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Alternative consent models in pragmatic palliative care clinical trials

CARPENTER, Joan G. ; ULRICH, Connie ; HODGSON, Nancy ; HANSON, Laura C. ; ERSEK, Mary
JOURNAL OF PAIN AND SYMPTOM MANAGEMENT, 28/10/2020, Pagination inconnue

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Nothing to lose - a grounded theory study of patients' and healthcare professionals' perspectives of being involved in the consent process for oncology trials with non-curative intent

MURPHY, Mary ; MCCAUGHAN, Eilís ; CARSON, Matthew A. ; DONOVAN, Monica ; WILSON, Richard H. ; FITZSIMONS, Donna
BMC palliative care, 30/10/2020, vol.19, n°1, p. 1-10

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Methodological reflections on the recruitment of adult child-parent dyads for end-of-life research in Germany - experiences from the Dy@EoL study

GAWINSKI, Laura ; STIEL, Stephanie ; SCHNEIDER, Nils ; ZIMMERMANN, Tanja ; HERBST, Franziska A.
JOURNAL OF PAIN AND SYMPTOM MANAGEMENT, 19/10/2020, Pagination inconnue

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Patient and public involvement in palliative care research - what works, and why? A qualitative evaluation

JOHNSON, Halle ; OGDEN, Margaret ; BRIGHTON, Lisa Jane ; ETKIND, Simon Noah ; OLUYASE, Adejoke O. ; CHUKWUSA, Emeka ; YU, Peihan ; DE WOLF-LINDER, Susanne ; SMITH, Pam ; BAILEY, Sylvia ; KOFFMAN, Jonathan ; EVANS, Catherine J.
PALLIATIVE MEDICINE, 11/09/2020, p. 1-10

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My child's legacy - a mixed methods study of bereaved parents and providers' opinions about collaboration with NICU teams in quality improvement initiatives

BOURQUE, Claude Julie ; DAHAN, Sonia ; MANTHA, Ginette ; REICHHERZER, Martin ; JANVIER, Annie
BMJ Open, 06/09/2020, vol.10, n°9, p. 1-9

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Processes of consent in research for adults with impaired mental capacity nearing the end of life - systematic review and transparent expert consultation (MORECare_Capacity statement)

EVANS, C. J. ; YORGANCI, E. ; LEWIS, P. ; KOFFMAN, J. ; STONE, K. ; TUNNARD, I. ; WEE, Bee ; BERNAL, W. ; HOTOPF, M. ; HIGGINSON, I. J. ; MORECARE_CAPACITY
BMC medicine, 22/07/2020, vol.18, n°1, p. 1-55

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Motivations for people with cognitive impairment to complete an advance research directive - a qualitative interview study

JONGSMA, Karin ; PERRY, Julia ; SCHICKTANZ, Silke ; RADENBACH, Katrin
BMC psychiatry, 08/07/2020, vol.20, n°1, 9 p.

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A clustered randomized trial informing patients on dialysis about their ability to donate organs and tissues

ANDREWS, Ann M. ; ZHANG, Nanhua ; SMITH, Allyce Haney ; LOUGHERY, Caitlin ; RESNICOW, Ken ; CHAPMAN, Remonia ; JENKINS RILEY, Holly ; STAV, Sheri ; YEE, Jerry
Progress in transplantation, 22/06/2020, Pagination inconnue

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Palliative care for young adults with life-limiting conditions - public health recommendations

COOK, Karen A ; BERGERON, Kim
BMJ supportive and palliative care, 19/06/2020, p. 1-8

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“My death will not [be] in vain” - testimonials from Last Gift rapid research autopsy study participants living with HIV at the end of life

PERRY, Kelly E. ; DUBÉ, Karine ; CONCHA-GARCIA, Susanna ; PATEL, Hursch ; KAYTES, Andy ; TAYLOR, Jeff ; JAVADI, Sogol Stephanie ; MATHUR, Kushagra ; LO, Megan ; BROWN, Brandon ; SAUCEDA, John A. ; WOHL, David A. ; LITTLE, Susan ; HENDRICKX, Steven ; RAWLINGS, Stephen A. ; SMITH, Davey M. ; GIANELLA, Sara
AIDS research and human retroviruses, 24/06/2020, Pagination inconnue

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Feasibility of delivering a tailored intervention for advance care planning in primary care practice

PAIVA, Andrea ; REDDING, Colleen A. ; IANNONE, Lynne ; ZENONI, Maria ; O'LEARY, John R. ; FRIED, Terri R.
Journal of the American Geriatrics Society, 01/01/2019, vol.67, n°9, p. 1917-1921

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Assessment of the decision-making capacity for clinical research participation in patients with advanced cancer in the last weeks of life

