The Data Source

Quality of Life and Influencing Factors in Ostomates Less Than 24 Months

Post Surgery

Thom NicholsPrincipal Clinical Research Statistician

Hollister Incorporated

November 15, 2008

• Hollister Ostomy Comprehensive Health and Life Assessment

• N=2,988 adult colostomates, ileostomates, and urostomates

• Geographically dispersed throughout North America and the UK

• Late 2004, and continues• Valid and reliable instrument containing 115

questions assessing pre and post surgical health and life status

• Crohnbach’s alpha, not less than 0.82

The Data Source

Subset of the data:

Colostomates, Ileostomates, and Urostomates

Those 24 months or less post surgery

n=663

The Ostomy Comprehensive Health and Life Assessment

• A self reported assessment of health status, marital status, occupational status, sexual and social well being, emotional status, family life, and overall contentment with life.

• Incorporates 3 validated instruments– SF 36– MOS Measures of Quality of Life Social Support

Survey– Hawthorne’s Index of Social Isolation

Distribution

• UK: n=324 48.9% NA: n=339 51.1%

• Colostomates; n=361 54.7%• Ileostomates; n=217 32.9%• Urostomates; n=68 10.3%

• Approximately 20 percent have temporary stomas

• 305 males; 46.1%• 356 females; 53.9%

Age

• Median age of colostomates; 61 years• Median age of ileostomates; 53 years• Median age of urostomates; 64.5 years

The Ostomate: 24 months or less post surgery

dx

Coping,

Adapting

Accepting

Premise: Who the ostomate is, is a function of the life forces that impact them. Who they are is a matter of how well they can control life forces.

The Ostomate

dx

Coping,

Adapting

Accepting

…and control over the life forces that impact them is a function of this.

Survey derived Index: Satisfaction with Life

• How much do you think having a stoma affects your life: 5 pt Likert Scale.

• Social Life• Family Life• Leisure Time• Financial status• Overall

contentment

Categorizing the ostomates

Negative life satisfaction index, n=73

Neutral life satisfaction index, n=180

Positive life satisfaction index, n=322

Has had a positive affect on my life

Has had a negative affect on my life






N=6, 8.2% N=30, 16.7%

N=157, 48.8%


N=67, 91.8%

N=150, 83.3%

N=165, 51.2%

Categorizing the permanent stomas





N=6, 8.2% 11.1%

N=30, 16.7% 20.0%

N=157, 48.8%50.2%


N=67, 91.8% 88.9%

N=150, 83.3%80.0%

N=165, 51.2%49.8%

Time effect?

0102030405060708090

100

0-4m 5-8m 9-12m

13-16m

17-20m

21-24m

Positiveeffect/Positiveindex

Negativeeffect/Negativeindex

Negativeeffect/Positiveindex






N=6, 8.2%

N=30, 16.7%

N=157, 48.8%


N=67, 91.8%

N=150, 83.3%

N=165, 51.2%






N=6, 8.2% N=30, 16.7%

N=157, 48.8%


N=67, 91.8%

N=150, 83.3%

N=165, 51.2%






N=6, 8.2% N=30, 16.7%

N=157, 48.8%


N=67, 91.8%

N=150, 83.3%

N=165, 51.2%






N=157, 48.8%


N=67, 91.8%

N=165, 51.2%

Group 1

Group 2 Group 3

Questions

• Why are some people in one group, and some in others?• Are there factors other than the permanence of the stoma that

influence this?• Can these factors be identified?

– Family life– Social support– Body image– Occupational stability– Personal relationships– Continued health problems– Peristomal skin issues

What do we know?

• Normalizing tasks undertaken by the patient, in the presence of life altering surgery, is intimately associated with the capacity to balance post-surgical expectations with the reality of the situation.

» Nichols& Riemer

JWOCN, V35, 2008

Items for discussion

• Health Status• Body Image• Social support / Social isolation• Spouse/Partner relationships

– Affection/Intimacy/Intercourse• Peristomal skin conditions• Occupational stability• Overall demographics• Your role

Health Status

Good health prior to surgery

Good health after surgery

Group 1+/+

35.0% 82.2% Improvement

Group 2-/-

46.2% 38.5% No change

Group 3-/+

70.3% 78.8% No change

Diagnosis of Cancer

• Group 1 +/+: 29.9% have originating DX of cancer.

• Group 2 -/-: 46.3% have originating DX of cancer.

• Group 3 -/+: 69.1% have originating DX of cancer.

What does this suggest?

Group 1 +/+

Group 2-/-

Group 3-/+

Colo 41.3% 69.7% 60.2%

Ileo 49.0% 22.7% 25.5%

Uro 7.1% 6.1% 14.3%

Other 2.6% 1.5% --

Body Image

• Question: When I stand in front of a mirror– I like the way I look– I do not like the way I look– What I see I am OK with

• I think my stoma has– Changed my appearance– Disfigured me– No effect on the way I look

Body Image, n=2,686

I think my stoma has…..

