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AAOMS Anesthesia Third Molar Study Help Manual

1. Indicate the anesthetist provider by selecting from the drop down list Anesthetist Provider is a required field and must be entered to save the Anesthesia form as Complete 3 Complete the module below for each person involved in patient support and care during the anesthetic and operative procedure and recovery Question 3 is a repeat group Each created entry group is meant to capture the details for an individual involved in patient support and care during the anesthetic and operative procedure and recovery To add more people involved in patient support and care during the anesthetic and operative procedure and recovery click Done after the first entry is completed and then click the Create Next Entry button to open a new blank record Type of personnel Indicate the type of personnel by selecting from the drop down list List of Duties performed List of Duties performed fields will be enabled if Type of personnel is selected If Type of personnel is selected you must select either Yes or No for each potential duty to save the Anesthesia form as Complete MONITORING PATIENT 1 Methods used to monitor patient Select any methods used to monitor the patient Check all that apply Individual monitoring timing fields will be enabled if corresponding method used to monitor the patient is selected Check all that apply If a method was used
2. Intrasocket Dressing Select each drug administered as an intrasocket dressing Check all that apply If an agent other than those listed was given check Other If Yes is selected for Intrasocket Dressing you must select at least one agent to save the 27 Molar Extraction form as Complete If Other specify field will be enabled if Other is selected for If YES please specify If Other is selected for If YES please specify you must specify the other intrasocket dressing to save the 3 Molar Extraction form as Complete Pain medications prescribed recommended field will be enabled if any molar is selected for 3rd molar s extracted If any molar is selected for 3rd molar s extracted you must specify whether pain medications were prescribed recommended by selecting Yes or No to save the 3 Molar Extraction form as Complete If YES please specify field will be enabled if Yes is selected for Pain medications prescribed recommended Select each drug prescribed recommended pain medication Check all that apply If an agent other than those listed was given check Other If Yes is selected for Pain medications prescribed recommended you must select at least one agent to save the 3 Molar Extraction form as Complete If Other specify field will be enabled if Other is selected
3. m Lidocaine Plain 2 Xylocaine Lidocaine 2 with epi 1 100 000 Xylocaine Lidocaine 2 with epi 1 50 000 Xylocaine Bupivacaine 0 5 with epi 1 200 000 Marcaine Septocaine with epi 1 100 000 Articaine YES e nog y YES no y Number of Dental Cartridges SM SM SH SH E Hl El ka Version 1 2 14 July 201 1 Confidential Page 29 of 55 OUTC 3ME eCRF COMPLETION GUIDELINES amp C Septocaine with epi 1 200 000 Articaine a r Prilocaine Plain Citanest ES D M Prilocaine with epi 1 200 000 Citanest Linn D Other Sa 2a 1 Other specify a D D 3 Narcotics YES e nog y 3a If YES please specify Check all that apply DOSE UNITS Alfentanil Alfenta D meg Fentanyl Sublimaze D meg Meperidine Demerol D ms 7 Nalbuphine Nubain D mg 7 Remifentanil Ultiva D meg 7 Other D D 3a 1 Other specify nD D 4 Parenteral Benzodiazepines YES e noe P 4a If YES please specify Check all that apply DOSE UNITS Diazepam Valium o Ly mg C Midazolam Versed en 7 mg Other H a 4a 1 Other specify a D D 5 Other Parenteral Anesthetics YES NCO 5a If YES please specify Check all that apply DOSE UNITS Ketamine Ketamine HCl Ketalar D mg Methohexital Brevital D mg M Propofol Diprivan D mg 7 Fospropofol Lusedra DH mg M Fresnius Propoven D mg C Dexmedetomidide Precedex D mcg
4. Version 1 2 14 July 2011 any of the planned extractions fields will be enabled if corresponding molar is selected for 3rd molar s extracted Check all that apply Check the molar number in the None disease free M3 row if the planned extractor is disease free Check the molar number in the Caries row if decay is present that involves more than one surface of the planned extractor with or without pulpal involvement Check the molar number in the Periodontal disease row if the planned extractor is associated with periodontitis with advanced destruction defined as presence of periodontal probing depths greater than 4 mm or radiologic evidence of bone loss Check the molar number in the Pathology of adjacent tooth due to 3rd molar row if preoperative pathology abnormal finding is found in tooth adjacent and due to planned extractor Examples include caries root resorption and periapical infection Check the molar number in the Other row if planned extractor is associated with preoperative pathology abnormal finding s that are not included among the options listed If corresponding molar is selected for 3rd molar s extracted you must specify the preoperative pathology abnormal finding if any of the planned extractions to save the 3 Molar Extraction form as Complete Confidential Page 38 of 55 Ee COPE COMPLETION BR Field Question Instructions OPERA
5. field will be enabled if Other is selected for If YES type of airway device If Other is selected for If YES type of airway device you must specify the other airway device to save the Anesthesia form as Complete Version 1 2 14 July 201 1 Confidential Page 18 of 55 OUTC 3 ME eCRF COMPLETION APR GUIDELINES OMS Field Question Instructions 2b Was use of the airway device Was use of the airway device field will be enabled if Yes is selected for Was an advanced airway employed If Yes is selected for Was an advanced airway employed you must select whether use of an advanced airway device was one of the following to save the Anesthesia form as Complete e Elective planned prior to the first administration of anesthetic e Emergent performed after the first administration of anesthesia on an emergency basis 2b 1 Describe emergent circumstances Describe emergent circumstances field will be enabled if Emergent is selected for Was use of the airway device If Emergent is selected for Was use of the airway device you must describe emergent circumstances to save the Anesthesia form as Complete SEDATIVE PREMEDICATIONS ADMINISTERED 1 Was the patient administered sedative premedications Indicate if patient was administered sedative premedica
6. Asthma COPD restrictive respiratory disease Diabetes F Coronary Heart Disease M Hypertension Immune Deficiency Malignancy Other local systemic Other 1a Other specify D RISK FACTORS 1 On average how many alcohol containing drinks drinks does the patient consume each day 2 What is the patient s level of tobacco use 7 2a How many packs per day B packs 2b How many years was tobacco used y years 2c Pack years of smoking y 3 Did the patient take any of the following medications within 10 days of the surgery Please select all that apply Oral contraceptives NSAID aspirin ibuprofen or other prescription or over the counter NSAIDs Anticoagulant Systemic corticosteroids not topical or inhalation D 4 Mallampati Class Class I Full visibility D A Class II Visibility of hard of tonsils uvula and and soft palate upper soft palate portion of tonsils and uvula Class III Soft and hard palate and base of the uvula are visible ecru Class IV Only hard palate visible Version 1 2 14 July 2011 Confidential Page 13 of 55 OUTC ME CCRE COMPLETION BA p 5 Height CS in cme 6 Weight PP lbs ko 7 BMI F PATIENT HISTORY Please indicate the current status of the form Complete Incomplete Save and Ex
7. during pre op intra op and post op clicking the All button will automatically check each individual option If corresponding method used to monitor the patient is selected you must specify monitoring timing s to save the Anesthesia form as Complete 1a Other specify Other specify field will be enabled if Other is selected for Methods used to monitor patient If Other is checked for Methods used to monitor patient you must specify the other method used to monitor the patient to save the Anesthesia form as Complete Version 1 2 14 July 201 1 Confidential Page 27 of 55 OUTC 3ME eCRF COMPLETION GUIDELINES OMS Anesthesia Patient ID Legend Clear Selection D Add Annotation A Show Warnings Created 03 30 2011 16 42 59 Last Updated 03 30 2011 16 42 59 D Show History I PREOPERATIVE LEVEL OF ANXIETY 1 Patient s self reported preoperative level of anxiety regarding anesthesia p PROCEDURES PERFORMED ON PATIENT 1 Procedures performed on patient Check all that apply m None 1a Explain None 3rd Molar Extraction Dentoalveolar Implant Trauma Pathology Orthognathic Cosmetic non orthognathic F Reconstructive Diagnostic block TMJ Examination requiring anesthesia Other ib Other sp
8. 1 2 14 July 201 1 Confidential Page 16 of 55 eCRF COMPLETION APA OUTC ME GUIDELINES PA Field Question Instructions 1a Explain None w Explain None field will be enabled if None is selected for Procedures performed on patient There may be some circumstance where no procedure is completed If so check None for Procedures performed on patient and explain why the patient was anesthetized and no procedure was completed If None is selected for Procedures performed on patient you must enter an explanation for why no procedures were performed to save the Anesthesia form as Complete 1b Other specify Other specify field will be enabled if Other is selected for Procedures performed on patient If Other is selected for Procedures performed on patient you must specify the other procedure s performed to save the Anesthesia form as Complete ANESTHESIA LEVEL INDUCED 1 Deepest anesthesia level induced in patient Indicate the deepest level of anesthesia obtained even if that level of anesthesia was obtained only transiently or was unintended by selecting from the drop down list Select only one e Select Local anesthesia alone if it is the only agent used e Select Minimal if the patient responds normally to verbal commands cognitive function and coordination may be impaired but v
