PSR-08940; No of Pages 6 Journal of Psychosomatic Research xxx (2014) xxx–xxx

Contents lists available at ScienceDirect

Journal of Psychosomatic Research

Concerns and worries in people living with inflammatory bowel disease (IBD): A mixed methods study Rachel L. Keeton a, Antonina Mikocka-Walus a,b,c,⁎, Jane M. Andrews d,e a

Department of Health Sciences, University of York, York, United Kingdom School of Nursing and Midwifery, University of South Australia, Adelaide, Australia School of Psychology, University of Adelaide, Adelaide, Australia d IBD Service, Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, Australia e School of Medicine, University of Adelaide, Adelaide, Australia b c

a r t i c l e

i n f o

Article history: Received 22 September 2014 Received in revised form 4 December 2014 Accepted 6 December 2014 Available online xxxx Keywords: Anxiety symptoms Concerns Depression symptoms Inflammatory bowel disease Remission

a b s t r a c t Objective: This mixed-methods study aimed to explore concerns and worries related to living with inflammatory bowel disease (IBD). Methods: Overall, 294 patients with a clinically established diagnosis of IBD were enrolled in this cross-sectional study. Concerns and worries were measured with one open-ended question. Measures of anxiety and depressive symptoms and disease activity were also administered. A thematic analysis was conducted and thematic map created. Spearman’s rho was used to identify univariate correlations between predictors and the main themes. Binary logistic regression was used to test the predictors of the main themes. Results: Despite the majority of study participants being in IBD remission (74%, n=217), all but 11 reported significant IBD-related concerns. Twenty two percent reported symptoms of depression and 41% of anxiety. Four themes were identified: Quality of life (51%); Unpredictability (35%); Symptoms (34%) and Treatments (19%). Males and older people were less concerned about Quality of life (OR=.597, 95% CI: .363–.980 and OR=.980, 95% CI: .965–.995, respectively). Those in remission were less concerned about Symptoms (OR=.510, 95% CI: .281- .926) while those with longer disease duration worried more about the Symptoms (OR=1.035, 95% CI: 1.010–1.061). Males were less concerned about Treatments (OR=.422, 95% CI: .229–.777). Conclusion: IBD patients report significant disease-related concerns even when in remission. Further exploration of what predicts patient concerns may help in shaping health-care delivery so that it better addresses patient needs. © 2014 Elsevier Inc. All rights reserved.

Introduction Inflammatory bowel disease (IBD) is a chronic relapsing disorder of the gastrointestinal tract, with an unpredictable course. The incidence of Crohn’s disease and ulcerative colitis is rising worldwide, with the debilitating condition now estimated to affect 200 per 100,000 of the western population [1]. Currently, there is no known cause or cure for IBD; it is thought that the condition may be due to an interplay amongst genetics, the environment, microbiome and the body’s immune response [1,2]. Common symptoms of IBD include abdominal pain, weight loss, and diarrhoea. The scope of social, physical, and psychological problems experienced by those with IBD is extensive, and these biopsychosocial factors

⁎ Corresponding author at: Senior Lecturer and Lead of Psychology in Relation to Health, Mental Health and Addiction Research Group, Department of Health Sciences, Area 4, ARRC Building, University of York, Heslington, York YO10 5DD, United Kingdom. Tel.: +44 01904 32 1521. E-mail address: [email protected] (A. Mikocka-Walus).

significantly influence patients’ experience of the illness [3]. For instance, depression and worrying have been associated with increased pain perception [3–5], while flares have been associated with poor quality of life (QOL) [6,7]. Due to the severity of the condition, psychological disturbances are common, and the distress patients face has been associated with poor coping, non-adherence and flares [8,9], although whether this is causal or a result of IBD is extremely difficult to tease out. Common concerns reported by people living with IBD have been their QOL, medication side effects, unpredictability, pain, heredity, need for surgery/stoma and cancer risk (although low) [10–17]. These concerns have been associated with high levels of distress, for instance, concerns regarding lacking knowledge about pregnancy and IBD [15]. Selinger and colleagues [16] found that 90% of their participants worried about the effects IBD would have on pregnancy, with 45% believing that IBD caused infertility (n=145). Concerns about inadequate IBD knowledge have been associated with low QOL and anxiety [18–20]. However, some studies which have applied an educational intervention have found no improvement in patients’ QOL, in some cases QOL and anxiety have worsened [21,

http://dx.doi.org/10.1016/j.jpsychores.2014.12.004 0022-3999/© 2014 Elsevier Inc. All rights reserved.

