{"title":"A study on the related influencing factors of the quality of bowel preparation and the compliance of middle-aged and elderly patients for colonoscopy.","authors":"Shanshan Chen, Tingting Zhang, Saie Zhu, Yi Zhou","doi":"10.1080/03007995.2024.2384589","DOIUrl":"10.1080/03007995.2024.2384589","url":null,"abstract":"<p><strong>Objective: </strong>Quality of bowel preparation and patient compliance are among the most important indicators to assess the quality of colonoscopy. To investigate the independent factors associated with the quality of bowel preparation in subjects undergoing colonoscopy and its impact on compliance.</p><p><strong>Methods: </strong>A total of 329 patient records were collected and were divided into an adequate bowel preparation group (272 cases) and an inadequate bowel preparation group (57 cases), or a compliant group (260 cases) and a non-compliant group (69 cases), based on bowel preparation quality or compliance. The quality of bowel preparation is evaluated using the Boston Bowel Preparation Scale. The comfort level of subjects during bowel preparation is assessed using the Kolcaba General Comfort Questionnaire (GCQ). Subjects' compliance was assessed according to a self-developed compliance questionnaire. Prediction analyses were conducted to identify factors associated with the quality of bowel preparation and compliance.</p><p><strong>Results: </strong>Age, bowel preparation duration, history of bowel inadequacy, and laxative dosage showed statistical differences between the adequate and inadequate bowel preparation groups (<i>p</i> < 0.05). Age, bowel preparation duration, and laxative dosage were independent influencing factors of bowel preparation quality. Correlation analysis showed that GCQ scores were significantly negatively correlated with age, bowel preparation duration, laxative dose, defecation frequency, and colonoscopy duration (<i>r</i> < 0, <i>p</i> < 0.05), and positively correlated with sleep duration (<i>r</i> > 0, <i>p</i> < 0.05). In addition, age, gender, bowel preparation duration, and laxative dosage showed statistical differences between the compliant and non-compliant groups (<i>p</i> < 0.05). Logistic regression analysis revealed that age, bowel preparation duration, and laxative dosage were independent influencing factors of bowel preparation compliance. Age and bowel preparation duration were independent influencing factors for bowel preparation adequacy and compliance.</p><p><strong>Conclusions: </strong>Age, bowel preparation duration, and laxative dosage are independent influencing factors for bowel preparation adequacy and compliance among patients undergoing colonoscopy at the First Affiliated Hospital, School of Medicine, Zhejiang University. It is recommended that a one-day low-residue diet combined with a 2000 mL laxative dosage be used as the bowel preparation protocol for the general colonoscopy population.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1545-1554"},"PeriodicalIF":2.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141751321","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Michael Adair, Rohini Bose, Simon Nitschky Schmidt
{"title":"Safety and effectiveness of vortioxetine in patients with major depressive disorder in a real-life clinical setting in India: results from an interventional, flexible-dose study.","authors":"Michael Adair, Rohini Bose, Simon Nitschky Schmidt","doi":"10.1080/03007995.2024.2382773","DOIUrl":"10.1080/03007995.2024.2382773","url":null,"abstract":"<p><strong>Objective: </strong>Vortioxetine has demonstrated safety and efficacy in improving symptoms of major depressive disorder (MDD), including overall functioning in real-world settings. This is the first study in a real-life clinical setting in India to evaluate effectiveness and safety of vortioxetine in patients with MDD.</p><p><strong>Methods: </strong>This interventional, open-label study consisted of a 12-week treatment period with flexible doses of vortioxetine (5-20 mg/day) in adult patients (aged 18-65 years) with a confirmed MDD diagnosis. Effectiveness outcomes included change from baseline to week 12 in Patient Health Questionnaire-9 (PHQ-9) and Clinical Global Impression-Severity (CGI-S) scores, along with CGI-Improvement (CGI-I) scores at week 12, using a mixed model for repeated measures. Adverse events (AEs) were recorded for safety outcome assessments.