Informed consent for pediatric phase 1 cancer trials: Physicians' perspectives

BACKGROUND.

This study was conducted to gather pediatric oncologists' opinions about and suggestions for improvement of informed consent (IC) in pediatric phase 1 cancer trials.

METHODS.

A questionnaire designed to elicit perspectives was distributed to 146 physicians at 6 participating institutions. A total of 103 completed surveys were returned for a 71% response rate.

RESULTS.

Pediatric oncologists believe providing information so families can decide about phase 1 study entry is the most important goal of the IC process (ICP). The majority of physicians (64%) report that they describe the phase 1 study without any attempt to influence parents' decisions. Several answers provided by physicians were associated with their gender and prior IC training. Male physicians were significantly more likely to endorse the no‐attempt‐to‐influence approach, whereas female physicians were more likely to suggest to parents that other children will benefit from what is learned in phase 1 studies. Responses to an open‐ended question provided 63 suggestions for improvement of the ICP, including document and training changes and tools to enhance physician‐family communication.

CONCLUSIONS.

Pediatric oncologists tended to present phase 1 trials as an option rather than a strong recommendation and were reluctant to influence decisions of families about these studies. They believe most but not all parents understand key concepts involved in consent to this type of research, and had ample suggestions for how to improve the ICP. Future research and education efforts around this ethically challenging topic were warranted. Cancer 2010. © 2010 American Cancer Society.     

Informed consent of the family in the chemotherapy for lung cancer

In Japan where the question of cancer notification has yet to be resolved, it is difficult to obtain an informed consent from the patient himself in clinical studies of the chemotherapies for cancer. In fact, the chemotherapy is administered while not enough explanation is given to the family let alone the patient. Such is the present situation. For the purpose of finding out the best possible method at present, we carried out a method whereby an informed consent of the family is substituted for a consent of the patient in phase II study of inoperable non-small cell carcinoma of the lung. As a result, the consent was obtained from 21 (91.3%) out of 23 families. This method should be taken into consideration as a feasible one under the present circumstances. It was in only one family (4.3%) that a consent on the notification of diagnosis from the family to the patient was obtained. In order for the informed consent to be established, efforts to form a social consensus on cancer notification are needed.     

Informed consent in oncology

Informed consent is not a new principle in the patient--physician relationship. It emphasizes the basic principle of the patient's autonomy and the respect which is due to him/her. In oncology it covers clinical examination, complementary investigations, different treatments and follow-up. Obtaining the necessary information may be complicated by difficulties concerning the patient, the cancers and the physicians. The problematical aspects can be alleviated if the patient's autonomy is acknowledged and respected and if the physician succeeds in establishing a sound personal relationship with the patient.     

Informed consent: issues for providers

Although obtaining informed consent is an important part of the hematologist/oncologist's practice, understanding the legal consequences can assist the practitioner to understand why it is necessary to disclose as much information as he or she does. By following the standard of care used in the state of practice, the physician can decrease the risk of being sued by patients for lack of informed consent, thus fulfilling his or her legal and ethical duties by providing the patient with all the information necessary to make an informed decision.     

Informed consent and sedation

The concept of autonomy was not included in the Hippocratic Oath. Nowadays the principles of respect for autonomy is an important right. The basic paradigm of autonomy in health-care, politics and other contexts is expressed as informed consent. In the palliative-care setting, there can be some difficulties in getting informed consent, especially at the end-of-life stage. Can it be good for the patient, always? Could there be some exceptions? At the time of agonising pain, getting informed consent could become and additional burden for the patient. This present article attempts to shed light on this issue. In our experience, it is not necessary to obtain written consent for a patient who has already expressed his priorities in advance. We believe that this is a good stance for patients as well as doctors.     

Informed consent forms for gynecologic cancer surgery: recommendations from the Korean Society of Gynecologic Oncology

The sociomedical environment is changing. In the traditional physician-patient relationship, the physician was authoritative and the patient was obedient. The contractual relationship featured patient consent to the physician’s decision. Today, the physician must explain fully the planned medical treatment, and any alternative, to the patient, who has the right to choose her treatment after considering the benefits and side-effects. The Korean Society of Gynecologic Oncology (KSGO) thus decided to standardize the surgical consent forms to meet the legal requirements of modern medicine, improve patient understanding of the surgical details, and protect medical staff from legal disputes. To determine the format and content, subcommittees for each cancer type collected and reviewed all relevant articles and the current consent forms of domestic medical institutions. After several meetings, 16 basic items to be included for each type of gynecologic cancer were selected. Also, to help patients understand the surgical details, figures were included. The revised forms were legally reviewed in terms of the appropriateness of the format and content. We also developed English versions to provide adequate information for foreign patients. We hope that these efforts will promote trust between patients and physicians, and contribute to effective treatment by laying a foundation of mutual respect.     

Informed consent and living wills

The text of this paper was originally presented to the RCN Cancer Nursing Society Conference which was held in June 1993. It was written in response to a request to cover the topics of informed consent, ethics and the multidisciplinary team and living wills. Clearly, this is an extremely broad range of topics so, in order to introduce some coherence into the paper, the 'Tuma' case is used to connect the themes of cancer nursing, informed consent and working in a multidisciplinary team. The topic of living wills and its parent concept, that of advance directives, constitute a particular aspect of informed consent. These ideas are introduced via two recent legal judgements concerning 'T' and Tony Bland. The focus then moves from legal to moral concerns, ending with a brief critique of the whole idea of living wills.     