9. Anesthesia Induction Intraoperative monitoring of patient Intraoperative bolus dose of anesthetic Assist with Emergency Assist with Surgery Monitor patient during recovery YES YES YES YES YES YES YES no y no Y no Y no y no Y noe y no y p MONITORING PATIENT 1 Methods used to monitor patient Check all that apply Blood pressure Pre op Intra op Post op Recovery D o Pulse oximetry Pre op Intra op Post op Recovery E Ca Precordial stethoscope Pre op Intra op Post op Recovery D an Pretracheal stethoscope Pre op Intra op Post op Recovery I a ECG Pre op Intra op Post op Recovery 9 an Monitoring of chest movement Pre op Intra op Post op Recovery a Capnography Pre op Intra op Post op Recovery D Jee A EEG BIS Pre op Intra op Post op Recovery I All Temperature Pre op Intra op Post op Recovery PA Other Pre op Intra op Post op Recovery All 1a Other specify D y i Ess Please indicate the current status of the form Complete Incomplete Save and Exit Form Save and Continue Data Entry Version 1 2 14 July 201 1 Confidential Page 32 of 55 OUTC JME COPE COMPLETION ER 2 1 4 Recovery Info Complications Tab Field Question Instructions PATIENT RECOVERY 1 Time anesthesia started Time anesthesia started
10. C Etomidate Amidate D mg M Thiopental Pentothal p mg Version 1 2 14 July 2011 Confidential Page 30 of 55 CRF COMPLETION APR OUTCERME Suipetines G Other p r 5a 1 Other specify y D 6 Vapor Agents YES e noe y 6a If YES please specify Check all that apply DOSE UNITS Nitrous oxide Desflurane Suprane Halothane Fluothane Isoflurane Forane Sevoflurane Ultane aa H EKKKKKZ Other 6a 1 Other specify f y D 7 Other Medications YES nog 7a If YES please specify Check all that apply DOSE UNITS Flumazenil Romazicon mg Naloxone Narcan mg Atropine mg Decadron Dexamethasone mg Glycopyrrolate Robinal mg Succinylcholine mg Ketorolac Toradol mg d SM SH SH SS g Other 7a 1 Other specify py D ANESTHESIA ADMINISTERED 1 Was anesthesia administered intravenously YES NCOP la If YES please specify flow With continuous flow Without continuous flow eV ib If YES please specify access device Straight needle Butterfly Angiocath eo 2 Anesthetist Provider p Version 1 2 14 July 2011 Confidential Page 31 of 55 OUTC 3ME eCRF COMPLETION GUIDELINES gS 3 Complete the module below for each person involved in patient support and care during the anesthetic and operative procedure and recovery Type of personnel List of Duties performed Established IV
11. Complete Version 1 2 14 July 201 1 Confidential Page 8 of 55 OUTC ts ME eCRF COMPLETION APR GUIDELINES OMS Anesthesia Patient ID Created 03 30 2011 16 42 59 Last Updated 03 30 2011 16 42 59 Legend Clear Selection Ei Add Annotation A Show Warnings Show History DEMOGRAPHICS SURGERY DATE 1 Date of Surgery VV A r MM DO Yyyy 2 Medical Record Number y DEMOGRAPHY 1 Date of Birth yO P MM CO Yyyy 2 Patient Age years 3 Patient Sex MALE gt FEMALE ei DEMOGRAPHICS Please indicate the current status of the form Complete Incomplete Save and Exit Form Save and Continue Data Entry Exit Without Saving Version 1 2 14 July 2011 Confidential Page 9 of 55 OUTC 3 ME eCRF COMPLETION APR GUIDELINES OMS 2 1 2 Patient History Tab Field Question PATIENT ASA CLASS Instructions 1 Patient ASA Class Select the American Society of Anesthesiologists ASA physical status classification that best describes the patient s clinical status at the time of surgery from the drop down list Please note that if patient s ASA class is ASA II or above then at least one chronic condition needs to be checked in the next section Patient ASA Class is a required field and must be entered to save the Anesthesia form as Complete CHRONIC CONDITIONS 1 Patient s chronic conditions Patient s
12. Questionnaire form as Complete Version 1 2 14 July 201 1 Confidential Page 54 of 55 OUTC JME E GE Field Question Instructions 5 Would they recommend the same Indicate whether the patient would recommend the kind of anesthetic to a loved one same kind of anesthetic to a loved one by selecting Yes or No from the drop down list Would they recommend the same kind of anesthetic to a loved one is a required field and must be entered to save the Satisfaction Questionnaire form as Complete 6 How anxious would the patient be Select how anxious the patient would be if he she were if he she were to have the same kind to have the same kind of anesthesia in the future from of anesthesia in the future the drop down list You can select only one response How anxious would the patient be if he she were to have the same kind of anesthesia in the future is a required field and must be entered to save the Satisfaction Questionnaire form as Complete Satisfaction Questionnaire Patient ID Created 03 30 2011 16 43 00 Last Updated 03 30 2011 16 43 00 Legend Clear Selection D Add Annotation A Show Warnings D Show History PATIENT ANESTHESIA SATISFACTION FORM 1 Date of Satisfaction Form Completed iv bes D MM CO Yyyy 2 Which of the following did the patient remember about their anesthetic experience Check all that apply F Pain during procedure after
13. based on packs smoked per day and total years tobacco was used 3 Did the patient take any of the Select any medications the patient has taken within 10 following medications within 10 days days of surgery Check all that apply If the patient has of the surgery not taken oral contraceptives aspirin ibuprofen or other non steroidal anti inflammatory drugs anticoagulants such as Coumadin or corticosteroids then leave this field blank 4 Mallampati Class Select the Mallampati Class that best characterizes the patient Refer to the diagrams provided Mallampati Class is a required field and must be entered to save the Anesthesia form as Complete Version 1 2 14 July 201 1 Confidential Page 11 of 55 OUTC 3 ME eCRF COMPLETION APR GUIDELINES OMS Field Question Instructions 5 Height 6 Weight Enter patient s height in inches or centimeters in format Provide units by selecting in or cm The expected range is 39 87 in or 100 220 cm If the height value is outside the expected range for a given unit then you must validate the entry to save the Anesthesia form as Complete This can be done by clicking the blue Validate link that is present below the error text in the Errors and Warnings window and providing the validation reason in the Validate Query window Height is a required field and must be entered to save the Anesthe
14. for If YES please specify If Other is selected for If YES please specify you must specify the other pain medications prescribed recommended to save the 3 Molar Extraction form as Complete Other medications field will be enabled if any molar is selected for 3rd molar s extracted If any molar is selected for 3rd molar s extracted you must specify whether other medications were administered by selecting Yes or No to save the 3 Molar Extraction form as Complete Version 1 2 14 July 201 1 Confidential Page 45 of 55 OUTC 3ME eCRF COMPLETION APR GUIDELINES OMS Field Question Instructions 5a If YES please specify If YES please specify field will be enabled if Yes is selected for Other medications Question 5a is a repeat group Each created entry group is meant to capture the details for an individual other medication administered To add more other medications click Done after the first entry is completed and then click the Create Next Entry button to open a new blank record If Yes is selected for Other medications you must provide at least one agent to save the 3 Molar Extraction form as Complete Other medication specify Enter the other medication name Version 1 2 14 July 201 1 Confidential Page 46 of 55 CRF COMPLETION APA OUTCERME u
15. log into the system Signature Users will also need their Username and Password to provide their electronic signature at the end of form in order to confirm data entered is accurate Your Username and Password were assigned to you by the Outcome Help Desk If you forget either of these please contact the Help Desk using the information above Printing Blank Forms The most up to date blank forms are available in this section of the Home tab Included are forms to document Anesthesia 3 Molar Extraction and Satisfaction Questionnaire The blank forms should be used as a reference only as not all forms will represent the true functionality of the EDC system Data can only be submitted via the EDC system and not via paper Data Collection Investigators and or designated qualified staff will enter the data into the eCRFs Investigators or designees will review and approve each patient s complete eCRF record Sites are responsible for entering patient data and completed forms into a secure internet based EDC registry database via an eCRF All sites will be fully trained on the EDC by Outcome Site Management via webinar on how to utilize the EDC system and the guidance documents available as resources including eCRF completion guidelines and User Manuals The following instructions apply to general entry of the data If you experience any technical issues select Contact Us in the top right hand corner of the registry webpage You will
16. the patient is not easily aroused but responds purposely to repeated or painful stimuli ability to independently maintain ventilatory function may be impaired the patient may require assistance in maintaining a patent airway and spontaneous ventilation may be inadequate cardiovascular function is usually maintained e Select General anesthesia if there is a loss of consciousness and patient is not aroused even by painful stimuli ability to independently maintain ventilatory function is often impaired patients often require assistance in maintaining a patent airway and positive pressure ventilation may be required cardiovascular function may be impaired Deepest anesthesia level induced in patient is a required field and must be entered to save the Anesthesia form as Complete 2 Was an advanced airway Indicate whether an advanced airway was employed by employed selecting Yes or No Was an advanced airway employed is a required field and must be entered to save the Anesthesia form as Complete 2a If YES type of airway device If YES type of airway device field will be enabled if Yes is selected for Was an advanced airway employed If Yes is selected for Was an advanced airway employed you must select the type of airway device from the drop down list to save the Anesthesia form as Complete 2a 1 If Other specify If Other specify