Please cite this article as: Keeton RL, et al, Concerns and worries in people living with inflammatory bowel disease (IBD): A mixed methods study, J Psychosom Res (2014), http://dx.doi.org/10.1016/j.jpsychores.2014.12.004

2

R.L. Keeton et al. / Journal of Psychosomatic Research xxx (2014) xxx–xxx

22], while concerns over the unpredictability of the condition have been found to affect social interactions [13,23]. These concerns not only impair patients’ quality of life, but the stress can also exacerbate symptoms, with research demonstrating that worries correlate with the disease course and become more intense as the symptoms worsen [10,24,25]. Having concerns about IBD appears to also affect coping [9]. For instance, people reporting disease-related concerns have used more depressive coping than those not concerned [26]. This, in turn, may explain why when patients are concerned their symptoms exacerbate, as when their concerns increase, their ability to cope decreases and so their symptoms worsen, which increases their concerns [27,28]. These concerns appear to differ between countries, for instance, Levenstein and colleagues [29] found that people in Portugal were more concerned about feeling dirty and the smell, while in Israel they were more concerned about the pain and suffering. These specific concerns need to be identified and explored, as there may be a need for the health care services to address the concerns which are locally relevant or applicable to certain patient subgroups (e.g. older vs. younger patients), rather than applying a general model. At present, little is still understood about IBD patients’ concerns, and the effect they may have on IBD. Previous research has faced many methodological issues, for instance, research which has used scales has been criticised for failing to capture the actual experience of living with IBD and limiting patient responses [30–32], while qualitative studies have used small samples, which limits their ability to represent the population [11]. Thus, the present mixed-methods study aimed to explore diseaserelated concerns and worries in people living with IBD. The study has been designed to address the shortcomings of the previous research by involving a relatively large sample who provided both qualitative data on concerns, and quantitative data on mental health, to facilitate the mixed-data analysis.

is a self-assessment mood scale developed for medical outpatients [38] containing 14 questions graded on a 4-point Likert scale, with subscales of anxiety and depression, with a sum score ranging from 0 to 21 for each. The scores of 0–7 are considered normal; 8–10 indicative of mild anxiety/depression symptoms; 11–14 indicative of moderate anxiety/ depression symptoms; 15–21 indicative of severe anxiety/depression symptoms. The DASS-21 is a widely used measure of mental health. The factor structure, reliability, and validity of the DASS-21 are well established [39]. For depression, the scores of 0–9 are considered normal; 10–13 indicative of mild symptoms; 14–20 indicative of moderate symptoms; 21–27 indicative of severe symptoms; and N27 indicative of extreme symptoms. For anxiety, the scores of 0–7 are considered normal; 8–9 indicative of mild symptoms; 10–14 indicative of moderate symptoms; 15–19 indicative of severe symptoms; and N 19 indicative of extreme symptoms. For stress, the scores of 0–14 are considered normal; 15–18 indicative of mild symptoms; 19–25 indicative of moderate symptoms; 26–33 indicative of severe symptoms; and N33 indicative of extreme symptoms. Scores on both these scales have been categorised into normal, mild, moderate, severe as per each scale norms and combined (in the case of the DASS severe and extremely severe symptoms were presented together to enable comparisons with the HADS), to facilitate the data analysis.

Remission/flare status Disease activity was scored with the Crohn’s Disease Activity Index (CDAI) [40] for those with CD (a cut-off point of N 149) or the Simple Clinical Colitis Activity Index (SCCAI) (a cut-off point of N3) [41] for those with UC as appropriate and categorised into remission or flare, with the exception of one of the studies [34] where participants were asked specifically whether they were in remission or flare of their IBD.

Statistical and qualitative analysis Method Design A cross-sectional survey was conducted. Participants Participants were patients at a large tertiary teaching hospital in South Australia, serving a local referral population of approx. 600,000 and also providing state-based specialty services for an additional 300–400,000 people. Participants were recruited as part of three separate studies [33–35] where the entry questionnaire asked about their concerns and worries. Participants must have had a clinically established diagnosis of IBD; be at least 18 years old; had sufficient knowledge of English to understand and answer the questionnaires; and had the competence to consent. Participants with serious mental illness (e.g. psychosis, schizophrenia), alcohol/substance dependence or significant cognitive impairment were excluded. Measurements Concerns and worries Across the three contributing studies concerns and worries about IBD were measured with one open-ended question: What are your main concerns with having IBD? This was the study’s primary outcome measure. Anxiety and depressive symptoms The contributing studies either used the Hospital Anxiety and Depression Scale (HADS) or the Depression, Anxiety and Stress Scale (DASS)-21 to measure symptoms of anxiety and depression. The HADS

