A Mixed-Methods Evaluation of Health-Related Quality of Life for Male Veterans with and without Intestinal Stomas

OriginalContributions

A Mixed-Methods Evaluationof Health-Related Quality of Lifefor Male Veteranswith and without Intestinal StomasRobert S. Krouse, M.D.,1 Marcia Grant, R.N., D.N.Sc.,2 Christopher S. Wendel, M.S.,3

M. Jane Mohler, Ph.D., M.P.H.,3,4 Susan M. Rawl, Ph.D.,5 Carol M. Baldwin, Ph.D.,6

Stephen Joel Coons, Ph.D.,7 Ruth McCorkle, Ph.D.,8 Clifford Y. Ko, M.D.,9

C. Max Schmidt, M.D., Ph.D.10

1 Southern Arizona Veterans Affairs Health Care System, University of Arizona College of Medicine,

Tucson, Arizona2 Department of Nursing Research and Education, City of Hope National Medical Center, Duarte, California3 Southern Arizona Veterans Affairs Health Care System, Tucson, Arizona4 University of Arizona Colleges of Medicine, Public Health, and Pharmacy, Tucson, Arizona5 Center for Nursing Research, Indiana University School of Nursing, Indianapolis, Indiana6 Arizona State University College of Nursing, Southwest Borderlands, Phoenix, Arizona7 Division of Social and Administrative Sciences, University of Arizona College of Pharmacy, Tucson, Arizona8 Yale University School of Nursing, New Haven, Connecticut9 VA Greater Los Angeles Healthcare System, UCLA Center for Health Sciences, Los Angeles, California10 Richard L. Roudebush VA Medical Center, Department of Surgery, Indiana University School of Medicine,

Indianapolis, Indiana

PURPOSE: Intestinal stomas have a major impact onCases_ lives. It is essential to better understand the areasin which interventions may help to minimize the negative

consequences. METHODS: This was a case-control surveystudy using validated instruments (City of Hope Quality ofLife-Ostomy and Short Form 36 for Veterans). Cases wereaccrued from Veterans Affairs Medical Centers in Tucson,Indianapolis, and Los Angeles. Eligibility included a majorintra-abdominal surgical procedure that led to an ostomy(cases), or a similar procedure that did not mandate a stoma(controls). Analysis included quantitative and qualitativeresponses. RESULTS: The response rate was 48 percent(511/1063). Cases and controls had relatively similardemographic characteristics. Because of low numbers offemale respondents (13 cases and 11 controls), only resultsfor males are reported. Based on both the City of HopeQuality of Life-Ostomy and Short Form 36 for Veterans,cases reported significantly poorer scores on scales/domains reflecting psychologic and social functioning andwell being. Additionally, cases reported poorer scores onShort Form 36 for Veterans scales reflecting physicalfunctioning and significantly lower scores on multiple

Supported by a grant from the Veterans Affairs Health ServicesResearch & Development Service (HSR&D Service) IIR 02-221-2:Health Related Quality of Life in VA Cases with Intestinal Stomas.The views expressed in this article are those of the authors and donot necessarily reflect the position or policy of the Department ofVeterans Affairs. The funder had no role in the design and conduct ofthe study, collection, management, analysis, and interpretation of thedata, or preparation, review, or approval of the manuscript.

Reprints are not available.

Correspondence to: Robert S. Krouse, M.D., Southern ArizonaVA Health Care System, Surgical Care Line, 2-112, 3601 S. 6thAvenue, Tucson, AZ 85723, e-mail: [email protected]

Dis Colon Rectum 2007; 00: 1–12DOI: 10.1007/s10350-007-9004-7* The American Society of Colon and Rectal Surgeons

items in the social domain of the City of Hope Quality ofLife-Ostomy compared with controls. Two-thirds of casesreplied to an open-ended question on their Bgreatestchallenge^ related to their ostomy, which led to furtherclarification of major issues. CONCLUSIONS: Multiplehealth-related quality of life problems were reported bymale veterans with intestinal stomas. The greatest differ-ences between cases and controls were observed in thesocial and psychologic domains/scales. Findings from thisstudy provide a greater understanding of the challengesfaced by ostomates and will inform the development andevaluation of urgently needed intervention strategies. [Keywords: Ostomy; Focus groups; Quality of life; Stomas]

T he number of persons with an intestinal stoma

(ostomy) is estimated to be > 1,000,000 in the

United States and Canada, with numbers increasing

at an annual rate of more than 100,000.1 Intestinal

stomas, or ostomies, are the surgical exteriorization

of the bowel to the anterior abdominal wall. This

may include the small (ileostomy) or large (colosto-

my) bowel, depending on the objective or site of the

stoma. Intestinal stomas are required in various

medical conditions and situations. These include

cancers, most frequently rectal cancer, and benign

etiologies, most commonly diverticulitis or inflam-

matory bowel disease. Intestinal stomas may be

placed on a temporary or a permanent basis based

on issues, such as the urgency of the procedure or

the status of the underlying disease. In addition,

there are variations of ileostomies that are placed

with intent for continence that may provide the

patient with the opportunity to control bowel move-

ments and avoid wearing a bag. Ostomies, nonethe-

less, in the vast majority of cases result in the loss of

control of intestinal contents, both stool and gas.

Whereas surgical standards of care attempt to

preserve bowel continuity for most conditions, many

people will continue to require stomal placement

each year in this country. Since the classic article by

Sutherland et al.2 was published in 1952, which

highlighted psychologic needs of ostomates, rela-

tively little research focusing on health-related

quality of life (HR-QOL) has been directed at this

group of Cases. This has created a huge gap in care

where time and resources need to be focused.

