is not cost effective. These findings are robust to sensitivity analyses. CONCLUSIONS Despite gains in QALY and PFS, the addition of B to single agent CT for treatment of platinum-resistant recurrent ovarian cancer is not cost effective. Benefits, risks, and costs associated with treatment should be taken into consideration when prescribing chemotherapy for this patient population.

Psychometric Evaluation of the Cushing’s Quality-of-Life Questionnaire

200 1 n/a 90% 10% 0% 200 2 0.0 0% 100% 0% 200 2 0.4 0% 100% 0% 200 2 0.7 0% 100% 0% 200 3 0.0 0% 0% 100% 200 3 0.4-0.7 0% 30% 70% 400 1 n/a 100% 0% 0% 400 2 0.0 0% 100% 0% 400 2 0.4 0% 100% 0% 400 2 0.7 0% 100% 0% 400 3 0.0 0% 0% 100% 400 3 0.4-0.7 0% 30% 70% Note: Percentages are based on a total of 10 simulated data sets under each condition. Note: Numbers in blue indicate results that align with the number of factors that were simulated; numbers in red indicate results that do not align with the number of factors that were simulated.