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652 results on '"Thorlund, Kristian"'

1. The importance of appropriate selection of clinical endpoints in outpatient COVID-19 clinical trials.

Author

Thorlund, Kristian, Smith, Davey, Linsell, Christopher, White, Nicholas, Butler, Christopher, Boulware, David, Currier, Judith, Harari, Ofir, Lhomme, Edouard, Strub-Wourgaft, Nathalie, Adam, Stacey, and Mills, Edward

Abstract

Clinical trial endpoints must be carefully and intentionally selected so that the results of the trial can be used to inform policy- and decision-making. The relative importance of potential endpoints often depends on the stakeholder, with patients having different preferences to policymakers and regulators. The set up of clinical trials for COVID-19 was problematic, as endpoints that could be reasonably measured did not always match the efficacy endpoints usually required by guideline panels. Thus, different endpoints were used, which made the timely comparison and evaluation of interventions difficult. Here we discuss the evolution of the COVID-19 landscape and the effect this is having on the selection of consistent and measurable clinical trial endpoints. Using appropriate endpoints is crucial for researchers to offer the most reliable, valid, and interpretable results possible.

Published
2023

2. Protocol for a sequential, prospective meta-analysis to describe coronavirus disease 2019 (COVID-19) in the pregnancy and postpartum periods

Author

Smith, Emily R, Oakley, Erin, He, Siran, Zavala, Rebecca, Ferguson, Kacey, Miller, Lior, Grandner, Gargi Wable, Abejirinde, Ibukun-Oluwa Omolade, Afshar, Yalda, Ahmadzia, Homa, Aldrovandi, Grace, Akelo, Victor, Barr, Beth A Tippett, Bevilacqua, Elisa, Brandt, Justin S, Broutet, Natalie, Buhigas, Irene Fernández, Carrillo, Jorge, Clifton, Rebecca, Conry, Jeanne, Cosmi, Erich, Delgado-López, Camille, Divakar, Hema, Driscoll, Amanda J, Favre, Guillaume, Flaherman, Valerie, Gale, Christopher, Gil, Maria M, Godwin, Christine, Gottlieb, Sami, Bellolio, Olivia Hernandez, Kara, Edna, Khagayi, Sammy, Kim, Caron Rahn, Knight, Marian, Kotloff, Karen, Lanzone, Antonio, Le Doare, Kirsty, Lees, Christoph, Litman, Ethan, Lokken, Erica M, Longo, Valentina Laurita, Magee, Laura A, Martinez-Portilla, Raigam Jafet, McClure, Elizabeth, Metz, Torri D, Money, Deborah, Mullins, Edward, Nachega, Jean B, Panchaud, Alice, Playle, Rebecca, Poon, Liona C, Raiten, Daniel, Regan, Lesley, Rukundo, Gordon, Sanin-Blair, Jose, Temmerman, Marleen, Thorson, Anna, Thwin, Soe, Tolosa, Jorge E, Townson, Julia, Valencia-Prado, Miguel, Visentin, Silvia, von Dadelszen, Peter, Waldorf, Kristina Adams, Whitehead, Clare, Yang, Huixia, Thorlund, Kristian, and Tielsch, James M

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Health Sciences, Clinical Research, Emerging Infectious Diseases, Pediatric, Prevention, Reproductive health and childbirth, Good Health and Well Being, Adolescent, COVID-19, Child, Female, Humans, Infant, Newborn, Meta-Analysis as Topic, Postpartum Period, Pregnancy, Prospective Studies, Retrospective Studies, SARS-CoV-2, General Science & Technology
Abstract

We urgently need answers to basic epidemiological questions regarding SARS-CoV-2 infection in pregnant and postpartum women and its effect on their newborns. While many national registries, health facilities, and research groups are collecting relevant data, we need a collaborative and methodologically rigorous approach to better combine these data and address knowledge gaps, especially those related to rare outcomes. We propose that using a sequential, prospective meta-analysis (PMA) is the best approach to generate data for policy- and practice-oriented guidelines. As the pandemic evolves, additional studies identified retrospectively by the steering committee or through living systematic reviews will be invited to participate in this PMA. Investigators can contribute to the PMA by either submitting individual patient data or running standardized code to generate aggregate data estimates. For the primary analysis, we will pool data using two-stage meta-analysis methods. The meta-analyses will be updated as additional data accrue in each contributing study and as additional studies meet study-specific time or data accrual thresholds for sharing. At the time of publication, investigators of 25 studies, including more than 76,000 pregnancies, in 41 countries had agreed to share data for this analysis. Among the included studies, 12 have a contemporaneous comparison group of pregnancies without COVID-19, and four studies include a comparison group of non-pregnant women of reproductive age with COVID-19. Protocols and updates will be maintained publicly. Results will be shared with key stakeholders, including the World Health Organization (WHO) Maternal, Newborn, Child, and Adolescent Health (MNCAH) Research Working Group. Data contributors will share results with local stakeholders. Scientific publications will be published in open-access journals on an ongoing basis.

