J Oral Maxillofac Surg. 2004 ... The numbers of signs, symptoms and instruments used to define ... Maxillofacial Surgery (ICOMS) in Santiago de Chile 2011;.
Design and validation of a scale for measuring post-surgical complication in third molar surgery
Pedro Aravena, DDS PhD UNIVERSITY OF CALIFORNIA Los Angeles, CA. July 24th 2014
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Introduction The third molar surgery (TMS) is the most frequent1. The rate of postsurgical complications (PSC) published was between 0,52 to 75,0%3 and depending of risk factor of patients3, of surgery3,4 and surgeon3,5. The numbers of signs, symptoms and instruments used to define PSC is variable.4 Diverse kind of signs and symptoms in PSC is recognized by using subjetive variables and depends on the interpretation of the surgeon.5 1. 2. 3. 4. 5.
Susarla SM & Dodson TB. J Oral Maxillofac Surg. 2004; 62:1363-‐71. Wiśniewska I et al. Ann Acad Med Ste6n. 2009;55:59-‐64. Baqain ZH et al. J Oral Maxillofac Surg. 2008; 66:2276-‐83. Haug RH et al. J Oral Maxillofac Surg. 2005; 63:1106-‐14 ArteagoiJa I et al. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005; 100:e11-‐8
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The criteria diagnosis about PSC is variable and difficult for the comparison of terms because there are inappropriate combination of data and opinions of researchers.1-3
All instrument must have properties of a valid and reliable design with mathematical models that would render clinical practice more objective and predictable.4
1. Long H, et al. J Dent Res 2012: 91: 659-‐65. 2. Carrasco-‐Labra A et al. Oral Maxillofac Surg 2012: 70: e441-‐57 3. Dodson TB. Evid Based Dent 2013: 14: 13-‐4. 4. Streiner DL & Norman GR. 2008. Health measurement scale.
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Psychometric scale in health1 Variability of answer (variance) Concept
Component Domain, factor
Items or variable
Talking and people understand you Chewing foods easily Oral function Eating the foods you want Opening your mouth wide Sleeping Quality of life after Going your everyday routine oral surgery Domestic function Taking your regular soial life Taking your favorite sport/hobby Rate de Average pain (VAS) Pain Rate the worst pain (VAS) !
Internal consistency Cronbach`s alpha>0.70
Shugars DA et al. J Oral Maxillofac Surg. 1996;54(12):1402-‐8. Terwee C. et al. J Clin Epidemiol. 2007;60(1): 34-‐42 Streiner DL & Norman GR. 2008. Health measurement scale.
Value scale
No /a little/some/ a bit/ lots of trouble No /a little/some/ a bit/ lots of trouble No /a little/some/ a bit/ lots of trouble No /a little/some/ a bit/ lots of trouble yes –no yes –no yes –no yes –no 0"to"10" 0"to"10"
Load Factor Cronbach`s alpha >0.50
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Research question
What are the items and components of a valid and reliable scale for recording measurement to determine and categorize of PSC of patients undergoing TMS?
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Aim To design and to validate a measurement scale for recording and categorize PSC in patients undergoing TMS.
1. Set the items and components of new scale. 2. To design the measurement scale. 3. To determine valid and reliable of scale design. 8
Stage 1
Collection of items of the scale Design of questionarie
Stage 2: Design a measurement scale (Nov. 2011 – March 2012)
Interview to expert (ICOMS 2011) Exploratory Factor Analysis. A preliminar scale design Using scale in patients with TMS in post-surgery examination
Stage 3: Reliability an validity of scale
To define of items of final scale To analize the reliability and validity
(March 2012 – Dec. 2013)
Presentation to expert
Stage 1 Systematic review of literature; Search clinical articles in MEDLINE; Web of Science and TripDatabase published in 2000-2010. Results: § 166 articles were selected. 56 signs and symptoms for measurement PSC in TMS were registered. § Not validated instruments were found. Dry socket
Abscess
Swelling
Alveolar osteitis
Pus
Inflammation
Local Alveolitis
Supuration
Edema
Osteomelitis
Purulence
Tumescence
Aravena PC et al. World J Clin Cases. 2014. In press
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Stage 2 §
Interview to 100 Maxillofacial Surgeons (MFS) and experts in International Conference of Oral and Maxillofacial Surgery (ICOMS) in Santiago de Chile 2011;
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Using a survey with a list of signs and symptoms;
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Assigning score Likert scale in evaluation by expert (1= none important to 5= greatest important).
§ Selection of items and components with internal consistency (cronbach`s alpha ≥0.7) • Design a preliminar scale and review by experts. 1. Aravena PC, et al. Int J Oral Maxillofac Surg. Aug;43(8):1008-‐14. 2014
Score range assigned (ordinal scale) 1 to 10 1 to 3 0 to 10 0 to 5 1 to 5 0 to 5 0 to 10
Alveolitis
1 or 10
Total score
4 to 58
item
1. Aravena PC et al. Int J Oral Maxillofac Surg. 2014. Aug;43(8):1008-‐14. 2. Terwee C. et al. J Clin Epidemiol. 2007;60(1): 34-‐42
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Stage 3 §
A prospective study design;
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62 patients (58,1% female) were selected. 7 MFS and 12 trainees participed.
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Three chilean hospital (March 2012 to August 2013) .
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MFS or trainees using the preliminar scale in patient undergoing TMS of in post-surgical examination;
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Each observer assigned a score of each item and wrote down the level of severity observed.
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Stage 3
Level of Severity recorded by the observers in the postoperative examination of patients after third molar surgery.
Type of complication
Definition
No complication
No functional limitation or discomfort
Mild
Involvement of surgical wound
Moderate
Involvement of surgical wound and deep regions
Severe
Involvement of wound, deep regions and general condition
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Stage 3 Data analysis: • Presence of PSC; • Total score calculate associate with severity for each item (score 4 to 58 points); • Level of Severity (no / mild / moderate / severe). §
Mathematical model in psychometric scale1,2: • Convergent and discriminant validity; • Internal consistence.
§ Score range for discriminate levels of PSC. 1. Streiner DL & Norman GR. Health measurement scale. 2008 2. Terwee C. et al. J Clin Epidemiol. 2007;60(1): 34-‐42.
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Scores by observers. Significance criteria selection by convergent validity of the scale items
Factor loadings of items in instrument Standardized Median Min Max p value2 1 loads 3 1 7 0.608