A randomized trial testing digital medicine support models for mild-to-moderate alcohol use disorder.

This paper reports the results of a hybrid effectiveness-implementation randomized trial that systematically varied levels of human oversight required to support the implementation of a digital medicine intervention for persons with mild-to-moderate alcohol use disorder (AUD). Participants were randomly assigned to three groups representing possible digital health support models within a health system: self-monitored use (SM; n = 185), peer-supported use (PS; n = 186), or a clinically integrated model CI; (n = 187). Across all three groups, the percentage of self-reported heavy drinking days dropped from 38.4% at baseline (95% CI [35.8%, 41%]) to 22.5% (19.5%, 25.5%) at 12 months. The clinically integrated group showed significant improvements in mental health and quality of life compared to the self-monitoring group (p = 0.011). However, higher attrition rates in the clinically integrated group warrant consideration in interpreting this result. Results suggest that making a self-guided digital intervention available to patients may be a viable option for health systems looking to promote alcohol risk reduction. This study was prospectively registered at clinicaltrials.gov on 7/03/2019 (NCT04011644).

Acute cough in outpatients: what causes it, how long does it last, and how severe is it for different viruses and bacteria?

OBJECTIVES: To describe the symptoms, duration, severity, and microbiology of lower respiratory tract infection (LRTI) in outpatients. METHODS: Prospective cohort study of adults in US primary or urgent care with a chief complaint of cough and symptoms consistent with LRTI. Baseline data included demographics, signs, symptoms, and PCR for 46 viruses and bacteria. The severity of symptoms reported for ≤28 days follow-up via diary and text message. The Bronchitis severity score assessed severity at baseline; overall severity was defined as the area under the symptom severity curve. RESULTS: Of 718 patients with complete baseline data, 618 had valid PCR results, and 443 were followed until symptoms resolved. Of those with valid PCR, 100 (16.2%) had 1+ viruses detected, 211 (34.1%) had 1+ bacteria, and 168 (27.2%) had both. Symptoms more likely with viral or mixed infection included feverishness (36.7-38.4% vs. 18.5%), chills or sweats (36.0-38.1% vs. 17.9%), being generally unwell (78.2-81.3% vs. 64.9%), and myalgias (42.7-48.2% vs. 28.6%). Coloured sputum (42.9% vs. 23.2-29.5%) was more common with a bacterial infection. The mean duration of cough was 14.7 days with viruses (95% CI: 13.2-16.2), 17.3 with bacteria (95% CI: 15.9-18.6), 16.9 with mixed infection (95% CI: 15.2-18.6), and 18.4 with no detection (95% CI: 16.1-20.8). Overall severity of cough was lower for viral infections (20.9 points, 95% CI: 18.6-23.3) than for other groups (range 24.2-26.3). The most common potential bacterial pathogens were Haemophilus influenza (28.0%), Moraxella catarrhalis (16.2%), and Streptococcus pneumoniae (10.2%), whereas the most common viral pathogens were rhinovirus (17.3%), influenza (12.8%), SARS-CoV-2 (11.5%), and seasonal coronaviruses (8.1%). DISCUSSION: The mean duration of cough was 16.4 days. Consistent with European studies, the type of infection or potential pathogen was not an important predictor of the duration or severity of LRTI.

"What helps your back pain?" A qualitative analysis of pain management strategies in opioid-treated adults with chronic low back pain.

