Common Design and Data Elements Reported on Idiopathic Intracranial Hypertension Trials: A Systematic Review.
Journal
Journal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Society
ISSN: 1536-5166
Titre abrégé: J Neuroophthalmol
Pays: United States
ID NLM: 9431308
Informations de publication
Date de publication:
21 Jun 2023
21 Jun 2023
Historique:
medline:
21
6
2023
pubmed:
21
6
2023
entrez:
21
6
2023
Statut:
aheadofprint
Résumé
There are an increasing number of controlled clinical trials and prospective studies, ongoing and recently completed, regarding management options for idiopathic intracranial hypertension (IIH). We present a Common Design and Data Element (CDDE) analysis of controlled and prospective IIH studies with the aim of aligning essential design and recommending data elements in future trials and enhancing data synthesis potential in IIH trials. We used PubMed and ClinicalTrials.gov to screen for ongoing and published trials assessing treatment modalities in people with IIH. After our search, we used the Nested Knowledge AutoLit platform to extract pertinent information regarding each study. We examined outputs from each study and synthesized the data elements to determine the degree of homogeneity between studies. The most CDDE for inclusion criteria was the modified Dandy criteria for diagnosis of IIH, used in 9/14 studies (64%). The most CDDE for outcomes was change in visual function, reported in 12/14 studies (86%). Evaluation of surgical procedures (venous sinus stenting, cerebrospinal fluid shunt placement, and others) was more common, seen in 9/14 studies (64%) as compared with interventions with medical therapy 6/14 (43%). Although all studies have similar focus to improve patient care, there was a high degree of inconsistency among studies regarding inclusion criteria, exclusion criteria, and outcomes measures. Furthermore, studies used different time frames to assess outcome data elements. This heterogeneity will make it difficult to achieve a consistent standard, and thus, making secondary analyses and meta-analyses less effective in the future. Consensus on design of trials is an unmet research need for IIH.
Sections du résumé
BACKGROUND
BACKGROUND
There are an increasing number of controlled clinical trials and prospective studies, ongoing and recently completed, regarding management options for idiopathic intracranial hypertension (IIH). We present a Common Design and Data Element (CDDE) analysis of controlled and prospective IIH studies with the aim of aligning essential design and recommending data elements in future trials and enhancing data synthesis potential in IIH trials.
METHODS
METHODS
We used PubMed and ClinicalTrials.gov to screen for ongoing and published trials assessing treatment modalities in people with IIH. After our search, we used the Nested Knowledge AutoLit platform to extract pertinent information regarding each study. We examined outputs from each study and synthesized the data elements to determine the degree of homogeneity between studies.
RESULTS
RESULTS
The most CDDE for inclusion criteria was the modified Dandy criteria for diagnosis of IIH, used in 9/14 studies (64%). The most CDDE for outcomes was change in visual function, reported in 12/14 studies (86%). Evaluation of surgical procedures (venous sinus stenting, cerebrospinal fluid shunt placement, and others) was more common, seen in 9/14 studies (64%) as compared with interventions with medical therapy 6/14 (43%).
CONCLUSIONS
CONCLUSIONS
Although all studies have similar focus to improve patient care, there was a high degree of inconsistency among studies regarding inclusion criteria, exclusion criteria, and outcomes measures. Furthermore, studies used different time frames to assess outcome data elements. This heterogeneity will make it difficult to achieve a consistent standard, and thus, making secondary analyses and meta-analyses less effective in the future. Consensus on design of trials is an unmet research need for IIH.
Identifiants
pubmed: 37342870
doi: 10.1097/WNO.0000000000001902
pii: 00041327-990000000-00381
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2023 by North American Neuro-Ophthalmology Society.
Références
Mollan SP, Aguiar M, Evison F, Frew E, Sinclair AJ. The expanding burden of idiopathic intracranial hypertension. Eye (Lond). 2019;33:478–485.
Mulla Y, Markey KA, Woolley RL, Patel S, Mollan SP, Sinclair AJ. Headache determines quality of life in idiopathic intracranial hypertension. J Headache Pain. 2015;16:521.
Grech O, Clouter A, Mitchell JL, et al. Cognitive performance in idiopathic intracranial hypertension and relevance of intracranial pressure. Brain Commun. 2021;3:fcab202.
Thaller M, Mytton J, Wakerley BR, Mollan SP, Sinclair AJ. Idiopathic intracranial hypertension: evaluation of births and fertility through the hospital episode statistics dataset. BJOG. 2022;129:2019–2027.
Adderley NJ, Subramanian A, Nirantharakumar K, et al. Association between idiopathic intracranial hypertension and risk of cardiovascular diseases in women in the United Kingdom. JAMA Neurol. 2019;76:1088–1098.
Wall M, McDermott MP, Kieburtz KD, et al. Effect of acetazolamide on visual function in patients with idiopathic intracranial hypertension and mild visual loss: the idiopathic intracranial hypertension treatment trial. JAMA. 2014;311:1641–1651.
Subramaniam S, Fletcher WA. Obesity and weight loss in idiopathic intracranial hypertension: a narrative review. J Neuroophthalmol. 2017;37:197–205.
Mollan SP, Mitchell JL, Ottridge RS, et al. Effectiveness of bariatric surgery vs community weight management intervention for the treatment of idiopathic intracranial hypertension. JAMA Neurol. 2021;78:678–686.
Nia AM, Srinivasan VM, Lall R, Kan P. Dural venous sinus stenting in idiopathic intracranial hypertension: a national database study of 541 patients. World Neurosurg. 2022;167:e451–e455.
Mollan SP, Mytton J, Tsermoulas G, Sinclair AJ. Idiopathic intracranial hypertension: evaluation of admissions and emergency readmissions through the hospital episode statistic dataset between 2002-2020. Life (Basel). 2021;11:417.
Friedman DI, Liu GT, Digre KB. Revised diagnostic criteria for the pseudotumor cerebri syndrome in adults and children. Neurology. 2013;81:1159–1165.
Friedman DI, Jacobson DM. Diagnostic criteria for idiopathic intracranial hypertension. Neurology. 2002;59:1492–1495.
Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71.
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240:205–213.
Derraik JGB, Parklak W, Albert BB, Boonyapranai K, Rerkasem K. Fundamentals of data collection in clinical studies: simple steps to avoid “garbage in, garbage out”. Int J Low Extrem Wounds. 2021;20:183–187.
Saver JL, Warach S, Janis S, et al. Standardizing the structure of stroke clinical and epidemiologic research data: the national Institute of neurological disorders and stroke (NINDS) stroke common data element (CDE) project. Stroke. 2012;43:967–973.
Redeker NS, Anderson R, Bakken S, et al. Advancing symptom science through use of common data elements. J Nurs Scholarsh. 2015;47:379–388.
Adusumilli G, Ghozy S, Kallmes KM, et al. Common data elements reported on middle meningeal artery embolization in chronic subdural hematoma: an interactive systematic review of recent trials. J Neurointerv Surg. 2022;14:1027–1032.
Mollan SP, Sinclair AJ. Outcomes measures in idiopathic intracranial hypertension. Expert Rev Neurother. 2021;21:687–700.
Patino CM, Ferreira JC. Inclusion and exclusion criteria in research studies: definitions and why they matter. J Bras Pneumol. 2018;44:84.
Coster WJ. Making the best match: selecting outcome measures for clinical trials and outcome studies. Am J Occup Ther. 2013;67:162–170.