OBJECTIVES Evidence suggests inflammation is associated with cognitive impairment, but previous epidemiological studies have reported conflicting results. DESIGN Prospective population-based cohort. SETTING Epidemiology of Hearing Loss Study participants. PARTICIPANTS Individuals without cognitive impairment in 1998–2000 (N = 2,422; 1,947 with necessary data). MEASUREMENTS Cognitive impairment (Mini-Mental State Examination score <24 or diagnosis of dementia) was ascertained in 1998–2000, 2003–2005, and 2009– 2010. Serum C-reactive protein (CRP) and interleukin-6 (IL-6) were measured in 1988–1990, 1998–2000, and 2009–2010; tumor necrosis factor-alpha was measured from 1998–2000. RESULTS Participants with high CRP in 1988–1990 and 1998–2000 had lower risk of cognitive impairment than those with low CRP at both time points (hazard ratio (HR) = 0.46, 95% confidence interval (CI) = 0.26–0.80). Risk did not differ according to 10-year IL-6 profile or baseline inflammation category in the whole cohort. In sensitivity analyses restricted to statin nonusers, those with high IL-6 at both times had greater risk of cognitive impairment than those with low IL-6 at both times (HR = 3.35, 95% CI = 1.09–10.30). In secondary analyses, each doubling of IL-6 change over 20 years was associated with greater odds of cognitive impairment in 2009–2010 in the whole cohort (odds ratio (OR) = 1.40, 95% CI = 1.04–1.89), whereas a doubling of CRP change over 20 years was associated with cognitive impairment only in statin nonusers (OR = 1.32, 95% CI = 1.06–1.65). CONCLUSION With data collected over 20 years, this study demonstrated greater likelihood of cognitive impairment in individuals with repeated high or increasing IL-6. The inconsistent CRP findings may reflect effects of statin medications, survival effects, or adverse effects associated with chronically low CRP. Further studies of long-term inflammation and cognitive impairment are needed.

Mental health problems disproportionately affect women, particularly during childbearing years. We sought to estimate the prevalence of antepartum mental health problems and determine potential risk factors in a representative USA population. We examined data on 3,051 pregnant women from 11 panels of the 1996–2006 Medical Expenditure Panel Survey. Poor antepartum mental health was defined by self report of mental health conditions or symptoms or a mental health rating of “fair” or “poor.” Multivariate regression analyses modeled the odds of poor antepartum mental health; 7.8% of women reported poor antepartum mental health. A history of mental health problems increased the odds of poor antepartum mental health by a factor of 8.45 (95% CI, 6.01–11.88). Multivariate analyses were stratified by history of mental health problems. Significant factors among both groups included never being married and self-reported fair/poor health status. This study identifies key risk factors associated with antepartum mental health problems in a nationally representative sample of pregnant women. Women with low social support, in poor health, or with a history of poor mental health are at an increased risk of having antepartum mental health problems. Understanding these risk factors is critical to improve the long-term health of women and their children.

Non-steroidal anti-inflammatory drugs (NSAIDs) may prevent dementia, but previous studies have yielded conflicting results. This study estimated the association of prior NSAID use with incident cognitive impairment in the population-based Epidemiology of Hearing Loss Study (n=2422 without cognitive impairment in 1998-2000). Prospectively collected medication data from 1988-1990, 1993-1995, and 1998-2000 were used to categorize NSAID use history at the cognitive baseline (1998-2000). Aspirin use and non-aspirin NSAID use were separately examined. Cox regression models were used to estimate the associations between NSAID use history at baseline and incident cognitive impairment in 2003-2005 or 2009-2010. Logistic regression analyses were used to estimate associations with a second outcome, mild cognitive impairment (MCI)/dementia, available in 2009-2010. Participants using aspirin at baseline but not 5 years prior were more likely to develop cognitive impairment (adjusted hazard ratio (HR) = 1.77; 95% confidence interval (CI) = 1.11, 2.82; Model 2), with non-significant associations for longer term use. Non-aspirin NSAID use was not associated with incident cognitive impairment or MCI/dementia odds. These results provided no evidence to support a potential protective effect of NSAIDs against dementia.

The prevalence of hearing impairment, as well as many other medical conditions, increases with age. Epidemiological evidence also suggests that the prevalence of hearing impairment, cardiovascular disease, and possibly dementia have declined during the 20th century. Differences in disease occurrence by birth year indicate that modifiable risk factors contribute to these diseases and that exposure to these risk factors changed over time. This article discusses the co-occurrence of chronic conditions at older ages, along with their shared risk factors and similar temporal trends. Recognition of these patterns is important for audiologists and other health care professionals who treat these complex patients, as well as for researchers investigating the underlying causes of these diseases. Various lines of evidence linking hearing impairment to other conditions and medication use point to the need for hearing health care to be better integrated with the broader health care system.Learning Outcomes: As a result of this activity, the participant will be able to (1) list at least three health conditions that may be more common in older people with hearing impairments and (2) identify findings from at least two studies that suggest that hearing impairment in older adults is at least partly preventable.

