Controlled Trials
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2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 320-320
Pamela Ginex ◽  
Haya Waseem ◽  
Kapeena Sivakumaran ◽  
Sarah Lagler-Clark ◽  
Nicole Palmer ◽  

320 Background: The increase in patients receiving oral oncolytics requires oncology health care professionals to have processes and interventions that support patient adherence. Because adherence to oral oncolytics is a priority for achieving optimal outcomes, the ASCO QOPI Standards emphasize the need to assess for adherence at meaningful intervals as well as implement interventions to promote adherence. Technology-based interventions have the potential to assess and support adherence. The objective of this review is to evaluate the overall effect of any technology-based intervention, as well as compare the use of interactive technology rather than non-interactive technology to improve oral oncolytic adherence. This review will serve as the evidence base for a clinical practice guideline on oral oncolytic adherence. Methods: A medical librarian searched EMBASE, PubMed, and CINAHL for comparative studies published in English from January 2000 to May 2021. Two reviewers screened titles and abstracts, and eligible full text articles independently and in duplicate using Covidence. When possible, quantitative findings were pooled in a meta-analysis. Risk of bias assessment for randomized controlled trials was done using the Cochrane Collaboration risk-of-bias 2.0 tool and for observational studies, the ROBINS-I instrument was used. The certainty of evidence was assessed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. Results: Out of 663 studies, we identified 14 as eligible for analysis. Of the six RCTs (n = 737) that compared any technological intervention to no intervention, there was some heterogeneity across interventions (e.g., text messaging, mobile app, computer program) and reported outcome measures for adherence, including adherence rates, relative dose intensity (RDI), and number of weeks adherent. Patients using any technology rather than no technology may have higher adherence rates (MD: 8.81; 95% CI: 3.82, 13.81); however, there may be little effect on RDI (MD: -0.01; 95% CI: -0.04, 0.02) and number of weeks adherent (MD: -0.70; 95% CI: -1.96, 0.56), respectively. One RCT (n = 444) reported on adolescents receiving interactive and non-interactive interventions. There may be little effect on adherence rates among patients receiving interactive technology interventions rather than non-interactive education intervention (MD: 1.5; 95% CI, −0.2, 3.2). Conclusions: Better systems of oral oncolytic care are needed to support patients and their caregivers. Technology-based interventions may improve medication adherence in cancer patients on oral oncolytics; however, we are uncertain about the impact on other measure of adherence or the superiority of interactive rather than non-interactive technology interventions. Due to inconsistency in the evidence, additional research in this area is recommended.

2021 ◽  
Vol 94 (1126) ◽  
pp. 20210187
Daya Nand Sharma ◽  
Randeep Guleria ◽  
Naveet Wig ◽  
Anant Mohan ◽  
Goura Rath ◽  

Objectives: The World Health Organization (WHO) has declared coronavirus disease 2019 (COVID-19) as pandemic in March 2020. Currently there is no specific effective treatment for COVID-19. The major cause of death in COVID-19 is severe pneumonia leading to respiratory failure. Radiation in low doses (<100 cGy) has been known for its anti-inflammatory effect and therefore, low dose radiation therapy (LDRT) to lungs can potentially mitigate the severity of pneumonia and reduce mortality. We conducted a pilot trial to study the feasibility and clinical efficacy of LDRT to lungs in the management of patients with COVID-19. Methods: From June to Aug 2020, we enrolled 10 patients with COVID-19 having moderate to severe risk disease [National Early Warning Score (NEWS) of ≥5]. Patients were treated as per the standard COVID-19 management guidelines along with LDRT to both lungs with a dose of 70cGy in single fraction. Response assessment was done based on the clinical parameters using the NEWS. Results: All patients completed the prescribed treatment. Nine patients had complete clinical recovery mostly within a period ranging from 3 to 7 days. One patient, who was a known hypertensive, showed clinical deterioration and died 24 days after LDRT. No patients showed the signs of acute radiation toxicity. Conclusion: The results of our pilot study suggest that LDRT is feasible in COVID-19 patients having moderate to severe disease. Its clinical efficacy may be tested by conducting randomized controlled trials. Advances in knowledge: LDRT has shown promising results in COVID-19 pneumonia and should be researched further through randomized controlled trials.

