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Adolescent Medicine/Menorrhagia/Evaluation/BESt 088 Best Evidence Statement (BESt) Date: February 18, 2011 Menorrhagia Clinical Questions Heavy Menstrual Bleeding P (population/problem) Among young menstruating females presenting with complaints of heavy or prolonged menstrual bleeding I (intervention) what subjective and objective initial evaluation provides sufficient information for O (outcome) designation of menorrhagia and differentiation of those with and without bleeding disorders such as von Willebrand disease? Menorrhagia P (population/problem) Among young menstruating females diagnosed with menorrhagia I (intervention) what tool/instrument/questionnaire/inventory O (outcome) provides useful menorrhagia-related quality of life outcome information practical for use in outpatient clinic setting for measuring baseline and treatment response over time? Target Population Menstruating females less than 25 years of age Recommendations Heavy Menstrual Bleeding 1. It is recommended, for young females being seen for heavy menstrual bleeding, that a history including specific items (see attachment 1) and the pictorial blood assessment chart (PBAC) (see attachment 2) score be used at the initial visit to identify those who may have a bleeding disorder (Philipp 2008 [3a], Local Consensus [5], NICE 2007 [5a], Demers 2005 [5a], RNZCOG 1999 [5a]). 2. It is recommended, for young females being seen for heavy menstrual bleeding, that a complete blood count (CBC) with platelets be obtained to assess for potential anemia (Hurskainen 2007 [5a], NICE 2007 [5a], Kaiser Permanente 2006 [5a], Demers 2005 [5a], RNZCOG 1999 [5a]). Note: In young females a pelvic examination is not likely to be useful due to the rare presence of pathology in this age group (RNZCOG 1999 [5a]). 3. It is recommended for young females being seen for heavy menstrual bleeding who screen positive for possible bleeding disorder in recommendation #1, that a coagulation screen be conducted (NICE 2007 [5a], Kaiser Permanente 2006 [5a], Demers 2005 [5a], RNZCOG 1999 [5a]). Menorrhagia 4. It is recommended, for otherwise healthy young females being seen for menorrhagia, that the following laboratory and imaging tests not be routinely conducted: ferritin female hormone testing thyroid testing endometrial biopsy MRI Magnetic resonance Imaging dilation and curettage hysteroscopy (NICE 2007 [5a], RNZCOG 1999 [5a]). Copyright © 2011 Cincinnati Children's Hospital Medical Center; all rights reserved. Page 1 of 10 Adolescent Medicine / Hemorrhagic / Evaluation / BESt 088 5. It is recommended, for young females being seen for menorrhagia, that a menorrhagia-specific quality of life questionnaire be administered at baseline to guide initial management, and periodically to measure response to treatment (see attachment 3) (Lukes 2010 [2a], Winkler 2001 [3a]). Note: General quality of life questionnaires are not helpful in managing women with menorrhagia (Clark 2002 [1a], Jones 2002 [1a], Habiba 2010 [2a], Jenkinson 1996 [2a]). Discussion/summary of evidence The recommendations are based upon synthesized evidence from 5 clinical practice guidelines (Hurskainen 2007 [5a], NICE 2007 [5a], Kaiser Permanente 2006 [5a], Demers 2005 [5a], RNZCOG 1999 [5a]) and 3 individual studies (Lukes 2010 [2a], Philipp 2008 [3a], Winkler 2001 [3a]). The guidelines, developed by clinical experts and based upon evidence identified in a comprehensive and systematic literature search, identify assessment parameters used to diagnose menorrhagia. None of the guidelines had clear evidence-based recommendations for evaluation of menorrhagia in young females. These guidelines were appraised using the AGREE (Appraisal of Guidelines