Shari Barlow

Validation of a short form Wisconsin Upper Respiratory Symptom Survey (WURSS-21)

BackgroundThe Wisconsin Upper Respiratory Symptom Survey (WURSS) is an illness-specific health-related quality-of-life questionnaire outcomes instrument.ObjectivesResearch questions were: 1) How well does the WURSS-21 assess the symptoms and functional impairments associated with common cold? 2) How well can this instrument measure change over time (responsiveness)? 3) What is the minimal important difference (MID) that can be detected by the WURSS-21? 4) What are the descriptive statistics for area under the time severity curve (AUC)? 5) What sample sizes would trials require to detect MID or AUC criteria? 6) What does factor analysis tell us about the underlying dimensional structure of the common cold? 7) How reliable are items, domains, and summary scores represented in WURSS? 8) For each of these considerations, how well does the WURSS-21 compare to the WURSS-44, Jackson, and SF-8?Study Design and SettingPeople with Jackson-defined colds were recruited from the community in and around Madison, Wisconsin. Participants were enrolled within 48 hours of first cold symptom and monitored for up to 14 days of illness. Half the sample filled out the WURSS-21 in the morning and the WURSS-44 in the evening, with the other half reversing the daily order. External comparators were the SF-8, a 24-hour recall general health measure yielding separate physical and mental health scores, and the eight-item Jackson cold index, which assesses symptoms, but not functional impairment or quality of life.ResultsIn all, 230 participants were monitored for 2,457 person-days. Participants were aged 14 to 83 years (mean 34.1, SD 13.6), majority female (66.5%), mostly white (86.0%), and represented substantive education and income diversity. WURSS-21 items demonstrated similar performance when embedded within the WURSS-44 or in the stand-alone WURSS-21. Minimal important difference (MID) and Guyatts responsiveness index were 10.3, 0.71 for the WURSS-21 and 18.5, 0.75 for the WURSS-44. Factorial analysis suggested an eight dimension structure for the WURSS-44 and a three dimension structure for the WURSS-21, with composite reliability coefficients ranging from 0.87 to 0.97, and Cronbachs alpha ranging from 0.76 to 0.96. Both WURSS versions correlated significantly with the Jackson scale (W-21 R = 0.85; W-44 R = 0.88), with the SF-8 physical health (W-21 R = -0.79; W-44 R = -0.80) and SF-8 mental health (W-21 R = -0.55; W-44 R = -0.60).ConclusionThe WURSS-44 and WURSS-21 perform well as illness-specific quality-of-life evaluative outcome instruments. Construct validity is supported by the data presented here. While the WURSS-44 covers more symptoms, the WURSS-21 exhibits similar performance in terms of reliability, responsiveness, importance-to-patients, and convergence with other measures.

Echinacea for Treating the Common Cold: A Randomized Trial

BACKGROUND Echinacea is widely used to treat the common cold. OBJECTIVE To assess the potential benefits of echinacea as a treatment of common cold. DESIGN Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00065715) SETTING Dane County, Wisconsin. PATIENTS 719 patients, aged 12 to 80 years, with new-onset common cold. INTERVENTION Patients were assigned to 1 of 4 parallel groups: no pills, placebo pills (blinded), echinacea pills (blinded), or echinacea pills (unblinded, open-label). Echinacea groups received the equivalent of 10.2 g of dried echinacea root during the first 24 hours and 5.1 g during each of the next 4 days. Indistinguishable placebo tablets contained only inert ingredients. MEASUREMENTS The primary outcome was the area under the curve for global severity, with severity assessed twice daily by self-report using the Wisconsin Upper Respiratory Symptom Survey, short version. Secondary outcomes included interleukin-8 levels and neutrophil counts from nasal wash, assessed at intake and 2 days later. RESULTS Of the 719 patients enrolled, 713 completed the protocol. Mean age was 33.7 years, 64% were female, and 88% were white. Mean global severity was 236 and 258 for the blinded and unblinded echinacea groups, respectively; 264 for the blinded placebo group; and 286 for the no-pill group. A comparison of the 2 blinded groups showed a 28-point trend (95% CI, -69 to 13 points) toward benefit for echinacea (P = 0.089). Mean illness duration in the blinded and unblinded echinacea groups was 6.34 and 6.76 days, respectively, compared with 6.87 days in the blinded placebo group and 7.03 days in the no-pill group. A comparison of the blinded groups showed a nonsignificant 0.53-day (CI, -1.25 to 0.19 days) benefit (P = 0.075). Median change in interleukin-8 levels and neutrophil counts were also not statistically significant (30 ng/L and 1 cell/high-power field [hpf] in the no-pill group, 39 ng/L and 1 cell/hpf in the blinded placebo group, 58 ng/L and 2 cells/hpf in the blinded echinacea group, and 70 ng/L and 1 cell/hpf in the open-label echinacea group). LIMITATION Higher-than-expected variability limited power to detect small benefits. CONCLUSION Illness duration and severity were not statistically significant with echinacea compared with placebo. These results do not support the ability of this dose of the echinacea formulation to substantively change the course of the common cold. PRIMARY FUNDING SOURCE National Center for Complementary and Alternative Medicine, National Institutes of Health.

