Randomized controlled trials in pediatric surgery: could we do better? Randomized controlled trials in surgery. Association between research sponsorship and study outcome in plastic surgery literature. Standards of reporting of randomized controlled trials in general surgery: can we do better? Quality of reporting in randomized trials published in high-quality surgical journals. The reporting quality of randomised controlled trials in surgery: a systematic review. Quality and retrieval of obstetrical anaesthesia randomized controlled trials. The quality of reporting of randomized controlled trials in solid organ transplantation. Handsearching the Journal of the Royal Naval Medical Service for Trials. The quality of randomized controlled trials in major anesthesiology journals. Reporting randomised clinical trials of analgesics after traumatic or orthopaedic surgery is inadequate: a systematic review. Surgeon volume does not predict outcomes in the setting of technical credentialing: results from a randomized trial in colon cancer. Teaching practicing surgeons critical appraisal skills with an Internet-based journal club: A randomized, controlled trial. Randomized controlled trial of virtual reality simulator training: transfer to live patients. Identification and analysis of randomised controlled trials in nursing: a preliminary study. Handsearching the Journal of the Royal Army Medical Corps for trials. Virtual reality training improves operating room performance: results of a randomized, double-blinded study. Quality of reporting of key methodological items of randomized controlled trials in clinical ophthalmic journals. Virtual reality training in laparoscopic surgery: a preliminary assessment of minimally invasive surgical trainer virtual reality (MIST VR). Examination of the analytic quality of behavioral health randomized clinical trials. Can evidence change the rate of back surgery? A randomized trial of community-based education. The retrieval of randomized clinical trials in liver disease from the medical literature. A comparison of MEDLARS and manual methods. Cumulative meta-analysis of clinical trials builds evidence for exemplary medical care. A comparison of patient teaching outcomes among postoperative coronary artery bypass graft (CABG) patients. Prospective randomized controlled trial of laparoscopic trainers for basic laparoscopic skills acquisition. Evidence-based postoperative pain management in nursing: is a randomized-controlled trial the most appropriate design? A prospective randomized controlled trial of multimodal perioperative management protocol in patients undergoing elective colorectal resection for cancer.
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 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. Financial and other competing interests have recently received increasing attention. In particular clinical research in plastic surgery attracts for-profit organizations, thus, explaining the increasing number of financial sponsorships. However, research articles often lack sufficient description of study design as well as disclosure of the source of funding. Furthermore, debate exists whether industry funding influences research findings and is leading to pro-industry results. A hand search was conducted identifying all randomized controlled (RCT) and controlled clinical trials (CCT) in 4 plastic surgery journals (Plastic and Reconstructive Surgery, British Journal of Plastic Surgery, Annals of Plastic Surgery, and Aesthetic Plastic Surgery) between 1990 and 2005. Subsequently, the influence of financial support on study outcome was analyzed. A total of 10,476 original articles were analyzed, resulting in the identification of 346 clinical trials which meet the Cochrane criteria for RCTs and CCTs. One hundred eighty-three trials and 163 studies were found to be RCTs and CCTs, respectively. Hereof, only 70 trials (20.2%) reported on grant support. Of these, 42 trials (60%) were supported by the industry. Depending on the topic addressed marked differences were detected regarding grant support. Studies with a focus on reconstructive plastic surgery were supported by the industry and by public institutions in almost equal shares (18 trials vs. 15 trials), whereas aesthetic surgical topics were predominantly funded by the industry (13 trials vs. 6 trials). Industry-funded trials reported more often statistically significant differences between treatment arms (28 trials vs. 16 trials). Authors' conclusions were found to be positively associated with financial competing interests. However, trial funding is rarely declared in the plastic surgery literature. Thus, the quality of reporting needs to be improved to be able to investigate these relationships in greater detail and draw more representative conclusions. 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. 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. In order to examine the reporting quality of urological RCTs, the initial objectives of this study were to evaluate the degree to which RCTs involving urological surgical techniques (as the intervention) published in the years 2000-2003 complied with the CONSORT statement, and to assess trends and patterns of compliance. Following our initial findings in urology, we extended the methodology to a number of other specialties to assess whether our findings in urology could be generalised to other surgical disciplines.
