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1.
BMJ Open ; 12(1): e058932, 2022 01 06.
Article in English | MEDLINE | ID: covidwho-1613014

ABSTRACT

INTRODUCTION: Respiratory rehabilitation is the use of exercise, education, and behavioural interventions to alleviate symptoms and improve quality of life. Recent studies highlight that respiratory rehabilitation is effective and safe for patients with COVID-19. We aim to evaluate the effectiveness and feasibility of respiratory telerehabilitation on patients infected with COVID-19 by conducting a systematic review and meta-analysis. METHODS AND ANALYSIS: PubMed, Web of Science, Science Direct, Physiotherapy Evidence Database, Google Scholar and Cochrane Library databases will be searched from inception to the end of November 2021. Randomised controlled trials investigating the effectiveness of telerehabilitation in the management of COVID-19 will be included. The primary outcomes will be functional capacity, cardiopulmonary exercise tests and quality of life. Secondary outcomes will include anxiety/depression level, sleep quality, mortality rate, completion rate, reason for withdrawal, adverse events, service satisfaction, cost-effectiveness and other potential factors. Two reviewers will independently screen and extract data and perform quality assessment of included studies. The Cochrane risk of bias tool will be used to assess risk of bias. Review Manager V.5.4 (Cochrane Collaboration) software will be used for statistical analysis. Heterogeneity will be analysed using I² statistics. Mean difference or standardised mean difference with 95% CI and p value will be used to calculate treatment effect for outcome variables. ETHICS AND DISSEMINATION: Ethical approval is not required because this systematic review and meta-analysis is based on previously published data. Final result will be published in peer-reviewed journal and presented at relevant conferences and events. PROSPERO REGISTRATION NUMBER: CRD42021287975.


Subject(s)
COVID-19 , Telerehabilitation , Feasibility Studies , Humans , Meta-Analysis as Topic , Quality of Life , SARS-CoV-2 , Systematic Reviews as Topic
2.
Eur J Anaesthesiol ; 38(12): 1284-1292, 2021 12 01.
Article in English | MEDLINE | ID: covidwho-1608616

ABSTRACT

BACKGROUND: During the surge in coronavirus disease 2019 (COVID-19) infections in early 2020, many medical organisations began developing strategies for implementing teleconsultation to maintain medical services during lockdown and to limit physical contact. Therefore, we developed a teleconsultation preoperative evaluation platform to replace on-site preoperative meetings. OBJECTIVE: This study assessed the feasibility of a teleconsultation for preoperative evaluation and procedure-associated adverse events. DESIGN: Implementation study. SETTING: A tertiary care university hospital in Germany from April 2020 to October 2020. PATIENTS: One hundred and eleven patients scheduled for elective surgery. INTERVENTION: Patients were assigned to receive teleconsultation for preoperative evaluation and to complete a subsequent survey. MAIN OUTCOME MEASURES: Primary endpoints were medical and technical feasibility, user satisfaction and time savings. RESULTS: For 100 out of 111 patients, telepreoperative consultations allowed for adequate perioperative risk assessment, patient education and also for effective collection of legal signatures. For six patients (5.4%), consultations could not be started because of technical issues, whereas for five patients (4.8%), clearance for surgery could not be granted because of medical reasons. A clear majority of anaesthetists (93.7%) rated the telepreoperative evaluations as equivalent to on-site meetings. The majority of the patients considered teleconsultation for preoperative evaluation as convenient as an on-site meeting (98.2%) and would choose a teleconsultation again (97.9%). Median travel time saved by patients was 60 min (Q1 40, Q3 80). We registered one adverse event: we detected atrial fibrillation in one patient only immediately prior to surgery. CONCLUSION: Telepreoperative evaluations are medically and technically feasible, yielding high satisfaction rates on both sides. However, regarding patient safety, not every patient is equally well suited. Overall, implementation of teleconsultation for preoperative evaluation into clinical routine could help maintain medical care during the COVID-19 pandemic. TRIAL REGISTRATION: NCT04518514, ClinicalTrials.gov.


Subject(s)
COVID-19 , Remote Consultation , Communicable Disease Control , Feasibility Studies , Humans , Pandemics , SARS-CoV-2
3.
JAMA Netw Open ; 5(1): e2142057, 2022 01 04.
Article in English | MEDLINE | ID: covidwho-1604871

