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Browsing by Author "Akl, Elie A."

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Comparison between the standard and a new alternative format of the Summary-of-Findings tables in Cochrane review users : study protocol for a randomized controlled trial
(2015) Neumann Burotto, Gonzalo Ignacio; Carrasco Labra, Alonso.; Brignardello Petersen, Romina.; Santesso, Nancy.; Mustafa, Reem A.; Mbuagbaw, Lawrence.; Ikobaltzeta, Itziar E.; De Stio, Catherine.; McCullagh, Lauren J.; Alonso Coello, Pablo.; Meerpohl, Joerg J.; Vandvik, Per O.; Brozek, Jan L.; Akl, Elie A.; Bossuyt, Patrick.; Churchill, Rachel.; Glenton, Claire.; Rosenbaum, Sarah.; Tugwell, Peter.; Welch, Vivian.; Guyatt, Gordon.; Schünemann, Holger.
Abstract Background Systematic reviews represent one of the most important tools for knowledge translation but users often struggle with understanding and interpreting their results. GRADE Summary-of-Findings tables have been developed to display results of systematic reviews in a concise and transparent manner. The current format of the Summary-of-Findings tables for presenting risks and quality of evidence improves understanding and assists users with finding key information from the systematic review. However, it has been suggested that additional methods to present risks and display results in the Summary-of-Findings tables are needed. Methods/Design We will conduct a non-inferiority parallel-armed randomized controlled trial to determine whether an alternative format to present risks and display Summary-of-Findings tables is not inferior compared to the current standard format. We will measure participant understanding, accessibility of the information, satisfaction, and preference for both formats. We will invite systematic review users to participate (that is clinicians, guideline developers, and researchers). The data collection process will be undertaken using the online 'Survey Monkey' system. For the primary outcome understanding, non-inferiority of the alternative format (Table A) to the current standard format (Table C) of Summary-of-Findings tables will be claimed if the upper limit of a 1-sided 95% confidence interval (for the difference of proportion of participants answering correctly a given question) excluded a difference in favor of the current format of more than 10%. Discussion This study represents an effort to provide systematic reviewers with additional options to display review results using Summary-of-Findings tables. In this way, review authors will have a variety of methods to present risks and more flexibility to choose the most appropriate table features to display (that is optional columns, risks expressions, complementary methods to display continuous outcomes, and so on). Trials registration NCT02022631 (21 December 2013)Abstract Background Systematic reviews represent one of the most important tools for knowledge translation but users often struggle with understanding and interpreting their results. GRADE Summary-of-Findings tables have been developed to display results of systematic reviews in a concise and transparent manner. The current format of the Summary-of-Findings tables for presenting risks and quality of evidence improves understanding and assists users with finding key information from the systematic review. However, it has been suggested that additional methods to present risks and display results in the Summary-of-Findings tables are needed. Methods/Design We will conduct a non-inferiority parallel-armed randomized controlled trial to determine whether an alternative format to present risks and display Summary-of-Findings tables is not inferior compared to the current standard format. We will measure participant understanding, accessibility of the information, satisfaction, and preference for both formats. We will invite systematic review users to participate (that is clinicians, guideline developers, and researchers). The data collection process will be undertaken using the online 'Survey Monkey' system. For the primary outcome understanding, non-inferiority of the alternative format (Table A) to the current standard format (Table C) of Summary-of-Findings tables will be claimed if the upper limit of a 1-sided 95% confidence interval (for the difference of proportion of participants answering correctly a given question) excluded a difference in favor of the current format of more than 10%. Discussion This study represents an effort to provide systematic reviewers with additional options to display review results using Summary-of-Findings tables. In this way, review authors will have a variety of methods to present risks and more flexibility to choose the most appropriate table features to display (that is optional columns, risks expressions, complementary methods to display continuous outcomes, and so on). Trials registration NCT02022631 (21 December 2013)
Completion and publication rates of randomized controlled trials in surgery an empirical study
(2015) Rosenthal, Rachel; Kasenda, Benjamin; Dell-Kuster, Salome; Von Elm, Erik; You, John; Neumann Burotto, Gonzalo Ignacio; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J.; Stegert, Mihaela; Tikkinen, Kari A. O.; Blümle, Anette; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail; Mertz, Dominik; Akl, Elie A.; Bassler, Dirk; Busse, Jason W.; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Olu, Kelechi K.; Raatz, Heike; Moja, Lorenzo; Ebrahim, Shanil; Schandelmaier, Stefan; Sun, Xin; Vandvik, Per O.; Johnston, Bradley C.; Walter, Martin A.; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G.; Bucher, Heiner C.; Guyatt, Gordon H.; Briel, Matthias
Do clinicians want recommendations? A multicenter study comparing evidence summaries with and without GRADE recommendations
(2018) Neumann Burotto, Gonzalo Ignacio; Alonso Coello, Pablo; Olav Vandvik, Per; Agoritsas, Thomas; Mas, Gemma; Akl, Elie A.; Brignardello Petersen, Romina; Emparanza, José; McCullagh, Lauren; Rivera Mercado, Solange
Evaluating patient values and preferences for thromboprophylaxis decision making during pregnancy: a study protocol
(2012) Alonso Coello, Pablo.; Neumann Burotto, Gonzalo Ignacio; Ebrahim, Shanil; Guyatt, Gordon H.; Tikkinen, Kari A.; Eckman, Mark H.; McDonald, Sarah D.; Akl, Elie A.; Bates, Shannon M.
