Scientific investigations
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1 Scientific investigations Gender Differences in Sleep Disruption and Fatigue on Quality of Life Among Persons with Ostomies Carol M. Baldwin, Ph.D. 1 ; Marcia Grant, R.N., D.N.Sc. 2 ; Christopher Wendel, M.S. 3 ; Mark C. Hornbrook, Ph.D. 4 ; Lisa J. Herrinton, Ph.D. 5 ; Carmit McMullen, Ph.D. 4 ; Robert S. Krouse, M.D. 3,6 1 Arizona State University College of Nursing & Health Innovation (Southwest Borderlands), Phoenix, AZ; 2 Beckman Research Institute, City of Hope National Medical Center, Duarte, CA; 3 Southern Arizona VA Healthcare System, Tucson, AZ; 4 The Center for Health Research, Kaiser Permanente Northwest, Portland, OR; 5 Kaiser Permanente-Northern California, Oakland, CA; 6 College of Medicine, University of Arizona, Tucson, AZ Study Objectives: The aim of this study is to examine differences in sleep disruption and fatigue of men and women colorectal cancer (CRC) survivors with intestinal ostomies and associated health-related quality of life (HR-QOL). Methods: Participants in this cross-sectional study of long-term (> 5 years) CRC survivors received care at Kaiser Permanente. Measures included the City of Hope QOL Ostomy questionnaire with narrative comments for ostomy-related greatest challenges. The Short Form-36 Version 2 (SF-36v2) health survey provided physical (PCS) and mental composite scale (MCS) scores to examine generic HR-QOL. The sleep disruption and fatigue items from the ostomy questionnaire (scale from 0 to 10 with higher scores indicating better HR-QOL) were dependent variables, while independent variables included age, ethnicity, education, partnered status, body mass index, and time since surgery. Data were analyzed using chi-square for nominal variables, Student t-tests for continuous variables, and logistic regression with significance set at p < Results: On the ostomy-specific measure, women (n = 118) compared to men (n = 168) reported more sleep disruption (p < 0.01), adjusted for age, and greater levels of fatigue (p < 0.01), adjusted for time since surgery. Women s PCS and MCS scores indicated poorer HR-QOL compared to men, and differences were clinically meaningful. Qualitative narrative comments suggested that sleep disruption could stem from ostomy-associated fear of or actual leakage during sleep. Conclusion: Although women CRC survivors with ostomies report more sleep disruption and fatigue, which is reflected in their reduced physical and mental health scores on the SF-36v2 compared to men with ostomies, their stated reasons for disrupted sleep are similar to their male counterparts. These findings can provide a foundation for gender-relevant ostomy interventions to improve sleep and HR-QOL in this patient population. Keywords: Quality of life, gender differences, sleep disruption, intestinal ostomies, mixed-methods Citation: Baldwin CM; Grant M; Wendel C; Hornbrook MC; Herrinton LJ; McMullen C; Krouse RS. Gender Differences in Sleep Disruption and Fatigue on Quality of Life Among Persons with Ostomies. J Clin Sleep Med 2009;5(4): Colorectal cancer (CRC) ranks as the third most common cancer and the third leading cause of death from cancer for both men and women. 1 Treatment approaches for CRC include surgery, radiation, and chemotherapy, often with placement of an intestinal ostomy, or stoma. Stomas result from exteriorization of the small (ileostomy) or large (colostomy) bowel and may be temporary, usually to protect low anastomoses in rectal cancer, or permanent, usually for distal rectal cancers or reasons other than for anastomosis, such as poor anal sphincter control. The prevalence and nature of CRC suggest greater morbidity and therapeutic consequences for CRC survivors compared to Submitted for publication November, 2008 Submitted in final revised form April, 2009 Accepted for publication April, 2009 Address correspondence to: Carol M. Baldwin, Ph.D., R.N., CHTP, AHN- BC, Associate Professor and Southwest Borderlands Scholar, Director, Office of World Health Promotion and Disease Prevention, Arizona State University, College of Nursing & Healthcare Innovation, 500 North 3rd Street, Phoenix, AZ 85004; Tel: (602) ; Fax: (602) ; carol.baldwin@asu.edu Journal of Clinical Sleep Medicine, Vol.5, No. 4, other cancers based on activities of daily living issues relevant to stoma and bowel care. 2-5 Advances in early detection and treatment are extending cancer survivorship. In turn, adaptation to living with cancer and maintaining one s health-related quality of life (HR-QOL) have garnered greater attention in order to identify the bio-psychosocial, spiritual, and socioeconomic factors that contribute to or detract from the well-being of CRC survivors with ostomies Studies of specific issues that affect the HR-QOL of CRC survivors with ostomies include appearance, work and travel-related activities, and intimacy, 9,13,14 as well as general HR-QOL domains, such as physical and psychological adaptation to CRC. 8,9 Although several studies have emerged that examine sleep disturbances of cancer patients, few studies have addressed HR-QOL specific to disturbed sleep of CRC survivors. 9-10,13 Studies have suggested sex differences for self-rated health, as well as different manifestations of and prevalence rates for sleep disorders by sex To date, however, there are no extant studies that describe the sleep disruption and fatigue of men and women CRC survivors with ostomies and any respective differences in their HR-QOL. Furthermore, a focus for a major-
