Included content in ethical implications explanation section

ui.R

@@ -183,7 +183,7 @@ body <- dashboardBody(
                              h3("Practical Considerations"),
                              p("If you play around with the sliders of this power calculation app, you can see that the samplse sizes for ", em("traditional"), " and ", em("precision"), " RCT can vary quite dramatically. If the effect size for the ", em("precision"), " RCT is set much smaller than the to-be-detected effect size of the ", em("traditional"), " RCT, you can get very small (or even negative) sample size requirements for the ", em("traditional"), " RCT as there are ", em("sufficient"), " participants included in the ", em("precision"), " RCT."),
 
-                             p("Here, it is important to consider the practical needs for identification of the precision algorithm. While you may have ", em("sufficient"), " participants available in the ", em("precision"), " RCT for testing intervention A versus B, for instance, there may not be sufficient time or participants available to actually explore potential precision algorithms. In this case, sample size requirements and power considerations have to be weighted against the practical requirements for the identification of the precision algorithm. Related to this, if the ", em("traditional"), " RCT is ongoing while the ", em("precision"), " algorithm is being developed, one has to allow sufficient time (in terms of sample recruitment) to move from exploration to a decision on a to-be-tested precision algorithm."),
+                             p("Here, it is important to consider the practical needs for identification of the precision algorithm. While you may have ", em("sufficient"), " participants available in the ", em("precision"), " RCT for testing intervention A versus B, for instance, there may not be sufficient time or participants available to actually explore potential precision algorithms. In this case, sample size requirements and power considerations have to be weighed against the practical requirements for the identification of the precision algorithm. Related to this, if the ", em("traditional"), " RCT is ongoing while the ", em("precision"), " algorithm is being developed, one has to allow sufficient time (in terms of sample recruitment) to move from exploration to a decision on a to-be-tested precision algorithm."),
 
 
 
@@ -195,8 +195,16 @@ body <- dashboardBody(
                              title = "Ethical Implications",
                              color = "blue",
 
-                             #h2("Ethical Implications"),
-                             p("There are the following ethical implications.")
+                             h3("Sample Size and Power"),
+                             p("Most importantly, we deem the npRCT superior to two independent RCTs in terms of Power and sample size since less participants have to be recruited for answering research questions of the ", em("traditional"), " and ", em("precision"), " RCTs using the nesting procedure."),
+                             p("Related to this, as one can see when playing around with the power calculation app, when decreasing the to-be-detected effect size of the ", em("precision"), " RCT, only relatively fewer participants have to be recruited as part of the ", em("traditional"), " RCT phase. This emphasizes the feasibility of the npRCT for fostering precision medicine research."),
+
+                             h3("Differential Expectations"),
+                             p("Another major consideration of the npRCT are the differential expectations imposed upon participants in ", em("traditional"), " versus ", em("precision"), " RCT."),
+                             p("In the ", em("traditional"), "RCT, participants will expect having received intervention A or B. Depending on the nature of the intervention, participants will know (e.g., when testing different psychotherapies) or not know (e.g., identical capsules with two different drugs) the nature of the intervention received, which will feed into their treatment expectations."),
+                             p("In the ", em("precision"), "RCT, participants will have different expectations in that they will be aware of the nature of random versus precision algorithm stratification. Even if interventions A or B are ", em("known"), " interventions, however, such as different psychotherapies, participants will be unaware of the type of allocation that occurred (i.e., whether they were randomly assigned or stratified). Superimposed on the expectations regarding the allocation scheme, participants will then hold intervention-specific expectations. "),
+                             p("Importantly, in the ", em("precision"), " RCT there will be a reasonable expectancy that stratified/ precision allocation will be superior to completely randomised allocation. Based on this, it could be argued that it is unethical not to use the precision algorithm as a means of allocation generally. Although we understand this potential concern, we still deem an empirical test/ validation of the precision algorithm necessary before it can ultimately be implemented clinically. Similarly, we deem the npRCT design helpful as such empirical validation is often not pursued in practice."),
+                             p("To minimise sample size requirements for the ", em("precision"), "RCT, however, one statistical means could be the use of a one-sided test for this part of the npRCT. It could be argued that a one-sided test is appropriate for the ", em("precision"), "RCT as we would expect the precision algorithm to outperform randomised allocation (because it has been developed this way) and we would not expect it to be worse than randomised allocation.")
 
                           )