Comparison of face-down and seated position after idiopathic macular hole surgery: a randomized clinical trial. Value of internal limiting membrane peeling in surgery for idiopathic macular hole stage 2 and 3: a randomised clinical trial. A randomized controlled trial of alleviated positioning after small macular hole surgery. Idiopathic macular hole surgery in Chinese patients: a randomised study to compare indocyanine green-assisted internal limiting membrane peeling with no internal limiting membrane peeling. Internal limiting membrane peeling versus no peeling for idiopathic full-thickness macular hole: a pragmatic randomized controlled trial. Randomized controlled trials in pediatric surgery: could we do better? The reporting of methodological factors in randomized controlled trials and the association with a journal policy to promote adherence to the Consolidated Standards of Reporting Trials (CONSORT) checklist. Standards of reporting of randomized controlled trials in general surgery: can we do better? Efficacy and acceptability of different modes of oxygen administration in children: implications for a community hospital. Systematic review of symptom control and quality of life in studies on chemotherapy for advanced non-small cell lung cancer: how CONSORTed are the data? The impact of the CONSORT statement on reporting of randomized clinical trials in psychiatry.
To compare two therapeutic modalities on anatomic and functional results after idiopathic macular hole (MH) surgery: seated vs face-down position.
                Multicenter, prospective, randomized trial.
                Setting: University Hospital Dijon and University Hospital Nancy. Patients: One hundred and forty-four patients (150 eyes) were enrolled and randomly separated into two groups for postoperative position: for the 72 eyes in the P0 group and the 78 eyes in the P1 group, the patients were asked to keep the seated (P0 group) and the face-down position (P1 group) after the idiopathic MH surgery. Intervention: All patients underwent a complete vitrectomy with a fluid-air exchange and an intraocular gas tamponade. After the surgery, patients were asked to keep one of the two randomly chosen positions for five days. Main Outcome Measures: Best-corrected visual acuity (VA), fundus examination, and macular optical coherence tomography were performed before and six months after surgery.
                The overall anatomic success rate was 92.7%. The idiopathic MH sealed in 63 of 72 P0 eyes (87.5%) and 76 of 78 P1 eyes (97.4%) (P = .027). The mean VA increased from 0.86 to 0.61 logMAR (0.88 to 0.61 in P0 and 0.84 to 0.60 in P1). However, in a post hoc analysis based on the size of the idiopathic MH, the success rate in idiopathic MHs smaller than 400 microm was not influenced by the postoperative position (P = .47).
                A face-down postoperative position is highly recommended in holes larger than 400 microm. The size of the idiopathic MH seems to be an important factor affecting outcome. To determine the effect of internal limiting membrane (ILM) peeling on anatomical and functional success rates in stage 2 and 3 idiopathic macular hole surgery (MHS).
                Randomised clinical trial of stage 2 and 3 idiopathic macular hole without visible epiretinal fibrosis and with less than 1 year's duration of symptoms. Eyes were randomised to (1) vitrectomy alone without retinal surface manipulation, (2) vitrectomy plus 0.05% isotonic Indocyanine Green (ICG)-assisted ILM peeling or (3) vitrectomy plus 0.15% Trypan Blue (TB)-assisted ILM peeling. Main outcomes were hole closure after 3 and 12 months and best-corrected visual acuity after 12 months.
                78 eyes were enrolled. Primary closure rates were significantly higher with ILM peeling than without peeling for both stage 2 holes (ICG peeling 100%, non-peeling 55%, p = 0.014) and for stage 3 holes (ICG peeling 91%, TB peeling 89%, non-peeling 36%, p<0.001). Visual outcomes in eyes with primary hole closure were not significantly different between the groups.
                Dye-assisted ILM peeling was associated with significantly higher closure rates than non-peeling in both stage 2 and 3 MHS. Intraoperative ILM staining with 0.05% isotonic ICG was not associated with a significantly different visual outcome than non-peeling or TB peeling in eyes with primary hole closure. Trial registration number: NCT00302328. To establish whether the success rate of surgery for small idiopathic macular holes (diameter, ≤ 400 μm) is significantly reduced if facedown positioning is replaced by simply taking care to avoid the supine position.