2021 ◽  
Noppacharn Uaprasert ◽  
Krissana Panrong ◽  
Ponlapat Rojnuckarin ◽  
Thita Chiasakul

Abstract Background: Thromboembolic and bleeding events after vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are major public concerns leading to vaccine hesitancy. Due to low incidence, an individual randomized controlled trial (RCT) is underpowered to determine whether SARS-CoV-2 vaccines increase the risks of thromboembolism and hemorrhage. Methods: We performed a literature search using PubMed, EMBASE, Cochrane, medRxiv databases, and reference lists of relevant articles to identify RCTs that reported thromboembolic and hemorrhagic events and thromboembolism/hemorrhage-related death after SARS-CoV-2 vaccination. The primary aim of this systematic review and meta-analysis was to estimate the pooled thromboembolic risk related to SARS-CoV-2 vaccines compared to placebo. The secondary outcomes included estimating the risks of arterial thromboembolism (ATE), venous thromboembolisms (VTE), hemorrhage, and thromboembolism/hemorrhage-related death. Results: Eight RCTs of 4 vaccine platforms comprised of 195,196 participants were retrieved. SARS-CoV-2 vaccines were not associated with an increased risk of overall thromboembolism (risk ratio [RR], 1.14; 95%CI [confidence interval], 0.61-2.14; I2 = 35%), ATE (RR, 0.97; 95%CI, 0.46-2.06; I2 = 21%), VTE (RR, 1.47; 95%CI, 0.72-2.99; I2 = 0%), hemorrhage (RR, 0.97; 95%CI, 0.35-2.68; I2 = 0), and thromboembolism/hemorrhage-related death (RR, 0.53; 95%CI, 0.16-1.79; I2 = 0). Compared to the baseline estimated risk of these outcomes in participants administered placebos, the risk differences with vaccines were very small and not statistically significant. These findings were consistent in the subgroup analysis across 4 vaccine platforms. Conclusion: Vaccines against SARS-CoV-2 are not associated with an increased risk of thromboembolism, hemorrhage, and thromboembolism/hemorrhage-related death.

E. J. Bass ◽  
A. Pantovic ◽  
M. J. Connor ◽  
S. Loeb ◽  
A. R. Rastinehad ◽  

Abstract Background Multiparametric MRI localizes cancer in the prostate, allowing for MRI guided biopsy (MRI-GB) 43 alongside transrectal ultrasound-guided systematic biopsy (TRUS-GB). Three MRI-GB approaches exist; visual estimation (COG-TB); fusion software-assisted (FUS-TB) and MRI ‘in-bore’ biopsy (IB-TB). It is unknown whether any of these are superior. We conducted a systematic review and meta-analysis to address three questions. First, whether MRI-GB is superior to TRUS-GB at detecting clinically significant PCa (csPCa). Second, whether MRI-GB is superior to TRUS-GB at avoiding detection of insignificant PCa. Third, whether any MRI-GB strategy is superior at detecting csPCa. Methods A systematic literature review from 2015 to 2019 was performed in accordance with the START recommendations. Studies reporting PCa detection rates, employing MRI-GB and TRUS-GB were included and evaluated using the QUADAS-2 checklist. 1553 studies were found, of which 43 were included in the meta-analysis. Results For csPCa, MRI-GB was superior in detection to TRUS-GB (0.83 vs. 0.63 [p = 0.02]). MRI-GB was superior in detection to TRUS-GB at avoiding detection of insignificant PCa. No MRI-GB technique was superior at detecting csPCa (IB-TB 0.87; COG TB 0.81; FUS-TB 0.81, [p = 0.55]). There was significant heterogeneity observed between the included studies. Conclusions In patients with suspected PCa on MRI, MRI-GB offers superior rates of csPCa detection and reduces detection of insignificant PCa compared to TRUS-GB. No individual MRI-GB technique was found to be better in csPCa detection. Prospective adequately powered randomized controlled trials are required.

2021 ◽  
pp. 194589242110414
Kathy Zhang ◽  
Andraia R. Li ◽  
Amar Miglani ◽  
Shaun A. Nguyen ◽  
Rodney J. Schlosser

Background Intranasal corticosteroids (INCS), oral antihistamines (POAH), and allergen-specific immunotherapy (ASIT) are widely used in the treatment of allergic rhinitis (AR); however, appraisal of treatment effect has been heterogenous, and few studies have interpreted these outcomes in context with measures of nasal airflow. Objective To provide a systematic review and meta-analysis of randomized placebo-controlled trials for common therapy classes for AR to assess standardized treatment effect on validated patient-reported outcomes and physiologic measures of airflow. Methods A systematic search was performed in PubMed, Scopus, OVID, and Cochrane library databases to identify randomized controlled trials meeting inclusion criteria. Treatment effects of INCS, POAH, and ASIT on total nasal symptom score (TNSS), visual analog scale (VAS), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), and peak nasal inspiratory flow (PNIF) were analyzed by meta-analysis. Results Twenty-two studies with 4673 AR patients were identified, with 5 INCS, 8 POAH, and 9 ASIT trials. INCS improved TNSS (mean difference [MD] 0.90; P = .002) and PNIF (MD 13.31 L/min [ P = .0007]. POAH improved quality of life assessed by RQLQ [MD 0.36; P < .001], but no improvement was found in PNIF. ASIT improved RQLQ [MD 0.65; P < .001], with a trend toward improvement in TNSS. Conclusion Overall, INCS resulted in a clinically and statistically meaningful improvement in symptom scores and physiologic measures in AR. POAH and ASIT both improved symptom scores and quality of life, but their impacts upon nasal airflow are uncertain. There is a lack of studies assessing the effect of INCS on quality of life and the effect of POAH on symptom severity, particularly for mild AR. Future studies should assess the effect of treatment for each of these patient-reported measures.

