Neuromuscular Electrical Stimulation for Intermittent Claudication (NESIC): multicentre, randomized controlled trial.

METHODS: This was an open, multicentre, randomized controlled trial. Patients with intermittent claudication attending vascular surgery outpatient clinics were randomized (1:1) to receive either neuromuscular electrical stimulation (NMES) or not in addition to local standard care available at study centres (best medical therapy alone or plus supervised exercise therapy (SET)). The objective of this trial was to investigate the clinical efficacy of an NMES device in addition to local standard care in improving walking distances in patients with claudication. The primary outcome was change in absolute walking distance, measured by a standardized treadmill test at 3 months. Secondary outcomes included intermittent claudication (IC) distance, adherence, quality of life, and haemodynamic changes. RESULTS: Of 200 participants randomized, 160 were included in the primary analysis (intention to treat, Tobit regression model). The square root of absolute walking distance was analysed (due to a right-skewed distribution) and, although adjunctive NMES improved it at 3 months, no statistically significant effect was observed. SET as local standard care seemed to improve distance compared to best medical therapy at 3 months (3.29 units; 95 per cent c.i., 1.77 to 4.82; P < 0.001). Adjunctive NMES improved distance in mild claudication (2.88 units; 95 per cent c.i., 0.51 to 5.25; P = 0.02) compared to local standard care at 3 months. No serious adverse events relating to the device were reported. CONCLUSION: Supervised exercise therapy is effective and NMES may provide further benefit in mild IC.This trial was supported by a grant from the Efficacy and Mechanism Evaluation Program, a Medical Research Council and National Institute for Health and Care Research partnership. Trial registration: ISRCTN18242823.

Patients with intermittent claudication experience pain in their legs during walking or exercise which ends with rest. This severely impairs physical activity and quality of life. Treatment for such patients typically involves best medical therapy, which includes exercise advice. This study aimed to determine whether a neuromuscular electrical stimulation device improved the walking distance of patients with intermittent claudication compared to local standard care available (which may include supervised exercise therapy) in a trial. Supervised exercise improved walking distances but there was no difference in those that received a device in this patient group.

Coronavirus Disease 2019 (COVID-19) Prevalences Among People Experiencing Homelessness and Homelessness Service Staff During Early Community Transmission in Atlanta, Georgia, April-May 2020.

BACKGROUND: In response to reported coronavirus disease 2019 (COVID-19) outbreaks among people experiencing homelessness (PEH) in other US cities, we conducted multiple, proactive, facility-wide testing events for PEH living sheltered and unsheltered and homelessness service staff in Atlanta, Georgia. We describe the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) prevalence and associated symptoms, and review shelter infection prevention and control (IPC) policies. METHODS: PEH and staff were tested for SARS-CoV-2 by reverse transcription polymerase chain reaction (RT-PCR) during 7 April-6 May 2020. A subset of PEH and staff was screened for symptoms. Shelter assessments were conducted concurrently at a convenience sample of shelters using a standardized questionnaire. RESULTS: Overall, 2875 individuals at 24 shelters and 9 unsheltered outreach events underwent SARS-CoV-2 testing, and 2860 (99.5%) had conclusive test results. The SARS-CoV-2 prevalences were 2.1% (36/1684) among PEH living sheltered, 0.5% (3/628) among PEH living unsheltered, and 1.3% (7/548) among staff. Reporting fever, cough, or shortness of breath in the last week during symptom screening was 14% sensitive and 89% specific for identifying COVID-19 cases, compared with RT-PCR. Prevalences by shelter ranged 0-27.6%. Repeat testing 3-4 weeks later at 4 shelters documented decreased SARS-CoV-2 prevalences (0-3.9%). Of 24 shelters, 9 completed shelter assessments and implemented IPC measures as part of the COVID-19 response. CONCLUSIONS: PEH living in shelters experienced a higher SARS-CoV-2 prevalence compared with PEH living unsheltered. Facility-wide testing in congregate settings allowed for the identification and isolation of COVID-19 cases, and is an important strategy to interrupt SARS-CoV-2 transmission.

Estimating the Unknown: Greater Racial and Ethnic Disparities in COVID-19 Burden After Accounting for Missing Race and Ethnicity Data.