OBJECTIVE: The purpose of this qualitative analysis was to better understand what pain management strategies adults with opioid-treated chronic low back pain (CLBP) found most helpful. DESIGN: A subgroup of participants from a larger randomized control trial of two psychological interventions were asked: "What helps your back pain?" at baseline and 12 months (exit) in brief, video-recorded interviews. Videos were analyzed using qualitative thematic content analysis utilizing Transana™. SETTING: Participants were recruited from the community and outpatient clinics in three United States sites. PARTICIPANTS: Seventy-nine adults with long-term (≥3 months) opioid-treated (≥15 mg/day morphine equivalent) CLBP. MAIN OUTCOME MEASURE(S): Participants' baseline and exit qualitative responses to the question "What helps your back pain?" RESULTS: At baseline, participants identified medication (n = 63), body position (n = 59), thermal application (n = 50), physical activity (n = 49), and stretching (n = 24) as the CLBP management strategies they found helpful. At exit, the reports of medication (n = 55), physical activity (n = 41), and stretching (n = 21) were often considered helpful for CLBP and remained relatively stable, while position (n = 36) and thermal application (n = 35) strategies were mentioned less frequently and psychological strategies (n = 29) were mentioned more frequently (up from n = 5) compared to baseline. CONCLUSIONS: Over time, the reports of medication and active pain management strategies, eg, physical activity, remained stable, while the reports of some passive pain management strategies, eg, position and thermal, declined over time. Increased use of psychological strategies implies that study interventions were incorporated as useful pain self-management strategies.

Testing support models for implementing an evidence-based digital intervention for alcohol use disorder: results of a pragmatic hybrid implementation-effectiveness trial.

This paper reports results of a hybrid effectiveness-implementation randomized trial that systematically varied levels of human oversight required to support implementation of a digital medicine intervention for persons with mild to moderate alcohol use disorder (AUD). Participants were randomly assigned to three groups representing possible digital health support models within a health system: self-monitored use (n = 185), peer-supported use (n = 186), or a clinically integrated model (n = 187). Across all three groups, percentage of risky drinking days dropped from 38.4% at baseline (95%CI [35.8%, 41%]) to 22.5% (19.5%, 25.5%) at 12 months. The clinically integrated group showed significant improvements in mental health quality of life compared to the self-monitoring group (p = 0.011). However, higher rates of attrition in the clinically integrated group warrants consideration in interpreting this result. Results suggest that making a self-guided digital intervention available to patients may be a viable option for health systems looking to promote alcohol risk reduction.

Antibiotics Not Associated with Shorter Duration or Reduced Severity of Acute Lower Respiratory Tract Infection.

BACKGROUND: Antibiotic use remains common for the treatment of lower respiratory tract infections. The objective of this study was to evaluate the impact of antibiotic use on the duration and severity of acute lower respiratory tract infection (LRTI). PARTICIPANTS: Adult patients presenting to US primary or urgent care sites with a chief complaint of cough and symptoms consistent with LRTI. MAIN MEASURES: Collected data included demographics, comorbidities, symptoms, and 48 viral and bacterial respiratory pathogens by PCR. Severity of signs/symptoms was reported for up to 28 days using diaries and text messages. Interpolation was used where data were missing. KEY RESULTS: Of 718 patients with baseline data, 29% had an antibiotic prescribed at baseline. The most common antibiotics were amoxicillin-clavulanate, azithromycin, doxycycline, and amoxicillin in 85% of patients. Provision of an antibiotic had no effect on the duration or overall severity of cough, including in patients with viral, bacterial, and mixed infections. Receipt of an antibiotic did reduce the likelihood of a follow-up visit (14.1% vs 8.2%, aOR 0.47, 95% CI 0.26-0.84), perhaps by removing the motivation of getting an antibiotic at a follow-up visit. However, they were also more likely to receive a systemic corticosteroid (31.9% vs 4.5%, p < 0.001) and were also more likely to receive an albuterol inhaler (22.7% vs 7.6%, p < 0.001). Patients believed that receiving an antibiotic would reduce the duration of their illness by nearly 4 days. CONCLUSIONS: In this large prospective study in the US primary and urgent care setting, antibiotics had no measurable impact on the severity or duration of cough due to acute LRTI. Patients had unrealistic expectations regarding the duration of LRTI and the effect of antibiotics which should be the target of antibiotic stewardship efforts.

Qualitative findings from a randomized trial of mindfulness-based and cognitive-behavioral group therapy for opioid-treated chronic low back pain.