2021 ◽  
Vol 3 (Supplement_4) ◽  
pp. iv7-iv8
Timothy Brown ◽  
Christina Zoccoli ◽  
Alireza Mansouri ◽  
Michael Glantz

Abstract BACKGROUND Despite an American Academy of Neurology Practice Guideline and ASCO/SNO endorsement against the routine use of anticonvulsant prophylaxis in patients with primary and metastatic brain tumors, there remains widespread variation in practice and several unanswered questions. METHODS Exhaustive evidence-based literature searches were conducted, and patient-level data from randomized controlled trials (RCTs) were analyzed to answer three questions: does anticonvulsant prophylaxis reduce the risk of first seizures in patients with primary and metastatic brain tumors; does prophylaxis improve one-year overall survival in patients with primary and metastatic brain tumors; and what effect have practice guidelines had on practice patterns. RESULTS Five RCTs (n=441 patients) addressed anticonvulsant prophylaxis in patients with brain tumors. Overall, anticonvulsant prophylaxis did not reduce the risk of a first seizure in patients with any brain tumor (RR= 0.95 [0.58-1.55], p= 0.85, anticonvulsant prophylaxis vs. placebo), brain metastasis (RR = 0.96 [0.73-1.25], p=0.77, 5 RCTs) or primary brain tumors (RR= 1.03 [0.19-5.72], p=0.97, 4 RCTs). Eleven RCTs of anticonvulsant prophylaxis (n=3767 patients with CNS tumors) provided data for survival analysis and demonstrated a lower RR of death at one year compared to those who did not receive prophylaxis (0.88 [0.81-0.94] p = 0.0006). Physician-reported practice of prescribing anticonvulsant prophylaxis diminished only negligibly after initial guideline publication (54.9% [1 study] vs. 51.6%, [3 studies] p&lt;0.014). CONCLUSION Prophylactic anticonvulsants in patients without a history of seizures does not reduce the risk of first seizures in patients with primary or metastatic brain tumors. Despite this, anticonvulsant prophylaxis provides a small survival benefit at one year, although, this finding may be driven by confounded studies. Rates of anticonvulsant prophylaxis prescription have decreased only minimally and remain very high despite strong evidence against this practice and guideline publication. Evidence-based medicine requires additional mechanisms for encouraging practice change.

2021 ◽  
pp. 1-31
Shima Abdollahi ◽  
Fatemeh Meshkini ◽  
Cain C. T. Clark ◽  
Javad Heshmati ◽  
Sepideh Soltani

Abstract Despite the apparent beneficial effects of probiotics/synbiotics on glucose hemostasis, lipid profile, and inflammatory responses, it is not clear whether these beneficial effects also impact renal and hepatic function in diabetes. Therefore, we sought to assess the effect of probiotics/synbiotics supplementation on renal and liver biomarkers in adults with type 2 diabetes (T2DM) using a systematic review and meta-analysis of randomized controlled trials (RCTs). PubMed, Scopus, Web of Science, and Cochrane Library were systematically searched, up to February 2021. The pooled weighted mean difference (WMD) was estimated using a random-effect model. The methodological quality of studies, as well as certainty of evidence, was assessed using standard scales. Fifteen related trials were identified. Meta-analysis of six trials, involving 426 participants, indicated that probiotics/synbiotics supplementation reduced serum levels of creatinine (WMD= −0.10 mg/dl, 95% CI: −0.20, −0.00; P= 0.01; I 2 = 87.7%; P-heterogeneity<0.001), without any significant effect on blood urea nitrogen (BUN), glomerular filtration rate, or microalbuminuria. No significant improvement was found on liver biomarkers following probiotics/synbiotics supplementation. The subgroup analysis showed a significant improvement in BUN when follow-up duration lasted for 12 weeks or more (WMD= −1.215 mg/dl, 95% CI: −1.933, −0.496 ; P= 0.001), and in creatinine levels in patients with renal dysfunction (WMD= −0.209 mg/dl, 95% CI: −0.322, −0.096; P<0.001). Our results are insufficient to advocate the use of probiotics/synbiotics for improving renal or liver function in patients with T2DM. Indeed, due to the low certainty of evidence, these findings need to be affirmed in further high-quality RCTs.

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