2 CM Baldwin, M Grant, C Wendel et al ity of sleep and HR-QOL studies provide quantitative comparisons between men and women. Studies are beginning to emerge in the health services and clinical care milieus, however, that incorporate mixed methodology (quantitative and qualitative components) to gain knowledge regarding contributing factors and insights for improving care delivery, or to examine relevant interventions in the clinical care setting. 24,25 This study provides a comprehensive investigation to document the impact of living with an ostomy on the sleep HR-QOL of men and women. A key issue is how persons with ostomies cope with their appliance while sleeping. Most persons with ostomies have experienced nighttime rupture or separation of their ostomy pouches and need to clean themselves and change their bedding. It is not known, however, if these are primary factors for sleep disruption, if other factors impinge on sleep, or if both the qualitative and quantitative HR-QOL of persons with ostomies, who report sleep problems differ by sex. Therefore, the focus of this paper is to examine sex differences in sleep disruption and fatigue of persons with intestinal ostomies using mixed-method approaches to understand better and develop sleep management strategies for this patient population. Recruitment and Participants METHODS This work is a secondary analysis of data collected in the Health-related Quality of Life in Long-Term Colorectal Cancer Survivors Study. Detailed information regarding the parent study is reported elsewhere. 26 In brief, the parent study utilized a cross-sectional matched cohort (284 CRC survivors with ostomies/395 CRC survivors without ostomies) to study the HR- QOL of long-term (> 5 years) CRC survivors with ostomies. Participants received care at the Kaiser Permanente health systems in California, Oregon/Washington, and Hawaii. A mixedmethod (quantitative and qualitative components) approach was used to collect data, including a mailed survey with sociodemographic, health, health care utilization items, and openended items, as well as focus groups. A large sample of persons with ostomies from diverse racial/ethnic and sociodemographic groups and geographic areas were recruited using tumor registries, membership data systems, and electronic data systems that provide information on medical care services provided to health maintenance organization members. All quantitative data were obtained by mail survey. An overall response rate of 52% (679/1308) was obtained. The study protocol and survey instruments were reviewed and approved by the Institutional Review Boards at the University of Arizona, Tucson, and the Kaiser Permanente Hawaii, Northwestern and Northern California sites. For this study, only data from CRC survivors with ostomies (cases) were analyzed to explicate sleep disruption and fatigue problems relevant to having an intestinal ostomy. Survey Instruments City of Hope Quality of Life Ostomy Measure Data regarding the sleep disruption and fatigue components of HR-QOL were obtained using the validated City of Hope Quality of Life Ostomy-specific (COHQOL-O) survey questionnaire (recall in the recent past ). This measure has demographic, ordinal-based non-scaled and scaled items; the latter range from 0 (poor) to 10 (excellent). The non-scaled items include marital status, work, health insurance, sexual activity, psychological support, and diet. Scaled items are mapped onto 4 domains (physical, psychological, social, and spiritual well-being), as well as the mean of all scaled items representing overall ostomy-related QOL ( total COHQOL-O ). The 2 items used as dependent variables in this study, sleep disruption and fatigue, are physical domain components of the ostomyspecific survey. Psychometric testing for the measure used in a similar study of United States military veterans showed an overall Cronbach α coefficient of 0.95; subscale reliabilities r = 0.88 for the physical, r = 0.83 for the psychological, r = 0.90 for the social, and r = 0.81 for the spiritual domains, 27 which are consistent with the reliabilities from the original study. 28 The COHQOL-O survey also elicited narrative comments from participants in the open-ended question at the close of the survey relevant to sleep disruption and fatigue using the following prompt: Many people have shared stories about their lives with an ostomy. Please share with us the greatest challenge you have encountered in having an ostomy. Sh o rt Fo r m-36 Ve r s i o n 2 Ph y s i c a l a n d Me n ta l Co m p o s i t e Sc a l e s Health-related quality of life (HR-QOL) was examined using the physical (PCS) and mental composite scales (MCS) of the Short Form-36 Version 2 (SF-36v2) (recall in the past 4 weeks). This self-administered HR-QOL measure, derived from a crosssectional and longitudinal study of variations in health practices and outcomes in over 10,000 outpatients, can discriminate between subjects with and without chronic diseases, and has excellent internal consistency The SF-36v2 subscales and composite scores are presented as means and standard deviations and range from 0 to 100 with higher scores indicating better health and well-being. PCS and MCS composite means and standard deviations are 50 ± 10 for the U.S. general population. 