Advertisement

Identification and description of controlled clinical trials published in Spanish Gynaecology and Obstetrics journals and risk of bias assessment of trials on assisted reproductive techniques

      Abstract

      Objectives

      To identify and describe controlled clinical trials (CCTs) published in Spanish Gynaecology and Obstetrics journals. In addition, to assess the quality of the CCTs on Assisted Reproduction Techniques (ART) identified in this project.

      Study design

      In order to identify eligible CCTs, all Spanish Gynaecology and Obstetrics journals were handsearched. Handsearching was conducted following the guidelines provided by the Cochrane Collaboration, which state that each journal article must be carefully reviewed, including original articles and other types of studies, letters to the editor, abstracts, and conference presentations. The results of the handsearching process were compared with an electronic search conducted in MEDLINE (PubMed). A descriptive analysis of the main characteristics of the identified CCTs was performed, as well as a methodological assessment of CCTs on ART.

      Results

      Sixteen Gynaecology and Obstetrics journals were identified, four of which have been indexed in MEDLINE at some point, although not currently. The journal with the most CCTs was “Progresos de Obstetricia y Ginecología”. A total of 235 CCTs were published in these journals, of which 29 were on ART. Most CCTs (216, 91.9%) were carried out in a hospital setting; 201 (89.4%) were unicentric. Obstetrics was the most studied subspecialty (46.4%). Among CCTs on ART, the risk of bias was predominantly high.

      Conclusions

      The number of CCTs published in Spanish Gynaecology and Obstetrics journals is limited. CCTs on ART present deficiencies in the report of results and low methodological quality. It is advised that authors and journals adhere to the CONSORT statement and to the Cochrane Collaboration recommendations to reduce risk of bias when designing and disseminating research projects.

