Special Supplement: Empirical Research on Informed Consent: An Annotated Bibliography

Sugarman, Jeremy; McCrory, Douglas C; Powell, Donald M.; Krasny, Alex; Adams, Betsy; Ball, Eric; Cassell, Cynthia H.

doi:10.2307/3528546

Cited by 166 publications

(75 citation statements)

References 3 publications

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“…Oral and written presentation is an established effective method for improving understanding and comprehension. [35][36][37][38][39] Children responded to questions orally. On the basis of responses (ie, initial understanding), prompts were included to ensure that children comprehended each question's intent.…”

Section: Instrument Designmentioning

confidence: 99%

The Experiences of Children Enrolled in Pediatric Oncology Research: Implications for Assent

2010

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BACKGROUND: Most children with cancer enroll in clinical research trials. Whenever possible, children must provide their assent before enrolling in research studies. We studied what children aged 7 to 18 with cancer understand about research, their research-related treatment, and their preferences for inclusion in decision-making. PROCEDURE: Thirty-seven face-to-face, audiorecorded interviews using a novel, semi-structured tool, the quality-of-assent instrument, were conducted. Exploratory univariate and bivariate analyses of the quantitative data elucidated patterns and trends of understanding and preferences. RESULTS: Nineteen of the 37 children (51%) did not know or recall that their treatment was considered research, and 19 of 22 (86%) did not understand their doctor when he or she discussed the trial. More children enrolled in trials to help future children with cancer (27 of 37 [73%]), than to get better personally (22 of 37 [60%]). Irrespective of age, children with Hodgkin's disease, germ-cell tumors, and leukemia had significantly greater research awareness and appreciation than children with other cancers (P = .019 and P < .001, respectively). Although all children wanted to be involved in decision-making, 18 of 37 (49%) did not have or recall having a role in deciding to enroll in their trial, and 14 of 37 (38%) did not feel free to dissent to trial enrollment. Only 4 of 37 children (11%) discussed increased decision-making roles with parents, and only 7 of 37 (19%) discussed them with their doctors. CONCLUSIONS: Most children have limited understanding of research despite physicians' explanations. Many children reported that they feel minimally involved in the decision to enroll in clinical trials. Tools to assist investigators ascertain that children understand what they are agreeing to when they assent to research and to determine their preferences for inclusion in research may help make assent more meaningful.

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Section: Instrument Designmentioning

confidence: 99%

The Experiences of Children Enrolled in Pediatric Oncology Research: Implications for Assent

2010

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“…Many physical illnesses, as well as medications, can place patients at risk for impaired understanding of research or treatment Grisso and Appelbaum 1998). In fact, studies comparing the abilities of patients with and without psychiatric illness have shown that the presence of a psychiatric disorder, albeit a risk factor, does not predetermine whether a patient can understand key information Appelbaum et al 1999;Grisso and Appelbaum 1995;Appelbaum and Grisso 1995;Lidz et al 1984;Meisel and Roth 1981;Roth et al 1987;Stanley et al 1987;Sugarman et al 1999;Carpenter et al 2000). Several investigators have demonstrated that individuals with psychiatric disorders do possess definite strengths related to decision-making capacity (Grisso and Appelbaum 1998;Carpenter et al 2000;Kleinman et al 1993;Stanley et al 1981;Soskis 1978).…”

mentioning

confidence: 99%

“…A critical review of methods to improve understanding should reveal effective strategies and suggest potential areas for further investigation. Although the number of articles published on informed consent has increased substantially over the last 30 years (Kaufmann 1983;Sugarman et al 1999), the number of studies that actually test methods to improve the informed consent process has been limited.…”

mentioning

confidence: 99%

Enhancing Informed Consent for Research and Treatment

Dunn

Jeste

2001

Neuropsychopharmacology

218

169

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“…Bu terimlerin hiç biri sorunu çözmemektedir. Bu yüzden son 30 yılı aşkın bir sürede aydınlatılmış onam üzerine birçok makale yayınlanmış olmasına rağmen aydınlatılmış onam sürecinin nasıl geliştirileceği konusundaki araştırmalar sınırlı kalmıştır (17,18). Dunn ve Jeste, bu amaçla yeni teknolojilerden yararlanılabileceğini söylemişlerdir.…”