Numerical results of the survey were summarised using descriptive statistics, with means, standard deviations, frequencies and percentages presented. A thematic analysis was conducted on concerns and worries where similar themes were grouped together, with a thematic map created following the recommendations by Braun and Clarke [42]. Following Braun and Clarke [42] in order for a theme to be extracted from the data, it needed to be present in at least three transcripts/separate occurrences. The data were then analysed following the guidelines of the six phases of thematic analysis [42]: 1) familiarization with transcripts (reading and rereading the transcripts; noting down initial thoughts and ideas); 2) forming initial codes (systematic coding of interesting features of the data-set; collecting data relevant to each code); 3) searching for themes (amalgamation of codes into potential themes; data extraction for each potential theme); 4) reviewing themes (checking whether themes “work” in relation to the coded extracts and transcripts); 5) defining and naming themes; 6) producing the report (selection of data extracts to illustrate themes; linking analysis to the research questions and literature). Themes were created by RK and verified by AMW. No major discrepancies were identified. Univariate correlations between the identified main themes of concerns, demographics, anxiety and depression symptoms were conducted using the Spearman’s rho. Predictors of themes were thus identified and the logistic regressions run. The dependent variables included the three main themes: Quality of life, Symptoms and Treatments (at the univariate level, there had been no predictors of Unpredictability so the logistic regression was not run). The independent variables for Quality of life included: gender, age, anxiety; for Symptoms these were disease activity, gender, years since diagnosed and anxiety; for Treatments this was gender only. All the regression assumptions have been met. The two-sided significance level was set at 0.05

Please cite this article as: Keeton RL, et al, Concerns and worries in people living with inflammatory bowel disease (IBD): A mixed methods study, J Psychosom Res (2014), http://dx.doi.org/10.1016/j.jpsychores.2014.12.004

R.L. Keeton et al. / Journal of Psychosomatic Research xxx (2014) xxx–xxx

3

about incontinence mentioning “losing control of bowel actions” and “incontinence”. Again, more females expressed concern about symptoms than males (58% v 40%, P=.035).

Ethics approval Each of the contributing study has received ethics approval from the institutional Human Research Ethics Committee. Participants gave informed consent and patient anonymity was preserved. The study was conducted following the principles of the Declaration of Helsinki (updated in 2008). Results

Treatments Overall, only 57 (19%) participants were concerned about the treatments in IBD. Treatments consisted of: medicine side effects, colostomy bag, cure and knowledge. For instance, 43 of 57 (80%) participants were concerned about the side effects of the medication, mentioning “side effects of medications” and “being on medication with adverse side effects”. Of 57 participants, again more women expressed concern about the treatments than men (70% v 33%, P=.005).

Demographics and mental health status

Predictors of themes

A total of 294 participants with IBD were included in the study (Table 1). Male participants were significantly older (49.8 years (SD=16.7)) than female participants (45.8 years, SD=16.1, P=.042). Overall, 21% of the participants reported symptoms of depression and 40% of anxiety.

At the univariate level, Quality of life correlated significantly with gender, (r=.142, P=.017), age (r=−.196, P=.001), and anxiety (r=.154, P=.010), with females, younger people and those more anxious more likely to express concern about Quality of life. However, both these correlations were weak. At the multivariate level, Quality of life was significantly associated with sex, with males less concerned about Quality of life (OR=.597, 95% CI: .363–.980), and with age; older people were less concerned about their Quality of life (OR=.980, 95% CI: .965–.995). At the univariate level, there were no predictors of Unpredictability identified, thus, a multivariate analysis was not conducted. At the univariate level, Symptoms correlated significantly with disease activity status (r=.147, P=.015), gender (r=.126, P=.035), years since diagnosed (r=.120, P=.048), and anxiety (r=.137, P=.023), with those flaring, females, those with longer disease duration and greater anxiety more concerned about symptoms. However, all these correlations were weak. At the multivariate level, Symptoms were significantly associated with disease activity status, with people in remission less concerned about the symptoms (OR=.510, 95% CI: .281–.926), and with years since diagnosis, as the longer people had IBD the more worried they were about symptoms (OR=1.035, 95% CI: 1.010–1.061). At the univariate and multivariate levels, Treatments correlated significantly with gender (r=.168, P=.005 and OR=.422, 95% CI: .229–.777, respectively), with males less concerned about Treatments than females. Again, the correlation was weak.

