27 research outputs found

    Fear of illness & virus evaluation (FIVE) COVID-19 scales for children-parent/caregiver-report development and validation

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    ObjectiveCommonly-used youth anxiety measures may not comprehensively capture fears, worries, and experiences related to the pervasive impact of the COVID-19 pandemic. This study described the development of the Fear of Illness and Virus Evaluation (FIVE) scales and validated the caregiver-report version.MethodAfter initial development, feedback was obtained from clinicians and researchers, who provided suggestions on item content/wording, reviewed edits, and provided support for the updated FIVE's content and face validity. Factor structure, measurement invariance, and psychometric properties were analyzed using data from a multi-site, longitudinal study of COVID-19-related effects on family functioning with 1599 caregivers from the United States and Canada.ResultsConfirmatory factor analyses indicated a hierarchical five-factor structure best fit the data, resulting in a 31-item measure with four lower-order subscales: (1) Fears about Contamination and Illness; (2) Fears about Social Distancing, (3) Avoidance Behaviors, and (4) Mitigation Behaviors, and a higher-order factor, (5) Total Fears, indicated by the two fear-related lower-order subscales. Measurement invariance by country of residence, child age, and child sex was found. All subscales demonstrated strong internal consistency, appropriate item-scale discrimination, and no floor or ceiling effects. The Total Fears subscale demonstrated appropriate test-retest reliability. Concurrent validity supported by strong correlation with a youth anxiety measure.DiscussionThe FIVE provides a psychometrically-sound measure of COVID-19-related fears and behaviors in youth in a caregiver-report format. Future research is necessary to evaluate correlates and longitudinal symptom patterns captured by the FIVE caregiver-report, as well as the validity and reliability of a youth self-report version of the FIVE

    The clinical effectiveness of a physiotherapy delivered physical and psychological group intervention for older adults with neurogenic claudication: the BOOST randomised controlled trial.

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    This is the final version. Available from Oxford University Press via the DOI in this record. BACKGROUND: Neurogenic claudication (NC) is a debilitating spinal condition affecting older adults' mobility and quality of life. METHODS: A randomised controlled trial of 438 participants evaluated the effectiveness of a physical and psychological group intervention (BOOST programme) compared to physiotherapy assessment and tailored advice (best practice advice [BPA]) for older adults with NC. Participants were identified from spinal clinics (community and secondary care) and general practice records and randomised 2:1 to the BOOST programme or BPA. The primary outcome was the Oswestry Disability Index (ODI) at 12 months. Data was also collected at 6 months. Other outcomes included ODI walking item, 6-minute walk test (6MWT) and falls. The primary analysis was intention-to-treat. RESULTS: The average age of participants was 74.9 years (SD 6.0) and 57% (246/435) were female. There was no significant difference in ODI scores between treatment groups at 12 months (adjusted mean difference (MD): -1.4 [95% Confidence Intervals (CI) -4.03, 1.17]), but, at 6 months, ODI scores favoured the BOOST programme (adjusted MD: -3.7 [95% CI -6.27, -1.06]). At 12 months, the BOOST programme resulted in greater improvements in walking capacity (6MWT MD 21.7m [95% CI 5.96, 37.38]) and ODI walking item (MD -0.2 [95% CI -0.45, -0.01]) and reduced falls risk (odds ratio 0.6 [95% CI 0.40, 0.98]) compared to BPA. No serious adverse events were related to either treatment. CONCLUSIONS: The BOOST programme substantially improved mobility for older adults with NC. Future iterations of the programme will consider ways to improve long-term pain related disability.National Institute for Health Research (NIHR

    The Clinical Effectiveness of a Physiotherapy Delivered Physical and Psychological Group Intervention for Older Adults With Neurogenic Claudication: The BOOST Randomized Controlled Trial