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.

Placebo Effects and the Common Cold: A Randomized Controlled Trial

PURPOSE We wanted to determine whether the severity and duration of illness caused by the common cold are influenced by randomized assignment to open-label pills, compared with conventional double-blind allocation to active and placebo pills, compared with no pills at all. METHODS We undertook a randomized controlled trial among a population with new-onset common cold. Study participants were allocated to 4 parallel groups: (1) those receiving no pills, (2) those blinded to placebo, (3) those blinded to echinacea, and (4) those given open-label echinacea. Primary outcomes were illness duration and area-under-the-curve global severity. Secondary outcomes included neutrophil count and interleukin 8 levels from nasal wash at intake and 2 days later. RESULTS Of 719 randomized study participants, 2 were lost and 4 exited early. Participants were 64% female, 88% white, and aged 12 to 80 years. Mean illness duration for each group was 7.03 days for those in the no-pill group, 6.87 days for those blinded to placebo, 6.34 days for those blinded to echinacea, and 6.76 days for those in the open-label echinacea group. Mean global severity scores for the 4 groups were no pills, 286; blinded to placebo, 264; blinded to echinacea, 236; and open-label echinacea, 258. Between-group differences were not statistically significant. Comparing the no-pill with blinded to placebo groups, differences (95% confidence interval [CI]) were −0.16 days (95% CI, −0.90 to 0.58 days) for illness duration and −22 severity points (95% CI, −70 to 26 points) for global severity. Comparing the group blinded to echinacea with the open-label echinacea group, differences were 0.42 days (95% CI, −0.28 to 1.12 days) and 22 severity points (95% CI, −19 to 63 points). Median change in interleukin 8 concentration and neutrophil cell count, respectively by group, were 30 pg/mL and 1 cell for the no-pill group, 39 pg/mL and 1 cell for the group binded to placebo, 58 pg/mL and 2 cells for the group blinded to echinacea, and 70 pg/mL and 1 cell for the group with open-label echinacea, also not statistically significant. Among the 120 participants who at intake rated echinacea’s effectiveness as greater than 50 on a 100-point scale for which 100 is extremely effective, illness duration was 2.58 days shorter (95% CI, −4.47 to −0.68 days) in those blinded to placebo rather than no pill, and mean global severity score was 26% lower but not significantly different (−97.0, 95% CI, −249.8 to 55.8 points). In this subgroup, neither duration nor severity differed significantly between the group blinded to echinacea and the open-label echinacea group. CONCLUSIONS Participants randomized to the no-pill group tended to have longer and more severe illnesses than those who received pills. For the subgroup who believed in echinacea and received pills, illnesses were substantively shorter and less severe, regardless of whether the pills contained echinacea. These findings support the general idea that beliefs and feelings about treatments may be important and perhaps should be taken into consideration when making medical decisions.

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

Please cite this paper as: Obasi et al. (2012) Advantage of meditation over exercise in reducing cold and flu illness is related to improved function and quality of life. Influenza and Other Respiratory Viruses 00(0), 00–00.

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.

Meditation or exercise for preventing acute respiratory infection (MEPARI-2): A randomized controlled trial

Background Practice of meditation or exercise may enhance health to protect against acute infectious illness. Objective To assess preventive effects of meditation and exercise on acute respiratory infection (ARI) illness. Design Randomized controlled prevention trial with three parallel groups. Setting Madison, Wisconsin, USA. Participants Community-recruited adults who did not regularly exercise or meditate. Methods 1) 8-week behavioral training in mindfulness-based stress reduction (MBSR); 2) matched 8-week training in moderate intensity sustained exercise (EX); or 3) observational waitlist control. Training classes occurred in September and October, with weekly ARI surveillance through May. Incidence, duration, and area-under-curve ARI global severity were measured using daily reports on the WURSS-24 during ARI illness. Viruses were identified multiplex PCR. Absenteeism, health care utilization, and psychosocial health self-report assessments were also employed. Results Of 413 participants randomized, 390 completed the trial. In the MBSR group, 74 experienced 112 ARI episodes with 1045 days of ARI illness. Among exercisers, 84 had 120 episodes totaling 1010 illness days. Eighty-two of the controls had 134 episodes with 1210 days of ARI illness. Mean global severity was 315 for MBSR (95% confidence interval 244, 386), 256 (193, 318) for EX, and 336 (268, 403) for controls. A prespecified multivariate zero-inflated regression model suggested reduced incidence for MBSR (p = 0.036) and lower global severity for EX (p = 0.042), compared to control, not quite attaining the p<0.025 prespecified cut-off for null hypothesis rejection. There were 73 ARI-related missed-work days and 22 ARI-related health care visits in the MBSR group, 82 days and 21 visits for exercisers, and 105 days and 24 visits among controls. Viruses were identified in 63 ARI episodes in the MBSR group, compared to 64 for EX and 72 for control. Statistically significant (p<0.05) improvements in general mental health, self-efficacy, mindful attention, sleep quality, perceived stress, and depressive symptoms were observed in the MBSR and/or EX groups, compared to control. Conclusions Training in mindfulness meditation or exercise may help protect against ARI illness. Limitations This trial was likely underpowered. Trial registration Clinicaltrials.gov NCT01654289