17. then receive the toll free numbers listed above and will be provided with the option to create an email about the issue All data should be entered verbatim do not abbreviate CRF entries No punctuation should be used Do not use subscript or superscript when entering data on the eCRF Text exceeding field length will be flagged automatically by the EDC system Symbols should not be entered in the EDC system Ranges should not be entered into eCRF text fields i e 1 3 HR Quotes should not be used when entering data on the eCRF All text entries MUST be made in English To add an additional comment to any field click on the y icon this icon will Version 1 2 14 July 2011 Confidential Page 5 of 55 OUTC JME COPE COMPLETION ER appear after saving the form A new window will open for additional comments to be entered To save the comment click the Save Annotation button The types of edits that may appear in the Errors and Warnings window are CRITICAL ERROR and WARNING These messages are color coded to indicate their severity and the action that is required 1 CRITICAL messages are Red and must be addressed in order to save the form at all 2 ERROR messages are Dark Red and must be addressed in order to save the form with a status of Complete 3 WARNING messages are Grey and are informational These do not affect the saving the form These
18. was given check Other If Yes is selected for Vapor Agents you must select at least one agent to save the Anesthesia form as Complete DOSE Individual DOSE fields will be enabled if corresponding agent is selected Enter the maximum dose of a vapor anesthetic agent used even if the maximum dose is used only briefly If corresponding agent is selected you must specify dose to save the Anesthesia form as Complete UNITS Individual UNITS fields will be enabled if corresponding agent is selected If corresponding agent is selected you must specify units to save the Anesthesia form as Complete If the dose value is outside the expected range for a given unit then you must validate the entry to save the Anesthesia form as Complete This can be done by clicking the blue Validate link that is present below the error text in the Errors and Warnings window and providing the validation reason in the Validate Query window 6a 1 Other specify Other specify field will be enabled if Other is selected for If YES please specify If Other is checked for If YES please specify you must specify the vapor agent to save the Anesthesia form as Complete 7 Other Medications Indicate if patient was administered other medications by selecting Yes or No Other Medications is a required field and must be entered to
19. EE PRINTING BLANK FORMS eege annant nanata geg deeg eg aaea eegen DATA GOLLEC TION nosie enaa aa a a ar gad a EEE BO EE PATIENT IDENTIFIERS AND HEADER INFORMATION REPORTING DATES ciren eenia gege eege Deet ae Deeg EES veer 2 ECRF COMPLETION GUIDELINES 2 1 ANESTHESIA FORM ewcvvsenaccntiasensvvanceccbiaatersveaatencbvardavivvaacsnsveactariveagseutevaaderilVaadenllnactariveagdenivaadanlvees 2 1 1 Demographics Tab ch oss sch ch OoRWh A 212 ge ee TAD 555 oa wees tes nin Sates d arene neg ides va Sa e i vn tates ane ado 10 2 1 3 Procedure INFO Tab 15 2 1 4 Recovery Info Complications Tab 33 2 2 3 MOLAR EXTRACTION FORM visicccassvsucteosssasecouscvetandvasiecsscanntielietse dccdeinassaleacicvevsnaeiiagedsnatinscisde 37 2 2 1 3 Molar Extraction E 37 BOD 3 Molar Meds Tab erieiettegt ebe teknon nnen neo n ao En ee AD E D nann 43 233 3 Molar Follow Up Tab 2 3 SATISFACTION QUESTIONNAIRE FORM Version 1 2 14 July 201 1 Confidential Page 4 of 55 OUTC JME COPE COMPLETION BR 1 General Guidelines Electronic Case Report Form eCRF Completion Guidelines eCCGs provide assistance in completing the eCRF pages For additional questions regarding how to complete the forms or how to use the EDC system please refer to the EDC User Manual or contact the Help Desk at 1 1 1 2 1 3 Outcome support outcome com US amp Canada 888 526 6700 Username and Password Your Username and Password are needed to
20. Errors and Warnings provide guidance to the site on entering logical valid range appropriate information as specified in the protocol At the end of each form you have the option of saving the form as Complete or Incomplete You may only save the form as Complete if all CRITICAL and ERROR edits in the Errors and Warnings window have been resolved the data is accurate and the form is ready for an electronic signature You may save a form as Incomplete as long as all CRITICAL edits have been resolved If the form is saved as Incomplete the EDC system will save the most recently entered responses and the form can be updated at a later time NOTE Once the form is signed electronically only authorized Signature Users will have permission to modify it All forms must be signed at the end of the survey 1 4 Patient Data To enroll a new patient into the registry click the New Patient link on the main portal page after login You can also enroll a new patient by clicking the Enter New Patient link on the Patients tab After you have entered the information and ensured data accuracy select the Complete form option If you wish to save the data you have entered but want to return to the form to complete it at another time select the Incomplete option You will then have the option to Save and Exit the form or you can click Save and Continue Data Entry to move to the nex
21. OUTC ME ELECTRONIC CASE REPORT FORM COMPLETION GUIDELINES ASA OMS 2011 AAOMS Anesthesia and Third Molar Benchmark Study Version 1 2 14 July 201 1 OUTC 3 ME GUIDELINES eCRF COMPLETION APR OMS Revision History Document Date Author Description of Changes Version 0 1 02 Apr 2011 Matt Frano Initial draft 0 2 05 Apr 2011 Matt Frano Updated per client comments 1 0 11 Apr 2011 Stephan Rubin Corrected typo in client name updated Anesthesia End Time 1 1 18 May 2011 Stephan Rubin Updated sections based on client feedback 1 2 14 July 2011 Janet Marie Wilson Corrected instructions for Date of Birth and Weight Version 1 2 14 July 201 1 Confidential Page 2 of 55 OUTC JME CRE COMPLETION BA Signatures Approvals Document Prepared by Name and Function Matt Frano Clinical Data Manager Outcome Approval Name and Function Anastasia Derzko Associate Director Data Management Stephan Rubin Clinical Project Manager Sponsor Approval Name and Function Thomas Dodson Chair AAOMS Special Committee to Outcomes Version 1 2 14 July 2011 Confidential Page 3 of 55 eCRF COMPLETION APR OUTC ME GUIDELINES aN TABLE OF CONTENTS Je GENERAL GUIDELINES gege nues gebei DREES EeE ug USERNAME AND DAGSwWOnD ttit 11t ttt 1111r EEEE E EEEEEEEEEEEEEEEEEEEEEEEEEE EErEE
22. TION EXECUTED 1 Operation executed Individual Operation executed fields will be enabled if corresponding molar is selected for 3rd molar s extracted For each 3 molar extracted select the operation that was executed by selecting from the drop down list Please note that the definitions for the operation executed are different than the options for Preoperative classification of third molars extracted using the ADA codes The third molar is considered erupted if it is so positioned that the entire clinical crown is visible all five surfaces of the tooth can be examined for caries and there is attached gingival all around the tooth If the tooth does not meet the definition of an erupted tooth it is considered an impacted tooth There is no definition of a partially impacted tooth e Select Full bony impacted if molar was an impacted tooth that required an incision bone removal and sectioning of the tooth to remove it Select Full bony impacted difficult if molar was an impacted tooth that required an incision bone removal sectioning of the tooth to remove it and it was more difficult than usual Select Partial bony impacted if molar was an impacted tooth that required an incision and bone removal to remove the tooth Select Soft tissue impacted if molar was an impacted tooth that was removed and required an incision to access the tooth Select Erupted simple if molar w
23. Warnings window and providing the validation reason in the Validate Query window 4a 1 Other specify Other specify field will be enabled if Other is selected for If YES please specify If Other is checked for If YES please specify you must specify the parenteral benzodiazepine to save the Anesthesia form as Complete 5 Other Parenteral Anesthetics Indicate if patient was administered other parenteral anesthetics by selecting Yes or No Other Parenteral Anesthetics is a required field and must be entered to save the Anesthesia form as Complete Version 1 2 14 July 201 1 Confidential Page 23 of 55 OUTC JME COPE COMPLETION BR Field Question Instructions 5a If YES please specify If YES please specify field will be enabled if Yes is selected for Other Parenteral Anesthetics Select each drug administered as an other parenteral anesthetic for the surgical procedure Check all that apply If an agent other than those listed was given check Other If Yes is selected for Other Parenteral Anesthetics you must select at least one agent to save the Anesthesia form as Complete DOSE Individual DOSE fields will be enabled if corresponding agent is selected If corresponding agent is selected you must specify dose to save the Anesthesia form as Complete Indivi
24. and days For example April 2 2011 is entered as 04 02 2011 Date of Satisfaction Form Completed is a required field and must be entered to save the Satisfaction Questionnaire form as Complete Enter what the patient remembered about their anesthetic experience Check all that apply If none check None of the above Which of the following did the patient remember about their anesthetic experience is a required field and must be entered to save the Satisfaction Questionnaire form as Complete If patient received deep or general anesthesia was put to sleep or received other medications to relax them during the procedure select what the patient remembered about their anesthetic experience from the drop down list You can select only one response If not applicable select N A Local anesthetic alone or minimum sedation used If patient received deep or general anesthesia was put to sleep or received other medications to relax them during the procedure which of the following did they remember about their anesthetic experience is a required field and must be entered to save the Satisfaction Questionnaire form as Complete Select how satisfied the patient was with their anesthetic experience from the drop down list You can select only one response How Satisfied was the patient with their anesthetic experience is a required field and must be entered to save the Satisfaction
