Systemic reviews on implantable medical devices provide a quality of reporting – Pubrica

1. SYSTEMICREVIEWSON IMPLANTABLEMEDICAL DEVICESPROVIDEA QUALITYOFREPORTING AnAcademicpresentationby Dr.NancyAgnes,Head,TechnicalOperations,Pubrica Group: www.pubrica.com Email:sales@pubrica.com

2. Today'sDiscussion Outline In-Brief Introduction DefiningActiveImplantableMedicalDevices LiteratureSearch EligibilityCriteriaandCitationScreening DataExtraction RecommendationsofReportingItemsforSystemic ReviewsofImplantableMedicalDevices Conclusion

3. In-Brief Eventhoughtherehavebeenmanysystematicreviewsofimplantablemedical devices published, no empirical evaluation of the reviews has been done. To understand the methodology utilized, identify existing strengths, limitations, flaws, and specific issues, and provide recommendations to enhance future conduct and reporting, we undertook a critical appraisal of the quality of reporting in systematic reviews of implanted medical devices. These characteristicsmayhave animpact onthe studyoutcomes.

4. Introduction In medical practice and research, systematic reviews servicehavea well-establishedplace. Clinicians utilize systematic reviews to stay up to date oncurrentresearchandcomparetheefficacyof competingtherapies. Althoughmanysystematicevaluationsofmedical devices have been published, no empirical evaluation ofthereviews hasbeen conducted. Contd...

5. The findings of an empirical evaluation of systematic reviews of medical devices could be utilized to design newreportingrulesandimprovetheconductand qualityofsystematicreviewsofmedicaldevices reporting. TheConsolidatedStandardsofReportingTrials (CONSORT)Statementwasrecentlyupdatedto includetrialsofnon-pharmacologicaltreatments; however,therearestillnorecommendationsfor systematic evaluation of medical devices. Implantable medicaldevicesareonebiggroupofdevicesof interest. Contd...

6. the Food and Drug Administration are devices that are partially or According to (FDA), these implanted into the body or a natural orifice via surgical or medical procedures and are intended to remain in the body or orifice for at least 30 days, according to theFoodandDrugAdministration(FDA)(or permanently). Suchdevicescanonlybephysicallyremovedor medically deactivated. Implantable devices can also beutilizedtoreplaceanepitheliumorocularsurface. Contd...

7. Themarketforimplantablemedicaldevicesinthe United States is expected to expand 8.3% year to $49 billion,withspinalimplants,cardiacimplants,and orthobiologicsbeingthefastest-growingcategories (substancesthatacceleratehealingofinjuredbones). Hereassumedacriticalappraisalofthequalityof reporting in systematic reviews of implanted medical devicesastheEvidence-basedPracticeCenter (EPC)designatedforthecrosscuttingconcentration ofdiagnostictesting,imagingtechnologies,and medicaland assistivedevices. Contd...

8. Theproject'sobjectivesweretoassesspublished systematic reviews and meta-analyses to understand betterthemethodologiesusedandidentifycurrent conductandreporting. They chose to focus on five broad categories of implantable medical devices based on recommendations of the Technical Expert the Panel (TEP) and to ensure inclusion of the most commonly usedandexpensivedevices:cardiacimplantable devices, vascular interventional devices, orthopaedic implants,skin-replacementgrafts,and neurostimulators.

9. Defining Active Implantable Medical Devices An active medical device operates by using and convertingalarge amountof energy. Except for gravitational and direct human energies, activedevicescan useany energy. Active medical devices, as defined by the Therapeutic Goods(MedicalDevices)Regulations2002,canbe broadlyclassifiedinto twocategories: Contd...

10. The manufacturer intends for active medical devices for diagnosis to be used on a human being to provide information for detecting, diagnosing, monitoring, or treating physiological conditions, states of health, illnesses, or congenital deformities, either aloneor incombination with anothermedical device. The manufacturer intends for active medical devices for therapy to be used on a human being to maintenance, modify, replace, or restore biological functions or structurestotreatoralleviateanillness,injury,orhandicap,eitheraloneorin combinationwith another medicaldevice.