                The Royal Society of Medicine (RSM) Library was commissioned to search the Medline and Cochrane databases for RCTs in compliance with the study inclusion criteria below. Additional analyses of five other specialties (non-urological trials: cardiovascular, gastrointestinal, hepatic, orthopaedic and vascular) were also made. For the non-urological trials, 15 English language trials (from each specialty) were randomly picked from a blast search conducted by the RSM for the year 2003. The RCTs were given a score out of 22, reflecting how many of the 22 CONSORT items were complied with (with each item being given equal weighting), this score was termed the "CONSORT score".
                Urology trials: In total 122 RCT abstracts were identified which met the inclusion criteria for this study. From these, 32 were excluded as they were follow-up studies, involved a virtual procedure or were a cost analysis, leaving 90 RCTs published across 35 different journals which were analysed (68.2%, 90/122). The average score of 11.1 for urological trials indicates that RCTs in our sample do not comply with the CONSORT statement. No trials reported how they implemented their randomisation process. Only 46% of RCTs stated that they had permission from an ethics review board, 20% had declared their sources of funding, 14% stated whether there were any conflicts of interest and only 1.1% stated their trial registry number. For non-urological studies, an average CONSORT score of 11.2 was obtained.
                Clinical research teams conducting RCTs in urology and other surgical disciplines demonstrate poor compliance with the CONSORT statement. We would recommend that trials should be registered at their outset and that urological and other surgical journals to consider supporting the CONSORT statement and to have compliance 'hard-wired' into their submission, editorial and peer-review processes. Since it seems the best researchers are unable to produce an RCT results which enable surgical techniques to be critically assessed, there is a need for education about the CONSORT statement and its importance at all levels of surgical training. We believe that an open debate is needed on the possible role of other research designs, such as tracker studies. Whether this study actually raises the question of how appropriate RCTs are to surgical techniques, we leave to the reader. Randomized controlled trials (RCTs) are suitable for meta-analysis and systematic reviews provided they are of high quality and are easy to retrieve. We determined these attributes of RCTs in obstetrical anaesthesia in a sample of available journals that are indexed in MEDLINE.
                Randomized controlled trials published between January 1985 and December 1994 in seven anaesthetic and three obstetric journals were identified by a MEDLINE search, and by handsearch of the same journals. Each RCT was assigned a quality score by a blinded rater using a reliable and validated scaled. The quality of each RCT was described and compared over time and by journal. The comparative yield of MEDLINE and hand-search was evaluated.
                Three hundred and forty RCTs were retrieved by MEDLINE and handsearch. Two hundred and twenty seven (65%) were identified by the MEDLINE search and 333 by the handsearch (98%). The median quality score was 3/5. There was no difference in score over time. Anesthesiology had the highest median score, Anaesthesia had the lowest (P < 0.05).
