Reliability and Construct Validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) Instruments in Women with Fibromyalgia.

OBJECTIVE: The Patient-Reported Outcomes Measurement Information System (PROMIS) was developed to standardize measurement of clinically relevant patient-reported outcomes. This study evaluated the reliability and construct validity of select PROMIS static short-form (SF) instruments in women with fibromyalgia. DESIGN: Analysis of baseline data from the Fibromyalgia Activity Study with TENS (FAST), a randomized controlled trial of the efficacy of transcutaneous electrical nerve stimulation. SETTING: Dual site, university-based outpatient clinics. SUBJECTS: Women aged 20 to 67 years diagnosed with fibromyalgia. METHODS: Participants completed the Revised Fibromyalgia Impact Questionnaire (FIQR) and 10 PROMIS static SF instruments. Internal consistency was calculated using Cronbach alpha. Convergent validity was examined against the FIQR using Pearson correlation and multiple regression analysis. RESULTS: PROMIS static SF instruments had fair to high internal consistency (Cronbach α = 0.58 to 0.94, P < 0.05). PROMIS 'physical function' domain score was highly correlated with FIQR 'function' score (r = -0.73). The PROMIS 'total' score was highly correlated with the FIQR total score (r = -0.72). Correlations with FIQR total score of each of the three PROMIS domain scores were r = -0.65 for 'physical function,' r = -0.63 for 'global,' and r = -0.57 for 'symptom' domain. PROMIS 'physical function,' 'global,' and 'symptom' scores explained 58% of the FIQR total score variance. CONCLUSIONS: Select PROMIS static SF instruments demonstrate convergent validity with the FIQR, a legacy measure of fibromyalgia disease severity. These results highlight the potential utility of select PROMIS static SFs for assessment and tracking of patient-reported outcomes in fibromyalgia.

An Analysis of Conjunctival Map Biopsies in Sebaceous Carcinoma.

PURPOSE: To evaluate the need for standardized conjunctival map biopsies in periocular sebaceous carcinoma and to formulate recommendations regarding map biopsy number, location, size, and utility based on analysis of biopsy locations, results, and outcomes. METHODS: Retrospective consecutive series of patients with sebaceous carcinoma treated at a tertiary care hospital from 1988 to 2013. Main outcome measures included conjunctival biopsy locations, number, size, and pathology. RESULTS: A diffuse eyelid pattern was evident on presentation in 28/51 patients (54.9%) versus a solitary eyelid nodule in 23/51 (45.1%). Forty-five patients underwent a total of 429 conjunctival biopsies. The conjunctiva was negative in 277 specimens (64.6%), positive in 121 (28.2%), suspicious in 26 (6.1%), and nondiagnostic in 5 (1.2%). Intraepithelial conjunctival involvement was present in 36 patients (70.6%) of whom 23 (63.9%) presented with a diffuse eyelid appearance. There was no statistically significant correlation between primary tumor location and sites of positive biopsies or biopsy size. The pattern at presentation and location of primary tumor did not correlate with biopsy results. Clinical assessment regarding conjunctival involvement was incorrect in 10 of 23 patients (43.5%) with a solitary nodule. Despite primary tumor resection with clear margins confirmed on pathology, 5 of 45 (11%) patients had locally recurrent sebaceous carcinoma. CONCLUSIONS: Conjunctival biopsy size does not correlate with the presence of tumor in the biopsy. Primary tumor location and pattern of tumor at presentation do not correlate with conjunctival biopsy results. Irrespective of the clinical tumor features, standardized conjunctival map biopsies are essential in staging periocular sebaceous carcinoma.

Test-Retest Reliability and Responsiveness of PROMIS Sleep Short Forms Within an RCT in Women With Fibromyalgia.

