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Knowledge of and Attitudes Toward Clinical Trials in Saudi Arabia: a Cross- Sectional Study

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Knowledge of and Attitudes Toward Clinical Trials in Saudi Arabia: a Cross- Sectional Study Open access Original research BMJ Open: first published as 10.1136/bmjopen-2019-031305 on 22 October 2019. Downloaded from Knowledge of and attitudes toward clinical trials in Saudi Arabia: a cross- sectional study Nedal Al-Rawashdeh,1,2,3,4 Rana Damsees,1,2,3,4 Majed Al-Jeraisy,1,3,4 Eman Al Qasim,1,3,4 Ahmad M Deeb 1,3,4 To cite: Al-Rawashdeh N, ABSTRACT Strengths and limitations of this study Damsees R, Al-Jeraisy M, Objectives Clinical trials (CTs) are considered an et al. Knowledge of and important method for developing new treatments and ► The Saudi public’s knowledge of and attitudes to- attitudes toward clinical trials providing access to potentially effective drugs that are still in Saudi Arabia: a cross- ward clinical trials (CTs) are under-researched. under investigation. Measuring the public’s knowledge sectional study. BMJ Open ► This is the first study to explore the Saudi public’s of and attitudes toward CTs is important for assessing 2019;9:e031305. doi:10.1136/ knowledge and attitudes in terms of the different their readiness for and acceptance of human drug testing, bmjopen-2019-031305 phases of CTs in adult and paediatric populations. which has previously not been assessed in the Kingdom of ► The main limitation is possible selection bias due to ► Prepublication history for Saudi Arabia (KSA). The objective of this study is to explore convenience sampling. this paper is available online. the Saudi public’s knowledge of and attitudes toward CTs To view these files, please visit as well as participation in trials to test new or approved the journal online (http:// dx. doi. drugs. org/ 10. 1136/ bmjopen- 2019- The involvement of an adequate number of 031305). Design Cross-sectional. Setting The 2016 Al Jenadriyah cultural/heritage festival participants is crucial in achieving the study’s Received 27 April 2019 in Riyadh, KSA. objectives, namely testing the hypothesis and Revised 10 September 2019 Participants Participating booths and exhibition halls, as answering the research questions. Failure Accepted 26 September 2019 well as festival visitors, were approached to participate in to recruit an adequate number of partici- the study. pants could result in wasted time, money and Primary and secondary outcome measures Knowledge effort.2 It may also delay the acceptance of the of and attitudes toward CTs. trial results and the completion of the drug Results The final number of participants was 938. The http://bmjopen.bmj.com/ development process. responses were converted to a percentage mean score (out of 100) for each knowledge-related response and Knowledge of and attitudes toward CTs are considered major challenges in participant attitude. The total mean knowledge score was 56.8±24.8 3–6 and the attitude-related score was 61.5±28.0. Although recruitment. Several studies have reported most of the participants supported testing approved or that knowledge of CTs and attitudes toward 7–11 off-label and new drugs on adult and paediatric patients, participation are interrelated, as increased only a third (30.5%) agreed that new drugs could be tested knowledge promotes a positive attitude on healthy volunteers. The results indicated that gender, toward CT participation. Low recruitment © Author(s) (or their educational level, income, medical background, age and on September 29, 2021 by guest. Protected copyright. employer(s)) 2019. Re-use rates for CTs may be improved by increasing health insurance were independently associated with the 6 9 11 permitted under CC BY-NC. No the public’s knowledge about CTs and commercial re-use. See rights level of knowledge of CTs. In terms of attitudes toward by highlighting how participation can CTs, the factors that were independently associated were and permissions. Published by contribute to the improvement of the public’s BMJ. gender, educational level and medical background. health.12 13 Improving the public’s knowledge 1Research Office, King Abdullah Conclusions The Saudi public has a low level of of CTs represents an important initial step in International Medical Research knowledge and a moderately positive attitude toward CTs. 9 12 14 Center, Riyadh, Saudi Arabia There is a moderate positive correlation between the two improving CT recruitment in the future. 