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the informed consent process in pediatric otolaryngology

and determine what factors may influence recall of the

information discussed during surgical consultations.

The primary objective of this study was to evaluate par-

ental recall of surgical risks and benefits associated with

common operations in pediatric otolaryngology. The sec-

ondary objective was to assess for factors that may influ-

ence recall. In particular, assessment was performed of

whether the context of the discussion (eg, other people in

the room), prior surgical history, parental education level, or

treatment choice (watchful waiting or surgery) would influ-

ence the rate of recall.

Materials and Methods

This study was part of a larger mixed-methods research

project assessing shared decision making in pediatric otolar-

yngology.

6

Local Institutional Review Board (IWK Health

Centre) approval was obtained.

Participants

Participants were recruited from a tertiary-level pediatric

hospital in eastern Canada. Consecutive parents were pro-

spectively enrolled if they had children

\

6 years of age

who were being evaluated for 1 of 4 conditions that may be

treated with surgery (

Table 1

). Exclusion criteria included

inability to speak English and/or the lack of decision-

making authority on behalf of the child. Clinic nurses

informed eligible parents of the study in the waiting room

before the consultation, and interested parents met with a

research assistant who described the study in detail and

obtained consent.

Procedure

If surgery was considered to be a treatment option, health

care providers discussed the risks and benefits of the surgi-

cal procedure during the consultation. After the discussion,

the surgeon obtained consent for surgery, which was then

followed by a short visit with the clinic nurse who covered

information pertaining to preoperative details (eg, where to

go for surgery, when to stop eating/drinking) and postopera-

tive care (eg, pain management/analgesic use). All visits

were video recorded with dual wall-mounted cameras in the

consultation room (one camera captured a full room view

and another captured the health care providers’ faces).

Two weeks following the consultation, participants com-

pleted a telephone interview with the research assistance

consisting of open- and closed-ended questions regarding

their recall of the information discussed during the visit.

Specifically, parents were encouraged to recall all risks and

benefits of the surgery discussed during the consultation.

Although parents were aware that this telephone call would

occur (‘‘cold calling’’ was not allowed according to the

Institutional Review Board), they were not made aware of

the purpose. Each interview was transcribed; transcriptions

of these conversations were later checked for accuracy.

Measures

Demographic questionnaire.

Relevant questions included rela-

tionship to child, parent and child age, parent marital status,

education level, ethnicity, household income, presence of

siblings, and previous surgical history of the patient and/or

sibling.

Risks and benefits coding.

Video recordings of the consultation

visits and transcripts of the follow-up phone calls were coded

for mention of the risks and benefits of surgery. Coding

sheets were created for each operation based on review

of the literature (see Appendix 1 at www.otojournal.org/ supplemental).

Table 1.

Baseline Information of Participants.

n

%

Age of child, mo

12

8

9.5

13-24

28

33.3

25-36

20

23.8

37-48

16

19.0

49-60

12

14.3

Martial status

Married

59

70.2

Common law

12

14.3

Single

11

13.1

Divorced/separated

2

2.4

Ethnicity

Caucasian

75

89.3

African Canadian

4

4.8

Asian Canadian

2

2.4

First Nations/Native

1

1.2

Middle Eastern

1

1.2

Other

1

1.2

Education level

Completed high school or less

19

22.6

Community college

26

31.0

Undergraduate university

20

23.8

Graduate or postgraduate training

19

22.6

Conditions/surgery

a

Chronic/recurrent tonsillitis/

adenotonsillectomy

7

8.3

Obstructive sleep apnea/

adenotonsillectomy

31

36.9

Chronic/recurrent acute otitis media/ear

tubes

55

65.5

Chronic/recurrent nasal obstruction/

adenoidectomy

7

8.3

Surgical decision

Surgery

49

58.3

Watchful waiting

35

41.7

a

Sixteen children (19.0%) had

.

1 of these conditions.

Pianosi et al

82