Background: Nonrestorative sleep is commonly reported by individuals with fibromyalgia, but there is limited information on the reliability and responsiveness of self-reported sleep measures in this population. Objectives: (1) Examine the reliability and validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) sleep measures in women with fibromyalgia, and (2) Determine the responsiveness of the PROMIS sleep measures to a daily transcutaneous electrical nerve stimulation (TENS) intervention in women with fibromyalgia over 4 weeks compared with other measures of restorative sleep. Methods: In a double-blinded, dual-site clinical trial, 301 women with fibromyalgia were randomly assigned to utilize either Active-TENS, Placebo-TENS, or No-TENS at home. Measures were collected at baseline and after 4 weeks of treatment. To assess self-reported sleep, the participants completed three PROMIS short forms: Sleep Disturbance, Sleep-Related Impairment, Fatigue, and the Pittsburgh Sleep Quality Index (PSQI). To assess device-measured sleep, actigraphy was used to quantify total sleep time, wake after sleep onset, and sleep efficiency. Linear mixed models were used to examine the effects of treatment, time, and treatment*time interactions. Results: The PROMIS short forms had moderate test-retest reliability (ICC 0.62 to 0.71) and high internal consistency (Cronbach's alpha 0.89 to 0.92). The PROMIS sleep measures [mean change over 4 weeks, 95% confidence interval (CI)], Sleep Disturbance: -1.9 (-3.6 to -0.3), Sleep-Related Impairment: -3 (-4.6 to -1.4), and Fatigue: -2.4 (-3.9 to -0.9) were responsive to improvement in restorative sleep and specific to the Active-TENS group but not in the Placebo-TENS [Sleep Disturbance: -1.3 (-3 to 0.3), Sleep-Related Impairment: -1.2 (-2.8 to 0.4), Fatigue: -1.1 (-2.7 to 0.9)] or No-TENS [Sleep Disturbance: -0.1 (-1.6 to 1.5), Sleep-Related Impairment: -0.2 (-1.7 to 1.4), Fatigue: -.3 (-1.8 to 1.2)] groups. The PSQI was responsive but not specific with improvement detected in both the Active-TENS: -0.9 (-1.7 to -0.1) and Placebo-TENS: -0.9 (-1.7 to 0) groups but not in the No-TENS group: -0.3 (-1.1 to 0.5). Actigraphy was not sensitive to any changes in restorative sleep with Active-TENS [Sleep Efficiency: -1 (-2.8 to 0.9), Total Sleep Time: 3.3 (-19.8 to 26.4)]. Conclusion: The PROMIS sleep measures are reliable, valid, and responsive to improvement in restorative sleep in women with fibromyalgia. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT01888640.

Timing of Esophagectomy after Neoadjuvant Chemoradiation Therapy Affects the Incidence of Anastomotic Leaks.

BACKGROUND: Neoadjuvant chemoradiation therapy (nCRT) has become the standard of care for esophageal cancer patients prior to esophagectomy. However, the optimal timing for surgery after completion of nCRT remains unclear. METHODS: A retrospective review was performed of patients who underwent esophagectomy with cervical anastomosis for esophageal cancer at a single institution between January 2000 and June 2015. Patients were categorized into 3 cohorts: those who did not receive nCRT prior to esophagectomy (no nCRT), those who underwent esophagectomy within 35 days after nCRT (≤35d), and those who underwent esophagectomy more than 35 days after nCRT (>35d). RESULTS: A total of 366 esophagectomies were performed during the study period, and 348 patients met the inclusion criteria. Anastomotic leaks occurred in 11.8% of all patients included in the study (41 of 348). Within each cohort, anastomotic leaks were detected in 14.7% of patients (17 of 116) in the no nCRT cohort, 7.3% (13 of 177) in the ≤35d cohort, and 20.0% (11 of 55) in the >35d cohort (p=0.020). Significant differences in the occurrence of anastomotic leaks were observed between the no nCRT and ≤35d cohorts (p=0.044), and between the ≤35d and >35d cohorts (p=0.007). CONCLUSION: Esophagectomy with cervical anastomosis within 35 days of nCRT resulted in a lower percentage of anastomotic leaks.

Physical activity is related to function and fatigue but not pain in women with fibromyalgia: baseline analyses from the Fibromyalgia Activity Study with TENS (FAST).

BACKGROUND: Although exercise is an effective treatment for fibromyalgia, the relationships between lifestyle physical activity and multiple symptomology domains of fibromyalgia are not clear. Thus, the purpose of this study was to comprehensively examine the relationships between lifestyle physical activity with multiple outcome domains in women with fibromyalgia, including pain, fatigue, function, pain-related psychological constructs, and quality of life. METHODS: Women (N = 171), aged 20 to 70 years, diagnosed with fibromyalgia, recruited from an ongoing two-site clinical trial were included in this prespecified subgroup analysis of baseline data. Physical activity was assessed using self-report and accelerometry. Symptomology was assessed using questionnaires of perceived physical function, quality of life, fatigue, pain intensity and interference, disease impact, pain catastrophizing, and fear of movement. In addition, quantitative sensory testing of pain sensitivity and performance-based physical function were assessed. Correlation coefficients, regression analyses and between-group differences in symptomology by activity level were assessed, controlling for age and body mass index (BMI). RESULTS: Lifestyle physical activity was most closely associated with select measures of physical function and fatigue, regardless of age and BMI. Those who performed the lowest levels of lifestyle physical activity had poorer functional outcomes and greater fatigue than those with higher physical activity participation. No relationships between lifestyle physical activity and pain, pain sensitivity, or pain-related psychological constructs were observed. CONCLUSIONS: Lifestyle physical activity is not equally related to all aspects of fibromyalgia symptomology. Lifestyle physical activity levels have the strongest correlations with function, physical quality of life, and movement fatigue in women with fibromyalgia. No relationships between lifestyle physical activity and pain, pain sensitivity, or psychological constructs were observed. These data suggest that physical activity levels are more likely to affect function and fatigue, but have negligible relationships with pain and pain-related psychological constructs, in women with fibromyalgia. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01888640 . Registered on 28 June 2013.

