dosing details, route of Comparable route of formulation administration, active administration and route of Comparable ingredient, or administration dosing details formulation and and dosing details formulation Relevance to Population Population Some differences target studied is studied is differences or differences of population identical to the comparable to between study uncertain target the target and target clinical population population populations but significance exist between ‘clinically reasonable’ to study and target extrapolate populations evidence to the target population Relevance to Study directly Study directly Study directly Study does not health benefit measures measures measures health directly health benefit health benefit benefit in measure health in listable in listable listable benefit in indication as indication as indication as listable primary secondary post-hoc indication outcome outcome analysis Relevance to Study context Study context Probably Study context context of directly applicable to applicable to not applicable use applicable to Australian self Australian self to Australian Australian self care context care context self care care context with few context caveats Only studies achieving ratings of or above in ALL four relevance ‘satisfactory’ categories are considered relevant to a proposed listable indication. 4. Evidence level and quality (for each included study) (sections 3.2.1.6-7) Level of evidence: Quality of experimental studies (e.g. randomised controlled clinical trials) Item Parameter Yes (1) or No (0)
dosing details, formulation and route of administration route of administration, Comparable dosing details and formulation Comparable active ingredient, or formulation and dosing details route of administration Relevance to target population Population studied is identical to the target population Population studied is comparable to the target population Some differences between study and target populations but ‘clinically reasonable’ to extrapolate evidence to the target population differences or differences of uncertain clinical significance exist between study and target populations Relevance to health benefit Study directly measures health benefit in listable indication as primary outcome Study directly measures health benefit in listable indication as secondary outcome Study directly measures health benefit in listable indication as post-hoc analysis Study does not directly measure health benefit in listable indication Relevance to context of use Study context directly applicable to Australian self care context Study context applicable to Australian self care context with few caveats Probably applicable to Australian self care context Study context not applicable to Australian self care context Only studies achieving ratings of ‘satisfactory’ or above in ALL four relevance categories are considered relevant to a proposed listable indication. 4. Evidence level and quality (for each included study) (sections 3.2.1.6-7) Level of evidence: Quality of experimental studies (e.g. randomised controlled clinical trials) Item Parameter Yes (1) or No (0)
consult-cm-evidence-listed-medicines-120827-a.docx