scholarly journals Informed consent for phase I studies: Evaluation of quantity and quality of information provided to patients

1995 ◽  
Vol 6 (4) ◽  
pp. 363-369 ◽  
Author(s):  
M. Tomamichel ◽  
C. Sessa ◽  
S. Herzig ◽  
J. de Jong ◽  
O. Pagani ◽  
...  
Keyword(s):  
Informed Consent ◽  
Phase I ◽  
Quality Of Information ◽  
Phase I Studies

Informed consent in phase I clinical trials: Implications for trends in design.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14077-e14077
Author(s):  
Paul Henry Frankel ◽  
Susan G. Groshen
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Phase I ◽  
Dose Finding ◽  
Institutional Review Boards ◽  
Severe Toxicity ◽  
Phase I Clinical Trials ◽  
Traditional Use ◽  
Phase I Studies ◽  
Definition Of

e14077 Background: Informed Consent (IC) is a critical aspect of human subjects protection. Institutional Review Boards are tasked with insuring proper IC as one aspect of protecting participants in clinical trials. Phase I trials in oncology present special issues with IC, as often neither the risks nor the benefits are well-known. This has resulted in carefully worded IC templates for Phase I studies based on the traditional use of dose-finding designs that are geared towards finding the “Maximum Tolerated Dose (MTD)”. As the definition of this term varies by study, the implication for patient risk and informed consent are rarely discussed. Methods: We reviewed Phase I designs to present options for improving the informed consent process for Phase I oncology trials. Results: Phase I studies have seen an increase in designs based on work from the early 1990s seeking a dose that results in a targeted percent of patients experiencing a “Dose Limiting Toxicity (DLT)” to define the MTD. The most common definition of a DLT is a treatment-related toxicity that results in a particularly concerning severe toxicity (grade 3 or higher) in the first cycle of therapy and the most common rate targeted (in designs that define toxicity as a goal) is 25%. In that setting, while lower doses may have a lower likelihood of DLT, higher doses or the expansion cohort are likely to have a 25% chance of DLT if the target is pursued. This information is rarely quantitatively communicated in the informed consent. Conclusions: IRBs and investigators should consider communicating through informed consent the quantitative summary of goals of the study and related risk. For example, transparency suggests conveying when the goal (target) of the study is to find the dose where there is a one in four chance of experiencing a severe adverse event in the first cycle.

Quality of Information in the Process of Informed Consent for Anaesthesia

2013 ◽  
Vol 91 (9) ◽  
pp. 595-601
Author(s):  
José Guillén-Perales ◽  
Aurelio Luna-Maldonado ◽  
María Fernández-Prada ◽  
José Francisco Guillén-Solvas ◽  
Aurora Bueno-Cavanillas
Keyword(s):  
Informed Consent ◽  
Quality Of Information

Informed consent in China: quality of information provided to participants in a research project

2004 ◽  
Vol 32 (6) ◽  
pp. 472-475 ◽  
Author(s):  
Niels Lynöe ◽  
Mikael Sandlund ◽  
Lars Jacobsson ◽  
Gunnar Nordberg ◽  
Taiyi Jin
Keyword(s):  
Informed Consent ◽  
Quality Of Information ◽  
Research Project

scholarly journals Informed consent: study of quality of information given to participants in a clinical trial.

BMJ ◽  
1991 ◽  
Vol 303 (6803) ◽  
pp. 610-613 ◽  
Author(s):  
N Lynoe ◽  
M Sandlund ◽  
G Dahlqvist ◽  
L Jacobsson
Keyword(s):  
Clinical Trial ◽  
Informed Consent ◽  
Quality Of Information

How did partners experience cancer patients' participation in a phase I study? An observational study after a patient's death

2015 ◽  
Vol 14 (3) ◽  
pp. 241-249 ◽  
Author(s):  
Simone M.C.H. Langenberg ◽  
Marlies E.W.J. Peters ◽  
Winette T.A. van der Graaf ◽  
Anke N. Machteld Wymenga ◽  
Judith B. Prins ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Psychological Distress ◽  
Observational Study ◽  
Phase I ◽  
Phase I Study ◽  
Complicated Grief ◽  
Well Being ◽  
Negative Consequences ◽  
Phase I Studies

