Guidance on Using Study Registries
- Reviewers should always search ClinicalTrials.gov and the ICTRP for trials that began recruitment after 2005.
- Match trials with publications found from the standard search, noting (1) trials with existing publication, and (2) trials for which no publication was found.
- Construct a table that provides information on trials found in the registry, their publication status, and whether they are completed or currently active trials, and provide a count of the number of unique trials found along with their status at the time of the search.
Because of its broader coverage, and because that coverage includes trials registered in ClinicalTrials.gov, we recommend that EPCs always consider conducting a search of the ICTRP in addition to ClinicalTrials.gov. However, because ICTRP does not require results reporting, systematic reviewers will always want to directly search ClinicalTrials.gov. Unpublished studies should be identified by matching studies found in the registry search with publications found in the literature search. This is specifically true for trials that began recruitment after 2008 and for which at least one of the participating centers was based in the United States. While mandatory reporting of results in ClinicalTrials.gov came into effect in Dec 2007, the registry was launched in 2000. The ICMJE required prospective trial registration as a precondition for publication in 2005. This latter date coincides with the launch of ICTRP and appears a reasonable cut-off for when the registries should be searched.
The definition that we came up with after working with a national expert consensus
panel, with patients, and going to the literature is that an activated consumer or patient
is one who has the motivation, knowledge, skill, and confidence to take on the role of
managing their health or their healthcare. That is, an individual who understands what
their role is and feels competent and able to do it. This was one of the first things that
we learned after working on measurement in this area is in almost any population
group that we have looked at you see a full range. You see people who are very passive
about their health and people who are very proactive. And that doesn’t matter if they
are eighty-‐five year olds you’re looking at or if it is Medicaid; you’ll see that full
distribution.What you do see is that the mean will move a bit. For some groups the
mean will be lower and for some groups the mean will be higher. But the point is that
you don’t know. Just because someone is maybe disadvantaged in certain ways, that
doesn’t mean that they aren’t proactive about their health. And, in fact, demographics -‐
age, education, income, gender -‐ account for about five or six percent of the variation
in patient activation scores. But it is there. it is just not very powerful.We looked at the
same question per health literacy and it is about twenty-‐five percent of the variation is
accounted for by those same variables.
T. Hibbard notes from AHRQ
“The reasons for my lack of care for everyone who I was not grieving or praying for was that I had tried to explain a difficulty with healing, with having this one virus that shows when leukocytes are immature even, and that my promoted reserved personality was careful.”
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