                Care must be taken when reviewing obstetrical anaesthesia research. Strategies in addition to a MEDLINE search must be used to identify RCTs since more than one third were missed using MEDLINE alone. Poor quality RCTs are more likely to be biased in favour of a new treatment. Therefore, to increase the validity of reviews sensitivity analyses based on quality should be done. 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. As part of the Cochrane Collaboration's international research endeavour, the authors carried out a handsearch of the Journal of the Royal Naval Medical Service from 1948 to 1998, searching for randomised controlled trials (RCTs) and controlled clinical trials (CCTs). Five trials were identified, of which three were RCTs and two were CCTs. The first trial was published in 1960. The identified trials were in the fields of dentistry (two trials), gastroenterology, occupational medicine and orthopaedic surgery. Of the five trials, only two had been located previously through a rigorous interrogation of Medline. The three newly identified trials were reported to the UK Cochrane Centre, and details of these three trials were entered into Medline for use by clinicians and investigators in the future. Increased attention has been directed at the quality of randomized controlled trials (RCTs) and how they are being reported. We examined leading anesthesiology journals to identify if there were specific areas for improvement in the design and analysis of published clinical studies. All RCTs that appeared between January 2000 and December 2000 in leading anesthesiology journals (Anesthesiology,Anesthesia & Analgesia,Anaesthesia, and Canadian Journal of Anaesthesia) were retrieved by a MEDLINE search. We used a previously validated assessment tool, including 14 items associated with study quality, to determine a quality score for each article. The overall mean weighted quality score was 44% +/- 16%. Overall average scores were relatively high for appropriate controls (77% +/- 7%) and discussions of side effects (67% +/- 6%). Scores were very low for randomization blinding (5% +/- 2%), blinding observers to results (1% +/- 1%), and post-beta estimates (16% +/- 13%). Important pretreatment clinical predictors were absent in 32% of all studies. Significant improvement in the reporting and conduct of RCTs is required and should focus on randomization methodology, the blinding of investigators, and sample size estimates. Repeat assessments of the literature may improve the adoption of guidelines for the improvement of the quality of randomized controlled trials. Several randomised clinical trials (RCTs) of analgesics in postoperative pain after traumatic or orthopaedic surgery (TOS) have been published, but no studies have assessed the quality of these reports. We aimed to examine the quality of reporting RCTs on analgesics for postoperative pain after TOS.
                Reports of RCTs assessing analgesics in postoperative pain after TOS were systematically searched from electronic databases. The quality of reports was assessed using the CONSORT checklist (scoring range from 0 to 22). The quality was considered poor when scoring was 12 or lesser. The publication year and the impact factor of journals were recorded.
                A total of 92 reports of RCTs were identified and 69 (75%) scored 12 or lesser in CONSORT checklist (range 5-17). The mean (SD) CONSORT score of all reports was 10.6 (2.7). Missing CONSORT items included primary and secondary outcome measures (11%), the specific objectives and hypothesis definition (12%), the sample size calculation (12%), the dates defining the periods of recruitment (12%), the discussion of external validity of findings (14%), the allocation sequence generation (24%), and the interpretation of potential bias or imprecision of results (25%). There was a little improvement in CONSORT scores over time (r = 0.62; p < 0.001) and with impact factor of journals (r = 0.30; p < 0.001).
                Quality of reporting RCTs on analgesics after TOS is poor. Reporting of those RCTs should be improved according to methodological standard checklists in the next years. To test the hypothesis that surgeon volume would not predict short- and long-term outcomes when evaluated in the setting of technical credentialing.
                Surgical volume is a known predictor of outcomes; the importance of technical credentialing has not been evaluated.
                Fifty-three credentialed surgeons operated on 871 patients in the Clinical Outcomes of Surgical Therapy Study (NCT00002575), investigating laparoscopic versus open surgery for colon cancer. Credentialing required that each surgeon document performance of at least 20 laparoscopic colon cases and demonstrate oncologic techniques on a video-recorded case. Surgeons were separated based on volume entered into the trial (low, < or =5 cases (n = 39); medium, 6-10 cases (n = 9); or high, >10 cases (n = 5)) and compared by outcomes.
                Patients treated by high volume compared with medium or low volume surgeons were older (70, 66, and 68 years; P < 0.001), more often had right-sided tumors (63%, 46%, and 53%; P < 0.001) and had more previous operations (48%, 38% and 45%; P < 0.004), respectively. Mean operative times were shorter (123, 147 and 145 minutes; P < 0.001), distal margins longer (13.4, 12.4 and 11.6 cm; P = 0.005), and lymph node harvest greater (14.8, 12.8, 12.6; P = 0.05) for high versus medium versus low volume surgeons. However, rates of conversion, complications, 5-year survival, and disease-free survival showed no significant differences.
