The quality of reporting of randomized trials in the Journal of Bone and Joint Surgery from 1988 through 2000

BACKGROUND: The purpose of this study was threefold: (1) to determine the scientific quality of published randomized trials in the American Volume of The Journal of Bone and Joint Surgery from 1988 through 2000, (2) to identify predictors of study quality, and (3) to evaluate inter-rater agreement in the scoring of study quality with use of a simple scale. METHODS: Hand searches of The Journal of Bone and Joint Surgery were conducted in duplicate to identify randomized clinical trials. Of 2468 studies identified, seventy-two (2.9%) met all eligibility criteria. Two investigators each assessed the quality of the study under blinded conditions and abstracted relevant data. RESULTS: The mean score (and standard error) for the quality of the seventy-two randomized trials was 68.1% plus minus 1.6%; 60% (forty-three) scored <75%. Drug trials had a significantly higher mean quality score than did surgical trials (72.8% compared with 63.9%, p < 0.05). Regression analysis revealed that cited affiliation with an epidemiology department and cited funding were associated with higher quality scores. Failure to conceal randomization, to blind outcome assessors, and to describe why patients were excluded resulted in significantly lower quality scores (p < 0.05), more than the 5% decrease expected by removal of each item. A priori calculations of sample size were rarely performed in the reviewed studies, and only 2% of the studies with negative results included a post hoc power analysis. The Detsky quality scale met accepted standards of interobserver reliability (kappa, 0.87; 95% confidence interval, 0.70 to 0.95). CONCLUSIONS: Few studies published in The Journal of Bone and Joint Surgery were randomized trials. More than half of the trials were limited by a lack of concealed randomization, lack of blinding of outcome assessors, or failure to report reasons for excluding patients. Application of standardized guidelines for the reporting of clinical trials in orthopaedics should improve quality.     

Vattikuti Institute prostatectomy, a technique of robotic radical prostatectomy for management of localized carcinoma of the prostate: experience of over 1100 cases

Advances in surgical techniques, technology, and surgeons' skills have allowed robot-assisted radical prostatectomy to be an option in the management of organ-confined prostate cancer. The goals of the VIP technique are to cure cancer, preserve urinary continence, preserve potency, and decrease morbidity, along with the benefits of a minimally invasive surgery and excellent cosmesis. VIP is nearly equal to traditional retro-pubic prostatectomy, with certain outstanding advantages.     

The impact of non-injury-related factors on disability secondary to whiplash associated disorder type II: a retrospective file review

BACKGROUND: There is evidence to suggest that Whiplash Associated Disorders (WADs) are influenced by physical trauma and psychosocial factors, as well as by medicolegal and compensation systems. OBJECTIVE: To investigate the impact of noninjury related variables on self-reported disability at initial assessment among patients presenting with WAD type II injuries. DESIGN AND SETTING: We reviewed a total of 1101 consecutive files of patients presenting to a single chiropractor's office in British Columbia, Canada. We included those who met the inclusion criteria. We extracted demographic variables and noninjury related information from 33 eligible patient files. We calculated correlations between variables and created a multivariable linear regression model to evaluate their relative associations with Neck Disability Index (NDI) scores on presentation. RESULTS: Higher NDI scores on initial assessment correlated with female sex (r = 0.40, P =.02), a greater number of subsequent treatments (r = 0.44, P =.01), a higher number of providers seen before presentation (r = 0.40, P =.02), and most strongly with the involvement of a lawyer (r = 0.73, P <.01). A multivariable linear regression model found that only female sex (P =.03) and the involvement of a lawyer (P =.01) remained significantly associated with higher NDI scores on presentation (adjusted R2 = 0.68 for the model). Female sex was associated with a 10-point increase in NDI scores on presentation (beta coefficient = 10.5; 95% confidence interval [CI] 2.8-18.2), and involvement of a lawyer was associated with a 15-point increase in NDI scores on presentation (beta coefficient = 14.9; 95% CI 5.0-24.7). CONCLUSION: Our analysis of WAD type II patients in receipt of compensation found that higher self-reported disability on initial assessment was associated with female sex and in particular by retaining a lawyer. Large prospective studies are needed to establish the validity of these findings.     

Immediate haemostasis with recombinant factor VIIa for haemorrhage following Hickman line insertion in acute myeloid leukaemia

Bleeding following Hickman line insertion is not uncommon but can be life threatening, especially in the presence of coagulopathy and thrombocytopenia following chemotherapy. Treatment to control the bleeding can be challenging and treatment options are limited. We present our experience of a patient who had persisting haemorrhage immediately following Hickman line insertion for administration of chemotherapy for relapsed acute myeloid leukaemia. Haemostasis could not be achieved after FFP and platelet administration. A single dose of recombinant factor VIIa (rhFVIIa) stopped the bleeding immediately, avoiding the need for surgical intervention or line removal. Our experience indicates rhFVIIa may be an effective option for bleeding related to Hickman line insertion.     

