Application of the ‘5-2-1’ Screening Criteria in Advanced Parkinson’s Disease: Interim Analysis of DUOGLOBE

Abstract

Aim: A Delphi expert consensus panel proposed that fulfilling ≥1 of the ‘5-2-1 criteria’ (≥five-times daily oral levodopa use, ≥two daily hours with ‘Off’ symptoms or ≥one daily hour with troublesome dyskinesia) suggests advanced Parkinson’s disease (PD). Patients & methods: DUOdopa/Duopa in Patients with Advanced PD – a GLobal OBservational Study Evaluating Long-Term Effectiveness (DUOGLOBE) – is a single-arm, postmarketing, observational, long-term effectiveness study of levodopa–carbidopa intestinal gel (LCIG) for advanced PD. Results: This 6-month interim analysis (n = 139) affirms that most (98%) enrolled patients fulfill ≥1 of the 5-2-1 criteria. These patients responded favorably to LCIG treatment. Safety was consistent with other LCIG studies. Conclusion: In advanced PD patients, the 5-2-1 criteria generally aligns with clinician assessment. Clinical Trial Registration: NCT02611713 ( ClinicalTrials.gov )

Timely referral for advanced therapy in Parkinson’s disease. Development of a screening tool

“…presented a consensus statement of international experts that eventually led to the development of the so-called 5-2-1 criteria. [14,31] The 5-2-1 criteria were introduced to help general neurologists identify advanced PD patients who are possibly eligible for AT. [17] These criteria are easy to use and the name itself serves as a mnemonic device.…”

Parkinson’s Disease in Romania: A Scoping Review

“…The studies investigating different diagnostic tools for PD patients (n = 35) contributed to 23.48% of the research. The Romanian researchers participated in developing various clinical scales, including the non-motor symptoms scale (NMSS) [60,61], scales for outcomes in Parkinson's disease-cognition (SCOPA-COG) [62], King's Parkinson's disease scale [77] and King Parkinson's disease questionnaire [87], Parkinson's disease composite scale (PDCS) [90,92], and the "5-2-1" screening criteria for advanced PD [93]. Nonetheless, the number of neuroimaging studies is low (n = 3), and there is a lack of studies on other more expensive diagnostic tools (e.g., dopamine transporters imaging, DaTscan).…”

“…Our systematic review identified 35 studies investigating different diagnostic tools (Supplemental Material: Table S2). Among them, 13 [60,62,63,93]. The rest of 41 studies were performed in national settings.…”

“…Our systematic review identified 35 studies investigating different diagnostic tools (Supplemental Material: Table S2). Among them, 13 were international multicenter studies [60-64,77,79,80,88,90,92-94]; 9 were published as original papers [61,64,77,79,80,87,88,90,92], and four were abstracts of research presented at international conferences [60,62,63,93]. The rest of 41 studies were performed in national settings.…”

Personalised Advanced Therapies in Parkinson’s Disease: The Role of Non-Motor Symptoms Profile

“…This has led to the development of the ‘5-2-1’ paradigm (≥5-times oral levodopa doses/day, ≥2 h of ‘off’ symptoms/day, ≥1 h of troublesome dyskinesia/day) to identify motor aspects of advanced PD and ensure timely referral for DAT initiation [ 10 ]. The interim analysis of DUOGLOBE, an observational study evaluating the long-term effectiveness of LCIG in patients with advanced PD, showed that only 20% of patients met all of the 5-2-1 criteria, but 98% met at least one criterion, highlighting the need for further refinement and personalisation of DAT selection [ 12 ].…”