25. anesthetic was given F Discharge instructions E TF None of the above 3 If patient received deep or general anesthesia was put to sleep or received other medications to relax them during the procedure which of the following did they remember about their anesthetic experience p 4 How satisfied was the patient with their anesthetic experience 9 5 Would they recommend the same kind of anesthetic to a loved one p 6 How anxious would the patient be if he she were to have the same kind of anesthesia in the future D e Please indicate the current status of the form Complete Incomplete Save and Exit Form Save and Continue Data Entry Exit Without Saving Version 1 2 14 July 201 1 Confidential Page 55 of 55
26. aoperative postoperative complication s to final resolution of the third molar problem s or complication s 1 Antibiotics Antibiotics field will be enabled if any molar is selected for 3rd molar s extracted If any molar is selected for 3rd molar s extracted you must specify whether antibiotics were administered by selecting Yes or No to save the 3 Molar Extraction form as Complete 1a If YES please specify If YES please specify field will be enabled if Yes is selected for Antibiotics Question 1a is a repeat group Each created entry group is meant to capture the details for an individual antibiotic administered To add more antibiotics click Done after the first entry is completed and then click the Create Next Entry button to open a new blank record If Yes is selected for Antibiotics you must provide at least one agent to save the 3 Molar Extraction form as Complete Antibiotic Name Indicate the antibiotic name by selecting from the drop down list Select Other is antibiotic is not listed Other Antibiotic Name specify Other Antibiotic Name specify field will be enabled if Other is selected for Antibiotic Name If Other is selected for Antibiotic Name you must specify the other antibiotic to save the 27 Molar Extraction form as Complete Time Administered Time Administered f
27. as an erupted tooth removed without the use of a flap or sectioning or bone removal Select Erupted surgical if molar was an erupted tooth that required sectioning a flap or bone removal or any combination of the three techniques If corresponding molar is selected for 3rd molar s extracted you must specify the operation executed on the molar to save the 3 Molar Extraction form as Complete 2 Were there any intra operative Were there any intra operative complications field will complications be enabled if any molar is selected for 3rd molar s extracted If any molar is selected for 3rd molar s extracted you must specify whether there were any intra operative complications by selecting Yes or No to save the 3 Version 1 2 14 July 201 1 Confidential Page 39 of 55 OUTC 3 ME eCRF COMPLETION APR GUIDELINES OMS Field Question Instructions 2a If YES specify complications 2a 1 Other specify Molar Extraction form as Complete If YES specify complications field will be enabled if Yes is selected for Were there any intra operative complications Check all that apply Check Unplanned need for parenteral drugs fluids if the need was for other than blood or blood components If Yes is selected for Were there any intra operative complications you must select at least one complication to save
28. as given check Other If Yes is selected for Local Anesthetic you must select at least one agent to save the Anesthesia form as Complete Number of Dental Cartridges Individual Number of Dental Cartridges fields will be enabled if corresponding agent is selected If corresponding agent is selected you must specify number of dental cartridges to save the Anesthesia form as Complete If the number of dental cartridges value is outside the expected range then you must validate the entry to save the Anesthesia form as Complete This can be done by clicking the blue Validate link that is present below the error text in the Errors and Warnings window and providing the validation reason in the Validate Query window 2a 1 Other specify Other specify field will be enabled if Other is selected for If YES please specify If Other is checked for If YES please specify you must specify the local anesthetic to save the Anesthesia form as Complete 3 Narcotics Indicate if patient was administered narcotics by selecting Yes or No Narcotics is a required field and must be entered to save the Anesthesia form as Complete Version 1 2 14 July 201 1 Confidential Page 21 of 55 OUTC JME COPE COMPLETION BR Field Question Instructions 3a If YES please specify If YES please spe
29. atient ID Created 03 30 2011 16 43 00 Last Updated 03 30 2011 16 43 00 Legend clear Selection DW add annotation A show Warnings Show History 3RD MOLAR FOLLOW UP 1 Was at least one follow up visit conducted YES a noe y FOLLOW UP VISIT DATE 1 Date of Follow up fo D MM CO Yyyy POST OPERATIVE COMPLICATIONS 1 Post operative complications YES NO p Check all that apply Alveolar osteitis la Molars 1 16 17 32 Check all that apply DS Persistent postoperative pain 1b Molars 1 16 17 32 Check all that apply F4 Surgical site infection 1c Molars 1 16 17 32 Check all that apply D Delayed wound healing id Molars 1 16 17 32 Check all that apply D Inferior alveolar nerve injury Le Molars 17 329 Check all that apply Lingual nerve injury 1f Molars 17 327 Check all that apply Facial nerve dysfunction Unexpected prolonged trismus Unexpected prolonged hemorrhage Unplanned need for parenteral drugs fluids Unplanned transfusions of blood blood components Retention aspiration migration or ingestion of root tooth fragment Mandibular fracture Injury to adjacent tooth or restoration Oro antral or oro nasal fistula formation Condition requiring unplanned additional surgery ig Report details of condition requiring unplanned additional surgery OCS EA Death Other 1h Report details of Other post operative complication RP Unplanned hospital admission related to the procedur
30. cavity other than those associated with a third molar or involved a coronectomy of the third molar or removal of third molar root tips e Check Implant if the procedure involved the use of implants to rehabilitate and restore form and function to the edentulous or partially edentulous jaws and the craniomaxillofacial skeleton of patients utilizing fixed or removable prostheses or to assist stabilization of prostheses which replace missing maxillofacial parts such as the nose eyes and ears e Check Trauma if the procedure performed related to treatment of injuries to teeth and or supporting structures or to maxillofacial structures that occurred as a result of trauma e Check Pathology if the procedure was performed to treat diseases of the oral and maxillofacial region including diseases of bone soft tissue or salivary glands Such pathologic conditions may include for example cysts benign and malignant tumors infections and diseases of metabolism or function Version 1 2 14 July 201 1 Confidential Page 15 of 55 OUTC JME COPE COMPLETION ER Field Question Instructions e Check Orthognathic if the procedure involves surgical correction of maxillofacial skeletal deformities including reconstructive procedures that correct deformities of the jaws facial skeleton and associated soft tissues These abnormalities may be caused by genetic environmental developm
31. chronic conditions field will be enabled if ASA Il or above is selected for Patient ASA Class Indicate any chronic medical conditions the patient has at the time of surgery Check all that apply If the patient has a condition s not included among the options listed check Other If ASA II or above is selected for Patient ASA Class then at least one chronic medical condition must be selected to save the Anesthesia form as Complete 1a Other specify Other specify field will be enabled if Other is selected for Patient s chronic conditions If Other is checked for Patient s chronic conditions you must specify the chronic medical condition s to save the Anesthesia form as Complete RISK FACTORS 1 On average how many alcohol containing drinks does the patient consume each day Enter the number of alcohol containing drinks the patient consumes each day in format Please enter a number greater than or equal to zero One drink one oz of liquor or 1 glass of wine or one 12 oz beer On average how many alcohol containing drinks does the patient consume each day is a required field and must be entered to save the Anesthesia form as Complete 2 What is the patient s level of tobacco use Select the patient s level of tobacco use at the time of surgery from the drop down list What is the patient s level of tobacco us
32. cify field will be enabled if Yes is selected for Narcotics Select each drug administered as a narcotic for the surgical procedure Check all that apply If an agent other than those listed was given check Other If Yes is selected for Narcotics you must select at least one agent to save the Anesthesia form as Complete DOSE Individual DOSE fields will be enabled if corresponding agent is selected If corresponding agent is selected you must specify dose to save the Anesthesia form as Complete Individual UNITS fields will be enabled if applicable if SES corresponding agent is selected If corresponding agent is selected you must specify units to save the Anesthesia form as Complete If the dose value is outside the expected range for a given unit then you must validate the entry to save the Anesthesia form as Complete This can be done by clicking the blue Validate link that is present below the error text in the Errors and Warnings window and providing the validation reason in the Validate Query window 3a 1 Other specify Other specify field will be enabled if Other is selected for If YES please specify If Other is checked for If YES please specify you must specify the narcotic to save the Anesthesia form as Complete 4 Parenteral Benzodiazepines Indicate if patient was administered parent
