ارزیابی کیفیت کارآزمایی‌های بالینی در زمینه تأثیر روش‌های محافظه‌کارانه در زنان مبتلا به اختلالات کف لگن با استفاده از ابزار CONSORT

نوع مقاله : مروری

نویسندگان

1 استادیار گروه مامایی، مرکز تحقیقات مراقبت‌های پرستاری و مامایی، دانشگاه علوم پزشکی مشهد، مشهد، ایران.

2 استاد گروه مامایی، مرکز تحقیقات مراقبت‌های پرستاری و مامایی، دانشگاه علوم پزشکی مشهد، مشهد، ایران. استاد گروه مامایی، دانشکده پرستاری و مامایی، دانشگاه علوم پزشکی مشهد، مشهد، ایران.

چکیده

مقدمه: در هنگام طراحی یک برنامه درمانی مبتنی بر شواهد، جهت کمک به بیماران مبتلا به اختلالات کف لگن با استفاده از انواع روش­های محافظه‌کارانه، لازم است مطالعاتی انتخاب شوند که علاوه بر تمرکز بر موضوع مورد نظر، از کیفیت مناسبی نیز برخوردار باشند، لذا مطالعه حاضر با هدف ارزیابی کیفیت کارآزمایی­ های بالینی در زمینه تأثیر روش‌های محافظه­ کارانه­ در زنان مبتلا به اختلالات کف لگن با استفاده از ابزار CONSORT انجام شد.
روش‌کار: در این مطالعه مرور نقادانه، کارآزمایی­ های بالینی چاپ شده بین سال‌های 2021-2001 که در پایگاه­ های بین‌المللی PubMed، Medline، Cochrane، Web of Science و Scopus و همچنین پایگاه­ های ایرانی Magiran و SID نمایه شده بودند، با کلیدواژه ­های فارسی و انگلیسی جستجو شدند. از 416 مقاله بازیابی شده، 64 مقاله از نظر چکیده و متن کامل با استفاده از ابزار CONSORT 2017 مورد ارزیابی قرار گرفتند. داده ­ها با نرم‌افزار آماری SPSS (نسخه 16) و روش ­های آمار توصیفی مورد تجزیه و تحلیل قرار گرفتند.
یافته ­ها: در بررسی کامل مقالات، میانگین نمره­ کلی کیفیت بر اساس معیار CONSORT برابر 7/5±85/28 (حداقل 12 و حداکثر 41) بود. عنوان، مقدمه، هدف و بحث، بیشترین و روش­­ کار و یافته ­ها، کمترین میانگین نمره را کسب کردند. 9/33% از مقالات به نوع مطالعه در عنوان اشاره نکرده بودند. در قسمت چکیده، 75% مقالات به نوع مطالعه، 5/87% به چگونگی تصادفی ­سازی و بیش از 2/73% مقالات به کورسازی اشاره نکرده بودند.
نتیجه ­گیری: کیفیت کارآزمایی‌های بالینی ارزیابی شده در حد متوسط بود. بهبود کیفیت مطالعات کارآزمایی، خصوصاً در بخش روش‌­ کار، برای استفاده­ بیشتر در بالین و ارائه مراقبت­های بهتر ضروری می­ باشد. با اخذ کمک از متخصصین آمار و متدولوژی و ابزارهای استاندارد جهت ارزیابی نقادانه، می­توان به ارتقای کیفی مقالات کمک نمود. 

کلیدواژه‌ها

عنوان مقاله [English]

Assessing the quality of published clinical trials regarding the effect of conservative methods in women with pelvic floor disorders using CONSORT tool

نویسندگان [English]

  • Zahra Hadizadeh-Talasaz 1
  • Mona Larki 1
  • Robab Latifnejad Roudsari 2
1 Assistant Professor, Department of Midwifery, Nursing and Midwifery Care Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
2 Professor, Department of Midwifery, Nursing and Midwifery Care Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Professor, Department of Midwifery, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.
چکیده [English]

Introduction: When designing an evidence-based treatment program to help patients with pelvic floor disorders through conservative methods, it is necessary to select studies that, in addition to focusing on the desired subject, also have a suitable quality. Therefore, the present study was performed with aim to assess the quality of published clinical trials regarding the effect of conservative methods in women with pelvic floor disorders using CONSORT tool.
Methods: In this critical review, published RCTs which are indexed in PubMed, Scopus, Medline, Cochrane، Web of Science as well as Persian databases such as SID and Magiran from 2001 to 2021 were searched using Persian and English keywords. Out of 416 articles, 64 RCTs were assessed using CONSORT 2017 checklist. Data were analyzed using SPSS (version 16) and descriptive statistical tests.
Results: In the complete assessment of the articles, the mean overall score of articles quality based om CONSORT criteria was 28.85 ± 7.5 (minimum and maximum range of 12-41). Title, introduction, objectives and discussion had the highest mean score; whereas method and results section had the lowest mean score. Also, 33.9% of the articles had not point out the type of the article in the title. In the abstract section, 75% of the articles did not report the study type, 87.5% did not describe the method of randomization, and more than 73.2% did not report blinding.
Conclusion: The appraised articles in the present study had a moderate quality. Improving the quality of clinical trials, especially in the method section, is essential for more use at the bedside and providing better care. Getting help from experts in the statistics and methodology as well as using standard tools for critical appraisal, the quality of articles could be improved.

کلیدواژه‌ها [English]

  • Clinical trials
  • Conservative methods
  • CONSORT
  • Pelvic floor disorders
  • Quality Assessment

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مجله زنان، مامایی و نازایی ایران
دوره 26، شماره 3
خرداد 1402
صفحه 109-122

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