scholarly journals Impact of convalescent plasma therapy on SARS CoV-2 antibody profile in COVID-19 patients

2021 ◽  
Author(s):  
Juanjie Tang ◽  
Gabrielle Grubbs ◽  
Youri Lee ◽  
Hana Golding ◽  
Surender Khurana
Keyword(s):  
Fatal Outcome ◽  
Standard Of Care ◽  
Affinity Maturation ◽  
Plasma Therapy ◽  
Iga Response ◽  
Marked Decline ◽  
Antibody Profile ◽  
Antibody Kinetics ◽  
The Impact

Abstract Convalescent plasma (CP) have been used for treatment of COVID-19, but their effectiveness varies significantly. Moreover, the impact of CP treatment on the composition of SARS-CoV-2 antibodies in COVID-19 patients and antibody markers that differentiate between those who survive and those who succumb to the COVID-19 disease are not well understood. Herein, we performed longitudinal analysis of antibody profile on 115 sequential plasma samples from 16 hospitalized COVID-19 patients treated with either CP or standard of care, only half of them survived. Differential antibody kinetics was observed for antibody binding, IgM/IgG/IgA distribution, and affinity maturation in ‘survived’ vs. ‘fatal’ COVID-19 patients. Surprisingly, CP treatment did not predict survival. Strikingly, marked decline in neutralization titers was observed in the fatal patients prior to death, and convalescent plasma treatment did not reverse this trend. Furthermore, irrespective of CP treatment, higher antibody affinity to the SARS-CoV-2 prefusion spike was associated with survival outcome, while sustained elevated IgA response was associated with fatal outcome in these COVID-19 patients. These findings propose that treatment of COVID-19 patients with convalescent plasma should be carefully targeted, and effectiveness of treatment may depend on the clinical and immunological status of COVID-19 patients as well as the quality of the antibodies in the convalescent plasma.

scholarly journals Impact of simple, specific, verbal instructions on the quality of bowel preparation in hospitalized patients undergoing colonoscopy: a multicenter randomized controlled trial

2021 ◽  
Vol 09 (03) ◽  
pp. E378-E387
Author(s):  
Konstantinos Triantafyllou ◽  
Paraskevas Gkolfakis ◽  
Alexandros Skamnelos ◽  
Georgia Diamantopoulou ◽  
Athanasios Dagas ◽  
...  
Keyword(s):  
Bowel Preparation ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Intervention Group ◽  
Standard Of Care ◽  
Hospitalized Patients ◽  
Verbal Instructions ◽  
Multicenter Randomized Controlled Trial ◽  
The Impact

Abstract Background and study aims Bowel preparation for colonoscopy is frequently inadequate in hospitalized patients. We explored the impact of specific verbal instructions on the quality of inpatients bowel preparation and factors associated with preparation failure. Patients and methods Randomized (1:1), two strata (mobilized vs. bedridden; 3:2) trial of consecutive inpatients from four tertiary centers, who received either specific, verbal instructions or the standard of care (SOC) ward instructions about bowel preparation. The rate of adequate bowel preparation (Boston Bowel Preparation Score [BBPS] ≥ 6, no segment < 2) comprised the primary endpoint. Mean BBPS score, good (BBPS score ≥ 7, no segment score < 2) and excellent (BBPS = 9) were among secondary endpoints. Results We randomized 300 inpatients (180 mobile) aged 71.7 ± 15.1 years in the intervention (49.7 %) and SOC (50.3 %) groups, respectively. Overall, more patients in the intervention group achieved adequate bowel preparation, but this difference did not reach statistical significance neither in the intention-to-treat [90/149 (60.4 %) vs. 82/151 (54.3 %); P = 0.29] nor in the per-protocol analysis [90/129 (69.8 %) vs. 82/132 (62.1 %); P = 0.19]. Overall BBPS score did not differ statistical significantly in the two groups, but the provision of specific verbal instructions was associated with significant higher rates of good (58.1 % vs. 43.2 %; P = 0.02) and excellent (31.8 % vs. 16.7 %; P = 0.004) bowel preparation compared to the SOC group. Administration of same-day bowel preparation and patient American Society of Anesthesiologists score > 2 were identified as risk factors for inadequate bowel preparation. Conclusions Provision of specific verbal instructions did not increase the rate of adequate bowel preparation in a population of mobilized and bedridden hospitalized patients.

