Artigo Acesso aberto

Gender Differences in Sleep Disruption and Fatigue on Quality of Life Among Persons with Ostomies

2009; American Academy of Sleep Medicine; Volume: 05; Issue: 04 Linguagem: Inglês

10.5664/jcsm.27544

ISSN

1550-9397

Autores

Carol M. Baldwin, Marcia Grant, Christopher S. Wendel, Mark C. Hornbrook, Lisa J. Herrinton, Carmit K. McMullen, Robert S. Krouse,

Tópico(s)

Congenital gastrointestinal and neural anomalies

Resumo

Free AccessSurgeryGender Differences in Sleep Disruption and Fatigue on Quality of Life Among Persons with Ostomies Carol M. Baldwin, Ph.D., Marcia Grant, R.N., D.N.Sc., Christopher Wendel, M.S., Mark C. Hornbrook, Ph.D., Lisa J. Herrinton, Ph.D., Carmit McMullen, Ph.D., Robert S. Krouse, M.D. Carol M. Baldwin, Ph.D. 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(602) 496-0791(602) 496-0988 E-mail Address: [email protected] Arizona State University College of Nursing & Health Innovation (Southwest Borderlands), Phoenix, AZ , Marcia Grant, R.N., D.N.Sc. Beckman Research Institute, City of Hope National Medical Center, Duarte, CA , Christopher Wendel, M.S. Southern Arizona VA Healthcare System, Tucson, AZ , Mark C. Hornbrook, Ph.D. The Center for Health Research, Kaiser Permanente Northwest, Portland, OR , Lisa J. Herrinton, Ph.D. Kaiser Permanente-Northern California, Oakland, CA , Carmit McMullen, Ph.D. The Center for Health Research, Kaiser Permanente Northwest, Portland, OR , Robert S. Krouse, M.D. Southern Arizona VA Healthcare System, Tucson, AZ College of Medicine, University of Arizona, Tucson, AZ Published Online:August 15, 2009https://doi.org/10.5664/jcsm.27544Cited by:30SectionsAbstractPDF ShareShare onFacebookTwitterLinkedInRedditEmail ToolsAdd to favoritesDownload CitationsTrack Citations AboutABSTRACTStudy 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 < 0.05.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.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):335-343.INTRODUCTIONColorectal 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 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.6–12 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.8,9Although several studies have emerged that examine sleep disturbances of cancer patients,15–18 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,19–20 as well as different manifestations of and prevalence rates for sleep disorders by sex.21–23 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 majority 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.24,25This 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.METHODSRecruitment and ParticipantsThis 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 mixed-method (quantitative and qualitative components) approach was used to collect data, including a mailed survey with sociodemographic, health, health care utilization items, and open-ended 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 InstrumentsCity of Hope Quality of Life—Ostomy MeasureData 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 ostomy-specific 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."Short Form-36 Version 2 Physical and Mental Composite ScalesHealth-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 cross-sectional and longitudinal study of variations in health practices and outcomes in over 10,000 outpatients,29–33 can discriminate between subjects with and without chronic diseases, and has excellent internal consistency.29–32 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.30–32Poor (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 ProtocolFollowing the return of all completed mail surveys, focus groups were recruited from participants whose total scores fell 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 AnalysisThe 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 2004-2007) 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 < 0.05.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 AnalysisContent analysis36 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 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 AnalysisEach 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 1997-2007) 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.RESULTSDemographicsCharacteristics 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 < 0.0001). 