1. Quality of Life and Influencing Factors in Ostomates Less Than 24 Months Post Surgery Thom Nichols Principal Clinical Research Statistician Hollister Incorporated November 15, 2008

2. 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

3. 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

4. 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%

5. Age Median age of colostomates; 61 years Median age of ileostomates; 53 years Median age of urostomates; 64.5 years

6. 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.

7. The Ostomate dx Coping, Adapting Accepting …and control over the life forces that impact them is a function of this.

8. 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

9. 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

10. 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 N=6, 8.2%N=30, 16.7%N=157, 48.8% Has had a negative affect on my life N=67, 91.8%N=150, 83.3% N=165, 51.2%

11. Categorizing the permanent stomas 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 N=6, 8.2% 11.1% N=30, 16.7% 20.0% N=157, 48.8% 50.2% Has had a negative affect on my life N=67, 91.8% 88.9% N=150, 83.3% 80.0% N=165, 51.2% 49.8%

12. Time effect?

13. 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 N=6, 8.2% N=30, 16.7%N=157, 48.8% Has had a negative affect on my life N=67, 91.8%N=150, 83.3% N=165, 51.2%

14. 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 N=6, 8.2%N=30, 16.7%N=157, 48.8% Has had a negative affect on my life N=67, 91.8%N=150, 83.3% N=165, 51.2%

15. 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 N=6, 8.2%N=30, 16.7%N=157, 48.8% Has had a negative affect on my life N=67, 91.8%N=150, 83.3% N=165, 51.2%

16. 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 N=157, 48.8% Has had a negative affect on my life N=67, 91.8%N=165, 51.2% Group 1 Group 2Group 3

17. 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

18. 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

19. 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

20. 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

21. 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.

22. What does this suggest? Group 1 +/+Group 2 -/- Group 3 -/+ Colo41.3%69.7%60.2% Ileo49.0%22.7%25.5% Uro7.1%6.1%14.3% Other2.6%1.5%--

23. 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

24. 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%

25. Body Image, Group 1 +/+ 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 5.1%---4.5% I do not like the way I look 21.2%8.3%5.1% What I see, I am OK with 21.2%1.3%33.3% 29.5%

26. Body Image, Group 2 -/- 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 --- I do not like the way I look 30.3%60.6%1.5% What I see, I am OK with 3.0% 1.5% 90.9%

27. Body Image, Group 3 -/+ 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%---4.8% I do not like the way I look 20.5%9.7%4.2% What I see, I am OK with 17.0%1.2%41.2% 30.2%

28. Social Isolation Hawthorne 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.

29. Social Isolation Hawthorne Index of Social Isolation Index rating Group 1 +/+Group 2 -/- Group 3 -/+ Negative0.6%28.4%0% Neutral4.5%50.8%0.6% Positive94.9%20.9%99.4% The correlation between social isolation and life satisfaction is r=0.705.

30. 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 Support MOS: Measures of QoL Soc Sup Survey

31. Index rating Group 1 +/+Group 2 -/- Group 3 -/+ Negative5.8%37.3%3.0% Neutral9.0%29.8%6.7% Positive85.3%32.8%90.3% The correlation between social support and life satisfaction is r=0.460.

32. 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…

33. Spouse/Life Partner Affection Does this manifest itself anywhere else?

34. Spouse/Life Partner Affection Normal/strong desire for sexual intimacy pre-surgerycurrentlychange Group 158.6%51.3%12.5% Group 257.8%30.3%47.6% Group 366.4%50.6%23.7% Do you and your spouse/partner avoid intercourse Occasionally my stoma No causes problems YesImpotent NA Group 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%

35. Spouse/Life Partner Affection Normal/strong desire for sexual intimacy pre-surgerycurrentlychange Group 158.6%51.3%12.5% Group 257.8%30.3%47.6% Group 366.4%50.6%23.7% Do you and your spouse/partner avoid intercourse Yes Group 1 21.3% Group 2 67.7% Group 3 33.3%

36. 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 3 appearing skin? 51.3% 25.8% 57.7%

37. Change work habits Because of your ostomy surgery did you need to change how you go about working (work habits)? yesno does not apply Group 126.3%41.0%32.7% Group 262.1% 6.1%31.8% Group 325.6%40.8%33.5%

38. Change work habits Because of your ostomy surgery did you need to change occupations? yesno does not apply Group 1 3.2%52.6%44.2% Group 222.7%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%

39. Who are these people? Group 1: –42% are male, 58 % are female –Median age of 55 years Group 2: –49% are male, 51 % are female –Median age of 56 years Group 3: –56% are male, 44 % are female –Median age of 63 years

40. Who are these people? 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%

41. Who are these people? 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%

42. Who are these people? 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).

43. 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

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

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

46. 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.

47. Thank you