Patient-reported nausea after implementation of an enhanced recovery after surgery protocol for gynae-oncology patients.

OBJECTIVES: This study aimed to analyze the adherence to strategies to prevent post-operative nausea and vomiting after implementation of an enhanced recovery after surgery (ERAS) protocol for gynae-oncology patients. Patient-reported nausea before and after ERAS was also studied. METHODS: This prospective observational study included all patients undergoing laparotomy for a suspicious pelvic mass or confirmed advanced ovarian cancer before (pre-ERAS) and after the implementation of ERAS (post-ERAS) at Oslo University Hospital, Norway. Patients were a priori stratified according to the planned extent of surgery into two cohorts (Cohort 1: Surgery of advanced disease; Cohort 2: Surgery for a suspicious pelvic tumor). Clinical data including baseline characteristics and outcome data were prospectively collected. RESULTS: A total of 439 patients were included, 243 pre-ERAS and 196 post-ERAS. At baseline, 27% of the patients reported any grade of nausea. In the post-ERAS cohort, statistically significantly more patients received double post-operative nausea and vomiting prophylaxis (64% pre-ERAS vs 84% post-ERAS, p<0.0001). There was no difference in the need for rescue medication (82% pre-ERAS vs 79% post-ERAS; p=0.17) and no statistically significant difference between pre- and post-ERAS or between the surgical cohorts in patient-reported nausea of any grade on day 2. Patients who reported none/mild nausea on day 2 had significantly less peri-operative fluid administered during surgery than those who reported moderate or severe nausea (median 12.5 mL/kg/hour vs 16.5 mL/kg/hour, p=0.045) but, in multivariable analysis, fluid management did not remain significantly associated with nausea. CONCLUSION: Implementation of an ERAS protocol increased the adherence to post-operative nausea and vomiting prevention guidelines. Nausea, both before and after laparotomy, remains an unmet clinical need of gynae-oncology patients also in an ERAS program. Patient-reported outcome measures warrant further investigation in the evaluation of ERAS.

Fatigue in Patients with Newly Diagnosed Inflammatory Bowel Disease: Results from a Prospective Inception Cohort, the IBSEN III Study.

BACKGROUND AND AIMS: Although fatigue is common in inflammatory bowel disease [IBD], its pathogenesis remains unclear. This study aimed to determine the prevalence of fatigue and its associated factors in a cohort of patients newly diagnosed with IBD. METHODS: Patients ≥18 years old were recruited from the Inflammatory Bowel Disease South-Eastern Norway [IBSEN III] study, a population-based, observational inception cohort. Fatigue was assessed using the Fatigue Questionnaire and compared with data from a Norwegian general population. Univariate and multivariate linear and logistic regression analyses were performed to evaluate the associations of total fatigue [TF; continuous score] and substantial fatigue [SF; dichotomized score ≥4] with sociodemographic, clinical, endoscopic, laboratory, and other relevant patient data. RESULTS: In total, 983/1509 [65.1%] patients with complete fatigue data were included (ulcerative colitis [UC], 68.2%; Crohn's disease [CD], 31.8%). The prevalence of SF was higher in CD [69.6%] compared with UC [60.2%] [p < 0.01], and in both diagnoses when compared to the general population [p < 0.001]. In multivariate analyses, depressive symptoms, pain intensity, and sleep disturbances were associated with increased TF for both diagnoses. In addition, increased clinical disease activity and Mayo endoscopic score were significantly associated with TF in UC, whereas all disease-related variables were insignificant in CD. Similar findings were observed for SF, except regarding the Mayo endoscopic score. CONCLUSIONS: SF affects approximately two-thirds of patients newly diagnosed with IBD. Fatigue was associated with depressive symptoms, sleep disturbances, and increased pain intensity in both diagnoses, while clinical and endoscopic activity were associated factors only in UC.

Health-related quality of life in patients with newly diagnosed inflammatory bowel disease: an observational prospective cohort study (IBSEN III).