Abstract Background Pregnant women with prior venous thromboembolism (VTE) are at risk of recurrence. Low molecular weight heparin (LWMH) reduces the risk of pregnancy-related VTE. LMWH prophylaxis is, however, inconvenient, uncomfortable, costly, medicalizes pregnancy, and may be associated with increased risks of obstetrical bleeding. Further, there is uncertainty in the estimates of both the baseline risk of pregnancy-related recurrent VTE and the effects of antepartum LMWH prophylaxis. The values and treatment preferences of pregnant women, crucial when making recommendations for prophylaxis, are currently unknown. The objective of this study is to address this gap in knowledge. Methods We will perform a multi-center cross-sectional interview study in Canada, USA, Norway and Finland. The study population will consist of 100 women with a history of lower extremity deep vein thrombosis (DVT) or pulmonary embolism (PE), and who are either pregnant, planning pregnancy, or may in the future consider pregnancy (women between 18 and 45 years). We will exclude individuals who are on full dose anticoagulation or thromboprophylaxis, who have undergone surgical sterilization, or whose partners have undergone vasectomy. We will determine each participant's willingness to receive LMWH prophylaxis during pregnancy through direct choice exercises based on real life and hypothetical scenarios, preference-elicitation using a visual analog scale (“feeling thermometer”), and a probability trade-off exercise. The primary outcome will be the minimum reduction (threshold) in VTE risk at which women change from declining to accepting LMWH prophylaxis. We will explore possible determinants of this choice, including educational attainment, the characteristics of the women’s prior VTE, and prior experience with LMWH. We will determine the utilities that women place on the burden of LMWH prophylaxis, pregnancy-related DVT, pregnancy-related PE and pregnancy-related hemorrhage. We will generate a “personalized decision analysis” using participants’ utilities and their personalized risk of recurrent VTE as inputs to a decision analytic model. We will compare the personalized decision analysis to the participant’s stated choice. Discussion The preferences of pregnant women at risk of VTE with respect to the use of antithrombotic therapy remain unexplored. This research will provide explicit, quantitative expressions of women's valuations of health states related to recurrent VTE and its prevention with LMWH. This information will be crucial for both guideline developers and for clinicians.
Impact of missing participant data for dichotomous outcomes on pooled effect estimates in systematic reviews: a protocol for a methodological study
(2014) Akl, Elie A.; Neumann Pohl, Carlos Ignacio.; Kahale, Lara A.; Agarwal, Arnav.; Al-Matari, Nada.; Ebrahim, Shanil.; Alexander, Paul E.; Briel, Matthias.; Brignardello-Petersen, Romina.; Busse, Jason W.