</p><p><strong>Results: </strong>Of 395 patients who received vortioxetine, 42.3% were women mean age 38.9 years; 322 patients completed the study. Significant improvement in depressive symptoms was observed in change from baseline to week 12 least squares (LS) mean (SE) PHQ-9 total score (-9.36 [0.276]; <i>p</i><.0001) and CGI-S score (-2.14 [0.065]; <i>p</i><.0001). LS mean (SE) CGI-I score showed significant improvement at week 12 (1.93 [0.067]; <i>p</i><.0001). Subgroup analysis across age, sex, disease severity, and body mass index showed significant improvements in depression symptoms and severity. A total of 35.4% (<i>n</i> = 140) of patients experienced treatment-emergent AEs (mostly mild-moderate); nausea and pruritus were the most frequent (6.6%, <i>n</i> = 26 each).</p><p><strong>Conclusion: </strong>Safety and effectiveness of vortioxetine in improving symptoms of MDD over a 12-week period was demonstrated in a real-life clinical setting in India.</p><p><strong>Clinical trial registration information: </strong>Open-label, flexible-dose study of vortioxetine in patients with major depressive disorder in India; Clinical Trials.gov ID: NCT04288895; https://www.clinicaltrials.gov/study/NCT04288895.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1637-1645"},"PeriodicalIF":2.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141901202","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Exploring the interplay of abstinence self-efficacy, locus of control, and perceived social support in substance use disorder recovery.","authors":"Priti Rekha Das, Rita Rani Talukdar, Chandan Jyoti Kumar","doi":"10.1080/03007995.2024.2390046","DOIUrl":"10.1080/03007995.2024.2390046","url":null,"abstract":"<p><strong>Introduction: </strong>Substance use disorder (SUD) poses a significant public health challenge globally, with substantial impacts on physical and social well-being. This study investigates the interplay between abstinence self-efficacy (ASE), locus of control (LOC), perceived social support (PSS), and various socio-demographic and psychosocial factors among individuals undergoing SUD rehabilitation.</p><p><strong>Methods: </strong>Researchers obtained permission from drug rehabilitation centers in Assam, India, and conducted orientation programs for prospective participants. A total of 144 participants, aged 18-65 years, predominantly from rural areas participated in the study. Data was collected through one-to-one interviews, covering socio-demographic history, drug abuse, and administering scales for ASE, LOC and PSS. Collected data underwent digitization and subsequent descriptive and inferential statistical analyses.</p><p><strong>Results: </strong>Significant associations were found between ASE and socio-demographic variables, family dynamics, and drug use history, highlighting the importance of considering these factors in SUD rehabilitation. Disturbed family relationships were linked to diminished ASE and higher risk of relapse, emphasizing the role of family support in recovery. Additionally, a negative correlation was observed between ASE and LOC, suggesting that individuals with higher ASE tend to have a more internal locus of control, which positively influences recovery outcomes. Moreover, positive correlations were found between ASE and PSS, particularly from family members, underscoring the importance of social support in fostering recovery. Regression analysis further elucidated the relationships between ASE, LOC, and PSS, emphasizing the predictive value of LOC and the impact of family support on ASE.</p><p><strong>Conclusion: </strong>Findings of this study have several implications for developing targeted interventions aimed at strengthening ASE, promoting internal locus of control, and enhancing social support systems.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1625-1635"},"PeriodicalIF":2.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141901201","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Noffar Bar, Joris Diels, Suzy van Sanden, João Mendes, Teresa Hernando, Heather Burnett, Patricia Cost, Jordan M Schecter, Nikoletta Lendvai, Nitin Patel, Tadao Ishida, Jeremy Er, Simon J Harrison, Nieves Lopez-Muñoz