                When tested in a randomized controlled trial with case-specific surgical technical credentialing and auditing, surgeon volume did not predict differences in rates of conversion, complications, or long-term cancer outcomes. Case-specific technical credentialing should be further studied specific to the role it could play in creating consistent, high quality outcomes. The effectiveness of interventions for developing critical appraisal skills in practicing physicians has not been studied, despite the documented importance of reading the literature in caring for patients and in continuing professional development. The objective of this study was to evaluate whether an Internet-based intervention would lead to enhanced critical appraisal skills in practicing surgeons.
                General surgeons who agreed to participate were randomized into 2 groups. The intervention was a curriculum in critical appraisal skills that included a clinical and methodologic article, a listserve discussion, and clinical and methodologic critiques. The control group received only the clinical articles. The primary outcome measure was a previously validated 2-hour test of critical appraisal.
                Of the 55 surgeons who completed the examination, subjects in the intervention group performed better on the test of critical appraisal skills than those in the control group (mean score: intervention group, 58% +/- 8 vs control group, 50% +/- 8), with a large effect size of 1.06 standard deviation units (t+3.92, P <.0001). Training conditions accounted for 22% of the variance in total scores.
                A multifaceted, Internet-based intervention resulted in improved critical appraisal skills of practicing general surgeons. New Residency Review Committee requirements in general surgery require 50 colonoscopies. Simulators have been widely suggested to help prepare residents for live clinical experience. We assessed a computer-based colonoscopy simulator for effective transfer of skills to live patients.
                A randomized controlled trial included general surgery and internal medicine residents with limited endoscopic experience. Following a pretest, the treatment group (n = 12) practiced on the simulator, while controls (n = 12) received no additional training. Both groups then performed a colonoscopy on a live patient. Technical ability was evaluated by expert endoscopists using previously validated assessment instruments.
                In the live patient setting, the treatment group scored significantly higher global ratings than controls (t(22) = 1.84, P = .04). Only 2 of the 8 computer-based performance metrics correlated significantly with previously validated global ratings of performance.
                Residents trained on a colonoscopy simulator prior to their first patient-based colonoscopy performed significantly better in the clinical setting than controls, demonstrating skill transfer to live patients. The simulator's performance metrics showed limited concurrent validity, suggesting the need for further refinement. 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. As part of the Cochrane Collaboration's international research endeavour, the authors carried out a handsearch of the RAMC Journal from 1948 to 1998, searching for randomised controlled trials (RCTs) and controlled clinical trials (CCTs). Ten trials were identified, of which 6 were RCTs and 4 were CCTs. The first trial was published in 1967. Four of the 10 identified trials were in the field of respiratory medicine, and 2 were in obstetrics and gynaecology. Of the 10 trials, only 3 had been found through a rigorous interrogation of Medline. The 7 newly identified trials were reported to the UK Cochrane Centre, and summary details of these trials were entered into Medline for use by clinicians and investigators in the future. To demonstrate that virtual reality (VR) training transfers technical skills to the operating room (OR) environment.
                The use of VR surgical simulation to train skills and reduce error risk in the OR has never been demonstrated in a prospective, randomized, blinded study.
                Sixteen surgical residents (PGY 1-4) had baseline psychomotor abilities assessed, then were randomized to either VR training (MIST VR simulator diathermy task) until expert criterion levels established by experienced laparoscopists were achieved (n = 8), or control non-VR-trained (n = 8). All subjects performed laparoscopic cholecystectomy with an attending surgeon blinded to training status. Videotapes of gallbladder dissection were reviewed independently by two investigators blinded to subject identity and training, and scored for eight predefined errors for each procedure minute (interrater reliability of error assessment r > 0.80).
