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6. ISSCR Guidelines for Stem Cell Research and Clinical Translation: The 2021 update.

Author

Lovell-Badge, Robin, Anthony, Eric, Barker, Roger A, Bubela, Tania, Brivanlou, Ali H, Carpenter, Melissa, Charo, R Alta, Clark, Amander, Clayton, Ellen, Cong, Yali, Daley, George Q, Fu, Jianping, Fujita, Misao, Greenfield, Andy, Goldman, Steve A, Hill, Lori, Hyun, Insoo, Isasi, Rosario, Kahn, Jeffrey, Kato, Kazuto, Kim, Jin-Soo, Kimmelman, Jonathan, Knoblich, Jürgen A, Mathews, Debra, Montserrat, Nuria, Mosher, Jack, Munsie, Megan, Nakauchi, Hiromitsu, Naldini, Luigi, Naughton, Gail, Niakan, Kathy, Ogbogu, Ubaka, Pedersen, Roger, Rivron, Nicolas, Rooke, Heather, Rossant, Janet, Round, Jeff, Saitou, Mitinori, Sipp, Douglas, Steffann, Julie, Sugarman, Jeremy, Surani, Azim, Takahashi, Jun, Tang, Fuchou, Turner, Leigh, Zettler, Patricia J, and Zhai, Xiaomei

Subjects
Biochemistry and Cell Biology, Clinical Sciences
Abstract

The International Society for Stem Cell Research has updated its Guidelines for Stem Cell Research and Clinical Translation in order to address advances in stem cell science and other relevant fields, together with the associated ethical, social, and policy issues that have arisen since the last update in 2016. While growing to encompass the evolving science, clinical applications of stem cells, and the increasingly complex implications of stem cell research for society, the basic principles underlying the Guidelines remain unchanged, and they will continue to serve as the standard for the field and as a resource for scientists, regulators, funders, physicians, and members of the public, including patients. A summary of the key updates and issues is presented here.

Published
2021

12. Co-developing The Canadian MPS Registry: A longitudinal rare disease patient registry

Author

Mitchell, John J., primary, Inbar-Feigenberg, Michal, additional, Angel, Kim, additional, Chakraborty, Pranesh, additional, Lamoureux, Monica, additional, Adams, John, additional, Potter, Beth K., additional, Stockler-Ipsirolgu, Sylvia, additional, Howie, Alison H., additional, Pace, Alex, additional, Butcher, Nancy J., additional, Greenberg, Cheryl, additional, Hayeems, Robin, additional, Laberge, Anne-Marie, additional, Round, Jeff, additional, Offringa, Martin, additional, Oskoui, Maryam, additional, Ruth, Chelsea, additional, Schulze, Andreas, additional, Speechley, Kathy, additional, Thavorn, Kednapa, additional, Trakadis, Yannis, additional, Wilson, Kumanan, additional, and Lacaze, Thierry, additional

Published
2024
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14. Capturing Valuation Study Sampling Uncertainty in the Estimation of Health State Utility Values Using the EQ-5D-3L.

Author

Poulimenos, Spyridon, Round, Jeff, and Baio, Gianluca

Abstract

Objectives: Utility scores associated with preference-based health-related quality-of-life instruments such as the EQ-5D-3L are reported as point estimates. In this study, we develop methods for capturing the uncertainty associated with the valuation study of the UK EQ-5D-3L that arises from the variability inherent in the underlying data, which is tacitly ignored by point estimates. We derive a new tariff that properly accounts for this and assigns a specific closed-form distribution to the utility of each of the 243 health states of the EQ-5D-3L. Methods: Using the UK EQ-5D-3L valuation study, we used a Bayesian approach to obtain the posterior distributions of the derived utility scores. We constructed a hierarchical model that accounts for model misspecification and the responses of the survey participants to obtain Markov chain Monte Carlo (MCMC) samples from the posteriors. The posterior distributions were approximated by mixtures of normal distributions under the Kullback–Leibler (KL) divergence as the criterion for the assessment of the approximation. We considered the Broyden–Fletcher–Goldfarb–Shanno (BFGS) algorithm to estimate the parameters of the mixture distributions. Results: We derived an MCMC sample of total size 4,000 × 243. No evidence of nonconvergence was found. Our model was robust to changes in priors and starting values. The posterior utility distributions of the EQ-5D-3L states were summarized as 3-component mixtures of normal distributions, and the corresponding KL divergence values were low. Conclusions: Our method accounts for layers of uncertainty in valuation studies, which are otherwise ignored. Our techniques can be applied to other instruments and countries' populations. Highlights: Guidelines for health technology assessments typically require that uncertainty be accounted for in economic evaluations, but the parameter uncertainty of the regression model used in the valuation study of the health instrument is often tacitly ignored. We consider the UK valuation study of the EQ-5D-3L and construct a Bayesian model that accounts for layers of uncertainty that would otherwise be disregarded, and we derive closed-form utility distributions. The derived tariff can be used by researchers in economic evaluations, as it allows analysts to directly sample a utility value from its corresponding distribution, which reflects the associated uncertainty of the utility score. [ABSTRACT FROM AUTHOR]