This article reports qualitative outcomes from a randomized controlled trial comparing eight weeks of cognitive-behavioral group therapy for chronic pain (CBT-CP) and mindfulness-based group therapy (MBT) in individuals with chronic low back pain (CLBP). Approximately 10 months post-treatment, 108 participants completed structured qualitative interviews to express how the study treatment affected their life or health. Responses were qualitatively analyzed to generate a set of themes and subthemes, with between-groups comparisons to evaluate differences (if any) in treatment-response between MBT and CBT-CP. A majority of participants (n = 88, 81.5%) across both groups reflected positively on the study intervention and outcomes, identifying benefits in pain management (31.5%), meditation and mindfulness skills (25.9%), and relaxation skills (22.2%). Perceived benefits varied widely, suggesting no one intervention may be ideal for CLBP. Future research should examine tailoring interventions to target diverse clinical presentations to achieve optimal outcomes.

Prospective external validation of the FluScore risk score for influenza in outpatients.

BACKGROUND: Testing for influenza in patients with acute lower respiratory tract infection (LRTI) is common and in some cases is performed for all patients with LRTI. A more selective approach to testing could be more efficient. METHODS: We used data from two prospective studies in the US primary and urgent care settings that enrolled patients with acute LRTI or influenza-like illness. Data were collected in the 2016, 2019, 2021, and 2022 flu seasons. All patients underwent polymerase chain reaction (PCR) testing for influenza and the FluScore was calculated based on patient-reported symptoms at their initial visit. The probability of influenza in each risk group was reported, as well as stratum-specific likelihood ratios (SSLRs) for each risk level. RESULTS: The prevalence of influenza within risk groups varied based on overall differences in flu seasons and populations. However, the FluScore exhibited consistent performance across various seasons and populations based on the SSLRs. The FluScore had a consistent SSLR range of 0.20 to 0.23 for the low-risk group, 0.63 to 0.99 for the moderate-risk group, and 1.46 to 1.67 for the high-risk group. The diagnostic odds ratio based on the midpoints of these ranges was 7.25. CONCLUSIONS: The FluScore could streamline patient categorization, identifying patients who could be exempted from testing, while identifying candidates for rapid influenza tests. This has the potential to be more efficient than a "one size fits all" test strategy, as it strategically targets the use of tests on patients most likely to benefit. It is potentially usable in a telehealth setting.

Mindful Eco-Wellness: Steps Toward Personal and Planetary Health.

Rising greenhouse gas levels heat the earth's surface and alter climate patterns, posing unprecedented threats to planetary ecology and human health. At the same time, obesity, diabetes, and cardiovascular disease have reached epidemic proportions across the globe, caused in part by decreases in physical activity and by over-consumption of carbon-intensive foods. Thus, interventions that support active transportation (walking or cycling rather than driving) and healthier food choices (eating plant-based rather than meat-based diets) would yield health and sustainability "co-benefits." Emerging research suggests that mindfulness-based practices might be effective means toward these ends. At the University of Wisconsin-Madison, we have developed a mindfulness-based group program, Mindful Eco-Wellness: Steps Toward Healthier Living. Loosely based on the Mindfulness-Based Stress Reduction course, our curriculum teaches mindfulness practices in tandem with sustainability principles, following weekly themes of Air, Water, Food, Energy, Transportation, Consumption, Nature Experience, and Ethics. For example, the "Air" class offers participants practice in guided breath meditations while they learn about the benefits of clean air. The theme of "Food" is presented through mindful eating, accompanied by educational videos highlighting the consequences of food production and consumption. "Transportation" includes walking/movement meditations and highlights the health benefits of physical activity and detriments of fossil-fueled transportation. Pedagogical lessons on energy, ecological sustainability, and the ethics of planetary health are intertwined with mindful nature experience and metta (loving-kindness) meditation. Curricular materials, including teaching videos, are freely available online. Pilot testing in community settings (n = 30) and in group medical visits (n = 34) has demonstrated feasibility; pilot data suggests potential effectiveness. Rigorous evaluation and testing are needed.

Using microbiological data to improve the use of antibiotics for respiratory tract infections: A protocol for an individual patient data meta-analysis.