{"title":"Comparative efficacy of ciltacabtagene autoleucel versus idecabtagene vicleucel in the treatment of patients with relapsed or refractory multiple myeloma previously treated with 2-4 prior lines of therapy: a matching-adjusted indirect comparison.","authors":"Noffar Bar, Joris Diels, Suzy van Sanden, João Mendes, Teresa Hernando, Heather Burnett, Patricia Cost, Jordan M Schecter, Nikoletta Lendvai, Nitin Patel, Tadao Ishida, Jeremy Er, Simon J Harrison, Nieves Lopez-Muñoz","doi":"10.1080/03007995.2024.2391112","DOIUrl":"10.1080/03007995.2024.2391112","url":null,"abstract":"<p><strong>Objective: </strong>To estimate the comparative efficacy of ciltacabtagene autoleucel (cilta-cel) versus idecabtagene vicleucel (ide-cel) in patients with relapsed/refractory multiple myeloma (RRMM) treated with 2-4 prior lines of therapy.</p><p><strong>Methods: </strong>Matching adjusted indirect comparison (MAICs) were performed using individual patient-level data (IPD) for cilta-cel from CARTITUDE-1 and CARTITUDE-4 and published aggregated data for ide-cel from KarMMa-3. Cilta-cel patients who met inclusion criteria from KarMMa-3 were selected, and outcomes were compared against data for ide-cel using simulated IPD derived from aggregate-level data from KarMMa-3. Patient characteristics were adjusted by reweighting cilta-cel IPD to match the distribution of prognostic factors in KarMMa-3. Comparative efficacy was estimated for response outcomes using a weighted logistic regression analysis and for progression-free survival using a weighted Cox proportional hazards model.</p><p><strong>Results: </strong>Patients treated with cilta-cel were 1.2 times more likely to achieve overall response (relative response ratio [RR]: 1.18 [95% confidence interval: 1.03-1.34]; <i>p</i> = 0.04), 1.3 times more likely to achieve very good partial response or better (RR: 1.34 [1.15-1.57]; <i>p</i> = 0.003), and 1.9 times more likely to achieve complete response or better (RR: 1.91 [1.54-2.37]; <i>p</i> < 0.0001) versus ide-cel patients from KarMMa-3. Cilta-cel was associated with a significant 49% reduction in risk of disease progression or death versus ide-cel (hazard ratio: 0.51 [95% confidence interval: 0.31, 0.84]; <i>p</i> = 0.0078).</p><p><strong>Conclusion: </strong>For patients with triple-class exposed RRMM treated with 2-4 prior lines of treatment, cilta-cel was found to provide superior clinical benefit over ide-cel in terms of response and progression-free survival.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1597-1603"},"PeriodicalIF":2.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141916272","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Frederick Berro Rivera, Eloise Arias-Aguirre, Zedrick Aguirre, Mc John C Ybañez, Janos Marc M Rubia, Danica Janine Galang, Grace Nooriza Lumbang, Jade Monica Marie J Ruyeras, John Vincent Magalong, Polyn Luz Pine, John Andrew C Amigo, Marie Francesca M Ansay, Nenad Zelenkov, Steve Samuel Thomas, Krishnaswami Vijayaraghavan
{"title":"Evaluating the safety profile of semaglutide: an updated meta-analysis.","authors":"Frederick Berro Rivera, Eloise Arias-Aguirre, Zedrick Aguirre, Mc John C Ybañez, Janos Marc M Rubia, Danica Janine Galang, Grace Nooriza Lumbang, Jade Monica Marie J Ruyeras, John Vincent Magalong, Polyn Luz Pine, John Andrew C Amigo, Marie Francesca M Ansay, Nenad Zelenkov, Steve Samuel Thomas, Krishnaswami Vijayaraghavan","doi":"10.1080/03007995.2024.2383731","DOIUrl":"10.1080/03007995.2024.2383731","url":null,"abstract":"<p><strong>Background: </strong>Semaglutide is increasingly used in the management of type 2 diabetes mellitus and obesity. Ensuring the safety of this medication is crucial for its clinical use. This meta-analysis evaluates the safety profile of semaglutide across patient populations and treatment durations.</p><p><strong>Methods: </strong>Randomized controlled trials assessing the safety of semaglutide <i>vs.</i> placebo, with specified treatment durations were identified. The primary outcome was occurrence of any cardiovascular adverse events. Secondary outcomes included sudden cardiac death, adverse events leading to death, adverse events, gastrointestinal side effects, occurrence of hypoglycemia, and new-onset neoplasm.