What we need

We are evaluating the following review question:

What is the comparative clinical effectiveness and cost effectiveness, for people with Parkinson’s disease whose symptoms are no longer controlled by existing pharmacological treatment(s), of:

• deep brain stimulation surgery (of any surgical target) or
• levodopa and carbidopa intestinal gel or
• best medical treatment (which may or may not include apomorphine infusion).

We would like:

• Unpublished data from any randomised controlled trial comparing 2 or more of the above interventions
• Unpublished non-randomised data detailing long-term follow-up (1 year or longer) of any of the above interventions (to inform our original health economic analysis)
• Existing health economic data or models comparing any 2 or more of the above interventions.

We require data reporting any of the following outcomes:

Patient-reported outcomes:

• EQ-5D (summary index score)
• PDQ-39 (at domain and summary level)
• PDQ-8 (at domain and summary level)
• ON and/or OFF times (reported as hours per day or quartile percentages)

 Markers of disease progression (in ON and/or OFF states):

o UPDRS (total score and/or subscores for parts III, IVa IVb and IVc)

o Hoehn and Yahr stages

• Resource use (including concomitant medication and care requirements)
• Rates of entry to full-time institutional care (e.g. time-to-event data)
• Any adverse events (rates or numbers of events and people)

Data can be submitted in aggregate (with appropriate measures of dispersion) or appropriately anonymised individual form. In addition to the outcomes listed, supporting data covering the number of participants, baseline participant characteristics and any concomitant medication(s) taken should be submitted.

We cannot accept promotional material, non-evidence-based assertions of effectiveness or opinion pieces. Please see the call for evidence request document for full details.

Sending information

You should ensure that any data you wish to submit:

• Directly addresses the review question listed
• Fits into 1 of the 3 categories of data required
• Reports outcomes listed and supporting data

There is no need to submit data that have already been published.

For unpublished information, send:

• a link to any relevant trials registered with the Cochrane Central Register of Controlled Trials, or with the US National Institutes of Health trials registry
• paper or electronic copies of other relevant unpublished information
• data in Microsoft Word, Microsoft Excel, Adobe PDF or comma-separated value formats. Health economic models may also be submitted as R, WinBUGS or TreeAge files. If you wish to submit data in any other format, please get in touch to discuss with us.

Highlight any confidential sections (unpublished research or commercially sensitive information) in unpublished information. For more details about this, see our guidelines manual.

Please email Stephanie Mills  at stephanie.mills@nice.org.uk this form with any relevant information by 12 noon 20 July 2015.

Send paper copies to:

Stephanie Mills
Project Manager
National Institute for Health and Care Excellence
Level 1A
City Tower
Piccadilly Plaza
Manchester
M1 4BT

Please indicate whether your organisation will be submitting evidence for consideration by email. We look forward to receiving any information and thank you in advance for your help.