32 PCS and MCS factors have been found to account for 80% to 85% of the reliable variance in the 8 SF-36 scales in patient, as well as general populations Poor (low) scores on the PCS indicate limitations in physical/role functions, bodily pain, and general health, while better (higher) scores suggest no physical limitations, disabilities, or decrements in well-being. In like manner, a low score on the MCS suggests frequent limitations in psychosocial health, emotional problems, and reduced vitality (a fatigue construct), while a high score indicates frequent positive affect and vitality, absence of psychological distress, and reduced or no limitations in daily social and role activities. Utilizing data from both the ostomy and the SF-36v2 surveys in this study provided information on ostomy-specific and general aspects of HR-QOL relevant to sleep disruption and fatigue in this population. Focus Group Participants and Protocol Following the return of all completed mail surveys, focus groups were recruited from participants whose total scores fell Journal of Clinical Sleep Medicine, Vol.5, No. 4,
3 within the highest and lowest quartiles of the total COHQOL- O scores. These extremes were intended to create groups that had adapted either successfully or poorly, respectively, to having an intestinal ostomy. Separate focus groups for men (High HR-QOL n = 12; Low HR-QOL n = 5) and women (High HR- QOL n = 10; Low HR-QOL n = 7) with intestinal ostomies were recruited to determine different coping skills and strategies. Groups were held in Oakland, California, and Portland, Oregon, to sample a wide variety of geographic, ethnic, and racial viewpoints. A focus group discussion guide was developed by the research team that allowed for elaboration and exploration of their responses to the 4 domains contained in the ostomy-specific survey, as well as for other issues related to living with an ostomy. A team member with expertise in leading focus groups (MG) served as facilitator for each group. Participants completed institutional review board-approved written informed consent and were assured anonymity of the voice-recorded data. All focus groups were audio-taped and transcribed verbatim. The time frame for each group was approximately 2 hours in order to assure adequate saturation of information repetition of emergent themes between and among groups. Saturation is a sampling component in qualitative research. 34 The responses reported in this study were derived from focus group data relevant to the sleep disruption and fatigue items from the COHQOL-O physical domain. Quantitative Analysis The 2 items from the physical domain of the COHQOL-O, sleep disruption and fatigue, served as the dependent variables for this analysis. Age, sex, ethnicity, education, partnered status, body mass index (BMI), and time since ostomy surgery were included in regression modeling as independent variables. QualityMetric Health Outcomes Scoring Software 2.0 (Quality/ Metric, Lincoln, RI, USA ) was used to calculate the PCS and MCS scores. If a respondent missed more than half of the responses for the scale s items, SF-36v2 scale scores were coded as missing. Chi-square was used to compare categorical demographic variables between men and women. Student t-tests were used to compare continuous variables, including demographic measures and PCS and MCS scores (presented as means and standard deviations consistent with manual guidelines), 32 as well as to compare PCS and MCS within sex and between high and low sleep item groups. All analyses, including ordinal logistic regression modeling, were accomplished using Stata (Version 8.2) with statistical significance set at p < Clinical significance was determined using the criteria for the clinically meaningful minimally important difference (MID), a difference of 2 points. 35 For this study, the MID is calculated as the difference between men s and women s PCS and MCS mean scores, as well as the within-group mean scores by sex. Narrative Survey Analysis Content analysis 36 was conducted on the narrative comments provided in the open-ended question included in the COHQOL- O survey. The study team reviewed the responses using linked Ostomates Sleep Disruption and Fatigue by Gender Table 1 Demographics of the Studied Population Demographic/Lifestyle Men Women Variables (n = 168) (n = 118) Age (Mean ± SD) 72.3 ± ± 11.0 Education (%) High school or less Beyond high school Married/Partnered (%)** Race/Ethnicity (%)* Non-Hispanic White Asian Non-Hispanic Black Hispanic Other BMI (Mean ± SD) 26.6 ± ± 7.7 Years since Surgery (Mean ± SD) 11.5 ± ± 7.8 *p < 0.05; **p < activities including processing of the raw data, data reduction, data display, and conclusion drawing and verification. 34,37 The study team read and examined data to identify units of analysis, which were defined in paragraph, sentence, verb phrase, or single words that conveyed a single meaning or concept. 