Results of a RCT assessing saline and xylitol nasal irrigation for CRS and fatigue in Gulf War illness.

OBJECTIVE: To assess the efficacy of saline nasal irrigation (S-NI) and xylitol nasal irrigation (X-NI) for chronic rhinosinusitis in participants with Gulf War illness (GWI). METHODS: This 26 week, 3-arm (1:1:1) randomized controlled trial examined veterans meeting criteria for GWI with moderate-to-severe chronic rhinosinusitis and fatigue symptoms. All participants received standard of care for chronic rhinosinusitis (CRS); additionally, S-NI or X-NI participants added twice-daily NI using 2% saline or 5% xylitol solutions. Outcomes included disease-specific quality of life (primary; sino-nasal outcome test [SNOT-20]; 0-100 points), overall quality of life (Short-Form 36), and fatigue (Multidimensional Fatigue Index). Outcome assessors were blind to allocation group. Intention-to-treat analysis used repeated measures modeling; statistical significance was evaluated at the two-sided α level of .05. RESULTS: Randomization (N = 40) produced three similar groups regarding sex (male, 80%), age (53.8 ± 7.8 years), duration (19.8 ± 7.7 years), and illness severity (48.5 ± 12.7 SNOT-20 points). Age- and gender-adjusted between-group comparison showed that X-NI participants, compared with control, reported improved SNOT-20 scores at 8 weeks (13.5 points, 95% confidence interval [CI] -27.9 to 0.9) and at 26 weeks (15.4 points, 95% CI -30.1 to -0.6). S-NI participants improved by 13.4 points (95% CI -28.8, 2.1) at 26 weeks compared with control.The improvement in both NI groups approached minimal clinical important difference compared to control for the SNOT-20 in the general population. Secondary outcomes were not different between groups. Satisfaction in both irrigation groups was high. CONCLUSIONS: This randomized controlled trial suggests that NI with saline or xylitol improves chronic sinus symptoms among participants with GWI with improvement scores similar to those in the general population. LEVEL OF EVIDENCE: 1b, individual randomized controlled trial.

Correlation of prevention practices with rates of health care-associated Clostridioides difficile infection.

OBJECTIVE: We examined Clostridioides difficile infection (CDI) prevention practices and their relationship with hospital-onset healthcare facility-associated CDI rates (CDI rates) in Veterans Affairs (VA) acute-care facilities. DESIGN: Cross-sectional study. METHODS: From January 2017 to February 2017, we conducted an electronic survey of CDI prevention practices and hospital characteristics in the VA. We linked survey data with CDI rate data for the period January 2015 to December 2016. We stratified facilities according to whether their overall CDI rate per 10,000 bed days of care was above or below the national VA mean CDI rate. We examined whether specific CDI prevention practices were associated with an increased risk of a CDI rate above the national VA mean CDI rate. RESULTS: All 126 facilities responded (100% response rate). Since implementing CDI prevention practices in July 2012, 60 of 123 facilities (49%) reported a decrease in CDI rates; 22 of 123 facilities (18%) reported an increase, and 41 of 123 (33%) reported no change. Facilities reporting an increase in the CDI rate (vs those reporting a decrease) after implementing prevention practices were 2.54 times more likely to have CDI rates that were above the national mean CDI rate. Whether a facility's CDI rates were above or below the national mean CDI rate was not associated with self-reported cleaning practices, duration of contact precautions, availability of private rooms, or certification of infection preventionists in infection prevention. CONCLUSIONS: We found considerable variation in CDI rates. We were unable to identify which particular CDI prevention practices (i.e., bundle components) were associated with lower CDI rates.

Health care worker perspectives of their motivation to reduce health care-associated infections.

BACKGROUND: Health care-associated infections (HAIs) are largely preventable, but are associated with considerable health care burden. Given the significant cost of HAIs, many health care institutions have implemented bundled interventions to reduce HAIs. These complex behavioral interventions require considerable effort; however, individual behaviors and motivations crucial to successful and sustained implementation have not been adequately assessed. We evaluated health care worker motivations to reduce HAIs. METHODS: This was a phenomenologic qualitative study of health care workers in different roles within a university hospital, recruited via a snowball strategy. Using constructs from the Consolidated Framework for Implementation Research model, face-to-face semi-structured interviews were used to explore perceptions of health care worker motivation to follow protocols on HAI prevention. RESULTS: Across all types of health care workers interviewed, patient safety and improvement in clinical outcomes were the major motivators to reducing HAIs. Other important motivators included collaborative environment that valued individual input, transparency and feedback at both organizational and individual levels, leadership involvement, and refresher trainings and workshops. We did not find policy, regulatory considerations, or financial penalties to be important motivators. CONCLUSIONS: Health care workers perceived patient safety and clinical outcomes as the primary motivators to reduce HAI. Leadership engagement and data-driven interventions with frequent performance feedback were also identified as important facilitators of HAI prevention.

