The association between pre-diagnostic levels of psychological distress and adverse effects after radical prostatectomy.

Objectives: To prospectively analyse the associations between pre-diagnostic levels of anxiety and depression and patient-reported urinary and sexual adverse effects after radical prostatectomy in a population-based setting. Patients and Methods: In three Norwegian county hospitals, men referred with a suspicion of prostate cancer were asked to fill out a patient-reported outcome measurement (PROM) questionnaire prior to prostate biopsy. Those who later underwent radical prostatectomy were stratified into three distress groups according to their Hopkins Symptom Checklist 5-score. Additional PROM questionnaires, including the EPIC-26 to measure adverse effects, were collected at 6 and 12 months postoperatively. Multivariable mixed models were estimated and post hoc pairwise comparisons performed to explore differences in adverse effects between distress groups. Results: A total of 416 men were included at baseline and of those, 365 (88%) returned questionnaires at 6 months and 360 (87%) at 12 months. After adjusting for confounders, men with high distress at baseline had worse urinary incontinence domain score (58.9 vs. 66.8, p = 0.028), more urinary bother (64.7 vs. 73.6, p = 0.04) and a higher risk of using incontinence pads (70.6% vs. 54.2%, p = 0.034) at 6 months than those with low distress. There was no difference in the sexual domain scores between distress groups postoperatively, but the high-distress group expressed more sexual bother (24.9 vs. 37.5, p = 0.015) and the intermediate-distress group had a greater probability of using sexual medications or devices (63.8% vs. 50.0%, p = 0.015) than the low-distress group at 6 months. At 12 months scores generally improved slightly and differences between distress groups were less evident. Conclusion: Men with higher levels of anxiety and depression before prostate biopsy report more urinary and sexual adverse effects after radical prostatectomy. This should be considered both in treatment decision-making and during follow-up after radical prostatectomy.

Thyroidectomy for Euthyroid Patients with Hashimoto Disease and Persistent Symptoms: An Observational, Postrandomization Study.

Background: Despite adequate hormone substitution in Hashimoto disease, some patients may have persistent symptoms with a possible autoimmune pathophysiology. A recent randomized trial (RCT) using patient-reported outcome measures as the primary endpoint showed benefit in total thyroidectomy, but at a cost of high complication rates. Objective: To verify results from the RCT in an observational study including a wider range of patients and explore means of predicting who may benefit from such surgery. Design: A total of 154 patients with Hashimoto disease, euthyroid with or without thyroid hormone substitution, and persistent Hashimoto-related symptoms were subjected to total thyroidectomy and followed for 18 months after surgery. The primary outcome was the General Health (GH) dimensional score in the Short Form-36 Health Survey (SF-36). Results: Eighteen months after surgery, a clinically significant improvement in GH was seen, similar to the findings in the previous RCT. Anti-TPO antibody titers were markedly reduced after surgery, but preoperative titers or other preoperative parameters could not predict the outcome of surgery. Three (1.9%) of 154 patients experienced permanent unilateral recurrent nerve palsy and six (3.9%) experienced hypoparathyroidism after surgery. Conclusions: Thyroidectomy had a beneficial symptom-reducing effect in euthyroid patients with Hashimoto disease and persistent symptoms. The pathophysiology of residual symptoms remains unclear, and surgical complication rates are high. If thyroidectomy is considered as a treatment option, it should be performed in dedicated centers with experienced endocrine surgeons and as part of further studies on persistent symptoms. This trial is registered with NCT-02319538.

Coeliac disease in the Trøndelag Health Study (HUNT), Norway, a population-based cohort of coeliac disease patients.

