Patients’ regrets after participating in a randomized controlled trial depended on their involvement in the decision making

Mancini, Julien; Genre, Dominique; Dalenc, Florence; Ferrero, Jean-­Marc; Kerbrat, Pierre; Martin, Anne‐Laure; Roché, Henri; May-Levin, F; Tarpin, Carole; Viens, Patrice; Gamet, Corinne; Julian‐Reynier, Claire

doi:10.1016/j.jclinepi.2011.12.003

Cited by 22 publications

(15 citation statements)

References 34 publications

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“…A difficulty that remains, however, is how to interpret these results. Several authors have characterized DRS scores ranging from 5 to 25 on 100 as mild decision regret [10, 29–33, 37], yet no consensus exists and the clinical significance of different scores and categorizations remains to be determined. While it is reassuring that most patients report relatively low levels of decision regret in primary care settings where the bulk of healthcare services are delivered, further research is needed to identify valid and reliable cut-off points for distinguishing clinically significant regret and its impact on patient health.…”

Section: Discussionmentioning

confidence: 99%

More primary care patients regret health decisions if they experienced decisional conflict in the consultation: a secondary analysis of a multicenter descriptive study

et al. 2016

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BackgroundWe sought to estimate the extent of decision regret among primary care patients and identify risk factors associated with regret.MethodsSecondary analysis of an observational descriptive study conducted in two Canadian provinces. Unique patient-physician dyads were recruited from 17 primary care clinics and data on patient, physician and consultation characteristics were collected before, during and immediately after consultations, as well as two weeks post-consultation, when patients completed the Decision Regret Scale (DRS). We examined the DRS score distribution and performed ordinal logistic regression analysis to identify predictors of regret.ResultsAmong 258 unique patient-physicians dyads, mean ± standard deviation of decision regret scores was 11.7 ± 15.1 out of 100. Overall, 43 % of patients reported no regret, 45 % reported mild regret and 12 % reported moderate to strong regret. In multivariate analyses, higher decision regret was strongly associated with increased decisional conflict and less significantly associated with patient age and education, as well with male (vs. female) physicians and residents (vs. teachers).ConclusionAfter consulting family physicians, most primary care patients experience little decision regret, but some experience more regret if there is decisional conflict. Strategies for reducing decisional conflict in primary care, such as shared decision-making with decision aids, seem warranted.

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Section: Discussionmentioning

confidence: 99%

More primary care patients regret health decisions if they experienced decisional conflict in the consultation: a secondary analysis of a multicenter descriptive study

et al. 2016

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“…; Mancini et al . ), and are more satisfied with their participation (Coyne et al ). However, added information about risks, benefits of trial participation (Stryker et al .…”

Section: Introductionmentioning

confidence: 99%

“…Discussions have therefore continued regarding how to minimise this misconception. Well-informed and active patients are less likely to regret their decision to participate (Stryker et al 2006;Mancini et al 2012), and are more satisfied with their participation (Coyne et al 2003). However, added information about risks, benefits of trial participation (Stryker et al 2006) and increased knowledge do not seem to make the patients more likely to participate (Garcea et al 2005).…”

Section: Introductionmentioning

confidence: 99%

Hope for a cure and altruism are the main motives behind participation in phase 3 clinical cancer trials

Godskesen

Hansson²,

Nygren

et al. 2014

Eur J Cancer Care (Engl)

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It is necessary to carry out randomised clinical cancer trials (RCTs) in order to evaluate new, potentially useful treatments for future cancer patients. Participation in clinical trials plays an important role in determining whether a new treatment is the best therapy or not. Therefore, it is important to understand on what basis patients decide to participate in clinical trials and to investigate the implications of this understanding for optimising the information process related to study participation. The aims of this study were to (1) describe motives associated with participation in RCTs, (2) assess if patients comprehend the information related to trial enrolment, and (3) describe patient experiences of trial participation. Questionnaires were sent to 96 cancer patients participating in one of nine ongoing clinical phase 3 trials at the Department of Oncology, Uppsala University Hospital in Sweden. Eighty-eight patients completed the questionnaire (response rate 92%); 95% of these were patients in adjuvant therapy and 5% participated in clinical trials on palliative care. Two main reasons for participation were identified: personal hope for a cure and altruism. Patients show adequate understanding of the information provided to them in the consent process and participation entails high patient satisfaction.

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“…21 Further studies will help refine the optimal methods for delivering this type of information to patients to build trust and comprehension of a specific medical problem and the various treatment options in a range of RCTs and settings.…”

Section: Future Researchmentioning

confidence: 99%

Increased Patient Enrollment to a Randomized Surgical Trial Through Equipoise Polling of an Expert Surgeon Panel

et al. 2016

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Patients’ regrets after participating in a randomized controlled trial depended on their involvement in the decision making

Cited by 22 publications

References 34 publications

More primary care patients regret health decisions if they experienced decisional conflict in the consultation: a secondary analysis of a multicenter descriptive study

More primary care patients regret health decisions if they experienced decisional conflict in the consultation: a secondary analysis of a multicenter descriptive study

Hope for a cure and altruism are the main motives behind participation in phase 3 clinical cancer trials

Increased Patient Enrollment to a Randomized Surgical Trial Through Equipoise Polling of an Expert Surgeon Panel

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