EBP and Otolaryngology: Where Are We Now? Where Are We Going?
The integration of evidence-based medicine into everyday clinical practice, now termed evidence-based practice (EBP), aims to synthesize patient information, current evidence, and clinical experience to decrease variations in patient care and improve patient outcomes.1,2 As the complexity of medical decision-making increases, access to data and current evidence is imperative to determine the best course of action for each patient. The Outcomes Research and Evidence Based Medicine (OREBM) Committee of the American Academy of Otolaryngology—Head and Neck Surgery exists to assist the otolaryngologist in this quest for high-quality evidence and data to guide one’s practice. Its formal stated charge is: “To serve as a repository of expertise on health services research and evidence-based medicine, including outcomes and effectiveness research generally and specifically in otolaryngology—head and neck surgery; to advise and support other Academy and Foundation committees on outcomes and clinical effectiveness; to liaison with the Quality Improvement Committee on research aspects of the development of clinical practice guidelines; to develop and maintain educational material, instruction courses, and Annual Meeting mini-seminars in these areas, including an Outcomes Primer; and to develop and maintain a prioritized list of project areas suitable for research on outcomes and clinical effectiveness.” With this charge in mind, the OREBM aims to: 1) highlight relevant, current research data that can assist the otolaryngologist with patient decision-making and 2) guide research efforts into clinical areas that will most benefit our specialty based on identified gaps in evidence and emerging clinical importance. Where Are We Now? Table 1 provides a brief glimpse into our progress as a specialty in the publication of EBP supportive articles over the past several years. This is not meant to be an exhaustive search but rather presents a few indicators of our progress. The rapidly increasing numbers of EBP supportive publications in otolaryngology demonstrate clearly that our specialty has embraced the need to publish data that support the pursuit of evidence-based practice. Table 1: Evidence-Based Medicine Publications for Otolaryngology by Decade Decade Number of Randomized Clinical Trials Published Number of Meta-Analyses Published Number of Clinical Practice Guidelines Published 1980-1989 55 2 0 1990-1999 356 26 8 2000-2009 678 108 31 Note: Numbers obtained by searching PUBMED with limits by study type, by decade, with keyword search term of “otolaryngology.” Randomized clinical trials (RCTs) represent the highest level of clinical evidence available, with less potential for systematic bias. Not all clinical questions can be addressed with an RCT, but a well-designed and executed RCT can directly compare treatment options and produce results to potentially change and improve patient management. The OREBM Committee will present a mini-seminar at this year’s annual meeting discussing the key, landmark RCTs in otolaryngology in the last several years. If attending the meeting in San Francisco this fall, plan on joining us for this informative, high-yield session, as well as other mini-seminar sessions on the history of outcomes research in otolaryngology, EBP in rhinology, and EBP in sleep surgery supported by the committee. A meta-analysis (MA) is a qualitative and quantitative assessment of currently available data on a clinical topic. It is especially useful in the development of an EBP as it can provide a summation of the key data that are currently available and allows a practitioner to access those data efficiently to guide decision-making, rather than locating, reading, and analyzing multiple individual studies on their own. Table 2: Recently PublishedClinical Practice Guidelines Clinical Practice Guideline Topic Year Published Acute Otitis Externa (AOE) 2006 Adult Sinusitis 2007 Impacted Cerumen 2008 Benign Paroxysmal Positional Vertigo 2008 Hoarseness (Dysphonia) 2009 Nasal Valve Compromise 2010 Tonsillectomy in Children 2011 Polysomnography forSleep-Disordered Breathing Prior to Tonsillectomy in Children 2011 Clinical practice guidelines (CPGs) represent the most user-friendly tool to develop an EBP, as they are the summation of the review of currently available data on a topic by a group of experts presented as a series of clinical management recommendations. Each clinical practice guideline represents the end-product of a large amount work and discussion. Our specialty as a whole is extremely fortunate that the leadership of the American Academy of Otolaryngology has so thoroughly embraced the challenge of producing clinical practice guidelines for the benefit of all otolaryngologists. A list of recently completed guidelines is shown in Table 2. Where Do We Go From Here? Our specialty has made steady, committed progress in the pursuit and development of the tools to guide an EBP. However, when on a long journey, it is always wise to pause at times and consider the direction you are headed and the destinations ahead. In the pursuit of an EBP, where do we head from here? The OREBM Committee as a group has spent considerable time pondering this question for otolaryngology as a specialty. We have made it our task to reflect on our own practices and consider which areas are in most need of future data (i.e., “evidence gaps”) to help improve