PURPOSE: Coeliac disease (CD) is a common disorder and affects about 1% of the population worldwide. CD in the Trøndelag Health Study (HUNT) is a population-based cohort study which was established to provide new knowledge about CD that can improve the diagnostics and management, prevent the onset or progression and expand the knowledge about the role of genetics of the disease. PARTICIPANTS: The cohort is based on the fourth wave of the population-based HUNT study (HUNT4), Norway, performed during 2017-2019, also including linkage to hospital records and the Norwegian Patient Registry (NPR). A total of 54 541 HUNT4 participants with available sera were screened for CD by serology. All seropositive participants were invited to a clinical assessment, including endoscopy with duodenal biopsies, during 2019-2023. FINDINGS TO DATE: A total of 1107 HUNT4 participants (2%) were seropositive for CD and 1048 were eligible for clinical assessment, including biopsy. Of these, 724 participants attended the clinical assessment and 482 were identified with CD. In addition, 371 participants with CD were identified through the hospital records and NPR. In total, 853 participants in HUNT4 with biopsy-verified CD diagnosis were identified. FUTURE PLANS: All participants in the study will be invited to a follow-up assessment after at least 1 year, including repeated standard serological testing, endoscopy and tissue sampling. The collected data and material will be used to establish the true population-based prevalence of CD. The consequences of CD, including symptoms, deficiencies and comorbidity, will be investigated and possible triggers and predictors, will be studied. With access to serum samples from the previous HUNT surveys in HUNT Biobank, serological signs of CD in prediagnostic samples of seropositive individuals will be used. Genetic studies will identify new CD markers, assess genotype-phenotype links and explore gene-environment correlations. REGISTRATION: clinicaltrials.gov identifier: NCT04041622.

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.

Type and Severity of Mental Illness and Participation in Colorectal Cancer Screening.

INTRODUCTION: The effectiveness of colorectal cancer screening programs depends on the participation rate. This study examined the association between type and severity of mental illness and colorectal cancer screening participation. METHODS: Between 2012 and 2017, a total of 46,919 individuals were invited to sigmoidoscopy screening in Norway, and 70,019 were invited to fecal immunochemical testing. In 2022, logistic regression was used to evaluate the association between the use of antipsychotics, anxiolytics, hypnotics, and antidepressants in the year preceding the screening invitation and screening participation, adjusted for demographic and socioeconomic factors. Defined daily doses of individual drugs were used to assess dose‒response relationships. RESULTS: Overall, 19.2% (24.8% of women, 13.4% of men) of all invitees used at least 1 psychotropic medication. Nonparticipation in the 2 arms combined was associated with the use of anxiolytics (60.7% in users vs 43.2% in nonusers; OR=1.53; 95% CI=1.45, 1.62) and antipsychotics (64.3% vs 43.8%; OR=1.41; 95% CI=1.30, 1.53) and increased with higher doses for both drugs. Hypnotics and antidepressants were only weakly associated with nonparticipation in higher doses. Participation rates were 57.3%, 52.3%, 42.9%, and 35.4% in those prescribed 0, 1, 2, and 3-4 classes of psychotropic medications, respectively. The associations between the use of psychotropic medications and nonparticipation were similar for the 2 screening tests. CONCLUSIONS: These findings show significant disparities in colorectal cancer screening participation for individuals with mental illness, independent of the screening method. Moreover, screening participation varied depending on the type and severity of mental illness. Targeted interventions are warranted to ensure that people with mental illness are supported to access the benefits of colorectal cancer screening.

Characteristics of nonparticipants in a randomised colorectal cancer screening trial comparing sigmoidoscopy and faecal immunochemical testing.