Interrater reliability in grading abstracts for the orthopaedic trauma association

Only a small proportion of submitted abstracts to the annual meeting of the Orthopaedic Trauma Association can be accepted for podium presentation. Annual program committee members must ensure that the selection of abstracts is free from bias and transparent to investigators. The objectives of this study are to examine the consistency of reviewers in grading abstracts submitted for podium presentations at the 2001 and 2002 Annual Meetings of the Orthopaedic Trauma Association and to evaluate whether the grades of the actual podium presentations at the meeting are consistent with the grades based on abstracts only. Reviewers independently graded all abstracts submitted to the Orthopaedic Trauma Association for presentation in a blinded manner. Abstracts submitted by members of the review panel were independently adjudicated by six reviewers who were not members of the committee. Before final decision-making, all reviewers met to discuss the abstracts submitted for oral presentation. Among the 440 papers reviewed in 2001 and 438 papers reviewed in 2002, the interreviewer reliability for abstract review was 0.23 and 0.27, respectively. Despite disagreements in the quality of the abstracts, reviewers achieved consensus by discussions to determine the final program. Agreement among unblinded reviewers of the 67 and 73 podium presentations during the 2001 and 2002 meetings, respectively, did not improve interreviewer agreement. Of the papers of the 2002 meeting that ultimately ranked in the top 20 after the full presentation of the papers, 15 papers originally had been ranked less than 20 in the initial grading. Only one of the top three papers of the meeting originally was ranked in the top three before the meeting.     

Doubling the impact: publication of systematic review articles in orthopaedic journals

BACKGROUND: Investigators aim to publish their research papers in top journals to disseminate their findings to the widest possible audience. Systematic reviews of the literature occupy the highest position in currently proposed hierarchies of evidence. We hypothesized that the number of citations (a measure of scholarly interest) for systematic reviews (or meta-analyses) published in leading orthopaedic journals would be greater than the number of citations for narrative reviews published in the same journals. METHODS: We identified fifteen journals that had high Science Citation Index impact factors for the orthopaedic subspecialty and were believed to have a higher yield of studies and reviews of scientific merit and clinical relevance. For the year 2000, six research associates applied methodological criteria to each article in each issue of the fifteen journals to determine whether the article was scientifically sound (rigorous versus nonrigorous). Of the 3916 articles identified, 2331 were original or review articles. We queried the ISI (Institute for Scientific Information) Web of Science database to ascertain, as of March 2003, the number of subsequent citations to each one of the reviews after its original publication in all journals that published both narrative and systematic reviews. RESULTS: Of the 2331 articles published across the fifteen journals in the year 2000, 110 were review articles. Only seventeen (15%) of the 110 reviews met our criteria for systematic reviews with rigor. Rigorous systematic reviews received more than twice the mean number of citations compared with other systematic or narrative reviews (13.8 compared with 6.0, p = 0.008). The rigor of a review was a significant predictor of the number of citations in other orthopaedic journals (p = 0.01). In addition, rigor was significantly associated with the number of citations in nonorthopaedic journals (p = 0.03). CONCLUSIONS: Our findings suggest that journal editors and authors can improve the relevance and scholarly interest in their reviews (as shown by the number of citations) by meeting standard guidelines for methodological rigor.     

Fractures of the shaft of the ulna

BACKGROUND: The optimal management for ulnar shaft fractures remains debatable. Investigators have advocated nonoperative management as well as internal fixation of these fractures. OBJECTIVE: The primary objective of this study was to determine the effect of alternative management strategies of fractures of the ulnar shaft on rates of union, infection, and functional outcomes. A secondary objective was to examine outcomes after alternative strategies in managing patients with bone defects.     