</p><p><strong>Results: </strong>A total of 23 studies met the inclusion criteria with a combined sample size of 57,911 participants. The meta-analysis revealed that the adverse event associated with semaglutide is gastrointestinal in nature (nausea and vomiting). No significant differences were observed between semaglutide and comparator groups.</p><p><strong>Conclusion: </strong>Semaglutide appears to have a favorable safety profile across diverse patient populations and treatment durations, supporting its continued use in the management of type 2 diabetes mellitus and obesity. It is generally well-tolerated, with a low incidence of adverse events. Clinicians should be aware of these findings and monitor patients accordingly. Further long-term studies are warranted to assess the safety of semaglutide in clinical practice.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1495-1514"},"PeriodicalIF":2.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141751322","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Yu-Cheng Chen, Hai-Long Dai, Chun-Li Liu, Jiang Li, Qiu-Shang Ji, Yun-Shan Cao, Jing Xiao, Rong Jian, Jian-Min Zhuo, Xin-Chao Luo, Hong Gu
{"title":"Real-world effectiveness and safety of macitentan in patients with pulmonary artery hypertension: a multicenter, retrospective, observational study in China.","authors":"Yu-Cheng Chen, Hai-Long Dai, Chun-Li Liu, Jiang Li, Qiu-Shang Ji, Yun-Shan Cao, Jing Xiao, Rong Jian, Jian-Min Zhuo, Xin-Chao Luo, Hong Gu","doi":"10.1080/03007995.2024.2349733","DOIUrl":"10.1080/03007995.2024.2349733","url":null,"abstract":"<p><strong>Background: </strong>Macitentan, either as monotherapy or part of combination therapy, improved clinical outcomes in patients with pulmonary artery hypertension (PAH) in clinical trials. Evidence on the effectiveness and safety of macitentan administered in real-world clinical practice in China is limited.</p><p><strong>Methods: </strong>This real-world, retrospective, multicenter chart review study was conducted at seven hospitals in China. Adult patients with a diagnosis of PAH who initiated macitentan and had medical assessments at 3-7 months after macitentan initiation were included. The primary outcomes were changes in the World Health Organization functional class (WHO-FC), 6-min walk distance (6MWD), and N-terminal pro-B-type natriuretic peptide (NT-proBNP)/B-type natriuretic peptide from baseline to first follow-up visit (months 3-7). Serious adverse events (SAEs) and adverse drug reactions (ADRs) of macitentan were collected.</p><p><strong>Results: </strong>From 30 August 2021 to 31 March 2022, 214 eligible patients were included in the safety analysis set and 105 patients were included in the analysis of effectiveness. At the first follow-up visit compared with baseline, significant changes in WHO-FC were observed (<i>p =</i> .04), 93.5% patients had their WHO-FC improved (25.8%) or maintained (67.7%). 6MWD changed by a mean (standard deviation [SD]) of 45.0 (81.4) meters (<i>p <</i> .001), with 94.7% having their 6MWD improved (34.7%) or maintained (60.0%). The mean (SD) of NT-proBNP decreased from 1667.4 (3233.0) ng/L to 1090.0 (2230.1) ng/L (<i>p <</i> .001). In the safety analysis set, 24 (11.2%) patients experienced at least one ADR and/or SAE. ADRs and SAEs were reported in 11 (5.1%) and 18 (8.4%), respectively. No deaths or unexpected safety events were observed.</p><p><strong>Conclusion: </strong>This study provided real-world evidence on the clinical benefits and good tolerance of macitentan in Chinese patients with PAH treated in routine clinical practice.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1455-1464"},"PeriodicalIF":2.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141751324","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Salman Razvi, Nemencio Nicodemus, Jeyakantha Ratnasingam, Dasgupta Arundhati, Wah Ek Abel Soh, Tada Kunavisarut, Hendra Zufry, Harshal Chaudhari, Alina Markova