Public health systems should guarantee universal access to health care services, including cancer screening. We assessed whether certain population subgroups were underrepresented among participants in colorectal cancer screening with sigmoidoscopy and faecal immunochemical testing (FIT). Between 2012 and 2019, about 140 000 individuals aged 50 to 74 years were randomly invited to once-only sigmoidoscopy or first round of FIT screening. Our study included 46 919 individuals invited to sigmoidoscopy and 70 019 to FIT between 2012 and 2017. We used logistic regression models to evaluate if demographic and socioeconomic factors and use of certain drugs were associated with participation. Twenty-four thousand one hundred and fifty-nine (51.5%) individuals attended sigmoidoscopy and 40 931 (58.5%) FIT screening. Male gender, young age, low education and income, being retired or unemployed, living alone, being an immigrant, long driving time to screening centre, and use of antidiabetic and psychotropic drugs were associated with low participation in both screening groups. Many of these factors also predicted low acceptance of colonoscopy after positive FIT. While male gender, young age and living alone were more strongly associated with nonparticipation in FIT than sigmoidoscopy, low education and income, being retired or immigrant and long driving time were more strongly associated with nonparticipation in sigmoidoscopy than FIT. In conclusion, participation was lower in sigmoidoscopy than FIT. Predictors of nonparticipation were similar between arms. However, low socioeconomic status, being an immigrant and long driving time affected participation more in sigmoidoscopy screening, suggesting that FIT may guarantee more equal access to screening services than sigmoidoscopy.

Liquid biopsies and patient-reported outcome measures for integrative monitoring of patients with early-stage breast cancer: a study protocol for the longitudinal observational Prospective Breast Cancer Biobanking (PBCB) study.

INTRODUCTION: Breast cancer is still the most common malignancy among women worldwide. The Prospective Breast Cancer Biobank (PBCB) collects blood and urine from patients with breast cancer every 6 or 12 months for 11 years from 2011 to 2030 at two university hospitals in Western Norway. The project aims to identify new biomarkers that enable detection of systemic recurrences at the molecular level. As blood represents the biological interface between the primary tumour, the microenvironment and distant metastases, liquid biopsies represent the ideal medium to monitor the patient's cancer biology for identification of patients at high risk of relapse and for early detection systemic relapse.Including patient-reported outcome measures (PROMs) allows for a vast number of possibilities to compare PROM data with biological information, enabling the study of fatigue and Quality of Life in patients with breast cancer. METHODS AND ANALYSIS: A total of 1455 patients with early-stage breast cancer are enrolled in the PBCB study, which has a one-armed prospective observational design. Participants consent to contribute liquid biopsies (i.e., peripheral blood and urine samples) every 6 or 12 months for 11 years. The liquid biopsies are the basis for detection of circulating tumour cells, circulating tumour DNA (ctDNA), exosomal micro-RNA (miRNA), miRNA in Tumour Educated Platelet and metabolomic profiles. In addition, participants respond to 10 PROM questionnaires collected annually. Moreover, a control group comprising 200 women without cancer aged 25-70 years will provide the same data. ETHICS AND DISSEMINATION: The general research biobank PBCB was approved by the Ministry of Health and Care Services in 2007, by the Regional Ethics Committee (REK) in 2010 (#2010/1957). The PROM (#2011/2161) and the biomarker study PerMoBreCan (#2015/2010) were approved by REK in 2011 and 2015 respectively. Results will be published in international peer reviewed journals. Deidentified data will be accessible on request. TRIAL REGISTRATION NUMBER: NCT04488614.

Comparing the use of patient-reported outcomes in clinical studies in Europe in 2008 and 2018: a literature review.

PURPOSE: Several guidelines for the use of patient-reported outcomes (PROs) in clinical studies have been published in the past decade. This review primarily aimed to compare the number and compliance with selected PRO-specific criteria for reporting of clinical studies in Europe using PROs published in 2008 and 2018. Secondarily, to describe the study designs, PRO instruments used, patient groups studied, and countries where the clinical studies were conducted. METHODS: A literature search was conducted in MEDLINE to identify eligible publications. To assess the number of publications, all abstracts were screened for eligibility by pairs of reviewers. Compliance with PRO-specific criteria and other key characteristics was assessed in a random sample of 150 eligible full-text publications from each year. Randomized controlled trials (RCTs) were assessed according to the full CONSORT-PRO checklist. RESULTS: The search identified 1692 publications in 2008 and 4290 in 2018. After screening of abstracts, 1240 from 2008 and 2869 from 2018 were clinical studies using PROs. By full-text review, the proportion of studies discussing PRO-specific limitations and implications was higher in 2018 than in 2008, but there were no differences in the other selected PRO-specific criteria. In 2018, a higher proportion of studies were longitudinal/cohort studies, included ≥ 300 patients, and used electronic administration of PRO than in 2008. The most common patient groups studied were those with cancer or diseases of the musculoskeletal system or connective tissue. CONCLUSION: The number of clinical studies from Europe using PROs was higher in 2018 than in 2008, but there was little difference in compliance with the PRO-specific criteria. The studies varied in terms of study design and PRO instruments used in both publication years.