Concerns and worries After coding, four main themes summarising participants’ concerns and worries emerged: Quality of life, Unpredictability, Symptoms, and Treatments. See Fig. 1 for the thematic map. Quality of life Overall, 150 (51%) participants reported concerns about how IBD would affect their quality of life. Quality of life encompassed two main sub-themes; Normal life and Fear and isolation. Normal life referred to how the condition interfered with their general life and consisted of: general life style, toilet frequency, career, social life, diet and travelling. For instance, 99 (66%) participants were concerned about how IBD would affect them having a normal life, with 59 (59%) participants specifically concerned about the condition’s effect on their general life style, mentioning “effects on life” and “inconvenience”. Fear and isolation referred to fear about the consequences of having IBD, this consisted of: cancer, body image issues, family life, mortality and embarrassment. For instance, 85 (56%) participants were concerned about the fear and isolation the condition elicits, with 38 (44%) participants concerned about getting cancer due to the condition, specifying “Increased risk of cancer” and “That I will get bowel cancer and won’t be able to watch my kids grow up or do the things I want to do in life”. Whilst this area of concern was globally prevalent, it was expressed by a greater proportion of females than males (57% v 43%, P=.017). Unpredictability Overall, 104 (35%) participants expressed concern about the unpredictable nature of IBD. The theme Unpredictability encompassed future and long term health, surgery, flare, and control. Each one of these sub-themes referred to the unpredictable nature of the condition, for instance, 45 (43%) participants reported concern about their future and long term health, with statements such as “not knowing what lies ahead” and “will I ever be better than I am now?” while 36 (35%) participants were concerned about the possible need for surgery, with statements such as “the thought of more surgery” and “more operations”. Symptoms Overall, 101 (34%) participants expressed concern about symptoms associated with IBD. Symptoms reported included pain, incontinence, low energy, diarrhoea, bleeding and wind. For instance, 52 (51%) participants were concerned about the pain, specifying “pains” and “pains which tormented me”, while 32 (32%) participants were concerned

Table 1 Demographic characteristics. Variables Age, mean (SD) Time since diagnosis in years, mean (SD) Gender, n (%) Education, n (%)

IBD activity, n (%) Depressive symptoms, n (%)

Anxiety symptoms, n (%)

Female 1–9 years 10–12 years Trade Tertiary Remission Normal Mild Moderate Severe Normal Mild Moderate Severe

n=294 47.8 (16) 12.2 (10.5) 147 (50) 10 (3) 154 (54) 20 (7) 103 (36) 217 (74) 224 (78) 36 (12) 17 (6) 10 (4) 172 (59) 52 (18) 53 (19) 12 (4)

Discussion Unlike previous studies, this study explored IBD-related concerns without some of the methodological limitations other research has faced. For instance, previous research using scales may have underestimated the complex effect IBD has on patients’ lives [31,32], while qualitative research has used small samples which limit their evidence and conclusions [10,11]. Using mixed methods, this study enabled a large number (n=294) of participants' concerns to be examined, offering a more in-depth understanding of concerns, while also exploring their predictors. The most important finding of our study was that despite the majority of study participants being in remission (74%, n=217) of their IBD, all but 11 reported significant IBD-related concerns. This demonstrates that IBD remission, often considered to be the period free of symptoms (and worry), is a time when the patients still experience considerable problems potentially impairing their QOL. This likely reflects that these patients do not use the most adaptive coping strategies and thus studies examining whether interventions can improve coping in IBD and influence QOL are needed. Cognitive-behavioural therapy (CBT) may offer help in this respect and there is some preliminary evidence of its usefulness in IBD [43,44]. The effect IBD may have on participants’ future QOL was the most prevalent concern documented in this work. This is consistent with the previous research which identified that patients were concerned about how the condition may prevent them from having a normal life [19]. Impaired QOL is a recognized consequence of IBD, in particular due to living with the constant threat that the condition may exacerbate [45]. Women report this concern at a greater rate than men, which is consistent with the previous research, whereby women demonstrated significantly lower QOL scores and greater concern [46]. Similarly, women were more often concerned about the treatments than men. Since gender predicted QOL, this suggests that health care providers need to include gender specific concerns into the treatment, as this would ensure all patients’ needs are addressed. Age also predicted whether patients would be concerned about their QOL, with younger participants more concerned, and this was not explained by disease duration (PN.05). This finding supports previous research which found

Please cite this article as: Keeton RL, et al, Concerns and worries in people living with inflammatory bowel disease (IBD): A mixed methods study, J Psychosom Res (2014), http://dx.doi.org/10.1016/j.jpsychores.2014.12.004

R.L. Keeton et al. / Journal of Psychosomatic Research xxx (2014) xxx–xxx

Fig. 1. Thematic map.

