Evidence map›Paper›PMID 40125723›Full record

ArticlePsychological medicine2025

Minimal clinically important differences for treatment of hallucinations in Parkinson's disease and dementia with Lewy bodies.

Suzanne Reeves, Josef Mahdi, Matthew Appleby, Olga Zubko, Teresa Lee, Julie A Barber, Kathy Y Liu, John-Paul Taylor, Emily J Henderson, Anette Schrag and 3 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Psychological medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04167813 (Trial of Ondansetron as a Parkinson's HAllucinations Treatment), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04167813 phase2unknown statusnot on this map

Trial of Ondansetron as a Parkinson's HAllucinations Treatment

TypeinterventionalSponsorUniversity College, LondonRan2021 to 2024Enrolled168ConditionsParkinson's Hallucinations, Dementia With Lewy BodiesArmsOndansetron 8mg or matched placebo tablets
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Suzanne ReevesDivision of Psychiatry, University College London, London, UK.ORCID https://orcid.org/0000-0001-8053-7024
Josef MahdiDivision of Psychiatry, University College London, London, UK.
Matthew ApplebyNational Hospital for Neurology & Neurosurgery, London, UK.
Olga ZubkoDivision of Psychiatry, University College London, London, UK.
Teresa LeeDepartment of Statistical Science, University College London, London, UK.
Julie A BarberDepartment of Statistical Science, University College London, London, UK.ORCID https://orcid.org/0000-0001-5762-762X
Kathy Y LiuDivision of Psychiatry, University College London, London, UK.ORCID https://orcid.org/0000-0002-7482-2758
John-Paul TaylorCampus for Ageing and Vitality, Newcastle University, Newcastle upon Tyne, UK.ORCID https://orcid.org/0000-0001-7958-6558
Emily J HendersonAgeing and Movement Research Group, Bristol Medical School, University of Bristol, Bristol, UK.ORCID https://orcid.org/0000-0002-0016-1870
Anette SchragMovement Disorders Centre, Queen Square Institute of Neurology, University College London, Russell Square House, London, UK.ORCID https://orcid.org/0000-0002-9872-6680
Robert HowardDivision of Psychiatry, University College London, London, UK.ORCID https://orcid.org/0000-0002-3071-2338
Rimona S WeilNational Hospital for Neurology & Neurosurgery, London, UK.ORCID https://orcid.org/0000-0002-5092-6325
Hallucinations Working Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHallucinations are common and distressing symptoms in Parkinson's disease (PD). Treatment response in clinical trials is measured using validated questionnaires, including the Scale for Assessment of Positive Symptoms-Hallucinations (SAPS-H) and University of Miami PD Hallucinations Questionnaire (UM-PDHQ). The minimum clinically important difference (MCID) has not been determined for either scale. This study aimed to estimate a range of MCIDs for SAPS-H and UM-PDHQ using both consensus-based and statistical approaches.

methodsA Delphi survey was used to seek opinions of researchers, clinicians, and people with lived experience. We defined consensus as agreement ≥75%. Statistical approaches used blinded data from the first 100 PD participants in the Trial for Ondansetron as Parkinson's Hallucinations Treatment (TOP HAT, NCT04167813). The distribution-based approach defined the MCID as 0.5 of the standard deviation of change in scores from baseline at 12 weeks. The anchor-based approach defined the MCID as the average change in scores corresponding to a 1-point improvement in clinical global impression-severity scale (CGI-S).

resultsFifty-one researchers and clinicians contributed to three rounds of the Delphi survey and reached consensus that the MCID was 2 points on both scales. Sixteen experts with lived experience reached the same consensus. Distribution-defined MCIDs were 2.6 points for SAPS-H and 1.3 points for UM-PDHQ, whereas anchor-based MCIDs were 2.1 and 1.3 points, respectively.

conclusionsWe used triangulation from multiple methodologies to derive the range of MCID estimates for the two rating scales, which was between 2 and 2.7 points for SAPS-H and 1.3 and 2 points for UM-PDHQ.

Indexed as

HallucinationsLewy Body DiseaseMinimal Clinically Important DifferenceOutcome Assessment, Health CareParkinson DiseaseAgedConsensusDelphi TechniqueFemaleHumansMaleMiddle AgedDelphi consensusdementia with Lewy bodieshallucinationsMinimum clinical important differenceParkinson’s diseaseSAPS-HUM-PDHQ

Identifiers

PMID40125723
PMCPMC12080632

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.