Info

328e

Questionnaire after enrollment

60% expect to benefit

64% "unsure" or "maybe"

aThe initial publication by Daugherty et al.19 of 27 patients is included in the 144 patients.

bSurvey of patients participating in phase I, II, and III studies. Total number of patients was 207 of which 50 were enrolled in phase I studies. Unfortunately, the analysis of the responses failed to stratify according to phase.

aThe initial publication by Daugherty et al.19 of 27 patients is included in the 144 patients.

bSurvey of patients participating in phase I, II, and III studies. Total number of patients was 207 of which 50 were enrolled in phase I studies. Unfortunately, the analysis of the responses failed to stratify according to phase.

cThe initial publication by Cheng et al. of 30 patients, included in the 328 patients.

oncology study were verbally stated by physicians to cancer patients in more than 90% of consultations and the lack of sufficient knowledge of toxicity of the drug in more than 80%.39 Two other studies report similar findings.40-41

Several studies have focused on evaluating understanding by the research participant and found that the participants did not understand various aspects of the study.28,42 For example, a study by Penman et al. of 144 cancer patients participating in trials at academic cancer centers found that participants did not fully understand toxicity;42 participants recalled an average of 3 risks when the consent forms mentioned an average of 11 risks. More importantly, participants tended to recall the minor toxicities, such as hair loss, rather than major potential toxicities.

Studies evaluating understanding have consistently found that participants most frequently fail to understand details of research design. In a study of 299 Finnish patients with breast cancer enrolled in a randomized control trial of hormonal treatment, 51% thought the doctor had chosen the therapy.43 More recently, Joffe et al. reported on 207 patients enrolled in Phase I, II, and III oncology studies surveyed 3 to 14 days after consent.19 Overall, 75% of participants knew that the main reason cancer trials are done is to improve the treatment of future cancer patients, while 71% reported that they may not experience direct medical benefit from participating in the clinical trial, yet 48% thought the treatments and procedures were standard for their type of cancer. The understanding aspect of informed consent in Phase I oncology trials has been the most extensively studied area of Phase I ethics research. Most participants in Phase I oncology studies are motivated to participate by hopes for stabilization, improvement, or even cure of their cancer (see Table 9.3).44-48 This observation has been widely interpreted to suggest patients have deficient understanding of the objectives, benefits, and risks of Phase I research. However, the data also show that patient decisions to participate may reflect a motivation to maintain hope in a difficult situation rather than misunderstanding of the information.44 For example, although Daugherty et al. found that 85% of patients were motivated to participate for possible therapeutic benefit, 78% were either unwilling or unable to state whether they believed they personally would receive benefit from participating in a Phase I trial.49 Similarly, Itoh et al. found 63% of the participants did not expect any benefit but wished to participate anyway.41 The largest study evaluating understanding by Meropol et al., which asked Phase I participants how confident they were being among those who would benefit, found only 27% thought they would definitely benefit from participating in research.48

Second, several intervention studies have been conducted in an attempt to improve the informed consent process. Three broad types of interventions have been tried: (1) modifying the consent form, (2) augmenting the discussion between research participants and investigators, and (3) using a multimedia or computer-based intervention.22,50 Regardless of the approach, the majority of the studies have not shown meaningful improvements in the understanding of research participants. The major exception is by Aaronson et al., finding that using a telephone-based nursing intervention could improve participants' understanding.50 About 15% to 20% of participants in the intervention group showed improvements in the level of their understanding of side effects, trial objectives, and randomization. It should be noted that although studies using consent forms have failed to show a consistent and substantial improvement in understanding, they may still be important to research participants. Joffe et al. found that 84% read the consent carefully and 86% found it easy to understand.28

Finally, despite deficiencies, virtually all the studies report that research participants are generally satisfied with the informed consent process.23,42,51-53 Hietanen et al. reported that of 299 breast cancer patients, 68% thought they had enough time for decision making and 87% were happy with their decision to participate.43 Similarly, Verheggen et al. evaluated 198 research participants in 26 clinical trials, finding that the majority of participants were "quite satisfied with the oral and written information disclosure."51 Daugherty et al., Tomamichel et al., and others report more than 95% satisfaction in the informed consent process by research participants of Phase I oncology trials.28,39,49

A Disquistion On The Evils Of Using Tobacco

A Disquistion On The Evils Of Using Tobacco

Among the evils which a vitiated appetite has fastened upon mankind, those that arise from the use of Tobacco hold a prominent place, and call loudly for reform. We pity the poor Chinese, who stupifies body and mind with opium, and the wretched Hindoo, who is under a similar slavery to his favorite plant, the Betel but we present the humiliating spectacle of an enlightened and christian nation, wasting annually more than twenty-five millions of dollars, and destroying the health and the lives of thousands, by a practice not at all less degrading than that of the Chinese or Hindoo.

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