DO NOT DUPLICATE. Quality of life is an important issue for patients QUALITY OF LIFE IN PATIENTS WITH STOMAS: THE MONTREUX STUDY

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1 QUALITY OF LIFE IN PATIENTS WITH STOMAS: THE MONTREUX STUDY Patrick Marquis, MD; Alexia Marrel; and Bernard Jambon, MS Ostomy surgery profoundly affects a person s life. To determine the extent of the effect, the Stoma Care Quality of Life Index instrument was developed from a quality-of-life index. After ascertaining its validity and reliability, the instrument was used to measure patient quality of life in a European-wide study (16 countries). Six hundred, eighteen (618) stoma care nurses recruited 4,739 patients following stoma surgery. The self-administered questionnaire was completed immediately following surgery and after 3,6, 9, and 12 months. The mean age of patients was 61.6 years (± 13.4 years), 53.7% were men, and the majority (66.5%) had a colostomy. Stoma Care Quality of Life Index scores were fairly consistent in all patients throughout Europe immediately following surgery. While scores improved steadily over time, only the difference between the postoperative and 3- month scores was significant (P < 0.001). Stoma Care Quality of Life Index scores were significantly higher in patients who were satisfied with the care received than in those who were not satisfied. Similarly, patients who had a good relationship with the stoma care nurse and felt confident about changing the appliance had significantly higher Stoma Care Quality of Life Index scores than those who did not have a good relationship or feel confident. The results of this study suggest that stoma patient quality of life can be assessed, that it changes over time, and that patient access to specialist ostomy care nurses is particularly important during the first 3 to 6 months following surgery. Ostomy/Wound Management 2003;49(2):48-55 Quality of life is an important issue for patients with stomas. They have undergone mutilating surgery that can cause a permanent change in body image and affect quality of life. Most patients who receive stoma surgery have colorectal cancer; therefore, they have to cope with having cancer as well as face the impact of extensive surgery. Both can significantly influence quality of life. Enterostomal therapists (known in the United States as Wound Ostomy and Continence Nurses) help such patients come to terms with their situation and help care for them throughout their life with a stoma. To date, an effective method for measuring quality of life in patients with stomas does not exist. Although tools for measuring quality of life in cancer patients are available, 1,2 they are inadequate for ostomy patients because they do not take other factors into account that can affect their quality of life. In addition, a significant number of ostomy patients do not have a history of cancer. In 1993, ConvaTec, a leading manufacturer of ostomy equipment, conducted a survey to establish the training needs of enterostomal therapists in Europe. One of the main findings of this survey was that enterostomal therapists needed a tool to help them measure patient quality of life. 3 To help meet this need, ConvaTec worked with Mapi Values (Lyon, France), an international company specializing in patient-reported outcomes (quality of life and patient satisfaction and preferences) for healthcare organizations, to produce and test a quality-of-life instrument for patients with a stoma. Dr. Marquis is Scientific Director, Ms. Marrel is Project Coordinator, and Mr. Jambon is General Manager of Mapi Values, Lyon, France. Please address correspondence to: Graham Jones, 19 Swan Drive, Aldermaston, Reading, RG7 4UZ, UK; graham@ukmessage.com. Financial support for the Montreux Study was provided by ConvaTec Europe. 48 OstomyWound Management

2 The Stoma Quality of Life Index is a tool to help that affect sexuality, the presence of an ileostomy can enterostomal therapists accurately assess the quality of lead to nutritional complications that affect quality of life of their patients. It was validated in 16 countries in life. 6 Patients who have a urostomy may experience difficulties in coping with their stoma as a result of urine Europe, where it was applied to more than 4,000 stoma care patients in a research effort called The Montreux leakage that causes skin irritation or breakdown. 7 Study. The instrument used in this research was tested Consequently, the entire range of stoma operations for internal consistency reliability; Cronbach s alpha may precipitate a variety of problems that can lead to varied from 0.57 to In addition, the instrument deterioration in a person s quality of life. was tested in a pilot study in the UK and France. Some Quality of life has been defined as contentment 500 centers were involved in this study; each center was with everyday life: the degree of enjoyment and satisfaction experienced in everyday life as opposed to a stoma care unit within a general hospital or a private practice run by an enterostomal therapist. The completion of the Montreux Study has provided enterostomal tions are available, but each centers on the theme of financial or material well-being. 