ABSTRACT

Importance: Closure of day care centers has been implemented globally to contain the COVID-19 pandemic but has negative effects on children's health and psychosocial well-being. Objective: To investigate the feasibility of surveillance among children and childcare workers and to model the efficacy of surveillance on viral spread prevention. Design, Setting, and Participants: This nonrandomized controlled trial was conducted at 9 day care centers in Wuerzburg, Germany, from October 2020 to March 2021. Participants included children attending day care, childcare workers, and household members. Participating day care centers were assigned to different surveillance modules in a nonrandomized feasibility study. A mathematical model for SARS-CoV-2 spread in day care centers was developed to identify optimal surveillance. Interventions: Modules 1, 2, and 3 involved continuous surveillance of asymptomatic children and childcare workers by SARS-CoV-2 polymerase chain reaction testing of either midturbinate nasal swabs twice weekly (module 1) or once weekly (module 2) or self-sampled saliva samples twice weekly (module 3). Module 4 involved symptom-based, on-demand testing of children, childcare workers, and their household members by oropharyngeal swabs. All participants underwent SARS-CoV-2 antibody status testing before and after the sampling period. Questionnaires on attitudes and perception of the pandemic were administered in weeks 1, 6, and 12. Mathematical modeling was used to estimate SARS-CoV-2 spread in day care centers. Main Outcomes and Measures: The primary outcomes were acceptance of the respective surveillance protocols (feasibility study) and the estimated number of secondary infections (mathematical modeling). Results: Of 954 eligible individuals (772 children and 182 childcare workers), 592 (62%), including 442 children (median [IQR] age, 3 [2-4] years; 214 [48.6%] female) and 150 childcare workers (median [IQR] age, 29 [25-44] years; 129 [90.8%] female) participated in the surveillance. In total, 4755 tests for SARS-CoV-2 detected 2 infections (1 childcare worker and 1 adult household member). Acceptance for continuous surveillance was highest for biweekly saliva testing (150 of 221 eligible individuals [67.9%; 95% CI, 61.5%-73.7%]) compared with biweekly (51 of 117 individuals [43.6%; 95% CI, 35.0%-52.6%]) and weekly (44 of 128 individuals [34.4%; 95% CI, 26.7%-43.0%]) midturbinate swabbing (P < .001). Dropout rates were higher for midturbinate swabbing (biweekly, 11 of 62 participants [18%]; once weekly, 11 of 55 participants [20%]) than for saliva testing (6 of 156 participants [4%]). Mathematical modeling based on study and literature data identified biweekly testing of at least 50% of children and childcare workers as minimal requirements to limit secondary infections. Conclusions and Relevance: In this nonrandomized controlled trial, surveillance for SARS-CoV-2 in 9 German day care centers was feasible and well accepted. Mathematical modeling estimated that testing can minimize the spread of SARS-CoV-2 in day care centers. These findings enable setup of surveillance programs to maintain institutional childcare. Trial Registration: German Registry for Clinical Trials Identifier: DRKS00023721.


Subject(s)
COVID-19 Testing , COVID-19/prevention & control , Caregivers , Child Care , Child Day Care Centers , Child Health , Adult , COVID-19/diagnosis , COVID-19/virology , Child , Child, Preschool , Feasibility Studies , Female , Germany , Humans , Male , Models, Theoretical , Pandemics , Patient Acceptance of Health Care , Polymerase Chain Reaction , SARS-CoV-2 , Saliva , Specimen Handling
4.
BMJ Open Diabetes Res Care ; 9(2)2021 12.
Article in English | MEDLINE | ID: covidwho-1598547

ABSTRACT

INTRODUCTION: Early diagnosis of prediabetes based on blood sampling for the oral glucose tolerance test (OGTT) is crucial for intervention but multiple barriers hinder its uptake. This study aimed to assess the feasibility and precision of a self-administered capillary OGTT for type-2 diabetes mellitus (T2DM) in high-risk individuals. RESEARCH DESIGN AND METHODS: Participants with history of gestational diabetes or prediabetes were recruited in primary care. Due to their prediabetic status and previous diagnosis of gestational diabetes mellitus, a proportion of participants had previous experience doing OGTT. They self-administered the capillary OGTT and concurrently their venous glucose samples were obtained. They filled a questionnaire to collect their demographic information, views of their capillary OGTT, and their preferred site of the test. RESULTS: Among 30 participants enrolled in this feasibility study, 93.3% of them felt confident of performing the capillary OGTT themselves, and 70.0% preferred the test at home. Older, less educated participants found it less acceptable. Mean capillary glucose values were significantly higher than venous glucose values, with mean difference at 0.31 mmol/L (95% CI 0.13 to 0.49) at fasting, and 0.47 mmol/L (95% CI 0.12 to 0.92) 2 hours post-OGTT. Capillary and venous glucose measurements were correlated for fasting (r=0.95; p<0.001) and 2-hour-post-OGTT (r=0.95;p<0.001). The Fleiss-Kappa Score (0.79, p<0.0001) indicated fair agreement between the two methods. The capillary OGTT had excellent sensitivity (94.1%) and negative predictive value (NPV=91.7%) in identifying prediabetes or T2DM status, vis-a-vis to venous glucose samples. CONCLUSION: Self-administered capillary OGTT is feasible and acceptable, especially among younger adults, with excellent sensitivity and NPV compared with plasma-based OGTT.


Subject(s)
Diabetes, Gestational , Prediabetic State , Adult , Blood Glucose , Diabetes, Gestational/diagnosis , Feasibility Studies , Female , Glucose Tolerance Test , Humans , Prediabetic State/diagnosis , Pregnancy
5.
AAPS PharmSciTech ; 23(1): 44, 2021 Dec 29.
Article in English | MEDLINE | ID: covidwho-1595653

ABSTRACT

Investigating bicelles as an oral drug delivery system and exploiting their structural benefits can pave the way to formulate hydrophobic drugs and potentiate their activity. Herein, the ability of non-ionic surfactants (labrasol®, tween 80, cremophore EL and pluronic F127) to form curcumin loaded bicelles with phosphatidylcholine, utilizing a simple method, was investigated. Molecular docking was used to understand the mechanism of bicelles formation. The % transmittance and TEM exhibited bicelles formation with labrasol® and tween 80, while cremophor EL and pluronic F127 tended to form mixed micelles. The surfactant-based nanostructures significantly improved curcumin dissolution (99.2 ± 2.6% within 10 min in case of tween 80-based bicelles) compared to liposomes and curcumin suspension in non-sink conditions. The prepared formulations improved curcumin ex vivo permeation over liposomes and drug suspension. Further, the therapeutic antiviral activity of the formulated curcumin against SARS-CoV-2 was potentiated over drug suspension. Although both Labrasol® and tween 80 bicelles could form bicelles and enhance the oral delivery of curcumin when compared to liposomes and drug suspension, the mixed micelles formulations depicted superiority than bicelles formulations. Our findings provide promising formulations that can be utilized for further preclinical and clinical studies of curcumin as an antiviral therapy for COVID-19 patients. Graphical Abstract.


