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Clinical evidence guidelines: Medical devices
Appendix 3: Source material
Search Method: Identification and selection of clinical studies
The search method used by ASERNIP-S to identify, retrieve and review the evidence that supports this guidance document was a pragmatic adaption of a rapid systematic review259.
Selection criteria were established a priori and include publication type, type of medical device under review, intended purpose of the medical device, adverse events (safety), and clinical outcomes related to device performance.
Using the PubMed Clinical queries tool, representative articles were identified through scoping searches. These results informed the selection of appropriate text words and subject headings.
All searches were executed using the Ovid platform for Medline, Embase and the Cochrane library and Evidence-based medicine databases. Through the application of search filters for study type (Systematic Reviews, Randomised Controlled Trials and Registry trials) search results were restricted to appropriate level evidence.
For joint prostheses - Search title: Total and partial joint arthroplasty: Search terms: Shoulder surgery[MeSH], Shoulder Joint/surgery[MeSH]; Knee surgery [MeSH]; 'knee Joint' surgery[MeSH]; hip Joint surgery [MeSH]; arthroplasty[MeSH]; ((shoulder OR hip OR Knee) adj2 replacement). [text word]; ((shoulder OR hip OR Knee) adj2 joint).[text word]; ((shoulder OR hip OR Knee) adj3 arthroplasty)[text word]; ((shoulder OR hip OR Knee) adj3 surger?)[text word].
For cardiovascular devices for patency and functional flow- Search title: Cardiovascular devices for patency and functional flow: Search terms: Heart [MeSH]; aneurysm [MeSH]; aorta[MeSH]; Venae cavae[MeSH]; 'Ductus Arteriosus, Patent'[MeSH]; vascular.[text word]; endovascular.[text word]; cardiovascular. [text word]; heart.[text word]; cardiac.[text word]; ; 'vena cava'.[text word]; aorta.[text word]; 'Patent ductus arteriosus'.[text word] ; aneurism.[text word]
Selected CV flow implants included the following types:
- Arterial stents (carotid, coronary and peripheral)
- Implants for AAA repair
- Implants for PDA repair
For implantable pulse generators - Search title: electrical impulse generators: Search terms: Pacemaker, Artificial[MeSH]; Biological Clocks[MeSH]; Tachycardia, Ectopic Atrial[MeSH]; implantable cardioverter-defibrillators[MeSH]; Defibrillators, Implantable[MeSH]; Tachycardia, Ventricular[MeSH]; Ventricular Fibrillation[MeSH]; Pain Management[MeSH]; Postoperative pain[MeSH]; Analgesia, Patient-Controlled[MeSH]; Magnetic Field Therapy[MeSH]
Selected implantable pulse generators of the following types:
- Active Implantable Cardiac Devices (AICD) including:
- single and dual chamber pacemakers
- cardiac resynchronisation therapy pacemakers, with or without defibrillation (i.e. CRT-D and CRT respectively)
- implantable cardiac defibrillators (ICDs)
- Electrical nerve stimulation devices
For heart valve prostheses- Search title: Heart valve replacement using a prosthetic valve: Search terms: Heart valve prosthesis [MeSH]; heart valve prosthesis implantation[MeSH]; (valv$ adj3 prosthe$).[text word]; (valv$ adj3 bioprosthe$).[text word]; (artificial adj3 valv$).[text word]; (mechanical adj3 valv$).[text word]; (bioprosthe$ OR prosthe$ OR mechanical).[text word]; (aortic adj3 valv$).[text word]; (mitral adj3 valv$).[text word]; (pulmon$ adj3valv$).[text word].
For supportive devices- Search title: Supportive devices - meshes, patches and tissue adhesives: Search terms: Surgical mesh [MeSH]; Bioabsorbable Implants; Absorbable Implants [MeSH]; Coated Materials. Biocompatible [MeSH]; Tissue scaffolds [MeSH]; Tissue adhesives [MeSH]; Fibrin Tissue Adhesive [MeSH]; Blood patch, Epidural [MeSH].
For active implantables in the magnetic resonance environment - Search title: safety of active implantables in the magnetic resonance environment: Search terms: Magnetic Resonance Imaging[MeSH]; magnetic resonance [text word]; MRI [text word]; MR [text word]; Cardiac Pacing, Artificial[MeSH]; Pacemaker, Artificial[MeSH]; defibrillators, implantable[MeSH]; safe*[text word]; performance [text word]; efficacy [text word]; heat* [text word]; scar*[text word]; burn*[text word]; artefact* [text word]; ;dislodge*[[text word]; interference [text word]; ICD [text word]; Defibrillator [text word]; pacemaker* [text word] ; resynch* [text word]; cardiac monitor [text word] ; loop recorder [text word]; ICM [text word].
- A focused internet search was conducted to identify recent and relevant legislation, current guidance documents and other standards/documents to assist in the compilation and presentation of clinical evidence. Only documents that are publicly available to manufacturers were included. For regulatory documents, the scope of the search was confined to Australia and the comparable jurisdictions of Canada, the EU/UK, Japan and the USA.
Evidence from both the targeted internet searches and peer reviewed literature focused on study designs that are based on solid scientific principles which generate clinical evidence on the safety and performance of the device. Such evidence sources include, but are not limited to, controlled clinical trials, case control studies, case series and post-market registry data.
Summaries of exemplar articles documenting clinical research on the safety and performance of the device types have also been presented. Reports were selected based on recency and relevance and to be representative of those currently used in clinical practice in Australia.
Searches were restricted to English language articles published between January 2009 and June 2014 with updates for some topics to January 2015. All citations were retrieved and initial selection was based on title and abstract with potentially relevant articles retrieved in full text for final selection.
Identified study designs
Based on the NHMRC levels of evidence study59, designs used to evaluate the safety and performance of high risk medical devices range from systematic reviews of RCTs to case-series reports (Level IV). Irrespective of level of evidence the quality of reporting varied from low to high as assessed by validated quality tools.
In summary, the clinical evidence in this document includes:
- systematic reviews of RCTs, comparative cohort trials and cases-series
- given the diversity of included evidence these systematic reviews do not meet the Level I classification as prescribed by the NHMRC
- RCTs (Level II)
- when practical, this should be the preferred study design
- clinical trials of a RCT design are reported for the high risk devices and included in the evidence base
- observational studies (Level III)
- case series (Level IV)
- these can inform on the safety and performance of the high risk devices and have a high sensitivity for adverse events
- post-market registries
- these are established for some of the high risk devices and provide a valuable resource for post-market safety and performance data from other jurisdictions that can be used to support a pre- or post-market review of safety and performance of a high risk device.