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4. Bayesian emulation and history matching of JUNE

Author

Vernon, I., primary, Owen, J., additional, Aylett-Bullock, J., additional, Cuesta-Lazaro, C., additional, Frawley, J., additional, Quera-Bofarull, A., additional, Sedgewick, A., additional, Shi, D., additional, Truong, H., additional, Turner, M., additional, Walker, J., additional, Caulfield, T., additional, Fong, K., additional, and Krauss, F., additional

Published
2022
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9. Contributor contact details

Author

Atala, Anthony, primary, Davis, John, additional, Ilic, Dusko, additional, Stevenson, Danielle, additional, Patel, Heema, additional, Braude, Peter, additional, Sidhu, Kuldip, additional, Hollands, Peter, additional, Kumar, Anujith, additional, Verfaillie, Catherine, additional, Hammersla, Ann M., additional, Rohrbaugh, Mark L., additional, Fink, D.W., additional, Bauer, S.R., additional, Au, P., additional, Haudenschild, C.C., additional, Lee, M.H., additional, McCright, B.K., additional, Brindley, David, additional, Mason, Chris, additional, Zarzeczny, A., additional, Rachul, C., additional, Caulfield, T., additional, Madonna, Rosalinda, additional, Shahaduzzaman, M., additional, Willing, A.E., additional, Abbas, Leila, additional, Rivolta, Marcelo N., additional, Mackay-Sim, A., additional, Zhang, Weibo, additional, Yelick, Pamela C., additional, Lee, Techung, additional, Saha, Sushmita, additional, Kirkham, Jennifer, additional, Wood, David J., additional, Yang, Xuebin B., additional, Nurzynska, Daria, additional, Castaldo, Clotilde, additional, Montagnani, Stefania, additional, Meglio, Franca Di, additional, Yamaleyeva, Liliya M., additional, Mirmalek-Sani, Sayed-Hadi, additional, Atala, Anthony, additional, Yoo, James J., additional, and Neuringer, Isabel P., additional

Published
2012
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20. New Evidence on Mutual Fund Performance: A Comparison of Alternative Bootstrap Methods

Author

Blake, D., Caulfield, T., Ioannidis, C., and Tonks, I.

Subjects
HG
Abstract

We compare two bootstrap methods for assessing mutual fund performance. Kosowski, Timmermann, Wermers and White (2006) produces narrow confidence intervals due to pooling over time, while Fama and French (2010) produces wider confidence intervals because it preserves the cross-correlation of fund returns. We then show that the average UK equity mutual fund manager is unable to deliver outperformance net of fees under either bootstrap. Gross of fees, 95% of fund managers on the basis of the first bootstrap and all fund managers on the basis of the second bootstrap fail to outperform the luck distribution of gross returns.

Published
2017

21. Waldenstrom macroglobulinemia cells devoid of BTKC481S or CXCR4WHIM-like mutations acquire resistance to ibrutinib through upregulation of Bcl-2 and AKT resulting in vulnerability towards venetoclax or MK2206 treatment

Author

Paulus, A, primary, Akhtar, S, additional, Yousaf, H, additional, Manna, A, additional, Paulus, S M, additional, Bashir, Y, additional, Caulfield, T R, additional, Kuranz-Blake, M, additional, Chitta, K, additional, Wang, X, additional, Asmann, Y, additional, Hudec, R, additional, Springer, W, additional, Ailawadhi, S, additional, and Chanan-Khan, A, additional

Published
2017
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22. Mortality following cardiovascular and bleeding events occurring beyond 1 year after coronary stenting: A secondary analysis of the Dual Antiplatelet Therapy (DAPT) Study.

