Quality of reporting in randomized trials published in high-quality surgical journals. Randomized controlled trials in pediatric surgery: could we do better? Standards of reporting of randomized controlled trials in general surgery: can we do better? Randomized controlled trials in surgery. A pilot study of the effects of Vivostat patient-derived fibrin sealant in reducing blood loss in primary hip arthroplasty. Debridement could be a solution to promote healing of established oral mucositis in children. Impact of the method of surface debridement and decontamination on the clinical outcome following combined surgical therapy of peri-implantitis: a randomized controlled clinical study. The quality of reporting of randomized controlled trials in solid organ transplantation. Identification and analysis of randomised controlled trials in nursing: a preliminary study.
Randomized controlled trials (RCTs) in surgery can provide valuable evidence of the efficacy of interventions if they are well-designed, appropriately executed, and adequately reported. Adequate reporting of methodology in surgical RCTs is known to be poor, and adverse-event reporting in surgical research is inconsistent. The Consolidated Standards of Reporting Trials (CONSORT) statement is a framework to help authors report their findings in a transparent manner. Extensions to the CONSORT statement have been published recently to address deficiencies in adverse-event reporting and in reporting of specific criteria related to nonpharmacologic treatments. The aim of this study was to assess the quality of reporting of trial methodology and adverse events in a sample of general surgical RCTs published in high-quality surgical journals using the criteria specified in the CONSORT statements.
                We used impact factor to identify the top three ranked surgical journals in 2004. We then obtained information on all RCTs published in these journals in the 2005 calendar year. We assessed quality of reporting using Jadad score, compared the quality of RCTs from CONSORT-endorsing journals with nonendorsers, and assessed the number of RCTs adequately reporting key generic methodologic, adverse-event-related, and specific nonpharmacologic criteria.
                Of 42 RCTs analyzed, only 40% (17 of 42) had a Jadad score > or = 3. There was no significant difference in the number of high-quality RCTs published in CONSORT-endorsing journals compared with nonendorsers (p = 0.3). The median percentage of RCTs adequately reporting generic methodologic, adverse-event-related, and specific nonpharmacologic criteria was 32.5%, 17%, and 36.5%, respectively.
                Quality of reporting of generic methodologic, adverse-event-related, and specific nonpharmacologic criteria in surgical RCTs is poor. Increased attention to quality of reporting of surgical RCTs is required if studies are to meet published criteria. 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. 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. The objective was to determine the number of randomized controlled trials (RCT) performed by surgeons, published in surgical journals, or comprising a surgical arm and to assess their characteristics and overall quality.
                RCT in general surgery (including gastrointestinal, breast, surgical oncology, vascular, critical care, and trauma) published in 1990 were retrieved by MEDLINE and analyzed to determine the funding agency, type of therapy, area of surgery, journal published, country of origin, number of centers, and whether a surgeon was the principal author. The completeness of the MEDLINE search was compared to a manual search of the literature. All RCT were assessed with Chalmers' qualitative score.
                MEDLINE retrieved 202 surgical RCT (46% of those retrieved by a manual search) with a mean score of 0.40 +/- 0.13. However, surgical RCT were performed by surgeons in only one third of trials, compared surgical therapies in only one quarter of trials, and were published in surgical journals in less than one third of trials. Only 22% of surgical RCT were funded by peer reviewed granting agencies. The strongest variables determining the quality of surgical RCT were the type of therapy tested (p = 0.0001), the type of journal published (p = 0.006), and the area of general surgery (p = 0.007).
                Although surgical RCT are being performed, there are a relatively low proportion and standard of RCT performed by surgeons as the principal author, published in surgical journals, and comparing surgical therapies. This may reflect a lack of expertise by surgeons in clinical trials, lack of funding for surgical trials, methodologic problems peculiar to surgical trials, or a need for adoption of other research designs to assess surgical therapies. A pilot study evaluated the effectiveness of Vivostat patient-derived fibrin sealant in reducing blood loss in patients who underwent primary hip arthroplasty. Eighty adult patients undergoing elective surgery were randomized to receive either Vivostat sealant or control (no additional hemostatic treatment). Patients allocated Vivostat sealant donated 120 mL of blood, which was then processed perioperatively to produce a fibrin sealant that was applied to the bleeding wound surfaces just before closure. Transfusion requirements, blood loss during surgery, drain volumes, and daily hematocrit and hemoglobin levels were measured. Hospitalization times, adverse events, and postoperative wound complications were also monitored. Blood loss during surgery and wound drainage volume was lower in the Vivostat group than in the control group, although the differences were not significantly different. Transfusion requirements (median, 270 mL of packed red blood cells) and hospitalization times (both median 7 days) were the same for both groups. No adverse events related to the use of Vivostat occurred. There were indications of a possible reduction in the incidence of postoperative wound oozing (15% vs 25%) and hematomas (6% vs 11%) with the use of Vivostat compared with the control group, although differences were not statistically significant. In conclusion, in this pilot study, use of Vivostat patient-derived fibrin in hip arthroplasty was not associated with a significant reduction in blood loss. Further studies, with larger numbers of patients, may be warranted to investigate a possible benefit of Vivostat in reducing postoperative wound complications. The aim of the study was to present a novel approach to promote healing of established oral mucositis and to alleviate symptom clusters in a group of children who were on induction chemotherapy.
