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Guideline Summary
Guideline Title
Best evidence statement (BESt). Quality of life in children with sequential bilateral cochlear implants.
Bibliographic Source(s)
Cincinnati Children's Hospital Medical Center. Best evidence statement (BESt). Quality of life in children with sequential bilateral cochlear implants. Cincinnati (OH): Cincinnati Children's Hospital Medical Center; 2011 Jun 9. 6 p. [28 references]
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)

Permanent bilateral hearing loss with no benefit from conventional amplification (i.e., hearing aids)

Guideline Category
Treatment
Clinical Specialty
Family Practice
Internal Medicine
Otolaryngology
Pediatrics
Intended Users
Advanced Practice Nurses
Nurses
Physician Assistants
Physicians
Guideline Objective(s)

To evaluate, among children with permanent hearing loss, if sequential bilateral cochlear implantation versus unilateral cochlear implantation improves quality of life

Target Population

Children, age 0-21, with permanent bilateral hearing loss who do not benefit from conventional amplification (i.e., hearing aids)

Note: Children with simultaneous bilateral cochlear implants are not included.

Interventions and Practices Considered
  1. Sequential bilateral cochlear implants
  2. Unilateral cochlear implant
Major Outcomes Considered

Quality of life (QoL)

Methodology

Methods Used to Collect/Select the Evidence
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

Search Strategy

Databases: PubMed, Medline/OVID, Google Scholar, CINAHL and hand searching. National Association of Children's Hospitals and Related Institutions (NACHRI) electronic mailing list and benchmarking with other established cochlear implant (CI) programs: inquiry included patient population size, cochlear implant team members, and subjective and objective evaluations pre and post implantation, as well as their recommended follow-up time intervals

Keywords: Bilateral cochlear implants (BICI), sequential CI, subjective benefit of bilateral CI, qualitative benefit of bilateral CI, perceptual benefit of cochlear implantation, psychosocial development (of pediatric CI users), benefits of BICI, BICI candidacy, quality of life with BICIs/CIs

Limits: English language, pediatrics (age 0-21), sequential bilateral cochlear implantation; all dates included

Retrieved: July 29, 2010–December 31, 2010

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Table of Evidence Levels

Quality Level Definition
1a† or 1b† Systematic review, meta-analysis, or meta-synthesis of multiple studies
2a or 2b Best study design for domain
3a or 3b Fair study design for domain
4a or 4b Weak study design for domain
5 or 5a or 5b Other: General review, expert opinion, case report, consensus report, or guideline

†a = good quality study; b = lesser quality study

Methods Used to Analyze the Evidence
Systematic Review
Description of the Methods Used to Analyze the Evidence

Not stated

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

Not stated

Rating Scheme for the Strength of the Recommendations

Table of Recommendation Strength

Strength Definition
"Strongly recommended" There is consensus that benefits clearly outweigh risks and burdens (or vice-versa for negative recommendations).
"Recommended" There is consensus that benefits are closely balanced with risks and burdens.
No recommendation made There is lack of consensus to direct development of a recommendation.
Dimensions: In determining the strength of a recommendation, the development group makes a considered judgment in a consensus process that incorporates critically appraised evidence, clinical experience, and other dimensions as listed below.
  1. Grade of the body of evidence (see note above)
  2. Safety/harm
  3. Health benefit to patient (direct benefit)
  4. Burden to patient of adherence to recommendation (cost, hassle, discomfort, pain, motivation, ability to adhere, time)
  5. Cost-effectiveness to healthcare system (balance of cost/savings of resources, staff time, and supplies based on published studies or onsite analysis)
  6. Directness (the extent to which the body of evidence directly answers the clinical question [population/problem, intervention, comparison, outcome])
  7. Impact on morbidity/mortality or quality of life
Cost Analysis

Published cost analyses were reviewed.

Method of Guideline Validation
Peer Review
Description of Method of Guideline Validation

Reviewed against quality criteria by two independent reviewers.

Recommendations

Major Recommendations

There is insufficient evidence and a lack of consensus to make a recommendation on the use of sequential bilateral cochlear implants rather than a unilateral cochlear implant to improve the quality of life in children with hearing loss.

Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see the "Major Recommendations" field).

