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BackgroundChronic obstructive pulmonary disease (COPD) is a progressive chronic disease characterized by airflow obstruction that leads to shortness of breath and substantial negative impacts on health-related quality of life (HRQL). The course of COPD includes periodic acute exacerbations that require changes in treatment and/or hospitalizations. This study was designed to examine the responsiveness of Patient-Reported Outcomes Measurement Information System® (PROMIS®) measures to changes associated with COPD exacerbation recovery.MethodsA longitudinal analysis using mixed-effects models was conducted of people who were enrolled while stable (n = 100) and those who experienced an acute exacerbation (n = 85). PROMIS (physical function, pain interference, pain behavior, fatigue, anxiety, depression, anger, social roles, discretionary social activities, Global Health, dyspnea severity and dyspnea functional limitations) and COPD-targeted HRQL measures were completed at baseline and at 12 weeks.ResultsWe administered PROMIS measures using computer adaptive testing (CAT), followed by administration of any remaining short form (SF) items that had not yet been administered by CAT. Examination of the difference between group differences from baseline to 12 weeks in the stable and exacerbation groups revealed that the exacerbation group changed (improved) significantly more than the stable group in anxiety (p

BackgroundLittle is known about short- and long-term pain and functional activity after surgery for pelvic organ prolapse.ObjectiveThe objectives of the study were to describe postoperative pain and functional activity after transvaginal native tissue reconstructive surgery with apical suspension and retropubic synthetic midurethral sling and to compare these outcomes between patients receiving 2 common transvaginal prolapse repairs, uterosacral ligament, and sacrospinous ligament vaginal vault suspension.Study designThis planned secondary analysis of a 2 × 2 factorial randomized trial included 374 women randomized to receive uterosacral (n = 188) or sacrospinous (n = 186) vaginal vault suspension to treat both stages 2-4 apical vaginal prolapse and stress urinary incontinence between 2008 and 2013 at 9 medical centers. Participants were also randomized to receive perioperative pelvic muscle therapy or usual care. All patients received transvaginal native tissue repairs and a midurethral sling. Participants completed the Surgical Pain Scales (0-10 numeric rating scales; higher scores = greater pain) and Activity Assessment Scale (0-100; higher score = higher activity) prior to surgery and at 2 weeks, 4-6 weeks, and 3 months postoperatively. The MOS 36-item Short-Form Health Survey was completed at baseline and 6, 12, and 24 months after surgery; the bodily pain, physical functioning, and role-physical subscales were used for this analysis (higher scores = less disability). Self-reported pain medication use was also collected.ResultsBefore surgery, average pain at rest and during normal activity were (adjusted mean ± SE) 2.24 ± 0.23 and 2.76 ± 0.25; both increased slightly from baseline at 2 weeks (+0.65, P = .004, and +0.74, P = .007, respectively) and then decreased below baseline at 3 months (-0.87 and -1.14, respectively, P < .001), with no differences between surgical groups. Pain during exercise/strenuous activity and worst pain decreased below baseline levels at 4-6 weeks (-1.26, P = .014, and -0.95, P = .002) and 3 months (-1.97 and -1.50, P < .001) without differences between surgical groups. Functional activity as measured by the Activity Assessment Scale improved from baseline at 4-6 weeks (+9.24, P < .001) and 3 months (+13.79, P < .001). The MOS 36-item Short-Form Health Survey Bodily Pain, Physical Functioning, and Role-Physical Scales demonstrated significant improvements from baseline at 6, 12, and 24 months (24 months: +5.62, +5.79, and +4.72, respectively, P < .001 for each) with no differences between groups. Use of narcotic pain medications was reported by 14.3% of participants prior to surgery and 53.7% at 2 and 26.1% at 4-6 weeks postoperatively; thereafter use was similar to baseline rates until 24 months when it decreased to 6.8%. Use of nonnarcotic pain medication was reported by 48.1% of participants prior to surgery, 68.7% at 2 weeks, and similar to baseline at 3 months; thereafter use dropped steadily to 26.6% at 2 years. Uterosacral ligament suspension resulted in less new or worsening buttock pain than sacrospinous suspension at 4-6 weeks postoperatively (4.6% vs 10.5%, P = .043) but no difference in groin or thigh pain.ConclusionPain and functional activity improve for up to 2 years after native tissue reconstructive surgery with uterosacral or sacrospinous vaginal vault suspension and midurethral sling for stages 2-4 pelvic organ prolapse. On average, immediate postoperative pain is low and improves to below baseline levels by 4-6 weeks.

BackgroundThere is a need for valid self-report measures of core health-related quality of life (HRQoL) domains.ObjectiveTo derive brief, reliable and valid health profile measures from the Patient Reported Outcomes Measurement Information System® (PROMIS®) item banks.MethodsLiterature review, investigator consensus process, item response theory (IRT) analysis, and expert review of scaling results from multiple PROMIS data sets. We developed 3 profile measures ranging in length from 29 to 57 questions. These profiles assess important HRQoL domains with highly informative subsets of items from respective item banks and yield reliable information across mild-to-severe levels of HRQoL experiences. Each instrument assesses the domains of pain interference, fatigue, depression, anxiety, sleep disturbance, physical function, and social function using 4-, 6-, and 8-item short forms for each domain, and an average pain intensity domain score, using a 0-10 numeric rating scale.ResultsWith few exceptions, all domain short forms within the profile measures were highly reliable across at least 3 standard deviation (30 T-score) units and were strongly correlated with the full bank scores. Construct validity with ratings of general health and quality of life was demonstrated. Information to inform statistical power for clinical and general population samples is also provided.ConclusionsAlthough these profile measures have been used widely, with summary scoring routines published, description of their development, reliability, and initial validity has not been published until this article. Further evaluation of these measures and clinical applications are encouraged.

PurposeThe Patient-Reported Outcomes Measurement Information System (PROMIS(®)) initiative was developed to advance the methodology of PROs applicable to chronic diseases. Chronic obstructive pulmonary disease (COPD) is a progressive chronic disease associated with poor health. This study was designed to examine the correlation of PROMIS health-related quality of life (HRQOL) scales and clinical measures among COPD patients.MethodsA cross-sectional analysis was conducted comparing patients who were stable (n = 100) with those currently experiencing a COPD exacerbation (n = 85). All PROMIS measures for adults available at the time of the study (2008), disease-targeted and other HRQOL instruments, health literacy, percent predicted FEV1, and a 6-min walk distance were assessed when patients were considered clinically stable.ResultsStable COPD patients reported significantly (p ≤ 0.05) better health-related quality of life on PROMIS domains than patients experiencing an exacerbation. PROMIS domain scores were significantly (p ≤ 0.01) correlated with each of legacy measures. Six-min walk scores were most highly correlated with the PROMIS physical function domain scores (r = 0.53) followed by the fatigue (r = -0.26), social (r = 0.24) and to a lesser extent depression (r = -0.23), and anxiety (r = -0.22) domain scores. Percent predicted FEV1 score was significantly associated with PROMIS physical function scores (r = 0.27).ConclusionThis study provides support for the validity of the PROMIS measures in COPD patients.