BACKGROUND:Arthritis at the proximal interphalangeal joint can be a disabling chronic condition. Silicone arthroplasty is a common surgical treatment option to provide pain relief and maintain joint mobility. Pyrocarbon implants are gaining popularity as an alternative to silicone prostheses. The purpose of this systematic review is to compare the outcomes of silicone and pyrocarbon arthroplasties for patients with proximal interphalangeal joint arthritis.METHODS:A computerized search was conducted to identify studies evaluating outcomes of silicone and pyrocarbon arthroplasties. The data extracted were patient demographics, pain relief, range of motion, grip and pinch strength, costs, quality of life, and complications.RESULTS:Thirty-five relevant citations were identified. Available data showed that both arthroplasties offered satisfactory pain relief. The implants also provided similar postoperative weighted mean arcs of motion, with a value of 37.4 ± 13.6 degrees for silicone and 44.8 ± 16.8 degrees for pyrocarbon. There were comparable results in grip and pinch strengths as well. No studies were identified that performed an economic analysis of arthroplasty. Six studies assessed quality-of-life outcomes after pyrocarbon surgery, and results were mixed. The rates of revision and salvage procedures performed secondary to complications were higher after pyrocarbon arthroplasty.CONCLUSIONS:Based on the available low level of evidence, pyrocarbon arthroplasty does not demonstrate clear superiority over silicone implants. In fact, there is concern about the complication rates of these implants. Future studies should focus on more rigorous study designs using validated quality-of-life scales and economic evaluations before widespread adoption of this new implant.CLINICAL QUESTION/LEVEL OF EVIDENCE:Therapeutic, IV.
Blood transfusion after joint arthroplasty occurs in up to two thirds of patients. We conducted a systematic review of the literature to determine the methodological quality of published randomized controlled trials (RCTs). We searched MEDLINE, EMBASE, and Cochrane to identify RCTs in arthroplasty with blood conservation as the primary outcome from 2001 to 2007. Methodological quality was evaluated using the Detsky index. We identified 62 RCTs. The mean Detsky score was 73% ± 14%. Epidemiology affiliation (P = .003), funding support (<.001), and year of publication (<.001) were the predictors of reporting quality, predicting 46% of the variability (R2 = 0.46). This suggests poor reporting quality of trials in blood conservation. The inclusion of an epidemiologist or a biostatistician for the design of a trial is strongly recommended.
Hamilton, Ontario, Canada From the Department of Clinical Epidemiology and Biostatistics and the Surgical Outcomes Research Center, McMaster University, and the Department of Surgery, Division of Plastic and Reconstructive Surgery, St. Joseph's Healthcare. Received for publication July 23, 2009; accepted October 29, 2009. Disclosure: No funding was received for this study. The authors have no financial interest to declare. Achilleas Thoma, M.D., M.Sc., 101-206 James Street South, Hamilton, Ontario L8P 3A9, Canada, [email protected]
One of the most common challenges of randomized controlled trials (RCTs), both published and unpublished, is related to problems with recruitment. Investigators’ enthusiasm for ambitious recruitment in a trial often dissipates quickly with the realization that ambitious recruitment is often misguided. This common error has been dubbed “Lasagna’s Law”1 and Muench’s Third Law.2 Both laws point to the same principle: investigators greatly overestimate the pool of available patients who meet the inclusion criteria.3 Insufficient or untimely patient recruitment into RCTs has serious consequences. The length of the trial may need to be extended, leading to increased resource use and costs. Lengthy trials delay the availability of potentially beneficial treatments to the public.4 The integrity and validity of the study also rely on an adequate sample size. If the sample size is not achieved, there is an increased chance of committing a type II error (e.g., you are more likely to find no difference between treatments when one actually exists). The trial may have to be abandoned, and the results may not be publishable. The recruitment rate is influenced by both patient and investigator factors. A recent systematic review by Abraham and colleagues5 identified reasons why eligible patients may not want to participate in real or hypothetical surgical RCTs. Surgeons were also asked why they did not want to enroll eligible patients into real or hypothetical surgical trials. The top reasons for patient nonentry were that the patient had a preference for a certain therapy, he or she did not understand the trial (trial too complex), the patient did not want to be randomly assigned to a treatment and he or she feared a negative outcome or receiving a treatment that he or she felt was inferior. Investigators had similar reasons for not entering eligible patients, including difficulty following the study protocol (trial too complex) and completing the follow-up requirements, preference for a certain therapy and difficulties obtaining informed consent from patients. Understanding and addressing potential patient and investigator concerns is important when developing a recruitment strategy. In this article, we discuss the common issues encountered in recruiting patients for surgical trials. It is intended for anyone conducting surgical trials, including medical students, residents, and junior and senior researchers. By the end of this article, readers will be able to develop strategies to avoid some of the common pitfalls in recruitment and, if these difficulties occur, to rectify them.