8 Many other defini- therapists with a sufficiently large and reliable data satisfaction with everyday life as a whole. The World bank with which they can compare their own patients. Health Organization definition ( individuals perceptions of their position in life in the context of the Factors Affecting Quality of Life culture and value systems in which they live, and in Stoma surgery is a mutilating procedure, requiring relation to their goals, expectations, standards and concerns ) and the definition from Schipper ( health- the formation of an opening between the intestines or bladder and abdominal wall. In most instances, this related quality of life represents the functional effect of opening or stoma is permanent, and patients must an illness and its treatment upon a patient as perceived apply an ostomy pouch for the collection of urine by the patient) 9 contain four broad domains that contribute to overall quality of life: physical and occupa- and/or feces. Despite the significant psychological impact of this procedure and subsequent alteration of a tional function, psychological state, social interaction, person s body image that can harm quality of life, 4 and somatic sensation. studies conducted by surgeons to evaluate the quality of life of patients who have undergone stoma surgery Methods and Procedures could not be located. Study purpose. The aim of this study was to determine whether an adapted Quality of Life Index (QLI) Many patients who undergo stoma surgery have cancer, and several studies assessing the quality of life of was suitable for patients with a stoma. In addition, this people with cancer have been conducted. 5 Patients with cancer-related Ostomy/Wound Management 2003;49(2):48-55 stomas have to cope with a life-threatening condition in addition to accepting a dramatic change in body image. KEY POINTS Information about the quality of life of ostomy patients and the Younger patients usually have a disease effects of specialty nursing care on their recovery is limited. that is not immediately life threatening, such as ulcerative colitis or Quality of Life Index, the authors gathered longitudinal quality-of-life After establishing the validity and reliability of the Stoma Care Crohn s Disease. These patients usually data from more than 4,000 patients in 16 European countries. have an ileostomy, where the entire The results indicate that patient quality of life improves steadily following surgery, but that the first three to six postoperative months, large bowel is removed and the anus a good relationship with the stoma care nurse, confidence in managing the appliances, and satisfaction with care received are important closed. This leads to a highly liquid output from the stoma because feces to overall recovery. formation is no longer possible, Studies among different populations and analysis of individual domain increasing the potential difficulties scores will help ostomy care nurses improve the care they provide, associated with coping with the stoma. which may further enhance the effectiveness of the apparently crucial care they provide; thereby, lessening the impact of this traumatic procedure. In addition to the body image changes February 2003 Vol. 49 Issue 2 49

3 a stoma were TABLE 1 STOMA QUALITY OF LIFE INDEX (SQLI): SCALE AND CONTENT added. One includes questions Scale Item Number and Content related to the quality of Quality of Life care received Psychological well-being (PWB) 9 How much fun do you have? 13 How useful do you feel? and the other 14 How much happiness do you feel? seeks to ascertain information 15 How satisfying is your life? 18 How good is your quality of life? Physical well-being (PHWB) 1 How much strength do you have? about patient 2 Is the amount of time you sleep sufficient? confidence in 3 Do you tire easily? 7 How is your present state of health? dealing with the 11 How much can you work at your tasks? stoma. Each Body image (BI) 5 Do you feel worried about your stoma? question is 8 How easy is it to adjust your stoma? 19 How fearful are you of odor or leakage? answered on a 22 How difficult is it to look at your stoma? 6-point rating Pain (PA) 16 How much pain do you feel? 17 How often do you feel pain? scale with end Sexual activity (SXA) 6 Sexual activity sufficient to meet your needs? points (0 or 5) Nutrition (NU) 4 Do you feel your weight is a problem? labeled with 10 Do you find eating a pleasure? 12 Is the amount you eat sufficient to meet your needs? opposite Social concerns (SC) 20 Level of contact with your family/friends sufficient to extreme meet your needs? 21 Do you feel rejected by your family and loved ones? responses (such Satisfaction with medical care as none at all Patient satisfaction (PS) 24 I am satisfied with the medical care I receive. versus a great 25 When I go for medical care, they are careful to check everything when treating/examining me. deal ; extremely 26 The stoma care nurses who take care of me have a poor versus genuine interest in me as a person. 