for Research and Evaluation) instrument and the results by domain were: AGREE Domains (Hurskainen 2007 [5a]) (NICE 2007 [5a]) (Kaiser Permanente 2006 [5a]) (Demers 2005 [5a]) (RNZCOG 1999 [5a]) Scope and Purpose Stakeholder Involvement Rigor of Development Clarity and Presentation Applicability Editorial Independence 63% 22% 75% 53% 7% 39% 96% 78% 92% 89% 63% 83% 74% 31% 79% 94% 33% 0% 67% 28% 56% 78% 0% 17% 78% 61% 59% 75% 33% 6% Philipp et al. describe a questionnaire to screen women with heavy menstrual bleeding to rule out those with a bleeding disorder from those with menorrhagia (Philipp 2008 [3a]). This is in agreement with recommendations in three of the guidelines regarding completion of an initial assessment including the pictorial blood assessment chart (NICE 2007 [5a], Demers 2005 [5a], RNZCOG 1999 [5a]). Two menorrhagia treatment studies (Winkler 2001 [3a]), including an RCT (Lukes 2010 [2a]), discuss the use of a questionnaire to evaluate quality of life at baseline and during treatment. Health Benefits, Side Effects and Risks Women with undiagnosed bleeding disorders who present with heavy menstrual bleeding benefit from screening as a result of being identified for further testing and evaluation (Philipp 2008 [3a]). Adherence to these recommendations will decrease unnecessary pelvic examinations and unnecessary diagnostic studies in menstruating young females with menorrhagia (RNZCOG 1999 [5a]), and will direct appropriate treatment to prevent anemia, transfusions, and hospital admissions in those with bleeding disorders (NICE 2007 [5a], RNZCOG 1999 [5a]). Adherence to the recommendations carries minimal risks or burden to patients which includes venipunctures, giving family medical and gynecological history, and completing quality of life questionnaires. References (evidence grade in [ ]; see Table of Evidence Levels following references) Note: When using the electronic version of this document, indicates a hyperlink to the PubMed abstract. A hyperlink following this symbol goes to the article PDF when the user is within the CCHMC network. 1. Clark, T. J.; Khan, K. S.; Foon, R.; Pattison, H.; Bryan, S.; and Gupta, J. K.: Quality of life instruments in studies of menorrhagia: a systematic review. European Journal of Obstetrics, Gynecology, & Reproductive Biology, 104(2): 96-104, 2002, [1a] . http://ovidsp.ovid.com/ovid web.cgi? T=JS &NEWS =N&PAGE =fu lltext&D=med4 &AN=12 206918 http://group s/p2 /EBC_ Files/Ar ticles_ Cited_ in_Epic_ Menorrhagia/Menorrhagia.Clark. 2002.pdf 2. Demers, C.; Derzko, C.; David, M.; Douglas, J.; and Society of Obstetricians and Gynecologists of Canada: Gynaecological and obstetric management of women with inherited bleeding disorders.[Reprint in Int J Gynaecol Obstet. 2006 Oct;95(1):75-87; PMID: 17106950]. Journal of Obstetrics & Gynaecology Canada: JOGC, 27(7): 707-32, 2005, [5a] . http://ovidsp.ovid.com/ovid web.cgi? T=JS &NEWS =N&PAGE =fulltext&D=med4 &AN=161 00628 Copyright © 2011 Cincinnati Children's Hospital Medical Center; all rights reserved. http ://gro ups/p 2/E BC_ Files/Articles_ Cited_in_Ep ic_Menorrhagia/Menorrhagia.Demers2005Full.p df Page 2 of 10 Adolescent Medicine / Hemorrhagic / Evaluation / BESt 088 3. Habiba, M.; Julian, S.; Taub, N.; Clark, M.; Rashid, A.; Baker, R.; and Szczepura, A.: Limited role of multi-attribute utility scale and SF-36 in predicting management outcome of heavy menstrual bleeding. European Journal of Obstetrics, Gynecology, & Reproductive Biology, 148(1): 81-5, 2010, [2a] . http://ovidsp.ovid.com/ovid web.cgi? T=JS &NEW S=N&PAGE =fulltext&D=med l&A N=1 981960 6 4. http://groups /p2/E BC_Files/Articles_Cited_in _Epic_Menorrhagia/Menorrhagia.Habiba.2010. pdf Higham, J. M.; O'Brien, P. M.; and Shaw, R. W.: