ABSTRACT
Evusheld is a combination injection of tixagevimab/cilgavimab for pre-exposure COVID-19 prophylaxis and was made available to UK private clinics from October 2022. NICE review is ongoing. Whilst efficacy analysis of Evusheld has focused on the risk-reduction of contracting COVID-19, anecdotal reports suggest additional psychological benefits from Evusheld, although supportive objective data are lacking. In this study, we used 4 well-established psychological health questionnaires to assess different psychological parameters (EQ5D-3 L quality of life (QoL) score, DSM5 Agoraphobia score, Duke's Social Support Index (DSSI) and the hospital anxiety and depression score (HADS)) in blood cancer patients treated with Evusheld at the Genesis Care (GC) Clinic, Cambridge. Patient data (pre-and post-Evusheld) were compared with a control group of GC blood cancer patients who had not received Evusheld. The study was approved by GC and all patients had consented to email contact. Questionnaire replies were anonymised and free-text comments were invited. Questionnaires were completed by 29/40 Evusheld and 54/100 control patients. With EQ5D, Evusheld did not impact mobility, self-care and pain/discomfort scores and patient/ control groups scored at similar levels. EQ5D scores for 'usual activities' and 'anxiety/depression' improved post-Evusheld (patients reporting 'normal activities' increased from 52% to 76% (control = 78%);patients reporting 'no anxiety/ depression' increased from 45% to 66% (control = 65%)). The mean global EQ5D QoL score improved post-Evusheld [69.4% to 72.9% (control = 75.7%)]. With the DSM5 agoraphobia score, Evusheld treatment improved agoraphobia parameters, reducing the mean score from 15.7 to 5.1 (control = 3.7;max = 40) with certain striking changes;72% of pretreatment patients avoided crowded situations all of/most of the time, reducing to 14% post-Evusheld (control = 11%). The DSSI score assessed social/work interactions with external household contacts and post-Evusheld the mean number of interactions over 3 weeks increased from 1.48 to 3.37 (control = 3.77). Pre-Evusheld, 52% of patients had no interactions outside their household, dropping to 20% in the 3 weeks post-Evusheld (control = 17%). Using the HADS 14-point analysis of depression and anxiety revealed on average that each parameter was 25.3% 'significantly improved' and 25.4% 'a little improved' post-Evusheld. Accepting limitations of a small study and potential biases associated with a self-funding patient cohort, Evusheld treatment broadly improved all psychological scores assessed. Free-text comments clearly indicate that Evusheld had a major positive impact on QoL/social mobility for specific patients. The Evusheld patients had higher baseline scores for social isolation, anxiety, depression and agoraphobia compared with control patients, yet Evusheld treatment appeared to improve these parameters to a level similar to control patients.
ABSTRACT
Introduction: Covid-19 was classed as a global pandemic by the World Health Organization (WHO) in March 2020. This had an overwhelming effect on the National Health Services (NHS) in the United Kingdom resulting in the disruption and subsequent prioritization of the elective recovery services. Despite the various limitations of delivering services during a pandemic, Barts Neuromodulation Centre maintained the importance of multidisciplinary assessment in the selection of patients suitable for this form of therapy. We present the data on our continued activity through pandemic, dependent on the performance feasibility. The aim of this effectiveness project was to evaluate the post SCS outcome data during covid-19 pandemic. Method(s): This was a telephone and in person data collection of patient responses to standardized and validated pain outcome questionnaires following SCS implant performed at St Bartholomew's Hospital, London during January-December 2021. Data was collated from a tertiary Neuromodulation center at Barts Health NHS Trust, UK. Patients completed the questionnaires prior to SCS implant and post implant 1, 3, 6, and 12 month follow- up appointments with our neuromodulation specialists Results: Two hundred and fifteen patients underwent face to face or telephonic consultation during January to December 2021 for the follow ups. Total 178 patients registered their responses with F:M being 63%:37% and the average age 55 years. At each time point, the following number of patients completed: baseline n= 52;1 month n= 27;3 months n=28;6-month n= 21 and 12 months, n= 26. We demonstrate that NRS pain scores reduced by 43%, ODI disability improved by 35%, HADS anxiety reduced by 45%, depression reduced by 46%, PSQ sleep improved by 77% and EQ5D quality of life improved by 66% at 12 months when compared to baseline. There were no serious adverse events reported through this time. Conclusion(s): To our knowledge, this is one of the first reported real-world post SCS outcome data of prospective follow ups. We demonstrate safe delivery of services and data collection feasibility through pandemic. Moreover, our patient cohort showed improvement in the all dimensions of chronic refractory pain following SCS therapy despite clinical burden of COVID-19. Disclosure: Alia Ahmad: None, Angie Alamgir, PHD: None, Sanskriti Sharma: None, Joanne Lascelles, Clinical nurse specialist: None, Amin Elyas, FRCS: None, Helen Bonar: None, Serge Nikolic, MD: None, Habib Ellamushi: None, Vivek Mehta: None, Kavita Poply, PHD: NoneCopyright © 2023
ABSTRACT
