a large randomized trial might be able to achieve, she said. However, she said, an observational study might be preferable to a randomized trial under certain circumstances: when patients are too ill to be randomized, when no acceptable alternate therapy exists, when patients or their families decline to participate in a randomized trial, or when a disorder is so rare that it affects too few individuals to randomize. In such cases, an observational investigation might not produce the best data, she said, “but it gives you larger numbers of patients, so you don’t base decisions on 1 or 2 patients.” Sedrakyan suggested that a good combination of observational and randomized trials is essential. “We need to do a really good job of identifying those questions in surgery that are pragmatically good candidates for clinical study using randomized trials and those that are good candidates for observational investigations,” he said.
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Mike Mitka (2009) studied this question.