Assessment of menstrual blood loss using a pictorial chart. BJOG: An International Journal of Obstetrics & Gynaecology, 97(8): 734-739, 1990, [3b] . http://www. ncbi.nlm.nih.gov/pu bmed?term =97%5Bvolume%5D +A ND+1 990%5Bpd at%5D +AND +higham%5Bau thor%5D &cmd=detailssearch http://group s/p2/EBC_ Files/Ar ticles_ Cited_in_Epic_ Menorrhagia/Menorrhagia.Higham.1990. pdf 5. Hurskainen, R. et al.: Diagnosis and treatment of menorrhagia. Acta Obstet Gynecol Scand, 86(6): 749-57, 2007, [5a] 6. Jenkinson, C.; Peto, V.; and Coulter, A.: Making sense of ambiguity: evaluation in internal reliability and face validity of the SF 36 questionnaire in women presenting with menorrhagia. Quality in Health Care, 5(1): 9-12, 1996, [2a] . http://ovidsp.ovid.com/ovid web.cgi? T=JS &NEW S=N&PAGE =fulltext&D=med4 &A N=10 157276 7. http://group s/p2/EBC_Files/Articles_Cited_in_Epic_ Menorrhagia/Menorrhagia. Hurskainen.2007.p df . http://groups/p2/E BC_ Files/Articles _Cited_in_E pic_Menorrhagia/Menorrhagia.Jen kinso n.1996. pdf Jones, G. L.; Kennedy, S. H.; and Jenkinson, C.: Health-related quality of life measurement in women with common benign gynecologic conditions: a systematic review. American Journal of Obstetrics & Gynecology, 187(2): 501-11, 2002, [1a] . http://ovidsp.ovid.com /ovidweb.cg i?T=JS&NEWS =N&PAGE =fu lltext&D =med4 &AN=1219 3950 http://group s/p2 /EBC_ Files/Ar ticles_ Cited_ in_Epic_ Menorrhagia/Menorrhagia.Jones. 2002.pdf 8. Kaiser Permanente: Chronic abnormal uterine bleeding in non-gravid women. 2006, [5a] 9. Local Consensus: During BESt development timeframe. [5] . http://www.g uidelines.gov/conten t.aspx?id=10 889&search=chr onic+abnorma l+uterine+bleedin g http://groups/p2/E BC_Files/Articles _Cited_in_ Epic_Menorrhagia/Menorrhagia.Kaiser.2006.pdf . 10. Lukes, A. et al.: Tranexamic acid treatment for heavy menstrual bleeding: a randomized controlled trial. Obstet Gynecol., 116(4): 865-75., 2010, [2a] . 11. NICE: Heavy Menstrual Bleeding. 1-192, 2007, [5a] http://www.guidelines.gov/con tent.aspx? id=10476 http ://gro up s/p2/E BC_Files/Articles_Cited_in _Epic_Menorrhagia/Menorrhagia.NICE.200 7.pdf . 12. Philipp, C. S.; Faiz, A.; Dowling, N. F.; Beckman, M.; Owens, S.; Ayers, C.; and Bachmann, G.: Development of a screening tool for identifying women with menorrhagia for hemostatic evaluation. American Journal of Obstetrics & Gynecology, 198(2): 163.e1-8, 2008, [3a] . http://ovids p.ovid.com/ovidweb.cgi?T=JS&NEWS =N&PAGE=fulltext&D =medl&AN=1822 6613 http://group s/p2 /EBC_ Files /Articles_ Cited_ in_Ep ic_Menorrhagia/Menorrhagia.Philipp.20 08.pdf 13. RNZCOG, and RNZCGP: An evidence-based guideline for the management of heavy menstrual bleeding. Working Party for Guidelines for the Management of Heavy Menstrual Bleeding. New Zealand Medical Journal, 112(1088): 174-7, 1999, [5a] . http://ovidsp.ovid.com /ovidweb.cg i?T=JS&NEWS =N&PAGE =fu lltext&D =med4 &AN=1039 1640 http://group s/p2 /EBC_ Files/Ar ticles_ Cited_ in_Epic_ Menorrhagia/Menorrhagia.RNZ COG.19 99.pdf 14. Winkler, U. H.: The effect of tranexamic acid on the quality of life of women with heavy menstrual bleeding. European Journal of Obstetrics, Gynecology, & Reproductive Biology, 99(2): 238-43, 2001, [3a] . http://www.ncbi.n lm.nih. gov/entrez/query.fcgi?cmd =Retrieve&db =PubMed &dopt=Cita tion &li st_u ids =11788 179 http://group s/p2 /EBC_ Files/Ar ticles_ Cited_ in_Epic_Menorrhagia/Menorrhagia.Win kler.2001. pdf Note: Full tables of evidence grading system available in separate document: Table of Evidence Levels of Individual Studies by Domain, Study Design, & Quality (abbreviated table below) Grading a Body of Evidence to Answer a Clinical Question Judging the Strength of a Recommendation (abbreviated table below) Table