BJS Open, 2022, zrac085 https://doi.org/10.1093/bjsopen/zrac085 Original Article Surviving rectal cancer at the cost of a colostomy: global survey of long-term health-related quality of life in 10 countries Helle Ø Kristensen1,2* , Anne Thyø1,2,3, Katrine J. Emmertsen1,2,3, Neil J. Smart4, Thomas Pinkney5, Andrea M. Warwick6, Dong Pang7, Hossam Elfeki8 , Mostafa Shalaby8, Sameh H. Emile8 , Mohamed Abdelkhalek9 , Mohammad Zuhdy9, Tomas Poskus10 , Audrius Dulskas10 , Nir Horesh11 , Edgar J. B. Furnée12, Sanne J. Verkuijl12 , Nuno José Rama13, Hugo Domingos14, João Maciel15, Alejandro Solis-Peña16, Eloy Espín-Basany16, Marta Hidalgo-Pujol17, Sebastiano Biondo17 , Annika Sjövall18,19 and Peter Christensen1 1 Department of Surgery, Aarhus University Hospital, Aarhus, Denmark 2 Danish Cancer Society Centre for Research on Survivorship and Late Adverse Effects After Cancer in the Pelvic Organs, Aarhus, Denmark 3 Surgical Department, Randers Regional Hospital, Randers, Denmark 4 Royal Devon and Exeter NHS Foundation Trust, Royal Devon and Exeter Hospital, Exeter, UK 5 University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK 6 Brisbane Academic Functional Colorectal Unit, QEII Hospital, Brisbane, Queensland, Australia 7 Peking University School of Nursing, Peking, China 8 Colorectal Surgery Unit, Mansoura University Hospital, Mansoura, Egypt 9 Surgical Oncology Department, Oncology Center Mansoura University (OCMU), Mansoura, Egypt 10 Department of Abdominal and General Surgery and Oncology, Faculty of Medicine, Vilnius University, National Cancer Institute, Vilnius, Lithuania 11 Sheba Medical Center, Ramat Gan, Israel 12 Department of Surgery, Division of Abdominal Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands 13 Surgery Colorectal Unit, Centro Hospitalar de Leiria, Leiria, Portugal 14 Colorectal Surgery Unit, Champalimaud Foundation, Lisbon, Portugal 15 Colorectal Surgery Unit, Instituto Português de Oncologia, Lisbon, Portugal 16 Colorectal Surgery Unit, General Surgery Department, Universitat Autonoma de Barcelona, Hospital Vall d’Hebron, Barcelona, Spain 17 Department of General and Digestive Surgery, Colorectal Unit, Bellvitge University Hospital, University of Barcelona and IDIBELL, Barcelona, Spain 18 Division of Coloproctology, Department of Pelvic Cancer, Karolinska University Hospital, Stockholm, Sweden 19 Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockhom, Sweden *Correspondence to: Helle Ø Kristensen, Department of Surgery, Aarhus University Hospital, Palle Juul-Jensens Blvd 35, DK-8200 Aarhus N, Denmark (e-mail: hellkren@rm.dk) Abstract Background: Colorectal cancer management may require an ostomy formation; however, a stoma may negatively impact health- related quality of life (HRQoL). This study aimed to compare generic and stoma-specific HRQoL in patients with a permanent colostomy after rectal cancer across different countries. Method: A cross-sectional cohorts of patients with a colostomy after rectal cancer in Denmark, Sweden, Spain, the Netherlands, China, Portugal, Australia, Lithuania, Egypt, and Israel were invited to complete questionnaires regarding demographic and socioeconomic factors along with the Colostomy Impact (CI) score, European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and five anchor questions assessing colostomy impact on HRQoL. The background characteristics of the cohorts from each country were compared and generic HRQoL was measured with the EORTC QLQ-C30 presented for the total cohort. Results were compared with normative data of reference European populations. The predictors of reduced HRQoL were investigated by multivariable logistic regression, including demographic and socioeconomic factors and stoma-related problems. Results: A total of 2557 patients were included. Response rates varied between 51–93 per cent. Mean time from stoma creation was 2.5– 6.2 (range 1.1–39.2) years. A total of 25.8 per cent of patients reported that their colostomy impairs their HRQoL ‘some’/‘a lot’. This group had significantly unfavourable scores across all EORTC subscales compared with patients reporting ‘no’/‘a little’ impaired HRQoL. Generic HRQoL differed significantly between countries, but resembled the HRQoL of reference populations. Multivariable logistic regression showed that stoma