37 Statements regarding sleep disruption and fatigue were bracketed and displayed in a table organized according to the physical domain of the ostomy survey, as were the items for the other domains. Focus Group Analysis Each of the focus groups was transcribed verbatim as rich text format. Each participant was assigned a number to maintain anonymity. Content analysis was performed using the guidelines described for the survey narratives; however, focus group transcripts were coded using HyperRESEARCH qualitative software (ResearchWare ) by members of the team having expertise in qualitative analysis. As with the survey narratives, the focus group statements were bracketed and displayed in a table organized according to ostomy survey domain item categories for this study. Demographics RESULTS Characteristics of the studied sample are shown in Table 1. Women (n = 118) compared to men with intestinal ostomies (n = 168) were less likely to be partnered (25% vs. 55%, p < ). There were more Hispanic men, and more African American and Asian women; however, there was no significant difference in the proportion of Non-Hispanic White to other ethnic categories combined. There were no differences for age, ethnicity, education, BMI, or time since surgery. Quantitative Findings for Sleep Disruption and Fatigue Women were significantly more likely than men to have lower (poorer) scores on the ostomy survey for both sleep disruption (p < 0.01) and fatigue (p < 0.001) (Table 2). Regression modeling for sleep disruption showed women to have poorer osto- Journal of Clinical Sleep Medicine, Vol.5, No. 4,
4 CM Baldwin, M Grant, C Wendel et al Table 2 Disrupted Sleep and Fatigue by Sex Sleep Items+ Men Women Adjusted p-value 2 (n = 168) (n = 118) Difference 1 Sleep Disruption 7.7 ± ± p < 0.01 Fatigue 7.8 ± ± p < Sleep disruption adjusted for age; Fatigue adjusted for time since surgery. 2 Z-test from ordinal logistic regression. + Sleep Disruption and Fatigue are physical domain items from the City of Hope Quality of Life-Ostomy specific survey; scores range from 0 to 10 with 10 suggesting best quality of life. Table 3 City of Hope Quality-of-Life Ostomy Greatest Challenge Narrative and Focus Group Statements for Sleep Disruption Reported by Men and Women with Intestinal Ostomies in the Upper and Lower Quartiles Number Sex COHQOL O Total Mean Score Statement 1 F 5.81 Another challenge was the unpredictable number of days before the wafer would begin to leak, and the many occasions when I discovered this in the middle of the night and had to stay awake to carry out the 90-minute process of cleaning the colostomy and applying a new wafer. 2 M 5.67 A lot of times, I am afraid to go to sleep in fear that the bag may come off. It has happened. 3 F 9.09 I m using now the concave pouch in order to keep it So I have the pocket on the bottom. So if I don t watch it at night and I fill this with something, of course it s going to leak while I have a space there. So I have to be very careful and have to be watching and aware of turning over. 4 F 5.17 If I get up in the middle of the night, which I That s one of the things that s changed is I wake up more often at night It was like I was constantly reaching down to find out if it was full. 5 M 5.36 Tried sideways, back, on the stomach for a little while I toss a lot at night. I probably just get about three or four hours of sleep. 6 M 7.90 It was challenging finding any position in which to sleep. 7 M 5.29 loss of stamina and energy. 8 M 4.98 The handicap of the ostomy is certainly a nuisance I would rather miss. Long after the operation, the dream reappeared in my sleep in which things were back to normal, but it was only a dream. my-associated HR-QOL after adjusting for age (0.57 decrease, p < 0.01). There was a modest increase in ostomy-associated HR-QOL with age (p < 0.001). There were no independent effects for education, minority status, BMI, time since surgery, or partnered status. Regression modeling for fatigue showed women to have lower ostomy-associated HR-QOL compared to men after adjusting for time since surgery (0.65 decrease, p < 0.01). There was a modest increase noted in ostomy associated HR-QOL with time since surgery (p < 0.05). There were no independent effects for education, minority status, BMI, age, or partnered status for fatigue. Qualitative Findings Written survey narratives and focus group statements are displayed in Table 3 and are representative samples from men and women in the high and low COHQOL-O groups. Qualitative comments from both the greatest challenge narratives and the focus groups suggest that sleep disruption is associated with several factors related to ostomy care or leakage for men and women across the COHQOL-O groups. For example, men and women in high and low groups reported disrupted sleep related to fear of leakage (participants 1 through 4), or the need to perform ostomy care during hours of sleep to prevent leakage, or reapply the appliance due to leakage (participants 1, 3, and 4). Men and women in both groups also reported disrupted sleep (participants 3 and 6), or insufficient sleep (participant 5) due to positional changes during the night that could result in leakage. One participant, a man in the low COHQOL-O group mentioned fatigue, which he reported as loss of stamina and energy. No women CRC survivors