of Evidence Levels (see note above) Quality level Definition Systematic review, meta-analysis, or meta1a† or 1b† 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 Other: General review, expert opinion, case 5 or 5a or 5b report, consensus report, or guideline †a = good quality study; b = lesser quality study Copyright © 2011 Cincinnati Children's Hospital Medical Center; all rights reserved. Page 3 of 10 Adolescent Medicine / Hemorrhagic / Evaluation / BESt 088 Table of Recommendation Strength (see note above) Strength Definition “Strongly recommended” There is consensus that benefits clearly outweigh risks and burdens (or visa-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 Copyright © 2011 Cincinnati Children's Hospital Medical Center; all rights reserved. Page 4 of 10 Adolescent Medicine / Hemorrhagic / Evaluation / BESt 088 Attachment 1: Heavy menstrual bleeding initial screening tool Baseline Data 1. Age at Menarche: ___ years____months 2. Cycle length a. Regular every 21-34 days b. More frequent- less than 21 days apart c. Less frequent- >45 days apart d. Irregular /unpredictable Bleeding Severity 3. How many days do most of your periods last? a. < 7 days b. ≥ 7 days c. Always different 4. How often do you experience “gushing” or flooding sensations? a. Never b. Only some periods c. Every period, or most periods 5. How often do you „bleed through‟ you pad/tampon i.e. soak clothing, bedsheets a. Never b. Only some periods c. Every period, or most periods 6. How often does heavy menstrual bleeding prevent you from activities such as attending school, participating in sports, socializing with friends, or going away from home? a. Never b. Only some periods c. Every period, or most periods 7. About how many days in the last 3 months did heavy menstrual bleeding limit your activities? 8. Do you need to „double-up‟ protection to manage your menstrual bleeding? a. Never b. Only some periods c. Every period, or most periods 9. Do you need to change your sanitary pad/tampon during the night? a. Never b. Only some periods c. Every period, or most periods Spontaneous Bleeding Symptoms 10. Do you have a history of frequent or severe nosebleeds? a. Yes b. No 11. Do you have a history of easy bruising, i.e., bruises > 2 inches across? a. Yes b. No 12. Do you have a history of excessive bleeding after dental procedures? a. Never had dental procedures b. Yes c. No 13. Do you have a history of excessive bleeding after surgery? a. Never had surgery b. Yes c. No Copyright © 2011 Cincinnati Children's Hospital Medical Center; all rights reserved. Page 5 of 10 Adolescent Medicine / Hemorrhagic / Evaluation / BESt 088 14. Do you have a history of excessive bleeding after miscarriage/abortion/delivery? a. Never had miscarriage/abortion/delivery b. Yes c. No Anemia 15. Have you ever had anemia? a. Yes b. No c. I Don‟t Know 16. If you answered „Yes‟ to question 14, what was the management of anemia? a. Observation b. Medical therapy c. Inpatient admission 17. Have you ever had a blood transfusion for anemia? a. Yes b. No Family History 18. Is there a history of heavy periods (menorrhagia) in your mother or sister? a. Yes b. No c. I Don‟t Know 19. Has anyone in your family been diagnosed with a bleeding disorder? a. Yes b. No c. I Don‟t Know PBAC (Pictorial Bleeding Assessment Chart) score 20. Fill out the PBAC for the last month a. total number of bleeding days ___ b. Score _____ 21. How was PBAC collected? a. retrospectively (remembering past periods) b. prospectively (recorded each month) A screening may be considered to be positive for bleeding disorder if any one of the following five conditions are met: (positive responses to bolded questions above) 1) Duration of menses was greater than or equal to 7 days AND the patient reported for at least some periods “gushing,” bleeding through pads, and impairment of daily activities. Cluster of questions: 3(b) + All of the following: 4 (b OR c), 5 (b OR c), 6 (b OR c) 2) History of excessive bleeding with tooth extraction or surgery. 