Background: The phase III EMERALD trial (NCT03778931) reported significantly prolonged progression-free survival (PFS) and a manageable safety profile with elacestrant vs SoC endocrine therapy (ET) in patients (N=478) with ER+/HER2- advanced or mBC following progression on prior CDK4/6i plus ET. PROs measuring quality of life (QoL) are reported here. Method(s): EMERALD patients (pts) completed 3 PRO tools at prespecified time points: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), the PRO version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and the EuroQoL 5 Dimension 5 Level (EQ-5D-5L). Result(s): The ratio of PROs tools completed vs. PROs tools expected was 80-90% through cycle 4 and approximately 70% at cycle 6;likely due to clinical study period overlapping with COVID-19 period. Overall, the EORTC QLQ-C30 scores were similar for elacestrant and SoC, with no differences across all time points for both functional and symptom scales. However, PRO-CTCAE results showed that fewer pts who received elacestrant reported very severe nausea (4.0% vs 14.3% by cycle 6) or very severe vomiting (9.1% vs 50% by cycle 6) compared with SoC. There were no clinically meaningful differences across all time points in adverse events typically observed with pts with cancer on ET, such as fatigue, nausea, vomiting, joint and muscle pain and hot flashes. EQ-5D-5L scores were generally comparable throughout treatment for both study arms, with elacestrant showing numerically better outcomes vs SoC for mobility, self-care and usual activities. Similar trends were observed for the full intent-to-treat population and in pts with detectable estrogen receptor 1 mutations (ESR1m). Conclusion(s): This analysis confirmed that QoL was maintained between treatment groups in the EMERALD trial. Together with the previously described statistically significant prolonged PFS and manageable safety profile, these PRO results provide additional evidence that oral elacestrant is clinically meaningful in this patient population with limited therapeutic options. Clinical trial identification: NCT03778931. Editorial acknowledgement: Jeffrey Walter, IQVIA. Legal entity responsible for the study: Stemline Therapeutics/Menarini Group. Funding(s): Stemline Therapeutics/Menarini Group. Disclosure: J. Cortes: Financial Interests, Personal, Advisory Board: Roche, Celgene, Cellestia, AstraZeneca, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Lilly, MERCK SHARP& DOHME, GSK, LEUKO, Bioasis, Clovis oncology, Boehringer Ingelheim, Ellipses, Hibercell, BioInvent, Gemoab, Gilead, Menarini, Zymeworks, Reveal Genomics;Financial Interests, Personal, Invited Speaker: Roche, Novartis, Celgene, Eisai, Pfizer, Samsung Bioepis, Lilly, MERCK SHARP& DOHME, Daiichi Sankyo;Financial Interests, Personal, Other, Consulting/advisor: Expres2ion Biotechnologies;Financial Interests, Personal, Stocks/Shares: MedSIR, Nektar Therapeutics;Financial Interests, Institutional, Research Grant: Roche, Ariad Pharmaceuticals, AstraZeneca, Baxalta GMBH/Servier Affaires, Bayer healthcare, Eisai, Guardant Health, Merck Sharp & Dohme, Pfizer, Piqur Therapeutics, Puma B, Queen Mary University of London;Other, Travel cost and expenses: Roche, Novartis, Eisai, Daiichi Sankyo, Pfizer, Gilead, AstraZeneca. F.C. Bidard: Financial Interests, Personal, Advisory Role: Pfizer, AstraZeneca, Lilly, Novartis, Radius Health, Menarini;Financial Interests, Institutional, Advisory Role: Menarini;Financial Interests, Personal, Speaker's Bureau: Pfizer, Novartis, AstraZeneca, Roche, Lilly, Rain Therapeutics;Financial Interests, Institutional, Research Grant: Novartis, Pfizer, Menarini Silicon Biosystems, Prolynx;Financial Interests, Institutional, Other, patents: ESR1 & MSI detection techniques;Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Roche, Pfizer, AstraZeneca, Novartis. A. Bardia: Financial Interests, Personal, Advisory Board: Pfizer, Novartis, Genentech, Merck, Sanofi, Eisa , Lilly, Mersana, AstraZeneca/Daiichi, Menarini, Gilead;Financial Interests, Personal, Royalties: UpToDate;Financial Interests, Institutional, Invited Speaker: Genentech, Novartis, Pfizer, Merck, Sanofi, Radius Health, Immunomedics/Gilead, Daiichi Pharma/AstraZeneca, Eli Lilly.;Non-Financial Interests, Principal Investigator: Gilead, Mersana, AstraZeneca/Daiichi, Novartis, Pfizer, Genentech, Lilly, Merck, Sanofi. V.G. Kaklamani: Financial Interests, Personal, Other, Honoraria: Genentech, Novartis, Pfizer, Genomic Health, Puma Biotechnology, AstraZeneca, Seattle Genetics, Daichi, Gilead Sciences;Financial Interests, Personal, Advisory Role: Amgen, Eisai, Puma Biotechnology, Celldex, AstraZeneca, Athenex, bioTheranostics;Financial Interests, Personal, Speaker's Bureau: Genentech, Novartis, Genomic Health, Puma Biotechnology, Pfizer, AstraZeneca/Daiichi Sankyo;Financial Interests, Personal, Research Grant: Eisai. I. Vlachaki: Financial Interests, Personal, Full or part-time Employment: Menarini Hellas A.E. G. Tonini: Financial Interests, Personal, Full or part-time Employment: Menarini Ricerche S.p.A. N. Habboubi: Financial Interests, Personal, Full or part-time Employment: Stemline Therapeutics;Financial Interests, Personal, Leadership Role: Stemline Therapeutics. P.G. Aftimos: Financial Interests, Personal, Advisory Board: Boehringer Ingelheim, Macrogenics, Roche, Novartis, Amcure, Servier, G1 Therapeutics, Radius, Deloitte, Menarini, Gilead, Novartis, Eisai, Lilly;Financial Interests, Personal, Invited Speaker: Synthon, Amgen;Financial Interests, Institutional, Research Grant: Roche.Copyright © 2023
ABSTRACT
Introduction/Aim: Pulmonary rehabilitation (PR) is a vital component in the management of chronic respiratory disorders (CRDs). New models of delivering PR are emerging to increase the uptake and completion of this important intervention. The aim of this study is to evaluate participant rate of attendance to PR delivered via two different delivery modes (centre based and mobile technology (mPR)). Secondary aims are to evaluate the patient preference for mode of delivery, and if mPR is non -inferior to centre-based PR in health outcomes. Method(s): A multi-centre, two-arm parallel preference based clinical trial was conducted. Participants with a chronic respiratory disorder referred for PR were offered the choice of centre-based or web-based (mPR) PR. Both programmes were 8 weeks in duration. The primary outcome was attendance. Result(s): 105 participants were recruited to the study with 67 opting for centre-based and 38 preferring web-based PR (mPR). The attendance rate was higher in the centre-based group than mPR. Results showed mPR was not inferior in terms of changes in symptom scores (CAT) or time spent in sedentary behaviour (SBQ) but inferiority could not be confirmed for changes in dyspnoea scores (mMRC) or health related quality of life (EQ5D-3L). Changes in exercise capacity could not be determined due to COVID-19 restrictions. Conclusion(s): This pragmatic study has shown that mPR was preferred by 38% of participants and a significant percentage were younger, working, with higher education inferring the demand will likely increase over time. The attendance rate with mPR was lower than anticipated. Further research with larger sample size is required to assess efficacy of mPR.