Monocytosis and a Low Lymphocyte to Monocyte Ratio Are Effective Biomarkers of Ulcerative Colitis Disease Activity.

BACKGROUND: Current biomarkers in ulcerative colitis (UC) are limited by their performance, cost, and limited availability in daily practice. This study examined alterations in the leukocyte profiles as biomarkers of UC activity, including the effects of age, gender, and medications. METHODS: Case-control study that included 110 UC subjects, 75 subjects with Clostridium difficile infection, and 75 non-inflammatory bowel disease (IBD) subjects, randomly selected from a single-institution IBD database. Mean values of neutrophils (N), lymphocytes (L), monocytes (M) and their ratios were compared between groups. Receiver operator curve analyses assessed the performance of each biomarker in discriminating disease states. Subgroup analyses examined leukocytes profiles with endoscopic activity. RESULTS: Elevated monocyte counts and decreased L/M values significantly differed between subjects with active UC and UC in remission and performed better than the other leukocyte profiles. A monocyte count of 483 and L/M ratio of 3.1 were 60% sensitive and had a specificity of 61% and 53%, respectively for active UC. Monocyte count >860 and L/M value <1.6 had a 75% positive predictive value for UC activity. Those markers also correlated with endoscopically active disease. L/M and N/L values performed best at differentiating active UC from non-IBD controls, whereas N/L and N values performed best at differentiating from C. difficile controls. CONCLUSIONS: Monocytosis and a low L/M ratio might be effective, readily available, and low-cost biomarkers to identify disease activity in UC patients. N/L values were more effective in distinguishing active UC patients from patients without IBD and those with C. difficile infection.

Effect of transcutaneous electrical nerve stimulation on pain, function, and quality of life in fibromyalgia: a double-blind randomized clinical trial.

BACKGROUND: Fibromyalgia is a common chronic pain condition that has a significant impact on quality of life and often leads to disability. To date, there have been few well-controlled trials assessing the utility of nonpharmacological treatment modalities such as transcutaneous electrical nerve stimulation (TENS) in the management of pain and improvement in function in individuals with fibromyalgia. OBJECTIVES: The purpose of this study will be to complete a long-term, multicenter study to assess the effects of TENS in women with fibromyalgia. DESIGN: This will be a phase II randomized, double-blind, placebo-controlled, multicenter clinical trial. PARTICIPANTS: Three hundred forty-three participants with fibromyalgia will be recruited for this study. INTERVENTION: Participants will be randomly assigned to 1 of 3 groups: the intervention (TENS), placebo, or no treatment. After completing the randomized period, all participants will receive the intervention for 1 month. The participants will be asked to use TENS at the highest tolerable level for at least 2 hours daily during physical activity. MEASUREMENTS: The primary outcome will be pain with movement, with secondary outcomes assessing functional abilities, patient-reported outcomes, and quantitative sensory testing. LIMITATIONS: Because having participants refrain from their typical medications is not practical, their usage and any change in medication use will be recorded. CONCLUSIONS: The results of this study will provide some of the first evidence from a large-scale, double-blind, placebo-controlled trial on the effectiveness of TENS on pain control and quality-of-life changes in patients with fibromyalgia.

The Agility total ankle arthroplasty. Seven to sixteen-year follow-up.