Clinicians and researchers increasingly regard HR-

QOL as an important end point for chronic disease

and cancer management.3 HR-QOL is a complex,

multidimensional concept, which involves a person_s

appraisal of his level of well-being, satisfaction with

life, and ability to perform various tasks.4 HR-QOL

can be viewed as encompassing perceptions of both

positive and negative aspects of physical, emotional,

social, cognitive, and spiritual functioning and well-

being, as well as the discomfort and symptoms

produced by disease or its treatment.5–7 This defini-

tion considers the patient as the ultimate authority

regarding his or her own HR-QOL; hence data are

derived from patient responses to HR-QOL measures.

Stomas have been associated with lower levels of

HR-QOL in multiple domains, irrespective of the type

or reason for the ostomy.8–10 For Cases with colosto-

mies and ileostomies, HR-QOL has been shown to

improve with time as noted by Jenks et al.11 and M.

Grant (unpublished data, 2000), although this finding

is not consistent.12 The many issues that impact HR-

QOL include problems with travel, intimacy, and

satisfaction with appearance. Several studies have

documented additional problem areas, including

sexuality,13–19 psychologic well being2,20–23 and inter-

ference with work, recreational, and sporting activi-

ties19,23,24 (also M. Grant, unpublished data, 2000).

Although all potential losses in functioning and

well being experienced by ostomates may not be

remediable, the evidence from the literature suggests

that more can be done. To understand better the

levels of HR-QOL experienced by veterans living

with intestinal stomas, the VA Ostomy Health-Related

Quality of Life Study was undertaken.25 The results of

this study are intended to provide the basis for

developing and evaluating clinical interventions

designed to mitigate ostomy-related HR-QOL defi-

cits.8 The purpose of this article is to report the main

study findings regarding the self-reported HR-QOL of

veterans who had a major gastrointestinal procedure

that resulted in an intestinal stoma compared with

veterans who experienced similar procedures for

which an ostomy was not required. In addition, we

report responses to an open-ended question asking

about ostomy-specific challenges, which further

illustrated the experience and the potential for

targeted interventions. We hypothesized that there

would be differences in the HR-QOL domains as well

as individual HR-QOL items (such as satisfaction with

appearance, anxiety, ability to travel, and the

ability to be intimate). In addition, we believed

that Cases would explicate their experience to help

understand better all issues related to living with

an ostomy from their personal experiences. These

findings have potential to guide development of

targeted interventions to improve HR-QOL for

ostomates and can be used by health care pro-

KROUSE ET AL Dis Colon Rectum, 2007

viders to improve care for those Cases as they

adapt to living with an ostomy.

MATERIALS AND METHODS

An in-depth presentation of the mixed-methods

design of the VA Ostomy Health-Related Quality of

Life Study has been published elsewhere.25 Briefly, all

subjects were veterans receiving care at VA Medical

Centers in Tucson, Indianapolis, or Los Angeles.

Subjects included 239 Cases with known intestinal

stomas (cases), and 272 Cases who had similar

procedures that did not lead to an ostomy (controls).

Cases who had an ostomy reversed were excluded

from both cases and controls. A mailed survey included

the City of Hope Quality of Life Ostomy-specific

(mCOH-QOL-Ostomy) questionnaire26 and the Medi-

cal Outcomes Study (MOS) Short Form 36 for Veterans

(SF-36V), a measure of general HR-QOL adapted for

use in veteran populations27,28 from the widely used

MOS SF-36.29 The mCOH-QOL-Ostomy has demo-

graphic, nonscaled and scaled items (on an ordinal

scale from 0 = poor to 10 = excellent QOL), along

with several open-ended questions to allow Cases the

opportunity to provide comments about living with an

ostomy. The nonscaled items address the areas of

marital status, work, health insurance, sexual activity,

psychologic support, and diet. The scaled items are

reported based on individual domains (physical,

psychologic, social, and spiritual well being), which

were mapped based on psychometric analysis.30 The

SF-36V retains the original SF-36 measurement model,

which includes eight multi-item scales (i.e., physical

function, role limitations as a result of physical

problems, bodily pain, general health perceptions,

vitality, social functioning, role limitations as a result

of emotional problems, and mental health) as well as

physical (PCS) and mental component summary

(MCS) scores. The subscales and component summary

scores have a possible range of 0 to 100, with higher

scores reflecting better functioning and/or well being.

The overall survey response rate was 48 percent

(511/1,063), including 51 percent of cases (239/467)

and 45 percent of controls (272/596). There are

multiple Cases within the VA system with addresses

that were found or suspected to be incorrect. For

Cases ascertained to have received the mailings, the

response rate was 69 percent. Of the veterans who

completed the survey instrument, 68 percent of the

ostomy Cases (n = 163) chose to write in an essay

response to describe their greatest challenges. As

reported earlier, the estimated internal consistency

reliability coefficients (i.e., Cronbach_s alpha) ranged

from 0.8 to 0.96 and 0.71 to 0.94 for the scales of the

mCOH-QOL-Ostomy and SF-36V questionnaires, re-

spectively.25

Medical history items obtained from VA administra-

tive databases and electronic charts included type of

stoma, reason for stoma, length of time since surgery,

preoperative marking by a stoma nurse, type of

operation, operative findings, and other medical prob-

lems. The Charlson-Deyo comorbidity index31 was

constructed from ICD-9 codes from the VA Patient

Treatment File (admissions) and Outpatient Encounter

(reasons for visits) databases during the year before

the index surgery. For Cases whose reason for an

ostomy was cancer, the type of tumor was confirmed

to the extent possible from the tumor registry.