dysfunction, including high CI score (OR 3.32), financial burden from the stoma (OR 1.98), unemployment (OR 2.74), being single/widowed (OR 1.35) and young age (OR 1.01 per year) predicted reduced stoma-related HRQoL. Conclusion: Overall HRQoL is preserved in patients with a colostomy after rectal cancer, but a quarter of the patients interviewed reported impaired HRQoL. Differences among several countries were reported and socioeconomic factors correlated with reduced quality of life. Received December 23, 2021; Revised April 22, 2022; Accepted May 20, 2022 © The Author(s) 2022. Published by Oxford University Press on behalf of BJS Society Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. 2 | BJS Open, 2022, Vol. 6, No. 6 Introduction generic HRQoL in individuals with a permanent colostomy after rectal cancer in 10 different countries. Colorectal cancer is the most common reason for formation of an end stoma1,2, and it is well established that some patients have long-term reduced health-related quality of life (HRQoL) because of this condition3. Nevertheless, literature indicates that the impact Methods of a stoma on HRQoL depends not only on the altered anatomy and Participating centres in Denmark, Sweden, Spain, China, the the consequent stoma-related difficulties and complications, but it Netherlands, Portugal, Australia, Egypt, Lithuania and Israel is also due to demographic4–8 and socioeconomic factors9–11 and formed an ad hoc collaboration for the purpose of this study, and cultural features12; however, previous research on the differences identified eligible patients (those with a permanent colostomy in HRQoL among people with a stoma of different sex, age, and after rectal cancer) from national or regional databases, hospital socioeconomic status reported conflicting results. A few studies record systems or in stoma clinics. Inclusion criteria were found poorer HRQoL in younger compared with older patients6,11, surgery with curative intent for rectal cancer with the formation whereas others did not find an impact of age8,10,13. Studies on of a permanent colostomy. Exclusion criteria were age under 18 differences in HRQoL between sexes have also shown varying years, recurrence and a time since stoma creation of less than 12 results with most reporting poorer HRQoL in women8,10,11,14 and months. Participating centres were responsible for securing local others showing no differences. Furthermore, although differences approvals. Eligible patients were contacted in person, by phone between sociodemographic groups have been reported13, most or by mail depending on local setup and were invited to research documented no difference in HRQoL when comparing self-complete a web-based or pen-and-paper version of the groups with respect to education, employment status and questionnaires or invited to an interview. Non-responders in all household income. To date, most studies have been conducted on countries received a second invitation or a phone call, except for small (fewer than 100 patients) cross-sectional cohorts10,13 and in Israel and Australia due to local organizational circumstances, those comparing HRQoL in patients with ostomies across including for example, enrolment in a stoma care clinic. geographical and cultural borders are very limited12. On this basis, Disease and treatment-specific data (ASA score, TNM stage, this study aimed to investigate the predictors of self-reported oncological treatment, procedure, setting, complications and stoma-related reduced HRQoL by investigating differences in time since stoma creation) were collected from a national Table 1 Patient characteristics per country Denmark Sweden Spain The NL China Portugal Australia Lithuania Egypt Israel 1583 258 207 117 110 97 95 39 36 14 Population/inclusion method National National Hospital Dutch surgical Hospital med. Hospital Hospital Hospital Hospital Hospital register (DCCG) register register colorectal audit record system database database database database database (SCRCR) Response rate 74% 61% 67% 82% 93% 80% 51% MOA Web-based 942 (60) 0 0 43 (37) 24 (22) 0 1 (2) 0 0 1 (7) Pen and paper 641 (40) 258 (100) 46 (23) 73 (63) 83 (78) 29 (30) 53 (94) 0 0 1 (7) Interview 0 0 156 (77) 0 0 67 (69) 2 (4) 38 (97) 36 (100) 12 (86) Sex Ratio (M:F) Male 985 (63) 153 (59) 136 (66) 71 (62) 