Quality of reporting of key methodological items of randomized controlled trials in clinical ophthalmic journals. Studying injury prevention: practices, problems, and pitfalls in implementation. In the dark: the reporting of blinding status in randomized controlled trials. Randomized controlled trials in pediatric surgery: could we do better?
To evaluate the reporting quality of key methodological items in randomized controlled trials (RCTs) in four general clinical ophthalmology journals.
                The reporting of 11 key methodological items in RCTs published in American Journal of Ophthalmology, Archives of Ophthalmology, British Journal of Ophthalmology and Ophthalmology in the year 2005 was assessed.
                Sixty-seven eligible RCTs were assessed and the mean number of items reported was 6.3 per RCT. No significant difference in the mean number of items reported was found between the four journals (P=0.20). The most frequently reported item was ethics approval and informed consent (97.0%), followed by masking status (85.1%), description of withdrawals (76.1%), adverse events (73.1%), and intention-to-treat analysis (71.6%). Details on sequence generation, randomization restriction, allocation concealment, allocation implementation, patient flow diagrams, and sample size calculation were reported in <50% of the RCTs assessed. Both sample size and page length of the RCTs correlated with the number of methodological items reported (P=0.024 and P=0.008, respectively).
                Similar to other specialties, rooms for improvement exist in the reporting of key methodological items of RCTs in clinical ophthalmic journals. Stricter adoption of the CONSORT statement might enhance the reporting quality of RCTs in ophthalmic journals. This prospective, randomized, controlled trial was conducted to determine feasibility and effectiveness of a chronic care model approach to injury prevention compared with standard anticipatory guidance. Enrolled caregivers of children aged 0 to 5 years received focused counseling from a physician and health assistant, educational handouts, phone follow-up, and access to free safety devices and automobile restraint evaluations. Only 35.1% of eligible parents participated. Home visits were completed at 6 months to observe safety practices. Injuries were gleaned from parent report and medical record review. Safety practices were evaluated in 27 households. Chart review showed no significant difference in the number of medically attended injuries between groups (P = 0.6). The impact of the chronic care model on injury prevention in primary care could not be determined with certainty. Evaluating effectiveness of injury prevention strategies on actual safety practices with direct observation is challenging. To determine the quality of reporting of blinding in randomized controlled trials (RCTs), we evaluated 40 consecutive RCTs published in each of five leading journals. We noted whether authors reported the blinding status of participants, health care providers, data collectors, judicial assessors of outcomes, data analysts, and manuscript writers. Explicit reporting of blinding status occurred in <25% of RCTs for all groups. Eighty-three RCTs, reported as double-blind, provided eight combinations of blinded groups. In conclusion, prestigious journals do not currently report blinding status optimally. To do so, journals should abandon the term "double blind" and explicitly report the blinding status of the groups involved in RCTs. Until such reporting occurs, clinicians will be left with uncertainty about the validity of RCTs that guide their clinical practice. Randomized controlled trials (RCTs) are accepted as the gold standard for assessing the effectiveness of clinical interventions but are rarely reported in pediatric surgery. Have RCTs submitted to the British Association of Paediatric Surgeons (BAPS) Annual Congress during the last 5 years been adequately designed and large enough to produce a valid result?
                Abstracts accepted by the Annual BAPS Congress meetings between 1996 and 2000 were examined in collaboration with a senior health services researcher. The quality of the design, methodology, statistical analysis and conclusions, and the adequacy of the sample size were assessed for all identifiable clinical RCTs.
                From 760 accepted abstracts, there were only 9 RCTs (1%) of clinical interventions. In only 4 trials was the relevant primary end-point specified at the outset of the study, and none documented the method of randomization. Only one abstract mentioned blinding with respect to the intervention or outcome measure. Sample sizes were inadequate to detect even large clinical differences. To date, only one of these RCTs has been published in an English-language, peer-reviewed journal.
                Clear guidelines exist for the conduct of RCTs, yet compliance with these standards was rarely documented in abstracts of pediatric surgical RCTs presented at BAPS. Sample sizes were inadequate. RCTs in pediatric surgery are difficult to perform, but the specialty would benefit from well-designed, carefully conducted, multicentre, clinical RCTs to advance evidence-based practice.
                Copyright 2003, Elsevier Science (USA). All rights reserved.
The included studies do not provide reliable evidence that educational interventions are effective in preventing eye injuries. There is a need for well-conducted RCTs with adequate allocation concealment and masking (blinding). Studies should have a longer follow-up time and more studies need to be conducted in low and middle-income countries.