Scales were scored and missing data were handled

according to the instrument developers_ scoring

algorithms. The SF-36V scale scores were coded as

missing if more than half of the responses for the

scale_s items were missing. Responses were rarely

missing in the mCOH-QOL-Ostomy questionnaire;

the most common missing items were those assessing

intimacy, personal spiritual activities, and religious

activities.

Statistical Analysis

We compared demographic and clinical charac-

teristics between cases and controls by using the

Student_s t-test for continuous measures and the chi-

squared test for categorical measures. In the event of

a significant chi-squared for a categorical variable,

a two-sample test of proportions was performed

for each category. Differences between cases and

controls on measures from the mCOH-QOL-Ostomy

and SF-36V were determined with multivariate

regression, adjusting for subject age, time since

index surgery, and an indicator for Charlson-Deyo

index > 2; these are all variables that had been

hypothesized a priori as potential confounders

based on clinical literature and experience. Other

variables assessed in multivariate models for po-

tential confounding between ostomy status and

HR-QOL outcomes were transformations of time

since surgery, married/partnered status, cancer as

the reason for the ostomy or surgery, race/ethnicity,

ostomy type (ileostomy vs. colostomy), income,

education, and distance from home to VA medical

center.

QUALITY OF LIFE FOR VETERANS WITH STOMAS

The mCOH-QOL-Ostomy and SF-36V domains/

scales and total/summary scores were modeled with

multiple linear regression, whereas individual items

from the COH-QOL-Ostomy were modeled with

maximum-likelihood ordered logit estimation in Stata

version 8.2. Comparisons of individual measures

within an instrument were subjected to a Bonferroni

adjustment. In addition to testing for statistical differ-

ence, we used the empirical rule effect size (ERES)

method to judge minimally important differences

(MID) in outcome measures.32 The ERES defines a

minimally important (or Bclinically significant^) differ-

ence as equivalent to 8 percent of the HR-QOL tool_s

theoretical range, which for the mCOH-QOL-Ostomy

is 0.88 and for the SF-36V is 8 units.

Qualitative Analysis

Qualitative analysis was conducted on answers

identified in the open-ended question at the end of

the mCOH-QOL-Ostomy questionnaire: BMany people

have shared stories about their lives with an ostomy.

Please share with us the greatest challenge you have

encountered in having an ostomy.^ The investigators

individually reviewed the responses by using content

analysis.33 This was performed on the transcriptions of

the written correspondence using four linked pro-

cesses: processing the raw data, data reduction, data

display, and conclusion drawing/verification.34,35 The

data were analyzed by using the four domains of the

mCOH-QOL-Ostomy model: physical, psychologic,

social, and spiritual well being.

Original data were deidentified and assigned a

subject identification (ID). Investigators, trained in

qualitative content analysis, read and examined all data

to identify units of analysis, which were defined as a

paragraph, sentence, verb phrase, or single word that

conveyed a single meaning, idea or concept.34,35

Responses frequently had several themes within an

essay. Thus, some responses were divided into two or

more themes, but individual statements were not

double coded. Each essay was coded by at least three

investigators. Differences were discussed with the

entire investigative team, and the group as a whole

decided final coding. Data within each of these

themes were compared by using thematic analysis.

All of the themes were identified and validated

through discussion, review, verification, and consen-

sus by the authors. This review occurred during

weekly conference calls with the investigative team.

Units that corresponded to a theme in the mCOH-

QOL-Ostomy questionnaire were bracketed and dis-

played in a table organized according to the QOL

themes encompassed by the physical, psychologic,

social, or spiritual domains. Units that did not

correspond to a QOL theme but were deemed

significant based on repetition and emphases through-

out the data were bracketed, and two additional

themes were identified: ostomy-specific content and

health care issues content. Final review was then

performed by two investigators to ensure consistency,

clarity, and any discrepancies were identified.

RESULTS

There were 239 cases and 272 controls who

returned completed survey instruments. They were

noted to be similar based on demographic and

clinical characteristics, including no significant differ-

ence in the Charlson comorbidity index (Tables 1

and 2). Fourteen percent of ostomy subjects believed

that their stoma was placed on a temporary basis.

The Btemporary^ subgroup did not show statistically

significant differences in outcome measures com-

pared with other cases, and thus these Cases were

not analyzed separately in this report. The major

clinical differences noted were a longer time since

surgery in cases (11.2 vs. 4.1 years; P < 0.001) and

significantly different proportions of reasons for

surgery. Time since surgery was significantly longer

for subjects with reason for surgery of inflammatory

bowel disease or benign tumor compared with other

reasons (13 vs. 5.7 years; P < 0.001), and this contrast

was more pronounced in cases (20 vs. 8 years;

P < 0.001) than controls (4.8 vs. 3.9 years; P < 0.05).

Cases and controls had similar frequencies of colo-

rectal cancer but within that cases had significantly

more rectal cancer. Cases also had significantly fewer

subjects with benign tumors and acute inflammatory/

infections and significantly more subjects with in-

flammatory bowel disease. The higher percentage of

married/partnered status in preoperative cases was

gone by the time of the surgery, showing that 6

percent of the ostomates had lost their married/

partnered status. Because of the small number of

females in the sample (13 cases and 11 controls) and

the known differences in QOL between males and

females, we report results from analyses that includ-

ed only male respondents.