27 The medical staff who treat me know about the latest excellent, and medical developments. the like). Scores Improvement (IMP) 28 Some things about medical care could be better. are linearly Experience (EXP) 29 Some doctors lack experience with my medical problems. Self-Efficacy transformed to Self-efficacy (SE) 30 How confident are you about cleaning your stoma? provide ranges 31 How confident are you about changing your appliance? 32 How confident are you about disposing of your appliance? from 0 to How confident are you about obtaining appliance supplies? The questions Help and advice (ADV) 34 How confident are you about obtaining advice or on quality of assistance when necessary? care were added because in study was designed to use the adapted instrument (the Stoma Quality of Life Index SQLI) to obtain data on the quality of life of patients residing in Europe who had a stoma. Instrument development. After reviewing existing questionnaires, the Quality of Life Index (QLI) for patients with cancer was considered to be most appropriate because the majority of patients with a stoma have cancer. The original questionnaire was developed in the mid-1980s and validated by Ferrans. 11 Two sections that were particularly appropriate to patients with Europe, patients with a stoma have a dedicated, specialist nurse who cares for them in the hospital and in the community, often over many years. Confidence in dealing with the stoma and associated appliances also was considered to be a unique element in the daily life of a stoma patient. Once changes to the QLI questionnaire were made, the new, 34-item questionnaire the Stoma Quality of Life Index (SQLI) (see Table 1) was validated in Britain and France. The validation process determined whether enterostomal therapists and their patients 50 OstomyWound Management

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5 could use the SQLI effectively. Two hundred, fifty-five (255) patients in the UK and 132 patients in France who had received a colostomy, ileostomy, or urostomy operation, as well as 85 healthy control subjects, participated in the validation study. Because the questionnaire was designed for use throughout Europe in a wide range of languages, the robustness of the questionnaire translation process needed to be assessed to ensure the SQLIs produced comparable results. The reliability of the questionnaire was satisfying, with a Cronbach s alpha coefficient of 0.92, which is above the recommended values of ; the correlation of the French and British groups was Details of the pilot study were presented at a meeting of 1,500 European enterostomal therapists in Montreux in April Following the meeting in Montreux, enterostomal therapists were invited to participate in a European-wide quality of life study involving patients with a stoma. This study became known as the Montreux Study and included more than 600 enterostomal therapists providing ostomy care in general hospitals or private practice. Study method. Enterostomal therapist participation in the Montreux Study was by self-selection, and the ET nurses, in turn, recruited patients into the study. Patients were eligible to participate if they were able to read and complete the SQLI and had their permanent ostomy surgery within the previous month. The enterostomal therapists were advised to enter all eligible patients into the study in order to provide the most reliable data. Informed consent to participate in the study was obtained by each enterostomal therapist and ethical review board approval was obtained from appropriate local committees. During the first year, each patient completed the questionnaire four times: following hospital discharge, and at 3 months, 6 months, and 12 months after surgery. In the following year, assessment was on a voluntary basis, with one questionnaire completed every 6 months (18 and 24 months following surgery). The questionnaire was self-administered and completion time was a few minutes. Completed questionnaires were returned by the enterostomal therapists in a pre-paid, pre-addressed envelope to the Mapi Values CORCE Centre, a centralized data center in Lyon, France. Each enterostomal therapist participating in the study also was provided with a grid for calculating individual patient SQLIs. They were advised to plot the figures on the charts provided, enabling them to monitor changes in SQLI using a validated tool. Summaries of the on-going results of the Montreux Study were published twice a year in Eurostoma, the European journal for enterostomal therapists. Using these published data, nurses were able to compare the results of their patients with national and European averages. Data analysis. The 34 items in the quality of liferelated questions were pooled into seven domains: psychological well-being, physical well-being, body