Several qualitative studies describe how surgical ostomies can impact all aspects of life; their themes include being different from others and learning how to live with a stoma1 and coping with an altered sense of self, living a restricted life, and overcoming resulting restrictions.2 Research regarding quality of life (QoL), including a prospective, longitudinal, multicenter study3 of follow-up programs for patients with an ostomy, seek to gain a better understanding of the impact of living with an ostomy and to develop appropriate care and long-term plans for patients with ostomies. Overall, QoL is understood to encompass satisfaction in all aspects of life, including material comfort, health, independency, recreation, and relationships with others,4,5 whereas the more specific concept of health-related quality of life (HRQoL) relates only to the effects of illness on health and well-being.6
Several instruments have been used to assess QoL related to health conditions. The 34-item Ostomy Adjustment Scale (OAS) includes the patient’s care of the ostomy, feelings about having an ostomy, leisure and work ability, opinions regarding instructions received for the ostomy, and feelings about the enterostomal therapist (ET nurse) or physician.7 Items are scored from 1 to 6 (1 = totally disagree and 6 = totally agree); the total score ranges from 34 to 204 with higher scores associated with better levels of adjustment. The psychometric properties of the OAS have shown good levels of internal consistency, as illustrated by Cronbach alpha values ranging from 0.87 to 0.95.7,8-11 Furthermore, the test-retest reliability of the OAS has been calculated in several studies using Pearson correlation with reported values ranging from 0.59-0.82.7,8,10,11 The OAS has been validated in a Norwegian population8 but has not been further validated in a clinical context.
The Short Form-36 (SF-36) measures the symptoms and functions known to be most affected by disease and treatment.12 The scale includes 8 subscales that can be divided into 2 summary scores: the physical component summary (PCS), including physical functioning, physical role functioning, bodily pain, and general health subscales; and the mental component summary (MCS), including vitality, social functioning, emotional role function, and mental health subscales. The question responses are on an ordinal scale. The subdomains are calculated into a continuous scale that ranges from 0 to 100, and the summary scores are calculated so a score of 50 with a standard deviation of 10 equals the average scores of the United States population. Higher scores are associated with better HRQoL. The SF-36 has been previously validated in Norway, and the Norwegian population norm scores for the SF-36 have been published.13
Overall QoL can be measured using the Quality of Life Scale (QOLS)14 questionnaire, which facilitates assessment of an individual’s overall satisfaction with life, such as material comfort, health, independence, recreation, and relationships with others. The 16 items are scored on a scale from 1 to 7 (1 = very dissatisfied and 7 = very satisfied, with cumulative scores ranging from 16 to 112. Higher scores are associated with a better QoL. The QOLS has been found to be valid for measuring domains of QoL across patient groups and cultures. The scale has been validated in Norway,15 and scores are available for comparison.15-17
Many cross-sectional studies have investigated HRQoL in patients with an ostomy using the SF-36 instrument and compared results with scores from a control group within the general population: a survey18 from Japan of 102 colostomy patients found significantly lower SF-36 scores in physical role functioning and social functioning scales than in the general population scores; and a study19 of 64 urostomy patients showed all SF-36 scores (except for pain) were lower than the general population. A descriptive study20 (N = 44 colostomy patients) found scores of all SF-36 scales were lower than general population scores. A longitudinal, prospective study21 among 57 patients with a loop ileostomy or permanent colostomy who completed the SF-36 found scores decreased 1 month following surgery, but all scores were higher than preoperative scores after 6 months. However, the physical role functioning, social functioning, emotional role functioning, and mental health scores were still lower than the general (reference) population after 6 months (P <0.05). A cross-sectional study22 using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EORTC colorectal quality of life questionnaire (QLQ-CR38) examined the physical and mental consequences of an ostomy in 1019 rectal cancer survivors; the health status/QoL was lower in the 408 patients with an ostomy compared to those without.
The general finding is that HRQoL is slightly reduced in patients who require an ostomy, typically in the role functioning and social domain items of the instrument(s).18-21 Although knowledge is lacking regarding how ostomy-specific measures are associated with and predict HRQoL and overall QoL outcomes in patients with an ostomy, studies have found sociodemographic and clinical factors were related to HRQoL and overall QoL. The study by Furukawa et al19 of 64 urostomy patients using the SF-36 found the presence of a supportive person at home and participation in a support group were associated with better HRQoL. The descriptive survey study by Kement et al20 among 44 patients using the SF-36 indicated that gender, marital status, and household (living alone or together with partner or family) affected several SF-36 scores. The cross-sectional study by Mahjoubi et al23 found a significantly higher QoL in 38 patients with an appropriate stoma site compared to 174 patients with an inappropriate stoma site selection as measured with the EORTC 30. A cross-sectional study24 used an ostomy-specific QoL instrument in 105 patients and found significantly higher QoL in patients in whom the stoma site was marked preoperatively. In a multicenter, descriptive study of 748 patients, Baykara et al25 found significantly more skin problems, separation, and retraction of the ostomy in patients where the stoma site was not marked. Fear of leakage and altered sexual function that negatively affected QoL were noted in 1 cross-sectional study26; in another27 that used the City of Hope Quality of Life Questionnaire among 307 patients with urinary diversions, skin problems, difficulties in managing the ostomy, fear of recurrence, financial worries, family stress, and uncertainty about the future were found to negatively affect QoL. Additional cross-sectional studies found poor sleeping patterns, which may be related to fear of leakage from the equipment, were implicated in reducing HRQoL and overall QoL28; and improving self-care and inspiring hope were important factors in increasing stoma-related QoL (N = 76 ostomy patients).29 A longitudinal study11 found the fear of being dependent on other people and the uncertain nature of living with cancer are the most frequent concerns in the first 6 months after surgery.
In general, studies that have used a qualitative approach or disease-specific or health-related scales have shown patients with a stoma with limitations in their everyday living have lower HRQoL or overall QoL scores than patients unaffected by these issues.2,19,29 A case-control study30 found HRQoL can be improved if patients attend a patient education group.
In summary, a large body of research19-21,24-30 has assessed overall QoL, HRQoL, and ostomy-specific QoL in ostomy patients and several variables were noted to influence scores. However, to the authors’ knowledge, no studies have assessed ostomy-specific adjustments, HRQoL, and overall QoL in the same population of individuals and related these findings to population norms. It is also unknown whether an ostomy-specific adjustment is a predictor of HRQoL and overall QoL, which could lead to strategies that can improve the QoL of patients living with an ostomy.
Proposed relationships between ostomy-specific QoL as measured with the OAS, HRQoL as measured by the SF-36, and overall QoL measured with the QOLS are shown in Figure 1. The main purpose of this study was to assess whether ostomy-specific adjustment, assessed by the total OAS score, was a predictor for HRQoL and overall QoL, and if any specific ostomy-specific adjustments were strongly related. In addition, HRQoL and overall QoL scores were compared in a cross-sectional study among Norwegian patients with an ostomy and a control group of individuals selected from the general Norwegian population. Specifically, research questions focused on:
- Does ostomy-specific adjustment measured with the OAS predict HRQoL measured with SF-36 and overall QoL measured with the QOLS?
- Which issues of the ostomy-specific adjustments are most strongly related to HRQoL and overall QoL?
- How do ostomy patients evaluate their HRQoL and overall QoL compared to the normal Norwegian population?