BACKGROUND: Resistance to antibiotics is rising and threatens future antibiotic effectiveness. 'Antibiotic targeting' ensures patients who may benefit from antibiotics receive them, while being safely withheld from those who may not. Point-of-care tests may assist with antibiotic targeting by allowing primary care clinicians to establish if symptomatic patients have a viral, bacterial, combined, or no infection. However, because organisms can be harmlessly carried, it is important to know if the presence of the virus/bacteria is related to the illness for which the patient is being assessed. One way to do this is to look for associations with more severe/prolonged symptoms and test results. Previous research to answer this question for acute respiratory tract infections has given conflicting results with studies has not having enough participants to provide statistical confidence. AIM: To undertake a synthesis of IPD from both randomised controlled trials (RCTs) and observational cohort studies of respiratory tract infections (RTI) in order to investigate the prognostic value of microbiological data in addition to, or instead of, clinical symptoms and signs. METHODS: A systematic search of Cochrane Central Register of Controlled Trials, Ovid Medline and Ovid Embase will be carried out for studies of acute respiratory infection in primary care settings. The outcomes of interest are duration of disease, severity of disease, repeated consultation with new/worsening illness and complications requiring hospitalisation. Authors of eligible studies will be contacted to provide anonymised individual participant data. The data will be harmonised and aggregated. Multilevel regression analysis will be conducted to determine key outcome measures for different potential pathogens and whether these offer any additional information on prognosis beyond clinical symptoms and signs. TRIAL REGISTRATION: PROSPERO Registration number: CRD42023376769.

Experiences of adults with opioid-treated chronic low back pain during the COVID-19 pandemic: A cross-sectional survey study.

This study aimed to evaluate the impact of the COVID-19 pandemic on adults with opioid-treated chronic low back pain (CLBP), an understudied area. Participants in a "parent" clinical trial of non-pharmacologic treatments for CLBP were invited to complete a one-time survey on the perceived pandemic impact across several CLBP- and opioid therapy-related domains. Participant clinical and other characteristics were derived from the parent study's data. Descriptive statistics and latent class analysis analyzed quantitative data; qualitative thematic analysis was applied to qualitative data. The survey was completed by 480 respondents from June 2020 to August 2021. The majority reported a negative pandemic impact on their life (84.8%), with worsened enjoyment of life (74.6%), mental health (74.4%), pain (53.8%), pain-coping skills (49.7%), and finances (45.3%). One-fifth (19.4%) of respondents noted increased use of prescribed opioids; at the same time, decreased access to medication and overall healthcare was reported by 11.3% and 61.6% of respondents, respectively. Latent class analysis of the COVID-19 survey responses revealed 2 patterns of pandemic-related impact; those with worse pandemic-associated harms (n = 106) had an overall worse health profile compared to those with a lesser pandemic impact. The pandemic substantially affected all domains of relevant health-related outcomes as well as healthcare access, general wellbeing, and financial stability among adults with opioid-treated CLBP. A more nuanced evaluation revealed a heterogeneity of experiences, underscoring the need for both increased overall support for this population and for an individualized approach to mitigate harms induced by pandemic or similar crises.

Risk Factors for Self-Harm Ideation Among Persons Treated With Opioids for Chronic Low Back Pain.

OBJECTIVES: Chronic pain is a significant health concern that adversely affects all aspects of life, including emotional well-being. Opioids are prescribed for the management of refractory, severe chronic pain, although they have been associated with adverse effects, including addiction and overdose. The aim of this study was to examine factors that predict thoughts of self-harm among adults with chronic pain who are prescribed opioids. MATERIALS AND METHODS: Seven hundred sixty-five (N=765) persons with opioid-treated chronic lower back pain completed the Current Opioid Misuse Measure (COMM) and other validated questionnaires as part of a larger study. Response to 1 question from the COMM ("How often have you seriously thought about hurting yourself?") was used to assess suicide risk on a 5-point scale (0=never; 4=very often). RESULTS: Participants were categorized into 3 groups according to their responses to the self-harm question: never (N=628; 82.1%), seldom or sometimes (N=74; 9.7%), and often or very often (N=63; 8.2%). Multivariate adjusted odds ratio (aOR) analyses indicated that reports of alcohol or drug overuse within the past month (aOR=1.41,[95% CI 1.11-1.78]), posttraumatic stress (PTSD; aOR=1.24,[1.07 to 1.44]), pain catastrophizing (aOR=1.03,[1.01 to 1.05]), not loving oneself (aOR=0.99,[.98-1.00]) and poor perceived mental health (aOR=0.94,[.92 to 97]) were most associated with thoughts of self-harm. Importantly, the ideation frequency of self-harm was highest among individuals treated with higher daily doses of opioids. DISCUSSION: These results support the need for continued monitoring of adults treated with opioids for chronic pain, particularly among those on high-dose opioids who present with increased negative affect and concerns of substance misuse.