Opioid and GABA receptors involved in mediation and modulation of tonic and stimulus-evoked inhibition of a spinal reflex in the decerebrated and spinalized rabbit

The purposes of this study were to investigate: (i) the identity of the opioid peptide(s) mediating tonic and stimulus-evoked inhibition of the sural-medial gastrocnemius reflex of the decerebrated, spinalized rabbit and (ii) the modulation of these processes by endogenous GABA. The selective delta receptor antagonist naltrindole (100 nmol kg(-1) i.v.), the GABA(A) blocker bicuculline (300 nmol intrathecal, i.th.), and the GABA(B) antagonist CGP 35348 (1 micromol i.th.) increased gastrocnemius reflexes to 150-160% of pre-drug values, whereas a sub-maximal dose of naloxone (30 nmol kg(-1) i.v.) augmented reflexes to >500% of controls. Kelatorphan, an inhibitor of enkephalin metabolism (2 micromol i.th.), depressed gastrocnemius responses by 50% and potentiated the inhibitory effects of methionine enkephalin.Repetitive electrical stimulation of the superficial or common peroneal nerves inhibited reflexes for 15-20 min. This effect was significantly reduced by naltrindole and CGP 35348. It was not reduced by a low dose (30 nmol kg(-1) i.v.) of naloxone or by bicuculline. When naloxone and naltrindole were combined at 30 nmol kg(-1) each, stimulus-evoked inhibition was blocked. Given after bicuculline, naloxone at 100 nmol kg(-1) i.v. abolished peroneal-evoked inhibition, but a dose of 300 nmol kg(-1) was required to produce the same effect after CGP 35348. Kelatorphan augmented the depth and duration of inhibition evoked by peroneal nerve stimulation. These data are consistent with the involvement of enkephalin-like peptides in tonic and stimulus-evoked inhibition of the sural-gastrocnemius reflex. Tonic inhibition in rabbit spinal cord is dominated by opioids acting through mu receptors, whereas co-activation of delta, mu and GABA(B) receptors mediates stimulus-evoked inhibition. It is possible that GABA(B) receptors inhibit the release of spinal opioids while simultaneously supporting their actions at post-synaptic targets.     

Insulin regulation of protein translation repressor 4E-BP1, an eIF4E-binding protein, in renal epithelial cells

BACKGROUND: Augmented protein translation by insulin involves activation of eukaryotic initiation factor 4E (eIF4E) that follows release of eIF4E from a heterodimeric complex by phosphorylation of its inhibitory binding protein, 4E-BP1. We examined insulin regulation of 4E-BP1 phosphorylation in murine proximal tubular epithelial cells. METHODS AND RESULTS: Insulin (1 nmol/L) increased de novo protein synthesis by 58 +/- 11% (P < 0.001). Insulin also augmented 4E-BP1 phosphorylation and phosphatidylinositol 3-kinase (PI 3-kinase) activity in antiphosphotyrosine immunoprecipitates. This could be prevented by PI 3-kinase inhibitors, Wortmannin, and LY294002. Insulin also activated Akt that lies downstream of PI 3-kinase. Rapamycin abrogated 4E-BP1 phosphorylation in response to insulin, suggesting involvement of mammalian target of rapamycin (mTOR), a kinase downstream of Akt. Insulin-stimulated phosphorylation of 4E-BP1 was also inhibited by PD098059, implying involvement of Erk-1/-2 mitogen-activated protein (MAP) kinase. An increase in Erk-1/-2 type MAP kinase activity by insulin was directly confirmed in an immunokinase assay and was found to be PI 3-kinase dependent. CONCLUSIONS: In proximal tubular epithelial cells, insulin augments 4E-BP1 phosphorylation, which is PI 3-kinase and mTOR dependent. The requirement for Erk-1/-2 MAP kinase activation for 4E-BP1 phosphorylation by insulin suggests a cross-talk between PI 3-kinase and Erk-1/-2-type MAP kinase pathways.     

Sequential bilateral total knee arthroplasty under 1 anesthetic in patients > or = 75 years old: complications and functional outcomes

The objectives of this study were to determine the perioperative surgical and medical risks associated with sequential bilateral total knee arthroplasty (TKA) in patients > or = 75 years old and to assess their functional status and overall level of satisfaction at follow-up. Study participants were 82 consecutive patients > or = 75 years old who underwent a sequential bilateral TKA and 82 matched patients who underwent a unilateral TKA. There were 46 postoperative complications in the bilateral TKA group compared with 27 in the unilateral TKA group (P = .003). Postoperative cardiovascular complications were significantly greater in the sequential bilateral TKA group and were associated significantly with preoperative cardiovascular comorbidity. The mean Modified Hospital for Special Surgery knee score was rated as good (mean, 63.5 out of 80), and 95% of patients rated their knees as excellent or good at follow-up. Sequential bilateral TKA in patients > or =75 years old results in high patient satisfaction and good functional status at follow-up; however, there is an increased risk of cardiovascular complications during the postoperative period in bilateral sequential TKA patients when compared with a matched cohort of unilateral TKA patients.