Abstract Background There is no consensus on how authors conducting meta-analysis should deal with trial participants with missing outcome data. The objectives of this study are to assess in Cochrane and non-Cochrane systematic reviews: (1) which categories of trial participants the systematic review authors consider as having missing participant data (MPD), (2) how trialists reported on participants with missing outcome data in trials, (3) whether systematic reviewer authors actually dealt with MPD in their meta-analyses of dichotomous outcomes consistently with their reported methods, and (4) the impact of different methods of dealing with MPD on pooled effect estimates in meta-analyses of dichotomous outcomes. Methods/Design We will conduct a methodological study of Cochrane and non-Cochrane systematic reviews. Eligible systematic reviews will include a group-level meta-analysis of a patient-important dichotomous efficacy outcome, with a statistically significant effect estimate. Teams of two reviewers will determine eligibility and subsequently extract information from each eligible systematic review in duplicate and independently, using standardized, pre-piloted forms. The teams will then use a similar process to extract information from the trials included in the meta-analyses of interest. We will assess first which categories of trial participants the systematic reviewers consider as having MPD. Second, we will assess how trialists reported on participants with missing outcome data in trials. Third, we will compare what systematic reviewers report having done, and what they actually did, in dealing with MPD in their meta-analysis. Fourth, we will conduct imputation studies to assess the effects of different methods of dealing with MPD on the pooled effect estimates of meta-analyses. We will specifically calculate for each method (1) the percentage of systematic reviews that lose statistical significance and (2) the mean change of effect estimates across systematic reviews. Discussion The impact of different methods of dealing with MPD on pooled effect estimates will help judge the associated risk of bias in systematic reviews. Our findings will inform recommendations regarding what assumptions for MPD should be used to test the robustness of meta-analytical results.
Improving social justice in observational studies: protocol for the development of a global and Indigenous STROBE-equity reporting guideline
(2023) Funnell, Sarah; Jull, Janet; Mbuagbaw, Lawrence; Welch, Vivian; Dewidar, Omar; Wang, Xiaoqin; Lesperance, Miranda; Ghogomu, Elizabeth; Rizvi, Anita; Akl, Elie A.; Avey, Marc T.; Antequera, Alba; Bhutta, Zulfiqar A.; Chamberlain, Catherine; Craig, Peter; Cuervo, Luis G.; Dicko, Alassane; Ellingwood, Holly; Feng, Cindy; Francis, Damian; Greer-Smith, Regina; Hardy, Billie-Jo; Harwood, Matire; Hatcher-Roberts, Janet; Horsley, Tanya; Juando-Prats, Clara; Kasonde, Mwenya; Kennedy, Michelle; Kredo, Tamara; Krentel, Alison; Kristjansson, Elizabeth; Langer, Laurenz; Little, Julian; Loder, Elizabeth; Magwood, Olivia; Mahande, Michael J.; Melendez-Torres, G. J.; Moore, Ainsley; Niba, Loveline L.; Nicholls, Stuart G.; Nkangu, Miriam N.; Lawson, Daeria O.; Obuku, Ekwaro; Okwen, Patrick; Pantoja Calderón, Tomás; Petkovic, Jennifer; Petticrew, Mark; Pottie, Kevin; Rader, Tamara; Ramke, Jacqueline; Riddle, Alison; Shamseer, Larissa; Sharp, Melissa; Shea, Bev; Tanuseputro, Peter; Tugwell, Peter; Tufte, Janice; Von Elm, Erik; Waddington, Hugh S.; Wang, Harry; Weeks, Laura; Wells, George; White, Howard; Wiysonge, Charles S.; Wolfenden, Luke; Young, Taryn
Background Addressing persistent and pervasive health inequities is a global moral imperative, which has been highlighted and magnified by the societal and health impacts of the COVID-19 pandemic. Observational studies can aid our understanding of the impact of health and structural oppression based on the intersection of gender, race, ethnicity, age and other factors, as they frequently collect this data. However, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline, does not provide guidance related to reporting of health equity. The goal of this project is to develop a STROBE-Equity reporting guideline extension. Methods We assembled a diverse team across multiple domains, including gender, age, ethnicity, Indigenous background, disciplines, geographies, lived experience of health inequity and decision-making organizations. Using an inclusive, integrated knowledge translation approach, we will implement a five-phase plan which will include: (1) assessing the reporting of health equity in published observational studies, (2) seeking wide international feedback on items to improve reporting of health equity, (3) establishing consensus amongst knowledge users and researchers, (4) evaluating in partnership with Indigenous contributors the relevance to Indigenous peoples who have globally experienced the oppressive legacy of colonization, and (5) widely disseminating and seeking endorsement from relevant knowledge users. We will seek input from external collaborators using social media, mailing lists and other communication channels. Discussion Achieving global imperatives such as the Sustainable Development Goals (e.g., SDG 10 Reduced inequalities, SDG 3 Good health and wellbeing) requires advancing health equity in research. The implementation of the STROBE-Equity guidelines will enable a better awareness and understanding of health inequities through better reporting. We will broadly disseminate the reporting guideline with tools to enable adoption and use by journal editors, authors, and funding agencies, using diverse strategies tailored to specific audiences.