evidence-based clinical decision-making. We developed a selected list of prioritized, current areas for future study that are listed in Table 3. Note that only some areas of otolaryngology are listed. We are well represented currently with pediatric otolaryngologists, rhinologists, laryngologists, and sleep surgeons on the committee. We are in need of more neuro-otologists, head and neck surgeons, and facial plastic surgeons to join us. If this is your area of expertise, please consider participation in the OREBM Committee. In addition to pondering evidence gaps, the OREBM Committee has been considering and attempting to identify clinical areas that may benefit from compiling and critically analyzing the currently available data in the form of a systematic review or meta-analysis. These efforts may lead to future studies and/or help sharply develop clinical areas where true evidence gaps lie. The completion of a high-quality Table 3: Possible Prioritized Evidence Gaps Subspecialty Evidence Gap PediatricOtolaryngology 1. Diagnosis and management of residual obstructive sleep apnea after adenotonsillectomy to include use of sleep endoscopy and cine MRI 2. Management of otitis media with effusion diagnosed in neonates within neonatal hearing screening programs 3. Use of imaging in evaluation of hearing loss in children – MRI versus CT 4. Benefits of proton pump inhibitor therapy in neonates with laryngomalacia/stridor 5. Use of balloon dilation in the management of pediatric subglottic stenosis Rhinology 1. Standardization of maximal medical therapy for chronic rhinosinusitis 2. Accuracy of diagnosis of chronic rhinosinusitis in the primary care setting, e.g., family practice, internal medicine 3. Development of a chronic rhinosinusitis treatment data registry 4. Role of bioflims in chronic rhinosinusitis Laryngology 1. Long-term compliance and benefits of voice therapy 2. Effectiveness of antibiotic therapy in the setting of acute laryngitis 3. Determination of which hoarse patients benefit the most from proton pump inhibitor therapy 4. Efficacy of neurontin, elavil, and/or lyrica in treating chronic cough 5. Utility of voice rest of after vocal surgery Sleep Surgery 1. Outcomes for nasal (and pharyngeal) surgery in improving long-term CPAP compliance 2. Benefit of turbinoplasty in addition to adenotonsillectomy for management of pediatric obstructive sleep apnea 3. Use of home sleep testing in a sleep surgical practice 4. Outcomes for medical and surgical treatments for treatment of socially bothersome primary snoring 5. Development of a sleep surgery data registry meta-analysis is not a simple task. Some committee members were selected after an academy-wide competitive search for sponsorship to attend the International Cochrane Colloquium Meeting in October 2011. This meeting will include training in advanced meta-analysis techniques. The expectation of receiving this support is a resulting submission of a completed meta-analysis for publication in the Otolaryngology—Head and Neck Surgery journal. Thus, academy members can expect to see more and more high-quality meta-analyses in our journal in the future. Our specialty is fortunate that our Academy not only recognizes the importance of EBP but is willing to support it. The OREBM Committee has several ongoing and recently completed studies targeting what is believed to be important evidence gaps. Table 4 on page 33 lists and provides a brief update on the status of these projects. As the committee strives to identify key evidence gaps, it is the goal that future projects of the committee and research sponsored by the Academy CORE grants will translate to a continually improving evidence basis on which to guide clinical decision-making. In conclusion, we hope you agree it is a worthy goal to develop a strong evidence basis to your practice for the benefit of current and future patients. It is the goal of the OREBM committee to continually support this pursuit for the otolaryngologist with educational endeavors, research activities, and emphasis of targeted areas within our specialty that are most in need of investigation to build an otolaryngology EBP. Table 4: Status Reports on the Ongoing Studies of the OREBM Committee Study PrincipalInvestigator Open to Enrollment Status Parent Response to Ear Disease in Children with and without Tubes (PREDICT) Quality of Life Research Study Judith E. C. Lieu, MDWashington University SOM St Louis, MO Yes The study is 64% to our goal of 1000 complete (physician and patient) records. 1,896 sets of forms have been sent out to our 23 participating sites. Of those, 1,138 physician forms (60%) and 696 patient forms (37%) have been returned to the AAO-HNSF for data entry. TALC (Treatment of Advanced Laryngeal Cancer) Study Bevan Yueh, MD, MPHUniversity of Minnesota Minneapolis, MN Yes As of February 2011, the study had enrolled 48 patients.Mean age = 60.5 Gender = 39 Male and 9 Female Treatment Group = 30 Laryngectomy and 18 Chemoradiation Studying Life Effects and Effectiveness of Palatopharyngoplasty (SLEEP) Edward M. Weaver, MD, MPHUniversity of Washington Seattle, WA No Results PublishedStudying Life Effects & Effectiveness of Palatopharyngoplasty (SLEEP) Study: Subjective Outcomes of Isolated Uvulopalatopharyngoplasty. Weaver EM, Woodson BT, Yueh B, Smith T, Stewart MG, Hannley M, Schulz K, Patel MM, Witsell D; the SLEEP Study Investigators. Otolaryngol Head Neck Surg. 2011 Apr; 144(4):623-631. Epub 2011 Feb 10.
