Trial reportHealth expectations : an international journal of public participation in health care and health policy2008
Improving informed consent: pilot of a decision aid for women invited to participate in a breast cancer prevention trial (IBIS-II DCIS).
Trial report in Health expectations : an international journal of public participation in health care and health policy, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00072462 (International Breast Cancer Intervention Study II), which is not on this map. Cited by 32 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
International Breast Cancer Intervention Study II (IBIS-II) (DCIS)
Who cites it
32 citing papers in PubMed, 3 syntheses or guidelines pooled it, 71 citations in OpenAlex.
- Measuring and evaluating participant understanding of consent processes in clinical trials: a systematic review.Trials · 2026Pooled it
- Pooled it
- Decision aids for people considering taking part in clinical trials.The Cochrane database of systematic reviews · 2015Pooled it
- Improving decision making about clinical trial participation - a randomised controlled trial of a decision aid for women considering participation in the IBIS-II breast cancer prevention trial.British journal of cancer · 2014Trial
- Barriers to recruitment in a pre-surgical trial for ductal carcinoma in situ: an exploratory qualitative study of at-risk women, survivors, and providers.Breast cancer research and treatment · 2025Article
- Factors that influence clinical trial participation for oncology patients in Australia: a scoping review.BMJ open · 2025Article
- Understanding the Role of Patient-Reported Outcomes for Decision-Making in Early-Phase Dose-Finding Clinical Trials.Current oncology (Toronto, Ont.) · 2025Article
- "I'm tired of seeing my friends die": Barriers and facilitators to participating in clinical trials among rural people who use drugs in the United States.The Journal of rural health : official journal of the American Rural Health Association and the National Rural Health Care Association · 2025Article
- Decision-making and autonomy among participants in early-phase cancer immunotherapy trials: a qualitative study.BMC cancer · 2024Article
- Patient and public involvement in cancer research: A scoping review.Cancer medicine · 2023Article
- Decision Making When Cancer Becomes Chronic: Needs Assessment for a Web-Based Medullary Thyroid Carcinoma Patient Decision Aid.JMIR formative research · 2021Article
- Patient Engagement Partnerships in Clinical Trials: Development of Patient Partner and Investigator Decision Aids.The patient · 2020Article
- Why 'understanding' of research may not be necessary for ethical emergency research.Philosophy, ethics, and humanities in medicine : PEHM · 2020Review
- Development of a Plain Language Decision Support Tool for Cancer Clinical Trials: Blending Health Literacy, Academic Research, and Minority Patient Perspectives.Journal of cancer education : the official journal of the American Association for Cancer Education · 2020Article
- Evaluating Adaptation of a Cancer Clinical Trial Decision Aid for Rural Cancer Patients: A Mixed-Methods Approach.Journal of cancer education : the official journal of the American Association for Cancer Education · 2019Article
- Review
- Stop, think, reflect, realize-first-time mothers' views on taking part in longitudinal maternal health research.Health expectations : an international journal of public participation in health care and health policy · 2019Article
- Assessment of the understanding of informed consent including participants' experiences, and generation of a supplemental consent decision aid for Gestational Diabetes Mellitus (GDM) research.HRB open research · 2018Article
- Development of Plain Language Supplemental Materials for the Biobank Informed Consent Process.Journal of cancer education : the official journal of the American Association for Cancer Education · 2017Article
- Facilitating psychosexual adjustment for women undergoing pelvic radiotherapy: pilot of a novel patient psycho-educational resource.Health expectations : an international journal of public participation in health care and health policy · 2016Article
Corrections and comments
- Commented on by
Authors and funding
9 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPatients and clinicians report difficulties with the process of informed consent to clinical trials and audiotape audits show that critical information is often omitted or poorly presented. Decision aids (DAs) may assist in improving consent.
aimsThis study piloted a DA booklet for a high priority breast cancer prevention trial, IBIS-II DCIS, which compares the efficacy of an aromatase inhibitor (anastrozole) with tamoxifen in women who have had surgery for ductal carcinoma in situ (DCIS).
methodThirty-one Australian women participating in the IBIS-I breast cancer prevention trial and who are currently in follow-up agreed to read the IBIS-II DCIS participant information sheet and the DCIS DA booklet, complete a set of standardized questionnaires, and provide feedback on the DA via a semi-structured phone interview.
resultsWomen found the DA helpful in deciding about trial participation, reporting that it aided their understanding over and above the approved IBIS-II DCIS participant information sheet and was not anxiety provoking. Women's understanding of the rationale and methods of clinical trials and the IBIS-II DCIS trial was very good; with more than 80% of items answered correctly. The only areas that were not understood well were the concepts of randomization and blinding.
conclusionsThis study suggests that the DA will be acceptable to and valued by potential participants in the IBIS-II DCIS study. The revised DA is currently being evaluated prospectively in a randomized controlled trial. If successful, such DAs could transform the consent process to large clinical trials and may also reduce dropout rates.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.