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Introduction: Long COVID is a syndrome characterised by persistence of symptoms after acute SARS-CoV-2 infection. Patients with long COVID may present with a wide range of symptoms, including respiratory, cardiovascular, musculoskeletal, neurological, gastrointestinal and other symptoms. These symptoms can lead to a decrease in activity levels and health-related quality of life of patients. Objetive: The main objetive of this study was to evaluate the activity levels and health-related quality of life of long COVID patients one year after infection. Patients and Methods: In this observational study, long COVID patients were included. These patients were evaluated one year after infection and they were compared to a control group of subjects who had successfully recovered from COVID infection without persistent symptoms matched by age and gender. The activity levels of the patients were assessed with the international physical activity questionnaire (IPAQ) and the health-related quality of life was assessed with the EuroQoL 5 dimensions 5 levels (EQ-5D-5L). Result(s): A total of 455 patients and 451 controls were included in this study. The IPAQ (p<0,001) and the five dimensions of EQ-5D-5L (p<0,001) showed significant results compared to the control group. Conclusion(s): This study found that long COVID syndrome patients presented poorer activity levels and health-related quality of life. The development of treatment programmes tailored to their needs will help to prevent the deterioration caused by this syndrome.
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Introduction: Lung Ultrasound (LUS) can track interstitial changes of COVID-19 pneumonia (CP) in the acute phase. CT has been used to evaluate the development of lung fibrosis post CP but its use is associated with increased ionising radiation. Aims and Objectives: We conducted a prospective single-centre pilot to assess the utility and feasibility of using serial LUS in adult patients recovering from CP. We hypothesize that LUS may provide a safe and acceptable alternative to CT imaging for the outpatient follow-up of these patients. Method(s): 21 subjects provided consent on the day of hospital discharge (D0) and were followed up for 83 days. High-resolution CT was performed on Day 83 and correlated with LUS on Days 0/41/83. Serum Ferritin, LDH, CRP, D-Dimer (Days 0/41/83), Spirometry (Day 41/83) and Quality of Life measures (EQ-5D Day 41/83) were obtained. 3 clinicians reviewed and scored the LUS images independently;CT scoring was performed by 2 thoracic radiologists blinded to the LUS findings. Result(s): 19 subjects completed the study (10 males [52%];mean age: 52 years [range:37-74]). LUS scores were significantly lower at Days 83 and 41 compared to Day 0 (Mean = 1.5 [D83] / 2.8 [D41] / 10.9 [D0] p<0.0001). Ground glass change was the most common finding on CT at Day 83. Correlation between LUS with HRCT at Day 83 was weak (Pearson r2=0.44). However a better correlation was observed in % change of LUS scores and KCO at Day 84 compared to Day 42 (r2=0.64). Conclusion(s): LUS may be a useful point of care tool for the assessment of patients recently recovered from CP. However its role in the evaluation of post CP lung fibrosis requires further study.
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Background: A spectrum of long-term COVID19 effects have been reported. Much less data areavailable about how COVID19 will affect sleep over time in recovered patients. We Assessed the long-term impact of COVID 19 infection on sleep. Methodology:A prospective cohort study including 84 Tunisian COVID19 patients discharged fromhospital. Patients were asked about the period before SARS COV2 related hospital stay, and the 6-9 month-period after hospital discharge, using several self- reported evaluation scales (Pittsburgh Sleep Quality Inde, the Insomnia Severity Index, Epworth Sleepiness Scale, Patient Health Questionnaire (PHQ)-9 and the EuroQol five-dimension five-level questionnaire). Result(s): The mean age was 57,59 years with 46 men and 38 women. As compared with baseline statue of patients, all assessed outcomes were significantly impaired (VAS pain: 1,71+/-1,1 Vs 3,8+/-2,84;PSQI: 3,25+/-2,4 VS 6,39+/-4,73;ESS: 1,94+/-2,44 VS 3,59+/-4,53;ISI: 1,95+/-2,76 VS 6,07+/-5,96, and PHQ-9: 1,45+/-2,74 VS 7,47 +/- 6,61;p=0.0001). The percentage of poor sleepers (PSQI global score higher than 5) and patients with insomnia had significantly increased from 15,5% to 48,8% and from 1,2 to 11%, respectively (p=0.0001). The percentage of patients experiencingdepression symptoms has also doubled (25% to 58,3%), while severe pain was reported by more than one out of five patients against only 1,2% at baseline. The post-COVID -19 PSQI was significantly correlated with body mass index (r=0,328, p=0,003);the post-COVID-19 VAS pain (r=0,479, p=0,0001) as well as the post-COVID-19 PHQ-9 scale (r=0,712, p=0,0001). Conclusion(s): Sleep disturbances, depression symptoms as well as chronic pain are highly prevalent in long-term follow-up period in hospitalized COVID19 survivors therefore,they should be systematically screened.
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Introduction: Significant portion of the patients manifest symptoms, like coughing, dyspnoea, fatigue, exercise intolerance, sleep disorders or neuropsychological symptoms in post-COVID condition. It has influence on patients' quality of life and workability. Pulmonary rehabilitation (PR) has favourable effect on the cardiovascular system, metabolism, respiratory and peripheral muscles, lung mechanics and psychological condition of the patient. Aim(s): Our aim was to assess the effectiveness of a post-COVID PR program in terms of the improvement of patients' functional condition and quality of life. Method(s): 50 patients were involved (female:male=26:24, age 55+/-12 years, BMI: 31+/-8 kg/m2) at the Department of Pulmonology, Semmelweis University, Budapest, Hungary. At the onset of the program we measured lung function, 6-minute walking distance (6MWD), chest wall expansion (CWE), lung function and quality of life (EQ5D and postCovid Functional Scale (PCFS). The post-COVID rehabilitation included controlled breathing techniques, chest wall mobilization, strengthening of respiratory and peripheral muscle, endurance training for cycle and treadmill, dietetic, psychological health assessment and counselling. Result(s): Rehabilitation resulted in improvement in 6MWD (496.16 (80-780) vs. 526.32 (328-744) m;p<0.05), CWE (39.4 (15.2-98.9) vs. 47.4 (20.1-100.5) cm;p<0.05) and quality of life (EQ5D, PCFS). Statistically significant improvement was detected in IVC and FVC. No side effect was observed related to the PR program. Conclusion(s): There is an urgent need of an available PR for patients who suffer from post-COVID pulmonary symptoms to avoid serious medical, social and economic complications and it is safe for the patients.