Rasch Analysis of The WURSS-21 Dimensional Validation and Assessment of Invariance.

BACKGROUND: The purpose of this study is to use Rasch analysis to explore the validity of considering self-report scores from Wisconsin Upper Respiratory Symptom Survey (WURSS-21) as a single global illness severity domain. The WURSS-21 is a widely used questionnaire instrument that assesses symptom severity and functional impact of common cold and flu-like illness. METHODS: This study applies item response theory, specifically Rasch modeling, to investigate dimensional and measurement properties of the WURSS-21, and looks at invariance over time. The data assessed represents 1167 people, each scoring the WURSS-21 once daily for up to seven consecutive days of acute upper respiratory infection (URI) illness. RESULTS: Rasch analysis supports a single domain WURSS-21 global symptom score. Assessment of differential item functioning across seven days of illness provides evidence for measurement invariance. While individual items rating physical symptoms were somewhat variable, items rating functional impairment and quality of life impact appeared quite consistent across a single domain over seven days of illness. CONCLUSION: Rasch analysis of WURSS-21 items provides evidential support for a single invariant domain. These findings support the practice of using a simply summed daily global illness severity score to represent the overall symptomatic and functional impairments arising from URI.

Effectiveness of nasal irrigation for chronic rhinosinusitis and fatigue in patients with Gulf War illness: protocol for a randomized controlled trial.

INTRODUCTION: Gulf War Illness (GWI) affects 1 in 7 returned Persian Gulf War veterans. Quality-of-life impact is large; there is no cure. Chronic sinus symptoms and fatigue are common. Nasal irrigation with saline (NI-S) or xylitol (NI-X) improve sinus symptoms and fatigue in the general population. This trial will assess the effect of NI-S and NI-X on sinus and fatigue symptoms, economic outcomes and pro-inflammatory milieu among participants with GWI. METHODS: 75 participants (age 35 to 65 years, 25 in each of three arms) with GWI will be recruited from the Veteran's Administration and the community. They will use routine care for sinus symptoms and fatigue and be randomized to continued usual care alone or additional therapy with NI-S or NI-X. Participants will be able to adjust specific elements of the NI procedure. The primary outcome (Sinonasal Outcome Test, SNOT-20) and other self-reported assessments will occur at baseline, 8 and 26 weeks; lab assessment of pro-inflammatory cellular and cytokine profiles will occur at baseline and 26 weeks. Other outcomes will include fatigue-specific and overall health-related quality of life, pro-inflammatory cellular and cytokine profiles, cost-effectiveness and participant satisfaction. RESULTS: Baseline demographic and clinical data from the first 10 participants show effective participant recruitment, enrollment, randomization, retention and data collection. CONCLUSION: Early study conduct suggests that our participant-oriented approach will yield high rates of participant adherence and data capture, facilitating robust analysis. Results of this study will clarify the value of NI for chronic sinus symptoms and fatigue among patients with GWI. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov identifier NCT01700725.

Age and psychological influences on immune responses to trivalent inactivated influenza vaccine in the meditation or exercise for preventing acute respiratory infection (MEPARI) trial.

BACKGROUND: Strategies to improve influenza vaccine protection among elderly individuals are an important research priority. Mindfulness-based stress reduction (MBSR) and exercise have been shown to affect aspects of immune function in some populations. We hypothesized that influenza vaccine responses may be enhanced with meditation or exercise training as compared with controls. RESULTS: No differences in vaccine responses were found comparing control to MBSR or exercise. Individuals achieving seroprotective levels of influenza antibody ≥160 units had higher optimism, less anxiety, and lower perceived stress than the nonresponders. Age correlated with influenza antibody responses, but not with IFNγ or IL-10 production. CONCLUSION: The MBSR and exercise training evaluated in this study failed to enhance immune responses to influenza vaccine. However, optimism, perceived stress, and anxiety were correlated in the expected directions with antibody responses to influenza vaccine. METHODS: Healthy individuals≥50 y were randomly assigned to exercise (n=47) or MBSR (n=51) training or a waitlist control condition (n=51). Each participant received trivalent inactivated influenza vaccine after 6 weeks, and had blood draws prior to and 3 and 12 weeks after immunization. Serum influenza antibody, nasal immunoglobulin A, and peripheral blood mononuclear cell interferon-γ (IFNγ) and interleukin-10 (IL-10) concentrations were measured. Measures of optimism, perceived stress, and anxiety were obtained over the course of the study. Seroprotection was defined as an influenza antibody concentration≥160 units. Vaccine responses were compared using ANOVA, t tests, and Kruskal-Wallis tests. The correlation between vaccine responses and age was examined with the Pearson test.