73 (66) 63 (65) 67 (68) 31 (79) 18 (50) 6 (43) Female 584 (37) 105 (41) 70 (34) 44 (38) 37 (34) 34 (35) 31 (32) 8 (21) 18 (50) 8 (57) BMI mean (range) 27.0 (14–68) 25.9 (15–61) 26.9 (15–66) 27.1 (16–55) 23.5 (16–32) 26.9 (16–35) 26.9 (16–41) 28.8 (20–38) 26.5 (19–44) 26.6 (22–32) Age (years) mean (range) 74.4 (30–96) 72.7 (36–91) 76.1 (47–96) 70.7 (37–94) 67.0 (31–93) 71.9 (35–97) 69.6 (35–93) 66.3 (51–89) 49.1 (22–74) 64.2 (33–95) Time since stoma creation 6.2 (2.1–12.2) 4.1 (1.0–7.9) 6.1 (1.0–15.1) 5.7 (1.8–10.7) 4.6 (1.0–39.2) 5.6 (1.6– 4.5 (1.0–15.0) 5.4 (2.1–12.2) 4.8 (1.6–21.7) 2.5 (1.1–5.3) (years) (range) 16.6) Access stoma to nurse Yes 1180 (77) 190 (77) 160 (78) 101 (89) 120 (98) 77 (87) 86 (85) 35 (90) 32 (89) 10 (71) No 47 (3) 24 (10) 32 (16) 7 (6) 3 (2) 4 (4) 10 (10) 4 (10) 4 (11) 0 Do not know 308 (20) 34 (13) 12 (6) 6 (5) 0 8 (9) 5 (5) 0 0 4 (29) Stage (TNM) 0 0 18 (7) 10 (5) 0 3 (3) 11 (11) 3 (3) 0 0 0 I 523 (39) 83 (32) 42 (21) 18 (15) 28 (28) 30 (31) 35 (39) 8 (21) 12 (39) 0 II 426 (31) 68 (26) 59 (30) 39 (34) 32 (32) 28 (29) 28 (31) 8 (21) 2 (6) 8 (80) III 399 (29) 71 (27) 79 (40) 59 (51) 25 (25) 24 (25) 22 (24) 23 (58) 17 (55) 2 (20) IV 5 (1) 20 (8) 8 (4) 0 12 (12) 4 (4) 2 (2) 0 0 0 Procedure Abdominal perineal excision 1237 (78) 258 (100) 167 (83) 79 (68) 105 (97) 80 (82) 70 (76) 38 (97) 29 (81) 6 (43) Hartmann’s resection 346 (22) 0 14 (7) 21 (18) 2 (2) 9 (9) 6 (7) 1 (3) 4 (11) 7 (50) Pelvic exenteration 0 0 5 (2) 16 (14) 0 1 (1) 15 (16) 0 3 (8) 0 Setting Acute 13 (1) 0 6 (3) 3 (3) 0 6 (6) 1 (1) 0 2 (6) 7 (50) Elective 1570 (99) 258 (100) 195 (97) 113 (97) 95 (86) 90 (93) 87 (99) 39 (100) 34 (94) 7 (50) ASA score 1–2 1356 (86) 179 (69) 131 (66) 108 (93) 99 (80) 57 (59) 67 (77) 39 (199) 35 (97) 8 (57) ≥3 214 (14) 78 (31) 68 (34) 8 (7) 10 (8) 39 (40) 20 (23) 0 1 (3) 6 (43) Complications No complications 1250 (79) 152 (58) 119 (59) 75 (65) 101 (83) 64 (66) 25 (26) 32 (82) 26 (72) 12 (86) Clavien–Dindo I–II 29 (2) 71 (27) 50 (25) 21 (18) 0 16 (17) 51 (53) 4 (10) 9 (25) 1 (7) Clavien–Dindo III 57 (4) 33 (13) 25 (12) 18 (15) 6 (5) 14 (14) 9 (9) 3(8) 1 (3) 1 (7) Clavien–Dindo IV 19 (1) 2 (1) 6 (3) 2 (2) 0 0 2 (2) 0 0 0 Unknown 228 (14) 2 (1) 1 (1) 0 15 (12) 3 (3) 9 (9) 0 0 0 Values are n (%) unless otherwise indicated. Single institution. DCCG, Danish Colorectal Cancer Group; SCRCR, Swedish Colorectal Cancer Registry; MOA, mode of administration; The NL, The Netherlands. Kristensen et al. | 3 a EORTC QLQ-C30 functional scales EORTC QLQ-C30 symptom scales 100 40 90 30 Mean score Mean score 80 20 70 10 60 0 Global QoL PF RF EF CF SF FA NV PA DY SL AP CO DI FI No/a little Some/a lot No/a little Some/a lot b EORTC QLQ-C30 functional scales EORTC QLQ-C30 symptom scales 100 40 90 30 Mean score Mean score 80 20 70 10 60 0 Global QoL PF RF EF CF SF FA NV PA DY SL AP CO DI FI No/a little Some/a lot European norm No/a little Some/a lot European norm Fig. 1 Mean scores (s.d.) of EORTC QLQ-C30 in patients reporting no/a little impaired quality of life by the colostomy versus patients reporting some/a lot impaired quality of life a Total cohort. b European part of the cohort along with European general population normative data17. EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30; QoL, quality of life; PF, physical function; RF, role function; EF, emotional function; CF, cognitive function; SF, social function; FA, fatigue; NV, nausea/vomiting; PA, pain; DY, dyspnoea; SL, insomnia; AP, appetite loss; CO, constipation; DI, diarrhoea; FI, financial difficulties. database (Denmark, Sweden and the Netherlands) or from 10–38 points is categorized as major CI, representing worse hospital databases or hospital charts (Spain, China, Portugal, stoma function. Calculation of the CI score requires completion Australia, Lithuania, Egypt and Israel). of all items, and patients with one or more missing items were excluded from analyses involving the CI score. Questionnaires EORTC QLQ-C30 version 3.0 is a multidimensional generic Participants completed a questionnaire on demographic (sex, HRQoL measure for patients with cancer consisting of 30 items: weight, height and age) and socioeconomic information 28 questions with answer options on a four-point scale, ‘not at (employment status, marital status, educational level and all’, ‘a little’, ‘quite a bit’ and ‘very much’ and two questions whether the stoma burdens the household finances), five anchor asking responders to state overall health and overall quality of questions stating the overall impact of the colostomy on aspects life on a seven-point scale16. The EORTC QLQ-C30 provides five of their lives (quality of life, satisfaction with life, adjustment, multi-item functional scales and a multi-item global health embarrassment and restrictions in everyday activities), the status/quality of life scale, three multi-item symptom scales Colostomy Impact (CI) score15 and the European Organization and six single-item measures. The EORTC QLQ-C30 global for Research and Treatment of Cancer (EORTC) Quality of Life health status was used to testing for differences between Questionnaire Core30 (QLQ-C30)16. countries to reduce multiple testing and the risk of type 1 In brief, the CI score is a patient-reported outcome measure errors18. All scale scores were calculated by linear developed at Aarhus University Hospital assessing stoma transformation into scales ranging from 0 to 100, according to dysfunction. It is short and simple, consisting of seven items the scoring manual. Higher scores in the functional scales covering stoma-related problems, symptoms and complications represent better functioning, whereas higher scores in the that are associated with HRQoL. The CI score has been validated symptom scores represent worse symptoms19. Similarly, in all participating countries17, except for Egypt, Lithuania and missing data were handled according to the scoring manual. Israel, where validation is currently underway. The CI score has Questionnaires that were not available beforehand in all a weighted scoring system and provides a total sum score languages, were translated by professional interpreters in ranging from 0 to 38. A CI score of 0–9 points is categorized accordance with the WHO recommendations of translation and as minor CI, representing better stoma function and a score of adaptation of instruments. This included the background 4 | BJS Open, 2022, Vol. 6, No. 6 a EORTC QLQ-C30 functional scales EORTC QLQ-C30 symptom scales 100 40 90 30 Mean score Mean score 80 20 70 10 60 0 Global QoL PF RF EF CF SF FA NV PA DY SL AP CO DI FI Minor CI Major CI Minor CI Major CI b EORTC QLQ-C30 functional scales EORTC QLQ-C30 symptom scales 100 40 90 30 Mean score 80 Mean score 20 70 10 60 0 Global QoL PF RF EF CF SF FA NV PA DY SL AP CO DI FI Minor CI Major CI European norm Minor CI Major CI European norm Fig. 2 Mean scores (s.d.) of EORTC QLQ-C30 in patients with minor CI versus major CI a Total cohort. b European part of the cohort along with European general population normative data17. EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30; CI, colostomy impact; QoL, quality of life; PF, physical function; RF, role function; EF, emotional function; CF, cognitive function; SF, social function; FA, fatigue; NV, nausea/vomiting; PA, pain; DY, dyspnoea; SL, insomnia; AP, appetite loss; CO, constipation; DI, diarrhoea; FI, financial difficulties. Mean EORTC QLQ-C30 scores by country 80.4 Lithuania 78.5 The Netherlands 77.4 Denmark 73.7 73 71.1 Sweden 69.2 China 68.5 Spain 67.2 66.8 Australia 67.1 68.5 66.1 Portugal 58.5 Egypt Global QoL 58.3 Israel Population norm 0 20 40 60 80 100 Score Fig. 3 Mean of EORTC QLQ-C30 global health status per country along with country-specific population reference values where available20–22 EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30; QoL, quality of life. Kristensen et al. | 5 Overall satisfaction with life Impaired quality of life Lithuania Lithuania The Netherlands The Netherlands Denmark Denmark Sweden Sweden China China Spain Spain Australia Australia Portugal Portugal Egypt Egypt Israel Israel 0 20 40 60 80 100 0 20 40 60 80 100 Good Adequate/acceptable Not at all A little Poor Very poor Some A lot Got used to the colostomy Embarrassment Lithuania Lithuania The Netherlands The Netherlands Denmark Denmark Sweden Sweden China China Spain Spain Australia Australia Portugal Portugal Egypt Egypt Israel Israel 0 20 40 60 80 100 0 20 40 60 80 100 A lot Some Not at all A little A little Not at all Some A lot Restrictions Lithuania The Netherlands Denmark Sweden China Spain Australia Portugal Egypt Israel 0 20 40 60 80 100 Not at all