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Background. Post-COVID-19 syndrome occurs usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis (WHO definition, 2021). Our objective was to describe the prevalence, type, and duration of symptoms and their impact on the quality of life of patients hospitalized for COVID-19. Methods. A cross-sectional descriptive study was done, digital informed consent was obtained. Patients with a history of hospitalization for COVID-19 between March 2020 and October 2021 were invited to answer electronically an adaptation of the questionnaire for the identification of post-COVID-19 syndrome and the instrument EuroQol-5D (quality of life). Both were performed at 3, 6, 9 and 12 months after the initial evaluation for COVID-19. Results. We included 246 patients, of whom 76% (187/246) met the definition of post-COVID-19 syndrome, 54% were men, with a median age of 50 years (IQR 41-63). Sixty-three percent (117/187) of post-COVID-19 syndrome patients described a worse health status (OR 9.2, 95% CI 4.1-22.6, p=< 0.0001). The median time to symptoms onset after hospital discharge was 1 day (IQR 1-20), and the median duration of symptoms was 150 days (IQR 90-225). The most frequent symptoms were dyspnea 75% (141), arthralgia 71% (132), fatigue 68% (127), hair loss 60% (112), myalgia 53% (99), sleep disturbances 52% (97), dizziness 47% (88), and palpitations 41% (76) (Figure 1). Regarding quality of life, the post-COVID-19 syndrome patients presented a lower visual analog scale of the EQ-5D versus the group without syndrome (80mm [IQR 70-90] vs. 89.5mm [IQR 75-90], p=0.05). All five dimensions of the quality of life were affected in the post-COVID-19 syndrome group;and dimensions of pain/ discomfort, usual activities, and anxiety/depression showed a statistical difference (Fig 2). Euroqol (EQ)-5D:Specific instrument to describe and value health-related quality of life. Conclusion. Post-COVID-19 syndrome occurred in 76% of hospitalized patients, with prolonged duration and quality of life impairment. Dyspnea was the most frequent symptom. Timely diagnostic and therapeutic intervention is required.
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Objectives: Cardiac rehabilitation (CR) is recognised as a cost-effective intervention which can be offered to people following a cardiac event. Home-based alternatives are being increasingly used (versus centre-based options), particularly since the COVID-19 pandemic. This study aimed to assess whether home-based interventions in the CR pathway have been demonstrated to be cost-effective, compared to conventional centre-based delivery, in a population undergoing CR. Method(s): Electronic searches of the PsycINFO, MEDLINE and Embase databases (via Ovid) were conducted to identify relevant published full economic evaluations. Studies were included if they reported a full economic evaluation of home-based CR programmes or an intervention that may be classed as an individual aspect of a comprehensive home-based CR programme, compared to centre-based CR options. The review was restricted to English language studies published within the last 15 years. The protocol was registered on the PROSPERO database (CRD42018108226). Result(s): Database searches identified 2,572 initial records (1,865 after the removal of duplicates). Following screening of titles/s, 53 full-text articles were assessed. Nine studies were included in the review. Interventions were heterogeneous in terms of delivery, components of care (e.g. exercise and behaviour change) and duration. All studies were economic evaluations alongside clinical trials, with sample sizes ranging from 53 to 778. All studies reported quality-adjusted life-years (QALYs), with the EQ-5D as the most common measure of health status (6/9 studies). Most studies (7/9 studies) concluded that home-based CR was cost-effective compared to centre-based options. Conclusion(s): Evidence suggests that home-based CR is cost-effective, which is particularly pertinent given the need for non-centre-based options following the COVID-19 pandemic. There were some limitations to the evidence base, including sample size and limited time horizons. Given heterogeneity in intervention design and delivery, future research is needed to investigate patient preferences for CR intervention and the cost-effectiveness of different modes of delivery. Copyright © 2022
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Aims: The COVID-19 pandemic caused significant disruption to clinical research, reducing the ability of patients to visit clinical sites for face-to-face visits. This has accelerated the trend of initiating decentralised research, where patients complete some, or all, of the study procedures at home. These studies have potential upsides of greater convenience for the patient and possibly lower costs for sponsors. Conversely de-centralised trials bring the challenge of ensuring rigour and high levels of completion when administering PROs via an electronic PRO (ePRO) solution. The methodology and compliance levels of an de-centralised observational validation study are presented. Method(s): A 10-week de-centralised, observation study was completed in US, UK and Germany to assess the psychometric properties of the Asthma Daytime and Night-time Symptoms Diaries (ADSD/ANSD). Following IRB review and approval, multiple PROs were administered via a Bring your Own Device ePRO solution, including the ADSD/ANSD, SGRQ, EQ-5D, PROMIS Sleep Disturbance 8a. Fair-market value honoraria were phased over the period of the study. PRO compliance was monitored throughout the study, with pre-programmed scheduled reminders and escalating triggered alerts implemented to facilitate compliance. Result(s): 235 moderateto-severe asthma patients have been recruited. An interim assessment of the compliance indicates that over 90% of patients completed at least 4 days of daily data each week. The end of study overall compliance will be analysed and stratified by days completed per week. The frequency and distribution pattern of reminders will be assessed. Compliance patterns by country, demographics and baseline characteristics will be reported. Lessons learned will be discussed in detail to inform best practice. Conclusion(s): Decentralised trials are increasing in popularity. PROs are progressively being viewed as fundamental to Patient Focused Drug Development. The interim results from this ongoing study demonstrate that high levels of PRO completion are possible in a decentralised, BYOD study, with numerous and variable PRO administration frequency. This highlights the importance of well designed, patient friendly research protocols, in ensuring high levels of patient compliance in remote settings. On completion of study, compliance and compliance reminder metrics will be presented, stratified by baseline and demographic characteristics.