Stratified analysis by reason for surgery revealed a

demarcation in QOL outcomes between two subgroups:

Group A (colorectal cancer, acute inflammatory/

KROUSE ET AL Dis Colon Rectum, 2007

Table 1.Demographic Characteristics of Respondents

Sociodemographic Characteristic Cases (n = 239) Controls (n = 272) P Value

Age (yr)Mean (SD) 68.8 (12.4) 67.5 (11.5) 0.23Median 70 69

Male gender (%) 92 94.5 0.52Race/ethnicity (%)

White, non-Hispanic 83.7 78.3Black, non-Hispanic 6.7 11.4 0.28Hispanic/Latino 6.7 6.6Other/unknown 2.9 3.7

Education (%)Not a high school graduate 15.5 14.3High school graduate 27.6 27.9Vocational school degree 3.4 3.3Some college, no degree 28 33.1 0.43College graduate 15.1 9.2Some graduate school, no degree 2.5 4.4Graduate school degree 5.4 6.3

Annual household income (%)$15,000 or less 32.6 39$15,001 to $30,000 35.2 32.7$30,001 to $50,000 15.9 18$50,001 to $75,000 7.5 5.2 0.46$75,001 to $100,000 1.7 1.1More than $100,000 0.8 0.4Unknown/no answer 6.3 3.7

Married/partnered before surgery (%) 65.3 56.5 0.03Married/partnered currently (%) 59 55.9 0.42Employment (%)

Full-time 10 15.4Part-time 7.5 8.5 0.19Retired 68.6 65.1Unemployed/unknown 13.9 11

SD = standard deviation.

Table 2.Clinical Characteristics

Clinical Characteristic Cases (n = 239) Controls (n = 272) P Value

Years since surgery*Mean (SD) 11.2 (11.6) 4.1 (3) <0.0001Median 8.4 3.4

Reason for surgery (%)Colorectal cancer 50.6 45.6 0.26

Colon cancer 18.8 38.2 <0.001Rectal cancer 31.8 7.4 <0.001

Benign tumor 2.5 14.4 <0.001Inflammatory bowel disease. 23.9 4.8 <0.001Acute inflammatory/infection- 10.9 20.7 0.003Other` 12.1 14.4 0.45

Charlson index > 2 (%) 24.7 31.5 0.09

SD = standard deviation.*Time since surgery significantly longer for reason for surgery inflammatory bowel disease or benign tumor compared

with other reasons (13 vs. 5.7; P < 0.001).. Ulcerative colitis and Crohn_s disease.- Includes diverticulitis, appendicitis, acute colitis, and other acute inflammatory diseases.` Includes bowel ischemia, trauma, volvulus, and cancer other than colorectal.

QUALITY OF LIFE FOR VETERANS WITH STOMAS

infection, and Bother^) and Group B (inflammatory

bowel disease and benign tumor). Table 3 shows mean

differences between cases and controls in the domains

of the mCOH-QOL-Ostomy, separately by reason for

surgery and adjusted for age, time since surgery, and

Charlson comorbidity score. In Group A, all differences

suggest lower QOL for cases and reach statistical

significance for the social domain subscale, total QOL

scores, and in the psychologic subscale score for

colorectal cancer cases. By contrast, in Group B, most

differences suggest higher QOL for cases, but none

reach statistical significance.

When analysis was limited to Cases with CRC, we

found that mCOH-QOL-Ostomy domains subscale

and total QOL scores did not differ between Cases with

rectal and Cases with colon cancer, when adjusted for

age, time since surgery, and comorbidity score. For the

115 cases with CRC, the difference of a score of 10

favored rectal cancer by only 0.06 (P =0.85), and for

the 116 controls, the difference favored colon cancer

by only 0.09 (P = 0.83).

Adjusted mean scores for the domains of the

mCOH-QOL-Ostomy were compared between cases

and controls for Groups A and B separately (Table 4).

Statistically significant differences were found in

Group A for the total score, as well as the psychologic

and social domains. When comparing scores for

potentially meaningful differences regardless of statis-

Table 3.City of Hope Quality of Life-Ostomy Domain Score* Adjusted. Mean Difference Between Cases and Controls

for Male Veterans by Reason for Surgery

Group A Group B

City of Hope Quality ofLife-Ostomy Domain

Other-

(n = 60)Acute Inflammatory`

(n = 79)Colorectal Cancer

(n = 231)Benign Tumor

(n = 45)IBDË

(n = 65)

Total QOL 1.03{ 0.95{ 0.63{ j0.03 j0.39Physical 0.18 0.48 0.22 j0.72 j0.56Psychologic 0.94# 0.81 0.71{ 0.66 j0.54Social 1.93{ 1.91{ 1.10{ j0.12 j0.55Spiritual 0.93 0.34 0.41 j0.31 0.14

QOL = quality of life; IBD = inflammatory bowel disease.*Based on a response scale of 0 to 10, with higher scores reflecting more positive outcomes.. Difference adjusted for age, time since surgery, and comorbidity score (positive number indicates lower QOL for cases).- Includes bowel ischemia, trauma, volvulus, and cancer other than colorectal.` Includes diverticulitis, appendicitis, acute colitis, and other acute inflammatory diseases.Ë Ulcerative colitis and Crohn_s disease.{P < 0.05.# P = 0.055.

Table 4.City of Hope Quality of Life-Ostomy Domain Scores* for Male Veterans

Reason for Surgery Group A. Reason for Surgery Group B.