Published
2024
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27. Author Reply

Author

Paulden, Mike, Sampson, Chris, O’Mahony, James F., Spackman, Eldon, McCabe, Christopher, Round, Jeff, and Snowsill, Tristan

Published
2024
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31. Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP): Protocol for a multicentre cluster randomised trial comparing a complex intervention for medication optimization against usual care

Author

Payne, Rupert A., primary, Blair, Peter S., additional, Caddick, Barbara, additional, Chew-Graham, Carolyn A., additional, Dreischulte, Tobias, additional, Duncan, Lorna J., additional, Guthrie, Bruce, additional, Mann, Cindy, additional, Parslow, Roxanne M., additional, Round, Jeff, additional, Salisbury, Chris, additional, Turner, Katrina M., additional, Turner, Nicholas L., additional, and McCahon, Deborah, additional

Published
2022
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34. Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP)

Author

Payne, Rupert, Blair, Peter, Caddick, Barbara, Chew-Graham, Carolyn, Dreischulte, Tobias, Duncan, Lorna, Guthrie, Bruce, Mann, Cindy, Parslow, Roxanne, Round, Jeff, Salisbury, Chris, turner, katrina, Turner, Nicholas, and mccahon, deborah

Subjects
general practice, primary care, medicines optimisation, Medicine and Health Sciences, clinical trial, polypharmacy
Abstract

Polypharmacy is increasingly common, and is associated with undesirable consequences. Polypharmacy management necessitates balancing therapeutic benefits and risks, and varying clinical and patient priorities. Current guidance for managing polypharmacy is not supported by high quality evidence. The aim of the Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP) trial is to evaluate the effectiveness of an intervention to optimise medication use for patients with polypharmacy in a general practice setting.

Published
2022
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35. An Innovative Model of Pediatric Emergency Department Mental Health Care: Protocol for a Multicenter Type 1 Effectiveness-Implementation Cluster Randomized Trial

Author

Newton, Amanda S., primary, Prisnie, Kassi, additional, Macdonald, Lee A., additional, Eltorki, Mohamed, additional, Finkelstein, Yaron, additional, Fitzpatrick, Eleanor, additional, Gagnon, Isabelle, additional, Greenfield, Brian, additional, Joubert, Gary I., additional, Katz, Laurence Y., additional, Lipman, Ellen L., additional, Mater, Ahmed, additional, Plotnick, Laurie H., additional, Porter, Robert, additional, Sawyer, Scott, additional, St John, Kimberly A., additional, Sukhera, Javeed, additional, Szatmari, Peter, additional, Rasiah, Jananee, additional, Steele, Margaret, additional, Hall, Patricia, additional, Thull-Freedman, Jennifer, additional, Taljaard, Monica, additional, Cappelli, Mario, additional, Clark, Sharon E., additional, Cost, Katherine T., additional, Round, Jeff, additional, Cherry, Jonathan, additional, Monga, Suneeta, additional, Sareen, Jitender, additional, Klassen, Terry P., additional, and Freedman, Stephen B., additional

Published
2022
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36. Heal-me PiONEer (personalized online nutrition and exercise): An RCT assessing 2 levels of app-based programming in individuals with chronic disease

Author

Tandon, Puneeta, primary, Purdy, Graeme, additional, Ismond, Kathleen P., additional, Cruz, Christofer, additional, Etruw, Evelyn, additional, Suderman, Kirsten, additional, Hyde, Ashley, additional, Stickland, Michael, additional, Spence, John C., additional, Lien, Dale C., additional, Bhanji, Rahima, additional, Prado, Carla M., additional, Cruz, Antonio Miguel, additional, Joy, Anil A., additional, Yaskina, Maryna, additional, Round, Jeff, additional, Harback, Kate, additional, Padwal, Raj, additional, and McNeely, Margaret L., additional

Published
2022
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40. sj-docx-1-mpp-10.1177_23814683221134098 – Supplemental material for Optimal Planning of Health Services through Genetic Algorithm and Discrete Event Simulation: A Proposed Model and Its Application to Stroke Rehabilitation Care

Author

Yan, Charles, McClure, Nathan, Dukelow, Sean P., Mann, Balraj, and Round, Jeff

Subjects
111799 Public Health and Health Services not elsewhere classified, FOS: Health sciences
Abstract

Supplemental material, sj-docx-1-mpp-10.1177_23814683221134098 for Optimal Planning of Health Services through Genetic Algorithm and Discrete Event Simulation: A Proposed Model and Its Application to Stroke Rehabilitation Care by Charles Yan, Nathan McClure, Sean P. Dukelow, Balraj Mann and Jeff Round in MDM Policy & Practice

Published
2022
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44. Differences in the organisation of early pregnancy units and the effect of senior clinician presence, volume of patients and weekend opening on emergency hospital admissions: Findings from the VESPA Study

