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19/79 Idiopathic intracranial hypertension

 

Contents

Introduction

The aim of the HTA Programme is to ensure that high quality research information on the effectiveness, costs and broader impact of health technology is produced in the most efficient way for those who use, manage, provide care in or develop policy for the NHS. Topics for research are identified and prioritised to meet the needs of the NHS. Health technology assessment forms a substantial portfolio of work within the National Institute for Health Research and each year about fifty new studies are commissioned to help answer questions of direct importance to the NHS. The studies include both primary research and evidence synthesis.

Research Question: What is the comparative clinical and cost-effectiveness of venous sinus stenting versus cerebrospinal fluid shunting for medically refractory idiopathic intracranial hypertension?

  1. Intervention: Cerebral venous sinus stenting.
  2. Patient group: Adults with medically refractory idiopathic intracranial hypertension (IIH) being considered for cerebral venous diversion surgery. Applicants to define and justify inclusion criteria.
    Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field.
  3. Setting: Secondary care.
  4. Control: Ventriculoperitoneal shunting (or other cerebrospinal fluid diversion procedure). To be defined and justified by applicants.
  5. Study design: Applicants should define and justify a suitable study design to answer the research question.
  6. Important outcomes: Improvement in IIH symptoms and signs (applicants to define and justify); Quality of life, number of infections & repeat IIH-related surgeries; cost-effectiveness.
    Other outcomes: Adverse events; medication usage.
  7. Minimum duration of follow-up: 24 months.

Rationale:

Idiopathic intracranial hypertension (IIH) is a neurological condition of unknown cause defined by increased intracranial pressure around the brain without the presence of tumour or disease. Common symptoms of IIH include headaches, visual loss, pulsatile tinnitus, and back and neck pain. If left untreated, the disorder can lead to substantial visual morbidity. IIH is strongly associated with obesity.

Weight loss and treatment with acetazolamide (a carbonic anhydrase inhibitor used for glaucoma, some types of epilepsy and fluid retention) are the principal management strategies, together with steroids, amitriptyline, topiramate and pain killers. For the most severe cases, to protect vision or when medications and other treatments are unsuccessful or not tolerated, a number of surgical options are available.

Cerebrospinal fluid (CSF) shunts can be inserted to reduce the intracranial CSF pressure with several specific techniques available. Failure rate of such shunts is high which can have a significant impact on patient quality of life and has important cost implications.

Alternatively, venous sinus stenting can be conducted which can reduce venous pressure and relieve symptoms. Stenting has a reported lower failure rate than CSF shunt procedures.

No direct comparison has been done of CSF shunts versus stenting in an appropriate study  to guide management of this difficult to treat condition. Such a study should determine which type of surgery is most effective, and for who, and if such surgery is cost effective.

Making an application

If you wish to submit a Stage 1 application for this call, the online application form can be found on the Funding opportunities page.  To select this call, use the filters on the right of the screen or search using the call name and/or number.

Your application must be submitted on-line no later than 1pm on the 4th December 2019. Applications will be considered by the HTA Funding Committee at its meeting in January.

Guidance notes and supporting information for HTA Programme applications are available by clicking the links.

IMPORTANT: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in May.

Applications received after 1300 hours on the due date will not be considered.

Should you have any queries please contact us:

Email: htacommissioning@nihr.ac.uk

Telephone: Commissioning Funding Committee 02380 595510