BACKGROUND: Black, Hispanic, and Indigenous persons in the United States have an increased risk of SARS-CoV-2 infection and death from COVID-19, due to persistent social inequities. However, the magnitude of the disparity is unclear because race/ethnicity information is often missing in surveillance data. METHODS: We quantified the burden of SARS-CoV-2 notification, hospitalization, and case fatality rates in an urban county by racial/ethnic group using combined race/ethnicity imputation and quantitative bias analysis for misclassification. RESULTS: The ratio of the absolute racial/ethnic disparity in notification rates after bias adjustment, compared with the complete case analysis, increased 1.3-fold for persons classified Black and 1.6-fold for those classified Hispanic, in reference to classified White persons. CONCLUSIONS: These results highlight that complete case analyses may underestimate absolute disparities in notification rates. Complete reporting of race/ethnicity information is necessary for health equity. When data are missing, quantitative bias analysis methods may improve estimates of racial/ethnic disparities in the COVID-19 burden.

A systematic review and meta-analysis of the diagnostic accuracy of point-of-care tests used to establish the presence of peripheral arterial disease in people with diabetes.

OBJECTIVE: No agreement has been reached regarding which bedside test is the most useful for the diagnosis of peripheral arterial disease (PAD) in patients with diabetes. The aim of the present systematic review and meta-analysis was to evaluate the performance of bedside tests for the detection of PAD in individuals with diabetes. METHODS: MEDLINE and EMBASE databases were systematically searched for studies providing data on the diagnostic performance of bedside tests used for the detection of PAD in those with diabetes. A meta-analysis was performed to obtain pooled estimates of sensitivity and specificity for the diagnosis of PAD. RESULTS: A total of 18 studies, reporting on a total of 3016 limbs of diabetic patients, were included in our qualitative review. Of these, 11 studies (1543 limbs) were included in the meta-analysis of diagnostic accuracy: ankle-brachial pressure index (9 studies and 1368 limbs; sensitivity, 63.5% [95% confidence interval (CI), 51.7%-73.9%]; specificity, 89.3% [95% CI, 81.1%-94.2%]); toe-brachial pressure index (3 studies and 221 limbs; sensitivity, 83.0% [95% CI, 59.1-94.3%]; specificity, 66.3% [95% CI, 41.3%-84.6%]); and tibial waveform assessment (4 studies and 397 limbs; sensitivity, 82.8% [95% CI, 73.3%-89.4%], specificity, 86.8% [95% CI, 75.5%-93.3%]). Overall, we found a high risk of bias across the studies, most frequently relating to patient selection and the lack of blinding. CONCLUSIONS: The toe-brachial pressure index, pulse oximetry, and tibial arterial waveform assessment demonstrated some promise, warranting further investigation.

The 6 E Framework of Public Health Preparedness for Mass Gatherings-Lessons Learned From Super Bowl LIII, Fulton County, Georgia, 2019.

CONTEXT: On February 3, 2019, Atlanta, Georgia, hosted Super Bowl LIII, which is classified as a National Special Security Event. The festivities comprising this major sporting event brought approximately half a million people to Atlanta, which posed significant challenges to the local public health community. As the lead local agency for public health planning, preparedness, and response efforts, Fulton County Board of Health (FCBOH) needed to address multiple specific tasks based on core functional areas outlined in the Emergency Support Function (ESF) 8 (eg, bioterrorism preparedness and epidemiological surveillance). PROGRAM: To prepare for the Super Bowl, FCBOH developed a systematic approach to ensure community-wide public health preparedness for mass gatherings. This approach came to be known as the 6 E framework, which consists of (1) engaging stakeholders, (2) examining current capabilities and identifying gaps, (3) establishing roles and responsibilities, (4) executing plans to fill gaps, (5) exercising plans, and (6) evaluating impact. IMPLEMENTATION: We define each step of the 6 E framework and present practical examples of how FCBOH implemented each step when preparing for the Super Bowl. Challenges that FCBOH faced and the lessons learned in the process are illustrated. The 6 E framework provides a systematic approach to community preparedness and allows local health departments to tailor the approach to serve local public health needs. EVALUATION: The successful implementation of the 6 E framework allowed for stakeholders at the federal, state, and local levels (including law enforcement) to effectively coordinate an epidemiological investigation and response when 4 staff members reported gastrointestinal symptoms after eating at a feeding station. DISCUSSION: Preparation for the Super Bowl required months of diligent cross-sectoral and cross-jurisdictional partnership building, and the 6 E framework can help other local public health jurisdictions prepare to host major mass gatherings.