Subject(s)
COVID-19 , Curcumin , Antiviral Agents , Feasibility Studies , Humans , Micelles , Molecular Docking Simulation , SARS-CoV-2 , Surface-Active Agents
6.
Asian Nurs Res (Korean Soc Nurs Sci) ; 15(5): 345-352, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1594617

ABSTRACT

PURPOSE: The purpose of this study was to develop a novel mouth contactless breathing exercise solution based on virtual reality (VR), and to test its feasibility. METHODS: We developed the Virtual Reality-based Breathing Exercise System (VR-BRES), a self-regulating biofeedback breathing exercise with gaming characteristics and a soft stretch sensor. The feasibility and efficacy of the VR-BRES prototype were investigated through a randomized crossover trial. Fifty healthy adults participated in the trial, and their respiratory parameters and user evaluation of the VR-BRES were compared with conventional deep breathing (CDB) exercises. RESULTS: The respiratory parameters, forced vital capacity (Z = 4.82, 4.95, p < .001), forced expiratory volume in one second (t = 6.02, 6.26, p < .001), and peak expiratory flow (t = 5.35, 5.68, p < .001) were significantly higher during breathing exercises using the VR-BRES. User evaluation was also significantly higher for the VR-BRES in terms of efficiency (Z = 3.86, p < .001), entertainingness (Z = 5.00, p < .001), and intention to use (Z = 3.22, p = .001) compared to CDB. However, there was no difference in convenience between the two methods (Z = -0.90, p = .369). CONCLUSION: The VR-BRES has the potential to be an efficient breathing exercise solution. We recommend a clinical study that evaluates the effects of the VR-BRES for a certain period of time for people who need breathing exercises.


Subject(s)
Virtual Reality , Adult , Breathing Exercises , Cross-Over Studies , Feasibility Studies , Humans , Mouth
7.
BMC Fam Pract ; 22(1): 248, 2021 12 16.
Article in English | MEDLINE | ID: covidwho-1582112

ABSTRACT

BACKGROUND: The novel coronavirus disease in 2019 (COVID-19) has placed unprecedented strain on healthcare providers, in particular, primary care services. General practitioners (GP) have to effectively manage patients remotely preserving social distancing. We aim to assess an app-based remote patient monitoring solution in reducing the workload of a clinician and reflect this as time-saved in an economic context. Primary care COVID patients in West London deemed medium risk were recruited into the virtual ward. Patients were monitored for 14 days by telephone or by both the Huma app and telephone. Information on number of phone calls, duration of phone calls and duration of time spent reviewing the app data was recorded. RESULTS: The amount of time spent reviewing one patient in the telephone only arm of the study was 490 min, compared with 280 min spent reviewing one patient who was monitored via both the Huma app and telephone. Based on employed clinicians monitoring patients, this equates to a 0.04 reduction of full-time equivalent staffing I.e. for every 100 patients, it would require 4 less personnel to remotely monitor them. There was no difference in mortality or adverse events between the two groups. CONCLUSION: App-based remote patient monitoring potentially holds large economic benefit to COVID-19 patients. In wake of further waves or future pandemics, and even in routine care, app-based remote monitoring patients could free up vital resources in terms of clinical team's time, allowing a better reallocation of services.


Subject(s)
COVID-19 , Mobile Applications , Feasibility Studies , Humans , Monitoring, Physiologic , Pandemics , Primary Health Care , SARS-CoV-2 , Workload
8.
Ann Med ; 53(1): 402-409, 2021 12.
Article in English | MEDLINE | ID: covidwho-1574118

ABSTRACT

INTRODUCTION: Coronavirus disease 2019 (COVID-19) has a high burden on the healthcare system. Prediction models may assist in triaging patients. We aimed to assess the value of several prediction models in COVID-19 patients in the emergency department (ED). METHODS: In this retrospective study, ED patients with COVID-19 were included. Prediction models were selected based on their feasibility. Primary outcome was 30-day mortality, secondary outcomes were 14-day mortality and a composite outcome of 30-day mortality and admission to medium care unit (MCU) or intensive care unit (ICU). The discriminatory performance of the prediction models was assessed using an area under the receiver operating characteristic curve (AUC). RESULTS: We included 403 patients. Thirty-day mortality was 23.6%, 14-day mortality was 19.1%, 66 patients (16.4%) were admitted to ICU, 48 patients (11.9%) to MCU, and 152 patients (37.7%) met the composite endpoint. Eleven prediction models were included. The RISE UP score and 4 C mortality scores showed very good discriminatory performance for 30-day mortality (AUC 0.83 and 0.84, 95% CI 0.79-0.88 for both), significantly higher than that of the other models. CONCLUSION: The RISE UP score and 4 C mortality score can be used to recognise patients at high risk for poor outcome and may assist in guiding decision-making and allocating resources.