4

Please cite this article as: Keeton RL, et al, Concerns and worries in people living with inflammatory bowel disease (IBD): A mixed methods study, J Psychosom Res (2014), http://dx.doi.org/10.1016/j.jpsychores.2014.12.004

R.L. Keeton et al. / Journal of Psychosomatic Research xxx (2014) xxx–xxx

that QOL was worse in younger participants [46] and could be due to IBD occurring during an already stressful time in their lives when they are under pressure academically, or are starting a career. Interestingly, despite previous research demonstrating an association between disease activity and poor QOL [47], current disease activity only predicted concerns about symptoms. It appears from our data that IBD has a continuous impact on patients’ lives irrespective of disease activity, as the majority of our participants were in remission yet still expressed concerns. These concerns may, in fact, be a reflection of a self-perpetuating cycle, in which concerns cause distress which exacerbate the symptoms, causing more distress and greater concerns [48], as concerns have been found to contribute to psychological distress [49], with stress resulting in a 20% greater chance of perceived exacerbation [48]. This distress is reflected in our results, as despite 74% being in remission, depression/anxiety symptoms (22%/41%) were still considerably high. For instance, concerns regarding unpredictability contribute to distress [50], with this distress suggested to contribute to further uncertainty, illness exacerbation [51] and depressive coping [27]. The unpredictability of IBD has a profound effect on patients’ lives, as they feel that they live with the constant threat of the unknown [13,23]. Concerns regarding the unpredictable nature of IBD were particularity common in this study’s participants, which is consistent with other research [23,30,52]. These concerns may explain why patients still had symptoms of depression/anxiety despite being in remission, as while distress has been associated with flares [53], clearly concerns impact patients’ psychological state and may influence symptom exacerbation. Another explanation can be the co-morbid functional bowel symptoms and the associated fatigue. We did not measure these factors in the present study, however, other researchers have linked both irritable bowel syndrome-like symptoms and fatigue to the patient reported concerns during remission [36,37]. Also, and predictably, flaring participants were significantly more concerned about symptoms than those in remission, and the worry about symptoms was also explained by disease duration. The latter is somewhat paradoxical, as one would assume that patients adjust to the chronic illness in time. One possible explanation may be that greater disease duration has been associated with non-adherence [54]. For instance, Moser and colleagues [55] found that the longer participants had IBD, the more likely they were to try the unconventional and untested therapies so as to prevent symptom returning. However, a longitudinal study of concerns over time is required to verify this effect. Concerns about treatments are highly prevalent, both in this study and across wider research, and if participants doubt the effectiveness of the medicine, this may create a substantial barrier to adherence. Consequently, concerns about treatments and any misconceptions should be addressed so as to reduce doubt and increase adherence.

Limitations A limitation of this study is that by incorporating the results from three separate studies, albeit conducted at one IBD service, we were unable to examine a large number of predictors of concerns, such as disease behaviour over time or personality. The study setting was a tertiary clinic, and thus the participants were a group of patients with disease which may be harder to control than seen in primary care settings, therefore, their concerns might not represent the larger IBD population, but rather the patients attending specialty hospital clinics. As the study was conducted in Australia, and previous research has indicated differences between countries for IBD-related concerns, this study may represent the Australian population only. This, however, also makes it unique as there is a scarcity of research on concerns amongst Australian IBD patients. Finally, all the correlations in the study were within the weak range and this should be kept in mind while interpreting these data.