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Background: Anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV) is a debilitating disease that can impact on a patient's quality of life. The aim of this study was to assess longitudinal quality of life among patients with AAV using the EQ-5D instrument. Method(s): 343 patients with AAV were recruited from the Irish Rare Kidney Disease Registry. The EQ-5D instrument was used to evaluate the domains of mobility, selfcare, usual activities, pain/discomfort, anxiety/depression and to generate an index score. Health was also rated using a visual analogue scale (0-100). Questionnaires were completed during nephrology clinics and through a patient support phone app. Data was screened for missing data and questionnaires with clear inconsistencies in responses were excluded. 2082 episodes and 283 patients were analysed. A random effects model was used to control for multiple entries relating to individual patients. Result(s): A poorer quality of life was seen amongst those with AAV (median index value 0.80, UK average 0.856). The mean visual analogue scale was 75.6 (UK average 82.8). Pain and discomfort levels were most affected while self-care was least affected. The index score decreased with increasing age with a 1.5% reduction in index score per decade. A 6% reduction in index score was seen during periods of disease activity compared to periods of remission. Patients requiring dialysis had a 5% reduction in index score. Covid-19 lockdown resulted in a 5.5% index score reduction. Using a median survival rate of 6.16 years for patients with small vessel vasculitis, we calculated the QALYs for this population as 4.9 years. Conclusion(s): We have defined for the first time the EQ-5D index value over the full disease course in patients with AAV. Other studies have demonstrated a reduction in quality of life during active disease using the AAV-PRO and the Medical Outcomes Study Short Form-36. A prior study among Japanese patients reported a mean index value of 0.72. This is lower than our observed index value however a smaller population (n=34) was examined. In conclusion, our research highlights the negative impact of AAV on patients' lives with a further reduction in quality of life seen during periods of increased disease activity, with increasing age and during the Covid-19 pandemic.
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Purpose: Post-acute sequelae of SARS-CoV-2 infection (PASC) is an increasingly recognized phenomenon manifested by long lasting cognitive, mental, and physical symptoms. We aimed to estimate the prevalence of PASC symptoms in solid organ transplant recipients (SOTRs) in the short (1- 6 months) and long-term (> 6 months) periods after SARS-CoV-2 infection. We also compared the prevalence of these symptoms between those with SARS-CoV-2 infection requiring hospitalization and those not requiring hospitalization. Method(s): We surveyed 111 SOTRs with self-reported SARS-CoV-2 infection diagnosed more than 4 weeks prior to survey administration. The survey consisted of 7 validated questionnaires ("Quick Dementia Rating System (QDRS)", "Patient Health Questionnaire (PHQ9)", "Generalized Anxiety Disorder 7 (GAD-7)", "Impact of Events Scale (IES-6)", "EuroQol- 5 Dimension (EQ-5D)", "PROMIS global physical health scale (GHS) "and "Breathlessness, Cough and Sputum Scale (BCSS)"). Result(s): Of the 111 survey participants, 32 (33%) had been hospitalized and 35 (36%) had SARS-CoV-2 infection >6 months ago. Median (IQR) age was 58 years (46, 65). Median time from SARS-CoV-2 diagnosis was 167 days (138, 221). Cognitive impairment, anxiety, depression, insomnia, feeling of trauma, fatigue, pain, breathing problems, cough, abnormal smell, abnormal taste, and diarrhea were reported by 40%, 23%, 36%, 55%, 53%, 41%, 19%, 33%, 33%, 21%, 22%, and 32% of patients respectively. Hospitalized patients had poorer scores in cognition (QDRS survey score of 2 versus 0.75, p=0.048) (Figure 1), quality of life (EQ-5D survey score of 2 versus 1, p=0.043), physical health (PROMIS GHS survey score of 10 versus 11, p=0.013), respiratory status (BCSS survey score of 1 versus 0, p=0.056), and pain (Pain score of 3 versus 0, p 0.006). Among patients who had SARS-CoV-2 infection >6 months ago, abnormal breathing, cough, abnormal smell, abnormal taste, and diarrhea continued to be reported by 31%, 31%, 29%, 32%, and 32% of patients respectively. Conclusion(s): After SARS-CoV-2 infection, SOTRs had a high prevalence of PASC symptoms. Some of the symptoms are more severe in patients who had required hospitalization and persist beyond 6 months. Further studies are needed to understand the long term sequalae of SARS-CoV-2 infection in SOTRs and to develop an evidence-based multidisciplinary approach for caring for these patients beyond the acute phase. (Table Presented).
