Prevention of Orthopaedic Implant Infection in Patients Undergoing Dental Procedures Peer Review and Public Commentary Comments with AAOS Responses Peer Review February 16, 2012 – March 15, 2012 Public Comment July 27, 2012 – August 27, 2012 Changes Made to the Confidential Draft of the Guideline on the “Prevention of Orthopaedic Implant Infection in Patients Undergoing Dental Procedures” Peer Review February 16, 2012 – March 15, 2012 Line 66 (Summary of Recommendations) Text was added to further stress that these recommendations should be thoroughly considered with all available patient information in mind. Line 546 (Burden of Disease And Etiology) Numbers were updated to be more current. Projections are now for 2020, not 2010. Table 2 (IOM Systematic Review Standards) Manage data collection information changed to reflect the data management process in this guideline. 2 independent reviewers were utilized to extract data and appraise the quality of the literature Lines 826, 1128 (Methods) Editorial changes made to text for clarity. Table 10 (High and Low Risk Dental Procedures Defined by Berbari et al.) Spelling error corrected. Lines 1434, 1442, 1453, 1454 (Indirect Evidence: Background Microbiology) Text italicized were appropriate. Lines 1501-1505 (Recommendations) Paragraph added before full recommendations to remind the practitioner that these recommendations are not intended to stand alone and that treatment decisions should be made in light of all circumstances presented by the patient. Line 1572 and following figure and table titles (Results) Editorial changes made to clarify what is being presented. Lines 1575-1577 (Results) Text added to define “network meta-analysis”. Line 1661 (Findings) Grammatical error corrected. Line 1674 and following figure and table titles (Results) Editorial changes made to clarify what is being presented. Lines 1813-1815 and 1826-1827 (Future Research) Content added to recommend for future research on formal cost-benefit analysis of antimicrobial prophylaxis for patients with orthopaedic implants undergoing dental procedures. ALL REVIEW COMMENTS, RESPONSES AND REVIEWER CONFLICTS OF INTEREST DISCLSOURE WILL BE AVAILABLE ON OUR WEBSITE FOLLOWING APPROVAL OF THIS DOCUMENT. Review of any AAOS confidential draft allows us to improve the overall guideline but does not imply endorsement by any given individual or any specialty society who participates in our review processes. The AAOS review process may result in changes to the documents; therefore, endorsement cannot occur until the AAOS Board of Directors officially approves the final guideline. The ADA will also employ a formal approval process. Please note that if you return a review:  Your review comments will be published on the AAOS website, and may be published on the ADA website, with our explanation of why we did or did not change the draft document in response to your comments.  Your conflicts of interest disclosures will be published on the AAOS website, and may be published on the ADA website, with your review comments. Reviewer Information: Name of Reviewer: Not listed as requested Address: City: State: Zip Code: Phone: Fax: E-mail: Specialty Area/Discipline: Work setting: Public Health Credentials: PhD May we list you as a Peer Reviewer in the final Guidelines? Yes X No PLEASE READ: If you do not wish to be listed, your name will be removed for identification purposes. However, your review comments, our responses and your COI will still be available for public review on our website with the posted Guideline if you complete this review. Are you reviewing this guideline as a representative of a professional society? Yes X No If yes, may we list your society as a reviewer of this guideline? Yes X No Society Name: (Listing the specialty society as a reviewing society does not imply or otherwise indicate endorsement of this guideline.) Conflicts of Interest (COI): All Reviewers must declare their conflicts of interest. If the boxes below are not checked and/or the reviewer does not attach his/her conflicts of interest, the reviewer’s comments will not be addressed by the AAOS nor will the reviewer’s name or society be listed as a reviewer of this GL. If a committee reviews the guideline, only the chairperson or lead of the review must declare their relevant COI. X I have declared my conflicts of interest on page 2 of this form. I have declared my conflicts of interest in the AAOS database; my customer # is I understand that the AAOS will post my declared conflicts of interest with my comments concerning review of this guideline on the AAOS website. 