Author

Hopkins J., McGarry T., Nygaard T., Pow T., Larkin T., Caulfield T., Stys T., Lee T., Mansouri V., Srinivas V., Gupta V., Marquardt W., Ballard W., Bachinsky W., Colyer W., Dillon W., Felten W., French W., Kuehl W., Nicholas W., Nicholson W., Phillips W., Khatib Y., Al-Saghir Y., Hawa Z., Masud Z., Jafar Z., Muller D., Meredith I., Rankin J., Worthley M., Jepson N., Thompson P., Hendriks R., Whitbourn R., Duffy S., Stasek J., Novobilsky K., Naplava R., Coufal Z., Vaquette B., Bressollette E., Teiger E., Coste P., Rihani R., Darius H., Bergmann M.W., Radke P., Sebastian P., Strasser R., Hoffmann S., Behrens S., Moebius-Winkler S., Rutsch W., Lupkovics G., Horvath I., Kancz S., Forster T., Koszegi Z., Devlin G., Hart H., Elliott J., Ormiston J., Abernathy M., Fisher N., Kay P., Harding S., Jaffe W., Hoffmann A., Sosnowski C., Trebacz J., Buszman P., Dobrzycki S., Kornacewicz-Jach Z., Iancu A.C., Ginghina C.D., Matei C., Dobreanu D., Bolohan F.R., Dorobantu M., Jacques A., Jain A., Bakhai A., Gershlick A., Adamson D., Newby D., Felmeden D., Purcell I., Edmond J., Irving J., De Belder M., Pitt M., Kelly P., O'Kane P., Clifford P., Suresh V., Secemsky E.A., Yeh R.W., Kereiakes D.J., Cutlip D.E., Cohen D.J., Steg P.G., Cannon C.P., Apruzzese P.K., D'Agostino R.B., Massaro J.M., Mauri L., Kaplan A., Ahmed A., Ahmed A.-H., Albirini A., Moreyra A., Rabinowitz A., Shroff A., Moak A., Jacobs A., Kabour A., Gupta A., Irimpen A., Rosenthal A., Taussig A., Ferraro A., Chhabra A., Pucillo A., Spaedy A., White A., Pratsos A., Shakir A., Ghitis A., Agarwal A., Chawla A., Tang A., Barker B., Bertolet B., Uretsky B., Erickson B., Rama B., McLaurin B., Dearing B., Negus B., Price B., Brott B., Bhambi B., Bowers B., Watt B., Donohue B., Hassel C.D., Croft C., Lambert C., O'Shaughnessy C., Shoultz C., Kim C., Caputo C., Nielson C., Scott C., Wolfe C., McKenzie C., Brachfeld C., Thieling C., Fisher D., Simon D., Churchill D., Dobies D., Eich D., Goldberg D., Griffin D., Henderson D., Kandzari D., Lee D., Lewis D., Mego D., Paniagua D., Rizik D., Roberts D., Safley D., Abbott D., Shaw D., Temizer D., Canaday D., Myears D., Westerhausen D., Ebersole D., Netz D., Baldwin D., Letts D., Harlamert E., Kosinski E., Portnay E., Mahmud E., Korban E., Hockstad E., Rivera E., Shawl F., Shamoon F., Kiernan F., Aycock G.R., Schaer G., Kunz G., Kichura G., Myers G., Pilcher G., Tadros G., Kaddissi G.I., Ramadurai G., Eaton G., Elsner G., Mishkel G., Simonian G., Piegari G., Chen H., Liberman H., Aronow H., Tamboli H.P., Dotani I., Marin J., Fleischhauer J.F., Leggett J., Mills J., Phillips J., Revenaugh J., Mann J.T., Wilson J., Pattanayak J., Aji J., Strain J., Patel J., Carr J., Moses J., Chen J.-C., Williams J., Greenberg J., Cohn J., Douglas J., Gordon J., Griffin J., Hawkins J., Katopodis J., Lopez J., Marshall J., Wang J., Waltman J., Saucedo J., Galichia J., McClure M., Kozina J., Stella J., Tuma J., Kieval J., Giri K., Ramanathan K., Allen K., Atassi K., Baran K., Khaw K., Clayton K., Croce K., Skelding K., Patel K., Garratt K., Harjai K., Chandrasekhar K., Kalapatapu K., Lin L., Dean L., Barr L., MacDonald L., Cannon L., Satler L., Gruberg L., Tami L., Bikkina M., Shah M., Atieh M., Chauhan M., Litt M., Unterman M., Lechin M., Zughaib M., Fisch M., Grabarczyk M., Greenberg M., Lurie M., Rothenberg M., Stewart M., Purvis M., Hook M., Leesar M., Buchbinder M., Weiss M., Guerrero M., Abu-Fadel M., Ball M., Chang M., Cunningham M., Del Core M., Jones M., Kelberman M., Lim M., Ragosta M., Rinaldi M., Rosenberg M., Savage M., Tamberella M., Kellett M., Vidovich M., Effat M., Mirza M.A., Khan M., Dib N., Laufer N., Kleiman N., Farhat N., Amjadi N., Schechtmann N., Bladuell N., Quintana O., Gigliotti O., Best P., Flaherty P., Hall P., Gordon P., Gurbel P., Ho P., Luetmer P., Mahoney P., Mullen P., Teirstein P., Tolerico P., Ramanathan P., Kerwin P., Lee P.V., Kraft P., Wyman R.M., Gonzalez R., Kamineni R., Dave R., Sharma R., Prashad R., Aycock R., Quesada R., Goodroe R., Magorien R., Randolph R., Bach R., Kettelkamp R., Paulus R., Waters R., Zelman R., Ganim R., Bashir R., Applegate R., Feldman R., Frankel R., Hibbard R., Jobe R., Jumper R., Maholic R., Siegel R., Smith R., Stoler R., Watson R., Wheatley R., Gammon R., Hill R., Sundrani R., Caputo R., Jenkins R., Stella R., Germanwala S., Hadeed S., Ledford S., Dube S., Gupta S., Davis S., Martin S., Waxman S., Dixon S., Naidu S., Potluri S., Cook S., Crowley S., Kirkland S., McIntyre S., Thew S., Lin S., Marshalko S., Guidera S., Hearne S., Karas S., Manoukian S., Rowe S., Yakubov S., Pollock S., Banerjee S., Allaqaband S., Choi S., Mulukutla S., Papadakos S., Bajwa T., Addo T., Schreiber T., Haldis T., Mathew