                A clinical prospective study.
                Children (40) diagnosed with Grade 3 or 4 oral mucositis were randomly assigned into two groups: In Group I (n=20), accumulated debris on ulcerations was removed (debridement); In Group II (n=20), subjects had no debridement. The condition of oral lesions, speech, lips, teeth, saliva, gingiva, and swallowing ability were examined 3 x week during the study. All subjects received the same oral care regimen. They were well balanced in respect of age, the type of antineoplastic treatment, and the number.
                Debridement promoted resolution and decreased the severity of oral mucositis significantly. Thus, the subjects had less oral discomfort, pain, and nutritional difficulties. Statistics: The data were entered in the SPSS 13.0 program, and the tests used were Kolmogorov-Smirnov, Shapiro-Wilk, Mann-Whitney, and Spearman's correlation coefficient with a 5% significance level.
                Well-controlled, prospective clinical studies related to the management of established oral mucositis will lead to the development of potential interventions and improved patient care. The study aimed at investigating the impact of two surface debridement/decontamination (DD) methods on the clinical outcomes of combined surgical treatment of peri-implantitis.
                Thirty-two patients suffering from advanced peri-implantitis (n=38 combined supra- and intra-bony defects) were treated with flap surgery, granulation tissue removal, and implantoplasty at buccally and supracrestally exposed implant parts. The intra-bony aspects were randomly allocated to surface DD using either (i) an Er:YAG laser (ERL) device, or (ii) plastic curets+cotton pellets+sterile saline (CPS). In both groups, the intra-bony component was augmented with a natural bone mineral and covered with a collagen membrane. Clinical and radiographic parameters were recorded at baseline and after 6 months of non-submerged healing.
                Two patients were lost during follow-up. At 6 months, ERL-treated sites failed to reveal higher reductions in mean bleeding on probing (ERL: 47.8 ± 35.5 versus CPS: 55.0 ± 31.1%) and CAL values (ERL: 1.5 ± 1.4 versus CPS: 2.2 ± 1.4 mm) when compared with the CPS group. Both groups exhibited a comparable radiographic bone fill at the intra-bony defect component.
                The study failed to demonstrate a significant impact of the method of surface DD on the clinical outcome following combined surgical therapy of advanced peri-implantitis lesions.
                © 2011 John Wiley & Sons A/S. Randomized controlled trials (RCTs) of interventions provide the highest level of evidence about efficacy but their value either alone or within a meta-analysis is dependent on its methodological quality. For this reason recent RCTs in organ transplantation were assessed for quality. RCTs published between 2004 and 2006 (n = 332) were assessed, after excluding duplicate and nonEnglish reports. Quality was evaluated using the Jadad score plus allocation concealment and intention to treat analysis. We noted journal type, journal author instructions, funding source, sample size and number and location of study centres. Around one-third of RCTs had a Jadad score of 3 or greater (indication of a methodologically good quality trial) and the other two parameters were satisfied in just over one third. Although the majority of trials were published in speciality journals the quality of those published in general journals was superior. Commercially sponsored trials were of better quality as were multicentre trials in contrast to single centre trials. Overall quality of reporting of RCTs in organ transplantation is poor and as RCTs provide the highest level of evidence in evaluations of interventions there needs to be a concerted effort within the transplant community to improve the standards of RCTs. To describe preliminary work undertaken for development of a nursing contribution to the Cochrane Collaboration. To ascertain whether there are randomised controlled trials (RCTs) on nursing care which need to be identified for inclusion in systematic reviews of the effects of health care.
                Searches by Medline (1966-94) and by hand of 11 nursing research journals from inception to the end of 1994 to identify RCTs and systematic reviews; and a comparison of searches by hand and by Medline for three nursing research journals.
                Total number of RCTs identified and number of RCTs published in nursing journals; the sensitivity of Medline searches; and aspects of nursing care evaluated by RCT.
                The work is ongoing and 522 reports of RCTs and 20 systematic reviews of effectiveness have been identified so far. The sensitivity of Medline searches for RCTs in nursing journals is as low as 36% for one journal and the lack of reference to research design in the title or abstract was the main reason for the lack of sensitivity.
                There are RCTs that evaluate aspects of nursing care, and are published in nursing and non-nursing journals, and are largely undertaken by nurses. These must be reviewed in ongoing systematic reviews of the effects of health care (including those undertaken as part of the Cochrane Collaboration). Nursing journals must be hand searched to identify these studies as the lack of reference to study design in the titles and abstracts of nursing trials leads to poor indexing in electronic databases such as Medline.
There is a lack of large, high-quality published RCTs evaluating debridement per se, or comparing different methods of debridement for surgical wounds, to guide clinical decision-making.