33. d as 04 02 2011 Version 1 2 14 July 201 1 Confidential Page 49 of 55 OUTC 3 ME eCRF COMPLETION APR GUIDELINES OMS Field Question Instructions 1 Post operative complications 1a 1f Molars Indicate if any post operative complications occurred by selecting Yes or No If Yes is selected for Post operative complications you must select at least one complication to save the 3 Molar Extraction form as Complete Check all complications that apply A diagnosis of Alveolar osteitis is made if the following elements were present e By history there was a new onset or increasing pain more than 36 hours after the operation By examination there was a loss of the blood clot in the extraction site as evidenced by exposed bone gentle probing or irrigation of the wound duplicated the pain and there was significant pain relief after application of an anodyne dressing All elements needed to be present to make the diagnosis of Alveolar osteitis If the elements are not present then consider persistent postoperative pain or surgical site infection as alternative diagnostic options Persistent postoperative pain is defined as that requiring an additional prescription or other interventions e g placement of a dressing for management more than 7 days after the operation Surgical site infection is made if there is visual evidence of frank purulence in the e
34. dual UNITS fields will be enabled if applicable if i corresponding agent is selected If corresponding agent is selected you must specify units to save the Anesthesia form as Complete If the dose value is outside the expected range for a given unit then you must validate the entry to save the Anesthesia form as Complete This can be done by clicking the blue Validate link that is present below the error text in the Errors and Warnings window and providing the validation reason in the Validate Query window 5a 1 Other specify Other specify field will be enabled if Other is selected for If YES please specify If Other is checked for If YES please specify you must specify the other parenteral anesthetic to save the Anesthesia form as Complete 6 Vapor Agents Indicate if patient was administered vapor agents by selecting Yes or No Vapor Agents is a required field and must be entered to save the Anesthesia form as Complete Version 1 2 14 July 201 1 Confidential Page 24 of 55 OUTC JME COPE COMPLETION BR Field Question Instructions 6a If YES please specify If YES please specify field will be enabled if Yes is selected for Vapor Agents Select each drug administered as a vapor agent for the surgical procedure Check all that apply If an agent other than those listed
35. e Version 1 2 14 July 201 1 Confidential Page 52 of 55 OUTCDME eCRF COMPLETION GUIDELINES ah 1i Report details of unplanned hospitalization admission related to the procedure 2 Days of usual activity missed due to the procedure Please indicate the current status of the form Complete Incomplete Save and Exit Form Save and Continue Data Entry Co PB 3RD MOLAR FOLLOW UP Delete Entry Exit Without Saving Version 1 2 14 July 201 1 Confidential Page 53 of 55 eCRF COMPLETION GUIDELINES OUTC 3 ME 2 3 Satisfaction Questionnaire Form Field Question Images SOS PATIENT ANESTHESIA SATISFACTION FORM General Instructions e The patient will be asked to complete the satisfaction form either just after their procedure involving anesthesia or at a follow up visit 1 Date of Satisfaction Form Completed 2 Which of the following did the patient remember about their anesthetic experience 3 If patient received deep or general anesthesia was put to sleep or received other medications to relax them during the procedure which of the following did they remember about their anesthetic experience 4 How satisfied was the patient with their anesthetic experience Enter the date the satisfaction form was completed using an 8 digit format with the month day and 4 digit year Use leading zeros before single digit months
36. e is a required field and must be entered to save the Anesthesia form as Complete Version 1 2 14 July 201 1 Confidential Page 10 of 55 OUTC JME COPE COMPLETION AL Field Question Instructions 2a How many packs per day How many packs per day field will be enabled if Past Smoker or Current Smoker is selected for What is the patient s level of tobacco use It is acceptable to enter fractional packs For example if a patient reports smoking 5 cigarettes a day that would be 0 25 packs per day If Past Smoker or Current Smoker is selected for What is the patient s level of tobacco use you must enter the number of packs smoked each day in to save the Anesthesia form as Complete 2b How many years was tobacco How many years was tobacco used field will be used enabled if Past Smoker or Current Smoker is selected for What is the patient s level of tobacco use It is acceptable to enter fractional years For example if a patient reports smoking for two and a half years that would be 2 5 years If Past Smoker or Current Smoker is selected for What is the patient s level of tobacco use you must enter the number of years tobacco was used in to save the Anesthesia form as Complete 2c Pack years of smoking Field will be automatically calculated by the EDC system and is
37. e cause of death listed on the death certificate For example if a patient arrests and dies following severe hemorrhage the primary cause of death listed on the death certificate may be cardiorespiratory arrest but the underlying reason the patient went into arrest was exsanguination In this case you would record exsanguination as the cause of death Similarly fora patient who arrested and died as a result of fulminant sepsis you should record sepsis as the cause of death If Death is selected for If YES what was the outcome of complication you must specify the cause of death to save the Anesthesia form as Complete Version 1 2 14 July 201 1 Confidential Page 35 of 55 CRF COMPLETION APR OUTCERME Scipetnes ous Anesthesia Patient ID Created 03 30 2011 16 42 59 Last Updated 03 30 2011 16 42 59 Legend Clear Selection D Add Annotation A Show Warnings Show History RECOVERY INFO COMPLICATIONS PATIENT RECOVERY 1 Time anesthesia started Lem gt GP 24 Hour Clock Skip if only local anesthesia used MM OD ren HH MI 2 Time anesthesia ended La gt GP 24 Hour Clock Skip if only local anesthesia used MM D rent HH MI 3 Time discharged NN gt 24 Hour Clock Skip if only local anesthesia used wu D ren HH MI 4 Anesthesia related complications experienced by the patient Check all that apply Vomiting without aspirati
38. e the Anesthesia form as Complete 5 EMS 911 system activated Indicate whether EMS 911 system activated by selecting Yes or No EMS 911 system activated is a required field and must be entered to save the Anesthesia form as Complete 6 Was patient hospitalized for any Indicate whether patient hospitalized for any reason reason within 48 hours after within 48 hours after discharge by selecting Yes or No discharge Was patient hospitalized for any reason within 48 hours after discharge is a required field and must be entered to save the Anesthesia form as Complete 6a If YES please provide admitting If YES please provide admitting diagnosis field will be diagnosis enabled if Yes is selected for Was patient hospitalized for any reason within 48 hours after discharge If Yes is selected for Was patient hospitalized for any reason within 48 hours after discharge you must provide admitting diagnosis to save the Anesthesia form as Complete 6b If YES was the hospitalization If YES was the hospitalization due to anesthetic field due to anesthetic will be enabled if Yes is selected for Was patient hospitalized for any reason within 48 hours after discharge If Yes is selected for Was patient hospitalized for any reason within 48 hours after discharge you must specify if the hospitalization
39. ecify r D ANESTHESIA LEVEL INDUCED 1 Deepest anesthesia level induced in patient 2 Was an advanced airway employed 2a If YES type of airway device 2a 1 If Other specify 2b Was use of the airway device 2b 1 Describe emergent circumstances Version 1 2 14 July 201 1 p YES no y Jp y E 9 p Confidential Page 28 of 55 OUTC 3ME eCRF COMPLETION GUIDELINES OMS SEDATIVE PREMEDICATIONS ADMINISTERED 1 Was the patient administered sedative premedications la If YES please specify Check all that apply Diazepam Valium Midazolam Versed Fentanyl Sublimaze Chloral hydrate Noctec Lorazepam Ativan Droperidol Inapsine Ketamine Ketamine HCI Ketalar Pentobarbital Nembutal Triazolam Halcion 7 Promethazine Phenergan Zolpidem Ambien M Meperidine Demerol C Temazepam Restoril Diphenhydramine Benadryl a Hydoxyzine Vistaril Other YES noe P TOTAL DOSE 1a 1 Other specify r D SM SW SW d SS SS SS SS d UNITS ROUTE mg PO B y mg PO D mg IM ma 18 D mg PO mg P0 l mg IM mg PO Jy D Jy MEDICATIONS ADMINISTERED 1 Was supplemental oxygen administered 2 Local Anesthetic 2a If YES please specify Check all that apply Mepivacaine Plain 3 Carbocaine Mepivacaine 2 with vasoconstrictor Carbocaine Etidocaine 1 5 with epi Duranest
40. ental functional and or pathological aberrations apparent at birth or manifested in subsequent growth and development or acquired through trauma neoplastic processes and degenerative diseases e Check Cosmetic non orthognathic if the procedure involved enhancing and improving form and appearance of the maxillofacial region e Check Reconstructive if the procedure involved surgical correction of soft and or hard tissue defects of the jaws face and contiguous structures including reduction revision augmentation grafting and implantation for the correction or replacement of defective structures to assist in restoring functions to the compromised patient e Check Diagnostic block if the procedure involved injection of nerve or soft tissue with local anesthetic or other pharmaceutical in order to determine the source of pain e Check TMJ if the procedure involved treatment of pathologic conditions involving the temporomandibular joint e Check Other if the intraoral procedure type is not included among the options listed If 3 molar is checked you should complete the ga Molar Extraction eCRF upon completion of the Anesthesia eCRF You may complete the 3 Molar Extraction eCRF even if you have not yet completed the Satisfaction Questionnaire eCRF Procedures performed on patient is a required field and must be entered to save the Anesthesia form as Complete Version