2The Office of Scientific Affairs factors such that as knowledge of CTs increases, the Saudi Clinical research in the Kingdom of and Research, King Hussein public will hold more positive attitudes toward CTs. Saudi Arabia (KSA) has made advance- Cancer Center, Amman, Jordan ments during the last few decades.15 Saudi 3King Saud bin Abdulaziz University for Health Sciences, researchers have contributed to medical Riyadh, Saudi Arabia INTRODUCTION literature by conducting different types of 4Ministry of the National Guard A clinical trial (CT) is a superior research tool research, including investigator-initiated CTs - Health Affairs, Riyadh, Saudi for advancing medical knowledge and prac- and international multicenter-sponsored Arabia tice as the results are considered to provide CTs.15 Measuring the Saudi public’s knowl- Correspondence to the highest level of evidence for medical edge of and attitudes toward CTs is crucial 1 Ahmad M Deeb; practice and decision-making. Volunteer for assessing their acceptance of CTs and rn_ a_ deeb@ hotmail. com participation is at the core of a successful CT. to provide an evidence base to improve CT Al-Rawashdeh N, et al. BMJ Open 2019;9:e031305. doi:10.1136/bmjopen-2019-031305 1 Open access BMJ Open: first published as 10.1136/bmjopen-2019-031305 on 22 October 2019. Downloaded from recruitment and decision-making. In addition, such an basis of this population estimate, a 0.05 margin of error, endeavour can provide reliable information that can aid a 95% confidence level and a response rate of 50%, the researchers and healthcare leaders in strategic planning minimum sample size calculated for this study was 385. of public engagement in CT awareness campaigns. From We targeted a sample size of 1000 to account for sampling the public’s perspective, these efforts may be beneficial errors and variability between the characteristics of our through increasing their knowledge and awareness of sample and the general Saudi population. CTs, improving medical knowledge through dissemina- tion of CT results and sharing of public preferences for Data collection future CTs. A structured questionnaire, developed in Arabic, was Several studies have reported the knowledge and atti- divided into three sections: demographic information, tudes of patients or families toward CTs in healthcare knowledge and attitudes. settings in the KSA16–20; however, studies measuring the The following variables were included in the demo- knowledge and attitudes of the general Saudi public are graphic information section: gender, age, educational lacking. The purpose of this study was to assess the Saudi level, monthly income, nationality, residential area, public’s general knowledge of and attitudes toward CTs marital status, employment status, health insurance, and more specifically, their attitudes toward participation chronic diseases, medical background (working in a in CTs for drug development. healthcare facility or having health-related education) The study addressed the following four questions: What and previous participation in medical research. does the Saudi public know about CTs? What is the atti- The knowledge section was composed of 12 questions, tude of individuals in the KSA toward CTs and participa- and the participants’ responses were scored as correct tion in CTs? Is there a correlation between the level of (score=1) or incorrect/not sure (score=0). The total public knowledge and the attitudes of Saudi individuals knowledge score was converted to a percentage mean toward CTs? What factors are associated with the levels of score with a possible maximum value of 100, where a public knowledge and attitudes toward CTs in the Saudi score of 100 indicates perfect knowledge of CTs. population? The attitude section was composed of 9 direct questions, and participant answers were scored as positive (score=1) or negative/not sure (score=0). The total attitude score MATERIALS AND METHODS was converted to a percentage mean score with a possible Setting maximum value of 100, where a score of 100 indicates a This cross-sectional study was conducted between 2 positive attitude toward CTs. February 2016 and 19 February 2016 at the Al Jenadriyah Based on previous studies, the overall knowledge cultural and heritage festival. The festival takes place in and attitude levels were classified into three categories Riyadh and hosts millions of residents and visitors from following Bloom’s cut-off point criteria: above 80% (high http://bmjopen.bmj.com/ different regions in the country. We selected this event as level), 60% to 79% (moderate level) and less than 60% 22–24 it provided us with a unique chance to interview a repre- (low level). sentative cross-section from all regions of the KSA. We used simple language so as to enable the partici- pants to answer the questions even if they were not aware Study participants of CTs. The questionnaire was validated using a content The study included adults of both genders who were validation process. A panel of expert analysts evaluated willing to participate. A convenience sampling approach the questions, rating each one as essential, useful or irrel- was used. Participating booths and exhibition halls in the evant in the context of measuring knowledge and atti- on September 29, 2021 by guest. Protected copyright. festival were approached and festival visitors were invited tudes. The questionnaire was pretested using a sample to participate in the study. All participants provided of 28 participants. As a result of the pretest, complex informed consent by checking the YES box indicating scientific terms were simplified. Reliability was tested by their willingness to complete the questionnaire. Respon- calculating the Cronbach’s alpha for the pretest sample dents did not receive any compensation for participation for both the knowledge and attitude sections (21 items).
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