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Introduction: Mechanical chronic low back pain (CLBP) can be caused by impaired neuromuscular control and degeneration of the multifidus muscles, the most important stabilizers of the lumbar spine. An implantable Restorative Neurostimulation system bilaterally stimulates the medial branches of the L2 dorsal rami to override underlying multifidus inhibition to facilitate motor control restoration. A randomized sham-controlled pivotal trial provided evidence of safety, effectiveness and durability of this therapy (clinicaltrials.gov/show/NCT02577354).[1,2] Here we will report the three-year durability results. Materials / Methods: Eligible patients had activity limiting mechanical CLBP (VAS >=6cm;Oswestry Disability Index (ODI) >=21 points) despite medical management, which included at least pain medications and physical therapy. They had evidence of impaired multifidus motor control (positive prone instability test) and no indication for spine surgery. All patients were implanted with a Restorative Neurostimulation system (ReActiv8, Mainstay Medical, Dublin, Ireland). During the long-term follow-up phase, all participants delivered stimulation for up to 30 minutes twice daily eliciting repetitive, tonic multifidus contractions. Result(s): At baseline (N=204), participants were 47+/-9 years of age, had history of backpain for 14+/-11 years, had an average low back pain VAS of 7.3+/-0.7 cm, ODI of 39+/-10, EQ-5D of 0.585+/-0.174 points and had pain on 97+/-8% of days in the year prior to enrollment. Three-year data are available for 124 participants*. Average VAS improved by 5.0+/-2.4 cm, ODI by 23+/-15 points and EQ-5D by 0.223+/-0.199 (All P<0.0001);78% of participants had a >=50% VAS improvement;69% reported LBP-Resolution (VAS<=2.5 cm);65% had a >=20-point ODI improvement and 86% of participants were "definitely satisfied" with the treatment. Pain intensity and disability are interdependent symptoms and treatment success is determined by composite improvements in ODI and VAS: 84% had a substantial improvement of >=50% in VAS and/or >=20points in ODI, and 59% had these improvements in both VAS and ODI. Of participants using opioids at baseline, 72% had voluntarily discontinued or decreased consumption. Overall safety compares favorably to other neurostimulation systems, and no lead migrations were observed. During the third year of follow-up, 6 participants requested device removal citing resolution of pain. Discussion(s): See conclusions. Conclusion(s): Restorative-Neurostimulation is an effective, durable, and safe treatment for patients with refractory, activity-limiting CLBP secondary to impaired multifidus neuromuscular control. Consistent with the restorative mechanism, improvements accrue progressively over time. *Twenty-five follow-ups pending (Covid-19 restrictions) Learning Objectives: 1. Understand the long term pain outcomes (three year outcomes) of restorative neurostimulation for refractory chronic low back pain. 2. Understand the long term function outcomes (three year outcomes) of restorative neurostimulation for refractory chronic low back pain. 3. Understand the long term safety outcomes (three year outcomes) of restorative neurostimulation for refractory chronic low back pain. Keywords: nociceptive low back pain, multifidus, motor control, Restorative neurostimulation, chronic low back pain Copyright © 2022
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SESSION TITLE: What Lessons Will We Take From the Pandemic? SESSION TYPE: Rapid Fire Original Inv PRESENTED ON: 10/19/2022 11:15 am - 12:15 pm PURPOSE: Post-intensive care syndrome (PICS) affects 50% of ICU survivors leading to significant healthcare utilization. COVID-19 survivors are at higher risk for developing PICS given the prolonged duration of critical illness. The aim of this study was to determine the feasibility and acceptability of using telemedicine (TM) for the transitional care (TC) of post ICU COVID-19 survivors. METHODS: This prospective randomized un-blinded controlled study was conducted from July 2021 to January 2022. Adults admitted to the ICU with a diagnosis of acute respiratory distress syndrome secondary to COVID-19 infection and discharged home were included. Those who lacked communication and internet services, and had pre-morbid conditions preventing independent self-care were excluded. 40 patients were recruited with 20 patients in each arm. The study group (SG) underwent a telemedicine (TM) visit within 2 weeks of discharge, where vital signs logs (VSL), virtual six-minute walk test (v6MWT), and EuroQoL 5-Dimension (EQ-5D) questionnaire were reviewed. The control group (CG) received a TM visit within 6 weeks of discharge and completed the EQ-5D questionnaire. This study was approved by the WVU IRB (#2104284924). RESULTS: Both groups had similar baseline characteristics. Completion rate of the VSL and v6MWT was 50% in the SG. 39% of SG came off oxygen supplementation compared to 33% in the CG. There was less anxiety/depression, increased request, and compliance to follow-up in pulmonary clinic noted in SG compared to CG, however this difference was not statistically significant. All readmissions were non- preventable (n=3;2 CG, 1 SG). 100% survival rate was noted in both groups at 30-days. 5% of patients were lost to follow up in both groups due to non-working communication devices and lack of response despite multiple attempts made for the TM visit. 67% (2/3) of primary care physicians (PCP) felt that this intervention helped establish continuity of care. 83% (5/6) of participants felt that an intensivist led TC visit provided closure for their ICU hospitalization. CONCLUSIONS: There was no significant difference noted in outcomes between the 2 groups, however, this is likely due to underpowered sample sizes. This form of TC is well received by both PCP and patients in screening and mitigation of PICS. CLINICAL IMPLICATIONS: This pilot study is the first in the region to show the acceptability and feasibility of using TM for the TC of ICU COVID survivors. It is vital to ensure ICU survivors receive targeted multidisciplinary management to prevent PICS. TM can be utilized in the future for the TC of all ICU survivors. DISCLOSURES: No relevant relationships by Ariful Alam No relevant relationships by Bathmapriya Balakrishnan No relevant relationships by Lucas Hamrick No relevant relationships by Sunil Sharma Consultant relationship with Res Med Please note: 7/2021-Present Added 03/31/2022 by Robert Stansbury, value=Consulting fee No relevant relationships by Jesse Thompson
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Introduction: Admission and survival from critical care is not without its far-reaching consequences to both the patient and their families. Follow-up clinic for critical care patients is something that has been established to try to 'mop up' some of these consequences. However, resource allocation to this vital line for many patients is patchy and often inadequate. Within the LSCCC Network there are Four Trusts with critical care follow up services. Three sites agreed to participate in the project to evaluate the issues patients report at clinics and the provision of services for ongoing support for these patients. Objectives: To evaluate the physical, functional, psychological and cognitive issues patient identify at follow up clinic reviews and the service provision for ongoing support for these patients. Methods: From the period of July 2020 -July 2021 we collected data on patients attending follow up clinics at three sites. We collected basic demographic data, level of care, type of ventilatory support, length of ventilation, length of critical care and hospital stay and COVID-19 status. We used the EQ-5D Health Related Quality of Life score (HRQoL) questionnaire, Health Score and Trauma Screening Questionnaire to assess how respondents rated their own health. We identified physical/ functional and psychological issues patients reported at the clinic appointments. We identified onward referrals to other specialities and if these services were available. We identified if patients had returned to work after their admission to critical care and whether patients would benefit from further Follow Up appointments. Results: We collected data on 249 patients. 58% of these were male and 42% of these patients were admitted due to COVID-19. The median age of our patients was 59 (16-86), with 53% of patients requiring Level 3 care. The median length of invasive ventilation was nine days (0-88 days), noninvasive ventilation was 2 days (0-16 days) and median total ventilation was 11 days (0-100 days). The median length of Critical Care stay was 15 days (3-108 days), and the median hospital length of stay was 28 days (4-280 days). The HRQoL data identified issues in all the dimensions of quality of life and highlighted the problems patients face in their recovery from critical illness. The health score also identified that most patients felt their illness has impacted on the overall health status with some patients reporting significant reductions. The most common physical issues reported were fatigue and muscle weakness, however there was a range of physical issues identified showing the complexity of issues patients have during their recovery. The psychological issues highlighted high levels of anxiety in patients and sleep disturbance, as well as delusional memories and cognitive issues. The Trauma Screening questionnaire also identified self-reported psychological issues with the median score 3 but some patients reporting scores of 10 indicating severe psychological distress. The data identified patients requiring a high number of onward referrals to Medical and Allied Health Professional services to support their recovery. This is due to their being limited clinicians present in the Follow Up Clinics at the different sites. Most clinics had services available for onward referral except Psychology which was only available in one site. In the patients who were working prior to the period of hospitalisation only a limited number had been able to return to work by the time of the clinic appointment. Nearly a quarter of patients were identified as potentially benefitting from further appointments. Conclusion: We identified that patients in the LSSCC Network who are admitted to Critical care, have significant impairments following a stay in critical care. They often require referral to further specialty services which are not always available within the follow up clinic that they attend. However, what is clear from our data is that our patients they need access to a range of Health and Social Care Professionals when they atte d Follow Up Clinics and ability to access further ongoing health and support services.