Imagining Eco-Wellness: A Scoping Review of Interventions Aimed at Changing Individual Behaviors to Promote Personal Health and Environmental Sustainability.

INTRODUCTION: Climate change poses enormous threats to humanity and much of life on earth. Many of the behavioral patterns that drive climate change also contribute to the epidemics of obesity, diabetes, and cardiovascular disease. OBJECTIVES: The primary objective of this study was to compile and categorize the literature on interventions aimed at modifying individual behaviors to promote both personal health and environmental sustainability. Secondary objectives were to help define the emerging field of behavioral eco-wellness and to discuss future directions, including the need for assessment tools and analytic strategies. METHODS: A scoping review was conducted to locate, categorize, and interpret current scientific studies of interventions aimed at changing individual behaviors to promote both personal health and environmental sustainability. RESULTS: Other than a pilot study that this team previously conducted, nothing was found that strictly fit the inclusion criteria. However, we did find 16 relevant studies that fit neatly within 4 broad topical areas: active transportation, dietary intake, indoor air quality, and green space immersion. DISCUSSION: While this systematic scoping review found little meeting original criteria, we did find that 4 separate fields of study are converging on a scientific area that we are calling behavioral eco-wellness, defined as the simultaneous pursuit of both personal health and environmental sustainability. The emerging field could provide a conceptual framework and methodological toolkit for those seeking to enhance sustainability while supporting health behaviors, including dietary intake. This, in turn, could help to inform and motivate the urgent action needed to confront both climate change and the epidemics of obesity, diabetes, and cardiovascular disease.

To be aware, or to accept, that is the question: Differential roles of awareness of automaticity and pain acceptance in opioid misuse.

BACKGROUND: Individuals with chronic low back pain (CLBP) are commonly prescribed long-term opioid therapy (LTOT) for analgesia, placing this population at increased risk for opioid misuse and opioid use disorder. Acceptance of aversive experiences (e.g., chronic pain) and awareness of automatic thoughts and behaviors (i.e., automaticity) are two facets of dispositional mindfulness that may serve as protective mechanisms against opioid misuse risk. Therefore, the aim of the current study was to examine the differential contributions of these constructs to opioid misuse risk among adults with CLBP receiving LTOT. METHODS: Data were obtained from a sample of 770 adults with opioid-treated CLBP. Bivariate correlations and hierarchical linear regression analyses were used to determine whether chronic pain acceptance and awareness of automatic thoughts and behaviors explained a statistically significant portion of variance in opioid misuse risk after accounting for the effects of other relevant confounders. RESULTS: Hierarchical regression results revealed that chronic pain acceptance and awareness of automatic thoughts and behaviors contributed a significant portion in the variance of opioid misuse risk. Awareness of automatic thoughts and behaviors was negatively associated with opioid misuse risk, such that individuals with lower levels of awareness of automaticity were at higher risk of opioid misuse. By contrast, pain acceptance was not associated with opioid misuse. CONCLUSIONS: Findings suggest that awareness of automaticity may buffer against opioid misuse risk. Interventions designed to strengthen awareness of automaticity (e.g., mindfulness-based interventions) might be especially efficacious among this population.

External Validation of the COVID-NoLab and COVID-SimpleLab Prognostic Tools.