Published
2022

9. Comparative efficacy, tolerability and safety of dolutegravir and efavirenz 400mg among antiretroviral therapies for first-line HIV treatment: A systematic literature review and network meta-analysis

Author

Kanters, Steve, Vitoria, Marco, Zoratti, Michael, Doherty, Meg, Penazzato, Martina, Rangaraj, Ajay, Ford, Nathan, Thorlund, Kristian, Anis, Prof. Aslam H., Karim, Mohammad Ehsanul, Mofenson, Lynne, Zash, Rebecca, Calmy, Alexandra, Kredo, Tamara, and Bansback, Nick

Published
2020
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16. Association Between Myocardial Injury and Cardiovascular Outcomes of Orthopaedic Surgery: A Vascular Events in Noncardiac Surgery Patients Cohort Evaluation (VISION) Substudy

Author

Thomas, Sabu, Borges, Flavia, Bhandari, Mohit, De Beer, Justin, Urrútia Cuchí, Gerard, Adili, Anthony, Winemaker, Mitchell, Avram, Victoria, Chan, Matthew T.V., Lamas, Claudia, Cruz, Patricia, Aguilera, Xavier, Garutti, Ignacio, Alonso-Coello, Pablo, Villar, Juan Carlos, Jacka, Michael, Wang, C.Y., Berwanger, Otavio, Chow, Clara, Srinathan, Sadeesh, Pettit, Shirley, Heels-Ansdell, Dianne, Rubery, Paul, Devereaux, P.J., Thomas, Sabu, Walsh, Michael, Tiboni, Maria, Guyatt, Gordon, Heels-Ansdell, Diane, Thorlund, Kristian, Thabane, Lehana, Bhandari, Mohit, Bosch, Jackie, Chan, Matthew T.V., Shatin, NT, Alonso-Coello, Pablo, Berwanger, Otavio, Carlos Villar, Juan, Wang, C.Y., Garutti, R. Ignacio, Jacka, Michael J., Sigamani, Alben, Srinathan, Sadeesh, Biccard, Bruce M., Rodseth, Reitze N., Chow, Clara K., Abraham, Valsa, Pettit, Shirley, McQueen, Matthew J., VanHelder, Tomas, Szczeklik, Wojciech, Buse, Giovanna Lurati, Botto, Fernando, Yusuf, Salim, Sessler, Daniel I., Kurz, Andrea, Garg, Amit X., Mrkobrada, Marko, Pearse, Rupert M., Polanczyk, Carisi A., Malaga, German, Nagele, Peter, Le Manach, Yannick, Leuwer, Martin, and Devereaux, P.J.

Published
2020
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32. Interventions to promote adherence to antiretroviral therapy in Africa: a network meta-analysis

Author

Mills, Edward J, Lester, Richard, Thorlund, Kristian, Lorenzi, Maria, Muldoon, Katherine, Kanters, Steve, Linnemayr, Sebastian, Gross, Robert, Calderon, Yvette, Amico, K Rivet, Thirumurthy, Harsha, Pearson, Cynthia, Remien, Robert H, Mbuagbaw, Lawrence, Thabane, Lehana, Chung, Michael H, Wilson, Ira B, Liu, Albert, Uthman, Olalekan A, Simoni, Jane, Bangsberg, David, Yaya, Sanni, Bärnighausen, Till, Ford, Nathan, and Nachega, Jean B

Published
2014
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33. Interventions to improve linear growth during exclusive breastfeeding life-stage for children aged 0-6 months living in LMICs: a systematic review with network and pairwise meta-analyses

Author

Park, Jay, Siden, Ellie, Harari, Ofir, Dron, Louis, Majzoub, Reham, Jeziorska, Virginia, Zannat, Noor-E, Gadalla, Heather, Thorlund, Kristian, and Mills, Edward

Abstract

Evaluation of various interventions through network meta-analysis to look at their effectiveness on linear growth in children aged 0-6 months.