image, pain, sexual activity, nutrition, and social concerns. Additional questions measuring patient satisfaction and confidence were pooled into other domains. The questionnaire can be divided into three main sections: Quality of life (consisting of 22 items in 7 domains and one additional item) Satisfaction (consisting of 6 items in 3 domains) Self-efficacy (consisting of 5 items in 2 domains). The questionnaire results were reviewed by generating one score per domain, enabling analysis of the results to be performed more easily and accurately. A global score, called the Stoma Quality of Life Index, was generated from the quality of life-related questions, which gave the best overall information regarding patients quality of life. The quality of questionnaire completion was assessed by analyzing the amount of missing data per patient (absence of answers to an item). The assumption was that the lower the level of missing data, the better the acceptability of the questionnaire. The amount of missing data was less than 1%. Questionnaire reliability is an estimate of the measurement error. It was estimated by the internal consistency of the questionnaire using Cronbach s alpha. A level of 0.70 is considered satisfying. Frequency distributions of demographic variables were obtained and the distribution of quantitative variables was described with the mean, STD, median, Quartiles 1 and 3, extreme values (minimum and maximum values), and number of missing data. Wilcoxon signed rank tests and Kruskal-Wallis tests were used to ascertain statistically significant differences. Results Four thousand, seven hundred, thirty-nine (4,739) patients with stomas were recruited after surgery by 52 OstomyWound Management

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7 Average Scores Figure 1 Average quality-of-life scores. * Statistically significant increase (P<0.001) from hospital discharge Range: 0 (poor QoL) to 100 (good QoL) 618 stoma care nurses in 16 European countries, and 11,097 questionnaires in 12 languages were returned to the CORCE Centre for analysis. The mean age of patients was 61.6 years (± 13.4 years) and more males (53.7%) than females (37.3%) participated in the study. Nine percent (9%) of the questionnaires were returned without identifying the sex of the patient. The majority (66.5%) of patients had a colostomy, 16.4% had an ileostomy, and 16.5% had a urostomy (missing data, 0.6%). The most common pre-existing disease requiring surgery was carcinoma (70.0%). Other conditions were Crohn s Disease (4.0%), ulcerative colitis (7.9%), and other conditions (13.5%) (missing data, 4.6%). A concurrent illness was present in 36.3% of the sample. Cardiovascular conditions were the most common form of concurrent disease, with Average Scores * Figure 2 QLI scores after hospital discharge/country (n = 3,042, median number of patients/country = 238). * Score range: 0 (poor) to 100 (good) 54 OstomyWound Management respiratory and rheumatic disease the next most frequent chronic conditions. The Montreux Study revealed a fairly consistent SQLI in all patients throughout Europe immediately following surgery. Mean scores ranged from 54 (± 16) in Israel to 70 (± 13) in Belgium. Physical well being and sexual activity received the lowest scores postsurgery (49.6 and 49.8, respectively). The psychological well-being score was 59.8, while the average pain and body image scores were 63 and 60.8, respectively. The average SQLI rose sharply in the first 3 months after surgery to 73.30, with further moderate improvement over time. The initial increase in quality-of-life scores was significant (P < Wilcoxon signed rank test) (see Figure 1). Some differences in the scores after surgery were evident between different countries, but the scores of most countries were fairly consistent (see Figure 2). The only countries that differed significantly (Portugal and Israel) also had the smallest sample sizes. The longer the time between the hospital discharge and the first assessment of the questionnaire, the higher the quality-of-life scores. Slight differences existed between scores per domain in the changes over time, but the overall pattern was of improved patient quality of life. Results also were generated in response to specific statements in the questionnaire, such as, I am very satisfied with the medical care I receive, (response range from 0 = strongly disagree, to 5 = strongly agree). The vast majority of patients (2,223 out of 3,042) indicated that they were very satisfied with the care received. Patients who were very satisfied with the care received had higher SQLI scores and, therefore, a better qualityof-life index than those who were not satisfied with their care (Kruskal-Wallis test, P < 0.01). Results related to the responses given to the statement, The stoma care nurses who take care of me have a genuine interest in me as a person, showed that the vast majority of the patients (2,852 out of 3,042) regarded the stoma care nurses as having a genuine interest in them.