41. entilatory and cardiovascular functions are unaffected Per the AAOMS position paper on enteral sedation and the use of a combination of enteral and inhalation sedation minimal sedation would be either 1 less than 50 nitrous oxide in oxygen with no other sedative or analgesic medications by any route with or without local anesthesia or 2 a single oral sedative or analgesic medication in doses appropriate for the unsupervised treatment of insomnia anxiety or pain Or if oral agents are used incrementally or supplemented to a total dosage of 1 5 of the initial dose and or combined with nitrous oxide oxygen then the level of anesthesia is beyond minimal e Select Moderate Sedation if there is depressed consciousness but the patient responds purposely not simply reflex withdrawal to painful stimuli to verbal commands either alone or accompanied by light tactile stimulation no interventions are required to maintain a patent airway and spontaneous ventilation is adequate cardiovascular function is usually maintained The administration of incremental and supplemental doses of oral agents and the use Version 1 2 14 July 201 1 Confidential Page 17 of 55 eCRF COMPLETION APA OUTC ME GUIDELINES PA Field Question Instructions of inhalational enteral sedation qualifies as at least moderate sedation e Select Deep Sedation if there is depressed consciousness and
42. eral benzodiazepines by selecting Yes or No Parenteral Benzodiazepines is a required field and must be entered to save the Anesthesia form as Complete Version 1 2 14 July 201 1 Confidential Page 22 of 55 OUTC JME COPE COMPLETION BR Field Question Instructions 4a If YES please specify If YES please specify field will be enabled if Yes is selected for Parenteral Benzodiazepines Select each drug administered as a parenteral benzodiazepine for the surgical procedure Check all that apply If an agent other than those listed was given check Other If Yes is selected for Parenteral Benzodiazepines you must select at least one agent to save the Anesthesia form as Complete DOSE Individual DOSE fields will be enabled if corresponding agent is selected If corresponding agent is selected you must specify dose to save the Anesthesia form as Complete Individual UNITS fields will be enabled if applicable if i corresponding agent is selected If corresponding agent is selected you must specify units to save the Anesthesia form as Complete If the dose value is outside the expected range for a given unit then you must validate the entry to save the Anesthesia form as Complete This can be done by clicking the blue Validate link that is present below the error text in the Errors and
43. f 55 EE COPE COMPLETION ER 2 2 3 3 Molar Follow Up Tab Field Question Instructions 1 Was at least one follow up visit Was at least one follow up visit conducted field will conducted be enabled if any molar is selected for 3rd molar s extracted If any molar is selected for 3rd molar s extracted you must specify whether at least one follow up visit was conducted by selecting Yes or No to save the 3 Molar Extraction form as Complete General Instructions e FOLLOW UP VISIT DATE and POST OPERATIVE COMPLICATIONS sections will be enabled if Yes is selected for Was at least one follow up visit conducted FOLLOW UP VISIT DATE and POST OPERATIVE COMPLICATIONS sections are a repeat group Each created entry group is meant to capture the details for an individual follow up visit To add more follow up visits click Done after the first entry is completed and then click the Create Next Entry button to open a new blank record If Yes is selected for Was at least one follow up visit conducted you must provide at least one follow up visit record to save the 3 Molar Extraction form as Complete FOLLOW UP VISIT DATE 1 Date of Follow up Enter the date of the follow up visit using an 8 digit format with the month day and 4 digit year Use leading zeros before single digit months and days For example April 2 2011 is entere
44. field will be enabled if anything other than Local anesthesia alone is selected for Deepest anesthesia level induced in patient on the Procedure Info tab If anything other than Local anesthesia alone is selected for Deepest anesthesia level induced in patient on the Procedure Info tab please specify the time anesthesia started time at which an enteral inhalation or intravenous medication is initially administered with the intent to begin inducing the planned anesthetic in HH MM format 24 Hour Clock to save the Anesthesia form as Complete 2 Time anesthesia ended Time anesthesia ended field will be enabled if anything other than Local anesthesia alone is selected for Deepest anesthesia level induced in patient on the Procedure Info tab If anything other than Local anesthesia alone is selected for Deepest anesthesia level induced in patient on the Procedure Info tab you must specify the time anesthesia ended The time at which the surgeon or anesthetist transfers care to the recovery room personnel as evidenced by his her leaving the treatment room operative suite in HH MM format 24 Hour Clock to save the Anesthesia form as Complete 3 Time discharged Time discharged field will be enabled if anything other than Local anesthesia alone is selected for Deepest anesthesia level induced in patient on the Procedure Info tab Time discha
45. ield will be enabled if Antibiotic Name is provided If Antibiotic Name is provided you must specify the time the antibiotic was administered by selecting from the drop down list to save the 3 Molar Extraction form as Complete Version 1 2 14 July 201 1 Confidential Page 43 of 55 OUTC JME COPE COMPLETION ER Field Question Instructions Route field will be enabled if Antibiotic Name is provided If Antibiotic Name is provided you must specify the route the antibiotic was administered by selecting from the drop down list to save the 3 Molar Extraction form as Complete 2 Other Chemotherapeutics Other Chemotherapeutics field will be enabled if any molar is selected for 3rd molar s extracted If any molar is selected for 3rd molar s extracted you must specify whether other chemotherapeutics were administered by selecting Yes or No to save the 3 Molar Extraction form as Complete 2a If YES please specify If YES please specify field will be enabled if Yes is selected for Other Chemotherapeutics Select each drug administered as an other chemotherapeutic Check all that apply If an agent other than those listed was given check Other If Yes is selected for Other Chemotherapeutics you must select at least one agent to save the 3 Molar Extraction form as Complete I
46. it Form Save and Continue Data Entry Exit Without Saving Version 1 2 14 July 2011 Confidential Page 14 of 55 EE COPE COMPLETION ER 2 1 3 Procedure Info Tab Field Question Instructions PREOPERATIVE LEVEL OF ANXIETY 1 Patient s self reported Indicate the level of the patient s anxiety regarding the preoperative level of anxiety anesthesia before the anesthesia is administered by regarding anesthesia selecting from the drop down list Obtain this information by reading the question and response options to the patient and asking the patient to choose the single best response option Do not use your own impression of the patient s level of anxiety to answer this question Patient s self reported preoperative level of anxiety regarding anesthesia is a required field and must be entered to save the Anesthesia form as Complete PROCEDURES PERFORMED ON PATIENT 1 Procedures performed on patient Check all types of intraoral procedures that were performed during this operative visit Check all that apply e Check None if no procedures were performed e Check 3 Molar Extraction if the procedure performed involved the third molar extraction Do not include extraction of retained third molar root tips planned coronectomy or supernumerary teeth e Check Dentoalveolar if the procedure performed involved teeth and supporting structures associated with the oral
47. n MM DD YYYY format e g April 02 2011 would be entered 04 02 2011 Version 1 2 14 July 201 1 Confidential Page 7 of 55 EE COPE COMPLETION BR 2 eCRF COMPLETION GUIDELINES 2 1 Anesthesia Form 2 1 1 Demographics Tab Field Question Instructions SURGERY DATE 1 Date of Surgery Enter the date of the surgery using an 8 digit format with the month day and 4 digit year Use leading zeros before single digit months and days For example April 2 2011 is entered as 04 02 2011 Date of Surgery is a required field and must be entered to save the Anesthesia form 2 Medical Record Number Enter the medical record number assigned to the patient Medical Record Number is a required field and must be entered to save the Baseline form DEMOGRAPHY 1 Date of Birth Enter the date of the birth using an 8 digit format with the month day and 4 digit year Use leading zeros before single digit months and days For example April 2 2011 is entered as 04 02 2011 Date of Birth is a required field and must be entered to save the Anesthesia form as Complete 2 Patient Age Field will be automatically calculated by the EDC system and is based on the date of surgery and the date of birth 3 Patient Sex Select whether the patient is Male or Female Patient Sex is a required field and must be entered to save the Anesthesia form as
48. n of an erupted tooth it is considered an impacted tooth There is no definition of a partially impacted tooth e Select Erupted surgical D7210 if a mucoperiosteal flap is elevated or the tooth sectioned or bone removed Select Erupted nonsurgical D7140 if the tooth is removed without making a soft tissue incision or sectioning the tooth or removing bone Select Soft tissue D7220 if the occlusal surface of tooth partially or completely covered by soft tissues requires mucoperiosteal flap Version 1 2 14 July 201 1 Confidential Page 37 of 55 OUTC 3 ME eCRF COMPLETION APR GUIDELINES OMS elevation Select Partial bony D7230 if part of the crown is covered by bone requires mucoperiosteal flap elevation and bone removal Select Full bony D7240 if most or all of crown covered by bone requires mucoperiosteal flap elevation and bone removal Select Full bony difficult D7241 if most or all of the crown is covered by bone requires mucoperiosteal flap bone removal and is difficult If corresponding molar is selected for 3rd molar s extracted you must specify the preoperative classification of the molar by selecting from the drop down list to save the 3 Molar Extraction form as Complete 3 Preoperative pathology abnormal Individual Preoperative pathology abnormal finding if finding if any of the planned extractions