City of Hope Quality ofLife-Ostomy Domain

Cases(n = 176)

Controls(n = 218)

AdjustedMean Diff-

AdjustedP Value-

Cases(n = 63)

Controls(n = 52)

AdjustedMean Diff-

AdjustedP Value-

Total QOL 6.3 (2.0) 6.8 (1.8) 0.77 <0.001` 7.2 (1.9) 6.8 (1.8) j0.08 0.86Physical domain 6.6 (2.1) 6.6 (2.3) 0.23 0.33 7.2 (1.9) 6.7 (2.3) j0.42 0.39Psychologic domain 6.4 (2.1) 6.9 (1.9) 0.77 <0.001Ë 7.2 (2.0) 6.8 (1.9) j0.06 0.90Social domain 6.0 (2.6) 7.0 (2.6) 1.45{ <0.001Ë 7.0 (2.4) 6.9 (2.6) j0.32 0.58Spiritual domain 6.3 (2.3) 6.7 (2.3) 0.51 0.043 7.2 (2.4) 6.8 (2.3) j0.30 0.61

QOL = quality of life; diff = difference.Data are means with standard deviations in parentheses unless otherwise indicated.*Based on a response scale of 0 to 10, with higher scores reflecting more positive outcomes.. Group A includes colorectal cancer, acute inflammatory/infection, and other; Group B includes inflammatory bowel

disease and benign tumor.- Difference adjusted for age, time since surgery, and comorbidity score (positive number indicates lower QOL for cases).` Statistically significant (P < 0.05) with no Bonferroni adjustment.Ë Statistically significant after Bonferroni adjustment (adjusted alpha = 0.05/4 = 0.0125).{Exceeds Minimally Important Difference (empirical rule effect size).

KROUSE ET AL Dis Colon Rectum, 2007

tical significance, only the social domain exceeded the

estimated MID.

Table 5 compares mCOH-QOL-Ostomy items for

cases and controls in Group A only. To adjust for

multiple comparisons, the Bonferroni correction was

made, resulting in a critical alpha level of < 0.0014 for

significance. Compared with controls, cases had

significantly lower scores on numerous HR-QOL

items. In the psychologic domain the mean score for

Benjoyment or satisfaction in life^ was lower among

cases. Within the social domain, cases reported

significantly lower scores (poorer functioning) on:

ability to travel, interference with personal relation-

ships, recreational/sports activities, social activities,

ability to be intimate, and isolation. All of the social

domain items that were statistically significant met the

criteria for MID, whereas the enjoyment of life item

did not. Multiple items that were hypothesized to be

lower for cases than controls did not reach statistical

significance. These included sleep disturbances

(P = 0.19), feelings of control (P = 0.08), satisfaction

with appearance (P = 0.009), and anxiety (P = 0.035).

Table 5.City of Hope Quality of Life-Ostomy Scaled Item Scores* in Male Veterans in Reason for Surgery Group A.

Cases (n = 176) Controls (n = 218) Adjusted Difference- P Value.

Physical domain itemsStrength 6.0 (3.1) 6.5 (3.3) 0.48 0.01Fatigue 5.9 (3.1) 6.0 (3.2) 0.24 0.23Sleep disturbances 6.5 (3.1) 6.5 (3.3) 0.26 0.19Aches/pains 6.8 (3.3) 6.5 (3.3) j0.04 0.84Gas 6.1 (2.7) 5.8 (3.3) j0.02 0.92Constipation 8.3 (2.5) 7.5 (3.2) j0.49 0.02Diarrhea 7.2 (2.9) 7.6 (3.0) 0.48 0.015Overall physical well being 6.5 (3.0) 6.4 (2.8) 0.02 0.92

Psychologic domain itemsUseful 5.4 (3.0) 6.3 (2.7) 0.59 0.003Enjoyment 5.7 (3.0) 6.9 (2.7) 0.78 <0.001`

Remembering 5.9 (3.0) 6.3 (2.7) 0.32 0.1Control 6.3 (3.1) 6.6 (2.9) 0.34 0.08Appearance 5.8 (2.8) 6.1 (2.8) 0.51 0.009Anxiety 6.0 (3.1) 6.5 (2.8) 0.41 0.035Depression 6.4 (3.2) 7.1 (2.9) 0.63 0.002Fear of recurrence 6.5 (3.6) 6.5 (3.4) 0.31 0.11Difficulty meeting new people 7.5 (3.3) 8.4 (2.6) 0.63 0.004Support 7.2 (3.0) 7.7 (2.8) 0.36 0.07Privacy 8.5 (2.5) 8.7 (2.4) 0.23 0.3Uncertainty 5.6 (3.4) 6.2 (3.4) 0.51 0.009

Social domain itemsFinancial burden 5.4 (3.6) 6.1 (3.5) 0.49 0.01Family distress 6.2 (3.3) 6.4 (2.9) 0.29 0.13Travel challenges 5.8 (3.3) 7.8 (3.1) 1.39Ë <0.001`

Personal relationships 5.9 (3.9) 7.8 (3.0) 1.2Ë <0.001`

Isolation 6.7 (3.3) 8.3 (2.9) 1.24Ë <0.001`

Recreational activities 4.3 (3.8) 5.9 (3.7) 0.95Ë <0.001`

Social activities 5.4 (3.7) 7.3 (3.2) 1.16Ë <0.001`

Intimacy 3.6 (3.9) 6.6 (3.8) 1.63Ë <0.001`

Spiritual domain itemsReason to be alive 6.9 (3.0) 7.2 (3.2) 0.26 0.18Sense of inner peace 6.6 (2.9) 7.3 (2.9) 0.63 0.001`

Hopeful 6.7 (2.8) 7.3 (2.7) 0.61 0.002Spiritual activities 6.9 (3.4) 7.2 (3.2) 0.25 0.21Religious activities 6.0 (3.9) 6.1 (3.8) 0.19 0.33Positive changes 4.8 (3.9) 5.0 (3.8) 0.18 0.35

Data are means with standard deviations in parentheses unless otherwise indicated.*Based on a response scale of 0 to 10, with higher scores reflecting more positive outcomes.. Group A includes colorectal cancer, acute inflammatory/infection, and other.- Difference adjusted for age, time since surgery, and comorbidity score (positive number indicates lower QOL for cases).` Statistically significant after Bonferroni adjustment (adjusted alpha = 0.05/34 = 0.0014).Ë Exceeds Minimally Important Difference (empirical rule effect size).