Sensitivity and Specificity of the Quidel Sofia Influenza A+B FIA Rapid Influenza Detection Test in Long-Term Care Facilities

Abstract Background Influenza is a significant pathogen for long-term care facility (LTCF) residents. As part of a randomized controlled trial to assess early detection of influenza in LTCFs, we deployed rapid influenza detection tests (RIDTs) at intervention LTCFs. Our primary objectives for this interim analysis were to evaluate the sensitivity and specificity of the Quidel Sofia® Influenza A+B Fluorescent Immunoassay RIDT in a high-risk, nontraditional population, and to describe the virology of acute respiratory infections (ARI) in LTCF residents. Methods Personnel at LCTFs identified cases of ARI, collected nasal specimens, and ran RIDTs from 10/21/2016 to 4/28/2017. The residual nasal swab and leftover lysis buffer were placed into a viral transport medium tube and sent to the Wisconsin State Laboratory of Hygiene for confirmatory influenza RT-PCR testing. In addition, all specimens were tested for other viruses using the Luminex NxTAG® Respiratory Pathogen Panel. Sensitivity and specificity of the Sofia RIDT were calculated using RT-PCR results as the reference standard. Results Specimens were collected from 228 residents (mean age = 71.3 ± 22.4 years). The mean time from symptom onset to specimen collection was 1.4 ± 1.6 days (range: 0-7 days). Respiratory viruses were identified in 134/228 cases (58.8%); influenza viruses (A: 7.5% and B: 14.5%) were the most commonly detected virus by PCR, followed by rhinovirus/enterovirus (13.2%), RSV (11.0%) and coronaviruses (10.1%). The sensitivities of Sofia RIDT for influenza A and influenza B were 77.8% (95% CI: 52.4–93.6%) and 80.0% (95% CI: 61.4–92.3%), respectively, with specificities of 98.4% (95.3–99.7%) and 97.1% (93.4–99.1%), respectively. Overall performance assessment for influenza A or B yielded a sensitivity of 79.2% (65.0–89.5%) and specificity of 96.1% (91.7–98.6%). The estimated likelihood of discovering one of the first two influenza cases at a LTCF using this RIDT is estimated to be ≥95.7%. Conclusion Although a wide constellation of respiratory viruses cause ARIs within LTCF populations, influenza is very common. Early ARI recognition in residents, with testing shortly after symptom onset, likely contributed to high performance of the Sofia RIDT. Use of RIDTs allows early identification of influenza with high sensitivity and specificity in elderly LTCF residents. Disclosures J. Temte, Quidel: Investigator, Research support

New Method for Real Time Influenza Surveillance in Primary Care: A Wisconsin Research and Education Network (WREN) Supported Study

Introduction: The goal of public health infectious disease surveillance systems is to provide accurate laboratory results in near-real time. When it comes to influenza surveillance, most current systems are encumbered with inherent delays encountered in the real-life chaos of medical practice. To combat this, we implemented and tested near-real-time surveillance using a rapid influenza detection test (RIDT) coupled with immediate, wireless transmission of results to public health entities. Methods: A network of 19 primary care clinics across Wisconsin were recruited, including 4 sites already involved in ongoing influenza surveillance and 15 sites that were new to surveillance activities. Each site was provided with a Quidel Sofia Influenza A+B RIDT analyzer attached to a wireless router. Influenza test results, along with patient age, were transmitted immediately to a cloud-based server, automatically compiled, and forwarded to the surveillance team daily. Weekly counts of positive influenza A and B cases were compared with positive polymerase chain reaction (PCR) detections from an independent surveillance system within the state. Results: Following Institutional Review Board (IRB) and institutional approvals, we recruited 19 surveillance sites, installed equipment, and trained staff within 4 months. Of the 1119 cases tested between September 15, 2013 and June 28, 2014, 316 were positive for influenza. The system provided early detection of the influenza outbreak in Wisconsin. The influenza peak between January 12 and 25, 2014, as well as the epidemic curve, closely matched that derived from the established PCR laboratory network (r = 0.927; P < .001). Conclusions: A network of influenza RIDTs with wireless transmission of results approximated the long-sought-after goal of real-time influenza surveillance. Results from the initial year strongly support this approach to highly accurate and timely influenza surveillance.

Partial Protection of Influenza Vaccine in a Primary Care Population—Wisconsin: 2012–2015

1Department of Family Medicine, University of Wisconsin-Madison, 2Wisconsin Division of Public Health, 3Wisconsin State Laboratory of Hygiene 4U.S. Centers for Disease Control and Prevention. The findings and conclusions in the this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention Jonathan Temte, MD/PhD jon.temte@fammed.wisc.edu 1100 Delaplaine Court Madison, WI 53715 Phone: 608-263-3111 Fax: 608-263-6663