The reporting quality of parallel randomised controlled trials in ophthalmic surgery in 2011: a systematic review

Abstract

Purpose Randomised controlled trials (RCTs) represent a gold standard for evaluating therapeutic interventions. However, poor reporting clarity can prevent readers from assessing potential bias that can arise from a lack of methodological rigour. The Consolidated Standards of Reporting Trials statement for non-pharmacological interventions 2008 (CONSORT NPT) was developed to aid reporting. RCTs in ophthalmic surgery pose particular challenges in study design and implementation. We aim to provide the first assessment of the compliance of RCTs in ophthalmic surgery to the CONSORT NPT statement. Method In August 2012, the Medline database was searched for RCTs in ophthalmic surgery reported between 1 January 2011 and 31 December 2011. Results were searched by two authors and relevant papers selected. Papers were scored against the 23-item CONSORT NPT checklist and compared against surrogate markers of paper quality. The CONSORT score was also compared between different RCT designs. Results In all, 186 papers were retrieved. Sixty-five RCTs, involving 5803 patients, met the inclusion criteria. The mean CONSORT score was 8.9 out of 23 (39%, range 3.0-14.7, SD 2.49). The least reported items related to the title and abstract (1.6%), reporting intervention adherence (3.1%), and interpretation of results (4.7%). No significant correlation was found between CONSORT score and journal impact factor (R ¼ 0.14, P ¼ 0.29), number of authors (R ¼ 0.01, P ¼ 0.93), or whether the RCT used pairedeye, one-eye, or two-eye designs in their randomisation (P ¼ 0.97). ConclusionsThe reporting of RCTs in ophthalmic surgery is suboptimal. Further work is needed by trial groups, funding agencies, authors, and journals to improve reporting clarity.

Evolution of poor reporting and inadequate methods over time in 20 920 randomised controlled trials included in Cochrane reviews: research on research study

“…[17][18][19][20][21][22][23][24][25][26][27][28][29][30] But most have focused on small numbers of trials or specific diseases, journals, or time periods. These studies used various criteria for their assessments, which were frequently not defined.…”

Systematic review of the methodological and reporting quality of case series in surgery

“…Strengths of this review include conduct by a group with significant interest and experience in this area of methodological and reporting quality. Limitations include restriction to the English language, although it has been estimated that 80–90 per cent of papers in scientific journals are written in English.…”

Umsetzungshilfe zu methodischen Kriterien des CONSORT-Statements zur transparenten Publikation von RCTs in der Augenheilkunde

“…Anhand dieser Vorlagen können die einzelnen Studiencharakteristika standardisiert zusammengestellt werden [7]. Eine Untersuchung von Yao et al 2015 zur Beurteilung der Berichterstattung von RCTs in der ophthalmologischen Chirurgie [8] zeigte suboptimale Ergebnisse: Von den untersuchten 65 RCTs erfüllte nicht ein einziges alle CONSORT-Kriterien; im Mittel wurden nur 9 von (beurteilten) 23 Kriterien (Min.-Max. 3-15) als berücksichtigt attestiert, entsprechend nur knapp 40 % der Transparenz-und Qualitätskriterien des CONSORT-Statements.…”