in either group wrote about or discussed fatigue. One long-term CRC survivor, a man in the low COHQOL-O group, summarized the ostomy experience in a recurring dream during sleep in which things were back to normal only to find on awakening that it was only a dream. Sleep Disruption and Fatigue Findings by Sex Table 4a displays the comparisons for men and women who reported less or greater sleep disruption and fatigue with their PCS and MCS mean scores and standard deviations (SD). Women who indicated less sleep disruption and fatigue on the ostomy survey reported significantly poorer physical HR-QOL on the PCS compared to their male counterparts with less sleep disruption (p < 0.01) and fatigue (p < 0.05). Mental health, as defined by the MCS, was significantly poorer for women compared to men with less sleep disruption (p < 0.05). There were no significant differences on the MCS for either men or women with low fatigue. Women who reported greater fatigue showed poorer mental health on the MCS than men who reported greater fatigue (p < Journal of Clinical Sleep Medicine, Vol.5, No. 4,
5 Ostomates Sleep Disruption and Fatigue by Gender Table 4a PCS and MCS Between Group Comparisons for Men and Women who Reported Low or High Sleep Disruption and Fatigue Physical Composite Scale Mental Composite Scale COHQOL-O Sleep Item 50 ± SD 1 p-value [MID score] 2 50 ± SD 1 p-value [MID score] 2 Between sex 3 Between sex 3 Low Sleep Disruption p < 0.01 [6.1] p < 0.05 [5.9] Men (n = 81) 47.4 ± ± 9.5 Women (n = 44) 41.3 ± ± 16.4 High Sleep Disruption n.s. [2.1] n.s. [0.8] Men (n = 81) 40.6 ± ± 14.1 Women (n = 69) 38.5 ± ± 12.8 Low Fatigue p < 0.05 [5.1] n.s. [0.6] Men (n = 87) 47.7 ± ± 13.9 Women (n = 42) 42.6 ± ± 15.4 High Fatigue n.s. [2.0] p < 0.05 [4.6] Men (n = 74) 39.8 ± ± 10.2 Women (n = 71) 37.8 ± ± 13.2 Table 4b PCS and MCS Within Group Comparisons for Men and Women who Reported Low or High Sleep Disruption and Fatigue Physical Composite Scale Mental Composite Scale COHQOL-O Sleep Item 50 ± SD 1 p-value [MID score] 2 50 ± SD 1 p-value [MID score] 2 Within sex 4 Within sex 4 Sleep Disruption in Men p < [6.8#] p < [6.3#] Low (n = 81) 47.4 ± ± 9.5 High (n = 81) 40.6 ± ± 14.1 Sleep Disruption in Women n.s. [2.8 ] n.s. [1.2 ] Low (n = 44) 41.3 ± ± 16.4 High (n = 69) 38.5 ± ± 12.8 Fatigue in Men p < [7.9#] n.s. [2.4#] Low (n = 87) 47.7 ± ± 13.9 High (n = 74) 39.8 ± ± 10.2 Fatigue in Women p = 0.02 [4.8 ] p = 0.02 [6.4 ] Low (n = 42) 42.6 ± ± 15.4 High (n = 71) 39.8 ± ± 13.2 PCS = Physical Composite Scale (physical function/role, bodily pain, general health) MCS = Mental Composite Scale (vitality, socio/emotional function, mental health) SD = Standard deviation n.s. = not significant 1 Mean and SD for the PCS and MCS in the U.S. general population 32 2 MID = Minimally Important Difference (empirical rule effect size; 2 suggests clinical significance) 3 Compares composite scale scores between men and women within sleep item groups 4 Compares composite scale scores within sexes between high and low sleep item groups [#] = Minimally important difference scores between men in high and low sleep item groups [ ] = Minimally important difference scores between women in high and low sleep item groups 0.05). Men and women with high fatigue did not differ on their PCS scores (Table 4a). There were no significant differences for men and women with greater sleep disruption for physical or mental health. Differences within Sex by Degree of Sleep Disruption and Fatigue Within-sex differences for disrupted sleep and fatigue compared to the PCS and MCS are displayed in Table 4b. Men with greater disrupted sleep differed significantly from men with low sleep disruption on their physical (p < ) and mental health (p < 0.001) scores. Women with low or high sleep disruption, however, did not differ on either the PCS or MCS. Men who reported greater fatigue on the ostomy survey showed poorer physical HR-QOL on the PCS compared to men with low fatigue (p < ). Men with high or low fatigue did not differ significantly on the MCS. Women with greater fatigue reported poorer physical (p < 0.05) and mental HR-QOL (p < 0.05) than women who reported low fatigue. Clinically Meaningful Findings Table 4a presents between sex clinically meaningful findings. Women in both the low and high sleep disruption and fatigue groups met the 2-point or greater criteria for minimally important difference (MID) 35 for their PCS scores. The difference score was greater between men and women with low sleep disruption and low fatigue (MID = 6.1 and 5.1, respectively), while the score narrowed for men and women who reported greater disrupted sleep (MID = 2.1) and fatigue (MID = 2.0) for the PCS. Women who reported little sleep disruption and women who reported high fatigue showed difference scores that met Journal of Clinical Sleep Medicine, Vol.5, No. 4,
