Intervention Studies Step 3: Appraise Study 3a. Describe study by hanging it on the GATE frame (also enter study numbers into the separate excel GATE calculator) Study Setting Describe when & from where participants recruited (e.g. what year(s), which country, urban / rural / hospital / community) Eligible Define eligible population / main eligibility (inclusion and exclusion) criteria. population Population Describe recruitment process (e.g. were eligibles recruited Recruitment from electoral / birth / hospital admission register, or media process advert, etc). How they were recruited (e.g. random sample, consecutive eligibles) Participants What percentage of the invited eligibles participated? What reasons were given for non-participation among those otherwise eligible? Allocation For RCTs: describe method used to generate random Exposure Group Comparison Group allocation sequence and method used to ensure that the methods Exposure (EG) (CG) allocation outcome could not be changed by the participants or those assigning interventions For non-randomised studies: describe method/measures & used to allocate participants to EG & CG Comparison Describe main intervention: what, how much, how, when, Exposure for how long & by whom administered. Comparison Describe comparison intervention (given to CG): as above Primary Describe the primary outcome. How was it defined? How & by whom was it measured? Is it categorical (the variable is Outcomes grouped into categories; e.g. dead/alive) or numerical (the Outcomes variable has a numerical value; e.g. weight, days in hospital) Describe any secondary outcomes Secondary How & by whom were they measured? Outcomes Adverse Describe any adverse outcomes measured How & by whom were they measured? Outcomes Time If outcomes measured cross-sectionally (e.g. diabetes, BP), state when it was measured in relation to when the Time intervention(s) began. If outcomes measured over a period of time (e.g. deaths), state the length of follow-up time after initiation of intervention(s) Effect Outcome Confidence Interval Reported estimate Enter the main reported results Include type of measure; Results eg. RR, HR Complete the Numbers on the separate GATE Calculator for Intervention Studies
Intervention Studies Step 3: Appraise Study 3a. Describe study by hanging it on the GATE frame (also enter study numbers into the separate excel GATE calculator) Population Study Setting Describe when & from where participants recruited (e.g. what year(s), which country, urban / rural / hospital / community) Eligible population Recruitment process Define eligible population / main eligibility (inclusion and exclusion) criteria. Describe recruitment process (e.g. were eligibles recruited from electoral / birth / hospital admission register, or media advert, etc). How they were recruited (e.g. random sample, consecutive eligibles) Participants What percentage of the invited eligibles participated? What reasons were given for non-participation among those otherwise eligible? Exposure & Comparison Exposure Group Comparison Group (EG) (CG) Allocation methods For RCTs: describe method used to generate random allocation sequence and method used to ensure that the allocation outcome could not be changed by the participants or those assigning interventions For non-randomised studies: describe method/measures used to allocate participants to EG & CG Exposure Describe main intervention: what, how much, how, when, for how long & by whom administered. Comparison Describe comparison intervention (given to CG): as above Outcomes Primary Outcomes Describe the primary outcome. How was it defined? How & by whom was it measured? Is it categorical (the variable is grouped into categories; e.g. dead/alive) or numerical (the variable has a numerical value; e.g. weight, days in hospital) Secondary Outcomes Describe any secondary outcomes How & by whom were they measured? Adverse Outcomes Describe any adverse outcomes measured How & by whom were they measured? Time Time If outcomes measured cross-sectionally (e.g. diabetes, BP), state when it was measured in relation to when the intervention(s) began. If outcomes measured over a period of time (e.g. deaths), state the length of follow-up time after initiation of intervention(s) Reported Results Enter the main reported results Outcome Effect estimate Confidence Interval Include type of measure; eg. RR, HR Complete the Numbers on the separate GATE Calculator for Intervention Studies
GATE%20CAT%20Intervention%20Studies%20May%202014%20V8.docx