ارزیابی مقالات کارآزمایی بالینی شاهددار تصادفی شده مجله‌ زنان، مامائی و نازایی ایران: 1398-1388

نوع مقاله : اصیل پژوهشی

نویسندگان

1 استاد گروه آمار زیستی، مرکز تحقیقات عوامل اجتماعی مؤثر بر سلامت، دانشکده بهداشت، دانشگاه علوم پزشکی مشهد، مشهد، ایران.

2 استاد گروه اپیدمیولوژی، مرکز تحقیقات عوامل اجتماعی مؤثر بر سلامت، دانشکده بهداشت، دانشگاه علوم پزشکی مشهد، مشهد، ایران.

3 دانشجوی کارشناسی ارشد آمار زیستی، دانشکده بهداشت، دانشگاه علوم پزشکی مشهد، مشهد، ایران.

4 کمیته تحقیقات دانشجویی، دانشکده بهداشت، دانشگاه علوم پزشکی مشهد، مشهد، ایران. دانشجوی دکتری آمار زیستی، دانشکده بهداشت، دانشگاه علوم پزشکی مشهد، مشهد، ایران.

چکیده

مقدمه: مطالعات کارآزمایی بالینی شاهددار تصادفی شده، از جمله معتبرترین نوع مطالعات هستند که طراحی مناسب و گزارش صحیح آنها در علم پزشکی از اهمیت ویژه‌ای برخوردار است. مطالعه حاضر با هدف ارزیابی نقادانه مطالعات کارآزمایی بالینی شاهددار تصادفی شده مجله‌ زنان، مامایی و نازایی ایران انجام شد.
روش‌کار: در این مطالعه مقطعی- تحلیلی، مقالات کارآزمایی بالینی مجله‌ زنان، مامایی و نازایی ایران در بازه سال‌های 98-1388، بر اساس آخرین ویرایش چک‌لیست کانسورت، توسط 3 کارشناس آمار زیستی که کفایت آموزش آنها با اندازه‌گیری ضریب توافق کاپا تأیید شد، امتیازدهی شدند. مقالات بر اساس امتیاز کسب شده در 5 دسته‌ بسیار ضعیف تا عالی طبقه‌بندی شدند. تجزیه و تحلیل داده‌ها با استفاده از نرم‌افزار آماری SPSS (نسخه‌ 25) و آمار توصیفی انجام شد.
یافته‌ها: از مجموع 1318 مقاله منتشر شده در بازه زمانی 11 ساله، 325 مورد را مقالات کارآزمایی بالینی تشکیل داده‌اند که از بین آنها، تنها 6 مقاله (85/1%) با درجه عالی ارزیابی شدند. کم‌ترین و بیشترین امتیاز در میان مقالات مورد بررسی به‌ترتیب 14 و 28 (حداکثر امتیازات 37) به‌دست آمد و میانگین و انحراف معیار امتیازات کسب شده در تمام مقالات به‌ترتیب 34/0±05/19 محاسبه گردید. با این‌حال، به دو مبحث اساسی تصادفی‌سازی و کورسازی در مطالعات کارآزمایی توجه کمتری شده بود.
نتیجه‌گیری: با توجه به اهمیت مطالعات کارآزمایی بالینی، توجه به کیفیت مقالات بر اساس چک‌لیست کانسورت ضروری است، همچنین به نویسندگان این‌گونه مقالات پیشنهاد می‌شود به 2 بنیاد اساسی مطالعات بالینی یعنی تصادفی‌سازی و کورسازی، توجه بیشتری نشان داده تا از این طریق قدرت تعمیم‌پذیری نتایج افزایش یابد.

کلیدواژه‌ها


عنوان مقاله [English]

Assessment of Randomized Controlled Clinical Trials articles in Iranian Journal of Obstetrics, Gynecology and Infertility: 2009-2019

نویسندگان [English]

  • Mohammad Taghi Shakeri 1
  • Ali Taghipour 2
  • Davoud Tanbakouchi 3
  • Mahboobe Sharifi Moghadam Bajestani 3
  • Reyhane Sadeghi 3
  • Ali Hadianfar 4
  • Razieh Yousefi 4
1 Professor, Department of Biostatistics, Social Determinants of Health Research Center, School of Health, Mashhad University of Medical Sciences, Mashhad, Iran.
2 Professor, Department of Epidemiology, Social Determinants of Health Research Center, School of Health, Mashhad University of Medical Sciences, Mashhad, Iran
3 M.Sc. student of Biostatistics, School of Health, Mashhad University of Medical Sciences, Mashhad, Iran.
4 Student Research Committee, School of Health, Mashhad University of Medical Sciences, Mashhad, Iran. PhD student of Biostatistics, School of Health, Mashhad University of Medical Sciences, Mashhad, Iran.
چکیده [English]

Introduction: Randomized controlled clinical trial studies are the most valuable types of studies that their proper design and accurate reporting are of particular importance in medical science. This study was performed with aim to critically evaluate the randomized controlled clinical trial studies in the Iranian Journal of Obstetrics, Gynecology and Infertility.
 Methods: In this cross-sectional analytic study, the clinical trial articles of the Iranian Journal of Obstetrics, Gynecology and Infertility between 2009 and 2019 were collected and scored based on the latest edition of the Consort Checklist (2010) by three biostatisticians that their training's adequacy was confirmed by measuring the kappa agreement coefficient. The articles were scored, and based on the scores, they were classified into five categories: very poor to excellent. Data were analyzed by SPSS software (version 25) and descriptive statistics.
Results: Out of a total of 1318 articles published during 11 years, 325 were clinical trials, among them only 6 articles (1.85%) were rated as excellent. The lowest and highest scores among the reviewed articles were 14 and 28 (maximum score was 37). The mean and standard deviation of the scores obtained in all articles was calculated as 19.05± 0.34. However, less attention was paid to the two main issues of randomization and blindness in the clinical trials.
Conclusion: Due to the importance of clinical trial studies, it is necessary to pay attention to the articles' quality based on the consort checklist. It is also suggested that authors of such articles pay more attention to the two essential foundations of clinical studies, randomization and blindness, to increase the generalization of the results.