Fear of Recurrence in Prostate Cancer Patients: A Cross-sectional Study After Radical Prostatectomy or Active Surveillance.

BACKGROUND: Fear of recurrence (FoR) is a distressing consequence of cancer. Little is known about the prevalence of FoR in different treatment groups and factors associated with FoR among prostate cancer (PCa) survivors. OBJECTIVE: To investigate the prevalence of high FoR among PCa survivors after radical prostatectomy (RP) or under active surveillance (AS) and to explore clinical and psychological factors potentially associated with FoR. DESIGN SETTING AND PARTICIPANTS: This is a retrospective cross-sectional study of 606 patients with PCa, treated with either RP (n = 442) or AS (n = 164) at two Norwegian regional hospitals. The 440 patients (73%) who gave consent to participate were invited in 2017 to complete a questionnaire measuring FoR, self-rated health, adverse effects, and psychological factors at a mean of 4.1 yr (standard deviation 1.7) after their treatment decision. Clinical data were retrieved from medical records. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: FoR was measured using the Concerns About Recurrence Questionnaire, with high FoR defined as a sum score of =12 points (range 0-40). Using multivariable logistic regression analyses, factors associated with high FoR were identified. RESULTS AND LIMITATIONS: One-third of the participants had high FoR; scores were higher in the AS group and in the RP group with treatment failure. Younger age was significantly associated with high FoR in the AS group, while high prostate-specific antigen at diagnosis, biochemical recurrence, positive surgical margin, higher fatigue, and a type D personality were significantly associated with high FoR in the RP group. CONCLUSIONS: At 4 yr after a diagnosis of PCa, high FoR was common, especially among AS patients and among RP patients with treatment failure. PATIENT SUMMARY: In this study, we examined fear that their disease will return or progress among prostate cancer survivors. We found that such fear was common, especially among young patients under active surveillance and among radical prostatectomy patients with treatment failure or with certain psychological features.

Work status and work ability after radical prostatectomy or active surveillance for prostate cancer.

Objective: Being able to work is important for health-related quality of life (HRQoL), and little is known about work life after radical treatment for prostate cancer (PCa). The aim was to investigate work status (WS) and work ability (WA) after radical prostatectomy (RP) or active surveillance (AS) for PCa, and to identify factors associated with reduced WA.Materials and methods: This is a retrospective cross-sectional study of 606 men treated with RP (n = 442) or AS (n = 164) at two Norwegian general hospitals. In 2017, they were asked to complete questionnaires measuring adverse effects (AE), HRQoL, aspects of work life and psychological factors at a median of 4.1 (range 1.3-8.1) years after diagnosis. Clinical data were retrieved from medical records. WS was categorized into employed, unemployed or retired. WA was rated using the Work Ability Index. Regression analyses were performed to find factors associated with reduced WA.Results: WS was similar for the RP and AS groups at diagnosis and survey. There was a small reduction in WA from diagnosis to survey and the difference between the RP and AS groups was non-significant. Older age, poorer self-rated health, poorer incontinence score, more chronic fatigue, and increased anxiety and depressive symptoms were associated with reduced WA, while treatment method, urinary bother and use of pads were not.Conclusion: The impact of RP and AS on WS and WA was almost similar. Age and psychological variables were more strongly associated with reduced WA than cancer-related variables.

Risk of colorectal cancer in a population-based study 20 years after diagnosis of ulcerative colitis: results from the IBSEN study.