PURPOSE: This unselected, population-based cohort study aimed to determine the level of health-related quality of life (HRQoL) in patients with Crohn's disease (CD) and ulcerative colitis (UC) at the time of diagnosis compared with a reference population and identify the demographic factors, psychosocial measures, and disease activity markers associated with HRQoL. METHODS: Adult patients newly diagnosed with CD or UC were prospectively enrolled. HRQoL was measured using the Short Form 36 (SF-36) and Norwegian Inflammatory Bowel Disease Questionnaires. Clinical significance was assessed using Cohen's d effect size and further compared with a Norwegian reference population. Associations between HRQoL and symptom scores, demographic factors, psychosocial measures, and disease activity markers were analyzed. RESULTS: Compared with the Norwegian reference population, patients with CD and UC reported significantly lower scores in all SF-36 dimensions, except for physical functioning. Cohen's d effect sizes for men and women in all SF-36 dimensions were at least moderate, except for bodily pain and emotional role for men with UC and physical functioning for both sexes and diagnoses. In the multivariate regression analysis, depression subscale scores ≥ 8 on the Hospital Anxiety and Depression Scale, substantial fatigue, and high symptom scores were associated with reduced HRQoL. CONCLUSION: Patients newly diagnosed with CD and UC reported statistically and clinically significantly lower scores in seven of the eight SF-36 dimensions than the reference population. Symptoms of depression, fatigue, and elevated symptom scores were associated with poorer HRQoL.

Patients with inflammatory bowel disease on immunosuppressive drugs: perspectives' on COVID-19 and health care service during the pandemic.

BACKGROUND AND AIMS: Patients with inflammatory bowel diseases (IBD) have experienced changes to the routine management because of the SARS-CoV-2 pandemic. The aim of this study was to examine patients with IBD's adherence to the restrictions imposed by society and the hospital, worries and concerns regarding medical treatment and clinical follow-up under the pandemic. METHODS: IBD patients (≥18 years) at the outpatient clinic at Oslo University Hospital were included and answered a self-report questionnaire including concerns regarding their disease, medical therapy and follow-up during SARS-CoV-2 pandemic. RESULTS: In total, 522 IBD patients were included, 317 Crohn's disease, 205 ulcerative colitis, 386 patients <50 years. Eighteen percent were in obligatory quarantine, and more often patients <50 years compared to patients ≥50 years. Five patients tested positive to SARS- CoV-2. A higher proportion <50 years reported worries for their medical treatment and risk of COVID -19 disease compared to those ≥50 years. Forty percent avoided family, two-thirds avoided friends, and 4% cancelled their scheduled consultation at the hospital. The hospital changed physical consultation to telephone consultation for 15% of the patients. The preferred follow-up was physical consultation. A higher proportion of the patients <50 years preferred telephone consultation compared to those ≥50 years. Four out of five IBD patients were satisfied with the information about their IBD and COVID-19. CONCLUSIONS: SARS-CoV-2 pandemic affects the daily lives for patients with IBD. It is important to develop evidence-base guidelines in follow-up and treatment, as well as patient information about COVID-19and IBD.

Health-related quality-of-life after radical cystectomy among Norwegian men and women compared to the general population.

Objective: The aim of this study was to assess health-related quality-of-life (HRQoL) in men and women operated on with radical cystectomy, compared to the general Norwegian population.Materials and methods: All patients with bladder cancer who had undergone radical cystectomy (RC) between 2011-2017 and either received ileal conduit (IC) or orthotopic neobladder (ONB) as urinary diversion were included in a cross-sectional study. HRQoL and sociodemographic data was collected and measured with a questionnaire consisting of the generic EORTC QLQ-C30.v3 and the cancer specific EORTC QLQ-BLM30 and compared to a general population sample.Results: Of the 220 invited patients, 173 patients (78.6%) returned the questionnaires. The global quality-of-life (QoL) score was comparable with the general population. Women had significantly higher fatigue score, worse future perspective and symptoms like bloating, compared to male patients. Men had significantly lower social functioning, more constipation, diarrhoea and sleep disturbance compared to the general male population. There was no significant difference in HRQoL domains between female patients and the general female population. A follow-up (FU) period longer than 37 months since surgery was associated with significantly improved physical- and role-functioning, less fatigue and fewer problems with the urostoma, compared to a shorter FU time.Conclusion: This study found a high global QoL score after radical cystectomy, comparable with the general Norwegian population. Symptoms seem to improve over time. Difference in HRQoL outcomes between men and woman in the study population was comparable with the difference found in the general population.