1 REVIEWER CONFLICT OF INTEREST - The Orthopaedic Disclosure Program Each item below requires an answer. Please report information for the last 12-months. Do you or a member of your immediate family receive royalties for any pharmaceutical, biomaterial or Yes X No orthopaedic product or device? If YES, please identify product or device: Within the past twelve months, have you or a member of your immediate family served on the speakers Yes X No bureau or have you been paid an honorarium to present by any pharmaceutical, biomaterial or orthopaedic product or device company? If YES, please identify company: Are you or a member of your immediate family a PAID EMPLOYEE for any pharmaceutical, biomaterial or Yes X No orthopaedic device or equipment company, or supplier? If YES, please identify company or supplier: Are you or a member of your immediate family a PAID CONSULTANT for any pharmaceutical, biomaterial Yes X No or orthopaedic device or equipment company, or supplier? If YES, please identify company or supplier: Are you or a member of your immediate family an UNPAID CONSULTANT for any pharmaceutical, Yes X No biomaterial or orthopaedic device or equipment company, or supplier? If YES, please identify company or supplier: Do you or a member of your immediate family own stock or stock options in any pharmaceutical, Yes X No biomaterial or orthopaedic device or equipment company, or supplier (excluding mutual funds) If YES, please identify company or supplier: Do you or a member of your immediate family receive research or institutional support as a principal investigator from any pharmaceutical, biomaterial or orthopaedic device or equipment company, or Yes X No supplier? If YES, please identify company or supplier: Do you or a member of your immediate family receive any other financial or material support from any Yes X No pharmaceutical, biomaterial or orthopaedic device and equipment company or supplier? If YES, please identify company or supplier: Do you or a member of your immediate family receive any royalties, financial or material support from any Yes X No medical and/or orthopaedic publishers? If YES, please identify publisher: Do you or a member of your immediate family serve on the editorial or governing board of any medical Yes X No and/or orthopaedic publication? If YES, please identify: Do you or a member of your immediate family serve on the Board of Directors or a committee of any Yes X No medical and/or orthopaedic professional society? If YES, please identify: 2 Structured Peer Review Form Instructions Please read and review this Draft Clinical Practice Guideline with particular focus on your area of expertise. Your responses will be used to assess the validity, clarity and accuracy of the interpretation of the evidence. If applicable, please specify the draft page and line numbers in your comments. Please feel free to also comment on the overall structure and content of the document. If you need more space than is provided, please attach additional pages. Please complete and return this form electronically in WORD format to [email protected]; please contact Kevin Boyer at (847) 384-4328 if you have any questions. Thank you in advance for your time in completing this form and giving us your feedback. We value your input and greatly appreciate your efforts. Please return the completed form in WORD format by end of day March 15, 2012. Please indicate your level of agreement with each of the following statements by placing an “X” in the appropriate box. Somewhat Somewhat Disagree Disagree Agree Agree 1. The recommendations are clearly stated X 2. There is an explicit link between the recommendations and the X supporting evidence 3. Given the nature of the topic and the data, all clinically important X outcomes are considered 4. The guideline’s target audience is clearly described X 5. The patients to whom this guideline is meant to apply are specifically X described 6. The criteria used to select articles for inclusion are appropriate X 7. The reasons why some studies were excluded are clearly described X 8. All important studies that met the article inclusion criteria are X included 9. The validity of the studies is appropriately appraised X 10. The methods are described in such a way as to be reproducible. X 11. The statistical methods are appropriate to the material and the X objectives of this guideline 12. Important parameters (e.g., setting, study population, study design) X that could affect study results are systematically addressed 13. Health benefits, side effects, and risks are adequately addressed X 14. The writing style is appropriate for health care professionals. X 15. The grades assigned to each recommendation are appropriate X 3 COMMENTS PLEASE RETURN ALL COMMENTS IN WORD FORMAT Please provide a brief explanation of both your positive and negative