scholarly journals A Mobile Phone–Based Telemonitoring Program for Heart Failure Patients After an Incidence of Acute Decompensation (Medly-AID): Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Emily Seto ◽  
Heather Ross ◽  
Alana Tibbles ◽  
Steven Wong ◽  
Patrick Ware ◽  
...  
Keyword(s):  
Heart Failure ◽  
Controlled Trial ◽  
Hospital Readmissions ◽  
Intervention Group ◽  
Self Care ◽  
Standard Of Care ◽  
Randomized Controlled ◽  
Acute Decompensation ◽  
The Impact

BACKGROUND Patients with heart failure (HF) are at the highest risk for hospital readmissions during the first few weeks after discharge when patients are transitioning from hospital to home. Telemonitoring (TM) for HF management has been found to reduce mortality risk and hospital readmissions if implemented appropriately; however, the impact of TM targeted for patients recently discharged from hospital, for whom TM might have the biggest benefit, is still unknown. Medly, a mobile phone–based TM system that is currently being used as a standard of care for HF at a large Canadian hospital, may be an effective tool for the management of HF in patients recently discharged from hospital. OBJECTIVE The objective of the <italic>Medly-After an Incidence of acute Decompensation</italic> (Medly-AID) trial is to determine the effect of Medly on the self-care and quality of life of patients with HF who have been recently discharged from hospital after an HF-related decompensation. METHODS A multisite multimethod randomized controlled trial (RCT) will be conducted at 2 academic hospitals and at least one community hospital to evaluate the impact of Medly-enabled HF management on the outcomes of patients with HF who had been hospitalized for HF-related decompensation and discharged during the 2 weeks before recruitment. The trial will include 144 participants with HF (74 in each control and intervention groups). Control patients will receive standard of care, whereas patients in the intervention group will receive standard of care and Medly. Specifically, patients in the intervention group will record daily weight, blood pressure, and heart rate and answer symptom-related questions via the Medly app. Medly will generate automated patient self-care messages such as to adjust diuretic medications, based on the rules-based algorithm personalized to the individual patient, and send real-time alerts to their health care providers as necessary. All patients will be followed for 3 months. Primary outcome measures are self-care and quality of life as measured through the validated questionnaires Self-Care of Heart Failure Index, EQ-5D-5L, and the Kansas City Cardiomyopathy Questionnaire-12. Secondary outcome measures for this study include cost of health care services used and health outcomes. RESULTS Patient recruitment began in November 2018 at the Sunnybrook Health Sciences Centre, with a total of 35 participants recruited by July 30, 2019 (17 in the intervention group and 18 in the control group). The final analysis is expected to occur in the fall of 2020. CONCLUSIONS This RCT will be the first to assess the effectiveness of the Medly TM system for use following discharge from hospital after a HF-related decompensation. CLINICALTRIAL ClinicalTrials.gov NCT03358303; https://clinicaltrials.gov/ct2/show/NCT03358303

scholarly journals A systematic review and meta-analysis examining the effects of cannabis and its derivatives in adults with malignant CNS tumors

2020 ◽  
Vol 7 (4) ◽  
pp. 376-383
Author(s):  
Jesus-Eduardo Rodriguez-Almaraz ◽  
Susan Chang ◽  
Jennifer Clarke ◽  
Nancy Ann Oberheim-Bush ◽  
Jennie Taylor ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Meta Analysis ◽  
Scientific Evidence ◽  
Progression Free Survival ◽  
Cochrane Collaboration ◽  
Standard Of Care ◽  
Cns Tumors ◽  
The Impact ◽  
Quality Evidence