Subject(s)
COVID-19/mortality , Emergency Service, Hospital/statistics & numerical data , Aged , COVID-19/diagnosis , Feasibility Studies , Female , Hospital Mortality , Humans , Length of Stay/statistics & numerical data , Logistic Models , Male , Middle Aged , Netherlands/epidemiology , Prognosis , ROC Curve , Retrospective Studies , Risk Assessment/methods , SARS-CoV-2/isolation & purification
9.
Trials ; 22(1): 910, 2021 Dec 11.
Article in English | MEDLINE | ID: covidwho-1571920

ABSTRACT

BACKGROUND: The COVID-19 pandemic poses challenges for timely outcome assessment in randomized clinical trials (RCT). Our aim was to describe our remote neurocognitive testing (NCT) protocol administered by telephone in patients with Parkinson's disease (PD) and obstructive sleep apnea (OSA). METHODS: We studied PD patients with OSA and Montreal Cognitive Assessment (MoCA) score ≤ 27 participating in a RCT assessing OSA treatment impact on cognition. Trial outcomes included change in MoCA and specific cognitive domains from baseline to 3 and 6 months. With COVID19 pandemic-related restrictions, 3-month visits were converted from in-person to telephone administration with materials mailed to participants for compatible tests and retrieved by courier the same day. In exploratory analyses, we compared baseline vs. 3-month results in the control arm, which were not expected to change significantly (test-re-test), using a paired t-test and assessed agreement with the intraclass correlation coefficient (ICC). RESULTS: Seven participants were approached and agreed to remote NCT at 3-month follow-up. Compared to the in-person NCT control arm group, they were younger (60.6 versus 70.6 years) and had a shorter disease course (3.9 versus 9.2 years). Remote NCT data were complete. The mean test-retest difference in MoCA was similar for in-person and remote NCT control-arm groups (between group difference - 0.69; 95%CI - 3.67, 2.29). Agreement was good for MOCA and varied for specific neurocognitive tests. CONCLUSION: Telephone administration of the MoCA and a modified neurocognitive battery is feasible in patients with PD and OSA. Further validation will require a larger sample size.


Subject(s)
COVID-19 , Parkinson Disease , Sleep Apnea, Obstructive , Cognition , Feasibility Studies , Humans , Pandemics , Parkinson Disease/diagnosis , Parkinson Disease/therapy , SARS-CoV-2 , Sleep Apnea, Obstructive/diagnosis , Sleep Apnea, Obstructive/therapy
10.
BMC Infect Dis ; 21(1): 1241, 2021 Dec 11.
Article in English | MEDLINE | ID: covidwho-1571743

ABSTRACT

BACKGROUND: Living conditions in homeless shelters facilitate the transmission of COVID-19. Social determinants and pre-existing health conditions place homeless people at increased risk of severe disease. Described outbreaks in homeless shelters resulted in high proportions of infected residents and staff members. In addition to other infection prevention strategies, regular shelter-wide (universal) testing for COVID-19 may be valuable, depending on the level of community transmission and when resources permit. METHODS: This was a prospective feasibility cohort study to evaluate universal testing for COVID-19 at a homeless shelter with 106 beds in Berlin, Germany. Co-researchers were recruited from the shelter staff. A PCR analysis of saliva or self-collected nasal/oral swab was performed weekly over a period of 3 weeks in July 2020. Acceptability and implementation barriers were analyzed by process evaluation using mixed methods including evaluation sheets, focus group discussion and a structured questionnaire. RESULTS: Ninety-three out of 124 (75%) residents were approached to participate in the study. Fifty-one out of the 93 residents (54.8%) gave written informed consent; thus 41.1% (51 out of 124) of all residents were included in the study. Among these, high retention rates (88.9-93.6%) of a weekly respiratory specimen were reached, but repeated collection attempts, as well as assistance were required. Around 48 person-hours were necessary for the sample collection including the preparation of materials. A self-collected nasal/oral swab was considered easier and more hygienic to collect than a saliva specimen. No resident was tested positive by RT-PCR. Language barriers were the main reason for non-participation. Flexibility of sample collection schedules, the use of video and audio materials, and concise written information were the main recommendations of the co-researchers for future implementation. CONCLUSIONS: Voluntary universal testing for COVID-19 is feasible in homeless shelters. Universal testing of high-risk facilities will require flexible approaches, considering the level of the community transmission, the available resources, and the local recommendations. Lack of human resources and laboratory capacity may be a major barrier for implementation of universal testing, requiring adapted approaches compared to standard individual testing. Assisted self-collection of specimens and barrier free communication may facilitate implementation in homeless shelters. Program planning must consider homeless people's needs and life situation, and guarantee confidentiality and autonomy.


Subject(s)
COVID-19 , Homeless Persons , COVID-19 Testing , Cohort Studies , Feasibility Studies , Germany , Humans , Prospective Studies , SARS-CoV-2
11.
J Emerg Manag ; 19(7): 193-202, 2021.
Article in English | MEDLINE | ID: covidwho-1551756

ABSTRACT

INTRODUCTION: Having an adequate supply of personal protective equipment during the COVID-19 pandemic has been a constant challenge for hospitals across the United States. In the event of shortages, our assembled mask might offer noninferior protection compared to an N95 respirator. OBJECTIVE: To study the ability of an assembled mask to pass a quantitative fit testing. METHODS: We conducted a feasibility study at the Oklahoma City Veteran Affairs Health Care System. Volunteers were fitted with an assembled mask made of either a Hans Rudolph half-face mask or a Respironics Performax full-face mask, attached to an Iso-Gard HEPA light Filter 28022 through a Performax SE elbow hinge. Quantitative fit testing was conducted using the Occupation Safety and Health Administration fit testing protocol. The primary outcome was the percentage of participants who pass the quantitative fit test. Secondary outcomes included the overall fit factor (FF), average FF for different exercises, changes in pulse oximetry and end-tidal CO2 at 0 and 15 minutes, willingness to use the mask, and visibility assessment. RESULTS: Twenty participants completed the study, and all (100 percent) passed the quantitative fit testing. The overall FF had a geometric mean of 2,317 (range: 208-16,613) and a geometric standard deviation of 3.8. The lowest FF was recorded while the subjects were talking. Between time 0 and 15 minutes, there was no clinically significant change in pulse oximetry and end-tidal CO2 levels. Most participants reported "very good" visibility and were "highly likely" to use the Hans Rudolph half-face mask in the case of shortage. CONCLUSION: Our assembled respirator offers noninferior protection to N95 respirators in the setting of hypothetical protective equipment shortage.


