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The minimum clinically important difference (MCID) for a falls intervention in Parkinson's: A delphi study
Emily J Henderson1, Gemma S Morgan2, Jigisha Amin3
1Department of Population Health Sciences, Bristol Medical School, University of Bristol, 39 Whatley Road, Bristol, BS8 2PS, United Kingdom; Royal United Hospitals NHS Foundation Trust Bath, BA1 3NG, United Kingdom.
Background:
Falls are common in Parkinson's disease so any intervention that reduced falls risk would be of value. One potential intervention is the use of cholinesterase inhibitor (ChEi) drugs.
Objective:
To establish the minimum clinically important difference (MCID) for fall rates to inform the effect estimate for sample size calculations of future clinical trials.
Methods:
We performed a Delphi study assembling a panel of experts in Parkinson's disease from academic and clinical medicine in order to reach a consensus of opinion. Responses from a panel were summarised and resent to the group, until consensus was reached.
Results:
780 clinicians, who had been caring for people with Parkinson's for an average of 14 years, were contacted via three routes. The median (Interquartile range (IQR)) MCID after round 1 was 25% (IQR 20-30%) which equates to the prevention of 5 (IQR 4-6) falls per year. Increasing consensus after round two confirmed the MCID of 25%, narrowing the (IQ) range to 20%-25%. This was unchanged when the panel were shown the number of participants that would need to be recruited to a clinical trial in order to achieve this difference.
Conclusions:
We have established that an expert panel of PD specialists consider that an intervention that demonstrated a 25% (IQR 20-25%) relative reduction in falls rate would be clinically meaningful. This estimate can be used to help determine the sample size for any future clinical trial.
Insights
Experts determined that a 25% reduction in fall rates is clinically meaningful for Parkinson's disease patients. This finding helps calculate sample sizes for future clinical trials investigating fall prevention interventions.
Area of Science:
- Neurology
- Clinical Trials
- Geriatrics
Background:
- Falls are a significant challenge for individuals with Parkinson's disease (PD).
- Interventions to reduce fall risk are crucial for improving patient quality of life.
- Cholinesterase inhibitor (ChEi) drugs are a potential therapeutic avenue for fall reduction in PD.
Purpose of the Study:
- To establish the minimum clinically important difference (MCID) for fall rates in Parkinson's disease.
- To provide an evidence-based effect estimate for sample size calculations in future clinical trials.
Main Methods:
- A Delphi study was conducted with a panel of Parkinson's disease experts.
- Expert opinions were gathered and refined through multiple rounds to reach a consensus.
- The study involved 780 clinicians with an average of 14 years of experience in PD care.
Main Results:
- The median MCID for fall rates was established at 25% after the first round of the Delphi study.
- This 25% reduction equates to preventing an average of 5 falls per year per patient.
- Consensus was strengthened in the second round, confirming the 25% MCID with a narrower interquartile range of 20%-25%.
Conclusions:
- An expert consensus identified a 25% relative reduction in fall rate as clinically meaningful for Parkinson's disease.
- This established MCID is vital for designing future clinical trials and determining appropriate sample sizes.
- The findings support the development of targeted interventions to mitigate fall risk in PD patients.