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Systemic Reviews on Implantable Medical

Devices Provide a Quality of Reporting

Dr. Nancy Agnes, Head, Technical Operations, Pubrica, sales@pubrica.com

In brief

Even though there have been many systematic

reviews of implantable medical 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 characteristics may have an impact

on the study outcomes (1)

.

I. 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 (2)

.

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. The

market for implantable medical devices in the United

States is expected to expand 8.3% year to $49 billion,

with spinal implants, cardiac implants, and

orthobiologics being the fastest-growing categories

(substances that accelerate healing of injured bones).

Here assumed a critical appraisal of the quality of

reporting in systematic reviews of implanted medical

devices as the Evidence-based Practice Center (EPC)

designated for the crosscutting concentration of

diagnostic testing, imaging technologies, and medical

and assistive devices. The project's objectives were to

assess published systematic reviews and meta-

analyses to understand better the methodologies used

and identify current strengths, limitations,

deficiencies, and unique challenges and make

recommendations for future conduct and reporting.

They chose to focus on five broad categories of

implantable medical devices based on the

recommendations of the Technical Expert Panel

(TEP) and to ensure inclusion of the most commonly

used and expensive devices: cardiac implantable

devices, vascular interventional devices, orthopaedic

implants, skin-replacement grafts, and

neurostimulators(3)

.

II. 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.

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 structures to treat or

alleviate an illness, injury, or handicap, either

alone or in combination with another medical

device(4)

.

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III. 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.

IV. ELIGIBILITY CRITERIA AND CITATION

SCREENING

Many published systematic reviews of implantable

medical devices did not explicitly report all three

fundamental components during full-text screening.

Because the goal was to assess reporting

characteristics, it included reviews of any implantable

device from any of the five categories that looked at a

recent publication. For example, a review of a

pacemaker, a review of a defibrillator, or a review of

both a pacemaker and a defibrillator might be

included in the cardiac implantable device category.

Systematic reviews of any type (randomized trials,

non-randomized comparative studies, or

observational research), as well as synthesis

technique, were considered (qualitative or

quantitative synthesis including meta-analyses of

individual patient data) (5)

.

Table: 1 Reporting items for systematic reviews of

implantable medical devices

V. 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.

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VI. RECOMMENDATIONS OF REPORTING

ITEMS FOR SYSTEMIC REVIEWS OF

IMPLANTABLE MEDICAL DEVICES

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

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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

o frequency

o intensity

o pulse width

Electrode location

VII. 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. Eight device- or operator-specific items were

also identified as potentially useful in reporting on

systematic reviews of implanted devices and might be

included in reporting recommendations.In recent

years, the number of systematic evaluations of

implantable medical devices has increased

dramatically, with reviews appearing in a wide range

of journals. Failure to include data on procedures and

devices could lead to incorrect synthesis or

interpretation of results because there is no widely

acknowledged standard for reporting information to

implantable medical device research(7)

.

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