6 CM Baldwin, M Grant, C Wendel et al Table 5 SF-36v2 PCS and MCS Standard Form Disease-Specific Norms* for Comparisons with PCS and MCS Scores for Men and Women with Ostomies Disease Specific Norms PCS ± SD MCS ± SD 50 ± SD 1 50 ± SD 1 Back pain/sciatica (n = 2,916) ± ± Cancer (except skin) (n = 247) ± ± Depression (n = 1,006) ± ± Diabetes (n = 602) ± ± Hypertension (n = 1,898) ± ± 9.92 *From Ware JE et al. 32 SF-36v2 = Short Form-36 Version 2. PCS = Physical Composite Scale (physical function/role, bodily pain, general health). MCS = Mental Composite Scale (vitality, socio/ emotional function, mental health). SD = Standard deviation. 1 Mean and SD for the PCS and MCS in the U.S. general population. 32 the criteria for clinically meaningful findings on the MCS (MID = 5.9 and 4.6, respectively). There were no statistically significant or clinically meaningful differences for men and women who reported disrupted sleep or low fatigue. The empirical rule effect size was also applied to withingroup findings for men and women with high and low sleep disruption and fatigue with respect to their PCS and MCS scores (Table 4b). Men with disrupted sleep and fatigue met the criteria for clinically meaningful findings in both the physical and mental health categories. These findings for men were clinically significant except for the MCS comparison between men with low and high fatigue; although not statistically significant (p = 0.22), the MID score for the fatigue comparison was 2.4, suggesting clinical significance. Comparisons of women who reported high and low fatigue indicated both statistically (each p = 0.02) and clinically meaningful findings for the PCS (MID = 4.8) and MCS (MID = 6.4). Notably, neither the PCS nor the MCS showed statistical significance for women with high or low sleep disruption; however, the MID (2.8) suggested clinical significance for physical health. The difference score between women with and without sleep disruption on the MCS did not meet criteria for clinical meaningfulness. Comparisons with Other Health Conditions Table 5 provides SF-36v2 PCS and MCS standard (over the past 4 weeks) disease specific norms 32 for comparison with the PCS and MCS scores of participants with ostomies in this study. In general, women ostomates with or without sleep disturbance or fatigue showed PCS scores equivalent to or lower (poorer physical health) than all of the disease specific norms represented. Men with ostomies who reported sleep disruption and fatigue showed their physical HR-QOL to be equivalent to diabetes and any cancer except skin, or lower (poorer) than persons with depression, hypertension, and back pain. With respect to mental health, women ostomates with or without disrupted sleep and women with fatigue had scores equivalent to or lower than all disease specific norms except for depression. Women who did not report fatigue had higher (better) mental health compared to the disease specific norms presented. Only men with sleep disruption or fatigue had scores equivalent to disease specific norms, particularly hypertension and diabetes. Men with ostomies who did not report disrupted sleep or fatigue indicated higher (better) mental health than persons in the general population with the diseases outlined in Table 5. DISCUSSION This comprehensive mixed-methods study of intestinal ostomy on HR-QOL for long term CRC survivors extends our knowledge of sleep disruption and fatigue in this population. Quantitative findings suggest that women compared to men CRC survivors with intestinal ostomies report more sleep disruption and fatigue that may contribute to poorer HR-QOL. Women s sleep and fatigue problems were mirrored in their lower scores on the PCS and MCS scales, as well as their comprehensive equivalent or lower (poorer) HR-QOL scores compared to disease specific norms in the U.S., including all cancers except skin, back pain, depression, diabetes, and hypertension. Notably, women who reported less disrupted sleep had SF-36v2 PCS and MCS scores that were lower (poorer HR-QOL) than their male cohorts and similar to women with ostomies who reported greater sleep disruption. Qualitative narrative and focus group comments indicated similar reasons for sleep disruption for both men and women with ostomies whether they scored high or low on the COHQOL-O sleep items. These results warrant further mixed-methods research as to differences in the ways in which men and women with ostomies perceive and report sleep disorders, fatigue, and HR-QOL. To our knowledge, this is the first study that provides mean MCS and PCS scores for men and women with intestinal ostomies reporting sleep disruption and fatigue. The mean PCS and MCS scores for women and men with CRC were consistent with preliminary findings for Non-Hispanic White, African American, and Hispanic participants with insomnia and excessive daytime sleepiness in the Sleep Heart Health Study. 38 Scores for women with CRC were consistent with PCS and MCS scores for women with ovarian and endometrial cancer. 39 The statistically significant and clinically meaningful differences between men who report high and low fatigue and sleep disruption compared to men with ostomies who do not point to a gap in the HR-QOL literature for men with CRC. Notably, men with ostomies who do not report sleep disruption or fatigue not only have better physical and mental HR-QOL compared to men with ostomies who do report disturbed sleep or fatigue, but higher (better) physical and mental HR-QOL scores than those of the disease specific norms described in this paper. These findings suggest that absence of fatigue and uninterrupted sleep promote positive HR-QOL for some men despite having an ostomy, and that their HR-QOL surpasses that of persons with back pain, other cancers, depression, diabetes, or hypertension. Future clinical sleep medicine research should address the physical, psychosocial, or other factors that may support restful sleep and reduce fatigue in some men with ostomies but not others, which would support interventions geared to men. Additional studies need to be undertaken to determine in greater detail relationships between men with ostomies who report sleep problems and fatigue with the generic MCS and PCS scores to enhance the generalizability of these findings. Few studies have addressed sleep disturbances of CRC survivors with ostomies and there are no extant studies that have Journal of Clinical Sleep Medicine, Vol.5, No. 4,