Preventing COVID-19 Outbreaks in Long-Term Care Facilities Through Preemptive Testing of Residents and Staff Members - Fulton County, Georgia, March-May 2020.

Long-term care facility (LTCF) residents are at particularly high risk for morbidity and mortality associated with infection with SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), given their age and high prevalence of chronic medical conditions, combined with functional impairment that often requires frequent, close contact with health care providers, who might inadvertently spread the virus to residents (1,2). During March-May 2020 in Fulton County, Georgia, >50% of COVID-19-associated deaths occurred among LTCF residents, although these persons represented <1% of the population (3,4). Mass testing for SARS-CoV-2 has been an effective strategy for identifying asymptomatic and presymptomatic infections in LTCFs (5). This analysis sought to evaluate the timing at which mass testing took place in relation to the known presence of a COVID-19 infection and the resulting number of infections that occurred. In 15 LTCFs that performed facility-wide testing in response to an identified case, high prevalences of additional cases in residents and staff members were found at initial testing (28.0% and 7.4%, respectively), suggesting spread of infection had already occurred by the time the first case was identified. Prevalence was also high during follow-up, with a total of 42.4% of residents and 11.8% of staff members infected overall in the response facilities. In comparison, 13 LTCFs conducted testing as a preventive strategy before a case was identified. Although the majority of these LTCFs identified at least one COVID-19 case, the prevalence was significantly lower at initial testing in both residents and staff members (0.5% and 1.0%, respectively) and overall after follow-up (1.5% and 1.7%, respectively). These findings indicate that early awareness of infections might help facilities prevent potential outbreaks by prioritizing and adhering more strictly to infection prevention and control (IPC) recommendations, resulting in fewer infections than would occur when relying on symptom-based screening (6,7).

Neuromuscular electrical stimulation for the treatment of diabetic sensorimotor polyneuropathy: A prospective, cohort, proof-of-concept study.

OBJECTIVE: To assess a potential efficacy signal, safety and feasibility of neuromuscular electrical stimulation (NMES) therapy as an adjunct to standard care in patients with diabetic sensorimotor polyneuropathy (DSPN). METHODS: In this single-centre, prospective, cohort, proof-of-concept study, 25 patients with DSPN consented to at least one daily 30-minute NMES therapy session (Revitive® IX) for 10 weeks, with 20 patients completing the study. The primary outcome measure was nerve conductivity assessed using a nerve conduction study of the sural, superficial peroneal, common peroneal and tibial nerves at 10 weeks compared to baseline. Secondary outcomes included superficial femoral artery (SFA) haemodynamics during NMES therapy compared to rest and quality-of-life at 10 weeks compared to baseline. RESULTS: At 10 weeks, there were significant increases in sural sensory nerve action potential amplitude and conduction velocity (p < 0.001), superficial peroneal sensory nerve action potential amplitude (p = 0.001) and conduction velocity (p = 0.002), common peroneal nerve conduction velocity (p = 0.004) and tibial nerve compound muscle action potential amplitude (p = 0.002) compared to baseline. SFA volume flow and time-averaged mean velocity significantly increased (p ≤ 0.003) during NMES compared to rest. Patient-reported Michigan Neuropathy Screening Instrument scores significantly decreased (p = 0.028) at 10 weeks compared to baseline. Three unrelated adverse events occurred, and 15 participants adhered to treatment. CONCLUSIONS: NMES therapy as an adjunct to standard care for 10 weeks significantly increased lower limb nerve conductivity in patients with DSPN and may be beneficial in the treatment of DSPN.

Examining the benefit of graduated compression stockings in the prevention of hospital-associated venous thromboembolism in low-risk surgical patients: a multicentre cluster randomised controlled trial (PETS trial).