5

Conclusions These IBD patients report significant disease-related concerns which are present despite the majority of them being in IBD remission at the time of survey. Capturing patients’ concerns and worries is imperative to understanding the impact IBD has on patients’ daily lives. Further exploration of what predicts concerns may help in shaping healthcare delivery so that it better addresses patient needs. By using mixed methods, this study offered an in-depth look at what worries and concerns people with IBD, and what predicts these concerns. Future research could further explore concerns by utilizing mixed methods research and examining other factors which may predict concerns across different countries, as this may help prevent concerns, psychological distress and improve adaptation to the condition. Acknowledgements The second author received the Angela McAvoy Fellowship from the Crohn’s and Colitis of Australia to allow for the conduct of this study. The studies from which the data came were all investigator-initiated and received additionally the unsolicited funding from Abbott Australia, MSD Australia and Janssen. No editorial support was received in the preparation of this paper. Study sponsors had no involvement in the study design, in the collection, analysis and interpretation of data; in the writing of the manuscript; or in the decision to submit the manuscript for publication. The authors have no competing interests to report. References [1] Cosnes J, Gower-Rousseau C, Seksik P, Cortot A. Epidemiology and natural history of inflammatory bowel diseases. Gastroenterology May 2011;140:1785–94 [PubMed PMID: 21530745]. [2] Loftus Jr EV. Clinical epidemiology of inflammatory bowel disease: incidence, prevalence, and environmental influences. Gastroenterology May 2004;126:1504–17 [PubMed PMID: 15168363]. [3] Fuller-Thomson E, Sulman J. Depression and inflammatory bowel disease: findings from two nationally representative Canadian surveys. Inflamm Bowel Dis Aug 2006;12:697–707 [PubMed PMID: 16917224]. [4] Srinath AI, Walter C, Newara MC, Szigethy EM. Pain management in patients with inflammatory bowel disease: insights for the clinician. Ther Adv Gastroenterol Sep 2012;5:339–57 [PubMed PMID: 22973418. Pubmed Central PMCID: 3437534]. [5] Farrokhyar F, Marshall JK, Easterbrook B, Irvine EJ. Functional gastrointestinal disorders and mood disorders in patients with inactive inflammatory bowel disease: prevalence and impact on health. Inflamm Bowel Dis Jan 2006;12:38–46 [PubMed PMID: 16374257]. [6] Faust AH, Halpern LF, Danoff-Burg S, Cross RK. Psychosocial factors contributing to inflammatory bowel disease activity and health-related quality of life. Gastroenterol Hepatol (N Y) Mar 2012;8:173–81 [PubMed PMID: 22675279. Pubmed Central PMCID: 3365520]. [7] Pallis AG, Vlachonikolis IG, Mouzas IA. Assessing health-related quality of life in patients with inflammatory bowel disease, in Crete, Greece. BMC Gastroenterol 2002;2 [PubMed PMID: 11866863. Pubmed Central PMCID: 65681]. [8] Goodhand JR, Wahed M, Mawdsley JE, Farmer AD, Aziz Q, Rampton DS. Mood disorders in inflammatory bowel disease: relation to diagnosis, disease activity, perceived stress, and other factors. Inflamm Bowel Dis 2012;18:2301–9. [9] Knowles SR, Wilson JL, Connell WR, Kamm MA. Preliminary examination of the relations between disease activity, illness perceptions, coping strategies, and psychological morbidity in Crohn's disease guided by the common sense model of illness. Inflamm Bowel Dis Dec 2011;17:2551–7 [PubMed PMID: 21425208]. [10] Casati J, Toner BB, de Rooy EC, Drossman DA, Maunder RG. Concerns of patients with inflammatory bowel disease: a review of emerging themes. Dig Dis Sci Jan 2000;45: 26–31 [PubMed PMID: 10695609]. [11] Hall NJ, Rubin GP, Hungin AP, Dougall A. Medication beliefs among patients with inflammatory bowel disease who report low quality of life: a qualitative study. BMC Gastroenterol 2007;7 [PubMed PMID: 17559670. Pubmed Central PMCID: 1896170]. [12] Jelsness-Jorgensen LP, Bernklev T, Henriksen M, Torp R, Moum B. Chronic fatigue is associated with increased disease-related worries and concerns in inflammatory bowel disease. World J Gastroenterol Feb 2012;18:445–52 [PubMed PMID: 22346250. Pubmed Central PMCID: 3270510]. [13] Nicholas DB, Otley A, Smith C, Avolio J, Munk M, Griffiths AM. Challenges and strategies of children and adolescents with inflammatory bowel disease: a qualitative examination. Health Qual Life Outcomes 2007;5 [PubMed PMID: 17531097. Pubmed Central PMCID: 1892542]. [14] Rogers A, Kennedy A, Nelson E, Robinson A. Patients' experiences of an open access follow up arrangement in managing inflammatory bowel disease. Qual Saf Health Care Oct 2004;13:374–8 [PubMed PMID: 15465941. Pubmed Central PMCID: 1743885].

Please cite this article as: Keeton RL, et al, Concerns and worries in people living with inflammatory bowel disease (IBD): A mixed methods study, J Psychosom Res (2014), http://dx.doi.org/10.1016/j.jpsychores.2014.12.004