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    Background Neurogenic claudication (NC) is a debilitating spinal condition affecting older adults’ mobility and quality of life. Methods A randomized controlled trial of 438 participants evaluated the effectiveness of a physical and psychological group intervention (BOOST program) compared to physiotherapy assessment and tailored advice (best practice advice [BPA]) for older adults with NC. Participants were identified from spinal clinics (community and secondary care) and general practice records and randomized 2:1 to the BOOST program or BPA. The primary outcome was the Oswestry Disability Index (ODI) at 12 months. Data were also collected at 6 months. Other outcomes included ODI walking item, 6-minute walk test (6MWT), and falls. The primary analysis was intention-to-treat. Results The average age of participants was 74.9 years (standard deviation [SD] 6.0) and 57% (246/435) were female. There was no significant difference in ODI scores between treatment groups at 12 months (adjusted mean difference [MD]: −1.4 [95% confidence intervals (CI) −4.03, 1.17]), but, at 6 months, ODI scores favored the BOOST program (adjusted MD: −3.7 [95% CI −6.27, −1.06]). At 12 months, the BOOST program resulted in greater improvements in walking capacity (6MWT MD: 21.7m [95% CI 5.96, 37.38]) and ODI walking item (MD: −0.2 [95% CI −0.45, −0.01]) and reduced falls risk (odds ratio: 0.6 [95% CI 0.40, 0.98]) compared to BPA. No serious adverse events were related to either treatment. Conclusions The BOOST program substantially improved mobility for older adults with NC. Future iterations of the program will consider ways to improve long-term pain-related disability. Clinical Trials Registration Number: ISRCTN1269867

    Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial

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    Background: Many patients with COVID-19 have been treated with plasma containing anti-SARS-CoV-2 antibodies. We aimed to evaluate the safety and efficacy of convalescent plasma therapy in patients admitted to hospital with COVID-19. Methods: This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]) is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. The trial is underway at 177 NHS hospitals from across the UK. Eligible and consenting patients were randomly assigned (1:1) to receive either usual care alone (usual care group) or usual care plus high-titre convalescent plasma (convalescent plasma group). The primary outcome was 28-day mortality, analysed on an intention-to-treat basis. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936. Findings: Between May 28, 2020, and Jan 15, 2021, 11558 (71%) of 16287 patients enrolled in RECOVERY were eligible to receive convalescent plasma and were assigned to either the convalescent plasma group or the usual care group. There was no significant difference in 28-day mortality between the two groups: 1399 (24%) of 5795 patients in the convalescent plasma group and 1408 (24%) of 5763 patients in the usual care group died within 28 days (rate ratio 1·00, 95% CI 0·93–1·07; p=0·95). The 28-day mortality rate ratio was similar in all prespecified subgroups of patients, including in those patients without detectable SARS-CoV-2 antibodies at randomisation. Allocation to convalescent plasma had no significant effect on the proportion of patients discharged from hospital within 28 days (3832 [66%] patients in the convalescent plasma group vs 3822 [66%] patients in the usual care group; rate ratio 0·99, 95% CI 0·94–1·03; p=0·57). Among those not on invasive mechanical ventilation at randomisation, there was no significant difference in the proportion of patients meeting the composite endpoint of progression to invasive mechanical ventilation or death (1568 [29%] of 5493 patients in the convalescent plasma group vs 1568 [29%] of 5448 patients in the usual care group; rate ratio 0·99, 95% CI 0·93–1·05; p=0·79). Interpretation: In patients hospitalised with COVID-19, high-titre convalescent plasma did not improve survival or other prespecified clinical outcomes. Funding: UK Research and Innovation (Medical Research Council) and National Institute of Health Research

    Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

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    Background: In this study, we aimed to evaluate the effects of tocilizumab in adult patients admitted to hospital with COVID-19 with both hypoxia and systemic inflammation. Methods: This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. Those trial participants with hypoxia (oxygen saturation <92% on air or requiring oxygen therapy) and evidence of systemic inflammation (C-reactive protein ≥75 mg/L) were eligible for random assignment in a 1:1 ratio to usual standard of care alone versus usual standard of care plus tocilizumab at a dose of 400 mg–800 mg (depending on weight) given intravenously. A second dose could be given 12–24 h later if the patient's condition had not improved. The primary outcome was 28-day mortality, assessed in the intention-to-treat population. The trial is registered with ISRCTN (50189673) and ClinicalTrials.gov (NCT04381936). Findings: Between April 23, 2020, and Jan 24, 2021, 4116 adults of 21 550 patients enrolled into the RECOVERY trial were included in the assessment of tocilizumab, including 3385 (82%) patients receiving systemic corticosteroids. Overall, 621 (31%) of the 2022 patients allocated tocilizumab and 729 (35%) of the 2094 patients allocated to usual care died within 28 days (rate ratio 0·85; 95% CI 0·76–0·94; p=0·0028). Consistent results were seen in all prespecified subgroups of patients, including those receiving systemic corticosteroids. Patients allocated to tocilizumab were more likely to be discharged from hospital within 28 days (57% vs 50%; rate ratio 1·22; 1·12–1·33; p<0·0001). Among those not receiving invasive mechanical ventilation at baseline, patients allocated tocilizumab were less likely to reach the composite endpoint of invasive mechanical ventilation or death (35% vs 42%; risk ratio 0·84; 95% CI 0·77–0·92; p<0·0001). Interpretation: In hospitalised COVID-19 patients with hypoxia and systemic inflammation, tocilizumab improved survival and other clinical outcomes. These benefits were seen regardless of the amount of respiratory support and were additional to the benefits of systemic corticosteroids. Funding: UK Research and Innovation (Medical Research Council) and National Institute of Health Research

