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Medical Journal of Islamic Republic of Iran، جلد ۳۱، شماره ۱، صفحات ۴۲۴-۴۲۷
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عنوان انگلیسی Critical appraisal of fundamental items in approved clinical trial research proposals in Mashhad University of Medical Sciences
چکیده انگلیسی مقاله Background: Writing, designing, and conducting a clinical trial research proposal has an important role in achieving valid and reliable findings. Thus, this study aimed at critically appraising fundamental information in approved clinical trial research proposals in Mashhad University of Medical Sciences (MUMS) from 2008 to 2014.    Methods: This cross-sectional study was conducted on all 935 approved clinical trial research proposals in MUMS from 2008 to 2014. A valid and reliable as well as comprehensive, simple, and usable checklist in sessions with biostatisticians and methodologists, consisting of 11 main items as research tool, were used. Agreement rate between the reviewers of the proposals, who were responsible for data collection, was assessed during 3 sessions, and Kappa statistics was calculated at the last session as 97%.    Results: More than 60% of the research proposals had a methodologist consultant, moreover, type of study or study design had been specified in almost all of them (98%). Appropriateness of study aims with hypotheses was not observed in a significant number of research proposals (585 proposals, 62.6%). The required sample size for 66.8% of the approved proposals was based on a sample size formula; however, in 25% of the proposals, sample size formula was not in accordance with the study design. Data collection tool was not selected appropriately in 55.2% of the approved research proposals. Type and method of randomization were unknown in 21% of the proposals and dealing with missing data had not been described in most of them (98%). Inclusion and exclusion criteria were (92%) fully and adequately explained. Moreover, 44% and 31% of the research proposals were moderate and weak in rank, respectively, with respect to the correctness of the statistical analysis methods.    Conclusion: Findings of the present study revealed that a large portion of the approved proposals were highly biased or ambiguous with respect to randomization, blinding, dealing with missing data, data collection tool, sampling methods, and statistical analysis. Thus, it is essential to consult and collaborate with a methodologist in all parts of a proposal to control the possible and specific biases in clinical trials.  
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نویسندگان مقاله محمد تقی شاکری | mohammad taghi shakeri
department of epidemiology amp; biostatistics, health school, mashhad university of medical science, mashhad, iran.


علی تقی پور | ali taghipour
department of epidemiology amp; biostatistics, health school, mashhad university of medical science, mashhad, iran.


معصومه صادقی | masoumeh sadeghi
department of epidemiology, school of public health, shahid beheshti university of medical sciences, tehran, iran.

سازمان اصلی تایید شده: دانشگاه علوم پزشکی شهید بهشتی (Shahid beheshti university of medical sciences)

حسین نظامی | hossein nezami
department of epidemiology amp; biostatistics, health school, mashhad university of medical science, mashhad, iran amp; department of biostatistics amp; medical informatics, faculty of medicine, gonabad university of medical sciences, gonabad, iran.

سازمان اصلی تایید شده: دانشگاه علوم پزشکی گناباد (Gonabad university of medical sciences)

علیرضا امیرآبادی زاده | ali reza amirabadizadeh
department of epidemiology amp; biostatistics, health school, mashhad university of medical science, mashhad, iran.


حسین بنکچی | hossein bonakchi
department of epidemiology amp; biostatistics, health school, mashhad university of medical science, mashhad, iran.
نشانی اینترنتی http://mjiri.iums.ac.ir/browse.php?a_code=A-10-3234-1&slc_lang=en&sid=en
فایل مقاله دریافت فایل مقاله
کد مقاله (doi)
زبان مقاله منتشر شده en
موضوعات مقاله منتشر شده Epidemiology
نوع مقاله منتشر شده Original Research
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