Design and validation of a scale for measuring post-surgical

0 downloads 0 Views 2MB Size Report
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

2  

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  

4  

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.    

5  

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  

6  

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?

7  

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  

10  

Stage 2 § 

Interview to 100 Maxillofacial Surgeons (MFS) and experts in International Conference of Oral and Maxillofacial Surgery (ICOMS) in Santiago de Chile 2011;

§ 

Using a survey with a list of signs and symptoms;

§ 

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    

11  

ITEM Abscess Alveolar bleeding Alveolitis Anesthesia Anxiety Bleeding Complication in socket Dehiscence Depression Discomfort Dysfunction facial nerve Dysfunction trigeminal nerve Dysphagia Ecchymosis Edema Erythema Exposure of socket Exudation Fever Halitosis Hematoma Hemorrhage Inflammation Jaw bone fracture Lymphadenopathy Neuropathy Orofacial fissure Osteitis Osteomyelitis Pain Paresthesia Petechiae Purulence Suppuration Temperature increase Trismus

1: none

IMPORTANCE 2: less 3: median 4: big

x   x  

x   x  

x   x   x   x  

x  

x   x   x   x  

x  

x   x   x  

x   x   x  

x  

x  

x  

x  

x  

x  

x   x  

x  

x  

5: greatest

x  

x   x   x   x   x  

12  

Results - Stage 2 Preliminar scale1. Internal consistency of each component2 and their selected item.   Component Secondary complication

Cronbach`s alpha 0,79

Soft tissue infection

0,68

Hard tissue infeccion

0,79

Inflammation Erythema Pain Trismus Edema Abscess Purulence

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  

13  

Stage 3 § 

A prospective study design;

§ 

62 patients (58,1% female) were selected. 7 MFS and 12 trainees participed.

§ 

Three chilean hospital (March 2012 to August 2013) .

§ 

MFS or trainees using the preliminar scale in patient undergoing TMS of in post-surgical examination;

§ 

Each observer assigned a score of each item and wrote down the level of severity observed.

14  

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

15  

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.  

16  

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