Self-esteem in patients with inflammatory bowel disease.

PURPOSE: The purpose of this study was to explore self-esteem and associations between self-esteem and sociodemographic, clinical, and psychological factors in patients with inflammatory bowel disease (IBD), a disease of chronic relapsing inflammation of the gastrointestinal tract. IBD symptoms, including pain, fatigue, and diarrhea, as well as potential life-long medical treatment and surgery, may be demanding, cause significant challenges, and influence self-esteem. METHODS: In this cross-sectional multicenter study, participants were recruited from nine hospitals in the southeastern and western regions of Norway from March 2013 to April 2014. Data were collected using self-report questionnaires. Self-esteem was assessed by the Rosenberg Self-Esteem Scale, fatigue was assessed by the Fatigue Questionnaire, self-efficacy was assessed by the General Self-Efficacy Scale, and disease activity was assessed by the Simple Clinical Colitis Activity Index for ulcerative colitis (UC) and Harvey Bradshaw Index for Crohn's disease (CD). Multiple linear regression analysis was applied to examine associations between self-esteem and sociodemographic, clinical, and psychological factors. RESULTS: In total, 411 of 452 (91%) patients had evaluable data and were included in this study. The mean scores on self-esteem, self-efficacy, total fatigue, anxiety, and depression were similar between UC patients and CD patients. Male gender, being employed, and higher self-efficacy were independently associated with higher self-esteem, whereas anxiety and depression were independently associated with lower self-esteem. Neither disease activity nor fatigue were associated with self-esteem in the final multiple regression analyses. CONCLUSION: Patient-centered interventions that improve self-esteem and reduce anxiety and depression seem to be important to optimize IBD management.

Validity, Reliability, and Responsiveness of the Brief Pain Inventory in Inflammatory Bowel Disease.

Background and Aims. No patient-reported outcome measures targeting pain have yet been validated for use in IBD patients. Consequently, the aim of this study was to test the psychometrical properties of the brief pain inventory (BPI) in an outpatient population with IBD. Methods. Participants were recruited from nine hospitals in the southeastern and western parts of Norway. Clinical and sociodemographic data were collected, and participants completed the BPI, as well as the Short-Form 36 (SF-36). Results. In total, 410 patients were included. The BPI displayed high correlations with the bodily pain dimension of the SF-36, as well as moderate correlations with disease activity indices. The BPI also displayed excellent internal consistency (Cronbach's alpha value of 0.91, regardless of diagnosis) and good to excellent test-retest values (intraclass correlation coefficient (ICC) 0.84-0.90 and Kappa values > .70). In UC, calculation of responsiveness revealed that only BPI interference in patients reporting improvement reached the threshold of 0.2. In CD, Cohen's d ranged from 0.26 to 0.68. Conclusions. The BPI may serve as an important supplement in patient-reported outcome measurement in IBD. There is need to confirm responsiveness in future studies. Moreover, responsiveness should ideally be investigated using changes in objective markers of inflammation.

Fatigue interference with daily living among patients with inflammatory bowel disease.