Objective: The association between ulcerative colitis (UC) and colorectal cancer (CRC) is widely accepted, although attenuated risk has been reported in recent years. Colonoscopic surveillance is recommended with intervals based on established clinical risk factors. Nevertheless, a significant number of patients develop interval cancers, indicating the need of improved individualised assessment. In the present study, we evaluated clinical risk factors associated with CRC during a prescheduled follow-up 20 years after diagnosis, the IBSEN study. Design: A population-based inception cohort of patients diagnosed with inflammatory bowel disease from 1 January 1990 until 31 December 1993, prospectively followed at 1, 5, 10 and 20 years after diagnosis. A total of 517 patients with UC were included; 264 (51 %) men; median age at inclusion 37.4 years (4-88). Results: The overall incidence of CRC was 1.6% (8/517) at a 20-year follow-up. The total lifetime risk of CRC prior to or after UC diagnosis was 2.3%. (12/517). Patients older than 70 years at diagnosis had a 15-fold higher risk of CRC compared with those diagnosed when younger than 40 years, with HR 15.68 (95% CI: 1.31 to 187.92). Neither sex, first-degree relative with CRC, extent of colitis nor primary sclerosing cholangitis affected the risk of CRC. Conclusion: The risk of CRC in UC was low and comparable with the risk of CRC in the background population of Norway.

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.

Pain Severity and Vitamin D Deficiency in IBD Patients.

Background: Pain and vitamin D deficiency are common in inflammatory bowel disease (IBD). Disease activity, fatigue, frequent relapses, prior surgery and psychological factors all seem to influence the experience of pain in IBD. Vitamin D deficiency has been associated with muscle and skeletal pain. This study aimed to determine whether there is an association between vitamin D deficiency and severity of pain in patients with IBD, and to investigate the influence of other socio-demographic and psychological variables on the experience of pain. Methods: Patients with IBD were recruited from nine hospitals in Norway in a multicenter cross-sectional study. The Brief Pain Inventory (BPI) questionnaire was used to measure pain. Disease activity was assessed using clinical disease activity indices, C-reactive protein (CRP) and fecal calprotectin. Regression models were fitted to explore a possible association between 25-hydroxyvitamin D and pain severity. Results: Of 407 patients included in the analyses, 229 (56%) had Crohn's disease (CD) and 178 (44%) had ulcerative colitis (UC). Vitamin D deficiency was present in half (203/407) of patients. Presence of pain was reported by 76% (309/407). More severe pain was associated with female gender and increased disease activity scores, but not with increased CRP or fecal calprotectin. In CD, patients without prior intra-abdominal surgery reported more severe pain. In multivariate analyses, there was no association between 25-hydroxyvitamin D and pain severity. Conclusions: In this study, no significant association between pain severity and vitamin D deficiency was revealed in patients with IBD.

Thyroidectomy Versus Medical Management for Euthyroid Patients With Hashimoto Disease and Persisting Symptoms: A Randomized Trial.