INTRODUCTION: Hospital-acquired thrombosis (HAT) is defined as any venous thromboembolism (VTE)-related event during a hospital admission or occurring up to 90 days post discharge, and is associated with significant morbidity, mortality and healthcare-associated costs. Although surgery is an established risk factor for VTE, operations with a short hospital stay (<48 hours) and that permit early ambulation are associated with a low risk of VTE. Many patients undergoing short-stay surgical procedures and who are at low risk of VTE are treated with graduated compression stockings (GCS). However, evidence for the use of GCS in VTE prevention for this cohort is poor. METHODS AND ANALYSIS: A multicentre, cluster randomised controlled trial which aims to determine whether GCS are superior in comparison to no GCS in the prevention of VTE for surgical patients undergoing short-stay procedures assessed to be at low risk of VTE. A total of 50 sites (21 472 participants) will be randomised to either intervention (GCS) or control (no GCS). Adult participants (18-59 years) who undergo short-stay surgical procedures and are assessed as low risk of VTE will be included in the study. Participants will provide consent to be contacted for follow-up at 7-days and 90-days postsurgical procedure. The primary outcome is the rate of symptomatic VTE, that is, deep vein thrombosis or pulmonary embolism during admission or within 90 days. Secondary outcomes include healthcare costs and changes in quality of life. The main analysis will be according to the intention-to-treat principle and will compare the rates of VTE at 90 days, measured at an individual level, using hierarchical (multilevel) logistic regression. ETHICS AND DISSEMINATION: Ethical approval was granted by the Camden and Kings Cross Research Ethics Committee (22/LO/0390). Findings will be published in a peer-reviewed journal and presented at national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN13908683.

Pathogenesis of Distal Symmetrical Polyneuropathy in Diabetes.

Distal symmetrical polyneuropathy (DSPN) is a serious complication of diabetes associated with significant disability and mortality. Although more than 50% of people with diabetes develop DSPN, its pathogenesis is still relatively unknown. This lack of understanding has limited the development of novel disease-modifying therapies and left the reasons for failed therapies uncertain, which is critical given that current management strategies often fail to achieve long-term efficacy. In this article, the pathogenesis of DSPN is reviewed, covering pathogenic changes in the peripheral nervous system, microvasculature and central nervous system (CNS). Furthermore, the successes and limitations of current therapies are discussed, and potential therapeutic targets are proposed. Recent findings on its pathogenesis have called the definition of DSPN into question and transformed the disease model, paving the way for new research prospects.

Prevention and Management Strategies for Diabetic Neuropathy.

Diabetic neuropathy (DN) is a common complication of diabetes that is becoming an increasing concern as the prevalence of diabetes rapidly rises. There are several types of DN, but the most prevalent and studied type is distal symmetrical polyneuropathy, which is the focus of this review and is simply referred to as DN. It can lead to a wide range of sensorimotor and psychosocial symptoms and is a major risk factor for diabetic foot ulceration and Charcot neuropathic osteoarthropathy, which are associated with high rates of lower limb amputation and mortality. The prevention and management of DN are thus critical, and clinical guidelines recommend several strategies for these based on the best available evidence. This article aims to provide a narrative review of DN prevention and management strategies by discussing these guidelines and the evidence that supports them. First, the epidemiology and diverse clinical manifestations of DN are summarized. Then, prevention strategies such as glycemic control, lifestyle modifications and footcare are discussed, as well as the importance of early diagnosis. Finally, neuropathic pain management strategies and promising novel therapies under investigation such as neuromodulation devices and nutraceuticals are reviewed.

Use of surveillance data to elucidate household clustering of SARS-CoV-2 in Fulton County, Georgia a major metropolitan area.

BACKGROUND: Households are important for SARS-CoV-2 transmission due to high intensity exposure in enclosed spaces over prolonged durations. We quantified and characterized household clustering of COVID-19 cases in Fulton County, Georgia. METHODS: We used surveillance data to identify all confirmed COVID-19 cases in Fulton County. Household clustered cases were defined as cases with matching residential address. We described the proportion of COVID-19 cases that were clustered, stratified by age over time and explore trends in age of first diagnosed case within households and subsequent household cases. RESULTS: Between June 1, 2020 and October 31, 2021, 31,449(37%) of 106,233 cases were clustered in households. Children were the most likely to be in household clusters than any other age group. Initially, children were rarely (∼ 10%) the first cases diagnosed in the household but increased to almost 1 of 3 in later periods. DISCUSSION: One-third of COVID-19 cases in Fulton County were part of a household cluster. Increasingly children were the first diagnosed case, coinciding with temporal trends in vaccine roll-out among the elderly and the return to in-person schooling in Fall 2021. Limitations include restrictions to cases with a valid address and unit number and that the first diagnosed case may not be the infection source for the household.

Characteristics and Risk Factors for Mortality by Coronavirus Disease 2019 Pandemic Waves in Fulton County, Georgia: A Cohort Study March 2020-February 2021.