PURPOSE: The purpose of the study was to examine fatigue interference with daily living in patients with inflammatory bowel disease (IBD) and to explore relationships between severe fatigue interference and socio-demographic and clinical variables, including use of complementary and alternative medicine (CAM). METHODS: Data were collected using self-report questionnaires from adult IBD outpatients. Fatigue interference was assessed with the 5-item Fatigue Severity Scale, and scores ≥ 5 were defined as severe fatigue interference. CAM use was assessed with the International CAM Questionnaire. Multivariate logistic regression analysis was used to examine associations between severe fatigue interference and socio-demographic factors, clinical factors, and CAM use. RESULTS: In total, 428 patients had evaluable questionnaires (response rate 93 %). Severe fatigue interference was reported by 39 % of the total sample. Patients with Crohn's disease (CD) (n = 238) were more likely than patients with ulcerative colitis (UC) (n = 190) to report severe fatigue interference (43 and 33 %, respectively, p = 0.003). In addition, patients reporting severe fatigue interference were more likely to have active disease than patients without severe fatigue interference (p < 0.001 for both diagnoses). Patients with inactive disease had scores comparable to the general population. Factors independently associated with severe fatigue interference in UC included disease activity and CAM use, while in CD they included disease activity and current smoking. CONCLUSIONS: Severe fatigue interference is common among IBD patients with active disease. Among patients with UC, but not CD, CAM use was associated with severe fatigue interference. The relationship between fatigue interference and personal factors should be considered further in subsequent studies.

Use of complementary and alternative medicine in patients with inflammatory bowel disease: results of a cross-sectional study in Norway.

OBJECTIVE: To determine the proportion of complementary and alternative medicine (CAM) use in patients with inflammatory bowel disease (IBD) and to identify demographic and clinical factors that are associated with CAM use. MATERIAL AND METHODS: In this cross-sectional study design, patients with confirmed diagnosis of ulcerative colitis (UC) or Crohn's disease (CD), and ≥18 years old, attending outpatient clinics at 14 hospitals in Norway were eligible to complete questionnaires including demographics, clinical variables, and the International CAM Questionnaire (I-CAM-Q). RESULTS: Of 460 patients included in the study, 430 had evaluable questionnaires (response rate 93%). Forty-nine percent (95% CI: 44-54) had used some type of CAM within the past 12 months. CAM services were utilized by 27% (95% CI: 23-31) of the patients, 21% (95% CI: 16-23) reported use of CAM products, and 28% (95% CI: 23-31) used CAM self-help practices. The most common pattern of CAM use was to combine CAM services and CAM products. Significantly, more UC patients (56%) than CD patients (44%) reported CAM use, p = 0.03. In UC, only the presence of at least one comorbid condition was directly related to CAM use. In CD, being a woman, being aged 31-50 years, having a higher education level, and experiencing adverse drug reactions from IBD medication were factors independently associated with the use of CAM. CONCLUSION: Use of CAM was common among IBD patients attending outpatient clinics. Both demographic and clinical factors were associated to CAM use, but the factors differed in their significance for UC and CD.

Complementary and alternative medicine in patients with inflammatory bowel disease: the results of a population-based inception cohort study (IBSEN).

BACKGROUND AND AIMS: The use of complementary and alternative medicine (CAM) has been increasing in recent decades. Our aim was to determine the proportion of CAM use among patients with inflammatory bowel disease (IBD) in a longitudinal, population-based cohort and to identify predictive factors for CAM use. METHODS: The Inflammatory Bowel South-Eastern Norway (IBSEN) study is a population-based IBD cohort that has been followed prospectively for 10 years. The ten-year follow-up was conducted from 2000 to 2004 and included a questionnaire regarding CAM, a structured interview, a review of hospital records, a clinical examination, laboratory tests, and an ileocolonoscopy. RESULTS: Of the 620 patients evaluated at the ten-year follow-up, 517 (84%) completed the CAM questionnaire, 353 had ulcerative colitis (UC), 164 had Crohn's disease (CD), and 50% were male. Thirty percent reported the use of CAM at some point since their IBD diagnosis, and 7.5% reported current CAM use. More CD patients than UC patients reported CAM use (38% vs. 27%, respectively; p=0.01). Younger age, female gender, and higher education level predicted CAM use in UC, whereas younger age was the only predictor of CAM use in CD. Thirty-six percent of the CAM users were mostly satisfied or very satisfied with the treatment. CONCLUSION: One third of the patients in this population-based cohort had used CAM at some point during a ten-year disease course, but only 7.5% reported current CAM use. CAM use was more common in the CD than in the UC patients. Only socio-demographic factors, such as age, gender and education, predicted CAM use.