Observational Studies in a Learning Health System Workshop Summary (2013) / Chapter Skim
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7 Strategies Going Forward
7 Strategies Going Forward
Pages 69-78
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From page 69... ...
Slutsky • Certain study designs are appropriate for answering specific types of questions, and these questions should address the needs of decision makers. • Few studies are robust enough to stand on their own.
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From page 70... ...
• Funding agencies, including PCORI, should fund efforts to validate different methods for exploring relationships in high quality databases. This would be key to giving the field confi dence about these methods.
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From page 71... ...
She recommended that any observational studies that PCORI funds should start with clearly identified questions and outcomes of interest so that those who read the resulting papers can be assured that selective reporting has not occurred. With respect to the last issue, Michael McGinnis asked Mulrow for suggestions on how to better capture the array of observational data or studies that are under way to improve transparency.
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From page 72... ...
Hlatky's work on percutaneous coronary intervention versus coronary artery bypass grafting to patients and clinicians. Clinicians, Slutsky said, were "obsessed with mortality as an endpoint, but patients were obsessed with angina that was disabling and got quite angry when we tried to put the dissemination document in the context of mortality." She then listed six ideas that she gleaned from the workshop and that she thought were important for PCORI and other funding agencies such as hers, as well as for researchers.
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From page 73... ...
For example, PCORI could mandate or strongly encourage that any RCT for which a request for funding is submitted include a parallel observation study that would at a minimum follow patients who would not agree to be in the RCT but would agree to be followed. It would represent a tremendous opportunity for the field to conduct such studies in a systematic way that would provide an ongoing opportunity to develop methods for examining the factors that make RCTs and observational studies equivalent or not.
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From page 74... ...
Doing so would "institutionalize the richness of the cross talk that we saw here to make sure that the best wisdom of the best thinkers on the methodological side and on the clinical research and clinical side, as well as the patients, is brought to bear in everything that PCORI does." DISCUSSION Nancy Santanello said that most large pharmaceutical companies do register their observational studies on clinicaltrials.gov, though she said that doing so was difficult. She noted, too, that the European Medicines Agency now requires all observational safety studies conducted in the European Union to register with the agency using a registry that provides a more userfriendly interface for observational studies.
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From page 75... ...
Hernán commented on the importance of data quality and selective reporting of multiple comparisons. He said that these are at least as important as confounding, and he encouraged funding agencies to pay attention to research on the importance of biases due to both poor data quality and selective reporting on multiple comparisons.
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From page 76... ...
In his closing remarks, Selby summarized some of what he learned from written comments that workshop participants submitted during the lunch break. Many of the comments called for more complete data, higherquality data, more observations, and more data per observation.
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From page 77... ...
That will require careful thinking about the needs of those systems in formulating the questions that trials will be designed to answer.
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