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Core Assessment Program for Surgical Interventional Therapies in PD (CAPSIT-PD)
Core Assessment Program for Surgical Interventional Therapies in PD (CAPSIT-PD)
| Availability |
Please visit this website for more information about the instrument:
Core Assessment Program for Surgical Interventional Therapies in Parkinson's Disease |
| Classification |
Supplemental - Highly Recommended: Parkinson's Disease (PD)
Recommendations for use: Indicated for studies assessing motor fluctuations.
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| Short Description of Instrument |
This scale that assesses motor fluctuations in PD was originally developed to assess patients undergoing surgery. The scale has also been applied in non-surgical contexts. The Core Assessment Program for Surgical Interventional Therapies in Parkinson's Disease (CAPSIT-PD) has developed an ON-OFF diary, which differentiates among four motor conditions: OFF, partial OFF, ON, and ON with dyskinesia. The diary is also applicable to non-surgical programs and places special interest on the differentiation of OFF from partial-OFF periods.
Motor fluctuation diaries are designed for patients to assess their own health status without clinician bias, especially useful in understanding symptoms' temporal dynamics to evaluate the impact of their treatment.
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| Comments/Special Instructions |
For PD patient diaries, subjects should receive training during screening from certified instructors with hands-on explanation of the process. At the end of the training session, patients are required to reach a certain degree (i.e., 80%) of diary concordance with a site rater. Therefore, the accuracy of this data is dependent on the patient being able to understand the definition of the various motor states and being able to correctly self-identify his/her status.
In an observational study with CAPSIT-PD diary, the patient-clinician agreement for diary entries during a 4-hour observation period was good for OFF and ON with dyskinesias but moderate for partial OFF and ON. The overall validity of patient-kept diaries was also supported by expected differences in motor assessment scores between diary categories during the 4-hour observation period.
Electronic diaries have some advantages over paper diaries in that they can remind the patients to complete the diary entries on time, allow only one answer per entry and record the exact time and date were entered, increasing compliance and reliability of outcomes and reducing data entry errors. However, electronic diaries require more rigorous training and caregiver participation.
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| Scoring and Psychometric Properties |
Scoring: Generally, patients are requested to complete home diaries for 2-3 consecutive days preceding baseline and scheduled visits. For results interpretation, pre-visit diary recorded "OFF" times are averaged and compared to baseline.
Psychometric Properties: Overall patient-clinician agreement in diary entries is good (kappa = 0.62; weighted kappa = 0.84). Agreement for individual diary categories is good for "off" and "on with dyskinesias" (kappa = > or =0.72), but moderate for "partial off" and "on" (kappa = 0.49). The overall validity of patient kept diaries is supported by expected symptom severity variability across diary categories, as assessed in the clinic (Reimer et al., 2004).
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| Rationale/Justification |
Strengths: Patient diaries have gained wide acceptance as a primary endpoint for clinical development of therapeutics aiming to reduce treatment-related motor complications. Diaries are presently the best way of following an outpatient throughout a full day over the course of a study. There is evidence that a brief standardized training session can yield good agreement between patients and clinicians in categorizing parkinsonian motor fluctuation.
Weaknesses: Diaries have significant caveats including reduced compliance, recall biases, and diary fatigue. Delays in denoting motor status during an interval likely reduce the accuracy of the data. In addition, if a patient returns the diary with missing data, it cannot be recaptured. The compliance rate appears to fall when patients are requested to complete a greater number of consecutive days of diaries.
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| References |
Key Reference:
Defer GL, Widner H, MariÉ RM, RÉmy P, Levivier M. Core assessment program for surgical interventional therapies in Parkinson's disease (CAPSIT-PD). Mov Disord. 1999 Jul;14(4):572-84.
Additional References:
Antonini A, Martinez-Martin P, Chaudhuri RK, Merello M, Hauser R, Katzenschlager R, Odin P, Stacy M, Stocchi F, Poewe W, Rascol O, Sampaio C, Schrag A, Stebbins GT, Goetz CG. Wearing-off scales in Parkinson's disease: critique and recommendations. Mov Disord. 2011 Oct;26(12):2169-75.
Hauser RA, Deckers F, Lehert P. Parkinson's disease home diary: further validation and implications for clinical trials. Mov Disord. 2004 Dec;19(12):1409-13.
Papapetropoulos SS. Patient diaries as a clinical endpoint in Parkinson's disease clinical trials. CNS Neurosci Ther. 2012 May;18(5):380-7.
Reimer J, Grabowski M, Lindvall O, Hagell P. Use and interpretation of on/off diaries in Parkinson's disease. J Neurol Neurosurg Psychiatry. 2004 Mar;75(3):396-400.
Document last updated August 2022
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