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. 2023 Dec 9;13(12):e071641. doi: 10.1136/bmjopen-2023-071641

Table 3.

Data to be extracted

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.