11. Literature Search Systematic reviewspublished between January 2009 and December 2010 were found using keywords for eachofthefivecategoriesofimplantablemedical devices in MEDLINE® and the Cochrane Database of SystematicReviews. Articleswithabstractsthatdescribedsearchesor eligibilitycriteriaforstudyidentificationorincluded terms like "systematic," "evidence," "evidence-based," "meta-analysis," or "pooled analysis" were considered potentiallyrelevant reviews.

12. Eligibility Criteriaand Citation Screening Many published systematic reviewsof implantablemedicaldevicesdidnotexplicitly report all three fundamental components during full-textscreening. goal was to it included assess reporting reviews of any Because the characteristics, implantabledevicefromanyofthefivecategories thatlookedata recentpublication. Contd...

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14. Forexample,areviewofapacemaker,areviewof adefibrillator,orareviewofbothapacemakerand adefibrillatormightbeincludedinthecardiac implantabledevicecategory. Systematic reviews of any type (randomized trials, non-randomizedcomparativestudies,or observationalresearch),aswellassynthesis technique,wereconsidered(qualitativeor quantitativesynthesisincludingmeta-analysesof individualpatient data).

15. Data Extraction Therearecurrentlynodefinedtechniquesor protocols for assessing the quality of systematic reviewsofimplantablemedicaldevicesreporting. HereexaminedtheTEPtoidentifydevice-and operator-specificinformationrelevanttothese devices'evaluation. In addition to the 30 systematic reviews, specific informationitemsdescribedintheMOOSEand PRISMArecommendationshavefoundeight device-andoperator-specificinformationitems.

16. RecommendationsofReportingItemsforSystemic ReviewsofImplantableMedicalDevices Reportingofdeviceorprocedure-specificdata PROSPERO—the International Prospective Register of Systematic Reviews—also offers systematic review reporting, conduct, scientific writing, and publication through aformal protocol registration process. At the time of registration of systematic review protocols, propose include eight new device-andoperator-specificelementsuniquetoimplantedmedicaldeviceresearch. Contd...

17. This project would encourage academics to report systematic reviews of implantablemedicaldevices moreaccurately andtransparently. Also, propose adding eight new device- and operator-specific topics to the extensionguide uniqueto implantablemedical devicestudies. Cardiacdefibrillatorswithorwithoutpacemakers Devicetype Contd...

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19. Methodofimplantation Positionoftheelectrode Descriptionofmicroprocessortechnologyandprogrammablefeatures Alertfeatures thatmonitor leadimpedance Vascularinterventionaldevices(e.g.,stents) Contd...

20. Typeofstentandstentingtechnique Generationofthestent(e.g.,firstorsecondgeneration) Typeofantiproliferative drugused Deliverysystem Polymerlayer Contd...

21. Stentframe Orthopaedicimplants Typeofdevice Surgical technique or approach Numberandlocationofdevices Contd... Fixationandsupplementarymaterialssuchasplatesandscrews

22. Typeofdevicecoating Neurostimulators Skin-replacementgrafts Stimulationparameters frequency intensity pulsewidth Typeofskingraftrequired Compositionofgraft Grafttype:bioabsorbableorrequiringremoval Electrodelocation

23. Conclusion The lack of reporting of some essential general items applicable to any systematic review and device- and operator-specific information is revealed in a review of systematicreviewsonimplantablemedicaldevices. Eightdevice-oroperator-specificitemswerealso identifiedaspotentiallyusefulinreportingon systematic reviews of implanted devices and might be includedinreportingrecommendations. Contd...

24. In recent years, the number of systematic evaluations ofimplantablemedicaldeviceshasincreased dramatically, with reviews appearing in a wide range of journals. Failuretoincludedataonproceduresanddevices could lead to incorrect synthesis or interpretation of resultsbecausethereisnowidelyacknowledged standardforreportinginformationtoimplantable medicaldevice research.

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