Determinants of informed consent in a cataract surgery clinical trial: why patients participate

doi:10.1016/j.jcjo.2012.01.006

Canadian Journal of Ophthalmology

Volume 47, Issue 2, April 2012, Pages 118-123

Presented at the annual meeting of European Association of Vision and Eye Research, 2010.

https://doi.org/10.1016/j.jcjo.2012.01.006 Get rights and content

Abstract

Objective

To identify the determinants of patients' decision-making for participation in a cataract surgery clinical trial in a tertiary care hospital.

Design

Prospective observational study.

Participants

We interviewed by questionnaire 40 patients scheduled to have cataract surgery.

Methods

The data collected from patients included attitudes about informed consent, evaluation of the provision of information, and sociodemographic variables.

Results

Overall, 20 (50%) patients consented to enter the trial. All patients (n = 20;100%) in the consenting group expected positive implications compared to 6 (30%) in the nonconsenting group, who expected negative implications (p = 0.008). The majority of patients (90%) in the nonconsenting group felt that the degree of risk incurred by undergoing trial treatment was moderate to high. The perceived burden imposed on daily life by participating was seen by the nonconsenting group to be moderately higher in 11 patients (55%) compared to 3 patients (15%) in the consenting group (p = 0.026). Of the nonconsenting patients, 50% were dissatisfied with the attitudes of medical experiments as compared to 2% of those who did consent (p = 0.023).

Conclusion

The major reasons for participation in a cataract surgery trial were (i) expected positive implications resulting from involvement; and (ii) satisfaction with the attitudes of medical experiments. Patients who refused to enter the trial felt that the degree of risk as well as the burden imposed on daily life by participating were high. Demographic variables did not have any impact on a patients' decisions to accept or decline entry into the trial.

Résumé

Objet

Identifier les déterminants du consentement des patients à participer à un essai clinique de chirurgie de la cataracte dans un hôpital de soins tertiaires.

Nature

Étude prospective observationnelle.

Participants

Quarante patients prévus pour la chirurgie de la cataracte ont été interviewés par questionnaire.

Méthodes

Les données recueillies des patients comprenaient les attitudes sur le consentement éclairé, l'évaluation de l'information transmise et les diverses données sociodémographiques.

Résultats

En tout, 20 patients (50 %) ont consentis à participer à l'essai. Tous les patients (n = 20,100 %) du groupe consentant s'attendaient à des implications positives comparativement à 6 (30 %) du groupe non-consentant qui prévoyaient des implications négatives (p = 0,008). La majorité des patients (90 %) du groupe non consentant estimait que le degré de risque de la participation au traitement d'essai variait de modéré à élevé. Chez le groupe non-consentant, la perception du fardeau imposé à la vie quotidienne par la participation était modérément plus élevée chez 11 patients (55 %) comparativement à trois (15 %) du groupe consentant (p = 0,026). Parmi les patients non-consentants, 50 % n'étaient pas satisfaits de l'attitude concernant les expériences médicales, comparativement à 2 % chez ceux qui étaient consentants (p = 0,023).

Conclusion

Les raisons principales en faveur de la participation à un essai de chirurgie de la cataracte portaient sur les implications positives qui en découlaient et la satisfaction des attitudes face aux expériences médicales. Les patients qui ont refusé de participer à l'essai estimaient trop élevés le risque de la participation de même que le fardeau imposé sur la vie quotidienne. Les variables démographiques n'avaient aucun impact sur la décision d'un patient d'accepter ou de refuser de participer à l'essai.

Section snippets

Methods

Respondents were sampled consecutively among patients who were approached to participate in a prospective cataract clinical study titled A Randomised, Single Centre Study of the Equivalence of Two Intraocular Lenses Used in Cataract Surgery at the Royal Victorian Eye and Ear Hospital in Melbourne, Australia, between January 2008 and June 2009. The Human Research Ethics Committee of the hospital approved the study. Intention to participate in the cataract clinical trial was determined after

Results

Over the course of study, 40 patients were asked to participate. All 40 patients agreed to participate and were interviewed by questionnaire. Of these 40 patients, 20 (50%) consented to enter the randomized controlled clinical trial assessing IOLs, and 20 (50%) declined. There were no statistically significant differences between the 2 groups in terms of age, sex, level of education, or annual income (Table 1).

Of those who did not consent, 14 (74%) reported that they had completed primary or

Discussion

In our study, the expected comforts and discomforts of participating in the trial differed significantly between consenting and nonconsenting patients. The factors that were independently associated with patients' consent were the amount of time required and the burden imposed on daily life resulting from participation in the trial. Demographic variables did not have any significant impact on a patients' decisions to accept or decline entry into the trial. Most patients who entered the trial

Disclosure

The authors have no proprietary or commercial interest in any materials discussed in this article.

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Original articleDeterminants of informed consent in a cataract surgery clinical trial: why patients participate

Abstract

Objective

Design

Participants

Methods

Results

Conclusion

Résumé

Objet

Nature

Participants

Méthodes

Résultats

Conclusion

Section snippets

Methods

Results

Discussion

Disclosure

Impact of risk communication on accrual, regimen, and follow-up compliance

Recruitment of subjects for clinical trials after informed consent: Does gender and educational status make a difference?

J Postgrad Med

Determinants of patient participation in clinical studies requiring informed consent: Why patients enter a clinical trial

Patient Educ Counsel

A randomized controlled trial comparing quantitative informed consent formats

J Clin Epidemiol

Why cancer patients enter randomized clinical trials: Exploring the factors that influence their decision

J Clin Oncol

Reasons for accepting or declining to participate in randomized clinical trials for cancer therapy

Br J Cancer

Who will participate in acute stroke trials?

Neurology

Surgical and oncology trials for rectal cancer: Who will participate?

Surgery

Patients' perceptions of informed consent and the quality of information disclosure in clinical trials

Patient Educ Couns

A theory of care-seeking behaviour

J Nurs Schol

Understanding the uptake of cervical cancer screening: The contribution of the health belief model

Br J Gen Pract

Original article
Determinants of informed consent in a cataract surgery clinical trial: why patients participate