7 Ostomates Sleep Disruption and Fatigue by Gender included narrative statements of these patients experiences of having an ostomy on their sleep. A Scandinavian descriptive comparative study indicated a major post-discharge concern of CRC patients to be sleep problems; however, their self-reported well-being was improved if they were living with relatives rather than alone. 40 Baker et al. provided a more comprehensive snapshot of concerns to 752 cancer survivors from three states in the U.S. who were diagnosed with one of 10 common cancers. 13 Overall, cancer survivors ranked fatigue second (67.1%) and sleep difficulties fifth (47.9%), and women with cancer were significantly more likely to report fatigue and sleep difficulties than men. 13 Although the study of Baker et al. 13 provided a glimpse at the sleep HR-QOL of cancer survivors, their sample drew from 10 cancer types, thereby limiting the number of participants in each group (n = 65 participants in the CRC group); that study examined survivors from > 1 to 10 years, whereas our study focused specifically on men and women CRC survivors 5 years since diagnosis. Our findings replicate the reports of fatigue, further suggesting that sleep difficulties are an under-recognized and under-addressed component of HR-QOL in this patient population. It is intuitive that an individual with an intestinal ostomy would have difficulty getting adequate sleep at night due to disruptions from leakage, the need to change the appliance, fear that the appliance will come undone, or sleep position issues. Our mixedmethods approach, however, expands the literature by providing support for these concerns based on the participants own narrative experiences of having an ostomy. Notably, although women with ostomies quantitatively reported poorer physical and mental HR-QOL than their male counterparts with respect to disturbed sleep and fatigue, the narrative reasons given by men and women were very similar. Reasons for this seeming dichotomy are not known. Although the comments are similar, the impact of the ostomy on sleep disruption and fatigue could be greater for women, or there could be other factors in addition to the ostomy that affect women s HR-QOL. In their report of ways in which sleep disorders and medical conditions are differentially experienced by women compared to men, Phillips et al. 23 reported that the prevalence of insomnia increases as women age. The reasons posited were multifactorial, including hormonal and psychological changes relevant to life transitions, as well as greater prevalence rates for pain and depression in women, all of which affect their HR-QOL. Future studies will need to incorporate specific sleep symptoms, including insomnia, restless legs syndrome, daytime sleepiness, and obstructive sleep apnea to further delineate sleep problems experienced by both men and women with ostomies in lieu of the generic sleep disturbance and fatigue items used in this study. The seeming dichotomy in the quantitative differences and qualitative similarities of men s and women s reports points to a major benefit of mixed methods research. Given that the narrative information for sleep disruption is similar for men and women, innovative educational interventions can be developed to improve the sleep quality of persons with ostomies in the clinical sleep medicine and oncology settings, such as strategies to reduce or prevent leaks during the night, alternative sleep positions, relaxation training to reduce anxiety, and other activities relevant to qualitative concerns that will promote sleep during the night despite having an ostomy. The quantitative dif- ferences between men s and women s HR-QOL suggests that tactics will need to be gender specific and will require intervention studies to further determine factors that will enhance men s and women s sleep quality, thereby improving their HR-QOL. Higher reports of fatigue among women with ostomies compared to their male counterparts replicate previous sleep, HR- QOL, and health services research in other populations ,41-43 Women were shown to have higher symptom complaints, including fatigue, that were independent of psychiatric comorbidity. 