There are many anatomical variations in and around the carpal tunnel that affect the nerves, tendons and arteries in this area. Awareness of these variations is important both during the clinical examination and during carpal tunnel release. The purpose of the present review is to highlight recognized anatomical variations within the carpal tunnel including variation in nerve anatomy, tendon anatomical variants, vascular anatomical variations and muscle anatomical variations.
This article explains the concepts of an economic evaluation relevant to evidence-based hand surgery. Cost-effectiveness analysis in hand surgery is increasingly important as health care resources become scarce in most jurisdictions. Hand surgeons need to incorporate the "manager of health care system" competency in their daily practice. Hand surgery literature may claim that "a novel hand technique" is more cost-effective than a prevailing one; it is important that hand surgeons and other users of clinical research appraise such innovation claims before adopting them in their practices. Clinical researchers can use the methodological principles described here for their cost-effectiveness analysis.
BACKGROUND:Debate continues about what split-thickness skin graft donor-site dressing provides the best outcomes for patients at the lowest cost. The goal of this systematic review was to determine which donor-site dressings are associated with the best outcomes for the following: pain, infection rate, healing quality, healing rate, quality of life, and cost. METHODS:A comprehensive literature review and assessment was undertaken by two independent reviewers. Articles were selected using specific inclusion criteria. Split-thickness skin graft donor-site dressings were classified as either moist or nonmoist based on the state of the dressing upon initial application. Methodological quality of randomized controlled trials was assessed using the Jadad scale. RESULTS:Seventy-five relevant articles were included in the final analysis, three of which were review articles. The most commonly measured outcome was healing rate (64 of 72), followed by pain (58 of 72), infection rate (40 of 72), healing quality (40 of 72), and cost (15 of 72). No studies measured quality of life. The majority of articles were randomized controlled trials (35 of 75), followed by observational studies (22 of 75), unsystematic clinical observations (15 of 75), and review articles (three of 75). It was difficult to compare moist and nonmoist dressings in this review because of the methodological heterogeneity of the included articles. The available evidence suggests, however, that moist dressings are superior in terms of pain. CONCLUSIONS:Some weak evidence exists that supports "wet dressings." To determine the best split-thickness skin graft donor-site dressing, more methodologically sound randomized controlled trials are needed. Trials with parallel economic evaluations should be undertaken to answer this question.
The goal of this article is to introduce clinical investigators to the basic concepts of cost-effectiveness analysis. This line of research is not commonly pursued in clinical studies probably because of unfamiliarity of plastic surgeons with the field of health economics and health research methodology in general. The authors believe that the coupling of cost-effectiveness analysis with clinical studies is important and should be incorporated into surgical clinical research.
Well-conducted systematic reviews and meta-analyses provide the best quality evidence for clinical decision-making. This article presents the key role of systematic reviews in clinical decision-making, discussing the steps and pitfalls to avoid in conducting systematic reviews and meta-analyses.
The most important precondition for performing a clinical research project in plastic surgery, or any other surgical subspecialty, is the need to ask the "right question." Although this might seem to be an easy task, in truth it requires a lot of effort and hard work. This article addresses the key points to remember when formulating a research question.
The purpose of this article is to help residents, fellows, and junior faculty who aspire to an academic career, and seasoned plastic surgeons who may wish to have a second research-oriented "lease on life," to become successful clinical investigators. The preconditions for academic success, including mentoring, making periodic priority lists, and time management are discussed in detail.