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 Table of Contents  
ORIGINAL ARTICLE
Year : 2019  |  Volume : 7  |  Issue : 2  |  Page : 69-74

Patients' attitudes and knowledge toward clinical trial participation


1 Department of Surgery, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia
2 Department of Special Education, Faculty of Educational Graduate Studies, King Abdulaziz University, Jeddah, Saudi Arabia

Date of Web Publication6-Sep-2019

Correspondence Address:
Abdulmalik Altaf
Department of Surgery, Faculty of Medicine, King Abdulaziz University, PO Box 80200, Jeddah 21589
Saudi Arabia
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ssj.ssj_23_19

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  Abstract 

Objective: The study objective was to investigate patients' attitudes toward clinical trial participation and the barriers to participation. We also aimed to estimate the proportion of patients willing to participate in clinical trials.
Methods: We conducted a survey on patients who were scheduled to have minor or major surgery at King Abdulaziz University Hospital between May 2018 and December 2018. We used a questionnaire that comprised 27 multiple-choice questions to assess patients' attitudes and knowledge toward trial participation. Data were analyzed using the Statistical Package for the Social Sciences software.
Results: We recruited 200 patients, of whom 123 (61.5%) were male; 129 patients (64.5%) agreed that they were knowledgeable about the importance of clinical researches, whereas 34 (17.0) reported that they had no knowledge about its importance. One-hundred and thirty-eight patients (69.0%) were positive about clinical trial participation, 30 patients (15.0%) were negative, and 32 (16.0%) had no opinion. There was no statistically significant association between patients' attitudes toward trial participation and age (P = 0.422) or gender (P = 0.066). Conversely, there was a statistically significant association between the level of education and patients' willingness to participate in clinical trials (P = 0.05). We found a statistically significant association between patients' perception of clinical trials in their community and age (P = 0.001) as well as educational level (P = 0.003).
Conclusion: The findings suggest general support of clinical trials, with 69% of the patients willing to consider enrolling in a clinical trial.

Keywords: Clinical trials, patient enrollment, patients' attitude, surgery, trial participation


How to cite this article:
Altaf A, Bokhari R, Enani G, Judeeba S, Hemdi A, Maghrabi AA, Tashkandi H, Aljiffry M. Patients' attitudes and knowledge toward clinical trial participation. Saudi Surg J 2019;7:69-74

How to cite this URL:
Altaf A, Bokhari R, Enani G, Judeeba S, Hemdi A, Maghrabi AA, Tashkandi H, Aljiffry M. Patients' attitudes and knowledge toward clinical trial participation. Saudi Surg J [serial online] 2019 [cited 2019 Sep 16];7:69-74. Available from: http://www.saudisurgj.org/text.asp?2019/7/2/69/266209


  Introduction Top


Medicine has been practiced based on evidences obtained from randomized clinical trials, bringing the term “evidence-based medicine” into practice.[1] Medical researches have led to the achievement of well-established medical care guidelines, cost-effective treatment, and the most-wanted outcomes. Clinical trials are considered the ultimate tool to evaluate the effectiveness of new surgical techniques and treatment modalities, including new cancer treatment.[2] Although randomized controlled trials are powerful tools, their use is limited by ethical and practical concerns. Exposing patients to an intervention believed to be inferior to the current treatment is often thought unethical. Therefore, the ethical aspect of clinical research has been a major concern in the past years, especially in developing countries.[3],[4],[5] In addition, the declining number of patients willing to participate in researches and the difficulties researchers face in recruiting participants have been noticed recently.[6] The lack of patients' participation in clinical researches calls attention to how new findings can be obtained from clinical trials.[6]

There are a number of studies that addressed the barriers to participation in clinical trials, including the level of education,[7],[8] age,[9] means of communication,[10] race,[11],[12],[13] patient preference for a certain treatment,[14] fear or mistrust,[1],[15],[16] and cultural beliefs about diseases.[17] Few data supported the importance of encouraging researchers to find new strategies to increase participation among patients in clinical researches. Factors such as patients' attitudes toward research and researchers and the risks and benefits of participating in researches are still important for investigations.[18],[19],[20] These factors are highly influenced by cultural and religious beliefs, and they must be taken under consideration when planning to conduct local clinical trials.[21],[22],[23],[24] Although many studies looked at these data in the West, only very few studies were conducted in the Middle East.[23]

To date, there are no data in Saudi Arabia that show people's attitude and knowledge toward clinical trials. Therefore, this study was conducted to investigate patients' attitudes toward clinical trial participation and the barriers to participation. We also aimed to estimate the proportion of surgical patients willing to participate in clinical trials.


  Methods Top


Patients

We conducted a survey on patients who were scheduled to have minor or major surgery at King Abdulaziz University Hospital between May 2018 and December 2018. Patients were included provided they were able to communicate and understand the survey questions. We excluded patients with psychiatric disorders or cognitive disabilities and those who declined to participate. Consent was obtained from all the patients prior to their inclusion in the study. Permission to conduct the study was granted by the Ethics Research Committee of the Faculty of Medicine, King Abdulaziz University.