Subject(s)
COVID-19 , Pandemics , Equipment Design , Feasibility Studies , Humans , N95 Respirators , Pandemics/prevention & control , Personal Protective Equipment , SARS-CoV-2 , United States
12.
J Med Internet Res ; 23(11): e28322, 2021 11 05.
Article in English | MEDLINE | ID: covidwho-1547122

ABSTRACT

BACKGROUND: We present the results of a feasibility, randomized waitlist control group (CG) parallel design study with a 1:1 allocation ratio. Participants were randomized into an intervention group (IG) or a waitlist CG. The intervention was a 6-week digital self-management program, Help to Overcome Problems Effectively (HOPE), for people with cancer. OBJECTIVE: This study aims to test the feasibility of a digitally delivered self-management program for people with cancer. This will inform the design of a definitive randomized controlled trial. In addition, a preliminary assessment of the impact of the HOPE program via secondary outcomes will be used to assess signals of efficacy in a trial context. METHODS: Participants were drawn from an opportunity sample, referred by Macmillan Cancer Support, and were invited via email to participate in the study (N=61). Primary outcomes were rates of recruitment, retention, follow-up, completion and adherence, sample size and effect size estimation, and assessment of progression criteria for a definitive trial. Secondary outcomes were self-report measures of participants' positive mental well-being, depression, anxiety, and patient activation (ie, confidence in managing their cancer). The intervention and data collection took place on the web. RESULTS: The recruitment rate was 77% (47/61). A total of 41 participants completed the baseline questionnaires and were randomized to either the IG (n=21) or the waitlist CG (n=20). The retention rate (attending all program sessions) was greater than 50% (all: 21/41, 51%, IG: 10/21, 48%; and CG: 11/20, 55%). The follow-up rate (completing all questionnaires) was greater than 80% (all: 33/41, 80%; IG: 16/21, 76%; and CG: 17/20, 85%). The completion rate (attending ≥3 sessions and completing all questionnaires) was greater than 60% (all: 25/41, 61%; IG: 13/21, 62%; and CG: 12/20, 60%). Engagement data showed that participants viewed between half (5.1/10, 51%) and three-quarters (12.2/16, 76%) of the pages in each session. CONCLUSIONS: All progression criteria for a definitive trial were met, as supported by the primary outcome data. The IG showed improved postprogram scores on measures of positive mental well-being, depression, anxiety, and patient activation. A full-scale trial of the digital HOPE program for people with cancer will allow us to fully evaluate the efficacy of the intervention relative to a CG. TRIAL REGISTRATION: ISRCTN Registry ISRCTN79623250; http://www.isrctn.com/ISRCTN79623250. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/24264.


Subject(s)
Neoplasms , Self-Management , Anxiety , Anxiety Disorders , Feasibility Studies , Humans , Neoplasms/therapy
13.
Am J Speech Lang Pathol ; 30(2): 740-747, 2021 03 26.
Article in English | MEDLINE | ID: covidwho-1545668

ABSTRACT

Purpose Youth with cochlear implants (CIs) are at risk for delays in verbal short-term memory (STM)/working memory (WM), which adversely affect language, neurocognitive, and behavioral outcomes. Assessment of verbal STM/WM is critical for identifying and addressing these delays, but standard assessment procedures require face-to-face (FTF) administration. The purpose of this study was to determine the feasibility and validity of remote testing methods (teleassessment) of verbal STM/WM in youth with CIs as a method of addressing COVID-19-related restrictions on FTF test administration. Method Tests of verbal STM/WM for nonwords, digit spans, letter-number sequences, sentences, and stories were individually administered by speech-language pathologists over a teleassessment platform to 28 youth (aged 9-22 years) with CIs and 36 same-aged normal-hearing peers. Examiners, parents, and participants completed quality and satisfaction ratings with the teleassessment procedure. Teleassessment scores were compared to results of tests obtained at FTF visits an average of 1.6 years earlier. Results Quality and satisfaction ratings for teleassessment were high and in almost all cases did not differ between the CI and normal-hearing samples. Youth with CIs scored lower than normal-hearing peers on measures of verbal STM/WM, and scores for digit span and letter-number sequencing did not differbetween teleassessment and FTF methods. Correlations across teleassessment and FTF visits were strong for digit span, letter-number sequencing, and sentence memory, but were more modest for nonword repetition. Conclusion With some caveats, teleassessment of verbal STM/WM was feasible and valid for youth with CIs.


