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. However, the ethical principles of performing sham surgery to measure any placebo effect have been questioned, and sham-controlled surgical trials are rarely conducted. 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.

Novel measures of cardiovascular health and its association with prevalence and progression of age-related macular degeneration: the CHARM Study.

BACKGROUND: To determine if novel measures of cardiovascular health are associated with prevalence or progression of age-related macular degeneration (AMD). METHODS: Measures of the cardiovascular system: included intima media thickness (IMT), pulse wave velocity (PWV), systemic arterial compliance (SAC), carotid augmentation index (AI). For the prevalence study, hospital-based AMD cases and population-based age- and gender-matched controls with no signs of AMD in either eye were enrolled. For the progression component, participants with early AMD were recruited from two previous studies; cases were defined as progression in one or both eyes and controls were defined as no progression in either eye. RESULTS: 160 cases and 160 controls were included in the prevalence component. The upper two quartiles of SAC, implying good cardiovascular health, were significantly associated with increased risk of AMD (OR = 2.54, 95% CL = 1.29, 4.99). High PWV was associated with increased prevalent AMD. Progression was observed in 82 (32.3%) of the 254 subjects recruited for the progression component. Higher AI (worse cardiovascular function) was protective for AMD progression (OR = 0.30, 95%CL = 0.13, 0.69). Higher aortic PWV was associated with increased risk of AMD progression; the highest risk was seen with the second lowest velocity (OR = 6.22, 95% CL = 2.35, 16.46). CONCLUSION: The results were unexpected in that better cardiovascular health was associated with increased risk of prevalent AMD and progression. Inconsistent findings between the prevalence and progression components could be due to truly different disease etiologies or to spurious findings, as can occur with inherent biases in case control studies of prevalence. Further investigation of these non-invasive methods of characterizing the cardiovascular system should be undertaken as they may help to further elucidate the role of the cardiovascular system in the etiology of prevalent AMD and progression.

Choosing outcome assessment instruments for trauma registries.

While trauma registries have the potential to collect detailed information about patient outcomes, the most commonly reported outcome, mortality, only represents the outcome from a small proportion of the total trauma population. If trauma registries are to progress to routine monitoring of outcomes in trauma survivors, instruments that measure relevant outcomes in the remainder of the trauma population must be identified and implemented. This report provides an overview of the specific needs of trauma registries with respect to assessing patient outcomes other than mortality. The use of previously recommended outcome assessment instruments is discussed, with a focus on the utility of these instruments for use in routine monitoring of trauma outcomes other than mortality through trauma registries.

Outcome instruments for the assessment of the upper extremity following trauma: a review.

Orthopaedic injuries are common among trauma patients and can result in long-term problems. Considerable data are available regarding functional outcomes following lower extremity trauma. There is, however, a paucity of data available for upper extremity trauma patients. Whilst currently available instruments appear to assess outcomes of relevance in trauma populations, the reliability, validity and responsiveness of these instruments have not been evaluated in the upper extremity trauma population. This paper reviews instruments designed for patient self-evaluation of musculoskeletal disorders of the upper extremity, and instruments used in an orthopaedic trauma population to assess functional recovery following injury. The Musculoskeletal Functional Assessment (MFA), Short Musculoskeletal Functional Assessment (SMFA), Disabilities of the Arm, Shoulder, and Hand (DASH), American Shoulder and Elbow Surgeons Shoulder Scale (ASES-s), American Shoulder and Elbow Surgeons Elbow Scale (ASES-e), Patient Rated Elbow Evaluation (PREE), and the Patient Rated Wrist Evaluation (PRWE) were reviewed. Until research is published outlining the evaluation of assessment instruments in upper extremity orthopaedic populations, authors will need to conduct their own validation studies before investigating outcomes in specific trauma populations.