Changed my appearance

Disfigured me

Had no effect on the way I look

When I stand in front of a mirror

I like the way I look

1.2% --- 4.1%

I do not like the way I look

20.9% 17.2% 6.9%

What I see, I am OK with

15.1% 3.1% 31.5%

38.1%

Body Image, Group 1 +/+



Disfigured me




5.1% --- 4.5%


21.2% 8.3% 5.1%


21.2% 1.3% 33.3%

29.5%

Body Image, Group 2 -/-



Disfigured me




--- --- ---


30.3% 60.6% 1.5%


3.0% 3.0% 1.5%

90.9%

Body Image, Group 3 -/+



Disfigured me




1.2% --- 4.8%


20.5% 9.7% 4.2%


17.0% 1.2% 41.2%

30.2%

Social IsolationHawthorne Index of Social Isolation

• During the past four weeks – I felt alone and friendless– I had someone to share my feelings with– It has been easy for me to relate to others– I felt isolated from other people– I found it easy to get in touch with others when I

needed to– When with other people I felt separate from them

The correlation between social isolation and life satisfaction is r=0.705.

Social IsolationHawthorne Index of Social Isolation

Index ratingGroup 1 +/+ Group 2

-/-Group 3-/+

Negative 0.6% 28.4% 0%

Neutral 4.5% 50.8% 0.6%

Positive 94.9% 20.9% 99.4%

The correlation between social isolation and life satisfaction is r=0.705.

• There is some to listen to me when I need to talk• There is someone to confide in or talk about my

problems• There is someone to share my most private worries

and fears with• There is someone who understands my problems.

Social SupportMOS: Measures of QoL Soc Sup Survey

Social SupportMOS: Measures of QoL Soc Sup Survey

Index ratingGroup 1 +/+ Group 2

-/-Group 3-/+

Negative 5.8% 37.3% 3.0%

Neutral 9.0% 29.8% 6.7%

Positive 85.3% 32.8% 90.3%

The correlation between social support and life satisfaction is r=0.460.

Is Group 2 a group that is not socially connected (for whatever reason)?

• Spouse /life partner affection– Within the year prior to your surgery, were you and

your spouse/partner….– Are you and your spouse/life partner now…

Spouse/Life Partner Affection

0102030405060708090 group 1 (prior)

group 2 (prior)

group 3 (prior)

group 1(current)

group 2(current)

group 3(current)

Does this manifest itself anywhere else?


Normal/strong desire for sexual intimacy

pre-surgery currently change

Group 1 58.6% 51.3% 12.5%

Group 2 57.8% 30.3% 47.6%

Group 3 66.4% 50.6% 23.7%

Do you and your spouse/partner avoid intercourse Occasionally my stoma

No causes problems Yes Impotent NAGroup 1 39.7% 11.9% 14.6% 8.0% 25.8%Group 2 12.5% 6.2% 37.5% 12.5% 31.2%Group 3 29.8% 6.2% 19.2% 18.0% 26.7%


Normal/strong desire for sexual intimacy

pre-surgery currently change

Group 1 58.6% 51.3% 12.5%

Group 2 57.8% 30.3% 47.6%

Group 3 66.4% 50.6% 23.7%

Do you and your spouse/partner avoid intercourse

YesGroup 1 21.3%Group 2 67.7% Group 3 33.3%

Skin Irritation

The very last time you changed your pouch/barrier and looked at the skin around your stoma would you say it was …..

yes yes yes

normal healthy Group 1 Group 2 Group 3appearing skin? 51.3% 25.8% 57.7%

Change work habits

Because of your ostomy surgery did you need to change how you go about working (work habits)?

yes no does not apply

Group 1 26.3% 41.0% 32.7%

Group 2 62.1% 6.1% 31.8%

Group 3 25.6% 40.8% 33.5%

Change work habits

Because of your ostomy surgery did you need to change occupations?

yes no does not apply

Group 1 3.2% 52.6% 44.2%

Group 2 22.7% 33.3% 43.9%

Group 3 3.0% 56.1% 40.8%Removing “does not apply” and looking at those that answered yes to both questions we find:

Group 1 = 2.4%

Group 2 = 41.7%

Group 3 = 5.4%

Who are these people?

• Group 1:– 42% are male, 58 % are female– Median age of 55 years




• Planned/expected surgery?– Group 1: Yes 66.0%– Group 2: Yes 45.4%– Group 3: Yes 59.4%

• Adapted to living with a stoma?– Group 1: No 0%– Group 2: No 23.9%– Group 3: No 1.2%

• Disabled (stoma related)?– Group 1: Yes 7.7%– Group 2: Yes 48.5%– Group 3: Yes 8.5%


• Continue to undergo treatment of the disease or injury that caused the stoma surgery?– Group 1: Yes 33.8%– Group 2: Yes 43.3%– Group 3: Yes 31.7%


• Those is Group 1 and Group 3 are twice as likely to have had the assistance of a ET pre and post surgery than those in Group 2 (odds ratios: 2.0 and 2.1 respectively).

Summary

• Identifying factors: – Type of stoma– Originating DX of cancer– No change in health status– Poor body image– Peristomal skin trauma– Lack of occupational stability

Summary

• Identifying factors: – Surgery (planned/unplanned)– Adapted?– Disabled related to stoma– Continued treatment– ET assistance

Summary

• Manifestations– A lack of social support and social isolation– Decreased spouse/life partner affection– Decreased desire for sexual intimacy– Sexual intercourse avoidance

Conclusions

• That factors exist that influence the post surgical return to a “quality of life”

• The factors are recognizable (identifiable).• The factors can be part of a prophylactic regimen of

treatment• The identification of the factors may be

incorporated into post surgical health intervention regimens.

Thank you

Documents

The Data Source