Abstract Background Primary CNS tumors constitute a heterogeneous group of neoplasms that share a considerable morbidity and mortality rate. To help control tumor growth and clinical outcomes (overall survival, progression-free survival, quality of life) symptoms, patients often resort to alternative therapies, including the use of cannabis. Despite rapidly growing popularity, cannabis and its impact on patients with primary malignant CNS tumors is understudied. Methods To shed light on the lack of scientific evidence in this field, in November 2018 we conducted a search and examination of cannabis in neuro-oncology in major journal databases and bibliographies of selected articles, and through abstracts of annual meetings using prespecified criteria in line with the Cochrane Collaboration guidelines. Results We identified 45 publications, of which 9 were selected. Five studies were included. Publication dates ranged from 2004 to 2018 and included varying histologies of primary brain tumors. The average survival at 1 year was 56.09% (95% CI: 48.28-63.9). There was no difference in risk ratio (RR) for death at 1 year between groups (RR: 1.069 [95% CI: 0.139-8.25]). We found strong evidence of heterogeneity (Q = 74.0%; P = .021). We found no statistical evidence of publication bias (P = .117; SD = 1.91). Conclusions There was limited moderate-quality evidence that supports the use of cannabinoids as adjuvant to the standard of care in the treatment of brain and CNS tumors. There was very low-quality evidence suggesting that cannabinoids were associated with adult-onset gliomas. Further prospective clinical trials are necessary to adequately evaluate the impact of cannabinoids on CNS tumors, specifically on survival and quality of life.

Investigating bacterial decolonization for the prevention of radiation dermatitis: A randomized controlled trial and quality of life assessment.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS12137-TPS12137
Author(s):  
Karolina Mieczkowska ◽  
Alana Deutsch ◽  
Kosaku Shinoda ◽  
Johanna Daily ◽  
Nitin Ohri ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Life Assessment ◽  
Radiation Dermatitis ◽  
Low Grade ◽  
Randomized Controlled ◽  
The Impact

TPS12137 Background: Radiation dermatitis (RD) can be therapy-limiting and detrimental to quality of life for cancer patients receiving radiation therapy (RT). Bacteria play an important role in many inflammatory dermatoses. In an observational clinical study, our group discovered that nasal colonization with bacteria, specifically with Staphylococcus aureus (SA), prior to RT was an independent predictor of higher-grade RD (grade ≥2). Higher-grade RD patients were also found to have more SA on the irradiated skin after treatment. If successful, bacterial decolonization could be a safe and cost-effective method to prevent RD. Methods: This is a randomized controlled trial assessing the efficacy of universal bacterial decolonization in preventing RD. Subject inclusion criteria include patients who are aged ≥ 18 years with a diagnosis of a solid tumor of the breast or head and neck with plans for fractionated RT (≥ 15 fractions) with curative intent. Based on previous studies and power analyses, we plan to recruit a total of 80 patients. Patients in the control arm will be treated according to standard of care, including daily application of emollients and gentle bathing. In addition to standard of care, patients in the intervention arm will receive a decolonization regimen consisting of intranasal mupirocin ointment used twice daily and chlorhexidine wash used daily for 5 days prior to the initiation of RT and repeated for 5 days every other week throughout RT. Study evaluations for both groups will include bacterial cultures obtained via superficial swab from the nares, irradiated skin, and contralateral non-radiated skin performed at the beginning, middle, and end of RT. Additionally, standardized photographs of the skin at the radiated site will be performed prior to and at the completion of RT, which will be graded by a dermatologist blinded to study arm. Lastly, at identical timepoints, each patient will complete the SKINDEX-16 questionnaire, a validated quality of life (QoL) assessment. The primary endpoint is development of grade ≥ 2 RD, as compared to low-grade RD (grade 0-1), during RT. The secondary endpoint includes the impact of bacterial decolonization on QoL. Pearson’s chi square or Fisher’s exact tests will be used to compare the incidence rates of higher-grade RD between the interventional arm and control arm to assess if the intervention is associated with a lower incidence rate of higher-grade RD. Paired t-tests will be used to compare the QoL score change from baseline to after RT between the two arms. Linear regression models will be used in both analyses to adjust for covariates. Clinical trial information: NCT03883828.

