A minority of published evidence -based PA interventions for adults with T2D were both effective and pragmatic for clinical implementation .
Although regular physical activity ( PA ) is a cornerstone of treatment for type 2 diabetes ( T2D ) , most adults with T2D are sedentary .
R and omized controlled trials ( RCTs ) have proven the effectiveness of PA behavioral interventions for adults with T2D but have rarely been conducted in healthcare setting s. We sought to identify PA interventions that are effective and practical to implement in clinical practice setting s. Our first aim was to use the valid Pragmatic-Explanatory Continuum Indicator Summary 2 ( PRECIS-2 ) tool to assess the potential for future implementation of PA interventions in clinical practice setting s. Our second aim was to identify interventions that effectively increased PA and glycemic control among the interventions in the top tertile of PRECIS-2 scores .
A pragmatic–explanatory continuum indicator summary (PRECIS): a tool to help trial designers
CMAJ • MAY 12 , 2009 • 180(10 ) © 2009 Canadian Medical Association or its licensors E47 R and omized trials have traditionally been broadly categorized as either an effectiveness trial or an efficacy trial , although we prefer the terms “ pragmatic ” and “ explanatory . ” Schwartz and Lellouch described these 2 approaches toward clinical trials in 1967 . These authors coined the term “ pragmatic ” to describe trials that help users choose between options for care , and “ explanatory ” to describe trials that test causal research hypotheses ( i.e. , that a given intervention causes a particular benefit ) . We take the view that , in general , pragmatic trials are primarily design ed to determine the effects of an intervention under the usual conditions in which it will be applied , whereas explanatory trials are primarily design ed to determine the effects of an intervention under ideal circumstances . Thus , these terms refer to a trial ’s purpose and , in turn , structure . The degree to which this purpose is met depends on decisions about how the trial is design ed and , ultimately , conducted . Very few trials are purely pragmatic or explanatory . For example , in an otherwise explanatory trial , there may be some aspect of the intervention that is beyond the investigator ’s control . Similarly , the act of conducting an otherwise pragmatic trial may impose some control result ing in the setting being not quite usual . For example , the very act of collecting data required for a trial that would not otherwise be collected in usual practice could be a sufficient trigger to modify participant behaviour in unanticipated ways . Further , several aspects of a trial are relevant , relating to choices of trial participants , health care practitioners , interventions , adherence to protocol and analysis . Thus , we are left with a multidimensional continuum rather than a dichotomy , and a particular trial may display varying levels of pragmatism across these dimensions . In this article , we describe an effort to develop a tool to assess and display the position of any given trial within the pragmatic – explanatory continuum . The primary aim of this tool is to help trialists assess the degree to which design decisions align with the trial ’s stated purpose ( decision-making v. explanation ) . Our tool differs , therefore , from that of Gartlehner and associates in that it is intended to inform trial design rather than provide a method of classifying trials for the purpose of systematic review s. It can , however , also be used by research funders , ethics committees , trial registers and journal editors to make the same assessment , provided trialists declare their intended purpose and adequately report their design decisions . Hence , reporting of pragmatic trials is addressed elsewhere
A minority of published evidence -based PA interventions for adults with T2D were both effective and pragmatic for clinical implementation .
Although regular physical activity ( PA ) is a cornerstone of treatment for type 2 diabetes ( T2D ) , most adults with T2D are sedentary .
R and omized controlled trials ( RCTs ) have proven the effectiveness of PA behavioral interventions for adults with T2D but have rarely been conducted in healthcare setting s. We sought to identify PA interventions that are effective and practical to implement in clinical practice setting s. Our first aim was to use the valid Pragmatic-Explanatory Continuum Indicator Summary 2 ( PRECIS-2 ) tool to assess the potential for future implementation of PA interventions in clinical practice setting s. Our second aim was to identify interventions that effectively increased PA and glycemic control among the interventions in the top tertile of PRECIS-2 scores .