Detection of viral and bacterial pathogens in acute respiratory infections.

OBJECTIVES: The role of bacteria in acute respiratory illnesses (ARI) of adults and interactions with viral infections is incompletely understood. This study tested the hypothesis that bacterial co-infection during ARI adds to airway inflammation and illness severity. METHODS: Two groups of 97 specimens each were randomly selected from multiplex-PCR identified virus-positive and virus-negative nasal specimens obtained from adults with new onset ARI, and 40 control specimens were collected from healthy adults. All specimens were analyzed for Haemophilus influenzae(HI), Moraxella catarrhalis(MC) and Streptococcus pneumoniae(SP) by quantitative-PCR. General linear models tested for relationships between respiratory pathogens, biomarkers (nasal wash neutrophils and CXCL8), and ARI-severity. RESULTS: Nasal specimens from adults with ARIs were more likely to contain bacteria (37% overall; HI = 28%, MC = 14%, SP = 7%) compared to specimens from healthy adults (5% overall; HI = 0%, MC = 2.5%, SP = 2.5%; p < 0.001). Among ARI specimens, bacteria were more likely to be detected among virus-negative specimens compared to virus-positive specimens (46% vs. 27%; p = 0.0046). The presence of bacteria was significantly associated with increased CXCL8 and neutrophils, but not increased symptoms. CONCLUSION: Pathogenic bacteria were more often detected in virus-negative ARI, and also associated with increased inflammatory biomarkers. These findings suggest the possibility that bacteria may augment virus-induced ARI and contribute to airway inflammation.

Item reduction of the Wisconsin Upper Respiratory Symptom Survey (WURSS-21) leads to the WURSS-11.

PURPOSE: To develop a shorter version of the Wisconsin Upper Respiratory Symptom Survey (WURSS-21), a self-report questionnaire for evaluating daily symptoms and functional impairments during acute respiratory illness (ARI). METHODS: WURSS-21 data were retrieved from 4 studies (n = 1167) spanning the years 2002-2010. Similar methodologies were employed among these studies. Degree of missingness, ceiling/floor effects, and exploratory (EFA) and confirmatory (CFA) factor analyses were investigated and used to guide item retention. Stability of the reduced WURSS was evaluated across the first 3 days of ARI. RESULTS: Degree of missingness was <1 % and appeared to be completely at random. Seven WURSS items with >30 % of ratings of zero (floor effects) were eliminated. Cross-loading items (head congestion, sleep well and breathe easily) were excluded following EFA on subset-1. Subsequent CFA using subset-2 showed satisfactory indices of fit. The reduced WURSS-11 instrument demonstrated 3 dimensions of 3 items each and was stable across 3 days of illness. The indicated dimensions (items) include nasal (runny nose, plugged nose, sneezing), throat (cough, sore throat, scratchy throat), and quality of life (feeling tired, think clearly, accomplish daily activities). CONCLUSION: The WURSS-11 has similar dimensional structure as the WURSS-21. This shorter version may reduce the time and burden required for completing the survey.

Randomized controlled trial of mindfulness meditation and exercise for the prevention of acute respiratory infection: possible mechanisms of action.

Background. A randomized trial suggests that meditation and exercise may prevent acute respiratory infection (ARI). This paper explores potential mediating mechanisms. Methods. Community-recruited adults were randomly assigned to three nonblinded arms: 8-week mindfulness-based stress reduction (N = 51), moderate-intensity exercise (N = 51), or wait-list control (N = 52). Primary outcomes were ARI illness burden (validated Wisconsin Upper Respiratory Symptom Survey). Potential mediators included self-reported psychophysical health and exercise intensity (baseline, 9 weeks, and 3 months). A Baron and Kenny approach-based mediational analysis model, adjusted for group status, age, and gender, evaluated the relationship between the primary outcome and a potential mediator using zero-inflated modeling and Sobel testing. Results. Of 154 randomized, 149 completed the trial (51, 47, and 51 in meditation, exercise, and control groups) and were analyzed (82% female, 94% Caucasian, 59.3 ± SD 6.6 years old). Mediational analyses suggested that improved mindfulness (Mindful Attention Awareness Scale) at 3 months may mediate intervention effects on ARI severity and duration (P < 0.05); 1 point increase in the mindfulness score corresponded to a shortened ARI duration by 7.2-9.6 hours. Conclusions. Meditation and exercise may decrease the ARI illness burden through increased mindfulness. These preliminary findings need confirmation, if confirmed, they would have important policy and clinical implications. This trial registration was Clinicaltrials.gov: NCT01057771.