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

The objective benefits of bilateral cochlear implantation (BICI) correspond with the primary benefits of bilateral hearing, which include improved speech perception in noise and localization abilities.

Potential Harms

Arguments against bilateral cochlear implantation note the need to preserve the contralateral ear for future technology and rehabilitative methods and potential damage to residual hearing, as the internal placement of cochlear implants (CIs) destroy the hair cells in the cochlea. In addition, the use of additional anesthesia and potential harm to the vestibular system were once thought to be areas of concern and have been studied in depth. Subsequently, several authors have concluded that cochlear implantation in children continues to be reliable and safe in experienced hands, with a low percentage of severe complications. It is also important to note, the financial costs accrued by the hospital (i.e., surgical costs, anesthesia costs, physicians costs) and the family (i.e., cost of device and accessories, follow up programming appointments, follow up therapy sessions) for lifelong support of bilateral cochlear implants need continued consideration and warrants further investigation.

Qualifying Statements

Qualifying Statements

This Best Evidence Statement addresses only key points of care for the target population; it is not intended to be a comprehensive practice guideline. These recommendations result from review of literature and practices current at the time of their formulation. This Best Evidence Statement does not preclude using care modalities proven efficacious in studies published subsequent to the current revision of this document. This document is not intended to impose standards of care preventing selective variances from the recommendations to meet the specific and unique requirements of individual patients. Adherence to this Statement is voluntary. The clinician in light of the individual circumstances presented by the patient must make the ultimate judgment regarding the priority of any specific procedure.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Patient Resources
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
IOM Domain
Effectiveness
Patient-centeredness

Identifying Information and Availability

Bibliographic Source(s)
Cincinnati Children's Hospital Medical Center. Best evidence statement (BESt). Quality of life in children with sequential bilateral cochlear implants. Cincinnati (OH): Cincinnati Children's Hospital Medical Center; 2011 Jun 9. 6 p. [28 references]
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2011 Jun 9
Guideline Developer(s)
Cincinnati Children's Hospital Medical Center - Hospital/Medical Center
Source(s) of Funding

Cincinnati Children's Hospital Medical Center

Guideline Committee

Not stated

Composition of Group That Authored the Guideline

Group/Team Leader: Christine Eby Fishman, AuD, FAAA, Operations Coordinator, Cochlear Implant Team, Cincinnati Children's Hospital Medical Center, Division of Audiology

Other Group/Team Members: Barbara K. Giambra, MS, RN, CPNP, Evidence-based Practice Mentor, Center for Professional Excellence, Research and Evidence-based Practice

Financial Disclosures/Conflicts of Interest

No financial conflicts of interest were found.

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available from the Cincinnati Children's Hospital Medical Center External Web Site Policy.

Print copies: For information regarding the full-text guideline, print copies, or evidence-based practice support services contact the Cincinnati Children's Hospital Medical Center Health James M. Anderson Center for Health Systems Excellence at EBDMInfo@cchmc.org.

Availability of Companion Documents

The following are available:

Print copies: For information regarding the full-text guideline, print copies, or evidence-based practice support services contact the Cincinnati Children's Hospital Medical Center Health James M. Anderson Center for Health Systems Excellence at EBDMInfo@cchmc.org.

Patient Resources

The following is available:

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC Status

This NGC summary was completed by ECRI Institute on November 18, 2011.

Copyright Statement

This NGC summary is based on the original full-text guideline, which is subject to the following copyright restrictions:

Copies of this Cincinnati Children's Hospital Medical Center (CCHMC) External Web Site Policy Best Evidence Statement (BESt) are available online and may be distributed by any organization for the global purpose of improving child health outcomes. Examples of approved uses of the BESt include the following:

  • Copies may be provided to anyone involved in the organization's process for developing and implementing evidence based care
  • Hyperlinks to the CCHMC website may be placed on the organization's website
  • The BESt may be adopted or adapted for use within the organization, provided that CCHMC receives appropriate attribution on all written or electronic documents; and
  • Copies may be provided to patients and the clinicians who manage their care

Notification of CCHMC at EBDMInfo@cchmc.org for any BESt adopted, adapted, implemented or hyperlinked by the organization is appreciated.

Disclaimer

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