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Introduction: The negative impact of Post-Intensive Care Syndrome on the quality of life of critical illness survivors has previously been well characterised.1 Survivors of Covid-19 critical illness are a relatively new cohort in terms of younger age and less prior comorbidity.2 The healthrelated quality of life, psychological problems, resilience, or wellbeing of survivors of Covid-19 critical illness have not been fully explored. Objectives: To characterise the resilience, wellbeing, selfefficacy, and quality of life of ICU-survivors, who were admitted with Covid-19, 6-9 months post-hospital discharge. To explore any potential associations with baseline characteristics. Methods: This was a prospective follow-up study of ICUsurvivor patients who were admitted with Covid-19 and discharged alive from the Royal Infirmary Edinburgh or St John's Hospital, Scotland. Eligible patients were identified by 2 specialist research nurses from the medical records and were contacted via telephone for consent. Paper copies of the questionnaire pack were posted to patients who consented. Demographic characteristics were captured from WardWatcher IT system (age, sex, length of ICU stay). 2 investigators telephoned participants to complete the questionnaires. Outcomes measured were: resilience, using the 10-item Connor-Davidson Resilience Scale (CDRISC), self-efficacy, using the General Self-Efficacy (GSE) Scale, overall health state, using The EuroQol EQ5D-5L Health Questionnaire, and Wellbeing, using 6 10-point visual analogue scales. Statistical analysis was conducted using R-Studio. Associations were tested with Fisher's exact test for categorical variables, and Kruskal-Wallis for continuous variables. Statistical significance was accepted at p<=0.05. Results: Of the 52 eligible patients consented to be contacted, 40 (76.9%) completed the questionnaires. 59.6% (31/52) were male;median age was 59.0 (IQR:53.0-66.2), and participants spent median 6.3 (IQR: 4.1-11.0;) days in ICU. Questionnaires were completed median 202 days (IQR:187.5-224.0) from hospital discharge. The median total CDRISC score was 34.5 (IQR: 30.8-38.0), which has previously been defined as normal resilience (27-37/40)3. 12.5% (5/40) and 32.5% (13/40) reported low (<27/40) and high (>=38/40) resilience respectively.3 The median total GSE score was 34.0 (IQR: 30.0-38.0) (international mean: 29.554). For overall health state (EQ5D-5L), the median overall health score was 80.0% (IQR:75.0-81.2), with the results in each domain as follows: Mobility: 27% (11/40) reported moderate or worse problems (with the remainder reporting no problems);Self-care: 10% (4/40) reported moderate or worse problems;Usual activities: 17% (7/40) reported moderate or worse problems;Pain: 17.5% (7/40) reported moderate or worse problems;Anxiety or depression: 17.5% (7/40) reported moderate or worse problems. For the wellbeing measures, participants rated 'Overall satisfaction with life as a whole' median 8/10 (IQR: 7-9), and 'I have a sense of direction and purpose in life' median 8/10 (IQR:7-9.5). Resilience, self-efficacy, health-related quality of life, and wellbeing were not significantly associated with age, length of ICU-stay, or time between discharge and questionnaire completion. Conclusion: Overall, ICU-survivors of Covid-19 critical illness reported normal resilience, and high levels of selfefficacy and wellbeing at 6-9 months post-hospital discharge. Many ICU-survivors experienced problems affecting their overall health state, such as with mobility and pain. Future studies are indicated to investigate how to best support ICU-survivors in their recovery.
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Objectives: Financial toxicity (FT) impacts approximately 50% of patients with gynecologic malignancies. Still, little is known about factors that predispose patients receiving radiation therapy to financial distress or what impact the COVID-19 pandemic had on their financial well-being. We evaluated FT in patients with gynecologic cancer treated with radiation before and after the start of the COVID- 19 pandemic. Methods: Patients from an urban, academic gynecologic radiation oncology practice completed a survey one month after completing radiation from August 2019-March 2020 and November 2020-June 2021. The survey included demographic questions, the Comprehensive Score for Financial Toxicity (COST) tool, and the EQ-5D to measure the quality of life (QOL). Pandemic-related questions were added during the second survey period (pandemic cohort). As with our prior work, high FT was defined as a COST score of ≤23. We assessed the correlation of COST scores with QOL. We used logbinomial regression to examine associations between FT and costcoping strategies, adjusting for age and insurance. Results: Of 97 respondents (92% response rate), 49% completed the survey before, and 51% completed it after the pandemic started. Among the participants, 76% identified as White, 11% as Black, and 8% as Asian. Most patients had uterine (64%), followed by cervical (24%) and vaginal (6%) cancer. Two-thirds (60%) received external beam radiation with or without brachytherapy;the remaining 40% had brachytherapy alone. The median COST score was 15 (IQR: 7-19) in the high FT group (n=27) and 33 (IQR: 28-36) in the low FT group (n=70). High FT correlated with worse QOL (r=-0.37, p<0.01) and was associated with younger age and type of insurance (both p <0.03). Patients with high FT were more likely to move from full- to parttime employment (22% vs 1%, p<0.01), six (95% CI: 1.0-36) times more likely to delay/avoid medical care, 14 (95% CI: 3-64) times more likely to borrow money, and seven (95% CI: 2-27) times as likely to reduce spending on basic goods. Patients with high FT were more likely to report that decreased ability to work (48% vs 13%), medical bills (41% vs 13%), and transportation or parking (15% vs 3%) mostly contributed to their financial stress (p<0.05 for all). The pandemic cohort had fewer patients with high FT than the pre-pandemic cohort (20% vs 35%, p=0.10) and a higher median COST score (32 [IQR: 25-35] vs 27 [IQR: 19-34], p=0.07). The use of cost-coping strategies did not differ between cohorts. Conclusions: Privately insured, younger patients who received radiation for gynecologic cancer were at risk for FT. High FT correlated with worse QOL and was associated with delays or avoidance of medical care and other cost-coping strategies. The prevalence of high FT was not statistically different before and during the pandemic, though we observed less FT in the pandemic cohort. More work is needed regarding the impact of the COVID-19 pandemic on the financial well-being of patients with cancer.