The integration of evidence-based medicine into everyday clinical practice, now termed evidence-based practice (EBP), aims to synthesize patient information, current evidence, and clinical experience to decrease variations in patient care and improve patient outcomes.1,2 As the complexity of medical decision-making increases, access to data and current evidence is imperative to determine the best course of action for each patient.
The Outcomes Research and Evidence Based Medicine (OREBM) Committee of the American Academy of Otolaryngology—Head and Neck Surgery exists to assist the otolaryngologist in this quest for high-quality evidence and data to guide one’s practice. Its formal stated charge is:
“To serve as a repository of expertise on health services research and evidence-based medicine, including outcomes and effectiveness research generally and specifically in otolaryngology—head and neck surgery; to advise and support other Academy and Foundation committees on outcomes and clinical effectiveness; to liaison with the Quality Improvement Committee on research aspects of the development of clinical practice guidelines; to develop and maintain educational material, instruction courses, and Annual Meeting mini-seminars in these areas, including an Outcomes Primer; and to develop and maintain a prioritized list of project areas suitable for research on outcomes and clinical effectiveness.”
With this charge in mind, the OREBM aims to: 1) highlight relevant, current research data that can assist the otolaryngologist with patient decision-making and 2) guide research efforts into clinical areas that will most benefit our specialty based on identified gaps in evidence and emerging clinical importance.
Where Are We Now?
Table 1 provides a brief glimpse into our progress as a specialty in the publication of EBP supportive articles over the past several years. This is not meant to be an exhaustive search but rather presents a few indicators of our progress. The rapidly increasing numbers of EBP supportive publications in otolaryngology demonstrate clearly that our specialty has embraced the need to publish data that support the pursuit of evidence-based practice.
Table 1: Evidence-Based Medicine Publications for Otolaryngology by Decade | |||
Decade | Number of Randomized Clinical Trials Published | Number of Meta-Analyses Published | Number of Clinical Practice Guidelines Published |
1980-1989 | 55 | 2 | 0 |
1990-1999 | 356 | 26 | 8 |
2000-2009 | 678 | 108 | 31 |
Note: Numbers obtained by searching PUBMED with limits by study type, by decade, with keyword search term of “otolaryngology.” |
Randomized clinical trials (RCTs) represent the highest level of clinical evidence available, with less potential for systematic bias. Not all clinical questions can be addressed with an RCT, but a well-designed and executed RCT can directly compare treatment options and produce results to potentially change and improve patient management. The OREBM Committee will present a mini-seminar at this year’s annual meeting discussing the key, landmark RCTs in otolaryngology in the last several years. If attending the meeting in San Francisco this fall, plan on joining us for this informative, high-yield session, as well as other mini-seminar sessions on the history of outcomes research in otolaryngology, EBP in rhinology, and EBP in sleep surgery supported by the committee.
A meta-analysis (MA) is a qualitative and quantitative assessment of currently available data on a clinical topic. It is especially useful in the development of an EBP as it can provide a summation of the key data that are currently available and allows a practitioner to access those data efficiently to guide decision-making, rather than locating, reading, and analyzing multiple individual studies on their own.
Table 2: Recently PublishedClinical Practice Guidelines | |
Clinical Practice Guideline Topic | Year Published |
Acute Otitis Externa (AOE) | 2006 |
Adult Sinusitis | 2007 |
Impacted Cerumen | 2008 |
Benign Paroxysmal Positional Vertigo | 2008 |
Hoarseness (Dysphonia) | 2009 |
Nasal Valve Compromise | 2010 |
Tonsillectomy in Children | 2011 |
Polysomnography forSleep-Disordered Breathing
Prior to Tonsillectomy in Children |
2011 |
Clinical practice guidelines (CPGs) represent the most user-friendly tool to develop an EBP, as they are the summation of the review of currently available data on a topic by a group of experts presented as a series of clinical management recommendations. Each clinical practice guideline represents the end-product of a large amount work and discussion. Our specialty as a whole is extremely fortunate that the leadership of the American Academy of Otolaryngology has so thoroughly embraced the challenge of producing clinical practice guidelines for the benefit of all otolaryngologists. A list of recently completed guidelines is shown in Table 2.