                Randomized, controlled, parallel-assignment, open-label, interventional, multicenter clinical trial.
                Sixty-nine patients from 6 specialized vitreoretinal units, randomized into 2 parallel groups and followed up after surgery for 3 months.
                All patients underwent pars plana vitrectomy, peeling of any epiretinal membrane, and 17% C₂F₆ gas filling. Patients then were advised randomly to observe either strict facedown positioning for 22 of 24 hours or simply to avoid the supine position for 10 days.
                The primary outcome measure was the rate of anatomic closure 3 months after surgery. Main secondary measurements included Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity, progression of cataract, and frequency of complications.
                The mean size of macular holes was approximately 300 μm in both groups. Closure rates were more than 90% in both groups: 32 (91.4%) of 34 eyes in the alleviated positioning group versus 32 (94.1%) of 35 eyes in the facedown positioning group (lower margin of 95% confidence interval of difference, -14.88%). The ETDRS scores at 3 months increased in both groups by 10.23 ± 14.64 and 10.52 ± 14.54 letters, respectively. Progression of cataract and the rate of other complications were not significantly different in the 2 groups.
                The success rate of surgery for idiopathic macular holes of 400 μm or smaller is not significantly reduced if facedown positioning is replaced by simply taking care to avoid the supine position. These macular holes can be treated by streamlined surgery, that is, with no internal limiting membrane peeling and no facedown positioning (only avoidance of the supine position) with a closure rate of more than 90% and a mean gain in visual acuity of more than 2 ETDRS lines at 3 months.
                Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved. To compare the anatomical and visual outcomes of primary idiopathic macular hole surgery using indocyanine green-assisted internal limiting membrane peeling versus no internal limiting membrane peeling.
                Prospective randomised controlled clinical trial.
                University teaching hospital, Hong Kong.
                Fifty-one eyes of 49 Chinese patients with primary idiopathic macular hole were studied.
                Patients were randomised to undergo pars plana vitrectomy with indocyanine green-assisted internal limiting membrane peeling (26 eyes) or surgery without internal limiting membrane peeling (25 eyes). Perfluorocarbon gas was used in all cases as internal tamponade.
                Primary macular hole closure rate and best-corrected visual acuity.
                The mean follow-up duration was 12 months (range, 6-23 months). Respectively to the indocyanine green-assisted internal limiting membrane peeling group and non-internal limiting membrane peeling group, the primary anatomical closure rate was 92.3% and 32.0% (P<0.001), whereas improvement in best-corrected visual acuity was 3.7 and 1.5 lines (P=0.002). More eyes in the first group (84.6%) had improvement of 2 or more lines of best-corrected visual acuity after surgery than in the second group (32.0%) [P<0.001]. Multivariate logistic regression showed indocyanine green-assisted internal limiting membrane peeling was the only significant predictor for primary closure of the macular hole (adjusted odds ratio=30.8).
                Indocyanine green-assisted internal limiting membrane peeling in idiopathic macular hole surgery results in significantly better anatomical and visual outcomes compared with non-internal limiting membrane peeling in Chinese patients. To determine whether internal limiting membrane (ILM) peeling is effective and cost effective compared with no peeling in patients with idiopathic stage 2 or 3 full-thickness maculay hole (FTMH).
                This was a pragmatic multicenter randomized controlled trial. Eligible participants from nine centers were randomized to ILM peeling or no peeling (1:1 ratio) in addition to phacovitrectomy, including detachment and removal of the posterior hyaloid and gas tamponade. The primary outcome was distance visual acuity (VA) at 6 months after surgery. Secondary outcomes included hole closure, distance VA at other time points, near VA, contrast sensitivity, reading speed, reoperations, complications, resource use, and participant-reported health status, visual function, and costs.