49. ndividual DOSE fields will be enabled if corresponding agent is selected If corresponding agent is selected you must specify dose to save the 3 Molar Extraction form as Complete Individual UNITS fields will be enabled if corresponding agent is selected If corresponding agent is selected you must specify units to save the 3 Molar Extraction form as Complete 2a 1 Other specify If Other specify field will be enabled if Other is selected for If YES please specify If Other is selected for If YES please specify you must specify the other chemotherapeutic to save the 3 Molar Extraction form as Complete 3 Intrasocket Dressing Intrasocket Dressing field will be enabled if any molar is selected for 3rd molar s extracted If any molar is selected for 3rd molar s extracted you must specify whether intrasocket dressings were administered by selecting Yes or No to save the 3 Molar Extraction form as Complete Version 1 2 14 July 201 1 Confidential Page 44 of 55 OUTC 3 ME eCRF COMPLETION APR GUIDELINES OMS Field Question Instructions 3a If YES please specify 3a 1 Other specify 4 Pain medications prescribed recommended Aa If YES please specify 4a 1 Other specify 5 Other medications If YES please specify field will be enabled if Yes is selected for
50. on Vomiting with aspiration Laryngospasm Bronchospasm Respiratory arrest hypoventilation requiring intervention New cardiac arrhythmia requiring intervention Syncope Tachycardia Seizure New neurological impairment Prolonged emergence from anesthesia Venipuncture complication Airway obstruction requiring intervention Other 4a Other specify p D 5 EMS 911 system activated e YES HOI 6 Was patient hospitalized for any reason within 48 YES A VO hours after discharge d j 6a If YES please provide admitting diagnosis Pp 6b If YES was the hospitalization due to anesthetic YES NO D 6c If YES what was the outcome of complication No residual effects Residual effects 6c 1 Specify residual effects D Death 6c 2 Indicate cause of death IT D el RECOVERY INFO COMPLICATIONS Please indicate the current status of the form Complete Incomplete _ Save and Exit Form Save and Continue Data Entry Version 1 2 14 July 2011 Confidential Page 36 of 55 OUTC JME COPE COMPLETION BR 22 3 Molar Extraction Form 2 2 1 3 Molar Extraction Tab Field Question Instructions THIRD MOLAR EXTRACTION 1 3rd molar s extracted Indicate the 3rd molar s extracted by selecting from the available options Check all that apply excluding retained r
51. oot tips planned coronectomy or supernumerary teeth If 3 molar extraction was planned however no 3 molars are extracted then check None 3rd molar s extracted is a required field and must be entered to save the 3 Molar Extraction form as Complete 1a Explain None Explain None field will be enabled if None is selected for 3rd molar s extracted There may be some circumstance where no 3 molars are extracted e g procedure aborted after inducing or administering anesthesia In this circumstance check None for 3rd molar s extracted and explain briefly why no 3 molars were removed If None is selected for 3rd molar s extracted you must enter an explanation for why no 3rd molar s were extracted to save the 3 Molar Extraction form as Complete 2 Preoperative ADA billing code Individual Preoperative classification of third molars classification of third molars extracted fields will be enabled if corresponding molar extracted is selected for 3rd molar s extracted Indicate the preoperative classification of the 3 molars extracted using the ADA codes based on clinical and radiologic findings The third molar is considered erupted if it is so positioned that the entire clinical crown is visible all five surfaces of the tooth can be examined for caries and there is attached gingival all around the tooth If the tooth does not meet the definitio
52. ost operative complication If Other is selected as a post operative complication you must enter the details of the other post operative complication to save the 3 Molar Extraction form as Complete 1i Report details of unplanned Report details of unplanned hospitalization admission hospitalization admission related to related to the procedure field will be enabled if the procedure Unplanned hospital admission related to the procedure is selected as a post operative complication If Unplanned hospital admission related to the procedure is selected as a post operative complication you must enter the details of the unplanned hospitalization admission related to the procedure to save the 3 Molar Extraction form as Complete 2 Days of usual activity missed due Days of usual activity missed due to the procedure is to the procedure outside of the repeat group and can only be answered once Days of usual activity missed due to the procedure field will be enabled if any molar is selected for 3rd molar s extracted If any molar is selected for 3rd molar s extracted you must specify the number of days of usual activity missed due to the procedure in format to save the 3 Molar Extraction form as Complete Version 1 2 14 July 201 1 Confidential Page 51 of 55 CRF COMPLETION OUTC TIME GUIDELINES OMS 3rd Molar Extraction P
53. penes OMS 3rd Molar Extraction Patient ID Created 03 30 2011 16 43 00 Last Updated 03 30 2011 16 43 00 Legend clear Selection Wadd Annotation show Warnings Show History Ess Ee MEDICATIONS PRESCRIBED 1 Antibiotics ves no p la If YES please specify Indicate al that apply Antibiotic Name Other Antibiotic Name specify Time Administered Route Jy i y Jy y 2 Other Chemotherapeutics ves no y 2a If YES please specify DOSE UNITS Peridex CS CS Other D D 2a 1 Other specify p y 3 Intrasocket Dressing ves a no y 3a If YES please specify Gel Foam Tetracycline Clindamycin Other 3a 1 Other specify FA D 4 Pain medications prescribed recommended YES NO D 4a If YES please specify Check all that apply Acetaminophen Acetaminophen with codeine Acetaminophen with oxycodone Ibuprofen Naproxen Acetaminophen with hydrocodone Tramadol Other 4a 1 Other specify D Version 1 2 14 July 201 1 Confidential Page 47 of 55 CRF COMPLETION APR OUTC ME GUIDELINES AY 5 Other medications ves noe y 5a If YES please specify Indicate all that apply Other medication specify D 3RD MOLAR MEDS Please indicate the current status of the form Complete Incomplete Save and Exit Form Save and Continue Data Entry Exit Without Saving Version 1 2 14 July 201 1 Confidential Page 48 o
54. rged is the time the patient is medically cleared for discharge and should not include any additional time that a patient may wait for the designated responsible person to bring the patient home If anything other than Local anesthesia alone is selected for Deepest anesthesia level induced in patient on the Procedure Info tab you must specify the time discharged in HH MM format 24 Hour Clock to save the Anesthesia form as Complete Version 1 2 14 July 201 1 Confidential Page 33 of 55 OUTC JME COPE COMPLETION AL 4 Anesthesia related complications Select any anesthesia related complications experienced experienced by the patient by the patient whether the complications were transient or were associated with residual adverse effects Check all that apply Check Prolonged emergence from anesthesia if emergence occurred beyond the time you deemed appropriate for the particular patient and procedure under consideration Check Other if a complication occurred that is not included in the list provided If none leave this field blank 4a Other specify Other specify field will be enabled if Other is selected for Anesthesia related complications experienced by the patient If Other is checked for Anesthesia related complications experienced by the patient you must specify the anesthesia related complications experienced by the patient to sav
55. rm as Complete This can be done by clicking the blue Validate link that is present below the error text in the Errors and Warnings window and providing the validation reason in the Validate Query window 1a 1 Other specify Other specify field will be enabled if Other is selected for If YES please specify If Other is checked for If YES please specify you must specify the sedative premedication to save the Anesthesia form as Complete MEDICATIONS ADMINISTERED 1 Was supplemental oxygen administered Indicate if patient was administered supplemental oxygen by selecting Yes or No Was supplemental oxygen administered is a required field and must be entered to save the Anesthesia form as Complete Version 1 2 14 July 201 1 Confidential Page 20 of 55 OUTC JME COPE COMPLETION ER Field Question Instructions 2 Local Anesthetic Indicate if patient was administered local anesthetic by selecting Yes or No Local Anesthetic is a required field and must be entered to save the Anesthesia form as Complete 2a If YES please specify If YES please specify field will be enabled if Yes is selected for Local Anesthetic Select each drug administered as a local anesthetic for the surgical procedure Check all that apply If an agent other than those listed w
56. save the Anesthesia form as Complete Version 1 2 14 July 201 1 Confidential Page 25 of 55 OUTC 3 ME eCRF COMPLETION APR GUIDELINES OMS Field Question Instructions 7a If YES please specify DOSE UNITS If YES please specify field will be enabled if Yes is selected for Other Medications Select each drug administered as an other medication for the surgical procedure Check all that apply If an agent other than those listed was given check Other If Yes is selected for Other Medications you must select at least one agent to save the Anesthesia form as Complete Individual DOSE fields will be enabled if corresponding agent is selected If corresponding agent is selected you must specify dose to save the Anesthesia form as Complete Individual UNITS fields will be enabled if applicable if corresponding agent is selected If corresponding agent is selected you must specify units to save the Anesthesia form as Complete If the dose value is outside the expected range for a given unit then you must validate the entry to save the Anesthesia form as Complete This can be done by clicking the blue Validate link that is present below the error text in the Errors and Warnings window and providing the validation reason in the Validate Query window 7a 1 Other specify Other specif