IntroductionPatient-reported outcome (PRO) measures are increasingly developed with multisite, representative patient populations so that they can serve as a primary endpoint in clinical trials and longitudinal studies. Creating multisite infrastructure during PRO measure development can facilitate future comparative effectiveness trials. We describe our protocol to simultaneously develop a PRO measure and create a collaborative of tertiary care centres to address the needs of patients with unilateral vocal fold paralysis (UVFP). We describe the stakeholder engagement, information technology and regulatory foundations for PRO measure development and how the process enables plans for multisite trials comparing treatments for this largely iatrogenic condition.Methods and analysisThe study has three phases: systematic review, measure development and measure validation. Systematic reviews and qualitative interviews (n=75) will inform the development of a conceptual framework. Qualitative interviews with patients with UVFP will characterise the lived experience of the condition. Candidate PRO measure items will be derived verbatim from patient interviews and refined using cognitive interviews and expert input. The PRO measure will be administered to a large, multisite cohort of adult patients with UVFP via the CoPE (vocal Cord Paralysis Experience) Collaborative. We will establish CoPE to facilitate measure development and to create preliminary infrastructure for future trials, including online data capture, stakeholder engagement, and the identification of barriers and facilitators to participation. Classical test theory psychometrics and grounded theory characterise our approach, and validation includes assessment of latent structure, reliability and validity.Ethics and disseminationOur study is approved by the University of Wisconsin Health Sciences Institutional Review Board. Findings from this project will be published in open-access journals and presented at international conferences. Subsequent use of the PRO measure will include comparative effectiveness trials of treatments for UVFP at CoPE Collaborative sites.

IMPORTANCE Unilateral vocal fold paralysis (UVFP) is a common and life-changing complication of cancer, trauma, and an estimated 500 000 head, neck, and chest surgeries performed annually in the US, among other causes (eg, idiopathic). Consequent disabilities are profound and often permanent and can include severe voice, swallowing, and breathing dysfunction and concomitant anxiety, isolation, and fear. Physiological measures often correlate poorly with patient-reported disability. The measure described herein was designed to be a comprehensive, psychometrically sound UVFP-specific patient-reported outcome measure (PROM) for use in clinical trials or at point of care. OBJECTIVE To evaluate the reliability and validity of the CoPE (vocal Cord Paralysis Experience) PROM in a nationally representative sample for both clinical and research use. DESIGN, SETTING, AND PARTICIPANTS This survey validation study was performed at 34 tertiary care centers across the US and included English-speaking adults with unilateral vocal fold immobility confirmed via laryngoscopy.MAIN OUTCOMES AND MEASURES Reliability (internal consistency, alternate form, and test-retest) and validity (convergent and known-group). RESULTSIn total, 613 patients (mean [SD] age, 58 [15.3] years; 394 [64.5%] women) were recruited, and 555 (92.3%) completed surveys for all time points. Internal consistency was high in the overall 22-item PROM and psychosocial, swallow, and voice subscales (Cronbach α > 0.91). Intraclass correlations for individuals between the baseline and 2-week administrations were moderate for the overall score and subscales (intraclass correlations range, 0.66-0.80). There were significant differences between the online and 2-week paper administrations for the overall score and voice and psychosocial subscales (overall scale mean: 54.4 [95% CI, 49.7-59.1] vs 48.9 [95% CI, 43.7-54.0] at 2 weeks). The confirmatory model was found to be suitably fitted based on average r 2 values 0.5 or greater for subscale and overall scores. Correlations between subscales and existing PROMs (Voice-Related Quality of Life, Eating Assessment Tool, and Communication Participation Item Bank) were all greater than 0.69, and mean PROM subscale scores were significantly different across known quartiles of existing PROMs. CONCLUSIONS AND RELEVANCEThe findings of this survey validation study suggest that the CoPE PROM could serve as a psychometrically sound, comprehensive measure of UVFP-attributed disability suitable for use in clinical and research settings to assess within-person changes. The results will inform a user manual to facilitate use in clinical trials comparing the effectiveness and durability of treatments including behavioral (speech therapy), temporary (eg, injection augmentation), and permanent surgical treatments for UVFP.

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