    The Decline in Hydrocodone/Acetaminophen Prescriptions in Emergency Departments in the Veterans Health Administration Between 2009 to 2015

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    Introduction: The purpose of the study was to measure national prescribing patterns for hydrocodone/acetaminophen among veterans seeking emergency medical care, and to see if patterns have changed since this medication became a Schedule II controlled substance.Methods: We conducted a retrospective cohort study of emergency department (ED) visits within the Veterans Health Administration (VA) between January 2009 and June 2015. We looked at demographics, comorbidities, utilization measures, diagnoses, and prescriptions.Results: During the study period, 1,709,545 individuals participated in 6,270,742 ED visits and received 471,221 prescriptions for hydrocodone/acetaminophen (7.5% of all visits). The most common diagnosis associated with a prescription was back pain. Prescriptions peaked at 80,776 in 2011 (8.7% of visits), and declined to 35,031 (5.6%) during the first half of 2015 (r=‒0.99, p<0.001). The percentage of hydrocodone/acetaminophen prescriptions limited to 12 pills increased from 22% (13,949) in 2009 to 31% (11,026) in the first half of 2015. A prescription was more likely written for patients with a painscore≥7 (OR 3.199, CI [3.192‒3.205]), a musculoskeletal (OR 1.622, CI [1.615‒1.630]) or soft tissue(OR 1.656, CI [1.649‒1.664]) diagnosis, and those below the first quartile for total ED visits (OR 1.282, CI [1.271‒1.293]) and total outpatient ICD 9 codes (OR 1.843, CI [1.833‒1.853]).Conclusion: Hydrocodone/acetaminophen is the most frequently prescribed ED medication in the VA. The rate of prescribing has decreased since 2011, with the rate of decline remaining unchanged after it was classified as a Schedule II controlled substance. The proportion of prescriptions falling within designated guidelines has increased but is not at goal

    Repeat lactate level predicts mortality better than rate of clearance

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    Background Lactate clearance has been developed into a marker of resuscitation in trauma, but no study has compared the predictive power of the various clearance calculations. Our objective was to determine which method of calculating lactate clearance best predicted 24-hour and in-hospital mortality after injury. Study design Retrospective chart review of patients admitted to a Level-1 trauma center directly from the scene of injury from 2010 to 2013 who survived \u3e15 min, had an elevated lactate at admission (≥3 mmol/L), followed by another measurement within 24 h of admission. Lactate clearance was calculated using five models: actual value of the repeat level, absolute clearance, relative clearance, absolute rate, and relative rate. Models were compared using the areas under the respective receiver operating curves (AUCs), with an endpoint of death at 24 h and in-hospital mortality. Results 3910 patients had an elevated admission lactate concentration on admission (mean = 5.6 ± 3.0 mmol/L) followed by a second measurement (2.7 ± 1.8 mmol/L). Repeat absolute measurement best predicted 24-hour (AUC = 0.85, 95% CI: 0.84–0.86) and in-hospital death (AUC = 0.77; 95% CI, 0.76–0.78). Relative clearance was the best model of lactate clearance (AUC = 0.77, 95% CI: 0.75–0.78 and AUC = 0.705, 95% CI: 0.69–72, respectively) (p \u3c 0.0001 for each). A sensitivity analysis using a range of initial lactate measures yielded similar results. Conclusions The absolute value of the repeat lactate measurement had the greatest ability to predict mortality in injured patients undergoing resuscitation
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