Damian R. Griffin

Randomised trials in surgery: problems and possible solutions

The quality and quantity of randomised trials of surgical techniques is acknowledged to be limited. According to Peter McCulloch and colleagues, however, some aspects of surgery present special difficulties for randomised trials. In this article they analyse what these difficulties are and propose some solutions for improving the standards of clinical research in surgery.

Is arthroscopic surgery for stabilisation of chronic shoulder instability as effective as open surgery?: a systematic review and meta-analysis of 62 studies including 3044 arthroscopic operations

A systematic search of the literature published between January 1985 and February 2006 identified 62 studies which reported the results of arthroscopic procedures for chronic anterior shoulder instability or comparisons between arthroscopic and open surgery. These studies were classified by surgical technique and research methodology, and when appropriate, were included in a meta-analysis. The failure rate of arthroscopic shoulder stabilisation using staples or transglenoid suture techniques appeared to be significantly higher than that of either open surgery or arthroscopic stabilisation using suture anchors or bio-absorbable tacks. Arthroscopic anterior stabilisation using the most effective techniques has a similar rate of failure to open stabilisation after two years.

Pelvic ring disruptions: Prediction of associated injuries, transfusion requirement, pelvic arteriography, complications, and mortality

Objective To determine if age, fracture pattern, systolic blood pressure on arrival, base deficit, or the Revised Trauma Score is predictive of mortality, transfusion requirements, use of pelvic arteriography, later complications, or injuries associated with the pelvic ring disruption. Study Design Retrospective review of a prospectively collected database. Methods All closed pelvic ring disruptions seen between November 1, 1997 and November 30, 1999 were included. Predictive variables and outcome variables were recorded for each patient. Statistical analysis was used to determine if the above variables were predictive. Results Shock on arrival and the Revised Trauma Score were significantly associated with mortality, transfusion requirement, Injury Severity Score, and all the Abbreviated Injury Scores except the one for skin. In addition, the Revised Trauma Score was significantly associated with the use of pelvic arteriography and predicted more complications than did shock on arrival. Age was significantly associated with transfusion requirement, Injury Severity Score, the chest and skin Abbreviated Injury Scores, use of arteriography, and death. The mortality rate among patients who presented in shock was 57 percent. A Revised Trauma Score of less than 11 predicted mortality with a sensitivity and specificity of 58 percent and 92 percent, respectively. Shock on arrival predicted mortality with a sensitivity and specificity of 27 percent and 96 percent, respectively. Age greater than sixty years predicted mortality with a sensitivity and specificity of 26 percent and 91 percent, respectively. In our analysis of the fracture patterns, we were unable to demonstrate consistent, meaningful links between specific fracture classes and the outcome variables. Conclusions Shock on arrival and the Revised Trauma Score are useful predictors of mortality and transfusion requirements, Injury Severity Score, and Abbreviated Injury Scores for the head and neck, face, chest, abdomen, and extremities. In addition, the Revised Trauma Score predicts the use of pelvic arteriography and later complications. Age predicted transfusion requirement, Injury Severity Score, the chest and skin Abbreviated Injury Scores, use of arteriography, and death.

The Development and Validation of a Self-Administered Quality-of-Life Outcome Measure for Young, Active Patients With Symptomatic Hip Disease: The International Hip Outcome Tool (iHOT-33)