T., Hopkins J., McGarry T., Nygaard T., Pow T., Larkin T., Caulfield T., Stys T., Lee T., Mansouri V., Srinivas V., Gupta V., Marquardt W., Ballard W., Bachinsky W., Colyer W., Dillon W., Felten W., French W., Kuehl W., Nicholas W., Nicholson W., Phillips W., Khatib Y., Al-Saghir Y., Hawa Z., Masud Z., Jafar Z., Muller D., Meredith I., Rankin J., Worthley M., Jepson N., Thompson P., Hendriks R., Whitbourn R., Duffy S., Stasek J., Novobilsky K., Naplava R., Coufal Z., Vaquette B., Bressollette E., Teiger E., Coste P., Rihani R., Darius H., Bergmann M.W., Radke P., Sebastian P., Strasser R., Hoffmann S., Behrens S., Moebius-Winkler S., Rutsch W., Lupkovics G., Horvath I., Kancz S., Forster T., Koszegi Z., Devlin G., Hart H., Elliott J., Ormiston J., Abernathy M., Fisher N., Kay P., Harding S., Jaffe W., Hoffmann A., Sosnowski C., Trebacz J., Buszman P., Dobrzycki S., Kornacewicz-Jach Z., Iancu A.C., Ginghina C.D., Matei C., Dobreanu D., Bolohan F.R., Dorobantu M., Jacques A., Jain A., Bakhai A., Gershlick A., Adamson D., Newby D., Felmeden D., Purcell I., Edmond J., Irving J., De Belder M., Pitt M., Kelly P., O'Kane P., Clifford P., Suresh V., Secemsky E.A., Yeh R.W., Kereiakes D.J., Cutlip D.E., Cohen D.J., Steg P.G., Cannon C.P., Apruzzese P.K., D'Agostino R.B., Massaro J.M., Mauri L., Kaplan A., Ahmed A., Ahmed A.-H., Albirini A., Moreyra A., Rabinowitz A., Shroff A., Moak A., Jacobs A., Kabour A., Gupta A., Irimpen A., Rosenthal A., Taussig A., Ferraro A., Chhabra A., Pucillo A., Spaedy A., White A., Pratsos A., Shakir A., Ghitis A., Agarwal A., Chawla A., Tang A., Barker B., Bertolet B., Uretsky B., Erickson B., Rama B., McLaurin B., Dearing B., Negus B., Price B., Brott B., Bhambi B., Bowers B., Watt B., Donohue B., Hassel C.D., Croft C., Lambert C., O'Shaughnessy C., Shoultz C., Kim C., Caputo C., Nielson C., Scott C., Wolfe C., McKenzie C., Brachfeld C., Thieling C., Fisher D., Simon D., Churchill D., Dobies D., Eich D., Goldberg D., Griffin D., Henderson D., Kandzari D., Lee D., Lewis D., Mego D., Paniagua D., Rizik D., Roberts D., Safley D., Abbott D., Shaw D., Temizer D., Canaday D., Myears D., Westerhausen D., Ebersole D., Netz D., Baldwin D., Letts D., Harlamert E., Kosinski E., Portnay E., Mahmud E., Korban E., Hockstad E., Rivera E., Shawl F., Shamoon F., Kiernan F., Aycock G.R., Schaer G., Kunz G., Kichura G., Myers G., Pilcher G., Tadros G., Kaddissi G.I., Ramadurai G., Eaton G., Elsner G., Mishkel G., Simonian G., Piegari G., Chen H., Liberman H., Aronow H., Tamboli H.P., Dotani I., Marin J., Fleischhauer J.F., Leggett J., Mills J., Phillips J., Revenaugh J., Mann J.T., Wilson J., Pattanayak J., Aji J., Strain J., Patel J., Carr J., Moses J., Chen J.-C., Williams J., Greenberg J., Cohn J., Douglas J., Gordon J., Griffin J., Hawkins J., Katopodis J., Lopez J., Marshall J., Wang J., Waltman J., Saucedo J., Galichia J., McClure M., Kozina J., Stella J., Tuma J., Kieval J., Giri K., Ramanathan K., Allen K., Atassi K., Baran K., Khaw K., Clayton K., Croce K., Skelding K., Patel K., Garratt K., Harjai K., Chandrasekhar K., Kalapatapu K., Lin L., Dean L., Barr L., MacDonald L., Cannon L., Satler L., Gruberg L., Tami L., Bikkina M., Shah M., Atieh M., Chauhan M., Litt M., Unterman M., Lechin M., Zughaib M., Fisch M., Grabarczyk M., Greenberg M., Lurie M., Rothenberg M., Stewart M., Purvis M., Hook M., Leesar M., Buchbinder M., Weiss M., Guerrero M., Abu-Fadel M., Ball M., Chang M., Cunningham M., Del Core M., Jones M., Kelberman M., Lim M., Ragosta M., Rinaldi M., Rosenberg M., Savage M., Tamberella M., Kellett M., Vidovich M., Effat M., Mirza M.A., Khan M., Dib N., Laufer N., Kleiman N., Farhat N., Amjadi N., Schechtmann N., Bladuell N., Quintana O., Gigliotti O., Best P., Flaherty P., Hall P., Gordon P., Gurbel P., Ho P., Luetmer P., Mahoney P., Mullen P., Teirstein P., Tolerico P., Ramanathan P., Kerwin P., Lee P.V., Kraft P., Wyman R.M., Gonzalez R., Kamineni R., Dave R., Sharma R., Prashad R., Aycock R., Quesada R., Goodroe R., Magorien R., Randolph R., Bach R., Kettelkamp R., Paulus R., Waters R., Zelman R., Ganim R., Bashir R., Applegate R., Feldman R., Frankel R., Hibbard R., Jobe R., Jumper R., Maholic R., Siegel R., Smith R., Stoler R., Watson R., Wheatley R., Gammon R., Hill R., Sundrani R., Caputo R., Jenkins R., Stella R., Germanwala S., Hadeed S., Ledford S., Dube S., Gupta S., Davis S., Martin S., Waxman S., Dixon S., Naidu S., Potluri S., Cook S., Crowley S., Kirkland S., McIntyre S., Thew S., Lin S., Marshalko S., Guidera S., Hearne S., Karas S., Manoukian S., Rowe S., Yakubov S., Pollock S., Banerjee S., Allaqaband S., Choi S., Mulukutla S., Papadakos S., Bajwa T., Addo T., Schreiber T., Haldis T., and Mathew T.