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Background: One of the problems with the COVID-19 epidemic is infodemic. Insufficient and inaccurate information can be confusing and hinder treatment. In Japan, tabloid TV show might be an easily accessible source of information, but its reliability is low and it has a harmful effect on patients' mental status and lifestyle. There are no reports to examine what is the source of COVID-19 news for patients with rheumatoid arthritis and how these information affect patients' daily lives and disease activity. By using NinJa, Japanese largest database of rheumatoid arthritis, it may be possible to examine them in detail. Objectives: To investigate the impact of the COVID-19 news sources on rheumatoid arthritis patients' lifestyle and their disease activity using NinJa 2020 cohort study. Methods: At the timing of collection of patients' data of NinJa2020, questionnaire about their lifestyle and news source of COVID-19 was given. Questionnaire includes questions about frequency of scheduled visit, going out and exercise, weakness and news source. Results: 6677 patients out of 15553 patients answered questionnaire. Most patients did not change the interval of scheduled visit. The frequency of hospital visits was 'unchanged' in 85.8%, 'longer' in 13.6%, and 'shortened' in 0.6%. The chances of going out were 'unchanged' at 14.4%, 'signifcantly decreased' at 57.5%, 'slightly decreased' at 27.8%, and 'increased' at 0.3%. 42.6% answered that the amount of exercise did not change, 30.2% answered that it decreased considerably, 26.1% answered that it decreased a little, and 1.1% answered that it increased. Regarding muscular strength and physical strength, 46.0% answered 'no change', 19.9% answered 'signifcantly dropped', 33.5% answered 'slightly dropped', and 0.6% answered 'increased'. The media used as information sources are 'newspaper (86.4%)', 'tabloid show (54.5%)', 'family, acquaintances and friends (43.7%)', and 'official web of Ministry of Health, Labor and Welfare and academic societies (9.4. %)'. Respondents often referred to multiple media and 30.6% of them listed three sources (Figure 1). There was a positive correlation between the decrease in frequency of going out and the number of information sources, and a negative correlation between age and the number of information sources. We also found a negative correlation with age for muscle weakness. No correlation was found between the number of information sources and SDAI, CDAI, HAQ-DI, EQ-5D, HADS (A), HADS (D). Conclusion: The more sources of information, the less chance of going out. About 80% of the patients refrained from going out, the opportunity for exercise decreased in more than 50% of the patients, and the decrease in physical ft-ness was also noticed in nearly 50% of the patients. Newspapers, tabloid shows, and acquaintances were the most common sources of medical information, and relatively few patients used official sources. He provision of accurate information about COVID-19 was important to avoid infodemic. From this questionnaire, more practical information delivery system was required in Japan.
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Objectives: To evaluate the dynamics of pain on the VAS scale, functional activity according to the WOMAC index and quality of life according to the EQ-5D questionnaire in elderly and senile patients with knee joint osteoarthritis (OA) after COVID-19. Methods: A total of 32 elderly and senile male patients with an established diagnosis of knee joint OA (according to the criteria of ACR, 1986) of stage II-III according to Kellgren-Lawrence, with pain ≥40 mm on a visual analog scale (VAS), who needed to take nonsteroidal anti-infammatory drugs (NSAIDs), were included in the study. The median age of the patients included in this study was 72.6 (66.0;79.3) years. All patients have been ill with COVID-19 for the last 6 months. Pain dynamics was assessed on the VAS scale, functional activity-on the WOMAC index, quality of life-on the EQ-5D questionnaire. Results: When analyzing the clinical picture, it was found that the majority of patients-22 people (68.8%)-had moderate COVID-19, 4 people (12.5%)-in mild form, 6 patients (18.7%)-in severe. The average duration of hospitalization was 14.0 (9.0;17.0) days. The majority of patients were discharged with recovery-30 people (93.75%), 2 people died (6.25%). The most frequent manifestations of postcovid syndrome in elderly and senile patients with OA: weakness-in 18 (56.2%) patients, arthralgia-in 17 (53.1%) and memory loss-in 14 (43.8%). There was a signifcant increase in the pain index on the VAS scale and the total WOMAC index after COVID-19. Pain on the VAS scale before COVID-19 was 45.9 (34.8;72.4), after the disease-60.9 (51.4;68.5) (p<0.001);the total WOMAC index was 46.3 (38.5;51.2) and 63.1 (48.9;76.2), respectively (p=0.007). There were no differences in the need for NSAIDs before and after the disease. When flling out the EQ-5D questionnaire, all the interviewed patients indicated health problems to one degree or another. When calculating the quantitative index after COVID-19, there was a deterioration in the health index, but the changes were unreliable. The 'health thermometer' also changed in a similar way. Conclusion: COVID-19 in elderly and senile patients with OA occurred in a variant of moderate severity in 22 (68.8%), severe-in 6 (18.7%), mild-in 4 (12.5%). The most frequent manifestations of postcovid syndrome in elderly and senile patients with OA: weakness, arthralgia and memory loss. Negative dynamics of indicators of functional activity according to the WOMAC index and pain on the scale VAS after COVID-19 was registered.