Advantage of meditation over exercise in reducing cold and flu illness is related to improved function and quality of life.

PURPOSE: To examine whether apparent advantages following training in meditation over exercise can be attributed to specific symptoms, functional impairments, or quality-of-life indicators assessed by the Wisconsin Upper Respiratory Symptom Survey (WURSS-24). METHODS: Results from the randomized controlled trial "Meditation or Exercise for Preventing Acute Respiratory Illness" showed mean global severity and total days of illness were worse in control (358, 8·9) compared with exercise (248, 5·1) or meditation (144, 5·0). Global severity of illness was estimated using area under the curve from daily self-reported severity scores on the WURSS-24. For this project, we estimated within-group WURSS item-level severity and between-group effect sizes (Cohen's "d" statistic) relative to control. The item-level effect sizes were grouped into (i) symptom and (ii) function and quality of life domains. RESULTS: Among the three groups, mediators showed the lowest severity estimates for 21 of 22 WURSS items. Item-level Cohen's "d" indicated most benefit was evident in WURSS items representing function and quality of life. Compared with exercise, meditation fostered larger reductions in illness severity, although due mostly to improved function and the quality of life domain (d=-0·33, P<0·001) compared with symptom domain (d=-0·22, P<0·001). CONCLUSIONS: The apparent advantage of training in meditation over exercise for reducing cold and flu illness is explained more by improved function and quality of life than by a reduction in symptom severity.

Meditation or exercise for preventing acute respiratory infection: a randomized controlled trial.

PURPOSE: This study was designed to evaluate potential preventive effects of meditation or exercise on incidence, duration, and severity of acute respiratory infection (ARI) illness. METHODS: Community-recruited adults aged 50 years and older were randomized to 1 of 3 study groups: 8-week training in mindfulness meditation, matched 8-week training in moderate-intensity sustained exercise, or observational control. The primary outcome was area-under-the-curve global illness severity during a single cold and influenza season, using the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) to assess severity. Health care visits and days of missed work were counted. Nasal wash collected during ARI illness was assayed for neutrophils, interleukin-8, and viral nucleic acid. RESULTS: Of 154 adults randomized into the study, 149 completed the trial (82% female, 94% white, mean age 59.3 ± 6.6 years). There were 27 ARI episodes and 257 days of ARI illness in the meditation group (n = 51), 26 episodes and 241 illness days in the exercise group (n = 47), and 40 episodes and 453 days in the control group (n = 51). Mean global severity was 144 for meditation, 248 for exercise, and 358 for control. Compared with control, global severity was significantly lower for meditation (P = .004). Both global severity and total days of illness (duration) trended toward being lower for the exercise group (P=.16 and P=.032, respectively), as did illness duration for the meditation group (P=.034). Adjusting for covariates using zero-inflated multivariate regression models gave similar results. There were 67 ARI-related days of-work missed in the control group, 32 in the exercise group (P = .041), and 16 in the meditation group (P <.001). Health care visits did not differ significantly. Viruses were identified in 54% of samples from meditation, 42% from exercise, and 54% from control groups. Neutrophil count and interleukin-8 levels were similar among intervention groups. CONCLUSIONS: Training in meditation or exercise may be effective in reducing ARI illness burden.

Association of Biomarkers for Inflammation, Endothelial Dysfunction and Oxidative Stress with Cognitive Impairment. The Epidemiology of Hearing Loss Study (EHLS).