Abstract

Importance: Early cardiovascular and bleeding events after coronary stenting are associated with high risk of morbidity and mortality. Objective(s): To assess the prognosis of cardiovascular and bleeding events occurring beyond 1 year after coronary stenting. Design, Setting, and Participant(s): This secondary analysis is derived from data from the Dual Antiplatelet Therapy (DAPT) Study, a multi center trial involving 220 US and in ternational clinical sites from 11 countries. The study dateswere August 2009 to May 2014. Individuals who underwent coronary stenting and completed 12 months of thienopyridine plus aspirin therapy without ischemic or bleeding events remained on an aspirin regimen and were randomized to continued thienopyridine therapy vs placebo for 18 additional months. Individuals were then followed up for 3 additional months while receiving aspirin therapy alone. The analysis began in August 2015. Exposures: Ischemic events (myocardial infarction not related to stent thrombosis, stent thrombosis, and ischemic stroke) and bleeding events (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries [GUSTO] classification moderate or severe bleeding). Main Outcomes and Measures: Ischemic events (myocardial infarction not related to stent thrombosis, stent thrombosis, and ischemic stroke) and bleeding events (GUSTO classification moderate or severe bleeding). Death at 21 months after randomization (33 months after coronary stenting). Result(s): Intotal, 25 682 individuals older than 18 years with an indication for coronarystentingwere enrolled, and 11 648(meanage,61.3 years; 25.1%female)were randomized. After randomization, 478 individuals (4.1%) had 502 ischemic events (306 with myocardial infarction, 113 with stent thrombosis, and 83 with ischemic stroke), and 232 individuals (2.0%) had 235 bleeding events (155 with moderate and 80 with severe bleeding). Among individuals with ischemic events, 52(10.9%) died. The annualize

Published
2017

23. Walking Together: Towards a Collaborative Model for Maternal Health Care in Pastoralist Communities of Laikipia and Samburu, Kenya

Author

Kermode, M, Morgan, A, Nyagero, J, Nderitu, F, Caulfield, T, Reeve, M, Nduba, J, Kermode, M, Morgan, A, Nyagero, J, Nderitu, F, Caulfield, T, Reeve, M, and Nduba, J