19 Women attending an integrative medicine clinic reported more symptoms, including fatigue and insomnia, and scored higher on perceived stress ratings of family and health compared to men. 42 The statistically significant and clinically meaningful findings for higher reports of fatigue in the present study could be accounted for, in part, by the demographic calculus of women with intestinal ostomies to be less likely to be married or partnered than their male counterparts. Several sleep studies have also suggested that women in general may have a more expansive vocabulary for fatigue, such as tiredness, reduced energy, feeling unrested, and lack of vigor that could assist sleep clinicians by means of a sex-specific fatigue taxonomy to improve diagnosis of sleep problems in men and women, and in the development of interventions to reduce fatigue related to disease, social support, or other factors in men and women CRC survivors with ostomies. 21,22,41,43 The ostomy measure includes one self-rated fatigue item. Future studies need to examine the concept of fatigue relevant to ostomy to advance the sleep clinician s knowledge of ways in which it is expressed and experienced by men and women CRC survivors, thereby enhancing sleep HR-QOL of these patients. Limitations As with other studies, there are limitations that must be addressed when considering the interpretation of these findings. The cross-sectional nature of this mixed-methods study cannot infer causality between disease and HR-QOL outcome. The City of Hope Quality of Life measure is a validated instrument specific for persons with intestinal ostomies that assesses subjective reports of two sleep items, nonspecific sleep disruption and fatigue. Future sleep and HR-QOL studies will need to address more specific problems in this population, such as insomnia, excessive daytime sleepiness, snoring, and other sleep issues that could be distinct from or result from having an ostomy. The composite scales of the SF-36v2 are generic measures of HR-QOL and do not necessarily reflect physical and mental health factors specific to sleep and fatigue problems reported by persons with ostomies. 44 This study, like others, has shown women to report higher rates of fatigue, yet the nature of the fatigue and associations with ostomy require further exploration. One participant, a man with a low (poorer) COHQOL-O self-defined fatigue as loss of stamina and energy. One other participant, a man with self-reported sleep disruption reported a recurring dream of normalcy. Opportunities for both men and women with ostomies to provide more in-depth narrative reports that define fatigue, disrupted sleep, and other sleep symptoms, such as recurring dreams, are warranted in order to design appropriate and relevant sleep promotion interventions in the clinical setting. Journal of Clinical Sleep Medicine, Vol.5, No. 4,
8 CM Baldwin, M Grant, C Wendel et al Summary Despite any limitations, this research provides a comprehensive study of sleep problems experienced by men and women with ostomies. Little is known about ostomy-related sleep problems, or specific factors that could impinge on the quality of sleep. The quantitative data provide statistical and clinically meaningful comparisons between men and women with ostomies in their reports of disturbed sleep and fatigue and their associations with HR-QOL, while the narrative and focus group comments lend insight into the challenges that contribute to sleep disruption. This study also provides mean PCS and MCS scores for men and women who reported better or poorer scores on the City of Hope ostomy measure for sleep disruption and fatigue to use for comparison in future HR-QOL sleep studies of men and women with ostomies. Although the PCS and MCS are generic measures of HR-QOL, this study has provided some concurrent validity to the constructs of the sleep disturbance and fatigue COHQOL-O items with the generic physical and mental health constructs. The sex differences noted in this study highlight the need to examine sleep assessment, and to refine or develop measures that are responsive to men and women with ostomies in future sleep studies. In like manner, differences in social support, other comorbid conditions, access to care factors are all relevant to sleep HR-QOL and require further study among men and women with ostomies. The findings from this study can ultimately guide sleep clinicians and primary care providers to a greater awareness of the unique sleep problems of men and women with ostomies, and serve as heuristic approaches for future comparison and intervention studies that are sex and ostomy specific. Abbreviations BMI - Body mass index COHQOL-O - City of Hope Quality of Life Ostomy survey CRC - Colorectal cancer HR-QOL - Health-related quality of life MCS - Mental Composite Scale PCS - Physical Composite Scale SF-36v2 - Short Form-36 Version 2 SD - Standard deviation Acknowledgments The authors gratefully acknowledge Mary Wagner and Debora Harrison for their administrative assistance in this study, as well as all of the participants who made this study possible. This study was supported by National Cancer Institute Grant #1R01 CA , HR-QOL in Colorectal Cancer Survivors with Stomas (PI: R. Krouse). This paper was presented, in part, at the nd Annual Meeting of the Associated Professional Sleep Societies, Baltimore, MD. Disclosure Statement This was not an industry supported study. The authors have indicated no financial conflicts of interest. References 1. Jemal A, Murray T, Ward E, et al. 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