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Paper text:
the randomized controlled trial ( rct ) has long been recognized as the most robust , technique for evaluating the effects of mental health care interventions .
sometimes these trials are impossible , sometimes unethical , and sometimes impractical . the first , rct was the 1948 medical research council streptomycin trial . in the austere times of bankrupt , post - war england , just as the national health service was being established ,
it , was suggested that , a new drug would be of value for treatment of tuberculosis . the only equitable way to distribute this scarce resource was through randomization and then , by the establishment of good evidence , to encourage those funding health care to support its use .
there are many interesting and important examples preceding this date , but this landmark and courageous trial radically changed the pathway of evaluation of medical treatments .
the mrc streptomycin trial coincided with the discovery of psychoactive compounds that were potentially therapeutic , as well as an increasing push towards deinstitutionalization .
mental health professionals discovered , discussed , and , largely , embraced the use of rcts .
up to the advent of antipsychotic drugs such as chlorpromazine , psychiatric care had been likened to  little more than zoo keeping  and , perhaps because of that stinging criticism , those undertaking the trials did not necessarily follow the path of that first tuberculosis trial .
there was the yearning for rigorous science , collective subspecialty insecurity , and also the needs of regulatory authorities .
mental health trials drifted towards use of as rigorous diagnoses as possible , rather rigid regimens of care and use of fine - grained outcome measures that , are not usually part of routine practice .
this planted the rct firmly in the realm of researchers , and there it has stayed .
the needs of regulatory authorities did have to be met , but , there was less consideration of needs of clinicians and of recipients of care and their families .
. took leaders in the fields of cancer care , heart disease , and perinatal medicine to recall and refine the techniques of generous inclusion , simple treatment , and routine data collection that underpinned the mrc trial of 1948 .
many examples now exist in these areas of rcts where entry criteria are broad and encompass as many relevant people as possible , the treatment packages are those that would be given in everyday care , and outcomes are essentially routinely recorded data .
examples of such open work were rare in mental health until relatively recently . the description of  pragmatic  or  practical  is increasingly employed of trials in psychiatry or psychology but there are clearly different interpretations of what , this really means
. a recent series of papers has highlighted the problems in interpretation of the explanatory / pragmatic domains in trials and presented some practical solutions .
there are many elements of design that should be considered to allow a judgment to take place about whether a randomized trial is investigating whether , in ideal circumstances , a treatment could work ( explanatory ) or , at the other extreme , whether this accessible treatment would work in everyday practice ( pragmatic ) .
to use one example , funders , on receiving a proposal , may wish to consider whether the proposed trial fits with the ethos in which that support was proffered .
for example one funding body may be interested in discovering potentially new treatments . in this instance , explanatory studies , undertaken in very rigorous circumstances with fine measures of outcome to highlight , any - even modest , - effects , may be best . on the other hand , another funder ,
using public money , may wish to consider whether the study is likely to produce evidence of practical importance regarding accessible treatments relevant , to the majority of people suffering with the condition in that , community . here
how explanatory or pragmatic a study ( or a group of studies ) is has also obvious and direct implications for clinicians , policymakers , patients , and the public .
the main goal of this study is to adapt the instrument described by thorpe et al ( precis ) to assist , researchers in making those judgments in the protocol stage of rcts in mental health ( the pragmascope tool ) .
this tool is based on the ten domains described in the development , of the pragmatic - explanatory continuum indicator summary ( precis ) .
it can be used to assess applicability of results from any given rct , based on what , was planned at the protocol stage .
each included rct protocol was scored in ten domains by three independent , reviewers ( gt , ksw , cea ) .
the reviewers made a judgment and rated the protocol from 1 ( most explanatory ) to 5 ( most , pragmatic ) by reading the details of the protocol .
if the protocol did not contain any information on which to base the decision , these domains were rated as zero .
the average scores for each included protocol were placed on the wheel diagram and the dots joined for visual clarity ( figure 1 ) .
we searched the cochrane schizophrenia group trials register and medline ( november 2010 ) for references of rct protocols and chose a random sample of 10 protocols dealing with schizophrenia , depression , post - traumatic stress disorders , and psychiatric rehabilitation .
three independent reviewers ( gt , ksw , cea ) scored each included rct protocol .
the overall score can be from 0 to 50 and a diagram illustrating how open ( pragmatic ) or restrictive ( explanatory ) the study is likely to be was created using the average score of the three independent reviewers .