Abstract

Purpose In 2009 the Kenyan Government introduced health system reforms to address persistently high maternal and newborn mortality including deployment of skilled birth attendants (SBAs) to health facilities in remote areas, and proscription of births attended by traditional birth attendants (TBAs). Despite these initiatives, uptake of SBA services remains low and inequitably distributed. This paper describes the development of an SBA/TBA collaborative model of maternal health care for pastoralist communities in Laikipia and Samburu. Description A range of approaches were used to generate a comprehensive understanding of the maternal and child health issues affecting these pastoralist communities including community and government consultations, creation of a booklet and film recognising the contributions of both TBAs and SBAs that formed the basis of subsequent discussions, and mixed methods research projects. Based on the knowledge and understanding collectively generated by these approaches we developed an evidence-based, locally acceptable and feasible model for SBA/TBA collaborative care of women during pregnancy and childbirth. Assessment The proposed collaborative care model includes: antenatal and post-natal care delivered by both SBAs and TBAs; TBAs as birth companions who support women and SBAs; training TBAs in recognition of birth complications, nutrition during pregnancy and following birth, referral processes, and family planning; training SBAs in respectful maternity care; and affordable, feasible redesign of health facility infrastructure and services so they better meet the identified needs of pastoralist women and their families. Conclusion The transition from births predominantly attended by TBAs to births attended by SBAs is likely to be a gradual one, and an interim SBA/TBA collaborative model of care has the potential to maximise the safety of pastoralist women and babies during the transition phase, and may even accelerate the transition itsel

Published
2017

24. Non-refundable Tax Credits Are an Inequitable Policy Instrument for Promoting Physical Activity Among Canadian Children

Author

Spence, J. C., Nicholas Holt, Sprysak, C. J., Spencer-Cavaliere, N., and Caulfield, T.

Subjects
Male, Canada, Medically Uninsured, Adolescent, Health Policy, education, Income Tax, Public Health, Environmental and Occupational Health, Eligibility Determination, Tax Exemption, General Medicine, humanities, Commentary, Humans, Female, Child, Poverty, health care economics and organizations, Sports
Abstract

A clear income gradient exists for the sport and physical activity (PA) participation of Canadian children. Governments in Canada recently introduced tax credits to alleviate the financial burden associated with registering a child in organized physical activity (including sport). The majority of these credits, including the Children's Fitness Tax Credit, are non-refundable (i.e., reduces the amount of income tax a person pays). Such credits are useful only for individuals who incur a certain level of tax liability. Thus, low-income families who may pay little or no income tax will not benefit from the presence of non-refundable tax credits. In this commentary, we argue that the non-refundable tax credit is inherently inequitable for promoting PA. We suggest that a combination of refundable tax credits and subsidized programming for low-income children would be more equitable than the current approach of the Canadian government and several provinces that are expending approximately $200 million to support these credits.

Published
2012
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25. Creating Needs?

Author

Wertz D and Caulfield T

Subjects
Warrant, medicine.diagnostic_test, Public Health, Environmental and Occupational Health, medicine, Survey data collection, Survey research, Marketing, Psychology, Commercialization, Genetics (clinical), Selection (genetic algorithm), Public interest, Genetic testing
Abstract

An increasing number of genetic tests are moving from the laboratory to the clinical setting. It seems an appropriate time to assess the interest and receptivity of the public toward genetic testing services. This is particularly so given the concerns that have been expressed about the commercialization of genetic testing technologies. To this end, the paper begins with an overview of the concerns and benefits associated with commercialization. This is followed by a review of a selection of survey data relevant to the potential ‘genetic testing market’ (i.e., the attitudes, perceptions and knowledge of the public, patients and professionals). We conclude that although emerging data and past experience suggest that the actual uptake of genetic tests may fall short of expectations, the strong public interest and perceived right of access disclosed in the survey research indicate a future potential for a large testing market. As such, the concerns associated with the commercialization process warrant careful consideration.

Published
2001
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26. Factors influencing place of delivery for pastoralist women in Kenya: a qualitative study

Author

Caulfield, T, Onyo, P, Byrne, A, Nduba, J, Nyagero, J, Morgan, A, Kermode, M, Caulfield, T, Onyo, P, Byrne, A, Nduba, J, Nyagero, J, Morgan, A, and Kermode, M