Published
2022
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34. Interventions to improve birth outcomes of pregnant women living in low- and middle-income countries: a systematic review and network meta-analysis

Author

Park, Jay, Harari, Ofir, Siden, Ellie, Zoratti, Michael, Dron, Louis, Zannat, Noor-E, Lester, Richard, Thorlund, Kristian, and Mills, Edward

Subjects
Psychological intervention, Medicine (miscellaneous), Biochemistry, Genetics and Molecular Biology (miscellaneous), law.invention, Deworming, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Immunology and Microbiology (miscellaneous), Pregnancy, law, Environmental health, Medicine, low- and middle-income countries, 030212 general & internal medicine, network meta-analysis, business.industry, Health Policy, birth outcomes, Public Health, Environmental and Occupational Health, evidence synthesis, Articles, medicine.disease, Micronutrient, Clinical trial, birthweight, Meta-analysis, Gestation, Systematic Review, preterm, business, 030217 neurology & neurosurgery
Abstract

Background: Improving the health of pregnant women is important to prevent adverse birth outcomes, such as preterm birth and low birthweight. We evaluated the comparative effectiveness of interventions under the domains of micronutrient, balanced energy protein, deworming, maternal education, and water sanitation and hygiene (WASH) for their effects on these adverse birth outcomes. Methods: For this network meta-analysis, we searched for randomized clinical trials (RCTs) of interventions provided to pregnant women in low- and middle-income countries (LMICs). We searched for reports published until September 17, 2019 and hand-searched bibliographies of existing reviews. We extracted data from eligible studies for study characteristics, interventions, participants’ characteristics at baseline, and birth outcomes. We compared effects on preterm birth ( Results: Our network meta-analyses were based on 101 RCTs (132 papers) pertaining to 206,531 participants. Several micronutrients and balanced energy food supplement interventions demonstrated effectiveness over standard-of-care. For instance, versus standard-of-care, micronutrient supplements for pregnant women, such as iron and calcium, decreased risks of preterm birth (iron: RR=0.70, 95% credible interval [Crl] 0.47, 1.01; calcium: RR=0.76, 95%Crl 0.56, 0.99). Daily intake of 1500kcal of local food decreased the risks of preterm birth (RR=0.36, 95%Crl 0.16, 0.77) and LBW (RR=0.17, 95%Crl 0.09, 0.29), respectively when compared to standard-of-care. Educational and deworming interventions did not show improvements in birth outcomes, and no WASH intervention trials reported on these adverse birth outcomes. Conclusion: We found several pregnancy interventions that improve birth outcomes. However, most clinical trials have only evaluated interventions under a single domain (e.g. micronutrients) even though the causes of adverse birth outcomes are multi-faceted. There is a need to combine interventions that of different domains as packages and test for their effectiveness. Registration: PROSPERO CRD42018110446; registered on 17 October 2018.

Published
2022
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35. Interventions to improve linear growth during complementary feeding period for children aged 6-24 months living in low- and middle-income countries: a systematic review and network meta-analysis

Author

Park, Jay, Harari, Ofir, Siden, Ellie, Dron, Louis, Zannat, Noor-E, Singer, Joel, Lester, Richard, Thorlund, Kristian, and Mills, Edward

Subjects
0301 basic medicine, child development, 030109 nutrition & dietetics, Health Policy, Public Health, Environmental and Occupational Health, stunting, Medicine (miscellaneous), Complementary feeding, Articles, Biochemistry, Genetics and Molecular Biology (miscellaneous), 03 medical and health sciences, 0302 clinical medicine, Immunology and Microbiology (miscellaneous), height-for-age, Medicine and Health Sciences, 030212 general & internal medicine, Systematic Review, low- and middle-income countries, network meta-analysis
Abstract

