Table 3.
Extraction domain | Data to extract |
General study information | Intervention studied* |
Status of study* | |
Year of publication* | |
Year of registration† | |
Year of completion/termination* | |
Named sites† | |
Number of countries† | |
Lead site country† | |
Eligibility criteria | Age limits† |
Disease duration* | |
Hoehn and Yahr stage* | |
Hoehn and Yahr on/off state* | |
Inclusion criteria present: cognition† | |
Definition of cognition criterion† | |
Inclusion criteria present: depression† | |
Definition of depression score† | |
Inclusion criteria present: drug naive* | |
PD drug stability† | |
Changes to PD drugs permitted?† | |
Outcome measures | Primary outcome measures* |
Other outcome measures* | |
Outcome domains* | |
Study design | Primary endpoints met* |
Other endpoints met* | |
Phase of trial* | |
Number of sites* | |
Number of arms* | |
Number of participants enrolled/estimated* | |
Attrition (control arm)* | |
Attrition (active arm)* | |
Level of blinding† | |
Type of control* | |
Stratification parameters† | |
Wash out present† | |
Wash in present† | |
Overarching design type and details† | |
Dose ranging† | |
Study duration (baseline to final visit)* | |
Number of follow-ups* | |
Follow-up frequency* | |
Treatment extension† |
*Required for planned analyses.
†Other exploratory extraction fields.
PD, Parkinson’s disease.