{"title":"Importance of right communication with healthcare providers and patients about the new levothyroxine formulation: an expert opinion from Asia Pacific Thyroid Advisory Board.","authors":"Salman Razvi, Nemencio Nicodemus, Jeyakantha Ratnasingam, Dasgupta Arundhati, Wah Ek Abel Soh, Tada Kunavisarut, Hendra Zufry, Harshal Chaudhari, Alina Markova","doi":"10.1080/03007995.2024.2378984","DOIUrl":"10.1080/03007995.2024.2378984","url":null,"abstract":"<p><p>Levothyroxine (LT4), being \"narrow therapeutic index\" drug, may lead to significant fluctuations in thyroid stimulating hormone (TSH) levels. Such fluctuations can result in clinically noteworthy disruptions in thyroid function and give rise to adverse clinical consequences. Consequently, regulatory standards for LT4 potency have been tightened, with the most stringent specifications requiring maintenance of potency within the range of 95-105% of the labeled dose throughout the entire shelf-life of the product. The LT4 new formulation with tightened specification adheres to these rigorous standards, demonstrating established bioequivalence to its older formulation while upholding an equivalent standard of safety and efficacy. Furthermore, the novel formulation exhibits enhanced stability and an extended shelf-life. Of paramount significance is its capacity to provide patients with accurate and consistent dosing, thereby effectively catering to their medical requirements. The primary objective of the Asia-Pacific advisory board meeting (held in June 2022 with endocrinologists, experts from India, Indonesia, Philippines, Thailand, Malaysia and Singapore) was to establish the importance of appropriate communication to HCPs, patients and other stakeholders regarding the LT4 new formulation. The aim of this brief review is to highlight the importance of communication with healthcare professionals that should focus on providing accurate information on the LT4 new formulation, emphasizing efficacy, safety, and bioequivalence with clear guidance and ensure that patients and clinicians are fully informed about any changes to medications such as LT4 to reduce the risk of unrelated adverse events being incorrectly attributed to the newer formulation.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1533-1536"},"PeriodicalIF":2.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141893068","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Elisabet Sanchez-Garcia, Alfonso J Cruz-Jentoft, Paula Ravasco, Merja Suominen, Prof Kaisu Pitkälä
{"title":"Nutritional care in older adults: are we doing everything? An expert opinion review.","authors":"Elisabet Sanchez-Garcia, Alfonso J Cruz-Jentoft, Paula Ravasco, Merja Suominen, Prof Kaisu Pitkälä","doi":"10.1080/03007995.2024.2380007","DOIUrl":"10.1080/03007995.2024.2380007","url":null,"abstract":"<p><p>Malnutrition is a prevalent, yet often underdiagnosed and undertreated, condition in older adults. It is characterized by weight loss and/or reduced muscle mass due to diminished caloric intake, inflammation, and/or disease burden. In return, malnutrition can lead to diminished skeletal muscle functionality and disability, among others. Malnutrition plays a crucial role in the pathogenesis of two prevalent geriatric syndromes, namely sarcopenia and frailty. The complex interplay between malnutrition, sarcopenia, and frailty significantly impacts the older population, leading to increased morbidity, mortality, hospitalization rates, quality-of-life, and healthcare costs. Given the prognostic significance of malnutrition in geriatric care, recent guidelines emphasized the role of nutritional support in vulnerable populations. A group of vulnerable populations to malnutrition, sarcopenia, and frailty are older patients with hip fractures, cancer patients, and those with sarcopenic dysphagia. This article highlights the importance of individualized nutritional assessment and treatment in the management of vulnerable populations such as older patients with hip fractures, cancer, and those suffering from sarcopenic dysphagia. It presents practical protocols and guidelines that can be instrumental in enhancing the nutritional care of these groups, thereby improving their overall health outcomes.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1563-1576"},"PeriodicalIF":2.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141751323","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