PURPOSE The purpose of this study was to develop a self-administered evaluative tool to measure health-related quality of life in young, active patients with hip disorders. METHODS This outcome measure was developed for active patients (aged 18 to 60 years, Tegner activity level ≥ 4) presenting with a variety of symptomatic hip conditions. This multicenter study recruited patients from international hip arthroscopy and arthroplasty surgeon practices. The outcome was created using a process of item generation (51 patients), item reduction (150 patients), and pretesting (31 patients). The questionnaire was tested for test-retest reliability (123 patients); face, content, and construct validity (51 patients); and responsiveness over a 6-month period in post-arthroscopy patients (27 patients). RESULTS Initially, 146 items were identified. This number was reduced to 60 through item reduction, and the items were categorized into 4 domains: (1) symptoms and functional limitations; (2) sports and recreational physical activities; (3) job-related concerns; and (4) social, emotional, and lifestyle concerns. The items were then formatted using a visual analog scale. Test-retest reliability showed Pearson correlations greater than 0.80 for 33 of the 60 questions. The intraclass correlation statistic was 0.78, and the Cronbach α was .99. Face validity and content validity were ensured during development, and construct validity was shown with a correlation of 0.81 to the Non-Arthritic Hip Score. Responsiveness was shown with a paired t test (P ≤ .01), effect size of 2.0, standardized response mean of 1.7, responsiveness ratio of 6.7, and minimal clinically important difference of 6 points. CONCLUSIONS We have developed a new quality-of-life patient-reported outcome measure, the 33-item International Hip Outcome Tool (iHOT-33). This questionnaire uses a visual analog scale response format designed for computer self-administration by young, active patients with hip pathology. Its development has followed the most rigorous methodology involving a very large number of patients. The iHOT-33 has been shown to be reliable; shows face, content, and construct validity; and is highly responsive to clinical change. In our opinion the iHOT-33 can be used as a primary outcome measure for prospective patient evaluation and randomized clinical trials.

Vertically unstable pelvic fractures fixed with percutaneous iliosacral screws: does posterior injury pattern predict fixation failure?

Objective To measure the failure rate of percutaneous iliosacral screw fixation of vertically unstable pelvic fractures and particularly to test the hypothesis that fixations in which the posterior injury is a vertical fracture of the sacrum are more likely to fail than fixations with dislocations or fracture-dislocations of the sacroiliac joint. Design Retrospective review. Setting Level 1 trauma center. Methods All patients with pelvic fractures admitted between January 1, 1993, and December 31, 1998, were identified from the trauma registry. Hospital records were used to identify patients treated with iliosacral screws. Radiologic studies were examined to identify patients who had unequivocally vertically unstable pelvic fractures. Immediate postoperative and follow-up anteroposterior, inlet, and outlet radiographs from a minimum of 12 months postinjury were examined. Position, length, and numbers of iliosacral screws and any evidence of screw failure (eg, bending or breakage) were recorded. Residual postoperative displacement and late displacement of the posterior pelvis were measured. The main outcome measure was failure, defined as at least 1cm of combined vertical displacement of the posterior pelvis compared with immediate postoperative position. The main analysis was for association between fracture pattern and failure. Patient demographic data, iliosacral screw position, and anterior pelvic fixation method also were studied. Results The study group comprised 62 patients with unequivocally vertically unstable pelvic fractures in whom the posterior injury was treated with closed reduction and percutaneous iliosacral screw fixation. Of patients, 32 had dislocations or fracture-dislocations of the sacroiliac joint, and 30 had vertical fractures of the sacrum. Fixation failed in four patients, all with vertical sacral fractures and all within the first 3 weeks after surgery. These four patients required revision fixation. In two further cases with vertical sacral fractures, there was evidence that the fracture had only barely been held by the fixation, but these fractures healed, and follow-up radiographs did not meet the displacement criteria for failure. A vertical sacral fracture pattern was associated significantly with failure (Fisher exact test, P =0.04); the excess risk of failure compared with sacroiliac joint injury was 13% (95% confidence interval 1% to 25%). There was no significant association between failure and anterior fixation method, iliosacral screw arrangement or length, or any demographic or injury variable. Conclusions Percutaneous iliosacral screw fixation is a useful technique in the management of vertically unstable pelvic fractures, but a vertical sacral fracture should make the surgeon more wary of fixation failure and loss of reduction.

Doha agreement meeting on terminology and definitions in groin pain in athletes

Background Heterogeneous taxonomy of groin injuries in athletes adds confusion to this complicated area. Aim The ‘Doha agreement meeting on terminology and definitions in groin pain in athletes’ was convened to attempt to resolve this problem. Our aim was to agree on a standard terminology, along with accompanying definitions. Methods A one-day agreement meeting was held on 4 November 2014. Twenty-four international experts from 14 different countries participated. Systematic reviews were performed to give an up-to-date synthesis of the current evidence on major topics concerning groin pain in athletes. All members participated in a Delphi questionnaire prior to the meeting. Results Unanimous agreement was reached on the following terminology. The classification system has three major subheadings of groin pain in athletes: 1. Defined clinical entities for groin pain: Adductor-related, iliopsoas-related, inguinal-related and pubic-related groin pain. 2. Hip-related groin pain. 3. Other causes of groin pain in athletes. The definitions are included in this paper. Conclusions The Doha agreement meeting on terminology and definitions in groin pain in athletes reached a consensus on a clinically based taxonomy using three major categories. These definitions and terminology are based on history and physical examination to categorise athletes, making it simple and suitable for both clinical practice and research.