12 (b) or 13 (b) 3) History of excessive bleeding after miscarriage/abortion/delivery AND management of anemia with medical therapy or hospitalization. 16 (b or c) 4) History of blood transfusion 17 (a) 5) Family history of a diagnosed bleeding disorder 19 (a) Adapted from Development of a screening tool for identifying women with menorrhagia for hemostatic evaluation. (Philipp 2008 [3a], Local Consensus [5]). Copyright © 2011 Cincinnati Children's Hospital Medical Center; all rights reserved. Page 6 of 10 Adolescent Medicine / Hemorrhagic / Evaluation / BESt 088 Attachment 2: Pictorial Blood Assessment Chart (PBAC) Count the number of sanitary pads and/or tampons you use each day (24 hour period). Calculate a score for each day, then add up the score at the end of the month. A score of 100 or more may indicate heavy menstrual bleeding. (Higham 1990 [3b]). Copyright © 2011 Cincinnati Children's Hospital Medical Center; all rights reserved. Page 7 of 10 Adolescent Medicine / Hemorrhagic / Evaluation / BESt 088 Attachment 3: Menorrhagia-specific quality of life questionnaire In the last 3 months 1. What is your cycle length? a. Regular every 21-34 days b. More frequent- less than 21 days apart c. Less frequent- >45 days apart d. Irregular /unpredictable Bleeding Severity 2. How many days do most of your periods last? a. < 7 days b. ≥ 7 days c. Always different 3 How often do you experience “gushing” or flooding sensations? a. Never b. Only some periods c. Every period, or most periods 4 How often do you „bleed through‟ you pad/tampon i.e. soak clothing, bedsheets a. Never b. Only some periods c. Every period, or most periods 5. How often does heavy menstrual bleeding prevent you from activities such as attending school, participating in sports, socializing with friends, or going away from home? a. Never b. Only some periods c. Every period, or most periods 6. About how many days in the last 3 months did heavy menstrual bleeding limit your activities __________? 7. Do you need to „double-up‟ protection to manage your menstrual bleeding? a. Never b. Only some periods c. Every period, or most periods 8. Do you need to change your sanitary pad/tampon during the night? a. Never b. Only some periods c. Every period, or most periods 9. Overall, how would you rate your bleeding compared to your last visit? a. No change b. Better, less bleeding c. Worse, more bleeding PBAC (Pictorial Bleeding Assessment Chart) score 10. Fill out the PBAC for the last month a. total number of bleeding days ___ b. Score _____ 11. How was PBAC Collected? a. Retrospectively (remembering past periods) b. Prospectively (recorded each month) Adapted from Development of a screening tool for identifying women with menorrhagia for hemostatic evaluation (Philipp 2008 [3a], Local Consensus [5]). Copyright © 2011 Cincinnati Children's Hospital Medical Center; all rights reserved. Page 8 of 10 Adolescent Medicine / Hemorrhagic / Evaluation / BESt 088 Supporting information Introductory/background information Menorrhagia has been defined as heavy menstrual bleeding occurring at regular intervals with blood loss in excess of 80 milliliters during a menstrual cycle (Hurskainen 2007 [5a]). Objective measurement of blood loss is not feasible in the clinical setting, but subjective evaluation of the woman‟s physical, emotional, social and material quality of life, which can occur alone or in combination with other symptoms can aid diagnosis (NICE 2007 [5a]). Underlying bleeding disorders may present as heavy menstrual bleeding, and are therefore considered in the differential diagnosis (Demers 2005 [5a]). Group/Team members Group/Team Leader Jill Huppert, MD, Associate Professor, Adolescent Gynecology Other group/team members Lesley Breech, MD, Associate Professor, Adolescent Gynecology Leslie Ayensu-Coker, MD, Assistant Professor, Adolescent Gynecology Lisa Reebals, NP, Adolescent Gynecology Debbie Morse, RN, Care Manager, Division of Adolescent Medicine Amy Vallerie, MD, Clinical Fellow, Adolescent Gynecology Samantha Montgomery, MD, Clinical Fellow, Adolescent Gynecology Barbara DePompei, LPN, Division of Adolescent Medicine Support personnel Anjali Basu, MS, Associate Outcomes Manager, Anderson Center for Health Systems Excellence, Eloise Clark, MPH, MBA, Lead Guidelines Program Administrator, Anderson Center for Health Systems Excellence Wendy Engstrom Gerhardt, MSN, RN-BC, Guidelines Program Administrator, Anderson Center for Health Systems Excellence Karen Vonderhaar, MS, RN, Guidelines Program Administrator, Anderson Center for Health Systems Excellence Search strategy 1. Initial Search Databases: OVID Medline, Cochrane and National Guideline Clearinghouse Dates 1996 through September 2010 Search terms (OVID): (guideline or meta analysis or practice guidelines or systematic review).pt. or "the cochrane library".jn. or "cochrane database of systematic reviews".jn. AND menorrhagia.mp. or exp heavy menstrual bleeding or abnormal uterine bleeding Search terms (National Guideline Clearinghouse): menorrhagia or “heavy menstrual bleeding” or “abnormal uterine bleeding” Limit: English language 2. Specific search on questionnaires for menorrhagia Databases: OVID Medline Dates 1996 through September 2010 Search terms: (menorrhagia.mp. or exp Menorrhagia/) AND outcomes.mp. AND (questionnaire.mp. or *Questionnaires/) NOT (hysterectomy.mp. or ablat$.ti. or surger$.ti.) Limit: English language 3. Additional articles identified by clinicians Copyright © 2011 Cincinnati Children's Hospital Medical Center; all rights reserved. Page 9 of 10 Adolescent Medicine / Hemorrhagic / Evaluation / BESt 088 Applicability issues Measures that are proposed to be audited: Percentage of females presenting to the Teen Health Center with “vaginal bleeding” as chief complaint who had all three of the following assessments completed: CBC, Menorrhagia questionnaire and PBAC assessment. Percentage of females presenting to the Teen Health Center with “vaginal bleeding” as the chief complaint, and with positive results on a Menorrhagia Assessment who also had bleeding disorder workup conducted (CBC with platelets, coagulation screen). Percentage of females presenting to the Teen Health Center with “vaginal bleeding” as the chief complaint who were hospitalized within 30 days of most recent outpatient visit as a result of heavy menstrual bleeding. Copies of this Best Evidence Statement (BESt) are available online and may be distributed by any organization for the global purpose of improving child health outcomes. Website address: http://www.cincinnatichildrens.org/svc/alpha/h/health-policy/ev-based/default.htm 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 [email protected] for any BESt adopted, adapted, implemented or hyperlinked by the organization is appreciated. For more information about this CCHMC Best Evidence Statement and the development process contact one of the listed team members at the Teen Health Center: 513-636-4681, or [email protected] . Note 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. Reviewed against quality criteria by 2 independent reviewers. Copyright © 2011 Cincinnati Children's Hospital Medical Center; all rights reserved. Page 10 of 10