Rheumatoid Arthritis Swollen/Tender Joint Count Assessment


This example illustrates the data collected for the Swollen/Tender Joint Count assessment, specifically the 68-joint count. After determining whether each joint is swollen or tender, the assessor will add up the number of "Yes" responses for swollen joints and tender joints to obtain a total count for each. Entering these total counts into the CRF is at the sponsor's discretion, since they are typically derived in the ADaM datasets.

In this example, the total counts are not collected on the CRF for this reason. There is a field for marking a joint Not Evaluable when that joint meets a condition (e.g., infection of the overlying tissue or skin, grossly edematous, fused), which precludes joint assessment and is specified by the protocol or the protocol-related joint-assessor training. In general, capturing the reason that a joint is not evaluable is not needed; thus a field for "reason not evaluable" is not provided in the example. Note that there is a field for marking a joint assessment as Not Done; this is to be used if the joint assessor overlooked or missed that joint while performing the joint assessment.



"Swollen/Tender Joint Count Assessment [RA_STJCA]" Form Preview
Swollen/Tender Joint Count Assessment
Swollen/Tender Joint Count Assessment
Date of Collection
 01 Jan 2000
Laterality Right  Left  
UPPER BODY
Joint Location Tender - Joint Not Evaluable Tender - Result Tender - Not Done Swollen - Joint Not Evaluable Swollen - Result Swollen - Not Done
Temporomandibular  Yes  No   Yes  No  
Sternoclavicular  Yes  No   Yes  No  
Acromioclavicular  Yes  No   Yes  No  
UPPER EXTREMITY
Joint Location Tender - Joint Not Evaluable Tender - Result Tender - Not Done Swollen - Joint Not Evaluable Swollen - Result Swollen - Not Done
Shoulder  Yes  No   Yes  No  
Elbow  Yes  No   Yes  No  
Wrist  Yes  No   Yes  No  
HAND
Joint Location Tender - Joint Not Evaluable Tender - Result Tender - Not Done Swollen - Joint Not Evaluable Swollen - Result Swollen - Not Done
MCP I  Yes  No   Yes  No  
MCP II  Yes  No   Yes  No  
MCP III  Yes  No   Yes  No  
MCP IV  Yes  No   Yes  No  
MCP V  Yes  No   Yes  No  
IP I  Yes  No   Yes  No  
PIP II  Yes  No   Yes  No  
PIP III  Yes  No   Yes  No  
PIP IV  Yes  No   Yes  No  
PIP V  Yes  No   Yes  No  
DIP II  Yes  No   Yes  No  
DIP III  Yes  No   Yes  No  
DIP IV  Yes  No   Yes  No  
DIP V  Yes  No   Yes  No  
LOWER EXTREMITY
Joint Location Tender - Joint Not Evaluable Tender - Result Tender - Not Done Swollen - Joint Not Evaluable Swollen - Result Swollen - Not Done
Hip  Yes  No   Yes  No  
Knee  Yes  No   Yes  No  
Ankle  Yes  No   Yes  No  
Tarsus  Yes  No   Yes  No  
FOOT
Joint Location Tender - Joint Not Evaluable Tender - Result Tender - Not Done Swollen - Joint Not Evaluable Swollen - Result Swollen - Not Done
MTP I  Yes  No   Yes  No  
MTP II  Yes  No   Yes  No  
MTP III  Yes  No   Yes  No  
MTP IV  Yes  No   Yes  No  
MTP V  Yes  No   Yes  No  
IP  Yes  No   Yes  No  
PIP II  Yes  No   Yes  No  
PIP III  Yes  No   Yes  No  
PIP IV  Yes  No   Yes  No  
PIP V  Yes  No   Yes  No  
* Mandatory field

Package(s)
Rheumatoid_Arthritis_Swollen_Tender_Joint_Count_Assessment_2023_06_27.zip