QUALITY OF LIFE FOR VETERANS WITH STOMAS

Several items on the mCOH-QOL-Ostomy were

not included in the survey for controls because they

had no relevance. Although these items have no

control comparison, they do give further insight into

life with a stoma. These items addressed problems

with skin surrounding the ostomy (mean = 6.4),

leaking from the pouch (or around the appliance;

mean = 6.4), privacy when traveling for conducting

ostomy care (mean = 6.4), difficulty adjusting to the

ostomy (mean = 6), embarrassment from ostomy

(mean = 6.2), difficulty looking at the ostomy

(mean = 8.3), and difficulty in caring for the ostomy

(mean = 7.5).

Nonscaled items showed few differences between

cases and controls with two important exceptions.

Compared with controls, higher proportions of

ostomates reported having felt depressed (52 vs. 36

percent; P < 0.01) and having had suicidal ideation

(12 vs. 5 percent; P < 0.01) after their operations.

There were no significant differences between

Groups A and B in these contrasts.

Comparisons of cases and controls revealed mul-

tiple differences on the SF-36V scales among Group

A patients (Table 6). Significant differences between

cases and controls were observed on mean scores on

seven of the eight scales and the PCS and MCS.

Differences between the groups exceeded the MID

for the seven significant scales.

Sixty-eight percent of ostomates took the oppor-

tunity to expand on the final qualitative statement

asking to share Bthe greatest challenge you have

encountered in having an ostomy.^ Themes were

coded by using the four domains of the mCOH-QOL-

Ostomy model of HR-QOL. Two additional themes

emerged that were separated into new Bdomains^:1) ostomy-specific issues, and 2) medical care issues.

Respondents identified problems related to sexuality

and intimacy, travel, clothing, equipment, and other

common issues that they faced. Comments and

themes that represent the most frequent challenges

faced by these males are presented in Table 7.

Common issues included coping and acceptance of

their stoma, comorbidities, travel limitations, sexual

issues, embarrassment, and daily care. Challenges

were frequently ostomy-specific rather than direct

comparisons to the control group in the quantitative

data. In addition, some issues, such as sleep chal-

lenges, pain, and financial difficulties, that were not

significant in the quantitative comparison data were

still important challenges for ostomates. Importantly,

many ostomates described relying on their partners

during the immediate postoperative period or for a

Table 6.Short Form 36 for Veterans_ Scale Scores* for Male Veterans

Reason for Surgery Group A. Reason for Surgery Group B.

SF-36V ScalesCases

(n = 176)Controls(n = 218)

AdjustedMean Diff-

AdjustedP Value-

Cases(n = 63)

Controls(n = 52)

AdjustedMean Diff-

AdjustedP Value-

Physical function 43.2 (29.4) 54.4 (30.8) 11.6` <0.001Ë 63.1 (29.9) 54.7 (33.8) 0.99 0.89General health 48.4 (25.1) 56.9 (24.1) 10.0` <0.001Ë 57.0 (25.8) 46.9 (24.9) j4.0 0.51Vitality 38.5 (23.8) 45.2 (25.2) 8.0` 0.003Ë 51.4 (29.2) 43.8 (26.7) j3.2 0.65Mental health 63.6 (23.5) 71.7 (22.9) 9.7` <0.001Ë 76.4 (21.9) 68.8 (23.2) j1.6 0.78Role-Physical 47.5 (30.7) 58.0 (30.4) 12.1` <0.001Ë 62.7 (31.8) 57.9 (34.1) 1.4 0.86Role-Emotional 57.4 (30.7) 69.5 (29.8) 13.8` <0.001Ë 74.7 (28.5) 67.8 (30.1) 1.3 0.85Social function 60.4 (31.3) 72.7 (29.7) 13.3` <0.001Ë 73.0 (30.4) 68.6 (27.8) 0.96 0.89Bodily pain 44.7 (29.2) 47.8 (27.6) 2.7 0.40 52.7 (29.2) 43.6 (29.1) j3.8 0.60PCS 34.2 (10.6) 37.3 (10.4) 3.3 0.006{ 39.1 (10.6) 35.7 (11.6) 0.03 0.99MCS 45.4 (12.0) 50.4 (10.9) 5.8 <0.001{ 51.2 (11.0) 47.3 (11.6) j0.76 0.80

diff = difference; PCS = Physical Component Summary score; MCS = Mental Component Summary score.Data are means with standard deviations in parentheses unless otherwise indicated.*Scale and summary scores can range from 0 to 100, with higher scores reflecting better functioning and/or well-

being. Unlike the individual SF-36V scale scores, the PCS and MCS scores are standardized to reflect a mean of 50 anda standard deviation of 10 in the general adult U.S. population.

. Group A includes colorectal cancer, acute inflammatory/infection, and other; Group B includes inflammatory boweldisease and benign tumor.

- Difference adjusted for age, time since surgery, and comorbidity score (positive number indicates lower QOL for cases)` Exceeds Minimally Important Difference (empirical rule effect size).Ë Statistically significant after Bonferroni adjustment (adjusted alpha = 0.05/8 = 0.00625).{Statistically significant (P < 0.05) with no Bonferroni adjustment.