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      References

        • Schulz K.F.
        • Chalmers I.
        • Hayes R.J.
        • Altman D.G.
        Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials.
        JAMA. 1995; 273: 408-412
        • Kjaergård L.
        • Villumsen J.
        • Gluud C.
        Quality of randomised clinical trials affects estimates of intervention efficacy.
        in: Abstracts for workshops and scientific sessions, 7th international cochrane colloquium, Rome. 1999 ([Abstract])
        • McAuley L.
        • Pham B.
        • Tugwell P.
        • Moher D.
        Does the inclusion of grey literature influence estimates of intervention effectiveness reported in meta-analyses?.
        Lancet. 2000; 356: 1228-1233
        • Sackett D.L.
        • Rosenberg W.M.C.
        • Gray J.A.M.
        • et al.
        Evidenced-based medicine: what it is and what it isn’t.
        BMJ. 1996; 312: 71-72
        • Smith R.
        • Rennie D.
        Evidence based medicine an oral history.
        BMJ. 2014; 348: g371
        • Qaseem A.
        • Forland F.
        • Macbeth F.
        • et al.
        Guidelines International Network: toward international standards for clinical practice guidelines.
        Ann Intern Med. 2012; 156: 525-531https://doi.org/10.7326/0003-4819-156-7-201204030-00009
        • Laine C.
        • Taichman D.B.
        • Mulrow C.
        Trustworthy clinical guidelines.
        Ann Intern Med. 2011; 154: 774-775https://doi.org/10.7326/0003-4819-154-11-201106070-00011
        • Hopewell S.
        • Clarke M.
        • Lusher A.
        • Lefebvre C.
        • Westby M.
        A comparison of handsearching versus MEDLINE searching to identify reports of randomized controlled trials.
        Stat Med. 2002; 21: 1625-1634
      1. Higgins J.P.T. Green S. Cochrane handbook for systematic reviews of interventions version 5.1.0. The Cochrane Collaboration, 2011 (Available from www.cochrane-handbook.org [updated March 2011])
        • Lefebvre C.
        The Cochrane Collaboration: the role of the UK Cochrane Centre in identifying the evidence.
        Health Libr Rev. 1994; 11: 235-242
        • Lefebvre C.
        • Glanville J.
        • Wieland L.S.
        • Coles B.
        • Weightman A.L.
        Methodological developments in searching for studies for systematic reviews: past, present and future?.
        Syst Rev. 2013; 2: 78
        • OMS
        Plataforma de registros internacionales de ensayos clínicos.
        2015 (Accesible en http://www.who.int/ictrp/about/es/)
        • Hopewell S.
        • Clarke M.
        • Lefebvre C.
        • Scherer R.
        Handsearching versus electronic searching to identify reports of randomized trials.
        Cochrane Database Syst Rev. 2007; : MR000001
        • Garcia-Alamino J.M.
        • Perrotta C.
        • Clopés A.
        • Parera A.
        • Perez-de-la-ossa N.
        • Bonfill X.
        Description of controlled trials published in methods and findings 1979–2002.
        Methods Find Exp Clin Pharmacol. 2006; 28: 527-531
        • Marti J.
        • Bonfill X.
        • Urrutia G.
        • Lacalle J.
        • Bravo R.
        Identificacion y descripción de ensayos clínicos publicados en revistas españolas de medicina general e interna n durante el periodo 1971–1995.
        Med Clin (Barc). 1999; 112 (Es 13): 28-34
        • Dickersin K.
        • Scherer R.
        • Lefebvre C.
        Identifying relevant studies for systematic reviews.
        Br Med J. 1994; 309: 1286-1291
        • Barajas-Nava L.A.
        • Calvache J.A.
        • López-Alcalde J.
        • Sola I.
        • Bonfill X.
        Identification and description of randomized controlled trials and systematic reviews on patient safety published in medical journals.
        J Patient Saf. 2013; 9 (Es 14)
        • Alfirevic Z.
        • Stampalija T.
        • Gyte G.M.L.
        Fetal and umbilical Doppler ultrasound in high-risk pregnancies.
        Cochrane Database Syst Rev. 2013; 11: CD007529https://doi.org/10.1002/14651858.CD007529.pub3
        • Nannini L.J.
        • Poole P.
        • Milan S.J.
        • Holmes R.
        • Normansell R.
        Different corticosteroids and regimens for accelerating fetal lung maturation for women at risk of preterm birth.
        Cochrane Database Syst Rev. 2013; 11 (Review): CD003794https://doi.org/10.1002/14651858.CD003794.pub4
        • Sullivan E.A.
        • Zegers-Hochschild F.
        • Mansour R.
        • et al.
        International Committee for Monitoring Assisted Reproductive Technologies (ICMART) world report: assisted reproductive technology 2004.
        Hum Reprod (Oxford, England). 2013; 28: 1375-1390
        • Nyboe Andersen A.
        • Goossens V.
        • Bhattacharya S.
        • et al.
        Assisted reproductive technology and intrauterine inseminations in Europe, results generated from European register by ESHRE.
        Hum Reprod. 2009; 4: 1267-1287
        • de Mouzon J.
        • Goossens V.
        • Bhattacharya S.
        • et al.
        Assisted reproductive technology in Europe, 2007: results generated from European registers by ESHRE.
        Hum Reprod. 2012; 27: 954-966
        • Kupka M.S.
        • Ferraretti A.P.
        • de Mouzon J.
        • Erb K.
        • D’Hooghe T.
        • Castilla J.A.
        Assisted reproductive technology in Europe, 2010: results generated from European registers by ESHRE.
        Hum Reprod. 2014; (pii: deu175 [Epub ahead of print])
        • IndexMundi
        Comparación de países: Tasa de fertilidad.
        2014 (Available from http://www.indexmundi.com/g/r.aspx?c=sp&v=31&l=es [accessed 31.07.14])
        • Schulz K.F.
        • Altman D.G.
        • Moher D.
        • CONSORT Group
        CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials.
        BMJ. 2010; 340: c332https://doi.org/10.1136/bmj.c332