BACKGROUND: We previously reported the intermediate-term results with the early version of the Agility total ankle replacement, a unique design that takes advantage of arthrodesis of the tibiofibular syndesmosis for tibial component support. The purpose of this study was to report longer-term results of this procedure in the treatment of disabling ankle arthritis. METHODS: We conducted an independent review of all Agility total ankle replacements performed by a single surgeon between 1984 and 1994. Follow-up evaluation consisted of completion of a validated ankle osteoarthritis scale and a short questionnaire and a review of the radiographs. All radiographs were evaluated for evidence of the development of progressive hindfoot arthritis, nonunion of the tibiofibular syndesmosis, progressive radiolucent lines, osteolysis, and component subsidence. RESULTS: One hundred and thirty-two arthroplasties were performed in 126 patients. After a mean follow-up period of nine years, thirty-three patients (thirty-six implants) had died, fourteen patients (11%) had a revision of the implant or an ankle arthrodesis, and one had the leg amputated because of an unrelated cause. Of the remaining seventy-eight patients (eighty-one ankles), sixty-seven (sixty-nine ankles) were followed clinically. More than 90% of them reported that they had decreased pain and were satisfied with the outcome of the surgery. We found modest differences in a comparison of the pain and disability scores with those of age-matched controls. Of the 117 ankles that had been followed radiographically for a minimum of two years, twenty-two (19%) had progressive subtalar arthritis, seventeen (15%) had progressive talonavicular arthritis, and nine (8%) had a syndesmosis nonunion. Eighty-nine (76%) of the 117 ankles had some evidence of peri-implant radiolucency. CONCLUSIONS: Arthrodesis of the tibiofibular syndesmosis impacts the radiographic and clinical outcomes with the Agility total ankle replacement. The relatively low rates of radiographic hindfoot arthritis and revision procedures at an average of nine years after the arthroplasty are encouraging. Agility total ankle replacement is a viable and durable option for the treatment of ankle arthritis in selected patients.

Are treatments for vasovagal syncope effective? A meta-analysis.

BACKGROUND: Therapies used to treat vaso-vagal syncope (VVS) recurrence have not been proven effective in single studies. METHODS: Comprehensive search of PubMed, EMBASE and Cochrane Central databases of published trials was done. Randomized or non-randomized studies, comparing the intervention of interest to control group(s), with the endpoint of spontaneous recurrence or syncope on head-up tilt test, were included. Data were extracted on an intention-to-treat basis. Study heterogeneity was analyzed by Cochran's Q statistics. A random-effect analysis was used. RESULTS: α-adrenergic agonists were found effective (n=400, OR 0.19, CI 0.06-0.62, p<0.05) in preventing VVS recurrence. ß-blockers were not found to be effective when only randomized studies comparing ß-blockers to non-pharmacologic agents were assessed (9 studies, n=583, OR 0.48, CI 0.22-1.04, p=0.06). Tilt-training had no effect when only randomized studies were considered (4 studies, n=298, OR 0.47, CI 0.21-1.05, p=0.07). Selective serotonin reuptake inhibitors were found effective (n=131, OR 0.28, CI 0.10-0.74, p<0.05), though the analysis contained only 2 studies. Pacemakers were found effective in preventing syncope recurrence when all studies were analyzed (n=463, OR 0.13, CI 0.05-0.36, p<0.05). However, studies comparing active pacemaker to sensing mode only did not show benefit (3 studies, n=162, OR 0.45, CI 0.09-2.14, p=0.32). CONCLUSIONS: This meta-analysis highlights the totality of evidence for commonly used medications used to treat VVS, and the requirement for larger, double-blind, placebo controlled trials with longer follow-up.

In vitro fertilization patients support a single blastocyst transfer policy.

OBJECTIVE: To determine whether patients support a mandatory single blastocyst transfer (mSBT) policy in IVF. DESIGN: Prospective survey study. SETTING: Academic hospital-based infertility center. PATIENT(S): Two hundred sixty-two female patients presenting for fresh or cryopreserved/thawed ET after IVF. INTERVENTION(S): Internet-based in-clinic survey after ET. Follow-up at-home survey after pregnancy test results. MAIN OUTCOME MEASURE(S): Patient support for an mSBT policy and attitudes regarding patient input into IVF treatment. Logistic regression analyses tested associations among main outcome measures, patient characteristics, and treatment results. RESULT(S): Ninety-four percent of patients endorsed support for our mSBT policy; 95% and 87% felt they had the right amount of input in their IVF treatment and number of embryos transferred, respectively, and these subjects were more likely to support the mSBT policy. Other factors associated with stronger support were concern for multiples, availability of extra cryopreserved embryos, and shorter duration of infertility. Receiving a single blastocyst during treatment did not change the level of support. A negative pregnancy outcome decreased support, however. CONCLUSION(S): Policies restricting the number of embryos transferred may find wide patient acceptance.