                Of 141 participants randomized in nine centers, 127 (90%) completed the 6-month follow-up. Nonstatistically significant differences in distance visual acuity at 6 months were found between groups (mean difference, 4.8; 95% confidence interval [CI], -0.3 to 9.8; P = 0.063). There was a significantly higher rate of hole closure in the ILM-peel group (56 [84%] vs. 31 [48%]) at 1 month (odds ratio [OR], 6.23; 95% CI, 2.64-14.73; P < 0.001) with fewer reoperations (8 [12%] vs. 31 [48%]) performed by 6 months (OR, 0.14; 95% CI, 0.05-0.34; P < 0.001). Peeling the ILM is likely to be cost effective.
                There was no evidence of a difference in distance VA after the ILM peeling and no-ILM peeling techniques. An important benefit in favor of no ILM peeling was ruled out. Given the higher anatomic closure and lower reoperation rates in the ILM-peel group, ILM peeling seems to be the treatment of choice for idiopathic stage 2 to 3 FTMH. (Clinical Trials.gov number, NCT00286507.). 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 "Consolidated Standards of Reporting Trials" (CONSORT) was developed to improve the suboptimal reporting of randomized controlled trials (RCTs). However, little is known about the quality of reporting since this publication. We undertook an observational study to determine the quality of reporting key methodological factors in RCTs since the publication of the CONSORT statement and if a journal policy to promote adherence to the CONSORT checklist was associated with superior reporting. We recorded the reporting of 11 key methodological factors in 105 RCTs from 29 medical journals published subsequent to the CONSORT statement. We examined the quality of reporting in relation to whether a journal was a "CONSORT promoter" as defined by inclusion of the CONSORT checklist in a journal's "information to authors" section or a requirement that authors, manuscript reviewers, or copy editors complete the CONSORT checklist. Multivariate analysis controlled for journal impact factor, study outcome, and time of publication. Six of the 11 methodological factors were reported <50% of the time. The number of methodological factors reported was greater in CONSORT promoters than in journals not promoting CONSORT in both unadjusted (6.0 and 5.1, respectively, p-value = 0.03) and adjusted (6.4 and 4.8 of the 11 methodological factors, respectively, p-value = 0.0001) analyses. While journals that promote CONSORT demonstrate superior reporting of RCTs, persistent inadequacies in reporting remain. Until these inadequacies are resolved health-care providers will remain limited in their ability to make informed inferences about the validity of the studies upon which they base their clinical practice. To evaluate the quality of reporting of surgical randomized controlled trials published in surgical and general medical journals using Jadad score, allocation concealment, and adherence to CONSORT guidelines and to identify factors associated with good quality.
                Randomized controlled trials (RCTs) provide the best evidence about the relative effectiveness of different interventions. Improper methodology and reporting of RCTs can lead to erroneous conclusions about treatment effects, which may mislead decision-making in health care at all levels.
                Information was obtained on RCTs published in 6 general surgical and 4 general medical journals in the year 2003. The quality of reporting of RCTs was assessed under masked conditions using allocation concealment, Jadad score, and a CONSORT checklist devised for the purpose.
                Of the 69 RCTs analyzed, only 37.7% had a Jadad score of > or =3, and only 13% of the trials clearly explained allocation concealment. The modified CONSORT score of surgical trials reported in medical journals was significantly higher than those reported in surgical journals (Mann-Whitney U test, P < 0.001). Overall, the modified CONSORT score was higher in studies with higher author numbers (P = 0.03), multicenter studies (P = 0.002), and studies with a declared funding source (P = 0.022).