6

R.L. Keeton et al. / Journal of Psychosomatic Research xxx (2014) xxx–xxx

[15] Selinger CP, Eaden J, Selby W, Jones DB, Katelaris P, Chapman G, et al. Patients' knowledge of pregnancy-related issues in inflammatory bowel disease and validation of a novel assessment tool (‘CCPKnow’). Aliment Pharmacol Ther Jul 2012;36: 57–63 [PubMed PMID: 22568682]. [16] Selinger CP, Eaden J, Selby W, Jones DB, Katelaris P, Chapman G, et al. Inflammatory bowel disease and pregnancy: lack of knowledge is associated with negative views. J Crohns Colitis Jul 2013;7:e206–13 [PubMed PMID: 23040449]. [17] Mountifield R, Bampton P, Prosser R, Muller K, Andrews JM. Fear and fertility in inflammatory bowel disease: a mismatch of perception and reality affects family planning decisions. Inflamm Bowel Dis May 2009;15:720–5 [PubMed PMID: 19067431]. [18] Borgaonkar MR, Townson G, Donnelly M, Irvine EJ. Providing disease-related information worsens health-related quality of life in inflammatory bowel disease. Inflamm Bowel Dis 2002;8:264–9. [19] Irvine EJ. Review article: patients' fears and unmet needs in inflammatory bowel disease. Aliment Pharmacol Ther Oct 2004;4:54–9 [PubMed PMID: 15352895]. [20] Irvine EJ, Feagan B, Rochon J, Archambault A, Fedorak RN, Groll A, et al. Quality of life: a valid and reliable measure of therapeutic efficacy in the treatment of inflammatory bowel disease. Canadian Crohn's Relapse Prevention Trial Study Group. Gastroenterology Feb 1994;106:287–96 [PubMed PMID: 8299896]. [21] Borgaonkar MR, Townson G, Donnelly M, Irvine EJ. Providing disease-related information worsens health-related quality of life in inflammatory bowel disease. Inflamm Bowel Dis Jul 2002;8:264–9 [PubMed PMID: 12131610]. [22] Selinger CP, Lal S, Eaden J, Jones DB, Katelaris P, Chapman G, et al. Better disease specific patient knowledge is associated with greater anxiety in inflammatory bowel disease. J Crohns Colitis Jul 2013;7:e214–8 [PubMed PMID: 23062330]. [23] Cervesi C, Battistutta S, Martelossi S, Ronfani L, Ventura A. Health priorities in adolescents with inflammatory bowel disease: physicians' versus patients' perspectives. J Pediatr Gastroenterol Nutr Jul 2013;57:39–42 [PubMed PMID: 23403446]. [24] Jelsness-Jorgensen LP, Moum B, Bernklev T. Worries and concerns among inflammatory bowel disease patients followed prospectively over one year. Gastroenterol Res Pract 2011;492034 [PubMed PMID: 21912537. Pubmed Central PMCID: 3168269]. [25] Maunder RG, Levenstein S. The role of stress in the development and clinical course of inflammatory bowel disease: epidemiological evidence. Curr Mol Med Jun 2008; 8:247–52 [PubMed PMID: 18537632]. [26] Petrak F, Hardt J, Clement T, Borner N, Egle UT, Hoffmann SO. Impaired healthrelated quality of life in inflammatory bowel diseases: psychosocial impact and coping styles in a national German sample. Scand J Gastroenterol Apr 2001;36: 375–82 [PubMed PMID: 11336162]. [27] Mussell M, Bocker U, Nagel N, Singer MV. Predictors of disease-related concerns and other aspects of health-related quality of life in outpatients with inflammatory bowel disease. Eur J Gastroenterol Hepatol Nov 2004;16:1273–80 [PubMed PMID: 15618832]. [28] Sainsbury A, Heatley RV. Review article: psychosocial factors in the quality of life of patients with inflammatory bowel disease. Aliment Pharmacol Ther Mar 1 2005;21: 499–508 [PubMed PMID: 15740531]. [29] Levenstein S, Li Z, Almer S, Barbosa A, Marquis P, Moser G, et al. Cross-cultural variation in disease-related concerns among patients with inflammatory bowel disease. Am J Gastroenterol Jun 2001;96:1822–30 [PubMed PMID: 11419836]. [30] Drossman DA, Leserman J, Li ZM, Mitchell CM, Zagami EA, Patrick DL. The rating form of IBD patient concerns: a new measure of health status. Psychosom Med Nov-Dec 1991;53:701–12 [PubMed PMID: 1758953]. [31] Guyatt G, Mitchell A, Irvine EJ, Singer J, Williams N, Goodacre R, et al. A new measure of health status for clinical trials in inflammatory bowel disease. Gastroenterology Mar 1989;96:804–10 [PubMed PMID: 2644154]. [32] Kemp K, Griffiths J, Lovell K. Understanding the health and social care needs of people living with IBD: a meta-synthesis of the evidence. World J Gastroenterol Nov 21 2012; 18:6240–9 [PubMed PMID: 23180944. Pubmed Central PMCID: 3501772]. [33] Mikocka-Walus A, Turnbull DA, Moulding NT, Wilson IG, Holtmann GJ, Andrews JM. Does psychological status influence clinical outcomes in patients with inflammatory bowel disease (IBD) and other chronic gastroenterological diseases: an observational cohort prospective study. BioPsychoSocial Med 2008;2:11. [34] Mikocka-Walus A, Andrews JM. Experience with and attitudes towards psychotherapy and antidepressants among patients with inflammatory bowel disease and functional gastrointestinal disorders: An online patient survey to inform system design. Gastroenterol Nurs 2014 [in press].