A little Some A lot Fig. 4 Answers to the anchor questions by country questions, anchor questions and the CI score in Arabic, to identify factors potentially correlated to CI score and aspects Lithuanian and Hebrew, as shown in Appendix S1. of life as measured by the anchor questions. Variables showing Results were compared with normative data published in 2019 differences between groups with a P value of less than 0.25 in on a reference European population obtained from a 2019 survey univariable analysis were included in the multivariable logistic among representative samples of the population in 11 European regression21. To identify predictors of reduced HRQoL within countries20. countries, univariable followed by a multivariable regression was conducted per country if the rule of thumb of 10 events per Statistical analysis predictor variable was not violated. A receiver operating Descriptive statistics are presented as mean(s.d.), mean (range) or characteristic (ROC) was calculated along with area under the percentages. EORTC scale scores were presented as mean(s.d.)19 curve for the multivariable logistic regression. A significance and differences between countries were calculated with the level of 0.05 was chosen. Data collection and data management Mann–Whitney U test owing to the skewness of the data. was handled with Research Electronic Data Capture (REDCap) Univariate logistic regression was performed on the total cohort data collection tools hosted at Aarhus University22,23. Statistical 6 | BJS Open, 2022, Vol. 6, No. 6 Table 2 Logistic regression analysis showing correlations to the anchor question: overall, do you think that the colostomy impairs your quality of life? Univariable regression Multivariable regression Logistic regression OR Z P 95% c.i. OR Z P 95% c.i. Age (years) 1.02 − 3.69 ,0.001 1.01, 1.02 1.01 − 1.97 0.049 1.00, 1.02 Sex 0.96 − 0.41 0.684 0.79, 1.16 – – – – BMI 1.02 2.06 0.039 1.00, 1.04 1.00 0.35 0.723 0.98, 1.02 Employment Employed 1.00 – – – – – – – Unemployed 3.17 4.79 ,0.001 1.98, 5.09 2.74 3.52 ,0.001 1.56, 4.82 Retired 1.05 0.40 0.689 0.82, 1.35 1.18 0.92 0.355 0.83, 1.68 Marital status Married 1.00 – – – – – – – Single/widowed 1.31 2.77 0.006 1.08, 1.58 1.35 2.58 0.010 1.07, 1.69 Education* None – – – – – – – – Short 0.68 − 1.41 0.157 0.40, 1.15 1.08 0.25 0.800 0.57, 2.06 Long 0.64 − 1.60 0.109 0.37, 1.10 0.99 − 0.02 0.984 0.51, 1.93 Financially burdened 2.39 6.44 ,0.001 1.83, 3.12 1.98 4.26 ,0.001 1.44, 2.72 Colostomy impact score Minor 1.00 – – – – – – – Major 3.42 12.29 ,0.001 2.81, 4.15 3.32 10.69 ,0.001 2.66, 4.13 Time since stoma creation 0.95 − 2.97 0.003 0.92, 0.98 0.97 − 1.31 0.189 0.92, 1.01 Access to stoma nurse Yes 1.00 – – – – – – – No/do not know 0.86 − 1.30 0.194 0.68, 1.08 0.92 − 0.59 0.554 0.69, 1.21 Clavien–Dindo No complications 1.00 – – – – – – – I–II 0.97 − 0.17 0.866 – 0.79 − 1.21 0.227 0.54, 1.16 III–IV 1.24 1.30 0.194 0.89, 1.71 1.03 0.14 0.886 0.70, 1.51 Oncological treatment† None 1.00 – – – – – – – Any 1.06 0.32 0.748 0.73, 1.54 – – – – *Educational level was divided into three groups, where ‘short’ was less than a college degree or equivalent and patients reporting highest level of education college degree or further/higher or equivalent were grouped as having a ‘long’ education. †Any oncological treatment covered adjuvant or neoadjuvant chemo- and/or radiotherapy. analyses were performed with Stata 16.1 (StataCorp, College Patients reporting that the colostomy impairs their quality of life Station, Texas, USA). ‘not at all’/‘a little’ (n = 1850, 74.2 per cent) had significantly higher EORTC QLQ-C30 scores across all functional scales and lower scores across all symptom scales, when compared with Results patients reporting that the stoma impairs their quality of life Patients and demographics ‘some’/‘a lot’ (n = 642, 25.8 per cent). A total of 2557 patients were included in the survey. The mean time EORTC QLQ-C30 scores of the European part of the study from stoma creation was 2.5–6.2 years (range 1.1–39.2). Survey population is seen in Fig. 1 along with a European reference details and patient characteristics are presented per country in population of normative data20. Scale scores in the group of Table 1. No significant differences between countries were found patients reporting ‘not at