LOST to follow-up Information in Trials (LOST-IT): a protocol on the potential impact
(2009) Akl, Elie A.; Vera, Claudio.; Briel, Matthias.; You, John J.; Lamontagne, Francois.; Gangji, Azim.; Cukierman-Yaffe, Tali.; Alshurafa, Mohamad.; Sun, Xin.; Nerenberg, Kara A.
Abstract Background Incomplete ascertainment of outcomes in randomized controlled trials (RCTs) is likely to bias final study results if reasons for unavailability of patient data are associated with the outcome of interest. The primary objective of this study is to assess the potential impact of loss to follow-up on the estimates of treatment effect. The secondary objectives are to describe, for published RCTs, (1) the reporting of loss to follow-up information, (2) the analytic methods used for handling loss to follow-up information, and (3) the extent of reported loss to follow-up. Methods We will conduct a systematic review of reports of RCTs recently published in five top general medical journals. Eligible RCTs will demonstrate statistically significant effect estimates with respect to primary outcomes that are patient-important and expressed as binary data. Teams of 2 reviewers will independently determine eligibility and extract relevant information from each eligible trial using standardized, pre-piloted forms. To assess the potential impact of loss to follow-up on the estimates of treatment effect we will, for varying assumptions about the outcomes of participants lost to follow-up (LTFU), calculate (1) the percentage of RCTs that lose statistical significance and (2) the mean change in effect estimate across RCTs. The different assumptions we will test are the following: (1) none of the LTFU participants had the event; (2) all LTFU participants had the event; (3) all LTFU participants in the treatment group had the event; none of those in the control group had it (worst case scenario); (4) the event incidence among LTFU participants (relative to observed participants) increased, with a higher relative increase in the intervention group; and (5) the event incidence among LTFU participants (relative to observed participants) increased in the intervention group and decreased in the control group. Discussion We aim to make our objectives and methods transparent. The results of this study may have important implications for both clinical trialists and users of the medical literature.
Marcos GRADE de la evidencia a la decisión (EtD) : un enfoque sistemático y transparente para tomar decisiones sanitarias bien informadas. 1: Introducción
(2018) Alonso Coello, Pablo; Schünemann, Holger J.; Moberg, Jenny; Brignardello Petersen, Romina; Akl, Elie A.; Davoli, Marina; Treweek, Shaun; Mustafa, Reem A.; Rada G., Gabriel; Rosenbaum, Sarah; Morellid, Angela; Guyattbc, Gordon H.; Oxman, Andrew D.
Potential impact on estimated treatment effects of information lost to follow-up in randomised controlled trials (LOST-IT): systematic review
(BMJ PUBLISHING GROUP, 2012) Akl, Elie A.; Briel, Matthias; You, John J.; Sun, Xin; Johnston, Bradley C.; Busse, Jason W.; Mulla, Sohail; Lamontagne, Francois; Bassler, Dirk; Vera, Claudio; Alshurafa, Mohamad; Katsios, Christina M.; Zhou, Qi; Cukierman Yaffe, Tali; Gangji, Azim; Mills, Edward J.; Walter, Stephen D.; Cook, Deborah J.; Schuenemann, Holger J.; Altman, Douglas G.; Guyatt, Gordon H.
Objective To assess the reporting, extent, and handling of loss to follow-up and its potential impact on the estimates of the effect of treatment in randomised controlled trials.