Epidural steroid injection for nerve root compression A RANDOMISED, CONTROLLED TRIAL

We have assessed whether an epidural steroid injection is effective in the treatment of symptoms due to compression of a nerve root in the lumbar spine by carrying out a prospective, randomised, controlled trial in which patients received either an epidural steroid injection or an intramuscular injection of local anaesthetic and steroid. We assessed a total of 93 patients according to the Oxford pain chart and the Oswestry disability index and followed up for a minimum of two years. All the patients had been categorised as potential candidates for surgery. There was a significant reduction in pain early on in those having an epidural steroid injection but no difference in the long term between the two groups. The rate of subsequent operation in the groups was similar.

Path analysis of factors for delayed healing and nonunion in 416 operatively treated tibial shaft fractures

A prospective observational study was done in 41 trauma centers. Four hundred sixteen patients with tibial shaft fractures were treated operatively and followed up for at least 6 months. Fifty-two (13%) cases of delayed healing or nonunion were reported. In such nonrandomized observational studies, multiple interrelationships exist between prognostic factors and patient outcomes. We used path analyses to investigate prognostic factors associated with the occurrence of delayed healing or nonunion. The most important factors were identified using multivariate regression analyses, and interrelationships between factors were illustrated using a path diagram. Fractures with open injuries less than and greater than 5 cm were 3.6 and 5.7 times as likely, respectively, to have delayed healing or nonunion as fractures with no skin injuries. The Müller-AO classification of fractures did not provide additional prognostic information. The risk of healing problems was doubled for fractures of the distal shaft and for fractures showing a postoperative diastasis. Treatment options showed an indirect effect on outcome with the occurrence of diastasis. A model for predicting delayed healing or nonunion is proposed. We encourage the use of path analysis in orthopaedics as a powerful visual technique to interpret data from observational studies. Level of Evidence: Prognostic study, Level II-1 (retrospective study). See the Guidelines for Authors for a complete description of levels of evidence.

Compliance and use of the World Health Organization checklist in U.K. operating theatres.

The World Health Organization (WHO) Surgical Safety Checklist is reported to reduce surgical morbidity and mortality, and is mandatory in the UK National Health Service. Hospital audit data show high compliance rates, but direct observation suggests that actual performance may be suboptimal.

A Short Version of the International Hip Outcome Tool (iHOT-12) for Use in Routine Clinical Practice

PURPOSE The purpose of this study was to develop and validate a shorter version of the 33-item International Hip Outcome Tool (iHOT-33) that could be easily used in routine clinical practice to measure both health-related quality of life and changes after treatment in young, active patients with hip disorders. METHODS A development dataset (104 patients) was explored with forward-selection linear regression analysis to choose a reduced item set for the new scale. This was tested in a validation dataset (1,833 patients) and responsiveness subset (80 patients) to measure agreement between the shorter and longer versions and to test the sensitivity of the shorter instrument to change after treatment. RESULTS Twelve items were chosen for a short version of the International Hip Outcome Tool (iHOT-12). The iHOT-12 showed excellent agreement with the long version (iHOT-33). It captured 95.9% (95% confidence interval, 95.0% to 96.8%) of the variation of the iHOT-33 and showed equivalent sensitivity to change with a standardized effect size of 0.98 (95% confidence interval, 0.67 to 1.28). CONCLUSIONS A short version of the International Hip Outcome Tool (iHOT-12) has been developed. It has very similar characteristics to the original rigorously validated 33-item questionnaire, losing very little information despite being only one-third the length. It is valid, reliable, and responsive to change. We suggest that it be used for initial assessment and postoperative follow-up in routine clinical practice.