AbstractObjective:It can be assumed that patients' participation in a phase I study will have an important impact on their partners' life. However, evaluation of partners' experiences while patients are undergoing experimental treatment and of their well-being after the patient's death is lacking. We aimed to explore partners' experience of patients' participation in phase I studies and to investigate their well-being after a patient's death.Method:This was an observational study conducted after the patient's death. Partners of deceased patients who had participated in a phase I study completed a questionnaire designed by us for experience evaluation and the Beck Depression Inventory for Primary Care, the Hospital Anxiety and Depression Scale, the Inventory of Traumatic Grief, and the RAND-36 Health Survey.Results:The median age of the 58 participating partners was 58 years (range: 51–65), and 67% was female. Partners reported negative effects on patients' quality of life, but only 5% of partners regretted patients' participation. Approximately two years after the patients' death, 19% of partners scored for depression, 36% for psychological distress, and 46% for complicated grief, and partners generally scored significantly lower on social and mental functioning compared to normative comparators.Significance of Results:Although partners reported negative consequences on patients' quality of life, most did not regret patients' participation in the phase I studies. Prevalence of depression, psychological distress, and complicated grief seemed important problems after a patient's death, and these must be considered when shaping further support for partners of patients participating in phase I trials.

scholarly journals 638 The Implication of Telephone Consultations During COVID-19 Pandemic on Informed Consent

2021 ◽  
Vol 108 (Supplement_6) ◽  
Author(s):  
N Ayoub ◽  
F Gareb ◽  
M Akhtar
Keyword(s):  
Informed Consent ◽  
Hernia Repair ◽  
Lymph Node Biopsy ◽  
Quality Of Information ◽  
Day Case Surgery ◽  
Telephone Consultation ◽  
Patient Dissatisfaction ◽  
Case Surgery ◽  
The Right

Abstract Aim Is to find whether telephone consultations have affected patient’s comprehension of the proposed surgical management and possible risks until the day of surgery and accordingly ability for informed consent. Method This study included a sample of patients admitted to QEQM hospital for elective day case surgery during November 2020 and had only telephone consultation when referred for surgery. A feedback survey assessing quality of information given to patients before and on day of surgery was filled by the patients after the procedure. Results The sample included 40 patients undergoing different procedures [cholecystectomy (25), inguinal hernia repair (25), rectal examination under anaesthesia (5), ventral hernia repair (2), incisional hernia (2), inguinal lymph node biopsy (1)]. It was found that 27.5% of patients didn’t have thorough explanation of possible risks and no explanation about postoperative care in 35%.20% were not provided a leaflet about procedure, 57.5% had concerns before surgery and 75% of patients wished for a leaflet with illustrative diagrams, explanation of risks with their management to be able to take the right decision and majority of these patients were from cholecystectomy subgroup. Conclusions The lack of face-face appointment affected greatly the informed consent process resulting in patient dissatisfaction which raised the need for new leaflets containing diagrammatic explanation of procedures and possible risks with their management to ensure fulfilment of autonomy principle.

scholarly journals Informed consent in robotic surgery: quality of information and patient perception

Open Medicine ◽  
2016 ◽  
Vol 11 (1) ◽  
pp. 279-285 ◽  
Author(s):  
Alessia Ferrarese ◽  
Giada Pozzi ◽  
Felice Borghi ◽  
Luca Pellegrino ◽  
Pierpaolo Di Lorenzo ◽  
...  
Keyword(s):  
Informed Consent ◽  
Robotic Surgery ◽  
Literature Review ◽  
Forensic Medicine ◽  
Research Literature ◽  
Patient Perception ◽  
Quality Of Information ◽  
Surgical Field

AbstractIntroductionObtaining a valid informed consent in the medical and surgical field is a long debated issue in the literature. In robotic surgery we believe in the necessity to follow three arrangements to make the informed consent more complete.Material and methodsThis study presents correlations and descriptions based on forensic medicine concepts research, literature review, and the proposal of an integration in the classic concept of informed consent.ConclusionIn robotic surgery we believe in the necessity to follow three arrangements to make the IC more complete. Integrate the information already present in the informed consent with data on the surgeon’s experience in RS, the number of procedures of the department and the regional map of expertises by procedure.

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