                No differences in baseline assessments were found between groups. Gallbladder dissection was 29% faster for VR-trained residents. Non-VR-trained residents were nine times more likely to transiently fail to make progress (P <.007, Mann-Whitney test) and five times more likely to injure the gallbladder or burn nontarget tissue (chi-square = 4.27, P <.04). Mean errors were six times less likely to occur in the VR-trained group (1.19 vs. 7.38 errors per case; P <.008, Mann-Whitney test).
                The use of VR surgical simulation to reach specific target criteria significantly improved the OR performance of residents during laparoscopic cholecystectomy. This validation of transfer of training skills from VR to OR sets the stage for more sophisticated uses of VR in assessment, training, error reduction, and certification of surgeons. 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. The "fulcrum effect" of the body wall on surgical instrument manipulation is a major hurdle for novice endoscopic surgeons. Virtual reality training has not previously been evaluated as a means to overcome this problem.
                16 participants with no experience of endoscopy were required to make multiple defined incisions under laparoscopic laboratory conditions within 2-minute periods. Half of the subjects were randomized to receive initial training on the Minimally Invasive Surgical Trainer, Virtual Reality (MIST VR) computer programme.
                Participants with MIST VR training made significantly more correct incisions (P = 0.0001) than the control group on test trial 1, and even after extended practice by both groups (P = 0.0001). They were also significantly more likely to actively use both hands to perform the endoscopic evaluation task (P = 0.01).
                Virtual reality training represents a potential, viable solution for junior endoscopists, for overcoming the "fulcrum effect", in a replicable, safe learning environment which allows objective and reliable quantification of skill levels by trainers. Adoption of evidence-based practice (EBP) policy has implications for clinicians and researchers alike. In fields that have already adopted EBP, evidence-based practice guidelines derive from systematic reviews of research evidence. Ultimately, such guidelines serve as tools used by practitioners. Systematic reviews of treatment efficacy and effectiveness reserve their strongest endorsements for treatments that are supported by high-quality randomized clinical trials (RCTs). It is unknown how well RCTs reported in behavioral science journals fare compared to quality standards set forth in fields that pioneered the evidence-based movement. We compared analytic quality features of all behavioral health RCTs (n = 73) published in three leading behavioral journals and two leading medical journals between January 2000 and July 2003. A behavioral health trial was operationalized as one employing a behavioral treatment modality to prevent or treat an acute or chronic physical disease or condition. Findings revealed areas of weakness in analytic aspects of the behavioral health RCTs reported in both sets of journals. Weaknesses were more pronounced in behavioral journals. The authors offer recommendations for improving the analytic quality of behavioral health RCTs to ensure that evidence about behavioral treatments is highly weighted in systematic reviews.
                (c) 2006 Wiley Periodicals, Inc. Timely adoption of clinical practice guidelines is more likely to happen when the guidelines are used in combination with adjuvant educational strategies that address social as well as rational influences.
                To implement the conservative, evidence-based approach to low-back pain recommended in national guidelines, with the anticipated effect of reducing population-based rates of surgery.
                A randomized, controlled trial.
                Ten communities in western Washington State with annual rates of back surgery above the 1990 national average (158 operations per 100,000 adults).
                Spine surgeons, primary care physicians, patients who were surgical candidates, and hospital administrators.
                The five communities randomized to the intervention group received a package of six educational activities tailored to local needs by community planning groups. Surgeon study groups, primary care continuing medical education conferences, administrative consensus processes, videodisc-aided patient decision making, surgical outcomes management, and generalist academic detailing were serially implemented over a 30-month intervention period.
                Quarterly observations of surgical rates.
                After implementation of the intervention, surgery rates declined in the intervention communities but increased slightly in the control communities. The net effect of the intervention is estimated to be a decline of 20.9 operations per 100,000, a relative reduction of 8.9% (P = 0.01).
