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

 

Introduction:

In medical practice and research, systematic reviews service have a well-established place. Clinicians utilize systematic reviews to stay up to date on current research and compare the efficacy of competing therapies. Although many systematic evaluations of medical devices have been published, no empirical evaluation of the reviews has been conducted. The findings of an empirical evaluation of systematic reviews of medical devices could be utilized to design new reporting rules and improve the conduct and quality of systematic reviews of medical devices reporting.

The Consolidated Standards of Reporting Trials (CONSORT) Statement was recently updated to include trials of non-pharmacological treatments; however, there are still no recommendations for systematic evaluation of medical devices. Implantable medical devices are one big group of devices of interest. According to the Food and Drug Administration (FDA), these are devices that are partially or 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 the Food and Drug Administration (FDA) (or permanently). Such devices can only be physically removed or medically deactivated.Implantable devices can also be utilized to replace an epithelium or ocular surface.

Defining active implantable medical devices:

An active medical device operates by using and converting a large amount of energy. Except for gravitational and direct human energies, active devices can use any energy. Active medical devices, as defined by the Therapeutic Goods (Medical Devices) Regulations 2002, can be broadly classified into two categories:

·         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 alone or in combination with another medical device.

Literature search

Systematic reviews published between January 2009 and December 2010 were found using keywords for each of the five categories of implantable medical devices in MEDLINE® and the Cochrane Database of Systematic Reviews. Articles with abstracts that described searches or eligibility criteria for study identification or included terms like "systematic," "evidence," "evidence-based," "meta-analysis," or "pooled analysis" were considered potentially relevant reviews.



Data extraction

There are currently no defined techniques or protocols for assessing the quality of systematic reviews of implantable medical devices reporting. Here examined the TEP to identify device- and operator-specific information relevant to these devices' evaluation. In addition to the 30 systematic reviews, specific information items described in the MOOSE and PRISMA recommendations have found eight device- and operator-specific information items.

Reporting of device or procedure-specific data

PROSPERO—the International Prospective Register of Systematic Reviews—also offers systematic review reporting, conduct, scientific writing, and publication through a formal protocol registration process. At the time of registration of systematic review protocols, propose include eight new device- and operator-specific elements unique to implanted medical device research. This project would encourage academics to report systematic reviews of implantable medical devices more accurately and transparently.  Also, propose adding eight new device- and operator-specific topics to the extension guide unique to implantable medical device studies (6).

Cardiac defibrillators with or without pacemakers:

  • Device type
  • Method of implantation
  • Position of the electrode
  • Description of microprocessor technology and programmable features
  • Alert features that monitor lead impedance

Vascular interventional devices (e.g., stents)

  • Type of stent and stenting technique
  • Generation of the stent (e.g., first or second generation)
  • Type of antiproliferative drug used
  • Delivery system
  • Polymer layer
  • Stent frame

Orthopaedic implants

  • Type of device
  • Surgical technique or approach
  • Number and location of devices
  • Fixation and supplementary materials such as plates and screws
  • Type of device coating

Skin-replacement grafts

  • Type of skin graft required
  • Composition of graft
  • Graft type: bioabsorbable or requiring removal

Neurostimulators

  • Stimulation parameters
    • frequency
    • intensity
    • pulse width
  • Electrode location

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 systematic reviews on implantable medical devices.

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