Reporting handling and assessing the risk of bias associated with missing participant data in systematic reviews : a methodological survey
(2015) Akl, Elie A.; Carrasco Labra, Alonso; Brignardello Petersen, Romina; Neumann Burotto, Gonzalo Ignacio; Johnston, Bradley C.; Sun, Xin; Briel, Matthias; Busse, Jason W; Ebrahim, Shanil; Granados, Carlos; Iorio, Alfonso; Irfan, Affan; Martínez García, Laura; Mustafa, Reem A.; Ramírez Morera, Anggie; Selva, Anna; Solà, Ivan; Sanabria, Andrea Juliana; Tikkinen, Kari A. O.; Vandvik, Per O.; Vernooij, Robin W. M.; Zazueta, Oscar E.; Zhou, Qi; Guyatt, Gordon H.; Alonso Coello, Pablo
Reporting missing participant data in randomised trials : systematic survey of the methodological literature and a proposed guide
(2015) Akl, Elie A.; Shawwa, Khled; Kahale, Lara A.; Agoritsas, Thomas; Brignardello Petersen, Romina; Busse, Jason W.; Carrasco Labra, Alonso; Ebrahim, Shanil; Johnston, Bradley C.; Neumann Burotto, Gonzalo Ignacio; Sola, Ivan; Sun, Xin; Vandvik, Per; Zhang, Yuqing; Alonso Coello, Pablo; Guyatt, Gordon H.
Requirements of Clinical Journals for Authors' Disclosure of Financial and Non-Financial Conflicts of Interest : A. Cross Sectional Study
(2016) Shawwa, Khaled; Kallas, Romy; Koujanian, Serge; Agarwal, Arnav; Neumann Burotto, Gonzalo Ignacio; Alexander, Paul; Tikkinen, Kari A.; Guyatt, Gordon; Akl, Elie A.
Specific instructions for estimating unclearly reported blinding status in randomized trials were reliable and valid
(ELSEVIER SCIENCE INC, 2012) Akl, Elie A.; Sun, Xin; Busse, Jason W.; Johnston, Bradley C.; Briel, Matthias; Mulla, Sohail; You, John J.; Bassler, Dirk; Lamontagne, Francois; Vera, Claudio; Alshurafa, Mohamad; Katsios, Christina M.; Heels Ansdell, Diane; Zhou, Qi; Mills, Ed; Guyatt, Gordon H.
Objective: To test the reliability and validity of specific instructions to classify blinding, when unclearly reported in randomized trials, as "probably done" or "probably not done."
Spotlight : Patient Centred Care Decision aids that really promote shared decision making : the pace quickens
(2015) Agoritsas, Thomas; Heen, Anja Fog; Brandt, Linn; Alonso Coello, Pablo; Kristiansen, Annette; Akl, Elie A.; Neumann Burotto, Gonzalo Ignacio; Tikkinen, Kari; Van der Weijden, Trudy; Elwyn, Glyn; Montori, Victor M.; Guyatt, Gordon H.; Vandvik, Per Olav
Systematic evaluation of the methodology of randomized controlled trials of anticoagulation in patients with cancer
(2013) Rada G., Gabriel; Schünemann, Holger J.; Labedi, Nawman.; El-Hachem, Pierre.; Kairouz, Victor F.; Akl, Elie A.
Abstract Background Randomized controlled trials (RCTs) that are inappropriately designed or executed may provide biased findings and mislead clinical practice. In view of recent interest in the treatment and prevention of thrombotic complications in cancer patients we evaluated the characteristics, risk of bias and their time trends in RCTs of anticoagulation in patients with cancer. Methods We conducted a comprehensive search, including a search of four electronic databases (MEDLINE, EMBASE, ISI the Web of Science, and CENTRAL) up to February 2010. We included RCTs in which the intervention and/or comparison consisted of: vitamin K antagonists, unfractionated heparin (UFH), low molecular weight heparin (LMWH), direct thrombin inhibitors or fondaparinux. We performed descriptive analyses and assessed the association between the variables of interest and the year of publication. Results We included 67 RCTs with 24,071 participants. In twenty one trials (31%) DVT diagnosis was triggered by clinical suspicion; the remaining trials either screened for DVT or were unclear about their approach. 41 (61%), 22 (33%), and 11 (16%) trials respectively reported on major bleeding, minor bleeding, and thrombocytopenia. The percentages of trials satisfying risk of bias criteria were: adequate sequence generation (85%), adequate allocation concealment (61%), participants’ blinding (39%), data collectors’ blinding (44%), providers’ blinding (41%), outcome assessors’ blinding (75%), data analysts’ blinding (15%), intention to treat analysis (57%), no selective outcome reporting (12%), no stopping early for benefit (97%). The mean follow-up rate was 96%. Adequate allocation concealment and the reporting of intention to treat analysis were the only two quality criteria that improved over time. Conclusions Many RCTs of anticoagulation in patients with cancer appear to use insufficiently rigorous outcome assessment methods and to have deficiencies in key methodological features. It is not clear whether this reflects a problem in the design, conduct or the reporting of these trials, or both. Future trials should avoid the shortcomings described in this article.
