Search Results - "Current controlled trials in cardiovascular medicine"

The COMET Handbook: version 1.0 by Williamson, Paula R, Altman, Douglas G, Bagley, Heather, Barnes, Karen L, Blazeby, Jane M, Brookes, Sara T, Clarke, Mike, Gargon, Elizabeth, Gorst, Sarah, Harman, Nicola, Kirkham, Jamie J, McNair, Angus, Prinsen, Cecilia A C, Schmitt, Jochen, Terwee, Caroline B, Young, Bridget

“…The selection of appropriate outcomes is crucial when designing clinical trials in order to compare the effects of different interventions directly. For the…”
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How to select outcome measurement instruments for outcomes included in a "Core Outcome Set" - a practical guideline by Prinsen, Cecilia A C, Vohra, Sunita, Rose, Michael R, Boers, Maarten, Tugwell, Peter, Clarke, Mike, Williamson, Paula R, Terwee, Caroline B

“…In cooperation with the Core Outcome Measures in Effectiveness Trials (COMET) initiative, the COnsensus-based Standards for the selection of health Measurement…”
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Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of master protocols by Park, Jay J H, Siden, Ellie, Zoratti, Michael J, Dron, Louis, Harari, Ofir, Singer, Joel, Lester, Richard T, Thorlund, Kristian, Mills, Edward J

“…Master protocols, classified as basket trials, umbrella trials, and platform trials, are novel designs that investigate multiple hypotheses through concurrent…”
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The role of machine learning in clinical research: transforming the future of evidence generation by Weissler, E Hope, Naumann, Tristan, Andersson, Tomas, Ranganath, Rajesh, Elemento, Olivier, Luo, Yuan, Freitag, Daniel F, Benoit, James, Hughes, Michael C, Khan, Faisal, Slater, Paul, Shameer, Khader, Roe, Matthew, Hutchison, Emmette, Kollins, Scott H, Broedl, Uli, Meng, Zhaoling, Wong, Jennifer L, Curtis, Lesley, Huang, Erich, Ghassemi, Marzyeh

“…Interest in the application of machine learning (ML) to the design, conduct, and analysis of clinical trials has grown, but the evidence base for such…”
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Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of treating Healthcare Professionals with the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac - PROFISCOV: A structured summary of a study protocol for a randomised controlled trial by Palacios, Ricardo, Patiño, Elizabeth González, de Oliveira Piorelli, Roberta, Conde, Monica Tilli Reis Pessoa, Batista, Ana Paula, Zeng, Gang, Xin, Qianqian, Kallas, Esper G, Flores, Jorge, Ockenhouse, Christian F, Gast, Christopher

“…To evaluate the efficacy of two doses of the adsorbed vaccine COVID-19 (inactivated) produced by Sinovac in symptomatic individuals, with virological…”
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A literature review on the representativeness of randomized controlled trial samples and implications for the external validity of trial results by Kennedy-Martin, Tessa, Curtis, Sarah, Faries, Douglas, Robinson, Susan, Johnston, Joseph

“…Randomized controlled trials (RCTs) are conducted under idealized and rigorously controlled conditions that may compromise their external validity. A…”
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Pulmonary Metastasectomy versus Continued Active Monitoring in Colorectal Cancer (PulMiCC): a multicentre randomised clinical trial by Treasure, Tom, Farewell, Vern, Macbeth, Fergus, Monson, Kathryn, Williams, Norman R, Brew-Graves, Chris, Lees, Belinda, Grigg, Olivia, Fallowfield, Lesley

“…Lung metastasectomy in the treatment of advanced colorectal cancer has been widely adopted without good evidence of survival or palliative benefit. We aimed to…”
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Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial by Arabi, Yaseen M, Alothman, Adel, Balkhy, Hanan H, Al-Dawood, Abdulaziz, AlJohani, Sameera, Al Harbi, Shmeylan, Kojan, Suleiman, Al Jeraisy, Majed, Deeb, Ahmad M, Assiri, Abdullah M, Al-Hameed, Fahad, AlSaedi, Asim, Mandourah, Yasser, Almekhlafi, Ghaleb A, Sherbeeni, Nisreen Murad, Elzein, Fatehi Elnour, Memon, Javed, Taha, Yusri, Almotairi, Abdullah, Maghrabi, Khalid A, Qushmaq, Ismael, Al Bshabshe, Ali, Kharaba, Ayman, Shalhoub, Sarah, Jose, Jesna, Fowler, Robert A, Hayden, Frederick G, Hussein, Mohamed A

“…It had been more than 5 years since the first case of Middle East Respiratory Syndrome coronavirus infection (MERS-CoV) was recorded, but no specific treatment…”
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CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials by Grant, Sean, Mayo-Wilson, Evan, Montgomery, Paul, Macdonald, Geraldine, Michie, Susan, Hopewell, Sally, Moher, David

“…The CONSORT (Consolidated Standards of Reporting Trials) Statement was developed to help biomedical researchers report randomised controlled trials (RCTs)…”
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Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension by Montgomery, Paul, Grant, Sean, Mayo-Wilson, Evan, Macdonald, Geraldine, Michie, Susan, Hopewell, Sally, Moher, David

“…Randomised controlled trials (RCTs) are used to evaluate social and psychological interventions and inform policy decisions about them. Accurate, complete, and…”
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Why clinical trial outcomes fail to translate into benefits for patients by Heneghan, Carl, Goldacre, Ben, Mahtani, Kamal R