Background: Hashimoto disease is a chronic autoimmune thyroiditis. Despite adequate hormone substitution, some patients have persistent symptoms that may be the result of immunologic pathophysiology. Objective: To determine whether thyroidectomy improves symptoms in patients with Hashimoto thyroiditis who still have symptoms despite having normal thyroid gland function while receiving medical therapy. Design: Randomized trial. (ClinicalTrials.gov: NCT02319538). Setting: Secondary care hospital in Norway. Patients: 150 patients aged 18 to 79 years with persistent Hashimoto-related symptoms despite euthyroid status while receiving hormone replacement therapy and with serum antithyroid peroxidase (anti-TPO) antibody titers greater than 1000 IU/mL. Intervention: Total thyroidectomy or medical management with hormone substitution to secure euthyroid status in both groups. Measurements: The primary outcome was general health score on the Short Form-36 Health Survey (SF-36) at 18 months. Secondary outcomes were adverse effects of surgery, the other 7 SF-36 subscores, fatigue questionnaire scores, and serum anti-TPO antibody titers at 6, 12, and 18 months. Results: During follow-up, only the surgical group demonstrated improvement: Mean general health score increased from 38 to 64 points, for a between-group difference of 29 points (95% CI, 22 to 35 points) at 18 months. Fatigue score decreased from 23 to 14 points, for a between-group difference of 9.3 points (CI, 7.4 to 11.2 points). Chronic fatigue frequency decreased from 82% to 35%, for a between-group difference of 39 percentage points (CI, 23 to 53 percentage points). Median serum anti-TPO antibody titers decreased from 2232 to 152 IU/mL, for a between-group difference of 1148 IU/mL (CI, 1080 to 1304 IU/mL). In multivariable regression analyses, the adjusted treatment effects remained similar to the unadjusted effects. Limitation: Results are applicable only to a subgroup of patients with Hashimoto disease, and follow-up was limited to 18 months. Conclusion: Total thyroidectomy improved health-related quality of life and fatigue, whereas medical therapy did not. This improvement, along with concomitant elimination of serum anti-TPO antibodies, may elucidate disease mechanisms. Primary Funding Source: Telemark Hospital.

Defining the cut-off point of clinically significant postoperative fatigue in three common fatigue scales.

PURPOSE: Postoperative fatigue (POF) is an often underestimated problem after surgery. Studies on POF often report fatigue scores without relating this to the clinical relevance for the patients. The aim of this study was to define the cut-off point for clinically significant POF in three commonly applied fatigue scales; the Postoperative Fatigue Scale, Christensen's Fatigue Scale, and the Chalder Fatigue Questionnaire. The identification of cut-off points will make it possible to indicate whether statistically significant findings of increased fatigue are of clinical relevance. METHODS: We combined data from day 0 (pre-operatively) and day 1, 3, 6, and 30 after surgery in two fatigue-related studies with 442 patients. In order to define clinically significant fatigue, a key question was added in each questionnaire; "Given your current description of fatigue, would you say it has been of considerable significance to you?"; "Yes/No". We analysed each scale's ability to identify clinically significant fatigue, by performing receiver-operating characteristics (ROC) analyses, and calculated the optimal cut-off point between Sensitivity and Specificity. RESULTS: The average weighted cut-off point for clinically significant POF when measured with the Postoperative Fatigue Scale was ≥ 50 (scale range 0-100), with Christensen's Fatigue Scale ≥ 6 (scale range 1-10) and with the Chalder Fatigue Questionnaire ≥ 16 (scale range 0-33). CONCLUSION: In three commonly used fatigue scales, we have identified cut-off points for clinically significant fatigue among patients recovering from surgery. This can be particularly valuable for diagnostic purposes and in treatment evaluation. Further, it may be possible to analyse and review data from earlier studies in light of clinical relevance.

Fatigue is not associated with vitamin D deficiency in inflammatory bowel disease patients.

AIM: To investigate if vitamin D deficiency is associated with fatigue in patients with inflammatory bowel disease (IBD). METHODS: IBD patients were recruited from nine hospitals in the southeastern and western regions of Norway to participate in a multicenter cross-sectional study lasting from March 2013 to April 2014. Data were collected by interviews, from medical records and laboratory tests. The Fatigue Questionnaire (FQ) was used to measure fatigue. Linear and logistic regression models were applied to explore the possible association between vitamin D deficiency and total fatigue scores and chronic fatigue, respectively. The analyses were adjusted for age, gender, disease activity, depressive symptoms and sleep disturbance. RESULTS: In total, 405 patients were included in the analyses, of which 227 (56%) had Crohn's disease (CD) and 178 (44%) had ulcerative colitis (UC). Vitamin D deficiency (< 50 nmol/L) was present in half (203/405) of the patients. Chronic fatigue was reported by 116 (29%) of all included patients with substantial fatigue reported by 194 (48%). Vitamin D levels were neither associated with total fatigue nor with chronic fatigue. Higher total fatigue scores and chronic fatigue were both associated with increased disease activity scores in patients with UC and CD, but not with increased CRP or fecal calprotectin. In UC patients, female gender was associated with fatigue in the univariate analysis, but no such difference was found when adjusted for elevated disease activity scores. Sleep disturbance and more depressive symptoms were associated with total fatigue scores in both UC and CD patients, but with chronic fatigue only in CD patients. CONCLUSION: In this study, no significant association between fatigue and vitamin D deficiency in IBD patients was revealed.