GOSWAMI, Rachna ; MOORE, Jessica ; BRUERA, Eduardo ; HUI, David
JOURNAL OF PAIN AND SYMPTOM MANAGEMENT, 24/02/2020, Pagination inconnue

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Empowering older adults to discuss advance care planning during clinical visits - the PREPARE randomized trial

FREYTAG, Jennifer ; STREET, Richard L. ; BARNES, Deborah E. ; SHI, Ying ; VOLOW, Aiesha M. ; SHIM, Janet K. ; ALEXANDER, Stewart C. ; SUDORE, Rebecca L.
Journal of the American Geriatrics Society, 10/03/2020, Pagination inconnue

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Engaging fathers in pediatric palliative care research

NICHOLAS, David ; BEAUNE, Laura ; BELLETRUTTI, Mark ; BLUMBERG, Jonathan ; ING, Stanley ; RAPOPORT, Adam ; BARRERA, Maru
Journal of social work in end-of-life and palliative care, 17/01/2020, p. 1-15

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Community participation in palliative care - reflections from the ground

KUMAR, K. Suresh
PROGRESS IN PALLIATIVE CARE, 05/01/2020, p. 1-6

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Clinical trial participation and aggressive care at the end of life in patients with ovarian cancer

NITECKI, Roni ; BERCOW, Alexandra S. ; GOCKLEY, Allison A. ; LEE, Hang ; PENSON, Richard T. ; GROWDON, Whitfield B.
International journal of gynecological cancer, 06/01/2020, Pagination inconnue

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Intention-to-treat analyses for randomised controlled trials in hospice/palliative care - the case for analyses to be of people exposed to the intervention

KOCHOVSKA, Slavica ; HUANG, Chao ; JOHNSON, Miriam J. ; AGAR, Meera ; FALLON, Marie T. ; KAASA, Stein ; HUSSAIN, Jamilla A. ; PORTENOY, Russell K. ; HIGGINSON, Irene J. ; CURROW, David
JOURNAL OF PAIN AND SYMPTOM MANAGEMENT, 03/2020, vol.599, n°3, p.

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Thème : Recherche - Evaluation - Méthodologie. Cote : e00.07JPS

ESSAI CONTROLE RANDOMISE ; UNITE SOINS PALLIATIFS ; DEMARCHE PALLIATIVE ; PARTICIPATION

INTRODUCTION: Minimising bias in randomised controlled trials (RCTs) includes intention-to-treat (ITT) analyses. Hospice/palliative care RCTs are constrained by high attrition unpredictable when consenting, including withdrawals between randomisation and first exposure to the intervention. Such withdrawals may systematically bias findings away from the new intervention being evaluated if they are considered non-responders. This study aimed to quantify this impact within ITT principles.
METHODS: A theoretical model was developed to assess the impact of withdrawals between randomisation and first exposure on i) study power and ii) effect sizes. Ten reported hospice/palliative care studies had power recalculated accounting for such withdrawal.
RESULTS: In the theoretical model, when 5% of withdrawals occurred between randomisation and first exposure to the intervention, change in power was demonstrated in binary outcomes (2.0-2.2%), continuous outcomes (0.8-2.0%) and time-to-event outcomes (1.6-2.0%), and odds ratios were changed by 0.06-0.17. Greater power loss was observed with larger effect sizes. Withdrawal rates were 0.9%-10% in the ten reported RCTs, corresponding to power losses of 0.1%-2.2%. For studies with binary outcomes, withdrawal rates were 0.3-1.2%, changing odds ratios by 0.01-0.22.
DISCUSSION: If blinding is maintained and all interventions are available simultaneously, our model suggests that excluding data from withdrawals between randomisation and first exposure to the intervention minimises one bias. This is the safety population as defined by the International Committee on Harmonisation. When planning for future trials, minimising the time between randomisation and first exposure to the intervention will minimise the problem. Power should be calculated on people who receive the intervention.

Origine : PubMed

Involving consumers with palliative care needs and their families in research - a case study

VIRDUN, Claudia ; LUCKETT, Tim ; GILMORE, Imelda ; BRASSIL, Meg ; LILIAN, Ruth ; LORENZ, Karl A. ; PHILLIPS, Jane
Collegian, 12/2019, vol.26, n°6, p. 645-650

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Patient-centered family meetings in palliative care - a quality improvement project to explore a new model of family meetings with patients and families at the end of life

SANDERSON, Christine R. ; CAHILL, Philippa J. ; PHILLIPS, Jane L. ; JOHNSON, Anne ; LOBB, Elizabeth A.
Annals of palliative medicine, 12/2017, vol.6, n°Suppl 2, p. S195-S205

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Evaluation of the burdens and benefits of participation in research by parents of children with life-limiting illnesses

HOPPER, Audrey ; CRANE, Stacey
Nurse researcher, 24/07/2019, Pagination inconnue

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