KROUSE ET AL Dis Colon Rectum, 2007

long-term basis. This related to assistance in caring

for their stoma and for emotional support. Non-

partnered ostomates described frustration and anger

related to not having a partner and issues related to

isolation and perceptions of others.

DISCUSSION

Although many studies have described HR-QOL

difficulties related to intestinal stomas, we are not

aware of any published reports that have used

mixed-methods HR-QOL measures between osto-

mates and a control group using an HR-QOL

instrument specifically developed for ostomates.

Our methods have enabled us to identify and

describe HR-QOL issues that are directly attributable

to living with an ostomy in this sample of veterans.

The fact that our groups were relatively similar

supports the validity of this comparison and provides

additional information to inform ostomy patient care.

Table 7.BGreatest Challenge^ Essay Responses*

Domain Example.

PhysicalActivity/exercise Activities, such as stooping, squatting, kneeling, sitting, etc., squeeze the stoma area,

flatten the pouch, and cause leakage (and open sores).Pain/discomfort The greatest challenge by far is immediately after surgery. It seems to take forever

to heal and for the pain to become manageable.Skin irritation Sometimes, every two months or so, the skin around my ostomy gets red and hurts

for a day or so and then is fine.Sleep My greatest challenge with my ostomy was learning how to sleep, without turning

over causing my pouch to leak and soil the bed linen.Psychologic

Coping/acceptance You never get used to it. You learn to live with it.Fear of others_

perceptionHaving people understand that you are not a freak because you have a bag

on your side.Fear of ostomyBaccidents^

My biggest challenge is getting over the fear of having leakage in public.

SocialTravel limitations Any attempt to empty pouch in the tiny traveling aircraft toilet is so difficult and time

consuming as to elicit pounding on door accompanied by shouts of are you all rightin there.

Sexuality/relationships

For many years, my wife found having sex unpalatable because of presenceof colostomy pouch. After 10 years, this problem was finally overcome.

Embarrassment I don_t like to eat out in public because of odor or smell from my ostomy. Notas involved with my boys lives (such as sports) because of embarrassment.

Work/financialproblems

Not able to continue my heavy sweating construction work. Would unseal and releasepouch from stomach.

SpiritualMeaning to life God had spared me for a reason. I owe them so much. I thank God for giving

this extra time to show how much I really do love my wife and children. Without them,I don_t think I would have made it. They provided the reason for living. I have sovery much to be thankful for.

Ostomy-specificDaily care The pouch fills up almost immediately after eating a meal. I must empty the pouch

immediately after completing my meal and an hour thereafter.Equipment

problems/solutionsI wasn_t aware that there was a belt for the pouch and have talked to others that did

not know it either. I have helped them solve a few problems that I have had. Theclip at the bottom of the pouch is hard to unfasten the first few times and needsto be unfastened extremely carefully when it is clamped over two or more folds.

Clothing restrictions My greatest challenge is trying to find clothes to fit with a high waist line abovemy barrier.

Medical care issuesComorbidities I am unable to care for my ostomy myself, but I do have macular degeneration

in both eyes and am unstable because of arthritis.Complications Four operations left me with a larger herniated area. Because of the hernia,

it is impossible to get a good seal with the pouches. It has to be changedtwice per day.

*Most common themes written by respondents.. Direct quotes from respondents.

QUALITY OF LIFE FOR VETERANS WITH STOMAS

The major clinical differences that could have HR-QOL

implications (age, time since surgery, and comorbidity)

were controlled in our model, and we stratified by

reason for surgery. Sample size precluded examining

the data from females in our cohort to definitively

examine HR-QOL issues. This population will be

described separately in a future report. To account for

etiology differences, we stratified by reason for surgery,

and then combined categories with similar findings.

Although it must be recognized that there may be other

clinical differences in our ostomate and control groups,

they are all males of similar age and comorbidity profile

who have equivalent access and availability to VA

health care. Our results are generalizable for the VA

male population. Extrapolation into the general popu-

lation, especially females, can only be performed with

caution. Finally, our mixed methods allowed us to

cross-validate quantitative findings by using qualitative

data, which further specified ostomate challenges.

Qualitative and quantitative findings from this

study underscore the impact of having an intestinal

stoma, particularly in the social domain. Although

individual item analyses were conducted in an

exploratory manner, both statistically and clinically

meaningful findings were evident. Thus, specific

items that can be explored for differences include

those related to general QOL, such as fatigue, aches

and pains, or anxiety, or those more related directly

to an ostomy, such as recreational activities, travel

challenges, or dissatisfaction with appearance.30

We found a demarcation in QOL outcomes

between two subgroups of cause for stoma. There

has been some indication that ostomates with cancer

had better HR-QOL for most issues compared with

ostomates without cancer,24 but our data do not

confirm this for comparison of cancer to inflamma-

tory bowel or benign tumor as cause of stoma.

Because our study is controlled, has better access to

patient records, and recruited through primary care

providers, we believe that the present results are

likely to be more accurate. Cases with ulcerative

inflammatory bowel disease or benign tumors had

more positive HR-QOL scores than other cases; this

may be caused by greater symptom relief or cure

after surgery. Cancer Cases often have other treat-

ments that can impact HR-QOL, and those needing

emergency procedures may not look at their stomas

as Bcurative^ and remain dissatisfied that they must

endure this complication of their acute disease. Cases

with inflammatory bowel disease and benign tumors

had longer time since surgery compared with other

patients; this factor may contribute to lack of observed

impact of a stoma in these etiologic subgroups,

although we adjusted for time since surgery, but should

not bias the results that we report for Group A.