all’/‘a little’ impaired quality of life regarding sex and time since stoma creation. Egyptian patients were significantly higher compared with the population norm in were significantly younger compared with all other countries. all functional scores, except for physical functioning and role Chinese patients had significantly lower BMI, and no Chinese functioning. Similarly, they had lower symptom scores in all patient was categorized as having complications rated as scales except for diarrhoea. Looking at how stoma dysfunction, Clavien–Dindo grade I–II. The Israeli cohort had fewer patients of measured by the CI score, was related to generic HRQoL, the TNM stage 0–I and more patients of stage II compared with EORTC QLQ-C30 scores of patients with major CI and minor CI patients from all other countries, and more Israeli patients were are presented in Fig. 2. Patients with minor CI (n = 1244, 51.9 per operated on in the emergency setting. No Lithuanian patients cent) had higher scores in all functional scales and lower mean were categorized with an ASA score of 3 or higher. Besides this, scores in all symptom scales compared with patients with major there were no differences in ASA score between countries. The CI (n = 1154, 48.1 per cent). When looking at the European part Swedish cohort included patients undergoing abdominoperineal of the study population, patients with minor CI had significantly excision only. No other differences were present between higher scores on all functional scales and comparable or lower countries regarding the surgical procedure. in all symptom scales, except diarrhoea and dyspnoea, compared with the general European population, Fig. 2. Quality of life Figure 1 reports mean EORTC QLQ-C30 scores for the total cohort Differences between countries with participants divided into two groups depending on the EORTC QLQ-C30 global health status differed significantly between impact of the stoma on quality of life measured by the anchor the countries with generally higher scores in Northern European question with one group reporting ‘not at all’/‘a little’ impact on countries. The mean global health status for each country is HRQoL and another group reporting ‘some’/‘a lot’ impact. shown in Fig. 3, with reference data from the literature for the Kristensen et al. | 7 country-specific population norm where available20,24,25. HRQoL may be more prevalent in certain high-risk patients and Differences between the study cohorts of colostomy patients and confined to a few HRQoL domains. A Cochrane review from 2012 general populations ranged 0.4–1.9 with a slight tendency for concluded, however, that HRQoL is not superior in patients scores being higher in the stoma population in all countries undergoing sphincter preservation compared with Hartmann’s except for Australia. Nevertheless, there were significant operation or abdominoperineal excision26. It is well established differences between the cohorts depending on country and mean that poor bowel function after a low anterior resection impacts global health status ranged from 80.4 (Lithuania) to 58.3 (Israel). HRQoL negatively and with the present results demonstrating that most patients with a permanent colostomy do not Anchor questions experience reduced HRQoL from their colostomy it should be Major variations were seen between countries in the proportions of considered that the stoma is not necessarily worse than poor patients reporting how their colostomy impacts different aspects of bowel function after a low anterior resection. life. As seen in Fig. 4, patients generally reported high satisfaction A significant difference in generic HRQoL across the different with life with a colostomy with more than 80 per cent of patients included countries was found. A cross-sectional study from 2005 stating ‘good’ or ‘adequate/acceptable’ satisfaction in all countries investigating HRQoL in individuals with a colostomy after rectal except for Egypt. Fewer patients in the Northern European cancer across Europe and Middle-Eastern countries found a countries reported that their stoma impairs their overall quality of similar marked north-to-south gradient in HRQoL; however, life, whereas more patients in the Middle-Eastern countries when considering how the EORTC QLQ-C30 global health status and China