our initial interpretation of the scores was of 0 to 30 for an explanatory study investigating whether the experimental intervention will work in ideal circumstances and a total score > 35 for a more pragmatic study focusing mostly on whether , in routine practice , an intervention has a meaningful effect .
a total score between 31 and 39 were interpreted as an interim where trial design balances pragmatic and explanatory domains .
mean and variance were calculated for each domain of the pragmascope tool for each included rct protocol using stata ( version 10 ) .
this tool is based on the ten domains described in the development , of the pragmatic - explanatory continuum indicator summary ( precis ) .
it can be used to assess applicability of results from any given rct , based on what , was planned at the protocol stage .
each included rct protocol was scored in ten domains by three independent , reviewers ( gt , ksw , cea ) .
the reviewers made a judgment and rated the protocol from 1 ( most explanatory ) to 5 ( most , pragmatic ) by reading the details of the protocol .
if the protocol did not contain any information on which to base the decision , these domains were rated as zero .
the average scores for each included protocol were placed on the wheel diagram and the dots joined for visual clarity ( figure 1 ) .
we searched the cochrane schizophrenia group trials register and medline ( november 2010 ) for references of rct protocols and chose a random sample of 10 protocols dealing with schizophrenia , depression , post - traumatic stress disorders , and psychiatric rehabilitation .
three independent reviewers ( gt , ksw , cea ) scored each included rct protocol . the overall
score can be from 0 to 50 and a diagram illustrating how open ( pragmatic ) or restrictive ( explanatory ) the study is likely to be was created using the average score of the three independent reviewers .
our initial interpretation of the scores was of 0 to 30 for an explanatory study investigating whether the experimental intervention will work in ideal circumstances and a total score > 35 for a more pragmatic study focusing mostly on whether , in routine practice , an intervention has a meaningful effect .
a total score between 31 and 39 were interpreted as an interim where trial design balances pragmatic and explanatory domains .
mean and variance were calculated for each domain of the pragmascope tool for each included rct protocol using stata ( version 10 ) .
table i presents the average score of the three raters in each one of the domains for each rct protocols with a judgment based on the scores .
reliability among the three independent raters was high ( weighted kappa = 0.72 for categories 0 - 30 , 31 - 39 , 40 - 50 ) suggesting that this cluster of judgments might be useful to highlight and quantify important , issues during the protocol stage of an rct .
we recognize that validity is a more problematic issue , as this does depend on the rater 's perspective , but , work is ongoing involving raters from very different backgrounds . in any case , we concur that , consideration of these domains is useful and suggest that the pragmascope is one practical way of doing this .
systematic reviewing of trials , now industrially undertaken through initiatives like the cochrane collaboration , has highlighted issues with poor design and inconsistent reporting .
these systematic reviews are potent to guide care but , are undermined by trial evidence that is difficult or impossible to apply in the real world .
such pragmatic , real - world , practical design can be dovetailed within explanatory studies or sit independently . with maintained systematic reviews guiding practice , transparent priority setting for research funding for evaluative research , and the push towards defining core out come measures of agreed relevance in trials , a great , increase in pragmatic trial activity is likely .
of course explanatory trials have an important place in the portfolio of research , but .
the rigorously undertaken but highly pragmatic trial will give us the opportunity to learn much more about , the real effects of the potent , treatments we give .
in the pragmatic - explanatory continuum , a randomized controlled trial ( rct ) can at one extreme investigate whether a treatment could work in ideal circumstances ( explanatory ) , or at the other extreme , whether it would work in everyday practice ( pragmatic ) . 
 how explanatory or pragmatic a study is can have implications for clinicians , policy makers , patients , researchers , funding bodies , and the public . 
 there is an increasing need for studies to be open and pragmatic ; however , explanatory trials are also needed . the previously developed pragmatic - explanatory continuum indicator summary ( precis ) 
 was adapted into the pragmascope tool to assist mental health researchers in designing rcts , taking the pragmatic - explanatory continuum into account . 
 ten mental health trial protocols were randomly chosen and scored using the tool by three independent raters . 
 their results were compared for consistency and the tool was found to be reliable and practical . 
 this preliminary work suggests that evaluating different domains of an rct at the protocol level is useful , and suggests that using the pragmascope tool presented here might be a practical way of doing this .