Limits...
The MAGEC system for spinal lengthening in children with scoliosis: A NICE Medical Technology Guidance.

Jenks M, Craig J, Higgins J, Willits I, Barata T, Wood H, Kimpton C, Sims A - Appl Health Econ Health Policy (2014)

Bottom Line: Meta-analysis was used to compare the clinical evidence results with those of one conventional growth rod study, and equal efficacy of the two devices was concluded.Its critique highlighted limitations around study heterogeneity and variations in baseline characteristics and follow-up duration, precluding the ability to draw firm conclusions.The sponsor constructed a de novo costing model showing that MAGEC rods generated cost savings of £9,946 per patient after 6 years, compared with conventional rods.

View Article: PubMed Central - PubMed

Affiliation: York Health Economics Consortium, University of York, Level 2, Market Square, York, YO10 5NH, UK, michelle.jenks@york.ac.uk.

ABSTRACT
Scoliosis-structural lateral curvature of the spine-affects around four children per 1,000. The MAGEC system comprises a magnetically distractible spinal rod implant and an external remote controller, which lengthens the rod; this system avoids repeated surgical lengthening. Rod implants brace the spine internally and are lengthened as the child grows, preventing worsening of scoliosis and delaying the need for spinal fusion. The Medical Technologies Advisory Committee at the National Institute for Health and Care Excellence (NICE) selected the MAGEC system for evaluation in a NICE medical technologies guidance. Six studies were identified by the sponsor (Ellipse Technologies Inc.) as being relevant to the decision problem. Meta-analysis was used to compare the clinical evidence results with those of one conventional growth rod study, and equal efficacy of the two devices was concluded. The key weakness was selection of a single comparator study. The External Assessment Centre (EAC) identified 16 conventional growth rod studies and undertook meta-analyses of relevant outcomes. Its critique highlighted limitations around study heterogeneity and variations in baseline characteristics and follow-up duration, precluding the ability to draw firm conclusions. The sponsor constructed a de novo costing model showing that MAGEC rods generated cost savings of £9,946 per patient after 6 years, compared with conventional rods. The EAC critiqued and updated the model structure and inputs, calculating robust cost savings of £12,077 per patient with MAGEC rods compared with conventional rods over 6 years. The year of valuation was 2012. NICE issued a positive recommendation as supported by the evidence (Medical Technologies Guidance 18).

Show MeSH

Related in: MedlinePlus

Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram for External Assessment Centre (EAC) clinical evidence review
© Copyright Policy - OpenAccess
Related In: Results  -  Collection


getmorefigures.php?uid=PMC4232741&req=5

Fig1: Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram for External Assessment Centre (EAC) clinical evidence review

Mentions: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) diagram [23] (Fig. 1) shows the numbers of papers that were retrieved and excluded following dual selection by two independent reviewers, together with the reasons for exclusion. Of the 23 included studies, 15 [20, 24–37] were studies of conventional rods and eight were studies of MAGEC rods [7, 13, 14, 16, 18, 19, 38, 39]. Of the eight studies of MAGEC rods, two were additional to those found from running the sponsor’s search [38, 39]; however, the sponsor advised that patients in these studies were already included in another study [14]. The conventional rod arm of the case-matched study [19] included by the sponsor was also included within the evidence base, totalling 16 studies. Of the 16 conventional rod studies, 15 were retrospective case series and the remaining one was a prospective case series [28].Fig. 1


The MAGEC system for spinal lengthening in children with scoliosis: A NICE Medical Technology Guidance.

Jenks M, Craig J, Higgins J, Willits I, Barata T, Wood H, Kimpton C, Sims A - Appl Health Econ Health Policy (2014)

Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram for External Assessment Centre (EAC) clinical evidence review
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4232741&req=5

Fig1: Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram for External Assessment Centre (EAC) clinical evidence review
Mentions: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) diagram [23] (Fig. 1) shows the numbers of papers that were retrieved and excluded following dual selection by two independent reviewers, together with the reasons for exclusion. Of the 23 included studies, 15 [20, 24–37] were studies of conventional rods and eight were studies of MAGEC rods [7, 13, 14, 16, 18, 19, 38, 39]. Of the eight studies of MAGEC rods, two were additional to those found from running the sponsor’s search [38, 39]; however, the sponsor advised that patients in these studies were already included in another study [14]. The conventional rod arm of the case-matched study [19] included by the sponsor was also included within the evidence base, totalling 16 studies. Of the 16 conventional rod studies, 15 were retrospective case series and the remaining one was a prospective case series [28].Fig. 1

Bottom Line: Meta-analysis was used to compare the clinical evidence results with those of one conventional growth rod study, and equal efficacy of the two devices was concluded.Its critique highlighted limitations around study heterogeneity and variations in baseline characteristics and follow-up duration, precluding the ability to draw firm conclusions.The sponsor constructed a de novo costing model showing that MAGEC rods generated cost savings of £9,946 per patient after 6 years, compared with conventional rods.

View Article: PubMed Central - PubMed

Affiliation: York Health Economics Consortium, University of York, Level 2, Market Square, York, YO10 5NH, UK, michelle.jenks@york.ac.uk.

ABSTRACT
Scoliosis-structural lateral curvature of the spine-affects around four children per 1,000. The MAGEC system comprises a magnetically distractible spinal rod implant and an external remote controller, which lengthens the rod; this system avoids repeated surgical lengthening. Rod implants brace the spine internally and are lengthened as the child grows, preventing worsening of scoliosis and delaying the need for spinal fusion. The Medical Technologies Advisory Committee at the National Institute for Health and Care Excellence (NICE) selected the MAGEC system for evaluation in a NICE medical technologies guidance. Six studies were identified by the sponsor (Ellipse Technologies Inc.) as being relevant to the decision problem. Meta-analysis was used to compare the clinical evidence results with those of one conventional growth rod study, and equal efficacy of the two devices was concluded. The key weakness was selection of a single comparator study. The External Assessment Centre (EAC) identified 16 conventional growth rod studies and undertook meta-analyses of relevant outcomes. Its critique highlighted limitations around study heterogeneity and variations in baseline characteristics and follow-up duration, precluding the ability to draw firm conclusions. The sponsor constructed a de novo costing model showing that MAGEC rods generated cost savings of £9,946 per patient after 6 years, compared with conventional rods. The EAC critiqued and updated the model structure and inputs, calculating robust cost savings of £12,077 per patient with MAGEC rods compared with conventional rods over 6 years. The year of valuation was 2012. NICE issued a positive recommendation as supported by the evidence (Medical Technologies Guidance 18).

Show MeSH
Related in: MedlinePlus