answers in the preceding section. If applicable, please specify the draft page and line numbers in your comments. Please feel free to also comment on the overall structure and content of the Guideline Overall, the methods are well described and appropriate. Following, please find a few minor comments: Line 824 – would suggest rewording term in parenthesis to randomized controlled trials. The Cochrane Group’s Systematic Review of Sealants included both split mouth and parallel group studies.. Line 830 – Blinding protects against examiner bias as well as placebo effect. Line 1125-1127 – Is this sentence correct? Line 1539 – Could the review be more explicit on why there is a concern that reduced bacteremia could mask implant infection. Doctor, Thank you for your expert review of this clinical practice guideline. We have incorporated changes to clarify the content in the “Methods” section that you brought to our attention. Our concern with surrogate outcomes is explained starting on line 1098 in the “Outcomes Considered” section of the “Methods” section. An intervention that improves a surrogate outcome does not necessarily improve a patient-oriented outcome. The opposite can occur and using a surrogate outcome as a study endpoint can make a harmful treatment look beneficial. This is the reason for our concern in regards to bacteremia reduction masking implant infection. Please review this section of the guideline for more details on our concerns with surrogate outcomes. OVERALL ASSESSMENT Would you recommend these guidelines for use in clinical practice? (Check one) Strongly recommend Recommend (with provisions or alterations) Would not recommend X Unsure Note: Your answer to this question does not constitute an endorsement of this guideline. We ask this question as a means of monitoring the clinical relevance of our guideline. 4 ALL REVIEW COMMENTS, RESPONSES AND REVIEWER CONFLICTS OF INTEREST DISCLSOURE WILL BE AVAILABLE ON OUR WEBSITE FOLLOWING APPROVAL OF THIS DOCUMENT. Review of any AAOS confidential draft allows us to improve the overall guideline but does not imply endorsement by any given individual or any specialty society who participates in our review processes. The AAOS review process may result in changes to the documents; therefore, endorsement cannot occur until the AAOS Board of Directors officially approves the final guideline. The ADA will also employ a formal approval process. Please note that if you return a review:  Your review comments will be published on the AAOS website, and may be published on the ADA website, with our explanation of why we did or did not change the draft document in response to your comments.  Your conflicts of interest disclosures will be published on the AAOS website, and may be published on the ADA website, with your review comments. Reviewer Information: Name of Reviewer: Jamie Baisden MD FACS Address: MCW Neurosurgery 9200 W. Wisconsin Ave City: Milwaukee State: WI Zip Code: 53226 Phone: 414-805-5400 Fax: 414-955-0110 E-mail: [email protected] Specialty Area/Discipline: Neurosurgery/Complex Spine Work setting: Academic Credentials: MD, Masters in Medical Management May we list you as a Peer Reviewer in the final Guidelines? xxx Yes No PLEASE READ: If you do not wish to be listed, your name will be removed for identification purposes. However, your review comments, our responses and your COI will still be available for public review on our website with the posted Guideline if you complete this review. Are you reviewing this guideline as a representative of a professional society? Xxx Yes No If yes, may we list your society as a reviewer of this guideline? Xxxx Yes No Society Name: North American Spine Society (Listing the specialty society as a reviewing society does not imply or otherwise indicate endorsement of this guideline.) Conflicts of Interest (COI): All Reviewers must declare their conflicts of interest. If the boxes below are not checked and/or the reviewer does not attach his/her conflicts of interest, the reviewer’s comments will not be addressed by the AAOS nor will the reviewer’s name or society be listed as a reviewer of this GL. If a committee reviews the guideline, only the chairperson or lead of the review must declare their relevant COI. x I have declared my conflicts of interest on page 2 of this form. I have declared my conflicts of interest in the AAOS database; my customer # is x I understand that the AAOS will post my declared conflicts of interest with my comments concerning review of this guideline on the AAOS website. 