                We were able to use scientific evidence to engender voluntary change in back pain practice patterns across entire communities. Randomized clinical trials (RCTs) provide the most reliable therapeutic information available. Unfortunately, there are no systemic listing of RCTs. We compared a MEDLARS search of 3686 biomedical journals for RCTs with a manual search of the medical literature for the period 1966-1982. For the former search we used subject headings (1) liver disease or (2) biliary tract disease and subheadings (1) drug therapy, (2) surgery, (3) radiotherapy, or (4) therapy, and check tags (1) comparative study or (2) clinical research. For the manual search, the contents of 34 arbitrarily selected, gastroenterologic, hepatologic, surgical, or general journals were perused. The MEDLARS search identified 160 RCTs and 29 others were found in the references of the 160. One hundred fifty-four RCTs were identified by both methods. The manual search identified 208 RCTs and an additional 34 were found in the references of the 208. The MEDLARS search identified only 107 of 208 RCTs found in the references of the 208. The MEDLARS search identified only 107 of 208 RCTs found manually in the 36 journals, an efficiency rate of 51%. We estimate that 330 hepatobiliary RCTs had been published during this 17-year period. Sixty percent of the RCTs found by MEDLARS used the key word "randomized," "double blind," or "controlled" in the title, compared to 36% in those found by the manual search. In order to retrieve RCTs, it is essential that editors require that RCTs be identified in their titles or key words by specific terms such as "controlled," "randomized," and "double blind," that papers be so catalogued and indexed, and that searchers be instructed in appropriate search strategies. Cumulative meta-analysis of clinical trials (a Bayesian interpretation for accumulating evidence) will profoundly affect medical care by summarizing evidence in the assessment of technology innovations. Application of the technique to the randomized control trials (RCTs) of streptokinase treatment of acute myocardial infarction, reduction of peri-operative mortality by antibiotic prophylaxis, and prevention of death from bleeding peptic ulcers has revealed efficacy years before it was suspected by any other means. Arrangement of the trials according to event rate in the controls, effect sizes, quality of the trials or according to covariables of interest has supplied unique information. If carried out prospectively the technique supplies invaluable information regarding indications for another trial, the number of patients necessary to determine the validity of past trends, and the type of patients who might be benefitted. Careful examination in a cumulative manner of the prior trials can reduce the need for future large trials. Shortened hospitalizations following cardiac surgery necessitate re-evaluation of how pertinent information for self-care management and reduction of coronary artery disease risk factors can be incorporated into an effective inpatient cardiac patient teaching program. This study investigated the effect of three different teaching approaches (i.e., an inpatient teaching program, a postdischarge telephone follow-up program, and a postdischarge group teaching program) among 90 patients who had undergone coronary artery bypass graft surgery. Teaching outcomes were evaluated in this study by use of the Heart Disease Management Questionnaire and Cardiac Surgical Patient Teaching Satisfaction Inventory. Analyses of the data revealed similar patient teaching outcomes regardless of the type of teaching intervention the participant received. Findings supported the effectiveness of the inpatient teaching protocol which focused on "survival skills" for self-care management postdischarge. The findings are important in the redesign of teaching programs which are efficient yet meaningful to the patient within today's health care environment. Additional findings indicated that patients who had longer lengths of stay and those with more vessels bypassed were the least satisfied with their teaching. Further implications for nurses involved in patient teaching are discussed. Laparoscopic surgery requires a different set of skills than traditional open surgery. The acquisition of basic laparoscopic skills may help novices when learning laparoscopic procedures. This study tested the hypothesis that the combination of virtual reality and box trainers leads to better basic laparoscopic skill acquisition than either method alone or no training.
                A randomized control trial involving preclinical medical students with no prior operative experience was performed. The students were grouped according to four training methods: virtual reality training, inanimate box training, a combination of both, and no training (control). The pre- and posttraining scores for four skills in the porcine laboratory were the metrics chosen for this study.