stated that their HRQoL is impaired ‘some’/‘a lot’ by resembles that of the general population in our present study, their stoma. This variance between countries was consistent this gradient may not be attributed to the colostomy, but rather, throughout all anchor questions; in general, fewer Northern reflects the quality of life in the background population. European patients were embarrassed or restricted and more The present data did reveal differences in how patients patients had gotten used to having the stoma. In Israel and Egypt, appreciated their colostomy between countries. The more than half of the patients felt restricted ‘some’ or ‘a lot’ by abovementioned north-to-south gradient was consistent in all their stoma, and 79 per cent and 67 per cent respectively were the anchor questions with a higher proportion of patients ‘some’ or ‘a lot’ embarrassed by their stoma. reporting impaired HRQoL, dissatisfaction with life, restrictions, embarrassment and difficulty with adaptation in Israel, Egypt Predictors of stoma-related impaired HRQoL and China. The source of the geographical and cultural Multiple logistic regression analysis was performed on the total differences is not clear from this study, but it seems that generic cohort to determine predictors of self-reported reduced HRQoL, HRQoL is not affected compared with the general population. caused by the colostomy. Patients were categorized as having The multivariable regression showed that a number of stoma-related reduced HRQoL if they stated ‘some’ or ‘a lot’ in variables were associated with reduced HRQoL. The most the anchor question ‘Overall do you think that the colostomy important risk factor was stoma dysfunction as measured by impairs your quality of life?’ Table 2 shows the predictor the CI score. Patients with major CI had an OR of 3.32 for variables. In the multivariable analysis, stoma dysfunction reporting that their stoma reduces their quality of life compared measured by the CI score, young age, being single or widowed, with patients with a minor CI score. In the total cohort, young being unemployed, and being financially burdened by the stoma age was also associated with reduced HRQoL. Thus, for every were significantly associated with stoma-related reduced HRQoL. year increase in patient age, the risk of reporting stoma-related An ROC curve was calculated for the model showing area under reduced HRQoL was 1 per cent lower. Furthermore, being the curve of 0.701 (95 per cent c.i. 0.675 to 0.726), Fig. S1. unemployed or retired, uneducated and financially burdened by In four countries (Denmark, Sweden, Spain and the the colostomy was associated with a higher risk of the Netherlands), the number of included patients allowed for stoma impairing HRQoL. Previous studies on socioeconomic multivariable logistic regression per country. Only stoma factors have reported different results, most often reporting no dysfunction measured by the CI score was consistently difference in HRQoL depending on socioeconomic status8–12; associated with stoma-related reduced HRQoL in all four however, a cross-sectional study from 2005 found low countries. In addition to stoma dysfunction, in Spanish patients, educational status to be associated with worse body image in young age was associated with stoma-related impact on quality individuals with a colostomy after colorectal cancer13. The only of life (P = 0.001), whereas in Danish patients, being single or significant socioeconomic factor related to reduced widowed was associated with reduced stoma-related HRQoL (P = stoma-related HRQoL in our study was being financially 0.024), as shown in Tables S1–S4. burdened by the colostomy with an OR of 1.98 of reporting that the stoma impairs HRQoL. In addition to the cost of appliances, a financial burden can occur as the result of lost income and so Discussion this question was designed to capture a financial burden from This study demonstrates that about 25.8 per cent of patients the stoma regardless of the reason. Similarly, a study on US reported that the stoma impaired their HRQoL some or a lot, but veterans from 2007 reported that difficulty paying for ostomy this impairment is across all EORTC QLQ-C30 scales. Even supplies was associated with lower overall quality of life, but though, HRQoL resembles