The adequacy of consent forms for informing patients entering oncological clinical trials

The impact on 100 patients of information and consent formssigned prior to medical oncology clinical trials was evaluatedby a survey at a subsequent visit. Only 40 patients believedthat the purpose of the form was to explain the treatment. Theform was listed as the major source of information by 12 patientswhile 52 listed a doctor and 26 a nurse. Although 21 patientsbelieved that the form made them less anxious, 19 patients believedthat it made them more anxious. Despite 80 patients readingall of the form, 60 claiming to understand all of it and 68claiming that it con- tained adequate information, in testsof recall only 52 patients could name all of their drugs andonly 4 all of the side effects. The number of drugs named correlatedwith how much of the consent form had been read (p = 0.003)and the highest education level achieved by the patient (p =0.0003). Patients under 55 years had significantly better recall.Patients with a better ECOG performance status were more likelyto find the for very helpful. Such forms may not ensure thatthe requirements for informed consent are satisfied. clinical trial, informed consent, medical oncology     

(Informed consent in clinical trials and its impact on methods of randomization and statistical evaluation)]

If patients eligible for a clinical trial are fully informed on alternative therapies, randomization, risks, benefits and right to refuse some of them will disagree with randomization. Random procedures which pay regard to that fact are described. The effect on statistical evaluation and sample sizes is investigated.     

Informed consent for pediatric leukemia research: clinician perspectives

BACKGROUND: Good, fully informed consent is critical to the ethical conduct of clinical cancer research. The authors examined clinician perspectives on informed consent for pediatric research by surveying clinicians at five major medical centers that routinely enroll patients in Children's Cancer Group studies. METHODS: Building on a pilot study, a questionnaire was designed to elicit clinicians' general opinions, approaches, and suggestions related to informed consent in pediatric leukemia trials. Questionnaires were mailed to 132 clinicians. Eighty-nine questionnaires were returned, along with 13 nonparticipant forms notifying us of the clinician's inability to participate because of a lack of experience in pediatric informed consent. The response rate was 75%. RESULTS: Providing information so that families can decide about study entry was ranked as the most important goal of the informed consent process, whereas parents' state of shock was rated the most significant obstacle to good informed consent. Clinicians cited high levels of parental comprehension of key aspects of clinical research studies and reported information overload and increased anxiety as effects of the informed consent process on parents. Several key items were associated with clinicians' gender, race, and professional experience. Finally, one open-ended question yielded 126 suggestions for how to improve the informed consent process that were grouped into 10 meaningful categories. CONCLUSIONS: Clinicians report a range of approaches, opinions, concerns, and suggestions for improving the informed consent process. The article proposes that their views and suggestions be integrated with those of parents and patients in attempts to survey and improve informed consent in pediatric oncology.     

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

BACKGROUND: The process by which patients are informed and their consentis obtained in phase I trials has thus far been only marginallystudied. Since 1986 we have followed an oral procedure, consistingof three consecutive conversations in which the investigatorresponsible for phase I studies, the research nurse and thepatients' relatives and/or friends also participate, followedby the patients signing of a written consent form. It is requiredthat six items of information considered essential by our staffbe conveyed to patients by the responsible investigator. Meerwein'smodel, which defines three main dimensions of the informingprocess (the information itself, the emotional and interactiveaspects), has been studied to ascertain whether it can be appliedto evaluate the quality of the information proffered. METHODS: Thirty-two conversations were taped, transcribed and evaluatedby one psychiatrist and one psychologist. A quantitative analysisof information was performed by calculating the number of patientsto whom the essential items of information had been conveyed.The qualitative analysis was performed by rating on a five-pointscoring system, from 1 (very bad) to 5 (excellent), the threedimensions of the informing process for each patient and bycalculating for each dimension the mean score of the constituentitems. RESULTS: Complete information about the characteristics of the phaseI drug and the modalities of the treatment and follow up wasgiven to almost 80% of the patients. All but one of the itemsof the information dimension scored 3.5 or higher, with theone related to the assessment by the doctor of the patient'sunderstanding at the end of the consultation scoring less than3 in 53% of the patients. All items of the emotional dimensionscored higher than 3.5. Greater difficulty was encountered bythe physician with the interactive dimension, the lowest meanscores being reported on the items related to the doctor's awarenessof the indirectly expressed anxieties of the patients. In 71%of the consultations the three dimensions of information scoredmore than 3 and balanced one another, indicating a successfulconsultation by the Meerwein model. CONCLUSIONS: The informed consent procedure applied was satisfactory froma quantitative point of view, and the main items of informationwere acceptable to the patients. Meerweins's model proved tobe applicable and useful for identifying pitfalls in communication.Greater attention should be paid to the indirect messages andimplied criticisms of the patients to improve their participationin decision making. Physicians should become more skillful inproviding adequate information and improve their methods ofcommunication. informed consent, phase I studies, quality of information     

A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials

Recruitment to cancer clinical trials needs to be improved, as does patient knowledge and understanding about clinical trials, in order for patients to make an informed choice about whether or not to take part. Audiovisual patient information (AVPI) has been shown to improve knowledge and understanding in various areas of practice, but there is limited information about its effect in the cancer clinical trial setting, particularly in relation to consent rates. In this study, 173 patients were randomised to receive either the AVPI, in addition to the standard trial-specific written information, or the written information alone. There was no difference in clinical trial recruitment rates between the two groups with similar study entry rates: 72.1% in the AVPI group and 75.9% in the standard information group. The estimated odds ratio for refusal (intervention/no intervention) was 1.19 (95% CI 0.55-2.58, P=0.661). Knowledge scores increased more in the AVPI group compared to the standard group (P=0.0072). The change in anxiety score between the arms was also statistically significant (P=0.011) with anxiety improving in the intervention arm more than in the no intervention arm. Audiovisual patient information was shown to be a useful tool in improving patient knowledge and anxiety, but further work is necessary in relation to its effect on clinical trial recruitment rates.