BACKGROUND: Individual biomarkers of inflammation, endothelial dysfunction and oxidative stress have been associated with cognitive impairment. This study explored whether a combination of biomarkers could prospectively identify those who developed cognitive decline. METHODS: Biomarkers were obtained during the baseline examination of the Beaver Dam Eye Study (1988-90), and cognitive status was assessed during the 5-year follow-up examination of the Epidemiology of Hearing Loss Study (1998-2000). Cognitive impairment was defined as a score of < 24 points on the Mini-Mental State Examination or self- or proxy report of Alzheimer Disease or dementia. Among those with cognitive data, interleukin-6, isoprostanes, protein carbonyl, soluble inter-cellular adhesion molecule-1 and vascular cell adhesion molecule-1 were available for 950 participants and 2,336 had high sensitivity C-reactive protein. RESULTS: Biomarkers of inflammation and endothelial dysfunction were not associated with cognitive impairment. There was a weak inverse association between higher levels of protein carbonyl content and cognitive impairment (OR, 0.8 per quartile of protein carbonyl content, p=0.045 unadjusted for multiple comparisons). This was not significant on multiple testing and may have been a chance finding. CONCLUSION: We found that many markers of inflammation and endothelial dysfunction were not associated with cognitive impairment. An inverse association with carbonyl protein, a marker of oxidative stress needs further confirmation.

Sponges and incorrect sponge count: Minor contributions to the process of detecting retained foreign bodies.

Background: Postoperative retained foreign bodies [RFBs] can be a serious event, but they are rare. The x-ray is the current gold standard to detect RFBs. There has been scant research on the process of detection as opposed to the consequence of RFBs. Surgical sponges incorporating automatic data identity capture technology (radiofrequency tags, barcodes) have been proposed to detect RFBs. Because resources in healthcare are scarce, careful consideration needs to be given to developing the right technology in order to maximize the process of RFB elimination. There have been few studies that identify factors contributing to the process of RFB detection. Study design: Our goal was to determine the frequency with which x-rays were ordered to detect abdominal surgery post operative RFBs and the indications for ordering them. We reviewed the Johns Hopkins Hospital's Department of Radiology database to retrospectively study the demographic and radiologic data on patients who underwent exploratory surgery for RFBs following abdominal procedures performed between April 2004 and April 2008. Results: Of the 13,335 portable abdominal x-rays taken during the period, 203 (1.5%) were ordered to assess patients for the presence of an RFB. Of these, 57 (28%) were taken because no RFB count was made (e.g., for emergency procedures), 57 (28%) were taken per procedure or protocol, 51 (25%) were taken because of an incorrect instrument count, and 39 (19%) were taken because of an incorrect sponge count. Of the 203 x-rays, 192 (95%) were negative for RFBs, 11 (5%) were positive or had suspicious findings, and of these 3 (2%) revealed more than 1 RFB. The 11 patients with positive or suspicious findings underwent exploratory procedures immediately during the same operation; of these, 8 (72%) actually had an RFB and 3 (28%) had a negative result at exploration. Conclusion: Multiple pathways lead to the decision to obtain X-rays for RFBs, of which sponges/Incorrect sponge counts make up only one in five. Therefore, technology that focuses on sponges alone may not majorly impact clinical outcome because x-rays will still be required in the majority of cases of suspected high risk.

Contamination of equipment in emergency settings: an exploratory study with a targeted automated intervention.

BACKGROUND: Despite standard manual decontamination, hospital equipment remains contaminated with microorganisms, contributing to nosocomial transmission and hospital acquired infections. This has the potential to negate the effects of healthcare workers' hand-washing protocols. In order to decrease the likelihood of equipment contamination, there has been a rise in the use of disposable pieces of equipment, especially non-critical disposables. However, these carry a significant cost, both a direct financial cost (running into billions of dollars), as well as a cost to the environment. This is important because we hope to contain the cost of healthcare, one way to do that, is to look to the hospitals themselves, for innovative solutions that maintain the standard of care. OBJECTIVE: To develop and evaluate the effectiveness of an simple decontamination device for use with portable hospital equipment, by comparing rates of residual contamination after use of the novel device versus those seen with standard manual decontamination methods. METHODS: The Self-cleaning Unit for the Decontamination of Small instruments (SUDS) is a user-friendly, automated instrument developed via multi-disciplinary collaboration for decontamination in the clinical area. Pre- and post- utilization of portable medical equipment in an emergency department (ED) setting were cultured. To evaluate durability of the decrease in antimicrobial contamination, objects were re-cultured 48 hours after SUDS cleaning and following re-introduction into the clinical setting. RESULTS: After manual decontamination, 25% (23/91) of the tested objects in the ED were found to be culture positive with clinically significant microorganisms(CSO). Fifteen percent (ED) of non-critical equipment tested had multiple organisms. Following the use of SUDS, the colonization rate decreased to 0%. Following SUDS treatment and re-introduction into the clinical settings, after 48 hours the contamination rates as reflected by the cultures remained 0%. CONCLUSION: Standard non-critical equipment is contaminated with clinically significant microorganisms. The SUDS device allows for effective and durable decontamination of hospital equipment of varying sizes in the clinical area without disrupting patient care.