Telemedicine in oculoplastic and adnexal surgery: clinicians’ perspectives in the UK

2021 ◽  
pp. bjophthalmol-2020-318696
Author(s):  
Swan Kang ◽  
Laxmi Raja ◽  
Dawn A Sim ◽  
Peter B M Thomas ◽  
Daniel G Ezra
Keyword(s):  
Administrative Support ◽  
Standard Of Care ◽  
Poor Access ◽  
The Future ◽  
Barriers To Implementation ◽  
Adnexal Surgery ◽  
The Uk ◽  
Almost All ◽  
The Impact

Background/AimsThe COVID-19 has facilitated a paradigm shift in the sphere of ophthalmic telemedicine: its utility is no longer limited to providing care to remote regions, rather it is expeditiously being adopted as the new standard of care. The aim of our paper is to explore the current attitudes of oculoplastic surgeons towards telemedicine and its utility in the present landscape and its prospects in the future.MethodsA 39-item questionnaire was distributed to consultant oculoplastic surgeons practising across the UK and anonymised responses were collected and analysed.ResultsThe COVID-19 pandemic has allowed rapid implementation of telemedicine services in oculoplastic departments across the UK with 86.6% of the respondents incorporating telemedicine into the routine clinical practice. Clinicians reported a statistically significant increase in utility of telemedicine, confidence in using telemedicine and quality of infrastructure available to employ telemedicine following the COVID-19 outbreak. The greatest utility of telemedicine is in triaging, postoperative assessment and eyelid lesion assessment. Main barriers to implementation of telemedicine included difficulties in conducting clinical examinations, lack of administrative support and poor access to digital technologies for patients. Overall, most clinicians were satisfied with the impact of telemedicine services and almost all experts foresee themselves continuing to use telemedicine in the future.ConclusionsTelemedicine has become an integral part of the oculoplastic service delivery since the COVID-19 pandemic its use is likely to continue. Further development of digital infrastructure and improvement of clinical examination capabilities are required to enable its wider adoption.

scholarly journals The Effect of Drug Pricing on Outpatient Payments and Treatment for Three Soil-Transmitted Helminth Infections in the United States, 2010–2017

2021 ◽  
Author(s):  
Heesoo Joo ◽  
Junsoo Lee ◽  
Brian A. Maskery ◽  
Chanhyun Park ◽  
Jonathan D. Alpern ◽  
...  
Keyword(s):  
Quality Of Care ◽  
Prescription Drug ◽  
Parasitic Infection ◽  
Standard Of Care ◽  
The United States ◽  
Parasitic Infections ◽  
Treatment Pathways ◽  
Drug Prices ◽  
The Impact

The price of certain antiparasitic drugs (e.g., albendazole and mebendazole) has dramatically increased since 2010. The effect of these rising prices on treatment costs and use of standard of care (SOC) drugs is unknown. To measure the impact of drug prices on overall outpatient cost and quality of care, we identified outpatient visits associated with ascariasis, hookworm, and trichuriasis infections from the 2010 to 2017 MarketScan Commercial Claims and Encounters and Multi-state Medicaid databases using Truven Health MarketScan Treatment Pathways. Evaluation was limited to members with continuous enrollment in non-capitated plans 30 days prior, and 90 days following, the first diagnosis. The utilization of SOC prescriptions was considered a marker for quality of care. The impact of drug price on the outpatient expenses was measured by comparing the changes in drug and nondrug outpatient payments per patient through Welch’s two sample t-tests. The total outpatient payments per patient (drug and nondrug), for the three parasitic infections, increased between 2010 and 2017. The increase was driven primarily by prescription drug payments, which increased 20.6–137.0 times, as compared with nondrug outpatient payments, which increased 0.3–2.2 times. As prices of mebendazole and albendazole increased, a shift to alternative SOC and non-SOC drug utilization was observed. Using parasitic infection treatment as a model, increases in prescription drug prices can act as the primary driver of increasing outpatient care costs. Simultaneously, there was a shift to alternative SOC, but also to non-SOC drug treatment, suggesting a decrease in quality of care.

