One of the problems of health research is that it is usually “top down”. For example, in treatment effectiveness studies, researchers decide what is the outcome to measure. This is partly unavoidable in that to aid statistical analysis and demonstrate effectiveness, outcome measures that are common to all participants are used and the specific outcome measures need to be decided before participants are entered into the research. (This also prevents cherry-picking of one favourable result out of many less favourable results after the study data is collected). The “top down” problem comes from who decides what the important outcomes are; usually patients or participants are not consulted.
This can also occur in clinical practice where the doctor (or other health professional) may suggest or provide treatments that improve certain aspects of the condition, whilst the patient or client may prefer focussing on other areas.
Another assumption is that a health intervention that reduces symptoms will lead to improvements in the patient’s overall quality of life taking into account any negative effects of treatment such as side-effects.
The double-blind randomised trial this blog discusses (Grunder et al, 2016) focusses on improvements in “quality of life” or QOL (measured by the Short Form-36 measure) as well as improvement in clinical features such as symptoms (as measured by the Clinical Global Improvement Scale).
In this trial, the comparison is between the older “first generation antipsychotics” (FGAs) and the newer “second generation antipsychotics” (SGAs) in the treatment of schizophrenia spectrum disorders. The paper can be thought of as a “rematch” on the question of whether SGAs resulted in better quality of life and other outcomes than FGAs.
The best-known study that attempted to answer this question, the CUTLASS study (Jones et al, 2006), found that FGAs were at the very least not inferior to SGAs and actually may be superior in terms of improving QOL and reducing symptoms in participants with schizophrenia spectrum disorders.
Interesting that very few completed the treatment.