Abstract

BACKGROUND: Kenya's high maternal mortality ratio can be partly explained by the low proportion of women delivering in health facilities attended by skilled birth attendants (SBAs). Many women continue to give birth at home attended by family members or traditional birth attendants (TBAs). This is particularly true for pastoralist women in Laikipia and Samburu counties, Kenya. This paper investigates the socio-demographic factors and cultural beliefs and practices that influence place of delivery for these pastoralist women. METHODS: Qualitative data were collected in five group ranches in Laikipia County and three group ranches in Samburu County. Fifteen in-depth interviews were conducted: seven with SBAs and eight with key informants. Nineteen focus group discussions (FGDs) were conducted: four with TBAs; three with community health workers (CHWs); ten with women who had delivered in the past two years; and two with husbands of women who had delivered in the past two years. Topics discussed included reasons for homebirths, access and referrals to health facilities, and strengths and challenges of TBAs and SBAs. The data were translated, transcribed and inductively and deductively thematically analysed both manually and using NVivo. RESULTS: Socio-demographic characteristics and cultural practices and beliefs influence pastoralist women's place of delivery in Laikipia and Samburu counties, Kenya. Pastoralist women continue to deliver at home due to a range of factors including: distance, poor roads, and the difficulty of obtaining and paying for transport; the perception that the treatment and care offered at health facilities is disrespectful and unfriendly; lack of education and awareness regarding the risks of delivering at home; and local cultural values related to women and birthing. CONCLUSIONS: Understanding factors influencing the location of delivery helps to explain why many pastoralist women continue to deliver at home despite health services becoming mo

Published
2016

27. Setting Global Standards for Stem Cell Research and Clinical Translation: The 2016 ISSCR Guidelines

Author

Daley, GQ, Hyun, I, Apperley, JF, Barker, RA, Benvenisty, N, Bredenoord, AL, Breuer, CK, Caulfield, T, Cedars, MI, Frey-Vasconcells, J, Heslop, HE, Jin, Y, Lee, RT, McCabe, C, Munsie, M, Murry, CE, Piantadosi, S, Rao, M, Rooke, HM, Sipp, D, Studer, L, Sugarman, J, Takahashi, M, Zimmerman, M, Kimmelman, J, Daley, GQ, Hyun, I, Apperley, JF, Barker, RA, Benvenisty, N, Bredenoord, AL, Breuer, CK, Caulfield, T, Cedars, MI, Frey-Vasconcells, J, Heslop, HE, Jin, Y, Lee, RT, McCabe, C, Munsie, M, Murry, CE, Piantadosi, S, Rao, M, Rooke, HM, Sipp, D, Studer, L, Sugarman, J, Takahashi, M, Zimmerman, M, and Kimmelman, J

Abstract

The International Society for Stem Cell Research (ISSCR) presents its 2016 Guidelines for Stem Cell Research and Clinical Translation (ISSCR, 2016). The 2016 guidelines reflect the revision and extension of two past sets of guidelines (ISSCR, 2006; ISSCR, 2008) to address new and emerging areas of stem cell discovery and application and evolving ethical, social, and policy challenges. These guidelines provide an integrated set of principles and best practices to drive progress in basic, translational, and clinical research. The guidelines demand rigor, oversight, and transparency in all aspects of practice, providing confidence to practitioners and public alike that stem cell science can proceed efficiently and remain responsive to public and patient interests. Here, we highlight key elements and recommendations in the guidelines and summarize the recommendations and deliberations behind them.

Published
2016

28. Community and provider perceptions of traditional and skilled birth attendants providing maternal health care for pastoralist communities in Kenya: a qualitative study

Author

Byrne, A, Caulfield, T, Onyo, P, Nyagero, J, Morgan, A, Nduba, J, Kermode, M, Byrne, A, Caulfield, T, Onyo, P, Nyagero, J, Morgan, A, Nduba, J, and Kermode, M

Abstract

BACKGROUND: Kenya has a high burden of maternal and newborn mortality. Consequently, the Government of Kenya introduced health system reforms to promote the availability of skilled birth attendants (SBAs) and proscribed deliveries by traditional birth attendants (TBAs). Despite these changes, only 10% of women from pastoralist communities are delivered by an SBA in a health facility, and the majority are delivered by TBAs at home. The aim of this study is to better understand the practices and perceptions of TBAs and SBAs serving the remotely located, semi-nomadic, pastoralist communities of Laikipia and Samburu counties in Kenya, to inform the development of an SBA/TBA collaborative care model. METHODS: This descriptive qualitative study was undertaken in 2013-14. We conducted four focus group discussions (FGDs) with TBAs, three with community health workers, ten with community women, and three with community men. In-depth interviews were conducted with seven SBAs and eight key informants. Topic areas covered were: practices and perceptions of SBAs and TBAs; rewards and challenges; managing obstetric complications; and options for SBA/TBA collaboration. All data were translated, transcribed and thematically analysed. RESULTS: TBAs are valued and accessible members of their communities who adhere to traditional practices and provide practical and emotional support to women during pregnancy, delivery and post-partum. Some TBA practices are potentially harmful to women e.g., restricting food intake during pregnancy, and participants recognised that TBAs are unable to manage obstetric complications. SBAs are acknowledged as having valuable technical skills and resources that contribute to safe and clean deliveries, especially in the event of complications, but there is also a perception that SBAs mistreat women. Both TBAs and SBAs identified a range of challenges related to their work, and instances of mutual respect and informal collaborations between SBAs and TBAs we