scholarly journals Quality of Life Impact and Special Issues in Women with Inflammatory Bowel Diseases

2021 ◽  
Author(s):  
Gabriel Constantinescu ◽  
Gina Gheorghe ◽  
Ecaterina Rinja ◽  
Oana Plotogea ◽  
Vasile Sandru ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Inflammatory Bowel Diseases ◽  
Standard Of Care ◽  
Cross Sectional ◽  
Men And Women ◽  
Bowel Diseases ◽  
Inflammatory Bowel ◽  
The Impact ◽  
Gender Specific

Abstract Background: The impact of inflammatory bowel diseases (IBD) on quality of life (QoL) of patients is significant and has important social and professional consequences. Methods: We aimed to describe the patients’ perspective regarding the impact of IBD on their overall QoL and to evaluate the differences between men and women. An observational cross-sectional study, that included 180 patients with IBD in clinical remission, was conducted. All the patients completed a number of 3 questionnaires in order to evaluate the general aspects of their QoL. A separate questionnaire was created regarding gender-specific issues in women with IBD encounter. Also, particular features such as the incidence of anemia and osteoporosis among IBD patients were documented. The data obtained were analyzed and compared between the two gender-classified groups. Results: According to the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), patients had a general perception of a good QoL, but the impact was higher in women. Fatigue and tiredness were severely perceived almost to the same degree regardless of gender, whereas anxiety and unemployment were more present in men. No significant differences in women with IBD during active disease and during disease remission were found. Conclusions: The overall quality of life of IBD patients is affected in many aspects, leading to the deterioration of their social and professional lives, for both men and women, but some aspects remain gender-specific and require a personalized standard of care.

Physician and patient perspectives on the management of hereditary angioedema: a survey on treatment burden and needs

2021 ◽  
Vol 42 (3) ◽  
pp. S17-S25 ◽  
Author(s):  
Marc A. Riedl ◽  
Timothy J. Craig ◽  
Aleena Banerji ◽  
Kavita Aggarwal ◽  
Jessica M. Best ◽  
...  
Keyword(s):  
United States ◽  
Hereditary Angioedema ◽  
Standard Of Care ◽  
The United States ◽  
The Body ◽  
Current Standard ◽  
Prescribing Trends ◽  
Individualized Approach ◽  
The Impact

Hereditary angioedema (HAE) is a rare disorder caused by genetic mutations that lead to recurrent episodes of swelling in various parts of the body. Prophylactic treatment is common for patients with HAE, and the therapeutic options have expanded in recent years. The current standard of care for prophylactic HAE therapies is subcutaneous treatment, which can be self-administered at home, greatly improving patient quality of life. As new therapies emerge, it is important for patients and physicians to discuss the risks and benefits associated with each treatment to develop an individualized approach to HAE management. We conducted surveys of patients with HAE and physicians who treat patients with HAE to identify prescribing trends for prophylactic HAE treatments and the impact that such treatments has on patients. Our results confirmed that newer, subcutaneous therapies are prescribed for HAE prophylaxis more frequently than other therapies in the United States and that treatment burdens still exist for patients with HAE. We found that physicians and patients were not always aligned on how treatment choices affect patients’ lives, which may mean that there are opportunities for enhanced patient‐physician dialog and shared decision-making in HAE management in the United States.

