Knowledge and understanding of information after taking decision to participate or not in a randomized trial of surgery vs radiotherapy among patients with locally advanced prostate cancer – an observational study
Background and purpose: Informed consent from trial participants is mandatory. In a randomized clinical trial, we investigated (1) differences in knowledge and understanding of trial information between patients who participated and those who refrained, (2) differences in perceptions of information,...
Saved in:
| Main Authors: | , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Medical Journals Sweden
2025-01-01
|
| Series: | Acta Oncologica |
| Subjects: | |
| Online Access: | https://medicaljournalssweden.se/actaoncologica/article/view/42218 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832582891449614336 |
|---|---|
| author | Yvonne Brandberg Olof Akre Mia Bergenmar |
| author_facet | Yvonne Brandberg Olof Akre Mia Bergenmar |
| author_sort | Yvonne Brandberg |
| collection | DOAJ |
| description | Background and purpose: Informed consent from trial participants is mandatory. In a randomized clinical trial, we investigated (1) differences in knowledge and understanding of trial information between patients who participated and those who refrained, (2) differences in perceptions of information, and (3) differences in satisfaction with the information.
Patients: After the decision about participation in the randomized study, ‘Surgery versus radiotherapy for locally advanced prostate cancer’ (SPCG-15), patients were sent questionnaires (‘Quality of Informed Consent’, EORTC QLQ-INFO25). Patients were categorized in ‘Non-participants’ or ‘Participants’.
Results and interpretation: A total of 80 patients (80%) responded, 68% of non-participants and 95% of participants. Between-group differences in knowledge were found for duration of the trial, insurances in the trial, and if the trial intervention had been proven to be superior. Patients had high levels of knowledge (> 80%) regarding the trial aim, that participation implied research, the right to decline, that future patients benefit from research and, of the randomization procedure. Less than 50% responded correctly concerning risks associated with the trial, the unproven nature of the trial and issues about insurances. Non-participants scored lower concerning duration of trial participation, confidentiality of medical records, treatments and procedures in the trial, and experimental nature of treatments. There were no differences regarding satisfaction with information.
Non-participants and participants did not differ in satisfaction, or in knowledge and understanding of most aspects of the information. Knowledge levels were low in some areas, and thus, it seems to be room for improvement to fulfill the requirements of informed consent.
|
| format | Article |
| id | doaj-art-f6e99579396d4089ae7a96eb7a4efb08 |
| institution | Kabale University |
| issn | 1651-226X |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Medical Journals Sweden |
| record_format | Article |
| series | Acta Oncologica |
| spelling | doaj-art-f6e99579396d4089ae7a96eb7a4efb082025-01-29T07:55:52ZengMedical Journals SwedenActa Oncologica1651-226X2025-01-016410.2340/1651-226X.2025.42218Knowledge and understanding of information after taking decision to participate or not in a randomized trial of surgery vs radiotherapy among patients with locally advanced prostate cancer – an observational studyYvonne Brandberg0Olof Akre1Mia Bergenmar2https://orcid.org/0000-0002-7256-6105Department of Oncology-Pathology, Karolinska Institutet, Stockholm, SwedenDepartment of Urology, Karolinska University Hospital, Stockholm, Sweden; Clinical Epidemiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, SwedenDepartment of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden; Department of Care Science, Sophiahemmet University, Stockholm, SwedenBackground and purpose: Informed consent from trial participants is mandatory. In a randomized clinical trial, we investigated (1) differences in knowledge and understanding of trial information between patients who participated and those who refrained, (2) differences in perceptions of information, and (3) differences in satisfaction with the information. Patients: After the decision about participation in the randomized study, ‘Surgery versus radiotherapy for locally advanced prostate cancer’ (SPCG-15), patients were sent questionnaires (‘Quality of Informed Consent’, EORTC QLQ-INFO25). Patients were categorized in ‘Non-participants’ or ‘Participants’. Results and interpretation: A total of 80 patients (80%) responded, 68% of non-participants and 95% of participants. Between-group differences in knowledge were found for duration of the trial, insurances in the trial, and if the trial intervention had been proven to be superior. Patients had high levels of knowledge (> 80%) regarding the trial aim, that participation implied research, the right to decline, that future patients benefit from research and, of the randomization procedure. Less than 50% responded correctly concerning risks associated with the trial, the unproven nature of the trial and issues about insurances. Non-participants scored lower concerning duration of trial participation, confidentiality of medical records, treatments and procedures in the trial, and experimental nature of treatments. There were no differences regarding satisfaction with information. Non-participants and participants did not differ in satisfaction, or in knowledge and understanding of most aspects of the information. Knowledge levels were low in some areas, and thus, it seems to be room for improvement to fulfill the requirements of informed consent. https://medicaljournalssweden.se/actaoncologica/article/view/42218Clinical trialsProstate cancerQuality of Informed ConsentEORTC QLQ-INFO25Satisfaction with information |
| spellingShingle | Yvonne Brandberg Olof Akre Mia Bergenmar Knowledge and understanding of information after taking decision to participate or not in a randomized trial of surgery vs radiotherapy among patients with locally advanced prostate cancer – an observational study Acta Oncologica Clinical trials Prostate cancer Quality of Informed Consent EORTC QLQ-INFO25 Satisfaction with information |
| title | Knowledge and understanding of information after taking decision to participate or not in a randomized trial of surgery vs radiotherapy among patients with locally advanced prostate cancer – an observational study |
| title_full | Knowledge and understanding of information after taking decision to participate or not in a randomized trial of surgery vs radiotherapy among patients with locally advanced prostate cancer – an observational study |
| title_fullStr | Knowledge and understanding of information after taking decision to participate or not in a randomized trial of surgery vs radiotherapy among patients with locally advanced prostate cancer – an observational study |
| title_full_unstemmed | Knowledge and understanding of information after taking decision to participate or not in a randomized trial of surgery vs radiotherapy among patients with locally advanced prostate cancer – an observational study |
| title_short | Knowledge and understanding of information after taking decision to participate or not in a randomized trial of surgery vs radiotherapy among patients with locally advanced prostate cancer – an observational study |
| title_sort | knowledge and understanding of information after taking decision to participate or not in a randomized trial of surgery vs radiotherapy among patients with locally advanced prostate cancer an observational study |
| topic | Clinical trials Prostate cancer Quality of Informed Consent EORTC QLQ-INFO25 Satisfaction with information |
| url | https://medicaljournalssweden.se/actaoncologica/article/view/42218 |
| work_keys_str_mv | AT yvonnebrandberg knowledgeandunderstandingofinformationaftertakingdecisiontoparticipateornotinarandomizedtrialofsurgeryvsradiotherapyamongpatientswithlocallyadvancedprostatecanceranobservationalstudy AT olofakre knowledgeandunderstandingofinformationaftertakingdecisiontoparticipateornotinarandomizedtrialofsurgeryvsradiotherapyamongpatientswithlocallyadvancedprostatecanceranobservationalstudy AT miabergenmar knowledgeandunderstandingofinformationaftertakingdecisiontoparticipateornotinarandomizedtrialofsurgeryvsradiotherapyamongpatientswithlocallyadvancedprostatecanceranobservationalstudy |