The GRADE evidence-to-decision framework: a report of its testing and application in 15 international guideline panels
(2016) Neumann Burotto, Gonzalo Ignacio; Brignardello-Petersen, Romina.; Wiercioch, Wojtek.; Carrasco-Labra, Alonso.; Cuello, Carlos.; Akl, Elie A.; Mustafa, Reem A.; Al-Hazzani, Waleed.; Etxeandia-Ikobaltzeta, Itziar.; Rojas, Maria Ximena.
Abstract Background Judgments underlying guideline recommendations are seldom recorded and presented in a systematic fashion. The GRADE Evidence-to-Decision Framework (EtD) offers a transparent way to record and report guideline developers’ judgments. In this paper, we report the experiences with the EtD frameworks in 15 real guideline panels. Methods Following the guideline panel meetings, we asked methodologists participating in the panel to provide feedback regarding the EtD framework. They were instructed to consider their own experience and the feedback collected from the rest of the panel. Two investigators independently summarized the responses and jointly interpreted the data using pre-specified domains as coding system. We asked methodologists to review the results and provide further input to improve the structure of the EtDs iteratively. Results The EtD framework was well received, and the comments were generally positive. Methodologists felt that in a real guideline panel, the EtD framework helps structuring a complex process through relatively simple steps in an explicit and transparent way. However, some sections (e.g., “values and preferences” and “balance between benefits and harms”) required further development and clarification that were considered in the current version of the EtD framework. Conclusions The use of an EtD framework in guideline development offers a structured and explicit way to record and report the judgments and discussion of guideline panels during the formulation of recommendations. In addition, it facilitates the formulation of recommendations, assessment of their strength, and identifying gaps in research.
Using patient values and preferences to inform the importance of health outcomes in practice guideline development following the GRADE approach
(2017) Zhang, Yuan.; Neumann Burotto, Gonzalo Ignacio; Coello, Pablo Alonso.; Brozek, Jan L.; Wiercioch, Wojtek.; Etxeandia-Ikobaltzeta, Itziar.; Akl, Elie A.; Meerpohl, Joerg J.; Alhazzani, Waleed.; Carrasco-Labra, Alonso.
Women's values and preferences and health state valuations for thromboprophylaxis during pregnancy : A cross-sectional interview study
(2016) Bates, Shannon M.; Alonso Coello, Pablo; Tikkinen, Kari A. O.; Ebrahim, Shanil; Cruz Lopes, Luciane; McDonald, Sarah D.; Qi Zhou; Akl, Elie A.; Neumann Burotto, Gonzalo Ignacio; Jacobsen, Anne Flem; Yuqing Zhang; Santamaría, Amparo; Annichino Bizzacchi, Joyce Maria; Morten Sandset, Per; Bitar, Wael; Eckman, Mark H.; Guyatt, Gordon H.
Women’s Values and Preferences for Thromboprophylaxis during Pregnancy : A Comparison of Direct-choice and Decision Analysis using Patient Specific Utilities
(2015) Eckman, Mark H.; Alonso-Coello, Pablo; Guyatt, Gordon H.; Ebrahim, Shanil; Tikkinen, Kari A.O.; Lopes, Luciane Cruz; Neumann Burotto, Gonzalo Ignacio; Mcdonald, Sarah D.; Zhang, Yuqing; Zhou, Qi; Akl, Elie A.; Jacobsen, Ann Flem; Santamaría, Amparo; Annichino-Bizzacchi, Joyce Maria; Bitar, Wael; Sandset, Per Morten; Bates, Shannon M.

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