1 REVIEWER CONFLICT OF INTEREST - The Orthopaedic Disclosure Program Each item below requires an answer. Please report information for the last 12-months. Do you or a member of your immediate family receive royalties for any pharmaceutical, biomaterial or Yes xx No orthopaedic product or device? If YES, please identify product or device: Within the past twelve months, have you or a member of your immediate family served on the speakers Yes xx No bureau or have you been paid an honorarium to present by any pharmaceutical, biomaterial or orthopaedic product or device company? If YES, please identify company: Are you or a member of your immediate family a PAID EMPLOYEE for any pharmaceutical, biomaterial or Yes xx No orthopaedic device or equipment company, or supplier? If YES, please identify company or supplier: Are you or a member of your immediate family a PAID CONSULTANT for any pharmaceutical, biomaterial Yes xx No or orthopaedic device or equipment company, or supplier? If YES, please identify company or supplier: Are you or a member of your immediate family an UNPAID CONSULTANT for any pharmaceutical, Yes xx No biomaterial or orthopaedic device or equipment company, or supplier? If YES, please identify company or supplier: Do you or a member of your immediate family own stock or stock options in any pharmaceutical, Yes xx No biomaterial or orthopaedic device or equipment company, or supplier (excluding mutual funds) If YES, please identify company or supplier: Do you or a member of your immediate family receive research or institutional support as a principal investigator from any pharmaceutical, biomaterial or orthopaedic device or equipment company, or supplier? Yes xx No If YES, please identify company or supplier: Do you or a member of your immediate family receive any other financial or material support from any Yes xx No pharmaceutical, biomaterial or orthopaedic device and equipment company or supplier? If YES, please identify company or supplier: Do you or a member of your immediate family receive any royalties, financial or material support from any Yes xx No medical and/or orthopaedic publishers? If YES, please identify publisher: Do you or a member of your immediate family serve on the editorial or governing board of any medical xx Yes and/or orthopaedic publication? No If YES, please identify: Surgical Neurology International Do you or a member of your immediate family serve on the Board of Directors or a committee of any xx Yes medical and/or orthopaedic professional society? No If YES, please identify: EBM Guidelines Committee NASS, Performance Committee NASS, Patient Education Committee NASS, ETHICS Committee-AANS, 2 Structured Peer Review Form Instructions Please read and review this Draft Clinical Practice Guideline with particular focus on your area of expertise. Your responses will be used to assess the validity, clarity and accuracy of the interpretation of the evidence. If applicable, please specify the draft page and line numbers in your comments. Please feel free to also comment on the overall structure and content of the document. If you need more space than is provided, please attach additional pages. Please complete and return this form electronically in WORD format to [email protected]; please contact Kevin Boyer at (847) 384-4328 if you have any questions. Thank you in advance for your time in completing this form and giving us your feedback. We value your input and greatly appreciate your efforts. Please return the completed form in WORD format by end of day March 15, 2012. Please indicate your level of agreement with each of the following statements by placing an “X” in the appropriate box. Somewhat Somewhat Disagree Disagree Agree Agree 1. The recommendations are clearly stated xx 2. There is an explicit link between the recommendations and the xx supporting evidence 3. Given the nature of the topic and the data, all clinically important xx outcomes are considered 4. The guideline’s target audience is clearly described xx 5. The patients to whom this guideline is meant to apply are specifically xx described 6. The criteria used to select articles for inclusion are appropriate xx 7. The reasons why some studies were excluded are clearly described xx 8. All important studies that met the article inclusion criteria are xx included 9. The validity of the studies is appropriately appraised xx 10. The methods are described in such a way as to be reproducible. xx 11. The statistical methods are appropriate to the material and the xx objectives of this guideline 12. Important parameters (e.g., setting, study population, study design) xx that could affect study results are systematically addressed 13. Health benefits, side effects, and risks are adequately addressed xx 14. The writing style is appropriate for health care professionals. xx 15. The grades assigned to each recommendation are appropriate xx 3