Changes in health behavior 1 year after testing negative at a colorectal cancer screening: a randomized-controlled study.

When planning national screening programs, it is important to investigate potential changes in health behavior initiated by the screening. Knowledge of the consequences of different colorectal cancer (CRC) screening modalities for health behavior is limited. We aimed to investigate differences in 1-year health behavior changes after testing negative in CRC screening by one of two screening modalities. Participants of both sexes aged 50-74 years assigned randomly to five biennial rounds of fecal immunochemical test (FIT), one round of flexible sigmoidoscopy (FS), or no screening (control) were invited to complete a self-reported lifestyle questionnaire on smoking, body weight, physical activity, alcohol intake, and consumption of selected dietary items at baseline and at 1-year follow-up. In total, 1809 and 1327 individuals in the FIT and the FS arm, respectively, completed the lifestyle questionnaire, as did 1029 controls. We analyzed differences in 1-year health behavior changes between the arms at follow-up by analysis of covariance and logistic regression. Overall, 1-year changes in health behavior were moderate and probably of no clinical relevance. Participants with negative CRC screening test results in the first round of the FIT arm reduced their alcohol consumption significantly more than controls [-0.29 glass/week (95% confidence interval -0.54 to -0.04)]. Body weight decreased more in participants with negative screening test results in the FS than in the FIT arm [-0.31 kg (95% confidence interval -0.55 to -0.08)]. The present study did not suggest unfavorable short-term consequences in the health behavior of individuals who received a negative CRC screening test result from either a first round of FIT or a once-only FS screening.

Acceptability of two colorectal cancer screening tests: pain as a key determinant in sigmoidoscopy.

Background Participants' experience with a screening test can influence adherence, and therefore the efficacy of screening programs. We compared screening with unsedated flexible sigmoidoscopy and fecal immunochemical testing (FIT) for participants' satisfaction with the decision and for willingness to repeat colorectal cancer screening. Methods In a prospective, randomized trial 3257 individuals (50 - 74 years) were invited to either flexible sigmoidoscopy or FIT (1:1), of whom 1650 took up the offer (52.6 %). In total, 1497 screening participants completed at least one questionnaire, either before screening, and/or at three time points in the following year, that measured willingness to repeat screening, willingness to recommend screening, and satisfaction with decision to attend. There were 769 and 728 responders in the flexible sigmoidoscopy and FIT group, respectively. Additionally, 581 flexible sigmoidoscopy participants also completed a pain questionnaire. Results 1 year later, 10 % of the flexible sigmoidoscopy participants were not willing to repeat screening, compared to 5 % of FIT participants. A higher percentage of women compared to men would not repeat flexible sigmoidoscopy screening (adjusted odds ratio [OR] 2.52, 95 % confidence interval [95 %CI] 1.48 to 4.28). Notably, 22 % of women reported pain during flexible sigmoidoscopy compared to 5 % of men. When we added pain to the statistical model, pain was significantly associated with unwillingness to repeat flexible sigmoidoscopy (OR 3.15, 95 %CI 1.68 to 5.87), while gender was no longer associated (OR 1.53, 95 %CI 0.82 to 2.88). Conclusion Acceptability for flexible sigmoidoscopy and for FIT was high among Norwegian screening participants, though FIT participants were more willing to repeat screening. Women were less willing to repeat screening with flexible sigmoidoscopy compared to men. This gender difference seemed partly due to pain, and therefore preventable.This study is registered at ClinicalTrials.gov: NCT01538550.