Our objective was to externally validate 2 simple risk scores for mortality among a mostly inpatient population with COVID-19 in Canada (588 patients for COVID-NoLab and 479 patients for COVID-SimpleLab). The mortality rates in the low-, moderate-, and high-risk groups for COVID-NoLab were 1.1%, 9.6%, and 21.2%, respectively. The mortality rates for COVID-SimpleLab were 0.0%, 9.8%, and 20.0%, respectively. These values were similar to those in the original derivation cohort. The 2 simple risk scores, now successfully externally validated, offer clinicians a reliable way to quickly identify low-risk inpatients who could potentially be managed as outpatients in the event of a bed shortage. Both are available online (https://ebell-projects.shinyapps.io/covid_nolab/ and https://ebell-projects.shinyapps.io/COVID-SimpleLab/).

Health and sustainability co-benefits of eating behaviors: Towards a science of dietary eco-wellness.

Two of the greatest challenges of our times - climate change and the linked epidemics of obesity, diabetes, and cardiovascular disease - are fueled in part by the over-consumption of carbon-intensive high calorie foodstuffs. Converging evidence from hundreds of studies has confirmed that transitioning from diets high in meat and dairy to largely plant-based diets not only is necessary for climate change mitigation but will also lead to substantive reductions in morbidity and mortality. Nevertheless, there are only the faintest beginnings of a robust science of behavioral eco-wellness, defined here as the study of how individual choices, behaviors, and habits impact both personal health and environmental sustainability. This paper focusses on the sub-field of dietary eco-wellness, which looks at health and sustainability impacts of food production, procurement, preparation, and consumption. To advance this crucial agenda, investigators will need to invent, develop, and assess approaches aimed at helping people transition towards healthier and more sustainable diets. In order to accurately and reliably assess appropriate outcomes, existing assessment methods will need to be refined, new techniques will need to be advanced, and all measurement methods will need to be validated. Local conditions will influence the effectiveness of various approaches, and so it is important that scientists and communities share their stories of success and challenge for others to learn from. This paper reviews emerging evidence from relevant studies in dozens of countries, suggesting next steps, potential pathways, and a framework for interpretation.

Development and Validation of a Two-Step Predictive Risk Stratification Model for Coronavirus Disease 2019 In-hospital Mortality: A Multicenter Retrospective Cohort Study.

Objectives: An accurate prognostic score to predict mortality for adults with COVID-19 infection is needed to understand who would benefit most from hospitalizations and more intensive support and care. We aimed to develop and validate a two-step score system for patient triage, and to identify patients at a relatively low level of mortality risk using easy-to-collect individual information. Design: Multicenter retrospective observational cohort study. Setting: Four health centers from Virginia Commonwealth University, Georgetown University, the University of Florida, and the University of California, Los Angeles. Patients: Coronavirus Disease 2019-confirmed and hospitalized adult patients. Measurements and Main Results: We included 1,673 participants from Virginia Commonwealth University (VCU) as the derivation cohort. Risk factors for in-hospital death were identified using a multivariable logistic model with variable selection procedures after repeated missing data imputation. A two-step risk score was developed to identify patients at lower, moderate, and higher mortality risk. The first step selected increasing age, more than one pre-existing comorbidities, heart rate >100 beats/min, respiratory rate ≥30 breaths/min, and SpO2 <93% into the predictive model. Besides age and SpO2, the second step used blood urea nitrogen, absolute neutrophil count, C-reactive protein, platelet count, and neutrophil-to-lymphocyte ratio as predictors. C-statistics reflected very good discrimination with internal validation at VCU (0.83, 95% CI 0.79-0.88) and external validation at the other three health systems (range, 0.79-0.85). A one-step model was also derived for comparison. Overall, the two-step risk score had better performance than the one-step score. Conclusions: The two-step scoring system used widely available, point-of-care data for triage of COVID-19 patients and is a potentially time- and cost-saving tool in practice.

Testing an mHealth System for Individuals With Mild to Moderate Alcohol Use Disorders: Protocol for a Type 1 Hybrid Effectiveness-Implementation Trial.