کلیدواژه‌ها [English]

  • Critical evaluation
  • Clinical trial
  • randomization
  1. Zwierzyna M, Davies M, Hingorani AD, Hunter J. Clinical trial design and dissemination: comprehensive analysis of clinicaltrials. gov and PubMed data since 2005. bmj 2018; 361.
  2. Umscheid CA, Margolis DJ, Grossman CE. Key concepts of clinical trials: a narrative review. Postgraduate medicine 2011; 123(5):194-204.
  3. Nair B. Clinical trial designs. Indian dermatology online journal 2019; 10(2):193-201.
  4. Spilker B. Guide to clinical trials. New York: Raven; 1991.
  5. Talachi H, Orak RJ, Ravaghi H, Amanollahi A. Assessment of the quality of methodology reporting in the randomized trials. Journal of Health Administration (JHA) 2012; 15(48).
  6. Rennie D. CONSORT revised—improving the reporting of randomized trials. Jama 2001; 285(15):2006-7.
  7. Burls A. What is critical appraisal?. Hayward Medical Communications; 2009: 1-8.
  8. Adib-Hajbaghery M, Adib ME, Eshraghi Arani N. Evaluating the quality of randomized trials published in Persian nursing journals with more than 10 years of publishing using the CASP checklist. Iran Journal of Nursing 2017; 30(109):1-9.
  9. Moseley AM, Herbert RD, Maher CG, Sherrington C, Elkins MR. Reported quality of randomized controlled trials of physiotherapy interventions has improved over time. Journal of clinical epidemiology 2011; 64(6):594-601.
  10. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al. Improving the quality of reporting of randomized controlled trials: the CONSORT statement. Jama 1996; 276(8):637-9.
  11. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Trials 2010; 11(1):1-8.
  12. Vohra S, Shamseer L, Sampson M, Bukutu C, Schmid CH, Tate R, et al. CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. bmj 2015; 350.
  13. Hopewell S, Dutton S, Yu LM, Chan AW, Altman DG. The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed. Bmj 2010; 340.
  14. Estrada CA, Bloch RM, Antonacci D, Basnight LL, Patel SR, Patel SC, et al. Reporting and concordance of methodologic criteria between abstracts and articles in diagnostic test studies. Journal of general internal medicine 2000; 15(3):183-7.
  15. Hopewell S, Ravaud P, Baron G, Boutron I. Effect of editors’ implementation of CONSORT guidelines on the reporting of abstracts in high impact medical journals: interrupted time series analysis. Bmj 2012; 344.
  16. Ayoobi F, Rahmani MR, Assar S, Jalalpour S, Rezaeian M. The consort (consolidated standards of reporting trials). Journal of Rafsanjan University of Medical Sciences 2017; 15(10):977-94.
  17. Negahban Bonabi T, Ansari Jaberi A, Esmaeilzadeh S, Hasanshahi Ravizi A. Comparison of the effect of Acupressure at LI4 and SP6 points on the intensity of Post Cesarean Pain. Iran J Obstet Gynecol Infertil 2018; 21(6):9-17.
  18. Asadollahi F, Babazadeh R, Abdi H, Esmaeily H. Effect of foot solar plexus reflexology on severity of nausea and vomiting at first half of pregnancy: A Randomized Clinical Trial. Iran J Obstet Gynecol Infertil 2019; 22(6):54-64.
  19. Bosak Z, Iravani M, Moghimipour E, Haghighizadeh MH, Jelodarian P. Evaluation of the effect of chamomile vaginal gel on subjective symptoms of vaginal atrophy in postmenopausal women: a randomized clinical controlled trial. Iran J Obstet Gynecol Infertil 2019; 22(7):23-31.
  20. Khayatan J, Iravani M, Moghimipour E, Haghighizadeh MH, Jelodarian P. The effect of red clover vaginal cream on sexual function in postmenopausal women: A randomized, controlled clinical trial. Iran J Obstet Gynecol Infertil 2019; 22(8):26-34.
  21. Bagherinasab S. Comparing the effect of ferula oral capsule and metronidazole oral pill on improvement of clinical signs of infection by Trichomonas Vaginalis: A Controlled Clinical Trial. Iran J Obstet Gynecol Infertil 2019; 22(9):55-63.
  22. Schulz KF, Chalmers I, Grimes DA, Altman DG. Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals. Jama 1994; 272(2):125-8.
  23. Ayatollahi M, Jafari P, Ghaem H. An evaluation of the quality of published clinical trials in Iranian medical journals during 2001-2004. Journal of Babol University of Medical Sciences 2005; 7(4):64-70
  24. Taghipour A, Shakeri MT, Yousefi R, Barzanouni S. Assessment of Randomized Controlled Clinical Trials articles in the Journal of Dental School, Mashhad University of Medical Sciences: Published 2003-2015. Journal of Mashhad Dental School 2017; 41(1):11-20.
  25. Jamshidi Orak R, Amanollahi A. Survey of Blinding Methods, Type Of Intervention And Subject Areas In Randomized Controlled Clinical Trials. Payavard Salamat 2013; 6(5):25-26.     
  26. Mohammady M, Toghian Chaharsougi N, Abdoli S. Risk of bias in randomized controlled trials published in Iranian nursing and midwifery journals in 2010. Iranian Journal of Epidemiology 2014; 9(3):24-36.