                A total of 65 students participated in this study. There were no differences among any of the pretraining scores (p > 0.05). The posttraining times differed between the four groups. Post hoc analyses showed statistically significant differences (p < 0.05) between the participants trained with both trainers and the control subjects.
                Our data demonstrate that the combination of virtual reality training and inanimate box training leads to better laparoscopic skill acquisition than either training method alone or no training at all. Optimal preclinical laparoscopic training should incorporate both virtual reality trainers and inanimate box trainers. There is an increasing drive to make nursing care evidence-based. High quality evidence from systematic reviews relevant to postoperative pain relief exists, yet pain after surgery remains poorly controlled for many patients. This study aimed to assess whether implementing evidence-based pain management improved postoperative pain outcomes. Pain on a 0-10 scale was the primary outcome and analgesic consumption a secondary outcome. A baseline audit was undertaken on four surgical wards to establish whether there was a need for the study. A randomized-controlled trial was then designed to assess the effects of implementing an evidence-based approach to postoperative pain management. The four wards were randomized to receive the intervention or act as a control. Outcomes were assessed 3 months after the intervention on both intervention and control wards. The intervention (implementation of an oral analgesic algorithm derived from systematic reviews) was then implemented on the control wards and outcomes reassessed after 3 months on the control wards. The intervention was designed using an evidence-based approach to effective implementation. Four interactive sessions covered: (1) detailed feedback of baseline data and discussion (utilizing audit and feedback), (2) why systematic reviews, analgesic league tables and choice of drugs to develop an analgesic algorithm (see Figure 1), (3) principles of evidence based health care (EBHC), including critical appraisal and (4) facilitation and change workshop. The findings revealed no significant differences in pain level or drug use between the intervention and control wards. However, the control wards also changed during the control period. Possible explanations for this are discussed. When looking at changes compared with baseline, both intervention and control wards increased their use of algorithm drugs and reduced use of non-algorithm drugs during the study. No effects were found on pain in the intervention wards. Pain ratings at rest since surgery, on movement since surgery and worst pain on movement were significantly reduced compared with baseline in the control wards. Although there are many pressures to utilize a randomized-controlled trial study design in the culture of evidence-based health care, there will be times, especially when implementing complex changes in practice that other types of design should be considered. A prospective randomized controlled trial (RCT) of multimodal perioperative management protocol in patients undergoing elective colorectal resection for cancer.
                This study evaluates the use of a multimodal package in colorectal cancer surgery in the context of an RCT.
                Patients for elective resection for colorectal cancer were offered trial entry. Participants were stratified by sex and requirement for a total mesorectal excision and centrally randomized. Multimodal patients received intravenous fluid restriction, unrestricted oral intake with prokinetic agents, early ambulation, and fixed regimen epidural analgesia. Control patients received intravenous fluids to prevent oliguria, restricted oral intake until return of bowel motility, and weaning regimen epidural analgesia. Adherence to both regimens was reinforced using a daily checklist and protocol guidance sheets. Discharge decision was made using pre-agreed criteria. The primary endpoint was postoperative stay, and achievement of independence milestones. Secondary endpoints were postoperative complications, readmission rates, and mortality. Analysis was by intention to treat.
                Seventy patients were recruited. Approximately one fourth underwent TME. Median ages were similar (69.3 vs. 73.0 years). The median stay was significantly reduced in the multimodal group (5 vs. 7 days; P < 0.001, Mann-Whitney U test). Patients in the control arm were 2.5 times as likely to require a postoperative stay of more than 5 days. Patients in the multimodal group had less cardiorespiratory and anastomotic complications but more readmissions. There were 2 deaths, both controls.
                This RCT provides level 1b evidence that a multimodal management protocol can significantly reduce postoperative stay following colorectal cancer surgery. Morbidity and mortality are not increased.
Limited evidence is now available to support some aspects of surgical practice. Surgeons should be encouraged to perform further RCTs in this field.