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.Table 1 Demographics of the Studied PopulationDemographic/Lifestyle VariablesMen (n = 168)Women (n = 118)Age (Mean ± SD)72.3 ± 9.972.6 ± 11.0Education (%)High school or less3741Beyond high school6158Married/Partnered (%)**75.344.8Race/Ethnicity (%)*Non-Hispanic White73.775.2Asian7.213.7Non-Hispanic Black2.45.1Hispanic10.82.6Other5.93.4BMI (Mean ± SD)26.6 ± 4.427.8 ± 7.7Years since Surgery (Mean ± SD)11.5 ± 7.712.5 ± 7.8*p < 0.05;**p < 0.0001Quantitative Findings for Sleep Disruption and FatigueWomen 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 ostomy-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.Table 2 Disrupted Sleep and Fatigue by SexSleep Items+Men (n = 168)Women (n = 118)Adjusted Difference1p-value2Sleep Disruption7.7 ± 2.76.9 ± 3.00.57p < 0.01Fatigue7.8 ± 2.66.8 ± 3.00.65p < 0.011Sleep disruption adjusted for age; Fatigue adjusted for time since surgery.2Z-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.Qualitative FindingsWritten 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."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 QuartilesNumberSexCOHQOL—O Total Mean ScoreStatement1F5.81"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."2M5.67"A lot of times, I am afraid to go to sleep in fear that the bag may come off. It has happened."3F9.09"…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."4F5.17"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."5M5.36"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."6M7.90"It was challenging finding any position in which to sleep."7M5.29"…loss of stamina and energy."8M4.98"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."Sleep Disruption and Fatigue Findings by SexTable 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.Table 4Table 4a PCS and MCS Between Group Comparisons for Men and Women who Reported Low or High Sleep Disruption and FatigueCOHQOL-O Sleep ItemPhysical Composite ScaleMental Composite Scale50 ± SD1p-value [MID score]2 Between sex350 ± SD1p-value [MID score]2 Between sex3Low Sleep Disruptionp < 0.01 [6.1]p < 0.05 [5.9] Men (n = 81)47.4 ± 10.254.1 ± 9.5 Women (n = 44)41.3 ± 12.248.2 ± 16.4High Sleep Disruptionn.s. [2.1]n.s. [0.8] Men (n = 81)40.6 ± 10.747.8 ± 14.1 Women (n = 69)38.5 ± 12.247.0 ± 12.8Low Fatiguep < 0.05 [5.1]n.s. [0.6] Men (n = 87)47.7 ± 11.152.1 ± 13.9 Women (n = 42)42.6 ± 12.251.5 ± 15.4High Fatiguen.s. [2.0]p < 0.05 [4.6] Men (n = 74)39.8 ± 9.349.7 ± 10.2 Women (n = 71)37.8 ± 9.645.1 ± 13.2Table 4b PCS and MCS Within Group Comparisons for Men and Women who Reported Low or High Sleep Disruption and FatigueCOHQOL-O Sleep ItemPhysical Composite ScaleMental Composite Scale50 ± SD1p-value [MID score]2 Within sex450 ± SD1p-value [MID score]2 Within sex4Sleep Disruption in Menp < 0.0001 [6.8#]p < 0.001 [6.3#] Low (n = 81)47.4 ± 10.254.1 ± 9.5 High (n = 81)40.6 ± 10.747.8 ± 14.1Sleep Disruption in Womenn.s. [2.8§]n.s. [1.2§] Low (n = 44)41.3 ± 12.248.2 ± 16.4 High (n = 69)38.5 ± 12.247.0 ± 12.8Fatigue in Menp<0.0001 [7.9#]n.s. [2.4#] Low (n = 87)47.7 ± 11.152.1 ± 13.9 High (n = 74)39.8 ± 9.349.7 ± 10.2Fatigue in Womenp = 0.02 [4.8§]p = 0.02 [6.4§] Low (n = 42)42.6 ± 12.251.5 ± 15.4 High (n = 71)39.8 ± 9.345.1 ± 13.2PCS = Physical Composite Scale (physical function/role, bodily pain, general health)MCS = Mental Composite Scale (vitality, socio/emotional function, mental health)SD = Standard deviationn.s. = not significant1Mean and SD for the PCS and MCS in the U.S. general population322MID = Minimally Important Difference (empirical rule effect size; ≥ 2 suggests clinical significance)3Compares composite scale scores between men and women within sleep item groups4Compares 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 groupsWomen who reported greater fatigue showed poorer mental health on the MCS than men who reported greater fatigue (p < 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 FatigueWithin-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 < 0.0001) 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 < 0.0001). 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 FindingsTable 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 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 within-group 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 ConditionsTable 5 provides SF-36v2 PCS and MCS standard (over the past 4 weeks) disease specific norms32 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.Table 5 SF-36v2 PCS and MCS Standard Form Disease-Specific Norms* for Comparisons with PCS and MCS Scores for Men and Women with OstomiesDisease Specific NormsPCS ± SDMCS ± SD50 ± SD150 ± SD1Back pain/sciatica (n = 2,916)45.70 ± 10.7047.64 ± 11.10Cancer (except skin) (n = 247)40.91 ± 9.8847.65 ± 10.65Depression (n = 1,006)45.41 ± 11.6236.29 ± 11.86Diabetes (n = 602)41.10 ± 11.1647.75 ± 11.49Hypertension (n = 1,898)43.96 ± 10.4549.68 ± 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.1Mean and SD for the PCS and MCS in the U.S. general population.32With 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.DISCUSSIONThis 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 sc

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