Implementation of a Patient-Reported Outcomes Measure for Patients with Advanced Heart Failure

2020 ◽  
Author(s):  
Leanne Burke
Keyword(s):  
Heart Failure ◽  
Quality Of Care ◽  
Kansas City ◽  
Standard Of Care ◽  
High Morbidity ◽  
Patient Goals ◽  
Standard Clinical Practice ◽  
Patient Reported ◽  
The Impact

Heart failure (HF) is associated with high morbidity, mortality, and substantial cost. Despite treatment advancements, the quality of care and quality of life (QoL) remains suboptimal. Interventions to improve QoL, like palliative care (PC), are lacking. Aligning clinical management and patient goals of care is critical to improving outcomes and highlights patient-centeredness. Strategies to promote patient-centered care, such as utilizing patient-reported outcome measures (PROM), should be standard of care. Purpose/Aims: To improve QoL and quality of care for HF patients by integrating the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) as standard clinical practice. The aims were to use the KCCQ-12 as the new standard of care, evaluate the impact on patients’ QoL and evaluate the impact on quality of care.

scholarly journals A Mobile Phone–Based Telemonitoring Program for Heart Failure Patients After an Incidence of Acute Decompensation (Medly-AID): Protocol for a Randomized Controlled Trial

10.2196/15753 ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. e15753 ◽  
Author(s):  
Emily Seto ◽  
Heather Ross ◽  
Alana Tibbles ◽  
Steven Wong ◽  
Patrick Ware ◽  
...  
Keyword(s):  
Heart Failure ◽  
Controlled Trial ◽  
Hospital Readmissions ◽  
Intervention Group ◽  
Self Care ◽  
Standard Of Care ◽  
Randomized Controlled ◽  
Acute Decompensation ◽  
The Impact

Background Patients with heart failure (HF) are at the highest risk for hospital readmissions during the first few weeks after discharge when patients are transitioning from hospital to home. Telemonitoring (TM) for HF management has been found to reduce mortality risk and hospital readmissions if implemented appropriately; however, the impact of TM targeted for patients recently discharged from hospital, for whom TM might have the biggest benefit, is still unknown. Medly, a mobile phone–based TM system that is currently being used as a standard of care for HF at a large Canadian hospital, may be an effective tool for the management of HF in patients recently discharged from hospital. Objective The objective of the Medly-After an Incidence of acute Decompensation (Medly-AID) trial is to determine the effect of Medly on the self-care and quality of life of patients with HF who have been recently discharged from hospital after an HF-related decompensation. Methods A multisite multimethod randomized controlled trial (RCT) will be conducted at 2 academic hospitals and at least one community hospital to evaluate the impact of Medly-enabled HF management on the outcomes of patients with HF who had been hospitalized for HF-related decompensation and discharged during the 2 weeks before recruitment. The trial will include 144 participants with HF (74 in each control and intervention groups). Control patients will receive standard of care, whereas patients in the intervention group will receive standard of care and Medly. Specifically, patients in the intervention group will record daily weight, blood pressure, and heart rate and answer symptom-related questions via the Medly app. Medly will generate automated patient self-care messages such as to adjust diuretic medications, based on the rules-based algorithm personalized to the individual patient, and send real-time alerts to their health care providers as necessary. All patients will be followed for 3 months. Primary outcome measures are self-care and quality of life as measured through the validated questionnaires Self-Care of Heart Failure Index, EQ-5D-5L, and the Kansas City Cardiomyopathy Questionnaire-12. Secondary outcome measures for this study include cost of health care services used and health outcomes. Results Patient recruitment began in November 2018 at the Sunnybrook Health Sciences Centre, with a total of 35 participants recruited by July 30, 2019 (17 in the intervention group and 18 in the control group). The final analysis is expected to occur in the fall of 2020. Conclusions This RCT will be the first to assess the effectiveness of the Medly TM system for use following discharge from hospital after a HF-related decompensation. Trial Registration ClinicalTrials.gov NCT03358303; https://clinicaltrials.gov/ct2/show/NCT03358303 International Registered Report Identifier (IRRID) DERR1-10.2196/15753

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