Page 78 - Htain Manual
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               in the cancer cases continues to happen as late as 60 or 70 years or even later  . And it may
               not be feasible to have resources to follow-up a trial cohort for a lifetime. Hence, RCTs may

               not offer the medium to generate data for EE.

                       Fourthly,  a  trial  is  generally  conducted  to  evaluate  a  few  alternative  options  for

               treatment or addressing a particular health problem. However, decision making in the field

               of  policy  is  full  of  possible  scenarios  which  need  to  be  evaluated.  For  example,  a  single

               question of which is the most appropriate method to screen women for cervical cancer can

               be  further  stratified  into  several  scenarios  based  on  which  method  should  be  used  (pap
               smear, visual inspection with acetic acid or HPV DNA), which population should be screened

               (30-65 years, 40-65 years, 50-65 years), how frequently (annual, 3 yearly, 5 yearly, 10 yearly,

               once in a lifetime). Together these can constitute 16 possible scenarios. However, it may be
               difficult to have a single RCT with 16 arms to evaluate all possible scenarios. In view of this

               limitation again, RCT alone cannot be used to generate evidence for EE.


               Bridging the limitations of RCT: Role for Decision Modelling


                       A solution to bridge the limitations of RCT is to either undertake decision modelling

               alone, or use decision model alongside the evidence generated in RCT. A decision model used
               for EE is a biologically plausible sequence of occurrence of health consequences as a result of

               the decision of undertaking an intervention. The model so prepared, does not only shows

               relationships,  but  also  mathematically  quantifies  the  probability  of  occurrence  of  such  a
               health  consequence  or  outcome  as  a  result  of  an  intervention.  In  the  mathematical

               parameterization of a decision model, the researcher can use pragmatic data on effectiveness

               from a real-world study rather than a RCT. Alternatively, an assumption which justifies the

               constraints of program implementation or treatment administration in real-world could be

               incorporated to generate an output which is more acceptable. For example, one may consider
               findings of a national evaluation which shows that the coverage of routine immunization is

               not  likely  to  be  more  than  90%  in  the  best  possible  scenario,  and  hence  the  efficacy  of

               treatment derived from RCT could be modelled on only 90% of the intervention cohort to
               generate the health consequences.


                       Secondly, the evidence from a 1-year trial of anti-hypertensive drug on reduction in

               blood  pressure  could  then  be  used  along  with  evidence  from  other  studies  for  effect  of



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