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? Efficacy of the North American guidelines for children's agricultural tasks in reducing childhood agricultural injuries. Computer-based training for the treatment of partial blindness. Randomized trial of enhanced anticipatory guidance for injury prevention. Randomised controlled trial of anterior-chamber intraocular lenses. Preventing injuries in children: cluster randomised controlled trial in primary care.
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. We assessed whether active dissemination of the North American Guidelines for Children's Agricultural Tasks (NAGCAT) reduced childhood agricultural injuries.
                In this randomized controlled trial, lay educators visited intervention farms to review NAGCAT. New York State farms with resident or working children were randomized. Control farms were visited only to collect baseline data. Data on childhood injuries, tasks, and hours worked were obtained quarterly for 21 months. Injury rates per farm were compared between the treatment and control groups, along with time span to occurrence of an injury and to violation of NAGCAT age guidelines.
                Intervention farms were less likely than control farms to violate NAGCAT age guidelines in the areas of all-terrain-vehicle use and tractor and haying operations. Cox proportional hazards regression models showed a significant protective effect of the intervention on preventable injuries after adjustment for important covariates.
                Our results showed that dissemination of NAGCAT reduced rates of work-related childhood agricultural injuries. A comprehensive public health approach is needed to reduce non-work-related childhood injuries. Partial blindness after brain injury has been considered non-treatable. To evaluate whether patients with visual-field defects can profit from computer-based visual restitution training (VRT), two independent clinical trials were conducted using patients with optic nerve (n = 19) or post-chiasmatic brain injury (n = 19). In post-chiasma patients, VRT led to a significant improvement (29.4%) over baseline in the ability to detect visual stimuli; in optic nerve patients, the effects were even more pronounced (73.6% improvement). Visual-field enlargements were confirmed by the observation of a visual-field expansion of 4.9 degrees-5.8 degrees of visual angle and improved acuity in optic nerve patients. Ninety five percent of the VRT-treated patients showed improvements, 72.2% confirmed visual improvements subjectively. Patients receiving a placebo training did not show comparable improvements. In conclusion, VRT with a computer program improves vision in patients with visual-field defects and offers a new, cost-effective therapy for partial blindness. To develop and evaluate an injury prevention anticipatory guidance training program for pediatric residents.
                Thirty-one residents were randomly assigned to an intervention or control group. Both groups attended a 1-hour seminar about injury prevention and the American Academy of Pediatrics TIPP (The Injury Prevention Program) materials. The intervention group also received 5 hours of experiential instruction on injury prevention content and counseling skills (SAFE Counseling Framework). Families with infants from birth to age 6 months were enrolled in the study (N = 196); they were followed up until the child was aged 12 to 18 months. Data were collected by means of baseline and follow-up interviews, audiotapes of medical visits, parent exit surveys, and home observations.
                A hospital-based continuity clinic that serves families living in low-income, inner-city neighborhoods.
                Physician counseling and parent satisfaction, knowledge, beliefs, and behaviors.
                Parents seen by physicians in the intervention group received significantly more injury prevention counseling for 5 of the 6 safety practices, and they were significantly more satisfied with the help their physicians provided on safety topics. They were no less satisfied with their physicians' counseling on other anticipatory guidance topics. Parents' knowledge, beliefs, and home safety behaviors did not differ between the 2 groups.
                The frequency and impact of pediatric counseling can be enhanced by experiential training that targets specific injury hazards. Because low-income families face many barriers to carrying out the recommended safety practices, supplemental strategies are needed to ensure safer homes. There are an estimated 16 million people blind in both eyes with cataracts. Most live in rural areas of developing countries where surgical resources are scarce. There is no consensus on the most appropriate type of intraocular lens in situations where high-volume low-cost surgery is required. This study was undertaken to evaluate the safety of multiflex open-loop anterior-chamber lenses (ACIOLs).
                2000 people attending Lahan Eye Hospital, southern Nepal, with bilateral cataracts reducing vision to 6/36 or less were randomly allocated to receive standard surgery--intracapsular extraction (ICCE) with aphakic correction--or ICCE with an ACIOL in their first operated eye. The primary outcome was a visual acuity of less than 6/60 in the operated eye at 1 year follow-up. Visual acuity was measured for 91% of the cohort at 1 year. The sample size was estimated to detect a doubling in poor visual outcome from an estimated rate of 4% in the standard surgery (control) group.
                The median (range) time taken to do the surgery was 6.0 (3.0-17.2) min for the ACIOL group and 4.1 (2.4-10.3) min for the control group. 1 year after surgery, 5.0% of the ACIOL group and 5.4% of controls had functional vision less than 6/60 (OR 0.93 [0.60-1.43], p = 0.71). The causes of poor vision in the ACIOL and control groups were: correctable refractive error (22 and 29), uveitis/secondary glaucoma (13 and two), endophthalmitis (four and seven), pre-existing eye disease (four and five), retinal detachment (none and four), cystoid macular oedema (two and none), corneal ulcer (one and one), and corneal decompensation (none and one).
                This study provides evidence that, in rural areas of developing countries, multiflex open-loop ACIOLs can be implanted safely by experienced ophthalmologists after routine ICCE, avoiding the disadvantages of aphakic spectacle correction. Further follow-up is planned. To assess the effectiveness of safety advice at child health surveillance consultations, provision of low cost safety equipment to families receiving means tested state benefits, home safety checks, and first aid training on frequency and severity of unintentional injuries in children at home.
                Cluster randomised controlled trial.
                36 general practices in Nottingham.
                All children aged 3-12 months registered with participating practices.
                A package of safety advice at child health surveillance consultations at 6-9, 12-15, and 18-24 months; provision of low cost safety equipment to families on means tested state benefits; and home safety checks and first aid training by health visitors.
                Primary outcomes measures were frequency and severity of medically attended injuries. Secondary outcome measures were self reported safety practices, possession and use of safety equipment, knowledge and confidence in dealing with first aid, and perceptions of risk of injury and risk of hazards assessed by postal questionnaire at baseline and follow up at 25 months.
                At baseline, both groups had similar risk factors for injury, sociodemographic characteristics, safety practices, possession and use of safety equipment, knowledge and confidence in dealing with first aid, and perceptions of risk. No significant difference was found in frequency of at least one medically attended injury (odds ratio 0.97, 95% confidence interval 0.72 to 1.30), at least one attendance at an accident and emergency department for injury (1.02, 0.76 to 1.37), at least one primary care attendance for injury (0.75, 0.48 to 1.17), or at least one hospital admission for injury (0.69, 0.42 to 1.12). No significant difference in the secondary outcome measures was found between the intervention and control groups.
                The intervention package was not effective in reducing the frequency of minor unintentional injuries in children at home, and larger trials are required to assess the effect on more severe injuries.
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.