Instrument

We used a questionnaire (in Arabic) that comprised 27 multiple-choice questions to assess patients' attitudes and knowledge toward clinical trial participation. Investigators explained the content of the questionnaire to patients, who then completed the questionnaire. Help was provided to the illiterate.

The questionnaire was composed of four parts. The first included questions about demographic characteristics, namely age, nationality, educational level, and gender. The second part assessed participants' attitudes toward participating in clinical research and the type of research they would feel comfortable with participating in. There were five questions in this section, of which two were aimed at assessing participants' general attitude toward researches and another two that addressed their self-involvement and experience in participating in a clinical trial. The third part addressed general and specific factors that might influence participants' attitudes toward clinical trial participation. This section included 12 closed questions with fixed response options, namely “Agree,” “Neutral,” and “Disagree.” The fourth part included four questions about participants' attitudes regarding randomized clinical trials. There were also fixed response options to the questions, namely “Agree,” “Neutral,” and “Disagree.”

Data analysis

Data were analyzed using the Statistical Package for the Social Sciences (SPSS Inc., Chicago, IL, USA). Descriptive statistics was calculated for all variables, and Chi-square test was used to assess the relationship between the patients' attitudes and their gender, age, and level of education. Differences with P < 0.05 were considered statistically significant.


  Results Top


We recruited 200 patients, of whom 123 (61.5%) were male. Overall, 88 (44.0%), 73 (36.5%), and 21 (10.5%) patients were in the age groups of 21–39 years, 40–60 years, and ≥60 years, respectively. Only 18 patients (9.0%) were <18 years old. Saudis constituted over half of the study population (n = 124, 64%). Nearly half of the patients (n = 98, 49.0%) had completed at least secondary school education. Ninety-three patients (46.5%) had a bachelor's degree, seven (3.5%) had a master's degree, whereas two (1.0%) had a doctoral degree; only 13 patients (6.5%) were uneducated.

Twenty-five patients (12.5%) reported ever having participated in a clinical trial. While 138 patients (69.0%) were positive about participating in a clinical trial, 30 (15.0%) disagreed with the idea and 32 (16.0%) had no opinion.

Up to 129 patients (64.5%) agreed that they were knowledgeable about the importance of clinical researches, whereas 34 (17.0) reported that they had no knowledge about its importance. Regarding surgeries, only 47 patients (23.5%) believed that they were evidence based. The remainder of the patients either disagreed (n = 88, 44.0%) or had no opinion (n = 65, 32.5%).

Sixty-eight patients (34.0%) expressed their unwillingness to have clinical researches to be implemented in their community due to their lack of trust in our current health-care system. Although most patients thought that doctors' motives for conducting researches were to discover new treatments (n = 57, 28.0%) and help patients (n = 78, 39.0%), some patients thought that doctors did it for professional advancement (n = 60, 30.0%) or for financial reasons (n = 5, 2.5%). Overall, 146 patients (73.0%) admitted that they would participate in a clinical research trial if it was supervised from abroad. [Table 1] shows the factors that may influence trial participation.
Table 1: Factors that motivate and discourage patients from participating in a clinical trial

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The patients' opinions about people enrolled in clinical trials were as follows: 5 (2.5%) thought that they took unnecessary risks, 20 (10.0%) thought that clinical trial participants had financial interests, 135 (67.5%) thought that they were doing so to improve scientific development, while 40 (20.0%) had no opinion.

There was no significant association between patients' attitudes toward trial participation and age or gender [Table 2]. On the contrary, there was a significant association between the level of education and patients' willingness to participate in clinical trials.
Table 2: Patients' attitudes toward clinical trial participation based on age, gender, and educational attainment*

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We found a significant association between patients' age and their perception of clinical trials (P = 0.001), with those aged 40–60 years representing 91.8% of patients in that age group who had a positive attitude toward research in comparison to 78.4% aged 21–39 years and 71.4% aged >60 years [Table 3]. We also found a significant association between patients' educational level and their attitudes toward research, with patients who had a higher level of education expressing a more positive attitude toward research in their community. Gender, on the contrary, was not significantly associated with patients' views about research in their community. The type of clinical trials that patients would agree to participate is shown in [Table 4].
Table 3: Patients' attitude toward research conducted in their community*

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Table 4: Type of clinical trials that patients would agree to participate in

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When participants were asked on their willingness to participate in a randomized controlled clinical trial that investigates two novel treatment modalities using steroid injections or a surgical operation, 160 (73%) patients agreed on participating, whereas 54 (27%) patients disagreed. They were asked another example on whether they would agree to be selected in a randomized controlled clinical trial that investigates the effectiveness of a surgical operation with the two different approaches. Forty-five (22.5%) patients agreed on participating and 155 (77.5%) patients were not comfortable with being selected in the trial.