Section: Okunabilirlikunclassified

Informed Consent of Contrast Media Applications in Radiology: Assesment of Comprehensibility and The Anxiety Of The Patients

Ören¹,

Eren²,

Yeşildere³

et al. 2010

Tepecik Dergisi

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ÖZET AMAÇ:Hastanemizde kullanılan onam formuna ait yazılı metnin okunabilirliğini, içeriğinin anlaşılabilirliğini saptamak ve kontrast madde onam formunun hastalarda uyandırdığı kaygıyı ve hastaların bilgilendirilmeye tepkilerini değerlendirmek. GEREÇ VE YÖNTEM:Çalışmaya Radyoloji Bölümü'ne kontrastlı Bilgisayarlı Tomografi tetkiki için başvuran 122 hasta alındı. Hastalardaki anksiyete şiddetinin bilgilendirme ile değişimini ölçmek için onam formu okutulmadan önce ve okutulduktan sonra beşli Görsel Analog Ölçek kullanılarak kaygı seviyesi değerlendirildi. Daha sonra kısa bir anketle hastanın Ortak Karar Mekanizmasını ve onam formu metnini anlayıp anlamadığı, bilgilendirilmeye tepkileri değerlendirildi. Sonuçların yaş, cinsiyet ve eğitim düzeyi ile ilişkisi istatistiksel olarak değerlendirildi. BULGULAR:Hastanemizde kullanılan aydınlatılmış onam formunun hasta anksiyetesini anlamlı ölçüde artırdığı saptandı. Ancak yaş, cinsiyet, eğitim düzeyi ile bilgilendirilmeden önceki ve sonraki anksiyete düzeyleri arasında ilişki saptanmadı. Anket sorularında hastaların yaklaşık beşte birinin okudukları açıklayıcı metnin içeriğini anlamadığı, ortak karar mekanizması kavramının anlaşılabilirliğine yönelik sorulardaki olumsuz yanıt verme oranının %48.4'e kadar çıktığı görüldü. Anket sorularına verilen doğru yanıtların oranı yaş ve cinsiyet farkı gözetmezken, eğitimlilerde yükselmektedir. SONUÇ:Hastalar genel olarak bilgilendirilmekten memnundurlar. Ancak hastalarda bilgilendirilmekten kaynaklanan anksiyeteyi azaltmak ve açıklayıcı metnin anlaşılabilirliğini artırmak için iletişimci, psikolog ve eğitimcilerin teknik desteğine gereksinim vardır. Ortak karar mekanizmasının ataerkil tibbi düzen içerisinde hizmet almaya alışmış hastalara tanıtılması Sağlık Bakanlığı'nın ileriye dönük hedeflerinden birini oluşturmalıdır.Anahtar sözcükler: Aydınlatılmış onam, Kontrast madde, Hasta anksiyetesi SUMMARY PURPOSE: To assess the readability and comprehensibility the written informed consent form in our hospital, and to evaluate the pateint anxiety and satisfaction aroused by the informed consent process. MATERIALS AND METHODS:Hundred and twenty two patients, who were referred to the Radiology Department for a contrast enhanced Computed Tomography, were enrolled in the study. To evaluate the changes in the anxiety level, a 5-point Visual Analog scale was used before and after presenting the consent form to the patients. Then, a short questionnaire form was given to assess the comprehensibility of the text and patients' satisfaction aroused by the informed consent process. Readability was assessed independently by using SMOG (Simple Measure of Gobbledygook) index. The differential anxiety level and the results of the questionnaire were analyzed statisticaly with regard to age, sex and education level.

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Special Supplement: Empirical Research on Informed Consent: An Annotated Bibliography

Cited by 166 publications

References 3 publications

The Experiences of Children Enrolled in Pediatric Oncology Research: Implications for Assent

The Experiences of Children Enrolled in Pediatric Oncology Research: Implications for Assent

Enhancing Informed Consent for Research and Treatment

Informed Consent of Contrast Media Applications in Radiology: Assesment of Comprehensibility and The Anxiety Of The Patients

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