[35] Mikocka-Walus A, Andrews JM PB, Hetzel D, Hughes P, Esterman A. Cognitive-behavioural therapy improves QoL in IBD patients in need despite no global benefit on disease activity: 6 month data from a randomised controlled trial BMC. Gastroenterology 2014 [submitted]. [36] Jelsness-Jorgensen LP, Bernklev T, Moum B. Fatigue and disease-related worries among inflammatory bowel disease patients in remission; is it a reflection of coexisting IBS-like symptoms? A short report. J Psychosom Res Dec 2012;73: 469–72 [PubMed PMID: 23148817]. [37] Graff LA, Vincent N, Walker JR, Clara I, Carr R, Ediger J, et al. A population-based study of fatigue and sleep difficulties in inflammatory bowel disease. Inflamm Bowel Dis Sep 2011;17:1882–9 [PubMed PMID: 21830266]. [38] Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand Jun 1983;67:361–70 [PubMed PMID: 6880820]. [39] Antony MM, Cox BJ, Enns MW, Bieling PJ, Swinson RP. Psychometric properties of the 42-item and 21-item versions of the Depression Anxiety Stress Scales in clinical groups and a community sample. Psychol Assess 1998;10:176–81. [40] Best WR, Becktel JM, Singleton JW, Kern Jr F. Development of a Crohn's disease activity index. National Cooperative Crohn's Disease Study. Gastroenterology Mar 1976;70: 439–44 [PubMed PMID: 1248701]. [41] Walmsley RS, Ayres RC, Pounder RE, Allan RN. A simple clinical colitis activity index. Gut Jul 1998;43:29–32 [PubMed PMID: 9771402]. [42] Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol 2006;3: 77–101. [43] Knowles SR, Monshat K, Castle DJ. The efficacy and methodological challenges of psychotherapy for adults with inflammatory bowel disease: a review. Inflamm Bowel Dis Nov 2013;19:2704–15 [PubMed PMID: 23846488]. [44] McCombie AM, Mulder RT, Gearry RB. Psychotherapy for inflammatory bowel disease: a review and update. J Crohn's Colitis Dec 15 2013;7:935–49 [PubMed PMID: 23466412]. [45] De Boer M, Grootenhuis M, Derkx B, Last B. Health-related quality of life and psychosocial functioning of adolescents with inflammatory bowel disease. Inflamm Bowel Dis Apr 2005;11:400–6 [PubMed PMID: 15803032]. [46] Rubin GP, Hungin AP, Chinn DJ, Dwarakanath D. Quality of life in patients with established inflammatory bowel disease: a UK general practice survey. Aliment Pharmacol Ther Mar 1 2004;19:529–35 [PubMed PMID: 14987321]. [47] Cohen RD. The quality of life in patients with Crohn's disease. Aliment Pharmacol Ther Sep 2002;16:1603–9 [PubMed PMID: 12197839]. [48] Duffy LC, Zielezny MA, Marshall JR, Byers TE, Weiser MM, Phillips JF, et al. Relevance of major stress events as an indicator of disease activity prevalence in inflammatory bowel disease. Behav Med Fall 1991;17:101–10 [PubMed PMID: 1932843. Epub 1991/01/01. eng]. [49] Drossman DA, Patrick DL, Mitchell CM, Zagami EA, Appelbaum MI. Healthrelated quality of life in inflammatory bowel disease. Functional status and patient worries and concerns. Dig Dis Sci Sep 1989;34:1379–86 [PubMed PMID: 2766905]. [50] Gray WN, Graef DM, Schuman SS, Janicke DM, Hommel KA. Parenting stress in pediatric IBD: relations with child psychopathology, family functioning, and disease severity. J Dev Behav Pediatr May 2013;34:237–44 [PubMed PMID: 23669870. Pubmed Central PMCID: 3678249]. [51] Dudley-Brown S. Prevention of psychological distress in persons with inflammatory bowel disease. Issues Ment Health Nurs Jun 2002;23:403–22 [PubMed PMID: 12036497]. [52] Lesage AC, Hagege H, Tucat G, Gendre JP. Results of a national survey on quality of life in inflammatory bowel diseases. Clin Res Hepatol Gastroenterol Feb 2011;35: 117–24 [PubMed PMID: 21036501]. [53] Sajadinejad MS, Asgari K, Molavi H, Kalantari M, Adibi P. Psychological issues in inflammatory bowel disease: an overview. Gastroenterol Res Pract 2012;106502 [PubMed PMID: 22778720. Pubmed Central PMCID: 3388477]. [54] Horne R, Parham R, Driscoll R, Robinson A. Patients' attitudes to medicines and adherence to maintenance treatment in inflammatory bowel disease. Inflamm Bowel Dis Jun 2009;15:837–44 [PubMed PMID: 19107771]. [55] Moser G, Tillinger W, Sachs G, Maier-Dobersberger T, Wyatt J, Vogelsang H, et al. Relationship between the use of unconventional therapies and disease-related concerns: a study of patients with inflammatory bowel disease. Journal of psychosomatic research May 1996;40:503–9 [PubMed PMID: 8803859].

Please cite this article as: Keeton RL, et al, Concerns and worries in people living with inflammatory bowel disease (IBD): A mixed methods study, J Psychosom Res (2014), http://dx.doi.org/10.1016/j.jpsychores.2014.12.004