that of the background population. In also emphasized that the causal relationship is uncertain27. accordance with these results, an American cross-sectional Among the strengths of this survey are a representation of several survey in patients with faecal stomas found HRQoL similar to countries across three continents and the use of validated the background population in some but not all domains of the questionnaires. Most participants were recruited from national or Rand Medical Outcomes Study 36-Item Short-Form Health hospital-based registers reducing the risk of selection bias, which Survey (SF)-36® version 2. And a Dutch study on individuals is further reduced by the high response rates in most countries. after colorectal cancer found HRQoL to be equal to a reference Participants were assured anonymity and, where possible, patients population in the elderly6. The impact that a stoma has on self-completed the questionnaires. On the other hand, limitations 8 | BJS Open, 2022, Vol. 6, No. 6 include the cross-sectional design that does not allow for causal ostomy: a survey of 2647 patients of the Berlin OStomy-Study inferences and does not control for confounding, and the fact that (BOSS). Langenbecks Arch Surg 2016;401:1191–1201 the CI score has not been validated in 3 of 10 participating 6. Verweij NM, Bonhof CS, Schiphorst AHW, Maas HA, Mols F, countries. Furthermore, information on non-responders was not Pronk A et al. Quality of life in elderly patients with an ostomy available, which would have provided useful information on —a study from the population-based PROFILES registry. potential selection bias. The majority of patients in the cohort Colorectal Dis 2018;20:O92–102 were from Denmark and this overrepresentation may affect 7. Ayalon R, Bachner YG. Medical, social, and personal factors as results in the multivariable regression. correlates of quality of life among older cancer patients with This international study documented that HRQoL even with a permanent stoma. Eur J Oncol Nurs 2019;38:50–56 permanent colostomy is acceptable, and that most of the 8. Krouse RS, Herrinton LJ, Grant M, Wendel CS, Green SB, Mohler patients in fact have HRQoL at least equal to the background MJ et al. Health-related quality of life among long-term rectal population as reported in the literature20,24,25. However, there cancer survivors with an ostomy: manifestations by sex. J Clin are some patients with reduced HRQoL that should be identified Oncol 2009;27:4664–4670 and use of the CI score should be encouraged as the symptoms 9. Pereira AP, Cesarino CB, Martins MRI, Pinto MH, Netinho JG. represented in the score (such as pain, skin problems, Associations among socio-demographic and clinical factors constipation/diarrhoea and frequent leakages) can be managed and the quality of life of ostomized patients. Rev Lat Am by expert stoma care nursing. Enfermagem 2012;20:93–100 10. Kement M, Gezen C, Aydin H, Haksal M, Can U, Aksakal N et al. A descriptive survey study to evaluate the relationship Funding between socio-demographic factors and quality of life in H.Ø K. was funded by the Danish Cancer Society and the patients with a permanent colostomy. Ostomy Wound Manag Department of Clinical Medicine at Aarhus University Hospital. 2014;60:18–23 The Bengt Ihres Foundation funded data collection in Sweden. 11. Mahjoubi B, Mirzaei R, Azizi R, Jafarinia M, Zahedi-Shoolami L. A cross-sectional survey of quality of life in colostomates: a report from Iran. Health Qual Life Outcomes 2012;10:136 Acknowledgements 12. Holzer B, Matzel K, Schiedeck T, Christiansen J, Christensen P, We thank M. Pera Ferreruela at Vall D’Hebron Hospital in Spain for Rius J et al. Do geographic and educational factors influence support with the database and N. Vilela, J. Costa Pereira, the quality of life in rectal cancer patients with a permanent E. Amorim, D. Parente, R. Malaquias and A. Oliveira for colostomy? Dis Colon Rectum 2005;48:2209–2216 assistance with data acquisition in Portugal. 13. Sideris L, Zenasni F, Vernerey D, Dauchy S, Lasser P, Pignon JP et al. Quality of life of patients operated on for low rectal cancer: Impact of the type of surgery and patients’ characteristics. Dis Colon Rectum 2005;48:2180–2191 Disclosure 14. Hamashima C. 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