57. sia form as Complete Enter patient s weight in pounds or kilograms in format Provide units by selecting Ibs or kg The expected range is 66 1 330 7 Ibs or 30 150 kg If the weight value is outside the expected range for a given unit then you must validate the entry to save the Anesthesia form as Complete This can be done by clicking the blue Validate link that is present below the error text in the Errors and Warnings window and providing the validation reason in the Validate Query window Weight is a required field and must be entered to save the Anesthesia form as Complete Field will be automatically calculated by the EDC system and is based on the height and weight data entered regardless of whether it is entered in terms of the English or metric measures Version 1 2 14 July 201 1 Confidential Page 12 of 55 eCRF COMPLETION APR OUTC ME GUIDELINES OMS Anesthesia Patient ID Created 03 30 2011 16 42 59 Last Updated 03 30 2011 16 42 59 Legend Clear Selection D Add Annotation A Show Warnings m Show History o d PATIENT ASA CLASS 1 Patient ASA Class ASA 1 A patient with mild systemic disease P Please note that if patient s ASA class is ASA II or above then at least one chronic condition needs to be checked in the next section CHRONIC CONDITIONS 1 Patient s chronic conditions Please select all that apply
58. t form The system will alert you to any missing patient information prior to moving to the next form The completed form will be saved as a Date Link on the Patient Grid The Patient Grid is where you will see all saved patient forms Within the Patient Grid you will also have the ability to enter new forms for the patient Refer to the User Manual link located within the top right corner of the EDC system for further information on the Patient Grid 1 5 Patient Identifiers and Header Information The patient ID will be obtained at the time of enrollment As soon as the Anesthesia form is saved the patient will automatically be assigned a unique Patient ID in the following format The first part of the ID represents the Site ID The second part of the ID represents the unique patient number The Clinic ID and patient ID will not need to be entered at each visit and will populate automatically at the top of the screen after initial entry at the Baseline visit Version 1 2 14 July 201 1 Confidential Page 6 of 55 OUTC 3 ME eCRF COMPLETION GUIDELINES eS 1 6 Reporting Dates Many date fields for this registry require Month Day and Year in order to save the eCRF as Complete Each visit contact requires a Date to be entered at the top of the eCRF Next to each date field there is a calendar window in which dates can be selected to ease data entry All Dates are i
59. the 3 Molar Extraction form as Complete If Other specify field will be enabled if Other is selected for If YES specify complications If Other is selected for If YES specify complications you must specify the other complications to save the SH Molar Extraction form as Complete Version 1 2 14 July 201 1 Confidential Page 40 of 55 OUTC 3ME eCRF COMPLETION GUIDELINES OMS 1 3rd molar s extracted TP None 1 16 17 32 D Molar Classification 1 16 17 NM kW SW 32 Check all that apply exclude retained root tips or planned coronectomy 1a Explain None IS 2 Preoperative classification of third molars extracted 3 Preoperative pathology abnormal finding if any of the planned extractions Legend Clear Selection WD Add annotation d show Warnings Show History aro notan neos Erres THIRD MOLAR EXTRACTION 3rd Molar Extraction Patient ID Created 03 30 2011 16 43 00 Last Updated 03 30 2011 16 43 00 Check all that apply None disease free M3 16 17 32 D D D Caries 1 16 17 32 Periodontal disease 1 16 17 32 Acute chronic infection 1 16 17 32 Pathology of adjacent tooth due to 3rd molar 1 16 17 32 Acute chronic infection of adjacent tissues 1 16 17 32 Cyst Tumor 1 16 17 32 Fractured tooth or root 1 16 17 32 Internal or external resorption 1 16 17 32 Mandibular fract
60. tions by selecting Yes or No Was the patient administered sedative premedications is a required field and must be entered to save the Anesthesia form as Complete Version 1 2 14 July 201 1 Confidential Page 19 of 55 OUTC 3 ME eCRF COMPLETION GUIDELINES Field Question Instructions 1a If YES please specify TOTAL DOSE UNITS ROUTE If YES please specify field will be enabled if Yes is selected for Was the patient administered sedative premedications Select each drug administered as a sedative premedication for the surgical procedure Check all that apply If an agent other than those listed was given check Other If Yes is selected for Was the patient administered sedative premedications you must select at least one agent to save the Anesthesia form as Complete Individual TOTAL DOSE fields will be enabled if corresponding agent is selected If corresponding agent is selected you must specify total dose to save the Anesthesia form as Complete Individual UNITS ROUTE fields will be enabled if applicable if corresponding agent is selected If corresponding agent is selected you must specify units and route to save the Anesthesia form as Complete If the total dose value is outside the expected range for a given unit then you must validate the entry to save the Anesthesia fo
61. ure 1 16 17 32 Unopposed hyper erupted and or non functional 1 16 17 32 Other 1 16 17 32 D P4 D Version 1 2 14 July 201 1 Confidential Page 41 of 55 eCRF COMPLETION OUTC ME GUIDELINES OMS OPERATION EXECUTED 1 Operation executed Molar Classification 1 16 17 32 KKK 2 Were there any intra operative complications YES VO y Za If YES specify complications Check all that apply Inferior alveolar nerve injury Lingual nerve injury Unexpected prolonged hemorrhage Unplanned need for parenteral drugs fluids Unplanned transfusions of blood blood components Retention aspiration migration or ingestion of root tooth fragment Maxillary fracture Mandibular fracture Injury to adjacent tooth or restoration Condition requiring unplanned additional surgery Death Other 2a 1 Other specify 7 r 3RD MOLAR EXTRACTION Please indicate the current status of the form Complete Incomplete Save and Exit Form Save and Continue Data Entry Version 1 2 14 July 201 1 Confidential Exit Without Saving Page 42 of 55 OUTC JME COPE COMPLETION ER 2 2 2 3 Molar Meds Tab Field Question MEDICATIONS PRESCRIBED General Instructions e Only record medications that were prescribed for outpatient use e Indicate the medications that were prescribed for outpatient use from the time of detection of preoperative pathology abnormal finding s or intr
62. was due to the anesthetic by selecting Yes or No to save the Anesthesia form as Complete Version 1 2 14 July 201 1 Confidential Page 34 of 55 OUTC JME E AR 6c If YES what was the outcome of If YES what was the outcome of complication field will complication be enabled if Yes is selected for Was patient hospitalized for any reason within 48 hours after discharge If the patient fully recovered mark No residual effects If the patient recovered but suffered residual adverse effects as a result of the complication mark Residual Effects If the patient died mark Death If Yes is selected for Was patient hospitalized for any reason within 48 hours after discharge you must specify if the outcome of complication to save the Anesthesia form as Complete 6c 1 Specify residual effects Specify residual effects field will be enabled if Residual effects is selected for If YES what was the outcome of complication If Residual effects is selected for If YES what was the outcome of complication you must specify the residual effects to save the Anesthesia form as Complete 6c 2 Indicate cause of death Indicate cause of death field will be enabled if Death is selected for If YES what was the outcome of complication The cause you enter may or may not be the immediat
63. xtraction sites at any time postoperatively or unexpected pain and swelling warranting operative intervention or prescribing antibiotics Delayed healing was defined as an extraction site with incomplete coverage by soft tissue within 21 days of the operation with or without additional treatment Individual Molars fields will be enabled if corresponding post operative complication is checked Check all molars that were affected by the post operative complication If corresponding post operative complication is checked you must select at least one molar that was affected to save the 3 Molar Extraction form as Complete Version 1 2 14 July 201 1 Confidential Page 50 of 55 OUTC JME COPE COMPLETION BR Field Question Instructions 1g Report details of condition Report details of condition requiring unplanned requiring unplanned additional additional surgery field will be enabled if Condition surgery requiring unplanned additional surgery is selected as a post operative complication If Condition requiring unplanned additional surgery is selected as a post operative complication you must enter the details of condition requiring unplanned surgery to save the 3 Molar Extraction form as Complete th Report details of Other post Report details of Other post operative complication operative complication field will be enabled if Other is selected as a p
64. y field will be enabled if Other is selected for If YES please specify If Other is checked for If YES please specify you must specify the other medication to save the Anesthesia form as Complete ANESTHESIA ADMINISTERED 1 Was anesthesia administered intravenously Indicate whether anesthesia was administered intravenously by selecting Yes or No Was anesthesia administered intravenously is a required field and must be entered to save the Anesthesia form as Complete 1a If YES please specify flow If YES please specify flow field will be enabled if Yes is selected for Was anesthesia administered intravenously If Yes is selected for Was anesthesia administered intravenously you must specify the flow by selecting from the drop down list to save the Anesthesia form as Complete Version 1 2 14 July 201 1 Confidential Page 26 of 55 OUTC 3 ME eCRF COMPLETION GUIDELINES Field Question Instructions 1b If YES please specify access device If YES please specify access device field will be enabled if Yes is selected for Was anesthesia administered intravenously If Yes is selected for Was anesthesia administered intravenously you must select the access device type to save the Anesthesia form as Complete 2 Anesthetist Provider

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