Published
2016

29. Coinhibition of the deubiquitinating enzymes, USP14 and UCHL5, with VLX1570 is lethal to ibrutinib- or bortezomib-resistant Waldenstrom macroglobulinemia tumor cells

Author

Paulus, A, primary, Akhtar, S, additional, Caulfield, T R, additional, Samuel, K, additional, Yousaf, H, additional, Bashir, Y, additional, Paulus, S M, additional, Tran, D, additional, Hudec, R, additional, Cogen, D, additional, Jiang, J, additional, Edenfield, B, additional, Novak, A, additional, Ansell, S M, additional, Witzig, T, additional, Martin, P, additional, Coleman, M, additional, Roy, V, additional, Ailawadhi, S, additional, Chitta, K, additional, Linder, S, additional, and Chanan-Khan, A, additional

Published
2016
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36. Canadian newspaper coverage of the A/H1N1 vaccine program

Author

Rachul C, Ries N, and Caulfield T

Subjects
Canada, Influenza A Virus, H1N1 Subtype, Bibliometrics, Immunization Programs, Influenza, Human, Humans, Newspapers as Topic, Public Health, Journalism, Medical, Attitude to Health, 1117 Public Health and Health Services, 1302 Curriculum and Pedagogy
Abstract

OBJECTIVES:The A/H1N1 mass vaccination program in Canada garnered considerable attention from the media, including extensive newspaper coverage. Media reports have been shown to influence the public's health care decisions, including vaccination choices. We analyzed Canadian newspapers' portrayal of the A/H1N1 vaccine including mention of risks and benefits of the vaccine and whether the article supported, questioned or was neutral about the vaccine. METHODS:We compiled a data set of Canadian newspaper articles (N = 234) and conducted a frequency content analysis to examine discussion and/or mention of evidence concerning vaccination, risks of the A/H1N1 virus and the vaccine, and tone of article in regards to the vaccination program in Canada. RESULTS:Reasons for getting vaccinated appeared in 71.8% of the articles, whereas only 18.4% provided reasons against getting vaccinated. Discussion of evidence to support claims for or against getting vaccinated appeared in only 27.8% and 6.8% of the articles, respectively. Risks associated with contracting the A/H1N1 virus were discussed in 49.6% of the articles and risks of the A/H1N1 vaccine were discussed in 12.4% of the articles. CONCLUSION:Newspaper coverage in Canada was largely supportive of the A/H1N1 mass vaccination program. However, serious risks associated with contracting the A/H1N1 virus were also frequently discussed in the print media. The news articles rarely presented direct evidence to support statements that the vaccine was safe, effective and properly tested. Known risks (such as potential allergic reactions and flu-like side effects) of the vaccine were rarely reported. The relationship between media portrayals and vaccine uptake warrants further research.

Published
2011

38. Variations and voids: the regulation of human cloning around the world

Author

Pattinson, S.D. and Caulfield, T.

Subjects
health care economics and organizations
Abstract

Background\ud \ud No two countries have adopted identical regulatory measures on cloning. Understanding the complexity of these regulatory variations is essential. It highlights the challenges associated with the regulation of a controversial and rapidly evolving area of science and sheds light on a regulatory framework that can accommodate this reality.\ud \ud Methods\ud \ud Using the most reliable information available, we have performed a survey of the regulatory position of thirty countries around the world regarding the creation and use of cloned embryos (see Table 1). We have relied on original and translated legislation, as well as published sources and personal communications. We have examined the regulation of both reproductive cloning (RC) and non-reproductive cloning (NRC).\ud \ud Results\ud \ud While most of the countries studied have enacted national legislation, the absence of legislation in seven of these countries should not be equated with the absence of regulation. Senator Morin was not correct in stating that the majority of recent legislation bans both RC and NRC. Recent regulatory moves are united only with regard to the banning of RC. While NRC is not permitted in seventeen of the countries examined, it could be permitted in up to thirteen countries.\ud \ud Conclusions\ud \ud There is little consensus on the various approaches to cloning laws and policies, and the regulatory position in many countries remains uncertain.\ud

Published
2004

40. Representations of the health value of vitamin D supplementation in newspapers: Media content analysis

Author

Caulfield, T, Clark, MI ; https://orcid.org/0000-0002-9007-9829, McCormack, JP, Rachul, C, Field, CJ, Caulfield, T, Clark, MI ; https://orcid.org/0000-0002-9007-9829, McCormack, JP, Rachul, C, and Field, CJ