Subject(s)
Cochlear Implants/psychology , Memory, Short-Term , Speech Perception , Speech-Language Pathology/methods , Telemedicine/methods , Adolescent , COVID-19/epidemiology , Case-Control Studies , Child , Cochlear Implants/adverse effects , Feasibility Studies , Female , Humans , Male , Pandemics , SARS-CoV-2
14.
Trials ; 22(1): 856, 2021 Nov 27.
Article in English | MEDLINE | ID: covidwho-1542127

ABSTRACT

BACKGROUND: Systemic sclerosis (scleroderma; SSc) is a rare autoimmune connective tissue disease. We completed an initial feasibility trial of an online self-administered version of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program using the cohort multiple randomized controlled trial (RCT) design. Due to low intervention offer uptake, we will conduct a new feasibility trial with progression to full-scale trial, using a two-arm parallel, partially nested RCT design. The SPIN-SELF Program has also been revised to include facilitator-led videoconference group sessions in addition to online material. We will test the group-based intervention delivery format, then evaluate the effect of the SPIN-SELF Program on disease management self-efficacy (primary) and patient activation, social appearance anxiety, and functional health outcomes (secondary). METHODS: This study is a feasibility trial with progression to full-scale RCT, pending meeting pre-defined criteria, of the SPIN-SELF Program. Participants will be recruited from the ongoing SPIN Cohort ( http://www.spinsclero.com/en/cohort ) and via social media and partner patient organizations. Eligible participants must have SSc and low to moderate disease management self-efficacy (Self-Efficacy for Managing Chronic Disease (SEMCD) Scale score ≤ 7.0). Participants will be randomized (1:1 allocation) to the group-based SPIN-SELF Program or usual care for 3 months. The primary outcome in the full-scale trial will be disease management self-efficacy based on SEMCD Scale scores at 3 months post-randomization. Secondary outcomes include SEMCD scores 6 months post-randomization plus patient activation, social appearance anxiety, and functional health outcomes at 3 and 6 months post-randomization. We will include 40 participants to assess feasibility. At the end of the feasibility portion, stoppage criteria will be used to determine if the trial procedures or SPIN-SELF Program need important modifications, thereby requiring a re-set for the full-scale trial. Otherwise, the full-scale RCT will proceed, and outcome data from the feasibility portion will be utilized in the full-scale trial. In the full-scale RCT, 524 participants will be recruited. DISCUSSION: The SPIN-SELF Program may improve disease management self-efficacy, patient activation, social appearance anxiety, and functional health outcomes in people with SSc. SPIN works with partner patient organizations around the world to disseminate its programs free-of-charge. TRIAL REGISTRATION: ClinicalTrials.gov NCT04246528 . Registered on 27 January 2020.


Subject(s)
COVID-19 , Scleroderma, Systemic , Self-Management , Feasibility Studies , Humans , Patient-Centered Care , Randomized Controlled Trials as Topic
15.
Ann Vasc Surg ; 76: 28-37, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1525690

ABSTRACT

OBJECTIVES: The COVID-19 pandemic resulted in the cancellation of in-person testing across the country. We sought to understand the feasibility of conducting virtual oral examinations as well as solicit opinions of vascular surgery program directors (PD) regarding the use of virtual platforms to conduct both low stakes mock oral examinations with their trainees and potentially "real" high stakes certifying examinations (CE) moving forward. METHODS: Forty-four senior vascular surgery trainees from 17 institutions took part in a virtual mock oral examination conducted by 38 practicing vascular surgeons via Zoom. Each examination lasted 30 minutes with four clinical scenarios. An anonymous survey pertaining to the conduct of the examination and opinions on feasibility of using virtual examinations for the vascular surgery CE was sent to all examiners and examinees. A similar survey was sent to all vascular surgery program directors. RESULTS: The overall pass rate was 82% (36/44 participants) with no correlation with training paradigm. 32/44 (73%) of trainees, 29/38 (76%) of examiners and 49/103 (48%) of PDs completed the surveys. Examinees and examiners thought the experience was beneficial and PDs also thought the experience would be beneficial for their trainees. While the majority of trainees and examiners believed they were able to communicate and express (or evaluate) knowledge and confidence as easily virtually as in person, PDs were less likely to agree confidence could be assessed virtually. The majority of respondents thought the CE of the Vascular Surgery Board of the American Board of Surgery could be offered virtually, although no groups thought virtual exams were superior to in person exams. While cost benefit was perceived in virtual examinations, the security of the examination was a concern. CONCLUSIONS: Performing virtual mock oral examinations for vascular surgery trainees is feasible. Both vascular surgery trainees as well as PDs feel that virtual CEs should be considered by the Vascular Surgery Board.


Subject(s)
COVID-19 , Certification , Education, Medical, Graduate , Educational Measurement , Internship and Residency , Surgeons/education , Vascular Surgical Procedures/education , Clinical Competence , Educational Status , Feasibility Studies , Female , Humans , Male , Surveys and Questionnaires , Test Taking Skills , Verbal Behavior
16.
Air Med J ; 40(6): 395-398, 2021.
Article in English | MEDLINE | ID: covidwho-1525663