George N Okoli, Viraj K Reddy, Otto Lt Lam, Nicole Askin, Rasheda Rabbani
{"title":"Update on efficacy of the approved remdesivir regimen for treatment of COVID-19: a systematic review with meta-analysis and trial sequential analysis of randomized controlled trials.","authors":"George N Okoli, Viraj K Reddy, Otto Lt Lam, Nicole Askin, Rasheda Rabbani","doi":"10.1080/03007995.2024.2366443","DOIUrl":"10.1080/03007995.2024.2366443","url":null,"abstract":"<p><strong>Background: </strong>Efficacy of remdesivir for COVID-19 remains unclear. We updated our published systematic review to better inform on the use of remdesivir for COVID-19.</p><p><strong>Methods: </strong>We searched for randomized controlled trials (RCTs) among hospitalized COVID-19 patients. Meta-analysis was conducted using an inverse variance, random-effects model, presenting relative risk (RR) or mean difference (MD) and their associated 95% confidence intervals (CIs). Statistical heterogeneity was calculated using the <i>I</i><sup>2</sup> statistic. In addition, we conducted trial sequential analysis (TSA). Outcomes with additional data were clinical progression, hospitalization days, and all-cause mortality.</p><p><strong>Results: </strong>We included nine RCTs (12,876 individuals). Three trials each were of a low, unclear, and a high risk of bias. Compared with no treatment/placebo, remdesivir (100 mg daily, over 10 days) significantly improved clinical progression (RR 1.06, CI 1.02-1.11), but did not significantly reduce hospitalization days (MD -0.48, CI -2.18-1.21) and all-cause mortality (RR 0.92, CI 0.84-1.01). TSA suggested that further information is not required to conclude on the efficacy of remdesivir in improving clinical progression, and that, while more information is required for hospitalization days and all-cause mortality, further RCTs to prove fewer hospitalization days may be futile, as efficacy of remdesivir for this outcome is unlikely.</p><p><strong>Conclusions: </strong>Remdesivir appeared promising for COVID-19, but there is insufficient evidence of its efficacy. High quality RCTs are needed for a stronger evidence base.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1277-1287"},"PeriodicalIF":2.4,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141293259","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Seye Abogunrin, Alex Adelakun, Titilope Akinola, Usman Bashir, Bisoye Fagbohungbe, Elvira Mueller, Kurt Neeser, Oluseun Ogunnubi, Krupa Parekh
{"title":"Challenges of consolidating evidence collected during a pandemic and lessons for the future.","authors":"Seye Abogunrin, Alex Adelakun, Titilope Akinola, Usman Bashir, Bisoye Fagbohungbe, Elvira Mueller, Kurt Neeser, Oluseun Ogunnubi, Krupa Parekh","doi":"10.1080/03007995.2024.2377676","DOIUrl":"10.1080/03007995.2024.2377676","url":null,"abstract":"<p><strong>Objective: </strong>To illustrate the challenges encountered when gathering rapidly synthesized evidence in response to the coronavirus disease 2019 (COVID-19) pandemic.</p><p><strong>Methods: </strong>In this article, we describe the challenges encountered when we performed a systematic literature review (SLR) of randomized controlled trials (RCTs) on the efficacy and safety of treatments for severe COVID-19. The methods of the SLR are described in full, to show the context of our objectives. Then we use the results of the SLR to demonstrate the problems of producing synthesized evidence in this setting.</p><p><strong>Results: </strong>Various challenges were identified during this SLR. These were primarily a result of heterogeneity in the study methodology of eligible studies. Definitions of the patient populations and outcome measurements were highly variable and the majority of studies demonstrated a high risk of bias, preventing quantitative synthesis of the collated evidence.</p><p><strong>Conclusion: </strong>Consolidating evidence from RCTs evaluating COVID-19 interventions was problematic. Guidance is needed for scenarios with high rapid output in primary research.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1311-1322"},"PeriodicalIF":2.4,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141554373","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}