Abstract

Objective: To examine the nature of media coverage of vitamin D in relation to its role in health and the need for supplements. Design: Media content analysis. Setting: Print articles from elite newspapers in the UK, the USA and Canada. Participants: 294 print newspaper articles appearing over 5 years (2009-2014). Results: Newspaper coverage of vitamin D generally supported supplementation. The most common framing of vitamin D in print articles was "adequate vitamin D is necessary for good health." Articles also framed vitamin D as difficult to obtain from food supply and framed vitamin D deficiency as a widespread concern. In discussions of supplementation, 80% articles suggested supplementation is or may be necessary for the general population, yet almost none of the articles discussed the potential harms of vitamin D supplementation in any detail. Print articles named 40 different health conditions in relationship to vitamin D. The most commonly cited conditions included bone health, cancer and cardiovascular health. Although print articles referred to a wide range of scholarly research on vitamin D with varying degrees of endorsement for supplementation, a general tone of support for vitamin D supplementation in media coverage persisted. Conclusions: Newspaper articles conveyed overall support for vitamin D supplementation. News articles linked vitamin D to a wide range of health conditions for which there is no conclusive scientific evidence. Media coverage downplayed the limitations of existing science and overlooked any potential risks associated with supplementation.

Published
2014

41. A review of the key issues associated with the commercialization of biobanks

Author

Caulfield, T, Burningham, S, Joly, Y, Master, Z, Shabani, M, Borry, P, Becker, A, Burgess, M, Calder, K, Critchley, C, Edwards, K, Fullerton, SM, Gottweis, H, Hyde-Lay, R, Illes, J, Isasi, R, Kato, K, Kaye, J, Knoppers, B, Lynch, J, McGuire, A, Meslin, E, Nicol, D, O'Doherty, K, Ogbogu, U, Otlowski, M, Pullman, D, Ries, N, Scott, C, Sears, M, Wallace, H, Zawati, MH, Caulfield, T, Burningham, S, Joly, Y, Master, Z, Shabani, M, Borry, P, Becker, A, Burgess, M, Calder, K, Critchley, C, Edwards, K, Fullerton, SM, Gottweis, H, Hyde-Lay, R, Illes, J, Isasi, R, Kato, K, Kaye, J, Knoppers, B, Lynch, J, McGuire, A, Meslin, E, Nicol, D, O'Doherty, K, Ogbogu, U, Otlowski, M, Pullman, D, Ries, N, Scott, C, Sears, M, Wallace, H, and Zawati, MH

Published
2014

45. Handling ethical, legal and social issues in birth cohort studies involving genetic research: Responses from studies in six countries

Author

Ries, NM, Legrandeur, J, Caulfield, T, Ries, NM, Legrandeur, J, and Caulfield, T

Abstract

Background: Research involving minors has been the subject of much ethical debate. The growing number of longitudinal, pediatric studies that involve genetic research present even more complex challenges to ensure appropriate protection of children and families as research participants. Long-term studies with a genetic component involve collection, retention and use of biological samples and personal information over many years. Cohort studies may be established to study specific conditions (e.g. autism, asthma) or may have a broad aim to research a range of factors that influence the health and development of children. Studies are increasingly intended to serve as research platforms by providing access to data and biological samples to researchers over many years. This study examines how six birth cohort studies in North America and Europe that involve genetic research handle key ethical, legal and social (ELS) issues: recruitment, especially parental authority to include a child in research; initial parental consent and subsequent assent and/or consent from the maturing child; withdrawal; confidentiality and sample/data protection; handling sensitive information; and disclosure of results. Methods. Semi-structured telephone interviews were carried out in 2008/09 with investigators involved in six birth cohort studies in Canada, Denmark, England, France, the Netherlands and the United States. Interviewees self-identified as being knowledgeable about ELS aspects of the study. Interviews were conducted in English. Results. The studies vary in breadth of initial consent, but none adopt a blanket consent for future use of samples/data. Ethics review of new studies is a common requirement. Studies that follow children past early childhood recognise a need to seek assent/consent as the child matures. All studies limit access to identifiable data and advise participants of the right to withdraw. The clearest differences among studies concern handling of sensitive informat

Published
2010

46. Tissue banking, patient rights, and confidentiality: tensions in law and policy.

Author

Caulfield T and Caulfield, T

Abstract

The collection, storage and analysis of tissue samples, including genetic data, has become an increasingly common part of biomedical research. Though there are many scientific justifications for the creation of tissue and DNA databanks, the storage and use of human tissue continues to create legal dilemmas. In this paper, the impact and relevance of existing common law principles are reviewed. It is noted that the Canadian common law rules covering consent and confidentiality may create challenges for the research community. Emerging health information legislation does, however, create a somewhat more lenient research environment, largely because these laws allow, in some circumstances, research on identifiable health information without consent. Nevertheless, conflicts between existing common law, research ethics policy and new health information legislation illustrate profound policy dilemmas created by research involving storage and use of tissue and genetic material. [ABSTRACT FROM AUTHOR]

Published
2004

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