ABSTRACT

OBJECTIVE: Prehospital emergency anesthesia in the form of rapid sequence intubation (RSI) is a critical intervention delivered by advanced prehospital critical care teams. Our previous simulation study determined the feasibility of in-aircraft RSI. We now examine whether this feasibility is preserved in a simulated setting when clinicians wear personal protective equipment (PPE) for aerosol-generating procedures (AGPs) for in-aircraft, on-the-ground RSI. METHODS: Air Ambulance Kent Surrey Sussex is a helicopter emergency medical service that uses an AW169 cabin simulator. Wearing full AGP PPE (eye protection, FFP3 mask, gown, and gloves), 10 doctor-paramedic teams performed RSI in a standard "can intubate, can ventilate" scenario and a "can't intubate, can't oxygenate" (CICO) scenario. Prespecified timings were reported, and participant feedback was sought by questionnaire. RESULTS: RSI was most commonly performed by direct laryngoscopy and was successfully achieved in all scenarios. The time to completed endotracheal intubation (ETI) was fastest (287 seconds) in the standard scenario and slower (370 seconds, P = .01) in the CICO scenario. The time to ETI was not significantly delayed by wearing PPE in the standard (P = .19) or CICO variant (P = .97). Communication challenges, equipment complications, and PPE difficulties were reported, but ways to mitigate these were also reported. CONCLUSION: In-aircraft RSI (aircraft on the ground) while wearing PPE for AGPs had no significant impact on the time to successful completion of ETI in a simulated setting. Patient safety is paramount in civilian helicopter emergency medical services, but the adoption of in-aircraft RSI could confer significant patient benefit in terms of prehospital time savings, and further research is warranted.


Subject(s)
Anesthesia , COVID-19 , Emergency Medical Services , Aircraft , Feasibility Studies , Humans , Intubation, Intratracheal , Personal Protective Equipment , SARS-CoV-2
17.
BMJ Open Diabetes Res Care ; 9(2)2021 11.
Article in English | MEDLINE | ID: covidwho-1518143

ABSTRACT

INTRODUCTION: The COVID-19 pandemic has reduced the accessibility to hemoglobin A1c (HbA1c) tests required for virtual diabetes clinics. The aim was to develop and validate a user-friendly postal system for remote HbA1c monitoring. RESEARCH DESIGN AND METHODS: Validation: A total of 123 capillary blood samples from people with diabetes (PWD) needing face-to-face consultations along with healthy volunteers were measured on a point-of-care (POC) Siemens DCA Vantage Analyzer. Another sample of 5-10 drops was simultaneously collected in a K2EDTA tube (BD Microtainer) and stored for up to 12 days at room temperature for subsequent retesting. Feasibility: During October to December 2020, a total of 286 postal HbA1c kits were sent to PWD prior to their virtual consultation. These contained sample collection guidance, the necessary equipment and a feedback form. As per Packing Instruction 650 regulations, these were posted back to the diabetes center for HbA1c testing on the POC analyzer. RESULTS: There was a strong correlation between the first and the stored sample (R2=0.978). There was a small clinically insignificant negative bias -1.53 mmol/mol (2 SD = 3.10 mmol/mol). Bland-Altman plots showed 93% of results within 2 SD. Of the 87% of returned kits, only one sample failed to be analyzed. 94% of PWD who provided feedback were happy to use the postal HbA1c system again. CONCLUSIONS: A robust user-friendly postal HbA1c system has been created and successfully integrated into clinical practice using the existing POC equipment at the diabetes center. It provides accurate HbA1c results and is an invaluable tool for remote monitoring of HbA1c in PWD-both during and after the pandemic.


Subject(s)
COVID-19 , Pandemics , Feasibility Studies , Glycated Hemoglobin A/analysis , Humans , SARS-CoV-2
18.
J Spinal Cord Med ; 44(sup1): S256-S265, 2021.
Article in English | MEDLINE | ID: covidwho-1517695

ABSTRACT

BACKGROUND: The current pandemic has reduced access to safe, monitored physical activity (PA) programs for persons with spinal cord injury (SCI). The use of telerehabilitation has the potential for continuing activity engagement without risking virus exposure. The present study evaluates the feasibility and efficacy of an online group-based PA program for persons with SCI. METHODS: This preliminary pre-post study delivered an online group-based PA program to persons with SCI. The program consisted of 1-hour sessions twice weekly for six weeks. Online PA satisfaction questionnaires were assessed at post-treatment. Psychosocial subscales from the NeuroQOL-SF were assessed. RESULTS: Participants were adult females between 3 and 32 years post-injury, 1 tetraplegic and 3 paraplegics (n = 4). All participants were highly satisfied with the online instruction, overall content, and videoconferencing platform. Participants stated that the online program was beneficial for their overall physical and psychosocial wellbeing. The program resulted in improvement in anxiety and satisfaction with social roles and activities. CONCLUSION: The current pilot study demonstrates the acceptability and limited efficacy of an online PA program for those with SCI. The program resulted in improved overall perceived wellbeing and satisfaction with social roles and activities. These results have important implications for the clinical implementation of online PA programs in a hospital and community setting.


Subject(s)
COVID-19 , Spinal Cord Injuries , Adult , Exercise , Feasibility Studies , Female , Humans , Pandemics , Pilot Projects , SARS-CoV-2 , Spinal Cord Injuries/epidemiology
19.
BMJ Open ; 11(11): e047829, 2021 11 09.
Article in English | MEDLINE | ID: covidwho-1508363