BACKGROUND: The extent of human interaction needed to achieve effective and cost-effective use of mobile health (mHealth) apps for individuals with mild to moderate alcohol use disorder (AUD) remains largely unexamined. This study seeks to understand how varying levels of human interaction affect the ways in which an mHealth intervention for the prevention and treatment of AUDs works or does not work, for whom, and under what circumstances. OBJECTIVE: The primary aim is to detect the effectiveness of an mHealth intervention by assessing differences in self-reported risky drinking patterns and quality of life between participants in three study groups (self-monitored, peer-supported, and clinically integrated). The cost-effectiveness of each approach will also be assessed. METHODS: This hybrid type 1 study is an unblinded patient-level randomized clinical trial testing the effects of using an evidence-based mHealth system on participants' drinking patterns and quality of life. There are two groups of participants for this study: individuals receiving the intervention and health care professionals practicing in the broader health care environment. The intervention is a smartphone app that encourages users to reduce their alcohol consumption within the context of integrative medicine using techniques to build healthy habits. The primary outcomes for quantitative analysis will be participant data on their risky drinking days and quality of life as well as app use from weekly and quarterly surveys. Cost measures include intervention and implementation costs. The cost per participant will be determined for each study arm, with intervention and implementation costs separated within each group. There will also be a qualitative assessment of health care professionals' engagement with the app as well as their thoughts on participant experience with the app. RESULTS: This protocol was approved by the Health Sciences Minimal Risk Institutional Review Board on November 18, 2019, with subsequent annual reviews. Recruitment began on March 6, 2020, but was suspended on March 13, 2020, due to the COVID-19 pandemic restrictions. Limited recruitment resumed on July 6, 2020. Trial status as of November 17, 2021, is as follows: 357 participants were enrolled in the study for a planned enrollment of 546 participants. CONCLUSIONS: The new knowledge gained from this study could have wide and lasting benefits related to the integration of mHealth systems for individuals with mild to moderate AUDs. The results of this study will guide policy makers and providers toward cost-effective ways to incorporate technology in health care and community settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT04011644; https://clinicaltrials.gov/ct2/show/NCT04011644. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/31109.

Validation of the Wisconsin upper respiratory symptom survey-24, Chinese version.

BACKGROUND: The Wisconsin upper respiratory symptom survey (WURSS) is a validated English questionnaire to evaluate the quality of life and severity of upper respiratory tract infections (URTIs). We aimed to develop a Mandarin Chinese version of WURSS-24 (WURSS-24-C) and evaluate its reliability, validity and minimal important difference (MID). METHODS: The WURSS-24-C was developed using the forward-backward translation procedure. People with URTIs' symptoms within 48 h of onset were recruited and asked to fill in the WURSS-24-C daily for up to 14 d. Exploratory and confirmatory factor analyses were used to suggest domains. The 8-Item Short Form Health Survey (SF-8) assessing general mental and physical health was used to assess validity. Reliability estimated by Cronbach's alpha and mean day-to-day change for those indicating minimal improvement as MID were evaluated. RESULTS: The WURSS-24-C was found to be acceptable, relevant, and easy to complete in cognitive debriefing interviews. A total number of 300 participants (age 28.4 ± 9.3, female 70%) were monitored for 2500 person-days. Four domains (activity and function, systemic symptoms, nasal symptoms and throat symptoms) of the WURSS-24-C were confirmed (comparative fit index [CFI] = 0.93). The reliability of this 4-domain-structure is good (Cronbach's alphas varied from 0.849 to 0.943). Convergent validity is moderate (Pearson correlation coefficients between daily WURSS-24-C and the SF-8 were -0.780 and -0.721, for the SF-8 physical and mental health, respectively). Estimates of MID for individual items varied from -0.41 to -1.14. CONCLUSIONS: The WURSS-24-C is a reliable and valid questionnaire for assessing illness-specific quality-of-life health status in Chinese-speaking patients with URTIs.Key messagesThe Wisconsin upper respiratory symptom survey (WURSS) series are patient-oriented questionnaire instruments assessing the quality of life and severity of upper respiratory tract infections (URTIs).The WURSS-24 was translated into Mandarin Chinese using the forward-backward translation procedure, and evaluated its validity, reliability and minimal important difference (MID) in 300 Chinese participants with URTIs.The WURSS-24 Chinese version (WURSS-24-C) seems to be a reliable and valid questionnaire for assessing illness-specific quality-of-life health status in Chinese patients with URTIs.