  Discussion Top


Over half of the patients surveyed (64.5%) agreed that they were knowledgeable about the importance of clinical researches. Although most patients (84.5%) had a positive view about research in their community, a smaller proportion (69.0%) was willing to consider participation in a clinical trial. Excellent, supervised medical care; a sense of contributing to science; and altruism were factors that motivated participation in clinical research. On the other hand, fear of the possible adverse effects of trial medications, discomfort about the lack of medical information on the investigated drug, or lack of trust in the medical system, for the most part, were the reasons that the patients cited as barriers to clinical trial participation.

Many of the factors in this study have appeared in prior studies of clinical trial participation, albeit the relative importance of the factors is diverse. For example, among the factors motivating participation in clinical trials, willingness to help others and a desire to contribute to science have also been reported in a variety of Western settings.[18],[25],[26],[27],[28],[29],[30] This is of interest when it is recognized that financial compensation is also a common motivating factor that has been cited by participants.[25],[27],[31],[32],[33] Thus, it appears that even if participants are financially compensated, the sense that they are helping the society is still an important benefit of participating in research.

Risk–benefit considerations are an important aspect of decision-making regarding trial participation.[34] In other studies conducted in the West, barriers to trial participation were due to concerns about the unknown or unexpected future adverse effects.[34],[35],[36],[37] In addition, research has shown that patients and parents of potential trialists were less comfortable with trials that entailed more invasive and potentially painful protocols.[29],[38] In one report that assessed the reasons for participating in randomized controlled trials, the authors found that although people who agreed to be randomized saw it as a situation in which they could both help others and benefit, they were willing to do so provided they would not be harmed personally.[29]

A higher percentage of the patients in our study acknowledged that they would consider enrolling in a clinical trial if it was supervised from abroad, demonstrating mistrust in our medical system. It is not clear whether the patients' mistrust in our health-care system is because of previous poor experience or because research is still poorly organized in Saudi Arabia.[39] Findings from several studies in the United States have described racial discrepancies in research participation,[40] and this has been attributed to mistrust in medical researchers in most cases.[41],[42],[43] Mistrust has also been reported as a prominent barrier to clinical trial participation in Asians,[30],[44] and it has been associated with lack of knowledge and understanding of clinical trials.[30]

In this study, there was no statistically significant association between age and willingness to enroll in a clinical trial. Conversely, age was significantly associated with patients' perception of clinical trials conducted in their community, with those aged 40–60 years representing 91.8% of patients in that age group who had a positive attitude toward research in their community. The association between age and trial enrollment has also been explored by other authors, who found a strong relationship between age and enrollment fraction, defined as the number of trial enrollees divided by the estimated cancer cases in each race and age subgroup, with trial participants 30–64 years of age representing 3.0% of incident cancer patients in that age group, compared to 1.3% of 65- to 74-year-old patients and 0.5% of patients ≥75 years of age.[45]

Consistent with our findings, reports from studies on Asian patients revealed that gender[45],[46],[47] and educational level affected willingness to enroll in clinical trials.[47] However, contrary to our findings, Gitanjali et al.[46] found a statistically significant (P = 0.043) association between gender and clinical trial participation, with a lower percentage of women (30%) expressing willingness to participate in a trial. Similarly, Murthy et al.[45] reported that men were more likely than women to enroll in colorectal cancer trials (enrollment fractions: 2.1% vs. 1.6%, respectively; odds ratio, 1.30; 95%; confidence interval [CI], 1.24–1.35; P < 0.001) and lung cancer trials (enrollment fractions: 0.9% vs. 0.7%, respectively; odds ratio, 1.23; 95% CI, 1.16–1.31; P < 0.001). Our finding of a significant association between educational level and clinical trial participation has also been reported by other authors, who found that less educated patients were less likely to participate in clinical trials.[48] Furthermore, there are reports that older people with a lower level of education were less likely to participate in research.[49],[50]

Our study is the first in Saudi Arabia to examine potential participants' perspectives on clinical trial participation. More so, we further explored the type of clinical trials that patients would be willing to enroll in. However, because our study is hospital based, the findings cannot be generalized to the community. Another limitation of our study is that it examined patients' views about enrolling in hypothetical clinical trials, limiting the generalizability of results. Because disease burden, among other factors, might affect patients' attitude toward clinical trial participation,[35] we recommend conducting a study to assess the experiences and opinions of patients who are approached to enroll in a clinical trial.


  Conclusion Top


Most patients had a positive attitude toward research in their community. Sixty-nine percent of the patients were willing to consider enrolling in a clinical trial, and the rate was significantly higher in patients with a higher level of education. Although some patients described distrust of the medical system as a barrier to participation in clinical research, safety issues and lack of knowledge about investigational drugs were the major concerns. Given that patients are concerned about adverse effects, this underlines the importance of interventions aimed at increasing awareness and addressing specific beliefs and expectations.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
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  [Table 1], [Table 2], [Table 3], [Table 4]



 

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