Where Do We Go From Here?
Our specialty has made steady, committed progress in the pursuit and development of the tools to guide an EBP. However, when on a long journey, it is always wise to pause at times and consider the direction you are headed and the destinations ahead. In the pursuit of an EBP, where do we head from here? The OREBM Committee as a group has spent considerable time pondering this question for otolaryngology as a specialty. We have made it our task to reflect on our own practices and consider which areas are in most need of future data (i.e., “evidence gaps”) to help improve evidence-based clinical decision-making. We developed a selected list of prioritized, current areas for future study that are listed in Table 3. Note that only some areas of otolaryngology are listed. We are well represented currently with pediatric otolaryngologists, rhinologists, laryngologists, and sleep surgeons on the committee. We are in need of more neuro-otologists, head and neck surgeons, and facial plastic surgeons to join us. If this is your area of expertise, please consider participation in the OREBM Committee.
In addition to pondering evidence gaps, the OREBM Committee has been considering and attempting to identify clinical areas that may benefit from compiling and critically analyzing the currently available data in the form of a systematic review or meta-analysis. These efforts may lead to future studies and/or help sharply develop clinical areas where true evidence gaps lie. The completion of a high-quality
Table 3: Possible Prioritized Evidence Gaps | |||||||||||
Subspecialty | Evidence Gap | ||||||||||
PediatricOtolaryngology |
|
||||||||||
Rhinology |
|
||||||||||
Laryngology |
|
||||||||||
Sleep Surgery |
|
meta-analysis is not a simple task. Some committee members were selected after an academy-wide competitive search for sponsorship to attend the International Cochrane Colloquium Meeting in October 2011. This meeting will include training in advanced meta-analysis techniques. The expectation of receiving this support is a resulting submission of a completed meta-analysis for publication in the Otolaryngology—Head and Neck Surgery journal. Thus, academy members can expect to see more and more high-quality meta-analyses in our journal in the future.
Our specialty is fortunate that our Academy not only recognizes the importance of EBP but is willing to support it. The OREBM Committee has several ongoing and recently completed studies targeting what is believed to be important evidence gaps. Table 4 on page 33 lists and provides a brief update on the status of these projects. As the committee strives to identify key evidence gaps, it is the goal that future projects of the committee and research sponsored by the Academy CORE grants will translate to a continually improving evidence basis on which to guide clinical decision-making.
In conclusion, we hope you agree it is a worthy goal to develop a strong evidence basis to your practice for the benefit of current and future patients. It is the goal of the OREBM committee to continually support this pursuit for the otolaryngologist with educational endeavors, research activities, and emphasis of targeted areas within our specialty that are most in need of investigation to build an otolaryngology EBP.
Table 4: Status Reports on the Ongoing Studies of the OREBM Committee | |||
Study | PrincipalInvestigator | Open to Enrollment | Status |
Parent Response to Ear Disease in Children with and without Tubes (PREDICT) Quality of Life Research Study | Judith E. C. Lieu, MDWashington University SOM
St Louis, MO |
Yes | The study is 64% to our goal of 1000 complete (physician and patient) records. 1,896 sets of forms have been sent out to our 23 participating sites. Of those, 1,138 physician forms (60%) and 696 patient forms (37%) have been returned to the AAO-HNSF for data entry. |
TALC (Treatment of Advanced Laryngeal Cancer) Study | Bevan Yueh, MD, MPHUniversity of Minnesota
Minneapolis, MN |
Yes | As of February 2011, the study had enrolled 48 patients.Mean age = 60.5
Gender = 39 Male and 9 Female Treatment Group = 30 Laryngectomy and 18 Chemoradiation |
Studying Life Effects and Effectiveness of Palatopharyngoplasty (SLEEP) | Edward M. Weaver, MD, MPHUniversity of Washington
Seattle, WA |
No | Results PublishedStudying Life Effects & Effectiveness of Palatopharyngoplasty (SLEEP) Study: Subjective Outcomes of Isolated Uvulopalatopharyngoplasty. Weaver EM, Woodson BT, Yueh B, Smith T, Stewart MG, Hannley M, Schulz K, Patel MM, Witsell D; the SLEEP Study Investigators. Otolaryngol Head Neck Surg. 2011 Apr; 144(4):623-631. Epub 2011 Feb 10. |