ABSTRACT

OBJECTIVE: Despite available effective treatments for mental health disorders, few patients in need receive even the most basic care. Integrated telepsychiatry services may be a viable option to increase access to mental healthcare. The aim of this qualitative process evaluation embedded in a randomised controlled feasibility trial was to explore health providers' experiences with a mental healthcare model integrating mental health specialist video consultations (MHSVC) and primary care. METHODS: A qualitative process evaluation focusing on MHSVC in primary care was conducted. In 13 semistructured interviews, we assessed the experience of all mental health specialists, primary care physicians and medical assistants who participated in the trial. A thematic analysis, focusing on the implementation, mechanisms of impact and context, was applied to investigate the data. RESULTS: Considering (1) the implementation, participants evaluated the consultations as feasible, easy to use and time saving. Concerning (2) the mechanisms of impact, the consultations were regarded as effective for patients. Providers attributed the patients' improvements to two key aspects: the familiarity of the primary care practice and the fast access to specialist mental healthcare. Mental health specialists observed trustful therapeutic alliances emerging and described their experience as comparable to same-room care. However, compared with same-room care, specialists perceived the video consultations as more challenging and sometimes more exhausting due to the additional effort required for establishing therapeutic alliances. Regarding (3) the intervention's context, shorter travel distances for patients positively affected the implementation, while technical failures, that is, poor Internet connectivity, emerged as the main barrier. CONCLUSIONS: MHSVCs in primary care are feasible and successful in improving access to mental healthcare for patients. To optimise engagement and comfort of both patients and health providers, future work should focus on empirical determinants for establishing robust therapeutic alliances with patients receiving MHSVC (eg, leveraging non-verbal cues for therapeutic purposes). TRIAL REGISTRATION NUMBER: DRKS00015812; Results.


Subject(s)
Psychiatry , Telemedicine , Feasibility Studies , Humans , Mental Health , Primary Health Care , Referral and Consultation
20.
Health Technol Assess ; 25(61): 1-102, 2021 11.
Article in English | MEDLINE | ID: covidwho-1506527

ABSTRACT

BACKGROUND: Around 60,000 babies are born preterm (prior to 37 weeks' gestation) each year in the UK. There is little evidence on the optimal birth mode (vaginal or caesarean section). OBJECTIVE: The overall aim of the CASSAVA project was to determine if a trial to define the optimal mode of preterm birth could be carried out and, if so, determine what sort of trial could be conducted and how it could best be performed. We aimed to determine the specific groups of preterm women and babies for whom there are uncertainties about the best planned mode of birth, and if there would be willingness to recruit to, and participate in, a randomised trial to address some, but not all, of these uncertainties. This project was conducted in response to a Heath Technology Assessment programme commissioning call (17/22 'Mode of delivery for preterm infants'). METHODS: We conducted clinician and patient surveys (n = 224 and n = 379, respectively) to identify current practice and opinion, and a consensus survey and Delphi workshop (n = 76 and n = 22 participants, respectively) to inform the design of a hypothetical clinical trial. The protocol for this clinical trial/vignette was used in telephone interviews with clinicians (n = 24) and in focus groups with potential participants (n = 13). RESULTS: Planned sample size and data saturation was achieved for all groups except for focus groups with participants, as this had to be curtailed because of the COVID-19 pandemic and data saturation was not achieved. There was broad agreement from parents and health-care professionals that a trial is needed. The clinician survey demonstrated a variety of practice and opinion. The parent survey suggested that women and their families generally preferred vaginal birth at later gestations and caesarean section for preterm infants. The interactive workshop and Delphi consensus process confirmed the need for more evidence (hence the case for a trial) and provided rich information on what a future trial should entail. It was agreed that any trial should address the areas with most uncertainty, including the management of women at 26-32 weeks' gestation, with either spontaneous preterm labour (cephalic presentation) or where preterm birth was medically indicated. Clear themes around the challenges inherent in conducting any trial emerged, including the concept of equipoise itself. Specific issues were as follows: different clinicians and participants would be in equipoise for each clinical scenario, effective conduct of the trial would require appropriate resources and expertise within the hospital conducting the trial, potential participants would welcome information on the trial well before the onset of labour and minority ethnic groups would require tailored approaches. CONCLUSION: Given the lack of evidence and the variation of practice and opinion in this area, and having listened to clinicians and potential participants, we conclude that a trial should be conducted and the outlined challenges resolved. FUTURE WORK: The CASSAVA project could be used to inform the design of a randomised trial and indicates how such a trial could be carried out. Any future trial would benefit from a pilot with qualitative input and a study within a trial to inform optimal recruitment. LIMITATIONS: Certainty that a trial could be conducted can be determined only when it is attempted. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12295730. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 61. See the NIHR Journals Library website for further project information.


Around 60,000 babies are born preterm each year in the UK. We do not know what the safest mode of birth is for these babies. Birth options include a vaginal birth or a caesarean section (which involves an operation for the mother). Normally, the ideal way to find out what clinical options are best is to carry out a 'randomised trial' in which participants are allocated to a particular treatment group (in this case, vaginal birth or caesarean section) by chance. It is not clear if women who have their babies preterm would want to take part in such a trial or that the clinicians looking after the women would be happy to ask them to, as previous trials have failed to recruit sufficient participants. The purpose of the CASSAVA research project was to find out what people think is the best and safest method of delivering preterm babies, their views on doing a research trial and what sort of research trial could be carried out. We conducted a survey asking clinicians and women their views. We gathered clinicians and women together to discuss and agree the key questions for a trial to answer. We then developed a protocol (plan) for a possible trial. Using this trial protocol, we conducted telephone interviews with clinicians, asking them if they would be willing to be involved and if they would be willing to ask pregnant women to participate. We also conducted focus groups with women, using a vignette (storyboard) about a possible trial. We found that there is a lot of uncertainty about the best way for preterm babies to be born. Clinicians and women broadly agreed that it would be good to resolve this uncertainty through a trial. We were able to identify some areas of the greatest uncertainty where clinicians and women would consider participating in a study. We gained a lot of useful information about how we could best set up a trial and support clinicians and women to get involved.


Subject(s)
COVID-19 , Manihot , Premature Birth , Cesarean Section , Feasibility Studies , Humans , Infant , Infant, Newborn , Infant, Premature , Pandemics , Pregnancy , Premature Birth/epidemiology , SARS-CoV-2
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