The Journal of bone and joint surgery. American volume
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J Bone Joint Surg Am · Jul 2012
Ethical issues in the design of randomized trials: to sham or not to sham.
The placebo effect is based on the expectations of the patient regarding the effectiveness of the treatment. The high levels of stress and rituals involved with surgery can lead to a strong placebo effect. ⋯ While there are a number of ethical principles that must be considered to justify the implementation of a sham-controlled surgical clinical trial, four areas deserve particular attention: equipoise, risk minimization, informed consent, and deception. Particularly in orthopaedics, where equipoise is common, sham-controlled trials may be important to ensure that inferior or ineffective treatments do not become standard practice.
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J Bone Joint Surg Am · Jul 2012
On the prevention and analysis of missing data in randomized clinical trials: the state of the art.
We summarize and elaborate on the recently published National Research Council report entitled "The Prevention and Treatment of Missing Data in Clinical Trials." We tailor our discussion to orthopaedic trials. In particular, we discuss the intent-to-treat principle, review study design and prevention ideas to minimize missing data, and present state-of-the-art sensitivity analysis methods for analyzing and reporting the results of studies with missing data.
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Randomized controlled trials continue to be at the pinnacle of the evidence hierarchy. With this unique vantage point, they inform medical practice, clinical guidelines, health policy, and reimbursement. Prior to an emphasis on randomized controlled trials, traditional clinical research consisted primarily of uncontrolled case series and expert opinions. ⋯ From 1975 to 2005, the number of Level-I studies increased over fivefold and comprised >20% of studies published in The Journal of Bone and Joint Surgery (American Volume) (JBJS). With the emergence of comparative effectiveness research, the definition and methods of best evidence may continue to evolve. In conclusion, substantial improvements in both the quantity and the quality of randomized controlled trials in orthopaedic surgery have occurred, although unique considerations still limit their widespread use.
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J Bone Joint Surg Am · Jul 2012
Comparative StudyAcute Achilles tendon rupture: a questionnaire follow-up of 487 patients.
The optimum treatment of acute total Achilles tendon rupture remains controversial. In the present study, the outcomes of surgical and nonsurgical treatment in a large number of patients were compared on the basis of patient age and sex. ⋯ The good Achilles Tendon Total Rupture Score in the nonsurgically managed group, together with the relatively low rate of re-ruptures and other complications in these patients, makes this treatment a preferable option for most patients. However, the tendency for a lower re-rupture rate and better performance on the heel-raise test in surgically treated patients suggest surgery may be beneficial in selected patients.