“…Clinical research should ultimately improve patient care. For this to be possible, trials must evaluate outcomes that genuinely reflect real-world settings and…”
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Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement by Kirkham, Jamie J, Gorst, Sarah, Altman, Douglas G, Blazeby, Jane M, Clarke, Mike, Tunis, Sean, Williamson, Paula R

“…Several hundred core outcome set (COS) projects have been systematically identified to date which, if adopted, ensure that researchers measure and report those…”
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Blockchain technology for improving clinical research quality by Benchoufi, Mehdi, Ravaud, Philippe

“…Reproducibility, data sharing, personal data privacy concerns and patient enrolment in clinical trials are huge medical challenges for contemporary clinical…”
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Developing a roadmap to improve trial delivery for under-served groups: results from a UK multi-stakeholder process by Witham, Miles D, Anderson, Eleanor, Carroll, Camille, Dark, Paul M, Down, Kim, Hall, Alistair S, Knee, Joanna, Maier, Rebecca H, Mountain, Gail A, Nestor, Gary, Oliva, Laurie, Prowse, Sarah R, Tortice, Amanda, Wason, James, Rochester, Lynn

“…Participants in clinical research studies often do not reflect the populations for which healthcare interventions are needed or will be used. Enhancing…”
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Developing core outcome sets for clinical trials: issues to consider by Williamson, Paula R, Altman, Douglas G, Blazeby, Jane M, Clarke, Mike, Devane, Declan, Gargon, Elizabeth, Tugwell, Peter

“…The selection of appropriate outcomes or domains is crucial when designing clinical trials in order to compare directly the effects of different interventions…”
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Promoting inclusion in clinical trials—a rapid review of the literature and recommendations for action by Bodicoat, Danielle H, Routen, Ash C, Willis, Andrew, Ekezie, Winifred, Gillies, Clare, Lawson, Claire, Yates, Thomas, Zaccardi, Francesco, Davies, Melanie J, Khunti, Kamlesh

“…Abstract Background Without inclusion of diverse research participants, it is challenging to understand how study findings will translate into the real world…”
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Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-β1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial by Arabi, Yaseen M, Asiri, Ayed Y, Assiri, Abdullah M, Aziz Jokhdar, Hani A, Alothman, Adel, Balkhy, Hanan H, AlJohani, Sameera, Al Harbi, Shmeylan, Kojan, Suleiman, Al Jeraisy, Majed, Deeb, Ahmad M, Memish, Ziad A, Ghazal, Sameeh, Al Faraj, Sarah, Al-Hameed, Fahad, AlSaedi, Asim, Mandourah, Yasser, Al Mekhlafi, Ghaleb A, Sherbeeni, Nisreen Murad, Elzein, Fatehi Elnour, Almotairi, Abdullah, Al Bshabshe, Ali, Kharaba, Ayman, Jose, Jesna, Al Harthy, Abdulrahman, Al Sulaiman, Mohammed, Mady, Ahmed, Fowler, Robert A, Hayden, Frederick G, Al-Dawood, Abdulaziz, Abdelzaher, Mohamed, Bajhmom, Wail, Hussein, Mohamed A

“…The MIRACLE trial (MERS-CoV Infection tReated with A Combination of Lopinavir/ritonavir and intErferon-β1b) investigates the efficacy of a combination therapy…”
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Evaluating the effects of the novel GLP-1 analogue liraglutide in Alzheimer's disease: study protocol for a randomised controlled trial (ELAD study) by Femminella, Grazia Daniela, Frangou, Eleni, Love, Sharon B, Busza, Gail, Holmes, Clive, Ritchie, Craig, Lawrence, Robert, McFarlane, Brady, Tadros, George, Ridha, Basil H, Bannister, Carol, Walker, Zuzana, Archer, Hilary, Coulthard, Elizabeth, Underwood, Ben R, Prasanna, Aparna, Koranteng, Paul, Karim, Salman, Junaid, Kehinde, McGuinness, Bernadette, Nilforooshan, Ramin, Macharouthu, Ajay, Donaldson, Andrew, Thacker, Simon, Russell, Gregor, Malik, Naghma, Mate, Vandana, Knight, Lucy, Kshemendran, Sajeev, Harrison, John, Hölscher, Christian, Brooks, David J, Passmore, Anthony Peter, Ballard, Clive, Edison, Paul

“…Liraglutide is a glucagon-like peptide-1 (GLP-1) analogue currently approved for type 2 diabetes and obesity. Preclinical evidence in transgenic models of…”
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Trial Forge Guidance 1: what is a Study Within A Trial (SWAT)? by Treweek, Shaun, Bevan, Simon, Bower, Peter, Campbell, Marion, Christie, Jacquie, Clarke, Mike, Collett, Clive, Cotton, Seonaidh, Devane, Declan, El Feky, Adel, Flemyng, Ella, Galvin, Sandra, Gardner, Heidi, Gillies, Katie, Jansen, Jan, Littleford, Roberta, Parker, Adwoa, Ramsay, Craig, Restrup, Lynne, Sullivan, Frank, Torgerson, David, Tremain, Liz, Westmore, Matthew, Williamson, Paula R

“…Randomised trials are a central component of all evidence-informed health care systems and the evidence coming from them helps to support health care users,…”
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COMPare: a prospective cohort study correcting and monitoring 58 misreported trials in real time by Goldacre, Ben, Drysdale, Henry, Dale, Aaron, Milosevic, Ioan, Slade, Eirion, Hartley, Philip, Marston, Cicely, Powell-Smith, Anna, Heneghan, Carl, Mahtani, Kamal R

“…Discrepancies between pre-specified and reported outcomes are an important source of bias in trials. Despite legislation, guidelines and public commitments on…”
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