Background: We examined differences in mortality among coronavirus disease 2019 (COVID-19) cases in the first, second, and third waves of the COVID-19 pandemic. Methods: A retrospective cohort study of COVID-19 cases in Fulton County, Georgia, USA, reported to a public health surveillance from March 2020 through February 2021. We estimated case-fatality rates (CFR) by wave and used Cox proportional hazards random-effects models in each wave, with random effects at individual and long-term-care-facility level, to determine risk factors associated with rates of mortality. Results: Of 75 289 confirmed cases, 4490 (6%) were diagnosed in wave 1 (CFR 31 deaths/100 000 person days [pd]), 24 293 (32%) in wave 2 (CFR 7 deaths/100 000 pd), and 46 506 (62%) in wave 3 (CFR 9 deaths/100 000 pd). Compared with females, males were more likely to die in each wave: wave 1 (adjusted hazard ratio [aHR], 1.5; 95% confidence interval [CI], 1.2-1.8), wave 2 (aHR 1.5, 95% CI, 1.2-1.8), and wave 3 (aHR 1.7, 95% CI, 1.5-2.0). Compared with non-Hispanic whites, non-Hispanic blacks were more likely to die in each wave: wave 1 (aHR, 1.4; 95% CI, 1.1-1.8), wave 2 (aHR, 1.5; 95% CI, 1.2-1.9), and wave 3 (aHR, 1.7; 95% CI, 1.4-2.0). Cases with any disability, chronic renal disease, and cardiovascular disease were more likely to die in each wave compared with those without these comorbidities. Conclusions: Our study found gender and racial/ethnic disparities in COVID-19 mortality and certain comorbidities associated with COVID-19 mortality. These factors have persisted throughout the COVID-19 pandemic waves, despite improvements in diagnosis and treatment.

Study protocol for a multicentre comparative diagnostic accuracy study of tools to establish the presence and severity of peripheral arterial disease in people with diabetes mellitus: the DM PAD study.

INTRODUCTION: Peripheral arterial disease (PAD) is a key risk factor for cardiovascular disease, foot ulceration and lower limb amputation in people with diabetes. Early diagnosis of PAD can enable optimisation of therapies to manage these risks. Its diagnosis is fundamental, though challenging in the context of diabetes. Although a variety of diagnostic bedside tests are available, there is no agreement as to which is the most accurate in routine clinical practice.The aim of this study is to determine the diagnostic performance of a variety of tests (audible waveform assessment, visual waveform assessment, ankle brachial pressure index (ABPI), exercise ABPI and toe brachial pressure index (TBPI)) for the diagnosis of PAD in people with diabetes as determined by a reference test (CT angiography (CTA) or magnetic resonance angiography (MRA)). In selected centres, we also aim to evaluate the performance of a new point-of-care duplex ultrasound scan (PAD-scan). METHODS AND ANALYSIS: A prospective multicentre diagnostic accuracy study (ClinicalTrials.gov Identifier NCT05009602). We aim to recruit 730 people with diabetes from 18 centres across the UK, covering primary and secondary healthcare. Consenting participants will undergo the tests under investigation. Reference tests (CTA or MRA) will be performed within 6 weeks of the index tests. Imaging will be reported by blinded consultant radiologists at a core imaging lab, using a validated scoring system, which will also be used to categorise PAD severity. The presence of one or more arterial lesions of ≥50% stenosis, or tandem lesions with a combined value of ≥50%, will be used as the threshold for the diagnosis of PAD. The primary outcome measure of diagnostic performance will be test sensitivity. ETHICS AND DISSEMINATION: The study has received approval from the National Research Ethics Service (NRES) (REC reference 21/PR/1221). Results will be disseminated through research presentations and papers. TRIAL REGISTRATION NUMBER: NCT05009602.

Measuring the missing: greater racial and ethnic disparities in COVID-19 burden after accounting for missing race/ethnicity data.

Black, Hispanic, and Indigenous persons in the United States have an increased risk of SARS-CoV-2 infection and death from COVID-19, due to persistent social inequities. The magnitude of the disparity is unclear, however, because race/ethnicity information is often missing in surveillance data. In this study, we quantified the burden of SARS-CoV-2 infection, hospitalization, and case fatality rates in an urban county by racial/ethnic group using combined race/ethnicity imputation and quantitative bias-adjustment for misclassification. After bias-adjustment, the magnitude of the absolute racial/ethnic disparity, measured as the difference in infection rates between classified Black and Hispanic persons compared to classified White persons, increased 1.3-fold and 1.6-fold respectively. These results highlight that complete case analyses may underestimate absolute disparities in infection rates. Collecting race/ethnicity information at time of testing is optimal. However, when data are missing, combined imputation and bias-adjustment improves estimates of the racial/ethnic disparities in the COVID-19 burden.