                The overall quality of reporting of surgical RCTs was suboptimal. There is a need for improving awareness of the CONSORT statement among authors, reviewers, and editors of surgical journals and better quality control measures for trial reporting and methodology. Eighty under-five children admitted in the pediatric ward with acute respiratory distress requiring oxygen inhalation were prospectively studied. Oxygen was administered to all the children by head box, face mask, nasopharyngeal catheter, and twin-holed prenasal catheter in a predetermined sequence. Oxygen was delivered at a flow rate of 4 l/min in the head box and by face mask and at a rate of 1 l/min for nasopharyngeal catheter and twin-holed prenasal catheter. There was a significant rise in paO2 and SaO2 values with all the oxygen delivery methods. The number of children who achieved paO2 of > 90 mmHg with oxygen delivered by head box was 53 (69 per cent), with face mask 37 (57 per cent), with nasopharyngeal catheter 13 (26 per cent), and with twin-holed prenasal catheter 18 (25 per cent). In view of high acceptability of twin-holed prenasal catheter, a further pilot study involving 10 children was carried out to compare the efficacy of head box and twin-holed prenasal catheter at an identical oxygen flow rate of 4 l/min. The number of children achieving paO2 of > 90 mmHg were comparable, i.e. seven (70 per cent) and eight (80 per cent) when the oxygen was delivered by head box and twin-holed prenasal catheter, respectively. It is concluded that both head box and twin-holed prenasal catheter are equally effective, acceptable and safe methods for administration of oxygen to children with acute respiratory disorders. In view of the cost-effectiveness, and easy availability and affordability of twin-holed prenasal catheter, it should be popularized in the small hospitals in the community, while head box should be reserved for use in the referral hospitals. The effect of chemotherapy on survival of patients with advanced NSCLC is modest, therefore patient reported outcomes (PRO's) are of high interest in randomized controlled trials (RCTs). CONSORT (CONsolidated Standards On Reporting Trials) is a quality checklist of 22 items for the conduct and reporting of RCTs. The aim of this report was to analyse to what extent the different RCTs with information on PRO's adhere to the CONSORT statement.
                Systematic review of RCTs using PRO's either as primary or secondary endpoint. Compliance with the (revised) CONSORT statement was checked by 2 independent reviewers by making for each study the simple sum of the 22 CONSORT items, or a weighted score with a maximum rating of 31 points.
                The median weighted CONSORT score of the different RCTs was 25, with a remarkable difference from 12 till 30. There was no significant change over time, nor difference between academic and commercial studies, but a significant correlation between CONSORT agreement and journal type (P<0.0001). Adherence to CONSORT was similar for studies comparing chemotherapy with best supportive care alone, comparing different first-line chemotherapies with PRO either as primary or secondary endpoint, or studies looking at second-line chemotherapy. Benefit in PRO's was reported in all of these settings.
                The overall adherence of peer-reviewed RCTs to CONSORT is reasonable, with nonetheless major differences between journals, and with no clear sign of change over time. Apart from modest survival differences, benefits in PRO endpoints are present in all categories of studies we analysed. To determine whether the CONSORT recommendations influenced the quality of reporting of randomized controlled trials (RCTs) in the field of psychiatry, we evaluated the quality of clinical trial reports before and after the introduction of CONSORT statement. We selected seven high impact journals and retrieved the randomized, clinical trials in the field of psychiatry during the period of 1992-1996 (pre-CONSORT) and 2002-2007 (post-CONSORT). Among the total 5201 articles screened, 736 were identified and entered in our database. After critical review of the publications, 442 articles met the inclusion and exclusion criteria. The CONSORT Index (sum of 22 items of the checklist) during the post-CONSORT period was significantly higher than that during the pre-CONSORT period. However, over 40% of post-CONSORT studies did not adhere to CONSORT statement for reporting the process of randomization, and details of the process for obtaining informed consent were still insufficient. Furthermore, adherence to the CONSORT guidelines of reporting how blinding was accomplished and evaluated actually decreased after publication of the CONSORT statement. Although the overall quality of reporting on psychiatric RCTs generally improved after publication of the CONSORT statement, reporting the details of randomization, blinding, and obtaining informed consent remain insufficient.
There is currently insufficient evidence from which to draw firm conclusions about the impact of postoperative face-down positioning on the outcome of surgery for macular hole. Of three RCTs, two suggested a benefit in larger holes but none demonstrated evidence of a benefit in smaller holes.
CONSORT adherent RCTs and large scale, well designed non-randomised observational studies are needed to determine with confidence the value of this intervention.