Author

Memtsa, Maria, primary, Goodhart, Venetia, additional, Ambler, Gareth, additional, Brocklehurst, Peter, additional, Keeney, Edna, additional, Silverio, Sergio A., additional, Anastasiou, Zacharias, additional, Round, Jeff, additional, Khan, Nazim, additional, Hall, Jennifer, additional, Barrett, Geraldine, additional, Bender-Atik, Ruth, additional, Stephenson, Judith, additional, and Jurkovic, Davor, additional

Published
2021
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48. Length of Stay and Home Discharge for Patients with Inpatient Stroke Rehabilitation

Author

Tran, Dat T., Yan, Charles, Dukelow, Sean P., and Round, Jeff

Abstract

Abstract:Objective:To examine temporal trends and geographic variations and predict inpatient rehabilitation (IPR) length of stay (LOS) and home discharge for stroke patients.Methods:Patients aged ≥18 years who were admitted to an IPR facility in Alberta, Canada, between 04/2014 and 03/2018 (years 2014–2017) were included. Predictors of LOS and home discharge were examined using 2014–2016 data and validated using 2017 data. Multivariable linear regression (MLR), multivariable negative binomial (MNB), and multivariable quantile regressions (MQR) were used to examine LOS, and logistic regression was used for home discharge.Results:We included 2686 rehabilitation admissions between 2014 and 2017. The mean LOS decreased (2014: 71 days; 2017: 62.1 days; p = 0.003) during the study period and was shortest in Edmonton (59.1 days) compared to Calgary (66 days) or other localities (70.8 days; p < 0.001). Three-quarters of patients were discharged home and this proportion remained unchanged between 2014 and 2017. Calgary patients were more likely to be discharged home than those in Edmonton (OR = 0.62; p = 0.019) or other localities (OR = 0.39; p = 0.011). The MLR and MNB models provided accurate prediction for the mean LOS (predicted = 59.9 and 60.8 days, respectively, vs. actual = 62.1 days; both p > 0.5), while the MQR model did so for the median LOS (predicted = 44.3 days vs. actual = 44 days; p = 0.09). The logistic regression resulted in 82.4% of correct prediction, a sensitivity of 91.6%, and a specificity of 50.7% for home discharge.Conclusions:Rehabilitation LOS decreased while the proportion of home discharge remained unchanged during the study period. Both varied across health zones. Identifiable statistical models provided accurate prediction with a separate patient cohort.

Published
2023
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50. A novel preference-informed complementary trial (PICT) design for clinical trial research influenced by strong patient preferences

Author

Ali, Samina, Hopkin, Gareth, Poonai, Naveen, Richer, Lawrence, Yaskina, Maryna, Heath, Anna, Klassen, Terry Paul, McCabe, Chris, Drendel, Amy, Round, Jeff, Offringa, Martin, Pechlivanoglou, Petros, Pullenayegum, Eleanor, Rios, David, Auclair, Marie Christine, Kim, Kelly, Bourrier, Lise, Dawson, Lauren, DaSilva, Kamary Coriolano, Marples, Pamela, Watts, Rick, Thull-Freedman, Jennifer, McGrath, Patrick, and University of Manitoba

Subjects
Population, Applied psychology, Psychological intervention, Medicine (miscellaneous), law.invention, External validity, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, 030225 pediatrics, Humans, Pict (programming language), Medicine, Pharmacology (medical), Patient preference, 030212 general & internal medicine, Internal validity, Child, education, Caregiver preference, computer.programming_language, lcsh:R5-920, education.field_of_study, business.industry, Methodology, Correction, Patient Preference, Research Personnel, Preference, 3. Good health, Clinical trial, Treatment Outcome, Research Design, Health Services Research, lcsh:Medicine (General), business, computer
Abstract

Background Patients and their families often have preferences for medical care that relate to wider considerations beyond the clinical effectiveness of the proposed interventions. Traditionally, these preferences have not been adequately considered in research. Research questions where patients and families have strong preferences may not be appropriate for traditional randomized controlled trials (RCTs) due to threats to internal and external validity, as there may be high levels of drop-out and non-adherence or recruitment of a sample that is not representative of the treatment population. Several preference-informed designs have been developed to address problems with traditional RCTs, but these designs have their own limitations and may not be suitable for many research questions where strong preferences and opinions are present. Methods In this paper, we propose a novel and innovative preference-informed complementary trial (PICT) design which addresses key weaknesses with both traditional RCTs and available preference-informed designs. In the PICT design, complementary trials would be operated within a single study, and patients and/or families would be given the opportunity to choose between a trial with all treatment options available and a trial with treatment options that exclude the option which is subject to strong preferences. This approach would allow those with strong preferences to take part in research and would improve external validity through recruiting more representative populations and internal validity. Here we discuss the strengths and limitations of the PICT design and considerations for analysis and present a motivating example for the design based on the use of opioids for pain management for children with musculoskeletal injuries. Conclusions PICTs provide a novel and innovative design for clinical trials with more than two arms, which can address problems with existing preference-informed trial designs and enhance the ability of researchers to reflect shared decision-making in research as well as improving the validity of trials of topics with strong preferences.

Published
2021

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