Characteristics and Risk Factors for Hospitalization and Mortality among Persons with COVID-19 in Atlanta Metropolitan Area.

Background: We present data on risk factors for severe outcomes among patients with coronavirus disease 2019 (COVID-19) in the southeast United States (U.S.). Objective: To determine risk factors associated with hospitalization, intensive care unit (ICU) admission, and mortality among patients with confirmed COVID-19. Design: A retrospective cohort study. Setting: Fulton County in Atlanta Metropolitan Area, Georgia, U.S. Patients: Community-based individuals of all ages that tested positive for SARS-CoV-2. Measurements: Demographic characteristics, comorbid conditions, hospitalization, ICU admission, death (all-cause mortality), and severe COVID-19 disease, defined as a composite measure of hospitalization and death. Results: Between March 2 and May 31, 2020, we included 4322 individuals with various COVID-19 outcomes. In a multivariable logistic regression random-effects model, patients in age groups ≥45 years compared to those <25 years were associated with severe COVID-19. Males compared to females (adjusted odds ratio [aOR] 1.4, 95% confidence interval [CI]: 1.1-1.6), non-Hispanic blacks (aOR 1.9, 95%CI: 1.5-2.4) and Hispanics (aOR 1.7, 95%CI: 1.2-2.5) compared to non-Hispanic whites were associated with increased odds of severe COVID-19. Those with chronic renal disease (aOR 3.6, 95%CI: 2.2-5.8), neurologic disease (aOR 2.8, 95%CI: 1.8-4.3), diabetes (aOR 2.0, 95%CI: 1.5-2.7), chronic lung disease (aOR 1.7, 95%CI: 1.2-2.3), and "other chronic diseases" (aOR 1.8, 95%CI: 1.3-2.6) compared to those without these conditions were associated with increased odds of having severe COVID-19. Conclusions: Multiple risk factors for hospitalization, ICU admission, and death were observed in this cohort from an urban setting in the southeast U.S. Improved screening and early, intensive treatment for persons with identified risk factors is urgently needed to reduce COVID-19 related morbidity and mortality.

Mass Screening for SARS-CoV-2 Infection among Residents and Staff in Twenty-eight Long-term Care Facilities in Fulton County, Georgia.

Mass screening for SARS-CoV-2 infection in long-term care facilities revealed significantly higher prevalence of infection in facilities that screened in response to a known infection compared to those that screened as a prevention measure. "Response" facilities had a SARS-CoV-2 prevalence of 28.9% while "preventive" facilities' prevalence was 1.6% (p <0.001).

Multiple dimensions of excessive daytime sleepiness.

BACKGROUND: In this study we investigated subjective measures of sleepiness and related our findings to dimensions of affect, fatigue, emotion, mood and quality of life based on a hypothetical multidimensional model of sleepiness. METHODS: Patients referred to a sleep clinic were assessed regarding their excessive daytime sleepiness (EDS), sleep complaints, routine and symptoms. Age, gender and body mass index (BMI), the Epworth Sleepiness Scale (ESS), the Stanford Sleepiness Scale (SSS), the Samn-Perelli fatigue Scale (SPS), the Global Vigor and Affect Scale (GVS and GAS, respectively), the Hospital Anxiety and Depression Scale (HADS-A and HADS-D, respectively), and the Positive and Negative Affect Schedule (PAS and NAS, respectively) scores were recorded. RESULTS: Fifty patients [25 male, 45.2 (18.7) years] completed the questionnaires. The ESS scores were positively correlated with SSS, SPS, HADS-A, HADS-D and NAS scores and negatively with GVS and GAS scores (P<0.05). The SPS (P<0.001) and HADS-A scores (P=0.002) were independently associated with the ESS scores (R2=0.532, adjusted R2 =0.4794, P<0.001). CONCLUSIONS: A model of sleepiness that assesses dimensions of fatigue and anxiety could explain the symptom of subjective sleepiness better than the isolated use of the ESS.