8 Patients who indicated that the stoma care nurse had a genuine interest in them as a person had a higher SQLI score than those who said they had a poor relationship with the stoma care nurses. The difference SQLI score between these groups was significant (Kruskal-Wallis test, P < 0.01). Only 113 out of 1,091 patients responded with a high confidence (4 or 5) rating when answering the question, How confident are you about changing your appliance? Confidence in changing one s appliance also affected SQLI scores. Patients with higher confidence ratings had considerably higher SQLI scores than patients with lower confidence ratings (Kruskal-Wallis test, P < 0.01). Discussion The results of this study provide the first glimpse of the effect of ostomy surgery on patient quality of life over time. It was found that, for patients in all countries, the weeks following hospital discharge are crucial for improvement in patient quality of life. However, time was not the only factor related to improved quality of life after hospital discharge. Satisfaction with the care received, confidence in changing the appliance, and the relationship with the enterostomal therapist all appear to affect patient quality of life. Patients who reported that the stoma care nurse took a genuine interest had the highest quality-of-life index post surgery. Improvements in quality-of-life scores after surgery also were better for patients who had a good relationship with the nurses, were satisfied with the care received, and confident in changing their appliance. The findings appear to substantiate the belief that enterostomal therapists are of great importance in the treatment and support of patients with a stoma. Also, the results suggest that efforts to improve patient confidence in changing their appliances through education may have important quality-of-life benefits. These findings have significant implications for healthcare planning because they suggest that patient quality of life will improve more if patients have access to specialist care for 3 to 6 months following surgery. The results of this study also provide evidence that patient quality of life can be assessed following ostomy surgery. The questionnaire enables enterostomal therapists to use a validated and reliable instrument to assess quality of life in each patient and to identify potential concerns that can be addressed to help improve overall quality of life. Thus, this instrument appears to meet the needs expressed in the training needs survey conducted in In addition, the quality-of-life tool developed for the Montreux Study may provide enterostomal therapists with an important method of auditing their service. They can compare individual patient results to national and European data, enabling them to assess their own performance and identify issues affecting quality of life in their patient population. However, as this is the first study of this kind, more studies would be needed in order to confirm the results. Conclusions The results of this study suggest that the SQLI is a valid and reliable instrument to assess quality of life in patients with a stoma. Using the SQLI instrument, enterostomal therapists are now able to assess patient quality of life and compare their patients adjustment post surgery to the Montreux study data. - OWM References 1. Aaronson NK, Ahmedzai S, Bergman B et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality of life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85(5): Fairclough DL, Cella DF. Functional assessment of cancer therapy (FACT-G): non-response to individual questions. Qual Life Res. 1996;5: Hingley P. Eurostoma. 1995;Issue 11(June);8. 4. Black P. Eurostoma. 1994;Issue 7(June): McMillan SC. Quality of life assessment in palliative care. Cancer Control Journal. 1996;3:3. 6. Parascandolo L Eurostoma. 2000;Issue 29(January): Black P. Practical stoma care. Nursing Standard. 2000;14(41): Encarta. Encarta World English Dictionary. Microsoft Corporation; Schipper H, Clinch J, Powell V. Definitions and conceptual issues. In: Spilker B (ed.). Quality of Life Assessment in Clinical Trials.New York,NY:Raven Press;1990: Padillia GV, Presant C, Grant MM, et al. Quality of life index for patients with cancer. Res Nurs Health. 1983;6: Ferrans CE, Powers MJ. Quality of life index: development and psychometric properties. Adv Nurs Sci. 1985;8: Cronbach LJ. Coeffecient alpha and the internal structure of tests. Psychometrika. 1951;16: Marquis P, Marrel A, Blackman A. Quality of care: management of an international quality of life study in patients with an ostomy. Quality of Life Newsletter. 1996;15:12. February 2003 Vol. 49 Issue 2 55