Background:Optimizing linear growth in children during complementary feeding period (CFP) (6-24 months) are critical for their development. Several interventions, such as micronutrient and food supplements, deworming, maternal education, and water, sanitation and hygiene (WASH), could potentially be provided to prevent stunting, but their comparative effectiveness is currently unclear. In this study, we evaluated comparative effectiveness of interventions under these domains on child linear growth outcomes of height-for-age z-score (HAZ) and stunting (HAZ Methods:For this study, we searched for low- and middle-income country (LMIC)-based randomized clinical trials (RCTs) of aforementioned interventions provided to children during CFP. We searched for reports published until September 17, 2019 and hand-searched bibliographies of existing reviews. We performed random-effects network meta-analysis (NMA) for HAZ and stunting.Results:The evidence base for our NMA was based on 79 RCTs (96 papers) involving 81,786 children. Among the micronutrients, compared to standard-of-care, iron + folic acid (IFA) (mean difference =0.08; 95% credible interval [CrI]: 0.01, 0.15) and multiple micronutrients (MMN) (mean difference =0.06; 95%CrI: 0.01, 0.11) showed improvements for HAZ; MMN also reduced the risks for stunting (RR=0.86; 95%Crl: 0.73, 0.98), whereas IFA did not (RR=0.92; 95%Crl: 0.64, 1.23). For food supplements, flour in the caloric range of 270-340 kcal (RR=0.73; 95%Crl: 0.51, 1.00) and fortified lipid-based nutrient supplements (LNS) containing 220-285 kcal (RR=0.80; 95%Crl: 0.66, 0.97) decreased the risk of stunting compared to standard-of-care, but these interventions and other food supplements did not show improvements for HAZ. Deworming, maternal education, and WASH interventions did not show improvements for HAZ nor stunting.Conclusion:While we found micronutrient and food supplements to be effective for HAZ and/or stunting, the evidence base for other domains in this life stage was limited, highlighting the need for more investigation.Registration:PROSPEROCRD42018110449; registered on 17 October 2018.

Published
2022
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36. A multi-center, adaptive, randomized, platform trial to evaluate the effect of repurposed medicines in outpatients with early coronavirus disease 2019 (COVID-19) and high-risk for complications: the TOGETHER master trial

Author

Zannat, Noor-E, Reis, Gilmar, Silva, Eduardo, Silva, Daniela, Thorlund, Kristian, Thabane, Lehana, Guyatt, Gordon, Forrest, Jamie, Glushchenko, Alla, Chernecki, Cameron, McKay, Paula, Sprague, Sheila, Harari, Ofir, Ruton, Hinda, Rayner, Craig, and Mills, Edward

Subjects
Life Sciences
Abstract

Background Although vaccines are currently available for coronavirus disease 2019 (COVID-19), there remains a need for an effective and affordable outpatient treatment for early COVID-19. Multiple repurposed drugs have shown promise in treating COVID-19. We describe a master protocol that will assess the efficacy of different repurposed drugs as treatments for early COVID-19 among outpatients at a high risk for severe complications. Methods The TOGETHER Trial is an international (currently in Brazil), multi-center platform adaptive randomized, placebo-controlled, clinical trial. Patients are included if they are at least 18 years of age, have a positive antigen test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and have an indication for high risk of disease severity, including co-morbidities, older age, or high body mass index. Eligible patients are randomized with equal chance to an investigational product (IP) or to placebo. The primary endpoint is emergency room required observation for more than 6 hours or hospitalization due to clinical worsening of COVID-19; up to 28 days after randomization. Key secondary endpoints include viral clearance, clinical improvement, hospitalization for any cause, mortality for any cause, and safety and tolerability of each IP. Scheduled interim analyses are conducted and reviewed by the Data and Safety Monitoring Committee (DSMC), who make recommendations on continuing or stopping each IP. The platform adaptive design go-no go decision rules are extended to dynamically incorporate external evidence on COVID-19 interventions from ongoing independent randomized clinical trials. Discussion Results from this trial will assist in the identification of therapeutics for COVID-19 that can easily be scaled in low- and middle-income settings. The novel methodological extension of the platform adaptive design to dynamically incorporate external evidence is one of the first of its kind and may provide highly valuable information for all COVID-19 trials going forward.

Published
2022
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48. sj-pdf-1-ctj-10.1177_17407745221118366 – Supplemental material for A Bayesian adaptive design for clinical trials of rare efficacy outcomes with multiple definitions

Author

Golchi, Shirin, Willard, James J, Pullenayegum, Eleanor, Bassani, Diego G, Pell, Lisa G, Thorlund, Kristian, and Roth, Daniel E

Subjects
FOS: Clinical medicine, 160807 Sociological Methodology and Research Methods, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified, FOS: Sociology
Abstract

Supplemental material, sj-pdf-1-ctj-10.1177_17407745221118366 for A Bayesian adaptive design for clinical trials of rare efficacy outcomes with multiple definitions by Shirin Golchi, James J Willard, Eleanor Pullenayegum, Diego G Bassani, Lisa G Pell, Kristian Thorlund and Daniel E Roth in Clinical Trials

Published
2022
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