It has been reported that approximately one-

quarter of stoma Cases experience significant clinical

psychologic symptoms.36 Our quantitative analyses

provide further evidence of the overall lower emo-

tional well being of ostomates. One of the most

important findings of this study was increased self-

reported postoperative depression and suicidal ide-

ation for ostomates. We also found a trend of worse

current feelings of depression (scaled item) among

cases. Whereas others have shown depression in this

population,10,37 our findings are novel in describing

postoperative effects, including risk of suicide, which

must be addressed in the perioperative setting.

The psychologic issues of coping and acceptance

were the most frequent challenges encountered in

our qualitative analysis. Although anxiety scores

were not significantly different for ostomates com-

pared with controls, Cases with stomas frequently

described fears related to others_ perceptions of them

and fear of Baccidents^ related to their stoma.

Overcoming these fears may be difficult and lead to

greater isolation and social debilitation. These results

further suggest that early professional psychologic

evaluation for Cases who undergo intestinal stomas

is warranted. This may be especially important for

those with preoperative or perioperative psychiatric

history,36 or those who have displayed negative

reactions toward their stoma.36

The major HR-QOL differences between ostomates

and controls were related to social functioning. The

social implications of an ostomy were reported more

than 50 years ago in some detail,2,38,39 and more

recent reports also have described these deficien-

ces.10,18,19,21,23,24,37,40–44 Our study provides further

detail regarding the specific social consequences of

having an ostomy and reports results that reflect

meaningful decrements in aspects of social well-being

that should be the focus of targeted interventions.

Although it is clear that counseling and supportive

interventions could focus on these potential concerns,

improvement in some of these areas may be difficult.

Although some problems may not be easily amenable

to change (e.g., intimacy), social isolation and travel

techniques can be enhanced. If these issues are

addressed, intimacy also may improve, even if not in

a sexual sense. In fact, some Bgreatest challenges^statements, especially from nonpartnered respondents,

KROUSE ET AL Dis Colon Rectum, 2007

focused on isolation and travel concerns that keep

them from being more socially active. In addition, it is

important to consider the potential interrelationship of

the domains of HR-QOL. For example, if the ostomy

keeps Cases from participating in church, this may

impair both spiritual and social functioning. Therefore,

helping Cases who have or are likely to have social

difficulties related to their stoma could have great

impact on other domains, and importantly a patient_s

overall HR-QOL. Partnered status was not an indepen-

dent predictor of HR-QOL for ostomates. However, our

data showed that both cases and controls who were

partnered had higher HR-QOL scores (data not

shown). Qualitative data included descriptions of

ostomates_ reliance on partners for care or emotional

support and assistance in caring for their ostomy,

especially in the immediate postoperative period. This

must be considered when an ostomy is created to plan

for the training of partners and for the additional

support required by those who are not partnered or do

not have an adequate support system.

No difference was noted in the physical well-being

domain of the mCOH-QOL-Ostomy between cases

and controls, with little difference in individual items.

Others have shown more of a gas problem for

ostomates, which was not evident in our population,

but we did see less constipation for ostomates which

was in agreement with others.19 Interestingly, we did

see a difference in physical functioning and role

limitations on the SF-36V (Table 6). This is in contrast

to findings using the SF-36 in Japan when comparing

the physical functioning of ostomates vs. Japanese

norms (P = 0.37); however, they did note a difference

in role limitations (P < 0.001).45 Their study utilized

the general population as a comparison, which may

be the reason why there is no difference in physical

functioning, but the stoma may lead to role limi-

tations as a result of the stoma and its care.

Care of a stoma for older adults or persons with

multiple medical problems, such as arthritis, poor

vision, or obesity, may be even more difficult.

Challenges related to comorbidities and surgical

complications were clearly illustrated in the open-

ended essay question, with cases focusing on the

individual medical problem that added to the total

health burden of care, as well as all of the daily self-

management problems that they needed to master.

In examining ostomy-specific content, cases

reported relatively low scores on items, such as the

skin surrounding the ostomy, leaking from the pouch

(or around the appliance), privacy when traveling for

conducting ostomy care, difficulty adjusting to the

ostomy, and embarrassment from ostomy. It must be

remembered that these low scores occur in a

population averaging 11 years postoperatively; these

are obviously persistent problems that ostomates

have not been able to resolve. Practical care issues

that are clearly outlined by Cases must be addressed

early after surgery to ensure that they are facile with

supplies, have the correct equipment for them, and

know where to seek alternatives and help when

necessary. Long-term support and follow-up related

to these issues are clearly needed.

Our data show HR-QOL issues that should be a focus

for clinicians who care for Cases with intestinal stomas.

This may involve early psychologic evaluation and

subsequent follow-up to ensure emotional stability and

coping after surgery. Integrating significant others to

participate in care may lead to improved adjustment

and even save marriages and/or partnered status.

Encouraging social networking and participation in

recreational events is likely to have positive effects.

Networking with other ostomates also would be help-

ful to many Cases to clarify many issues, and limit the

lengthy trial and error approach that most Cases

experience. Finally, a clear educational strategy will

facilitate coping and adjustment to one_s stoma and

lead to improvement of multiple HR-QOL issues. Our

qualitative data have helped focus these strategies, such as

related to the importance of the timing of eating, clothing

restrictions, or specific travel restrictions. Our team is

working toward an integrative approach in a prospective

study setting to understand interventions that will best

help Cases with intestinal stomas.

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